عن الملكية الفكرية التدريب في مجال الملكية الفكرية إذكاء الاحترام للملكية الفكرية التوعية بالملكية الفكرية الملكية الفكرية لفائدة… الملكية الفكرية و… الملكية الفكرية في… معلومات البراءات والتكنولوجيا معلومات العلامات التجارية معلومات التصاميم الصناعية معلومات المؤشرات الجغرافية معلومات الأصناف النباتية (الأوبوف) القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية مراجع الملكية الفكرية تقارير الملكية الفكرية حماية البراءات حماية العلامات التجارية حماية التصاميم الصناعية حماية المؤشرات الجغرافية حماية الأصناف النباتية (الأوبوف) تسوية المنازعات المتعلقة بالملكية الفكرية حلول الأعمال التجارية لمكاتب الملكية الفكرية دفع ثمن خدمات الملكية الفكرية هيئات صنع القرار والتفاوض التعاون التنموي دعم الابتكار الشراكات بين القطاعين العام والخاص أدوات وخدمات الذكاء الاصطناعي المنظمة العمل مع الويبو المساءلة البراءات العلامات التجارية التصاميم الصناعية المؤشرات الجغرافية حق المؤلف الأسرار التجارية أكاديمية الويبو الندوات وحلقات العمل إنفاذ الملكية الفكرية WIPO ALERT إذكاء الوعي اليوم العالمي للملكية الفكرية مجلة الويبو دراسات حالة وقصص ناجحة في مجال الملكية الفكرية أخبار الملكية الفكرية جوائز الويبو الأعمال الجامعات الشعوب الأصلية الأجهزة القضائية الموارد الوراثية والمعارف التقليدية وأشكال التعبير الثقافي التقليدي الاقتصاد التمويل الأصول غير الملموسة المساواة بين الجنسين الصحة العالمية تغير المناخ سياسة المنافسة أهداف التنمية المستدامة التكنولوجيات الحدودية التطبيقات المحمولة الرياضة السياحة ركن البراءات تحليلات البراءات التصنيف الدولي للبراءات أَردي – البحث لأغراض الابتكار أَردي – البحث لأغراض الابتكار قاعدة البيانات العالمية للعلامات مرصد مدريد قاعدة بيانات المادة 6(ثالثاً) تصنيف نيس تصنيف فيينا قاعدة البيانات العالمية للتصاميم نشرة التصاميم الدولية قاعدة بيانات Hague Express تصنيف لوكارنو قاعدة بيانات Lisbon Express قاعدة البيانات العالمية للعلامات الخاصة بالمؤشرات الجغرافية قاعدة بيانات الأصناف النباتية (PLUTO) قاعدة بيانات الأجناس والأنواع (GENIE) المعاهدات التي تديرها الويبو ويبو لكس - القوانين والمعاهدات والأحكام القضائية المتعلقة بالملكية الفكرية معايير الويبو إحصاءات الملكية الفكرية ويبو بورل (المصطلحات) منشورات الويبو البيانات القطرية الخاصة بالملكية الفكرية مركز الويبو للمعارف الاتجاهات التكنولوجية للويبو مؤشر الابتكار العالمي التقرير العالمي للملكية الفكرية معاهدة التعاون بشأن البراءات – نظام البراءات الدولي ePCT بودابست – نظام الإيداع الدولي للكائنات الدقيقة مدريد – النظام الدولي للعلامات التجارية eMadrid الحماية بموجب المادة 6(ثالثاً) (الشعارات الشرفية، الأعلام، شعارات الدول) لاهاي – النظام الدولي للتصاميم eHague لشبونة – النظام الدولي لتسميات المنشأ والمؤشرات الجغرافية eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange الوساطة التحكيم قرارات الخبراء المنازعات المتعلقة بأسماء الحقول نظام النفاذ المركزي إلى نتائج البحث والفحص (CASE) خدمة النفاذ الرقمي (DAS) WIPO Pay الحساب الجاري لدى الويبو جمعيات الويبو اللجان الدائمة الجدول الزمني للاجتماعات WIPO Webcast وثائق الويبو الرسمية أجندة التنمية المساعدة التقنية مؤسسات التدريب في مجال الملكية الفكرية الدعم المتعلق بكوفيد-19 الاستراتيجيات الوطنية للملكية الفكرية المساعدة في مجالي السياسة والتشريع محور التعاون مراكز دعم التكنولوجيا والابتكار نقل التكنولوجيا برنامج مساعدة المخترعين WIPO GREEN WIPO's PAT-INFORMED اتحاد الكتب الميسّرة اتحاد الويبو للمبدعين WIPO Translate أداة تحويل الكلام إلى نص مساعد التصنيف الدول الأعضاء المراقبون المدير العام الأنشطة بحسب كل وحدة المكاتب الخارجية المناصب الشاغرة المشتريات النتائج والميزانية التقارير المالية الرقابة
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Food and Drug Regulations (C.R.C., c. 870)(version of document current to 2011)، كندا

عودة للخلف
النص مستبدل  الذهاب إلى أحدث إصدار في ويبو لِكس
التفاصيل التفاصيل سنة الإصدار 2011 تواريخ نص صادر : 1 يناير 1978 نوع النص اللوائح التنفيذية الموضوع البراءات، العلامات التجارية، الأسماء التجارية، المعلومات غير المكشوف عنها (الأسرار التجارية)، إنفاذ قوانين الملكية الفكرية والقوانين ذات الصلة، مواضيع أخرى، الملكية الصناعية

المواد المتاحة

النصوص الرئيسية النصوص ذات الصلة
النصوص الرئيسية النصوص الرئيسية بالفرنسية Règlement sur les aliments et les drogues (C.R.C., ch. 870)(version du document à jour en 2011)         بالإنكليزية Food and Drug Regulations (C.R.C., c. 870)(version of document current to 2011)        
 Food and Drug Regulations

Food and Drug Regulations

C.R.C., c. 870

FOOD AND DRUGS ACT

Regulations Respecting Food and Drugs

PART A ADMINISTRATION General A.01.001. These Regulations may be cited as the Food and Drug Regulations.

A.01.002. These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food or drug to which they refer.

A.01.003. [Repealed, SOR/94-289, s. 1]

Interpretation A.01.010. In these Regulations,

“acceptable method” means a method of analysis or examination designated by the Director as acceptable for use in the administration of the Act and these Regulations; (méthode acceptable)

“Act” means the Food and Drugs Act, except in Parts G and J; (Loi)

“common-law partner”, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year; (conjoint de fait)

“cubic centimetre” and its abbreviation “cc.” shall be deemed to be interchangeable with the term “millilitre” and its abbreviation “ml.”; (centimètre cube)

“Director” means the Assistant Deputy Minister, Health Products and Food Branch, of the Department of Health; (Directeur)

“inner label” means the label on or affixed to an immediate container of a food or drug; (étiquette intérieure)

“Lot number” means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution; (numéro de lot)

“manufacturer”[Repealed, SOR/97-12, s. 1]

“manufacturer” or “distributor” means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; (fabricantordistributeur)

“official method” means a method of analysis or examination designated as such by the Director for use in the administration of the Act and these Regulations; (méthode officielle)

“outer label” means the label on or affixed to the outside of a package of a food or drug; (étiquette extérieure)

“principal display panel” has the same meaning as in the Consumer Packaging and Labelling Regulations; (espace principal)

“security package” means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase. (emballage de sécurité)

SOR/84-300, s. 1(F); SOR/85-141, s. 1; SOR/89-455, s. 1; SOR/97-12, s. 1; SOR/2000-353, s. 1; SOR/2001-272, s. 5; SOR/2003-135, s. 1.

A.01.011. The Director shall, upon request, furnish copies of official methods.

A.01.012. The Director shall, upon request, indicate that a method is acceptable or otherwise upon its submission to him for a ruling.

A.01.013. Where a food, drug, vitamin or cosmetic has more than one name, whether proper or common, a reference in these Regulations to the food, drug, vitamin or cosmetic by any of its names is deemed to be a reference to the food, drug or vitamin by all of its names.

A.01.014. When a lot number is required by these Regulations to appear on any article, container, package or label it shall be preceded by one of the following designations:

(a) “Lot number”;

(b) “Lot No.”;

(c) “Lot”; or

(d) “(L)”.

A.01.015. (1) Subject to subsection (2), any statement, information or declaration that is required by these Regulations to appear on the label of any drug shall be in either the French or the English language in addition to any other language.

(2) The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to subparagraph C.01.004(1)(c)(iii) shall be in both the French and English languages if the drug is available for sale without prescription in an open self-selection area.

SOR/85-140, s. 1.

A.01.016. All information required by these Regulations to appear on a label of a food or drug shall be

(a) clearly and prominently displayed on the label; and

(b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

Analysts; Inspectors A.01.020. and A.01.021. [Repealed, SOR/81-935, s. 1]

A.01.022. An inspector shall perform the functions and duties and carry out the responsibilities in respect of foods and drugs prescribed by the Act, and these Regulations.

A.01.023. The authority of an inspector extends to and includes the whole of Canada.

A.01.024. The certificate of designation required pursuant to subsection 22(2) of the Act shall

(a) certify that the person named therein is an inspector for the purpose of the Act; and

(b) be signed by

(i) the Director and the person named in the certificate, in the case of an inspector on the staff of the Department, or

(ii) [Repealed, SOR/2000-184, s. 60]

SOR/80-500, s. 1; SOR/92-626, s. 1; SOR/95-548, s. 5; SOR/2000-184, s. 60.

A.01.025. Where authorized by a regulation made pursuant to the Broadcasting Act, inspectors shall act as representatives of the Canadian Radio-television and Telecommunications Commission for the purpose of enforcing the provisions of regulations made by the Canadian Radio-Television and Telecommunications Commission concerning the advertising of any article to which the Proprietary or Patent Medicine Act or the Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment.

A.01.026. An inspector may, for the proper administration of the Act or these Regulations, take photographs of

(a) any article that is referred to in subsection 23(2) of the Act;

(b) any place where, on reasonable grounds, he believes any article referred to in paragraph (a) is manufactured, prepared, preserved, packaged or stored; and

(c) anything that, on reasonable grounds, he believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any article referred to in paragraph (a).

SOR/90-814, s. 1.

Importations A.01.040. Subject to section A.01.044, no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations.

SOR/92-626, s. 2(F).

A.01.041. An inspector may examine and take samples of any food or drug sought to be imported into Canada.

A.01.042. Where an inspector examines or takes a sample of a food or drug pursuant to section A.01.041, he may submit the food or drug or sample to an analyst for analysis or examination.

A.01.043. Where an inspector, upon examination of a food or drug or sample thereof or on receipt of a report of an analyst of the result of an analysis or examination of the food or drug or sample, is of the opinion that the sale of the food or drug in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer.

SOR/84-300, s. 2(E).

A.01.044. (1) Where a person seeks to import a food or drug into Canada for sale and the sale would constitute a violation of the Act or these Regulations, that person may, if the sale of the food or drug would be in conformity with the Act and these Regulations after its relabelling or modification, import it into Canada on condition that

(a) the person gives to an inspector notice of the proposed importation; and

(b) the food or drug will be relabelled or modified as may be necessary to enable its sale to be lawful in Canada.

(2) No person shall sell a food or drug that has been imported into Canada under subsection (1) unless the food or drug has been relabelled or modified within three months after the importation or within such longer period as may be specified by

(a) in the case of a drug, the Director; or

(b) in the case of food, the Director or the President of the Canadian Food Inspection Agency.

SOR/92-626, s. 3; SOR/95-548, s. 5; SOR/2000-184, s. 61; SOR/2000-317, s. 18.

Exports A.01.045. A certificate referred to in section 37 of the Act shall be signed and issued by the exporter in the form set out in Appendix III.

SOR/80-318, s. 1; SOR/90-814, s. 2.

Sampling A.01.050. When taking a sample of an article pursuant to paragraph 23(1)(a) of the Act, an inspector shall inform the owner thereof or the person from whom the sample is being obtained of the inspector’s intention to submit the sample or a part thereof to an analyst for analysis or examination, and

(a) where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination

(i) divide the quantity into three parts,

(ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample,

(iii) seal each part in such a manner that it cannot be opened without breaking the seal, and

(iv) deliver the part identified as the owner’s portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination; or

(b) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination

(i) identify the entire quantity as the sample,

(ii) seal the sample in such a manner that it cannot be opened without breaking the seal, and

(iii) forward the sample to an analyst for analysis or examination.

SOR/90-814, s. 3.

A.01.051. Where the owner or the person from whom the sample was obtained objects to the procedure followed by an inspector under section A.01.050 at the time the sample was obtained, the inspector shall follow both procedures set out in that section if the owner or the person from whom the sample was obtained supplies him with a sufficient quantity of the article.

Tariff of Fees A.01.060. The cost of analysing a sample other than for the purpose of the Act, for a department of the Government of Canada for the purpose of legal action is $15.

Labelling of Food and Drugs in Pressurized Containers A.01.060.1. In sections A.01.061 and A.01.062,

“flame projection” means the ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (projection de flamme)

“flashback” means that part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (retour de flamme)

“principal display panel”[Repealed, SOR/2000-353, s. 2]

SOR/92-15, s. 1; SOR/2000-353, s. 2; SOR/2001-272, s. 6.

A.01.061. (1) Subject to section A.01.063, in the case of a food or a drug packaged in a disposable metal container designed to release pressurized contents by use of a manually operated valve that forms an integral part of the container, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:

(a) the hazard symbol set out in Column II of item 10 of Schedule II to those Regulations, accompanied by the signal word “CAUTION / ATTENTION”; and

(b) the primary hazard statement “CONTAINER MAY EXPLODE IF HEATED. / CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”.

(2) Subject to section A.01.063, one panel of the inner and outer labels of a food or drug referred to in subsection (1) shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement:

“Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.

Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50 °C.”

(3) The requirements of subsections (1) and (2) do not apply where

(a) in relation to a drug or cosmetic, in the opinion of the Director, or

(b) in relation to a food, in the opinion of the Minister of Consumer and Corporate Affairs,

the design of the container, the materials used in its construction or the incorporation of a safety device eliminate the potential hazard therein.

SOR/81-616, s. 1; SOR/85-1023, s. 1; SOR/92-15, s. 2; SOR/2001-272, s. 7.

A.01.062. (1) Subject to section A.01.063, if a food or drug is packaged in a container described in subsection A.01.061(1) and has a flame projection of a length set out in column I of any of items 1 to 3 of the table to this subsection or a flashback as set out in column I of item 4 of that table, as determined by official method DO-30, Determination of Flame Projection, dated October 15, 1981, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:

(a) the hazard symbol set out in Column II of the same item;

(b) in both official languages, the signal word set out in Column III of the same item; and

(c) in both official languages, the primary hazard statement set out in Column IV of the same item.

TABLE IS NOT DISPLAYED, SEE SOR/81-616, S. 2; SOR/92-15, S. 3

(2) In addition to the requirements of subsection (1), one panel of the inner label and outer labels of a food or drug referred to in that subsection shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement:

“Do not use in presence of open flame or spark.

Ne pas utiliser en présence d’une flamme nue ou d’étincelles.”

SOR/81-616, s. 2; SOR/82-429, s. 1; SOR/85-1023, s. 2; SOR/92-15, s. 3; SOR/2001-272, s. 8.

A.01.063. (1) Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) does not exceed 60 millilitres or 60 grams, the inner label may show only the information described in paragraph A.01.061(1)(a) or paragraphs A.01.062(1)(a) and (b), as the case may be.

(2) Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) exceeds 60 millilitres or 60 grams but does not exceed 120 millilitres or 120 grams, the inner label may show only the information described in subsection A.01.061(1) or subsection A.01.062(1), as the case may be.

(3) Where the labelled net quantity, in a container, of a food or drug referred to in subsection A.01.061(1) or A.01.062(1) is less than 30 mL or 30 g, the hazard symbol shall be of such size as to be capable of being circumscribed by a circle with a diameter of at least 6 mm.

(4) Where a container of a food or drug, described in subsection (1) or (2) is sold in a package, the outer label may show only the information described in subsection A.01.061(2) and, where applicable, subsection A.01.062(2).

SOR/81-616, s. 2; SOR/92-15, s. 4.

A.01.064. [Repealed, SOR/93-243, s. 2]

Security Packaging A.01.065 (1) In this section, “drug for human use” means a drug that is intended for human use, whether the drug is

(a) a mouthwash;

(b) to be inhaled, ingested or inserted into the body; or

(c) for ophthalmic use.

(2) Subject to subsection (3), no person shall sell or import a drug for human use that is packaged and available to the general public in a self-service display, unless the drug is contained in a security package.

(3) Subsection (2) does not apply to lozenges.

(4) Subject to subsection (5), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (2) shall be carried

(a) on the inner label of the package; and

(b) if the security feature is a part of the outer package, on the outer label.

(5) Subsection (4) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate product container.

SOR/85-141, s. 2; SOR/88-323, s. 1; SOR/92-664, s. 1.

Exemptions Application

A.01.066. Sections A.01.067 and A.01.068 do not apply to

(a) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act; or

(b) a drug that is listed or described in Schedule F, other than a drug that is listed or described in Part II of that Schedule and that is

(i) in a form not suitable for human use, or

(ii) labelled in the manner prescribed by paragraph C.01.046(b).

SOR/2007-288, s. 1.

Advertising

A.01.067. A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

SOR/2007-288, s. 1.

Sale

A.01.068. A drug is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

SOR/2007-288, s. 1.

PART B FOODS Division 1 General

B.01.001. (1) In this Part,

“agricultural chemical” means any substance that is used, or represented for use, in or on a food during its production, storage or transport, and whose use results, or may reasonably be expected to result, in a residue, component or derivative of that substance in or on a food and includes any pest control product as defined in subsection 2(1) of the Pest Control Products Act, plant growth regulator, fertilizer or any adjuvant or carrier used with that substance. This definition does not include any

(a) food additive that is listed in, and used in accordance with, the tables to section B.16.100,

(b) nutritive substance that is used, recognized or commonly sold as food or as an ingredient of food,

(c) vitamin, mineral nutrient or amino acid,

(d) essential oil, flavouring preparation, natural extractive, oleoresin, seasoning or spice,

(e) food packaging material or any substance of which that material is composed, or

(f) drug recommended for administration to animals that may be consumed as food; (produit chimique agricole)

“available display surface”, in respect of a prepackaged product, means

(a) the bottom of an ornamental container or the total surface area of both sides of a tag attached to the ornamental container, whichever is greater,

(b) the total surface area of both sides of a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, and

(c) the total surface area of any other package, excluding the bottom if the contents of the package leak out or are damaged when the package is turned over,

but does not include

(d) any area of a package on which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase,

(e) any part of a package that is intended to be destroyed when it is opened, other than a package of a food that is intended to be consumed by one person at a single eating occasion, or

(f) the area occupied by the universal product code; (surface exposée disponible)

“close proximity” means, with reference to the common name, immediately adjacent to the common name without any intervening printed, written or graphic matter; (à proximité)

“common name” means, with reference to a food,

(a) the name of the food printed in boldface type in these Regulations,

(b) the name prescribed by any other regulation, or

(c) if the name of the food is not so printed or prescribed, the name by which the food is generally known; (nom usuel)

“component” means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an ingredient; (constituant)

“daily value” means

(a) in respect of a vitamin or mineral nutrient referred to in the definition “recommended daily intake”, the recommended daily intake for that vitamin or mineral nutrient, and

(b) in respect of a nutrient referred to in the definition “reference standard”, the reference standard for that nutrient; (valeur quotidienne)

“durable life” means the period, commencing on the day on which a prepackaged product is packaged for retail sale, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal wholesomeness, palatability, nutritional value and any other qualities claimed for it by the manufacturer; (durée de conservation)

“durable life date” means the date on which the durable life of a prepackaged product ends; (date limite de conservation)

“energy value” means, in respect of a food, the amount of energy made available to a person’s body when the chemical constituents of the food, including protein, fat, carbohydrate and alcohol, are metabolized following ingestion of the food by the person; (valeur énergétique)

“extended meat product” means a meat product to which a meat product extender has been added; (produit de viande avec allongeur)

“extended poultry product” means a poultry product to which a poultry product extender has been added; (produit de volaille avec allongeur)

“fish product” means fish or prepared fish; (produit de poisson)

“flavouring preparation” includes any food for which a standard is provided in Division 10; (préparation aromatisante)

“food additive” means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include

(a) any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;

(b) vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,

(c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;

(d) agricultural chemicals, other than those listed in the tables to Division 16,

(e) food packaging materials and components thereof; and

(f) drugs recommended for administration to animals that may be consumed as food; (additif alimentaire)

“food colour” means those colours permitted for use in or upon food by Division 6; (colorant alimentaire)

“gelling agent” means gelatin, agar and carrageenan; (agent gélatinisant)

“ingredient” means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product; (ingrédient)

“meal replacement” means a formulated food that, by itself, can replace one or more daily meals; (substitut de repas)

“meat product” means meat, meat by-product, prepared meat or prepared meat by-product; (produit de viande)

“meat product extender” means a food that is a source of protein and that is represented as being for the purpose of extending meat products; (allongeur de produit de viande)

“monounsaturated fatty acids”, “monounsaturated fat”, “monounsaturates” or “monounsaturated” means cis-monounsaturated fatty acids; (acides gras monoinsaturés, graisses monoinsaturées, gras monoinsaturés, lipides monoinsaturésoumonoinsaturés)

“nutritional supplement” means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients; (supplément nutritif)

“nutrition facts table” means the nutrition facts table that is required by subsection B.01.401(1) to be carried on the label of a prepackaged product; (tableau de la valeur nutritive)

“omega-3 polyunsaturated fatty acids”, “omega-3 polyunsaturated fat”, “omega-3 polyunsaturates”, “omega-3 polyunsaturated” or “omega-3” means

(a) 9-cis, 12-cis, 15-cis octadecatrienoic acid or α-linolenic acid,

(b) 8-cis, 11-cis, 14-cis, 17-cis eicosatetraenoic acid,

(c) 5-cis, 8-cis, 11-cis, 14-cis, 17-cis eicosapentaenoic acid or EPA,

(d) 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosapentaenoic acid, or

(e) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosahexaenoic acid or DHA; (acides gras polyinsaturés oméga-3, graisses polyinsaturées oméga-3, gras polyinsaturés oméga-3, lipides polyinsaturés oméga-3, polyinsaturés oméga-3ouoméga-3)

“omega-6 polyunsaturated fatty acids”, “omega-6 polyunsaturated fat”, “omega-6 polyunsaturates”, “omega-6 polyunsaturated” or “omega-6” means

(a) 9-cis, 12-cis octadecadienoic acid or linoleic acid,

(b) 6-cis, 9-cis, 12-cis octadecatrienoic acid,

(c) 8-cis, 11-cis, 14-cis eicosatrienoic acid or di-homo-γ-linolenic acid,

(d) 5-cis, 8-cis, 11-cis, 14-cis eicosatetraenoic acid or arachidonic acid,

(e) 7-cis, 10-cis, 13-cis, 16-cis docosatetraenoic acid, or

(f) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis docosapentaenoic acid; (acides gras polyinsaturés oméga­ 6, graisses polyinsaturées oméga-6, gras polyinsaturés oméga-6, lipides polyinsaturés oméga­ 6, polyinsaturés oméga-6ouoméga-6)

“ornamental container” means a container that, except on the bottom, does not have any promotional or advertising material thereon, other than a trade mark or common name and that, because of any design appearing on its surface or because of its shape or texture, appears to be a decorative ornament and is sold as a decorative ornament in addition to being sold as the container of a product; (emballage décoratif)

“overage” means the amount of a vitamin or mineral nutrient that is, within the limits of good manufacturing practice, added to a food in excess of the amount declared on the label, in order to ensure that the amount of the vitamin or mineral nutrient declared on the label is maintained throughout the durable life of the food; (surtitrage)

“parts per million”[Repealed, SOR/2010-94, s. 1]

“parts per million” or “p.p.m.” means parts per million by weight unless otherwise stated; (parties par millionoup.p.m.)

“per cent” or “%” means per cent by weight, unless otherwise stated; (pour cent)

“polyunsaturated fatty acids”, “polyunsaturated fat”, “polyunsaturates” or “polyunsaturated” means cis-methylene interrupted polyunsaturated fatty acids; (acides gras polyinsaturés, graisses polyinsaturées, gras polyinsaturés, lipides polyinsaturésoupolyinsaturés)

“poultry product” means poultry meat, prepared poultry meat, poultry meat by-product or prepared poultry meat by-product; (produit de volaille)

“poultry product extender” means a food that is a source of protein and that is represented as being for the purpose of extending poultry products; (allongeur de produit de volaille)

“prepackaged meal” means a prepackaged selection of foods for one individual that requires no preparation other than heating and that contains at least one serving, as described in Canada’s Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of

(a) meat, fish, poultry, legumes, nuts, seeds, eggs or milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet; and

(b) vegetables, fruit or grain products; (repas préemballé)

“prepackaged product” means any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person; (produit préemballé)

“principal display panel” means, despite the meaning assigned to that term in section A.01.010,

(a) in the case of a label applied to a prepackaged product that is subject to the Consumer Packaging and Labelling Act the principal display panel as defined in the Consumer Packaging and Labelling Regulations,

(b) in the case of a label applied to a prepackaged product that is not subject to the Consumer Packaging and Labelling Act, that part of the label applied to all or part of the side or surface of the container that is displayed or visible under normal or customary conditions of sale or use, and where the container does not have such a side or surface, that part of the label applied to any part of the container, except the bottom, if any, and

(c) in the case of a label applied to a food that is not a prepackaged product, that part of the label applied to all or part of the side or surface of the food that is displayed or visible under normal or customary conditions of sale or use; (espace principal)

“reasonable daily intake”, in respect of a food set out in Column I of an item of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne raisonnable)

“recommended daily intake”, in respect of a vitamin or mineral nutrient set out in column I of Table I to Division 1 of Part D or in column I of Table I to Division 2 of Part D, means

(a) in the case of a prepackaged product intended solely for children under two years of age, the quantity set out in column III, and

(b) in any other case, the quantity set out in column II; (apport quotidien recommandé)

“reference amount”, in respect of a food set out in column 1 of Schedule M, means the amount of that food set out in column 2; (quantité de référence)

“reference standard”, in respect of a nutrient set out in column 1 of the table to section B.01.001.1, means the amount set out in column 2; (norme de référence)

“saturated fatty acids”, “saturated fat”, “saturates” or “saturated” means all fatty acids that contain no double bonds; (acides gras saturés, graisses saturées, gras saturés, lipides saturésousaturés)

“simulated meat product” means any food that does not contain any meat product, poultry product or fish product but that has the appearance of a meat product; (simili-produit de viande)

“simulated poultry product” means any food that does not contain any poultry product, meat product or fish product but that has the appearance of a poultry product; (simili-produit de volaille)

“sugars” means all monosaccharides and disaccharides; (sucres)

“sweetener” means any food additive listed as a sweetener in Table IX to section B.16.100; (édulcorant)

“sweetening agent” includes any food for which a standard is provided in Division 18, but does not include those food additives listed in the tables to Division 16; (agent édulcorant)

“trans fatty acids”, “trans fat” or “trans” means unsaturated fatty acids that contain one or more isolated or non-conjugated double bonds in a trans-configuration; (acides gras trans, graisses trans, gras trans, lipides transoutrans)

“unstandardized food” means any food for which a standard is not prescribed in this Part; (aliment non normalisé)

“weighted recommended nutrient intake”, in respect of a vitamin or mineral nutrient set out in column I of Table II to Division 1 of Part D or in column I of Table II to Division 2 of Part D, means the amount set out in column III; (apport nutritionnel recommandé pondéré)

“yolk-replaced egg” means a food that

(a) does not contain egg yolk but contains fluid, dried or frozen egg albumen or mixtures thereof,

(b) is intended as a substitute for whole egg, and

(c) meets the requirements of section B.22.032. (oeuf à jaune substitué)

(2) The definitions in this subsection apply for the purposes of the Act.

“agricultural chemical” has the same meaning as in subsection (1). (produit chimique agricole)

“food additive” has the same meaning as in subsection (1). (additif alimentaire)

SOR/78-403, s. 1(F); SOR/79-23, s. 1; SOR/81-83, s. 1; SOR/81-617, s. 1; SOR/88-336, s. 1; SOR/88-559, s. 1; SOR/89-175, s. 1; SOR/91-124, s. 1; SOR/91-527, s. 1; SOR/93-276, s. 1; SOR/95-474, s. 1; SOR/98-580, s. 1(F); SOR/2000-353, s. 3; SOR/2003-11, s. 1; err.(E), Vol. 137, No. 5; SOR/2005-98, s. 1; SOR/2008-181, s. 1; SOR/2008-182, s. 1; SOR/2010-94, s. 1. Previous Version B.01.001.1 (1) In this section, “fat” means all fatty acids expressed as triglycerides.

(2) The reference standard for a nutrient set out in column 1 of the table to this section is the amount set out in column 2.

TABLE

REFERENCE STANDARDS

Column 1 Column 2 Item Nutrient Amount 1. Fat 65 g 2. The sum of saturated fatty acids and trans fatty acids 20 g 3. Cholesterol 300 mg 4. Carbohydrate 300 g 5. Fibre 25 g 6. Sodium 2400 mg 7. Potassium 3500 mg

SOR/2003-11, s. 2.

B.01.002. Each provision in this Part in which the symbol [S] appears between the provision number and the name of the food described in that provision prescribes the standard of composition, strength, potency, purity, quality or other property of that food and a provision in which the symbol does not appear does not prescribe a standard for a food.

SOR/79-752, s. 1.

B.01.002A. (1) For the purposes of this Part, a serving of stated size of a food shall be

(a) based on the food as offered for sale; and

(b) expressed

(i) in grams, if

(A) the net quantity of the food is declared on the label by weight or by count, or

(B) the food is set out in column 1 of item 78, 149 or 150 of Schedule M, and

(ii) in millilitres, if the net quantity of the food is declared on the label by volume, except in the case of a food referred to in clause (i)(B).

(2) A serving of stated size shall be the net quantity of the food in the package if

(a) the quantity of food can reasonably be consumed by one person at a single eating occasion;

(b) the reference amount of the food is less than 100 g or 100 mL and the package contains less than 200% of that reference amount; or

(c) the reference amount of the food is 100 g or 100 mL or more and the package contains 150% or less of that reference amount.

SOR/88-559, s. 2; SOR/2003-11, s. 3.

B.01.003. (1) The following foods shall carry a label when offered for sale:

(a) all prepackaged products other than

(i) prepackaged confections, commonly known as one bite confections, that are sold individually, and

(ii) prepackaged products consisting of fresh fruits or fresh vegetables that are packaged in a wrapper or confining band of less than 1/2 inch in width;

(b) meat and meat by-products that are barbecued, roasted or broiled on the retail premises;

(c) poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;

(d) horse-meat or horse-meat by-product;

(e) any substance or mixture of substances for use as a food additive or food additive preparation; and

(f) flour and whole wheat flour that has been treated with gamma radiation from Cobalt 60 Source.

(2) [Repealed, SOR/79-23, s. 2]

SOR/79-23, s. 2.

B.01.004. (1) All or part of the label referred to in section B.01.003 shall be applied

(a) in the case of a prepackaged product, to the container in which the prepackaged product is sold; and

(b) in the case of a food that is not a prepackaged product, to the food itself.

(2) The label shall be applied in such a manner that the container of the prepackaged product or the food, as the case may be, will bear the label at the time it is sold.

SOR/84-300, s. 3.

B.01.005. (1) Subject to subsections (2) to (5), the information required to be shown on a label shall not be shown on that part of the label, if any, that is applied to the bottom of a food or container.

(2) The information required to be shown on a label may be shown on that part of the label, if any, that is applied to the bottom of a food or to the bottom of a container if such information is also shown in those parts of the label that are not applied to the bottom of the food or container.

(3) Notwithstanding subsection (2), where the container of a prepackaged product is an ornamental container and the label is applied to the bottom of the container, the information required to be shown may be shown on the label that is applied to the bottom of the container.

(4) Notwithstanding subsection (2), the information required by subparagraph B.01.007(1.1)(b)(i) or paragraph B.24.103(g) or B.25.057(1)(f) or (2)(f) may be shown on that part of the label that is applied to the bottom of the package if a clear indication of the location of the required information appears elsewhere on the label.

(5) Notwithstanding subsection (2), the nutrition facts table may be shown on that part of the label that is applied to the bottom of the food or container if the available display surface includes the bottom.

SOR/79-529, s. 1; SOR/92-626, s. 4; SOR/2003-11, s. 4.

B.01.006. (1) The common name of the food shall be shown on the principal display panel.

(2) Notwithstanding subsection (1), the common name of a fresh fruit or fresh vegetable that is prepackaged in such a manner that the fruit or vegetable is visible and identifiable in the package is not required to be shown on the label.

SOR/79-23, s. 3; SOR/92-626, s. 5.

B.01.007. (1) In this section, “packaging date” means

(a) the date on which a food is placed for the first time in a package in which it will be offered for sale to a consumer; or

(b) the date on which a prepackaged product is weighed by a retailer in a package in which it will be offered for sale for the first time to a consumer.

(1.1) The following information shall be shown on any part of the label:

(a) the identity and principal place of business of the person by or for whom the food was manufactured or produced;

(b) where a prepackaged product having a durable life of 90 days or less is packaged at a place other than the retail premises from which it is to be sold,

(i) the durable life date, and

(ii) instructions for the proper storage of the prepackaged product if it requires storage conditions that differ from normal room temperature; and

(c) where a prepackaged product having a durable life of 90 days or less is packaged on the retail premises from which it is to be sold,

(i) the packaging date, and

(ii) the durable life of the food, except when the durable life appears on a poster next to the food.

(1.2) The packaging date referred to in paragraph (1.1)(c) shall be shown in the form and manner prescribed for the durable life date by subsections (4) and (5) and the terms “best before” and “meilleur avant” on the label shall be replaced by the terms “packaged on” and “empaqueté le”.

(2) Paragraph (1.1)(a) does not apply to fresh fruits or fresh vegetables that are prepackaged on retail premises in such a manner that the fruits or vegetables are visible and identifiable in the package.

(3) Paragraphs (1.1)(b) and (c) do not apply to

(a) prepackaged products consisting of fresh fruits or fresh vegetables;

(b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;

(c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens; or

(d) prepackaged donuts.

(4) The durable life date shall be shown in the following manner:

(a) the words “best before” and “meilleur avant” shall be shown grouped together with the durable life date unless a clear explanation of the significance of the durable life date appears elsewhere on the label;

(b) where, for the sake of clarity, it is necessary to show the year in which the durable life date occurs, the year shall be shown first and shall be expressed by at least the last two numbers of the year;

(c) the month shall be shown in words after the year, if the year is shown, and may be abbreviated as prescribed by subsection (5); and

(d) the day of the month shall be shown after the month and shall be expressed in numbers.

(5) The month of the durable life date, when abbreviated, shall be abbreviated as follows and only one such abbreviation shall be used for the English language and the French language:

JA for JANUARY JL for JULY FE for FEBRUARY AU for AUGUST MR for MARCH SE for SEPTEMBER AL for APRIL OC for OCTOBER

MA for MAY NO for NOVEMBER JN for JUNE DE for DECEMBER

(6) Except as otherwise provided in these Regulations, no person shall use a durable life date marking system on the label of a prepackaged product or in advertising a prepackaged product other than the marking system set out in this section.

(7) Paragraph (1.1)(b) does not apply to prepackaged fresh yeast, if

(a) the date on which it is estimated that the product has lost its effectiveness is shown on the label in the form and manner prescribed for the durable life date by subsections (4) and (5); and

(b) the terms “best before” and “meilleur avant” are replaced by the terms “use by” and “employez avant”.

SOR/79-23, s. 4; SOR/79-529, s. 2; SOR/88-291, s. 1; SOR/92-626, s. 6.

B.01.008. (1) The following information shall be shown grouped together on any part of the label:

(a) any information required by these Regulations, other than the information required to appear on the principal display panel or the nutrition facts table and the information required by sections B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 and B.01.601; and

(b) where a prepackaged product consists of more than one ingredient, a list of all ingredients, including, subject to section B.01.009, components, if any.

(2) Paragraph (1)(b) does not apply to

(a) prepackaged products packaged from bulk on retail premises, except prepackaged products that are a mixture of nuts;

(b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;

(c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens;

(d) prepackaged meat and meat by-products that are barbecued, roasted or broiled on the retail premises;

(e) prepackaged poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;

(f) Bourbon whisky and prepackaged products subject to compositional standards in Division 2; or

(g) prepackaged products subject to compositional standards in Division 19.

(3) Ingredients shall be shown in descending order of their proportion of the prepackaged product or as a percentage of the prepackaged product and the order or percentage shall be the order or percentage of the ingredients before they are combined to form the prepackaged product.

(4) Notwithstanding subsection (3), the following ingredients may be shown at the end of the list of ingredients in any order:

(a) spices, seasonings and herbs, except salt;

(b) natural and artificial flavours;

(c) flavour enhancers;

(d) food additives, except ingredients of food additive preparations or mixtures of substances for use as a food additive;

(e) vitamins;

(f) salts or derivatives of vitamins;

(g) mineral nutrients; and

(h) salts of mineral nutrients.

(5) Components shall be shown

(a) immediately after the ingredient of which they are components in such a manner as to indicate that they are components of that ingredient; and

(b) in descending order of their proportion of the ingredient.

(6) Notwithstanding paragraph (1)(b) and subsection (5), but subject to section B.01.009, where one or more components of an ingredient are required by these Regulations to be shown in the list of ingredients on the label of a prepackaged product, the ingredient that contains the components is not required to be shown in the list if all components of that ingredient are listed by their common names with the other ingredients of the product

(a) in descending order of their proportion of the product, or

(b) as a percentage of the product,

the order or percentage, as the case may be, being based

(c) in the case of components, on the total amount of each of the components before they are combined to form ingredients in the product; and

(d) in the case of ingredients, on the amount of each of the ingredients before they are combined to form the product.

(7) Notwithstanding paragraph (1)(b), wax coating compounds and their components are not required to be shown on the label of a prepackaged fresh fruit or fresh vegetable as an ingredient or component thereof.

(8) Notwithstanding paragraph (1)(b), sausage casings are not required to be shown on the label of prepackaged sausages as an ingredient or component thereof.

(9) Notwithstanding paragraph (1)(b), hydrogen, when used for hydrogenation purposes, is not required to be shown on the label of any prepackaged product as an ingredient or component thereof.

(10) Notwithstanding paragraph (1)(b), components of ingredients of a sandwich made with bread are not required to be shown in the list of ingredients on the label of the sandwich.

SOR/79-23, s. 5; SOR/88-559, s. 3; SOR/92-626, s. 7; SOR/93-145, s. 1; SOR/2003-11, s. 5.

B.01.009. (1) Components of ingredients or of classes of ingredients set out in the following table are not required to be shown on a label:

TABLE

Item Ingredient 1. butter 2. margarine 3. shortening 4. lard 5. leaf lard 6. monoglycerides 7. diglycerides 8. rice 9. starches or modified starches 10. breads subject to compositional standards in sections B.13.021 to B.13.029 11. flour 12. soy flour 13. graham flour 14. whole wheat flour 15. baking powder 16. milks subject to compositional standards in sections B.08.003 to B.08.027 17. chewing gumbase 18. sweetening agents subject to compositional standards in sections B.18.001 to B.18.018 19. cocoa, low-fat cocoa 20. salt 21. vinegars subject to compositional standards in sections B.19.003 to B.19.007

Bourbon whisky and alcoholic beverages subject to compositional standards in22. sections B.02.001 to B.02.134 cheese for which a standard is prescribed in Division 8, if the total amount of cheese in a23. prepackaged product is less than 10 per cent of that packaged product jams, marmalades and jellies subject to compositional standards in sections B.11.201 to

24. B.11.241 when the total amount of those ingredients is less than 5 per cent of a prepackaged product olives, pickles, relish and horse-radish when the total amount of those ingredients is less25. than 10 per cent of a prepackaged product one or more vegetable or animal fats or oils for which a standard is prescribed in Division 9, and hydrogenated, modified or interesterified vegetable or animal fats or oils,26. if the total of those fats and oils as are contained in a prepackaged product is less than 15 per cent of that prepackaged product

27. prepared or preserved meat, fish, poultry meat, meat by-product or poultry by-product

Item Ingredient when the total amount of those ingredients is less than 10 per cent of a prepackaged product that consists of an unstandardized food alimentary paste that does not contain egg in any form or any flour other than wheat28. flour

29. bacterial culture 30. hydrolysed plant protein 31. carbonated water 32. whey, whey powder, concentrated whey, whey butter and whey butter oil 33. mould culture 34. chlorinated water and fluorinated water 35. gelatin 36. toasted wheat crumbs used in or as a binder, filler or breading in or on a food product

(2) Subject to subsection (3), where a preparation or mixture set out in the table to this subsection is added to a food, the ingredients and components of the preparation or mixture are not required to be shown on the label of that food.

TABLE

Item Preparation/Mixture 1. food colour preparations 2. flavouring preparations 3. artificial flavouring preparations 4. spice mixtures 5. seasoning or herb mixtures 6. vitamin preparations 7. mineral preparations 8. food additive preparations 9. rennet preparations 10. food flavour-enhancer preparations 11. compressed, dry, active or instant yeast preparations

(3) Where a preparation or mixture set out in the table to subsection (2) is added to a food, and the preparation or mixture contains one or more of the following ingredients or components, those ingredients or components shall be shown by their common names in the list of the ingredients of the food to which they are added as if they were ingredients of that food:

(a) salt;

(b) glutamic acid or its salts;

(c) hydrolysed plant protein;

(d) aspartame;

(e) potassium chloride; and

(f) any ingredient or component that performs a function in, or has any effect on, that food.

(4) Notwithstanding subsections (1) and (2), where any of the following components is contained in an ingredient set out in the tables to those subsections, that component shall be shown in the list of ingredients:

(a) peanut oil;

(b) hydrogenated or partially hydrogenated peanut oil; and

(c) modified peanut oil.

(5) Notwithstanding subsection B.01.008(10) and item 23 of the table to subsection (1), if lysozyme from egg-white is added to a food described in section B.08.033 or B.08.034, the label of the food shall show “lysozyme from egg-white" in the list of ingredients in the same manner that is required in subsection B.01.008(4) or (5), as applicable.

SOR/78-728, s. 1; SOR/79-23, s. 6; SOR/79-662, s. 1; SOR/88-559, s. 4; SOR/92-626, s. 8; SOR/93-145, s. 2; SOR/93-465, s. 1; SOR/95-548, s. 5(F); SOR/97-263, s. 1; SOR/2000-417, s. 1; SOR/2010-143, s. 39(E). Previous Version B.01.010. (1) In this section, “common name” includes a name set out in Column II of the tables to subsection (3).

(2) An ingredient or component shall be shown in the list of ingredients by its common name.

(3) For the purposes of subsection (2),

(a) the ingredient or component set out in Column I of an item of the following table shall be shown in the list of ingredients by the common name set out in Column II of that item:

TABLE

Column I Column II Item Ingredient or Component Common Name

the name of the meat from which theany oil, fat or tallow described in section1. oil, fat or tallow is obtained plus oil, fatB.09.002 of Division 9, except lard, leaf or suet or tallow shortening or margarine containing fats or oils, shortening or margarine modified by except shortening or margarine containing vegetable oil or marine oil or by the2. coconut oil, palm oil, palm kernel oil, peanut common name of the vegetable, animal oil or cocoa butter or marine oil or fat used shortening or margarine containing coconut oil, shortening or margarine modified by the

3. palm oil, palm kernel oil, peanut oil or cocoa common name of the vegetable oil or fat butter used

4. meat the name of the meat 5. poultry meat the name of the poultry 6. fish the name of the fish

the name of the plant plus protein7. plant protein product product 8. hydrolyzed plant protein produced by the hydrolyzed plus the name of the plant

Column I Item Ingredient or Component

enzymatic process

9. any protein isolate

any meat by-product described in section10. B.14.003, other than gelatin

any poultry meat by-product described in11. section B.22.003

any oil or fat referred to in section B.09.002 that has been hydrogenated or partially12. hydrogenated, including tallow, but not including lard any oil or fat referred to in section B.09.002 of Division 9, including tallow, that has been13. modified by the complete or partial removal of a fatty acid one or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut14. oil or cocoa butter, that have been hydrogenated or partially hydrogenated coconut oil, palm oil, palm kernel oil, peanut

15. oil or cocoa butter that has been hydrogenated or partially hydrogenated

one or more marine fats or oils that have been16. hydrogenated or partially hydrogenated

one or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut17. oil or cocoa butter, that have been modified by the complete or partial removal of a fatty acid coconut oil, palm oil, palm kernel oil, peanut

18. oil or cocoa butter that has been modified by the complete or partial removal of a fatty acid one or more marine fats or oils that have been

19. modified by the complete or partial removal of a fatty acid

Column II Common Name plus protein the name of the source of the protein plus protein or the common name of the protein isolate the name of the meat plus by-product or the name of the meat plus the name of the meat by-product the name of the poultry plus by-product or the name of the poultry plus the name of the poultry meat by-product

“hydrogenated” plus the name of the meat from which the oil, fat or tallow is obtained, plus oil, fat or tallow

modified plus the name of the meat from which the oil, fat or tallow is obtained, plus oil, fat or tallow

hydrogenated vegetable oil or hydrogenated vegetable fat or hydrogenated plus the specific name of the oil or fat

hydrogenated plus the specific name of the oil or fat

hydrogenated marine oil or hydrogenated marine fat or hydrogenated plus the specific name of the oil or fat

modified vegetable oil or modified vegetable fat or modified plus the specific name of the oil or fat

modified plus the specific name of the oil or fat

modified marine oil or modified plus the specific name of the oil or fat

(b) except when one of the ingredients or components set out in column I of the table to this paragraph is shown separately in the list of ingredients by its common name, all of the ingredients or components present in a food set out in column I of an item of that table may be shown collectively in the list of ingredients by the common name set out in column II of that item:

TABLE

Column I Column II Item Ingredient or Component Common Name

one or more vegetable fats or oils, except coconut oil, palm oil,1. palm kernel oil, peanut oil or cocoa butter 2. one or more marine fats or oils

one or more of the colours listed in Table III of Division 16, 3. except annatto where used in accordance with paragraph

B.14.031(i) or subparagraph B.14.032(d)(xvi) one or more substances prepared for their flavouring properties and produced from animal or vegetable raw materials or from4. food constituents derived solely from animal or vegetable raw materials one or more substances prepared for their flavouring properties

5. and derived in whole or in part from components obtained by chemical synthesis

6. one or more spices, seasonings or herbs except salt

any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, butter, buttermilk, butter oil, milk fat, cream, milk, partly skimmed milk, skim milk and any other7. component of milk the chemical composition of which has not been altered and that exists in the food in the same chemical state in which it is found in milk any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, calcium-reduced skim milk (obtained by the ion-exchange process), casein, caseinates, cultured milk

7.1 products, milk serum proteins, ultrafiltered milk, whey, whey butter, whey cream and any other component of milk the chemical state of which has been altered from that in which it is found in milk one or more ingredients or components set out in item 7 combined

7.2 with any one or more ingredients or components set out in item 7.1 any combination of disodium phosphate, monosodium phosphate,

8. sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate

9. one or more species of bacteria

10. one or more species of mould

11. preparation containing rennin milk coagulating enzymes from Aspergillus oryzae RET-1 (pBoel777), Endothia parasitica, Rhizomucor miehei (Cooney and12. Emerson) (previous name: Mucor miehei (Cooney and Emerson))or Mucor pusillus Lindt

13. one or more substances the function of which is to impart flavour

vegetable oil or vegetable fat marine oil

colour

flavour

artificial flavour, imitation flavour or simulated flavour spices, seasonings or herbs

milk ingredients

modified milk ingredients

modified milk ingredients

sodium phosphate or sodium phosphates

bacterial culture mold culture or mould culture rennet

microbial enzyme

the name of the plant

Column I Column II Item Ingredient or Component Common Name

and that are obtained solely from the plant or animal source after or animal source plus which the flavour is named the word “flavour” toasted wheat crumbs made by cooking a dough prepared with flour and water, which may be unleavened or chemically or yeast14. toasted wheat crumbsleavened, and which otherwise complies with the standard prescribed by section B.13.021 or B.13.022 that portion of chewing gum, other than the coating, that does not15. gum baseimpart sweetness, flavour or colour sugar, liquid sugar, invert sugar or liquid invert sugar, singly or in16. sugarcombination glucose syrups and isomerized glucose syrups, singly or in

17. combination, where the fructose fraction does not exceed 60 per glucose-fructose cent of the sweetener on a dry basis glucose syrups and isomerized glucose syrups, singly or in

18. combination, where the fructose fraction exceeds 60 per cent of fructose syrup the sweetener on a dry basis

sugar/glucose­19. sugar or glucose-fructose, singly or in combination fructose 20. water to which carbon dioxide is added carbonated water

one or more of the following food additives, namely, potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium sulphiting agents or21. metabisulphite, sodium sulphite, sodium dithionite, sulphurous sulphites acid and sulphur dioxide demineralized water or water otherwise treated to remove22. waterhardness or impurities, or fluoridated or chlorinated water wine vinegar, spirit vinegar, alcohol vinegar, white vinegar, grain

23. vinegar, malt vinegar, cider vinegar or apple vinegar, singly or in vinegar combination

(4) Notwithstanding subsection (2) and subsection B.01.008(5), where a food contains ingredients of the same class, those ingredients may be shown by a class name if

(a) they consist of more than one component and are not listed in the table to subsection B.01.009(1); and

(b) their components are shown

(i) immediately after the class name of the ingredients of which they are components, in such a manner as to indicate that they are components of the ingredients, and

(ii) in descending order of their collective proportion of those ingredients.

SOR/79-23, ss. 7, 8(F); SOR/79-529, s. 3; SOR/80-632, s. 1; SOR/84-300, ss. 4(E), 5(F); SOR/91-124, s. 2; SOR/92-626, s. 9; SOR/92-725, s. 1; SOR/93-243, s. 2(F); SOR/93-465, s. 2; SOR/95-548, s. 5(F); SOR/97-516, s. 1; SOR/98-458, ss. 1, 7(F); SOR/2005-98, s. 7; SOR/2007-302, s. 4(F). Previous Version

B.01.011. (1) Where it is an acceptable manufacturing practice for a manufacturer to

(a) omit from his prepackaged product any food that is ordinarily an ingredient or component, or

(b) substitute in whole or in part in his prepackaged product any other food for a food that is ordinarily an ingredient or component,

the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show as ingredients or components the foods that may be omitted and the foods that may be used as substitutes if

(c) all the foods that may be used as ingredients or components throughout the 12-month period are shown in the list of ingredients;

(d) it is clearly stated as part of the list of ingredients that the food shown as an ingredient or component may not be present or that another food may be substituted for a food shown as an ingredient or component; and

(e) the foods that may be omitted or substituted are grouped with the same class of foods that are used as ingredients or components and the foods within each such group are listed in descending order of the proportion in which they will probably be used during the 12-month period.

(2) Where it is an acceptable manufacturing practice for a manufacturer to vary the proportions of ingredients or components of his prepackaged product, the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show the ingredients or components in the same proportions throughout the 12­ month period if

(a) it is clearly stated as part of the list of ingredients that the proportions indicated are subject to change; and

(b) the ingredients or components are listed in descending order of the proportion in which they will probably be used during the 12-month period.

B.01.012. (1) In this section,

“local government unit” means a city, metropolitan government area, town, village, municipality or other area of local government but does not include any local government unit situated within a bilingual district established under the Official Languages Act; (collectivité locale)

“local food” means a food that is manufactured, processed, produced or packaged in a local government unit and sold only in

(a) the local government unit in which it is manufactured, processed or packaged,

(b) one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged, or

(c) the local government unit in which it is manufactured, processed, produced or packaged and in one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged; (produit alimentaire locan( �/p>

“mother tongue” means the language first learned in childhood by persons in any area of Canada and still understood by them as ascertained by the decennial census taken immediately preceding the date on which the food referred to in subsection (3) is sold to the consumer; (langue maternelle)

“official languages” means the English language and the French language; (langues officielles)

“specialty food” means a food that

(a) has special religious significance and is used in religious ceremonies; or

(b) is an imported food

(i) that is not widely used by the population as a whole in Canada, and

(ii) for which there is no readily available substitute that is manufactured, processed, produced or packaged in Canada and that is generally accepted as being a comparable substitute; (aliment spécial)

“test market food” means a food that, prior to the date of the notice of intention respecting that food referred to in subsection (5), was not sold in Canada in that form and that differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form and includes a food referred to in section B.01.054. (produit alimentaire d’essai)

(2) Subject to subsections (9), (10) and (11), all information required by these Regulations to be shown on the label of a food shall be shown in both official languages.

(3) Subject to subsections (4) to (6), subsection (2) does not apply to a local food or test market food if

(a) it is sold in a local government unit in which one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in the local government unit; and

(b) the information required by these Regulations to be shown on the label of a food is shown in the official language that is the mother tongue of at least 10 per cent of the total number of persons residing in the local government unit.

(4) Where one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in a local government unit and the other official language is the mother tongue of less than 10 per cent of the total number of persons residing in the same local government unit, subsection (3) does not apply.

(5) Subsection (3) does not apply to a test market food unless the person who intends to conduct the test marketing of the food has, six weeks prior to conducting the test marketing, filed with the President of the Canadian Food Inspection Agency a notice of intention in a form acceptable to the President.

(6) A test market food shall, for the purposes of subsection (3), cease to be a test market food upon the expiration of 12 cumulative months after the date on which it was first offered for sale as a test market food but any test market food that was acquired for resale by a person, other than the person who filed the notice of intention referred to in subsection (5), before the

expiration of those 12 cumulative months, shall continue to be a test market food for the purposes of subsection (3) until it is sold.

(7) Subsection (2) does not apply to a specialty food if the information required by these Regulations to be shown on the label thereon is shown in one of the official languages.

(8) Where there are one or more surfaces on the label of a food that are of at least the same size and prominence as the principal display panel, the information required by these Regulations to be shown on the principal display panel may be shown in one official language if such information is shown in the other official language on one of those other surfaces.

(9) Subsection (2) does not apply to the identity and principal place of business of the person by or for whom the food was manufactured, processed, produced or packaged for resale if this information is shown in one of the official languages.

(10) Subsection (2) does not apply to the following common names if the common name appears on the principal display panel in the following manner:

Scotch Whisky Akvavit Irish Whisky Aquavit Highland Whisky Armagnac Dry Gin Marc Bourbon Grappa Tennessee Whisky Calvados Tequila Poire William Mezcal Crème de Bleuets Rye Whisky Curaçao Orange Crème de Menthe Liqueur de Fraise Crème de Cacao Mandarinette Crème de Cassis Prunelle de Bourgogne Crème de Banane Chartreuse Triple Sec Pastis Anisette Fior d’Alpe Crème de Noyau Strega Brandy Campari Sake or Saki Americano Advocaat or Advokaat Apricot Brandy Liqueur Kirsch Peach Brandy Liqueur Slivovitz Sloe Gin Ouzo Manhattan Cherry Brandy Liqueur Martini Kummel

(11) Subsection (2) does not apply to the label of a shipping container destined to a commercial or industrial enterprise or institution, if

(a) the shipping container and its contents are not resold as a one unit prepackaged product to a consumer at the retail level; and

(b) all information required by these Regulations to be shown on a label of a food is shown in one of the official languages.

SOR/79-23, s. 9; SOR/79-529, s. 4; SOR/84-300, s. 6; SOR/93-603, s. 1; SOR/95-548, s. 5; SOR/2000-184, s. 62.

B.01.013. (1) Unless specifically required by the Act or these Regulations, no reference, direct or indirect, to the Act or to these Regulations shall be made on any label of, or in any advertisement for, a food.

(2) Notwithstanding subsection (1), where a food complies with a standard established by these Regulations and the manufacturer of the food has substantiated, by means of the results of tests carried out before the statement is made or by other evidence that exists before the statement is made, that the food so complies, a statement that the food “complies with the standard for (naming the common name of the food in respect of which the claim is made) in the Food and Drug Regulations” may be made on the label of, or in an advertisement for, the food.

SOR/92-626, s. 10; SOR/95-548, s. 5(F).

B.01.014. The label of a food, other than a sweetener, that contains aspartame shall carry the following information:

(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains aspartame or is sweetened with aspartame, in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) in the case where other sweeteners are used in conjunction with aspartame, a statement on the principal display panel to the effect that the food

(i) contains aspartame and (naming the other sweeteners), or

(ii) is sweetened with aspartame and (naming the other sweeteners),

in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(c) a statement on any part of the label to the effect that aspartame contains phenylalanine; and

(d) a statement setting out the aspartame content expressed in milligrams per serving of stated size.

SOR/81-617, s. 2; SOR/88-559, s. 5; SOR/2003-11, s. 6.

B.01.015. (1) The label of a food that is a sweetener that contains aspartame shall carry the following information:

(a) a statement on the principal display panel to the effect that the food contains aspartame or is sweetened with aspartame, in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) a statement on any part of the label to the effect that aspartame contains phenylalanine;

(c) a statement on any part of the label of the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and

(d) a statement setting out the aspartame content expressed in milligrams per serving of stated size.

(2) [Repealed, SOR/2007-176, s. 1]

SOR/81-617, s. 2; SOR/88-559, s. 6; SOR/2003-11, s. 7; SOR/2007-176, s. 1. Previous Version B.01.016. The label of a food, other than a table-top sweetener, that contains sucralose shall carry the following information:

(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains sucralose or is sweetened with sucralose, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) where sucralose is used in conjunction with another sweetener or a sweetening agent or both, the names thereof shown in a statement on the principal display panel to the effect that the food contains, or is sweetened with, sucralose and the other sweetener or the sweetening agent or both, as the case may be, in letters as described in paragraph (a); and

(c) a statement setting out the sucralose content expressed in milligrams per serving of stated size.

SOR/91-527, s. 2; SOR/94-625, s. 1; SOR/2003-11, s. 8.

B.01.017. (1) The label of a food that is a table-top sweetener that contains sucralose shall carry the following information:

(a) a statement on the principal display panel to the effect that the food contains sucralose or is sweetened with sucralose, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) a statement on any part of the label setting out the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and

(c) a statement setting out the sucralose content expressed in milligrams per serving of stated size.

(2) [Repealed, SOR/2007-176, s. 2]

SOR/91-527, s. 2; SOR/94-625, s. 2; SOR/2003-11, s. 9; SOR/2007-176, s. 2. Previous Version B.01.018. The label of a food that contains polydextrose shall indicate the amount of polydextrose expressed in grams per serving of stated size.

SOR/93-276, s. 2; SOR/94-779, s. 1; SOR/97-512, s. 1; SOR/2003-11, s. 10.

B.01.019. The label of a food, other than a table-top sweetener, that contains acesulfame­ potassium shall carry the following information:

(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains acesulfame-potassium or is sweetened with acesulfame-potassium, in letters of at least the same size and prominence as the characters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) where acesulfame-potassium is used in conjunction with another sweetener or a sweetening agent or both, the names thereof shown in a statement on the principal display panel to the effect that the food contains, or is sweetened with, acesulfame-potassium and the other sweetener or the sweetening agent or both, as the case may be, in letters as described in paragraph (a); and

(c) a statement setting out the acesulfame-potassium content expressed in milligrams per serving of stated size.

SOR/94-625, s. 3; SOR/2003-11, s. 11.

B.01.020. (1) The label of a food that is a table-top sweetener that contains acesulfame­ potassium shall carry the following information:

(a) a statement, on the principal display panel, to the effect that the food contains acesulfame­ potassium or is sweetened with acesulfame-potassium, in letters of at least the same size and prominence as the characters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) a statement, on any part of the label, setting out the sweetness per serving, expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and

(c) a statement setting out the acesulfame-potassium content expressed in milligrams per serving of stated size.

(2) [Repealed, SOR/2007-176, s. 3]

SOR/94-625, s. 3; SOR/2003-11, s. 12; SOR/2007-176, s. 3. Previous Version B.01.021. (1) The label of a food that contains erythritol shall carry a statement indicating the amount of erythritol expressed in grams per serving of stated size unless the label carries a nutrition facts table.

(2) The statement of the amount of erythritol shall be grouped together with the statement of the amount of any other sugar alcohols and the amount of polydextrose.

SOR/2004-261, s. 1.

B.01.022. The label of a food, other than a table-top sweetener, that contains neotame shall carry the following information:

(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains neotame or is sweetened with neotame, in letters of at least the same size and

prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) in the case where other sweeteners or sweetening agents are used in conjunction with neotame, a statement on the principal display panel, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations, to the effect that the food

(i) contains neotame and (naming the other sweeteners and the sweetening agents), or

(ii) is sweetened with neotame and (naming the other sweeteners and the sweetening agents);

(c) if the label of the food carries a nutrition facts table, a statement setting out the neotame content expressed in milligrams per serving of stated size; and

(d) if the label of the food does not carry a nutrition facts table, a statement setting out the following energy value and contents of the food, per serving of stated size, grouped together and given equal prominence on any part of the label:

(i) the energy value, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),

(ii) the protein, fat and carbohydrate content, expressed in grams, and

(iii) the neotame content, expressed in milligrams.

SOR/2007-176, s. 4.

B.01.023. The label of a food that is a table-top sweetener that contains neotame shall carry the following information:

(a) a statement on the principal display panel to the effect that the food contains neotame or is sweetened with neotame, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) a statement on any part of the label of the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness;

(c) if the label of the food carries a nutrition facts table, a statement setting out the neotame content expressed in milligrams per serving of stated size; and

(d) if the label of the food does not carry a nutrition facts table, a statement setting out the following energy value and contents of the food, per serving of stated size, grouped together and given equal prominence on any part of the label:

(i) the energy value, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),

(ii) the protein, fat and carbohydrate content, expressed in grams, and

(iii) the neotame content, expressed in milligrams.

SOR/2007-176, s. 4.

B.01.033. (1) Except in the case of infant formula or a formulated liquid diet, no person shall sell a food represented in any manner as containing hydrolyzed or partially hydrolyzed collagen, hydrolyzed or partially hydrolyzed gelatin or hydrolyzed or partially hydrolyzed casein unless the label carries the following statement on the principal display panel in the same size type used for the common name:

“CAUTION, DO NOT USE AS SOLE SOURCE OF NUTRITION”.

(2) In this section, “formulated liquid diet” means a food that meets the requirements of sections B.24.101 to B.24.103.

SOR/78-65, s. 1.

B.01.034. [Repealed, SOR/88-559, s. 7]

B.01.035. (1) Subject to subsection (8), where an irradiated food referred to in Column I of the table to Division 26 is offered for sale as a prepackaged product, the principal display panel of the label applied to the package shall carry the symbol described in subsection (5).

(2) Where an irradiated food referred to in Column I of the table to Division 26 is not a prepackaged product and is offered for sale, a sign that carries the symbol described in subsection (5) shall be displayed immediately next to the food.

(3) The symbol required pursuant to subsection (1) or (2) shall appear in close proximity on the principal display panel referred to in subsection (1) or on the sign referred to in subsection (2) to one of the following statements or a written statement that has the same meaning:

(a) “treated with radiation”;

(b) “treated by irradiation”; or

(c) “irradiated”.

(4) No person shall sell a food referred to in Column I of the table to Division 26 that has been irradiated in the manner set out in subsection B.26.003(2) unless the requirements of subsections (1) to (3) are met.

(5) For the purposes of subsections (1) to (3), the symbol that indicates the irradiated food shall

(a) have an outer diameter

(i) in the case referred to in subsection (1), equal to or greater than the height of the numerical quantity prescribed by section 14 of the Consumer Packaging and Labelling Regulations for the declaration of net quantity of the package, and

(ii) in the case referred to in subsection (2), not less than 5 cm; and

(b) be in the following form:

GRAPHIC IS NOT DISPLAYED, SEE SOR/89-172, S. 1

(6) Notwithstanding subsection B.01.009(1), any food referred to in Column I of the table to Division 26 that is an ingredient or component of a prepackaged product and that has been

irradiated shall, if the food constitutes 10 per cent or more of the prepackaged product, be included in the list of ingredients and preceded by the statement “irradiated”.

(7) The label attached to a shipping container containing any food referred to in Column I of the table to Division 26 that has been subjected to the maximum permitted absorbed dose set out in Column IV of that table shall carry the statement required by subsection (3) and the statement “Do not irradiate again”.

(8) Where a shipping container constitutes the package of the prepackaged product, the label attached to the shipping container shall carry the statement required by subsection (7) but need not carry the symbol required by subsection (5).

(9) Any advertising of an irradiated food referred to in Column I of the table to Division 26 shall identify the food as having been irradiated.

(10) The statements referred to in subsections (3) and (6) to (8) shall be in both official languages in accordance with subsection B.01.012(2).

SOR/89-172, s. 1.

B.01.037. [Repealed, SOR/88-559, s. 8]

B.01.040. [Repealed, SOR/88-559, s. 9]

B.01.042. Where a standard for a food is prescribed in this Part,

(a) the food shall contain only the ingredients included in the standard for the food;

(b) each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and

(c) if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive set out in one of the tables to section B.16.100 for use as an additive to that food for that purpose.

B.01.043. Subject to section B.25.062, where a standard for a food is not prescribed in this Part,

(a) the food shall not contain any food additives except food additives set out in a table to section B.16.100 for use as additives to that food for the purpose set out in that table; and

(b) each such food additive shall be incorporated in the food in a quantity within any limits prescribed for that food and food additive in that table.

SOR/87-640, s. 1.

B.01.044. Where the limit prescribed for a food additive in a table to section B.16.100 is stated to be “Good Manufacturing Practice”, the amount of the food additive added to a food in manufacturing and processing shall not exceed the amount required to accomplish the purpose for which that additive is permitted to be added to that food.

B.01.045. A food additive shall,

(a) where specifications are set out in this Part for that additive, meet those specifications;

(b) where no specifications are set out in this Part for that additive but specifications are set out for it in the Food Chemicals Codex, Fourth Edition, 1996, published by the National Academy of Sciences, Washington, D.C., United States, as amended from time to time, meet those specifications;

(c) in the case of lactitol and maltitol, meet the specifications established by the Joint FAO/WHO Expert Committee on Food Additives as set out in the Specifications for identity and purity of certain food additives — FAO Food and Nutrition Paper 38, published in 1988 by the Food and Agriculture Organization of the United Nations, Rome;

(d) [Repealed, SOR/2010-142, s. 1]

(e) [Repealed, SOR/97-512, s. 2]

(f) in the case of isomalt, meet the specifications established by the Joint FAO/WHO Expert Committee on Food Additives as set out in the Compendium of food additive specifications, Addendum 4 — FAO Food and Nutrition Paper 52, published in 1996 by the Food and Agriculture Organization of the United Nations, Rome.

(g) [Repealed, SOR/97-512, s. 2]

SOR/82-383, s. 1; SOR/91-527, s. 3; SOR/92-93, s. 1; SOR/92-551, s. 1; SOR/93-276, s. 3; SOR/94-625, s. 4; SOR/94-779, s. 2; SOR/95-172, s. 2; SOR/97-512, s. 2; SOR/2010-142, s. 1. Previous Version B.01.046. (1) A food is adulterated if any of the following substances or classes of substances are present therein or have been added thereto:

(a) mineral oil, paraffin wax or petrolatum or any preparation thereof;

(b) coumarin, an extract of tonka beans, the seed of Dipteryx odorata Willd. or Dipteryx oppositifolia Willd.;

(c) non-nutritive sweetening agents;

(d) cottonseed flour that contains more than 450 parts per million of free gossypol;

(e) fatty acids and their salts containing chick-edema factor or other toxic factors;

(f) dihydrosafrole;

(g) isosafrole;

(h) oil of American sassafras from Sassafras albidum (Nutt). Nees;

(i) oil of Brazilian sassafras from Ocotea cymbarum H.B.K.;

(j) oil of camphor sassafrassy from Cinnamomum camphorum Sieb.;

(k) oil of micranthum from Cinnamomum micranthum Hayata;

(l) safrole;

(m) oil, extract or root of calamus from Acorus calamus L.;

(n) nut and nut products that contain more than 15 parts per billion of aflatoxin;

(o) ethylene thiourea;

(p) chlorinated dibenzo-p-dioxins; or

(q) cinnamyl anthranilate.

(2) For the purpose of paragraph (1)(n), the aflatoxin content of a nut or nut product shall be calculated on the basis of the nut meat portion.

SOR/79-358, s. 1; SOR/80-501, s. 1; SOR/82-1071, s. 1; SOR/83-857, s. 1; SOR/84-300, s. 7; SOR/88-534, s. 1.

B.01.047. Notwithstanding section B.01.046

(a) a food, other than sausage casing, is not adulterated by reason only that it contains 0.3 per cent or less mineral oil, if good manufacturing practice requires the use of mineral oil;

(b) chewing gum is not adulterated by reason only that it contains a paraffin wax base;

(c) fresh fruits and vegetables, except turnips, are not adulterated by reason only that they are coated with not more than 0.3 per cent paraffin wax and petrolatum, if good manufacturing practices require the use of such coating;

(d) turnips and cheese are not adulterated by reason only that they are coated with paraffin wax in accordance with good manufacturing practice;

(e) sausage casing is not adulterated by reason only that it contains five per cent or less mineral oil by weight, if good manufacturing practice requires the use of mineral oil;

(f) fish is not adulterated by reason only that it contains 20 parts per trillion or less of 2,3,7,8­ tetrachlorodibenzoparadioxin;

(g) bakery products and confectionery are not adulterated by reason only that they contain 0.15 per cent or less petrolatum, if good manufacturing practice requires the use of petrolatum;

(h) a salt substitute is not adulterated by reason only that it contains 0.6 per cent or less mineral oil, if good manufacturing practice requires the use of mineral oil; and

(i) fruits, vegetables and cereals are not adulterated by reason only that they contain 0.05 parts per million or less of ethylene thiourea.

SOR/81-934, s. 1; SOR/82-122, s. 1; SOR/82-1071, s. 2; SOR/83-932, s. 1; SOR/84-17, s. 1; SOR/92-76, s. 1.

B.01.047.1 (1) The following definitions apply in this section.

“BSE” means Bovine Spongiform Encephalopathy. (ESB)

“specified risk material” means

(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and

(b) the distal ileum of cattle of all ages. (matériel à risque spécifié)

(2) No person shall sell or import for sale food that contains specified risk material.

(3) Subsection (2) does not apply in respect of food that originates from a country that is designated as being free from BSE in accordance with section 7 of the Health of Animals Regulations.

(4) Subsection (2) does not apply in respect of food that is packaged for sale or imported for sale before the day on which this subsection comes into force.

SOR/2003-265, s. 1.

B.01.048. (1) No person shall sell

(a) any animal intended for consumption as food if any product containing any drug listed in subsection (2) has been administered to the animal;

(b) any meat, meat by-products, eggs or milk intended for consumption as food and derived from an animal if any product containing any drug listed in subsection (2) has been administered to that animal; or

(c) any meat, meat by-products, eggs or milk that contains any residue of any drug listed in subsection (2).

(2) The drugs referred to in subsection (1) are

(a) chloramphenicol and its salts and derivatives;

(b) a 5-nitrofuran compound;

(c) clenbuterol and its salts and derivatives;

(d) a 5-nitroimidazole compound; and

(e) diethylstilbestrol and other stilbene compounds.

SOR/85-685, s. 1; SOR/87-626, s. 1; SOR/94-568, s. 1; SOR/97-510, s. 1; SOR/2003-292, s. 1.

B.01.049. No person shall use, in labelling, packaging, advertising or selling a food that does not meet the requirements of the kashruth applicable to it, the word “kosher” or any letters of the Hebrew alphabet or any other word, expression, depiction, sign, symbol, mark, device or other representation that indicates or that is likely to create an impression that the food is kosher.

SOR/84-300, s. 8.

B.01.053. No person shall sell a product represented as a ready breakfast or instant breakfast or by any similar designation unless each serving of stated size of the product contains

(a) not less than 4.0 mg. iron;

(b) Vitamin A, thiamine, riboflavin, niacin or niacinamide and Vitamin C;

(c) a good dietary source of protein; and

(d) where consumed as directed, not less than 300 calories.

SOR/2003-11, s. 13.

B.01.054. (1) In order to generate information in support of an amendment to the Regulations, the Director may issue to the manufacturer or distributor of a food, where the food or the packaging, labelling or advertising of the food does not comply with the requirements of these Regulations, a Temporary Marketing Authorization Letter that authorizes the sale of the food described therein or the packaging, labelling or advertising of the food described therein for a specified period of time, within a designated area and in a specified quantity, in the manner specified in the Letter if

(a) the manufacturer or distributor of the food has supplied to the Director the following information:

(i) the purpose for which the temporary marketing authorization of the food is required,

(ii) a description of the food including a sample and proposed label,

(iii) a description of any proposed variation from the requirements of these Regulations,

(iv) adequate data to show that the use of the food will not be detrimental to the health of the purchaser or user,

(v) the proposed quantity of the food to be sold,

(vi) the proposed period of time required for such sale,

(vii) the proposed area designated for such sale, and

(viii) such other data as the Director may require; and

(b) the manufacturer or distributor of the food has agreed to

(i) describe the food on a label or in an advertisement in a manner that is not false, misleading or deceptive,

(ii) use such marks or statements on the label or in any advertisement as the Director may require,

(iii) on request, submit to the Director results of the temporary marketing, and

(iv) on request, withdraw the product from sale where the Director is of the opinion that it is in the public interest to do so.

(2) The Director shall, in any Temporary Marketing Authorization Letter issued pursuant to subsection (1), set out

(a) the common name and description of the food to be sold;

(b) the name and address of the manufacturer or distributor of the food;

(c) the purpose for which the temporary marketing of the food is authorized;

(d) the quantity of the food that is authorized for sale;

(d.1) the type of packaging, labelling or advertising authorized in respect of the food where the Letter is intended to authorize a variation from a requirement of any provision of the Regulations respecting packaging, labelling or advertising;

(e) the period of time during which the food may be sold; and

(f) the designated area within which the food may be sold.

SOR/81-566, s. 1; SOR/85-275, s. 1.

B.01.055. (1) A manufacturer or distributor named in a Temporary Marketing Authorization Letter issued pursuant to subsection B.01.054(1) may, for the purpose set out in the Letter, sell the food in the manner authorized in the Letter and package, label or advertise that food in the manner authorized in the Letter for the period of time, within the designated area and in the quantity set out in the Letter.

(2) No provision of these Regulations made pursuant to paragraph 30(1)(b) of the Act applies in respect of a food or the packaging, labelling or advertising of a food for which a Temporary Marketing Authorization Letter has been issued pursuant to subsection B.01.054(1) to the extent that the food, or the packaging, labelling or advertising of the food, as authorized in the Letter, does not comply with that provision.

SOR/81-566, s. 1; SOR/85-275, s. 2; SOR/90-814, s. 4.

B.01.056. (1) This section applies in respect of interim marketing authorizations that the Minister may issue under subsection 30.2(1) of the Act.

(2) In this section, “food for special dietary use” has the same meaning as in section B.24.001.

(3) The manufacturer of a food or of an agricultural chemical, veterinary drug, food additive, vitamin, mineral nutrient or amino acid present in or on a food may submit an application in writing to the Minister for the issuance of an interim marketing authorization in respect of the food that provides for any matter referred to in subsection 30.2(2) of the Act.

(4) The application shall be accompanied by the following information:

(a) the common name and description of the food;

(b) the reasons for which the interim marketing authorization is requested;

(c) a description of every exemption requested in respect of the food from the application, in whole or in part, of sections 5 to 6.1 of the Act and the applicable requirements of these Regulations;

(d) adequate data, including results of tests and scientific analysis, that demonstrate that the food would not be harmful to the health of the purchaser or consumer;

(e) if the application relates to the addition of vitamins, mineral nutrients or amino acids to the food, a statement, with supporting documentation, indicating that the proposed addition is for one or more of the following purposes:

(i) to restore the levels of vitamins or mineral nutrients to the levels that were present in the food before processing or, in the case of amino acids, to provide protein of a nutritional quality that is equivalent to that which was present in the food before processing,

(ii) to make the food that is intended to be sold as a substitute for another food nutritionally equivalent to the food that it is intended to replace in the diet in respect of

(A) the levels of added vitamins or mineral nutrients, or

(B) the quality of protein provided through the addition of amino acids,

(iii) to prevent or correct a deficiency of vitamins or mineral nutrients in the population or specific population groups, or

(iv) to modify the levels of vitamins, mineral nutrients or amino acids in the food for special dietary use; and

(f) if the application relates to the use of a food additive in or on the food, the information described in section B.16.002.

(5) In addition to the matters that may be provided for in accordance with subsections 30.2(2) and (4) of the Act, an interim marketing authorization shall set out

(a) the common name and description of the food;

(b) the reasons for which the interim marketing authorization is issued; and

(c) the provisions of the Act and of these Regulations in respect of which the food is exempted.

(6) An interim marketing authorization may be cancelled by the Minister if the Minister determines, after reviewing any additional information that comes to his or her attention, that the food for which the authorization was issued is or may be harmful to the health of the purchaser or consumer.

SOR/97-313, s. 1; SOR/2008-181, s. 2. Previous Version B.01.060. to B.01.066. [Repealed, SOR/88-559, s. 10]

B.01.070. [S]. Mixed nuts or a mixture of nuts shall consist of a mixture of nuts in which not less than five per cent by weight of each type of nuts is present in the mixture.

B.01.071. Where a prepackaged product is a mixture of nuts, the percentage and common name of the nut that is present in the product in the greatest amount by weight shall be applied to the principal display panel of the package in close proximity to the common name of the product.

SOR/88-336, s. 3; SOR/92-626, s. 11.

B.01.072. Notwithstanding any requirement prescribed in Part B, a food product that has been subjected to heat in the presence of a vaporized liquid solution of smoke derived from hardwood, hardwood sawdust or corn cobs may be described as “smoked”.

SOR/92-626, s. 11.

B.01.080. (1) In this section, “frozen” means preserved by freezing temperature and does not include any surface freezing that may occur during holding and transportation.

(2) Where meat, meat by-products, poultry meat, poultry by-products or fish, or meat of any marine or fresh water animal, that has been frozen is thawed prior to sale, the words “previously frozen” shall be shown

(a) on the principal display panel in close proximity to the common name of the food and in letters at least as legible and conspicuous as those used in the common name;

(b) anywhere on the principal display panel in letters of not less than 1/4 of an inch (6.4 millimetres) in height; or

(c) on a sign displayed adjacent to the food in letters that are legible and conspicuous to a prospective purchaser.

(3) Where part of a food referred to in subsection (2) has been frozen and thawed prior to sale, the words “Made from fresh and frozen portions” or “Made from fresh and frozen (naming the food)” shall be shown in the manner described in paragraph (2)(a), (b) or (c).

SOR/88-336, s. 3.

B.01.090. (1) No person shall offer for sale at retail any solid cut meat or solid cut poultry meat to which phosphate salts or water has been added, unless that meat or poultry meat is contained in a package and carries a label.

(2) The label referred to in subsection (1) shall contain a statement of the minimum percentage of meat protein as part of the common name of the product on the principal display panel of the package in type that is as legible and conspicuous as any other type on that display panel, and in letters that are at least one half of the size of the letters used in the common name of the product but that are not less than 1.6 mm in height.

SOR/94-262, s. 1.

B.01.091. The label of any solid cut meat or solid cut poultry meat that has had phosphate salts or water added to it, that is not cured and that is prepackaged at retail shall contain a statement of the ingredients contained in the food in accordance with subsections B.01.008(3) to (5).

SOR/94-262, s. 1; SOR/2003-11, s. 14.

B.01.092. Sections B.01.090 and B.01.091 do not apply in respect of side bacon, Wiltshire bacon, pork jowls, salt pork or salt beef.

SOR/94-262, s. 1.

B.01.100. (1) The common name of a simulated meat product or simulated poultry product shall be the common name of the meat product or poultry product that is simulated, modified by the word “simulated”.

(2) The word “simulated” in the common name of a simulated meat product or simulated poultry product shall be shown in letters of at least the same size and prominence as those used in the remainder of the common name of that product.

(3) Where a simulated meat product or a simulated poultry product is not a prepackaged product, the common name of the product and the other information required by this section to be shown on the label of a simulated meat product or simulated poultry product shall be

shown on a sign displayed on or adjacent to the product in letters that are legible and conspicuous to a prospective purchaser.

(4) The words

(a) “contains no meat”, in the case of a simulated meat product, and

(b) “contains no poultry”, in the case of a simulated poultry product,

shall be shown on the principal display panel of the label of a simulated meat product or simulated poultry product in close proximity to the common name and in letters of at least the same size and prominence as those shown in the common name.

(5) to (7) [Repealed, SOR/88-559, s. 11]

SOR/88-336, s. 3; SOR/88-559, s. 11.

B.01.101. (1) For the purposes of this section and section B.01.102, “source of protein” means any food that contains protein, but does not include spices, seasonings, flavours, artificial flavours, flavour enhancers, food additives and similar foods that contain only small amounts of protein.

(2) The common name of a meat product extender shall be the common name of each food in the meat product extender that is a source of protein, plus

(a) the word “meat”, or the common name of the meat product that is to be extended, plus the word “extender”; or

(b) the words “extender for” plus the common name of the meat product that is to be extended.

(3) The common name of a poultry product extender shall be the common name of each food in the poultry product extender that is a source of protein, plus

(a) the word “poultry”, or the common name of the poultry product that is to be extended plus the word “extender”; or

(b) the words “extender for” plus the common name of the poultry product that is to be extended.

(4) Foods that are a source of protein in the meat product extender or poultry product extender shall be shown by their common names in the common name of that meat product extender or poultry product extender

(a) in descending order of their proportion of the meat product extender or poultry product extender; and

(b) in letters of at least the same size and prominence as those used in the remainder of the common name of the meat product extender or poultry product extender.

(5) and (6) [Repealed, SOR/88-559, s. 12]

SOR/88-559, s. 12.

B.01.102. (1) The common name of an extended meat product or an extended poultry product shall be the common name of the meat product or poultry product that is extended, modified by the common name of each of the foods that are sources of protein in the extended meat product or extended poultry product.

(2) Notwithstanding subsection (1),

(a) the word or words “meat”, “meat product”, “poultry”, “poultry meat” or “poultry meat by- product” as the case may be, may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a meat product or poultry product; and

(b) where it is an acceptable manufacturing practice for a manufacturer to omit from his meat product extender or poultry product extender any source of protein derived from a plant that is ordinarily an ingredient of that meat product extender or poultry product extender, or to substitute in whole or in part in his meat product extender or poultry product extender any source of protein derived from a plant for a source of protein that is ordinarily an ingredient of that meat product extender or poultry product extender, the word “plant” may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a plant.

(3) Foods that are a source of protein in an extended meat product or extended poultry product shall be shown by their common names in the common name of that product

(a) in descending order of their proportion of that product; and

(b) in letters of at least the same size and prominence as those used in the remainder of the common name of that product.

(4) Where an extended meat product or extended poultry product is not a prepackaged product, the common name of that product and the information required by this section to be shown on the label of an extended meat product or extended poultry product shall be shown on a sign displayed on or adjacent to that product in letters that are legible and conspicuous to a prospective purchaser.

(5) to (7) [Repealed, SOR/88-559, s. 13]

SOR/84-300, s. 9; SOR/88-559, s. 13.

B.01.103. (1) The common name of a yolk-replaced egg shall be “yolk-replaced egg”.

(2) to (4) [Repealed, SOR/88-559, s. 14]

SOR/88-559, s. 14.

B.01.300. [Repealed, SOR/2003-11, s. 15]

B.01.301. (1) No person shall, on the label of or in any advertisement for a food, other than in the nutrition facts table, if any, include a declaration of the food’s energy value or the amount of a nutrient contained in the food unless it is declared in the following manner, per serving of stated size:

(a) in the case of the energy value, in Calories;

(b) in the case of a vitamin set out in column I of Table I to Division 1 of Part D or a mineral nutrient set out in column I of Table I to Division 2 of Part D, in the units specified in that column;

(c) in the case of sodium, potassium or cholesterol, in milligrams;

(d) in the case of the mineral ion content of prepackaged water or ice, in parts per million; and

(e) in any other case, in grams.

(2) Despite subsection (1), a person may, on the label of a food or in any advertisement for a food, other than in the nutrition facts table, if any, include a declaration of the percentage of the daily value of a nutrient contained in the food if

(a) the nutrient is listed in column 1 of the table to section B.01.401 or the table to section B.01.402;

(b) the percentage of the daily value of the nutrient is required or permitted to be declared in the nutrition facts table; and

(c) the percentage of the daily value of the nutrient is declared per serving of stated size.

(3) A declaration referred to in subsection (1) or (2) that appears on the label of a food shall be

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

SOR/88-559, s. 15; SOR/2003-11, s. 16.

B.01.302. to B.01.304. [Repealed, SOR/2003-11, s. 17]

B.01.305. (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, respecting a protein unless the food meets the conditions set out in column 2 of item 8 of the table following section B.01.513 for the subject “source of protein” set out in column 1.

(2) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, respecting an amino acid unless

(a) the food meets the conditions set out in column 2 of item 8 of the table following section B.01.513 for the subject “source of protein” set out in column 1; and

(b) the label or advertisement includes a declaration of the amount of histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine contained in the food, expressed in grams per serving of stated size.

(3) Subsections (1) and (2) do not apply in respect of

(a) a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute;

(b) foods represented for use in gluten-free diets, protein restricted diets, low (naming the amino acid) diets and (naming the amino acid) free diets;

(c) the word “protein” when used as part of the common name of an ingredient in the list of ingredients;

(d) the declaration of amino acids in the list of ingredients;

(e) the common names set out in column II of items 7 to 9 of the table to paragraph B.01.010(3)(a), when shown in the list of ingredients in accordance with that paragraph;

(f) the common name of a single amino acid preparation that may be sold as a food;

(g) the statements required by paragraphs B.01.014(c) and B.01.015(1)(b);

(h) a statement or claim set out in column 4 of item 7 of the table following section B.01.513 respecting the subject “low in protein” set out in column 1;

(i) a declaration of the amount of protein in the nutrition facts table;

(j) a statement of the protein content of a food as required by paragraph B.24.103(c), subparagraph B.24.202(a)(ii), paragraph B.24.304(b) or B.25.057(1)(a) or subparagraph B.25.057(2)(c)(i) or (d)(i); or

(k) a statement that a food is not a source of protein.

(4) A representation referred to in subsection (1) or (2) that appears on the label of a food shall be

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

SOR/88-559, s. 15; SOR/90-830, s. 3(F); SOR/2003-11, s. 18.

B.01.306. to B.01.310. [Repealed, SOR/2003-11, s. 19]

B.01.311. (1) Subject to subsections (2) and (3), no person shall, on the label of or in any advertisement for a food, make a representation, express or implied, concerning the action or effect of the food’s energy value or of a nutrient contained in the food.

(2) The label of or advertisement for a food may carry a statement or claim set out in column 1 of the table following section B.01.603.

(3) Subject to section B.01.312, the label of or advertisement for a food may carry a statement or claim to the effect that the food’s energy value or a nutrient contained in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

(4) If a statement or claim described in subsection (3) concerns a nutrient not listed in column 1 of the tables to sections B.01.401 and B.01.402, the amount of the nutrient contained in the food must be expressed on any part of the label in grams per serving of stated size.

(5) A statement or claim referred to in subsection (2) or (3) that appears on the label of a food shall be

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

SOR/88-559, s. 15; SOR/2003-11, s. 20.

B.01.312. (1) If a statement or claim described in subsection B.01.311(3) is made on the label of or in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include a declaration, per serving of stated size, of

(a) the energy value, if the energy value is the subject of the statement or claim; or

(b) the amount of the nutrient, if a nutrient is the subject of the statement or claim.

(2) If the statement or claim is made in an advertisement other than a radio or television advertisement, the declaration referred to in subsection (1) shall be

(a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(3) If the statement or claim is made in a radio advertisement or in the audio portion of a television advertisement, the declaration referred to in subsection (1) shall immediately precede or follow the statement or claim.

(4) If the statement or claim is made in a television advertisement, the declaration referred to in subsection (1) shall be communicated

(a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or

(b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(5) If the declaration referred to in subsection (1) is communicated in the visual mode of a television advertisement, it shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

SOR/2003-11, s. 20.

Interpretation

B.01.400. The following definitions apply in sections B.01.401 to B.01.603.

“fat” means all fatty acids expressed as triglycerides. (lipides)

“point” means a unit of measurement for type size that is known as an Anglo-American point and is equal to 0.3514598 mm. (point)

SOR/2003-11, s. 20.

Nutrition Labelling

Core Information

B.01.401. (1) Except as otherwise provided in this section and sections B.01.402 to B.01.406 and B.01.467, the label of a prepackaged product shall carry a nutrition facts table that contains only the information set out in column 1 of the table to this section expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(2) Subsection (1) does not apply to a prepackaged product if

(a) all the information set out in column 1 of the table to this section, other than in respect of item 1 (“Serving of stated size”), may be expressed as “0” in the nutrition facts table in accordance with this section;

(b) the product is

(i) a beverage with an alcohol content of more than 0.5%,

(ii) a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with paraffin wax or petrolatum,

(iii) a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product,

(iv) a raw single ingredient marine or fresh water animal product,

(v) sold only in the retail establishment where the product is prepared and processed from its ingredients, including from a pre-mix if an ingredient other than water is added to the pre-mix during the preparation and processing of the product,

(vi) sold only at a road-side stand, craft show, flea market, fair, farmers’ market or sugar bush by the individual who prepared and processed the product,

(vii) an individual serving that is sold for immediate consumption and that has not been subjected to a process to extend its durable life, including special packaging, or

(viii) sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and has an available display surface of less than 200 cm2; or

(c) the product is

(i) a prepackaged confection, commonly known as a one bite confection, that is sold individually,

(ii) a prepackaged individual portion of food that is solely intended to be served by a restaurant or other commercial enterprise with meals or snacks, or

(iii) milk, partly skimmed milk, skim milk, goat’s milk, partly skimmed goat’s milk, skimmed goat’s milk, (naming the flavour) milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk or cream sold in a refillable glass container.

(3) Despite paragraphs (2)(a) and (b), subsection (1) applies to a prepackaged product if

(a) the product contains an added vitamin or mineral nutrient;

(b) a vitamin or mineral nutrient is declared as a component of one of the product’s ingredients other than flour;

(c) the product contains added acesulfame-potassium, aspartame, neotame or sucralose;

(d) the product is a meat, meat by-product, poultry meat or poultry meat by-product that is ground; or

(e) the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains

(i) a reference to the energy value, a nutrient set out in column 1 of the table to this section or in column 1 of the table to section B.01.402 or a constituent of such a nutrient, other than information required by Division 12 or a reference to the common name of an ingredient in the list of ingredients for the product,

(ii) a representation that expressly or implicitly indicates that the product has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004,

(iii) a health-related name, statement, logo, symbol, seal of approval or mark, or

(iv) the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

(4) Subsection (1) does not apply to a formulated liquid diet, a human milk substitute, a food represented as containing a human milk substitute, a meal replacement, a nutritional supplement or a food represented for use in a very low energy diet.

(5) The label of or advertisement for a formulated liquid diet, a human milk substitute, a food represented as containing a human milk substitute, a meal replacement, a nutritional supplement or a food represented for use in a very low energy diet shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

(6) If, for a prepackaged product other than one intended solely for children under two years of age, the information in respect of seven or more of the energy value and nutrients referred

to in column 1 of items 2 to 5 and 7 to 13 of the table to this section may be expressed as “0” in the nutrition facts table in accordance with this section, the nutrition facts table need only include the following information:

(a) the serving of stated size;

(b) the energy value;

(c) the amount of fat;

(d) the amount of carbohydrate;

(e) the amount of protein;

(f) the amount of any nutrient that is the subject of a representation referred to in subparagraph (3)(e)(ii);

(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, other than iodide added to salt for table or general household use or fluoride added to prepackaged water or ice;

(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour;

(i) the amount of any nutrient referred to in column 1 of item 4, 5, 7, 8, 10, 11 or 13 of the table to this section that may not be expressed as “0” in the nutrition facts table; and

(j) the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)” or, if the prepackaged product meets the condition specified in subsection B.01.455(3), the statement “Not a significant source of other nutrients”.

(7) Subsection (1) does not apply to a prepackaged product

(a) that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or institution; or

(b) that is a multiple-serving ready-to-serve prepackaged product intended solely to be served in a commercial or industrial enterprise or institution.

TABLE

CORE INFORMATION

Column 1 Column 2 Column 3 Column 4 Item Information Description Unit Manner of expression

“Serving Size (1) The size is (1) The size whenServing of1. (naming the serving expressed in one of the expressed in metric unitsstated size size)”, “Serving following units: is rounded off (naming the serving (a) in the case of a food (a) if it is less than 10 g or size)” or “Per that is usually divided 10 mL, to the nearest (naming the serving into pieces before being multiple of 0.1 g or size)” consumed (such as 0.1 mL; and

Column 1 Column 2 Column 3 Item Information Description Unit

cake, pie and pizza), a fraction of the entire food; (b) in the case of a food described in subsection B.01.002A(2), the entire container; and (c) in all other cases, in a commonly used unit in respect of which the quantity is visibly measurable, such as millilitres, cups, tablespoons or “(naming the unit of food)”.

(2) The size expressed in accordance with subitem (1) is followed by the size expressed in grams or millilitres, as specified by paragraph B.01.002A(1)(b).

2. Energy value

“Calories”, “Total The value is expressed Calories” or in Calories per serving “Calories, Total” of stated size.

Column 4 Manner of expression

(b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL.

(2) The size when expressed as a fraction is represented by a numerator and a denominator separated by a line.

(3) The size shall include the word “assorted” if the information in the nutrition facts table of a prepackaged product that contains an assortment of foods is set out as a composite value. The value is rounded off (a) if it is less than 5 Calories

(i) if the product meets the conditions set out in column 2 of item 1 of the table following section B.01.513 for the subject” free of energy” set out in column 1, to “0” Calorie, and

(ii) in all other cases, to the nearest multiple of 1 Calorie;

(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest

Column 1 Column 2 Item Information Description

3. Amount of fat “Fat”, “Total Fat” or“Fat, Total”

4. Amount of “Saturated Fat”, saturated fatty “Saturated Fatty acids Acids”, “Saturated”

Column 3 Unit

The amount is expressed (a) in grams per serving of stated size; and

(b) as a percentage of the daily value per serving of stated size.

The amount is expressed in grams per serving of stated size.

Column 4 Manner of expression multiple of 10 Calories. (1) The amount is rounded off

(a) if it is less than 0.5 g

(i) if the product meets the conditions set out in column 2 of item 11 of the table following section B.01.513 for the subject “free of fat” set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the nutrition facts table or are omitted from that table in accordance with subsection B.01.401(6) and no other fatty acids are declared in an amount greater than 0 g, to “0 g”, and

(ii) in all other cases, to the nearest multiple of 0.1 g;

(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to “0%“; and (b) in all other cases, to the nearest multiple of 1%. The amount is rounded off

(a) if it is less than 0.5 g

Column 1 Item Information

5.

Amount of trans fatty acids

The sum of6. saturated fatty acids and trans fatty acids

Column 2 Description or “Saturates”

“Trans Fat”, “Trans Fatty Acids” or “Trans”

“Saturated Fat + Trans Fat”, “Saturated Fatty Acids + Trans Fatty Acids”, “Saturated + Trans” or “Saturates

Column 3 Unit

The amount is expressed in grams per serving of stated size.

The sum is expressed as a percentage of the daily value per serving of stated size.

Column 4 Manner of expression

(i) if the product meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject “free of saturated fatty acids” set out in column 1, to “0 g”, and

(ii) in all other cases, to the nearest multiple of 0.1 g;

(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off

(a) if it is less than 0.5 g

(i) if the product meets the conditions set out in column 2 of item 22 of the table following section B.01.513 for the subject “free of trans fatty acids” set out in column 1, to “0 g”, and

(ii) in all other cases, to the nearest multiple of 0.1 g;

(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The percentage is rounded off

(a) if the amounts of saturated fatty acids and trans fatty acids are

Column 1 Column 2 Column 3 Item Information Description Unit

+ Trans”

7. Amount ofcholesterol “Cholesterol” The amount is expressed in milligrams per serving of stated size and may also be expressed as a percentage of the daily value per serving of stated size.

8. Amount ofsodium “Sodium” The amount is expressed (a) in milligrams per serving of stated size; and

(b) as a percentage of the daily value per serving of stated size.

Column 4 Manner of expression declared as “0 g”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. (1) The amount is rounded off (a) if the product meets the conditions set out in column 2 of item 27 of the table following section B.01.513 for the subject “free of cholesterol” set out in column 1, to “0 mg”; and (b) in all other cases, to the nearest multiple of 5 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg” to “0%”; and (b) in all other cases, to the nearest multiple of 1%. (1) The amount is rounded off

(a) if it is less than 5 mg

(i) if the product meets the conditions set out in column 2 of item 31 of the table following section B.01.513 for the subject “free of sodium or salt” set out in column 1, to “0 mg”, and

(ii) in all other cases, to the nearest multiple of 1 mg;

(b) if it is 5 mg or more

Column 1 Item Information

9. Amount of carbohydrate

10. Amount of fibre

Column 2 Description

“Carbohydrate”, “Total Carbohydrate” or “Carbohydrate, Total”

“Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber”

Column 3 Unit

The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.

Column 4 Manner of expression but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. (1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(b) if it is 0.5 g or more, to the nearest multiple of 1 g.

(2) The percentage is rounded off (a) if the amount is declared as “0 g”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%. (1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and

(b) if it is 0.5 g or more, to the nearest multiple of 1 g.

(2) The percentage is rounded off (a) if the amount is declared as “0 g”, to “0%”; and (b) in all other cases, to the nearest multiple of 1%.

Column 1 Column 2 Item Information Description 11. Amount of “Sugars”sugars

12. Amount of “Protein”protein

13. Amount of

(a) vitamin A (a) “Vitamin A” or“Vit A”

(b) “Vitamin C” or(b) vitamin C “Vit C”

(c) calcium (c) “Calcium”

(d) iron (d) “Iron”

SOR/2003-11, s. 20; SOR/2007-176, s. 5. Previous Version Additional Information

Column 3 Unit The amount is expressed in grams per serving of stated size.

The amount is expressed in grams per serving of stated size.

The amount is expressed as a percentage of the daily value per serving of stated size.

Column 4 Manner of expression The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The percentage is rounded off

(a) if it is less than 2%

(i) if the product contains less than 1% of the daily value per reference amount and per serving of stated size, to “0 %”, and

(ii) in all other cases, to “2%”;

(b) if it is 2% or more but not more than 10%, to the nearest multiple of 2%; (c) if it is more than 10% but not more than 50%, to the nearest multiple of 5%; and (d) if it is more than 50%, to the nearest multiple of 10%.

B.01.402. (1) The nutrition facts table may also contain information set out in column 1 of the table to this section.

(2) If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(3) The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids shall be in the nutrition facts table if

(a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is in the nutrition facts table or is shown on the label of the prepackaged product or in any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product; or

(b) the amount of any specific fatty acid is shown on the label of the prepackaged product or in any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product.

(4) If the label of a prepackaged product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information shall also be in the nutrition facts table.

(5) The amount of potassium shall be in the nutrition facts table if the prepackaged product contains added potassium salts and the label of the product or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product contains a statement or claim referred to in column 4 of any of items 31 to 36 of the table following section B.01.513 for the subject “free of sodium or salt”, “low in sodium or salt”, “reduced in sodium or salt”, “lower in sodium or salt”, “no added sodium or salt” or “lightly salted” set out in column 1.

(6) The nutrition facts table shall show the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, except in the case of iodide added to salt for table or general household use or fluoride added to prepackaged water or ice.

(7) The nutrition facts table shall show the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour.

(8) Despite subsection (1) and item 1 of the table to this section, the nutrition facts table shall not include information on servings per container if the serving of stated size is expressed in cups or tablespoons.

(9) If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be shown

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language.

TABLE

ADDITIONAL INFORMATION

Column 1 Column 2 Column 3 Column 4 Item Information Description Unit Manner of expression

Servings per “Servings Per Container” or The quantity (1) The quantity is1. container “(number of units) Per is expressed in rounded off

Column 1 Column 2 Column 3 Item Information Description Unit

Container” number of servings.

The value is expressed in

2. Energy value “kilojoules” or “kJ” kilojoules per serving of stated size.

3.

The value is expressed inEnergy value from “Calories from Fat” or Calories perfat “Calories from Total Fat” serving of stated size.

Column 4 Manner of expression (a) if it is less than 2, to the nearest multiple of 1; (b) if it is between 2 and 5, to the nearest multiple of 0.5; and (c) if it is more than 5, to the nearest multiple of 1. (2) If a quantity is rounded off, it shall be preceded by the word “about”. (3) If the product is of a random weight, the quantity may be declared as “varied”.

The value is rounded off to the nearest multiple of 10 kilojoules.

The value is rounded off (a) if it is less than 5 Calories

(i) if the amount of fat is declared as “0 g” in the nutrition facts table, to “0” Calorie, and

(ii) in all other cases, to the nearest multiple of 1 Calorie;

(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.

Column 1 Item Information

4.

Energy value from the sum of saturated and trans fatty acids

5.

Amount of polyunsaturated fatty acids

Amount of omega­6. 6 polyunsaturated fatty acids

Column 2 Description

“Calories from Saturated + Trans Fat”, “Calories from Saturated + Trans Fatty Acids”, “Calories from Saturated + Trans” or “Calories from Saturates + Trans”

“Polyunsaturated Fat”, “Polyunsaturated Fatty Acids”, “Polyunsaturated” or “Polyunsaturates”

(1) If the nutrition facts table includes the amount of polyunsaturated fatty acids: “Omega-6”, “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturated”

Column 3 Unit

The value is expressed in Calories per serving of stated size.

The amount is expressed in grams per serving of stated size.

The amount is expressed in grams per serving of stated size.

Column 4 Manner of expression The value is rounded off (a) if it is less than 5 Calories

(i) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the nutrition facts table, to “0” Calorie, and

(ii) in all other cases, to the nearest multiple of Calorie;

(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories. The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g;

(b) if it is 1 g or more but not more than 5 g, to the nearest

Column 1 Item Information

7.

Amount of omega­ 3 polyunsaturated fatty acids

8.

Amount of monounsaturated fatty acids

Amount of9. potassium

Column 2 Description

(2) In all other cases: “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturated”

(1) If the nutrition facts table includes the amount of polyunsaturated fatty acids: “Omega-3”, “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated”

(2) In all other cases: “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated”

“Monounsaturated Fat”, “Monounsaturated Fatty Acids”, “Monounsaturates” or “Monounsaturated”

“Potassium”

Column 3 Unit

The amount is expressed in grams per serving of stated size.

The amount is expressed in grams per serving of stated size.

The amount is expressed (a) in milligrams per serving of stated size; and

Column 4 Manner of expression multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.

The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and

(c) if it is more than 5 g, to the nearest multiple of 1 g.

The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. (1) The amount is rounded off

(a) if it is less than 5 mg

Column 1 Item Information

Amount of soluble10. fibre

Amount of11. insoluble fibre

Amount of sugar12. alcohol

Column 2 Description

“Soluble Fibre” or “Soluble Fiber”

“Insoluble Fibre” or “Insoluble Fiber”

(1) If the food contains only one type of sugar alcohol: “Sugar Alcohol”, “Polyol” or

Column 3 Unit

(b) as a percentage of the daily value per serving of stated size.

The amount is expressed as grams per serving of stated size.

The amount is expressed as grams per serving of stated size.

The amount is expressed as grams per

Column 4 Manner of expression

(i) if the product contains less than 5 mg of potassium per reference amount and per serving of stated size, to “0 mg”, and

(ii) in all other cases, to the nearest multiple of 1 mg;

(b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to “0%”; or (b) in all other cases, to the nearest multiple of 1%. The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The amount is rounded off

(a) if it is less than

Column 1 Item Information

13. Amount of starch

14. Amount of

(a) vitamin D

(b) vitamin E

(c) vitamin K

(d) thiamine

(e) riboflavin

(f) niacin (g) vitamin B6 (h) folate (i) vitamin B12 (j) biotin (k) pantothenic

Column 2 Description “(naming the sugar alcohol)”

(2) In all other cases: “Sugar Alcohols” or “Polyols”

“Starch”

(a) “Vitamin D” or “Vit D”

(b) “Vitamin E” or “Vit E”

(c) “Vitamin K” or “Vit K”

(d) “Thiamine”, “Thiamin”, “Thiamine (Vitamin B1)”, “Thiamine (Vit B1)”, “Thiamin (Vitamin B1)” or “Thiamin (Vit B1)”

(e) “Riboflavin”, “Riboflavin (Vitamin B2)” or “Riboflavin (Vit B2)” (f) “Niacin” (g) “Vitamin B6” or “Vit B6“ (h) “Folate” (i) “Vitamin B12“ or “Vit B12” (j) “Biotin” (k) “Pantothenic Acid” or

Column 3 Unit serving of stated size.

The amount is expressed as grams per serving of stated size.

The amount is expressed as a percentage of the daily value per serving of stated size.

Column 4 Manner of expression 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. The percentage is rounded off (a) if it is less than 2%

(i) if the product contains less than 1% of the daily value per reference amount and per serving of stated size, to “0%”, and

(ii) in all other cases, to the nearest multiple of 2%;

(b) if it is 2% or more but not more than 10%, to the nearest multiple of 2%; (c) if it is more than 10% but not more than 50%, to the nearest multiple of 5%; and (d) if it is more than 50%, to the nearest multiple of 10%.

Column 1 Column 2 Column 3 Column 4 Item Information Description Unit Manner of expression

acid “Pantothenate” (l) phosphorus (l) “Phosphorus” (m) iodide (m) “Iodide” or “Iodine” (n) magnesium (n) “Magnesium” (o) zinc (o) “Zinc” (p) selenium (p) “Selenium” (q) copper (q) “Copper” (r) manganese (r) “Manganese” (s) chromium (s) “Chromium” (t) molybdenum (t) “Molybdenum” (u) chloride (u) “Chloride”

In the version of the footnote that refers to nutrients, (a) the daily value for potassium is included only if the amount of

15. Basis of the percent daily values

One of the four footnotes to the subheading “% Daily Value” set out in Figures 18.1(E) and (F) of Schedule L

potassium is declared in the nutrition facts table; and (b) the daily value for cholesterol is included only if the amount of cholesterol is declared in the nutrition facts table as a percentage of the daily value per serving of stated size.

“Calories per gram:”, “Fat 9”,Energy conversion16. “Carbohydrate 4” andfactors “Protein 4”

SOR/2003-11, s. 20; err., Vol. 137, No. 5; SOR/2005-98, s. 2(F).

Foods for Children under Two Years of Age

B.01.403. (1) This section applies in respect of a prepackaged product intended solely for children under two years of age.

(2) The nutrition facts table of the product shall not contain

(a) the percentage of the daily value of fat, cholesterol, sodium, potassium, carbohydrate or fibre or of the sum of saturated fatty acids and trans fatty acids;

(b) the energy value from fat or from the sum of saturated fatty acids and trans fatty acids; or

(c) any of the footnotes to the subheading “% Daily Value” set out in Figures 18.1(E) and (F) in Schedule L.

(3) The nutrition facts table of the product may omit the amount of saturated fatty acids, trans fatty acids and cholesterol.

(4) Despite subsection (3), if the amount of cholesterol is in the nutrition facts table, the amounts of saturated fatty acids and trans fatty acids shall also be in the nutrition facts table.

(5) If the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2, 3 and 8 to 13 of the table to section B.01.401 may be expressed as “0” in the nutrition facts table of the product in accordance with that section, the nutrition facts table need only include the following information:

(a) the serving of stated size;

(b) the energy value;

(c) the amount of fat;

(d) the amount of carbohydrate;

(e) the amount of protein;

(f) the amount of any nutrient that is the subject of a representation referred to in subparagraph B.01.401(3)(e)(ii);

(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the product, other than fluoride added to prepackaged water or ice;

(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the product’s ingredients other than flour;

(i) the amount of any nutrient referred to in column 1 of item 8, 10, 11 or 13 of the table to section B.01.401 that may not be expressed as “0” in the nutrition facts table;

(j) except in the case described in paragraph (k), the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)”, but such a statement may be omitted in respect of saturated fatty acids, trans fatty acids and cholesterol; and

(k) if the product meets the condition specified in subsection B.01.462(3), the statement “Not a significant source of other nutrients” or the statement referred to in paragraph (j).

SOR/2003-11, s. 20.

Food for Use in Manufacturing other Foods

B.01.404. (1) This section applies to a prepackaged product that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or institution.

(2) No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser.

(3) The nutrition information

(a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product;

(b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and

(c) shall be expressed in accordance with sections B.01.401 and B.01.402, subject to the following modifications, namely,

(i) information for vitamins set out in column I of Table I to Division 1 of Part D and mineral nutrients set out in column I of Table I to Division 2 of that Part shall be expressed in the applicable units referred to in that column,

(A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or

(B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume,

(ii) information for other nutrients and the energy value set out in column 1 of the table to section B.01.401 or in column 1 of the table to section B.01.402 shall be expressed in the units referred to in column 3,

(A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or

(B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume,

(iii) percentages of daily values and information on servings of stated size may be omitted, and

(iv) the nutrition information shall be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information.

SOR/2003-11, s. 20.

Foods for Enterprise or Institution

B.01.405. (1) This section applies to a prepackaged product that is a multiple-serving ready­ to-serve prepackaged product intended solely to be served in a commercial or industrial enterprise or institution.

(2) No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser.

(3) The nutrition information

(a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product;

(b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and

(c) shall be expressed in accordance with sections B.01.401 and B.01.402.

SOR/2003-11, s. 20.

Basis of Information

B.01.406. (1) Subject to subsections (2) to (8), the information in the nutrition facts table shall be set out only on the basis of the prepackaged product as offered for sale.

(2) If a prepackaged product contains separately packaged ingredients or foods that are intended to be consumed together, the information in the nutrition facts table shall be set out for each ingredient or food or for the entire product.

(3) If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of only one of those foods, the information in the nutrition facts table shall be set out

(a) on the basis of each of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is different; or

(b) on the basis of one of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is the same.

(4) If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of more than one of those foods, the information in the nutrition facts table shall be set out for each of the foods contained in the product or as a composite value.

(5) If a prepackaged product contains a food that is to be prepared in accordance with directions provided in or on the package or that is commonly combined with other ingredients or another food or cooked before being consumed, the nutrition facts table may also set out information for the food as prepared, in which case

(a) the nutrition facts table shall set out the following information for the food as prepared, namely,

(i) except in the case described in subparagraph (ii), the amount of the food expressed in a unit specified in column 3 of paragraph 1(1)(a) or (c) of the table to section B.01.401 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),

(ii) if the food is commonly served combined with another food, the amount of the other food expressed in a unit specified in column 3 of paragraph 1(1)(c) of the table to section B.01.401 and, if applicable, in the manner specified in column 4 of subitem 1(1),

(iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4,

(iv) if it is declared in the nutrition facts table for the food as sold, the energy value from fat, expressed using a description set out in column 2 of item 3 of the table to section B.01.402, in the unit set out in column 3 and in the manner set out in column 4, and

(v) the information set out in column 1 of items 3, 6 to 10 and 13 of the table to section B.01.401 and in column 1 of items 9 and 14 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the food as sold, expressed using

a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4; and

(b) the nutrition facts table may also set out the following information for the added ingredients or the other food, if it is declared in the nutrition facts table for the food as sold, namely,

(i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and

(ii) the information set out in column 1 of items 5 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of item 9 and in grams for the information set out in column 1 of items 5 to 8 and 10 to 13 and in the manner specified in column 4.

(6) Subsection (5) does not apply in respect of a prepackaged product that is intended solely for children under two years of age.

(7) Subject to subsection (8), the information in the nutrition facts table may also be set out on the basis of other amounts of a food that reflect different uses or different units of measurement of a food, in which case

(a) the nutrition facts table shall set out the following information for each of the other amounts of food, namely,

(i) the amount of the food expressed in a unit specified in column 3 of subitem 1(1) of the table to section B.01.401 and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),

(ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4,

(iii) if it is declared in the nutrition facts table for the first amount of food for which information is declared, the energy value from fat, expressed using a description set out in column 2 of item 3 of the table to section B.01.402, in the unit set out in column 3 and in the manner set out in column 4, and

(iv) the information set out in column 1 of items 3, 6 to 10 and 13 of the table to section B.01.401 and in column 1 of items 9 and 14 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the first amount of food for which information is declared, expressed using a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4;

(b) if the nutrition facts table is set out in a version of the dual format specified in section B.01.458, it may also set out the amount of each of the other amounts of food expressed in the unit specified in column 3 of subitem 1(2) of the table to section B.01.401 and in the manner specified in column 4 of subitem 1(1), if that information is declared in the nutrition facts table for the first amount of food for which information is declared; and

(c) if the nutrition facts table is set out in a version of the aggregate format specified in section B.01.459 or B.01.464, it shall also set out the following information for each of the other

amounts of food, if that information is declared in the nutrition facts table for the first amount of food for which information is declared, namely,

(i) the amount of the food expressed in the unit specified in column 3 of subitem 1(2) of the table to section B.01.401 and in the manner specified in column 4 of subitem 1(1),

(ii) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and

(iii) the information set out in column 1 of items 5 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of item 9 and in grams for the information set out in column 1 of items 5 to 8 and 10 to 13 and in the manner specified in column 4.

(8) If the nutrition facts table of a prepackaged product that is intended solely for children under two years of age sets out information in accordance with subsection (7), it shall set out the information referred to in paragraphs (7)(a) and (c).

SOR/2003-11, s. 20.

[B.01.407 to B.01.449 reserved]

Presentation of Nutrition Facts Table

B.01.450. (1) Subject to subsections (2) to (6), the nutrition facts table shall be presented in accordance with the format specified in the applicable figure in Schedule L, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.

(2) The characters and rules in the nutrition facts table shall be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour.

(3) The characters in the nutrition facts table

(a) shall be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and

(b) may be displayed with larger dimensions than those specified in the applicable figure in Schedule L if all the characters in the table are enlarged in a uniform manner.

(4) A rule that is specified in the applicable figure in Schedule L as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the nutrition facts table.

(5) The information in the nutrition facts table shall be in accordance with sections B.01.400 to B.01.403 and B.01.406.

(6) In a nutrition facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in Schedule L.

SOR/2003-11, s. 20.

Location of Nutrition Facts Table

B.01.451. (1) Subject to subsection (2), the nutrition facts table shall be displayed on the label of the prepackaged product

(a) in a table in English and a table in French on the same continuous surface of the available display surface;

(b) in a table in both English and French on a continuous surface of the available display surface; or

(c) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.

(2) If in accordance with subsection B.01.012(3) or (7) the information required by these Regulations may be shown on the label of a prepackaged product in English only or in French only and is shown in that language, the nutrition facts table may be displayed on the label of the prepackaged product in a table in that language only on a continuous surface of the available display surface.

SOR/2003-11, s. 20.

Orientation of Nutrition Facts Table

B.01.452. (1) Subject to subsection (2), the nutrition facts table shall be oriented in the same manner as other information appearing on the label of the prepackaged product.

(2) If a version of a nutrition facts table cannot be oriented in the same manner as other information appearing on the label of the prepackaged product, it shall be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.

(3) Subsection (1) does not apply in respect of a nutrition facts table that is set out on the top or bottom of a prepackaged product.

SOR/2003-11, s. 20.

Application

B.01.453. (1) Sections B.01.454 to B.01.460 apply to prepackaged products other than those that are intended solely for children under two years of age.

(2) Sections B.01.461 to B.01.465 apply to prepackaged products that are intended solely for children under two years of age.

SOR/2003-11, s. 20.

Standard and Horizontal Formats

B.01.454. (1) This section applies to a prepackaged product unless any of sections B.01.455 to B.01.459 applies to the product.

(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of Schedule L;

(b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of Schedule L;

(c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of Schedule L;

(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or

(e) a manner described in section B.01.466.

(4) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table.

(5) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm2 or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 to 3 of the table to this section, without regard to any condition specified in column 2.

(6) Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 STANDARD FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 1.1(E) and (F)

1. (8 point type with 12 point leading)

2. 1.2(E) and (F) The version in item 1 cannot be displayed in accordance with

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 1.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 1.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 1.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 1.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 NARROW STANDARD FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 2.1(E) and (F)

1. (8 point type with 12 point leading) 2.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 2.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 2.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

PART 3 BILINGUAL STANDARD FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 3.1(B)

1. (8 point type with 12 point leading) 3.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 3.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 3.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

PART 4 BILINGUAL HORIZONTAL FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 4.1(B) The versions in Parts 1 to 3 cannot be displayed in accordance

1. (7 point condensed type with these Regulations on 15% or less of the available display with 11 point leading) surface. 4.2(B) The versions in Parts 1 to 3 and in item 1 cannot be displayed

2. (6 point condensed type in accordance with these Regulations on 15% or less of the with 10 point leading) available display surface.

SOR/2003-11, s. 20.

Simplified Formats

B.01.455. (1) This section applies to a prepackaged product if it satisfies the condition set out in subsection B.01.401(6) and its nutrition facts table includes only the information referred to in paragraphs B.01.401(6)(a) to (j).

(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.401(6)(a) to (j) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of Schedule L;

(b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of Schedule L;

(c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of Schedule L;

(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or

(e) a manner described in section B.01.466.

(4) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm2 or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to this section, without regard to any condition specified in column 2.

(5) Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 SIMPLIFIED STANDARD FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 5.1(E) and (F)

1. (8 point type with 12 point leading) 5.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 5.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 5.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 5.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. with these Regulations on 15% or less of the available display (6 point condensed type surface.

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) with 10 point leading) 5.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL SIMPLIFIED STANDARD FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 6.1(B)

1. (8 point type with 12 point leading) 6.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 6.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 6.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

PART 3 BILINGUAL SIMPLIFIED HORIZONTAL FORMAT

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 7.1(B) The versions in Parts 1 and 2 cannot be displayed in

1. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 7.2(B) The versions in Parts 1 and 2 and in item 1 cannot be displayed

2. in accordance with these Regulations on 15% or less of the (6 point condensed type available display surface.

Column 1 Column 2

Item Figure in Schedule N( fersion) Condition of use

with 10 point leading)

SOR/2003-11, s. 20.

Dual Format — Foods Requiring Preparation

B.01.456. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes information referred to in subsection B.01.406(5), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual dual format in accordance with Figure 9.5(B) or 9.6(B) of Schedule L; or

(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.01.406(5).

(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 DUAL FORMAT — FOODS REQUIRING PREPARATION

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 8.1(E) and (F)1. (8 point type with

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 12 point leading) 8.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 8.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 8.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 8.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 8.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL DUAL FORMAT — FOODS REQUIRING PREPARATION

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 9.1(B)

1. (8 point type with 12 point leading) 9.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 9.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 9.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

SOR/2003-11, s. 20.

Aggregate Format — Different Kinds of Foods

B.01.457. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out

(a) in the case of a product described in subsection B.01.406(2) or (4), in

(i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of Schedule L, or

(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or

(b) in the case of a product described in paragraph B.01.406(3)(a), in

(i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of Schedule L,

(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or

(iii) a manner described in section B.01.466.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in subparagraph (2)(a)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 10.1(E) and (F)

1. (8 point type with 12 point leading) 10.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 10.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 10.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 10.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 10.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 11.1(B)

1. (8 point type with 12 point leading) 11.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 11.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 11.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

SOR/2003-11, s. 20.

Dual Format — Different Amounts of Food

B.01.458. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraph B.01.406(7)(a) without including the information referred to in paragraph B.01.406(7)(c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual dual format in accordance with Figure 13.5(B) or 13.6(B) of Schedule L; or

(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 DUAL FORMAT — DIFFERENT AMOUNTS OF FOOD

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 12.1(E) and (F)

1. (8 point type with 12 point leading) 12.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 12.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. accordance with these Regulations on 15% or less of the (7 point condensed type available display surface.

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) with 11 point leading)

4. 12.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 12.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 12.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL DUAL FORMAT — DIFFERENT AMOUNTS OF FOOD

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 13.1(B)

1. (8 point type with 12 point leading) 13.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 13.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 13.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

SOR/2003-11, s. 20.

Aggregate Format — Different Amounts of Food

B.01.459. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraphs B.01.406(7)(a) and (c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of Schedule L; or

(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE PART 1 AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 14.1(E) and (F)

1. (8 point type with 12 point leading) 14.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 14.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 14.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4, (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 14.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 14.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 15.1(B)

1. (8 point type with 12 point leading) 15.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 15.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 15.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

SOR/2003-11, s. 20.

Presentation of Additional Information

B.01.460. (1) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed

(a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of Schedule L; and

(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.

(2) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed

(a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of Schedule L; and

(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.

(3) Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of Schedule L is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.454(3)(c) or the simplified linear format referred to in paragraph B.01.455(3)(c).

SOR/2003-11, s. 20.

Standard and Horizontal Formats — Children under Two Years of Age

[SOR/2003-11, s. 20; err.(E), Vol. 137, No. 5]

B.01.461. (1) This section applies to a prepackaged product that is intended solely for children under two years of age unless section B.01.462, B.01.463 or B.01.464 applies to the product.

(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual standard format in accordance with Figure 22.5(B), 22.6(B) or 22.7(B) of Schedule L;

(b) the bilingual horizontal format in accordance with Figure 23.3(B) or 23.4(B) of Schedule L;

(c) the linear format in accordance with Figures 31.1(E) and (F) or 31.2(E) and (F) of Schedule L;

(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or

(e) a manner described in section B.01.466.

(4) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table.

TABLE

PART 1 STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 20.1(E) and (F)

1. (8 point type with 12 point leading) 20.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 20.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 20.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 20.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 20.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 NARROW STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 21.1(E) and (F)

1. (8 point type with 12 point leading) 21.2(E) and (F) The version in item 1 cannot be displayed in accordance with2. (7 point type with these Regulations on 15% or less of the available display

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 11 point leading) surface. 21.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 21.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

PART 3 BILINGUAL STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 22.1(B)

1. (8 point type with 12 point leading) 22.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 22.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 22.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

PART 4 BILINGUAL HORIZONTAL FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 23.1(B) The versions in Parts 1 to 3 cannot be displayed in accordance

1. (7 point condensed type with these Regulations on 15% or less of the available display with 11 point leading) surface. 23.2(B) The versions in Parts 1 to 3 and in item 1 cannot be displayed

2. (6 point condensed type in accordance with these Regulations on 15% or less of the with 10 point leading) available display surface.

SOR/2003-11, s. 20.

Simplified Formats — Children under Two Years of Age

B.01.462. (1) This section applies to a prepackaged product that is intended solely for children under two years of age if it satisfies the condition set out in subsection B.01.403(5) and its nutrition facts table includes only the information referred to in paragraphs B.01.403(5)(a) to (k).

(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.403(5)(a) to (k) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual simplified standard format in accordance with Figure 25.5(B) or 25.6(B) of Schedule L;

(b) the bilingual simplified horizontal format in accordance with Figure 26.3(B) or 26.4(B) of Schedule L;

(c) the simplified linear format in accordance with Figures 32.1(E) and (F) or 32.2(E) and (F) of Schedule L;

(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or

(e) a manner described in section B.01.466.

TABLE PART 1 SIMPLIFIED STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 24.1(E) and (F)

1. (8 point type with 12 point leading) 24.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 24.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 24.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 24.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 24.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL SIMPLIFIED STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 25.1(B)

1. (8 point type with 12 point leading) 25.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 25.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 25.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. with these Regulations on 15% or less of the available display (6 point condensed type surface.

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) with 10 point leading)

PART 3 BILINGUAL SIMPLIFIED HORIZONTAL FORMAT — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 26.1(B) The versions in Parts 1 and 2 cannot be displayed in

1. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 26.2(B) The versions in Parts 1 and 2 and in item 1 cannot be displayed

2. (6 point condensed type in accordance with these Regulations on 15% or less of the with 10 point leading) available display surface.

SOR/2003-11, s. 20.

Aggregate Format — Different Kinds of Foods — Children under Two Years of Age

B.01.463. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for children under two years of age includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out

(a) in the case of a product described in subsection B.01.406(2) or (4), in

(i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of Schedule L, or

(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or

(b) in the case of a product described in paragraph B.01.406(3)(a), in

(i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of Schedule L,

(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or

(iii) a manner described in section B.01.466.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.

TABLE PART 1 AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 27.1(E) and (F)

1. (8 point type with 12 point leading) 27.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 27.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 27.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 27.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 27.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2

BILINGUAL AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 28.1(B)

1. (8 point type with 12 point leading) 28.2(B) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 28.3(B) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 28.4(B) The versions in items 1 to 3 cannot be displayed in accordance

4. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface.

SOR/2003-11, s. 20.

Aggregate Format — Different Amounts of Food — Children under Two Years of Age

B.01.464. (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for children under two years of age includes separate information for different amounts of the food as provided in subsection B.01.406(8), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in

(a) the bilingual aggregate format in accordance with Figure 30.5(B) or 30.6(B) of Schedule L; or

(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.

TABLE PART 1 AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule L Condition of use(Version) 29.1(E) and (F)

1. (8 point type with 12 point leading) 29.2(E) and (F) The version in item 1 cannot be displayed in accordance with

2. (7 point type with these Regulations on 15% or less of the available display 11 point leading) surface. 29.3(E) and (F) The versions in items 1 and 2 cannot be displayed in

3. (7 point condensed type accordance with these Regulations on 15% or less of the with 11 point leading) available display surface. 29.4(E) and (F) The versions in items 1 to 3 cannot be displayed in accordance

4. (7 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 29.5(E) and (F) The versions in items 1 to 4 cannot be displayed in accordance

5. (6 point condensed type with these Regulations on 15% or less of the available display with 10 point leading) surface. 29.6(E) and (F) The versions in items 1 to 5 cannot be displayed in accordance

6. (6 point condensed type with these Regulations on 15% or less of the available display with 9 point leading) surface.

PART 2 BILINGUAL AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD — CHILDREN UNDER TWO YEARS OF AGE

Column 1 Column 2

Item Figure in Schedule N( fersion) 30.1(B)

1. (8 point type with 12 point leading) 30.2(B)

2. (7 point type with 11 point leading) 30.3(B)

3. (7 point condensed type with 11 point leading) 30.4(B)

4. (6 point condensed type with 10 point leading)

SOR/2003-11, s. 20.

Condition of use

The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Presentation of Additional Information — Children under Two Years of Age

B.01.465. (1) This section applies to a prepackaged product that is intended solely for children under two years of age.

(2) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed

(a) in accordance with the order of presentation and the use of indents illustrated in Figures 33.1(E) and (F) of Schedule L; and

(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.

(3) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed

(a) in accordance with the order of presentation and the use of indents illustrated in Figure 34.1(B) of Schedule L; and

(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.

(4) Despite paragraph (2)(a), the use of indents illustrated in Figures 33.1(E) and (F) of Schedule L is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.461(3)(c) or the simplified linear format referred to in paragraph B.01.462(3)(c).

SOR/2003-11, s. 20.

Alternative Methods of Presentation

B.01.466. (1) Despite section A.01.016, the nutrition facts table of a prepackaged product that meets the condition specified in subsection B.01.454(3) or B.01.455(3), paragraph B.01.457(2)(b), subsection B.01.461(3) or B.01.462(3) or paragraph B.01.463(2)(b) may be set out on

(a) a tag attached to the package;

(b) a package insert;

(c) the inner side of a label;

(d) a fold-out label; or

(e) an outer sleeve, overwrap or collar.

(2) If the nutrition facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package shall indicate in a type size of not less than 8 points where the nutrition facts table is located.

(3) If the nutrition facts table is set out in a manner described in subsection (1), it shall be set out

(a) in the case of a product described in subsection B.01.454(3), in a version that is described in paragraph B.01.454(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.454;

(b) in the case of a product described in subsection B.01.455(3), in a version that is described in paragraph B.01.455(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.455;

(c) in the case of a product described in paragraph B.01.457(2)(b), in a version that is described in subparagraph B.01.457(2)(b)(i) or that is listed in column 1 of the table to section B.01.457;

(d) in the case of a product described in subsection B.01.461(3), in a version that is described in paragraph B.01.461(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.461;

(e) in the case of a product described in subsection B.01.462(3), in a version that is described in paragraph B.01.462(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.462; and

(f) in the case of a product described in paragraph B.01.463(2)(b), in a version that is described in subparagraph B.01.463(2)(b)(i) or that is listed in column 1 of the table to section B.01.463.

SOR/2003-11, s. 20.

Small Packages

B.01.467. (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a prepackaged product is less than 100 cm2, the label of the product need not carry a nutrition facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the nutrition information that would otherwise be required to be set out in a nutrition facts table on the label of the product.

(2) Subsection (1) does not apply to a prepackaged product that is

(a) described in paragraph B.01.401(3)(a), (b), (c) or (e); or

(b) contained in a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase.

(3) An indication referred to in subsection (1)

(a) shall be set out in a type size of not less than 8 points;

(b) shall include a postal address or a toll-free telephone number; and

(c) shall be

(i) in English and French, or

(ii) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language.

(4) The manufacturer of the prepackaged product shall provide the information referred to in subsection (1) to a purchaser or consumer on request

(a) without charge;

(b) in the following manner, namely,

(i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or

(ii) in one of the official languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language; and

(c) in the form of a nutrition facts table that is set out

(i) in a format, other than a horizontal format, that is specified in any of sections B.01.454 to B.01.459 or B.01.461 to B.01.464 and that would otherwise be carried on the label of the product in accordance with these Regulations, and

(ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i).

(5) In this section, “official languages” means the English language and the French language.

SOR/2003-11, s. 20.

[B.01.468 to B.01.499 reserved]

Nutrient Content Claims

Interpretation

B.01.500. (1) The following definitions apply in this section and in the table following section B.01.513.

“combination foods” means the category of food to which belong foods that contain as ingredients foods from more than one food group, or foods from one or more food groups mixed with foods from the category of other foods, such as pizza or lasagna. (aliments composés)

“food group” means one of the following categories of foods:

(a) milk products, and milk product alternatives such as fortified plant-based beverages;

(b) meat, poultry and fish, and alternatives such as legumes, eggs, tofu or peanut butter;

(c) bread and grain products; or

(d) vegetables and fruit. (groupe alimentaire)

“other foods” means the category of food to which belong foods that are not part of any food group, including

(a) foods that are mostly fats, such as butter, margarine, oil or lard;

(b) foods that are mostly sugars, such as jam, honey, syrup or confectionery;

(c) snack foods, such as potato chips or pretzels;

(d) beverages, such as water, tea, coffee or soft drinks; and

(e) herbs, spices and condiments, such as pickles, mustard or ketchup. (autres aliments)

“reference food of the same food group” means a food that can be substituted in the diet for the food to which it is compared and that belongs to

(a) the same food group as the food to which it is compared, such as cheese as a reference food for milk, or chicken as a reference food for tofu;

(b) the category of other foods, if the food to which it is compared also belongs to that category, such as pretzels as a reference food for potato chips; or

(c) the category of combination foods, if the food to which it is compared also belongs to that category, such as pizza as a reference food for lasagna. (aliment de référence du même groupe alimentaire)

“similar reference food” means a food of the same type as the food to which it is compared and that has not been processed, formulated, reformulated or otherwise modified in a manner that increases or decreases the energy value or the amount of a nutrient that is the subject of the comparison, such as whole milk as a similar reference food for partly skimmed milk or regular chocolate chip cookies as a similar reference food for fat-reduced chocolate chip cookies. (aliment de référence similaire)

(2) The similar reference food referred to in column 3 of item 45 of the table following section B.01.513, with respect to the subject “light in energy or fat” set out in column 1, shall have a nutrient value that is representative of foods of that type that have not been processed,

formulated, reformulated or otherwise modified in a manner that increases the energy value or the amount of fat.

SOR/2003-11, s. 20; SOR/2007-302, s. 4(F). Previous Version Languages

B.01.501. The representations provided for in sections B.01.503 to B.01.513 that appear on the label of a food shall be

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

SOR/2003-11, s. 20.

Statements or Claims

B.01.502. (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, that characterizes the energy value of the food or the amount of a nutrient contained in the food.

(2) Subsection (1) does not apply to

(a) a representation otherwise provided for in these Regulations;

(b) a representation provided for by section 35 of the Processed Products Regulations;

(c) a representation provided for by subsection 94(4) of the Meat Inspection Regulations, 1990;

(d) a representation that characterizes the amount of lactose in a food;

(e) a representation that characterizes the addition of salt to a food, other than any statement or claim set out in column 4 of the table following section B.01.513;

(f) a representation that characterizes the addition of sugars to a food, other than any statement or claim set out in column 4 of the table following section B.01.513;

(g) a representation that characterizes the amount of starch in a food, if the food is intended solely for children under two years of age;

(h) the representations “defatted (naming the food)”, “demineralized (naming the food)” and “high (naming the monosaccharide or disaccharide) (naming the syrup)”;

(i) a representation that characterizes the amount of a fatty acid in a vegetable oil and forms part of its common name;

(j) a representation that characterizes the amount of alcohol in beverages that contain more than 0.5% alcohol;

(k) the representation “light salted” with respect to fish; or

(l) the English representation “lean” with respect to a prepackaged meal represented for use in a weight reduction diet or a weight maintenance diet.

SOR/2003-11, s. 20.

B.01.503. (1) A person may, on the label of or in any advertisement for a food, make a statement or claim set out in column 4 of the table following section B.01.513, with respect to a subject set out in column 1, if

(a) the food meets the applicable conditions set out in column 2;

(b) the label or advertisement meets the conditions, if any, set out in column 3, in accordance with sections B.01.504 to B.01.506; and

(c) in the case of a food that is not a prepackaged product, or a prepackaged product for which an advertisement is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement includes, per serving of stated size, and in accordance with section B.01.505 or B.01.506 if applicable,

(i) the declaration of the energy value, if the energy value is the subject of the statement or claim, or

(ii) the amount of the nutrient, if a nutrient is the subject of the statement or claim.

(2) Despite subsection (1), no person shall, on the label of or in any advertisement for a food that is intended solely for children under two years of age, make a statement or claim set out in column 4 of the table following section B.01.513, unless it is a statement or claim respecting one of the following subjects set out in column 1:

(a) “source of protein”, set out in item 8;

(b) “excellent source of protein”, set out in item 9;

(c) “more protein”, set out in item 10;

(d) “no added sodium or salt”, set out in item 35; or

(e) “no added sugars”, set out in item 40.

(3) If a statement or claim set out in column 4 of the table following section B.01.513 is made on the label of or in any advertisement for a food, all the words, numbers, signs or symbols that constitute the statement or claim shall be of the same size and prominence.

(4) In the English version of the statements or claims, the word “fibre” may be spelled as “fiber”.

SOR/2003-11, s. 20.

B.01.504. If a statement or claim set out in column 4 of the table following section B.01.513 is made on the label of a food, the information required under the conditions set out in column 3 shall be

(a) adjacent to, without any intervening printed, written or graphic material,

(i) the statement or claim, if the statement or claim is made only once, or

(ii) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once; and

(b) shown in letters of at least the same size and prominence as

(i) those of the statement or claim, if the statement or claim is made only once, or

(ii) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once.

SOR/2003-11, s. 20.

B.01.505. If a statement or claim set out in column 4 of the table following section B.01.513 is made in an advertisement for a food, other than a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be

(a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

SOR/2003-11, s. 20.

B.01.506. (1) If a statement or claim set out in column 4 of the table following section B.01.513 is made in a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be provided in the advertisement, except for the information required under the condition set out in paragraph (a) of column 3, in respect of the following subjects set out in column 1, which may be on the label:

(a) “reduced in energy”, set out in item 3;

(b) “reduced in fat”, set out in item 13;

(c) “reduced in saturated fatty acids”, set out in item 20;

(d) “reduced in trans fatty acids”, set out in item 23;

(e) “reduced in cholesterol”, set out in item 29;

(f) “reduced in sodium or salt”, set out in item 33;

(g) “lightly salted”, set out in item 36;

(h) “reduced in sugars”, set out in item 38; and

(i) “light in energy or fat”, set out in item 45.

(2) Despite subsection (1), if the statement or claim is made in a radio or television advertisement that is not made or placed by or on the direction of the manufacturer of the food, the information required under the condition set out in paragraph (a) of column 3 of the table following section B.01.513, in respect of the subjects set out in paragraphs (1)(a) to (i), shall be provided in the advertisement.

(3) If the information required under the conditions set out in column 3 of the table following section B.01.513 and the information required by paragraph B.01.503(1)(c) is provided in a radio advertisement or in the audio portion of a television advertisement, that information shall immediately precede or follow the statement or claim.

(4) In the case of a television advertisement, the information required under the conditions set out in column 3 of the table following section B.01.513 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be communicated

(a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or

(b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(5) If the information required under the conditions set out in column 3 of the table following section B.01.513 and the information required by paragraph B.01.503(1)(c) is communicated in the visual mode of a television advertisement, it shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

SOR/2003-11, s. 20.

B.01.507. A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in an energy-reduced diet, if a statement or claim set out in column 4 of the table following section B.01.513, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503:

(a) “free of energy”, set out in item 1;

(b) “low in energy”, set out in item 2;

(c) “reduced in energy”, set out in item 3;

(d) “lower in energy”, set out in item 4; or

(e) “free of sugars”, set out in item 37.

SOR/2003-11, s. 20.

B.01.508. A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in a sodium-restricted diet, if a statement or claim set out in column 4 of the table following section B.01.513, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503:

(a) “free of sodium or salt”, set out in item 31;

(b) “low in sodium or salt”, set out in item 32;

(c) “reduced in sodium or salt”, set out in item 33; or

(d) “lower in sodium or salt”, set out in item 34.

SOR/2003-11, s. 20.

B.01.509. A person may, on the label of or in any advertisement for a food, make the statement or claim that the food is “unsweetened” if the food meets the conditions set out in column 2 of item 40 of the table following section B.01.513 for the subject “no added sugars” set out in column 1 and the food does not contain a sweetener set out in column I of Table IX to section B.16.100.

SOR/2003-11, s. 20.

B.01.510. A statement or claim set out in column 4 of the table following section B.01.513, respecting the following subjects set out in column 1, that is made on the label of or in an advertisement for a breakfast cereal with milk, shall be accompanied by an indication that it refers to 30 g of the breakfast cereal combined with 125 mL of milk:

(a) “source of protein”, set out in item 8;

(b) “excellent source of protein”, set out in item 9; and

(c) “more protein”, set out in item 10.

SOR/2003-11, s. 20.

B.01.511. (1) For greater certainty and subject to subsections (2) to (4), a statement or claim set out in column 4 of the table following section B.01.513 that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.

(2) The words “very”, “ultra” and “extra”, and all other words, numbers, signs or symbols that modify the nature of a statement or claim, shall not precede or follow the statement or claim.

(3) A statement or claim that is made on the label of or in any advertisement for a food that has not been processed, formulated, reformulated or otherwise modified to meet the conditions set out in column 2 of the table following section B.01.513 shall not be accompanied by the brand name of the food.

(4) Any words, numbers, signs or symbols preceding or following the statement or claim referred to in subsection (3) shall accompany the statement or claim in such a manner that the statement or claim characterizes all foods of that type, and not only the specific food.

SOR/2003-11, s. 20.

B.01.512. If a food meets the conditions set out in column 2 of the table following section B.01.513 for more than one of the subjects set out in column 1, it is not necessary to repeat the common element of the statements or claims set out in column 4 that are used on the label of or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate.

SOR/2003-11, s. 20.

Sensory Characteristic

B.01.513. (1) No person shall, on the label of or in any advertisement for a food, make the statement or claim “light” or “léger” — including any phonetic rendering of that statement or claim — respecting a sensory characteristic of the food unless the following conditions are met:

(a) if the statement or claim “light” or “léger” is made on the label of a food, the sensory characteristic shall be

(i) adjacent to, without any intervening printed, written or graphic material,

(A) the statement or claim, if the statement or claim is made only once, or

(B) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as

(A) those of the statement or claim, if the statement or claim is made only once, or

(B) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once;

(b) if the statement or claim “light” or “léger” is made in an advertisement for a food, other than a radio or television advertisement, the sensory characteristic shall be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(c) if the statement or claim “light” or “léger” is made in a radio advertisement or in the audio portion of a television advertisement, the sensory characteristic shall immediately precede or follow the statement or claim; and

(d) if the statement or claim “light” or “léger” is made in the visual portion of a television advertisement, the sensory characteristic shall

(i) appear concurrently with and for the same amount of time as the statement or claim,

(ii) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(iii) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(2) Subsection (1) does not apply to

(a) the English statement or claim “light” when used in accordance with subsection 12(1) of the Maple Products Regulations; or

(b) the statement or claim “light” or “léger” when used with respect to rum.

TABLE

Column 1 Column 2 Column 3 Column 4 Conditions — LabelItem Subject Conditions — Food Statement or Claimor Advertisement

“energy-free”, “free of energy”, “no energy”, “0 energy”, “zero energy”,

The food provides less “without energy”, than 5 Calories or “contains no energy”,Free of1. 21 kilojoules per “Calorie-free”, “free ofenergy reference amount and Calories”, “no Calories”, serving of stated size. “0 Calories”, “zero

Calories”, “without Calories” or “contains no Calories”

Low in2. The food providesenergy “low energy”, “low in (a) 40 Calories or energy”, “low source of 167 kilojoules or less per energy”, “little energy”, reference amount and “low Calorie”, “low in serving of stated size Calories”, “low source of and, in the case of a food Calories”, “contains only other than a table-top (number) Calories per sweetener, if the serving”, “contains less reference amount is 30 g than (number) Calories per or 30 mL or less, per serving” or “few Calories” 50 g; or (b) 120 Calories or 500 kilojoules or less per 100 g, if the food is a prepackaged meal.

“reduced energy”, “reduced in energy”,

3. Reduced in (1) The food is The following are “energy-reduced”, “less energy processed, formulated, identified: energy”, “lower energy”,

reformulated or otherwise modified so

Column 1

Item Subject

Lower in4. energy

Column 2

Conditions — Food

that it provides at least 25% less energy

(a) per reference amount of the food, than the reference amount of the similar reference food; or

(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.

(2) The similar reference food does not meet the conditions set out in column 2 of item 2 for the subject “low in energy” set out in column 1.

(1) The food provides at least 25% less energy (a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 2 for the subject “low in

Column 3 Conditions — Label or Advertisement

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and (c) the difference in energy value compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories. The following are identified:

(a) the reference food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in energy value compared to the reference food of the same food group, per serving

Column 4

Statement or Claim

“lower in energy”, “reduced Calorie”, “reduced in Calories”, “Calorie-reduced”, “less Calories”, “lower Calories”, “lower in Calories” or “fewer Calories”

“less energy”, “lower energy”, “lower in energy”, “less Calories”, “lower Calorie”, “lower in Calories” or “fewer Calories”

Column 1

Item Subject

Source of5. energy

6. More energy

Low in7. protein

Column 2

Conditions — Food

energy” set out in column 1.

The food provides at least 100 Calories or 420 kilojoules per reference amount and serving of stated size.

The food provides at least 25% more energy, totalling at least 100 more Calories or 420 more kilojoules (a) per reference amount of the food, than the reference amount of the reference food of the same food group or the similar reference food; or

(b) per 100 g, than 100 g of the reference food of the same food group or the similar reference food, if the food is a prepackaged meal.

The food contains no more than 1 g of protein

Column 3 Conditions — Label or Advertisement of stated size, expressed as a percentage or fraction or in Calories.

The following are identified:

(a) the reference food of the same food group or the similar reference food;

(b) the amounts of the food and the reference food of the same food group or the similar reference food being compared, if those amounts are not equal; and (c) the difference in energy value compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories.

Column 4

Statement or Claim

“source of energy”, “contains energy”, “provides energy”, “source of Calories”, “contains Calories” or “provides Calories”

“more Calories”, “contains more Calories”, “higher Calories” or “higher in Calories”

“low protein”, “low in protein”, “low source of

Column 1 Column 2 Column 3 Column 4 Conditions — LabelItem Subject Conditions — Food Statement or Claimor Advertisement

per 100 g of the food. protein”, “contains only (number) g of protein per serving” or “contains less than (number) g of protein per serving”

The food has a protein rating of 20 or more, as “source of protein”, determined by official “contains protein”, “goodSource of8. method FO-1, source of protein”, “highprotein Determination of Protein protein”, “high in protein” Rating, October 15, or “provides protein” 1981, (a) per reasonable daily intake; or (b) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal. The food has a protein rating of 40 or more, as “excellent source of

Excellent determined by official protein”, “very high 9. source of method FO-1, protein”, “very high in

protein Determination of Protein protein” or “rich in Rating, October 15, protein” 1981, (a) per reasonable daily intake; or (b) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal.

The following are10. More protein The food identified: (a) has a protein rating of 20 or more, as (a) the reference “more protein”, “higher determined by official food of the same protein” or “higher in method FO-1, food group or the protein” Determination of Protein similar reference Rating, October 15, food; 1981,

(b) the amounts of the food and the(i) per reasonable daily reference food ofintake, or the same food group or the similar

Column 1 Column 2

Item Subject Conditions — Food

(ii) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal; and

(b) contains at least 25% more protein, totalling at least 7 g more, per reasonable daily intake than the reference food of the same food group or the similar reference food.

11. Free of fat The food contains

(a) less than 0.5 g of fat per reference amount and serving of stated size; or

(b) less than 0.5 g of fat per serving of stated size, if the food is a

12. Low in fat prepackaged meal. The food contains (a) 3 g or less of fat per reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g; or (b) 3 g or less of fat per 100 g with 30% or less of the energy from fat, if the food is a prepackaged meal.

13. Reduced infat (1) The food is processed, formulated,

Column 3 Conditions — Label or Advertisement reference food being compared, if those amounts are not equal; and (c) the difference in protein compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.

The following are identified:

Column 4

Statement or Claim

“fat-free”, “free of fat”, “no fat”, “0 fat”, “zero fat”, “without fat”, “contains no fat” or “non­ fat”

“low fat”, “low in fat”, “low source of fat”, “little fat”, “contains only (number) g of fat per serving” or “contains less than (number) g of fat per serving”

“reduced fat”, “reduced in fat”, “fat-reduced”, “less

Column 1

Item Subject

14. Lower in fat

Column 2

Conditions — Food

reformulated or otherwise modified so that it contains at least 25% less fat (a) per reference amount of the food, than the reference amount of the similar reference food; or

(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.

(2) The similar reference food does not meet the conditions set out in column 2 of item 12 for the subject “low in fat” set out in column 1.

(1) The food contains at least 25% less fat (a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 12 for the subject “low in fat” set out in column 1.

Column 3 Conditions — Label or Advertisement

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and (c) the difference in fat compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams. The following are identified:

(a) the reference food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in fat compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or

Column 4

Statement or Claim

fat”, “lower fat” or “lower in fat”

“less fat”, “lower fat” or “lower in fat”

Column 1 Column 2

Item Subject Conditions — Food

100% fat­15. The foodfree (a) contains less than 0.5 g of fat per 100 g; (b) contains no added fat; and (c) meets the conditions set out in column 2 of item 11 for the subject “free of fat” set out in column 1. The food meets the conditions set out in(Percentage)16. column 2 of item 12 forfat-free the subject “low in fat” set out in column 1. (1) The food contains no added fats or oils set out in Division 9, or added

17. No added fat butter or ghee, or ingredients that contain added fats or oils, or butter or ghee. (2) The similar reference food contains added fats or oils set out in Division 9, or added butter or ghee.

18. The food contains (a) less than 0.2 g

Free of saturated fatty acids and saturated less than 0.2 g trans fatty fatty acids acids per reference

amount and serving of stated size; or

(b) less than 0.2 g saturated fatty acids and less than 0.2 g trans fatty acids per serving of stated size, if the food is a prepackaged meal.

Column 3 Conditions — Label or Advertisement fraction or in grams.

One of the following statements or claims is stated: “low fat” or “low in fat”.

Column 4

Statement or Claim

“100% fat-free” or “100% free of fat”

“(percentage) fat-free” or “(percentage) free of fat”

“no fat added”, “no added fat” or “without added fat”

“saturated fatty acids- free”, “free of saturated fatty acids”, “no saturated fatty acids”, “0 saturated fatty acids”, “zero saturated fatty acids”, “without saturated fatty acids”, “saturated fat-free”, “free of saturated fat”, “no saturated fat”, “0 saturated fat”, “zero saturated fat”, “without saturated fat”, “saturates-free”, “free of saturates”, “no saturates”, “0 saturates”, “zero saturates” or “without

Column 1

Item Subject

Low in 19. saturated

fatty acids

Reduced in 20. saturated

fatty acids

Column 2

Conditions — Food

(1) The food contains 2 g or less of saturated fatty acids and trans fatty acids combined (a) per reference amount and serving of stated size; or (b) per 100 g, if the food is a prepackaged meal.

(2) The food provides 15% or less energy from the sum of saturated fatty acids and trans fatty acids.

(1) The food is processed, formulated, reformulated or otherwise modified, without increasing the content of trans fatty acids, so that it contains at least 25% less saturated fatty acids (a) per reference amount of the food, than the reference amount of the similar reference food; or (b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.

Column 3 Conditions — Label or Advertisement

The following are identified:

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being

Column 4

Statement or Claim

saturates” “low saturated fatty acids”, “low in saturated fatty acids”, “low source of saturated fatty acids”, “little saturated fatty acids”, “contains only (number) g of saturated fatty acids per serving”, “contains less than (number) g of saturated fatty acids per serving”, “low saturated fat”, “low in saturated fat”, “low source of saturated fat”, “little saturated fat”, “contains only (number) g of saturated fat per serving”, “contains less than (number) g of saturated fat per serving”, “low saturates”, “low in saturates”, “low source of saturates”, “little saturates”, “contains only (number) g of saturates per serving” or “contains less than (number) g of saturates per serving” “reduced saturated fatty acids”, “reduced in saturated fatty acids”, “saturated fatty acids- reduced”, “less saturated fatty acids”, “lower saturated fatty acids”, “lower in saturated fatty acids”, “fewer saturated fatty acids”, “reduced saturated fat”, “reduced in saturated fat”, “saturated fat-reduced”, “less saturated fat”, “lower saturated fat”, “lower in saturated fat”, “reduced saturates”, “reduced in

Column 1

Item Subject

Lower in 21. saturated

fatty acids

22. Free of trans fatty acids

Column 2

Conditions — Food

(2) The similar reference food does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

(1) The food contains at least 25% less saturated fatty acids and the content of trans fatty acids is not higher (a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

The food (a) contains less than 0.2 g of trans fatty acids

Column 3 Conditions — Label or Advertisement compared, if those amounts are not equal; and

(c) the difference in saturated fatty acids compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.

The following are identified:

(a) the reference food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in saturated fatty acids compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.

Column 4

Statement or Claim

saturates”, “saturates­ reduced”, “less saturates”, “lower saturates”, “lower in saturates” or “fewer saturates”

“less saturated fatty acids”, “lower saturated fatty acids”, “lower in saturated fatty acids”, “fewer saturated fatty acids”, “less saturated fat”, “lower saturated fat”, “lower in saturated fat”, “less saturates”, “lower saturates”, “lower in saturates” or “fewer saturates”

“trans fatty acids-free”, “free of trans fatty acids”, “no trans fatty acids”, “0

Column 1

Item Subject

Reduced in 23. trans fatty

acids

24. Lower in trans fatty acids

Column 2

Conditions — Food

(i) per reference amount and serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal; and

(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1. (1) The food is processed, formulated, reformulated or otherwise modified, without increasing the content of saturated fatty acids, so that it contains at least 25% less trans fatty acids (a) per reference amount of the food, than the reference amount of the similar reference food; or

(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.

(2) The similar reference food does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

(1) The food contains at least 25% less trans fatty acids and the content of

Column 3 Conditions — Label or Advertisement

The following are identified:

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and (c) the difference in trans fatty acids compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.

The following are identified:

Column 4

Statement or Claim

trans fatty acids”, “zero trans fatty acids”, “without trans fatty acids”, “contains no trans fatty acids”, “trans fat-free”, “free of trans fat”, “no trans fat”, “0 trans fat”, “zero trans fat”, “without trans fat”, “contains no trans fat”, “trans-free”, “free of trans”, “no trans”, “0 trans”, “zero trans” or “without trans”

“reduced trans”, “reduced in trans”, “trans-reduced”, “reduced trans fatty acids”, “reduced in trans fatty acids”, “trans fatty acids- reduced”, “less trans fatty acids”, “lower trans fatty acids”, “lower in trans fatty acids”, “fewer trans fatty acids”, “reduced trans fat”, “reduced in trans fat”, “trans fat-reduced”, “less trans fat”, “lower trans fat” or “lower in trans fat”

“less trans fatty acids”, “lower trans fatty acids”, “lower in trans fatty

Column 1 Column 2 Column 3 Column 4 Conditions — LabelItem Subject Conditions — Food Statement or Claimor Advertisement

25. Source of omega-3 poly­ unsaturated fatty acids

26. Source of omega-6 poly-

saturated fatty acids is not higher (a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

The food contains (a) 0.3 g or more of omega-3 polyunsaturated fatty acids per reference amount and serving of stated size; or

(b) 0.3 g or more of omega-3 polyunsaturated fatty acids per 100 g, if the food is a prepackaged meal.

The food contains

(a) 2 g or more of omega-6 polyunsaturated

(a) the reference food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in trans fatty acids compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.

acids”, “fewer trans fatty acids”, “less trans fat”, “lower trans fat”, “lower in trans fat”, “less trans”, “lower trans” or “lower in trans”

“source of omega-3 polyunsaturated fatty acids”, “contains omega-3 polyunsaturated fatty acids”, “provides omega-3 polyunsaturated fatty acids”, “source of omega-3 polyunsaturated fat”, “contains omega-3 polyunsaturated fat”, “provides omega-3 polyunsaturated fat”, “source of omega-3 polyunsaturates”, “contains omega-3 polyunsaturates” or “provides omega-3 polyunsaturates” “source of omega-6 polyunsaturated fatty acids”, “contains omega-6

Column 1 Column 2

Item Subject Conditions — Food

unsaturated fatty acids per reference fatty acids amount and serving of

stated size; or

(b) 2 g or more of omega-6 polyunsaturated fatty acids per 100 g, if the food is a prepackaged meal.

Free of27. The foodcholesterol (a) contains less than 2 mg of cholesterol

(i) per reference amount and serving of stated size, or

(ii) per serving of stated size, if the food is a prepackaged meal; and

(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

Low in28. The foodcholesterol (a) contains 20 mg or less of cholesterol per

(i) reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g, or

Column 3 Conditions — Label or Advertisement

Column 4

Statement or Claim

polyunsaturated fatty acids”, “provides omega-6 polyunsaturated fatty acids”, “source of omega-6 polyunsaturated fat”, “contains omega-6 polyunsaturated fat”, “provides omega-6 polyunsaturated fat”, “source of omega-6 polyunsaturates”, “contains omega-6 polyunsaturates” or “provides omega-6 polyunsaturates”

“cholesterol-free”, “free of cholesterol”, “no cholesterol”, “0 cholesterol”, “zero cholesterol”, “without cholesterol” or “contains no cholesterol”

“low cholesterol”, “low in cholesterol”, “low source of cholesterol”, “little cholesterol”, “contains only (number) mg of cholesterol per serving” or “contains less than (number) mg of cholesterol per serving”

(ii) per 100 g, if the food is a prepackaged meal;

Column 1

Item Subject

Reduced in29. cholesterol

Lower in30. cholesterol

Column 2 Column 3 Conditions — LabelConditions — Food or Advertisement

and

(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1. (1) The food is processed, formulated, reformulated or The following are otherwise modified so identified: that it contains at least 25% less cholesterol (a) per reference amount of the food, than the (a) the similar reference amount of the reference food; similar reference food; or

(b) the amounts of the food and the(b) per 100 g, than 100 g similar referenceof the similar reference food beingfood, if the food is a compared, if thoseprepackaged meal. amounts are not equal; and (c) the difference in cholesterol(2) The similar reference compared to thefood does not meet the similar referenceconditions set out in food, per serving ofcolumn 2 of item 28 for stated size,the subject “low in expressed as acholesterol” set out in percentage orcolumn 1. fraction or in milligrams.

(3) The food meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1. (1) The food contains at The following areleast 25% less identified:cholesterol (a) per reference amount (a) the reference

Column 4

Statement or Claim

“reduced cholesterol”, “reduced in cholesterol”, “cholesterol-reduced”, “less cholesterol”, “lower cholesterol” or “lower in cholesterol”

“less cholesterol”, “lower cholesterol” or “lower in cholesterol”

Column 1

Item Subject

Free of 31. sodium or

salt

Low in 32. sodium or

salt

Column 2

Conditions — Food

of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 28 for the subject “low in cholesterol” set out in column 1.

(3) The food meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.

The food contains

(a) less than 5 mg of sodium per reference amount and serving of stated size; or (b) less than 5 mg of sodium per serving of stated size, if the food is a prepackaged meal.

The food contains

(a) 140 mg or less of sodium per reference amount and serving of

Column 3 Conditions — Label or Advertisement food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in cholesterol compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in milligrams.

Column 4

Statement or Claim

“sodium-free”, “free of sodium”, “no sodium”, “0 sodium”, “zero sodium”, “without sodium”, “contains no sodium”, “salt-free”, “free of salt”, “no salt”, “0 salt”, “zero salt”, “without salt” or “contains no salt”

“low sodium”, “low in sodium”, “low source of sodium”, “little sodium”, “contains only (number) mg of sodium per serving”, “contains less

Column 1

Item Subject

Reduced in 33. sodium or

salt

Lower in 34. sodium or

salt

Column 2

Conditions — Food

stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g; or

(b) 140 mg or less of sodium per 100 g, if the food is a prepackaged meal.

(1) The food is processed, formulated, reformulated or otherwise modified so that it contains at least 25% less sodium (a) per reference amount of the food, than the reference amount of the similar reference food; or

(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.

(2) The similar reference food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.

(1) The food contains at least 25% less sodium

(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

Column 3 Conditions — Label or Advertisement

The following are identified:

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and (c) the difference in sodium content compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in milligrams.

The following are identified:

(a) the reference food of the same food group;

Column 4

Statement or Claim

than (number) mg of sodium per serving”, “low salt”, “low in salt”, “low source of salt”, “little salt”, “contains only (number) mg of salt per serving” or “contains less than (number) mg salt per serving”

“reduced sodium”, “reduced in sodium”, “sodium-reduced”, “less sodium”, “lower sodium”, “lower in sodium”, “reduced salt”, “reduced in salt”, “salt-reduced”, “less salt”, “lower salt” or “lower in salt”

“less sodium”, “lower sodium”, “lower in sodium”, “less salt”, “lower salt” or “lower in salt”

(b) per 100 g, than 100 g (b) the amounts of

Column 1

Item Subject

No added 35. sodium or

salt

Lightly36. salted

Column 4

Statement or Claim

“unsalted”, “without added salt”, “no salt added”, “no added salt”, “without added sodium”, “no sodium added” or “no added sodium”

“lightly salted” or “salted lightly”

Column 2

Conditions — Food

of the reference food of the same food group, if the food is a prepackaged meal.

(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.

(1) The food contains no added salt, other sodium salts or ingredients that contain sodium that functionally substitute for added salt. (2) The similar reference food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1 and contains added salt or other sodium salts. (1) The food contains at least 50% less added sodium than the sodium added to the similar reference food.

(2) The similar reference reference food;food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.

Column 3 Conditions — Label or Advertisement the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in sodium content compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in milligrams.

The following are identified:

(a) the similar

(b) the amounts of the food and the similar reference food being compared, if those amounts are not

Column 1 Column 2 Column 3 Column 4 Conditions — LabelItem Subject Conditions — Food Statement or Claimor Advertisement equal; and (c) the difference in sodium content compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in milligrams.

Free of37. The foodsugars “sugar-free”, “free of (a) contains less than sugar”, “no sugar”, “0 0.5 g of sugars per sugar”, “zero sugar”, reference amount and “without sugar”, “contains serving of stated size; no sugar” or “sugarless” and (b) with the exception of chewing gum, meets the conditions set out in column 2 of item 1 for the subject “free of energy” set out in column 1. The food is processed, formulated, reformulated “reduced sugar”, “reduced

Reduced in or otherwise modified so The following are in sugar”, “sugar-reduced”,38. sugars that it contains at least identified: “less sugar”, “lower sugar” 25% less sugars, totalling or “lower in sugar” at least 5 g less, (a) per reference amount of the food, than the (a) the similar reference amount of the reference food; similar reference food; or

(b) the amounts of the food and the(b) per 100 g, than 100 g similar referenceof the similar reference food beingfood, if the food is a compared, if thoseprepackaged meal. amounts are not equal; and (c) the difference in sugars compared to the similar reference

Column 1 Column 2

Item Subject Conditions — Food

39. Lower insugars

The food contains at least 25% less sugars, totalling at least 5 g less, (a) per reference amount of the food, than the reference amount of the reference food of the same food group; or

(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.

40. No addedsugars

(1) The food contains no added sugars, no ingredients containing added sugars or ingredients that contain sugars that functionally substitute for added sugars. (2) The sugars content is not increased through some other means except if the functional effect is not to increase the sugars content of the food. (3) The similar reference food contains added

Column 3 Conditions — Label or Advertisement food, per serving of stated size, expressed as a percentage or fraction or in grams.

The following are identified:

(a) the reference food of the same food group;

(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and (c) the difference in sugars compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.

Column 4

Statement or Claim

“lower sugar”, “lower in sugar” or “less sugar”

“no sugar added”, “no added sugar” or “without added sugar”

Column 1

Item Subject

Source of41. fibre

High source42. of fibre

Column 2

Conditions — Food

sugars. (1) The food contains 2 g or more (a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or (b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim. (2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the food is a prepackaged meal. (1) The food contains 4 g or more (a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or (b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim. (2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the

Column 3 Conditions — Label or Advertisement

Column 4

Statement or Claim

“source of fibre”, “contains fibre”, “provides fibre”, “made with fibre”, “source of (naming the fibre)”, “contains (naming the fibre)”, “provides (naming the fibre)”, “made with (naming the fibre)”, “source of (naming the fibre source)”, “contains (naming the fibre source)”, “provides (naming the fibre source)”, “made with (naming the fibre source)”, “source of dietary fibre”, “contains dietary fibre”, “provides dietary fibre” or “made with dietary fibre”

“high source of fibre”, “high fibre”, “high in fibre”, “high source of (naming the fibre)”, “high (naming the fibre)”, “high in (naming the fibre)”, “high source of (naming the fibre source)”, “high (naming the fibre source)”, “high in (naming the fibre source)”, “high source of dietary fibre”, “high dietary fibre” or “high in dietary fibre”

Column 1

Item Subject

43.

Very high source of fibre

44. More fibre

Column 2

Conditions — Food

food is a prepackaged meal. (1) The food contains 6 g or more (a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or (b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim. (2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the food is a prepackaged meal. (1) The food contains at least 25% more fibre, totalling at least 1 g more, if no fibre or fibre source is identified in the statement or claim, or at least 25% more of an identified fibre or fibre from an identified fibre source, totalling at least 1 g more, if a fibre or fibre source is identified in the statement or claim (a) per reference amount of the food, than the reference amount of the reference food of the same food group or the similar reference food; or

Column 3 Conditions — Label or Advertisement

The following are identified:

(a) the reference food of the same food group or the similar reference food;

Column 4

Statement or Claim

“very high source of fibre”, “very high fibre”, “very high in fibre”, “fibre rich”, “rich in fibre”, “very high source of (naming the fibre)”, “very high (naming the fibre)”, “very high in (naming the fibre)”, “(naming the fibre) rich”, “rich in (naming the fibre)”, “very high source of (naming the fibre source)”, “very high (naming the fibre source)”, “very high in (naming the fibre source)”, “(naming the fibre source) rich”, “rich in (naming the fibre source)”, “very high source of dietary fibre”, “very high dietary fibre”, “very high in dietary fibre”, “dietary fibre rich” or “rich in dietary fibre” “more fibre”, “higher fibre”, “higher in fibre”, “more (naming the fibre)”, “higher (naming the fibre)”, “higher in (naming the fibre)”, “more (naming the fibre source)”, “higher (naming the fibre source)”, “higher in (naming the fibre source)”, “more dietary fibre”, “higher dietary fibre” or “higher in dietary fibre”

(b) per 100 g, than 100 g (b) the amounts of

Column 1

Item Subject

Light in45. energy or fat

Column 2

Conditions — Food

of the reference food of the same food group or the similar reference food, if the food is a prepackaged meal.

(2) The food contains (a) at least 2 g of fibre per reference amount and serving of stated size if no fibre or fibre source is identified in the statement or claim, or at least 2 g of identified fibre or fibre from an identified fibre source per reference amount and serving of stated size if a fibre or fibre source is identified in the statement or claim; or (b) at least one ingredient that meets the conditions set out in column 2 of item 41 for the subject “source of fibre” set out in column 1, if the food is a prepackaged meal. The food meets the conditions set out in column 2 (a) of item 3 for the subject “reduced in energy” set out in column 1; or

(b) of item 13 for the subject “reduced in fat” set out in column 1.

Column 3 Conditions — Label or Advertisement the food and the reference food of the same food group or the similar reference food being compared, if those amounts are not equal; and

(c) the difference in fibre compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.

The following are identified:

(a) the similar reference food;

(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and (c) the difference in

Column 4

Statement or Claim

“light” or “lite”

Column 1 Column 2 Column 3 Column 4

Item Subject Conditions — Food Conditions — Labelor Advertisement Statement or Claim

energy or fat value compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories or grams.

46. Lean The food “lean” (a) is meat or poultry that has not been ground, a marine or fresh water animal or a product of any of these; and (b) contains 10% or less fat.

47. Extra lean The food “extra lean” (a) is meat or poultry that has not been ground, a marine or fresh water animal or a product of any of these; and (b) contains 7.5% or less fat.

SOR/2003-11, s. 20; err.(F), Vol. 137, No. 5; SOR/2007-176, s. 6. Previous Version [B.01.514 to B.01.599 reserved]

Health Claims

Languages

B.01.600. A statement or claim set out in column 1 of the table following section B.01.603 that appears on the label of a food shall be

(a) in English and French; or

(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

SOR/2003-11, s. 20.

Statements or Claims

B.01.601. (1) A food with a label or advertisement that carries a statement or claim set out in column 1 of the table following section B.01.603 is exempt from the provisions of the Act and its Regulations with respect to drugs, and from subsections 3(1) and (2) of the Act, if

(a) the food meets the applicable conditions set out in column 2;

(b) the label of or the advertisement for the food meets the applicable conditions set out in column 3; and

(c) the food is not

(i) intended solely for children under two years of age, or

(ii) a food represented for use in a very low energy diet.

(2) Subsection (1) does not apply to a food that comes within the definition of “drug” as defined in section 2 of the Act for a reason other than the fact that its label or advertisement carries a statement or claim referred to in that subsection.

(3) Subsection (1) applies even if the word “graisses” in the French version of the statement or claim is replaced by the word “lipides”.

SOR/2003-11, s. 20.

B.01.602. (1) The information required under the conditions set out in column 3 of the table following section B.01.603 that appears in an advertisement for a food that is not a prepackaged product, or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, shall,

(a) in the case of an advertisement, other than a radio or television advertisement, be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim set out in column 1, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim set out in column 1; or

(c) in the case of a television advertisement, be communicated

(i) in the audio mode, if the statement or claim set out in column 1 is made only in the audio portion of the advertisement or in both the audio and visual portions, or

(ii) in the audio or visual mode, if the statement or claim set out in column 1 is made only in the visual portion of the advertisement.

(2) The information that is communicated in the visual mode of a television advertisement in accordance with subparagraph (1)(c)(ii) shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

SOR/2003-11, s. 20.

B.01.603. For greater certainty, a statement or claim set out in column 1 of the table following this section that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.

TABLE

Column 1 Column 2 Column 3 Conditions — Label orItem Statement or Claim Conditions — Food Advertisement

The food(1) “A healthy diet containing foods high (a) other than a vegetable or fruit, (1) If the statement or claimin potassium and low does not meet the conditions set is made on the label of or inin sodium may reduce out in column 2 of item 2 of the the advertisement for athe risk of high blood table following section B.01.513 prepackaged product, by orpressure, a risk factor for the subject “low in energy” on the direction of thefor stroke and heart set out in column 1; manufacturer of the product,disease. (Naming the

the nutrition facts table shallfood) is sodium-free.” (b) contains at least 10% of the include the amount ofweighted recommended nutrient (2) “A healthy diet potassium, in accordanceintake of a vitamin or a mineral containing foods high with subsection B.01.402(2).nutrient in potassium and low

(2) If the statement or claimin sodium may reduce (i) per reference amount and per is made on the label of or inthe risk of high blood serving of stated size, or 1. the advertisement for a foodpressure, a risk factor

for stroke and heart (ii) per serving of stated size, if that is not a prepackaged disease. (Naming the the food is a prepackaged meal; product, or in the

advertisement for afood) is low in (c) meets the conditions set out in prepackaged product that issodium.” column 2 of item 19 of the table not made or placed by or on

(3) “A healthy diet following section B.01.513 for the direction of the containing foods high the subject “low in saturated fatty manufacturer of the product, in potassium and low acids” set out in column 1; the label or advertisement in sodium may reduce shall include the amount of

(d) contains 0.5% or less alcohol;the risk of high blood sodium and potassium per pressure, a risk factor serving of stated size, in(e) meets the conditions set out in for stroke and heart accordance with sectioncolumn 2 of item 31 of the table disease. (Naming the B.01.602 if applicable.following section B.01.513 for food) is a good source the subject “free of sodium or of potassium and is salt” set out in column 1, if the

Column 1

Item Statement or Claim

sodium-free.”

(4) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is low in sodium.”

(5) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is sodium-free.”

(6) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is low in sodium.”

Column 2

Conditions — Food

label of or advertisement for the food carries statement or claim (1), (3) or (5) set out in column 1 of this item;

(f) meets the conditions set out in column 2 of item 32 of the table following section B.01.513 for the subject “low in sodium or salt” set out in column 1, if the label of or advertisement for the food carries statement or claim (2), (4) or (6) set out in column 1 of this item; and

(g) contains 350 mg or more of potassium, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,

(i) per reference amount and per serving of stated size, or

Column 3 Conditions — Label or Advertisement

Column 1

Item Statement or Claim

(1) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium.”

(2) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is

2. high in calcium.”

(3) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium.”

(4) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is

Column 2

Conditions — Food

(ii) per serving of stated size, if the food is a prepackaged meal.

The food

(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;

(b) contains no more phosphorus, excluding that provided by phytate, than calcium;

(c) contains 0.5% or less alcohol;

(d) contains, if the label of or advertisement for the food carries statement or claim (1) or (2) set out in column 1 of this item,

(i) 200 mg or more of calcium per reference amount and per serving of stated size, or

(ii) 300 mg or more of calcium per serving of stated size, if the food is a prepackaged meal;

(e) contains, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,

(i) 275 mg or more of calcium per reference amount and per serving of stated size, or

(ii) 400 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; and

Column 3 Conditions — Label or Advertisement

(1) If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of vitamin D and phosphorus, in accordance with subsection B.01.402(2).

(2) If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of vitamin D, calcium and phosphorus per serving of stated size, in accordance with section B.01.602 if applicable.

Column 1 Column 2 Column 3

Item Statement or Claim Conditions — Food Conditions — Label orAdvertisement very high in calcium.”

(5) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium and vitamin D.”

(6) “A healthy diet with adequate calcium and vitamin D, and

(f) contains 1.25 µg or more of vitamin D, if the label of or advertisement for the food carries

regular physical activity, help to achieve strong bones

statement or claim (5) or (6) set out in column 1 of this item,

and may reduce the (i) per reference amount and per risk of osteoporosis. serving of stated size, or (Naming the food) is very high in calcium and vitamin D.”

(ii) per serving of stated size, if the food is a prepackaged meal.

The food If the statement or claim is

(1) “A healthy diet low (a) other than a vegetable or fruit, made on the label of or in the in saturated and trans does not meet the conditions set advertisement for a food that fats may reduce the out in column 2 of item 2 of the is not a prepackaged product, risk of heart disease. table following section B.01.513 or in the advertisement for a (Naming the food) is for the subject “low in energy” prepackaged product that is free of saturated and set out in column 1; not made or placed by or on trans fats.” the direction of the3. (b) contains at least 10% of the manufacturer of the product,(2) “A healthy diet low weighted recommended nutrient the label or advertisementin saturated and trans intake of a vitamin or a mineral shall include the amount offats may reduce the nutrient saturated fatty acids and transrisk of heart disease. (Naming the food) is (i) per reference amount and per fatty acids per serving of low in saturated and serving of stated size, or stated size, in accordance

with section B.01.602 iftrans fats.” (ii) per serving of stated size, if applicable. the food is a prepackaged meal;

(c) contains 100 mg or less of

Column 1 Column 2 Column 3 Conditions — Label orItem Statement or Claim Conditions — Food Advertisement

cholesterol per 100 g of food;

(d) contains 0.5% or less alcohol;

(e) if it is a fat or an oil, meets the conditions set out in

(i) column 2 of item 25 of the table following section B.01.513 for the subject “source of omega­ 3 polyunsaturated fatty acids” set out in column 1,

(ii) column 2 of item 26 of the table following section B.01.513 for the subject “source of omega­ 6 polyunsaturated fatty acids” set out in column 1, or

(iii) subparagraphs (i) and (ii);

(f) contains

(i) 480 mg or less of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less, or

(ii) 960 mg or less of sodium per serving of stated size, if the food is a prepackaged meal;

(g) meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject “free of saturated fatty acids” set out in column 1, if the label of or advertisement for the food carries statement or claim (1) set out in column 1 of this item; and

(h) meets the conditions set out in column 2 of item 19 of the table following section B.01.513 for the subject “low in saturated fatty acids” set out in column 1, if the

Column 1 Column 2 Column 3

Item Statement or Claim Conditions — Food Conditions — Label orAdvertisement label of or advertisement for the food carries statement or claim (2) set out in column 1 of this item.

The food

(a) is one of the following vegetables, fruit, or juice, and may contain only sweetening agents, food additives as permitted by these Regulations,

“A healthy diet rich in a variety of vegetables

salt, herbs, spices, seasonings or water:

4. and fruit may help (i) a fresh, frozen, canned or reduce the risk of some dried vegetable, types of cancer.”

(ii) a fresh, frozen, canned or dried fruit,

(iii) a vegetable or fruit juice, or

(iv) a combination of the foods set out in subparagraphs (i) to (iii);

(b) is not one of the following:

(i) potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices,

(ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,

(iii) jams or jam-type spreads, marmalades, preserves and jellies,

(iv) olives, or

(v) powdered vegetables or fruit; and

(c) contains 0.5% or less alcohol.

Column 1 Column 2 Column 3 Conditions — Label orItem Statement or Claim Conditions — Food Advertisement

The food is a chewing gum, hard candy or breath freshener product that

5. (a) contains 0.25% or less starch, dextrins, mono-, di- and If the statement or claim isoligosaccharides or other(1) “Won’t cause made on the label of or in thefermentable carbohydratescavities.” advertisement for acombined; or prepackaged product, by or

(2) “Does not promote on the direction of the(b) does not, if it contains moretooth decay.” manufacturer of the product,than 0.25% fermentable the nutrition facts table shall(3) “Does not promote carbohydrates, lower plaque pH include the amount of sugardental caries.” below 5.7 by bacterial alcohols, if present, infermentation during 30 minutes

(4) “Non-cariogenic.” accordance with subsectionafter consumption as measured B.01.402(2).by the indwelling plaque pH test,

referred to in “Identification of Low Caries Risk Dietary Components” by T.N. Imfeld, Volume 11, Monographs in Oral Science, 1983.

SOR/2003-11, s. 20; err.(F), Vol. 137, No. 5; SOR/2010-142, s. 2. Previous Version

Division 2

Alcoholic Beverages B.02.001. The foods referred to in this Division are included in the term alcoholic beverage.

SOR/93-145, s. 3(F).

B.02.002. In this Division,

“absolute alcohol” means alcohol of a strength of 100 per cent; (alcool absolu)

“age” means the period during which an alcoholic beverage is kept under such conditions of storage as may be necessary to develop its characteristic flavour and bouquet; (âge)

“alcohol” means ethyl alcohol; (alcool)

“flavouring” means, in respect of a spirit, any other spirit or wine, domestic or imported, added as a flavouring to that spirit as authorized under the Excise Act; (substance aromatique)

“grain spirit” means an alcoholic distillate, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the

action of yeast or a mixture of yeast and other micro-organisms, and from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de grain)

“malt spirit” means an alcoholic distillate, obtained by pot-still distillation from a mash of cereal grain or cereal grain products saccharified by the diastase of malt and fermented by the action of yeast or a mixture of yeast and other micro-organisms; (esprit de malt)

“molasses spirit” means an alcoholic distillate, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms, from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de mélasse)

“small wood” means wood casks or barrels of not greater than 700 L capacity; (petit fût)

“sweetening agent” means glucose-fructose, fructose syrup or any food for which a standard is provided in Division 18, or any combination thereof. (agent édulcorant)

SOR/84-300, s. 10; SOR/93-145, s. 4.

B.02.003. Where an alcoholic beverage contains 1.1 per cent or more alcohol by volume, the percentage by volume of alcohol present in the alcoholic beverage shall be shown on the principal display panel followed by the words “alcohol by volume” or the abbreviation “alc./vol.”.

SOR/88-418, s. 1; SOR/93-145, s. 5(F).

Whisky

B.02.010. [S]. Whisky or Whiskey, other than Malt Whisky, Scotch Whisky, Irish Whisky, Canadian Whisky, Canadian Rye Whisky, Rye Whisky, Highland Whisky, Bourbon Whisky and Tennessee Whisky,

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro­ organisms; and

(b) may contain caramel and flavouring.

SOR/93-145, s. 6; SOR/93-603, s. 2.

B.02.011. and B.02.012. [Repealed, SOR/93-145, s. 7]

B.02.013. [S]. Malt Whisky

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of a mash of malted grain fermented by the action of yeast or a mixture of yeast and other micro-organisms;

(b) shall possess the aroma, taste and character generally attributed to malt whisky; and

(c) may contain caramel and flavouring.

SOR/93-145, s. 8.

B.02.014. and B.02.015. [Repealed, SOR/93-145, s. 9]

B.02.016. [S]. Scotch Whisky shall be whisky distilled in Scotland as Scotch whisky for domestic consumption in accordance with the laws of the United Kingdom.

B.02.017. No person shall blend or modify in any manner any Scotch whisky that is imported in bulk for the purpose of bottling and sale in Canada as Scotch whisky except by

(a) blending with other Scotch whisky,

(b) the addition of distilled or otherwise purified water to adjust to a required strength, or

(c) the addition of caramel.

B.02.018. [S]. Irish Whisky shall be whisky distilled in Northern Ireland or in the Republic of Ireland as Irish whisky for domestic consumption in accordance with the laws of Northern Ireland or the Republic of Ireland.

B.02.019. No person shall blend or modify in any manner any Irish whisky that is imported in bulk for the purpose of bottling and sale in Canada as Irish whisky except by

(a) blending with other Irish whisky,

(b) the addition of distilled or otherwise purified water to adjust to a required strength, or

(c) the addition of caramel.

B.02.020. [S]. (1) Canadian Whisky, Canadian Rye Whisky or Rye Whisky

(a) shall

(i) be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro­ organisms,

(ii) be aged in small wood for not less than three years,

(iii) possess the aroma, taste and character generally attributed to Canadian whisky,

(iv) be manufactured in accordance with the requirements of the Excise Act and the regulations made thereunder,

(v) be mashed, distilled and aged in Canada, and

(vi) contain not less than 40 per cent alcohol by volume; and

(b) may contain caramel and flavouring.

(2) Subject to subsection (3), no person shall make any claim with respect to the age of Canadian whisky, other than for the period during which the whisky has been held in small wood.

(3) Where Canadian whisky has been aged in small wood for a period of at least three years, any period not exceeding six months during which that whisky was held in other containers may be claimed as age.

SOR/93-145, s. 10; SOR/2000-51, s. 1.

B.02.021. [S]. Highland Whisky

(a) shall be a potable alcoholic beverage blended in Canada from

(i) not less than 25 per cent malt whisky calculated on an absolute alcohol basis, distilled in Canada or Scotland, and

(ii) whisky; and

(b) may, if it contains 51 per cent or more malt whisky distilled in Scotland, be labelled or advertised as containing malt whisky distilled in Scotland.

SOR/93-145, s. 10.

B.02.022. (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Bourbon Whisky, or in such a manner that it is likely to be mistaken for Bourbon whisky unless it is whisky manufactured in the United States as Bourbon whisky in accordance with the laws of the United States applicable in respect of Bourbon whisky for consumption in the United States.

(2) A person may modify Bourbon whisky that is imported for the purpose of bottling and sale in Canada as Bourbon whisky by the addition of distilled or otherwise purified water to adjust the Bourbon whisky to a required strength.

SOR/89-59, s. 2; SOR/93-145, s. 11(F).

B.02.022.1. (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tennessee Whisky, or in such a manner that it is likely to be mistaken for Tennessee whisky unless it is a straight Bourbon whisky produced in the State of Tennessee and manufactured in the United States as Tennessee whisky in accordance with the laws of the United States applicable in respect of Tennessee whisky for consumption in the United States.

(2) A person may modify Tennessee whisky that is imported for the purpose of bottling and sale in Canada as Tennessee whisky by the addition of distilled or otherwise purified water to adjust the Tennessee whisky to a required strength.

SOR/93-603, s. 3.

B.02.023. (1) Subject to sections B.02.022 and B.02.022.1, no person shall sell for consumption in Canada any whisky that has not been aged for a period of at least three years in small wood.

(2) Nothing in subsection (1) applies in respect of flavouring contained in whisky, but no person shall sell for consumption in Canada whisky containing any flavouring, other than wine, that has not been aged for a period of at least two years in small wood.

SOR/93-145, s. 12; SOR/93-603, s. 4.

Rum

B.02.030. [S]. Rum

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms; and

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations.

SOR/93-145, s. 13.

B.02.031. (1) No person shall sell for consumption in Canada any rum that has not been aged for a period of at least one year in small wood.

(2) Nothing in subsection (1) applies in respect of flavouring contained in rum, but no person shall sell for consumption in Canada rum containing any flavouring, other than wine, that has not been aged for a period of at least one year in small wood.

SOR/84-657, s. 1; SOR/93-145, s. 13.

B.02.032. [Repealed, SOR/93-145, s. 14]

B.02.033. No person shall blend or modify in any manner any rum that is imported in bulk for the purpose of bottling and sale in Canada as imported rum except by

(a) blending with other imported rum,

(b) adding distilled or otherwise purified water to adjust the rum to the strength stated on the label applied to the container; or

(c) the addition of caramel.

SOR/89-127, s. 1.

B.02.034. (1) Notwithstanding section B.02.033, no person shall blend or modify in any manner any rum made from sugar cane products of a Commonwealth Caribbean country that has been distilled and fermented in a Commonwealth Caribbean country and imported in bulk from a Commonwealth Caribbean Country for bottling and sale in Canada as Caribbean rum except by

(a) blending with other rum of a Commonwealth Caribbean country;

(b) blending with Canadian rum in proportions that result in one to 1.5 per cent Canadian rum by volume in the final product;

(c) adding distilled or otherwise purified water to adjust the rum to the strength stated on the label applied to the container; or

(d) adding caramel.

(2) In this section, “Commonwealth Caribbean country” means Anguilla, Antigua and Barbuda, Barbados, the Bahamas, Belize, Bermuda, the British Virgin Islands, the Caymen Islands, Dominica, Grenada, Guyana, Jamaica, Montserrat, St. Christopher and Nevis, Saint

Lucia, St. Vincent and the Grenadines, Trinidad and Tobago and the Turks and Caicos Islands.

SOR/89-127, s. 2.

Gin

B.02.040. [S]. Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin

(a) shall be a potable alcoholic beverage obtained

(i) by the redistillation of malt spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation,

(ii) by the redistillation of a combination of malt spirit and not more than four times its volume on an absolute alcohol basis of grain spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation, or

(iii) by the blending of malt spirit, redistilled with or over juniper berries, with not more than four times its volume on an absolute alcohol basis of grain spirit or molasses spirit, or by a mixture of the products of more than one such blending;

(b) may contain

(i) other aromatic botanical substances, added during the redistillation process, and

(ii) caramel;

(c) shall not contain more than two per cent sweetening agent;

(d) may be labelled or advertised as being distilled, where subparagraph (a)(i) or (ii) is complied with; and

(e) shall be described on the principal display panel of its label and in any advertisements as blended gin, where subparagraph (a)(iii) is complied with.

SOR/93-145, s. 15.

B.02.041. [S]. Gin, other than Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin,

(a) shall be a potable alcoholic beverage obtained

(i) by the redistillation of alcohol from food sources with or over juniper berries, or by a mixture of the products of more than one such redistillation, or

(ii) by the blending of alcohol from food sources, redistilled with or over juniper berries, with alcohol from food sources or by a mixture of the products of more than one such blending;

(b) may contain

(i) other aromatic botanical substances, added during the redistillation process,

(ii) a sweetening agent, and

(iii) a flavouring preparation for the purpose of maintaining a uniform flavour profile; and

(c) may be labelled or advertised as Dry Gin or London Dry Gin if sweetening agents have not been added.

SOR/93-145, s. 15.

B.02.042. [Repealed, SOR/93-145, s. 15]

B.02.043. No person shall make any claim for age for gin but gin that has been held in suitable containers may bear a label declaration to that effect.

Brandy

B.02.050. [S]. Brandy, other than Armagnac Brandy or Armagnac, Canadian Brandy, Cognac Brandy or Cognac, Dried Fruit Brandy, Fruit Brandy, Grappa, Lees Brandy and Pomace or Marc,

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine; and

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations.

SOR/84-300, s. 12; SOR/93-145, s. 16.

B.02.051. [S]. Armagnac Brandy or Armagnac shall be brandy manufactured in the Armagnac district of France in accordance with the laws of the French Republic for consumption in that country.

SOR/93-145, s. 16.

B.02.052. [S]. Canadian Brandy

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine that has been fermented in Canada; and

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations.

SOR/93-145, s. 16.

B.02.053. [S]. Cognac Brandy or Cognac shall be brandy manufactured in the Cognac district of France in accordance with the laws of the French Republic for consumption in that country.

SOR/93-145, s. 16.

B.02.054. [S]. Dried Fruit Brandy

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sound dried fruit; and

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations.

SOR/93-145, s. 16.

B.02.055. [S]. Fruit Brandy

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of

(i) fruit wine or a mixture of fruit wines, or

(ii) a fermented mash of sound ripe fruit other than grapes, or a mixture of sound ripe fruits other than grapes;

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations; and

(c) may be described on its label as “(naming the fruit) brandy” if all of the fruit or fruit wine used to make the brandy originates from the named fruit.

SOR/93-145, s. 16.

B.02.056. [S]. Grappa

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the pomace from sound ripe grapes after the removal of the juice or wine; and

(b) may contain

(i) caramel

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations.

SOR/93-145, s. 16.

B.02.057. [S]. Lees Brandy

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the lees of wine or fruit wine;

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations; and

(c) may be described on its label as “(naming the fruit) Lees Brandy” if all of the lees used to make the brandy originate from the named fruit.

SOR/93-145, s. 16.

B.02.058. [S]. Pomace or Marc

(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the skin and pulp of sound ripe fruit after the removal of the fruit juice, wine or fruit wine;

(b) may contain

(i) caramel,

(ii) fruit and other botanical substances, and

(iii) flavouring and flavouring preparations; and

(c) may be described on its label as “(naming the fruit) Pomace” or “(naming the fruit) Marc” if all of the skin and pulp used to make the brandy originate from the named fruit.

SOR/93-145, s. 16.

B.02.059. No person shall blend or modify in any manner any brandy that is imported in bulk for the purpose of bottling and sale in Canada as imported brandy, except by

(a) blending with other imported brandy;

(b) the addition of caramel; and

(c) the addition of distilled or otherwise purified water to adjust the brandy to a required strength.

SOR/93-145, s. 16.

B.02.060. Where brandy is wholly distilled in a country other than Canada, the label shall indicate the country of origin.

SOR/84-300, s. 13(F); SOR/93-145, s. 16.

B.02.061. (1) No person shall sell any brandy that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.

(2) Nothing in subsection (1) applies in respect of flavouring contained in brandy, but no person shall sell brandy containing any flavouring, other than wine, that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.

(3) Nothing in subsection (1) or (2) applies in respect of brandy that meets the standards prescribed by any of sections B.02.051 to B.02.058.

(4) No person shall make any claim with respect to the age of brandy other than for the period during which the brandy has been held in wooden containers or in small wood.

SOR/93-145, s. 16.

Liqueurs and Spirituous Cordials

B.02.070. [S]. Liqueur or Spirituous Cordial

(a) shall be a product obtained by the mixing or distillation of alcohol from food sources with or over fruits, flowers, leaves or other botanical substances or their juices or with extracts derived by the infusion, percolation or maceration of those botanical substances;

(b) shall have added, during the course of manufacture, a sweetening agent in an amount that is not less than 2.5 per cent of the finished product;

(c) shall contain not less than 23 per cent absolute alcohol by volume; and

(d) may contain

(i) natural and artificial flavouring preparations, and

(ii) colour.

SOR/93-145, s. 16.

Vodka

B.02.080. [S]. Vodka shall be a potable alcoholic beverage obtained by the treatment of grain spirit or potato spirit with charcoal so as to render the product without distinctive character, aroma or taste.

SOR/93-145, s. 16.

Tequila

B.02.090. (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tequila, or in such a manner that it is likely to be mistaken for Tequila unless it is Tequila manufactured in Mexico as Tequila in accordance with the laws of Mexico applicable in respect of Tequila for consumption in Mexico.

(2) A person may modify Tequila that is imported for the purpose of bottling and sale in Canada as Tequila by the addition of distilled or otherwise purified water to adjust the Tequila to a required strength.

SOR/93-603, s. 5.

Mezcal

B.02.091. (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Mezcal, or in such a manner that it is likely to be mistaken for Mezcal unless it is Mezcal manufactured in Mexico as Mezcal in accordance with the laws of Mexico applicable in respect of Mezcal for consumption in Mexico.

(2) A person may modify Mezcal that is imported for the purpose of bottling and sale in Canada as Mezcal by the addition of distilled or otherwise purified water to adjust the Mezcal to a required strength.

SOR/93-603, s. 6.

Wine

B.02.100. [S]. Wine

(a) shall be an alcoholic beverage that is produced by the complete or partial alcoholic fermentation of fresh grapes, grape must, products derived solely from fresh grapes, or any combination of them;

(b) may have added to it during the course of the manufacture

(i) yeast,

(ii) concentrated grape juice,

(iii) dextrose, fructose, glucose or glucose solids, invert sugar, sugar, or aqueous solutions of any of them, (iv) yeast foods, in accordance with Table XIV to section B.16.100,

(iv) yeast foods, in accordance with Table XIV to section B.16.100,

(v) calcium sulphate in such quantity that the content of soluble sulphates in the finished wine shall not exceed 0.2 per cent weight by volume calculated as potassium sulphate,

(vi) calcium carbonate in such quantity that the content of tartaric acid in the finished wine shall not be less than 0.15 per cent weight by volume,

(vii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed

(A) 70 parts per million in the free state, or

(B) 350 parts per million in the combined state, calculated as sulphur dioxide,

(viii) any of the following substances:

(A) citric acid, fumaric acid, lactic acid, malic acid, potassium bicarbonate, potassium carbonate, potassium citrate and tartaric acid, at a maximum level of use consistent with good manufacturing practice,

(B) metatartaric acid at a maximum level of use of 0.01 per cent, and

(C) potassium acid tartrate at a maximum level of use of 0.42 per cent,

(ix) amylase and pectinase at a maximum level of use consistent with good manufacturing practice,

(x) ascorbic acid or erythorbic acid, or their salts, at a maximum level of use consistent with good manufacturing practice,

(xi) antifoaming agents, in accordance with Table VIII to section B.16.100,

(xii) any of the following fining agents:

(A) activated carbon, albumen, casein, clay, diatomaceous earth, egg-white, isinglass, polyvinylpolypyrrolidone and silicon dioxide,

(B) acacia gum, agar, gelatin and potassium ferrocyanide, at a maximum level of use consistent with good manufacturing practice,

(C) tannic acid at a maximum level of use of 200 parts per million, and

(D) polyvinylpyrrolidone in an amount that does not exceed 2 parts per million in the finished product,

(xiii) caramel at a maximum level of use consistent with good manufacturing practice,

(xiv) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume,

(xv) any of the following substances:

(A) carbon dioxide and ozone at a maximum level of use consistent with good manufacturing practice, and

(B) oxygen,

(xvi) sorbic acid or salts thereof, not exceeding 500 parts per million calculated as sorbic acid,

(xvii) malolactic bacteria from the genera Lactobacillus, Leuconostoc and Pediococcus,

(xviii) copper sulphate in such a quantity that the content of copper in the finished product shall not exceed 0.0001 per cent,

(xix) nitrogen, and

(xx) oak chips and particles; and

(c) prior to final filtration may be treated with

(i) a strongly acid cation exchange resin in the sodium ion form, or

(ii) a weakly basic anion exchange resin in the hydroxyl ion form.

SOR/78-402, s. 1; SOR/81-565, s. 1; SOR/84-300, ss. 14(F), 15(E); SOR/2006-91, s. 1; SOR/2008-142, s. 1(F); SOR/2010-143, s. 39(E). Previous Version B.02.101. No person shall sell wine that contains more than 0.24 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981.

SOR/82-768, s. 2; SOR/2006-91, s. 2.

Previous Version B.02.102. [S]. Fruit spirit shall be an alcoholic distillate obtained from wine, fruit wine, grape pomace or fruit pomace.

B.02.103. [S]. Fruit Wine, or (naming the fruit) Wine shall be the product of the alcoholic fermentation of the juice of sound ripe fruit other than grape, and in all other respects shall meet the requirements of the standard for wine as prescribed by section B.02.100.

B.02.104. [S]. Vermouth shall be wine to which has been added bitters, aromatics or other botanical substances or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.

SOR/93-145, s. 17(F).

B.02.105. [S]. Flavoured Wine, Wine Cocktail, Aperitif Wine shall be wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.

B.02.105A. [S]. Flavoured (naming the fruit) Wine, (naming the fruit) Wine Cocktail, or Aperitif (naming the fruit) Wine shall be fruit wine, a mixture of fruit wines, or a mixture of fruit wine and wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.

B.02.106. [S]. Honey Wine

(a) shall be the product of the alcoholic fermentation of an aqueous solution of honey; and

(b) may have added to it during the course of manufacture any of the following substances:

(i) yeast;

(ii) yeast foods;

(iii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed

(A) 70 p.p.m. in the free state, or

(B) 350 p.p.m. in the combined state, calculated as sulphur dioxide;

(iv) tartaric or citric acid;

(v) potassium acid tartrate;

(vi) natural botanical flavours;

(vii) fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume;

(viii) caramel;

(ix) carbon dioxide;

(x) activated carbon, clay or tannic acid as fining agents; or

(xi) sorbic acid, and any salts thereof, calculated as sorbic acid, in a quantity such that the content of sorbic acid and its salts in the finished wine does not exceed 500 parts per million.

SOR/96-241, s. 1; SOR/2010-94, s. 9(E). Previous Version B.02.107. [S]. May Wine shall be wine to which has been added artificial woodruff flavouring preparation.

B.02.108. A clear indication of the country of origin shall be shown on the principal display panel of a wine.

SOR/84-300, s. 16(E).

Cider

B.02.120. [S]. Cider

(a) shall

(i) be the product of the alcoholic fermentation of apple juice, and

(ii) contain not less than 2.5 per cent and not more than 13.0 per cent absolute alcohol by volume; and

(b) may have added to it during the course of manufacture

(i) yeast,

(ii) concentrated apple juice,

(iii) sugar, dextrose, invert sugar, glucose, glucose solids, or aqueous solutions thereof,

(iv) yeast foods,

(v) sulphurous acid, including salts thereof, in such quantity that its content in the finished cider shall not exceed

(A) 70 parts per million in the free state, or

(B) 350 parts per million in the combined state, calculated as sulphur dioxide,

(vi) tartaric acid and potassium tartrate,

(vii) citric acid,

(viii) lactic acid,

(ix) pectinase and amylase,

(x) ascorbic or erythorbic acid, or salts thereof,

(xi) any of the following fining agents:

(A) activated carbon,

(B) clay,

(C) diatomaceous earth,

(D) gelatin,

(E) albumen,

(F) sodium chloride,

(G) silica gel,

(H) casein,

(I) tannic acid not exceeding 200 parts per million, or

(J) polyvinylpyrrolidone not exceeding two parts per million in the finished product,

(xii) caramel,

(xiii) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume,

(xiv) carbon dioxide,

(xv) oxygen,

(xvi) ozone, or

(xvii) sorbic acid or salts thereof, not exceeding 500 parts per million, calculated as sorbic acid.

SOR/81-565, s. 2; SOR/84-300, s. 17(E).

B.02.122. [S]. Champagne Cider shall be cider that is impregnated with carbon dioxide under pressure by

(a) conducting the afterpart of the fermentation in closed vessels, or

(b) secondary fermentation in closed vessels with or without the addition of sugar, dextrose, invert sugar, glucose or glucose solids or aqueous solutions thereof,

and shall contain not less than seven per cent absolute alcohol by volume.

SOR/84-300, s. 18.

B.02.123. No person shall sell cider or champagne cider that has more than 0.2 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981.

SOR/82-768, s. 3.

Beer

B.02.130. [S]. Beer

(a) shall be the product of the alcoholic fermentation by yeast of an infusion of barley or wheat malt and hops or hop extract in potable water and shall be brewed in such a manner as to possess the aroma, taste and character commonly attributed to beer; and

(b) may have added to it during the course of manufacture any of the following ingredients:

(i) cereal grain,

(ii) carbohydrate matter,

(iii) salt,

(iv) hop oil,

(v) hop extract, if the hop extract is added to the wort before or during cooking,

(vi) pre-isomerized hop extract,

(vi.1) reduced isomerized hop extract,

(vii) Irish moss seaweed of the species Chondrus crispus,

(viii) carbon dioxide,

(ix) caramel,

(x) dextrin,

(xi) food enzymes,

(xii) stabilizing agents,

(xiii) pH adjusting and water correcting agents,

(xiv) Class I preservatives,

(xv) Class II preservatives,

(xvi) sequestering agent,

(xvii) yeast foods,

(xviii) any of the following fining agents: acacia gum, activated carbon, aluminum silicate, bentonite, calcium silicate, cellulose, China clay, diatomaceous earth, gelatin, isinglass, magnesium silicate, Nylon 66, polyvinylpolypyrrolidone, silica gel and wood shavings derived from beech, cherry, hazelnut and oak wood,

(xix) polyvinylpyrrolidone,

(xx) ammonium persulphate,

(xxi) in the case of wort, dimethylpolysiloxane, and

(xxii) in the case of mash, hydrogen peroxide.

SOR/88-418, s. 2; SOR/92-92, s. 1; SOR/96-483, s. 1; SOR/2006-91, s. 3. Previous Version

B.02.131. [S]. Ale, Stout, Porter or Malt Liquor

(a) shall be the product of the alcoholic fermentation by yeast of an infusion of barley or wheat malt and hops or hop extract in potable water and shall be brewed in such a manner as to possess the aroma, taste and character commonly attributed to ale, stout, porter, or malt liquor, respectively; and

(b) may have added to it during the course of manufacture any of the ingredients referred to in paragraph B.02.130(b).

SOR/88-418, s. 2.

B.02.132. Where a beer, ale, stout, porter or malt liquor contains the percentage of alcohol by volume set out in Column I of an item of the table, the qualified common name or common name set out in Column II of that item shall be used in any advertisement of and on the label of the beer, ale, stout, porter or malt liquor.

TABLE

Column I Column II

Item Percentage alcohol by Qualified common name or Common namevolume Extra Light Beer, Extra Light Ale, Extra Light Stout, Extra Light1. 1.1 to 2.5 Porter

2. 2.6 to 4.0 Light Beer, Light Ale, Light Stout, Light Porter 3. 4.1 to 5.5 Beer, Ale, Stout, Porter

Strong Beer, Strong Ale, Strong Stout, Strong Porter, Malt4. 5.6 to 8.5 Liquor Extra Strong Beer, Extra Strong Ale, Extra Strong Stout, Extra5. 8.6 or more Strong Porter, Strong Malt Liquor

SOR/88-418, s. 2.

B.02.133. [S]. In this Division, “hop extract” means an extract derived from hops by a process employing the solvent

(a) hexane, methanol, or methylene chloride in such a manner that the hop extract does not contain more than 2.2 per cent of the solvent used; or

(b) carbon dioxide or ethyl alcohol in an amount consistent with good manufacturing practice.

SOR/86-89, s. 1; SOR/88-418, s. 3.

B.02.134. [S]. (1) In this Division, “pre-isomerized hop extract” means an extract derived from hops by

(a) the use of one of the following solvents:

(i) hexane,

(ii) carbon dioxide, or

(iii) ethanol; and

(b) the subsequent isolation of the alpha acids and their conversion to isomerized alpha acids by means of diluted alkali and heat.

(2) For the purposes of paragraph (1)(b), the residues of hexane shall not exceed 1.5 parts per million per per cent iso-alpha acid content of the pre-isomerized hop extract.

SOR/88-418, s. 4.

B.02.135. [S]. In this Division, “reduced isomerized hop extract” means

(a) tetrahydroisohumulones derived from hops

(i) by isomerization and reduction of humulones (alpha-acids) by means of hydrogen and a catalyst, or

(ii) by reduction of lupulones (beta-acids) by means of hydrogen and a catalyst, followed by oxidation and isomerization;

(b) hexahydroisohumulones derived from hops by reduction of tetrahydroisohumulones by means of sodium borohydride; and

(c) dihydroisohumulones derived from hops by reduction of isoalpha acids by means of sodium borohydride.

SOR/96-483, s. 2; SOR/2000-352, s. 1.

Division 3

Baking Powder B.03.001. In this Division, “acid-reacting material” means one or any combination of

(a) lactic acid or its salts;

(b) tartaric acid or its salts;

(c) acid salts of phosphoric acid; and

(d) acid compounds of aluminum.

B.03.002. [S]. Baking Powder shall be a combination of sodium or potassium bicarbonate, an acid-reacting material, starch or other neutral material, may contain an anticaking agent and shall yield not less than 10 per cent of its weight of carbon dioxide, as determined by official method FO-3, Determination of Carbon Dioxide in Baking Powder, October 15, 1981.

SOR/82-768, s. 4; SOR/92-626, s. 12.

Division 4

Cocoa And Chocolate Products B.04.001. The definitions in this section apply in this Division.

“chocolate product” means a product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate. (produit de chocolat)

“cocoa product” means a product derived from cocoa beans and includes cocoa nibs, cocoa liquor, cocoa mass, unsweetened chocolate, bitter chocolate, chocolate liquor, cocoa, low fat cocoa, cocoa powder and low fat cocoa powder. (produit du cacao)

“milk ingredient” means one or any combination of

(a) the following products for which a standard is prescribed in this Part, namely,

(i) milk or whole milk,

(ii) skim milk,

(iii) partly skimmed milk or partially skimmed milk,

(iv) sterilized milk,

(v) condensed milk or sweetened condensed milk,

(vi) evaporated milk,

(vii) evaporated skim milk or concentrated skim milk,

(viii) evaporated partly skimmed milk or concentrated partly skimmed milk,

(ix) milk powder or whole milk powder or dry whole milk or powdered whole milk,

(x) skim milk powder or dry skim milk,

(xi) skim milk with added milk solids,

(xii) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids,

(xiii) malted milk or malted milk powder,

(xiv) butter, and

(xv) cream; and

(b) the following products for which a standard is not prescribed by this Part, namely

(i) reconstituted milk or whole milk,

(ii) reconstituted skim milk,

(iii) reconstitued partly skimmed milk,

(iv) partly skimmed milk powder,

(v) buttermilk,

(vi) butter oil, and

(vii) reconstituted cream. (ingrédient laitier)

“sweetening ingredient” means any one or any combination of sweetening agents, except for icing sugar. (ingrédient édulcorant)

SOR/97-263, s. 2.

B.04.002. [S]. Cocoa Beans shall be the seeds of Theobroma cacao L. or a closely related species.

SOR/97-263, s. 2.

B.04.003. [S]. Cocoa Nibs shall be the product prepared by removing the shell from cleaned cocoa beans, of which the residual shell content may not exceed 1.75 per cent by mass, calculated to an alkali free basis if the nibs or the cocoa beans from which the nibs were prepared have been processed with alkali, as determined by the method prescribed in the Official Methods of Analysis of the Association of Official Analytical Chemists, 12th Ed. (1975), sections 13.010 to 13.014, under the heading “Shell in Cacao Nibs—Official Final Action”, published by the Association of Official Analytical Chemists, in Washington.

SOR/97-263, s. 2.

B.04.004. [S]. Cocoa Liquor, Cocoa Mass, Unsweetened Chocolate, Bitter Chocolate or Chocolate Liquor shall

(a) be the product obtained from the mechanical disintegration of the cocoa nib with or without removal or addition of any of its constituents; and

(b) contain not less than 50 per cent cocoa butter.

SOR/97-263, s. 2.

B.04.005. (1) Cocoa products may be processed with one or more of the following pH- adjusting or alkalizing agents:

(a) hydroxides of ammonia, carbonates of ammonia, bicarbonates of ammonia, hydroxides of sodium, carbonates of sodium, bicarbonates of sodium, hydroxides of potassium, carbonates of potassium or bicarbonates of potassium;

(b) carbonates of magnesium or hydroxides of magnesium; and

(c) carbonates of calcium.

(2) The quantity of any one pH-adjusting agent referred to in paragraphs (1)(a) to (c) shall not exceed the maximum level of use for that agent set out in column III of an item of Table X to section B.16.100.

(3) The total mass of the pH-adjusting agents referred to in paragraphs (1)(a) to (c) shall not be greater in neutralizing value, calculated from the respective masses of those agents, than the neutralizing value of five parts by mass of anhydrous potassium carbonate for each 100 parts by mass of cocoa product, calculated on a fat-free basis.

(4) Cocoa products may be processed with one or more of the following pH-adjusting or neutralizing agents, added as such or in aqueous solution:

(a) phosphoric acid;

(b) citric acid; and

(c) L-tartaric acid.

(5) The total mass of pH-adjusting agents referred to in subsection (4) shall not exceed in neutralizing value, calculated from the respective masses of those agents, the appropriate maximum levels of use set out in column III of Table X to section B.16.100.

(6) For the purpose of subsection (5),

(a) the total quantity of phosphoric acid shall not be greater than 0.5 part by mass, expressed as P2O5, for each 100 parts by mass of cocoa product, calculated on a fat-free basis; and

(b) the total quantity, singly or in combination, of citric acid and L-tartaric acid shall not be greater than 1.0 part by mass for each 100 parts by mass of cocoa product, calculated on a fat- free basis.

SOR/97-263, s. 2.

B.04.006. [S]. Chocolate, Bittersweet Chocolate, Semi-sweet Chocolate or Dark Chocolate

(a) shall be one or more of the following combined with a sweetening ingredient, namely,

(i) cocoa liquor,

(ii) cocoa liquor and cocoa butter, and

(iii) cocoa butter and cocoa powder;

(b) shall contain not less than 35 per cent total cocoa solids, of which

(i) not less than 18 per cent is cocoa butter, and

(ii) not less than 14 per cent is fat-free cocoa solids; and

(c) may contain

(i) less than 5 per cent total milk solids from milk ingredients,

(ii) spices,

(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iv) salt, and

(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin,

(C) ammonium salts of phosphorylated glycerides,

(D) polyglycerol esters of interesterified castor oil fatty acids, and

(E) sorbitan monostearate.

SOR/79-664, s. 2; SOR/97-263, s. 2.

B.04.007. [S]. Sweet Chocolate

(a) shall be one or more of the following combined with a sweetening ingredient, namely,

(i) cocoa liquor,

(ii) cocoa liquor and cocoa butter, and

(iii) cocoa butter and cocoa powder;

(b) shall contain not less than 30 per cent total cocoa solids, of which

(i) 18 per cent is cocoa butter, and

(ii) 12 per cent is fat-free cocoa solids; and

(c) may contain

(i) less than 12 per cent total milk solids from milk ingredients,

(ii) spices,

(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iv) salt, and

(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin,

(C) ammonium salts of phosphorylated glycerides,

(D) polyglycerol esters of interesterified castor oil fatty acids, and

(E) sorbitan monostearate.

SOR/97-263, s. 2.

B.04.008. [S]. Milk Chocolate

(a) shall be one or more of the following combined with a sweetening ingredient, namely,

(i) cocoa liquor,

(ii) cocoa liquor and cocoa butter, and

(iii) cocoa butter and cocoa powder;

(b) shall contain not less than

(i) 25 per cent total cocoa solids, of which

(A) not less than 15 per cent is cocoa butter, and

(B) not less than 2.5 per cent is fat-free cocoa solids,

(ii) 12 per cent total milk solids from milk ingredients, and

(iii) 3.39 per cent milk fat; and

(c) may contain

(i) less than 5 per cent whey or whey products,

(ii) spices,

(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iv) salt, and

(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin,

(C) ammonium salts of phosphorylated glycerides,

(D) polyglycerol esters of interesterified castor oil fatty acids, and

(E) sorbitan monostearate.

SOR/97-263, s. 2

B.04.009. [S]. White Chocolate

(a) shall contain the following combined together, namely,

(i) not less than 20 per cent cocoa butter,

(ii) not less than 14 per cent total milk solids from milk ingredients, and

(iii) not less than 3.5 per cent milk fat; and

(b) may contain

(i) less than 5 per cent whey or whey products,

(ii) spices,

(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iv) salt, and

(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin,

(C) ammonium salts of phosphorylated glycerides,

(D) polyglycerol esters of interesterified castor oil fatty acids, and

(E) sorbitan monostearate.

SOR/97-263, s. 2.

B.04.010. [S]. Cocoa or Cocoa Powder

(a) shall be the product that

(i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and

(ii) contains not less than 10 per cent cocoa butter; and

(b) may contain

(i) spices,

(ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iii) salt, and

(iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin, and

(C) ammonium salts of phosphorylated glycerides.

SOR/82-768, s. 5; SOR/97-263, s. 2.

B.04.011. [S]. Low Fat Cocoa or Low Fat Cocoa Powder

(a) shall be the product that:

(i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and

(ii) contains less than 10 per cent cocoa butter; and

(b) may contain

(i) spices,

(ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,

(iii) salt, and

(iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely,

(A) mono-glycerides and mono- and diglycerides,

(B) lecithin and hydroxylated lecithin, and

(C) ammonium salts of phosphorylated glycerides.

SOR/82-768, s. 6; SOR/97-263, s. 2.

B.04.012. No person shall sell a cocoa product or a chocolate product unless it is free from bacteria of the genus Salmonella as determined by official method MFO-11, Microbiological Examination of Cocoa and Chocolate, November 30, 1981.

SOR/97-263, s. 2.

Division 5

Coffee B.05.001. [S]. Green Coffee, Raw Coffee or Unroasted Coffee shall be the seed of Coffee arabica L., C. liberica Hiern, or C. robusta Chev., freed from all but a small portion of its spermoderm.

B.05.002. [S]. Roasted Coffee or Coffee shall be roasted green coffee, and shall contain not less than 10 per cent fat, and may contain not more than six per cent total ash.

B.05.003. [S]. Decaffeinated (indicating the type of coffee)

(a) shall be coffee of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than

(i) 0.1 per cent caffeine, in the case of decaffeinated raw coffee and decaffeinated coffee, or

(ii) 0.3 per cent caffeine, in the case of decaffeinated instant coffee; and

(b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16.

SOR/90-443, s. 1.

Division 6

Food Colours

B.06.001. In this Division,

“diluent” means any substance other than a synthetic colour present in a colour mixture or preparation; (diluant)

“dye” means the principal dye and associated subsidiary and isomeric dyes contained in a synthetic colour; (pigment)

“mixture” means a mixture of two or more synthetic colours or a mixture of one or more synthetic colours with one or more diluents; (mélange)

“official method FO-7” means official method FO-7, Determination of Dye Content of Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-7))

“official method FO-8” means official method FO-8, Determination of Water Insoluble Matter in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-8))

“official method FO-9” means official method FO-9, Determination of Combined Ether Extracts in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-9))

“official method FO-10” means official method FO-10, Determination of Subsidiary Dyes in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-1003))

“official method FO-11” means official method FO-11, Determination of Intermediates in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-11))

“official method FO-12” means official method FO-12, Determination of Volatile Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-12))

“official method FO-13” means official method FO-13, Determination of Sulphated Ash in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-13))

“official method FO-14” means official method FO-14, Determination of Water Soluble Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-14))

“official method FO-15” means offical method FO-15, Determination of Carbon Tetrachloride Insoluble Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle))

“preparation” means a preparation of one or more synthetic colours containing less than three per cent dye and sold for household use; (préparation)

“synthetic colour” means any organic colour, other than caramel, that is produced by chemical synthesis and has no counterpart in nature and for which a standard is prescribed in sections B.06.041 to B.06.053. (colorant synthétique)

SOR/80-500, s. 2; SOR/84-440, s. 1.

B.06.002. No person shall sell a food, other than a synthetic colour, mixture, preparation or flavouring preparation, that contains, when prepared for consumption according to label directions, more than

(a) 300 parts per million of Allura Red, Amaranth, Erythrosine, Indigotine, Sunset Yellow FCF or Tartrazine or any combination of those colours unless a higher maximum level of use is specified in column III of item 3 of Table III to section B.16.100;

(b) 100 parts per million of Fast Green FCF or Brilliant Blue FCF or any combination of those colours;

(c) 300 parts per million of any combination of the synthetic colours named in paragraphs (a) and (b) within the limits set by those paragraphs; or

(d) 150 parts per million of Ponceau SX.

SOR/80-500, s. 2; SOR/84-440, s. 2; SOR/86-178, s. 1(F); SOR/2007-75, s. 1. Previous Version B.06.003. No person shall sell a colour for use in or upon food that contains more than

(a) three parts per million of arsenic, calculated as arsenic, as determined by official method FO-4, Determination of Arsenic in Food Colours, October 15, 1981;

(b) 10 parts per million of lead, calculated as lead, as determined by official method FO-5, Determination of Lead in Food Colours, October 15, 1981; or

(c) 40 parts per million of heavy metals, except in the case of iron oxide, titanium dioxide, aluminum metal and silver metal.

SOR/80-500, s. 2; SOR/82-768, s. 7.

B.06.004. No person shall sell a synthetic colour for use in or upon food unless

(a) the label carries the lot number and common name of the synthetic colour and the words “Food Colour”;

(b) the Director, or an agency acceptable to the Director, has certified that each lot meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; and

(c) where the synthetic colour is certified by an agency, a copy of the certificate has been submitted to and accepted by the Director.

SOR/80-500, s. 2.

B.06.005. No person shall import a synthetic colour for use in or upon food unless

(a) the Director, or an agency acceptable to the Director, has certified that each lot meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; and

(b) where the synthetic colour is certified by an agency, a copy of the certificate has been submitted to and accepted by the Director.

SOR/80-500, s. 2.

B.06.006. No person shall sell a mixture for use in or upon food unless the label carries the lot number of the mixture and the words “Food Colour”.

SOR/80-500, s. 2.

B.06.007. No person shall sell a preparation for use in or upon food unless

(a) the label carries the words “Food Colour Preparation” on its principal display panel; and

(b) in the case of a liquid preparation, the container has a capacity of 60 ml or less and will permit dropwise discharge only.

SOR/80-500, s. 2.

B.06.008. No person shall import or sell a mixture or preparation for use in or upon food unless

(a) the Director, or an agency acceptable to the Director, has certified that any synthetic colour contained therein meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; or

(b) any synthetic colour contained therein has been previously certified and the certificate has been accepted as required by sections B.06.004 and B.06.005.

SOR/80-500, s. 2.

B.06.009. to B.06.013. [Repealed, SOR/80-500, s. 2]

Natural Colours

B.06.021. [S]. Oil-soluble Annatto, Annatto Butter Colour, or Annatto Margarine Colour

(a) shall be the extractives of Bixa orellana seeds

(i) dissolved in vegetable oil, castor oil, monoglycerides and diglycerides, propylene glycol or propylene glycol monoesters and diesters of fat-forming fatty acids, with or without one per cent potassium hydroxide, or

(ii) suspended upon sugar, lactose, starch or hydrated calcium silicate, with or without calcium phosphate, potassium aluminum sulphate, sodium bicarbonate or salt; and

(b) shall contain not less than 0.30 per cent total pigments calculated as natural (cis-) bixin, which pigments shall consist of not less than 40 per cent natural (cis-) bixin.

B.06.022. [S]. ß-Carotene shall be the food colour chemically known as ß-carotene that is manufactured synthetically and shall conform to the following specifications:

(a) one per cent solution in chloroform .......clear;

(b) loss of weight on drying .......not more than 0.2 per cent;

(c) residue on ignition .......not more than 0.2 per cent; and

(d) assay (spectrophotometric) .......96 to 101 per cent.

B.06.023. [S]. ß-Apo-8′-Carotenal shall be the food colour chemically known as ß-apo-8′ ­ carotenal and shall conform to the following specifications:

(a) one per cent solution in chloroform .......clear;

(b) melting point (decomposition) .......136°C. to 140°C (corrected);

(c) loss of weight on drying .......not more than 0.2 per cent;

(d) residue on ignition .......not more than 0.2 per cent; and

(e) assay (spectrophotometric) .......96 to 101 per cent.

B.06.024. [S]. Canthaxanthin shall be the food colour chemically known as canthaxanthin and shall conform to the following specifications:

(a) one per cent solution in chloroform .......clear;

(b) loss of weight on drying .......not more than 0.2 per cent;

(c) assay (spectrophotometric) .......96 to 101 per cent.

B.06.025. [S]. Ethyl ß-apo-8′-carotenoate shall be the food colour chemically known as ethyl ß-apo-8′-carotenoate and shall conform to the following specifications:

(a) one per cent solution in chloroform .......clear

(b) loss of weight on drying .......not more than 0.2 per cent, and

(c) assay (spectrophotometric) .......96 to 101 per cent.

SOR/84-300, s. 19(F).

Inorganic Colours

B.06.031. [S]. Carbon black shall be carbon prepared from natural gas by the “channel” or “impingement” process and shall contain no higher aromatic hydrocarbons or tarry materials as determined by official method FO-6, Determination of Higher Aromatic Hydrocarbons or Tarry Materials in Carbon Black and Charcoal, October 15, 1981.

SOR/82-768, s. 8.

B.06.032. [S]. Charcoal shall be carbon prepared by the incomplete combustion of vegetable matter and shall contain no higher aromatic hydrocarbons or tarry materials as determined by official method FO-6, Determination of Higher Aromatic Hydrocarbons or Tarry Materials in Carbon Black and Charcoal, October 15, 1981.

SOR/82-768, s. 8.

B.06.033. [S]. Titanium Dioxide shall be the chemical substance known as titanium dioxide and shall contain not less than 99 per cent titanium dioxide, and notwithstanding section B.06.006, shall contain not more than 50 parts per million of total antimony expressed as the metal and as determined by an acceptable method.

Synthetic Colours

B.06.041. [S]. Amaranth shall be the trisodium salt of 1-(4-sulpho-1-naphthylazo)-2­ naphthol-3,6-disulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 4.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 9; SOR/84-440, s. 3.

B.06.042. [S]. Erythrosine shall be the disodium salt of 2,4,5,7-tetraiodofluorescein, shall contain not less than 85 per cent dye calculated as the monohydrate, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 9; SOR/84-440, s. 3.

B.06.043. [S]. Ponceau SX shall be the disodium salt of 2-(5-sulpho-2,4-xylylazo)-1­ naphthol-4-sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 9; SOR/84-440, s. 3.

B.06.044. [S]. Allura Red shall be the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl­ 4-sulphophenyl)azo]-2-naphthalene sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 4.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/84-440, s. 3.

B.06.045. [S]. Tartrazine shall be the trisodium salt of 3-carboxy-5-hydroxy-1-p­ sulphophenyl-4-p-sulphophenyl-azopyrazole, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 10; SOR/84-440, s. 3.

B.06.046. [S]. Sunset Yellow FCF shall be the disodium salt of 1-p-sulphophenylazo-2­ naphthol-6-sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;

(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 10; SOR/84-440, s. 3.

B.06.049. [S]. Fast Green FCF shall be the disodium salt of 4,4′-di(N-ethyl-m­ sulphobenzylamino)-2″-sulpho-4″-hydroxytriphenylmethanol anhydride, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;

(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 1.0 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 11; SOR/84-440, s. 3.

B.06.050. [S]. Indigotine shall be the disodium salt of indigotine-5,5′-disulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;

(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 0.5 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 11; SOR/84-440, s. 3.

B.06.051. [S]. Brilliant Blue FCF shall be the disodium salt of 4,4′-di (N-ethyl-m­ sulphobenzylamino)-2″-sulphotriphenylmethanol anhydride, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;

(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;

(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and

(d) 2.0 per cent intermediates, as determined by official method FO-11.

SOR/82-768, s. 11; SOR/84-440, s. 3.

B.06.053. [S]. Citrus Red. No. 2 shall be 1-(2,5-dimethoxyphenylazo)-2-naphthol, shall contain not less than 98 per cent dye, as determined by official method FO-7, and may contain not more than

(a) 0.5 per cent volatile matter (at 100°C), as determined by official method FO-12;

(b) 0.3 per cent sulphated ash, as determined by official method FO-13;

(c) 0.3 per cent water soluble matter, as determined by official method FO-14;

(d) 0.5 per cent carbon tetrachloride insoluble matter, as determined by official method FO­ 15;

(e) 0.05 per cent uncombined intermediates; and

(f) 2.0 per cent subsidiary dyes.

SOR/82-768, s. 12; SOR/84-440, s. 3.

B.06.061. The lake of any water soluble synthetic colour for which a standard is provided in sections B.06.041, B.06.042, B.06.043, B.06.044, B.06.045, B.06.046, B.06.049, B.06.050 or B.06.051 shall be the calcium or aluminum salt of the respective colour extended on alumina.

SOR/82-1071, s. 3; SOR/84-300, s. 20; SOR/87-640, s. 2.

B.06.062. [Repealed, SOR/82-768, s. 13]

Division 7

Spices, Dressings And Seasonings B.07.001. [S]. Allspice or Pimento, whole or ground, shall be the dried, full but unripe whole berries of Pimenta dioica (L) Merr. and shall contain

(a) not more than

(i) 25 per cent crude fibre,

(ii) 5.5 per cent total ash,

(iii) 0.4 per cent ash insoluble in hydrochloric acid, and

(iv) 12 per cent moisture; and

(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.002. [S]. Anise or Anise Seed, whole or ground, shall be the dried fruit of Pimpinella anisum L. and shall contain

(a) not more than

(i) nine per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than two millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.003. [S]. Basil or Sweet Basil, whole or ground, shall be the dried leaves of Ocimum basilicum L. and shall contain

(a) not more than

(i) 15 per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than 0.2 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.004. [S]. Bay Leaves or Laurel Leaves, whole or ground, shall be the dried leaves of Laurus nobilis L. and shall contain

(a) not more than

(i) 4.5 per cent total ash,

(ii) 0.5 per cent ash insoluble in hydrochloric acid, and

(iii) seven per cent moisture; and

(b) not less than one millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.005. [S]. Caraway or Caraway Seed, whole or ground, shall be the dried fruit of the caraway plant, Carum carvi L. and shall contain

(a) not more than

(i) eight per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 11.5 per cent moisture; and

(b) not less than two millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.006. [S]. Cardamom or Cardamom Seed, bleached or green, whole or ground, shall be the dried ripe fruit of Elettaria cardamomum Maton and shall contain

(a) not more than

(i) eight per cent total ash,

(ii) three per cent ash insoluble in hydrochloric acid, and

(iii) 13 per cent moisture; and

(b) not less than three millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.007. [S]. Cayenne Pepper or Cayenne, whole or ground,

(a) shall be the dried ripe fruit of Capsicum frutescens L., Capsicum baccatum L., or other small-fruited species of Capsicum and shall contain not more than

(i) 1.5 per cent starch,

(ii) 28 per cent crude fibre,

(iii) 10 per cent total ash,

(iv) 1.5 per cent ash insoluble in hydrochloric acid, and

(v) 10 per cent moisture; and

(b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent.

SOR/79-659, s. 1; SOR/84-17, s. 2.

B.07.008. [S]. Celery Salt

(a) shall be a combination of

(i) ground celery seed or ground dehydrated celery, and

(ii) salt in an amount not exceeding 75 per cent; and

(b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent.

SOR/79-659, s. 1.

B.07.009. [S]. Celery Seed, whole or ground, shall be the dried ripe fruit of Apium graveolens L. and shall contain

(a) not more than

(i) 12 per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than 1.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.010. [S]. Celery Pepper

(a) shall be a combination of

(i) ground celery seed or ground dehydrated celery, and

(ii) ground black pepper in an amount not exceeding 70 per cent; and

(b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent.

SOR/79-659, s. 1.

B.07.011. [S]. Cinnamon or Cassia, whole or ground, shall be the dried bark of trees of the genus Cinnamomum of Species C. burmanni Blume, C. loureirii Nees or C. Cassia Blume and shall contain

(a) not more than

(i) six per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) 13 per cent moisture; and

(b) not less than 1.2 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.012. [S]. Ceylon Cinnamon, whole or ground, shall be cinnamon obtained exclusively from Cinnamomum zeylanicum Nees.

SOR/79-659, s. 1.

B.07.013. [S]. Cloves, whole or ground, shall be the dried unopened flower buds of Eugenia caryophyllus (Spreng) and shall contain

(a) not more than

(i) five per cent clove stems,

(ii) six per cent total ash,

(iii) 0.5 per cent ash insoluble in hydrochloric acid,

(iv) 10 per cent crude fibre, and

(v) eight per cent moisture; and

(b) not less than 13 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.014. [S]. Coriander or Coriander Seed, whole or ground, shall be the dried fruit of Coriandrum sativum L. and shall contain

(a) not more than

(i) seven per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than 0.3 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.015. [S]. Cumin or Cumin Seed, whole or ground, shall be the dried seeds of Cuminum cyminum L. and shall contain

(a) not more than

(i) 9.5 per cent total ash,

(ii) 1.5 per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.016. [S]. Curry Powder shall be any combination of

(a) turmeric with spices and seasoning; and

(b) salt in an amount not exceeding five per cent.

SOR/79-659, s. 1.

B.07.017. [S]. Dill Seed, whole or ground, shall be the dried fruit of Anethum graveolens L., or Anethum sowa D.C. and shall contain

(a) not more than

(i) 10 per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than two millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.018. [S]. Fennel or Fennel Seed, whole or ground, shall be the dried ripe fruit of Foeniculum vulgare Mill. and shall contain

(a) not more than

(i) 10 per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than one millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.019. [S]. Fenugreek, whole or ground, shall be the dried ripe fruit of Trigonella foenumgraecum L. and shall contain not more than

(a) five per cent total ash;

(b) one per cent ash insoluble in hydrochloric acid; and

(c) 10 per cent moisture.

SOR/79-659, s. 1.

B.07.020. [S]. Garlic Salt

(a) shall be a combination of

(i) powdered dehydrated garlic, and

(ii) salt in an amount not exceeding 75 per cent; and

(b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent:

calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicone dioxide in an amount not exceeding one per cent and sodium aluminum silicate.

SOR/79-659, s. 1.

B.07.021. [S]. Ginger whole or ground, shall be the washed and dried or decorticated rhizome of Zingiber officinale Roscoe and shall contain

(a) not more than

(i) seven per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 12.5 per cent moisture; and

(b) not less than 1.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.022. [S]. Mace, whole or ground, shall be the dried arillus of Myristica fragrans Houttyn and shall contain

(a) not more than

(i) 3.5 per cent total ash,

(ii) 0.5 per cent ash insoluble in hydrochloric acid, and

(iii) eight per cent moisture, and

(b) not less than 11 millilitres volatile oil per 100 grams of spice,

and the total non-volatile extracts obtainable therefrom by

(c) ethyl ether, shall not be less than 20 per cent nor more than 35 per cent, and

(d) ethyl ether, after preliminary extraction with petroleum ether, shall not exceed five per cent.

SOR/79-659, s. 1.

B.07.023. [S]. Marjoram, whole or ground, shall be the dried leaves, with or without a small proportion of the flowering tops, of Marjorana hortensis Moench and shall contain

(a) not more than

(i) 10 per cent stems and foreign material of plant origin,

(ii) 13.5 per cent total ash,

(iii) 4.5 per cent ash insoluble in hydrochloric acid, and

(iv) 10 per cent moisture; and

(b) not less than 0.7 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.024. [S]. Mustard Seed shall be the seed of Sinapis alba, Brassica hirta Moench, Brassica juncea (L) Cosson or Brassica nigra and shall contain

(a) not more than

(i) seven per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 11 per cent moisture; and

(b) not less than 25 per cent non-volatile ether extract.

SOR/79-659, s. 1.

B.07.025. [S]. Mustard, Mustard Flour or Ground Mustard shall be powdered mustard seed

(a) made from mustard seed from which

(i) most of the hulls have been removed, and

(ii) a portion of the fixed oil may have been removed; and

(b) that contains not more than

(i) 1.5 per cent starch, and

(ii) eight per cent total ash, on an oil-free basis.

SOR/79-659, s. 1; SOR/2010-142, s. 3(F). Previous Version B.07.026. [S]. Nutmeg, whole or ground, shall be the dried seed of Myristica fragrans Houttyn and may, prior to grinding, have a thin coating of lime and shall contain

(a) not more than

(i) three per cent total ash,

(ii) 0.5 per cent ash insoluble in hydrochloric acid, and

(iii) eight per cent moisture; and

(b) not less than

(i) 25 per cent non-volatile ether extract, and

(ii) 6.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.027. [S]. Onion Salt

(a) shall be a combination of

(i) powdered dehydrated onion, and

(ii) salt in an amount not exceeding 75 per cent; and

(b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent:

calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide in an amount not exceeding one per cent and sodium aluminum silicate.

SOR/79-659, s. 1.

B.07.028. [S]. Oregano, whole or ground, shall be the dried leaves of Origanum vulgar L. or Origanum Spp. and shall contain

(a) not more than

(i) 10 per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.029. [S]. Paprika shall be the dried, ground ripe fruit of Capsicum annuum L. and

(a) shall contain not more than

(i) 23 per cent crude fibre,

(ii) 8.5 per cent total ash,

(iii) one per cent ash insoluble in hydrochloric acid, and

(iv) 12 per cent moisture; and

(b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent.

SOR/79-659, s. 1; SOR/84-17, s. 3.

B.07.030. [S]. Black Pepper or Peppercorn, whole or ground, shall be the dried, immature berry of Piper nigrum L. and shall contain

(a) not more than

(i) seven per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) 12 per cent moisture;

(b) not less than

(i) six per cent non-volatile methylene chloride extract,

(ii) 30 per cent pepper starch, and

(iii) 2.0 millilitres volatile oil per 100 grams of spice; and

(c) when ground, all the parts of the berry in their normal proportions.

SOR/79-659, s. 1.

B.07.031. [S]. White Pepper, whole or ground, shall be the dried, mature berry of Piper nigrum L., from which the outer coating is and the inner coating may be removed and shall contain

(a) not more than

(i) five per cent crude fibre,

(ii) 2.5 per cent total ash,

(iii) 0.3 per cent ash insoluble in hydrochloric acid, and

(iv) 15 per cent moisture; and

(b) not less than

(i) six per cent non-volatile methylene chloride extract,

(ii) 52 per cent pepper starch, and

(iii) one millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.032. [S]. Poppy seed shall be the dried seed of Papaver somniferum L. and shall contain

(a) not more than

(i) seven per cent total ash, and

(ii) one per cent ash insoluble in hydrochloric acid; and

(b) not less than 40 per cent non-volatile ether extract.

SOR/79-659, s. 1.

B.07.033. [S]. Rosemary, whole or ground, shall be the dried leaves of Rosemarinus officinalis L. and shall contain

(a) not more than

(i) 7.5 per cent total ash,

(ii) one per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than 1.2 millilitres volatile oil per 100 grams of spice.

SOR/78-637, s. 1; SOR/79-659, s. 1.

B.07.034. [S]. Sage, whole or ground, shall be the dried leaves of the sage plant Salvia officinalis L., Salvia triloba L. or Salvia lavandulaefolia Vahl. and shall contain

(a) not more than

(i) 12 per cent stems excluding petioles and foreign material of plant origin,

(ii) 10 per cent total ash,

(iii) one per cent ash insoluble in hydrochloric acid, and

(iv) 10 per cent moisture; and

(b) not less than one millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.035. [S]. Savory, whole or ground, shall be the dried leaves and flowering tops of Satureja hortensis L. or Satureja montana L. and shall contain

(a) not more than

(i) 11 per cent total ash,

(ii) two per cent ash insoluble in hydrochloric acid, and

(iii) 14 per cent moisture; and

(b) not less than 0.8 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.036. [S]. Sesame Seed shall be the dried hulled seed of Sesamum indicum L. and shall contain

(a) not more than eight per cent moisture; and

(b) not less than 50 per cent non-volatile ether extract.

SOR/79-659, s. 1; SOR/2010-142, s. 4(F). Previous Version B.07.037. [S]. Tarragon, whole or ground, shall be the dried leaves and flowering tops of Artemisia dracunculus L. and shall contain

(a) not more than

(i) 15 per cent total ash,

(ii) 1.5 per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than 0.3 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.038. [S]. Thyme, whole or ground, shall be the dried leaves and flowering tops of the thyme plant Thymus vulgaris L. or Thymus zygis L. and shall contain

(a) not more than

(i) 12 per cent total ash,

(ii) five per cent ash insoluble in hydrochloric acid, and

(iii) nine per cent moisture; and

(b) not less than 0.9 millilitre volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.039. [S]. Turmeric, whole or ground, shall be the dried rhizome of Curcuma longa L. and shall contain

(a) not more than

(i) seven per cent total ash,

(ii) 1.5 per cent ash insoluble in hydrochloric acid, and

(iii) 10 per cent moisture; and

(b) not less than 3.5 millilitres volatile oil per 100 grams of spice.

SOR/79-659, s. 1.

B.07.040. [S]. Mayonnaise, Mayonnaise Dressing or Mayonnaise Salad Dressing

(a) shall be a combination of

(i) vegetable oil,

(ii) whole egg or egg yolk, in liquid, frozen or dried form, and

(iii) vinegar or lemon juice;

(b) may contain

(i) water,

(ii) salt,

(iii) a sweetening agent,

(iv) spice or other seasoning except turmeric or saffron,

(v) citric, tartaric or lactic acid, and

(vi) a sequestering agent; and

(c) shall contain not less than 65 per cent vegetable oil.

SOR/79-659, s. 1.

B.07.041. [S]. French Dressing

(a) shall be a combination of

(i) vegetable oil, and

(ii) vinegar or lemon juice;

(b) may contain

(i) water,

(ii) salt,

(iii) a sweetening agent,

(iv) spice, tomato or other seasoning,

(v) an emulsifying agent,

(vi) whole egg or egg yolk, in liquid, frozen or dried form,

(vii) citric, tartaric or lactic acid, and

(viii) a sequestering agent; and

(c) shall contain not less than 35 per cent vegetable oil.

SOR/79-659, s. 1.

B.07.042. [S]. Salad Dressing

(a) shall be a combination of

(i) vegetable oil,

(ii) whole egg or egg yolk, in liquid, frozen or dried form,

(iii) vinegar or lemon juice, and

(iv) starch, flour, rye flour or tapioca flour or any combination thereof;

(b) may contain

(i) water,

(ii) salt,

(iii) a sweetening agent,

(iv) spice or other seasoning,

(v) an emulsifying agent,

(vi) citric, tartaric or lactic acid, and

(vii) a sequestering agent; and

(c) shall contain not less than 35 per cent vegetable oil.

SOR/79-659, s. 1.

B.07.043. No person shall sell a dressing that contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the dressing.

SOR/79-659, s. 1.

Division 8

Dairy Products B.08.001. The foods referred to in this Division are dairy products.

B.08.001.1 The following definitions apply in this Division.

“milk product” means

(a) with respect to butter or whey butter, any of the following products, namely,

(i) partly skimmed milk, skim milk, cream, buttermilk and whey cream, and

(ii) milk in concentrated, dried or reconstituted form and any product referred to in subparagraph (i) in concentrated, dried or reconstituted form;

(b) with respect to cheese, any of the following products, namely,

(i) partly skimmed milk, skim milk, cream, buttermilk, whey and whey cream,

(ii) milk in concentrated, dried, frozen or reconstituted form and any product referred to in subparagraph (i) in concentrated, dried, frozen or reconstituted form,

(iii) butter, butter oil and whey butter,

(iv) any constituent of milk — other than water — singly or in combination with other constituents of milk, and

(v) whey protein concentrate;

(c) with respect to cold-pack cheese food, cold-pack cheese food with (naming the added ingredients), cream cheese spread, cream cheese spread with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread or processed cheese spread with (naming the added ingredients), any of the following products, namely,

(i) butter, whey butter and whey,

(ii) whey protein concentrate, and

(iii) any product referred to in subparagraph (i) in concentrated or dried form; and

(d) with respect to ice milk mix, ice cream mix or sherbet, any of the products referred to in subparagraph (a)(i) or (ii) or (c)(i) or (ii). (produit du lait)

“ultrafiltered”, in relation to milk, partly skimmed milk or skim milk, means that the milk, partly skimmed milk or skim milk has been subjected to a process in which it is passed over one or more semi-permeable membranes to partially remove water, lactose, minerals and water-soluble vitamins without altering the whey protein to casein ratio and that results in a liquid product. (ultrafiltré)

SOR/92-400, s. 1. SOR/97-543, s. 1(F); SOR/98-580, s. 1(F); SOR/2007-302, s. 1; SOR/2010-94, s. 2. Previous Version B.08.002. Except as provided in these Regulations, a dairy product that contains a fat other than milk fat is adulterated.

B.08.002.1. Sections B.08.003 to B.08.028 do not apply to a lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion.

SOR/85-623, s. 1.

B.08.002.2 (1) Subject to subsection (2), no person shall sell the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos, or of any other animal, or sell a dairy product made with any such secretion, unless the secretion or dairy product has been pasteurized by being held at a temperature and for a period that ensure the reduction of the alkaline phosphatase activity so as to meet the tolerances specified in official method MFO-3, Determination of Phosphatase Activity in Dairy Products, dated November 30, 1981.

(2) Subsection (1) does not apply to

(a) cheese; or

(b) any food that is sold for further manufacturing or processing in order to pasteurize it in the manner described in subsection (1).

SOR/91-549, s. 1; SOR/95-499, s. 1.

Milk

B.08.003. [S]. Milk or Whole Milk

(a) shall be the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos; and

(b) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

SOR/95-499, s. 2.

B.08.004. [S]. Skim Milk

(a) shall be milk that contains not more than 0.3 per cent milk fat;

(b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and

(c) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

SOR/78-656, s. 1.

B.08.005. [S]. Partly Skimmed Milk or Partially Skimmed Milk

(a) shall be derived from milk that has had its fat content reduced by mechanical separation or adjusted by the addition of cream, milk, partly skimmed milk or skim milk, either singly or in combination;

(b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and

(c) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

SOR/78-656, s. 2.

B.08.006. [S]. Milk Fat or Butter Fat shall be the fat of cow’s milk, and shall have

(a) a specific gravity of not less than 0.905 at a temperature of 40°,

(b) a tocopherol content not greater than 50 micrograms per gram, as determined by official method FO-16, Determination of Tocopherol in Milk Fat or Butter Fat, October 15, 1981,

(c) a Reichert-Meissl number not less than 24, and

(d) a Polenske number not exceeding 10 per cent of the Reichert-Meissl number and in no case shall the Polenske number exceed 3.5, and

where the tocopherol content is greater than 50 micrograms per gram or the Polenske number exceeds 10 per cent of the Reichert-Meissl number, there shall be deemed to have been an addition to the milk fat of fat other than that of cow’s milk.

SOR/82-768, s. 14.

B.08.007. [S]. Sterilized Milk

(a) and (b) [Repealed, SOR/97-148, s. 1]

(c) shall contain not less than

(i) 11.75 per cent milk solids, and

(ii) 3.25 per cent milk fat; and

(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

SOR/97-148, s. 1.

B.08.008. The percentage of milk fat contained in

(a) partly skimmed milk or partially skimmed milk,

(b) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids, or

(c) evaporated partly skimmed milk or concentrated partly skimmed milk

shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

B.08.009. [S]. Condensed Milk or Sweetened Condensed Milk shall be milk from which water has been evaporated and to which has been added sugar, dextrose, glucose, glucose solids or lactose, or any combination thereof, may contain added vitamin D and shall contain not less than

(a) 28 per cent milk solids; and

(b) eight per cent milk fat.

B.08.010. [S]. Evaporated Milk

(a) shall be milk from which water has been evaporated;

(b) shall contain not less than

(i) 25.0 per cent milk solids, and

(ii) 7.5 per cent milk fat;

(c) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;

(d) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(e) may contain

(i) added disodium phosphate or sodium citrate, or both, and

(ii) an emulsifying agent.

SOR/78-656, s. 3; SOR/92-400, s. 2.

B.08.011. [S]. Evaporated Skim Milk or Concentrated Skim Milk

(a) shall be milk that has been concentrated to at least one-half of its original volume by the removal of water;

(b) shall contain

(i) not more than 0.3 per cent milk fat, and

(ii) not less than 17.0 per cent milk solids other than fat;

(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(d) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;

(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(f) may contain added disodium phosphate or sodium citrate, or both.

B.08.012. [S]. Evaporated Partly Skimmed Milk or Concentrated Partly Skimmed Milk

(a) shall be milk from which part of the milk fat has been removed;

(b) shall be concentrated to at least one-half its original volume by the removal of water;

(c) shall contain not less than 17.0 per cent milk solids other than fat; and

(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(e) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;

(f) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(g) may contain

(i) an emulsifying agent, and

(ii) added disodium phosphate or sodium citrate, or both.

B.08.013. [S]. Milk Powder, Whole Milk Powder, Dry Whole Milk, or Powdered Whole Milk

(a) shall be dried milk;

(b) shall contain not less than

(i) 95 per cent milk solids, and

(ii) 26 per cent milk fat;

(c) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(d) may contain the emulsifying agent lecithin in an amount not exceeding 0.5 per cent.

SOR/78-656, s. 4; SOR/83-932, s. 2.

B.08.014. [S]. Skim Milk Powder or Dry Skim Milk

(a) shall be dried skim milk;

(b) shall contain not less than 95 per cent milk solids; and

(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(e) may contain an anti-foaming agent.

SOR/78-656, s. 5; SOR/80-501, s. 2(F).

B.08.014A. No person shall sell milk powder, whole milk powder, dry whole milk, powdered whole milk, skim milk powder or dry skim milk unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-12, Microbiological Examination of Milk Powder, November 30, 1981.

SOR/78-656, s. 6; SOR/82-768, s. 15.

B.08.015. No person shall sell milk, skim milk, partly skimmed milk, (naming the flavour) milk, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, skim milk

with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, condensed milk, evaporated milk, evaporated skim milk, evaporated partly skimmed milk, milk powder or skim milk powder, in which the vitamin content has been increased by either irradiation or addition unless

(a) in the case of the addition of vitamin D, the menstruum containing the vitamin D contributes not more than 0.01 per cent fat foreign to milk; and

(b) in cases where the vitamin D content is increased by irradiation, the principal display panel of the label carries the statement “Vitamin D Increased” immediately preceding or following the name of the food, without intervening written, printed or graphic matter.

SOR/88-336, s. 3.

B.08.016. [S]. (naming the flavour) Milk

(a) shall be the product made from

(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,

(ii) a flavouring preparation, and

(iii) a sweetening agent;

(b) shall contain not less than three per cent milk fat;

(c) shall contain added vitamin D in such an amount that a reasonable intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;

(d) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and

(e) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.

SOR/78-656, s. 7; SOR/82-768, s. 16; SOR/84-762, s. 1.

B.08.017. [S]. (naming the flavour) Skim Milk

(a) shall be the product made from

(i) skim milk, skim milk powder or evaporated skim milk or any combination thereof,

(ii) a flavouring preparation, and

(iii) a sweetening agent;

(b) shall contain not more than 0.3 per cent milk fat;

(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch.

SOR/78-656, s. 8; SOR/84-762, s. 2.

B.08.018. [S]. (naming the flavour) Partly (Partially) Skimmed Milk

(a) shall be the product made from

(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,

(ii) a flavouring preparation, and

(iii) a sweetening agent;

(b) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat;

(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;

(e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and

(f) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.

SOR/78-656, s. 9; SOR/82-768, s. 17; SOR/84-762, s. 3.

B.08.019. [S]. Skim Milk with Added Milk Solids

(a) shall be skim milk to which has been added skim milk powder or evaporated skim milk or both;

(b) shall contain not less than 10 per cent milk solids;

(c) shall contain not more than 0.3 per cent milk fat;

(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the dairy product contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and

(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

SOR/78-656, s. 10.

B.08.020. [S]. Partly Skimmed Milk with Added Milk Solids or Partially Skimmed Milk with Added Milk Solids

(a) shall be partly skimmed milk to which has been added skim milk powder, milk powder, evaporated milk, evaporated partly skimmed milk or evaporated skim milk or any combination thereof;

(b) shall contain not less than 10 per cent milk solids not including fat; and

(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and

(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.

B.08.021. [S]. Malted Milk or Malted Milk Powder

(a) shall be the product made by combining milk with the liquid separated from a mash of ground barley malt and meal;

(b) may have added to it, in such manner as to secure the full enzyme action of the malt extract, salt and sodium bicarbonate or potassium bicarbonate;

(c) may have water removed from it; and

(d) shall contain

(i) not less than 7.5 per cent milk fat, and

(ii) not more than 3.5 per cent moisture.

B.08.022. [S]. (naming the flavour) Malted Milk or (naming the flavour) Malted Milk Powder

(a) shall be malted milk or malted milk powder containing a flavouring preparation; and

(b) may contain lactase.

SOR/84-762, s. 4.

B.08.023. [S]. (naming the flavour) Skim Milk with Added Milk Solids

(a) shall be the product made from

(i) skim milk, skim milk powder, or evaporated skim milk or any combination thereof,

(ii) a flavouring preparation, and

(iii) a sweetening agent;

(b) shall contain not less than 10 per cent milk solids not including fat;

(c) shall contain not more than 0.3 per cent milk fat;

(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and

(f) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch.

SOR/78-656, s. 11; SOR/84-762, s. 5.

B.08.024. No person shall sell milk for manufacture into dairy products if it contains more than

(a) two million total aerobic bacteria per millilitre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981; or

(b) two milligrams of sediment per 16 fluid ounces, as determined by official method MFO-8, Determination of Sediment in Milk, November 30, 1981.

SOR/82-768, s. 18.

B.08.025. No manufacturer shall purchase milk for manufacture or manufacture milk into other dairy products if he has reason to believe it does not meet the requirements of section B.08.024.

B.08.026. [S]. (naming the flavour) Partly (Partially) Skimmed Milk with Added Milk Solids

(a) shall be the product made from

(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,

(ii) a flavouring preparation, and

(iii) a sweetening agent;

(b) shall contain not less than 10 per cent milk solids not including fat;

(c) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat;

(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;

(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;

(f) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and

(g) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.

SOR/78-656, s. 12; SOR/82-768, s. 19; SOR/84-300, s. 21(F); SOR/84-762, s. 6.

B.08.027. Notwithstanding anything contained in these Regulations, the following dairy products that are used in or sold for the manufacture of other foods are not required to contain added vitamins: milk; partly skimmed milk; partially skimmed milk; skim milk; sterilized milk; evaporated milk; evaporated skim milk; concentrated skim milk; evaporated partly skimmed milk; concentrated partly skimmed milk; milk powder; dry whole milk; powdered whole milk; skim milk powder; dry skim milk; partly skimmed milk powder; partially skimmed milk powder; skim milk with added milk solids; partly skimmed milk with added milk solids; and partially skimmed milk with added milk solids.

SOR/78-656, s. 13.

B.08.028. (1) The percentage of milk fat contained in

(a) (naming the flavour) milk,

(b) (naming the flavour) partly (partially) skimmed milk,

(c) (naming the flavour) partly (partially) skimmed milk with added milk solids,

(d) cream, and

(e) sour cream,

shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

(2) In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of stated size.

SOR/79-23, s. 10; SOR/88-559, s. 16; SOR/2010-94, s. 3(F). Previous Version

Goat’s Milk

B.08.028.1. A lacteal secretion obtained from themammary gland of any animal other than a cow, genus Bos, and a product or derivative of such secretion shall be labelled so as to identify that animal.

SOR/85-623, s. 2.

B.08.029. (1) Notwithstanding sections D.01.009 to D.01.011, no person shall sell goat’s milk or goat’s milk powder to which vitamin D has been added unless the goat’s milk or goat’s milk powder contains not less than 35 International Units and not more than 45 International Units of vitamin D per 100 mL of the food when ready-to-serve.

(2) Notwithstanding sections D.01.009 to D.01.011, no person shall sell partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder or skimmed goat’s milk powder to which vitamins have been added unless the product contains not less than 35

International Units of vitamin D and 140 International Units of vitamin A and not more than 45 International Units of vitamin D and 300 International Units of vitamin A per 100 mL of food when ready-to-serve.

(3) Notwithstanding sections D.01.009 to D.01.011, no person shall sell evaporated goat’s milk to which vitamins have been added unless 100 mL of the evaporated goat’s milk, when reconstituted according to directions for use, contains not less than seven milligrams of vitamin C, 35 International Units of vitamin D and 10 micrograms of folic acid and not more than nine milligrams of vitamin C, 45 International Units of vitamin D and 20 micrograms of folic acid.

(4) Notwithstanding sections D.01.009 to D.01.011, no person shall sell evaporated partly skimmed goat’s milk or evaporated skimmed goat’s milk to which vitamins have been added unless 100 mL of the evaporated partly skimmed goat’s milk or the evaporated skimmed goat’s milk, when reconstituted according to directions for use, contains not less than 140 International Units of vitamin A, seven milligrams of vitamin C, 35 International Units of vitamin D and 10 micrograms of folic acid and not more than 300 International Units of vitamin A, nine milligrams of vitamin C, 45 International Units of vitamin D and 20 micrograms of folic acid.

SOR/85-623, s. 2.

Cheese

B.08.030. (1) In this Division, when used with respect to cheese,

“pasteurized source” means milk, skim milk, cream, reconstituted milk powder, reconstituted skim milk powder or any combination thereof that has been pasteurized by being held at a temperature of not less than 61.6°C for a period of not less than 30 minutes, or for a time and a temperature that is equivalent thereto in phosphatase destruction, as determined by official method MFO-3, Determination of Phosphatase Activity in Dairy Products, November 30, 1981; (matière première pasteurisée)

“pickles and relishes” means foods that meet the standard prescribed in section B.11.051; (cornichons et achards)

“stored” means to have been kept or held at a temperature of 2°C or more for a period of 60 days or more from the date of the beginning of the manufacturing process; (entreposé)

“whole” means of the original size and shape as manufactured. (entier)

(2) The word “process” may be used in the place of the word “processed” in the following common names: processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, and processed cheese spread with (naming the added ingredients).

SOR/79-752, s. 2; SOR/82-768, s. 20; SOR/92-400, s. 3.

B.08.031. A cheese made from milk that is the normal lacteal secretion of the mammary gland of animals other than the cow, genus Bos, shall

(a) conform to all requirements in this Division applicable to the variety; and

(b) be labelled to show the source of the milk on the principal display panel.

SOR/79-752, s. 2.

B.08.032. (1) Each of the following foods for which a standard is prescribed, namely,

(a) (naming the variety) cheese,

(b) cheddar cheese,

(c) cream cheese,

(d) whey cheese,

(e) (naming the variety) whey cheese,

(f) cream cheese with (naming the added ingredients),

(g) cream cheese spread,

(h) cream cheese spread with (naming the added ingredients),

(i) processed (naming the variety) cheese,

(j) processed (naming the variety) cheese with (naming the added ingredients),

(k) processed cheese food,

(l) processed cheese food with (naming the added ingredients),

(m) processed cheese spread,

(n) processed cheese spread with (naming the added ingredients),

(o) cold-pack (naming the variety) cheese,

(p) cold-pack (naming the variety) cheese with (naming the added ingredients),

(q) cold-pack cheese food, and

(r) cold-pack cheese food with (naming the added ingredients),

shall be labelled to show on the principal display panel a statement of the percentage of milk fat in the food followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”, and the percentage of moisture in the food followed by the word “moisture” or “water”.

(2) Subject to subsection (3), no person shall make any direct or indirect reference on the label of a food referred to in subsection (1) to the milk fat content or moisture content of the food except as required by subsection (1).

(3) In addition to the statements referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of a stated size.

SOR/79-752, s. 2; SOR/88-559, s. 17; SOR/94-689, s. 2(E); SOR/2010-94, s. 8(E). Previous Version

B.08.033. (1) [S]. (Naming the variety) Cheese, other than cheddar cheese, cream cheese, whey cheese, cream cheese with (naming the added ingredients), cream cheese spread, cream cheese spread with (naming the added ingredients), processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, processed cheese spread with (naming the added ingredients), cold-pack (naming the variety) cheese, cold-pack (naming the variety) cheese with (naming the added ingredients), cold-pack cheese food, cold-pack cheese food with (naming the added ingredients), cottage cheese and creamed cottage cheese,

(a) shall

(i) be the product made by coagulating milk, milk products or a combination thereof with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey,

(i.1) except for feta cheese, have a casein content that is derived from milk or from ultrafiltered milk, partly skimmed milk, ultrafiltered partly skimmed milk, skim milk, ultrafiltered skim milk or cream, rather than from other milk products,that is at least the following percentage of the total protein content of the cheese, namely,

(A) 63 per cent in the case of Pizza Mozzarella cheese and Part Skim Pizza Mozzarella cheese,

(B) 83 per cent, in the case of Brick cheese, Canadian Style Brick cheese, Canadian Style Munster cheese, Colby cheese, Farmer’s cheese, Jack cheese, Monterey (Monterey Jack) cheese, Mozzarella (Scamorza) cheese, Part Skim Mozzarella (Part Skim Scamorza) cheese, Part Skim Pizza cheese, Pizza cheese, Skim milk cheese and any other variety of cheese not referred to in clause (A) or (C), and

(C) 95 per cent, in the case of any other variety of cheese named in the table to this section,

(i.2) have a whey protein to casein ratio that does not exceed the whey protein to casein ratio of milk,

(ii) possess the physical, chemical and organoleptic properties typical for the variety,

(iii) where it is a cheese of variety named in the table to this section, contain no more than the maximum percentage of moisture shown in Column II thereof for that variety,

(iv) where it is a cheese of a variety named in Part I of the table to this section, contain no less than the minimum percentage of milk fat shown in Column III for that variety, and

(v) where it is cheese of a variety named in Part II of the table to this section, contain no more than the maximum percentage of milk fat shown in Column III for that variety; and

(b) may contain

(i) salt, seasonings, condiments and spices,

(ii) flavouring preparations other than cheese flavouring,

(iii) micro-organisms to aid further ripening,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin or turmeric,

(B) in an amount not exceeding 35 parts per million, beta-apo-8’-carotenal, ethyl beta-apo-8’­ carotenoate or a combination thereof, and

(C) in an amount not exceeding 0.10 parts per million, brilliant blue FCF in feta cheese only,

(v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used,

(vi) paraffin wax as a coating in an amount consistent with good manufacturing practice,

(vii) where potassium nitrate, sodium nitrate or a combination thereof are used for the purpose and in the manner described in subsection (2), residues of potassium nitrate, sodium nitrate or a combination thereof in an amount not exceeding 50 parts per million,

(viii) wood smoke as a preservative in an amount consistent with good manufacturing practice,

(ix) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid,

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively, or

(D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million,

(x) in the case of grated or shredded cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anticaking agent, the total amount not to exceed 2.0 per cent, and

(xi) carbon dioxide as a pH adjusting agent in milk for cheese production, in an amount consistent with good manufacturing practice.

(1.1) A cheese of a variety set out in column I of Part I of the table to this section may contain more than the maximum percentage of moisture set out in column II and less than the minimum percentage of milk fat set out in column III if

(a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the table following section B.01.513 is shown on the label of the product as part of the common name; and

(b) the cheese has the characteristic flavour and texture of the named variety of cheese.

(1.2) The reference to “83 per cent” in clause (1)(a)(i.1)(B) shall be read as “78 per cent”, and the reference to “95 per cent” in clause (1)(a)(i.1)(C) shall be read as “90 per cent”, with respect to the named variety of cheese if

(a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the table following section B.01.513 is shown on the label of the product as part of the common name; and

(b) the cheese has the characteristic flavour and texture of the named variety of cheese.

(2) Potassium nitrate, sodium nitrate or a combination thereof may be used as a preservative in cheese providing the following requirements are met:

(a) the amount of the salt or combination of salts does not exceed 200 parts per million of the milk and milk products used to make the cheese;

(b) the cheese in which the preservative is used is

(i) mold ripened cheese packed in a hermetically sealed container, or

(ii) ripened cheese

(A) that contains not more than 68 per cent moisture on a fat free basis, and

(B) during the manufacture of which the lactic acid fermentation and salting was completed more than 12 hours after coagulation of the curd by enzymes; and

(c) the salting is, in the case of the cheese described in subparagraph (b)(ii), applied externally as a dry salt or in the form of a brine.

(3) No person shall use an enzyme other than

(a) aminopeptidase derived from Lactococcus lactis, bovine rennet derived from aqueous extracts from the fourth stomach of adult bovine animals, sheep and goats, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), pepsin derived from glandular layer of porcine stomach, phospholipase derived from Aspergillus oryzae (pPFJo142), protease derived from Micrococcus caseolyticus var. or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of any cheese to which subsection (1) applies;

(b) [Repealed, SOR/2010-143, s. 1]

(c) a milk coagulating enzyme derived from Endothia parasitica and enzymes described in paragraph (a), in the manufacture of Emmentaler (Emmental, Swiss) cheese, Mozzarella (Scamorza) cheese and Part Skim Mozzarella (Part Skim Scamorza) cheese;

(d) a milk coagulating enzyme derived from Endothia parasitica and enzymes described in paragraph (a), in the manufacture of Parmesan cheese and Romano cheese;

(e) protease derived from Aspergillus oryzae var., Aspergillus niger var. or Bacillus subtilis var., in the manufacture of Colby cheese; and

(f) lysozyme derived from egg-white.

(3.1) No person shall use an enzyme referred to in subsection (3) at a level of use above that consistent with good manufacturing practice.

(4) Where a flavouring preparation, other than a flavouring preparation that has been traditionally used in the variety, is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name on any label.

(5) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(6) Where a cheese is labelled as permitted in subsection (5), the word “smoked” shall be shown on the principal display panel.

TABLE PART I

Column I Column II Column III Maximum percentage of Minimum percentage ofItem Variety of Cheese moisture milk fat

1. Asiago 40.0 30.0 2. Baby Edam 47.0 21.0 3. Baby Gouda 45.0 26.0 4. Blue 47.0 27.0 5. Butter (Butterkäse) 46.0 27.0 6. Bra 36.0 26.0 7. Brick 42.0 29.0 8. Brie 54.0 23.0 9. Caciocavallo 45.0 24.0 10. Camembert (Carré de l’est) 56.0 22.0 11. Canadian Style Brick 42.0 29.0 12. Canadian Style Munster 46.0 27.0 13. Colby 42.0 29.0 14. Danbo 46.0 25.0 15. Edam 46.0 22.0 16. Elbo 46.0 25.0 17. Emmentaler (Emmental, Swiss) 40.0 27.0 18. Esrom 50.0 23.0 19. Farmer’s 44.0 27.0 20. Feta 55.0 22.0 21. Fontina 46.0 27.0 22. Fynbo 46.0 25.0

Column I Column II Column III Maximum percentage of Minimum percentage ofItem Variety of Cheese moisture milk fat

23. Gouda 43.0 28.0 24. Gournay 55.0 33.0 25. Gruyère 38.0 28.0 26. Havarti 50.0 23.0 27. Jack 50.0 25.0 28. Kasseri 44.0 25.0 29. Limburger 50.0 25.0 30. Maribo 43.0 26.0 31. Montasio 40.0 28.0 32. Monterey (Monterey Jack) 44.0 28.0 33. Mozzarella (Scamorza) 52.0 20.0 34. Muenster (Munster) 50.0 25.0 35. Neufchâtel 60.0 20.0 36. Parmesan 32.0 22.0

Part Skim Mozzarella (Part Skim37. 52.0 15.0Scamorza) 38. Part Skim Pizza 48.0 15.0 38.1 Part Skim Pizza Mozzarella 61.0 11.0 39. Pizza 48.0 20.0 39.1 Pizza Mozzarella 58.0 15.0 40. Provolone 45.0 24.0 41. Romano (Sardo) 34.0 25.0 42. St. Jorge 40.0 27.0 43. Saint-Paulin 50.0 25.0 44. Samsoë 44.0 26.0 45. Tilsiter (Tilsit) 45.0 25.0 46. Tybo 46.0 25.0

PART II

Column I Column II Column III Maximum percentage of Maximum percentage ofItem Variety of Cheese moisture milk fat

Harzkase (Harzer Käse,1. 55.0 3.0Mainzer Käse) 2. Skim Milk 55.0 7.0

SOR/79-752, s. 2; SOR/80-632, s. 2; SOR/82-383, ss. 2,3; SOR/82-566, s. 1; SOR/84-302, s. 1; SOR/86-89, s. 2; SOR/87-640, s. 3; SOR/88-534, s. 2; SOR/89-198, s. 1; SOR/90-469, s. 1; SOR/91-88, s. 1; SOR/92-197, s. 1; SOR/92-400, s. 4; SOR/93-477, s. 1; SOR/94-212, s. 1; SOR/94-417, s. 1; SOR/95-183, s. 1; SOR/97-191, s. 1; SOR/98-458, s. 2; SOR/2000-336, s.

1; SOR/2000-353, s. 4; SOR/2000-417, s. 2; SOR/2001-94, s. 1; SOR/2005-98, s. 7; SOR/2007-302, ss. 2, 4(F); SOR/2010-94, s. 8(E); SOR/2010-143, ss. 1, 39(E). Previous Version B.08.034. (1) [S]. Cheddar Cheese

(a) shall

(i) be the product that is made by coagulating milk, milk products or a combination of those things with the aid of bacteria to form a curd and subjecting the curd to the cheddar process or any process other than the cheddar process that produces a cheese having the same physical, chemical and organoleptic properties as those of cheese produced by the cheddar process,

(i.1) have a casein content that is derived from milk or from ultrafiltered milk, partly skimmed milk, ultrafiltered partly skimmed milk, skim milk, ultrafiltered skim milk or cream, rather than from other milk products, that is at least 83 per cent of the total protein content of the cheese,

(i.2) have a whey protein to casein ratio that does not exceed the whey protein to casein ratio of milk, and

(ii) contain

(A) not more than 39 per cent moisture, and

(B) not less than 31 per cent milk fat;

(b) may contain

(i) salt,

(ii) flavouring preparations other than cheese flavouring,

(iii) bacterial cultures to aid further ripening,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,

(v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used,

(vi) wood smoke as a preservative in an amount consistent with good manufacturing practice,

(vii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or a combination thereof in an amount not exceeding 2,000 parts per million calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or a combination thereof in an amount not exceeding 3,000 parts per million calculated as sorbic acid,

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million calculated as propionic acid and sorbic acid respectively, or

(D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million, and

(viii) in the case of grated or shredded cheddar cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anticaking agent, the total amount not to exceed 2.0 per cent; and

(c) shall not be labelled or advertised as cheddar cheese that has been aged unless

(i) it is made solely with milk, ultrafiltered milk, partly skimmed milk, ultrafiltered partly skimmed milk, skim milk, ultrafiltered skim milk or cream or a combination of those things, and

(ii) it has been aged for at least nine months and the period for which it has been aged is specified on the principal display panel of that label or in that advertising.

(1.1) Cheddar cheese may contain more than the maximum percentage of moisture set out in clause (1)(a)(ii)(A) and less than the minimum percentage of milk fat set out in clause (1)(a)(ii)(B) if

(a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the table following section B.01.513 is shown on the label of the product as part of the common name; and

(b) the cheese has the characteristic flavour and texture of cheddar cheese.

(1.2) The reference to “83 per cent” in subparagraph (1)(a)(i.1) shall be read as “78 per cent” if

(a) a statement or claim set out in column 4 of any of items 12 to 14, 16, 20, 21 and 45 of the table following section B.01.513 is shown on the label of the product as part of the common name; and

(b) the cheese has the characteristic flavour and texture of cheddar cheese.

(2) No person shall, in the manufacture of the cheddar cheese, use any enzyme other than

(a) aminopeptidase derived from Lactococcus lactis, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), pepsin derived from glandular layer of porcine stomach, phospholipase derived from Aspergillus oryzae (pPFJo142) or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs;

(b) protease derived from Aspergillus oryzae; and

(c) lysozyme derived from egg-white.

(2.1) No person shall use an enzyme referred to in subsection (2) at a level of use above that consistent with good manufacturing practice.

(3) Where a flavouring preparation is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name in any label.

(4) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(5) Where a cheese is labelled as permitted in subsection (4), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/82-383, s. 4; SOR/83-617, s. 1; SOR/84-302, s. 2; SOR/84-762, s. 7; SOR/88-534, s. 3; SOR/89-244, s. 1; SOR/90-469, s. 2; SOR/91-88, s. 2; SOR/92-197, s. 2; SOR/93-477, s. 2; SOR/94-212, s. 2; SOR/95-183, s. 2; SOR/97-191, s. 2; SOR/98-458, s. 3; SOR/2000-336, s. 2; SOR/2000-417, s. 3; SOR/2005-98, s. 7; SOR/2007-302, ss. 3, 4(F); SOR/2010-143, ss. 2, 39(E). Previous Version B.08.035. (1) [S]. Cream Cheese

(a) shall

(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and

(ii) contain

(A) not more than 55 per cent moisture, and

(B) not less than 30 per cent milk fat; and

(b) may contain

(i) cream added to adjust the milk fat content,

(ii) salt,

(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,

(iv) the following emulsifying, gelling, stabilizing and thickening agents:

ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and

(v) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) No person shall use any enzyme

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of cream cheese; and

(b) at a level of use above that consistent with good manufacturing practice.

SOR/79-752, s. 2; SOR/92-197, s. 3; SOR/94-212, s. 3; SOR/95-183, s. 3; SOR/2010-143, s. 3. Previous Version B.08.036. (1) [S]. Whey Cheese or (naming the variety) Whey Cheese

(a) shall be the product made by coagulating whey or concentrated whey with the aid of heat to form a curd and shaping the curd; and

(b) may contain

(i) micro-organisms to aid further ripening,

(ii) added milk and milk products, and

(iii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate, sodium hydroxide and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice.

(2) No person shall use, to aid coagulation of whey in the manufacture of whey cheese, a substance other than vinegar or sour whey.

SOR/79-752, s. 2; SOR/2007-302, s. 4(F); SOR/2010-142, s. 5. Previous Version B.08.037. (1) [S]. Cream Cheese with (naming the added ingredients)

(a) shall

(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese but not in amounts so large as to change the basic nature of the product:

(A) cheese other than cream cheese,

(B) seasonings, spices, flavouring preparations, condiments or chocolate,

(C) fruits, vegetables, pickles, relishes or nuts,

(D) prepared or preserved meat, or

(E) prepared or preserved fish, and

(iii) contain

(A) not more than 60 per cent moisture, and

(B) not less than 26 per cent milk fat; and

(b) may contain

(i) cream added to adjust the milk fat content,

(ii) salt,

(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and

(vi) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) No person shall use any enzyme

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from

Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

(b) at a level of use above that consistent with good manufacturing practice.

SOR/79-752, s. 2; SOR/92-197, s. 4; SOR/94-212, s. 4; SOR/95-183, s. 4; SOR/2010-143, s. 4. Previous Version B.08.038. (1) [S]. Cream Cheese Spread

(a) shall

(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and

(ii) contain

(A) added milk and milk products,

(B) not less than 51 per cent cream cheese,

(C) not more than 60 per cent moisture, and

(D) not less than 24 per cent milk fat; and

(b) may contain

(i) cream added to adjust the milk fat content,

(ii) salt, vinegar and sweetening agents,

(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium

gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and

(vii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) No person shall use any enzyme

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

(b) at a level of use above that consistent with good manufacturing practice.

SOR/79-752, s. 2; SOR/92-197, s. 5; SOR/94-212, s. 5; SOR/95-183, s. 5; SOR/2007-302, s. 4(F); SOR/2010-143, s. 5. Previous Version B.08.039. (1) [S]. Cream Cheese Spread with (naming the added ingredients)

(a) shall

(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese spread but not in amounts so large as to change the basic nature of the product:

(A) cheese other than cream cheese,

(B) seasonings, spices, flavouring preparation, condiments or chocolate,

(C) fruits, vegetables, pickles, relishes or nuts,

(D) prepared or preserved meat, or

(E) prepared or preserved fish, and

(iii) contain

(A) added milk and milk products,

(B) not more than 60 per cent moisture, and

(C) not less than 24 per cent milk fat; and

(b) may contain

(i) cream added to adjust the milk fat content,

(ii) salt, vinegar and sweetening agents,

(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and

(vii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) No person shall use any enzyme

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

(b) at a level of use above that consistent with good manufacturing practice.

SOR/79-752, s. 2; SOR/92-197, s. 6; SOR/94-212, s. 6; SOR/95-183, s. 6; SOR/2007-302, s. 4(F); SOR/2010-143, s. 6. Previous Version B.08.040. (1) [S]. Processed (naming the variety) Cheese

(a) shall

(i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,

(ii) in the case of processed cheddar cheese, be the product made by comminuting and mixing one or more of the following:

(A) cheddar cheese,

(B) stirred curd cheese,

(C) granular curd cheese, or

(D) washed curd cheese

into a homogeneous mass with the aid of heat,

(iii) have, where it is made from

(A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or

(B) two or more varieties of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent,

a moisture content that does not exceed, by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be,

(iv) subject to subparagraph (v), have, where it is made from

(A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or

(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more,

a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and

(v) in the case of processed skim milk cheese, contain not more than

(A) 55 per cent moisture, and

(B) seven per cent milk fat; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) in the case of processed skim milk cheese, added skim milk powder, buttermilk powder and whey powder,

(iv) salt, vinegar and sweetening agents,

(v) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(vi) the following emulsifying, gelling, stabilizing and thickening agents:

(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(vi.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(viii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(ix) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/91-409, s. 1.

B.08.041. (1) [S]. Processed (naming the variety) Cheese with (naming the added ingredients)

(a) shall

(i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed (naming the variety) cheese but not in amounts so large as to change the basic nature of the product:

(iii) have, where it is made from

(A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or

(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent,

a moisture content that does not exceed by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and

(iv) have, where it is made from

(A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or

(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more,

a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be; and

(b) may contain

(i) water added to adjust moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/91-409, s. 2; SOR/92-400, s. 5; SOR/2010-94, s. 4(E). Previous Version B.08.041.1. (1) [S]. Processed Cheese Food

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and

(ii) contain

(A) added milk or milk products,

(B) not less than 51 per cent cheese,

(C) not more than 46 per cent moisture, and

(D) not less than 23 per cent milk fat; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium

gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/91-409, s. 3; SOR/92-400, s. 6; SOR/2007-302, s. 4(F). Previous Version B.08.041.2. (1) [S]. Processed Cheese Food with (naming the added ingredients)

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese food but not in amounts so large as to change the basic nature of the product:

(A) seasonings, spices, flavouring preparations, condiments or chocolate,

(B) fruits, vegetables, pickles, relishes or nuts,

(C) prepared or preserved meat, or

(D) prepared or preserved fish, and

(iii) contain

(A) added milk or milk products,

(B) not more than 46 per cent moisture, and

(C) not less than 22 per cent milk fat; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/91-409, s. 4; SOR/92-400, s. 7; SOR/2007-302, s. 4(F). Previous Version B.08.041.3. (1) [S]. Processed Cheese Spread

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and

(ii) contain

(A) added milk or milk products,

(B) not less than 51 per cent cheese,

(C) not more than 60 per cent moisture, and

(D) not less than 20 per cent milk fat;

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol

alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/82-1071, s. 4; SOR/91-409, s. 5; SOR/2007-302, s. 4(F). Previous Version B.08.041.4. (1) [S]. Processed Cheese Spread with (naming the added ingredients)

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese spread but not in amounts so large as to change the basic nature of the product:

(A) seasonings, spices, flavouring preparations, condiments or chocolate,

(B) fruits, vegetables, pickles, relishes or nuts,

(C) prepared or preserved meat, or

(D) prepared or preserved fish, and

(iii) contain

(A) added milk or milk products,

(B) not more than 60 per cent moisture, and

(C) not less than 20 per cent milk fat; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,

(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,

(C) lecithin in an amount not exceeding 0.2 per cent, and

(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,

(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/82-1071, s. 5; SOR/91-409, s. 6; SOR/2007-302, s. 4(F). Previous Version B.08.041.5. (1) [S]. Cold-Pack (naming the variety) Cheese

(a) shall

(i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,

(ii) in the case of cold-pack cheddar cheese, be the product made by comminuting and mixing one or more of the following:

(A) cheddar cheese,

(B) stirred curd cheese,

(C) granular curd cheese, or

(D) washed curd cheese

into a homogeneous mass without the aid of heat,

(iii) contain, where it is made from

(A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and minimum fat content permitted for that variety, or

(B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and the average minimum fat content permitted for those varieties; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vi) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(vii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/92-400, s. 8.

B.08.041.6. (1) [S]. Cold-Pack (naming the variety) Cheese with (naming the added ingredients)

(a) shall

(i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack (naming the variety) cheese but not in amounts so large as to change the basic nature of the product:

(iii) contain, where it is made from

(A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and one per cent less than the minimum milk fat content permitted for that variety, or

(B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and one per cent less than the average minimum milk fat content permitted for those varieties; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/92-400, s. 9; SOR/2010-94, s. 5(E). Previous Version B.08.041.7. (1) [S]. Cold-Pack Cheese Food

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,

(ii) contain

(A) added milk or milk products,

(B) not less than 51 per cent cheese,

(C) not more than 46 per cent moisture, and

(D) not less than 23 per cent milk fat; and

(b) may contain

(i) water added to adjust the moisture content,

(ii) added milk fat,

(iii) salt, vinegar and sweetening agents,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/2007-302, s. 4(F). Previous Version B.08.041.8. (1) [S]. Cold-Pack Cheese Food with (naming the added ingredients)

(a) shall

(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,

(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack cheese food but not in amounts so large as to change the basic nature of the product:

(A) seasonings, spices, flavouring preparations, condiments or chocolate,

(B) fruits, vegetables, pickles, relishes or nuts,

(C) prepared or preserved meat, or

(D) prepared or preserved fish, and

(iii) contain

(A) added milk or milk products,

(B) not more than 46 per cent moisture, and

(C) not less than 22 per cent milk fat; and

(b) may contain

(i) water added to adjust moisture content,

(ii) added milk fat,

(iii) sweetening agents, salt and vinegar,

(iv) one or more of the following colouring agents:

(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and

(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,

(v) the following emulsifying, gelling, stabilizing and thickening agents:

ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,

(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,

(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and

(viii) the following preservatives:

(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,

(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or

(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.

(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.

(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.

SOR/79-752, s. 2; SOR/2007-302, s. 4(F). Previous Version B.08.042. No manufacturer shall sell whole cheese that is not made from a pasteurized source unless the date of the beginning of the manufacturing process is

(a) marked or branded thereon within three days thereof; or

(b) marked on the label at the time of packaging, if the cheese is such that, because of its texture, consistency, or physical structure, such date cannot be effectively branded or marked on the cheese.

B.08.043. No manufacturer shall sell any cheese that is not made from a pasteurized source if it has been cut into smaller portions, unless

(a) it has been duly stored; or

(b) each portion of cut cheese is marked, branded or labelled with the date of the beginning of the manufacturing process.

B.08.044. (1) Subject to subsection (2), no person shall sell cheese, including cheese curd, that is not made from a pasteurized source unless it has been stored.

(2) Cheese, including cheese curd, that is not made from a pasteurized source may be used as an ingredient in any food providing such food is manufactured or processed so as to pasteurize the cheese in the manner described in the definition “pasteurized source” in section B.08.030(1).

SOR/78-405, s. 1; SOR/79-752, s. 3.

B.08.045. Notwithstanding B.08.044, cheese that has not been manufactured from a pasteurized source and has not been stored but is marked or branded with the date of the beginning of the manufacturing process, may be sold to

(a) a wholesaler;

(b) a jobber; or

(c) in quantities of not less than 900 pounds, to a retailer.

B.08.046. No person shall sell any whole cheese that has not been made from a pasteurized source unless there is stamped thereon the date of the beginning of the manufacturing process.

B.08.047. Every manufacturer, wholesaler, or jobber who sells cheese not made from a pasteurized source and which has not been stored shall keep a record of

(a) the registered number of the cheese factory,

(b) the date of manufacture of the cheese,

(c) the vat number or vat numbers,

(d) the name and address of the person to whom the cheese is sold, and

(e) the weight sold from each vat,

for each lot of cheese sold.

B.08.048. (1) Subject to section B.08.054, no person shall sell cheese, including cheese curd, made from a pasteurized source if the cheese contains more than

(a) 100 Escherichia coli, or

(b) 100 Staphylococcus aureus

per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983.

(2) No person shall sell cheese, made from an unpasteurized source if the cheese contains more than

(a) 500 Escherichia coli, or

(b) 1,000 Staphylococcus aureus

per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983.

SOR/78-405, s. 2; SOR/82-768, s. 21; SOR/84-17, s. 4.

B.08.049. [S]. Whey

(a) shall be the product remaining after the curd has been removed from milk in the process of making cheese; and

(b) may contain

(i) catalase, in the case of liquid whey that has been treated with hydrogen peroxide,

(ii) lactase,

(iii) hydrogen peroxide, in the case of liquid whey destined for the manufacture of dried whey products,

(iv) benzoyl peroxide and calcium phosphate tribasic, as a carrier of the benzoyl peroxide, in the case of liquid whey destined for the manufacture of dried whey products other than those for use in infant formula, and

(v) sodium hexametaphosphate, in the case of liquid whey destined for the manufacture of concentrated or dried whey products.

SOR/79-752, s. 4; SOR/89-555, s. 1; SOR/2010-40, s. 1. Previous Version B.08.050. [Repealed, SOR/95-281, s. 1]

B.08.051. [S]. Cottage Cheese

(a) shall be the product, in the form of discrete curd particles, prepared from skim milk, evaporated skim milk or skim milk powder and harmless acid-producing bacterial cultures;

(b) shall contain not more than 80 per cent moisture;

(c) may contain not more than 0.5 per cent stabilizing agent; and

(d) may contain

(i) milk,

(ii) cream,

(iii) milk powder,

(iv) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs,

(v) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,

(vi) chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice,

(vi.1) chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice,

(vi.2) pepsin derived from glandular layer of porcine stomach,

(vii) salt,

(viii) calcium chloride,

(ix) added lactose,

(x) pH adjusting agents,

(xi) relishes,

(xii) fruits,

(xiii) vegetables, and

(xiv) carbon dioxide.

SOR/81-60, s. 4; SOR/92-197, s. 7; SOR/94-212, s. 7; SOR/95-183, s. 7; SOR/98-458, s. 4; SOR/2001-94, s. 2; SOR/2005-98, s. 7; SOR/2010-143, ss. 7, 39(E). Previous Version B.08.052. [S]. Creamed Cottage Cheese shall be cottage cheese containing cream or a mixture of cream with milk or skim milk, or both, in such quantity that the final product shall contain

(a) not less than four per cent milk fat; and

(b) not more than 80 per cent moisture and may contain emulsifying, gelling, stabilizing and thickening agents.

B.08.053. All dairy products used in the preparation of cottage cheese shall be from a pasteurized source.

B.08.054. No person shall sell cottage cheese or creamed cottage cheese that contains more than 10 coliform bacteria per gram, as determined by official method MFO-4, Microbiological Examination of Cottage Cheese, November 30, 1981.

SOR/82-768, s. 22.

Butter

B.08.056. [S]. Butter

(a) shall

(i) be the food prepared in accordance with good manufacturing practices from milk or milk products, and

(ii) contain not less than 80 per cent milk fat; and

(b) may contain

(i) milk solids,

(ii) bacterial culture,

(iii) salt, and

(iv) food colour.

SOR/92-400, s. 10.

B.08.057. [S]. Whey Butter shall be butter made from whey cream.

SOR/92-400, s. 10.

Ice Cream

B.08.061. [S]. Ice Cream Mix

(a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners;

(b) may contain

(i) egg,

(ii) a flavouring preparation,

(iii) cocoa or chocolate syrup,

(iv) a food colour,

(v) pH adjusting agents,

(vi) microcrystalline cellulose or a stabilizing agent or both in an amount that will not exceed 0.5 per cent of the ice cream made from the mix,

(vii) a sequestering agent,

(viii) salt,

(ix) not more than one per cent added edible casein or edible caseinates; and

(x) propylene glycol mono fatty acid esters in an amount that will not exceed 0.35 per cent of the ice cream made from the mix and sorbitan tristearate in an amount that will not exceed 0.035 per cent of the ice cream made from the mix; and

(c) shall contain not less than

(i) 36 per cent solids, and

(ii) 10 per cent milk fat or, where cocoa or chocolate syrup has been added, eight per cent milk fat.

SOR/92-400, s. 11; SOR/97-543, s. 2(F); SOR/2007-75, s. 2; SOR/2007-302, s. 4(F); SOR/2010-142, s. 6(F). Previous Version B.08.062. [S]. Ice Cream

(a) shall be the frozen food obtained by freezing an ice cream mix, with or without the incorporation of air;

(b) may contain cocoa or chocolate syrup, fruit, nuts or confections;

(c) shall contain not less than

(i) 36 per cent solids,

(ii) 10 per cent milk fat, or, where cocoa or chocolate syrup, fruit, nuts, or confections have been added, eight per cent milk fat, and

(iii) 180 grams of solids per litre of which amount not less than 50 grams shall be milk fat, or, where cocoa or chocolate syrup, fruit, nuts or confections have been added, 180 grams of solids per litre of which amount not less than 40 grams shall be milk fat; and

(d) shall contain not more than

(i) 100,000 bacteria per gram, and

(ii) 10 coliform organisms per gram,

as determined by official method MFO-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981.

SOR/82-768, s. 23; SOR/92-400, s. 12.

Sherbet

[SOR/98-580, s. 1(F)]

B.08.063. [S]. Sherbet

(a) shall be the frozen food, other than ice cream or ice milk, made from a milk product;

(b) may contain

(i) water,

(ii) a sweetening agent,

(iii) fruit or fruit juice,

(iv) citric or tartaric acid,

(v) a flavouring preparation,

(vi) a food colour,

(vii) not more than 0.75 per cent stabilizing agent,

(viii) a sequestering agent,

(ix) lactose,

(x) not more than 0.5 per cent microcrystalline cellulose, and

(xi) not more than one per cent added edible casein or edible caseinates; and

(c) shall contain

(i) not more than five per cent milk solids, including milk fat, and

(ii) not less than 0.35 per cent acid determined by titration and expressed as lactic acid.

SOR/92-400, s. 13; SOR/97-543, s. 3(F); SOR/98-580, s. 1(F); SOR/2007-302, s. 4(F). Previous Version

Ice Milk

B.08.071. [S]. Ice Milk Mix

(a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners;

(b) may contain

(i) egg,

(ii) a flavouring preparation,

(iii) cocoa or chocolate syrup,

(iv) a food colour,

(v) a pH adjusting agent,

(vi) a stabilizing agent, in an amount that will not result in more than 0.5 per cent stabilizing agent in the ice milk,

(vii) a sequestering agent,

(viii) added lactose, and

(ix) not more than 1.5 per cent microcrystalline cellulose,

(x) salt, and

(xi) not more than one per cent added edible casein or edible caseinates; and

(c) shall contain

(i) not less than 33 per cent solids, and

(ii) not less than three per cent and not more than five per cent milk fat.

SOR/92-400, s. 14; SOR/97-543, s. 4(F); SOR/2007-302, s. 4(F). Previous Version B.08.072. [S]. Ice Milk

(a) shall be the frozen food obtained by freezing an ice milk mix, with or without the incorporation of air;

(b) may contain cocoa or chocolate syrup, fruit, nuts or confections;

(c) shall contain

(i) not less than 33 per cent solids,

(ii) not less than three per cent and not more than five per cent milk fat, and

(iii) not less than 160 grams of solids per litre of which amount not less than 14 grams shall be milk fat; and

(d) shall contain not more than

(i) 100,000 bacteria per gram, and

(ii) 10 coliform organisms per gram,

as determined by official method MFO-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981.

SOR/82-768, s. 24; SOR/92-400, s. 15.

B.08.073. [Repealed, SOR/92-626, s. 13]

B.08.074. (1) The percentage of milk fat contained in

(a) yogurt,

(b) cottage cheese, and

(c) creamed cottage cheese,

shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

(2) In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in subsection (1), make a declaration of the fat content of the food, expressed in grams per serving of stated size.

SOR/88-559, s. 18.

Cream

B.08.075. [S]. Cream

(a) shall be the fatty liquid prepared from milk by separating the milk constituents in such a manner as to increase the milk fat content; and

(b) may contain

(i) a pH adjusting agent,

(ii) a stabilizing agent,

(iii) in the case of cream for whipping that has been heat-treated above 100°C, the following ingredients and food additives:

(A) skim milk powder in an amount not exceeding 0.25 per cent,

(B) glucose solids in an amount not exceeding 0.1 per cent,

(C) calcium sulphate in an amount not exceeding 0.005 per cent, and

(D) xanthan gum in an amount not exceeding 0.02 per cent, and

(E) [Repealed, SOR/2010-142, s. 7]

(iv) in the case of cream for whipping, microcrystalline cellulose in an amount not exceeding 0.2 per cent.

SOR/79-662, s. 2; SOR/82-1071, s. 6; SOR/88-419, s. 1; SOR/2010-142, s. 7. Previous Version B.08.076. (1) The percentage of milk fat contained in canned cream shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.

(2) In addition to the statement referred to in subsection (1), a person may, on the label of canned cream, make a declaration of the fat content of the cream, expressed in grams per serving of stated size.

SOR/88-559, s. 19.

B.08.077. [S]. Sour Cream

(a) shall be the product prepared by the souring of pasteurized cream with acid-producing bacterial culture and shall contain not less than 14 per cent milk fat; and

(b) may contain

(i) milk solids,

(ii) whey solids,

(iii) buttermilk,

(iv) starch in an amount not exceeding one per cent,

(v) salt,

(vi) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in an amount consistent with good manufacturing practice,

(vii) the following emulsifying, gelling, stabilizing and thickening agents:

(A) algin, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, pectin or propylene glycol alginate or any combination thereof in an amount not exceeding 0.5 per cent,

(B) monoglycerides, mono- and diglycerides, or any combination thereof, in an amount not exceeding 0.3 per cent, and

(C) sodium phosphate dibasic in an amount not exceeding 0.05 per cent,

(viii) sodium citrate as a flavour precursor in an amount not exceeding 0.1 per cent,

(ix) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,

(x) chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice, and

(xi) chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice.

SOR/78-876, s. 1; SOR/80-500, s. 3; SOR/81-60, s. 5; SOR/92-197, s. 8; SOR/94-212, s. 8; SOR/95-183, s. 8; SOR/98-458, s. 5; SOR/2005-98, s. 7; SOR/2010-143, ss. 8, 39(E). Previous Version

Division 9

Fats And Oils B.09.001. [S]. Vegetable fats and oils shall be fats and oils obtained entirely from the botanical source after which they are named, shall be dry and sweet in flavour and odour and, with the exception of olive oil, may contain emulsifying agents, Class IV preservatives, an antifoaming agent, and B-carotene in a quantity sufficient to replace that lost during processing, if such an addition is declared on the label.

SOR/85-179, s. 1.

B.09.002. [S]. Animal fats and oils shall be fats and oils obtained entirely from animals healthy at the time of slaughter, shall be dry and sweet in flavour and odour and may contain

(a) with the exception of milk fat and suet, Class IV preservatives; and

(b) with the exception of lard, milk fat and suet, an antifoaming agent.

B.09.003. [S]. Olive Oil or Sweet Oil

(a) shall be the oil obtained from the fruit of the olive tree (Olea europaea L);

(b) shall have a fatty acid content that is

(i) not less than 56.0 and not more than 83.0 per cent oleic acid,

(ii) not less than 7.5 and not more than 20.0 per cent palmitic acid,

(iii) not less than 3.5 and not more than 20.0 per cent linoleic acid,

(iv) not less than 0.5 and not more than 3.5 per cent stearic acid,

(v) not less than 0.3 and not more than 3.5 per cent palmitoleic acid,

(vi) not more than 1.5 per cent linolenic acid, and

(vii) not more than 0.05 per cent myristic acid, calculated as methyl esters;

(c) shall not contain more than minute amounts of arachidic acid, behenic acid, gadoleic acid or lignoceric acid;

(d) shall have

(i) a relative density of not less than 0.910 and not more than 0.916, calculated with the oil at 20°C and water at 20°C (20°C/water at 20°C),

(ii) a refractive index of not less than 1.4677 and not more than 1.4705, calculated using the sodium D-line as the light source and with the oil at 20°C (nD20°C),

(iii) an iodine value of not less than 75 and not more than 94, calculated using the Wijs test,

(iv) a saponification value of not less than 184 and not more than 196, expressed as milligrams of potassium hydroxide per gram of oil,

(v) an acid value of not more than 6.6 milligrams potassium hydroxide per gram of oil,

(vi) a free acidity of not more than 3.3 per cent expressed as oleic acid,

(vii) a peroxide value of not more than 20 milliequivalents peroxide oxygen per kilogram of oil,

(viii) an unsaponifiable matter content of not more than 15 grams per kilogram, and

(ix) a Bellier index of not more than 17;

(e) shall show negative results when tested for semi-siccative oil, olive-residue oil, cotton­ seed oil, tea-seed oil or sesame seed oil; and

(f) notwithstanding section B.09.001, may contain alpha-tocopherol in a quantity sufficient to replace that lost during refining, if such an addition is declared on the label.

SOR/78-655, s. 1.

B.09.004. [S]. Cotton Seed Oil

(a) shall be the oil of seeds of cultivated Gossypium spp.;

(b) shall have

(i) a relative density (20°C/water at 20°C) of not less than 0.918 and not more than 0.926,

(ii) a refractive index (nD40°C) of not less than 1.458 and not more than 1.466,

(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 198,

(iv) an iodine value (Wijs) of not less than 99 and not more than 119,

(v) an unsaponifiable matter content of not more than 15 grams per kilogram,

(vi) a positive Halphen test,

(vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and

(c) may contain oxystearin.

B.09.005. [S]. Cocoa Butter shall be the fat from cocoa nibs, obtained either before or after roasting, or cocoa liquor, and shall have

(a) a refractive index (40°C) of not less than 1.453 and not more than 1.458;

(b) a saponification value of not less than 188 and not more than 202;

(c) an iodine value (Hanus) of not less than 32 and not more than 41; and

(d) an acid value of not more than five.

SOR/97-263, s. 3.

B.09.006. [S]. Corn Oil or Maize Oil

(a) shall be the oil of the germ or embryo of Zea mays L.; and

(b) shall have

(i) a relative density of (20°C/water at 20°C) of not less than 0.917 and not more than 0.925,

(ii) a refractive index (nD40°C) of not less than 1.465 and not more than 1.468,

(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 195,

(iv) an iodine value (Wijs) of not less than 103 and not more than 128,

(v) an unsaponifiable matter content of not more than 28 grams per kilogram,

(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.

B.09.007. [S]. Peanut Oil or Arachis Oil

(a) shall be the oil of the seeds of Arachis hypogaea L.;

(b) shall have

(i) a relative density of (20°C/water at 20°C) of not less than 0.914 and not more than 0.917,

(ii) a refractive index (nD40°C) of not less than 1.460 and not more than 1.465,

(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 196,

(iv) an iodine value (Wijs) of not less than 80 and not more than 106,

(v) an unsaponifiable matter content of not more than 10 grams per kilogram,

(vi) an arachidic and higher fatty acids content of not less than 48 grams per kilogram,

(vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and

(c) not contain oxystearin.

SOR/84-300, s. 22(E).

B.09.008. [S]. Soybean Oil, Soya Bean Oil, Soja Oil or Soya Oil

(a) shall be the oil of the seeds of Glycine max (L.) Merr.;

(b) shall have

(i) a relative density of (20°C/water at 20°C) of not less than 0.919 and not more than 0.925,

(ii) a refractive index (nD40°C) of not less than 1.466 and not more than 1.470,

(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 195,

(iv) an iodine value (Wijs) of not less than 120 and not more than 143,

(v) an unsaponifiable matter content of not more than 15 grams per kilogram,

(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and

(c) may contain oxystearin.

SOR/84-300, s. 23(E).

B.09.009. [S]. Sunflowerseed Oil or Sunflower Oil

(a) shall be the oil of the seeds of Helianthus annuus L.; and

(b) shall have

(i) a relative density of (20°C/water at 20°C) of not less than 0.918 and not more than 0.923,

(ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.469,

(iii) an iodine value (Wijs) of not less than 110 and not more than 143,

(iv) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 188 and not more than 194,

(v) an unsaponifiable matter content of not more than 15 grams per kilogram,

(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.

B.09.009A. [S]. Safflowerseed Oil or Safflower Oil

(a) shall be the oil of the seeds of Carthamus tinctorius L.;

(b) shall have

(i) a relative density of (20°C/water at 20°C) of not less than 0.922 and not more than 0.927,

(ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.470,

(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 186 and not more than 198,

(iv) an iodine value (Wijs) of not less than 135 and not more than 150,

(v) an unsaponifiable matter content of not more than 15 grams per kilogram,

(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and

(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.

B.09.010. Notwithstanding item 1 of the table to paragraph B.01.010(3)(b), where a vegetable fat or oil is an ingredient of any cooking oil, salad oil or table oil, the fat or oil shall be shown in the list of ingredients by its common name.

SOR/98-458, s. 7(F).

B.09.011. [S]. Shortening, other than butter or lard, shall be the semi-solid food prepared from fats, oils or a combination of fats and oils, may be processed by hydrogenation and may contain

(a) Class IV preservatives,

(b) an antifoaming agent,

(c) stearyl monoglyceridyl citrate,

(d) monoglycerides or a combination of monoglycerides and diglycerides of fat forming fatty acids, the weight of the monoglycerides being not more than 10 per cent and the total weight of monoglycerides and diglycerides being not more than 20 per cent of the weight of the shortening,

(e) lactylated monoglycerides, or a combination of lactylated monoglycerides and diglycerides of fat forming fatty acids, the total weight being not more than eight per cent of the weight of the shortening, and

(f) sorbitan tristearate,

except that the total weight of the ingredients permitted under paragraphs (d) and (e) shall not be greater than 20 per cent of the weight of the shortening.

B.09.012. [Repealed, SOR/97-148, s. 2]

B.09.013. [S]. Lard

(a) shall be the rendered fat from hogs;

(b) shall have

(i) a relative density of not less than 0.894 and not more than 0.906, calculated with the lard at 40°C and water at 20°C (40°C/water at 20°C),

(ii) a refractive index of not less than 1.448 and not more than 1.461, calculated using the sodium D-line as the light source and with the lard at 40°C (nD40°C),

(iii) a titre of not less than 32°C and not more than 45°C,

(iv) a saponification value of not less than 192 and not more than 203, expressed as milligrams potassium hydroxide per gram of fat,

(v) an iodine value of not less than 45 and not more than 70, calculated using the Wijs test,

(vi) an unsaponifiable matter content of not more than 12 grams per kilogram,

(vii) an acid value of not more than 2.5 milligrams potassium hydroxide per gram of fat, and

(viii) a peroxide value of not more than 16 milliequivalents peroxide oxygen per kilogram of fat; and

(c) may contain

(i) lard stearine or hydrogenated lard,

(ii) a Class IV preservative, and

(iii) not more than one per cent of substances resulting from the rendering process, other than fatty acids and fat.

SOR/78-401, s. 1(F); SOR/84-300, s. 25(F).

B.09.014. [S]. Leaf Lard shall be lard that has been rendered at a moderately high temperature from the internal fat of the abdomen of the hog, excluding that adhering to the intestines, and shall have an iodine value (Hanus) of not more than 65.

B.09.015. [S]. Suet

(a) shall be the fat taken from the region of the kidney or loin or caul fat of a beef carcass;

(b) shall have

(i) a relative density of not less than 0.893 and not more than 0.898, calculated with the suet at 40°C and water at 20°C (40°C/water at 20°C),

(ii) a refractive index of not less than 1.448 and not more than 1.460, calculated using the sodium D-line as the light source and with the suet at 40°C (nD40°C),

(iii) a titre of not less than 42.5°C and not more than 47°C,

(iv) a saponification value of not less than 190 and not more than 200, expressed as milligrams of potassium hydroxide per gram of fat,

(v) an iodine value of not less than 32 and not more than 47, calculated using the Wijs test,

(vi) an unsaponifiable matter content of not more than 10 grams per kilogram,

(vii) an acid value of not more than 2.0 milligrams potassium hydroxide per gram of fat, and

(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of fat; and

(c) where sold in comminuted form, shall contain not more than three per cent cereal and one per cent salt.

SOR/78-655, s. 2(F).

B.09.016. [S]. Margarine

(a) shall be a plastic or fluid emulsion of water in fats, oil or fats and oil that are not derived from milk and may have been subjected to hydrogenation;

(b) shall contain

(i) not less than 80 per cent fat, oil or fat and oil calculated as fat, and

(ii) notwithstanding section D.01.009, not less than

(A) 3,300 International Units of vitamin A, and

(B) 530 International Units of vitamin D

per 100 grams; and

(c) may contain

(i) skim milk powder, buttermilk powder or liquid buttermilk,

(ii) whey solids or modified whey solids,

(iii) protein,

(iv) water,

(v) vitamin E, if added in such an amount as will result in the finished product containing not less than 0.6 International Unit of alphatocopherol per gram of linoleic acid present in the margarine,

(vi) a flavouring agent,

(vii) a sweetening agent,

(viii) potassium chloride and sodium chloride,

(ix) the following colouring agents: annatto, ß-apo-8′- carotenal, canthaxanthin, carotene, ethyl ß-apo-8′-carotenoate and turmeric, as set out in Table III to section B.16.100,

(x) the following emulsifying agents: lecithin, mono- and di-glycerides, mono-glycerides and sorbitan tristearate, as set out in Table IV to section B.16.100,

(xi) the following pH adjusting agents: citric acid, lactic acid, potassium bicarbonate, sodium bicarbonate, potassium carbonate, sodium carbonate, sodium citrate, sodium lactate, potassium citrate, potassium hydroxide, sodium hydroxide, potassium lactate, sodium potassium tartrate and tartaric acid, as set out in Table X to section B.16.100,

(xii) the following preservatives: ascorbyl palmitate, ascorbyl stearate, benzoic acid, butylated hydroxyanisole, butylated hydroxytoluene, calcium sorbate, monoglyceride citrate, monoisopropyl citrate, potassium benzoate, potassium sorbate, propyl gallate, sodium benzoate, sodium sorbate and sorbic acid, as set out in Table XI to section B.16.100, and

(xiii) the following sequestering agents: calcium disodium ethylenediaminetetraacetate and stearyl citrate, as set out in Table XII to section B.16.100.

SOR/81-60, s. 6; SOR/84-300, s. 26(F); SOR/93-466, s. 1.

B.09.017. [S]. Calorie-Reduced Margarine

(a) shall conform to the standard for margarine except it shall contain not more than

(i) 40 per cent fat, oil or fat and oil calculated as fat, and

(ii) 50 per cent of the calories that would be normally present in the product if it were not calorie-reduced;

(b) subject to paragraph (c), may contain, either singly or in combination, in an amount not exceeding 0.5 per cent,

(i) acacia gum,

(ii) agar,

(iii) algin,

(iv) carob bean gum,

(v) carrageenan,

(vi) furcelleran,

(vii) gellan gum,

(viii) guar gum,

(ix) karaya gum,

(x) propylene glycol alginate,

(xi) tragacanth gum, and

(xii) xanthan gum;

(c) may

(i) if it contains none of the ingredients mentioned in paragraph (b), contain polyglycerol esters of fatty acids in an amount not exceeding 0.2 per cent, or

(ii) if it contains a combination of one or more of the ingredients mentioned in paragraph (b) and polyglycerol esters of fatty acids, contain such esters in an amount not exceeding 0.2 per cent, provided that the total combination of such esters and ingredients does not exceed an amount of 0.5 per cent;

(d) notwithstanding subparagraph B.09.016(c)(x), may contain lecithin in an amount not exceeding 0.5 per cent; and

(e) may contain

(i) vegetable starch,

(ii) modified vegetable starch, and

(iii) maltodextrin.

SOR/94-38, s. 1; SOR/95-350, s. 1; SOR/96-160, s. 1.

B.09.020. and B.09.021. [Repealed, SOR/88-559, s. 20]

B.09.022. No person shall sell cooking oil, margarine, salad oil, simulated dairy product, shortening or food that resembles margarine or shortening, if the product contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the product.

Division 10

Flavouring Preparations B.10.003. [S]. (naming the flavour) Extract or (naming the flavour) Essence shall be a solution in ethyl alcohol, glycerol, propylene glycol or any combination of these, of sapid or odorous principles, or both, derived from the plant after which the flavouring extract or essence is named, and may contain water, a sweetening agent, food colour and a Class II preservative or Class IV preservative.

B.10.004. [S]. Artificial (naming the flavour) Extract, Artificial (naming the flavour) Essence, Imitation (naming the flavour) Extract or Imitation (naming the flavour) Essence shall be a flavouring extract or essence except that the flavouring principles shall be derived in whole, or in part, from sources other than the aromatic plant after which it is named, and if such extract or essence is defined in these Regulations, the flavouring strength of the artificial or imitation extract or essence shall be not less than that of the extract or essence.

B.10.005. [S]. (naming the flavour) Flavour

(a) shall be a preparation, other than a flavouring preparation described in section B.10.003, of sapid or odorous principles, or both, derived from the aromatic plant after which the flavour is named;

(b) may contain a sweetening agent, food colour, Class II preservative, thaumatin, Class IV preservative or emulsifying agent; and

(c) may have added to it the following liquids only:

(i) water,

(ii) any of, or any combination of, the following: benzyl alcohol; 1, 3-butylene glycol, ethyl acetate, ethyl alcohol, glycerol, glyceryl diacetate, glyceryl triacetate, glyceryl tributyrate, isopropyl alcohol, monoglycerides and diglycerides; 1, 2-propylene glycol or triethylcitrate,

(iii) edible vegetable oil, and

(iv) brominated vegetable oil, sucrose acetate isobutyrate or mixtures thereof, when such flavour is used in beverages containing citrus or spruce oils.

SOR/84-300, s. 27(E); SOR/86-1112, s. 1; SOR/2010-142, s. 8. Previous Version B.10.006. [S]. Artificial (naming the flavour) Flavour or Imitation (naming the flavour) Flavour shall be a flavour except that the flavouring principles may be derived in whole or in part from sources other than the aromatic plant after which it is named, and if such flavour is defined in these Regulations, the flavouring strength of the artificial or imitation flavour shall be not less than that of the flavour.

B.10.007. [S]. Notwithstanding sections B.10.003 and B.10.005, a (naming the fruit) Extract Naturally Fortified, (naming the fruit) Essence Naturally Fortified or (naming the fruit) Flavour Naturally Fortified shall be an extract, essence or flavour derived from the named fruit to which other natural extractives have been added and 51 per cent of the flavouring strength shall be derived from the named fruit.

B.10.008. On any label of or in any advertisement for an artificial or imitation flavouring preparation, the word “artificial”, or “imitation” shall be an integral part of the name of such flavouring preparation and shall be set out in identical type and identically displayed with such name.

SOR/84-300, s. 28.

B.10.009. [S]. Almond Essence, Almond Extract or Almond Flavour shall be the essence, extract or flavour derived from the kernels of the bitter almond, apricot or peach and shall contain not less than one per cent by volume of hydrocyanic acid-free volatile oil obtained therefrom.

B.10.010. [S]. Anise Essence, Anise Extract or Anise Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil of anise and shall correspond in flavouring strength to an alcoholic solution containing not less than three per cent by volume of oil of anise, the volatile oil obtained from the fruit of Pimpinella anisum L. or Illicium verum Hook.

B.10.011. [S]. Celery Seed Essence, Celery Seed Extract or Celery Seed Flavour shall be the essence, extract or flavour derived from celery seed, or oil of celery seed, or terpeneless

oil of celery seed and shall correspond in flavouring strength to an alcoholic solution containing not less than 0.3 per cent by volume of volatile oil of celery seed.

B.10.012. [S]. Cassia Essence, Cassia Extract, Cassia Cinnamon Essence, Cassia Cinnamon Extract, Cassia Flavour or Cassia Cinnamon Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil, obtained from leaves and twigs of Cinnamomum cassia L. containing not less than 80 per cent cinnamic aldehyde, and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of volatile oil of cassia cinnamon.

B.10.013. [S]. Ceylon Cinnamon Essence, Ceylon Cinnamon Extract or Ceylon Cinnamon Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from the bark of Cinnamomum zeylanicum Nees, and shall contain

(a) not less than two per cent by volume of oil of Ceylon cinnamon;

(b) not less than 65 per cent cinnamic aldehyde; and

(c) not more than 10 per cent eugenol.

B.10.014. [S]. Clove Essence, Clove Extract or Clove Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from clove buds, and shall contain not less than two per cent by volume of oil of clove.

B.10.015. [S]. Ginger Essence, Ginger Extract or Ginger Flavour shall be the essence, extract or flavour derived from ginger and shall contain in 100 millilitres the alcohol-soluble matter from not less than 20 grams of ginger.

B.10.016. [S]. Lemon Essence, Lemon Extract or Lemon Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of lemon or from lemon peel and shall contain not less than 0.2 per cent citral derived from oil of lemon.

B.10.017. [S]. Nutmeg Essence, Nutmeg Extract or Nutmeg Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of nutmeg and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of oil of nutmeg.

B.10.018. [S]. Orange Essence, Orange Extract or Orange Flavour shall be the essence, extract or flavour prepared from sweet orange peel, oil of sweet orange or terpeneless oil of sweet orange, and shall correspond in flavouring strength to an alcoholic solution containing five per cent by volume of oil of sweet orange, the volatile oil obtained from the fresh peel of Citrus aurantium L., that shall have an optical rotation, at a temperature of 25°C, of not less than +95° using a tube 100 millimetres in length.

B.10.019. [S]. Peppermint Essence, Peppermint Extract or Peppermint Flavour shall be the essence, extract or flavour prepared from peppermint or oil of peppermint, obtained from the leaves and flowering tops of Mentha piperita L., or of Mentha arvensis De.C., var. piperascens Holmes, and shall correspond in flavouring strength to an alcoholic solution of not less than three per cent by volume of oil of peppermint, containing not less than 50 per cent free and combined menthol.

B.10.020. [S]. Rose Essence, Rose Extract or Rose Flavour shall be the essence, extract or flavour prepared from the volatile oil obtained from the petals of Rosa damascena Mill., R.

centajolia L., or R. moschata Herrm, and shall contain not less than 0.4 per cent by volume of attar of rose.

B.10.021. [S]. Savory Essence, Savory Extract or Savory Flavour shall be the essence, extract or flavour prepared from savory or oil of savory and shall contain not less than 0.35 per cent by volume oil of savory.

B.10.022. [S]. Spearmint Essence, Spearmint Extract or Spearmint Flavour shall be the essence, extract or flavour prepared from spearmint or from oil of spearmint, obtained from the leaves and flowering tops of Mentha spicata L. and shall contain not less than three per cent by volume of oil of spearmint.

B.10.023. [S]. Sweet Basil Essence, Sweet Basil Extract or Sweet Basil Flavour shall be the essence, extract or flavour prepared from sweet basil or from oil of sweet basil, obtained from the leaves and tops of Ocymum basilicum L. and shall contain not less than 0.1 per cent by volume of oil of sweet basil.

B.10.024. [S]. Sweet Marjoram Essence, Sweet Marjoram Extract, Marjoram Essence, Marjoram Extract, Sweet Marjoram Flavour or Marjoram Flavour shall be the essence, extract or flavour prepared from marjoram or from oil of marjoram and shall contain not less than one per cent by volume of oil of marjoram.

B.10.025. [S]. Thyme Essence, Thyme Extract or Thyme Flavour shall be the essence, extract or flavour prepared from thyme or from oil of thyme and shall contain not less than 0.2 per cent by volume of oil of thyme.

B.10.026. [S]. Vanilla Extract, Vanilla Essence or Vanilla Flavour

(a) shall be the essence, extract or flavour prepared from the vanilla bean, the dried, cured fruit of Vanilla planifolia, Andrews, or Vanilla tahitensia, J. W. Moore;

(b) shall contain in 100 ml, regardless of the method of extraction, at least the quantity of soluble substances in their natural proportions that are extractable, according to official method FO-17, Extraction of Soluble Substances from Vanilla Beans, dated September 15, 1989, from

(i) not less than 10 g of vanilla beans, where the beans contain 25 per cent or less moisture, and

(ii) not less than 7.5 g of vanilla beans on the moisture-free basis, where the beans contain more than 25 per cent moisture; and

(c) notwithstanding sections B.10.003 and B.10.005, shall not contain added colour.

SOR/82-768, s. 25; SOR/84-300, s. 29(F); SOR/91-149, s. 1.

B.10.027. [S]. Wintergreen Essence, Wintergreen Extract or Wintergreen Flavour shall be the essence, extract or flavour prepared from oil of wintergreen, the volatile oil distilled from the leaves of Gaultheria procumbens L. or from Betula lenta L. and shall contain not less than three per cent by volume of oil of wintergreen.

Division 11

Fruits, Vegetables, Their Products And Substitutes [SOR/78-478, s. 1]

B.11.001. In this Division,

“acid ingredient” means

(a) citric, malic or tartaric acid,

(b) lemon or lime juice, or

(c) vinegar; (ingrédient acide)

“fruit juice” means the unfermented liquid expressed from sound ripe fresh fruit, and includes any such liquid that is heat treated and chilled; (jus de fruit)

“sweetening ingredient” means sugar, invert sugar, honey, dextrose, glucose or glucose solids or any combination thereof in dry or liquid form. (ingrédient édulcorant)

B.11.001.1. No person shall sell any fresh fruit or vegetable that is intended to be consumed raw, except grapes, if sulphurous acid or any salt thereof has been added thereto.

SOR/87-374, s. 1.

Vegetables

B.11.002. [S]. Canned (naming the vegetable)

(a) shall be the product obtained by heat processing the named fresh vegetable after it has been properly prepared;

(b) shall be packed in hermetically sealed containers;

(c) may contain

(i) a sweetening ingredient,

(ii) salt,

(iii) water, and

(iv) a firming agent; and

(d) may contain

(i) in the case of canned green beans and canned wax beans, pieces of green peppers, red peppers and tomato in an amount not exceeding 15 per cent of the final product, and dill seasonings and vinegar,

(ii) in the case of canned peas, garnishes composed of one or more of lettuce, onions, carrots, and pieces of green or red peppers in an amount not exceeding 15 per cent of the total drained vegetable ingredient, aromatic herbs, spices and seasonings, stock or juice of vegetables and aromatic herbs, calcium hydroxide in an amount not exceeding 0.01 per cent of the final product and magnesium hydroxide in an amount not exceeding 0.05 per cent of the final product,

(iii) in the case of

(A) canned asparagus, acetic acid, citric acid, malic acid and tartaric acid at levels consistent with good manufacturing practice,

(B) canned white asparagus, acetic acid, citric acid, malic acid, tartaric acid and ascorbic acid at levels consistent with good manufacturing practice, and

(C) canned chili peppers, citric acid at a level consistent with good manufacturing practice,

(iv) in the case of asparagus packed in glass containers or fully lined (lacquered) cans, stannous chloride in an amount not exceeding 25 parts per million, calculated as tin,

(v) in the case of canned artichokes, canned bean sprouts and canned onions, citric acid at levels consistent with good manufacturing practice, to be used as a pH adjusting agent,

(vi) in the case of canned ripe lima beans (butter beans) and canned pinto beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 130 parts per million,

(vi.1) in the case of canned fava beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 365 parts per million,

(vii) in the case of canned red kidney beans, canned chick peas (garbanzo beans) and canned black-eye peas, disodium ethylenediaminetetraacetate in an amount not exceeding 150 parts per million, and

(viii) in the case of canned asparagus, canned green beans, canned wax beans and canned peas

(A) butter or other edible animal or vegetable fats or oils, but if butter is added it shall be not less than three per cent of the final product,

(B) natural or enzymatically or physically modified starches when used with butter or other edible animal or vegetable fats and oils,

(C) acacia gum, algin, carrageenan, furcelleran, guar gum and propylene glycol alginate used with butter or other edible animal or vegetable fats or oils in an amount not exceeding one per cent, singly or in any combination, of the final product, and

(D) characterizing sauces, seasonings or flavouring agents if it is included in the common name of the product.

SOR/79-660, s. 1; SOR/84-300, s. 30; SOR/95-435, s. 1; SOR/97-561, s. 1.

B.11.003. [S]. Canned Mushrooms

(a) shall be the product obtained by heat-processing properly prepared mushrooms of the cultivated type;

(b) shall be packed in hermetically sealed containers; and

(c) may contain ascorbic acid, citric acid and salt.

SOR/84-300, s. 31.

B.11.003A. [S]. Frozen Mushrooms

(a) shall be the product obtained by freezing properly prepared mushrooms of the cultivated type; and

(b) may contain sodium metabisulphite, sodium phosphate dibasic, sodium sulphate and salt.

B.11.004. [S]. Frozen (naming the vegetable) shall be the product obtained by freezing the named fresh vegetable after it has been properly prepared and subjected to a blanching treatment and may contain added salt.

B.11.005. [S]. Tomatoes or Canned Tomatoes

(a) shall be the product made by heat processing properly prepared fresh ripe tomatoes;

(b) may contain

(i) a sweetening ingredient in dry form,

(ii) salt,

(iii) a firming agent,

(iv) citric acid, and

(v) spice or other seasoning; and

(c) shall contain not less than 50 per cent drained tomato solids, as determined by official method FO-18, Determination of Drained Tomato Solids, October 15, 1981.

SOR/82-768, s. 26.

B.11.007. [S]. Tomato Juice shall be the unconcentrated, pasteurized liquid containing a substantial portion of fine tomato pulp extracted from sound, ripe, whole tomatoes from which all stems and objectionable portions have been removed by any method that does not add water to the liquid and may contain salt and a sweetening ingredient in dry form.

B.11.009. [S]. Tomato Paste shall be the product made by evaporating a portion of the water from tomatoes or sound tomato trimmings, may contain salt and Class II preservatives and shall contain not less than 20 per cent tomato solids, as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981.

SOR/82-768, s. 27.

B.11.010. [S]. Concentrated Tomato Paste shall be tomato paste containing not less than 30 per cent tomato solids, as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981.

SOR/82-768, s. 27.

B.11.011. [S]. Tomato Pulp shall be the heat processed product made from whole, ripe tomatoes or sound tomato trimmings concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain salt and a Class II preservative.

B.11.012. [S]. Tomato Puree shall be the heat processed product made from whole, ripe tomatoes, with the skins and seeds removed, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain salt and a Class II preservative.

B.11.014. [S]. Tomato Catsup, Catsup or products whose common names are variants of the word Catsup

(a) shall be the heat processed product made from the juice of red-ripe tomatoes or sound tomato trimmings from which skins and seeds have been removed;

(b) shall contain

(i) vinegar,

(ii) salt,

(iii) seasoning, and

(iv) a sweetening ingredient; and

(c) may contain

(i) a Class II preservative, and

(ii) food colour.

B.11.015. [Repealed, SOR/97-151, s. 19]

B.11.016. No person shall sell canned tomatoes, tomato juice or vegetable juice that contains mould filaments in more than 25 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981.

SOR/82-768, s. 28.

B.11.017. No person shall sell tomato puree, tomato paste, tomato pulp or tomato catsup that contains mould filaments in more than 50 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981.

SOR/82-768, s. 28.

B.11.025. No person shall sell potatoes, sweet potatoes or yams that have been artificially coloured.

B.11.040. [S]. Beans with Pork or Beans and Pork shall be the food prepared from dried beans and pork, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 60 per cent drained solids, as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.

SOR/82-768, s. 29.

B.11.041. [S]. Beans or Vegetarian Beans shall be the food prepared from dried beans, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 60 per cent drained solids, as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.

SOR/82-768, s. 29.

B.11.050. [S]. Olives shall be the plain or stuffed fruit of the olive tree, and may contain

(a) vinegar;

(b) salt;

(c) a sweetening ingredient;

(d) spices;

(e) seasonings;

(f) lactic acid;

(g) sorbic acid or its potassium or sodium salt;

(h) calcium chloride;

(i) citric acid; and

(j) in the case of ripe olives, ferrous gluconate.

SOR/97-561, s. 2.

B.11.051. [S]. Pickles and relishes shall be the product prepared from vegetables or fruits with salt and vinegar, and may contain

(a) spices;

(b) seasonings;

(c) sugar, invert sugar, dextrose or glucose, in dry or liquid form;

(d) food colour;

(e) a Class II preservative;

(f) a firming agent;

(g) polyoxyethylene (20) sorbitan monooleate in an amount not exceeding 0.05 per cent;

(h) lactic acid;

(i) vegetable oils; and

(j) in the case of relishes and mustard pickles, a thickening agent.

SOR/84-300, s. 32.

Fruits

B.11.101. [S]. Canned (naming the fruit)

(a) shall be the product prepared by heat processing the named fresh fruit after it has been properly prepared;

(b) shall be packed in hermetically sealed containers; and

(c) may contain

(i) a sweetening ingredient,

(ii) water,

(iii) fruit juice, fruit juice from concentrate, concentrated fruit juice or any combination thereof,

(iv) in the case of canned pears, citric acid, malic acid, L-tartaric or lactic acid at a level sufficient to maintain pH 4.2 to 4.5, lemon juice, spices, spice oils, mint and a flavouring preparation other than that which simulates the flavour of canned pears,

(v) in the case of canned apples, a firming agent,

(vi) in the case of canned applesauce, citric acid and malic acid at a level sufficient to maintain pH 4.2 to 4.5, ascorbic acid and isoascorbic acid provided the total does not exceed 150 parts per million, spices, salt and a flavouring preparation other than that which simulates the flavour of canned applesauce,

(vii) in the case of canned grapefruit, citric acid at a level sufficient to maintain pH 4.2 to 4.5, lemon juice, calcium chloride and calcium lactate provided the total calcium content, whether naturally present or added, does not exceed 0.035 per cent, spices and a flavouring preparation other than that which simulates the flavour of canned grapefruit,

(viii) in the case of canned mandarin oranges, citric acid at a level sufficient to maintain pH 4.2 to 4.5,

(ix) in the case of canned peaches, L-ascorbic acid at a level not to exceed 550 parts per million, spices, peach pits and peach kernels intended for flavour development and a flavouring preparation other than that which simulates the flavour of canned peaches,

(x) in the case of canned pineapple, citric acid at a level sufficient to maintain pH 4.2 to 4.5, spices, spice oils, mint, dimethylpolysiloxane not to exceed 10 parts per million when pineapple juice is used as a packing medium and a flavouring preparation other than that which simulates the flavour of canned pineapple,

(xi) in the case of canned plums, a flavouring preparation other than that which simulates the flavour of canned plums, and

(xii) in the case of canned strawberries, citric acid, lactic acid, malic acid or L-tartaric acid at a level sufficient to maintain pH 4.2 to 4.5.

SOR/84-300, s. 33.

B.11.102. [S]. Frozen (naming the fruit) shall be the product obtained by freezing the named fresh fruit after it has been properly prepared and may contain

(a) a sweetening ingredient;

(b) water;

(c) fruit juice, fruit juice from concentrate, concentrated fruit juice or any combination thereof;

(d) ascorbic acid, citric acid, erythorbic acid or malic acid to prevent discolouration; and

(e) in the case of frozen sliced apples,

(i) a firming agent, and

(ii) sulphurous acid.

SOR/84-300, s. 34; SOR/95-436, s. 1.

B.11.103. and B.11.104. [Repealed, SOR/79-252, s. 1]

B.11.105. [Repealed, SOR/97-151, s. 20]

Fruit Juices

B.11.120. [S]. (Naming the fruit) Juice

(a) shall be the juice obtained from the named fruit; and

(b) may contain a sweetening ingredient in dry form, a Class II preservative, amylase, cellulase and pectinase.

SOR/78-402, s. 2; SOR/84-300, s. 35; SOR/90-87, s. 1; SOR/92-591, s. 2.

B.11.121. Notwithstanding section B.11.120, the fruit juice prepared from any fruit named in any of sections B.11.123 to B.11.128A shall conform to the standard prescribed for that fruit juice in that section.

B.11.123. [S]. Apple Juice

(a) shall be the fruit juice obtained from apples;

(b) may contain a Class II preservative, vitamin C, amylase, cellulase and pectinase;

(c) shall have a specific gravity of not less than 1.041 and not more than 1.065 (20°C/20°C); and

(d) shall contain, in 100 millilitres measured at a temperature of 20°C, not less than 0.24 gram and not more than 0.60 gram of ash of which not less than 50 per cent shall be potassium carbonate.

SOR/90-87, s. 2.

B.11.124. [S]. Grape Juice

(a) shall be the fruit juice obtained from grapes;

(b) shall have a specific gravity of not less than 1.040 and not more than 1.124 (20°C/20°C);

(c) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C,

(i) not less than 0.20 gram and not more than 0.55 gram of ash, and

(ii) not less than 0.015 gram and not more than 0.070 gram of phosphoric acid calculated as phosphorous pentoxide; and

(d) may contain a pH-adjusting agent, a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase and pectinase.

SOR/84-300, s. 36(E); SOR/86-1112, s. 2; SOR/90-87, s. 3.

B.11.125. [S]. Grapefruit Juice

(a) shall be fruit juice obtained from clean, sound, mature grapefruit;

(b) shall

(i) contain not less than 1.15 milliequivalents of free amino acid per 100 millilitres, as determined by official method FO-21, Determination of Amino Acids in Grapefruit Juice and Orange Juice, October 15, 1981,

(ii) contain not less than 70 milligrams of potassium per 100 millilitres, as determined by official method FO-22, Determination of Potassium in Grapefruit Juice and Orange Juice, October 15, 1981, and

(iii) have an absorbance value for total polyphenolics of not less than 0.310, as determined by official method FO-23, Determination of Absorbance Value for Total Polyphenolics in Grapefruit Juice and Orange Juice, October 15, 1981;

(c) shall, before the addition of sugar, invert sugar, dextrose or glucose solids,

(i) have a Brix reading of not less than 9.3°, as determined by official method FO-24, Determination of Brix Reading for Grapefruit Juice and Orange Juice, October 15, 1981, and

(ii) contain not less than 0.7 per cent and not more than 2.1 per cent of acid by weight calculated as anhydrous citric acid, as determined by official method FO-25, Determination of Acid in Grapefruit Juice or Orange Juice, October 15, 1981; and

(d) may contain sugar, invert sugar, dextrose in dry form, glucose solids, a Class II preservative, amylase, cellulase and pectinase.

SOR/82-768, s. 30; SOR/90-87, s. 4.

B.11.126. [S]. Lemon Juice

(a) shall be the fruit juice obtained from lemons;

(b) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, not less than

(i) 8.0 grams of soluble solids, as determined by official method FO-26, Determination of Soluble Solids in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981, and

(ii) 5.0 grams of acid calculated as anhydrous citric acid, as determined by official method FO-27, Determination of Acid in Lemon Juice, Lime Juice, or Lime Fruit Juice, October 15, 1981;

(c) may contain stannous chloride; and

(d) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase.

SOR/82-768, s. 31; SOR/90-87, s. 5.

B.11.127. [S]. Lime Juice or Lime Fruit Juice

(a) shall be the fruit juice obtained from limes;

(b) shall have

(i) a specific gravity of not less than 1.030 and not more than 1.040 (20°C/20°C),

(ii) its optical rotation between +0.5 and -1.5 degrees Ventzke, determined at a temperature of 20°C, using a tube 200 millimetres in length;

(c) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, not less than

(i) 8.0 grams of soluble solids, as determined by official method FO-26, Determination of Soluble Solids in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981, and

(ii) 5.5 grams of acid calculated as anhydrous citric acid, as determined by official method FO-27, Determination of Acid in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981;

(d) may contain stannous chloride; and

(e) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase.

SOR/82-768, s. 32; SOR/90-87, s. 6.

B.11.128. [S]. Orange Juice

(a) shall be fruit juice obtained from clean, sound, mature oranges;

(b) shall

(i) contain not less than 1.20 milliequivalents of free amino acids per 100 millilitres, as determined by official method FO-21, Determination of Amino Acids in Grapefruit Juice and Orange Juice, October 15, 1981,

(ii) contain not less than 115 milligrams of potassium per 100 millilitres, as determined by official method FO-22, Determination of Potassium in Grapefruit Juice and Orange Juice, October 15, 1981, and

(iii) have an absorbance value for total polyphenolics of not less than 0.380, as determined by official method FO-23, Determination of Absorbance Value for Total Polyphenolics in Grapefruit Juice and Orange Juice, October 15, 1981;

(c) shall, before the addition of sugar, invert sugar, dextrose or glucose solids,

(i) have a Brix reading of not less than 9.7°, as determined by official method FO-24, Determination of Brix Reading for Grapefruit Juice and Orange Juice, October 15, 1981, and

(ii) contain not less than 0.5 per cent and not more than 1.8 per cent of acid by weight calculated as anhydrous citric acid, as determined by official method FO-25, Determination of Acid in Grapefruit Juice or Orange Juice, October 15, 1981;

(d) may contain orange essences, orange oils and orange pulp adjusted in accordance with good manufacturing practice; and

(e) may contain sugar, invert sugar, dextrose in dry form, glucose solids, a Class II preservative, amylase, cellulase and pectinase.

SOR/82-768, s. 33; SOR/90-87, s. 7.

B.11.128A. [S]. Pineapple Juice

(a) shall be the fruit juice obtained from pineapple; and

(b) may contain a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase, pectinase and an antifoaming agent.

SOR/90-87, s. 8; SOR/91-90, s. 1.

B.11.129. [S]. Carbonated (naming the fruit) Juice or Sparkling (naming the fruit) Juice shall be the named fruit juice impregnated with carbon dioxide under pressure.

B.11.130. [S]. (1) Concentrated (naming the fruit) juice

(a) shall be fruit juice that is concentrated to at least one half of its original volume by the removal of water;

(b) may contain

(i) vitamin C,

(ii) food colour,

(iii) stannous chloride,

(iv) a sweetening ingredient, and

(v) a class II preservative; and

(c) may have added to it, for the purpose of adjustment in accordance with good manufacturing practice, all or any of the following, namely,

(i) essence, oil and pulp from the named fruit, and

(ii) water.

(2) Subparagraphs (1)(b)(i), (ii), (iii) and (v) do not apply in respect of frozen concentrated orange juice.

SOR/89-198, s. 2; SOR/91-124, s. 3.

B.11.131. [S]. (Naming the fruits) Juice shall be a mixture of fruit juices each of which meets the standard prescribed for that fruit juice in this Division.

B.11.132. [S]. Apple and (naming the fruit) Juice

(a) shall be a mixture of apple juice and another fruit juice, each of which meets the standard, if any, prescribed for that fruit juice in this Division; and

(b) may contain added vitamin C.

B.11.133. [S]. Reconstituted (naming the fruit) Juice or (naming the fruit) Juice from Concentrate

(a) shall be fruit juice that has been prepared by the addition of water to fruit juice of the same name from which water has been removed;

(b) may contain juice of the same name, a sweetening ingredient, and natural pulp, oils and esters of the named fruit;

(c) shall conform to the standards for the named fruit juices as prescribed in this Division; and

(d) may contain, in the case of reconstituted lemon or lime juice, not more than 10 parts per million dimethylpolysiloxane.

SOR/78-637, s. 2.

B.11.134. [S]. Apricot Nectar, Peach Nectar or Pear Nectar

(a) shall be the unfermented but fermentable pulpy product, intended for direct consumption, obtained by blending the total edible part of sound and ripe apricots, peaches and pears, as the case may be, concentrated or unconcentrated with water and, subject to subparagraph (e)(i), a sweetening ingredient;

(b) shall contain

(i) in the case of peach nectar and pear nectar, not less than 40 per cent by weight of the fruit or the equivalent derived from the concentrated fruit, and

(ii) in the case of apricot nectar, not less than 35 per cent by weight of the fruit or the equivalent derived from the concentrated fruit;

(c) shall contain not less than 13 per cent soluble solids by weight expressed as °Brix on the International Sucrose Scales and calculated by refractometer at 20°C and uncorrected for acidity;

(d) shall not contain more than 3 g/kg (3000 p.p.m.) of ethanol and 10 mg/kg (10 p.p.m.) of hydroxy methyl furfural; and

(e) may contain

(i) honey if no other sweetening ingredient is employed,

(ii) citric acid and malic acid at levels consistent with good manufacturing practice,

(iii) lemon juice, and

(iv) vitamin C.

SOR/79-660, s. 2; SOR/2010-94, s. 9(E). Previous Version

Fruit Flavoured Drinks

B.11.150. No person shall label, package, sell or advertise a fruit flavoured drink in a manner that is likely to create an impression that the fruit flavoured drink contains vitamins or has any other nutritional value commonly associated with any fruit juice unless the following requirements are met:

(a) it is sold as a substitute for fruit juice or as a breakfast drink;

(b) it is not carbonated;

(c) it is not represented to be or is not commonly known as

(i) a soft drink, or

(ii) a thirst-quenching or refreshment drink; and

(d) notwithstanding sections D.01.009, D.01.011 and D.02.009,

(i) it contains vitamin C in an amount not less than 24 milligrams and not more than 48 milligrams, and

(ii) it contains

(A) where folic acid has been added, an amount of folic acid of not less than 40 micrograms and not more than 80 micrograms,

(B) where thiamine has been added, an amount of thiamine of not less than 0.08 milligram and not more than 0.11 milligram,

(C) where iron has been added, an amount of iron of not less than 0.56 milligram and not more than 0.80 milligram, or

(D) where potassium has been added, an amount of potassium of not less than 100 milligrams and not more than 200 milligrams,

per 100 millilitres when the drink is ready to serve.

SOR/78-478, s. 2.

B.11.151. No person shall label, package, sell or advertise a base, concentrate or mix that is used for making a fruit flavoured drink in a manner that is likely to create an impression that the drink made therefrom will contain vitamins or have any other nutritional value commonly associated with fruit juice unless the following requirements are met:

(a) the base, concentrate or mix

(i) is sold for the purpose of making a breakfast drink or a substitute for fruit juice,

(ii) is not represented to be or is not commonly known as a product that is used for making a soft drink or a thirst-quenching or refreshment drink; and

(b) where a drink is made therefrom as directed, the drink meets the requirements described in paragraph B.11.150(d).

SOR/78-478, s. 2.

Jams

B.11.201. [S]. (Naming the fruit) Jam

(a) shall be the product obtained by processing fruit, fruit pulp, or canned fruit, by boiling to a suitable consistency with water and a sweetening ingredient;

(b) shall contain not less than

(i) 45 per cent of the named fruit, and

(ii) 66 per cent water soluble solids as estimated by the refractometer;

(c) may contain

(i) such amount of added pectin, pectinous preparation, or acid ingredient as reasonably compensates for any deficiency in the natural pectin content or acidity of the named fruit,

(ii) a Class II preservative,

(iii) a pH adjusting agent, and

(iv) an antifoaming agent; and

(d) shall not contain apple or rhubarb.

SOR/92-400, s. 16.

B.11.202. [S]. (Naming the fruit) Jam with Pectin

(a) shall be the product obtained by processing fruit, fruit pulp, or canned fruit by boiling to a suitable consistency with water and a sweetening ingredient;

(b) shall contain

(i) not less than 27 per cent of the named fruit,

(ii) not less than 66 per cent water soluble solids as estimated by the refractometer, and

(iii) pectin or pectinous preparations;

(c) may contain

(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,

(ii) food colour,

(iii) a Class II preservative,

(iv) a pH adjusting agent, and

(v) an antifoaming agent; and

(d) shall not contain apple or rhubarb.

SOR/92-400, s. 17.

B.11.203. [S]. Apple (or Rhubarb) and (naming the fruit) Jam

(a) shall be the product obtained by processing fruit, fruit pulp or canned fruit by boiling to a suitable consistency with water and a sweetening ingredient;

(b) shall contain not less than

(i) 12.5 per cent of the named fruit, except that where the named fruit is strawberry it shall contain not less than 15 per cent strawberries,

(ii) 20 per cent apple or rhubarb pulp, and

(iii) 66 per cent water soluble solids as estimated by the refractometer; and

(c) may contain

(i) pectin or pectinous preparation,

(ii) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the fruit used in its preparation,

(iii) food colour,

(iv) a Class II preservative,

(v) a pH adjusting agent, and

(vi) an antifoaming agent.

B.11.204. Where a jam for which a standard is prescribed in section B.11.203 contains added pectin or pectinous preparation, a statement to the effect that pectin or pectinous preparation has been added shall be shown on the principal display panel.

Marmalade

B.11.220. [S]. (Naming the citrus fruit) Marmalade shall be the food of jelly-like consistency made from any combination of peel, pulp or juice of the named citrus fruit by boiling with water and a sweetening ingredient and shall contain not less than 65 per cent water soluble solids as estimated by the refractometer and may contain

(a) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named citrus fruit;

(b) a pH adjusting agent; and

(c) an antifoaming agent.

B.11.221. [S]. (Naming the citrus fruit) Marmalade with Pectin

(a) shall be the food of jelly-like consistency made from any combination of peel, pulp or juice of the named citrus fruit by boiling with water and a sweetening ingredient;

(b) shall contain

(i) not less than 27 per cent of any combination of peel, pulp or juice of the named citrus fruit,

(ii) not less than 65 per cent water soluble solids as estimated by the refractometer, and

(iii) pectin or pectinous preparation; and

(c) may contain

(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the citrus fruit used in its preparation,

(ii) a Class II preservative,

(iii) a pH adjusting agent, and

(iv) an antifoaming agent.

B.11.222. [S]. Pineapple Marmalade or Fig Marmalade

(a) shall be the food of jelly-like consistency made from the pulp of juice of the named fruit by boiling with water and a sweetening ingredient;

(b) shall contain not less than

(i) 45 per cent of the named fruit, and

(ii) 65 per cent water soluble solids, as estimated by the refractometer;

(c) may contain such amounts of added pectin, pectinous preparation or acid ingredient as reasonably compensates for any deficiency in the natural pectin content or acidity of the named fruit;

(d) a pH adjusting agent; and

(e) an antifoaming agent.

B.11.223. [S]. Pineapple Marmalade with Pectin or Fig Marmalade with Pectin

(a) shall be the food of jelly-like consistency made from the pulp and juice of the named fruit by boiling with water and a sweetening ingredient;

(b) shall contain

(i) not less than 27 per cent of the named fruit,

(ii) not less than 65 per cent water soluble solids as estimated by the refractometer, and

(iii) pectin or pectinous preparation; and

(c) may contain

(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,

(ii) food colour,

(iii) a Class II preservative,

(iv) a pH adjusting agent, and

(v) an antifoaming agent.

SOR/84-300, s. 37(E).

B.11.224. [S]. (Naming the fruit) Preserve (Conserve) shall be the food made by processing fruit other than apple or rhubarb with a sweetening ingredient and shall contain not less than

(a) 45 parts by weight of the named fruit for each 55 parts by weight, on the dry basis, of a sweetening ingredient; and

(b) 60 per cent water-soluble solids, as estimated by the refractometer.

Jelly

B.11.240. [S]. (Naming the fruit) Jelly shall be the gelatinous food, free of seeds and pulp, made from the named fruit, the juice of the named fruit or a concentrate of the juice of the named fruit, which has been boiled with water and a sweetening ingredient, shall contain not less than 62 per cent water soluble solids as estimated by the refractometer and may contain

(a) such amount of added pectin, pectinous preparation or acid ingredient as reasonably compensates for any deficiency of the natural pectin content or acidity of the named fruit;

(b) a pH adjusting agent; and

(c) an antifoaming agent.

B.11.241. [S]. (Naming the fruit) Jelly with Pectin

(a) shall be the gelatinous food, free of seeds and pulp, made from the named fruit, the juice of the named fruit or a concentrate of the juice of the named fruit, which has been boiled with water and a sweetening ingredient;

(b) shall contain

(i) not less than the equivalent of 32 per cent juice of the named fruit,

(ii) not less than 62 per cent water soluble solids, as estimated by the refractometer, and

(iii) pectin or pectinous preparation; and

(c) may contain

(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,

(ii) juice of another fruit,

(iii) a gelling agent,

(iv) food colour,

(v) a Class II preservative,

(vi) a pH adjusting agent, and

(vii) an antifoaming agent.

B.11.242. The standards prescribed in these Regulations for jam and jelly do not apply to cranberry sauce, jellied cranberry, cranberry jelly, mint jelly and jellied mint.

Mince Meat

B.11.250. [S]. Mince, Mince Meat or Fruit Mince

(a) shall be the food prepared from

(i) fruit or dried fruit,

(ii) suet,

(iii) salt,

(iv) spices, and

(v) a sweetening agent; and

(b) may contain

(i) vinegar,

(ii) fresh, concentrated or fermented fruit juice,

(iii) spiritous liquor,

(iv) nuts,

(v) cooked meat,

(vi) a Class II preservative,

(vii) a thickening agent,

(viii) citric acid, and

(ix) caramel.

SOR/84-300, s. 38(F).

Boiled Cider

B.11.260. [S]. Boiled Cider shall be the liquid expressed from whole apples, apple cores, apple trimmings or apple culls and concentrated by boiling.

Division 12

Prepackaged Water And Ice [SOR/80-633, s. 1]

B.12.001. [S]. Water represented as mineral water or spring water,

(a) shall be potable water obtained from an underground source but not obtained from a public community water supply;

(b) shall not contain any coliform bacteria, as determined by official method MFO-9, Microbiological Examination of Mineral Water, November 30, 1981;

(c) shall not have its composition modified through the use of any chemicals; and

(d) notwithstanding paragraph (c), may contain

(i) added carbon dioxide,

(ii) added fluoride, if the total fluoride ion content thereof does not exceed one part per million, and

(iii) added ozone.

SOR/80-633, s. 2; SOR/82-768, s. 34.

B.12.002. The principal display panel of the label on a container of water represented as mineral water or spring water shall carry a statement

(a) of the geographical location of the underground source from which it is obtained;

(b) of the total dissolved mineral salt content expressed in parts per million;

(c) of the total fluoride ion content expressed in parts per million; and

(d) of any addition of fluoride or ozone thereto.

SOR/84-300, s. 39(F); SOR/88-336, s. 3; SOR/92-626, s. 14(F).

B.12.003. Where carbon dioxide has been added to water represented as mineral water or spring water, the word “carbonated” (“gazéifiée”) shall appear on the principal display panel of the label on the container thereof, as the first designation in the common name of the water when the added carbon dioxide

(a) did not originate from decarbonation of the water upon emergence from the underground source; or

(b) is present in a quantity greater than was present originally in the water.

SOR/84-300, s. 40(F); SOR/88-336, s. 3.

B.12.004. No person shall sell water in sealed containers, other than water represented as mineral water or spring water, if it contains

(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;

(b) more than 100 total aerobic bacteria per millilitre, as determined by official method MFO­ 15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;

(c) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or

(d) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.

SOR/80-633, s. 3; SOR/82-768, s. 35.

B.12.005. (1) No person shall sell prepackaged ice if it contains

(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;

(b) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or

(c) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.

(2) No person shall manufacture prepackaged ice for sale if the water from which it is made contains

(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;

(b) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or

(c) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.

SOR/80-633, s. 3; SOR/82-768, s. 36.

B.12.006. The common name of water in sealed containers, other than water represented as mineral water or spring water, shall be “Water”, modified by the word

(a) “Distilled” when the treatment of the water includes its vaporization and condensation;

(b) “Demineralized” when the treatment of the water is such that the mineral content of the water is reduced, by means other than distillation, to less than 10 parts per million; and

(c) “Carbonated” when the water contains added carbon dioxide.

SOR/80-633, s. 3.

B.12.007. Notwithstanding section B.01.008, when chlorine or any compounds of chlorine have been

(a) used in the treatment of water in sealed containers, other than water represented as mineral water or spring water, and

(b) subsequently removed from the water together with any chlorine and compounds of chlorine produced in the water,

chlorine or any compounds of chlorine need not be shown as ingredients on any part of the label on a sealed container of that water.

SOR/80-633, s. 3.

B.12.008. A statement of the total fluoride ion content expressed in parts per million shall appear on the principal display panel of the label on a sealed container of water, other than water represented as mineral water or spring water and on the label on a container of prepackaged ice.

SOR/80-633, s. 3; SOR/2000-353, s. 5(E).

B.12.009. The label on a sealed container of water, other than water represented as mineral water or spring water, shall bear a description on its principal display panel of any treatment the water has undergone, with the exception of the following:

(a) the addition of an ingredient declared in the list of ingredients;

(b) chlorination followed by the removal of the agent used for the chlorination together with any chlorine and compounds of chlorine produced in the water;

(c) decantation; and

(d) filtration.

SOR/80-633, s. 3; SOR/2000-353, s. 5(E).

Division 13

Grain And Bakery Products B.13.001. [S]. Flour, White Flour, Enriched Flour or Enriched White Flour

(a) shall be the food prepared by the grinding and bolting through cloth having openings not larger than those of woven wire cloth designated “149 microns (No. 100)”, of cleaned milling grades of wheat;

(b) shall be free from bran coat and germ to such an extent that the percentage of ash therein, before the addition of any other material permitted by this section, calculated on a moisture- free basis, does not exceed 1.20 per cent;

(c) shall have a moisture content of not more than 15 per cent;

(d) shall contain in 100 grams of flour

(i) 0.64 milligram of thiamine,

(ii) 0.40 milligram of riboflavin,

(iii) 5.30 milligrams of niacin or niacinamide,

(iv) 0.15 milligram of folic acid, and

(v) 4.4 milligrams of iron;

(e) may contain

(i) malted wheat flour,

(ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour,

(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase or xylanase,

(iv) chlorine,

(v) chlorine dioxide,

(vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide,

(vii) [Repealed, SOR/94-227, s. 1]

(viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour,

(ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour,

(x) acetone peroxide,

(xi) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour,

(xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour,

(xiii) l-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour,

(xiv) monocalcium phosphate in an amount not exceeding 7,500 parts by weight for each one million parts of flour, and

(xv) in 100 grams of flour

(A) 0.31 milligram of vitamin B6,

(B) 1.3 milligrams of d-pantothenic acid, and

(C) 190 milligrams of magnesium; and

(f) may contain calcium carbonate, edible bone meal, chalk (B.P.), ground limestone or calcium sulphate in an amount that will provide in 100 grams of flour 140 milligrams of calcium.

(g) [Repealed, SOR/97-151, s. 21]

SOR/78-402, s. 3; SOR/78-698, s. 2; SOR/80-632, s. 3; SOR/82-383, s. 5; SOR/84-300, s. 41(E); SOR/89-145, s. 1; SOR/92-63, s. 1; SOR/92-94, s. 1; SOR/94-227, s. 1; SOR/94-689, s. 2; SOR/96-527, s. 1; SOR/97-122, s. 1; SOR/97-151, s. 21; SOR/97-558, s. 1; SOR/98-550, s. 1; SOR/2003-130, s. 1.

B.13.002. Notwithstanding section B.13.001, flour, white flour, enriched flour or enriched white flour, used in or sold for the manufacture of gluten or starch is not required to contain added thiamine, riboflavin, niacin, folic acid or iron.

SOR/98-550, s. 2.

B.13.003. [S]. Vitamin B White Flour (Canada Approved)

(a) shall be flour that has been milled in such a way as to retain a high proportion of the vitamins naturally occurring in the original wheat berry;

(b) shall constitute not less than 70 per cent of the wheat from which it is milled;

(c) shall be bolted through at least one cloth having openings not larger than those of woven wire cloth designated “149 microns (No. 100)”; and

(d) shall contain, on a moisture-free basis,

(i) in one pound an amount of the vitamin B complex that will contribute not less than 1.2 milligrams of thiamine, and

(ii) not more than 0.70 per cent and not less than 0.61 per cent ash.

B.13.004. [Repealed, SOR/79-252, s. 2]

B.13.005. [S]. Whole Wheat Flour or Entire Wheat Flour

(a) shall be the food prepared by the grinding and bolting of cleaned, milling grades of wheat from which a part of the outer bran or epidermis layer may have been separated;

(b) shall contain the natural constituents of the wheat berry to the extent of not less than 95 per cent of the total weight of the wheat from which it is milled;

(c) shall have

(i) an ash content, calculated on a moisture-free basis, of not less than 1.25 per cent and not more than 2.25 per cent,

(ii) a moisture content of not more than 15 per cent, and

(iii) such a degree of fineness that not less than 90 per cent bolts freely through a No. 8 (2 380 micron) sieve, and not less than 50 per cent through a No. 20 (840 micron) sieve; and

(d) may contain

(i) malted wheat flour,

(ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour,

(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase, or xylanase,

(iv) chlorine,

(v) chlorine dioxide,

(vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide,

(vii) [Repealed, SOR/94-227, s. 2]

(viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour,

(ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour,

(x) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour,

(xi) acetone peroxide,

(xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour, and

(xiii) l-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour.

(e) [Repealed, SOR/97-151, s. 22]

SOR/78-402, s. 4; SOR/80-632, s. 4; SOR/82-383, s. 6; SOR/92-63, s. 2; SOR/92-94, s. 2; SOR/94-227, s. 2; SOR/94-689, s. 2; SOR/97-122, s. 2; SOR/97-151, s. 22; SOR/97-558, s. 2; SOR/2000-184, s. 63(F); SOR/2003-130, s. 2.

B.13.006. [S]. Graham Flour shall be flour to which has been added part of the bran and other constituents of the wheat berry, and shall have an ash content, calculated on a moisture- free basis, of not less than 1.20 per cent and not more than 2.25 per cent.

B.13.007. [S]. Gluten Flour shall be the food obtained by removing from flour a part of the starch and shall not contain more than

(a) 10 per cent moisture, and

(b) 44 per cent Starch, calculated on a moisture-free basis, as determined by official method FO-28, Determination of Starch in Gluten Flour, October 15, 1981.

SOR/82-768, s. 37.

B.13.008. [S]. Crushed Wheat or Coarse Ground Wheat shall be the food prepared by so crushing cleaned wheat that 40 per cent or more passes through a No. 8 (2 380 micron) sieve and less than 50 per cent through a No. 20 (840 micron) sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have

(a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and

(b) a moisture content of not more than 15.5 per cent.

B.13.009. [S]. Cracked Wheat shall be the food prepared by so cracking or cutting cleaned wheat into angular fragments that not less than 90 per cent passes through a No. 8 (2 380 micron) sieve and not more than 20 per cent through a No. 20 (840 micron) sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have

(a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and

(b) a moisture content of not more than 15.5 per cent.

B.13.010. [S]. Rice shall be the hulled or hulled and polished seed of the rice plant and, in the case of hulled and polished seeds, may be coated with magnesium silicate, talc and glucose.

SOR/78-403, s. 3.

B.13.010.1. (1) For the purposes of this Division, precooked rice means polished rice that has been cooked in water or steam and dried in such a manner as to retain the rice grains in a porous and open-structured condition.

(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell pre­ cooked rice to which a vitamin or mineral nutrient set out in Column I of an item of the table to this section has been added, either singly or in any combination, unless each 100 g of the pre-cooked rice as sold contains the added vitamin or mineral nutrient in the amount set out in Column II of that item.

TABLE

Column I Column II Item Vitamin or Mineral Nutrient Amount per 100 g of Pre-cooked Rice 1. Thiamine 0.45 mg 2. Niacin 4.2 mg 3. Vitamin B6 0.6 mg 4. Folic acid 0.016 mg 5. Pantothenic acid 1.2 mg 6. Iron 1.6 mg

(3) No person shall represent pre-cooked rice as “enriched” unless the food contains added thiamine, niacin and iron.

SOR/86-320, s. 1; SOR/98-458, s. 7(F).

B.13.011. [S]. Corn Starch shall be starch made from maize and shall contain not less than 84 per cent starch.

SOR/84-300, s. 42.

B.13.014. For the purpose of this Division, moisture, ash and fineness shall be determined by the following applicable official methods:

(a) FO-29, Determination of Moisture in Grain, October 15, 1981;

(b) FO-30, Determination of Ash in Grain, October 15, 1981; and

(c) FO-31, Determination of Degree of Fineness of Grain, October 15, 1981.

SOR/82-768, s. 38.

B.13.015. [S]. Cottonseed Flour or similar products from cottonseed shall be derived from decorticated, defatted or partially defatted, cooked, ground cottonseed kernels and contain not more than 450 parts per million of free gossypol.

B.13.020. In this Division, “milk solids” means the entire solids content from milk, partly skimmed milk or skim milk or their concentrated, dried or reconstituted form, singly or in any combination.

SOR/89-170, s. 1.

Bread

B.13.021. [S]. Bread or White Bread shall be the food made by baking a yeast-leavened dough prepared with flour and water and may contain

(a) salt;

(b) shortening, lard, butter or margarine;

(c) milk or milk product;

(d) whole egg, egg-white; egg-yolk, (fresh, dried, or frozen);

(e) a sweetening agent;

(f) malt syrup, malt extract or malt flour;

(g) inactive dried yeast of the genus Saccharomyces cerevisiae in an amount not greater than two parts by weight for each 100 parts of flour used;

(h) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase, or xylanase;

(i) subject to section B.13.029, one or more of the following in a total amount not exceeding five parts by weight per 100 parts of flour used, namely, whole wheat flour, entire wheat flour, graham flour, gluten flour, wheat meal, wheat starch, non-wheat flour, non-wheat meal or non-wheat starch, any of which may be wholly or partially dextrinized;

(j) other parts of the wheat berry;

(k) lecithin or ammonium salt of phosphorylated glyceride;

(l) monoglycerides and diglycerides of fat-forming fatty acids,

(m) ammonium chloride, ammonium sulphate, calcium carbonate, calcium lactate, diammonium phosphate, dicalcium phosphate, monoammonium phosphate or any combination thereof in an amount not greater than 0.25 parts by weight of all such additives for each 100 parts of flour used;

(n) monocalcium phosphate in an amount not greater than 0.75 parts by weight for each 100 parts of flour used;

(o) calcium peroxide, ammonium persulphate, potassium persulphate or any combination thereof in an amount not greater than 0.01 part by weight of all such additives for each 100 parts of flour used;

(p) acetone peroxide;

(q) vinegar;

(r) Class III preservative;

(s) food colour;

(t) calcium stearoyl-2-lactylate or sodium stearoyl-2-lactylate in an amount not greater than 0.375 parts by weight for each 100 parts of flour used;

(u) l-cysteine (hydrochloride) in an amount not greater than 0.009 parts by weight for each 100 parts of flour used;

(v) calcium sulphate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used;

(w) sodium stearyl fumarate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used;

(x) ascorbic acid in an amount not greater than 0.02 parts by weight for each 100 parts of flour used;

(y) lactic acid;

(z) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour;

(aa) calcium iodate, potassium iodate or any combination thereof in an amount not greater than 45 parts by weight of all such additives for each one million parts of flour; and

(bb) acetylated tartaric acid esters of mono- and diglycerides in an amount not greater than 0.6 parts by weight for each 100 parts of flour used.

SOR/78-402, s. 5; SOR/79-251, s. 2; SOR/82-383, ss. 7, 8; SOR/84-300, s. 43(E); SOR/92­ 63, s. 3; SOR/92-94, s. 3; SOR/94-227, s. 3; SOR/97-122, s. 3; SOR/97-558, s. 3; SOR/2003­ 130, s. 3; SOR/2007-302, s. 4(F). Previous Version B.13.022. [S]. Enriched Bread or Enriched White Bread

(a) shall be bread that is baked from a dough in which enriched flour is the only wheat flour used;

(b) shall contain

(i) for each 100 parts of flour used, not less than

(A) two parts by weight of skim milk solids,

(B) four parts by weight of dried whey powder, or

(C) such amount of the protein product made from peas (Pisum sativum) or soybeans (Glycine max) as will provide 0.5 parts by weight of protein, and

(ii) in 100 grams of bread,

(A) 0.40 milligram of thiamine,

(B) 0.24 milligram of riboflavin,

(C) 3.3 milligrams of niacin or niacinamide,

(D) 0.10 milligram of folic acid, and

(E) 2.76 milligrams of iron;

(c) may contain, in 100 grams of bread,

(i) 0.14 milligram of vitamin B6,

(ii) 0.6 milligram of d-pantothenic acid,

(iii) 90 milligrams of magnesium, and

(iv) 66 milligrams of calcium; and

(d) where it contains not less than six parts by weight of milk solids per 100 parts of enriched flour used, may be described by the common name “milk bread”.

SOR/78-698, s. 3; SOR/87-704, s. 1; SOR/89-170, s. 2; SOR/89-198, s. 3; SOR/98-550, s. 3.

B.13.023. and B.13.024. [Repealed, SOR/79-252, s. 3]

B.13.025. [S]. Raisin Bread shall be bread that contains for each 100 parts by weight of flour used not less than 50 parts by weight of seeded or seedless raisins, or raisins and currants of which not less than 35 parts shall be raisins and may contain spices or peel.

B.13.026. [S]. (naming the percentage) Whole Wheat Bread

(a) shall

(i) be bread in the making of which the named percentage of the flour used shall be whole wheat flour, and

(ii) contain not less than 60 per cent whole wheat flour in relation to the total flour used; and

(b) may

(i) contain caramel, and

(ii) where it contains not less than six parts by weight of milk solids per 100 parts of the total enriched flour and whole wheat flour used, be described by the common name “(naming the percentage) whole wheat milk bread”.

SOR/89-170, s. 3.

B.13.027. [S]. Brown Bread shall be bread coloured by the use of whole wheat flour, graham flour, bran, molasses or caramel.

B.13.028. [Repealed, SOR/97-151, s. 23]

B.13.029. A specialty bread may contain

(a) one or more of the ingredients specified in paragraph B.13.021(i) in a total amount greater than the total amount specified in that paragraph; and

(b) fruit, nuts, seeds and flavouring.

SOR/79-251, s. 3.

Alimentary Paste

B.13.051. No person shall sell macaroni, spaghetti, noodles or similar alimentary pastes, as egg macaroni, egg spaghetti, egg noodles or egg alimentary pastes, respectively, unless they contain, on the dry basis, not less than four per cent, egg-yolk solids derived from whole egg, dried egg, frozen egg or frozen egg-yolk.

B.13.052. (1) Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell an alimentary paste to which a vitamin or a mineral nutrient set out in column I of any item of the table to this section has been added unless each 100 g of the alimentary paste contains the added vitamin or mineral nutrient in an amount not less than the minimum amount set out in column II of that item and not more than the maximum amount set out in column III of that item.

(2) No person shall represent an alimentary paste as “enriched” unless the alimentary paste contains added thiamine, riboflavin, niacin, folic acid and iron, in accordance with the table to this section.

TABLE

Column I Column II Column III

Item Added Vitamin or Minimum Amount per 100 g of Maximum Amount per 100 gMineral Nutrient Alimentary Paste of Alimentary Paste 1. Thiamine 0.63 mg 1.50 mg 2. Riboflavin 0.11 mg 0.60 mg 3. Niacin 5.90 mg 7.50 mg 4. Folic Acid 0.20 mg 0.27 mg 5. Pantothenic Acid 1.00 mg 2.00 mg 6. Vitamin B6 0.40 mg 0.80 mg 7. Iron 2.90 mg 4.30 mg 8. Magnesium 150.00 mg 300.00 mg

SOR/94-37, s. 1; SOR/94-689, s. 2; SOR/96-527, s. 2; SOR/98-550, ss. 4, 5.

Breakfast Cereal

B.13.060. Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell a breakfast cereal to which a vitamin or mineral nutrient set out in Column I of an item of the table to this section has been added, either singly or in any combination, unless each 100 g of the breakfast cereal contains the added vitamin or mineral nutrient in the amount set out in Column II of that item.

TABLE

Column I Column II Item Vitamin or Mineral Nutrient Amount per 100 g of Breakfast Cereal 1. Thiamine 2.0 mg 2. Niacin 4.8 mg 3. Vitamin B6 0.6 mg 4. Folic Acid 0.06 mg 5. Pantothenic Acid 1.6 mg 6. Magnesium 160.0 mg 7. Iron 13.3 mg 8. Zinc 3.5 mg

SOR/83-858, s. 1; SOR/89-145, s. 2; SOR/98-458, s. 7(F).

Division 14

Meat, Its Preparations And Products B.14.001. In this Division,

“animal” means any animal used as food, but does not include marine and fresh water animals; (animal)

“filler” means any vegetable material (except tomato or beetroot), milk, egg, yeast or any derivative or combination thereof that is acceptable as food. (agent de remplissage)

SOR/82-768, s. 39; SOR/86-875, s. 1.

B.14.002. [S]. Meat shall be the edible part of the skeletal muscle of an animal that was healthy at the time of slaughter, or muscle that is found in the tongue, diaphragm, heart or oesophagus, and may contain accompanying and overlying fat together with the portions of bone, skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and are not separated from it in the process of dressing, but does not include muscle found in the lips, snout, scalp or ears.

B.14.003. [S]. Meat by-product shall be any edible part of an animal, other than meat, that has been derived from one or more animals that were healthy at the time of slaughter.

B.14.004. [S]. Meat, meat by-products or preparations thereof are adulterated if any of the following substances or class of substances are present therein or have been added thereto:

(a) mucous membranes, any organ or portions of the genital system, black gut, spleens, udders, lungs or any other organ or portion of animal that is not commonly sold as an article of food;

(b) preservatives other than those provided for in this Division; or

(c) colour other than annatto, allura red and sunset yellow FCF, where provided for in this Division, and caramel.

SOR/92-725, s. 2; SOR/97-516, s. 2.

B.14.005. [S]. Prepared meat or a prepared meat by-product shall be any meat or any meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations, or which has been preserved, placed in a hermetically-sealed container or cooked, and may contain

(a) in the case of prepared hams, shoulders, butts, picnics and backs, gelatin;

(b) in the case of partially defatted pork fatty tissue and partially defatted beef fatty tissue, a Class IV preservative;

(c) where a minimum total protein content or a minimum meat protein content is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

(i) sodium acid pyrophosphate,

(ii) sodium hexametaphosphate,

(iii) sodium phosphate, dibasic,

(iv) sodium phosphate, monobasic,

(v) sodium pyrophosphate, tetrabasic,

(vi) sodium tripolyphosphate,

(vii) potassium phosphate, monobasic,

(viii) potassium phosphate, dibasic, and

(ix) potassium pyrophosphate, tetrabasic; and

(d) in the case of vacuum-packed sliced roast beef and vacuum-packed sliced cooked ham, Carnobacterium maltaromaticum CB1.

SOR/94-262, s. 2; SOR/2010-264, s. 1. Previous Version B.14.006. Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of meat, meat by-product, prepared meat, prepared meat by-product, extended meat product and simulated meat product.

SOR/2010-142, s. 59(F). Previous Version B.14.007. [S]. Meat Binder or (naming the meat product) Binder shall be a filler with any combination of salt, sweetening agents, spices or other seasonings (except tomato), egg, egg albumen, and

(a) where sold for use in preserved meat or preserved meat by-product, may contain any of ascorbic acid, calcium ascorbate, erythorbic acid, iso-ascorbic acid, potassium nitrate, potassium nitrite, sodium ascorbate, sodium carbonate, sodium erythorbate, sodium iso­ ascorbate, sodium nitrate and sodium nitrite, provided that these nitrates and nitrites, if any, are packaged separately from any spice or seasoning.

(b) where sold for use in prepared meat or meat by-product in which a gelling agent is a permitted ingredient, may contain a gelling agent;

(c) where sold for use in fresh, uncooked sausage, may contain artificial maple flavour; and

(d) may contain an anticaking agent.

SOR/80-13, s. 1; SOR/82-913, s. 1; SOR/86-875, s. 2(F); SOR/2010-143, s. 9. Previous Version B.14.008. No person shall sell a meat binder, filler or preparations for pumping pickle, cover pickle or dry cure represented for use in meat products unless the label thereof carries directions for use that when followed will produce a food that will comply with the requirements of section B.14.030 insofar as the filler is concerned and the food will not contain food additives in excess of the maximum levels of use prescribed by these Regulations.

SOR/84-300, s. 44(E).

B.14.009. [S]. Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product may contain

(a) Class I preservatives if the nitrate or nitrite salts or both are packaged separately from any spice or seasoning;

(b) citric acid, sodium citrate or vinegar;

(c) sweetening agents, including maple sugar and maple syrup;

(d) liquid smoke flavour, liquid smoke flavour concentrate, salt, seasonings, spices, spice extracts, spice oils or spice oleoresins;

(e) sodium bicarbonate, sodium hydroxide or potassium hydroxide;

(f) in the case of pumping pickle for cured pork, beef and lamb cuts, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate;

(g) in the case of pumping pickle for cured beef cuts, enzymes, if the principal display panel of the label of the cured beef carries, immediately preceding or following the common name, the statement “Tenderized with (naming the proteolytic enzyme or enzymes)”;

(h) in the case of dry cure, an anticaking agent or a humectant; and

(i) in the case of pumping pickle

(i) for cured pork hams, shoulders and backs, artificial maple flavour, and

(ii) for cured pork bellies, artificial maple flavour and an orange flavour that meets the standard prescribed in section B.10.005.

SOR/79-251, s. 4; SOR/80-13, s. 2; SOR/82-596, s. 1; SOR/88-336, s. 3; SOR/94-567, s. 1; SOR/2010-143, s. 10(F).

Previous Version B.14.010. No person shall sell as food a dead animal or any part thereof.

B.14.011. No person shall sell as food, meat, meat by-products, preparations containing meat or meat derivatives obtained, prepared or manufactured from a dead animal.

B.14.012. For the purpose of Sections B.14.010 and B.14.011, “dead animal” means a dead animal that

(a) was not killed for the purpose of food in accordance with commonly accepted practice of killing animals for the purpose of food, which shall include exsanguination; or

(b) was affected with disease at the time it was killed.

B.14.013. and B.14.014. [Repealed, SOR/97-148, s. 3]

Meat, Meat By-products

B.14.015. [S]. Regular Ground Beef shall be beef meat processed by grinding and shall contain not more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.

SOR/82-768, s. 40.

B.14.015A. [S]. Medium Ground Beef shall be beef meat processed by grinding and shall contain not more than 23 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.

SOR/82-768, s. 40.

B.14.015B. [S]. Lean Ground Beef shall be beef meat processed by grinding and shall contain not more than 17 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.

SOR/82-768, s. 40.

B.14.015C. No person shall sell ground beef that contains more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.

SOR/82-768, s. 40.

B.14.016. No person shall sell horse-meat or horse-meat by-product, or any food containing horse-meat or horse-meat by-product unless

(a) it is labelled as such when offered or exposed for sale; and

(b) when in package form, the principal display panel of the label carries a declaration of the presence of horse-meat or of horse-meat by-product in type at least as legible and conspicuous as any other type upon such principal display panel.

SOR/88-336, s. 3.

B.14.017. [Repealed, SOR/2003-292, s. 2]

B.14.018 (1) Subject to subsection (2), if a carcass of beef or veal, or a portion of a carcass of beef or veal that weighs 7 kg or more, is advertised for sale, the advertisement shall indicate

(a) in the case of a carcass other than an imported carcass, the grade that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act or a provincial law;

(b) in the case of an imported beef carcass, the grade that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act or a provincial law or the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported;

(c) in the case of an imported veal carcass, the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported; and

(d) in the case of a beef carcass, the yield class, if any, that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act.

(2) Where, in the case of a carcass referred to in subsection (1), no grade has been assigned thereto as described in that subsection and the carcass or portion thereof that weighs 7 kg or more is advertised for sale, the advertisement shall clearly indicate that the carcass has not been graded.

SOR/92-626, s. 15; SOR/2003-6, s. 79.

B.14.019. (1) Where a carcass of beef, veal, pork or lamb or a portion thereof that weighs 7 kg or more is advertised for sale and a selling price is stated in the advertisement, the advertisement shall

(a) contain the words “price per kilogram is based on carcass weight before cutting, boning and trimming” or the words “price per kilogram is based on the weight of the meat after cutting, boning and trimming”, whichever words are applicable; and

(b) where in addition to the selling price a charge is payable for cutting, boning, trimming, wrapping or freezing the carcass or portion thereof, indicate

(i) the amount of the additional charge, and

(ii) where the additional charge is payable on a price per unit weight basis, whether the additional charge is based on the weight of the carcass or portion thereof before or after the carcass has been cut, boned and trimmed.

(2) Any information required by subsection (1) to appear in an advertisement shall be located therein immediately adjacent to the selling price stated therein, without any intervening written, printed or graphic matter.

SOR/92-626, s. 15; SOR/95-548, s. 5(F).

B.14.020. [S]. Solid cut meat shall be

(a) a whole cut of meat; or

(b) a product consisting of pieces of meat of which at least 80 per cent weigh at least 25 g each.

SOR/94-262, s. 3.

B.14.021. (1) No person shall sell solid cut meat to which phosphate salts or water has been added unless

(a) in the case of meat, other than side bacon, Wiltshire bacon, pork jowls, salt pork and salt beef, the meat

(i) where cooked, contains a meat protein content of not less than 12 per cent, and

(ii) where uncooked, contains a meat protein content of not less than 10 per cent; and

(b) that meat contains, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

(i) sodium acid pyrophosphate,

(ii) sodium hexametaphosphate,

(iii) sodium phosphate, dibasic,

(iv) sodium phosphate, monobasic,

(v) sodium pyrophosphate, tetrabasic,

(vi) sodium tripolyphosphate,

(vii) potassium phosphate, monobasic,

(viii) potassium phosphate, dibasic, and

(ix) potassium pyrophosphate, tetrabasic.

(2) A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a).

SOR/94-262, s. 3.

Prepared Meats, Prepared Meat By-products

B.14.030. (1) Subject to subsections (2) and (3) and section B.14.030A, no person shall sell a prepared meat or prepared meat by-product with a meat protein content of less than 1.5 percentage points below the total protein requirement for that food.

(2) Subsection (1) does not apply to an extended meat product.

(3) Where gelatin is an ingredient of a prepared meat or prepared meat by-product, that gelatin shall not be included when calculating the total protein content of the prepared meat or prepared meat by-product.

SOR/78-637, s. 3; SOR/79-251, s. 5(F); SOR/80-13, s. 3; SOR/82-768, s. 41; SOR/86-875, s. 3.

B.14.030A. For the purposes of sections B.14.030, B.14.032, B.14.033, B.14.035, B.14.074, B.14.075, B.14.076 and B.14.077, where any of the non-meat ingredients listed in paragraphs

B.14.032A(a) to (g) are present in a prepared meat or prepared meat by-product in separate identifiable pieces or chunks in any amount sufficient to differentiate those ingredients from the prepared meat or prepared meat by-product, those ingredients shall not be included when calculating the fat or protein content of the prepared meat or prepared meat by-product.

SOR/86-875, s. 3.

B.14.031. [S]. Preserved Meat or Preserved Meat By-product shall be cooked or uncooked meat or meat by-product that is salted, dried, pickled, corned, cured or smoked, may be glazed and may contain

(a) Class I preservative;

(b) sweetening agents;

(c) spices and seasonings, except tomato;

(d) vinegar;

(e) alcohol;

(f) smoke flavouring or artificial smoke flavouring;

(g) in the case of cured pork hams, shoulders, backs and bellies, artificial maple flavour;

(gg) in the case of cured pork bellies, an added orange flavour that meets the standard prescribed in section B.10.005;

(h) in the case of cured pork, beef and lamb cuts prepared with the aid of pumping pickle, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate;

(i) in the case of tocino, annatto in such amount as will result in the finished product containing not more that 0.1 per cent annatto, if annatto is shown, by the word “annatto”, in the list of ingredients on the label; and

(j) in the case of vacuum-packed sliced cooked ham, Carnobacterium maltaromaticum CB1.

SOR/79-251, s. 6; SOR/80-13, s. 4; SOR/82-596, s. 2; SOR/84-300, s. 45(E); SOR/88-336, ss. 2, 3; SOR/92-725, s. 3; SOR/97-151, s. 24; SOR/2010-264, s. 2. Previous Version B.14.032. [S]. Sausage or Sausage Meat

(a) shall be fresh or preserved comminuted meat;

(b) may be enclosed in a casing;

(c) may be dipped in vinegar, smoked, cooked or dried;

(d) may contain

(i) animal fat,

(ii) filler,

(iii) beef tripe,

(iv) liver,

(v) fresh or frozen beef and pork blood,

(vi) sweetening agents,

(vii) salt and spices,

(viii) seasoning, other than tomato,

(ix) lactic acid producing starter culture,

(x) meat binder,

(xi) beef and pork blood plasma,

(xii) in the case of preserved comminuted meat, smoke flavouring or artificial smoke flavouring,

(xiii) if cooked

(A) glucono delta lactone,

(B) partially defatted beef fatty tissue or partially defatted pork fatty tissue, and

(C) a dried skim milk product, obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding three per cent of the finished food,

(xiv) in the case of fresh uncooked sausage, artificial maple flavour or apple powder as a flavouring ingredient,

(xv) in the case of dry sausage or dry sausage meat, glucono delta lactone,

(xvi) in the case of longaniza,

(A) annatto in such amount as will result in the finished product containing not more than 1000 parts per million annatto, if annatto is shown, by the word “annatto”, in the list of ingredients on the label,

(B) allura red in such amount as will result in the finished product containing not more than 80 parts per million allura red, if allura red is shown, by the words “allura red”, in the list of ingredients on the label, and

(C) sunset yellow FCF in such amount as will result in the finished product containing not more than 20 parts per million sunset yellow FCF, if sunset yellow FCF is shown, by the words “sunset yellow FCF”, in the list of ingredients on the label, and

(xvii) in the case of vacuum-packed wieners, Carnobacterium maltaromaticum CB1;

(e) shall contain, in the case of a product sold as fresh sausage, not more than 40 per cent fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;

(f) shall have, if cooked, a total protein content of not less than 11 per cent;

(g) shall have, in the case of fresh uncooked sausage and fresh uncooked sausage meat, a total protein content of not less than nine per cent.

SOR/80-13, s. 5; SOR/82-768, s. 42; SOR/88-336, s. 3; SOR/92-725, s. 4; SOR/97-151, s. 25; SOR/97-516, s. 3; SOR/2010-264, s. 3. Previous Version B.14.032A. [S]. (naming the prepared meat or prepared meat by-product) with (naming the non-meat ingredients) shall be prepared meat to which has been added other non-meat ingredients including

(a) fruit;

(b) vegetables;

(c) nuts;

(d) cheese or processed cheese;

(e) macaroni;

(f) pickles; or

(g) olives.

SOR/84-300, s. 46.

B.14.032AA. Where the non-meat ingredients referred to in section B.14.032A are added to prepared meat in such a manner that they are not present in the final product in separate identifiable pieces or chunks, the final product shall meet the total protein content requirement established for (naming the prepared meat or prepared meat by-product) referred to in section B.14.032A.

SOR/86-875, s. 4.

B.14.033. [S]. Potted Meat, Meat Paste, or Meat Spread shall be comminuted and cooked, fresh or preserved meat and may contain meat binder, salt, sweetening agents, spices, other seasonings and a gelling agent and shall have a total protein content of not less than nine per cent.

SOR/80-13, s. 6.

B.14.034. [S]. Potted Meat By-product, Meat By-product Paste or Meat By-product Spread shall be a food that

(a) consists, wholly or in part, of meat by-products and conforms to the standard prescribed for potted meat; and

(b) in the case of liverpaste or liverwurst spread, may contain wheat germ and yeast.

SOR/78-637, s. 4; SOR/80-13, s. 7; SOR/86-875, s. 5.

B.14.035. [S]. Meat Loaf, Meat Roll, Meat Lunch or Luncheon Meat shall be comminuted and cooked, fresh or preserved meat, pressed into shape and may contain a dried skim milk product obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding three per cent of the finished food, filler, meat binder, salt, sweetening agents, glucono delta lactone, spices, other seasonings, milk, eggs, a gelling agent and partially defatted beef fatty tissue or partially defatted pork fatty tissue and shall have a total protein content of not less than 11 per cent.

SOR/80-13, s. 8.

B.14.036. [S]. Meat By-product Loaf or Meat and Meat By-product Loaf shall be the food consisting, wholly or in part, of meat by-products and shall otherwise conform to the standard prescribed for meat loaf.

B.14.037. [S]. Headcheese

(a) shall be comminuted cooked meat or comminuted cooked preserved meat,

(b) shall not contain

(i) less than 50 per cent head meat, or

(ii) skin, other than that naturally adherent to any pork meat used,

(c) may contain scalps, snouts, beef tripe, salt, spices, seasoning or an added gelling agent, and

(d) may contain

(i) ascorbic acid or its sodium salt, or

(ii) erythorbic acid or its sodium salt,

and for the purpose of this section scalp and snouts are deemed head meat.

SOR/80-500, s. 5.

B.14.038. [S]. Brawn shall be headcheese, except that it need not contain 50 per cent head meat.

B.14.039. Where a gelling agent has been added to prepared meat or prepared meat by- product, a statement to the effect that a gelling agent has been added shall be shown on the principal display panel or the word “jellied” shall be shown as an integral part of the common name of the food.

B.14.040. Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and filler, ground meat by-product and filler or ground meat, ground meat by-product and filler, unless that food

(a) has a total protein content of not less than 13 per cent;

(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and

(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture.

SOR/79-251, s. 7(F); SOR/82-768, s. 43.

B.14.041. Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and spices and seasonings, ground meat by- product and spices and seasonings, ground meat, ground meat by-product and spices and seasonings or ground meat and ground meat by-product, unless that food

(a) has a total protein content of not less than 16 per cent;

(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and

(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture.

SOR/79-251, s. 7(F); SOR/82-768, s. 44.

Meat Derivatives

B.14.061. [S]. Edible Bone Meal or Edible Bone Flour shall be the food prepared by grinding dry, defatted bones, obtained from animals healthy at the time of slaughter and shall contain

(a) not less than 85 per cent ash, as determined by official method FO-34, Determination of Ash in Edible Bone Meal or Edible Bone Flour, October 15, 1981.

(b) and (c) [Repealed, SOR/97-148, s. 4]

SOR/82-768, s. 45; SOR/97-148, s. 4.

B.14.062. [S]. (1) Gelatin or Edible Gelatin

(a) shall be the purified food obtained by the processing of skin, ligaments or bones of animals;

(b) shall contain not less than 82 per cent ash-free solids, when tested by official method FO­ 35, Determination of Ash-Free Solids in Gelatin, October 15, 1981;

(c) shall be free from objectionable taste and offensive odour when 2.5 grams thereof are dissolved in 100 millilitres of warm water;

(d) [Repealed, SOR/97-148, s. 5]

(e) shall not contain any residues of hydrogen peroxide where it has been used in the course of manufacture; and

(f) may contain

(i) not more than 2.6 per cent ash on a dry basis,

(ii) not more than 500 parts per million of sulphurous acid, including the salts thereof, calculated as sulphur dioxide, and

(iii) where intended for use in the manufacture of marshmallow, sodium hexametaphosphate or sodium lauryl sulphate.

(2) No person shall use, in the course of manufacturing gelatin or edible gelatin,

(a) acidic or basic compounds other than acetic acid, ammonium hydroxide, citric acid, fumaric acid, hydrochloric acid, lime, magnesium hydroxide, phosphoric acid, sodium carbonate, sodium hydroxide, sodium sulphide, sulphuric acid, sulphurous acid or tartaric acid; or

(b) filtering and clarifying agents other than activated carbon, alumina, aluminum sulphate, calcium phosphate, dibasic, cellulose, diatomaceous earth, perlite, strongly acidic cation exchange resin in the hydrogen ion form or basic anion exchange resins in the chloride ion or free base ion forms.

SOR/78-401, s. 2(E); SOR/78-874, s. 1; SOR/80-501, s. 3; SOR/82-768, s. 46; SOR/97-148, s. 5.

Meat Stews

B.14.063. For the purposes of sections B.14.064 to B.14.068, “stew meat” means meat that contains when raw not more than

(a) 25 per cent fat, in the case of meat in meat ball stews; and

(b) 20 per cent fat, in the case of meat in other stews.

SOR/78-874, s. 2.

B.14.064. [S]. Vegetable Stew with (naming the meat)

(a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients:

(i) 12 per cent or more stew meat, and

(ii) 38 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 2.

B.14.065. [S]. (naming the meat) Stew

(a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients:

(i) 20 per cent or more stew meat, and

(ii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 2.

B.14.066. [S]. Irish Stew

(a) shall contain mutton, lamb or beef, singly or in any combination, and vegetables, in the following amounts, calculated as raw ingredients:

(i) 20 per cent or more stew meat,

(ii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 2.

B.14.067. [S]. Meat Ball Stew

(a) shall contain vegetables and meat balls in the following amounts, calculated as raw ingredients:

(i) 22 per cent or more meat balls,

(ii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 2.

B.14.068. [S]. Specialty Meat Stews

(a) shall contain meat and vegetables in the following amounts, calculated as raw ingredients:

(i) 25 per cent or more stew meat,

(ii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 2.

Meat Specialties

B.14.070. [S]. Wieners and Beans or Wieners with Beans shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 25 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981.

SOR/82-768, s. 47.

B.14.071. [S]. Beans and Wieners or Beans with Wieners shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 10 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981.

SOR/82-768, s. 47.

Sale of Barbecued, Roasted or Broiled Meat or Meat By-Products

B.14.072. No person shall sell meat or a meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked meat or meat by-product

(a) at all times

(i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, or

(ii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and

(b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher.

SOR/78-403, s. 4(F); SOR/88-336, s. 3.

Meat Product Extender

B.14.073. No person shall sell a meat product extender intended to be used in a food consisting of a mixture described in section B.14.074, B.14.075, B.14.076, B.14.077 or B.14.078, unless that extender

(a) has, in the rehydrated state,

(i) a total protein content of not less than 16 per cent, and

(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 48.

Extended Meat Products

B.14.074. Subject to sections B.14.075 to B.14.079, no person shall sell a food that consists of a mixture of meat product and meat product extender, unless that food

(a) has a total protein content of not less than 16 per cent;

(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 49.

B.14.075. No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles fresh sausage, unless that food

(a) has a total protein content of not less than nine per cent;

(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 50; SOR/84-300, s. 47(F).

B.14.076. No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that food

(a) has a total protein content of not less than 11 per cent;

(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 51.

B.14.077. No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that food

(a) has a total protein content of not less than nine per cent;

(b) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 52; SOR/84-300, s. 48(E).

B.14.078. No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles regular ground beef, medium ground beef or lean ground beef, unless that food

(a) has a total protein content of not less than 16 per cent;

(b) has a fat content of

(i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular,

(ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or

(iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 53.

B.14.079. No person shall sell a food that consists of a mixture of meat product, filler and meat product extender, unless that food

(a) has a total protein content of not less than 13 per cent;

(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and

(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).

SOR/82-768, s. 54.

Simulated Meat Products

B.14.085. Subject to sections B.14.086 to B.14.090 no person shall sell a simulated meat product unless that product

(a) has, in the rehydrated state,

(i) a total protein content of not less than 16 per cent,

(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, and

(iii) a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;

(b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 55.

B.14.086. No person shall sell a simulated meat product that resembles fresh sausage, unless that product

(a) has a total protein content of not less than nine per cent;

(b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;

(d) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 56.

B.14.087. No person shall sell a simulated meat product that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that product

(a) has a total protein content of not less than 11 per cent;

(b) has a protein rating of not less than 28, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;

(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 57.

B.14.088. No person shall sell a simulated meat product that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that product

(a) has a total protein content of not less than nine per cent;

(b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;

(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each vitamin and mineral nutrient respectively; and

(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 58.

B.14.089. No person shall sell a simulated meat product that resembles regular ground beef, medium ground beef or lean ground beef, unless that product

(a) has a total protein content of not less than 16 per cent;

(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) has a fat content of

(i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular,

(ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or

(iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean;

(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient, respectively; and

(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 59.

B.14.090. No person shall sell a simulated meat product that resembles side bacon, unless that product

(a) has a total protein content of not less than 25 per cent;

(b) has a protein rating of not less than 20, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(d) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 60.

TABLE

Column I Column II

Item No. Vitamin or Mineral Nutrient Amount per gram of protein C.1 ....... Copper ....... 4.4 micrograms F.1 ....... Folic Acid ....... 0.45 microgram I.1 ....... Iron ....... 0.25 milligram M.1 ....... Magnesium ....... 1.1 milligrams N.1 ....... Niacin ....... 0.34 milligram P.1 ....... Pantothenic Acid ....... 0.04 milligram P.2 ....... Potassium ....... 20 milligrams P.3 ....... Pyridoxine ....... 0.02 milligram R.1 ....... Riboflavin ....... 0.01 milligram T.1 ....... Thiamine ....... 0.02 milligram V.1 ....... Vitamin B12....... 0.08 microgram Z.1 ....... Zinc ....... 0.20 milligram

SOR/98-458, s. 7(F).

Division 15

Adulteration Of Food B.15.001. A food named in Column III of an item of Table I to this Division is adulterated if the substance named in Column I of that item is present therein or has been added thereto in an amount exceeding the amount, expressed in parts per million, shown in Column II of that item for that food.

SOR/78-404, s. 1; SOR/79-249, s. 1.

B.15.002. (1) Subject to subsection (2), a food is adulterated if

(a) a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives, for which no maximum residue limit has been specified under sections 9 or 10 of that Act for that food, are present in or on the food, singly or in any combination, in an amount exceeding 0.1 part per million; or

(b) an agricultural chemical or its components or derivatives, other than a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives, are present in or on the food, singly or in any combination, in an amount exceeding 0.1 part per million.

(2) A food is exempt from paragraph 4(1)(d) of the Act if the following agricultural chemicals, or their components or derivatives, are the only agricultural chemicals, or components or derivatives of agricultural chemicals, that are present in or on the food, singly or in any combination:

(a) a fertilizer;

(b) an adjuvant or a carrier of an agricultural chemical;

(c) an inorganic bromide salt;

(d) silicon dioxide;

(e) sulphur;

(f) viable spores of Bacillus thuringiensis Berliner; or

(g) Kaolin.

(3) Subsection (2) does not apply to a food if there is present in or on the food an agricultural chemical, or a component or derivative of that agricultural chemical, referred to in that subsection that is a pest control product as defined in subsection 2(1) of the Pest Control Products Act, or a component or derivative of that product, in respect of which a maximum residue limit has been specified under sections 9 or 10 of that Act for that food.

(4) [Repealed, SOR/2008-181, s. 3]

SOR/78-404, s. 1; SOR/79-249, s. 1; SOR/81-83, s. 2; SOR/97-313, s. 2; SOR/98-98, s. 1; SOR/2005-67, s. 1; SOR/2008-181, s. 3; SOR/2008-182, s. 2. Previous Version B.15.003. A food named in Column IV of an item of Table III to this Division is exempt from paragraph 4(d) of the Act if the drug named in Column I, and analysed as being the substance named in Column II, of that item is present in the food in an amount not exceeding the limit, expressed in parts per million, set out in Column III of that item for that food.

SOR/78-404, s. 1; SOR/79-249, s. 1; SOR/91-255, s. 1.

TABLE I

I II III Item Substance Tolerance FoodsNo. p.p.m. 1. Arsenic (1) 3.5 (1) Fish protein

(2) 1 (2) Edible bone meal (3) Fruit juice, fruit nectar, beverages when ready-to-serve and

(3) 0.1 water in sealed containers other than mineral water or spring water

2. Fluoride (1) 650 (1) Edible bone meal (2) 150 (2) Fish Protein

3. Lead (1) 10 (1) Edible bone meal (2) 1.5 (2) Tomato paste and tomato sauce (3) 0.5 (3) Fish protein and whole tomatoes

(4) Fruit juice, fruit nectar, beverages when ready-to-serve and (4) 0.2 water in sealed containers other than mineral water or spring

water (5) Evaporated milk, condensed milk and concentrated infant(5) 0.15 formula

(6) 0.08 (6) Infant formula when ready-to-serve 4. Tin (1) 250 (1) Canned foods

SOR/78-404, s. 2; SOR/79-249, s. 2; SOR/86-258, s. 1; SOR/89-243, ss. 1, 2; SOR/91-149, s. 2(E); SOR/94-689, s. 2(F).

TABLE II [Repealed, SOR/2008-182, s. 3] TABLE III

VETERINARY DRUGS

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m.

A.01 albendazole albendazole-2-aminosulfone 0.2 Liver of cattle Edible tissue of

A.1 ampicillin ampicillin 0.01 swine and cattle; milk Muscle of chickensA.2 amprolium amprolium 0.5 and turkeys Liver and kidney

1.0 of chickens and turkeys

7.0 Eggs A.3 apramycin apramycin 0.1 Kidney of swine

Muscle of swine, A.4 arsanilic acid arsenic 0.5 chickens and

turkeys; eggs Liver of swine,

2.0 chickens and turkeys

B.1 buquinolate buquinolate 0.1 Muscle of chickens Liver, kidney, skin0.4 and fat of chickens

C.01 ceftiofur desfuroyl-ceftiofur (DFC) 0.1 Milk Muscle of cattle,1.0 sheep and swine Liver and fat of

2.0 cattle, sheep and swine

5.0 Kidney of swine Kidney of cattle6.0 and sheep

C.1 cephapirin cephapirin 0.02 Milk 0.1 Edible tissue of

Column I

Item Common Name (or No. Brand Name) of Drug

C.2 chlortetracycline

C.3 clopidol

D.1 decoquinate

D.1.1 diclazuril

D.2 dihydrostreptomycin D.3

dinitolmide (zoalene)

Column II

Name of Substance for Drug Analysis Purposes

chlortetracycline

clopidol

decoquinate

diclazuril

dihydrostreptomycin

dinitolmide, including the metabolite 3-amino-5-nitro­ o-toluamide

Column III Maximum Residue Limit p.p.m.

0.1

0.2 0.5

1.0

2.0

4.0

5.0

15.0

1.0

2.0

0.5

1.0

3.0

0.125 2.0

3.0

Column IV

Foods

cattle Kidney, liver and muscle of cattle; muscle of sheep Fat of swine Liver of sheep Muscle, liver, skin and fat of chickens and turkeys; muscle of swine; muscle and fat of calves; kidney of sheep Liver of swine Kidney of swine, chickens and turkeys; liver and kidney of calves Muscle of chickens and turkeys Liver and kidney of chickens and turkeys Muscle of cattle, goats and chickens Kidney, liver and fat of cattle and goats; kidney, liver, skin and fat of chickens Muscle of chickens and turkeys Skin and fat of chickens and turkeys Liver of chickens and turkeys Milk Fat of chickens Muscle of chickens and turkeys; liver and fat of turkeys

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m.

Liver and kidney6.0 of chickens D.4 doramectin doramectin 0.01 Muscle of swine

0.03 Muscle of cattle 0.035 Liver of swine 0.07 Liver of cattle

E.01 enrofloxacin desethylene ciprofloxacin 0.02 Muscle of cattle 0.07 Liver of cattle

E.02 eprinomectin eprinomectin B1a 0.02 Milk 0.1 Muscle of cattle 1.0 Liver of cattle

E.1 erythromycin erythromycin 0.05 Milk Edible tissue of0.1 swine Edible tissue of

0.125 chickens and turkeys

F.1 fenbendazole fenbendazole 0.45 Liver of cattle 4.5 Liver of swine

Muscle ofF.2 florfenicol florfenicol amine 0.8 salmonids 2 Liver of cattle

F.3 flunixin flunixin free acid 0.02 Muscle of cattle 0.08 Liver of cattle

Edible tissue ofG.1 gentamicin gentamicin 0.1 turkeys 0.4 Kidney of swine

H.01 halofuginone halofuginone 0.1 Liver of chicken H.1 hydrocortisone hydrocortisone 0.01 Milk I.1 ivermectin 22,23-dihydro-avermectin 0.015 Liver of swine

B1a 0.03 Liver of sheep 0.07 Liver of cattle

K.1 ketoprofen ketoprofen 0.05 Milk 0.1 Muscle of swine 0.25 Muscle of cattle 0.5 Kidney of swine 0.8 Kidney of cattle

Fat and skin ofL.01 lasalocid lasalocid 0.35 chicken

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m. 0.65 Liver of cattle 0.1 (calculated Edible tissue oflevamisoleL.1 levamisole as levamisol cattle, sheep andhydrochloride hydro- swine chloride)

Muscle of chickensL.2 lincomycin lincomycin 0.1 and swine Liver of chickens0.5 and swine Fat and skin ofM.01 maduramicin maduramicin 0.4 chicken

M.1 monensin monensin 0.01 Milk Edible tissue of

0.05 cattle, chickens and turkeys

M.2 morantel tartrate N-methyl-1,3-propane 0.1 Milk diamine 0.5 Liver of cattle

M.3 moxidectin moxidectin 0.55 Fat of cattle Muscle of chickens

N.01 narasin narasin 0.05 and swine; liver of swine

0.5 Fat of chickens Edible tissue ofN.1 neomycin neomycin 0.25 calves Muscle, liver,

N.2 nicarbazin N,N1-bis(4-nitrophenyl)urea 4.0 kidney and skin of chickens

0.5 Muscle of turkeysN.3 nitarsone arsenic 2.0 Liver of turkeys

Edible tissue of N.4 novobiocin novobiocin 1.0 cattle, chickens and

turkeys Muscle of cattle, chickens, lobster,O.1 oxytetracycline oxytetracycline 0.2 salmonids, sheep, swine and turkeys

0.3 Honey 0.4 Eggs

Liver of cattle,0.6 chickens, sheep,

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m.

swine and turkeys Kidneys of cattle, chickens, sheep, swine and turkeys;

1.2 fat of cattle and sheep; skin and fat of chicken, swine, and turkeys

P.1 penicillin G penicillin G 0.01 I.U./ml Milk Edible tissue of0.01 turkeys Edible tissue of0.05 cattle and swine

P.1.1 pirlimycin pirlimycin 0.3 Muscle of cattle 0.4 Milk 0.5 Liver of cattle

P.2 polymyxin B polymyxin B 4.0 u/ml Milk P.3 1.0

N-methyl-1,3-propane- (calculatedpyrantel tartrate Muscle of swinediamine as pyrantel tartrate) 10.0 (calculated Liver and kidney as pyrantel of swine tartrate)

Muscle, liver andR.1 0.1 kidney of chickens robenidine hydro- (calculatedrobenidinechloride as robenidine

hydro­ chloride) 0.2 (calculated Skin and fat of as robenidine chickens hydro­ chloride)

Muscle of swine, R.2 roxarsone arsenic 0.5 chickens and

turkeys; eggs Liver of swine,

2.0 chickens and turkeys

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m.

Fat and skin of S.01 salinomycin salinomycin 0.35 chicken; Liver of

cattle and swine Edible tissue ofS.1 spectinomycin spectinomycin 0.1 chickens

S.2 streptomycin streptomycin 0.125 Milk Edible tissue ofS.3 sulfachlorpyridazine sulfachlorpyridazine 0.1 cattle and swine Muscle ofS.3.1 sulfadiazine sulfadiazine 0.1 salmonids

S.4 0.01 Milk sulfadimethoxine sulfadimethoxine Edible tissue of0.1 cattle

Edible tissue ofS.5 sulfaethoxypyridazine sulfaethoxypyridazine 0.1 cattle S.6 sulfamethazine sulfamethazine 0.01 Milk

Edible tissue of calves, cattle,0.1 chickens, swine and turkeys Edible tissue ofS.7 sulfathiazole sulfathiazole 0.1 swine Muscle ofteflubenzuron teflubenzuron 0.3T.01 salmonids

3.2 Skin of salmonids Edible tissue of calves, swine,T.1 tetracycline tetracycline 0.25 sheep, chickens and turkeys

T.2 thiabendazole thiabendazole and total 5- 0.05 Milk hydroxythiabendazole

Edible tissue ofmetabolites (free form, 0.1 cattle, goats andglucuronide and sulfate

sheepconjugates) T.3 tiamulin 8-alpha-hydroxy-mutilin 0.4 Liver of swine T.3.1 tilmicosin tilmicosin 1.6 Liver of cattle

Muscle ofT.3.2 trimethoprim trimethoprim 0.1 salmonids Muscle, liver, kidney and fat ofT.4 tylosin tylosin 0.2 cattle, swine, chickens and

Column I Column II Column III Column IV MaximumItem Common Name (or Name of Substance for Drug Residue FoodsNo. Brand Name) of Drug Analysis Purposes Limit p.p.m.

turkeys

SOR/84-300, s. 49(E); SOR/91-255, s. 2; SOR/92-591, s. 2; SOR/2002-52, ss. 1 to 12; SOR/2005-396, ss. 1 to 4; SOR/2008-274, ss. 1 to 8; SOR/2010-39, ss. 1(F), 2(F). Previous Version

Division 16

Food Additives B.16.001. A quantitative statement of the amount of each additive present or directions for use that, if followed, will produce a food that will not contain such additives in excess of the maximum levels of use prescribed by these Regulations shall be shown, grouped together with the list of ingredients, of any substance or mixture of substances for use as a food additive.

B.16.002. A request that a food additive be added to or a change made in the Tables following section B.16.100 shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include

(a) a description of the food additive, including its chemical name and the name under which it is proposed to be sold, its method of manufacture, its chemical and physical properties, its composition and its specifications and, where that information is not available, a detailed explanation;

(b) a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use;

(c) where necessary, in the opinion of the Director, an acceptable method of analysis suitable for regulatory purposes that will determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food;

(d) data establishing that the food additive will have the intended physical or other technical effect;

(e) detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended;

(f) data to indicate the residues that may remain in or upon the finished food when the food additive is used in accordance with good manufacturing practice;

(g) a proposed maximum limit for residues of the food additive in or upon the finished food;

(h) specimens of the labelling proposed for the food additive; and

(i) a sample of the food additive in the form in which it is proposed to be used in foods, a sample of the active ingredient, and, on request a sample of food containing the food additive.

B.16.003. The Minister shall, within 90 days after the filing of a submission in accordance with section B.16.002, notify the person filing the submission whether or not it is his intention to recommend to the Governor-in-Council that the said food additive be so listed and the detail of any listing to be recommended.

B.16.004. [Repealed, SOR/97-148, s. 6]

B.16.006. Paragraph B.01.042(c) and paragraph B.01.043(a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives.

B.16.007. No person shall sell a food containing a food additive other than a food additive provided for in sections B.01.042, B.01.043 and B.25.062.

SOR/87-640, s. 5.

B.16.008. [Repealed, SOR/88-418, s. 5]

B.16.100. No person shall sell any substance as a food additive unless the food additive is listed in one or more of the following Tables:

TABLE I

FOOD ADDITIVES THAT MAY BE USED AS ANTICAKING AGENTS

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

1.0%, except in the case of fine

C.1 CalciumAluminum (1) Salt (1) grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the

Silicate (2) Garlic salt; Onion salt (2) requirement of paragraphsB.07.020(b) and B.07.027(b) respectively

(3) Unstandardized dry mixes (3) Good Manufacturing Practice 1.0%, except in the case of fine

Calcium grained salt 2.0%, in accordanceC.2 (1) Salt (1)Phosphate with the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the requirement of paragraphstribasic (2) Garlic salt; Onion salt (2) B.07.020(b) and B.07.027(b) respectively

(3) Dry cure (3) Good Manufacturing Practice (4) Unstandardized dry mixes (4) Good Manufacturing Practice (5) Oil soluble annatto (5) Good Manufacturing Practice

If used either singly or in combination with Calcium(6) Icing sugar (6) Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5% 1.0%, except in the case of fine grained salt 2.0%, in accordanceC.3 Calcium Silicate (1) Salt (1) with the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the requirement of paragraphs(2) Garlic salt; Onion salt (2) B.07.020(b) and B.07.027(b) respectively

(3) Baking Powder (3) 5.0% (4) Dry cure (4) Good Manufacturing Practice (5) Unstandardized dry mixes (5) Good Manufacturing Practice

If used either singly or in combination with Calcium Phosphate tribasic, Magnesium Carbonate, Magnesium Silicate,(6) Icing sugar (6) Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%

(7) Meat Binder or (naming (7) 1.0%the meat product) Binder Grated or shredded (naming the variety) If used singly or in combinationcheese; Grated or shredded with microcrystalline cellulose or(8) cheddar cheese; (8) cellulose, the total amount not toUnstandardized grated or exceed 2.0%shredded cheese preparations Dried egg-white (dried albumen); Dried whole

(9) egg; Dried whole egg mix; (9) 2.0% Dried yolk; Dried yolk mix

1.0%, except in the case of fine grained salt 2.0%, in accordanceC.4 Calcium Stearate (1) Salt (1) with the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the requirement of paragraphs(2) Garlic salt; Onion salt (2) B.07.020(b) and B.07.027(b) respectively

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

(3) Unstandardized dry mixes (3) Good Manufacturing Practice Grated or shredded (naming the variety) If used singly or in combinationcheese; Grated or shredded with calcium silicate orC.5 Cellulose cheddar cheese; microcrystalline cellulose, theUnstandardized grated or total amount not to exceed 2.0%shredded cheese preparations Salt (except when used in 1.0%, except in the case, of fine

M.1 Magnesium preparations of Meat and grained salt 2.0%, in accordance(1) (1)Carbonate Meat By-products of with the requirements of Division 14) paragraph B.17.001(1)(a) Garlic salt, Onion salt 2.0% in accordance with the(except when used in requirement of paragraphs(2) preparations of Meat and (2) B.07.020(b) and B.07.027(b)Meat By-products of respectivelyDivision 14) Unstandardized Dry Mixes (Except when used in

(3) preparations of Meat and (3) Good Manufacturing Practice Meat by-products of Division 14)

If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Silicate,(4) Icing sugar (4) Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%

Unstandardized dry mixes (Except when used in

M.2 Magnesium preparations of Meat and Good Manufacturing PracticeOxide Meat by-products of Division 14)

1.0%, except in the case of fine

M.3 Magnesium grained salt 2.0%, in accordance(1) Salt (1)Silicate with the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the requirement of paragraphs(2) Garlic salt; Onion salt (2) B.07.020(b) and B.07.027(b) respectively

(3) Unstandardized dry mixes (3) Good Manufacturing Practice

Column I Item AdditiveNo.

M.4 MagnesiumStearate

M.5 MicrocrystallineCellulose

P.1 Propylene Glycol

S.1 Silicon Dioxide

Column II Column III

Permitted in or Upon Maximum Level of Use

If used either singly or in combination with Calcium Phosphate tribasic, Calcium

(4) Icing sugar (4) Silicate, Magnesium Carbonate,Magnesium Silicate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5% 1.0%, except in the case of fine

(1) Salt (1) grained salt 2.0%, in accordancewith the requirement of paragraph B.17.001(1)(a) 2.0% in accordance with the

(2) Garlic salt; Onion salt (2) requirement of paragraphsB.07.020(b) and B.07.027(b) respectively

(3) Unstandardized dry mixes (3) Good Manufacturing Practice If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate,(4) Icing sugar (4) Magnesium Silicate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%

Grated or shredded (naming the variety) If used singly or in combinationcheese; Grated or shredded with calcium silicate or cellulose,cheddar cheese; the total amount not to exceedUnstandardized grated or 2.0%shredded cheese preparations Salt 0.035%

1.0% in accordance with the requirement of paragraphs(1) Garlic salt; Onion salt (1) B.07.020(b) and B.07.027(b) respectively

(2) Celery Salt; Celery Pepper (2) 0.5% (3) Unstandardized dry mixes (3) Good Manufacturing Practice

If used either singly or in combination with Calcium

(4) Icing sugar (4) Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Stearate or Sodium Aluminum Silicate the total must not exceed 1.5%

(5) Foods sold in tablet form (5) Good Manufacturing Practice Cayenne Pepper; Chili

(6) pepper; Chili Powder; (6) 2.0% Paprika; Red Pepper

1.0%, except in the case of fine

(7) Salt (7) grained salt 2.0%, in accordancewith the requirement of paragraph B.17.001(1)(a) 1.0%, except in the case of fine

S.2 SodiumAluminum (1) Salt (1) grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a) If used either singly or in combination with Calcium Phosphate tribasic, Calcium

Silicate (2) Icing sugar (2) Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate or Silicon Dioxide the total must not exceed 1.5%

Dried egg-white (dried albumen); Dried whole

(3) egg; Dried whole egg mix; (3) 2.0% Dried yolk; Dried yolk mix

2.0% in accordance with the requirement of paragraphs(4) Garlic salt; Onion salt (4) B.07.020(b) and B.07.027(b) respectively

(5) Unstandardized dry mixes (5) Good Manufacturing Practice Sodium Ferro- 13 p.p.m. calculated as anhydrousS.3 cyanide, Salt sodium ferrocyanidedecahydrate

SOR/79-662, ss. 3 to 13; SOR/82-913, s. 4; SOR/83-410, s. 2; SOR/84-17, s. 5; SOR/84-801, s. 2; SOR/86-1125, s. 1; SOR/88-534, s. 4; SOR/91-88, ss. 3, 4; SOR/93-477, ss. 3 to 5; SOR/94-689, s. 2(F); SOR/97-191, s. 3; SOR/2010-94, s. 8(E); SOR/2010-143, ss. 11, 12.

TABLE II

FOOD ADDITIVES THAT MAY BE USED AS BLEACHING, MATURING AND DOUGH CONDITIONING AGENTS

Column I Column II Column III

Item Additive Permitted in or UponNo.

(1) Bread; Flour; WholeA.1 Acetone Peroxide wheat flour

(2) Unstandardized bakeryproducts A.1A [Repealed, SOR/79-660, s. 3]

(1) Flour; Whole wheatA.2 Ammonium flour Persulphate (2) Bread

(3) Unstandardized bakeryproducts

(1) Bread; Flour; WholeA.2A Ascorbic Acid wheat flour

(2) Unstandardized bakeryproducts A.3 [Repealed, SOR/79-660, s. 4] A.3A [Repealed, SOR/79-660, s. 4]

A.4

B.1

C.1

C.2

C.3

C.4

C.5

C.6

Azodicarbonamide

Benzoyl Peroxide

Calcium Iodate

Calcium Peroxide

Calcium Stearoyl-2-

Lactylate

Chlorine

Chlorine Dioxide

L-Cysteine Hydrochloride

Bread; Flour; Whole wheat flour Flour; Whole wheat flour

(1) Bread

(2) Unstandardized bakeryproducts (1) Bread

(2) Unstandardized bakeryproducts (1) Bread

(2) Unstandardized bakeryproducts (3) Cake mixes

Flour; Whole wheat flour Flour; Whole wheat flour

(1) Bread; Flour; Wholewheat flour

(2) Unstandardized bakeryproducts P.1 [Repealed, SOR/94-227, s. 4] P.2 Potassium Iodate (1) Bread

(2) Unstandardized bakeryproducts

Maximum Level of Use

(1) Good Manufacturing Practice

(2) Good Manufacturing Practice

(1) 250 p.p.m.

(2) 100 p.p.m. of flour

(3) Good Manufacturing Practice

(1) 200 p.p.m. of flour

(2) 200 p.p.m. of flour

45 p.p.m. of flour

150 p.p.m.

(1) 45 p.p.m. of flour

(2) 45 p.p.m. of flour

(1) 100 p.p.m. of flour

(2) Good Manufacturing Practice

(1) 3,750 p.p.m. of flour

(2) 3,750 p.p.m. of flour

(3) 0.5% of dry weight of mix

Good Manufacturing Practice

Good Manufacturing Practice

(1) 90 p.p.m.

(2) Good Manufacturing Practice

(1) 45 p.p.m. of flour

(2) 45 p.p.m. of flour

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo. P.3 (1) Bread (1) 100 p.p.m. of flour

Potassium Persulphate (2) Unstandardized bakery (2) Good Manufacturing Practiceproducts

S.1 Sodium (1) Bread (1) 3,750 p.p.m. of flour

(2) Unstandardized bakeryStearoyl-2- (2) 3,750 p.p.m. of flourproducts

(3) Pancakes and pancake (3) 0.3% of dry ingredientLactylate mixes weight

(4) Waffles and waffle (4) 0.3% of dry ingredientmixes weight (5) Cake mixes (5) 0.5% of dry weight of mix

S.2 Sodium (1) Bread (1) 5,000 p.p.m. of flour

(2) Unstandardized bakeryStearyl Fumarate (2) 5,000 p.p.m. of flourproducts 500 p.p.m. calculated asS.3 Sodium Sulphite Biscuit dough Sulphur Dioxide

SOR/79-660, ss. 3, 4; SOR/87-640, s. 6; SOR/92-591, s. 2; SOR/94-227, s. 4; SOR/94-689, s. 2(F); SOR/2005-98, ss. 3, 8(F); SOR/2010-41, s. 9(E).

TABLE III

FOOD ADDITIVES THAT MAY BE USED AS COLOURING AGENTS

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Aluminum Apple (or rhubarb) and1. (1) (1) Good Manufacturing PracticeMetal (naming the fruit) jam; Bread; Butter; Concentrated fruitAlkanet juice except frozenAnnatto concentrated orange juice; Fig

Anthocyanins marmalade with pectin: Ice Beet Red cream mix; Ice milk mix; Canthaxanthin Icing sugar; (naming the fruit)

jam with pectin; (naming theCarbon Black fruit) jelly with pectin;Carotene Liqueurs and alcoholic

Charcoal cordials; (naming the flavour) Chlorophyll milk; Pickles and relishes; Cochineal Pineapple marmalade with

pectin; Sherbet; (naming theIron Oxide flavour) skim milk; (naming

Orchil the flavour) partly skimmed Paprika milk; (naming the flavour) Riboflavin skim milk with added milk

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup; Marinated or similar cold- processed packaged fish and meat (Division 21)

Saffron (2) Dried whole egg; Dried yolk; (2) Good Manufacturing PracticeFrozen whole egg; FrozenSaunderswood in accordance with paragraphsyolk; Liquid whole egg; B.22.034(b) and B.22.035(b)Silver Metal Liquid yolk Titanium (3) Unstandardized foods (3) Good Manufacturing PracticeDioxide Turmeric (4) (4) Good Manufacturing Practice

Vegetable fats and oils in accordance with section Xanthophyll B.09.001

(5) Margarine (5) Good Manufacturing Practice (naming the variety) Cheese; Cheddar cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Good Manufacturing PracticeProcessed (naming the in accordance with thevariety) cheese with (naming requirements of sectionsthe added ingredients); B.08.033, B.08.034, B.08.037,Processed cheese food; B.08.038, B.08.039, B.08.040,(6) Processed cheese food with (6) B.08.041, B.08.041.1,(naming the added B.08.041.2, B.08.041.3,ingredients); Processed cheese B.08.041.4, B.08.041.5,spread; Processed cheese B.08.041.6, B.08.041.7 andspread with (naming the B.08.041.8.added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold- pack cheese food; Cold-pack cheese food with (naming the added ingredients)

(7) A blend of prepared fish and (7) Good Manufacturing Practiceprepared meat referred to in

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

paragraph B.21.006(n) 0.1% in accordance with the requirements of paragraph(8) Longaniza; Tocino (8) B.14.031(i) or subparagraph B.14.032(d)(xvi)

(9) Edible collagen film (iron (9) Good Manufacturing Practiceoxide only) 1.0% (Residues of annatto in

(10) Sausage casings (annatto sausage prepared with such(10)only) casings not to exceed 100 p.p.m.) 0.75% (Residues of cochineal

(11) Sausage casings (cochineal in sausage prepared with such(11)only) casings not to exceed 75 p.p.m.)

Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholicß-apo- 8′­ cordials; Margarine; (namingcarotenal Ethyl1A. (1) the flavour) milk; Pickles and (1) 35 p.p.m.ß-apo- 8′­ relishes; Pineapple marmaladecarotenoate with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup

(2) Unstandardized foods (2) 35 p.p.m. (naming the variety) Cheese; 35 p.p.m., in accordance with Cheddar cheese; Cream the requirements of sections(3) (3)cheese with (naming the B.08.033, B.08.034, B.08.037, added ingredients); Cream B.08.038, B.08.039, B.08.040,

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

2. Caramel

cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold- pack cheese food; Cold-pack cheese food with (naming the added ingredients) A blend of prepared fish and

(4) prepared meat referred to in paragraph B.21.006(n) Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Brandy; Bread; Brown bread; Butter; Cider; Cider vinegar; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Holland’s gin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the(1) fruit) jelly with pectin; Light beer; Liqueurs and alcoholic cordials; Malt liquor; Malt vinegar; (naming the flavour) milk; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Porter; Rum; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim

B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8

(4) 35 p.p.m.

(1) Good Manufacturing Practice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Stout; Tomato catsup; Whisky; Wine; Wine vinegar; Honey wine

(2) Unstandardized foods (2) Good Manufacturing Practice A blend of prepared fish and

(3) prepared meat referred to in (3) Good Manufacturing Practice paragraph B.21.006(n)

15% (Residues of caramel in (4) Sausage casings (4) sausage prepared with such

casings not to exceed 0.15%) Allura Red Apple (or rhubarb) and3. (1) (1)Amaranth (naming the fruit) jam; Bread; Erythrosine Butter; Concentrated fruit Indigotine juice except frozen

concentrated orange juice; FigSunset Yellow marmalade with pectin; IceFCF cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic 300 p.p.m. singly or incordials; (naming the flavour) combination in accordancemilk; Pickles and relishes; with section B.06.002Pineapple marmalade with pectin; Sherbet; (naming the

Tartrazine flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup

300 p.p.m. singly or in (2) Unstandardized foods (2) combination in accordance

with section B.06.002 A blend of prepared fish and 300 p.p.m. singly or in

(3) prepared meat referred to in (3) combination in accordance paragraph B.21.006(n) with section B.26.002

Column I Column II Item Additive Permitted in or UponNo.

(4) Salted anchovy, salted scadand salted shrimp

(5) Longaniza

(6) Sausage casings (sunsetyellow FCF only)

Cheese-flavoured corn snacks(7) (sunset yellow FCF only)

Brilliant Blue Apple (or rhubarb) and4. (1)FCF (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic cordials; (naming the flavour) milk; Pickles and relishes;

Fast Green FCF Pineapple marmalade with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup

Column III

Maximum Level of Use

125 p.p.m. in accordance with (4) the requirements of paragraph

B.21.021(d) 80 p.p.m. allura red in accordance with the requirements of clause B.14.032(d)(xvi)(B) and 20(5) p.p.m. sunset yellow FCF in accordance with the requirements of clause B.14.032(d)(xvi)(C) 0.15% (Residues of sunset yellow FCF in sausage(6) prepared with such casings not to exceed 15 p.p.m.) 600 p.p.m. singly. If used in combination with other colours listed in column I of this item

(7) and of item 4 of this table, the maximum level of use is 300 p.p.m. in accordance with paragraph B.06.002(c)

(1)

100 p.p.m. singly or in combination in accordance with section B.06.002

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

100 p.p.m. singly or in (2) Unstandardized foods (2) combination in accordance

with section B.06.002 A blend of prepared fish and 100 p.p.m. singly or in

(3) prepared meat referred to in (3) combination in accordance paragraph B.21.006(n) with section B.06.002

(4) Feta cheese (brilliant blue (4) 0.10 p.p.m.FCF only) Citrus Red No.5. Skins of whole oranges 2 p.p.m.2

Fruit Peel; Glacé fruits;6. Ponceau SX 150 p.p.m.Maraschino Cherries 7. Gold Alcoholic beverages Good Manufacturing Practice

SOR/79-752, s. 5; SOR/80-500, s. 6; SOR/82-596, s. 3; SOR/84-440, s. 4; SOR/84-602, s. 1; SOR/89-198, ss. 6 to 10; SOR/92-725, s. 5; SOR/93-466, s. 2; SOR/94-689, s. 2(F); SOR/95­ 434, s. 1; SOR/95-493, s. 1; SOR/97-516, s. 4; SOR/98-580, s. 1(F); SOR/99-96, s. 1; SOR/2000-50, s. 1; SOR/2000-146, ss. 1 to 3; SOR/2007-75, s. 3; SOR/2010-94, s. 8(E); SOR/2010-143, s. 13.

TABLE IV

FOOD ADDITIVES THAT MAY BE USED AS EMULSIFYING, GELLING, STABILIZING AND THICKENING AGENTS

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Cream; French dressing; (naming the flavour) Milk; Mustard pickles; (naming the flavour) Partly skimmed milk; (naming the flavour)

A.1 Acacia Gum (1) Partly skimmed milk with (1) Good Manufacturing Practice added milk solids; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids;

(2) Ice cream; Ice cream mix; (2) 0.5%Ice milk; Ice milk mix (3) Sherbet (3) 0.75% (4) Unstandardized foods (4) Good Manufacturing Practice (5) Calorie-reduced (5) 0.5% in accordance with the

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

margarine requirements of section B.09.017

Canned asparagus; 1.0% in accordance with theCanned green beans;(6) (6) requirements of clauseCanned wax beans; B.11.002(d)(viii)(C)Canned peas Acetylated Mono-A.2 Unstandardized foods Good Manufacturing Practiceglycerides

A.3 Acetylated Tartaric (1) Bread (1) 6,000 p.p.m. of flour Acid Esters of (2) Unstandardized foods (2) Good Manufacturing Practice Mono- and Di- Infant formulas based on(3) (3) 240 p.p.m. as consumedglycerides crystalline amino acids

Brawn; Canned (naming the poultry); Cream; Headcheese; (naming the fruit) Jelly with pectin; Meat binder (when sold for use in prepared meat or meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the flavour) Milk; Mustard pickles; Potted meat;A.4 Agar (1) (1) Good Manufacturing PracticePotted meat by-product; Prepared fish or prepared meat (Division 21); Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids

(2) Ice cream; Ice cream mix; (2) 0.5%Ice milk; Ice milk mix (3) Sherbet (3) 0.75% (4) Unstandardized foods (4) Good Manufacturing Practice

Calorie-reduced 0.5% in accordance with the(5) (5)margarine requirements of section

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

B.09.017

A.5 Algin (1)

Ale; Beer; Cream; French dressing; Light beer; Malt liquor; (naming the flavour) Milk; Mustard pickles; Porter; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added

(1) Good Manufacturing Practice

milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Stout

0.03% as consumed. If used in combination with

(2) Infant formula (2) carrageenan or guar gum or both, the total not to exceed 0.03%

(3)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

(3) 0.5%

(4) Sherbet (4) 0.75% (5) Unstandardized foods (5) Good Manufacturing Practice

(6) Calorie-reducedmargarine (6) 0.5% in accordance with the requirements of section B.09.017 0.5% in accordance with the

(7) Sour cream (7) requirements of clause B.08.077(b)(vii)(A)

Canned asparagus; 1.0% in accordance with theCanned green beans;(8) (8) requirements of clauseCanned wax beans; B.11.002(d)(viii)(C)Canned peas Infant formula based on 0.1% as consumed. If used in isolated amino acids or combination with carrageenan(9) (9)protein hydrolysates, or or guar gum or both, the total both not to exceed 0.1% Lactose-free infant 0.05% as consumed. If used

(10) formula based on milk (10) in combination with protein carrageenan or guar gum or

Column I Column II Item Additive Permitted in or UponNo.

Same foods as listed forA.6 Alginic Acid Algin Ammonium Same foods as listed forA.7 Alginate Algin Ammonium Same foods as listed forA.8 Carrageenan Carrageenan Ammonium Same foods as listed forA.9 Furcelleran Furcelleran

Bread; Cream; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk;

Ammonium Salt of (naming the flavour) A.9A Phosphorylated (1) Partly skimmed milk;

Glyceride (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids Ice Cream; Ice cream

(2) mix; Ice milk; Ice milk mix

(3) Sherbet (4) Unstandardized foods

(5) Chocolate products;Cocoa products Essential oils; unstandardized dressings,

A.10 Arabino-galactan (1) pudding mixes; beverage bases and mixes; pie filling mixes

Baker’s yeastB.1 Unstandardized foods Glycan

Same foods as listed forC.1 Calcium Alginate Algin C.2 Calcium Carbonate (1) Unstandardized Foods

A blend of prepared fish (2) and prepared meat

referred to in paragraph

Column III

Maximum Level of Use

both, the total not to exceed 0.05% Same levels as prescribed for Algin Same levels as prescribed for Algin Same levels as prescribed for Carrageenan Same levels as prescribed for Furcelleran

(1) Good Manufacturing Practice

(2) 0.5%

(3) 0.75% (4) Good Manufacturing Practice

(5) 0.7%

(1) Good Manufacturing Practice

Good Manufacturing Practice

Same levels as prescribed for Algin

(1) Good Manufacturing Practice

(2) Good Manufacturing Practice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

B.21.006(n) Calcium Same foods as listed for Same levels as prescribed forC.3 Carrageenan Carrageenan Carrageenan

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed 4.0%, in accordance with the(naming the variety) requirements of sectionscheese with (naming the B.08.038, B.08.039,C.4 Calcium Citrate (1) added ingredients); (1) B.08.040, B.08.041,Processed cheese food; B.08.041.1, B.08.041.2,Processed cheese food B.08.041.3 and B.08.041.4with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(2) Unstandardized foods (2) Good Manufacturing Practice Calcium Same foods as listed for Same levels as prescribed forC.5 Furcelleran Furcelleran Furcelleran

C.6 Calcium Gluconate Unstandardized foods Good Manufacturing Practice Calcium Unstandardized dessertC.7 Good Manufacturing PracticeGlycerophosphate mixes Calcium Unstandardized dessertC.8 Good Manufacturing PracticeHypophosphite mixes

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed 3.5%, in accordance with the(naming the variety) requirements of sectionscheese with (naming theCalcium B.08.038, B.08.039,C.9 added ingredients); (1)Phosphate, dibasic (1) B.08.040, B.08.041,Processed cheese food; B.08.041.1, B.08.041.2,Processed cheese food B.08.041.3 and B.08.041.4with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(2) Unstandardized foods (2) Good Manufacturing Practice

C.10 CalciumPhosphate, tribasic Unstandardized foods Good Manufacturing Practice

C.11 Calcium Sulphate (1) Ice cream; Ice cream mix;Ice milk; Ice milk mix (1) 0.5%

(2) Sherbet (2) 0.75% (3) Unstandardized foods (3) Good Manufacturing Practice (4) Creamed cottage cheese (4) 0.05%

(5) Cream for whipping,heat-treated above 100°C (5) 0.005%

(6)

A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)

(6) 0.06%

C.12 Calcium Tartrate Unstandardized foods Good Manufacturing Practice

C.13 CarboxymethylCellulose

Same foods as listed for Sodium Carboxymethyl Cellulose

Same levels as prescribed for Sodium Carboxymethyl Cellulose

C.14 Carob Bean Gum (1)

Cream; French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids

(1) Good Manufacturing Practice

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

(2) 0.5%

(3) Calorie-reducedmargarine (3) 0.5% in accordance with the requirements of paragraph B.09.017(b)

(4) Sherbet (4) 0.75% 0.5% in accordance with the

(5) Sour cream (5) requirements of clause B.08.077(b)(vii)(A)

(6) Unstandardized Foods (6) Good Manufacturing Practice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with

(7)

(naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the

(7)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients) Ale; Beer; Brawn; Canned (naming the poultry); Cream; French dressing; Headcheese; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; Meat binder (when sold for use in prepared meat or prepared meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf;

C.15 Carrageenan (1) Meat loaf; (naming theflavour) Milk; Mustard (1) Good Manufacturing Practice

pickles; Porter; Potted meat; Potted meat by- product; Prepared fish or prepared meat (Division 21); Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed

Column I Item AdditiveNo.

Column II

Permitted in or Upon

milk with added milk solids; Stout Cottage cheese; Creamed cottage cheese; Ice cream;(2) Ice cream mix; Ice milk; Ice milk mix

(3) Evaporated milk (4) Sherbet

Evaporated partly skimmed milk;(5) Concentrated partly skimmed milk Infant formula based on isolated amino acids or(6) protein hydrolysates, or both

(7) Infant formula

(8) Unstandardized foods

Calorie-reduced(9) margarine

(10) Sour cream

Canned asparagus; Canned green beans;(11) Canned wax beans; Canned peas Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added

(12) ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the

Column III

Maximum Level of Use

(2) 0.5%

(3) 0.015% (4) 0.75%

(5) 0.01%

0.1% as consumed. If used in combination with algin or(6) guar gum or both, the total not to exceed 0.1% 0.03% as consumed. If used in combination with algin or(7) guar gum or both, the total not to exceed 0.03%

(8) Good Manufacturing Practice 0.5% in accordance with the

(9) requirements of section B.09.017 0.5%, in accordance with the

(10) requirements of clause B.08.077(b)(vii)(A)

1.0% in accordance with the (11) requirements of clause

B.11.002(d)(viii)(C)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037,

(12) B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients)

(13) Lactose-free infant formula based on milk protein

(13)

0.05% as consumed. If used in combination with algin or guar gum or both, the total not to exceed 0.05%

Same foods as listed for Same levels as prescribed for C.17 Cellulose Gum Sodium Carboxymethyl Sodium Carboxymethyl

Cellulose Cellulose

F.1 Furcelleran (1) Ale; Beer; Light beer;Malt liquor; Porter; Stout (1) Good Manufacturing Practice

(2) Unstandardized foods (2) Good Manufacturing Practice

(3) Calorie-reducedmargarine (3) 0.5% in accordance with the requirements of section B.09.017

(4)

Canned asparagus; Canned green beans; Canned waxed beans; Canned peas

(4) 1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)

Brawn; Canned (naming the poultry); Cream; Headcheese; (naming the fruit) Jelly with pectin; Meat binder (when sold for use in prepared meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the

G.1 Gelatin (1) flavour) Milk; Mustard (1) Good Manufacturing Practice pickles; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Prepared hams, shoulders, butts and picnics; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour)

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids Cottage cheese; Creamed

(2) cottage cheese; Ice cream;Ice cream mix; Ice milk; (2) 0.5%

Ice milk mix (3) Sherbet (3) 0.75%

0.5% in accordance with the (4) Sour cream (4) requirements of clause

B.08.077(b)(vii)(A) (5) Unstandardized Foods (5) Good Manufacturing Practice

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with

(6)

(naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the

(6)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients)

G.2 Gellan Gum (1) Frostings; Unstandardizedconfectionery (1) 0.5%

Fruit spreads; Aspic; Processed fruit products;

(2) (except for any of theseproducts for which (2) 0.3%

standards are set out in these Regulations) Calorie-reduced

(3) margarine; Reduced fat (3) 0.25% spreads

(4) Dairy products (exceptfor any of these products (4) 0.15%

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

G.3 Guar Gum

for which standards are set out in these Regulations) French Dressing; Salad Dressing; Dressings (except for any of these products for which(5) standards are set out in these Regulations); Gelatins; Puddings; Fillings Baking mixes; Bakery products; (except for any

(6) of these products for which standards are set out in these Regulations) Sauces; Toppings; Table syrups; (except for any of

(7) these products for which standards are set out in these Regulations) Beverages (except for any of these products for(8) which standards are set out in these Regulations) Snack foods (except for any of these products for(9) which standards are set out in these Regulations) Cream; French dressing; (naming the flavour) Milk; Mince meat; Mustard pickles; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the(1) flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids;

(5) 0.1%

(6) 0.1% of the dry mix

(7) 0.05%

(8) 0.08%

(9) 0.1%

(1) Good Manufacturing Practice

(2) Cottage cheese; Creamedcottage cheese; Ice cream; (2) 0.5%

Column I Item AdditiveNo.

Column II

Permitted in or Upon

Ice cream mix; Ice milk; Ice milk mix

(3) Infant formula

(4) Sherbet (5) Unstandardized foods

Calorie-reduced(6) margarine

(7) Sour cream

Canned asparagus; Canned green beans;(8) Canned waxed beans; Canned peas Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with(9) (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients) Infant formula based on isolated amino acids or(10) protein hydrolysates, or both

Lactose-free infant (11) formula based on milk

protein

Column III

Maximum Level of Use

0.03% as consumed. If used in combination with algin or(3) carrageenan or both, the total not to exceed 0.03%

(4) 0.75% (5) Good Manufacturing Practice

0.5% in accordance with the (6) requirements of section

B.09.017 0.5% in accordance with the

(7) requirements of clause B.08.077(b)(vii)(A)

1.0% in accordance with the (8) requirements of clause

B.11.002(d)(viii)(C)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037,

(9) B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

0.1% as consumed. If used in combination with algin or(10) carrageenan or both, the total not to exceed 0.1% 0.05% as consumed. If used in combination with algin or(11) carrageenan or both, the total not to exceed 0.05%

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Same foods as listed for Same level as prescribed forG.4 Gum Arabic Acacia Gum Acacia Gum

(1) Chocolate products;H.1 Hydroxylated (1) 1.0%Cocoa productsLecithin (2) Unstandardized foods (2) Good Manufacturing Practice

H.1A Hydroxypropyl Unstandardized foods Good Manufacturing PracticeCellulose French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour)HydroxypropylH.2 (1) Partly skimmed milk; (1) Good Manufacturing PracticeMethylcellulose (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing

(2) Unstandardized foods (2) Good Manufacturing Practice Same foods as listed for Same levels as prescribed forI.1 Irish Moss Gelose Carrageenan Carrageenan French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour)

K.1 Karaya Gum (1) Partly skimmed milk; (1) Good Manufacturing Practice (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing Cottage cheese; Creamed cottage cheese; Ice cream;(2) (2) 0.5%Ice cream mix; Ice milk; Ice milk mix

(3) Sherbet (3) 0.75% (4) Unstandardized foods (4) Good Manufacturing Practice

Calorie-reduced 0.5% in accordance with the(5) (5)margarine requirements of section

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

B.09.017 8.0% (except that the total combined mono- and di­

L.1 Lactylated Mono-and Di-glycerides (1) Shortening (1) glycerides and lactylated mono- and di-glycerides must not exceed 20.0% of the shortening)

(2) Unstandardized foods (2) 8.0% of the fat content

L.1A Lactylic Esters ofFatty Acids Unstandardized foods Good Manufacturing Practice

Bread; Cream; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour)

L.2 Lecithin (1) Partly skimmed milk; (1) Good Manufacturing Practice (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids Ice Cream; Ice cream 0.5%, singly or in

(2) mix; Ice milk; Ice milk (2) combination with other mix emulsifiers

(3) Infant formula (3) 0.03% as consumed (4) Sherbet (4) 0.75% (5) Unstandardized foods (5) Good Manufacturing Practice (6) Margarine (6) 0.2%

(7) Calorie-reducedmargarine (7) 0.5%

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food;(8) (8) 0.2%Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

ingredients) (9) Milk powder (9) 0.5%

(10) Chocolate products; (10) 1.0%Cocoa products Same foods as listed for Same levels as prescribed forL.3 Locust Bean Gum Carob Bean Gum Carob Bean Gum

Magnesium 0.3%, calculated as theM.1 TofuChloride anhydrous salt Ale; Beer; French dressing; Light beer; MaltM.2 Methylcellulose (1) (1) Good Manufacturing Practiceliquor; Porter; Salad dressing; Stout

(2) Unstandardized foods (2) Good Manufacturing Practice Methyl EthylM.3 Unstandardized foods Good Manufacturing PracticeCellulose

M.4 Mono-glycerides (1) Bread; Cream; Fish paste (1) Good Manufacturing Practice

(2) Chocolate products; (2) 1.5%Cocoa products A total of 0.5% of stabilizing agents in accordance with

(3) Ice cream mix; Ice milk (3) subparagraphsmix B.08.061(b)(vi) and B.08.071(b)(vi)

(4) Creamed cottage cheese (4) Good Manufacturing Practice (5) Infant formula (5) 0.25% as consumed (6) Sausage casings (6) 0.35% of the casing (7) Margarine (7) 0.5% (8) Sherbet (8) 0.75%

10.0% (except that the total combined mono and diglycerides and lactylated(9) Shortening (9) mono and diglycerides must not exceed 20.0% of the shortening)

(10) Sour Cream (10) 0.3% (11) Unstandardized Foods (11) Good Manufacturing Practice

Processed (naming the 0.5% in accordance with thevariety) cheese; Processed requirements of sections(naming the variety)(12) (12) B.08.040, B.08.041,cheese with (naming the B.08.041.1, B.08.041.2,added ingredients); B.08.041.3 and B.08.041.4Processed cheese food;

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

M.5 Mono- and Di­ glycerides

(1) Bread; Cream; Fish paste (1) Good Manufacturing Practice

(2) Chocolate products;Cocoa products (2) 1.5%

A total of 0.5% of stabilizing

(3) Ice cream mix; Ice milkmix (3) agents in accordance with subparagraphs B.08.061(b)(vi) and B.08.071(b)(vi)

(4) Cottage Cheese; CreamedCottage Cheese (4) Good Manufacturing Practice

(5) Infant formula (5) 0.25% as consumed (6) Sausage casings (6) 0.35% of the casing (7) Margarine (7) 0.5% (8) Sherbet (8) 0.75%

10.0% (except that the total combined mono and

(9) Shortening (9) diglycerides and lactylatedmono and diglycerides must not exceed 20.0% of the shortening)

(10) Sour Cream (10) 0.3% (11) Unstandardized Foods (11) Good Manufacturing Practice

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); 0.5% in accordance with the Processed cheese food; requirements of sections

(12) Processed cheese food (12) B.08.040, B.08.041, with (naming the added B.08.041.1, B.08.041.2, ingredients); Processed B.08.041.3 and B.08.041.4 cheese spread; Processed cheese spread with (naming the added ingredients)

M.6 Monosodium Saltsof Phosphorylated (1) Edible vegetable oil- based cookware coating (1) 4.0%

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Mono- and emulsions Diglycerides

O.1 Oat Gum (1) Unstandardized Foods (1) Good Manufacturing Practice Apple (or rhubarb) and (naming the fruit) Jam; Cream; Fig marmalade; Fig marmalade with pectin; French dressing; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade with pectin; (naming the flavour)

P.1 Pectin (1) Milk; Mince meat;Mustard pickles; (1) Good Manufacturing Practice

Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids

(2) Ice cream; Ice cream mix;Ice milk; Ice milk mix (2) 0.5%

0.5% in accordance with the (3) Sour cream (3) requirement of clause

B.08.077(b)(vii)(A) (4) Sherbet (4) 0.75% (5) Unstandardized foods (5) Good Manufacturing Practice

P.1A Polyglycerol Esters (1) Unstandardized foods (1) Good Manufacturing Practice of Fatty Acids (2) Vegetable oils (2) 0.025%

0.2% in accordance with theCalorie-reduced(3) (3) requirements of paragraphmargarine B.09.017(c) P.1B Polyglycerol Esters (1) Chocolate products (1) 0.5%

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

of Interesterified

Castor Oil Fatty Acids (2)

Unstandardized chocolate flavoured confectionery coatings

(2) 0.25%

(3)

Edible vegetable oil- based pan coating emulsions for use on (3) 2.0%

baking pans

P.2 Polyoxyethylene(20) Sorbitan Monooleate;

(1) (1)Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet

0.1%. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.1%

Polysorbate 80 (2) Unstandardized frozendesserts (2) 0.1%

(3) Pickles and relishes (3) 0.05%

(4) Beverage base or mix (4)

0.05% of the beverage. If sorbitan monostearate is also used the total must not exceed 0.05% of the beverage

(5) Imitation dry cream mix (5)

0.1%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4%

(6) Whipped vegetable oiltopping (6)

0.05%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4% 0.5% of the finished cake

(7) Cake icing; cake icingmix (7)

icing. If Polyoxyethylene (20) sorbitan monostearate, or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing

(8) Salt (8) 10 p.p.m.

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(9) Whipped cream (9) 0.1% (10) Breath freshener products (10) 100 p.p.m. (11) Creamed cottage cheese (11) 80 p.p.m.

Spice oils and spice oleoresins for use in

(12) pumping pickle employedin the curing of preserved meat or preserved meat by-product (Division 14)

(12) 0.2% of the pumping pickle

(13) Sausage casings (13) 0.15% of the casing Good Manufacturing Practice. Residues of

(14) Liquid Smoke Flavours (14) Polysorbate 80 must not exceed 275 p.p.m. in the finished food

(15) Vegetable oils (15) 0.125%

(16) Annatto formulations (16) 25% of the total colourformulation

(17) Turmeric formulations (17) 50% of the total colourformulation

(18) Liquid smoke flavourconcentrate (18)

Good Manufacturing Practice. Residues of Polysorbate 80 must not exceed 0.3% in the finished food.

(19) Unstandardized saladdressing (19) 0.25%

P.3 Polyoxyethylene(20) Sorbitan Monostearate;

Polysorbate 60

(1) (1)

Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix

0.4%. If Polyoxyethylene (20) sorbitan tristearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%, except that in the case of whipped vegetable oil topping a combination of Polysorbate 60 and Sorbitan monostearate may be used in excess of 0.4%, if the amount of the Polysorbate 60 does not exceed 0.77% and the amount of Sorbitan monostearate does not exceed 0.27% of the whipped vegetable oil topping

Column I Item AdditiveNo.

Column II

Permitted in or Upon

(2) Cakes

(3) Cakes; Cake mixes

Unstandardized confectionery coatings and unstandardized

(4) moulded confectionery products for use as confectionery or in baking

(5) Cake icing; Cake icingmix

(6) Pudding; Pie filling

(7) Beverage base or mix

(8) Sour Cream Substitute Unstandardized dressings;

(9) Unstandardized prepared canned cooking sauces Fat base formulation for

(10) self-basting of poultry by injection Unstandardized sandwich

(11) spreads; Unstandardized dips

(12) Dry soup base or mix

(13) Dry batter coating mixes

Column III

Maximum Level of Use

0.5% on a dry weight basis. If Polyoxyethylene (20) sorbitan

(2) tristearate is also used, the total must not exceed 0.5% on a dry weight basis 0.5% on a dry weight basis. If Sorbitan monostearate is also

(3) used, the total must not exceed 0.7% on a dry weight basis

0.5%. If any combination of Polyoxyethylene (20) Sorbitan tristearate, Sorbitan(4) monostearate or Sorbitan tristearate are all used the total must not exceed 1.0%

0.5% of the finished cake icing. If Sorbitan monostearate or Polyoxyethylene (20) sorbitan

(5) mono-oleate either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing

(6) 0.5% on a dry weight basis 0.05% of the beverage. If Sorbitan monostearate is also(7) used the total must not exceed 0.05% of the beverage

(8) 0.1%

(9) 0.3%

(10) 0.25%

(11) 0.2%

(12) 250 p.p.m. in soup asprepared for consumption (13) 0.5% of the dry mix

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(14) Prepared alcoholiccocktails (14) 120 p.p.m. in beverage as prepared for consumption

P.4 Polyoxyethylene(20) Sorbitan Tristearate;

(1) (Naming the flavour)Milk; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added

(1) 0.5%

Polysorbate 65 milk solids; (naming the flavour) Partly skimmed milk with added milk solids

(2) Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet

(2)

0.1%. If Polyoxyethylene (20) sorbitan mono-oleate is also used, the total must not exceed 0.1%

(3) Unstandardized frozendesserts (3) 0.1%

(4) Cakes (4)

0.3% on a dry weight basis. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.5% on a dry weight basis

(5) Unstandardizedconfectionery coatings (5)

0.5%. If any combination of Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate, or Sorbitan tristearate are also used, the total must not exceed 1.0%

(6) Beverage base or mix (6)

0.05% of the beverage. If Sorbitan monostearate is also used, the total must not exceed 0.05% of the beverage

(7)

Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix

(7)

0.4%. If Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%

(8) Breath freshener products (8) 200 p.p.m.

P.5 Polyoxyethylene(8) Stearate Unstandardized bakery products 0.4%

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

P.6 Potassium Alginate Same foods as listed forAlgin Same levels as prescribed for Algin

Potassium Same foods as listed for Same levels as prescribed forP.7 Carrageenan Carrageenan Carrageenan P.8 Potassium Chloride Unstandardized foods Good Manufacturing Practice

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed 4.0%, in accordance with the(naming the variety) requirements of sectionscheese with (naming the B.08.038, B.08.039,P.9 Potassium Citrate (1) added ingredients); (1) B.08.040, B.08.041,Processed cheese food; B.08.041.1, B.08.041.2,Processed cheese food B.08.041.3 and B.08.041.4with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

Potassium Same foods as listed for Same levels as prescribed forP.10 Furcelleran Furcelleran Furcelleran Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed 3.5%, in accordance with the(naming the variety) requirements of sectionscheese with (naming thePotassium B.08.038, B.08.039,P.11 added ingredients); (1)Phosphate, dibasic (1) B.08.040, B.08.041,Processed cheese food; B.08.041.1, B.08.041.2,Processed cheese food B.08.041.3 and B.08.041.4with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Ale; Beer; French

Propylene Glycol dressing; Light beer; MaltP.12 (1) (1) Good Manufacturing PracticeAlginate liquor; Mustard pickles; Porter; Relishes; Salad

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

dressing; Stout Cottage cheese; Creamed

(2) cottage cheese; Ice cream;Ice cream mix; Ice milk; (2) 0.5%

Ice milk mix (3) Sherbet (3) 0.75% (4) Unstandardized foods (4) Good Manufacturing Practice

(5) Calorie-reducedmargarine (5) 0.5% in accordance with the requirements of section B.09.017 0.5% in accordance with the

(6) Sour cream (6) requirements of clause B.08.077(b)(vii)(A)

(7)

Canned asparagus; Canned green beans; Canned wax beans; Canned peas

(7) 1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with

(8)

(naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the

(8)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients)

Propylene Glycol Same foods as listed for Same levels as prescribed for P.13 Ether of Hydroxypropyl Hydroxypropyl

Methylcellulose Methylcellulose Methylcellulose

P.14 Propylene GlycolMono Fatty Acid (1) Ice cream mix (1) 0.35% of the ice cream made from the mix

Esters (2) Unstandardized foods (2) Good Manufacturing Practice

S.1 Sodium AcidPyrophosphate (1) Cream cheese spread; Cream cheese spread with (naming the added

(1) 3.5%, in accordance with the requirements of sections B.08.038, B.08.039,

Column I Item AdditiveNo.

S.2 Sodium Alginate

Sodium Alumi-S.2A num Phosphate

Sodium S.3 Carboxymethyl

Cellulose

Column II

Permitted in or Upon

ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Same foods as listed for(1) Algin

(2) Coarse crystal salt (3) Glaze of frozen fish

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the

(1) added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Cream; French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; Salad dressing; (naming the flavour)(1) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids;

Column III

Maximum Level of Use

B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(1) Same levels as prescribed forAlgin (2) 15 p.p.m. (3) Good Manufacturing Practice

3.5%, in accordance with the requirements of sections B.08.038, B.08.039,(1) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(1) Good Manufacturing Practice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(naming the flavour) Partly skimmed milk with added milk solids

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

(2) 0.5%

(3) Sherbet (3) 0.75% (4) Unstandardized foods (4) Good Manufacturing Practice (5) Glaze of frozen fish (5) Good Manufacturing Practice

(6)

Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food

(6) 0.5%

with (naming the added ingredients)

(7)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients)

(7)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

S.4 SodiumCarrageenan Same foods as listed for Carrageenan

Same levels as prescribed for Carrageenan

S.5 Sodium CelluloseGlycolate

Same foods as listed for Sodium Carboxymethyl Cellulose

Same levels as prescribed for Sodium Carboxymethyl Cellulose

S.6 Sodium Citrate (1) Cream cheese spread; Cream cheese spread with (naming the added

(1) 4.0%, in accordance with the requirements of sections B.08.038, B.08.039,

S.7

Column I Item AdditiveNo.

Sodium Furcelleran

S.8 Sodium Gluconate (1)

Column II

Permitted in or Upon

ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Evaporated milk; evaporated skim milk or concentrated skim milk;

(2) evaporated partly skimmed milk or concentrated partly skimmed milk

(3) Ice cream; Ice cream mix;Ice milk; Ice milk mix (4) Sherbet

Same foods as listed for Furcelleran Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

Column III

Maximum Level of Use

B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

0.1% singly or in combination (2) with sodium phosphate,

dibasic

(3) 0.5%

(4) 0.75% Same levels as prescribed for Furcelleran

4.0%, in accordance with the requirements of sections B.08.038, B.08.039,(1) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

S.9 Sodium Hexameta- (1) Mustard pickles; Relishes (1) Good Manufacturing Practice phosphate (2) Ice cream; Ice cream mix; (2) 0.5%

Column I Column II Item Additive Permitted in or UponNo.

Ice milk; Ice milk mix (3) Infant formula (4) Sherbet (5) Unstandardized foods

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the

(6) added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) A blend of prepared fish and prepared meat(7) referred to in paragraph B.21.006(n) (Naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour)

Sodium Phosphate, Partly skimmed milk;S.11 (1)dibasic (naming the flavour) Skim Milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids

(2) Cottage cheese; Creamedcottage cheese Evaporated milk; evaporated skim milk or concentrated skim milk;(3) evaporated partly skimmed milk or concentrated partly

Column III

Maximum Level of Use

(3) 0.05% as consumed (4) 0.75% (5) Good Manufacturing Practice

3.5%, in accordance with the requirements of sections B.08.038, B.08.039,(6) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(7) 0.1%

(1) Good Manufacturing Practice

(2) 0.5%

(3) 0.1% singly or in combinationwith sodium citrate

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

(4)

(5)

(6)

Sodium Phosphate,S.12 (1)monobasic

(2)

Sodium Phosphate,S.13 (1)tribasic

skimmed milk

Sour cream

Unstandardized Foods Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) Unstandardized foods Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety)

0.05% in accordance with the (4) requirements of clause

B.08.077(b)(vii)(C) (5) Good Manufacturing Practice

3.5%, in accordance with the requirements of sections B.08.038, B.08.039,(6) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

3.5%, in accordance with the requirements of sections B.08.038, B.08.039,(1) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(2) Good Manufacturing Practice 3.5%, in accordance with the requirements of sections

(1) B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2,

Column I Item AdditiveNo.

Sodium PotassiumS.14 Tartrate

Sodium S.15 Pyrophosphate,

tetrabasic

Column II

Permitted in or Upon

cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(2) Unstandardized foods Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the

(1) added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(2) Unstandardized foods Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety)

(1) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with

Column III

Maximum Level of Use

B.08.041.3 and B.08.041.4

(2) Good Manufacturing Practice

4.0%, in accordance with the requirements of sections B.08.038, B.08.039,(1) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

(2) Good Manufacturing Practice

3.5%, in accordance with the requirements of sections B.08.038, B.08.039,(1) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(naming the added ingredients)

(2) Unstandardized foods (2) Good Manufacturing Practice A blend of prepared fish

(3) and prepared meatreferred to in paragraph (3) 0.1%

B.21.006(n) S.15A Sodium Stearoyl-2- (1) Icing and icing mixes (1) 0.4% of dry ingredient weight

Lac-tylate (2) Fillings and filling mixes (2) 0.5% of dry ingredient weight

(3) Puddings and pudding (3) 0.2% of the finished productmixes (4) Sour cream substitutes (4) 1.0% of dry ingredient weight

(5) Vegetable oil creaming (5) 2.0% of dry ingredient weightagents

(6) 0.75% of dry ingredient(6) Batter mix weight Unstandardized cream­(7) (7) 0.35% of the finished productbased liquors

(8) Salad dressing; French (8) 0.4% of the finished productdressing (9) Soups (9) 0.2% of the finished product

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed 4.0%, in accordance with the(naming the variety) requirements of sectionscheese with (naming the B.08.038, B.08.039,S.16 Sodium Tartrate (1) added ingredients); (1) B.08.040, B.08.041,Processed cheese food; B.08.041.1, B.08.041.2,Processed cheese food B.08.041.3 and B.08.041.4with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients) A blend of prepared fish

S.16A Sodium and prepared meat 0.1%Tripolyphosphate referred to in paragraph B.21.006(n)

S.18 Sorbitan (1) Imitation dry cream mix; (1) 0.4%. If Polyoxyethylene (20)

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Monostearate Vegetable oil creaming sorbitan tristearate, agent; Whipped vegetable Polysorbate 60 or oil topping; Vegetable oil Polyoxyethylene (20) sorbitan topping mix mono-oleate, either singly or

in combination is also used, the total must not exceed 0.4%, except that in the case of whipped vegetable oil topping a combination of Sorbitan monostearate and Polysorbate 60 may be used in excess of 0.4% if the amount of Sorbitan monostearate does not exceed 0.27% and the amount of Polysorbate 60 does not exceed 0.77% of the weight of the whipped vegetable oil topping 0.6% on a dry weight basis. If Polyoxyethylene (20) sorbitan

(2) Cake; Cake mix (2) monostearate is also used, the total must not exceed 0.7% on a dry weight basis

Unstandardized 1.0%. If any combination of confectionery coatings Polyoxyethylene (20) sorbitan and unstandardized monostearate,

(3) moulded confectionery (3) Polyoxyethylene (20) sorbitan products for use as tristrearate or Sorbitan confectionery or in tristearate are also used, the baking total must not exceed 1.0%

0.5% of the finished cake icing. If Polyoxyethylene (20) sorbitan mono-oleate or

(4) Cake icing; Cake icingmix (4) Polyoxyethylene (20) sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing 0.05% of the beverage. If Polyoxyethylene (20) sorbitan

(5) Beverage base or mix (5) mono-oleate is also used, thetotal must not exceed 0.05% of the beverage. If Polyoxyethylene (20) sorbitan

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

monostearate is also used, the total must not exceed 0.05% of the beverage. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.05% of the beverage

(6) Dry soup base or mix (6) 250 p.p.m. in soup asprepared for consumption 1.5% (Residues of sorbitan monostearate in bread and

(7) Dried yeast (7) other yeast leavened bakery products not to exceed 0.05%).

(8) Chocolate products (8) 1.0% (9) Puddings (9) 0.5%

S.18A Sorbitan trioleate Sausage casings 0.35% of the casing

S.18B SorbitanTristearate (1) Margarine; Shortening (1) 1.0%

(2)

Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as a confectionery or in baking

(2)

1.0% If any combination of Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate are also used, the total must not exceed 1.0% 0.035% of the ice cream made(3) Ice cream mix (3) from the mix

Unstandardized frozen(4) (4) 0.035%desserts Stearyl

S.19 Monoglyceridyl Shortening Good Manufacturing Practice Citrate Sucrose esters of Carotenoid colourS.20 (1) (1) 1.5%fatty acids preparations

Unstandardized confectionery;(2) (2) 0.5%Unstandardized confectionery coatings

T.2 [Repealed, SOR/2006-91, s. 5]

(1) French dressing; MustardT.3 Tragacanth Gum (1) Good Manufacturing Practicepickles; Salad dressing;

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Relishes

(2)

Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix

(2) 0.5%

(3) Sherbet (3) 0.75% (4) Lumpfish Caviar (4) 1.0% (5) Unstandardized foods (5) Good Manufacturing Practice

(6) Calorie-reducedmargarine (6) 0.5% in accordance with the requirements of section B.09.017

(7)

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)

(7)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

(8)

Comminuted prepared fish or prepared meat, other than lumpfish caviar; Comminuted preserved fish or preserved meat (Division 21)

(8) 0.75%

X.1 Xanthan Gum (1) French Dressing; Salad Dressing; Unstandardized Foods

(1) Good Manufacturing Practice

0.5% or, if used in combination with other

(2) Cottage Cheese; CreamedCottage Cheese (2) stabilizing agents, the total amount of the combined stabilizers shall not exceed 0.5%

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(3) Calorie-reducedmargarine (3) 0.5% in accordance with the requirements of section B.09.017

Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with

(4)

(naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the

(4)

0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8

added ingredients); Cold- pack cheese food; Cold- pack cheese food with (naming the added ingredients)

(5) Mustard pickles; relishes (5) 0.1% 0.1% or, if used in combination with microcrystalline cellulose and

(6) Ice Cream Mix (6) other stabilizers, the totalamount of combined stabilizers and microcrystalline cellulose shall not exceed 0.5% 0.1% or, if used in combination with other

(7) Ice Milk Mix (7) stabilizers, the total amount of combined stabilizers shall not exceed 0.5% 0.1% or, if used in combination with other

(8) Sherbet (8) stabilizers, the total amount of combined stabilizers shall not exceed 0.75%

(9) Cream for whipping,heat-treated above 100°C (9) 0.02%

SOR/78-403, ss. 5(F) to 13(F), 14 to 16, 17(F) to 21(F), 22; SOR/78-656, ss. 14, 15; SOR/78­ 876, s. 2; SOR/79-660, ss. 5 to 10; SOR/79-752, s. 6; SOR/80-501, s. 4; SOR/81-60, ss. 7 to 10; SOR/81-565, ss. 4, 5; SOR/81-934, ss. 2 to 6; SOR/82-383, s. 9; SOR/82-1071, ss. 9 to

16; SOR/83-932, ss. 3, 4; SOR/84-300, s. 50(E); SOR/84-602, s. 2; SOR/84-801, s. 3; SOR/85-179, ss. 2 to 4; SOR/85-623, s. 3(E); SOR/88-99, s. 3; SOR/88-419, ss. 2, 3; SOR/90­ 87, s. 9; SOR/91-710, s. 1; SOR/92-64, s. 1; SOR/92-93, s. 2; SOR/92-344, s. 1; SOR/93-466, ss. 3, 4; SOR/94-38, s. 2; SOR/94-567, s. 2; SOR/94-689, s. 2(F); SOR/96-160, s. 2; SOR/96­ 376, s. 1; SOR/96-497, s. 1; SOR/96-499, s. 1; SOR/97-29, s. 1; SOR/97-263, ss. 4 to 10; SOR/98-580, s. 1(F); SOR/2000-353, s. 7(F); SOR/2005-316, s. 1; SOR/2005-395, ss. 1 to 4, 5(F); SOR/2006-91, ss. 4, 5; SOR/2007-75, ss. 4 to 6; SOR/2007-76, ss. 1, 2; SOR/2010-41, s. 9(E); SOR/2010-94, ss. 8(E), 9(E); SOR/2010-142, ss. 9, 10(F), 11 to 13, 14(F), 15(F), 16.

TABLE V

FOOD ADDITIVES THAT MAY BE USED AS FOOD ENZYMES

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

Good A.01

α-Acetolactate Bacillus subtilis ToC46 (1) Brewers’ Mash (1) Manufacturing

Practice decarboxylase (pUW235) Good

(2) Distillers’ Mash (2) Manufacturing Practice

Cheddar cheese; Good A.02 Aminopeptidase Lactococcus lactis (1) (naming the variety) (1) Manufacturing

Cheese Practice Dairy based Good

(2) flavouring (2) Manufacturing preparations Practice Hydrolyzed animal, Good

(3) milk and vegetable (3) Manufacturing protein Practice Ale; Beer; Light beer; Good

A.1 Amylase (1) Malt liquor; Porter; (1) Manufacturing Stout Practice

Aspergillus niger var.; Aspergillus oryzae var.; Bacillus subtilis var.; Rhizopus oryzae var.; Barley Malt

(2) Bread; Flour; Wholewheat flour

(3) Cider; Wine

(2) Good Manufacturing Practice

(3) Good Manufacturing Practice Good

(4) Chocolate syrups (4) Manufacturing Practice Good

(5) Distillers’ Mash (5) Manufacturing Practice Good

(6) Malt-flavoured dry (6) Manufacturingbreakfast cereals Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

Good (7) Single-strength fruit (7) Manufacturingjuices Practice

Good (8) Precooked (instant) (8) Manufacturingcereals Practice

Starch used in the production of dextrins, maltose, Good

(9) dextrose, glucose (9) Manufacturing (glucose syrup) or Practice glucose solids (dried glucose syrup)

Good (10) Unstandardized (10) Manufacturingbakery products Practice

Good (11) Plant-based beverages (11) Manufacturing

Practice Good

(12) Infant cereal products (12) Manufacturing Practice

Ale; Beer; Light beer; GoodAspergillus niger STz18­ (1) Malt liquor; Porter; (1) Manufacturing9 (pHUda7) Stout Practice Good

(2) Distillers’ Mash (2) Manufacturing Practice

Starch used in the production of dextrins, dextrose, Good

(3) glucose (glucose (3) Manufacturing syrup) or glucose Practice solids (dried glucose syrup), maltose

Bacillus Good amyloliquefaciens EBA (1) Distillers’ Mash (1) Manufacturing 20 (pUBH2); Bacillus Practice licheniformis; Bacillus licheniformis BML 592 (pAmyAmp); Bacillus licheniformis BML 730 (pAmyAmp); Bacillus licheniformis LA 57 (pDN1981); Bacillus

(2) Starch used in the production of dextrins, maltose, dextrose, glucose

(2) Good Manufacturing Practice

(glucose syrup) or glucose solids (dried

Column I Column II Column III Column IV Item Additive Permitted SourceNo.

licheniformis LAT8(pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1346); Bacillus licheniformis PL 1303 (pPL1117); Bacillus licheniformis MOL2083 (pCA164-LE399)

Bacillus licheniformis 3253 (plCatH-3253); Bacillus licheniformis 3266 (plCatH-3266ori1); Bacillus stearothermophilus; Bacillus subtilis B1.109 (pCPC800)

Bacillus subtilis B1.109 (pCPC720) (ATCC 39, 705)

Maximum Level ofPermitted in or Upon Use glucose syrup)

Good (3) Brewers’ mash (3) Manufacturing

Practice

Starch used in the production of dextrins, maltose, Good

(1) dextrose, glucose (1) Manufacturing (glucose syrup) or Practice glucose solids (dried glucose syrup)

Good (2) Distillers’ Mash (2) Manufacturing

Practice Good

(3) Brewers’ Mash (3) Manufacturing Practice GoodBread; Flour; Whole(4) (4) Manufacturingwheat flour Practice GoodUnstandardized(5) (5) Manufacturingbakery products Practice

Starch used in the production of dextrins, maltose, Good

(1) dextrose, glucose (1) Manufacturing (glucose syrup) or Practice glucose solids (dried glucose syrup)

Good (2) Distillers’ Mash (2) Manufacturing

Practice Good

(3) Brewers’ Mash (3) Manufacturing Practice Good

(4) Bakery Products (4) Manufacturing Practice

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

A.2 Amylase(maltogenic)

Bacillus subtilis BRG-1 (pBRG1); Bacillus subtilis DN1413 (pDN1413); Bacillus subtilis LFA 63 (pLFA63); Bacillus subtilis RB-147 (pRB147)

(1)

Starch used in the production of dextrins, maltose, dextrose, glucose, (glucose syrup) or glucose solids (dried glucose syrup)

(1) Good manufacturing practice

(2) Bread; Flour; Wholewheat flour (2) Good manufacturing practice

(3) Unstandardizedbakery products (3) Good manufacturing practice

Cheddar cheese; Cottage cheese; Cream cheese; Cream

B.1 Bovine Rennet

Aqueous extracts from the fourth stomach of adult bovine animals, sheep and goats

cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming

Good Manufacturing Practice

the added ingredients); (naming the variety) Cheese Ale; Beer; Light beer; Good

B.2 Bromelain The pineapples Ananas comosus and Ananas bracteatus

(1)

(2)

Malt liquor; Porter; Stout

Bread; Flour; Whole wheat flour

(1)

(2)

Manufacturing Practice Good Manufacturing Practice Good

(3) Sausage casings (3) Manufacturing Practice

Hydrolyzed animal, Good (4) milk and vegetable (4) Manufacturing

protein Practice Good

(5) Meat cuts (5) Manufacturing Practice

(6) Meat tenderizingpreparations (6) Good Manufacturing Practice

(7) Pumping pickle for (7) Good

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

the curing of beef cuts Manufacturing Practice in accordance with paragraph B.14.009(g)

(8) Sugar wafers, waffles,pancakes (8) Good Manufacturing Practice Good

C.1 Catalase (1) Soft drinks (1) Manufacturing Practice

Liquid egg-white

Aspergillus niger var.; Micrococcus lysodeikticus; Bovine (Bos taurus) liver

(2) (liquid albumen), liquid whole egg or liquid yolk, destined for drying Liquid whey treated

(2) Good Manufacturing Practice

with hydrogen Good (3) peroxide in (3) Manufacturing

accordance with item Practice H.1, Table VIII

Good C.2 Cellulase (1) Distillers’ Mash (1) Manufacturing

Aspergillus niger var.

(2) Liquid coffeeconcentrate (2)

Practice Good Manufacturing Practice

Spice extracts; Good (3) Natural flavour and (3) Manufacturing

colour extractives Practice

Trichoderma reesei QM (1) Single-strength fruitjuices (1)

Good Manufacturing Practice

9414 Tea leaves for the Good (2) production of tea (2) Manufacturing

solids Practice Cheddar cheese; (naming the variety)

C.3 Chymosin (i) Chymosin A

Escherichia coli K-12, GE81 (pPFZ87A) (1)

cheese; Cottage cheese; Cream cheese; Cream cheese with

(1) Good Manufacturing Practice

(naming the added ingredients); Cream

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

cheese spread; Cream cheese spread with (naming the added ingredients); Sour cream Unstandardized milk- Good

(2) based dessert (2) Manufacturing preparations Practice Cheddar cheese; (naming the variety) cheese; Cottage

Aspergillus niger var. cheese; Cream cheese;

(ii) Chymosin B

awamori, GCC0349 (pGAMpR); Kluyveromyces marxianus var. lactis,

(1)

Cream cheese with (naming the added ingredients); Cream cheese spread; Cream

(1) Good Manufacturing Practice

DS1182 (pKS105) cheese spread with (naming the added ingredients); Sour cream Unstandardized milk- Good

(2) based dessert (2) Manufacturing preparations Practice Ale; Beer; Light beer; Good

F.1 Ficin (1) Malt liquor; Porter; (1) Manufacturing Latex of fig tree (Ficus Stout Practice sp.) Good

(2) Sausage casings (2) Manufacturing Practice

Hydrolyzed animal, Good (3) milk and vegetable (3) Manufacturing

protein Practice Good

(4) Meat cuts (4) Manufacturing Practice

(5) Meat tenderizingpreparations (5) Good Manufacturing Practice Good Manufacturing

(6) Pumping pickle forthe curing of beef cuts (6) Practice in accordance with paragraph B.14.009(g)

G.1

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

Glucoamylase (Amyloglucosidase; Maltase) Aspergillus niger var.;

Aspergillus oryzae var.; Rhizopus oryzae var.

Aspergillus niger STz18­ 9 (pHUda7)

Rhizopus niveus var.

Ale; Beer; Light beer; Good (1) Malt liquor; Porter; (1) Manufacturing

Stout Practice

(2) Bread; Flour; Wholewheat flour (2) Good Manufacturing Practice Good

(3) Chocolate syrups (3) Manufacturing Practice Good

(4) Distillers’ Mash (4) Manufacturing Practice

(5) Precooked (instant)cereals (5) Good Manufacturing Practice

Starch used in the production of dextrins, maltose, Good

(6) dextrose, glucose (6) Manufacturing (glucose syrup), or Practice glucose solids (dried glucose syrup)

(7) Unstandardizedbakery products (7) Good Manufacturing Practice

Ale; Beer; Light beer; Good (1) Malt liquor; Porter; (1) Manufacturing

Stout Practice Good

(2) Distillers’ Mash (2) Manufacturing Practice

Starch used in the production of dextrins, dextrose, Good

(3) glucose (glucose (3) Manufacturing syrup) or glucose Practice solids (dried glucose syrup), maltose

Good (1) Distillers’ Mash (1) Manufacturing

Practice

(2) Mash destined forvinegar manufacture (2) Good Manufacturing Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

Rhizopus delemar var.; Multiplici sporus

(1) Brewers’ Mash

(2) Distillers’ Mash

(1)

(2)

(3) Mash destined forvinegar manufacture (3)

Starch used in the

(4)

production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup)

(4)

G.2 Glucanase Aspergillus niger var.; Bacillus subtilis var.

(1) Ale; Beer; Light beer; Malt liquor; Porter; Stout

(2) Corn fordegermination

(1)

(2)

(3) Distillers’ Mash (3)

(4) Mash destined forvinegar manufacture (4)

(5) Unstandardizedbakery products (5)

Humicola insolens var. (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout

(1)

(2) Distillers’ Mash (2)

G.3 Glucose oxidase Aspergillus niger var.; Aspergillus oryzae Mtl­ 72 (pHUda107)

(1) Soft drinks (1)

(2)

Liquid egg-white (liquid albumen), liquid whole egg or liquid yolk, destined

(2)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

Good Manufacturing Practice

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice in accordance

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

for drying with paragraphs B.22.034(b), B.22.035(b) and B.22.036(b) GoodBread; flour; Whole(3) (3) manufacturingwheat flour practice GoodUnstandardized(4) (4) manufacturingbakery products practice

Bacillus coagulans var.; Streptomyces olivochromogenes var.; Actinoplanes missouriensis var.; Streptomyces olivaceus Glucose (glucose Goodvar.; Microbacterium syrup) to be partiallyG.4 Glucose Isomerase (1) (1) Manufacturingarborescens NRRL B- or completely Practice11022; Streptomyces isomerized to fructose murinus DSM 3252; Streptomyces rubiginosus ATCC No. 21,175; Streptomyces rubiginosus SYC 5406 (pSYC5239)

Good H.1 Hemicellulase Bacillus subtilis var. (1) Distillers’ Mash (1) Manufacturing

Practice Good

(2) Liquid coffee (2) Manufacturingconcentrate Practice GoodMash destined for(3) (3) Manufacturingvinegar manufacture Practice GoodAspergillus niger var.I.01 Inulinase Inulin ManufacturingTieghem Practice

Sucrose used in the Good I.1 Invertase Aspergillus japonicus production of Manufacturing

fructooligosaccharides Practice Unstandardized soft- Good

Saccharomyces sp. (1) centred and liquid- (1) Manufacturing centred confectionery Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

(2) Unstandardizedbakery products (2) Good Manufacturing Practice

L.1 Lactase (1) Lactose-reducingenzyme preparations (1) Good Manufacturing Practice

(2) Milk destined for usein ice cream mix (2) Good Manufacturing Practice

Aspergillus niger var.; GoodBread; Flour; wholeAspergillus oryzae var.; (3) (3) Manufacturingwheat flourKluyveromyces fragilis Practice (Kluyveromyces (naming the flavour) marxianus var. milk; (naming the marxianus); flavour) skim milk; Kluyveromyces lactis (naming the flavour) (Kluyveromyces partly skimmed milk; marxianus var. lactis); (naming the flavour) Good Saccharomyces sp. (4) malted milk; (naming (4) Manufacturing

the flavour) skimmed Practice milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids

GoodMilk destined for use(1) (1) Manufacturingin ice cream mixCell-free extracts from Practice Candida pseudotropicalis Good

(2) Yogurt (2) Manufacturing Practice Good

(3) Whey (3) Manufacturing Practice

(naming the flavour) milk; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; Good

(4) (naming the flavour) (4) Manufacturing malted milk; (naming Practice the flavour) skim milk with added milk solids; (naming the flavour) partly

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

skimmed milk with added milk solids Dairy based Good

L.2 Lipase (1) flavouring (1) Manufacturing preparations Practice

Animal pancreatic tissue; Dried egg-whiteAspergillus niger var.; Good(dried albumen);Aspergillus oryzae var.; (2) (2) ManufacturingLiquid egg-white (Edible forestomach tissue Practiceliquid albumen)of calves, kids or lambs; Rhizopus oryzae var. Cheddar cheese; Good(naming the variety)(3) (3) ManufacturingCheese; Processed Practicecheddar cheese

GoodBread; Flour; Whole(4) (4) Manufacturingwheat flour Practice GoodUnstandardized(5) (5) Manufacturingbakery products Practice

Hydrolyzed animal, Good (6) milk and vegetable (6) Manufacturing

protein Practice Good

(1) Modified fats and oils (1) Manufacturing PracticeAspergillus oryzae

(MLT-2) (pRML 787) Cheddar cheese; Good (p3SR2); Rhizomucor (2) (naming the variety) (2) Manufacturing miehei (Cooney and Cheese Practice Emerson) (previous Dairy based Good name: Mucor miehei (3) flavouring (3) Manufacturing (Cooney and Emerson)); preparations Practice Rhizopus niveus Hydrolyzed animal, Good

(4) milk and vegetable (4) Manufacturing protein Practice

GoodAspergillus oryzae AI-11 Bread; Flour; Whole(1) (1) Manufacturing(pBoel 960) wheat flour Practice GoodUnstandardized(2) (2) Manufacturingbakery products Practice Good

(3) Modified fats and oils (3) Manufacturing Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

Aspergillus oryzae GoodBECh2#3 (pCaHj559); Bread; Flour; Whole(1) (1) ManufacturingAspergillus oryzae wheat flour Practice(MStr115) (pMStr20) GoodUnstandardized(2) (2) Manufacturingbakery products Practice Good

(3) Modified lecithin (3) Manufacturing Practice Good

(4) Unstandardized egg (4) Manufacturingproducts Practice GoodAspergillus niger Modified fats and oils Manufacturing(pCaHj600/MBin118#11) Practice Good

Penicillium camembertii (1) Edible fats and oils (1) Manufacturing Practice GoodBread; Flour; WholeL.3 Lipoxidase Soyabean whey or meal (1) (1) Manufacturingwheat flour Practice

Cheddar cheese; Good L.4 Lysozyme Egg-white (naming the variety) Manufacturing

Cheese Practice Rhizomucor miehei Cheddar cheese;

M.1 Milk coagulating (Cooney and Emerson) Cottage cheese; Good

(1) (1) Manufacturingenzyme (previous name: Mucor (naming the variety) Practice miehei (Cooney and Cheese; Sour cream Emerson)) or Mucor Dairy based Good pusillus Lindt by pure (2) flavouring (2) Manufacturing culture fermentation preparations Practice process or Aspergillus Hydrolyzed animal, Good oryzae RET-1 (3) milk and vegetable (3) Manufacturing (pBoel777) protein Practice

Emmentaler Good (1) (Emmental, Swiss) (1) ManufacturingEndothia parasitica by Cheese Practicepure culture fermentation

Goodprocesses (2) Parmesan Cheese (2) Manufacturing

Practice Good

(3) Romano Cheese (3) Manufacturing Practice

Column I Column II Column III Column IV Item Additive Permitted SourceNo.

P.1 Pancreatin

Pancreas of the hog (Sus scrofa) or ox (Bos taurus)

P.2 Papain

Fruit of the papaya Carica papaya L. (Fam. Caricaceae)

Maximum Level ofPermitted in or Upon Use GoodMozzarella(4) (4) Manufacturing(Scamorza) Cheese Practice

Part Skim Mozzarella Good (5) (Part Skim Scamorza) (5) Manufacturing

Cheese Practice Dried egg-white Good(dried albumen);(1) (1) ManufacturingLiquid egg-white Practice(liquid albumen)

Good (2) Precooked (instant) (2) Manufacturingcereals Practice

Starch used in the production of dextrins, maltose, Good

(3) dextrose, glucose (3) Manufacturing (glucose syrup), or Practice glucose solids (dried glucose syrup) Hydrolyzed animal, Good

(4) milk and vegetable (4) Manufacturing proteins Practice Ale; Beer; Light beer; Good

(1) Malt liquor; Porter; (1) Manufacturing Stout Practice

Good (2) Beef before slaughter (2) Manufacturing

Practice Sausage casings; Good

(3) Water-soluble edible (3) Manufacturing collagen films Practice Hydrolyzed animal, Good

(4) milk and vegetable (4) Manufacturing protein Practice

Good (5) Meat cuts (5) Manufacturing

Practice Good

(6) Meat tenderizing (6) Manufacturingpreparations Practice Good

(7) Precooked (instant) (7) Manufacturingcereals Practice

Column I Column II Column III Column IV Maximum Level ofItem Additive Permitted SourceNo.

P.3 Pectinase Aspergillus niger var.; Rhizopus oryzae var.

Aspergillus oryzae Km-1­ 1 (pA2PEI)

P.4 Pentosanase Aspergillus niger var.; Bacillus subtilis var.

Permitted in or Upon Use

(8) Pumping pickle forthe curing of beef cuts (8)

Unstandardized(9) bakery products

(1) Cider; Wine

(2) Distillers’ Mash

(3) Single-strength fruitjuices

Natural flavour and(4) colour extractives

Skins of citrus fruits destined for jam,

(5) marmalade and candied fruit production

(6) Vegetable stock for

(7)

(1)

use in soups

Tea leaves for the production of tea solids

Cider; Wine

(2) Single-strength fruitjuices

Unstandardized fruit (3) and vegetable

products Ale; Beer; Light beer;

(1) Malt liquor; Porter; Stout

Corn for(2) degermination

(9)

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(1)

(2)

(3)

(1)

(2)

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

Good Manufacturing Practice

Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice Good Manufacturing Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted Source Permitted in or UponNo. Use

Trichoderma reesei (QM9414)

Glandular layer ofP.5 Pepsin porcine stomach

Good (3) Distillers’ Mash (3) Manufacturing

Practice GoodMash destined for(4) (4) Manufacturingvinegar manufacture Practice GoodUnstandardized(5) (5) Manufacturingbakery products Practice GoodBread; Flour; Whole(6) (6) Manufacturingwheat flour Practice GoodBread; Flour; Whole(1) (1) Manufacturingwheat flour Practice Good

(2) Distiller’s Mash (2) Manufacturing Practice GoodUnstandardized(3) (3) Manufacturingbakery products Practice

Ale; Beer; Light beer; Good (1) Malt liquor; Porter; (1) Manufacturing

Stout Practice Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with Good

(2) (naming the added (2) Manufacturing ingredients); Cream Practice cheese with (naming the added ingredients); (naming the variety) Cheese

Good (3) Defatted soya flour (3) Manufacturing

Practice Good

(4) Precooked (instant) (4) Manufacturingcereals Practice Hydrolyzed animal, Good

(5) milk and vegetable (5) Manufacturing proteins Practice

Column I Column II Column III Column IV Item Additive Permitted SourceNo.

StreptomycesP.5A Phospholipase violaceoruber

Aspergillus oryzae (pPFJo142)

P.6 Protease

Aspergillus oryzae var.; Aspergillus niger var.; Bacillus subtilis var.

Maximum Level ofPermitted in or Upon Use Good

(1) Modified lecithin (1) Manufacturing Practice Good

(2) Unstandardized egg (2) Manufacturingproducts Practice Cheddar cheese; Good (naming the variety) Manufacturing Cheese Practice Ale; Beer; Light beer; Good

(1) Malt liquor;Porter; (1) Manufacturing Stout Practice

GoodBread; Flour; Whole(2) (2) Manufacturingwheat flour Practice Dairy based Good

(3) flavouring (3) Manufacturing preparations Practice

Good (4) Distillers’ Mash (4) Manufacturing

Practice Good

(5) Sausage casings (5) Manufacturing Practice

Hydrolyzed animal, Good (6) milk and vegetable (6) Manufacturing

protein Practice Good

(7) Industrial spray-dried (7) Manufacturingcheese powder Practice Good

(8) Meat cuts (8) Manufacturing Practice Good

(9) Meat tenderizing (9) Manufacturingpreparations Practice Good

(10) Precooked (instant) (10) Manufacturingcereals Practice Good

(11) Unstandardized (11) Manufacturingbakery products Practice (12) Cheddar cheese; (12) Good

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

Cheddar cheese for Manufacturing processing (granular Practice curd cheese; Stirred curd cheese; Washed curd cheese); Colby cheese

Good (13) Plant-based beverages (13) Manufacturing

Practice GoodMicrococcus caseolyticus (1) (naming the variety) (1) Manufacturingvar. Cheese Practice

Bacillus licheniformis (Cx) (1)

Hydrolyzed animal, milk and vegetable protein

(1) Good Manufacturing Practice

P.7 Pullulanase

Bacillus acidopullulyticus NCIB 11647; Bacillus licheniformis SE2-Pul­ int211 (pUBCDEBR A11DNSI)

(1)

(2)

Bread; Flour; Whole wheat flour (1)

Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose

(2)

Good Manufacturing Practice

Good Manufacturing Practice

(3) Unstandardizedbakery products (3) Good Manufacturing Practice

Bacillus licheniformis (1) Bread; Flour; Wholewheat flour (1)

Good Manufacturing Practice

BMP 139 (pR11Amp) Good (2) Brewers’ Mash (2) Manufacturing

Practice Starch used in the

(3)

production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose

(3) Good Manufacturing Practice

(4) Unstandardized (4) Good

Column I Column II Column III Column IV Item No. Additive Permitted Source

Bacillus subtilis B1-163 (pEB301)

Bacillus subtilis RB121 (pDG268)

Aqueous extracts from R.1 Rennet the fourth stomach of

calves, kids or lambs

Maximum Level ofPermitted in or Upon Use bakery products Manufacturing

Practice GoodBread; Flour; Whole(1) (1) Manufacturingwheat flour Practice Good

(2) Brewers’ Mash (2) Manufacturing Practice Good

(3) Distillers’ Mash (3) Manufacturing Practice

Starch used in the production of dextrins, dextrose, Goodglucose (glucose(4) (4) Manufacturingsyrup), glucose solids Practice(dried glucose syrup) or fructose syrups and solids, maltose

GoodUnstandardized(5) (5) Manufacturingbakery products Practice Good

(1) Brewers’ Mash (1) Manufacturing Practice Good

(2) Distillers’ Mash (2) Manufacturing Practice

Starch used in the production of dextrins, dextrose, Good

(3) glucose (glucose (3) Manufacturing syrup), glucose solids Practice (dried glucose syrup) or maltose Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream Goodcheese spread with(1) (1) Manufacturing(naming the added Practiceingredients); Cream cheese with (naming the added ingredients); (naming

Column I Column II Column III Column IV Item No. Additive Permitted Source Permitted in or Upon

Maximum Level of Use

the variety) Cheese; Sour cream Unstandardized milk Good

(2) based dessert (2) Manufacturing preparations Practice

T.01 Transglutaminase Streptoverticillium mobaraense strain S­ 8112

(1)

(2)

Unstandardized prepared fish products (1)

Simulated meat products (2)

Good Manufacturing Practice Good Manufacturing Practice

(3) Unstandardizedcheese products (3) Good Manufacturing Practice

Unstandardized Good (4) processed cheese (4) Manufacturing

products Practice

(5) Unstandardized creamcheese products (5) Good Manufacturing Practice Good

(6) Yogurt (6) Manufacturing Practice

(7) Unstandardizedfrozen dairy desserts (7) Good Manufacturing Practice

T.1 Trypsin Pancreas of the hog (Susscrofa) (1) Hydrolyzed animal, milk and vegetable proteins

(1) Good Manufacturing Practice

X.1 Xylanase Aspergillus oryzae Fa 1–1 (pA2X1TI) (1) Bread; Flour; Whole wheat flour (1)

Good Manufacturing Practice

(2) Unstandardizedbakery products (2) Good Manufacturing Practice

Aspergillus oryzae JaL 339 (pJaL537); Bacillus subtilis DIDK 0115 (pUB110 OIS2)

(1) Bread; Flour; Wholewheat flour (1) Good Manufacturing Practice

(2) Unstandardizedbakery products (2) Good Manufacturing Practice

SOR/78-402, s. 6; SOR/78-876, s. 3; SOR/79-662, ss. 14 to 17; SOR/80-501, s. 4; SOR/80­ 632, s. 5; SOR/81-60, s. 11; SOR/81-934, ss. 7 to 10; SOR/82-383, s. 10; SOR/82-566, s. 2; SOR/82-1071, s. 17; SOR/84-302, s. 4; SOR/84-762, ss. 8, 9; SOR/84-801, s. 4; SOR/86-89, ss. 4 to 6; SOR/86-1112, s. 4; SOR/87-254, s. 2; SOR/87-640, s. 7; SOR/88-281, s. 1; SOR/90-24, ss. 1 to 3; SOR/90-87, ss. 10 to 12; SOR/90-469, s. 3; SOR/91-124, s. 5(F); SOR/91-487, s. 1; SOR/91-691, s. 1; SOR/92-63, s. 4; SOR/92-94, s. 4; SOR/92-195, s. 1; SOR/92-197, s. 9; SOR/92-231, s. 1; SOR/92-518, s. 1; SOR/92-591, s. 2(F); SOR/94-29, s. 1; SOR/94-182, s. 1; SOR/94-212, s. 9; SOR/94-417, s. 2; SOR/94-552, s. 1; SOR/94-689, s. 2; SOR/94-712, s. 1; SOR/95-65, s. 1; SOR/95-183, s. 9; SOR/95-525, ss. 1, 2; SOR/96-375, s. 1; SOR/97-81, s. 1; SOR/97-82, s. 1; SOR/97-122, ss. 4(F), 5;SOR/97-508, ss. 1, 2; SOR/97-513, s. 1; SOR/97-558, s. 4; SOR/98-454, s. 1; SOR/98-458, ss. 6, 7(F); SOR/2000­ 336, ss. 3 to 5; SOR/2000-417, s. 4; SOR/2003-130, s. 4; SOR/2004-84, s. 1; SOR/2005-98, ss. 4 to 7, 8(F); SOR/2005-394, ss. 1 to 6; SOR/2007-225, s. 1; SOR/2010-41, ss. 1 to 6, 9(E); SOR/2010-42, ss. 1 to 4; SOR/2010-94, s. 8(E); SOR/2010-142, s. 17; SOR/2010-143, ss. 14 to 26.

TABLE VI

FOOD ADDITIVES THAT MAY BE USED AS FIRMING AGENTS

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Canned crabmeat, lobster, A.1 Aluminum (1) salmon, shrimp and tuna; (1) Good Manufacturing Practice

Sulphate Pickles and relishes (2) Unstandardized foods (2) Good Manufacturing Practice

Ammonium (1) Pickles and relishes (1) Good Manufacturing PracticeA.2 Aluminum Sulphate (2) Unstandardized foods (2) Good Manufacturing Practice

C.1 (1) Canned apples (1) 0.026% calculated as calcium Calcium 0.035% calculated as calcium in Chloride (2) Canned grapefruit (2) accordance with subparagraph

B.11.101(c)(vii)

(3) (naming the variety) cheese; (3) 0.02% of the milk and milkCheddar cheese products used (4) Cottage cheese (4) Good Manufacturing Practice (5) Glaze of frozen fish (5) Good Manufacturing Practice (6) Olives (6) 1.5% of the brine (7) Pickles and relishes (7) 0.4%

Tomatoes; Canned 0.026% calculated as calcium, (8) vegetables (naming the (8) and in the case of canned peas

vegetable); Frozen apples 0.035% calculated as calcium (9) Unstandardized foods (9) Good Manufacturing Practice

Tomatoes; Canned C.2 Calcium Citrate (1) vegetables; Frozen apples; (1) 0.026% calculated as calcium

Frozen sliced apples (2) Canned apples (2) 0.026% calculated as calcium

Column I Column II Item No. Additive Permitted in or Upon

(3) Unstandardized foods

C.3 Calcium Unstandardized foodsGluconate

C.3A Calcium Lactate (1) Canned grapefruit

Calcium C.4 Phosphate,

dibasic

C.5 Calcium Phosphate, monobasic

CalciumC.6 Sulphate

PotassiumP.1 Aluminum Sulphate SodiumS.1 Aluminum Sulphate

(2) Canned peas

Unstandardized foods

(1) Tomatoes; Cannedvegetables; Frozen apples (2) Canned apples (3) Unstandardized foods

(1) Tomatoes; Cannedvegetables; Frozen apples (2) Canned apples

(1) Pickles and relishes

(2) Unstandardized foods

(1) Pickles and relishes

(2) Unstandardized foods

Column III

Maximum Level of Use

(3) Good Manufacturing Practice

Good Manufacturing Practice

0.035% calculated as calcium in (1) accordance with subparagraph

B.11.101(c)(vii) (2) 0.035% calculated as calcium

Good Manufacturing Practice

(1) 0.026% calculated as calcium

(2) 0.026% calculated as calcium (3) Good Manufacturing Practice

(1) 0.026% calculated as calcium

(2) 0.026% calculated as calcium

(1) Good Manufacturing Practice

(2) Good Manufacturing Practice

(1) Good Manufacturing Practice

(2) Good Manufacturing Practice

SOR/78-402, s. 7; SOR/79-660, ss. 11, 12; SOR/79-752, s. 7; SOR/93-445, s. 1; SOR/94-689, s. 2(F); SOR/2007-302, s. 4(F); SOR/2010-94, s. 8(E).

TABLE VII

FOOD ADDITIVES THAT MAY BE USED AS GLAZING AND POLISHING AGENTS

Column I Item AdditiveNo.

AcetylatedA.1 Monoglycerides

B.1 Beeswax C.1 Carnauba Wax C.2 Candelilla Wax G.1 Gum Arabic G.2 Gum Benzoin M.1 Magnesium Silicate

Column II Column III

Permitted in or Upon Maximum Level of Use

(1) Unstandardized confectionery (1) 0.4%

(2) Frozen fish (2) Good ManufacturingPractice Unstandardized confectionery 0.4% Unstandardized confectionery 0.4% Unstandardized confectionery 0.4% Unstandardized confectionery 0.4% Unstandardized confectionery 0.4% Unstandardized confectionery 0.4%

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo. M.2 Mineral Oil Unstandardized confectionery 0.15% P.1 Petrolatum Unstandardized confectionery 0.15%

Cake decorations;S.1 Shellac 0.4%Unstandardized confectionery S.2 Spermaceti Wax Unstandardized confectionery 0.4% Z.1 Zein Unstandardized confectionery 1.0%

SOR/94-689, s. 2(F); SOR/2010-142, ss. 18 to 29.

TABLE VIII

MISCELLANEOUS FOOD ADDITIVES

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

Ale; Beer; Light Good ManufacturingA.01 Acacia Gum beer; Malt liquor; Fining agent PracticePorter; Stout; Wine Acetylated Unstandardized Coating; Good ManufacturingA.1 Monoglycerides foods Release agent Practice

Good ManufacturingA.1.01 Agar Wine Fining agent Practice Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen egg-white (frozen To stabilize albumen); Frozen albumenA.1.1 Aluminum Sulphate 0.036%whole egg; Frozen during yolk; Liquid egg- pasteurization white (liquid albumen); Liquid whole egg; Liquid yolk

Ammonium AntimicrobialA.2 Brewer’s yeast 0.1%Persulphate agent A.3 [Repealed, SOR/93-276, s. 4] A.4 [Repealed, SOR/93-276, s. 5]

Unstandardized AntistickingB.2 Beeswax 0.4%foods agent Liquid whey destined for theB.2.1 Benzoyl Peroxide To decolourize 100 p.p.m.manufacture of dried whey

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

products other than those for use in infant formula (Naming the flavour) Flavour 15 p.p.m. in

Brominated vegetable for use in Density beverages containingB.3 oil beverages adjusting agent citrus or spruce oils containing citrus or as consumed spruce oils Edible vegetable oil-based or Good ManufacturingB.4 n-Butane lecithin-based pan Propellant Practicecoatings or a mixture of both

ToCola type 200 p.p.m. in theC.1 Caffeine characterizebeverages finished productthe product To 200 p.p.m. calculatedCola typeC.2 Caffeine Citrate characterize as caffeine, in thebeverages the product finished product

900 p.p.m., in Carrier of accordance with

(1) Flour; WholeC.3 Calcium Carbonate (1) benzoyl (1) subparagraphswheat flour peroxide B.13.001(e)(vi) and B.13.005(d)(vi)

(2) [Repealed, SOR/94-227, s. 5] Unstandardized (3) Creaming and (3) Good Manufacturing(3) confectionery fixing agent Practice

(4) Good Manufacturing(4) Chewing gum (4) Filler Practice Unstandardized Carrier and (5) Good Manufacturing(5) (5)foods dusting agent Practice

Good Manufacturing Restoration of Practice (Quantity of

(1) Egg albumenC.3A Calcium Lactate (1) functional (1) calcium added not to(delysozymized) properties exceed that lost during processing)

A blend of prepared fish and prepared meat (2) To modify (2) Good Manufacturing(2) referred to in texture Practice paragraph B.21.006(n)

C.4 Calcium Oxide (1) Frozen crustaceans (1) To facilitate (1) When used in

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

and molluscs the removal of combination with extraneous sodium chloride matter and to (salt) and sodium reduce hydroxide in moisture loss solution, calcium during cooking oxide not to exceed

30 p.p.m. A blend of prepared fish and prepared meat (2) To modify (2) Good Manufacturing(2) referred to in texture Practice paragraph B.21.006(n)

900 p.p.m. in Carrier of accordance withCalcium Phosphate Flour; WholeC.5 (1) (1) benzoyl (1) subparagraphsdibasic wheat flour peroxide B.13.001(e)(vi) and

B.13.005(d)(vi) (2) [Repealed, SOR/94-227, s. 6]

900 p.p.m. in Carrier of accordance withCalcium Phosphate, Flour; WholeC.6 (1) (1) benzoyl (1) subparagraphstribasic wheat flour peroxide B.13.001(e)(vi) and

B.13.005(d)(vi) (2) [Repealed, SOR/94-227, s. 7]

Liquid whey destined for the manufacture of Carrier of

(3) 0.04% of dried whey(3) dried whey (3) benzoyl productproducts other than peroxide those for use in infant formula Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the To improve added ingredient); colour, texture,

(4) Processed cheese (4) consistency (4) 1.0% food; Processed and cheese food with spreadability (naming the added ingredients); Processed cheese spread; Processed

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

cheese spread with (naming the added ingredients)

Good ManufacturingC.7 Calcium Silicate Oil-soluble annatto Carrier Practice Unstandardized Good ManufacturingC.8 Calcium Stearate Release agentconfectionery Practice Frozen egg-white (frozen albumen); (1) WhippingC.9 (1) (1) 0.05%Calcium Stearoyl- 2- Liquid egg-white agent

Lactylate (liquid albumen)

(2) Dried egg-white (2) Whipping (2) 0.5%(dried albumen) agent

(3) Vegetable fat (3) Whipping (3) 0.3%toppings agent

(4) Dehydrated (4) Conditioning (4) 0.2% of dry weightpotatoes agent 900 p.p.m. in

Carrier of accordance with (1) Flour, WholeC.10 Calcium Sulphate (1) benzoyl (1) subparagraphswheat flour peroxide B.13.001(e)(vi) and

B.13.005(d)(vi) (2) [Repealed, SOR/94-227, s. 8]

(3) Good Manufacturing(3) Baking powder (3) Neutral filler Practice Ale; Beer; Carbonated (naming the fruit) juice; Cider; Light beer; Malt liquor; (1) Good ManufacturingC.11 Carbon Dioxide (1) (1) CarbonationPorter; Stout; Practice Wines; Water represented as mineral water or spring water

Carbonation Unstandardized and pressure (2) Good Manufacturing(2) (2)foods dispensing Practice

agent Cottage Cheese; To extend (3) Good Manufacturing(3) Creamed Cottage (3) durable life PracticeCheese Unstandardized Good ManufacturingC.12 Castor Oil Release agentconfectionery Practice

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

C.13 [Repealed, SOR/2010-142, s. 35] C.13.1 (1) Batter and breading (1) Bulking agent (1) 1%Cellulose, Powdered

(2) Canapé toast (2) Bulking agent (2) 2% Unstandardized confectionery that meet the conditions set out in column 2 of item 3 of the

(3) table following (3) Bulking agent (3) 25% section B.01.513 for the subject “Reduced in energy” set out in column 1 Unstandardized(4) (4) Bulking agent (4) 3%edible ices

(5) Fillings (5) Bulking agent (5) 0.5% Foods sold in tablet(6) (6) Bulking agent (6) 50%form

(7) Icings (7) Bulking agent (7) 1% (8) Seasonings (8) Bulking agent (8) 3% (9) Sweet baked goods (9) Bulking agent (9) 8%

Pressure C.14A Chloropentafluo- Unstandardized Good Manufacturingdispensing androethane foods Practiceaerating agent

C.15 Citric Acid (1) Beef blood (1) Anticoagulant (1) Good ManufacturingPractice Unstandardized Culture (2) Good Manufacturing(2) (2)foods nutrient Practice

ToBreath freshenerC.16 Copper gluconate characterize 50 p.p.m.products the product 0.0001%, calculated

C.17 Copper Sulphate Wine Fining agent as copper, in the finished product

Apple (or rhubarb) and (naming the fruit) Jam; Fats and

Dimethylpolysiloxane oils; Fig (1) Antifoaming (1) 10 p.p.m. ofD.1 (1)Formulations marmalade; Fig agent dimethylpolysiloxane marmalade with pectin; (naming the fruit) Jam; (naming

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade; Pineapple marmalade with pectin; Reconstituted lemon juice; Reconstituted lime juice; Shortening; Skim milk powder; Wine Pineapple juice; Blends of pineapple juice

(2) with other fruit juices; canned pineapple (when

(2) Anti-foamingagent (2) 10 p.p.m. of dimethylpolysiloxane

pineapple juice is used as the packing medium)

Good Manufacturing Surfaces that come Practice (Residue of

(3) in contact with (3) Release agent (3) dimethylpolysiloxane food in food not to exceed

10 p.p.m.)

(4) Unstandardizedfoods (4) Antifoaming agent (4)

10 p.p.m. of dimethylpolysiloxane

Wort used in the

(5) manufacture of Ale, Beer, Light beer, Malt liquor,

(5) Antifoamingagent (5) 10 p.p.m. of dimethylpolysiloxane

Porter and Stout

D.3 Dioctyl sodiumsulfosuccinate (1) Fumaric acid- acidulated dry beverage bases

(1) Wetting agent (1) 10 p.p.m. in thefinished drink

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

(2) Reduce casing (2) 200 p.p.m. of the(2) Sausage casings breakage casing To promotePaprika; GroundE.1 Ethoxyquin colour 100 p.p.m.chili pepper retention

Whole or ground G.M.P. (Residues of spice (except ethyleneE.2 Ethylene Oxide Fumigationmixtures chlorohydrin not to containing salt) exceed 1,500 p.p.m.)

Colour Good ManufacturingF.1 Ferrous Gluconate Ripe olives retention Practice Good ManufacturingG.1 Gelatin Beer; Cider; Wine Fining agent Practice

G.2 [Repealed, SOR/89-175, s. 2] To accelerateG.2A Glucono delta lactone (1) Cooked sausage, (1) (1) 0.5%Meat Loaf colour fixing To assist in (2) Good Manufacturing(2) Dry Sausage (2) curing Practice

Meat curing (1) Good ManufacturingG.3 Glycerol (1) compounds; (1) Humectant PracticeSausage casings

Glaze forPreserved meats (2) Good Manufacturing(2) (2) preserved(Division 14) Practicemeats Unstandardized (3) Humectant; (3) Good Manufacturing(3) foods Plasticizer Practice BeveragesGlycerol ester of DensityG.4 containing citrus or 100 p.p.m.wood rosin adjusting agentspruce oils

Clarification (1) 135 p.p.m. in theH.1 Hydrogen Peroxide (1) Brewers’ mash (1) aid mash Liquid whey destined for the To decolourize 100 p.p.m. (see also

(2) manufacture of (2) and maintain (2) subitem C.1(3) of dried whey pH Table V) products Oat hulls used in

(3) Bleaching (3) Good Manufacturing(3) the manufacture of agent Practiceoat hull fibre Edible vegetable oil-based or Good ManufacturingI. Isobutane Propellantlecithin-based pan Practice coatings or a

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

mixture of both

L.1 Lactylic Esters ofFatty Acids Unstandardized foods

Plasticizing agent

Good Manufacturing Practice

L.2 Lanolin Chewing gum Plasticizingagent Good Manufacturing Practice

L.3 Lecithin Surfaces that come in contact with food

Release agent Good ManufacturingPractice

L.4 L-Leucine

Table-top sweetener tablets containing aspartame

Lubricant in tablet manufacture

3% of tablet weight

Magnesium Good ManufacturingM.1 Chewing gum Dusting agentAluminum Silicate Practice 900 p.p.m. in

Carrier of accordance withMagnesium Flour, WholeM.2 (1) (1) benzoyl (1) subparagraphsCarbonate wheat flour peroxide B.13.001(e)(vi) and B.13.005(d)(vi)

(2) [Repealed, SOR/94-227, s. 9] Unstandardized (3) Good Manufacturing(3) (3) Release agentconfectionery Practice

Good Manufacturing Practice (Quantity ofRestoration ofEgg albumen magnesium addedM.2A Magnesium Chloride functional(delysozymized) not to exceed thatproperties lost during processing)

Unstandardized (1) Good ManufacturingM.3 (1) (1) Release agentconfectionery PracticeMagnesium Silicate (2) Dusting agent (2) Good Manufacturing(2) Chewing gum Practice

(3) Good Manufacturing(3) Rice (3) Coating Practice Unstandardized (1) Good ManufacturingM.4 Magnesium (1) (1) Release agentconfectionery Practice Foods sold in tablet (2) Binding agent (2) Good ManufacturingStearate (2) form Practice

Good Manufacturing Restoration of Practice (Quantity ofEgg albumenM.4A Magnesium Sulphate functional magnesium added(delysozymized) properties not to exceed that

lost during

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

processing) M.5A [Repealed, SOR/93-276, s. 6]

Methyl Ethyl Unstandardized Good ManufacturingM.5C Aerating agentCellulose foods Practice

M.6 MicrocrystallineCellulose (1) Ice milk mix (1) Bodying and texturizing agent

(1) 1.5%

Bodying and (2) Sherbet (2) texturizing (2) 0.5%

agent Unstandardized foods that meet the conditions set out in column 2 of item

(3) 3 of the tablefollowing section (3) Filler (3) Good Manufacturing Practice

B.01.513 for the subject “Reduced in energy” set out in column 1

(4) Whipped vegetableoil topping (4) Bodying and texturizing agent

(4) 1.5%

(5) Unstandardizedfrozen desserts (5) Bodying and texturizing agent

(5) 0.5%

(6)

Unstandardized sandwich spreads; Unstandardized dips

(6) Bodying and texturizing agent

(6) 3.0%

Unstandardized

(7)

foods other than those unstandardized foods referred to in

(7) Bodying and texturizing agent

(7) 2.0%

this item 0.5% or, if used in combination with

(8) Ice cream mix (8) Bodying and texturizing agent

(8)

stabilizing agents, the combined amount shall not exceed 0.5% of the ice cream made from the mix

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

Table-top

(9) sweetener tabletscontaining (9) Tablet disintegration (9) 2.2%

aspartame

(10) Cream forwhipping (10) Stabilizing and thickening agent

(10) 0.2%

(11) Breath freshenerproducts (11) Bodying and texturizing agent

(11) 9.0%

0.3% in accordance with section B.01.047. If

M.7 Mineral Oil (1)

Bakery products; Seeded raisins; Unstandardized confectionery

(1) Release agent (1)

petrolatum is also used as a release agent in bakery products the total of any combination of petrolatum and mineral oil must not exceed 0.15%

(2) Fresh fruits andvegetables (2) Coating (2) 0.3% in accordance with section B.01.047 5% in accordance with paragraph B.01.047(e) (Residues of mineral

(3) Sausage casings (3) Lubricant (3) oil in a raw sausageprepared with such casings not to exceed 200 p.p.m.; in cooked sausage, 30 p.p.m.)

Binding agent 0.6% in accordance (4) Salt Substitute (4) and protective (4) with paragraph

coating B.01.047(h)

M.8 Monoacetin Unstandardizedbakery products Plasticizer Good Manufacturing Practice

Apple (or rhubarb) and (naming the

M.9 Mono- and di-glycerides (1) fruit) Jam; Fats and oils; Fig (1)

Antifoaming agent (1)

Good Manufacturing Practice

marmalade; Fig marmalade with

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade; Pineapple marmalade with pectin

Antifoaming

(2) Unstandardizedfoods (2) agent; Humectant; (2)

Good Manufacturing Practice

Release agent Antifoaming

M.10 Mono-glycerides Unstandardizedfoods agent; Humectant;

Good Manufacturing Practice

Release agent Cream cheese; Cream cheese with (naming the added

N.1 Nitrogen (1) ingredients); Cream cheese spread; Cream

(1) To improvespreadability (1) Good Manufacturing Practice

cheese spread with (naming the added ingredients)

(2) Margarine (2) To improvespreadability (2) Good Manufacturing Practice

(3) Unstandardizedfoods (3) Pressure dispensing agent

(3) Good ManufacturingPractice

PressureUnstandardized Good ManufacturingN.2 Nitrous Oxide dispensingfoods Practiceagent PressureOctafluorocyclobu- Unstandardized Good Manufacturingdispensing andtane foods Practiceaerating agent

O.1

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

Cotton seed oil; To inhibit O.2 Oxystearin Peanut oil; Soy crystal 0.125%

bean oil formation

(1) Maturing (1) Good ManufacturingO.3 Ozone (1) Cider agent Practice Water represented

(2) as mineral water or (2) Chemosterilant (2) Good ManufacturingPracticespring water

(3) Maturing (3) Good Manufacturing(3) Wine agent Practice Acid producing To control Good ManufacturingP.1 Pancreas Extract bacterial cultures bacteriophages Practice

P.1A Paraffin Wax (1) Fresh fruits andvegetables (1) Coating (1) 0.3% in accordance with section B.01.047

(2) Cheese and turnips (2) Coating (2)

Good Manufacturing Practice in accordance with section B.01.047 0.15% in accordance with section B.01.047. If mineral oil is also used as a

P.2 Petrolatum (1) Bakery products (1) Release agent (1) release agent thetotal of any combination of petrolatum and mineral oil must not exceed 0.15%

(2) Fresh fruits andvegetables (2) Coating (2) 0.3% in accordance with section B.01.047

P.2A

P.2B

P.3

(1) Soft drinks Polyethylene glycol (molecular weight 3000-9000) (2)

Table-top sweetener tablets containing aspartame

(3) L-Lysine tablets

Polydextrose Unstandardizedfoods

Polyvinylpyrroli-done (1) Ale; Beer; Cider;Light beer; Malt

(1) Antifoamingagent

(2) Lubricant

(3) Tablet binder Bodying and texturizing agent

(1) Fining agent

(1) 10 p.p.m.

(2) 1.0%

(3) 7.0%

Good Manufacturing Practice

(1) 2 p.p.m. in thefinished product

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

liquor; Porter; Stout; Wine Table-top sweetener tablets(2) (2) Tablet binder (2) 0.3%containing aspartame

Viscosity Good ManufacturingColour lake reduction Practice (Residues ofdispersions for use agent and polyvinyl(3) in unstandardized (3) (3)stabilizer in pyroliodone not toconfectionery in colour lake exceed 100 p.p.m. intablet form dispersions the finished foods) 900 p.p.m., in

Carrier of accordance withPotassium Aluminum Flour; WholeP.4 benzoyl subparagraphsSulphate wheat flour peroxide B.13.001(e)(vi) and B.13.005(d)(vi)

Potassium Good ManufacturingP.4.1 Wine Fining agentFerrocyanide Practice

(1) Plasticizing (1) Good ManufacturingP.5 (1) Chewing gum agent Practice Emulsifying

Potassium Stearate preparations (2) Stabilizing(2) containing (2) 2%agentpropylene glycol

monoesters PressureUnstandardized Good ManufacturingP.6 Propane dispensing andfoods Practiceaerating agent

(1) Good Manufacturing(1) Oil-soluble annatto (1) Solvent PracticeP.7 Propylene Glycol Unstandardized (2) Good Manufacturing(2) (2) Humectantfoods Practice Beverage bases; Foaming Good ManufacturingQ.1 Quillaia Extract Beverage mixes; Agent PracticeSoft drinks Beverage bases; Good ManufacturingS.1 Saponin Beverage mixes; Foaming agent PracticeSoft drinks Edible vegetable SuspendingS.1.01 Silicon Dioxide oil-based cookware 2.0% of preparationagentcoating emulsions

Sodium Acid Frozen fish fillets; To reduce Used in combinationS.1.1 Pyrophosphate frozen minced fish; processing with sodium

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

frozen lobster; losses and to tripolyphosphate and frozen crab; frozen reduce thaw sodium clams; frozen drip pyrophosphate shrimp tetrabasic, total

added pyrophosphate not to exceed 0.5% calculated as sodium phosphate, dibasic 900 p.p.m. in

Carrier of accordance withSodium Aluminum Flour; WholeS.2 benzoyl subparagraphsSulphate wheat flour peroxide B.13.001(e)(vi) and B.13.005(d)(vi)

UnstandardizedS.3 Sodium (1) (1) Aerating agent (1) Good Manufacturingconfectionery Practice To stabilize

(2) Good ManufacturingBicarbonate (2) Salt (2) potassium Practiceiodide in salt In combination with sodium 15% of thehexametophosphate combination offor use on frozen To reduceS.3A Sodium Carbonate sodium carbonatefish fillets, frozen thaw drip and sodiumlobster, frozen hexametaphosphatecrabs, frozen clams and frozen shrimp

Sodium Coating toS.3B Carboxymethyl Sausage casings 0.25% of the casingenable peelingCellulose S.4 Sodium Citrate (1) Beef blood (1) Anticoagulant (1) 0.5%

Flavour(2) Sour cream (2) (2) 0.1%precursor A blend of prepared fish and prepared meat (3) To modify (3) Good Manufacturing(3) referred to in texture Practice paragraph B.21.006(n)

As an adjuvant in the 13 p.p.m. calculatedSodium FerrocyanideS.5 Dendritic salt production of as anhydrous sodiumDecahydrate dendritic salt ferrocyanide crystals

S.6 Sodium Hexameta- (1) Beef blood (1) Anti-coagulant (1) 0.2%

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

phosphate Frozen fish fillets; 0.5% total addedfrozen lobsters; To reduce phosphate calculated(2) frozen crab; frozen (2) (2)thaw drip as sodium phosphate,clams and frozen dibasicshrimp Gelatin intended

(3) Whipping(3) for marshmallow (3) 2%agentcompositions When used inTo facilitate combination withthe removal of sodium chlorideextraneousFrozen crustaceans (salt) and calciumS.6A Sodium Hydroxide matter and toand molluscs oxide in solution,reduce sodium hydroxidemoisture loss not to exceed 70during cooking p.p.m.

(1) Dried egg-white (1) WhippingS.6.1 (1) 0.1%(dried albumen) agent Sodium Lauryl Frozen egg-white Sulphate (frozen albumen); (2) Whipping(2) (2) 0.0125%Liquid egg-white agent

(liquid albumen) Gelatin intended

(3) Whipping(3) for marshmallow (3) 0.5%agentcompositions ToSodium Potassium Breath freshenerS.6.2 characterize 700 p.p.m.Copper Chlorophyllin products the product To preventSodium Phosphate, (1) Good ManufacturingS.7 (1) Frozen fish (1) cracking ofdibasic Practiceglaze

(2) Good Manufacturing(2) Frozen mushrooms (2) To preventdiscolouration Practice Used in combination with sodiumFrozen fish fillets; To reduce tripolyphosphate andfrozen minced fish;Sodium processing sodium acidfrozen lobster;S.7.1 Pyrophosphate, losses and to pyrophosphate, totalfrozen crab; frozentetrabasic reduce thaw added phosphate notclams; frozen drip to exceed 0.5%shrimp calculated as sodium phosphate, dibasic

Canned drinking Corrosion Good ManufacturingS.8 Sodium Silicate water inhibitor Practice

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use

S.9 Sodium Stearate Chewing gum Plasticizingagent Good Manufacturing Practice

S.9A Sodium Stearoyl- 2­ Lactylate

(1)

Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)

(2) Dried egg-white(dried albumen)

(1) Whippingagent

(2) Whippingagent

(1) 0.05%

(2) 0.5%

(3) Oil toppings ortopping mixes (3) Whipping agent (3) 0.3%

(4) Dehydratedpotatoes (4) Conditioning agent (4) 0.2% of dry weight

S.9B Sodium Sulphate Frozen mushrooms To preventdiscolouration Good Manufacturing Practice

S.9C Sodium Sulphite Canned flaked tuna To preventdiscolouration 300 p.p.m.

S.10 Sodium Thiosulphate Salt To stabilize potassium iodine in salt

Good Manufacturing Practice

Used singly or in combination with

S.11 SodiumTripolyphosphate

Frozen fish fillets; frozen minced fish; frozen comminuted fish; frozen lobster; frozen crab; frozen clams and frozen shrimp

To reduce processing losses and to reduce thaw drip

sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

S.12 [Repealed, SOR/93-276, s. 8]

S.13 Stannous Chloride (1)

Asparagus packed in glass containers or fully lined (lacquered) cans

(1) Flavour and colour stabilizer

(1) 25 p.p.m. calculatedas tin

Canned carbonated

(2)

soft drinks; concentrated fruit juices except frozen concentrated

(2) Flavour and colour stabilizer

(2) Good ManufacturingPractice

orange juice; lemon juice; lime juice Unstandardized (1) Good ManufacturingS.14 Stearic Acid (1) (1) Release agentconfectionery Practice

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo.

(2) Plasticizing (2) Good Manufacturing(2) Chewing gum agent Practice Foods sold in tablet (3) Release agent (3) Good Manufacturing(3) form and lubricant Practice

A processing aid, the result of methylation of pectin by

Sodium Methyl sulfuric acidS.15 Pectin 0.1% of pectinSulphate and methyl alcohol and neutralized by sodium bicarbonate

S.15A [Repealed, SOR/93-276, s. 9] (Naming the flavour) Flavour 300 p.p.m. in

Sucrose Acetate for use in Density beverages containingS.16 Isobutyrate beverages adjusting agent citrus or spruce oils containing citrus or as consumed spruce oils

To improve the extraction Good ManufacturingS.17 Sulphuric Acid Coffee beans yield of coffee Practice solids

(1) Coating agent (1) Good ManufacturingT.1 Talc (1) Rice Practice

(2) Good Manufacturing(2) Chewing gum base (2) Filler Practice

(3) Dusting agent (3) Good Manufacturing(3) Chewing gum Practice To reduce (1) Good ManufacturingT.2 Tannic Acid (1) Chewing gum (1) adhesion Practice

(2) Cider; Honey wine; (2) Fining agent (2) 200 p.p.mWine T.2A [Repealed, SOR/93-276, s. 10]

Good ManufacturingT.3 Triacetin Cake mixes Wetting agent Practice Dried egg-white (dried albumen); Frozen egg-white WhippingT.4 Triethyl Citrate 0.25%(frozen albumen); agent Liquid egg-white (liquid albumen)

Column I Column II Column III Column IV Item Additive Permitted in or Upon Purpose of Use Maximum Level of UseNo. X.1 [Repealed, SOR/93-276, s. 11]

SOR/78-401, s. 3; SOR/78-403, ss. 23 to 25; SOR/78-876, s. 4; SOR/79-660, s. 13; SOR/79­ 752, s. 8; SOR/80-632, ss. 6 to 13; SOR/81-83, s. 4; SOR/81-617, s. 3; SOR/81-934, ss. 11, 12; SOR/82-566, ss. 3, 4; SOR/82-1071, ss. 18 to 20; SOR/83-410, s. 3; SOR/83-584, s. 1; SOR/83-932, ss. 5, 6; SOR/84-17, s. 6; SOR/84-441, s. 1; SOR/84-602, s. 3; SOR/84-762, s. 10; SOR/84-801, ss. 5, 6; SOR/86-1112, s. 5; SOR/86-1125, s. 2; SOR/87-469, s. 1; SOR/87­ 640, s. 8; SOR/88-419, s. 4; SOR/88-534, ss. 5, 6; SOR/89-175, s. 2; SOR/89-197, s. 1; SOR/89-198, s. 11; SOR/89-555, ss. 2, 3; SOR/91-90, s. 2; SOR/91-124, ss. 6 to 9; SOR/91­ 149, s. 3; SOR/91-186, s. 1; SOR/91-409, s. 7; SOR/91-527, s. 4; SOR/92-229, s. 1; SOR/92­ 344, ss. 2 to 4; SOR/93-276, ss. 4 to 11; SOR/94-416, s. 1; SOR/94-227, ss. 5 to 10; SOR/94­ 689, s. 2(F); SOR/94-723, s. 1; SOR/96-260, s. 1; SOR/96-378, s. 1;SOR/97-509, s. 1; SOR/98-580, s. 1(F); SOR/99-97, s. 1; SOR/99-420, s. 11(F); SOR/2000-353, s. 8(F); SOR/2001-94, s. 3; SOR/2005-316, ss. 2(F), 3; SOR/2006-91, ss. 6 to 12; SOR/2007-75, s. 7; SOR/2010-41, s. 9(E); SOR/2010-94, s. 8(E); SOR/2010-142, ss. 30(F), 31 to 39, 40(F), 41 to 45, 46(F), 47 to 51, 59(F); SOR/2010-143, ss. 27 to 31.

TABLE IX

FOOD ADDITIVES THAT MAY BE USED AS SWEETENERS

Column I Column II Column III Item Maximum Level ofAdditive Permitted in or onNo. Use

Good A.01 (1) Table-top sweeteners (1) Manufacturing

Acesulfame- Practice potassium 0.025% in

(2) Carbonated beverages (2) beverages as consumed

Beverages; Beverage concentrates; Beverage mixes; Dairy beverages; 0.05% in

(3) (except for any of these products for (3) beverages as which standards are set out in these consumed Regulations) Desserts; Dessert mixes; Toppings; Topping mixes; Fillings; Filling mixes;

(4) 0.1% in products(4) (except for any of these products for as consumedwhich standards are set out in these Regulations)

(5) Chewing gum; Breath freshener (5) 0.35%products Fruit spreads (except for any of these

(6) products for which standards are set (6) 0.1% out in these Regulations)

(7) Salad dressings (except for any of (7) 0.05%

Column I Item AdditiveNo.

A.1 Aspartame

Aspartame, encapsulated toA.2 prevent degradation during baking

E.1 Erythritol

Column II Column III Maximum Level ofPermitted in or on Use

these products for which standards are set out in these Regulations)

(8) Unstandardized confectionery (8) 0.25% Bakery mixes; Bakery products; (except for any of these products for (9) 0.1% in products(9) which standards are set out in these as consumed Regulations)

Good (1) Table-top sweeteners (1) Manufacturing

Practice (2) Breakfast cereals (2) 0.5%

Beverages; Beverage concentrates; 0.1% inBeverage mixes; (except for any of(3) (3) beverages asthese products for which standards are consumedset out in these Regulations) Desserts; Dessert mixes; Toppings; Topping mixes; Fillings; Filling mixes;

(4) 0.3% in products(4) (except for any of these products for as consumedwhich standards are set out in these Regulations)

(5) Chewing gum; Breath freshener (5) 1.0%products Fruit spreads; Purées and sauces; Table syrups; (except for any of these(6) (6) 0.2%products for which standards are set out in these Regulations) Salad dressings; Peanut and other nut spreads; (except for any of these(7) (7) 0.05%products for which standards are set out in these Regulations) Condiments (except for any of these

(8) products for which standards are set (8) 0.2% out in these Regulations) Confectionery glazes for snack foods;

(9) Sweetened seasonings or coating (9) 0.1% mixes for snack foods

(10) Unstandardized confectionery;Unstandardized confectionery coatings (10) 0.3%

Bakery products and baking mixes (except for any of these products for 0.4% in product which standards are set out in these as consumed Regulations)

(1) Table-top sweeteners (1) Good

Column I Column II Column III Item Maximum Level ofAdditive Permitted in or onNo. Use

Manufacturing Practice

(2) Dietetic beverages (2) 3.5% (3) Fat-based cream fillings and toppings (3) 60% (4) Dietetic cookies and wafers (4) 7% (5) Soft candies (5) 40% (6) Hard candies (6) 50% (7) Chewing gum (7) 60%

GoodHydrogenatedH.1 Unstandardized foods Manufacturingstarch hydrolysates Practice Good

I.1 Isomalt Unstandardized foods Manufacturing Practice Good

L.1 Lactitol Unstandardized foods Manufacturing Practice Good

M.1 Maltitol Unstandardized foods Manufacturing Practice Good

M.2 Maltitol syrup Unstandardized foods Manufacturing Practice Good

M.3 Mannitol Unstandardized foods Manufacturing Practice Good

N.1 Neotame (1) Table-top sweeteners (1) Manufacturing Practice

(2) Breakfast cereals (2) 0.016% Beverage mixes; Unstandardized 0.003% in

(3) beverages; Unstandardized beverage (3) beverages as concentrates consumed Dessert mixes; Fillings; Filling mixes; 0.01% in

(4) Toppings; Topping mixes; (4) products as Unstandardized desserts; Yogurt consumed

(5) Breath freshener products; Chewing (5) 0.032%gum Unstandardized fruit spreads;

(6) Unstandardized purées and sauces; (6) 0.007% Unstandardized table syrups

(7) Peanut and other nut spreads; (7) 0.002%

Column I Item AdditiveNo.

S.1 Sorbitol

S.1.1 Sorbitol syrup

S.2 Sucralose

Column II Column III Maximum Level ofPermitted in or on Use

Unstandardized salad dressings (8) Unstandardized condiments (8) 0.007%

Confectionary glazes for snack foods; (9) Sweetened seasonings or coating (9) 0.0032%

mixes for snack foods

(10) Unstandardized confectionery;Unstandardized confectionery coatings (10) 0.01%

0.013% in (11) Unstandardized bakery products and (11) products asbaking mixes consumed

A blend of prepared fish and prepared (1) meat referred to in paragraph (1) 6.0%

B.21.006(n) Good

(2) Unstandardized foods (2) Manufacturing Practice Good

Unstandardized foods Manufacturing Practice Good

(1) Table-top sweeteners (1) Manufacturing Practice

(2) Breakfast cereals (2) 0.1% Beverages; Beverage concentrates; Beverage mixes; Dairy beverages; 0.025% in

(3) (except for any of these products for (3) beverages as which standards are set out in these consumed Regulations) Desserts; Dessert mixes; Toppings; Topping mixes; Dairy Desserts; 0.025% inFrozen Desserts; Fillings; Filling(4) (4) products asmixes; (except for any of these consumedproducts for which standards are set out in these Regulations)

(5) Chewing gum; Breath freshener (5) 0.15%products Fruit spreads (except for any of these

(6) products for which standards are set (6) 0.045% out in these Regulations) Salad dressings; Condiments; (except for any of these products for which(7) (7) 0.04%standards are set out in these Regulations)

Column I Column II Column III Item No. Additive Permitted in or on

Maximum Level of Use

(8)

Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods; Unstandardized confectionery; Unstandardized confectionery coatings

(8) 0.07%

Baking mixes; Bakery products; 0.065% in(except for any of these products for(9) (9) products aswhich standards are set out in these consumedRegulations) Processed fruit and vegetable products (except for any of these products for(10) (10) 0.015%which standards are set out in these Regulations) Alcoholic beverages (except for any of

(11) these products for which standards are (11) 0.07% set out in these Regulations)

0.04% in (12) Puddings; Pudding mixes (12) products as

consumed Table syrups (except for any of these

(13) products for which standards are set (13) 0.15% out in these Regulations)

(1) Chewing gum; Breath freshenerT.1 Thaumatin (1) 500 p.p.m.products (2) Salt substitutes (2) 400 p.p.m.

(naming the flavour) Flavour referred (3) to in section B.10.005; Unstandardized (3) 100 p.p.m.

flavouring preparations Good

X.1 Xylitol Unstandardized foods Manufacturing Practice

SOR/93-276, s. 12; SOR/94-625, s. 5; SOR/94-689, s. 2(F); SOR/94-779, s. 3; SOR/97-512, ss. 3, 4; SOR/2004-261, s. 2; SOR/2007-76, s. 3; SOR/2007-176, s. 7; SOR/2010-142, ss. 52 to 55.

TABLE X

FOOD ADDITIVES THAT MAY BE USED AS PH ADJUSTING AGENTS, ACID­ REACTING MATERIALS AND WATER CORRECTING AGENTS

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

(1) Cream cheese spread; Cream (1) Good ManufacturingA.1 Acetic Acid cheese spread with (naming the Practice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(2) Good Manufacturing(2) Canned Asparagus Practice

(3) Good Manufacturing(3) Gelatin Practice

(4) Good Manufacturing(4) Unstandardized foods Practice Good ManufacturingA.2 Adipic Acid Unstandardized foods Practice

Ammonium (1) Good ManufacturingA.3 (1) Baking powderAluminum Practice

(2) Good ManufacturingSulphate (2) Unstandardized foods Practice Sufficient to process the cocoa products in

A.4 Ammonium (1) Cocoa products (1) accordance with the requirements of section B.04.005

(2) Good ManufacturingBicarbonate (2) Unstandardized foods Practice Sufficient to process the cocoa products inAmmoniumA.5 (1) Cocoa products (1) accordance with theCarbonate requirements of section B.04.005

(2) Good Manufacturing(2) Unstandardized foods Practice A.6 Ammonium Citrate, Unstandardized foods Good Manufacturing

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

dibasic Practice Ammonium Citrate, Good ManufacturingA.7 Unstandardized foodsmonobasic Practice

Sufficient to process the cocoa products inAmmoniumA.8 (1) Cocoa products (1) accordance with theHydroxide requirements of section B.04.005

(2) Good Manufacturing(2) Gelatin Practice

(3) Good Manufacturing(3) Unstandardized foods Practice Ale; Bacterial cultures; BakingAmmonium (1) Good ManufacturingA.9 (1) powder; Beer; Light beer; MaltPhosphate, dibasic Practiceliquor; Porter; Stout

(2) Good Manufacturing(2) Unstandardized bakery products Practice Ammonium Ale; Bacterial cultures; Baking

(1) Good ManufacturingA.10 Phosphate, (1) powder; Beer; Light beer; Malt Practicemonobasic liquor; Porter; Stout

(2) Good Manufacturing(2) Unstandardized bakery products Practice (3) Uncultured buttermilk (3) 0.1%

(1) Ale; Beer; Light beer; Malt liquor; (1) Good ManufacturingC.1 Calcium Acetate Porter; Stout Practice

(2) Good Manufacturing(2) Unstandardized foods Practice

C.2 Calcium Carbonate (1) Ice cream mix; Ice milk mix; Wine (1) Good ManufacturingPractice Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese

(2) Good Manufacturing(2) food; Processed cheese food with Practice(naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(3) Good Manufacturing(3) Grape juice Practice

(4) Good Manufacturing(4) Unstandardized foods Practice Sufficient to process the cocoa products in

(5) Cocoa products (5) accordance with the requirements of section B.04.005

(1) Ale; Beer; Light beer; Malt liquor; (1) Good ManufacturingC.3 Calcium Chloride Porter; Stout Practice

(2) Good Manufacturing(2) Unstandardized foods Practice

(1) Good ManufacturingC.4 Calcium Citrate (1) Infant formula Practice

(2) Good Manufacturing(2) Unstandardized foods Practice Good ManufacturingC.5 Calcium Fumarate Unstandardized foods Practice Good ManufacturingC.6 Calcium Gluconate Unstandardized foods Practice

Ale; Beer; Ice cream mix; Ice milk (1) Good ManufacturingC.7 Calcium Hydroxide (1) mix; Light beer; Malt liquor; PracticePorter; Stout

(2) Canned peas (2) 0.01%

(3) Good Manufacturing(3) Infant formula Practice

(4) Good Manufacturing(4) Grape Juice Practice

(5) Good Manufacturing(5) Unstandardized foods Practice

(1) Good ManufacturingC.8 Calcium Lactate (1) Baking powder Practice

(2) Good Manufacturing(2) Unstandardized foods Practice Ale; Beer; Ice cream mix; Ice milk

(1) Good ManufacturingC.9 Calcium Oxide (1) mix; Light beer; Malt liquor; PracticePorter; Stout (2) Unstandardized foods (2) Good Manufacturing

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Practice Calcium Phosphate, Good ManufacturingC.10 Unstandardized foodsdibasic Practice Calcium Phosphate, (1) Ale; Baking powder; Beer; Light (1) Good ManufacturingC.11 monobasic beer; Malt liquor; Porter; Stout Practice

(2) Good Manufacturing(2) Unstandardized foods Practice Calcium Phosphate, Good ManufacturingC.12 Unstandardized foodstribasic Practice

Ale; Beer; Light beer; Malt liquor; Good ManufacturingC.13 Calcium Sulphate Porter; Stout; Wine Practice Good ManufacturingC.13A Carbon Dioxide (Naming the variety) Cheese Practice

Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Canned artichokes; Canned asparagus; Canned bean sprouts; Canned chili peppers; Canned mushrooms; Canned onions; Canned pears; Canned shellfish; Canned spring mackerel; Cider; Cottage cheese; Creamed cottage cheese; Egg white (albumen) and yolk; Liquid, dried or frozen whole egg; Fig marmalade; Fig marmalade with pectin; French dressing; Frozen cooked shrimp;

(1) Good ManufacturingC.14 Citric Acid (1) Frozen (naming the fruit); Gelatin; PracticeGrape juice; Honey wine; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Mayonnaise; Mincemeat; Olives; Peach nectar; Pear nectar;Pineapple marmalade; Pineapple marmalade with pectin; Porter; Salad dressing; Sherbet; Stout; Tomatoes; Wine Canned applesauce; Canned

(2) Sufficient to maintain(2) grapefruit; Canned mandarin pH 4.2 to 4.5oranges; Canned pears; Canned

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

pineapple; Canned strawberries

(3) Good Manufacturing(3) Infant formula Practice

(4) Good Manufacturing(4) Margarine Practice Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients);

(5) Good Manufacturing(5) Processed cheese spread; Processed Practicecheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(6) Good Manufacturing(6) Unstandardized foods Practice 1%, singly or in combination with

(7) Cocoa products (7) tartaric acid, calculated on a fat- free basis Same levels as

Same foods as listed for Potassium prescribed forC.15 Cream of Tartar Acid Tartrate Potassium Acid Tartrate

(1) Good ManufacturingF.1 Fumaric Acid (1) Gelatin Practice

(2) Good Manufacturing(2) Unstandardized foods Practice

(3) Good Manufacturing(3) Wine Practice Good ManufacturingG.1 Gluconic Acid Unstandardized foods Practice

G.2 Glucono-delta- Unstandardized foods Good Manufacturing

Column I Item No. Additive

lactone

H.1 Hydrochloric Acid

L.1 Lactic Acid

Column II Column III

Permitted in or Upon Maximum Level of Use

Practice

(1) Ale; Beer; Gelatin; Light beer; (1) Good ManufacturingMalt liquor; Porter; Stout Practice

(2) Good Manufacturing(2) Infant formula Practice Ale; Baking powder; Beer; Bread; Cider; Cottage cheese; Creamed cottage cheese; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; French dressing; Frozen egg-white (frozen albumen); Frozen whole egg; (1) Good Manufacturing(1) Frozen yolk; Ice cream mix; Ice Practice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malt liquor; Mayonnaise; Olives; Pickles; Porter; Relishes; Salad dressing; Sherbet; Stout

(2) Canned pears; Canned strawberries (2) Sufficient to maintainpH 4.2 to 4.5

(3) Good Manufacturing(3) Margarine Practice Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients);

(4) Good Manufacturing(4) Processed cheese spread; Processed Practicecheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(5) Good Manufacturing(5) Unstandardized foods Practice (6) Wine (6) Good Manufacturing

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Practice Sufficient to process the cocoa products inMagnesiumM.2 (1) Cocoa products (1) accordance with theCarbonate requirements of section B.04.005

(2) Good Manufacturing(2) Ice cream mix; Ice milk mix Practice

(3) Good Manufacturing(3) Unstandardized foods Practice Good ManufacturingM.3 Magnesium Citrate Soft drinks Practice

Magnesium Good ManufacturingM.4 Unstandardized foodsFumarate Practice M.5 (1) Canned peas (1) 0.05%

Sufficient to process Magnesium the cocoa products in Hydroxide (2) Cocoa products (2) accordance with the

requirements of section B.04.005

(3) Gelatin; Ice cream mix; Ice milk (3) Good Manufacturingmix Practice

(4) Good Manufacturing(4) Bacterial cultures Practice Good ManufacturingM.6 Magnesium Oxide Ice cream mix; Ice milk mix Practice

M.6A Magnesium Good ManufacturingBacterial culturesPhosphate Practice Magnesium (1) Ale; Beer; Light beer; Malt liquor; (1) Good ManufacturingM.7 Sulphate Porter; Stout Practice

(2) Good Manufacturing(2) Bacterial cultures Practice Apple (or rhubarb) and (naming the fruit) jam; Apricot nectar; Canned asparagus; Fig marmalade; Fig marmalade with pectin; Frozen (naming the fruit); (naming the

(1) Good ManufacturingM.8 Malic Acid (1) fruit) Jam; (naming the fruit) Jam Practicewith pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin;

Column I Column II Item Additive Permitted in or UponNo.

Peach nectar; Pear nectar; Pineapple marmalade; Pineapple marmalade with pectin

(2) Canned applesauce; Canned pears;Canned strawberries Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients);

(3) Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(4) Unstandardized foods

(5) Wine

M.8A Manganese Sulphate Bacterial cultures

M.9 Metatartaric Acid Wine Ale; Beer; Cottage Cheese; Creamed cottage cheese; Gelatin;

P.1 Phosphoric Acid (1) Light beer; Malt liquor; Mono- glycerides and mono- and diglycerides; Porter; Stout Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese;

(2) Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients);

Column III

Maximum Level of Use

(2) Sufficient to maintainpH 4.2 to 4.5

(3) Good ManufacturingPractice

(4) Good ManufacturingPractice

(5) Good ManufacturingPractice Good Manufacturing Practice 0.01%

(1) Good ManufacturingPractice

(2) Good ManufacturingPractice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(3) Good Manufacturing(3) Fish protein Practice

(4) Good Manufacturing(4) Unstandardized foods Practice 0.5%, expressed as

(5) Cocoa products (5) P2O5, calculated on a fat-free basis

(1) Good Manufacturing(1) Baking powder; Honey winePotassium Acid PracticeP.2 Tartrate (2) Good Manufacturing(2) Unstandardized foods Practice

(3) Wine (3) 0.42% Ale; Baking powder; Beer; LightPotassium (1) Good ManufacturingP.3 beer; Malt liquor; Oil-solubleAluminum Sulphate (1) Practiceannatto; Porter; Stout

(2) Good Manufacturing(2) Unstandardized foods Practice Potassium (1) Baking powder; Malted milk; (1) Good ManufacturingP.4 Bicarbonate Malted milk powder Practice

Sufficient to process the cocoa products in

(2) Cocoa products (2) accordance with the requirements of section B.04.005

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) (3) Good Manufacturing(3) cheese with (naming the added Practice ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(4) Infant formula (4) Good ManufacturingPractice

(5) Margarine (5) Good ManufacturingPractice

(6) Unstandardized foods (6) Good ManufacturingPractice

(7) Wine (7) Good ManufacturingPractice

P.5 PotassiumCarbonate (1) Cocoa products (1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005

(2)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(2) Good ManufacturingPractice

(3) Margarine (3) Good ManufacturingPractice

(4) Unstandardized foods (4) Good ManufacturingPractice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

A blend of prepared fish and (5) Good Manufacturing(5) prepared meat referred to in Practiceparagraph B.21.006(n)

(6) Good Manufacturing(6) Wine Practice Ale; Beer; Light beer; Malt liquor; Good ManufacturingP.6 Potassium Chloride Porter; Stout Practice

(1) Good ManufacturingP.7 (1) Infant formula PracticePotassium Citrate (2) Good Manufacturing(2) Margarine Practice

(3) Good Manufacturing(3) Unstandardized foods Practice

(4) Good Manufacturing(4) Wine Practice Good ManufacturingP.8 Potassium Fumarate Unstandardized foods Practice

P.9 (1) Oil-soluble annatto (1) 1.0% Sufficient to process

Potassium the cocoa products in Hydroxide (2) Cocoa products (2) accordance with the

requirements of section B.04.005

Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and

(3) Good Manufacturing(3) dry cure employed in the curing of Practicepreserved meat or preserved meat by-product

(4) Good Manufacturing(4) Infant formula Practice

(5) Good Manufacturing(5) Margarine Practice

(6) Good Manufacturing(6) Grape juice Practice

(7) Good Manufacturing(7) Unstandardized foods Practice Good ManufacturingP.9A Potassium Lactate Margarine Practice

Potassium Good ManufacturingP.10 Unstandardized foodsPhosphate, dibasic Practice Ale; Beer; Light beer; Malt liquor; Good ManufacturingP.11 Potassium Sulphate Porter; Stout Practice

P.12 Potassium Tartrate Cider Good Manufacturing

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Practice Good ManufacturingS.1 Sodium Acetate Unstandardized foods Practice

(1) Good Manufacturing(1) Baking powderSodium Acid PracticeS.2 Pyrophosphate (2) Good Manufacturing(2) Unstandardized foods Practice

Sodium Acid Good ManufacturingS.3 Baking PowderTartrate Practice Sodium Aluminum Good ManufacturingS.4 Unstandardized foodsPhosphate Practice

(1) Good ManufacturingS.5 Sodium Aluminum (1) Baking powder Practice

(2) Good ManufacturingSulphate (2) Unstandardized foods Practice Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malted milk powder; (naming the citrus fruit) (1) Good ManufacturingS.6 Sodium Bicarbonate (1) Marmalade; (naming the citrus Practice fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Oil-soluble annatto; Pineapple marmalade; Pineapple marmalade with pectin; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

Sufficient to process the cocoa products in

(2) Cocoa products (2) accordance with the requirements of section B.04.005

Column I Column II Item No. Additive Permitted in or Upon

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(4) Infant formula

(5) Margarine

(6) Unstandardized foods

S.7 Sodium Bisulphate (1) Ale; Beer; Light beer; Malt liquor;Porter; Stout

(2) Unstandardized bakery products

S.8 Sodium Carbonate (1)

Apple (or rhubarb) and (naming the fruit) jam; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Gelatin; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Meat binder or (naming the meat product) binder where sold for use in preserved meat or preserved meat by-product; (naming the citrus fruit) Marmalade; (naming the citrus

Column III

Maximum Level of Use

(3) Good ManufacturingPractice

(4) Good ManufacturingPractice

(5) Good ManufacturingPractice

(6) Good ManufacturingPractice

(1) Good ManufacturingPractice

(2) Good ManufacturingPractice

(1) Good ManufacturingPractice

Column I Column II Item No. Additive Permitted in or Upon

fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Pineapple marmalade; Pineapple marmalade with pectin

(2) Cocoa products

(3)

Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(4) Margarine

(5) Unstandardized foods

S.9 Sodium Citrate (1)

Apple (or rhubarb) and (naming the fruit) jam; Cottage cheese; Cream; Creamed cottage cheese; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig

Column III

Maximum Level of Use

Sufficient to process the cocoa products in

(2) accordance with the requirements of section B.04.005

(3) Good ManufacturingPractice

(4) Good ManufacturingPractice

(5) Good ManufacturingPractice

(1) Good ManufacturingPractice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin; Sherbet

(2) Infant formula (2) Good ManufacturingPractice

(3) Unstandardized foods (3) Good ManufacturingPractice

(4) Margarine (4) Good ManufacturingPractice

S.12 Sodium Fumarate Unstandardized foods Good ManufacturingPractice

S.13 Sodium Gluconate Unstandardized foods Good ManufacturingPractice

S.14

S.15

Sodium Hexametaphosphate

Sodium Hydroxide

Unstandardized foods

(1) Cocoa products

Good Manufacturing Practice

(1)

Sufficient to process the cocoa products in accordance with the requirements of section B.04.005

(2)

Gelatin; Ice cream mix; Ice milk mix; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

(3) Infant formula

(2) Good ManufacturingPractice

(3) Good ManufacturingPractice

(4) Margarine (4) Good ManufacturingPractice

(5) Unstandardized foods (5) Good ManufacturingPractice

S.16 Sodium Lactate

(6) (Naming the variety) Whey cheese;Whey cheese (6) Good Manufacturing Practice

(1) Margarine (1) Good ManufacturingPractice

(2) Unstandardized foods (2) Good ManufacturingPractice

S.17 Sodium Phosphate,dibasic (1) Ale; Bacterial culture; Beer; Cream; Light beer; Malt liquor; Porter; Stout

(1) Good ManufacturingPractice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

(2) Unstandardized foods (2) Good ManufacturingPractice

S.18 Sodium Phosphate, (1) Ale; Beer; Light beer; Malt liquor;Porter; Stout (1) Good Manufacturing Practice

monobasic (2) Unstandardized foods (2) Good ManufacturingPractice

S.19 Sodium Phosphate,tribasic (1) Ale; Beer; Light beer; Malt liquor; Porter; Stout (1)

Good Manufacturing Practice

(2) Unstandardized foods (2) Good ManufacturingPractice

S.20 Sodium PotassiumTartrate (1)

Apple (or rhubarb) and (naming the fruit) jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin

(1) Good ManufacturingPractice

(2) Unstandardized foods (2) Good ManufacturingPractice

(3) Margarine (3) Good ManufacturingPractice

S.21 Sodium Pyrophosphate, tetrabasic

Unstandardized foods Good ManufacturingPractice

S.22 SodiumTripolyphos- phate Unstandardized foods Good Manufacturing Practice

S.23 Sulphuric Acid Ale; Beer; Light beer; Malt liquor;Porter; Stout Good Manufacturing Practice

S.24 Sulphurous Acid Gelatin

Good Manufacturing Practice provided the finished product does not contain more than 500 p.p.m. calculated as sulphur dioxide

T.1 Tartaric Acid (1)

Ale; Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Beer; Cider; Canned asparagus; Fig marmalade; Fig marmalade with pectin; French

(1) Good ManufacturingPractice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

dressing; Honey wine; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Mayonnaise; Pineapple marmalade; Pineapple marmalade with pectin; Porter; Salad dressing; Sherbet; Stout; Wine

(2) Canned pears; Canned strawberries (2) Sufficient to maintainpH 4.2 to 4.5 Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with

(3) (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the

(3) Good ManufacturingPractice

added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); (naming the variety) Whey cheese

(4) Margarine (4) Good ManufacturingPractice

(5) Unstandardized foods (5) Good ManufacturingPractice 1%, singly or in

(6) Cocoa products (6) combination withcitric acid, calculated on a fat-free basis

SOR/78-874, s. 4; SOR/79-660, ss. 14 to 17; SOR/79-664, ss. 3 to 13; SOR/79-752, s. 9; SOR/80-501, s. 4; SOR/86-1112, ss. 6 to 8; SOR/92-106, s. 1; SOR/92-344, s. 5; SOR/94­ 689, s. 2(F); SOR/95-281, ss. 2 to 5; SOR/95-436, ss. 2, 3; SOR/97-263, ss. 11 to 25;

SOR/97-561, s. 3; SOR/98-580, s. 1(F); SOR/2001-94, s. 3; SOR/2006-91, ss. 13 to 20; SOR/2007-75, s. 8; SOR/2010-41, s. 9(E); SOR/2010-94, s. 8(E); SOR/2010-142, s. 56; SOR/2010-143, ss. 32 to 36.

TABLE XI PART I

FOOD ADDITIVES THAT MAY BE USED AS CLASS I PRESERVATIVES

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Preserved fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product;A.1 Acetic Acid (1) (1) Good Manufacturing PracticePumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

(2) Unstandardized foods (2) Good Manufacturing Practice Ale; Beer; Canned mushrooms; Canned tuna; Canned white asparagus; Cider; Frozen fruit; Glaze of Frozen fish; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Porter;

Ascorbic Preserved fish; Frozen mincedA.2 (1) (1) Good Manufacturing PracticeAcid fish; Frozen comminuted fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by- product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine

If used either singly or in combination with Iso-Ascorbic(2) Canned applesauce (2) Acid, the total not to exceed 150 p.p.m.

(3) Canned peaches (3) 550 p.p.m. (4) Unstandardized foods (4) Good Manufacturing practice

Calcium Same foods as listed for Ascorbic Same levels as prescribed forC.1 Ascorbate Acid Ascorbic Acid

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Ale; Beer; Cider; Frozen fruit; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by- product (Division 14 only); Porter; Preserved fish; Frozen minced fish; Frozen comminuted

Erythorbic fish; Glaze of frozen fish;E.1 (1) (1) Good Manufacturing PracticeAcid Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by- product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine

If used either singly or in (2) Canned applesauce (2) combination with Ascorbic Acid,

the total not to exceed 150 p.p.m. (3) Unstandardized foods (3) Good Manufacturing Practice

I.1 Iso- Ascorbic Acid

Same foods as listed for Erythorbic Acid

Same levels as prescribed for Erythorbic Acid

When the meat binder is used in accordance with label instructions, whether potassium nitrate is added alone or in

P.1 PotassiumNitrate (1)

Meat binder for dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)

(1)

combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation When the cover pickle or dry

(2)

Cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)

(2)

cure is used in accordance with label instructions, whether potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of preserved meat or

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Where potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates added to eachDry sausage, semi-dry sausage, batch of dry sausage, semi-drypreserved meat and preserved(3) (3) sausage, preserved meat ormeat by-products prepared by preserved meat by-products shallslow cure processes (Division 14) not exceed 0.32 ounces per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of If used singly or in combinationwhich the lactic acid fermentation with sodium nitrate, the total notand salting is completed later than(4) (4) to exceed 200 p.p.m. (based in12 hours after coagulation of the milk). Residue in the finishedcurd by food enzymes and where cheese not to exceed 50 p.p.m.the added salt is applied externally to the cheese as dry salt or in the form of brine

If used singly or in combination with sodium nitrate, the total not

(5) Mold ripened cheese packed in (5) to exceed 200 p.p.m. (based inhermetically sealed containers milk). Residue in the finished cheese not to exceed 50 p.p.m. When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether potassium nitrite is added alone or inMeat binder, pumping pickle, combination with sodium nitrite,cover pickle and dry curePotassium the total amount of such nitritesP.2 (1) employed in the curing of (1)Nitrite thereby added to each batch ofpreserved meat and preserved preserved meat or preservedmeat by-products (Division 14) meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million calculated prior to any smoking, cooking or fermentation

Column I Column II Item Additive Permitted in or UponNo.

SodiumS.1 Ascorbate

S.2 Sodium Erythorbate

Sodium Iso­S.3 Ascorbate

SodiumS.4 Nitrate

Preserved meat except side bacon (2) and preserved meat by-products

(Division 14)

(3) Side bacon

Preserved poultry meat and (4) preserved poultry meat by-

products (Division 22)

Same foods as listed for Ascorbic Acid

(1) Same foods as listed forErythorbic Acid (2) Canned clams

Same foods as listed for Erythorbic Acid

Meat binder for dry sausage, semi-dry sausage, preserved meat

(1) and preserved meat by-products prepared by slow cure processes (Division 14)

Column III

Maximum Level of Use

Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved meat, except

(2) side bacon or preserved meat by- products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each

(3) batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved poultry meat

(4) or preserved poultry meat by- products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Same levels as prescribed for Ascorbic Acid

(1) Same levels as prescribed forErythorbic Acid (2) 350 p.p.m.

Same levels as prescribed for Erythorbic Acid When the meat binder is used in accordance with label instructions, whether sodium

(1) nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates thereby added to each

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation When the cover pickle or dry cure is used in accordance with label instructions, whether sodium nitrate is added alone or

Cover pickle and dry cure in combination with potassium employed in the curing of nitrate, the total amount of such

(2) preserved meat and preserved (2) nitrates thereby added to each meat by-products prepared by batch of preserved meat or slow cure processes (Division 14) preserved meat by-products shall

not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Where sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates added toDry sausage, semi-dry sausage, each batch of dry sausage, semi-preserved meat and preserved(3) (3) dry sausage, preserved meat ormeat by-products prepared by the preserved meat by-products shallslow cure processes (Division 14) not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of If used singly or in combinationwhich the lactic acid fermentation with potassium nitrate, the totaland salting is completed later than(4) (4) not to exceed 200 p.p.m. (based12 hours after coagulation of the in milk). Residue in the finishedcurd by food enzymes and where cheese not to exceed 50 p.p.m.the added salt is applied externally to the cheese as dry salt or in the form of brine

If used singly or in combination with potassium nitrate, the total

(5) Mold ripened cheese packed in (5) not to exceed 200 p.p.m. (basedhermetically sealed containers in milk). Residue in the finished cheese not to exceed 50 p.p.m.

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether sodium

S.5 SodiumNitrite (1)

Meat binder, pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products (Division 14)

(1)

nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to

Preserved meat, except side each batch of preserved meat, (2) bacon, and preserved meat by­ (2) except side bacon or preserved

products (Division 14) meat by-products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to

(3) Side bacon (3) each batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to

Preserved poultry meat and each batch of preserved poultry (4) preserved poultry meat by­ (4) meat or preserved poultry meat

products (Division 22) by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation

W.1 Wood (1) (naming the variety) Cheese; (1) Good Manufacturing Practice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Smoke Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold- pack cheese food with (naming the added ingredients) Preserved fish; Preserved meat (Divisions 14 and 21); Preserved meat by-product (Divisions 14(2) (2) Good Manufacturing Practiceand 21); Preserved poultry meat; Preserved poultry meat by- product; Sausage

(3) Unstandardized foods (3) Good Manufacturing Practice

PART II

FOOD ADDITIVES THAT MAY BE USED AS CLASS II PRESERVATIVES

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Apple (or rhubarb) and (naming the fruit) jam; Fig marmalade with pectin; Fruit juices except frozen concentrated orange juice; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Marinated or

B.1 Benzoic Acid (1) similar cold-processed packaged (1) 1,000 p.p.m. fish and meat (Division 21); (naming the citrus fruit) marmalade with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(2) Unstandardized foods [except (2) 1,000 p.p.m.

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

If used singly or in combination with

(3) Margarine (3) Sorbic Acid, the total shall not exceed 1,000 p.p.m. Same levels as

C.1 Calcium Sorbate Same foods as listed for sorbic acid prescribed for Sorbic Acid

Carnobacterium (1) Good ManufacturingC.2 maltaromaticum (1) Vacuum-packed wieners PracticeCB1

Vacuum-packed sliced roast beef (2) Good Manufacturing(2) in accordance with section PracticeB.14.005

Vacuum-packed sliced cooked ham (3) Good Manufacturing(3) in accordance with section PracticeB.14.005 or B.14.031

Vacuum-packed sliced cooked (4) Good Manufacturing(4) turkey in accordance with section PracticeB.22.006 or B.22.021

Good Manufacturing Practice. Residues in

H.1 4-Hexylresorcinol Crustaceans the edible portion ofthe uncooked product not to exceed 1.0 p.p.m.

Apple (or rhubarb) and (naming the fruit) jam; Fig marmalade with pectin; Fruit juices except frozen concentrated orange juice; (naming the fruit) jam; (naming the fruit)

M.1 Methyl-ρ-hydroxy jam with pectin; (naming the fruit)(1) (1) 1,000 p.p.m.Benzoate jelly with pectin; Marinated or similar cold-processed packaged fish and meat (Division 21); (naming the citrus fruit) marmalade with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

with pectin; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(2) Unstandardized foods [exceptunstandardized preparations of (2) 1,000 p.p.m.

(a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

M.2 Methyl Paraben Same foods as listed for Methyl-p­hydroxy Benzoate

Same levels as prescribed for Methyl- p-hydroxy Benzoate

P.1 PotassiumBenzoate Same foods as listed for Benzoic Acid

1,000 p.p.m. calculated as Benzoic Acid

P.2 PotassiumBisulphite Same foods as listed for Sulphurous Acid

Same levels as prescribed for Sulphurous Acid

P.3 PotassiumMetabi- sulphite Same foods as listed for Sulphurous Acid

Same levels as prescribed for Sulphurous Acid Same levels asSame foods as listed for SorbicP.4 Potassium Sorbate prescribed for SorbicAcid Acid

Apple (or rhubarb) and (naming the fruit) jam; Fig marmalade with pectin; Fruit juices except frozen concentrated orange juice; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; marinated orPropyl-ρ-hydroxyP.5 (1) similar cold-processed packaged (1) 1,000 p.p.m.Benzoate fish and meat (Division 21); (naming the citrus fruit) marmalade with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(2) Unstandardized foods [except (2) 1,000 p.p.m.unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and

Column I Item AdditiveNo.

P.6 Propyl Paraben

S.1 Sodium Benzoate

SodiumS.2 Bisulphite

SodiumS.3 Metabisulphite

Sodium Salt of S.4 Methyl-ρ-hydroxy

Benzoic Acid Sodium Salt of

S.5 Propyl-ρ-hydroxy Benzoic Acid

S.6 Sodium Sorbate

S.7 Sodium Sulphite

S.8 Sodium Dithionite

S.9 Sorbic Acid

Column II

Permitted in or Upon

(c) poultry meat and poultry meat by-product]

Same foods as listed for Propyl-p­ hydroxy Benzoate

Same foods as listed for Benzoic Acid

Same foods as listed for Sulphurous Acid

Same foods as listed for Sulphurous Acid

Same foods as listed for Methyl-p­ hydroxy Benzoate

Same foods as listed for Propyl-p­ hydroxy Benzoate

Same foods as listed for Sorbic Acid

Same foods as listed for Sulphurous Acid

Same foods as listed for Sulphurous Acid

Apple (or rhubarb) and (naming the fruit) jam; Fig marmalade with pectin; Fruit juices except frozen concentrated orange juice; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; (naming the citrus

(1) fruit) marmalade with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Smoked or salted dried fish; Smoked or salted fish paste; (naming the source of the glucose) syrup; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(2) Unstandardized foods [except

Column III

Maximum Level of Use

Same levels as prescribed for Propyl­ p-hydroxy Benzoate 1,000 p.p.m. calculated as Benzoic Acid Same levels as prescribed for Sulphurous Acid Same levels as prescribed for Sulphurous Acid 1,000 p.p.m. calculated as Methyl-p-hydroxy Benzoate 1,000 p.p.m. calculated as Propyl-p-hydroxy Benzoate Same levels as prescribed for Sorbic Acid Same levels as prescribed for Sulphurous Acid Same levels as prescribed for Sulphurous Acid

(1) 1,000 p.p.m.

(2) 1,000 p.p.m.

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(3) Olive brine (3) 300 p.p.m. If used singly or in combination with

(4) Margarine (4) Benzoic Acid, the total shall not exceed 1,000 p.p.m.

(5) Unstandardized salad dressings (5) 3,350 p.p.m. 70 p.p.m. in the free state or 350 p.p.m. in

S.10 Sulphurous Acid (1) Cider; Honey wine; Wine (1) the combined state calculated as sulphur dioxide

(2) Ale; Beer; Light beer; Malt liquor; (2) 15 p.p.m. calculated asPorter; Stout sulphur dioxide Apple (or rhubarb) and (naming the fruit) jam; Fancy molasses; Fig marmalade with pectin; Frozen sliced apples; Fruit juices except frozen concentrated orange juice; Gelatin; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; (3) 500 p.p.m. calculated(3) (naming the citrus fruit) marmalade as sulphur dioxide with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; (naming the source of the glucose) syrup; Refiners’ molasses; Table molasses; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree

(4) 100 p.p.m. calculated(4) Beverages as sulphur dioxide

(5) 2,500 p.p.m. calculated(5) Dried fruits and vegetables as sulphur dioxide Unstandardized foods [except in food recognized as a source of (6) 500 p.p.m. calculated(6) thiamine and except as sulphur dioxide unstandardized preparations of

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

(a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

(7) 90 p.p.m. calculated as(7) Frozen mushrooms sulphur dioxide

(8) Dextrose Anhydrous; Dextrose (8) 20 p.p.m. calculated asMonohydrate sulphur dioxide 40 p.p.m. except glucose or glucose syrup for the manufacture of sugar(9) Glucose or glucose syrup (9) confectionery not more than 400 p.p.m. calculated as sulphur dioxide 40 p.p.m. except glucose solids or dried glucose syrup for the

(10) Glucose solids or dried glucose manufacture of sugar(10)syrup confectionary not more than 150 p.p.m. calculated as sulphur dioxide Good Manufacturing Practice. Residues in the edible portion of

(11) Crustaceans (11) the uncooked product not to exceed 100 p.p.m., calculated as sulphur dioxide.

PART III

FOOD ADDITIVES THAT MAY BE USED AS CLASS III PRESERVATIVES

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Calcium (1) 2,000 p.p.m. calculated asPropionate (1) Same foods as listed for Propionic Acid Propionic Acid

(2) Soft flour tortillas (2) 4,000 p.p.m. Calcium Same maximum levels of useSame foods as listed for Sorbic AcidSorbate as listed for Sorbic Acid

C.1

C.2

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

20 p.p.m. in accordance with N.1 Natamycin (1) The surface of (naming the variety) (1) the requirements of sectionscheese and cheddar cheese B.08.033 and B.08.034

The surface of grated or shredded 10 p.p.m. in accordance with (2) (naming the variety) cheese and (2) the requirements of sections

grated or shredded cheddar cheese B.08.033 and B.08.034 PotassiumP.1 (1) Same foods as listed for Sorbic Acid (1) Same maximum levels of useSorbate as listed for Sorbic Acid

(2) Soft flour tortillas (2) 5,000 p.p.m. PropionicP.2 (1) Bread (1) 2,000 p.p.m.Acid

(naming the variety) Cheese; Cheddar cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); 2,000 p.p.m. or 3,000 p.p.m., Processed (naming the variety) as the case may be, in cheese; Processed (naming the accordance with the variety) cheese with (naming the requirements of sections added ingredients); Processed cheese B.08.033, B.08.034, B.08.035,

(2) food; Processed cheese food with (2) B.08.037, B.08.038, B.08.039, (naming the added ingredients); B.08.040, B.08.041, Processed cheese spread; Processed B.08.041.1, B.08.041.2, cheese spread with (naming the B.08.041.3, B.08.041.4, added ingredients); Cold-pack B.08.041.5, B.08.041.6, (naming the variety) cheese; Cold- B.08.041.7 and B.08.041.8 pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

(3) Unstandardized foods except (3) 2,000 p.p.m.unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product

SodiumS.1 (1) Bread (1) 3,000 p.p.m.Diacetate

(2) Unstandardized foods [except (2) 3,000 p.p.m.unstandardized preparations of (a) meat and meat by-product

Column I Column II Item Additive Permitted in or UponNo.

(Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-product]

Sodium Same foods as listed for PropionicS.2 Propionate Acid SodiumS.3 Same foods as listed for Sorbic AcidSorbate SorbicS.4 (1) BreadAcid

(naming the variety) Cheese; Cheddar cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese

(2) food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Cold-pack (naming the variety) cheese; Cold- pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients)

(3) Cider; Wine; Honey Wine

(4) Unstandardized foods exceptunstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by-products

PART IV

Column III

Maximum Level of Use

2,000 p.p.m. calculated as Propionic Acid Same maximum levels of use as listed for Sorbic Acid

(1) 1,000 p.p.m.

3,000 p.p.m. in accordance with the requirements of sections B.08.033, B.08.034, B.08.035, B.08.037, B.08.038,

(2) B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8

(3) 500 p.p.m.

(4) 1,000 p.p.m.

FOOD ADDITIVES THAT MAY BE USED AS CLASS IV PRESERVATIVES

Column I Column II Column III

Item Additive Permitted in or Upon Maximum Level of UseNo. Fats and oils; Lard; Monoglycerides andA.1 Ascorbic Acid (1) (1) Good Manufacturing Practicediglycerides; Shortening Unstandardized(2) (2) Good Manufacturing Practicefoods Fats and oils; Lard; Monoglycerides andA.2 Ascorbyl Palmitate (1) (1) Good Manufacturing Practicediglycerides; Shortening Unstandardized foods [except(2) (2) Good Manufacturing Practiceunstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

0.02% of the fat content. If ascorbyl stearate is also used(3) Margarine (3) the total must not exceed 0.02% of the fat content

(4) Infant formula (4) 0.001% as consumed Fats and oils; Lard; Monoglycerides andA.3 Ascorbyl Stearate (1) (1) Good Manufacturing Practicediglycerides; Shortening

0.02% of the fat content. If ascorbyl palmitate is also used(2) Margarine (2) the total must not exceed 0.02% of the fat content 0.02%. If butylated hydroxytoluene, propyl gallate

(1) Fats and oils, lard,B.1 Butylated Hydro- (1) or tertiary butyl hydroquinoneshortening xyanisole (a mixture of is also used, the total must not 2-tertiarybutyl-4- exceed 0.02% hydroxyanisole and 3- 0.005%. If butylatedDried breakfasttertiarybutyl-4- hydroxytoluene or propyl(2) cereals; Dehydrated (2)hydroxyanisole) gallate is also used the totalpotato products must not exceed 0.005%

(3) Chewing gum (3) 0.02%. If butylated

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

hydroxytoluene or propyl gallate is also used the total must not exceed 0.02% 0.125%. If butylatedEssential oils; Citrus hydroxytoluene or propyl(4) oil flavours; Dry (4) gallate is also used the totalflavours must not exceed 0.125% 0.5%. If butylated hydroxytoluene or propyl(5) Citrus oils (5) gallate is also used the total must not exceed 0.5%

Partially defatted 0.0065%. If butylated pork fatty tissue; hydroxytoluene is also used(6) (6)Partially defatted the total must not exceed beef fatty tissue 0.0065%

(7) Vitamin A liquids (7) 5 mg/1,000,000 Internationalfor addition to food Units Dry beverage mixes;

(8) Dry dessert and (8) 0.009% confection mixes

(9) Active dry yeast (9) 0.1% Other unstandardized 0.02% of the fat or the oil

(10) foods [except (10) content of the food. If unstandardized butylated hydroxytoluene or preparations of propyl gallate is also used the (a) meat and meat total must not exceed 0.02% of by-product the fat or the oil content of the (Divisions 14 and food 21); (b) fish; and (c) poultry meat and poultry meat by- product] Dry Vitamin D

(11) 10 mg/1,000,000 International(11) preparations for Unitsaddition to food 0.01% of the fat content. If butylated hydroxytoluene or

(12) Margarine (12) propyl gallate or both are also used the total must not exceed 0.01% of the fat content

(13) Dried cooked (13) 0.015% of the fat content. Ifpoultry meat propyl gallate or citric acid or

B.2

Column I Item AdditiveNo.

Butylated Hydroxytol- uene (3,5-ditertiary- butyl-4-hydroxytoluene

Column II

Permitted in or Upon

(1) Fats and oils, lard,shortening

Dried breakfast (2) cereals; Dehydrated

potato products

(3) Chewing gum

Essential oils; Citrus (4) oil flavours; Dry

flavours

(5) Citrus oils

Partially defatted pork fatty tissue;(6) Partially defatted beef fatty tissue

(7) Vitamin A liquidsfor addition to food (8) Parboiled rice

Other unstandardized

(9) foods [except unstandardized preparations of (a) meat and meat by-products (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

Column III

Maximum Level of Use

both are also used, the total must not exceed 0.015% of the fat content. 0.02%. If butylated hydroxyanisole, propyl gallate

(1) or tertiary butyl hydroquinone is also used, the total must not exceed 0.02% 0.005%. If butylated hydroxyanisole or propyl(2) gallate is also used the total must not exceed 0.005% 0.02%. If butylated hydroxyanisole or propyl(3) gallate is also used the total must not exceed 0.02% 0.125%. If butylated hydroxyanisole or propyl(4) gallate is also used the total must not exceed 0.125% 0.5%. If butylated hydroxyanisole or propyl(5) gallate is also used the total must not exceed 0.5%

0.0065%. If butylated (6) hydroxyanisole is also used the

total must not exceed 0.0065%

(7) 5 mg/1,000,000 InternationalUnits (8) 0.0035%

0.02% of the fat or the oil (9) content of the food. If

butylated hydroxyanisole or propyl gallate is also used the total must not exceed 0.02% of the fat or the oil content of the food

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

Dry Vitamin D (10) 10 mg/1,000,000 Internatinal(10) preparations for Unitsaddition to food

0.01% of the fat content. If butylated hydroxyanisole or

(11) Margarine (11) propyl gallate or both are also used the total must not exceed 0.01% of the fat content

Fats and oils; Lard; Monoglycerides andC.1 Citric Acid (1) (1) Good Manufacturing Practicediglycerides; Shortening Unstandardized foods [except(2) (2) Good Manufacturing Practiceunstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

0.015% of the fat content. If butylated hydroxyanisole orDried cooked(3) (3) propyl gallate or both are alsopoultry meat used, the total must not exceed 0.015% of the fat content.

Nutritional C.1.1 L-Cysteine supplements set out Good Manufacturing Practice

in section B.24.201 Sulphite replacementL-CysteineC.2 formulations for Good Manufacturing PracticeHydrochloride prepared fruits and vegetables Fats and oils; Lard; Monoglycerides andG.1 Gum Guaiacum (1) (1) Good Manufacturing Practicediglycerides; Shortening Unstandardized

(2) foods [except (2) Good Manufacturing Practice unstandardized

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product] Fats and oils; Lard;

L.1 Lecithin (1) Monoglycerides anddiglycerides; (1) Good Manufacturing Practice

Shortening Unstandardized

(2) foods [exceptunstandardized (2) Good Manufacturing Practice

preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product] Fats and oils; Lard;

L.2 Lecithin Citrate (1) Monoglycerides anddiglycerides; (1) Good Manufacturing Practice

Shortening Unstandardized

(2) foods [exceptunstandardized (2) Good Manufacturing Practice

preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

M.1 Monoglyceride Citrate (1) Fats and oils; Lard;Monoglycerides and (1) Good Manufacturing Practice

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

diglycerides; Shortening Unstandardized

(2) foods [exceptunstandardized (2) Good Manufacturing Practice

preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

0.01% of the fat content. If monoisopropyl citrate or

(3) Margarine (3) stearyl citrate or both are also used the total must not exceed 0.01% of the fat content

Fats and oils; Lard;

M.2 Monoisopropyl Citrate (1) Monoglycerides anddiglycerides; (1) Good Manufacturing Practice

Shortening Unstandardized

(2) foods [exceptunstandardized (2) Good Manufacturing Practice

preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

0.01% of the fat content. If monoglyceride citrate or

(3) Margarine (3) stearyl citrate or both are also used, the total must not exceed 0.01% of the fat content 0.02%. If butylated

P.1 Propy1 Gallate (1) Fats and oils, lard,shortening (1) hydroxyanisole, butylated hydroxytoluene or tertiary butyl hydroquinone is also

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

used, the total must not exceed 0.02%

(2) Dried breakfast cereals; Dehydrated potato products

(2)

0.005%. If butylated hydroxyanisole or butylated hydroxytoluene is also used the total must not exceed 0.005%

(3) Chewing gum (3)

0.02%. If butylated hydroxyanisole or butylated hydroxytoluene is also used the total must not exceed 0.02%

(4) Essential oils; Dryflavours (4)

0.125%. If butylated hydroxyanisole or butylated hydroxytoluene is also used the total must not exceed 0.125%

(5) Citrus oils (5)

0.5%. If butylated hydroxyanisole or butylated hydroxytoluene is also used the total must not exceed 0.5%

Other unstandardized 0.02% of the fat or the oil

(6) foods [except unstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21);

(6) content of the food. If butylated hydroxyanisole or butylated hydroxytoluene is also used the total must not exceed 0.02% of the fat or the oil content of the food

(b) fish; and (c) poultry meat and poultry meat by- product]

0.01% of the fat content. If

(7) Margarine (7)

butylated hydroxyanisole or butylated hydroxytoluene or both are also used the total must not exceed 0.01% of the fat content 0.015% of the fat content. If

(8) Dried cookedpoultry meat (8) butylated hydroxyanisole or citric acid or both are also used the total must not exceed

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

0.015% of the fat content. Fats and oils; Lard; Monoglycerides andT.1 Tartaric Acid (1) (1) Good Manufacturing Practicediglycerides; Shortening Unstandardized foods [except(2) (2) Good Manufacturing Practiceunstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

0.02%. If butylated hydroxyanisole, butylated

T.1A Tertiary Butyl Fats and oils, lard, hydroxytoluene orHydroquinone shortening propylgallate is also used, the total must not exceed 0.02%

Fats and oils; Lard; Monoglycerides andT.2 (1) (1) Good Manufacturing Practicediglycerides;Tocopherols (alpha- Shorteningtocopherol; tocopherols Unstandardizedconcentrate, mixed) foods [except(2) (2) Good Manufacturing Practiceunstandardized preparations of (a) meat and meat by-product (Divisions 14 and 21); (b) fish; and (c) poultry meat and poultry meat by- product]

(3) Infant formula (3) 0.001% as consumed

SOR/79-285, ss. 1 to 4; SOR/79-660, s. 18; SOR/79-752, s. 10; SOR/80-500, s. 7; SOR/81­ 565, s. 6; SOR/81-934, ss. 13 to 15; SOR/82-383, s. 11; SOR/86-89, s. 7; SOR/86-1020, s. 1; SOR/87-138, ss. 1, 2; SOR/87-469, s. 2; SOR/89-198, ss. 12 to 16; SOR/91-124, ss. 10 to 12; SOR/92-226, s. 1; SOR/92-591, s. 2(F); SOR/94-689, s. 2(F); SOR/95-592, s. 1; SOR/96-241, s. 2; SOR/97-148, s. 7; SOR/97-191, s. 4; SOR/98-459, s. 1; SOR/99-289, ss. 1 to 4;

SOR/2003-156, s. 1; SOR/2005-316, ss. 4 to 6; SOR/2010-94, s. 8(E); SOR/2010-141, ss. 1, 2; SOR/2010-264, s. 4.

TABLE XII

FOOD ADDITIVES THAT MAY BE USED AS SEQUESTERING AGENTS

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

A.1 Ammonium Citrate, Good ManufacturingUnstandardized foodsdibasic Practice

A.2 Ammonium Citrate, Good ManufacturingUnstandardized foodsmonobasic Practice Good ManufacturingC.1 Calcium Citrate Unstandardized foods Practice

(1) Ale; Beer; Light beer; Malt (1) 25 p.p.m. calculated as theC.2 Calcium Disodium liquor; Porter; Stout anhydrous form French dressing;

Ethylenediamine- Mayonnaise; Salad (2) 75 p.p.m. calculated as the(2)tetraacetate dressing; Unstandardized anhydrous form dressings and sauces Potato salad;

(3) 100 p.p.m. calculated as the(3) Unstandardized sandwich anhydrous formspreads

(4) Canned shrimp; Canned (4) 250 p.p.m. calculated as thetuna anhydrous form Canned crabmeat; Canned (5) 275 p.p.m. calculated as the(5) lobster; Canned salmon anhydrous form

(6) 75 p.p.m. calculated as the(6) Margarine anhydrous form

(7) 340 p.p.m. calculated as the(7) Canned clams anhydrous form 130 p.p.m calculated as the anhydrous form and inCanned ripe lima beans accordance with the(8) (butter beans); Canned (8) requirements ofpinto beans subparagraph B.11.002(d)(vi)

Canned snails; Canned sea (9) 300 p.p.m. calculated as the(9) snails anhydrous form 365 p.p.m. calculated as the anhydrous form and in accordance with the(10) Canned fava beans (10) requirements of subparagraph B.11.002(d)(vi.1)

(11) Soft drinks; Ready-to-drink (11) 33 p.p.m. calculated as the

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

teas anhydrous form 100 p.p.m., singly or in

(12) Pasteurized sous-vide combination with disodium(12)potatoes EDTA, calculated as anhydrous disodium EDTA

Same foods as listed for Same levels as prescribedCalcium DisodiumC.3 Calcium Disodium for Calcium DisodiumEDTA Ethylenediaminetetraacetate Ethylenediaminetetraacetate Ice cream mix; Ice milk (1) Good Manufacturing(1)Calcium Phosphate, mix; Sherbet PracticeC.4 monobasic

(2) Unstandardized dairy (2) Good Manufacturingproducts Practice Calcium Phosphate, Ice cream mix; Ice milk Good ManufacturingC.5 tribasic mix Practice

Good ManufacturingC.6 Calcium Phytate Glazed fruit Practice Pumping pickle, cover pickle and dry cure

(1) Good ManufacturingC.7 Citric Acid (1) employed in the curing of Practicepreserved meat or preserved meat by-product

(2) Good Manufacturing(2) Unstandardized foods Practice Frozen fish fillets; frozen

(3) minced fish; frozen (3) 0.1% comminuted fish

D.1 (1) Dressing and sauces (1) 70 p.p.m. Unstandardized sandwich(2) (2) 90 p.p.mDisodium spreads

Ethylenediaminetetra- Canned red kidney beans; 150 p.p.m in accordance acetate Canned chick peas with the requirements of(3) (3)(garbanzo beans); Canned subparagraph

black-eye peas B.11.002(d)(vii) (4) Dried banana products (4) 265 p.p.m

Aqueous suspensions of colour lake preparations for 1% of the colour(5) (5)use in coating confectionery preparation tablets

100 p.p.m., singly or in combination with calciumPasteurized sous-vide(6) (6) disodium EDTA, calculatedpotatoes as anhydrous disodium EDTA

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Same foods as listed for Same levels as prescribedDisodiumD.2 Disodium EDTA for DisodiumEthylenediaminete- Ethylenediaminetetraacetatetraacetate G.1 Glycine Mono- and diglycerides 0.02% P.1 Phosphoric Acid Mono- and diglycerides 0.02%

Ice cream mix; Ice milk (1) Good ManufacturingP.2 (1)Potassium Phosphate, mix; Sherbet Practice monobasic

(2) Good Manufacturing(2) Unstandardized foods Practice Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,product; solid cut poultry(3) (3) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product

(1) Good ManufacturingP.3 (1) Meat tenderizers Practice Solid cut meat; preparedPotassium meat; prepared meat by-Pyrophosphate, 0.5% total added phosphate,product; solid cut poultrytetrabasic (2) (2) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,Potassium Phosphate, product; solid cut poultryP.4 calculated as sodiumdibasic meat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product

Used singly or in combination with sodium hexametaphosphate or

Sodium Acid sodium tripolyphosphate, orS.1 (1) Canned seafoods (1)Pyrophosphate both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

Ice cream mix; Ice milk (2) Good Manufacturing(2) mix Practice Injection or cover solution Good Manufacturing

(3) for the curing of poultry or (3) Practice, and in accordance poultry meat with B.22.021(e)

(4) Pumping pickle for the (4) Good Manufacturing

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

curing of pork, beef and Practice, and in accordance lamb cuts with B.14.009(f) and

B.14.031(h)

(5) Unstandardized foods (5) Good ManufacturingPractice Solid cut meat; prepared

(6)

meat; prepared meat by- product; solid cut poultry meat; prepared poultry (6)

0.5% total added phosphate, calculated as sodium phosphate, dibasicmeat; prepared poultry meat

by-product Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and dry cure (1) Good ManufacturingS.2 Sodium Citrate (1) employed in the curing of Practice preserved meat or preserved meat by-product; Sherbet

(2) Good Manufacturing(2) Unstandardized foods Practice Used singly or in combination with sodium acid pyrophosphate or

Sodium sodium tripolyphosphate, orS.3 (1)Hexametaphos- phate (1) Canned seafoods both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

Ice cream mix; Ice milk (2) Good Manufacturing(2) mix Practice Injection or cover solution Good Manufacturing

(3) for the curing of poultry or (3) Practice, and in accordance poultry meat with B.22.021(e)

Good ManufacturingPumping pickle for the Practice, and in accordance(4) curing of pork, beef and (4) with B.14.009(f) andlamb cuts B.14.031(h)

(5) Good Manufacturing(5) Unstandardized foods Practice Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,product; solid cut poultry(6) (6) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

Liquid whey destined for 800 p.p.m. in thethe manufacture of(7) (7) concentrated or dried wheyconcentrated or dried whey productsproducts Ice cream mix; Ice milk (1) Good ManufacturingS.4 (1) mix; Sherbet PracticeSodium Phosphate, Injection or cover solution Good Manufacturingdibasic

(2) for the curing of poultry or (2) Practice, and in accordance poultry meat with B.22.021(e)

Good ManufacturingPumping pickle for the Practice, and in accordance(3) curing of pork, beef and (3) with B.14.009(f) andlamb cuts B.14.031(h)

(4) Good Manufacturing(4) Unstandardized foods Practice Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,product; solid cut poultry(5) (5) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product Ice cream mix; Ice milk (1) Good ManufacturingS.5 (1) mix; Sherbet PracticeSodium Phosphate, Injection or cover solution Good Manufacturingmonobasic

(2) for the curing of poultry or (2) Practice, and in accordance poultry meat with B.22.021(e)

Good ManufacturingPumping pickle for the Practice, and in accordance(3) curing of pork, beef and (3) with B.14.009(f) andlamb cuts B.14.031(h)

(4) Good Manufacturing(4) Unstandardized foods Practice Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,product; solid cut poultry(5) (5) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product Ice cream mix; Ice milk (1) Good ManufacturingS.6 Sodium (1) mix; Sherbet PracticePyrophosphate,

(2) Good Manufacturingtetrabasic (2) Meat tenderizers Practice

(3) Injection or cover solution (3) Good Manufacturingfor the curing of poultry or Practice, and in accordance

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

poultry meat with B.22.021(e)

(4) Pumping pickle for the curing of pork, beef and lamb cuts

(4)

Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)

(5) Unstandardized foods (5) Good ManufacturingPractice Solid cut meat; prepared

(6)

meat; prepared meat by- product; solid cut poultry meat; prepared poultry (6)

0.5% total added phosphate, calculated as sodium phosphate, dibasicmeat; prepared poultry meat

by-product Injection or cover solution Good Manufacturing

S.7 (1) for the curing of poultry or (1) Practice, and in accordanceSodium Tripolyphos- poultry meat with B.22.021(e)phate (2) Good Manufacturing(2) Meat tenderizers Practice

Good ManufacturingPumping pickle for the Practice, and in accordance(3) curing of pork, beef and (3) with B.14.009(f) andlamb cuts B.14.031(h)

(4) Good Manufacturing(4) Unstandardized foods Practice Solid cut meat; prepared meat; prepared meat by­ 0.5% total added phosphate,product; solid cut poultry(5) (5) calculated as sodiummeat; prepared poultry phosphate, dibasicmeat; prepared poultry meat by-product

Used singly or in combination with sodium acid pyrophosphate or sodium

(6) Canned seafoods (6) hexametaphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic 0.01% of the fat content. If monoglyceride citrate or

S.8 Stearyl Citrate Margarine monoisopropyl citrate or both are also used, the total must not exceed 0.01% of

Column I Column II Column III Item No. Additive Permitted in or Upon Maximum Level of Use

the fat content

SOR/79-660, ss. 19, 20; SOR/80-501, s. 4; SOR/82-596, ss. 4 to 9; SOR/94-141, s. 1; SOR/94-262, ss. 4 to 12; SOR/94-689, s. 2; SOR/95-435, s. 2; SOR/97-30, s. 1; SOR/97-562, s. 1; SOR/580, s. 1(F); SOR/2005-316, ss. 7 to 11; SOR/2010-40, s. 2; SOR/2010-142, ss. 57, 58; SOR/2010-143, ss. 37(F), 38.

TABLE XIII

FOOD ADDITIVES THAT MAY BE USED AS STARCH MODIFYING AGENTS

Column I Column II Column III Item Permitted in orAdditive Maximum Level of UseNo. Upon A.1 Acetic Anhydride Starch Good Manufacturing Practice A.2 Adipic Acid Starch Good Manufacturing Practice A.3 Aluminum Sulphate Starch Good Manufacturing Practice E.1 Epichlorhydrin Starch Good Manufacturing Practice H.1 Hydrochloric Acid Starch Good Manufacturing Practice H.2 Hydrogen Peroxide Starch Good Manufacturing Practice M.1 Magnesium Sulphate Starch 0.4% N.1 Nitric Acid Starch Good Manufacturing Practice

Octenyl SuccinicO.1 Starch Good Manufacturing PracticeAnhydride P.1 Peracetic Acid Starch Good Manufacturing Practice

PhosphorusP.2 Starch Good Manufacturing PracticeOxychloride Potassium 50 p.p.m. of Manganese Sulphate calculatedP.3 StarchPermanganate as Manganese

P.4 Propylene Oxide Starch 25% S.1 Sodium Acetate Starch Good Manufacturing Practice S.2 Sodium Bicarbonate Starch Good Manufacturing Practice S.3 Sodium Carbonate Starch Good Manufacturing Practice S.4 Sodium Chlorite Starch Good Manufacturing Practice S.5 Sodium Hydroxide Starch Good Manufacturing Practice S.6 Sodium Hypochlorite Starch Good Manufacturing Practice

SodiumS.7 Starch 400 p.p.m. calculated as PhosphorusTrimetaphosphate Sodium Total residual phosphate not to exceed 0.4%S.7A StarchTripolyphosphate (calculated as Phosphorus)

S.8 Succinic Anhydride Starch Good Manufacturing Practice S.9 Sulphuric Acid Starch Good Manufacturing Practice

SOR/94-689, s. 2(F).

TABLE XIV

FOOD ADDITIVES THAT MAY BE USED AS YEAST FOODS

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo. A.1 (1) Flour; Whole wheat flour (1) 2,000 p.p.m. of the flour

Ammonium 2,500 p.p.m. of the flour. For Chloride (2) Bread (2) combinations see paragraph

B.13.021(m) (3) Unstandardized foods (3) Good Manufacturing Practice

Ammonium 2,500 p.p.m. of the flour. For A.2 Phosphate, (1) Bread (1) combinations see paragraph

dibasic B.13.021(m) (2) Cider; Honey wine; Wine (2) Good Manufacturing Practice

(3) Unstandardized bakery (3) Good Manufacturing Practiceproducts Ammonium 2,500 p.p.m. of the flour. For

A.3 Phosphate, (1) Bread (1) combinations see paragraph monobasic B.13.021(m)

Ale; Beer; Cider; Honey wine; (2) Light beer; Malt liquor; Porter; (2) Good Manufacturing Practice

Stout; Wine

(3) Unstandardized bakery (3) Good Manufacturing Practiceproducts 2,500 p.p.m. of the flour. ForAmmoniumA.4 (1) Bread (1) combinations see paragraphSulphate B.13.021(m)

(2) Cider; Honey wine; Wine (2) Good Manufacturing Practice

(3) Unstandardized bakery (3) Good Manufacturing Practiceproducts 2,500 p.p.m. of the flour. ForCalciumC.1 (1) Bread (1) combinations see paragraphCarbonate B.13.021(m)

(2) Unstandardized bakery (2) Good Manufacturing Practiceproducts Unstandardized bakeryC.2 Calcium Chloride Good Manufacturing Practiceproducts Unstandardized bakeryC.3 Calcium Citrate Good Manufacturing Practiceproducts

2,500 p.p.m. of the flour. For C.4 Calcium Lactate (1) Bread (1) combinations see paragraph

B.13.021(m) (2) Unstandardized bakery (2) Good Manufacturing Practice

Column I Column II Column III Item Additive Permitted in or Upon Maximum Level of UseNo.

products Calcium 2,500 p.p.m. of the flour. For

C.5 Phosphate, (1) Bread (1) combinations see paragraph dibasic B.13.021(m)

(2) Unstandardized bakery (2) Good Manufacturing Practiceproducts Calcium 7,500 p.p.m. of flour. For

C.6 Phosphate, (1) Bread (1) combinations see paragraph monobasic B.13.021(m)

(2) Flour (2) 7,500 p.p.m. of flour

(3) Unstandardized bakery (3) Good Manufacturing Practiceproducts Calcium Unstandardized bakeryC.7 Phosphate, Good Manufacturing Practiceproductstribasic

C.8 Calcium Sulphate (1) Bread (1) 5,000 p.p.m. of the flour

(2) Unstandardized bakery (2) Good Manufacturing Practiceproducts F.1 Ferrous Sulphate Bacterial cultures Good Manufacturing Practice

Manganese Ale; Beer; Light beer; MaltM.1 Good Manufacturing PracticeSulphate liquor; Porter; Stout Ale; Beer; Light beer; MaltP.1 Phosphoric Acid Good Manufacturing Practiceliquor; Porter; Stout

Potassium (1) Ale; Beer; Light beer; MaltP.2 (1) Good Manufacturing PracticeChloride liquor; Porter; Stout

(2) Unstandardized bakery (2) Good Manufacturing Practiceproducts Potassium Ale; Beer; Cider; Honey wine;

P.4 Phosphate, (1) Light beer; Malt liquor; Porter; (1) Good Manufacturing Practice dibasic Stout; Wine

(2) Unstandardized bakery (2) Good Manufacturing Practiceproducts Potassium Ale; Beer; Cider; Honey wine;

P.5 Phosphate, Light beer; Malt liquor; Porter; Good Manufacturing Practice monobasic Stout; Wine

Unstandardized bakeryS.1 Sodium Sulphate Good Manufacturing Practiceproducts U.1 [Repealed, SOR/87-5, s. 1]

(1) Ale; Beer; Light beer; MaltZ.1 Zinc Sulphate (1) Good Manufacturing Practiceliquor; Porter; Stout (2) Bacterial cultures (2) Good Manufacturing Practice

SOR/87-5, s. 1; SOR/94-689, s. 2(F); SOR/95-281, ss. 6, 7; SOR/2010-41, ss. 7(E), 9(E).

TABLE XV

FOOD ADDITIVES THAT MAY BE USED AS CARRIER OR EXTRACTION SOLVENTS

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted in or Upon Maximum ResidueNo. Use

(1) Spice extracts; Natural1. Acetone (1) 30 p.p.m.extractives Good

(2) Meat and Egg Marking (2) ManufacturingInks Practice Good

(1) (naming the flavour)2. Benzyl Alcohol (1) ManufacturingFlavour (Division 10) Practice Good

(2) Unstandardized (2) Manufacturingflavouring preparations Practice Good1,3-Butylene (1) (naming the flavour)3. (1) ManufacturingGlycol Flavour (Division 10) Practice Good

(2) Unstandardized (2) Manufacturingflavouring preparations Practice Green coffee beans and Good

3.1 Carbon Dioxide (1) tea leaves for (1) Manufacturing decaffeination purposes Practice Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10); Hop extract in accordance Goodwith subparagraph(2) (2) ManufacturingB.02.130(b)(v) and Practiceparagraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(ii)

Good (3) Egg Products (3) Manufacturing

Practice Good

(4) Cocoa powder (4) Manufacturing Practice

Oil-soluble annatto; Good4. Castor Oil Annatto butter colour; Manufacturing

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted in or Upon Maximum ResidueNo. Use

5. Ethyl Acetate

Ethyl Alcohol6. (Ethanol)

Annatto margarine colour Spice extracts; Natural extractives; (naming the(1) flavour) Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(3) Green coffee beans fordecaffeination purposes

(4) Tea leaves fordecaffeination purposes Spice extracts; Natural extractives; (naming the(1) flavour) Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(3) Colour mixtures andpreparations (Division 6)

(4) Meat and Egg MarkingInks

(5) Food additivepreparations

Hop extract in accordance with subparagraph B.02.130(b)(v) and

(6) paragraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(iii)

Practice

Good (1) Manufacturing

Practice

Good (2) Manufacturing

Practice 10 p.p.m. in both roasted and(3) decaffeinated soluble (instant) coffee

(4) 50 p.p.m.

Good (1) Manufacturing

Practice

Good (2) Manufacturing

Practice Good

(3) Manufacturing Practice Good

(4) Manufacturing Practice Good

(5) Manufacturing Practice

Good (6) Manufacturing

Practice

Ethyl alcohol 10 p.p.m.6.A Vegetable oil seed mealsdenatured with methanol

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Maximum Residue

Maximum Level of Use

methanol 7. [Repealed, SOR/82-406, s. 1]

Glycerol8. (Glycerin)

Glyceryl9. diacetate

Glyceryl 10. triacetate

(Triacetin)

Glyceryl 11. tributyrate

(Tributyrin)

12. Hexane

(naming the flavour) Extract; (naming the

(1) flavour) Essence; (naming the flavour) Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(3) Colour mixtures andpreparations (Division 6)

(4) Food additivepreparations

(1) (naming the flavour)Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(1) (naming the flavour)Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(1) (naming the flavour)Flavour (Division 10)

(2) Unstandardizedflavouring preparations

(1) Spice extracts; Natural (1) 25 p.p.m.extractives Hop extract in accordance with

(2) subparagraph (2) 2.2% B.02.130(b)(v) and paragraph B.02.133(a)

(3) Vegetable fats and oils (3) 10 p.p.m. (4) Vegetable oil seed meals (4) 10 p.p.m.

Good (1) Manufacturing

Practice

Good (2) Manufacturing

Practice Good

(3) Manufacturing Practice Good

(4) Manufacturing Practice Good

(1) Manufacturing Practice Good

(2) Manufacturing Practice Good

(1) Manufacturing Practice Good

(2) Manufacturing Practice Good

(1) Manufacturing Practice Good

(2) Manufacturing Practice

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted in or Upon Maximum ResidueNo. Use

1.5 p.p.m. perPre-isomerized hop percent iso­extract in accordance alpha acid(5) with subparagraph (5) content of theB.02.134(1)(a)(i) and pre-isomerizedsubsection B.02.134(2) hop extract

13. (1) Spice extracts; NaturalextractivesIsopropyl alcohol(Isopropanol) (2) Fish protein

(1) 50 p.p.m.

(2) 0.15%

(3) (naming the flavour)Flavour (Division 10) (3) Good Manufacturing Practice

(4) Unstandardizedflavouring preparations (4) Good Manufacturing Practice

(5) Meat and Egg MarkingInks (5) Good Manufacturing Practice

14. (1) Spice extracts; Naturalextractives (1) 50 p.p.m.

Methyl Alcohol (methanol)

(2)

Hop extract in accordance with subparagraph (2) 2.2% B.02.130(b)(v) and paragraph B.02.133(a)

(3) Meat and Egg MarkingInks (3) Good Manufacturing Practice

14.1 Methyl ethyl ketone (2­ Butanone)

Spice extracts; Natural extractives 50 p.p.m.

15. Methylene Chloride (Dichloro­ methane)

(1) Spice extracts; Naturalextractives

(2)

Hop extract in accordance with subparagraph B.02.130(b)(v) and

(1) 30 p.p.m.

(2) 2.2% in hopextract

paragraph B.02.133(a) 10 p.p.m. in

(3) Green coffee beans and Tea leaves for decaffeination purposes

(3)

decaffeinated roasted coffee, decaffeinated soluble (instant) coffee,

Column I Column II Column III Column IV Item Maximum Level ofAdditive Permitted in or Upon Maximum ResidueNo. Use

Monoglycerides and diglycerides (1)

(naming the flavour)16. Flavour (Division 10)

Oil-soluble annatto; Annatto butter colour;(2) Annatto margarine colour

(3) Unstandardizedflavouring preparations

(4) Food additivepreparations

Monoglyceride (1) Spice extracts; Natural17. citrate extractives

(2) Unstandardizedflavouring preparations

18. 2-Nitropropane Vegetable oils (naming the flavour)

1,2-Propylene Extract; (naming the 19. glycol (1,2- (1) flavour) Essence;

propanediol) (naming the flavour) Flavour (Division 10) Oil-soluble annatto; Annatto butter colour;(2) Annatto margarine colour

(3) Unstandardizedflavouring preparations

(4) Colour mixtures andpreparations (Division 6)

(5) Food additivepreparations

Propylene glycol Oil-soluble annatto;20. mono-esters and Annatto butter colour;

decaffeinated tea leaves and decaffeinated instant tea

0.5 p.p.m.

Good (1) Manufacturing

Practice

Good (2) Manufacturing

Practice

Good (3) Manufacturing

Practice Good

(4) Manufacturing Practice Good

(1) Manufacturing Practice Good

(2) Manufacturing Practice

Good (1) Manufacturing

Practice

Good (2) Manufacturing

Practice

Good (3) Manufacturing

Practice Good

(4) Manufacturing Practice Good

(5) Manufacturing Practice Good Manufacturing

Column I Column II Column III Column IV Item No. Additive Permitted in or Upon Maximum Residue

Maximum Level of Use

diesters of fat- Annatto margarine Practice forming fatty colour acids

21. Triethyl-citrate (1) (naming the flavour)Flavour (Division 10) (1) Good Manufacturing Practice

(2) Unstandardizedflavouring preparations (2) Good Manufacturing Practice

SOR/78-403, ss. 26, 27; SOR/82-383, s. 12; SOR/82-406, s. 1; SOR/82-913, s. 5; SOR/82­ 1071, ss. 21, 22; SOR/84-541, s. 1; SOR/86-89, ss. 8, 9; SOR/86-178, ss. 4 to 7; SOR/86­ 1112, s. 9; SOR/90-667, s. 1; SOR/94-689, s. 2; SOR/96-259, s. 1; SOR/96-377, s. 1. Previous Version

Division 17

Salt B.17.001. (1) [S]. Salt, other than crude rock salt, shall be crystalline sodium chloride and may contain

(a) one or more of the following anti-caking agents,

(i) calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide and sodium aluminum silicate, the total amount not to exceed one per cent and, in the case of fine grained salt, the total amount not to exceed two per cent,

(ii) propylene glycol in an amount not exceeding 0.035 per cent, and

(iii) sodium ferrocyanide decahydrate in an amount not exceeding 13 parts per million calculated as anhydrous sodium ferrocyanide;

(b) not more than

(i) 1.4 per cent, singly or in combination, of calcium sulphate or potassium chloride,

(ii) 13 parts per million anhydrous sodium ferrocyanide when added as sodium ferrocyanide decahydrate in the production of dendritic crystals of salt,

(iii) 10 parts per million of polyoxyethylene (20) sorbitan monooleate when used in the production of coarse crystal salt,

(iv) 15 parts per million of sodium alginate when used in the production of coarse crystal salt, and

(v) 0.1 per cent other ingredients; and

(c) notwithstanding paragraphs (a) and (b), the total level of sodium ferrocyanide decahydrate, whether added as an anti-caking agent or as an adjuvant in the production of dendritic salt, shall not exceed 13 parts per million, calculated as anhydrous sodium ferrocyanide.

(2) [Repealed, SOR/97-151, s. 26]

SOR/79-662, s. 18; SOR/86-1125, s. 3; SOR/97-151, s. 26.

B.17.002. [Repealed, SOR/79-662, s. 18]

B.17.003. Notwithstanding section B.17.001, salt for table or general household use shall contain 0.01 per cent potassium iodide, with or without dextrose, sodium thiosulphate or sodium bicarbonate as a stabilizer of the iodide and the presence of iodide shall be shown on the principal display panel.

Division 18 Sweetening Agents

B.18.001. [S]. Sugar

(a) shall be the food chemically known as sucrose; and

(b) shall contain not less than 99.8 per cent sucrose.

B.18.002. [S]. Liquid Sugar shall be the food obtained by dissolving sugar in water.

B.18.003. [S]. Invert Sugar shall be the food obtained by the partial or complete hydrolysis of sugar.

B.18.004. [S]. Liquid Invert Sugar shall be the food consisting of a solution of invert sugar in water.

B.18.005. [S]. No person shall sell liquid sugar or liquid invert sugar unless the label carries a statement of the percentage of sugar or invert sugar contained therein.

B.18.006. [S]. Icing Sugar

(a) shall be powdered sugar; and

(b) may contain

(i) food colour, and

(ii) either not more than five per cent starch or an anticaking agent.

B.18.007. [S]. Brown Sugar, Yellow Sugar or Golden Sugar

(a) shall be the food obtained from the syrups originating in the sugar refining process;

(b) may contain not more than

(i) 4.5 per cent moisture, and

(ii) 3.5 per cent sulphate ash; and

(c) shall not contain less than 90 per cent sugar and invert sugar.

B.18.008. [S]. Refined Sugar Syrup, Refiners’ Syrup or Golden Syrup

(a) shall be the food made from syrup originating in the sugar refining process;

(b) may be hydrolyzed; and

(c) shall not contain more than

(i) 35 per cent moisture, and

(ii) 2.5 per cent sulphated ash.

B.18.009. [S]. Fancy Molasses

(a) shall be the syrupy food obtained by the evaporation and partial inversion of the clarified or unclarified sugar cane juice from which sugar has not been previously extracted;

(b) may contain sulphurous acid or its salts; and

(c) shall not contain more than

(i) 25 per cent moisture, and

(ii) 3 per cent sulphated ash.

B.18.010. [S]. Table Molasses

(a) shall be the liquid food obtained in the process of manufacturing raw or refined sugar;

(b) may contain sulphurous acid or its salts;

(c) shall not contain more than

(i) 25 per cent moisture, and

(ii) 3 per cent sulphated ash.

B.18.011. [S]. Refiners’ Molasses, Blackstrap Molasses or Cooking Molasses

(a) shall be the residual liquid food obtained in the process of manufacturing raw or refined sugar;

(b) may contain sulphurous acid or its salts;

(c) shall not contain more than

(i) 25 per cent moisture, and

(ii) 12 per cent sulphated ash.

B.18.015. [S]. (1) Dextrose Anhydrous, for the purpose of Part B of these Regulations

(a) shall be the food chemically known as dextrose;

(b) shall contain not less than 99.5 per cent D-glucose on a dry basis;

(c) shall contain not more than 0.25 per cent sulphated ash on a dry basis;

(d) shall contain not less than 98 per cent total solids; and

(e) may contain sulphurous acid or its salts.

(2) Dextrose Monohydrate, for the purpose of Part B of these Regulations

(a) shall be the food chemically known as dextrose;

(b) shall contain not less than 99.5 per cent D-glucose on a dry basis;

(c) shall contain not more than 0.25 per cent sulphated ash on a dry basis;

(d) shall contain not less than 90 per cent total solids; and

(e) may contain sulphurous acid or its salts.

SOR/84-300, s. 51.

B.18.016. [S]. Glucose or Glucose Syrup

(a) shall be the purified concentrated solution of nutritive saccharides obtained from the incomplete hydrolysis, by means of acid or enzymes, of starch or of a starch-containing substance;

(b) shall have a total solids content of not less than 70 per cent;

(c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis;

(d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose on a dry basis; and

(e) may contain sulphurous acid or its salts.

SOR/78-402, s. 8.

B.18.017. [S]. Glucose Solids or Dried Glucose Syrup

(a) shall be glucose or glucose syrup from which the water has been partially removed;

(b) shall have a total solids content of not less than 93 per cent;

(c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis;

(d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose, on a dry basis; and

(e) may contain sulphurous acid or its salts.

B.18.018. [S]. (Naming the source of the glucose) Syrup

(a) shall be glucose;

(b) may contain

(i) a sweetening agent,

(ii) a flavouring preparation,

(iii) sorbic acid,

(iv) sulphurous acid or its salts,

(v) salt, and

(vi) water; and

(c) shall not contain more than

(i) 35 per cent moisture; and

(ii) 3 per cent ash.

SOR/94-83, s. 1.

B.18.019. [S]. Lactose

(a) shall be the carbohydrate normally obtained from whey and may

(i) be anhydrous,

(ii) contain one molecule of water of crystalization, or

(iii) be a mixture of both subparagraphs (i) and (ii);

(b) shall not contain less than 99.0 per cent anhydrous lactose on a moisture free basis;

(c) shall not contain more than 0.3 per cent sulphated ash on a moisture free basis;

(d) shall have a weight loss of not more than 6.0 per cent on drying; and

(e) shall have, in a 10 per cent solution, a pH of not less than 4.5 and not more than 7.0.

Honey

B.18.025. [S]. Honey shall be the food produced by honey bees and derived from

(a) the nectar of blossoms,

(b) secretions of living plants, or

(c) secretions on living plants,

and shall have

(d) a fluid, viscous or partly or wholly crystallized consistency;

(e) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than eight where the hydroxy-methyl-furfural content is not more than 0.004 per cent; or

(f) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than three where the hydroxy-methyl-furfural content is not more than 0.0015 per cent.

B.18.026. (1) Subject to subsection (2), honey derived mainly from nectar of blossoms shall not contain

(a) less than 65 per cent apparent reducing sugar, calculated as invert sugar;

(b) more than 20 per cent moisture;

(c) more than 5 per cent apparent sucrose;

(d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids;

(e) more than 0.6 per cent ash; and

(f) more than 40 milliequivalents acid per 1 000 grams.

(2) Honey derived mainly from the nectar of lavender, rubinia, alfalfa, or banksia menziesii shall meet the requirements of paragraphs (1)(a), (b) and (d) to (f) and shall contain not more than 10 per cent apparent sucrose.

B.18.027. Honey derived from secretions of living plants or from secretions on living plants shall not contain

(a) less than 60 per cent apparent reducing sugar, calculated as invert sugar;

(b) more than 20 per cent moisture;

(c) more than 10 per cent apparent sucrose;

(d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids;

(e) more than 1.0 per cent ash; and

(f) more than 40 milliequivalents acid per 1 000 grams.

SOR/84-300, s. 52.

Division 19

Vinegar B.19.001. Vinegar shall be the liquid obtained by the acetous fermentation of an alcoholic liquid and shall contain not less than 4.1 per cent and not more than 12.3 per cent acetic acid.

SOR/92-626, s. 16; SOR/93-243, s. 2.

B.19.002. The percentage of acetic acid by volume contained in any vinegar described in Division 19 shall be shown on the principal display panel followed by the words “acetic acid”.

B.19.003. [S]. Wine Vinegar shall be vinegar made from wine and may contain caramel.

B.19.004. [S]. Spirit Vinegar, Alcohol Vinegar, White Vinegar or Grain Vinegar shall be vinegar made from diluted distilled alcohol.

B.19.005. [S]. Malt Vinegar shall be vinegar made from an infusion of malt undistilled prior to acetous fermentation, may contain other cereals or caramel, shall be dextro-rotatory, and shall contain, in 100 millilitres measured at a temperature of 20°C, not less than

(a) 1.8 grams of solids, and

(b) 0.2 gram of ash.

B.19.006. [S]. Cider Vinegar or Apple Vinegar shall be vinegar made from the liquid expressed from whole apples, apple parts or apple culls and may contain caramel.

B.19.007. [S]. Blended Vinegar shall be a combination of two or more varieties of vinegar of which spirit vinegar shall contribute not more than 55 per cent of the total acetic acid.

B.19.008. No person shall name any of the varieties of vinegar forming a blended vinegar unless the label of such blended vinegar carries a complete list of all the varieties of vinegar present, in descending order of proportionate content, based on acetic acid.

B.19.009. The maximum limits for the acetic acid content of a vinegar described in section B.19.001 do not apply to vinegar sold only for manufacturing use if the words “For Manufacturing Use Only” are shown on the principal display panel and upon all documents pertaining to such vinegar.

Division 20

Tea B.20.001. [S]. Tea shall be the dried leaves and buds of Thea sinensis (L.) Sims prepared by the usual trade processes.

B.20.002. [S]. Black Tea shall be black tea or a blend of two or more black teas and shall contain, on the dry basis, not less than 30 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash.

SOR/82-768, s. 61.

B.20.003. The provisions of B.20.002 do not apply to original unblended black tea that contains, on the dry basis, not less than 25 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash, and is packaged according to good commercial practice in the country of origin.

SOR/82-768, s. 61.

B.20.004. [S]. Green Tea shall contain, on the dry basis, not less than 33 per cent water- soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash.

SOR/82-768, s. 61.

B.20.005. [S]. Decaffeinated (indicating the type of tea)

(a) shall be tea of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than 0.4 per cent caffeine; and

(b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16.

SOR/90-429, s. 2.

Division 21

Marine And Fresh Water Animal Products B.21.001. The foods referred to in this Division are included in the term marine and fresh water animal products.

B.21.002. In this Division,

“filler” means

(a) flour or meal prepared from grain or potato, but not from a legume,

(b) processed wheat flour containing not less than the equivalent of 80 per cent dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981,

(c) bread, biscuit or bakery products, but not those containing or made with a legume,

(d) milk powder, skim milk powder, buttermilk powder or whey powder, and

(e) starch; (remplissage)

“Marine and fresh water animal” includes

(a) fish,

(b) crustaceans, molluscs, other marine invertebrates,

(c) marine mammals, and

(d) frogs. (animaux marine et animaux d’eau douce)

SOR/82-768, s. 62.

B.21.003. [S]. Fish shall be the clean, dressed edible portion of fish, with or without salt or seasoning, and may

(a) in the case of frozen fillets, contain ascorbic acid or its sodium salt, citric acid, or erythorbic acid or its sodium salt, and

(i) sodium tripolyphosphate, sodium hexametaphosphate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, or

(ii) a mixture of sodium hexametaphosphate and sodium carbonate;

(b) if frozen, have a glaze consisting of water, acetylated monoglycerides, calcium chloride, sodium alginate, sodium carboxymethyl cellulose, sodium phosphate (dibasic), corn syrup,

dextrose, glucose, glucose solids, ascorbic acid or its sodium salt or erythorbic acid or its sodium salt; and

(c) if frozen minced, contain sodium tripolyphosphate, sodium hexametaphosphate, ascorbic acid or its sodium salt, citric acid, erythorbic acid or its sodium salt, or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic.

SOR/84-300, s. 53; SOR/88-534, s. 7; SOR/91-149, s. 4; SOR/97-562, s. 2; SOR/2000-353, s. 9(F).

B.21.004. [S]. In this Division, meat shall be the clean, dressed flesh of crustaceans, molluscs, other marine invertebrates and marine mammals, whether minced or not, with or without salt or seasoning, and in the case of frozen lobster, frozen crab, frozen shrimp and frozen clams, may contain sodium tripolyphosphate or sodium hexametaphosphate or a combination of sodium 0hexametaphosphate and sodium carbonate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic.

SOR/88-534, s. 8; SOR/91-149, s. 5.

B.21.005. Fish, except fish protein, and meat products or preparations thereof are adulterated if any of the following substances or any substance in one of the following classes is present therein or has been added thereto:

(a) mucous membranes, any organ or portion of the genital system, or any organ or portion of a marine or fresh water animal that is not commonly sold as an article of food;

(b) preservatives, other than those provided for in this Division, except

(i) sorbic acid or its salts in dried fish that has been smoked or salted, and in cold processed smoked and salted fish paste, and

(ii) benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate in marinated or similar cold-processed, packaged fish and meat products; and

(c) food colour except as provided for in this Division.

B.21.006. [S]. Prepared fish or prepared meat shall be the whole or comminuted food prepared from fresh or preserved fish or meat respectively, may be canned or cooked, and may,

(a) in the case of lobster paste and fish roe (caviar), contain food colour;

(b) in the case of canned shellfish, canned spring mackerel and frozen cooked shrimp, contain citric acid or lemon juice;

(c) in the case of fish paste, contain filler, fish binder, monoglycerides or mono and diglycerides;

(d) in the case of canned salmon, tuna, lobster, crabmeat and shrimp, contain calcium disodium ethylenediaminetetraacetate (calcium disodium EDTA) and aluminum sulphate;

(e) in the case of canned tuna, contain ascorbic acid;

(f) in the case of canned seafoods, contain sodium acid pyrophosphate, sodium hexametaphosphate or sodium tripolyphosphate, singly, or in combination, at a maximum level of total added phosphate not to exceed 0.5%, calculated as sodium phosphate, dibasic;

(g) contain liquid smoke flavour or liquid smoke flavour concentrate;

(h) contain edible oil, vegetable broth and tomato sauce or puree;

(i) contain a gelling agent if the principal display panel carries the word “jellied” as an integral part of the common name;

(j) contain salt;

(k) in the case of canned snails, canned sea snails and canned clams, contain calcium disodium ethylenediamine tetra-acetate;

(l) in the case of canned flaked tuna, contain sodium sulphite;

(m) in the case of lumpfish caviar, contain tragacanth gum;

(n) in the case of a blend of prepared fish and prepared meat that has the appearance and taste of the flesh of a marine or freshwater animal, contain filler, fish binder, whole egg, egg-white, egg-yolk, food colour, gelling or stabilizing agents, texture-modifying agents, natural and artificial flavouring preparations, pH-adjusting agents, sweetener and, in a proportion not exceeding two per cent of the blend, a legume;

(o) in the case of crustaceans, contain potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium dithionite, sodium metabisulphite, sodium sulphite or sulphurous acid;

(p) in the case of frozen crustaceans and molluscs, contain calcium oxide and sodium hydroxide;

(q) in the case of frozen pre-cooked battered or breaded fish products, contain citric acid at a level of use not exceeding 0.1 per cent;

(r) in the case of canned clams, contain sodium erythorbate at a level of use not exceeding 350 parts per million; and

(s) in the case of comminuted products, other than lumpfish caviar, contain tragacanth gum at a level of use not exceeding 0.75 per cent.

SOR/80-13, s. 9; SOR/81-60, s. 12; SOR/84-602, s. 4; SOR/86-1020, s. 2; SOR/89-197, s. 2; SOR/92-344, s. 6; SOR/93-276, s. 13; SOR/94-141, s. 2; SOR/94-567, s. 3; SOR/94-689, s. 2(E); SOR/97-151, s. 27; SOR/97-562, s. 3; SOR/2005-316, s. 12; SOR/2007-76, s. 4. Previous Version B.21.007. [S]. Fish binder for use in or upon prepared fish or prepared meat shall be filler with any combination of salt, sugar, dextrose, glucose, spices and other seasonings.

B.21.008. No person shall sell filler or a fish binder represented for use in fish products either by label or in any advertisement unless the label carries adequate directions for use in accordance with the limits provided in section B.21.020.

B.21.009. Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of marine and fresh water animal products.

SOR/2010-142, s. 59(F). Previous Version

Prepared Fish

B.21.020. No person shall sell prepared fish or prepared meat that contains more than

(a) that amount of filler, fish binder or other ingredients that is represented by four per cent reducing sugars, calculated as dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981; and

(b) 70 per cent moisture where such prepared fish contains filler.

SOR/82-768, s. 63.

B.21.021. [S]. Preserved fish or preserved meat shall be cooked or uncooked fish or meat that is dried, salted, pickled, cured or smoked and may contain Class I Preservatives, dextrose, glucose, spices, sugar and vinegar, and

(a) dried fish that has been smoked or salted, and cold-processed smoked and salted fish paste may contain sorbic acid or its salts;

(b) smoked fish may contain food colour;

(c) packaged fish and meat products that are marinated or otherwise cold-processed may contain saunderswood (sandalwood), benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate;

(d) salted anchovy, salted scad and salted shrimp may contain erythrosine in such amount as will result in the finished product containing not more than 125 parts per million of erythrosine; and

(e) comminuted products may contain tragacanth gum at a level of use not exceeding 0.75 per cent.

SOR/95-493, s. 2; SOR/97-562, s. 4(F); SOR/2007-76, s. 5. Previous Version B.21.022. and B.21.023. [Repealed, SOR/79-252, s. 4]

B.21.024. Notwithstanding section B.21.020 lobster paste shall not contain more than two per cent filler or fish binder.

B.21.025. No person shall sell marine and fresh water animals, or marine and fresh water animal products, that are packed in a container that has been sealed to exclude air and that are smoked or to which liquid smoke flavour or liquid smoke flavour concentrate has been added, unless

(a) the container has been heat-processed after sealing at a temperature and for a time sufficient to destroy all spores of the species Clostridium botulinum;

(b) the contents of the container contain not less than nine per cent salt, as determined by official method FO-38, Determination of Salt in Smoked Fish, dated March 15, 1985;

(c) the contents of the container are customarily cooked before eating; or

(d) the contents of the container are frozen and the principal display panel of the label of the container carries the statement “Keep Frozen Prior to Use” in the same size type used for the common name of the contents of the container.

SOR/80-13, s. 10; SOR/82-566, s. 5; SOR/82-768, s. 64; SOR/89-198, s. 17; SOR/94-567, s. 4.

B.21.027. [S]. Fish Protein

(a) shall be the food prepared by

(i) extracting water, fat and other soluble components through the use of isopropyl alcohol from fresh whole edible fish of the order Clupeiformes, families Clupeidae and Osmeridae and the order Gadiformes, family Gadidae, or from trimmings resulting from the filleting of such fish when eviscerated, and

(ii) drying and grinding the protein concentrate resulting from the operation described in subparagraph (i);

(b) may contain a pH adjusting agent; and

(c) shall not contain

(i) less than 75 per cent protein, which protein shall be at least equivalent to casein in protein quality, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981.

(ii) and (iii) [Repealed, SOR/97-148, s. 8]

SOR/82-768, s. 65; SOR/97-148, s. 8.

Froglegs

B.21.031. No person shall sell fresh or frozen froglegs unless they are free from bacteria of the genus Salmonella, as determined by official method MFO-10, Microbiological Examination of Froglegs, November 30, 1981.

SOR/82-768, s. 66.

Division 22

Poultry, Poultry Meat, Their Preparations And Products B.22.001. [S]. Poultry shall be any bird that is commonly used as food.

B.22.002. [S]. Poultry meat shall be the clean, dressed flesh including the heart and gizzard of eviscerated poultry that is healthy at the time of slaughter.

SOR/80-13, s. 11.

B.22.003. [S]. Poultry meat by-product shall be the clean parts of poultry other than poultry meat commonly used as food and includes liver and skin but excludes the oesophagus, feet and head.

SOR/80-13, s. 12.

B.22.004. [S]. Giblets shall be the heart, liver and gizzard of poultry.

B.22.005. Poultry meat, poultry meat by-products or preparations thereof are adultered if any of the following substances or any substance in the following classes is present therein or has been added thereto:

(a) any organ or portion of poultry that is not commonly sold as food;

(b) preservatives, other than those provided for in this Division; and

(c) colour, other than caramel.

B.22.006. [S]. Prepared poultry meat or a prepared poultry meat by-product shall be any poultry meat or any poultry meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations or that has been preserved, placed in a hermetically-sealed container or cooked, and may contain

(a) where a minimum total protein content or minimum meat protein requirement is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

(i) sodium acid pyrophosphate,

(ii) sodium hexametaphosphate,

(iii) sodium phosphate, dibasic,

(iv) sodium phosphate, monobasic,

(v) sodium pyrophosphate, tetrabasic,

(vi) sodium tripolyphosphate,

(vii) potassium phosphate, monobasic,

(viii) potassium phosphate, dibasic, and

(ix) potassium pyrophosphate, tetrabasic;

(b) in the case of dried, cooked poultry meat, a Class IV preservative; and

(c) in the case of vacuum-packed sliced cooked turkey, Carnobacterium maltaromaticum CB1.

SOR/81-934, s. 16; SOR/94-262, s. 13; SOR/2010-264, s. 5. Previous Version B.22.008. In this Division, “filler” means any vegetable material (except tomato or beetroot), milk, egg, yeast, or any derivative or combination thereof that is acceptable as food.

SOR/82-768, s. 67; SOR/84-300, s. 54(E); SOR/86-875, s. 6.

B.22.009. No person shall sell

(a) any poultry intended for consumption as food if any preparation having oestrogenic activity has been administered to the poultry; or

(b) poultry meat or poultry meat by-product that contains any residues of exogenous oestrogenic substances.

SOR/87-626, s. 2.

B.22.010. Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of poultry meat, poultry meat by-product, prepared poultry meat, prepared poultry meat by-product, extended poultry product and simulated poultry product.

SOR/2010-142, s. 59(F). Previous Version B.22.011. [S]. Solid cut poultry meat shall be

(a) a whole cut of poultry meat; or

(b) a product consisting of pieces of poultry meat of which at least 80 per cent weigh at least 25 g each.

SOR/94-262, s. 14.

B.22.012. (1) No person shall sell solid cut poultry meat to which phosphate salts or water has been added unless

(a) that meat

(i) where cooked, contains a meat protein content of not less than 12 per cent, and

(ii) where uncooked, contains a meat protein content of not less than 10 per cent; and

(b) that meat contains, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,

(i) sodium acid pyrophosphate,

(ii) sodium hexametaphosphate,

(iii) sodium phosphate, dibasic,

(iv) sodium phosphate, monobasic,

(v) sodium pyrophosphate, tetrabasic,

(vi) sodium tripolyphosphate,

(vii) potassium phosphate, monobasic,

(viii) potassium phosphate, dibasic, and

(ix) potassium pyrophosphate, tetrabasic.

(2) A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a).

SOR/94-262, s. 14.

B.22.013. No person shall sell the whole or any part of a dressed poultry carcass that has been placed in a chilling tank containing fluids to which phosphate salts have been added.

SOR/94-262, s. 14.

Poultry Meat Stews

B.22.016. For the purposes of sections B.22.017 to B.22.019, “stew poultry meat” means cooked or uncooked poultry meat containing not more than 15 per cent fat, calculated on the weight of uncooked stew poultry meat.

SOR/78-874, s. 3.

B.22.017. [S]. Vegetable Stew with (naming the poultry meat)

(a) shall contain vegetables and the named poultry meat in the following amounts:

(i) if uncooked, 12 per cent or more of the named stew poultry meat,

(ii) if cooked, 6 per cent or more of the named stew poultry meat,

(iii) 38 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 3.

B.22.018. [S]. (naming the poultry meat) Stew

(a) shall contain vegetables and the named poultry meat in the following amounts:

(i) if uncooked, 20 per cent or more of the named stew poultry meat,

(ii) if cooked, 10 per cent or more of the named stew poultry meat,

(iii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 3.

B.22.019. [S]. Specialty Poultry Meat Stew

(a) shall contain poultry meat and vegetables in the following amounts:

(i) if uncooked, 25 per cent or more of stew poultry meat,

(ii) if cooked, 15 per cent or more of stew poultry meat,

(iii) 30 per cent or more vegetables; and

(b) may contain gravy, salt, seasoning and spices.

SOR/78-874, s. 3.

Prepared Poultry Meats, Prepared Poultry Meat By-Products

B.22.020. [Repealed, SOR/86-875, s. 7]

B.22.021. [S]. Preserved poultry meat or poultry meat by-product shall be cooked or uncooked poultry meat or poultry meat by-product that is cured or smoked and may contain

(a) Class 1 preservatives;

(b) liquid smoke flavour, liquid smoke flavour concentrate or spices;

(c) sweetening agents;

(d) vinegar;

(e) in the case of cured poultry or poultry meat prepared by means of injection or cover solution, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate, in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate; and

(f) in the case of vacuum-packed sliced cooked turkey, Carnobacterium maltaromaticum CB1.

SOR/80-13, s. 13; SOR/82-596, s. 10; SOR/94-567, s. 5; SOR/2010-264, s. 6. Previous Version B.22.022. [S]. Canned (naming the poultry) shall be prepared from poultry meat and may contain

(a) those bones or pieces of bones attached to the portion of the poultry meat that is being canned;

(b) broth;

(c) salt;

(d) seasoning;

(e) gelling agents; and

(f) small amounts of fat.

SOR/84-300, s. 55.

B.22.023. [S]. Broth that is used in canned (naming the poultry) shall be the liquid in which the poultry meat has been cooked.

B.22.024. Where a gelling agent has been added to canned poultry, a statement to the effect that a gelling agent has been added shall be shown on the principal display panel or the word “jellied” shall be shown as an integral part of the common name of the food.

B.22.025. [S]. Boneless (naming the poultry) shall be canned poultry meat from which the bones and skin have been removed, shall contain not less than 50 per cent of the named poultry meat, as determined by official method FO-39, Determination of Meat in Boneless Poultry, October 15, 1981, and may contain broth having a specific gravity of not less than 1.000 at a temperature of 50°C.

SOR/82-768, s. 69.

B.22.026. No person shall sell poultry, poultry meat or poultry meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked poultry, poultry meat or poultry meat by-product

(a) at all times

(i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, or

(ii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and

(b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher.

SOR/78-403, s. 28(F); SOR/88-336, s. 3.

Poultry Product Extender

B.22.027. No person shall sell a poultry product extender unless that extender

(a) has, in the rehydrated state,

(i) a total protein content of not less than 16 per cent; and

(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(b) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 70.

Extended Poultry Products

B.22.028. No person shall sell a food that consists of a mixture of poultry product and poultry product extender, unless that food

(a) has a total protein content of not less than 16 per cent, and

(b) has a protein rating of not less than 40, as determined by official method, and unless

the poultry product extender meets the requirements of paragraphs B.22.027(a) to (c).

Simulated Poultry Products

B.22.029. No person shall sell a simulated poultry product unless that product

(a) has a total protein content of not less than 16 per cent;

(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) has a fat content of not more than 15 per cent;

(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and

(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.

SOR/82-768, s. 71.

Egg Products

B.22.032. No person shall sell any product simulating whole egg unless that product

(a) is made from liquid, dried or frozen egg albumen or mixtures thereof;

(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;

(c) notwithstanding sections D.01.009 and D.02.009, contains, per 100 grams on a ready-to­ use basis,

(i) not less than

(A) 50 milligrams calcium,

(B) 2.3 milligrams iron,

(C) 1.5 milligrams zinc,

(D) 130 milligrams potassium,

(E) 1000 International Units Vitamin A,

(F) 0.10 milligram thiamine,

(G) 0.30 milligram riboflavin,

(H) 3.60 milligrams niacin,

(I) 1.60 milligrams pantothenic acid,

(J) 0.20 milligram Vitamin B6′,

(K) 0.50 microgram Vitamin B12′,

(L) 0.02 milligram folic acid, and

(M) 2.0 International Units alpha tocopherol, and

(ii) not more than 3 milligrams cholesterol;

(d) has a calcium to phosphorous ratio of not less than one part calcium to four parts phosphorous; and

(e) contains in the total fat of any fat or oil used not less than 40 per cent cis-cis methylene interrupted polyunsaturated fatty acids and not more than 20 per cent saturated fatty acids.

SOR/82-768, s. 72; SOR/84-300, s. 56.

B.22.033. No person shall sell any egg product referred to in sections B.22.032, B.22.034, B.22.035, B.22.036 and B.22.037 for use as food unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-6, Microbiological Examination of Egg Products and Liquid Eggs, November 30, 1981.

SOR/82-768, s. 73.

B.22.034. [S]. Liquid Whole Egg, Dried Whole Egg or Frozen Whole Egg

(a) shall be the product obtained by removing the shell from wholesome fresh eggs or wholesome stored eggs, and

(i) in the case of dried whole egg, drying the product, or

(ii) in the case of frozen whole egg, freezing the product; and

(b) may

(i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene,

(ii) in the case of liquid whole egg destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or

(iii) in the case of dried whole egg, contain anti-caking agents.

B.22.035. [S]. Liquid Yolk, Dried Yolk or Frozen Yolk

(a) shall be the product obtained by removing the shell and egg-white from wholesome fresh eggs or wholesome stored eggs, and

(i) in the case of dried yolk, drying the product, or

(ii) in the case of frozen yolk, freezing the product, and

(b) may

(i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene,

(ii) in the case of liquid yolk destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or

(iii) in the case of dried yolk, contain anti-caking agents.

B.22.036. [S]. Liquid Egg-White, (Liquid Albumen), Dried Egg-White, (Dried Albumen) or Frozen Egg-White (Frozen Albumen)

(a) shall be the product obtained by removing the shell and yolk from wholesome fresh eggs or wholesome stored eggs, and

(i) in the case of dried egg-white, drying the product, or

(ii) in the case of frozen egg-white, freezing the product; and

(b) may

(i) contain whipping agents, aluminum sulphate and pH adjusting agents,

(ii) in the case of liquid egg-white destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture,

(iii) in the case of liquid egg-white and dried egg-white, contain lipase or pancreatin, or

(iv) in the case of dried egg-white, contain anti-caking agents.

B.22.037. [S]. Liquid Whole Egg Mix, Dried Whole Egg Mix, Frozen Whole Egg Mix, Liquid Yolk Mix, Dried Yolk Mix or Frozen Yolk Mix

(a) shall be the product obtained by adding salt, sweetening agent or both to Liquid Whole Egg, Dried Whole Egg, Frozen Whole Egg, Liquid Yolk, Dried Yolk or Frozen Yolk; and

(b) may, in the case of dried whole egg mix or dried yolk mix, contain anti-caking agents.

B.22.038. (1) No person shall use a common name referred to in sections B.22.034 to B.22.037 for an egg product that has been subjected to a process, other than a process referred to in those sections, if that process results in a decrease in the amount of a vitamin or mineral nutrient that before processing was present in 100 g of the egg product in an amount equal to at least 10 per cent of the weighted recommended nutrient intake, unless the amount of the vitamin or mineral nutrient is restored to the amount that was present before processing.

(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, a person may add any vitamin or mineral nutrient referred to in column II of item 27 of the table to section D.03.002 to any egg product referred to in sections B.22.034 to B.22.037 to restore the vitamin or mineral nutrient to the amount that was present in the egg product before processing.

(3) In this section, “weighted recommended nutrient intake” has the same meaning as in subsection D.01.001(1).

SOR/96-259, s. 2.

Division 23

Food Packaging Materials B.23.001. No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food.

B.23.002. Subject to section B.23.003 no person shall sell any food in a package that has been manufactured from a polyvinyl chloride formulation containing an octyltin chemical.

B.23.003. A person may sell food, other than milk, skim milk, partly skimmed milk, sterilized milk, malt beverages and carbonated non-alcoholic beverage products, in a package that has been manufactured from a polyvinyl chloride formulation containing any or all of the octyltin chemicals, namely, di(n-octyl)tin S,S′-bis(isooctylmercaptoacetate), di(n-octyl)tin maleate polymer and (n-octyl)tin S,S′,S″-tris(isooctylmercaptoacetate) if the proportion of such chemicals, either singly or in combination, does not exceed a total of three per cent of the resin, and the food in contact with the package contains not more than one part per million total octyltin.

SOR/81-60, s. 13; SOR/86-1125, s. 4.

B.23.004. (1) Di (n-octyl)tin S,S′-bis (isooctylmercaptoacetate) shall be the octyltin chemical made from di (n-octyl)tin dichloride and shall contain 15.1 to 16.4 per cent of tin and 8.1 to 8.9 per cent of mercapto sulfur.

(2) For the purposes of this Division, di (n-octyl)tin dichloride shall be the chemical having an organotin composition of not less than 95 per cent di (n-octyl)tin dichloride and shall contain no more than

(a) five per cent total of n-octyltin trichloride or tri(n-octyl)tin chloride or both;

(b) 0.2 per cent total of other eight (8) carbon isomeric alkyltin derivatives; and

(c) 0.1 per cent total of the higher and lower homologous alkyltin derivatives.

SOR/86-1125, s. 5.

B.23.005. Di(n-octyl)tin maleate polymer shall be the octyltin chemical made from di(n­ octyl)tin dichloride and shall have the formula ((C8H17)2 SnC4H2O4)n (where n is between 2 and 4 inclusive), and a saponification number of 225 to 255, and shall contain 25.2 to 26.6 per cent of tin.

SOR/86-1125, s. 6(F).

B.23.006. (1) (n-octyl)tin S,S′,S″-tris (isooctylmercaptoacetate), being an octyltin chemical having the formula n-C8H17Sn(SCH2CO2C8H17)3, shall be made from (n-octyl)tin trichloride and shall contain 13.4 to 14.8 per cent of tin and 10.9 to 11.9 per cent of mercapto sulfur.

(2) For the purposes of this Division, (n-octyl)tin trichloride shall be the chemical having an organotin composition of not less than 95 per cent (n-octyl)tin trichloride and shall contain not more than

(a) five per cent total of di(n-octyl)tin dichloride, tri(n-octyl)tin chloride or the higher (more than eight (8) carbons) alkyltin chlorides or any combination of the foregoing;

(b) 0.2 per cent total of alkyltin derivatives; and

(c) 0.1 per cent of the lower (less than eight carbons) homologous alkyltin derivatives.

SOR/86-1125, s. 7.

B.23.007. No person shall sell a food in a package than may yield to its contents any amount of vinyl chloride, as determined by official method, FO-40, Determination of Vinyl Chloride in Food, October 15, 1981, in respect of that food.

SOR/82-768, s. 74.

B.23.008. No person shall sell a food in a package that may yield to its contents any amount of acrylonitrile as determined by official method FO-41, Determination of Acrylonitrile in Food, February 16, 1982, in respect of that food.

SOR/82-541, s. 1.

Division 24 Foods for Special Dietary Use

B.24.001. In this Division,

“expiration date” means, in respect of a formulated liquid diet, a food represented for use in a very low-energy diet, a meal replacement or a nutritional supplement, the date

(a) after which the manufacturer does not recommend that it be consumed, and

(b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)

“food for special dietary use” means food that has been specially processed or formulated to meet the particular requirements of a person

(a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or

(b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods; (aliment à usage diététique spécial)

“formulated liquid diet” means a food that

(a) is sold for consumption in liquid form, and

(b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition “food for special dietary use”; (préparation pour régime liquide)

“hospital” means a facility

(a) that is licensed, approved or designated as a hospital by a province, in accordance with the laws of the province, to provide care or treatment to persons suffering from any form of disease or illness, or

(b) that is owned or operated by the government of Canada or of a province and that provides health services; (hôpital)

“major change” means, in respect of a food that is represented for use in a very low energy diet, any change in any of the following, where the manufacturer’s experience or generally

accepted theory would predict an adverse effect on the levels or availability of nutrients in, the microbiological or chemical safety of or the safe use of the food:

(a) an ingredient or the amount of an ingredient in the food,

(b) the manufacturing process or the packaging of the food, or

(c) the directions for the preparation and use of the food; (changement majeur)

“meal replacement”[Repealed, SOR/95-474, s. 3]

“pharmacist” means a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy under those laws in that province; (pharmacien)

“physician” means a person who is registered and entitled under the laws of a province to practise medicine and who is practicing medicine under those laws in that province; (médecin)

“prepackaged meal”[Repealed, SOR/95-474, s. 3]

“target body weight” means the anticipated body weight at the end of the weight reduction diet, as determined by the physician before the weight reduction diet begins; (poids corporel cible)

“very low energy diet” means a diet for weight reduction that provides less than 900 kilocalories per day when followed as directed. (régime à très faible teneur en énergie)

SOR/78-64, s. 1; SOR/78-698, s. 4; SOR/94-35, s. 1; SOR/95-474, s. 3.

B.24.003. (1) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use unless the food is

(a) to (e) [Repealed, SOR/2003-11, s. 21]

(f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102;

(f.1) a meal replacement for special dietary use that meets the requirements contained in section B.24.200;

(f.2) a nutritional supplement that meets the requirements contained in section B.24.201;

(g) a gluten-free food that meets the requirements contained in section B.24.018;

(h) represented for protein-restricted diets;

(i) represented for low (naming the amino acid) diets; or

(j) a food represented for use in a very low energy diet, where the food meets the requirements contained in section B.24.303.

(1.1) Despite subsection (1), a person may label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use if its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

(a) “free of energy”, set out in item 1;

(b) “low in energy”, set out in item 2;

(c) “free of sodium or salt”, set out in item 31;

(d) “low in sodium or salt”, set out in item 32; or

(e) “free of sugars”, set out in item 37.

(2) Subsection (1) does not apply to infant formulas.

(3) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is for use in a weight reduction diet unless that food is

(a) a meal replacement that meets the compositional requirements contained in section B.24.200;

(b) a prepackaged meal;

(c) a food sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic; or

(d) a food represented for use in a very low-energy diet that meets the compositional requirements contained in section B.24.303.

(4) Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as “dietetic” or “diet”, or use those words as part of the brand name of the food, unless its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

(a) “free of energy”, set out in item 1;

(b) “low in energy”, set out in item 2;

(c) “reduced in energy”, set out in item 3;

(d) “lower in energy”, set out in item 4; or

(e) “free of sugars”, set out in item 37.

SOR/78-64, s. 2; SOR/78-698, s. 5; SOR/84-334, s. 1; SOR/86-178, s. 8(E); SOR/94-35, s. 2; SOR/95-444, s. 1; SOR/95-474, s. 4; SOR/2003-11, s. 21.

B.24.004. to B.24.014. [Repealed, SOR/2003-11, s. 22]

B.24.015. and B.24.016. [Repealed, SOR/88-559, s. 6]

B.24.017. (1) Where the manufacturer of a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is requested in writing by the Director to submit, on or before a specified day, evidence with respect to that product, the manufacturer shall make no further sales of that product after that day unless the manufacturer has submitted the evidence requested.

(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall so notify the manufacturer in writing.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is not sufficient, the manufacturer shall make no further sales of that product unless the manufacturer submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

(4) A reference in this section to evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet means evidence to establish that the food is nutritionally adequate to be used as the sole source of nutrition in meeting the nutritional needs of a person for whom it is intended, when the food is consumed in accordance with the directions for use.

SOR/78-698, s. 6; SOR/94-35, s. 3.

B.24.018. No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food unless the food does not contain wheat, including spelt and kamut, or oats, barley, rye or triticale or any part thereof.

SOR/95-444, s. 2.

B.24.019. [Repealed, SOR/2003-11, s. 23]

Formulated Liquid Diets

B.24.100. No person shall advertise a formulated liquid diet to the general public.

SOR/78-64, s. 7; SOR/78-698, s. 7.

B.24.101. No person shall sell a formulated liquid diet unless the food

(a) if sold ready to serve, or

(b) if not sold ready to serve, when diluted with water, milk, or water and milk,

is a complete substitute for the total diet in meeting the nutritional requirements of a person.

SOR/78-64, s. 7.

B.24.102. (1) Subject to subsection (4), a formulated liquid diet shall contain, when ready to serve,

(a) either

(i) not less than 20 grams of protein of nutritional quality equivalent to casein, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, or

(ii) such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,

(A) the fraction will not be less than 85/100, and

(B) the result obtained by multiplying the fraction by the gram weight of the protein will not be less than 20; and

(b) not less than one gram linoleic acid in the form of a glyceride.

(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, a formulated liquid diet shall contain, when ready to serve, the vitamins and minerals named in Column I of the table to this section in amounts,

(a) where the recommended intake of the food is 2,500 kilocalories per day or less, not less than the amounts set out in Column II and not more than the amounts, if any, set out in Column III of that table opposite those vitamins and minerals; and

(b) where the recommended intake of the food is greater than 2,500 kilocalories per day, not less than the amounts set out in Column IV and not more than the amounts, if any, set out in Column V of the table opposite those vitamins and minerals.

(3) The amounts of the nutrients specified in paragraphs (1)(a) and (b) and subsection (2) shall be calculated

(a) per 1,000 available kilocalories, where the recommended intake of the food is 2,500 kilocalories per day or less; and

(b) per 1,500 available kilocalories, where recommended intake of the food is greater than 2,500 kilocalories per day.

(4) Paragraph (1)(a) does not apply to a formulated liquid diet represented as being for a protein restricted diet or a low (named amino acid) diet.

TABLE

Per 1,000 available kilocalories Per 1,500 available kilocalories Column I Column II Column III Column IV Column V Vitamins Minimum Maximum Minimum Maximum

2,000 5,000 2,000 3,000 Vitamin A International International International International

Units Units Units Units 100 International 400 International 100 International 200 InternationalVitamin D Units Units Units Units

Vitamin E (a- 5.0 International 5.0 International tocopherol) Units Units Ascorbic Acid 20 milligrams 20 milligrams Thiamine 0.5 milligram 0.6 milligram Riboflavin 0.7 milligram 0.84 milligram Niacin 6.6 milligrams 7.9 milligrams Vitamin B6 0.9 milligram 0.9 milligram Vitamin B12 1.5 micrograms 1.5 micrograms Folic Acid 100 micrograms 100 micrograms d-pantothenic 2.5 milligrams 2.5 milligramsAcid Mineral Nutrients Calcium 400 milligrams 400 milligrams

Per 1,000 available kilocalories Per 1,500 available kilocalories Column I Column II Column III Column IV Column V Vitamins Minimum Maximum Minimum Maximum Phosphorus 400 milligrams 400 milligrams Iron 8 milligrams 8 milligrams Iodine 50 micrograms 50 micrograms Magnesium 150 milligrams 150 milligrams Copper 1 milligram 1 milligram Zinc 7 milligrams 7 milligrams

SOR/78-64, s. 7; SOR/78-698, s. 8; SOR/82-768, s. 75; SOR/87-640, s. 9(F); SOR/90-830, s. 6(F).

B.24.103. The label of a formulated liquid diet shall carry the following information:

(a) a statement that the food is intended to be consumed orally or by tube feeding;

(b) a statement of the energy value of the food, expressed in Calories

(i) per 100 grams or per 100 millilitres of the food as offered for sale, and

(ii) per unit of ready-to-serve food;

(c) a statement of the content in the food of protein or protein equivalent, fat, linoleic acid, available carbohydrate and, where present, crude fibre, expressed in grams

(i) per 100 grams or per 100 millilitres of the food as offered for sale, and

(ii) per unit of ready-to-serve food;

(d) a statement of the content of vitamins and mineral nutrients that are listed in the table to section B.24.102, expressed in International Units or milligrams

(i) per 100 grams or per 100 millilitres of the food as offered for sale, and

(ii) per unit of ready-to-serve food;

(e) a statement of the content of any vitamin or mineral nutrient that is not listed in the table to section B.24.102, expressed in milligrams

(i) per 100 grams or per 100 millilitres of the food as offered for sale, and

(ii) per unit of ready-to-serve food;

(f) complete directions for the preparation and use of the food and for its storage after the container has been opened; and

(g) the expiration date of the formulated liquid diet.

SOR/78-64, s. 7; SOR/88-559, s. 27.

Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics

B.24.200. (1) No person shall sell or advertise a meal replacement unless, when in a ready-to­ serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:

(a) the meal replacement provides a minimum of 225 kcal or 945 kJ per serving;

(b) not less than 15 per cent and not more than 40 per cent of the energy available from the meal replacement is derived from its protein content, except that a meal replacement for use in a weight reduction diet shall derive not less than 20 per cent of its available energy from its protein content;

(c) subject to subsection (2), not more than 35 per cent of the energy available from the meal replacement is derived from its fat content;

(d) not less than 3.0 per cent of the energy available from the meal replacement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the meal replacement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1;

(e) the proteins present in the meal replacement are

(i) of a nutritional quality equivalent to that of casein, or

(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent, or not less than 20 per cent in the case of a meal replacement for use in a weight reduction diet, when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the meal replacement; and

(f) each serving of the meal replacement contains each vitamin and mineral nutrient listed in column I of the table to this section

(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and

(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

(2) No person shall sell or advertise a meal replacement that is represented as a replacement for all daily meals unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:

(a) not more than 30 per cent of the energy available from the meal replacement is derived from its fat content; and

(b) not more than 10 per cent of the energy available from the meal replacement is derived from its saturated fatty acid content.

(3) The minimum amount required under subparagraph (1)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a meal replacement that is not represented as a replacement for all daily meals and that does not contain added selenium, chromium or molybdenum, as the case may be.

(4) A vitamin or mineral nutrient that is not an added ingredient in the meal replacement shall not be taken into account for the purposes of subparagraph (1)(f)(ii).

(5) The maximum amount shown for vitamin C in column III of the table to this section does not include overage.

TABLE

COLUMN I COLUMN II COLUMN III Nutrients Minimum Amount per Serving Maximum Amount per Serving VITAMINS Vitamin A 250 RE 630 RE Vitamin D 1.25 µg 2.50 µg Vitamin E 2.5 mg 5.0 mg Vitamin C 10 mg 20 mg Thiamine 300 µg 750 µg Riboflavin 400 µg 800 µg Niacin 6 NE 12 NE Vitamin B6 400 µg 750 µg Vitamin B12 0.25 µg 0.75 µg Folacin 60 µg 120 µg Pantothenic acid 1.25 mg 2.50 mg Biotin 25 µg 75 µg MINERAL NUTRIENTS Calcium 200 mg 400 mg Phosphorus 250 mg 500 mg Iron 2.5 mg 5.0 mg Iodide 40 µg 120 µg Magnesium 60 mg 120 mg Copper 0.5 mg 1.0 mg Zinc 3 mg 6 mg Potassium 375 mg Sodium 250 mg Manganese 1 mg 2 mg Selenium 10 µg 20 µg Chromium 10 µg 20 µg Molybdenum 20 µg 40 µg

SOR/78-698, s. 9; SOR/80-13, s. 14; SOR/95-474, s. 5.

B.24.201. (1) No person shall sell or advertise a nutritional supplement that contains less than 225 kcal or 945 kJ per serving, unless it meets the following requirements:

(a) the nutritional supplement contains at least 150 kcal or 630 kJ per serving;

(b) not less than 15 per cent and no more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;

(c) the proteins present in the nutritional supplement are

(i) of a nutritional quality equivalent to that of casein, or

(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and

(d) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section

(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and

(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

(2) No person shall sell or advertise a nutritional supplement that provides 225 kcal or 945 kJ, or more, per serving unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk, skim milk, or a combination thereof, it meets the following requirements:

(a) the nutritional supplement provides at least 225 kcal or 945 kJ per serving;

(b) not more than 35 per cent of the energy available from the nutritional supplement is derived from its fat content;

(c) not less than 3.0 per cent of the energy available from the nutritional supplement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the nutritional supplement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1;

(d) not less than 15 per cent and not more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;

(e) the proteins present in the nutritional supplement are

(i) of a nutritional quality equivalent to that of casein, or

(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and

(f) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section

(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and

(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

(3) The minimum amount required under subparagraph (1)(d)(i) or (2)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a nutritional supplement that does not contain added selenium, chromium or molybdenum, as the case may be.

(4) A vitamin or mineral nutrient that is not an added ingredient in the nutritional supplement shall not be taken into account for the purposes of subparagraphs (1)(d)(ii) and (2)(f)(ii).

(5) The maximum amount shown for vitamin C in column III of the table to this section does not include overage.

TABLE

COLUMN I COLUMN II COLUMN III Minimum Amount per Available Maximum Amount per AvailableNutrients 100 Kcal or 420 KJ 100 Kcal or 420 KJ

VITAMINS Vitamin A 100 RE 250 RE Vitamin D 0.25 µg 1 µg Vitamin E 1.0 mg 2.0 mg Vitamin C 5 mg 10 mg Thiamine 140 µg 350 µg Riboflavin 180 µg 360 µg Niacin 3 NE 6 NE Vitamin B6 180 µg 350 µg Vitamin B12 0.1 µg 0.3 µg Folacin 30 µg 60 µg Pantothenic 0.6 mg 1.2 mgacid Biotin 12 µg 35 µg MINERAL NUTRIENTS Calcium 100 mg 175 mg Phosphorus 100 mg 175 mg Iron 1.0 mg 2.0 mg Iodide 15 µg 45 µg Magnesium 20 mg 40 mg Copper 0.15 mg 0.30 mg Zinc 1.4 mg 2.0 mg Potassium 175 mg Manganese 0.45 mg 0.90 mg Selenium 4 µg 8 µg Chromium 4 µg 8 µg Molybdenum 8 µg 15 µg

SOR/78-698, s. 9; SOR/95-474, s. 5.

B.24.202. The label of a meal replacement or nutritional supplement shall

(a) show the following information per serving of stated size and per stated quantity of food, when prepared according to the directions for use:

(i) the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),

(ii) the protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate contents of the food, expressed in grams,

(iii) the vitamin A, vitamin D, vitamin E, vitamin C, thiamin or vitamin B1, riboflavin or vitamin B2, niacin, vitamin B6, vitamin B12, folacin and pantothenic acid or pantothenate contents of the food, expressed, in the case of a meal replacement, as a percentage of the recommended daily intake specified in column II of the table to Division 1 of Part D for that vitamin and, in the case of a nutritional supplement, in retinol equivalents (RE) for vitamin A, in niacin equivalents (NE) for niacin and in milligrams for vitamin D, vitamin E, vitamin C, thiamin or vitamin B1, riboflavin or vitamin B2, vitamin B6, vitamin B12, folacin and pantothenic acid or pantothenate,

(iv) the calcium, phosphorus, iron, iodide, magnesium and zinc contents of the food, expressed, in the case of a meal replacement, as a percentage of the recommended daily intake specified for that mineral nutrient in column II of the table to Division 2 of Part D and, in the case of a nutritional supplement, expressed in milligrams, and

(v) the biotin, copper, potassium, sodium, manganese, selenium, chromium and molybdenum contents of the food, expressed in milligrams;

(b) in the case of a meal replacement or a nutritional supplement to which milk, partially skim milk or skim milk is to be added, carry a statement that the nutrient content of the food has been determined taking into consideration the milk, partially skim milk or skim milk that will be added according to the directions for use;

(c) in the case of a meal replacement that is sold or advertised as a replacement for all daily meals in a weight reduction diet, include directions for use that would result in a daily energy intake of at least 900 kcal or 3 780 kJ;

(d) include the expiration date of the meal replacement or nutritional supplement;

(e) in the case of a meal replacement for use in a weight reduction diet, carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET/UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE” prominently displayed on the principal display panel; and

(f) in the case of a meal replacement for use in a weight reduction diet that is not represented as a replacement for all daily meals in a diet, include the information required under section B.24.204.

SOR/78-698, s. 9; SOR/88-559, s. 28; SOR/95-474, s. 5.

B.24.203. The label of a prepackaged meal for use in a weight reduction diet or of a food to be sold in a weight reduction clinic shall

(a) [Repealed, SOR/2003-11, s. 24]

(b) carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET/UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE” prominently displayed on the principal display panel; and

(c) include the information required under section B.24.204.

SOR/78-698, s. 9; SOR/88-559, s. 29; SOR/95-474, s. 5; SOR/2003-11, s. 24.

B.24.204. The label of a prepackaged meal, or of a meal replacement other than a meal replacement represented as a replacement for all daily meals in a diet, that is packaged, sold or advertised for use in a weight reduction diet, or of a food to be sold in a weight reduction clinic, shall include, in the directions for use, a sample seven-day menu in which the prepackaged meal, meal replacement or food is used and which meets the following requirements:

(a) each daily meal includes a minimum of one serving, as described in Canada’s Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of one food from each of the following groups:

(i) milk, milk products or their alternatives,

(ii) meat and meat alternatives,

(iii) bread and grain products, and

(iv) vegetables and fruit;

(b) the daily energy intake provided for is not less than 1 200 kcal or 5 040 kJ;

(c) not more than 30 per cent of the total daily energy intake of the seven-day menu is derived from its fat content and not more than 10 per cent of the total daily energy intake of the menu is derived from its saturated fatty acid content;

(d) the mean daily intake of each nutrient listed in column I of the table to this section is not less than the amount shown in column II, in the case of a menu recommended for men, or in column III, in the case of a menu recommended for women; and

(e) the menu does not include any reference to vitamin or mineral supplements.

TABLE

COLUMN I COLUMN II COLUMN III MEAN DAILY INTAKE

NUTRIENTS MEN WOMEN Protein 65 g 55 g VITAMINS Vitamin A 1000 RE 800 RE

COLUMN I COLUMN II COLUMN III MEAN DAILY INTAKE

NUTRIENTS MEN WOMEN Vitamin D 5 µg 5 µg Vitamin E 10 mg 7 mg Vitamin C 40 mg 30 mg Thiamin 1 mg 1 mg Riboflavin 1 mg 1 mg Niacin 14 NE 14 NE Vitamin B6 1.5 mg 1.5 mg Vitamin B12 1 µg 1 µg Folacin 230 µg 200 µg Pantothenic Acid 5 mg 5 mg MINERAL NUTRIENTS Calcium 800 mg 800 mg Phosphorus 1000 mg 850 mg Iron 9 mg 13 mg Iodide 160 µg 160 µg Magnesium 250 mg 210 mg Copper 2 mg 2 mg Zinc 12 mg 9 mg

SOR/78-698, s. 9; SOR/95-474, s. 5.

B.24.205. (1) No person shall label, package, sell or advertise a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, in a manner likely to create an impression that consumption of a vitamin or mineral supplement must be part of a weight reduction diet.

(2) No person shall, on a label of or in an advertisement for a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, make any direct or indirect reference to a vitamin or mineral supplement.

(3) Every person who advertises a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, shall include in the advertisement the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET/UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE”.

SOR/78-698, s. 9; SOR/95-474, s. 5.

Foods Represented for Use in Very Low Energy Diets

B.24.300. No person shall advertise to the general public a food represented for use in a very low energy diet.

SOR/94-35, s. 4.

B.24.301. (1) No person shall sell, without a written order from a physician, a food represented for use in a very low energy diet.

(2) Notwithstanding subsection (1), a person may sell, without a written order from a physician, a food represented for use in a very low energy diet to

(a) a physician;

(b) a wholesale druggist;

(c) a pharmacist; or

(d) a hospital.

(3) No person other than a pharmacist shall sell to the general public a food represented for use in a very low energy diet.

SOR/94-35, s. 4.

B.24.302. A pharmacist shall retain the written order of a physician for a food represented for use in a very low energy diet for at least two years after the date on which the order is filled.

SOR/94-35, s. 4.

B.24.303. (1) A food represented for use in a very low energy diet, whether ready to serve or diluted with water according to the manufacturer’s directions, shall provide, per daily allowance recommended by the manufacturer

(a) either

(i) not less than 60 g of protein of a nutritional quality equivalent to that of casein, or

(ii) such an amount and quality of protein that, when the quality of the protein is expressed as a fraction of the quality of casein,

(A) the fraction is not less than 85/100, and

(B) the product obtained by multiplying the fraction by the gram weight of the protein is not less than 60;

(b) each vitamin or mineral nutrient named in column I of an item of the table to this subsection, in an amount not less than the minimum amount per day set out in column II of that item; and

(c) any nutritive substance added to the food other than those referred to in paragraph (a) or (b), in an amount that is appropriate for the purpose of the substance in the food as determined from clinical trials.

TABLE

Column I Column II Item Vitamin or Mineral Nutrient Minimum amount per day 1. Thiamine 1.3 mg 2. Riboflavin 1.6 mg 3. Niacin 23 mg

Column I Column II Item Vitamin or Mineral Nutrient Minimum amount per day 4. Folacin 0.22 mg 5. Biotin 0.15 mg 6. Pantothenic acid 7.0 mg 7. Vitamin B6 1.5 mg 8. Vitamin B12 0.001 mg 9. Vitamin A 1000 RE 10. Vitamin D 0.005 mg 11. Vitamin E 10 mg 12. Vitamin C 40 mg 13. Calcium 800 mg 14. Phosphorus 1000 mg 15. Magnesium 250 mg 16. Iron 13 mg 17. Iodine 0.16 mg 18. Zinc 12 mg 19. Copper 2 mg 20. Manganese 3.5 mg 21. Selenium 0.07 mg 22. Chromium 0.05 mg 23. Molybdenum 0.1 mg 24. Sodium 2000 mg 25. Potassium 3000 mg 26. Chloride 1500 mg

(2) Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in the daily intake by a person of at least 1.2 g of protein per kilogram target body weight.

SOR/94-35, s. 4.

B.24.304. The label of a food represented for use in a very low energy diet shall carry the following information:

(a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel;

(f) directions for use of the food, including

(i) a statement of the rationale for the use of the food,

(ii) criteria to be used for the selection of the persons to whom the food may be prescribed,

(iii) instructions for consultation with and evaluation of the patient and patient follow-up, and

(iv) a statement concerning adequate precautions and contra-indications;

(g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and

(h) the expiration date of the food.

SOR/94-35, s. 4.

B.24.305. (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell the food or advertise the food for sale.

(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information:

(a) the name under which the food is to be sold or advertised for sale;

(b) the name and address of the principal place of business of the manufacturer;

(c) the name and address of each establishment in which the food is manufactured;

(d) a list of the ingredients of the food, stated quantitatively;

(e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food;

(f) details of quality control procedures respecting the testing of the ingredients and of the food;

(g) details of the manufacturing process and quality control procedures used throughout the process;

(h) the results of tests carried out to determine the expiration date of the food;

(i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;

(j) a description of the type of packaging to be used;

(k) directions for use;

(l) the written text of all labels, including package inserts, to be used in connection with the food; and

(m) the name and title of the person who signed the notification and the date of signature.

(3) Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).

SOR/94-35, s. 4.

B.24.306. (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the food that has undergone the major change.

(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information:

(a) the name under which the food is to be sold or advertised for sale;

(b) the name and address of the principal place of business of the manufacturer;

(c) a description of the major change;

(d) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;

(e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;

(f) the written text of all labels, including package inserts, to be used in connection with the food; and

(g) the name and title of the person who signed the notification and the date of signature.

(3) Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).

SOR/94-35, s. 4.

Division 25 Interpretation

B.25.001. In this Division,

“expiration date” means, in respect of a human milk substitute, the date

(a) after which the manufacturer does not recommend that it be consumed, and

(b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)

“human milk substitute” means any food that is represented

(a) for use as a partial or total replacement for human milk and intended for consumption by infants, or

(b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)

“infant” means a person who is under the age of one year; (bébé)

“infant food” means a food that is represented for consumption by infants; (aliment pour bébés)

“junior (naming a food)” means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; ((nom d’un aliment) pour enfants en bas âge)

“major change” means, in respect of a human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk substitute where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk substitute; (changement majeur)

“new human milk substitute” means a human milk substitute that is

(a) manufactured for the first time,

(b) sold in Canada for the first time, or

(c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)

“strained (naming a food)” means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. ((nom d’un aliment) en purée ou tamisé)

SOR/78-637, s. 5; SOR/83-933, s. 1; SOR/90-174, s. 1.

Infant Foods

B.25.002. No person shall sell or advertise for sale an infant food that is set out in Column I of an item of Table I to this Division and contains more than the amount of sodium set out in Column II of that item.

SOR/83-933, s. 1.

B.25.003. (1) Subject to subsection (2), no person shall sell infant food that contains

(a) strained fruit,

(b) fruit juice,

(c) fruit drink, or

(d) cereal,

if sodium chloride has been added to that food.

(2) Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d).

SOR/83-933, s. 1.

Human Milk Substitutes and Food Containing Human Milk Substitutes

B.25.045. The common name of a human milk substitute or a new human milk substitute shall be “infant formula”. (préparation pour nourrissons)

SOR/90-174, s. 2.

B.25.046. (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the new human milk substitute.

(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information:

(a) the name under which it will be sold or advertised for sale;

(b) the name and the address of the principal place of business of the manufacturer;

(c) the names and addresses of each establishment in which it is manufactured;

(d) a list of all of its ingredients, stated quantitatively;

(e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute;

(f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute;

(g) details of the manufacturing process and quality control procedures used throughout the process;

(h) the results of tests carried out to determine the expiration date of the new human milk substitute;

(i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

(j) a description of the type of packaging to be used;

(k) directions for use;

(l) the written text of all labels, including package inserts, to be used in connection with the new human milk substitute; and

(m) the name and title of the person who signed the notification and the date of signature.

(3) Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.

SOR/90-174, s. 2.

B.25.047. Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes.

SOR/90-174, s. 2; SOR/2003-11, s. 25.

B.25.048. (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the human milk substitute.

(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information:

(a) the name under which it will be sold or advertised for sale;

(b) the name and the address of the principal place of business of the manufacturer;

(c) a description of the major change;

(d) the evidence relied on to establish that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

(e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute;

(f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and

(g) the name and title of the person who signed the notification and the date of signature.

(3) Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.

SOR/90-174, s. 2.

B.25.050. [Repealed, SOR/90-174, s. 2]

B.25.051. (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with the nutritional requirements set out in this Division for human milk substitutes.

SOR/83-933, s. 1.

B.25.052. (1) No person shall sell or advertise for sale a human milk substitute unless it meets the nutritional requirements of infants with normal or special dietary needs and it is of such a consistency that, when ready-to-serve, it passes freely through a nursing bottle nipple.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food meets the nutritional requirements of infants with normal or special dietary needs.

SOR/78-637, s. 6; SOR/82-768, s. 76; SOR/83-933, s. 1.

B.25.053. (1) No person shall sell or advertise for sale a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance, other than water or a source of carbohydrate or both.

(2) No person shall sell or advertise for sale a food represented as containing a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance other than water.

SOR/78-637, s. 7; SOR/83-933, s. 1.

B.25.054. (1) Except as otherwise provided in this Division, no person shall sell or advertise for sale a human milk substitute unless it contains, when prepared according to directions for use,

(a) per 100 available kilocalories

(i) not less than 3.3 and not more than 6.0 grams of fat,

(ii) not less than 500 milligrams of linoleic acid in the form of a glyceride,

(iii) not more than 1 kilocalorie from C22 Monoenoic Fatty Acids,

(iv) not less than 1.8 and not more than 4.0 grams of protein,

(v) not less than 1.8 grams of protein of nutritional quality equivalent to casein, or such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,

(A) the fraction will not be less than 85/100, and

(B) the product obtained by multiplying the fraction by the gram weight of the protein will not be less than 1.8,

(vi) notwithstanding sections D.01.010, D.01.011 and D.02.009, the vitamin and mineral nutrient set out in Column I of an item of Table II to this Division in an amount not less than the amount set out in Column II of that item and not more than the amount set out in Column III of that item, and

(vii) not less than 12 milligrams of choline; and

(b) a ratio of

(i) alpha-tocopherol to linoleic acid of not less than 0.6 International Units to one gram,

(ii) calcium to phosphorus of not less than 1.2 grams to one gram and not more than 2.0 grams to one gram, and

(iii) vitamin B6 to protein of not less than 15 micrograms to one gram.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with subsection (1).

SOR/78-637, s. 7; SOR/83-933, s. 1.

B.25.055. (1) Subparagraph B.25.054(1)(a)(i) does not apply to a human milk substitute represented as being for a fat-modified diet.

(2) Subparagraph B.25.054(1)(a)(iv), except that portion thereof that prescribes the maximum amount of protein, and subparagraph B.25.054(1)(a)(v) do not apply to a human milk substitute represented as being for a low (naming the amino acid) diet.

(3) All that portion of subparagraph B.25.054(1)(a)(vi) that prescribes the minimum amounts of vitamin D, calcium and phosphorus and subparagraph B.25.054(1)(b)(ii) do not apply to a human milk substitute represented as being for a low (naming the mineral) diet or a low vitamin D diet or both.

SOR/83-933, s. 1.

B.25.056. No person shall sell a human milk substitute or a food that is represented as containing a human milk substitute

(a) that contains an added nutritive substance that is

(i) normally contained in human milk, and

(ii) not referred to in paragraph B.25.054(1)(a)

unless the amount of that substance present per 100 available kilocalories of the human milk substitute or human milk substitute portion of the food, when prepared according to directions for use, is equal to the amount thereof present per 100 available kilocalories of human milk; or

(b) that contains added amino acids unless

(i) the amino acids are required to improve the quality of the protein in the human milk substitute or human milk substitute portion of the food and are present in an amount not exceeding the minimum required for that purpose, or

(ii) the protein content of the human milk substitute or human milk substitute portion of the food is supplied by isolated amino acids or by protein hydrolysate, or both

and only the L forms of the amino acids have been added.

SOR/78-637, s. 8; SOR/83-933, s. 1.

B.25.057. (1) The label of a human milk substitute shall carry the following information:

(a) a statement of the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in the food

(i) in grams per 100 grams or in grams per 100 millilitres of the human milk substitute as offered for sale, and

(ii) in grams in a stated quantity of the human milk substitute when ready-to-serve;

(b) a statement of the energy value expressed in

(i) calories per 100 grams or calories per 100 millilitres of the human milk substitute as offered for sale, and

(ii) calories in a stated quantity of the human milk substitute when ready-to-serve;

(c) a statement of the quantity of all vitamins and mineral nutrients listed in Table II to this Division

(i) in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute as offered for sale, and

(ii) in International Units or milligrams in a stated quantity of the human milk substitute when ready-to-serve;

(d) a statement of the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a)

(i) in milligrams or grams per 100 grams, or in milligrams or grams per 100 millilitres, of the human milk substitute as offered for sale, and

(ii) in milligrams or grams in a stated quantity of the human milk substitute when ready-to­ serve;

(e) adequate directions for the preparation, use and storage of the human milk substitute after the container has been opened; and

(f) the expiration date of the human milk substitute.

(2) The label of a food that is represented as containing human milk substitute shall carry the following information:

(a) a statement on the principal display panel of the proportion of the human milk substitute contained in the food as offered for sale in close proximity to any claim regarding the presence of the human milk substitute and given equal prominence to such a claim;

(b) the common name of the human milk substitute in the list of ingredients to be followed by a statement of all the components contained in the human milk substitute;

(c) a statement of

(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre contained in the human milk substitute portion of the food, expressed in grams per 100 grams or per 100 millilitres of the human milk substitute portion of the food as offered for sale,

(ii) the energy value of the human milk substitute portion of the food expressed in calories per 100 grams or in calories per 100 millilitres of the human milk substitute portion of the food as offered for sale,

(iii) the quantity of all the vitamins and mineral nutrients set out in Table II to this Division that are contained in the human milk substitute portion of the food in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute portion of the food as offered for sale, and

(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) contained in the human milk substitute portion of the food in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the human milk substitute portion of the food as offered for sale;

(d) a statement of

(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in grams per 100 grams or per 100 millilitres of the food as offered for sale and in grams per stated quantity of ready-to-serve food,

(ii) the energy value expressed in calories per 100 grams or in calories per 100 millilitres of the food as offered for sale and in grams per a stated quantity of the food when ready-to­ serve,

(iii) the quantity of all vitamins and mineral nutrients set out in Table II to this Division in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the food as offered for sale and in International Units or milligrams in a stated quantity of the food when ready-to-serve, and

(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the food as offered for sale and in milligrams or grams in a stated quantity of the food when ready-to-serve;

(e) adequate directions for the preparation, use and storage of the food after the container has been opened; and

(f) the expiration date of the food.

SOR/83-933, s. 1; SOR/88-559, s. 30.

B.25.058. Notwithstanding section D.02.005, no person shall make any claim with respect to the iron content of a human milk substitute except as required by paragraph B.25.057(1)(c), unless the human milk substitute contains at least one milligram of iron per 100 available kilocalories.

SOR/78-637, s. 9(F); SOR/83-933, s. 1.

B.25.059. No person shall, on the label of or in any advertisement for a human milk substitute or a food represented as containing a human milk substitute, make any statement or claim relating to the content in the food of

(a) the percentage of the daily value of

(i) fat,

(ii) saturated fatty acids and trans fatty acids,

(iii) sodium,

(iv) potassium,

(v) carbohydrate,

(vi) fibre, or

(vii) cholesterol; or

(b) the number of Calories from

(i) fat, or

(ii) saturated fatty acids and trans fatty acids.

SOR/2003-11, s. 26.

B.25.060. (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Director to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested.

(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

(4) In this section, “evidence with respect to the human milk substitute” means

(a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and

(b) the results of tests carried out to determine the expiration date of the human milk substitute.

SOR/83-933, s. 1; SOR/88-424, s. 2; SOR/90-174, s. 3.

B.25.061. (1) Subject to subsection (2), no person shall include on the label of a food any representation respecting the consumption of the food by an infant who is less than six months of age.

(2) Subsection (1) does not apply in respect of a human milk substitute or a new human milk substitute.

SOR/83-933, s. 1; SOR/90-174, s. 4.

B.25.062. (1) Subject to subsection (2), no person shall sell a food that is labelled or advertised for consumption by infants if the food contains a food additive.

(2) Subsection (1) does not apply to

(a) bakery products that are labelled or advertised for consumption by infants;

(b) ascorbic acid used in the following foods that are labelled or advertised for consumption by infants:

(i) fruit purées, and

(ii) cereals containing banana;

(c) soyabean lecithin used in rice cereal labelled or advertised for consumption by infants;

(d) citric acid used in foods that are labelled or advertised for consumption by infants;

(e) infant formula that contains the food additives set out in Tables IV and X to section B.16.100 for use in infant formula;

(f) infant formula that contains ingredients manufactured with food additives set out in Table V to section B.16.100;

(g) infant formula that contains concentrated or dried whey products manufactured with liquid whey to which sodium hexametaphosphate has been added;

(h) infant cereal products that contain amylase in accordance with Table V to section B.16.100;

(i) infant formula that contains ascorbyl palmitate or tocopherols; or

(j) infant formula that contains oils to which ascorbyl palmitate or tocopherols have been added.

SOR/83-933, s. 1; SOR/90-24, s. 4; SOR/91-149, s. 6; SOR/97-559, s. 1; SOR/2010-40, s. 3; SOR/2010-41, s. 8; SOR/2010-94, s. 6; SOR/2010-141, s. 3.

TABLE I

SODIUM CONTENT IN INFANT FOODS

Column I Column II Total Sodium in Grams perFood 100 Grams of Food

1. Junior Desserts ....... 0.10

2. Junior Meat, Junior Meat Dinners, Junior Dinners, 0.25Junior Breakfasts ....... 3. Junior Vegetables, Junior Soups ....... 0.20

Column I Column II Total Sodium in Grams perFood 100 Grams of Food

4. Strained Desserts ....... 0.05

5. Strained Meats, Strained Meat Dinners, Strained 0.15Dinners, Strained Breakfasts ....... 6. Strained Vegetables, Strained Soups ....... 0.10

SOR/78-637, s. 10; SOR/83-933, s. 1.

TABLE II

Column I Column II Column III Item Vitamin or Minimum amount per 100 Maximum amount per 100 No. Mineral nutrient available kilocalories available kilocalories B.1 Biotin 2 mcg — F.1 Folic acid 4 mcg — N.1 Niacin 250 mcg — P.1 d-pantothenic acid 300 mcg — R.1 Riboflavin 60 mcg — T.1 Thiamine 40 mcg — T.2 Alpha-tocopherol 0.6 I.U. — V.1 Vitamin A 250 I.U. 500 I.U. V.2 Vitamin B6 35 mcg — V.3 Vitamin B12 0.15 mcg — V.4 Vitamin C 8 mg — V.5 Vitamin D 40 I.U. 80 I.U. V.6 Vitamin K1 8 mcg — C.1 Calcium 50 mg — C.2 Chloride 55 mg 150 mg C.3 Copper 60 mcg — L.1 Iodine 5 mcg — L.2 Iron 0.15 mg — M.1 Magnesium 6 mg — M.2 Manganese 5 mcg — P.2 Phosphorous 25 mg — P.3 Potassium 80 mg 200 mg S.1 Sodium 20 mg 60 mg Z.1 Zinc 0.5 mg —

SOR/83-933, s. 1; SOR/98-458, s. 7(F). Previous Version

Division 26

Food Irradiation Interpretation

B.26.001. In this Division,

“ionizing radiation” means

(a) gamma-radiation from a Cobalt-60 or Cesium-137 source,

(b) X-rays generated from a machine source operated at or below an energy level of 5 MeV, and

(c) electrons generated from a machine source operated at or below an energy level of 10 MeV; (rayonnement ionisant)

“irradiation” means treatment with ionizing radiation. (irradiation)

SOR/89-175, s. 3.

Application

B.26.002. This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures.

SOR/89-175, s. 3.

General

B.26.003. (1) Subject to subsection (2), no person shall sell a food that has been irradiated.

(2) A food set out in Column I of an item of the table to this Division that has been irradiated may be sold if

(a) the food was irradiated from a source set out in Column II of that item for the purpose set out in Column III of that item; and

(b) the dose of ionizing radiation absorbed by the food is within the permitted absorbed dose set out in Column IV of that item.

SOR/89-175, s. 3.

Records

B.26.004. (1) A manufacturer who sells a food that has been irradiated shall keep on his premises, for at least two years after the date of the irradiation, a record containing the following information:

(a) the food irradiated and the quantity and lot numbers of the food;

(b) the purpose of the irradiation;

(c) the date of the irradiation;

(d) the dose of ionizing radiation absorbed by the food;

(e) the source of the ionizing radiation; and

(f) a statement indicating whether the food was irradiated prior to the irradiation by the manufacturer and, if so, the information referred to in paragraphs (a) to (e) in respect of that prior irradiation.

(2) Every person who imports a food that is intended for sale in Canada that has been irradiated shall keep on his premises a record of the information referred to in subsection (1) for at least two years after the date of importation.

SOR/89-175, s. 3.

Changes to the Table

B.26.005. A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Director containing the following information:

(a) the purpose and details of the proposed irradiation, including the source of ionizing radiation and the proposed frequency of and minimum and maximum dose of ionizing radiation;

(b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;

(c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;

(d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to­ serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;

(e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;

(f) where the Director so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;

(g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;

(h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and

(i) such other data as the Director may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food.

TABLE

Column I Column II Column III Column IV

Item Food Permitted Sources ofIonizing Radiation Purpose of Treatment

Permitted Absorbed Dose

1. Potatoes (Solanumtuberosum L.) Cobalt-60 To inhibit sprouting during storage

0.15 kGy max.

To inhibit 2. Onions (Allium cepa) Cobalt-60 sprouting during 0.15 kGy max.

storage Wheat, Flour, Whole To control insect

3. Wheat Flour (Triticum Cobalt-60 infestation in 0.75 kGy max. sp.) stored food Whole or ground spices Cobalt-60, Cesium-137, or 10.00 kGy max.To reduce4. and dehydrated electrons from machine total overallmicrobial loadseasoning preparations sources (3 MeV max.) average dose

SOR/89-175, s. 3; SOR/98-458, s. 7(F).

Division 27

Low-Acid Foods Packaged In Hermetically Sealed Containers B.27.001. In this Division,

“commercially sterile” means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; (stérilité commerciale)

“hermetically sealed container” means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement fermé)

“low-acid food” means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; (aliment peu acide)

“refrigeration” means exposure to a temperature of 4°C or less but does not mean frozen; (réfrigéré)

“shipping container” means a receptacle, package or wrapper in which containers of food are placed for transportation; (contenant d’expédition)

“water activity” means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)

SOR/89-309, s. 1.

B.27.002. (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile.

(2) Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where

(a) the low-acid food is kept under refrigeration and the statement “Keep Refrigerated” and “Garder au froid” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or

(b) the low-acid food is kept frozen and the statement “Keep Frozen” and “Garder congelé” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container.

(3) Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing.

SOR/89-309, s. 1; SOR/91-149, s. 7.

B.27.003. No person shall sell a low-acid food packaged in a hermetically sealed container where the container

(a) is swollen;

(b) is not properly sealed; or

(c) has any defect that may adversely affect its hermetic seal.

SOR/89-309, s. 1.

B.27.004. (1) Where, in the opinion of the Director, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Director may, by notice in writing, request that the manufacturer or importer of the food submit, on or before the date specified in the notice, evidence that establishes that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile.

(2) Where a manufacturer or an importer receives a notice issued pursuant to subsection (1), the manufacturer or importer shall make no further sales of the food on or after the day specified in the notice until he has submitted the evidence requested in that notice.

(3) Where the Director is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Director shall notify the manufacturer or importer in writing that the evidence is not sufficient.

(4) Where, pursuant to subsection (3), a manufacturer or importer is notified that the evidence he has submitted is not sufficient, the manufacturer or importer shall make no further sales of the food until he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

SOR/89-309, s. 1.

B.27.005. No person shall sell a commercially sterile low-acid food packaged in a hermetically sealed container unless

(a) the label or container of the food bears a code or lot number that identifies, in a legible and permanent manner,

(i) the establishment in which the product was rendered commercially sterile, and

(ii) the day, month and year on which the food was rendered commercially sterile; and

(b) the exact meaning of each item in any code or lot number referred to in paragraph (a) is available to an inspector at the establishment or, where the food is imported, from the importer.

SOR/89-309, s. 1.

Division 28

Novel Foods Interpretation

B.28.001. The definitions in this section apply in this Division.

“genetically modify” means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)

“major change” means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

(a) the composition, structure or nutritional quality of the food or its generally recognized physiological effects;

(b) the manner in which the food is metabolized in the body; or

(c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)

“novel food” means

(a) a substance, including a microorganism, that does not have a history of safe use as a food;

(b) a food that has been manufactured, prepared, preserved or packaged by a process that

(i) has not been previously applied to that food, and

(ii) causes the food to undergo a major change; and

(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

(i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,

(ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or

(iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)

SOR/99-392, s. 1.

Pre-market notification

B.28.002. (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food

(a) has notified the Director in writing of their intention to sell or advertise for sale the novel food; and

(b) has received a written notice from the Director under paragraph B.28.003(1)(a) or subsection B.28.003(2).

(2) A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:

(a) the common name under which the novel food will be sold;

(b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;

(c) a description of the novel food, together with

(i) information respecting its development,

(ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored,

(iii) details of the major change, if any,

(iv) information respecting its intended use and directions for its preparation,

(v) information respecting its history of use as a food in a country other than Canada, if applicable, and

(vi) information relied on to establish that the novel food is safe for consumption;

(d) information respecting the estimated levels of consumption by consumers of the novel food;

(e) the text of all labels to be used in connection with the novel food; and

(f) the name and title of the person who signed the notification and the date of signing.

SOR/99-392, s. 1.

B.28.003. (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Director shall review the information included in the notification and

(a) if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or

(b) if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.

(2) Within 90 days after receiving the additional information requested under paragraph (1)(b) the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient.

SOR/99-392, s. 1.

PART C DRUGS Division 1 General

C.01.001. (1) In this Part

“acetaminophen product” has the same meaning as in Division 9; (produit d’acétaminophène)

“adult standard dosage unit” has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)

“adverse drug reaction” means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)

“antibiotic” means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)

“brand name” means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

(a) that is assigned to the drug by its manufacturer,

(b) under which the drug is sold or advertised, and

(c) that is used to distinguish the drug; (marque nominative)

“case report” means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)

“children’s standard dosage unit” has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)

“child resistant package” means a package that meets the requirements of subsection (2); (emballage protège-enfants)

“common name” means, with reference to a drug, the name in English or French by which the drug is

(a) commonly known, and

(b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel)

“expiration date” means the earlier of

(a) the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and

(b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used; (date limite d’utilisation)

“immediate container” means the receptacle that is in direct contact with a drug; (récipient immédiat)

“internal use” means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)

“official drug” means any drug

(a) for which a standard is provided in these Regulations, or

(b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle)

“parenteral use” means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral)

“per cent” means per cent by weight unless otherwise stated; (pour cent)

“practitioner” means a person authorized by the law of a province of Canada to treat patients with any drug listed or described in Schedule F to the Regulations; (praticien)

“prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance)

“proper name” means, with reference to a drug, the name in English or French

(a) assigned to the drug in section C.01.002,

(b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,

(c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or

(d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre)

“salicylate product” has the same meaning as in Division 9; (produit de salicylate)

“serious adverse drug reaction” means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue)

“serious unexpected adverse drug reaction” means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue)

“teaspoon” means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)

“test group” means a group that meets the requirements of subsection (3); (groupe d’essai)

“withdrawal period” means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause injury to human health. (délai d’attente)

(2) A child resistant package is a package that

(a) when tested in accordance with an acceptable method,

(i) in the case of a test group comprising children, cannot be opened

(A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and

(B) by at least 80 per cent of those children after the demonstration, and

(ii) in the case of a test group comprising adults

(A) can be opened by at least 90 per cent of those adults, and

(B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or

(b) complies with the requirements of one of the following standards, namely,

(i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages, published January 1990, as amended from time to time,

(ii) European Standard EN 28317:1992, entitled Child-resistant packaging—Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and

(iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

(3) For the purposes of this section, “test group” means

(a) in relation to children, a group of at least 200 children who

(i) are healthy and have no obvious physical or mental disability,

(ii) are between 42 and 51 months of age, and

(iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and

(b) in relation to adults, a group of at least 100 adults who

(i) are healthy and have no obvious physical or mental disability,

(ii) are between 18 and 45 years of age, and

(iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.

(4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.

SOR/80-543, s. 1; SOR/85-966, s. 1; SOR/86-93, s. 1; SOR/87-484, s. 1; SOR/92-654, s. 1; SOR/93-202, s. 1; SOR/95-411, s. 1; SOR/95-521, s. 1; SOR/96-399, s. 1; SOR/96-240, s. 1; SOR/97-543, s. 5.

C.01.001A. [Repealed, SOR/98-423, s. 1]

C.01.002. The Proper Name of a drug shown opposite an item number in the following Table in the column headed “Chemical Names and Synonyms” shall be the name shown opposite that item number in the column headed “Proper Names”.

TABLE

Item Proper Names Chemical Names and SynonymsNo. A.1 Acepromazine ....... 2-acetyl-10-(3-dimethylaminopropyl) iephenothiazine

p-Acetaminophenol, Paracetamol, p-Hydroxyacetanilide: N­A.2 Acetaminophen ....... acetyl-p-aminophenol Acetanilide:A.3 Acetylaminobenzene: Antifebrin: PhenylacetamideAcetanilid ....... Acetylsalicylic AcidA.4 Acetylsalicylic acid.......

1-H-Pyrazolo [3,4-d] pyrimidin-4-ol: 4-Hydroxypyrazolo (3,4­A.5 Allopurinol ....... d) pyrimidine A.6 Amantadine ....... 1-Adamantanamine

Aminocaproic acidA.7 6-Aminohexanoic acid....... N-[4-(2,4-diamino-6-pteridyl methyl) amino-benzoyl]-L-A.8 Aminopterin ....... glumatic acid

Aminopyrine: 1,5-dimethyl-2-phenyl-4-dimethylamino-3-pyrazolone:A.9 Amidopyrine ....... Dimethylaminophenazone 3-(3-Dimethylaminopropylidene)-1,2: 4,5-dibenzocyclohepta­A.10 Amitriptyline ....... 1,4-diene

A.11 Azacyclonol ....... α,α-diphenyl-4-piperidinecarbinol B.1 Bemegride ....... 3-Ethyl-3-methylglutarimide

Item Proper Names Chemical Names and SynonymsNo. B.2 Benactyzine ....... Dimethylaminoethyl-1,1-diphenylglycolate

3-benzyl-3,4-dihydro-6-(trifluoro- methyl)-2H-1,2,4­BendroflumethiazideB.3 benzothiadiazine-7-sulfonamide-1,1-dioxide: Bendrofluazide....... (B.A.N.) B.4 Betahistine ....... 2-[2-(Methylamino)ethyl] pyridine

N-Benzyl-N′N″-dimethylguanidine: 1-Benzyl-2,3­B.5 Bethanidine ....... dimethylguanidine Bretylium tosylate N-2-Bromobenzyl-N-ethyl-N, N-dimethylammonium tosylateB.6 ....... (Tosylic acid is trivial name for p-toluenesulphonic acid)

B.7 Bromisoval ....... 2-monobromoisovalerylurea: Bromisovalum: Bromvalitone Calcium CarbimideC.1 Calcium cyanamide.......

C.2 Captodiamine ....... 4-butylthio-α-phenylbenzyl-2- dimethylaminoethylsulfide C.3 Carisoprodol ....... N-Isopropyl-2-methyl-2-propyl-1, 3-propanediol dicarbamate

1-[10-(3[4-(2-Hydroxyethyl)-1-piperazinyl]propyn( �.4 Carphenazine ....... phenothiazin-2yl]-1-propapone 7-[(2-Thienyl) acetamido]-3-(1-pyridylmethyl)-3-cephem-4­C.5 Cephaloridine ....... carboxylic acid betaine 2-(4-chlorophenyl)-3-methyl-4-methathiazanone-1,1-dioxide:C.6 Chlormezanone ....... Chlormethazone: Chlormethazanone

Chloromethapyrilene N,N-dimethyl-N′-(2-pyridyl)-N′-(5-chloro-2-thenyl)­C.7 ....... ethylenediamine: Chlorothen ChlorphentermineC.8 4-Chloro-α,α-dimethylphenethylamine.......

C.9 Cinchocaine ....... 2-butoxy-N-(2-diethylaminoethyl) cinchoninamide: Dibucaine C.10 Cinchophen ....... 2-phenylquinoline-4-carboxylic acid: Quinophan C.11 Clofibrate ....... Ethyl 2-(p-chlorophenoxy)-2-methylpropionate

1-Chloro-2-[4-(2-diethylamino-ethoxy)phenyl]-1,2­ C.12 Clomiphene ....... diphenylethylene: 2-[p-(2-Chloro-1,2-diphenylvinyl)phenoxy]

triethylamine D.1 Desipramine ....... 5-(3-Methylaminopropyl)-10,11-dihydro-5H-dibenz[b,f]azepine

7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4­D.2 Diazepam ....... benzodiazepin-2-one D.3 Diethylpropion ....... 1-phenyl-2-diethylaminopropanone-1 D.4 Diphenidol ....... 1,1-Diphenyl-4-piperidinobutan-1-ol D.5 Disulfiram ....... Tetraethylthiuram disulphide E.1 Ectylurea ....... 2-ethyl-cis-crotonylurea E.2 Emylcamate ....... 1-Ethyl-1-methylpropyl carbamate

[2,3-Dichloro-4-(2-methylenebutyryl) phenoxy] acetic acid: 2,3­E.3 Ethacrynic Acid ....... Dichloro-4-(2-ethylacryloyl) phenoxyacetic acid E.4 Ethchlorvynol ....... 3-(2-chlorovinyl)-1-pentyn-3-ol E.5 Ethinamate ....... 1-ethynylcyclohexyl carbamate

Item Proper Names Chemical Names and SynonymsNo. E.6 Ethionamide ....... 2-Ethylisonicotinthioamide E.7 Ethomoxane ....... 2-n-Butylaminomethyl-8-ethoxy-benzo-1,4-dioxan

Ethyl TrichloramateE.8 Ethyl n-[1-(2,2,2,-trichloro-1-hydroxyethyl)] carbamate....... E.9 Etryptamine ....... 3-(2-Aminobutyl) indole E.10 Etymemazine ....... 10-(3-Dimethylamino-2-methylpro-pyl)-2-ethylphenothiazine

10-{3-[4-(2-Hydroxyethyl) piperazin-1-yl] propyl}-2-tri­F.1 Fluphenazine ....... fluoromethylphenothiazine 4-Chloro-N-furfuryl-5-sulphamoylanthranilic acid: FrusemideF.2 Furosemide ....... (B.A.N.) 5-chloro-N-[2-[4-[[[(cyclohexylamino carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy benzamide:G.1 Glyburide ....... 1-4[4-[2-(5-chloro-2-methoxybenzamido)ethyl]phenyl- sulfonyl]-3-cyclohexylurea: Glibenclamide 4-(4-Chlorophenyl)-1-[3-(4-fluorobenzoyl) propyl]-piperidin-4­

H.1 Haloperidol ....... ol: 4-[4-(p-Chlorophenyl)-4-hydro-xypiperidino]-4’­ fluorobutyro-phenone

Hydroxychloroquine 7-Chloro-4[4-(N-ethyl-N-2-hydro-xyethylamino)-1­H.2 ....... methylbutyl-amino] quinoline 1-(p-chloro-α-phenylbenzyl)-4-(2-hydroxy ethoxyethyn( �.3 Hydroxyzine ....... piperazine

I.1 Idoxuridine ....... 5-Iodo-2′-deoxyuridine 5-(3-dimethylaminopropyl)-10,11-dihydro-5H­I.2 Imipramine ....... dibenz[b,f]azepine

I.3 Indomethacin ....... 1-(p-Chlorobenzoyl)-5-methoxy-2-methyl-indole-3-acetic acid I.4 Iproniazid ....... 1-isonicotinoyl-2-isopropylhydrazine I.5 Isocarboxazid ....... 3-N-Benzylhydrazinocarbonyl-5-methylisoxazole

3,4-Dihydroxy-α-[isopropylamino) methyl] benzyl alcohol:I.6 Isoproterenol ....... Isoprenaline L-α-Amino-3-[(4-hydroxy-3-iodophenoxy)-3,5-di-iodo-phenyl]L.1 Liothyronine ....... propionic acid

M.1 Mefenamic acid ....... N-(2,3-Xylyl)-anthranilic acid M.2 Melphalan ....... 4-Di-(2-chlorethyl)amino-L-phenylalanine M.3 Mepazine ....... 10-[(1-methyl-3-piperidyl) methyl] phenothiazine M.4 Mephenesin ....... 3-o-toloxy-1,2-propanediol M.5 Mephenoxalone ....... 5-(o-Methoxyphenoxymethyl)-2-oxazolidinone M.6 Meprobamate ....... 2,2-di(carbamoylmethyl) pentane

2-Methyl-3-o-tolyquinazolin-4-one: 2-Methyl-3-o-tolyl-4­M.7 Methaqualone ....... quinazolone 1-Methylindoline-2,3-dione-3-thiosemicarbazone: N­M.8 Methisazone ....... Methylisatin-ß-thiosemicarbazone

M.9 Methotrimeprazine 10-[3-(2-Methyl)dimethylamino propyl]-2­

Item Proper Names Chemical Names and SynonymsNo. ....... methoxyphenothiazine: Levomepromazine

M.10 Methyldopa ....... 1-3(3,4-Dihydroxyphenyl)-2-methylalanine M.11 Methylparafynol ....... 3-methyl-1-pentyn-3-ol: Methylpentynol M.12 Methylphenidate ....... Methyl-1-phenyl-1-(2-piperidyl) acetate M.13 Methyprylon ....... 3,3-diethyl-5-methyl-2,4-piperidinedione M.14 Methysergide ....... 1-(Hydroxymethyl)propylamide of 1-methyl-d-lysergic acid M.15 Metyrapone ....... 2-Methyl-1,2-di(3-pyridyl)propan-1-one N.1 Nalidixic Acid ....... 1-Ethyl-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acid N.2 Nialamide ....... 1-[2-(benzycarbamyl)ethyl]-2-isonicotinoyl-hydrazine

3-(3-Methylaminopropylidene)-1,2, 4,5-dibenzocyclohepta-1,4­N.3 Nortriptyline ....... diene O.1 Oxanimide ....... 2-ethyl-3-propyl-glycidamide

7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4-benzodiazepin­O.2 Oxazepam ....... 2-one Oxyphenbutazone 4-n-Butyl-2-(4-hydroxyphenyl)-1-phenyl-pyrazolidine-3,5­O.3 ....... dione

P.1 Paramethadione ....... 3,5-dimethyl-5-ethyl-2,4-oxazolidinedione P.2 Pargyline ....... N-Benzyl-N-methylprop-2-ynylamine P.3 Pemoline ....... 2-Imino-5-phenyloxazolidin-4-one

1,2,3,4,5,6-Hexahydro-8-hydroxy-6,11-dimethyl-3-(3­ methylbut-2-enyl)-2,6-methano-3-benzazocine: 1,2,3,4,5,6­P.4 Pentazocine ....... Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano­ 3-benzazocin-8-ol

Pentolinium Tartrate NN′-Pentamethylenedi-(methylpryrrolidinium hydrogen,P.5 ....... tartrate) 2-chloro-10-{3-[1-(2-hydroxyethyl)-4-piperazinyl]propyl}P.6 Perphenazine ....... phenothiazine

P.7 Phacetoperane ....... l-1-Phenyl-1(2′-piperidyl)-1-acetoxymethane P.8 Phenacemide ....... (Phenylacetyl)urea

p-acetphenetidin: Acetphenetidin: Acetophenetidin: p­P.9 Phenacetin ....... ethoxyacetanilid P.10 Phenaglycodol ....... 2-p-chlorophenyl-3-methyl-2,3-butanediol P.11 Phendimetrazine ....... 3,4-Dimethyl-2 Phenylmorpholine P.12 Phenelzine ....... 2-phenylethylhydrazine P.13 Phenformin ....... N′-ß-phenethylformamidinyliminourea P.14 Pheniprazine ....... α-Methylphenethylhydrazine

Tetrahydro-3-methyl-2-phenyl-1,4-oxazine: 3-methyl-2­P.15 Phenmetrazine ....... phenylmorpholine P.16 Phentermine ....... α, α-Dimethylphenethylamine: phenyl-tert-butylamine

PhenylindanedioneP.17 2-phenylindane-1,3-dione.......

Item Proper Names Chemical Names and SynonymsNo. PhenyltoloxamineP.18 N,N-dimethyl-2-(α-phenyl-o-tolyloxy) ethylamine.......

P.19 Pholedrine ....... p-(4-hydroxyphenyl)-isopropylmethylamine P.20 Piperliate ....... 1-piperidine-ethanol benzilate P.21 Pipradol ....... Diphenyl-2-piperidylmethanol P.22 Prochlorperazine ....... 2-Chloro-10-[3-(1-methyl-4-piperazinyl) propyl]phenothiazine P.23 Prodilidine ....... 1,2-Dimethyl-3-phenyl-3-pyrrolidinyl propionate P.24 Propranolol ....... 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol P.25 Prothipendyl ....... 9-(3-Dimethylaminopropyl)-10-thia-1,9-diaza-anthracene

7-(3-Methylaminopropyl)-1,2:5,6-dibenzocycloheptatrien: N­P.26 Protriptyline ....... Methyl-5H-dibenzo [a, d] cycloheptene-5-propylamine P.27 Pyrazinamide ....... Pyrazinoic acid amide

3-{[(4-methyl-1-piperazinyl)imino]methyl} rifamycin SV : R.1 Rifampin ....... Rifampicin (I.N.N.) (Rifamycin SV is an antibiotic produced by

Streptomyces mediterranei) 4H-1-Benzopyran-2-carboxylic acid, 5,5′-[(2-hydroxy-1,3­ propanediyl) bis(oxy)]bis[4-oxo-,disodium salt]:

Sodium Cromoglycate Disodium 5,5′-(2-hydroxytrimethylenedioxy) bis[4-oxo-4H-1­S.01 ....... benzopyran-2- carboxylate]: Disodium 4,4′-dioxo-5,5′-(2­ hydroxytrimethylenedioxy)di (chromene-2-carboxylate): Cromolyn Sodium (USP): Disodium Cromoglycate 2-(4-Aminobenzenesulphonamido)-5-methoxypyrimidine: N′ ­

S.1 Sulfameter ....... (5-methoxy-2-pyrimidinyl) sulfanilamide: Sulfamethoxydiazine (B.A.N.) N′-(4,6-dimethyl-2- pyrimidyl)sulfanilamide: 2-(p­

S.2 Sulfamethazine ....... aminobenzenesulphonamide)-4,6-dimethylpyrimidine: sulphadimedine

S.3 Sulfinpyrazone ....... 1,2-diphenyl-4-(2-phenylsulfinilethyl)-3,5-pyrazolidinedione S.4 Sulfisoxazole ....... 3,4-dimethyl-5-sulfanilamidoisoxazole: Sulphafurazole T.1 Tetracaine ....... 2-dimethylaminoethyl-p-n- butylaminobenzoate: Amethocaine

Thiethylperazine ....... 2-Ethylthio-10-[3-(4- methylpiperazin-1-yl)T.2 propyl]phenothiazine 2-chloro-10-[3-[1-(2-acetoxyethyl)-4-piperazinyl]T.3 Thiopropazate ....... propyl]phenothiazine

Thioproperazine ....... 2-Dimethylsulphamoyl-10-[3-(4-methylpiperazin-1-yl)-T.4 propyl]phenothiazine 10-{2-[2-(1-methylpiperidyl)] ethyl α}-2-methylthiopheno-T.5 Thioridazine ....... thiazine

T.6 Tranylcypromine ....... Trans d, 1-2-phenylcyclopropyl- amine T.7 Triamterene ....... 2,4,7-Triamino-6-phenylpteridine

10-(3-dimethylaminopropyl)-2-trifluoromethylphenothiazine:T.8 Triflupromazine ....... Fluopremazine

Item Proper Names Chemical Names and SynonymsNo. T.9 Trimeprazine ....... 10-(3-dimethylamino-2-methylpropyl) phenothiazine T.10 Trimethadione ....... 3,5,5-trimethyl-2,4-oxazolidine- dione: Troxidone

5-(3-Dimethylamino-2-methylpropyl)-10,11-dihydro-5H­ T.11 Trimipramine ....... dibenz[b,f]azepine: 5-(3′-Dimethylamino-2′ ­

methylpropyl)iminodibenzyl 2-Methyl-2-propyltrimethylene butylcarbamate carbamate: 2­T.12 Tybamate ....... (Hydroxymethyl)-2-methyl-pentyl butylcarbamate carbamate

V.1 Vinblastine ....... An alkaloid derived from Vinca rosea V.2 Vincristine ....... An alkaloid derived from Vinca rosea

SOR/87-565, s. 1; SOR/88-182, s. 1; SOR/88-482, s. 1(F); SOR/90-173, s. 1(F).

C.01.003. No person shall sell a drug that is not labelled as required by these Regulations.

SOR/80-544, s. 1.

C.01.004. (1) The inner and outer labels of a drug shall show

(a) on the principal display panel

(i) the proper name, if any, of the drug which, if there is a brand name for the drug, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,

(ii) if there is no proper name, the common name of the drug,

(iii) where a standard for the drug is prescribed in Division 6 of this Part, a statement that the drug is a Canadian Standard Drug, for which the abbreviation C.S.D. may be used,

(iv) where a standard for the drug is not prescribed in Division 6 of this Part but is contained in a publication mentioned in Schedule B to the Act, the name of the publication containing the standard used or its abbreviation as provided in Schedule B or, if a manufacturer’s standard is used, a statement setting forth the fact that such a standard is used, and

(v) in both official languages, the notation “sterile”stérile if the drug is required to be sterile by these Regulations;

(b) on the upper left quarter of the principal display panel

(i) the symbol Pr in the case of a drug required by this Part or Part D to be sold on prescription, but in no other case shall the symbol Pr appear on the label of a drug,

(ii) the symbol *“C” in a clear manner and a conspicuous colour and size, in the case of a controlled drug, other than a controlled drug contained in an agricultural implant and set out in Part III of the schedule to Part G, *Small graphic is not displayed.

(iii) the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon, in the case of a narcotic as defined in the Narcotic Control Regulations, and

(iv) in the case of a targeted substance as defined in subsection 1(1) of the Benzodiazepines and Other Targeted Substances Regulations, the following symbol in a colour contrasting with the rest of the label and in type not less than half the size of any other letter used on the main panel, namely,

GRAPHIC IS NOT DISPLAYED, SEE SOR/2000-219, S. 1

(c) on any panel

(i) the name and address of the manufacturer of the drug,

(ii) the lot number of the drug,

(iii) adequate directions for use of the drug,

(iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names,

(v) the expiration date of the drug, and

(vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.

(2) In addition to the requirements of subsection (1), the outer label of a drug shall show

(a) the net amount of the drug in the container in terms of weight, measure or number;

(b) in the case of a drug intended for parenteral use, a quantitative list of any preservatives present therein by their proper names or, if they have no proper names, by their common names; and

(c) in the case of a drug for human use that contains mercury or a salt or derivative thereof as a preservative, a quantitative list of all mercurial preservatives present therein by their proper names or, if they have no proper names, by their common names.

(3) Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if

(a) there is an outer label that complies with the labelling requirements of these Regulations; and

(b) the inner label shows

(i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug,

(ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug,

(iii) the net contents of the drug if it is not in a discrete dosage form,

(iv) the route of administration of the drug if other than oral,

(v) the lot number of the drug,

(vi) the name of the manufacturer of the drug,

(vii) the expiration date of the drug, and

(viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).

(4) [Repealed, SOR/92-654, s. 2]

(5) This section does not apply to

(a) a drug sold to a drug manufacturer; or

(b) a drug dispensed pursuant to a prescription, if its label carries suitable directions for use and complies with the requirements of section C.01.005.

SOR/80-543, s. 2; SOR/81-334, s. 1(E); SOR/85-715, s. 2; SOR/89-229, s. 1; SOR/90-216, s. 1; SOR/90-586, s. 1; SOR/92-654, s. 2; SOR/93-202, s. 2; SOR/97-228, s. 1; SOR/97-515, s. 1; SOR/2000-219, s. 1; SOR/2001-181, s. 4; SOR/2011-88, s. 1. Previous Version C.01.004.1 (1) No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug.

(2) No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug.

SOR/82-524, s. 1; SOR/93-475, s. 1; SOR/97-12, s. 2.

C.01.005. (1) The principal display panel of both the inner and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned by the Director for that drug pursuant to subsection C.01.014.2(1), preceded by the words “Drug Identification Number” or Drogue : identification numérique or both, or the letters “DIN”.

(2) Subsection (1) does not apply to a drug

(a) compounded by a pharmacist pursuant to a prescription or by a practitioner; or

(b) sold pursuant to a prescription, where the label of that drug indicates:

(i) the proper name, the common name or the brand name of the drug,

(ii) the potency of the drug, and

(iii) the name of the manufacturer of the drug.

(3) For the purposes of this section and section C.01.014, “a drug in dosage form” means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.

(4) and (5) [Repealed, SOR/81-248, s. 1]

SOR/81-248, s. 1; SOR/93-202, s. 3; SOR/98-423, s. 2; SOR/2001-181, s. 4.

C.01.006. Where a package of a drug has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and the outer labels.

C.01.007. No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations.

C.01.008. [Repealed, SOR/80-544, s. 2]

C.01.009. Where by any statute of the Parliament of Canada or any regulation made thereunder a standard or grade is prescribed for a drug and that standard is given a name or designation by such statute or regulation, no person shall on a label of or in any advertisement for that drug use that name or designation unless the drug conforms with the standard or grade.

C.01.010. Where it is necessary to provide adequate directions for the safe use of a parenteral drug or Schedule F drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, such diseases, disorders or abnormal physical state may be mentioned on the labels and inserts accompanying that drug and to such extent, that drug is hereby exempted from the provisions of section 3 of the Act.

C.01.011. (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication.

(2) [Repealed, SOR/93-243, s. 2]

(3) Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Director, on request, details of that standard and of a method of analysis for the drug acceptable to the Director.

(4) No person shall use a manufacturer’s standard for a drug that provides

(a) a lesser degree of purity than the highest degree of purity, or

(b) a greater variation in potency than the least variation in potency,

provided for that drug in any publication mentioned in Schedule B to the Act.

SOR/93-243, s. 2.

C.01.012. A manufacturer who makes representations on a label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a

medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug, shall

(a) before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and

(b) on request submit the record of such investigations to the Director.

SOR/89-455, s. 2; SOR/94-36, s. 1.

C.01.013. (1) Where the manufacturer of a drug is requested in writing by the Director to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested.

(2) Where the Director is of the opinion that the evidence submitted by a manufacturer, pursuant to subsection (1), is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Director that that further evidence is sufficient.

(4) A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended.

Assignment and Cancellation of Drug Identification Numbers

C.01.014. (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6.

(2) Subsection (1) does not apply in respect of a drug listed in Schedule C to the Act, whole blood and its components, or a medicated feed as defined in section 2 of the Feeds Regulations, 1983.

SOR/81-248, s. 2; SOR/97-12, s. 3.

C.01.014.1. (1) A manufacturer of a drug, a person authorized by a manufacturer or, in the case of a drug to be imported into Canada, the importer of the drug may make an application for a drug identification number for that drug.

(2) An application under subsection (1) shall be made to the Director in writing and shall set out the following information:

(a) the name of the manufacturer of the drug as it will appear on the label;

(b) the pharmaceutical form in which the drug is to be sold;

(c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration;

(d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended;

(e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names;

(f) the brand name under which the drug is to be sold;

(g) whether the drug is for human use, veterinary use or disinfection in premises;

(h) the name and quantity of each colouring ingredient that is not a medicinal ingredient;

(i) the use or purpose for which the drug is recommended;

(j) the recommended dosage of the drug;

(k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug;

(l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug;

(m) the written text of all labels and package inserts to be used in connection with the drug and of any further prescribing information stated to be available on request; and

(n) the name and position of the person who signed the application and the date of signature.

(3) In the case of a new drug, a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission filed under section C.08.002, C.08.002.01 or C.08.002.1 shall be regarded as an application for a drug identification number.

SOR/81-248, s. 2; SOR/93-202, s. 4; SOR/98-423, s. 3; SOR/2011-88, s. 2. Previous Version C.01.014.2. (1) Subject to subsection (2), if a manufacturer or importer has provided all the information described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Director shall issue to the manufacturer or importer a document that

(a) sets out

(i) the drug identification number assigned for the drug, preceded by the letters “DIN”, or

(ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”; and

(b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).

(2) Where the Director believes on reasonable grounds that a product in respect of which an application referred to in section C.01.014.1 has been made

(a) is not a drug, or

(b) is a drug but that its sale would cause injury to the health of the consumer or purchaser or would be a violation of the Act or these Regulations,

he may refuse to issue the document referred to in subsection (1).

(3) Where the Director, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Director to reconsider his decision.

(4) On the basis of the additional information submitted pursuant to subsection (3), the Director shall reconsider the grounds on which the refusal to issue the document was made.

SOR/81-248, s. 2; SOR/92-230, s. 1; SOR/98-423, s. 4; SOR/2011-88, s. 3. Previous Version C.01.014.3. The manufacturer or importer or person authorized by the manufacturer or importer shall, within 30 days after commencing sale of a drug, date and sign the document issued pursuant to subsection C.01.014.2(1) in respect of the drug and return the document

(a) with a confirmation that the information recorded therein is correct;

(b) indicating the date on which the drug was first sold in Canada; and

(c) accompanied by samples or facsimiles of all labels and package inserts and any further prescribing information stated to be available on request.

SOR/81-248, s. 2; SOR/98-423, s. 5.

C.01.014.4. If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information,

(a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f)

(i) that occurs prior to the sale of the drug, a new application shall be made, or

(ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and

(b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k)

(i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or

(ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Director of the change.

SOR/81-248, s. 2; SOR/92-230, s. 2; SOR/98-423, s. 6.

C.01.014.5. Every manufacturer of a drug shall, annually before the first day of October and in a form authorized by the Director, furnish the Director with a notification signed by the

manufacturer or by a person authorized to sign on his behalf, confirming that all the information previously supplied by the manufacturer with respect to that drug is correct.

SOR/81-248, s. 2.

C.01.014.6. (1) The Director shall cancel the assignment of a drug identification number for a drug where

(a) the person to whom the number was assigned advises that the sale or import of the drug has been discontinued;

(b) the drug is a new drug in respect of which the notice of compliance has been suspended pursuant to section C.08.006; or

(c) it has been determined that the product in respect of which the number was assigned is not a drug.

(2) The Director may cancel the assignment of a drug identification number for a drug where

(a) the manufacturer of the drug has failed to comply with section C.01.014.5; or

(b) the manufacturer to whom the number was assigned has been notified pursuant to section C.01.013 that the evidence he submitted in respect of the drug is insufficient.

SOR/81-248, s. 2.

C.01.014.7. Where a person who has been assigned a drug identification number for a drug discontinues sale of the drug in Canada, he shall, within 30 days of such discontinuation, inform the Director that he is no longer selling the drug.

SOR/81-248, s. 2.

Tablet Disintegration Times

C.01.015. (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,

(a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;

(b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and

(c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.

(2) Subsection (1) does not apply in respect of a drug in the form of a tablet where

(a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01;

(b) [Repealed, SOR/98-423, s. 7]

(c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;

(d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;

(e) the drug has been demonstrated by an acceptable method to be available to the body; or

(f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.

SOR/89-429, s. 2; SOR/89-455, s. 3; SOR/94-36, s. 2; SOR/98-423, s. 7; SOR/2011-88, s. 4. Previous Version

Prohibition

C.01.016. No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019.

SOR/95-521, s. 2; SOR/2011-31, s. 1. Previous Version

Serious Adverse Drug Reaction Reporting

C.01.017. The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first:

(a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and

(b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug.

SOR/95-521, s. 2; SOR/2011-31, s. 1. Previous Version

Annual Summary Report and Case Reports

C.01.018. (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.

(2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.

(3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.

(4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.

(5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following:

(a) the annual summary reports;

(b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer.

(6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period.

SOR/2011-31, s. 1. Previous Version

Issue-related Summary Report

C.01.019. (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.

(2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.

(3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may specify a period that is shorter than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.

(4) The manufacturer shall submit the report within the specified period.

SOR/2011-31, s. 1.

Maintenance of Records

C.01.020. (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019.

(2) The manufacturer shall retain the records for 25 years after the day on which they were created.

SOR/2011-31, s. 1.

Limits of Drug Dosage

C.01.021. Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of

(a) the quantitative content of the drug,

(b) the recommended single and daily adult dose designated as such, except for

(i) preparations solely for external use, or

(ii) preparations solely for children’s use; and

(c) adequate directions for use when the drug is recommended for children which shall be either

(i) the statement “CHILDREN: As directed by the physician”, or

(ii) a suitable reduced maximum single and daily dose which shall not exceed the following:

Age in years Proportion of adult dose

10 - 14 one-half 5 - 9 one-fourth 2 - 4 one-sixth under 2 years as directed by physician

TABLE

TABLE OF LIMITS OF DRUG DOSAGE FOR ADULTS

External Internal UseUse — —

Item Maximum Dosage UnlessMaximum otherwise stated, doses are inLimit milligrams Per cent Single Daily

Acetaminophen ....... — 650 4.0 g Acetanilide and derivatives (except N-Acetyl­ — 65 195ρ-amino phenol) ....... Acetylsalicylic Acid ....... — 650 4.0 g Aconitine, its preparations and derivatives ....... 0.2 0.1 0.1 Adonis vernalis ....... — 65 195 Amylocaine, its salts and derivatives when sold 0.0 0.0 0.0or recommended for opthalmic use ....... Amylocaine Hydrochloride, except when sold 1.0 0.0 0.0or recommended for ophthalmic use ....... Antimony, compounds of ....... — 3.3 13 Atropine, Methylatropine, and their salts ....... 1.0 0.13 0.44 Belladonna and its preparations, on the basis of 0.375 0.13 0.44belladonna alkaloids ....... Benzene (Benzol) ....... — — — Benzocaine ....... 8.0 195 585 Beta-Naphthol ....... — 195 585

Item

Butacaine, its salts and derivatives when sold or recommended for ophthalmic use ....... Butacaine Sulphate, except when sold or recommended for opthalmic use ....... Cadexomer Iodine ....... Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters ....... Cantharides, blisters only ....... Cedar Oil ....... Chlorbutol (not more often than every 4 hours) ....... Choline Salicylate ....... Cinchocaine Hydrochloride, except suppositories ....... Cinchocaine Hydrochloride, suppositories only ....... Colchicine and its salts ....... Colchicum and its preparations, on the basis of colchicine ....... Croton Oil ....... Cyproheptadine and its salts—when sold or recommended for the promotion of weight gain Ephedrine and its salts ....... Ephedrine and its salts, sprays ....... Epinephrine and its salts, sprays ....... Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) ....... Gelsemium and its preparations, on the basis of the crude drug ....... Hydrocyanic (Prussic) Acid as 2 per cent solution ....... Hydroquinone ....... Hyoscine (Scopolamine) and its salts ....... Hyoscine aminoxide hydrobromide ....... Hyoscyamine and its salts ....... Hyoscyamus and its preparations, on the basis

External Use —

Maximum Limit

Per cent

0.0

1.0

0.0

0.03

0.2 25.0

1.0

10.0

— 1.0 1.0

2.0 0.5 0.5 — —

Internal Use

— Maximum Dosage Unless otherwise stated, doses are in milligrams Single Daily

0.0 0.0

0.0 0.0

0.0 0.0

0.0 0.0

0.0 0.0 0.0 0.0

325 975

870 5.22 g

0.0 0.0

11 11

0.55 1.65

0.27 0.81

0.0 0.0

0.0 0.0

11 32.5 — — — —

0.55 1.65

16.2 48.6

0.062 ml 0.31 ml

— — 0.325 0.975 0.325 0.975 0.325 0.975 0.073 0.22

External Internal UseUse — —

Item Maximum Dosage UnlessMaximum otherwise stated, doses are inLimit milligrams Per cent Single Daily

of hyoscyamus alkaloids ....... Lobelia and its preparations, on the basis of the — 130 390crude drug ....... Lobeline and its salts ....... — 2.0 6.0 Magnesium Salicylate ....... — 650 4.0 g Methyl Salicylate ....... 30 — — Methylene Blue ....... — 130 390 Phenacetin ....... — 650 1.95 g Phenazone and compounds thereof ....... — 325 975 Phenol ....... 2.0 32.5 260 Phenylpropanolamine when sold or — 0.0 0.0recommended as an appetite depressent ....... Phosphorus ....... — 0.0 0.0 Podophyllin ....... 0.0 0.0 0.0 Potassium Chlorate ....... — 325 975 Potassium Chlorate, gargle ....... 2.5 — — Procaine and its salts ....... — — — Proxymetacaine, its salts and derivatives when 0.0 0.0 0.0sold or recommended for ophthalmic use ....... Salicylamide ....... — 975 2.925 g Santonin ....... — 65 130 Selenium and its compounds ....... 2.5 0.0 0.0 Sodium Chlorate ....... — 325 975 Sodium Fluoride ....... — 0.1 0.1 Sodium Salicylate ....... — 650 4.0 g Squill and its preparations, on the basis of — 32.5 97.5crude drug ....... Stramonium and its preparations, on the basis — 0.16 0.65of stramonium alkaloids ....... Strychnine and its salts ....... — 0.0 0.0 Tannic Acid ....... — 150 1 000 Tetracaine, its salts and derivatives when sold 0.0 0.0 0.0or recommended for ophthalmic use ....... Thiocyanates ....... 0.0 0.0 0.0 Urethane ....... 0.0 0.0 0.0

Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.

Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.

SOR/78-422, s. 1; SOR/80-544, s. 3; SOR/84-145, s. 1; SOR/85-715, s. 3; SOR/85-966, s. 2; SOR/88-94, s. 1; SOR/89-229, s. 2; SOR/89-548, s. 1.

C.01.022. Notwithstanding paragraph C.01.021(b), the recommended single and daily dosage of a drug

(a) intended to be burned and the smoke inhaled may be increased to 10 times the oral dose, and

(b) intended for use as suppositories may be increased to 33 1/3 per cent in excess of the oral dose.

C.01.024. (1) Sections C.01.021 and C.01.022 do not apply to

(a) a drug sold to a drug manufacturer; or

(b) a drug sold on prescription.

(2) Paragraph C.01.021(c) does not apply to

(a) acetaminophen;

(b) acetylsalicylic acid;

(c) magnesium salicylate;

(d) sodium salicylate; or

(e) choline salicylate.

(3) Where a drug mentioned in any of paragraphs (2)(a) to (d) is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended

(a) that the drug be used as directed by a physician; or

(b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.

TABLE

MAXIMUM DOSE

Column I Column II

Column III Column IV Column V

Column VI

Column VII

Maximum Maximum Maximum MaximumChildren’s Dose Maximum MaximumChildren’s Children’s Dose Adult’sItem Age (80 mg units) Single DailyDose (80 (160 mg units) Dose (325Acetaminophen Dose (mg) Dose (mg)mg units) Acetaminophen mg units)Drops 11 to

1. under — 6 3 1.5 480 2 400 12 years 9 to

2. under — 5 2.5 1.25 400 2 000 11 years 6 to

3. under — 4 2 1 320 1 600 9 years 4 to

4. under — 3 1.5 — 240 1 200 6 years 2 to

5. under — 2 1 — 160 800 4 years 1 to 1.5 or as

6. under directed by a — — — 120 600 2 years physician 4 months 1 or as directed7. to under — — — 80 400by a physician1 year 0 to 0.5 or as

8. under directed by a — — — 40 200 4 months physician

(4) Where choline salicylate is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended

(a) that the drug be used as directed by physician; or

(b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.

TABLE

MAXIMUM DOSE Age (Years) Adult Dosage Units (435 mg) Single Dose (mg) Maximum Daily Dose (mg) 11 to under 12 1 1/2 660 3 300 9 to under 11 1 1/4 550 2 750 6 to under 9 1 440 2 200 4 to under 6 3/4 330 1 650 2 to under 4 1/2 220 1 100 Under 2 As directed by physician

SOR/84-145, s. 2; SOR/90-587, s. 1.

C.01.025. Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician.

C.01.026. The provisions of section C.01.025 do not apply to

(a) a drug sold on prescription, or

(b) the inner label of a single-dose container.

C.01.027. (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it

(a) contains a drug set out in the table to section C.01.021; and

(b) carries on its label

(i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or

(ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.

(2) Subsection (1) does not apply to products containing

(a) acetaminophen;

(b) acetylsalicylic acid;

(c) choline salicylate;

(d) magnesium salicylate; or

(e) sodium salicylate.

(3) [Repealed, SOR/94-409, s. 1]

(4) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers.

SOR/81-358, s. 1; SOR/84-145, s. 3; SOR/85-715, s. 4(F); SOR/85-966, s. 3; SOR/93-202, s. 5; SOR/93-411, s. 1; SOR/94-409, s. 1.

Cautionary Statements and Child Resistant Packages

C.01.028. (1) Subject to subsection (2), the inner and outer labels of a drug that contains

(a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician;

(b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age;

(c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye;

(d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement:

“CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or

(e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.

(2) Subsection (1) does not apply to a drug that is

(a) intended for parenteral use only;

(b) dispensed pursuant to a prescription; or

(c) required to be sold on prescription pursuant to these Regulations or pursuant to the Narcotic Control Regulations.

SOR/86-93, s. 2; SOR/88-323, s. 2(F); SOR/93-411, s. 2.

C.01.029. (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug

(a) that contains

(i) salicylic acid, a salt thereof or salicylamide,

(ii) acetylsalicylic acid, or any of its salts or derivatives,

(iii) acetaminophen, or

(iv) more than five per cent alkyl salicylates, or

(b) that is in a package that contains

(i) more than the equivalent of 250 mg of elemental iron, or

(ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,

shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children.

(2) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug that is in a package that contains

(a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide,

(b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives,

(c) more than 3.2 g of acetaminophen,

(d) more than the equivalent of 250 mg of elemental iron, or

(e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,

shall carry a cautionary statement to the effect that there is enough drug in the package to seriously harm a child.

(3) The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour.

SOR/86-93, s. 2; SOR/87-484, s. 2; SOR/88-323, s. 3(F); SOR/90-587, s. 2; SOR/93-468, s. 1.

C.01.030. [Repealed, SOR/2003-196, s. 104]

C.01.031. (1) Subject to section C.01.031.2,

(a) no person shall sell a drug described in subsection C.01.029(1) unless

(i) where the drug is recommended solely for children, it is packaged in a child resistant package, or

(ii) where the drug is not recommended solely for children, at least one of the sizes of packages available for sale is packaged in a child resistant package; and

(b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package.

(2) [Repealed, SOR/93-468, s. 2]

SOR/86-93, s. 2; SOR/87-16, s. 1; SOR/93-468, s. 2.

C.01.031.1. [Repealed, SOR/87-484, s. 3]

C.01.031.2. (1) Sections C.01.029 to C.01.031 do not apply to a drug that is

(a) required by these Regulations or the Narcotic Control Regulations to be sold on prescription;

(b) intended for parenteral use only;

(c) in effervescent or powder form;

(d) in suppository form;

(e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates;

(f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or

(g) in toothpaste form.

(2) Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale.

(3) Section C.01.031 does not apply to a drug that is

(a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators;

(b) sold for exclusive use in animals other than household pets; or

(c) intended solely for use in dentists’ offices, or packaged for hospital use only.

SOR/86-93, s. 2; SOR/87-484, s. 4; SOR/88-323, s. 5(F); SOR/93-468, s. 3.

C.01.032. No person shall sell a corticosteroid drug for ophthalmic use unless

(a) the outer label or the package insert carries, as part of the directions for use, the following statements:

“Contraindications

Viral diseases of the cornea and conjunctiva;

Tuberculosis of the eye;

Fungal diseases of the eye;

Acute purulent untreated infections of the eye, which, like other diseases caused by micro­ organisms, may be masked or enhanced by the presence of the steroid.

Side Effects

Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;

and

(b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects.

C.01.033. Section C.01.032 does not apply to a corticosteroid drug that is dispensed by a registered pharmacist pursuant to a prescription.

C.01.034. No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature.

C.01.035. Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.

Miscellaneous

C.01.036. (1) No manufacturer or importer shall sell

(a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid;

(b) a drug for human use that contains

(i) oxyphenisatin,

(ii) oxyphenisatin acetate, or

(iii) phenisatin; or

(c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is

(i) a drug described in Schedule C or D to the Act, or

(ii) one of the following drugs, namely,

(A) an ophthalmic drug or other drug to be used in the area of the eye,

(B) a drug for nasal administration,

(C) a drug for otic administration, or

(D) a drug for parenteral administration that is packaged in a multi-dose container,

in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Director demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.

(2) For the purpose of clause (1)(c)(ii)(A), “area of the eye” means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge.

SOR/78-423, s. 2; SOR/86-93, s. 3; SOR/89-229, s. 3.

C.01.036.1 No person shall sell, or advertise for sale, nitrous oxide to the general public.

SOR/78-875, s. 1.

C.01.037. (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains

(a) more than 1.92 g of salicylamide or salicylic acid or the equivalent quantity of a salt of salicylic acid;

(b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof;

(c) more than 3.2 g of acetaminophen in 160 mg dosage units; or

(d) more than 1.92 g of acetaminophen in 80 mg dosage units.

(2) Subsection (1) does not apply to a drug dispensed pursuant to a prescription.

SOR/86-93, s. 4; SOR/87-484, s. 5; SOR/88-323, s. 6; SOR/90-587, s. 3.

C.01.038. A drug for human use is adulterated if it contains

(a) Strychnine or any of its salts;

(b) extracts or tinctures of

(i) Strychnos nux vomica,

(ii) Strychnos Ignatii, or

(iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii);

(c) Methapyrilene or any of its salts;

(d) Echimidine or any of its salts; or

(e) any of the following plant species or extracts or tinctures thereof:

(i) Symphytum asperum,

(ii) Symphytum x uplandicum, or

(iii) any other plant species containing echimidine.

SOR/79-512, s. 1; SOR/88-173, s. 1.

C.01.039. In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part.

SOR/97-12, s. 4.

C.01.040. No manufacturer or importer shall sell a drug for human use that contains as an ingredient

(a) chloroform; or

(b) arsenic or any of its salts or derivatives.

SOR/89-229, s. 4.

C.01.040.1. No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans.

SOR/78-422, s. 2; SOR/78-801, s. 1; SOR/81-334, s. 2(F); SOR/89-176, s. 1; SOR/92-662, s. 1.

Colouring Agents

C.01.040.2 (1) No manufacturer shall use a colouring agent in a drug other than a colouring agent listed in subsections (3) and (4).

(2) No person shall import for sale a drug that contains a colouring agent other than a colouring agent listed in subsections (3) and (4).

(2.1) In subsections (3) and (4),

“C.I. (indication of the number)” means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; (C.I. (indication du numéro))

“D & C (indication of the colour and the number)” means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; (D&C (indication de la couleur et du numéro))

“FD & C (indication of the colour and the number)” means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. (FD&C (indication de la couleur et du numéro))

(3) The following colouring agents are permitted in drugs for internal and external use, namely,

(a) ACID FUCHSIN D (D & C Red No. 33; C.I. No. 17200),

ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570),

ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035),

AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185),

ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES,

ß-APO-81-CAROTENAL (C.I. No. 40820),

BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090),

BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090),

CANTHAXANTHIN (C.I. No. 40850),

CARAMEL,

CARBON BLACK (C.I. No. 77266),

CARMINE (C.I. No. 75470),

CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720),

ß-CAROTENE (C.I. No. 40800),

CHLOROPHYLL (C.I. No. 75810),

EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2),

EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380),

ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430),

FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053),

FLAMING RED (D & C Red No. 36; C.I. No. 12085),

HELINDONE PINK CN (D & C Red No. 30; C.I. No. 73360),

INDIGO (D & C Blue No. 6; C.I. No. 73000),

INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015),

IRON OXIDES (C.I. Nos . 77489, 77491, 77492, 77499),

LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850),

LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1),

PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1),

PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410),

PONCEAU 4R (C.I. No. 16255),

PONCEAU SX (FD & C Red No. 4; C.I. No. 14700),

QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005),

RIBOFLAVIN,

SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985),

TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140),

TITANIUM DIOXIDE (C.I. No. 77891);

(b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

(i) alumina,

(ii) blanc fixe,

(iii) gloss white,

(iv) clay,

(v) zinc oxide,

(vi) talc,

(vii) rosin,

(viii) aluminum benzoate,

(ix) calcium carbonate, or

(x) any combination of the substances listed in subparagraphs (i) to (ix); and

(c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

(i) alumina,

(ii) blanc fixe,

(iii) gloss white,

(iv) clay,

(v) zinc oxide,

(vi) talc,

(vii) rosin,

(viii) aluminum benzoate,

(ix) calcium carbonate, or

(x) any combination of the substances listed in subparagraphs (i) to (ix).

(4) The following colouring agents are permitted in drugs for external use, namely,

(a) ACID VIOLET 43 (Ext. D & C Violet No. 2; C.I. No. 60730),

ALIZUROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725),

ANNATTO (C.I. No. 75120),

BISMUTH OXYCHLORIDE (C.I. No. 77163),

CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18 (C.I. No. 77289)),

DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1),

DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)),

FERRIC FERROCYANIDE (C.I. No. 77510),

GUANINE (C.I. No. 75170),

MANGANESE VIOLET (C.I. No. 77742),

MICA (C.I. No. 77019),

ORANGE II (D&C Orange No. 4; C.I. No. 15510),

PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040),

QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565),

TONEY RED (D&C Red No. 17; C.I. No. 26100),

URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1),

URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350);

ZINC OXIDE (C.I. No. 77947);

(b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

(i) alumina,

(ii) blanc fixe,

(iii) gloss white,

(iv) clay,

(v) zinc oxide,

(vi) talc,

(vii) rosin,

(viii) aluminum benzoate,

(ix) calcium carbonate, or

(x) any combination of the substances listed in subparagraphs (i) to (ix); and

(c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

(i) alumina,

(ii) blanc fixe,

(iii) gloss white,

(iv) clay,

(v) zinc oxide,

(vi) talc,

(vii) rosin,

(viii) aluminum benzoate,

(ix) calcium carbonate, or

(x) any combination of the substances listed in subparagraphs (i) to (ix).

(5) Subsections (1) and (2) do not apply in respect of a drug that is represented as being solely for use in the disinfection, for disease prevention, of

(a) medical devices;

(b) health care facilities; or

(c) premises in which food is manufactured, prepared or kept.

SOR/84-949, s. 1; SOR/86-590, s. 1(E); SOR/94-460, s. 1; SOR/95-431, s. 1; SOR/2002-369, s. 1; SOR/2005-95, s. 1.

Schedule F Drugs

C.01.041. (1) In this section and sections C.01.041.1 to C.01.046, “Schedule F Drug” means a drug listed or described in Schedule F to these Regulations.

(1.1) Subject to sections C.01.043 and C.01.046, no person shall sell a substance containing a Schedule F Drug unless

(a) the sale is made pursuant to a verbal or written prescription received by the seller; and

(b) where the prescription has been transferred to the seller under section C.01.041.1, the requirements of section C.01.041.2 have been complied with.

(2) Where the prescription for a Schedule F Drug is written, the person selling the drug shall retain the prescription for at least two years from the date of filling.

(3) Where the prescription for a Schedule F Drug is verbal, the person to whom the prescription is communicated by the practitioner shall forthwith reduce the prescription to writing and the person selling the drug shall retain that written prescription for a period of at least two years from the date of filling.

(4) The person reducing a verbal prescription to writing shall indicate on the written prescription

(a) the date and number of the prescription;

(b) the name and address of the person for whose benefit the prescription is given;

(c) the proper name, common name or brand name of the specified drug and the quantity thereof;

(d) his name and the name of the practitioner who issued the prescription; and

(e) the directions for use given with the prescription, including whether or not the practitioner authorized the refilling of the prescription and, if the prescription is to be refilled, the number of times it may be refilled.

(5) Subsections (1.1) to (4) do not apply to a substance containing

(a) chloral hydrate in preparations for external use, where it constitutes not more than one per cent of the substance, or

(b) hexachlorophene and its salts, where it constitutes not more than 0.75 per cent of the substance, calculated as hexachlorophene.

SOR/78-424, s. 2; SOR/80-543, s. 3; SOR/93-202, s. 6; SOR/93-407, s. 2.

C.01.041.1. A pharmacist may transfer to another pharmacist a prescription for a Schedule F Drug.

SOR/78-424, s. 3.

C.01.041.2. A pharmacist to whom a prescription has been transferred under section C.01.041.1 shall not sell a drug pursuant thereto until

(a) he has obtained from the pharmacist transferring the prescription his name and address, the number of authorized refills remaining and the date of the last refill; and

(b) he has

(i) received a copy of the prescription as written by the practitioner or as reduced to writing as required by subsections C.01.041(3) and (4), as the case may be, or

(ii) where the prescription has been transferred to him verbally, reduced the prescription to writing indicating therein the information specified in subsection C.01.041(4).

SOR/78-424, s. 3.

C.01.041.3. The pharmacist to whom a prescription for a Schedule F Drug is transferred under section C.01.041.1 shall retain in his files for a period of two years the information and documents referred to in section C.01.041.2.

SOR/78-424, s. 3.

C.01.041.4. A pharmacist who transfers a prescription under section C.01.041.1

(a) shall enter on the original of the prescription or in a suitable record of prescription kept under the name of each patient, the date of transfer; and

(b) shall not make any further sales under the prescription nor transfer it to another pharmacist.

SOR/78-424, s. 3.

C.01.042. (1) No person shall refill a prescription for a Schedule F Drug unless the practitioner so directs and no person shall refill such a prescription more times than the number of times prescribed by the practitioner.

(2) The person filling or refilling a prescription for a Schedule F Drug shall enter on the original of the prescription or in a suitable record of prescriptions kept under the name of each patient

(a) the date of filling;

(b) the date of each refill, if applicable;

(c) the quantity of drug dispensed at the original filling and each refill; and

(d) his name.

SOR/78-424, s. 4.

C.01.043. (1) A person may sell a Schedule F Drug, without having received a prescription therefor, to

(a) a drug manufacturer;

(b) a practitioner;

(c) a wholesale druggist;

(d) a registered pharmacist;

(e) a hospital certified by the Department of National Health and Welfare;

(f) a Department of the Government of Canada or of a province, upon receipt of a written order signed by the Minister thereof or his duly authorized representative; or

(g) any person, upon receipt of a written order signed by the Director.

(2) Where a person makes a sale authorized by paragraph (1)(f) or (1)(g), he shall retain the written order for the drug for a period of at least two years from the date of filling the order.

C.01.044. (1) Where a person advertises to the general public a Schedule F Drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.

(2) Subsection (1) does not apply where

(a) the drug is listed in Part II of Schedule F; and

(b) the drug is

(i) in a form not suitable for human use, or

(ii) labelled in the manner prescribed by paragraph C.01.046(b).

SOR/78-424, s. 5; SOR/93-202, s. 7; SOR/93-407, s. 3.

C.01.045. (1) Subject to subsection (2), no person other than

(a) a practitioner,

(b) a drug manufacturer,

(c) a wholesale druggist,

(d) a registered pharmacist, or

(e) a resident of a foreign country while a visitor in Canada,

shall import a Schedule F Drug.

(2) Any person may import a Schedule F Drug listed in Part II of Schedule F if the drug is imported in such form or so labelled that it could be sold by that person pursuant to section C.01.046.

SOR/93-407, s. 4.

C.01.046. A person may sell a drug listed or described in Part II of Schedule F to the Regulations, without having received a prescription therefor, if

(a) the drug is in a form not suitable for human use; or

(b) the principal display panel of both the inner label and the outer label carries, in both official languages, the statement “For Veterinary Use Only/Pour usage vétérinaire seulement” or “Veterinary Use Only/Usage vétérinaire seulement”, immediately following or preceding the brand name, proper name or common name, in type size not less than one-half as large as the largest type on the label.

SOR/93-202, s. 8; SOR/93-407, s. 5; SOR/2001-181, s. 1(E).

C.01.047. [Repealed, SOR/80-543, s. 4]

C.01.048. (1) Where a person who is a physician, dentist, veterinary surgeon or pharmacist registered and entitled to practise that person’s profession in a province has signed an order specifying the brand name, proper name or common name and the quantity of a drug, other than

(a) a narcotic as defined in the Narcotic Control Regulations,

(b) a controlled drug as defined in subsection G.01.001(1), or

(c) a new drug in respect of which a notice of compliance has not been issued under section C.08.004,

the person who receives the order may distribute the drug to the physician, dentist, veterinary surgeon or pharmacist as a sample if the drug is labelled in accordance with these Regulations.

(2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months.

SOR/93-202, s. 9; SOR/97-228, s. 2.

C.01.049. A person who, under section C.01.048, distributes a drug as a sample shall

(a) maintain records showing

(i) the name, address and description of each person to whom the drug is distributed,

(ii) the brand name, quantity and form of the drug distributed, and

(iii) the date upon which each such distribution was made; and

(b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made.

SOR/93-202, s. 10.

Recalls

C.01.051. Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Director the following information:

(a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;

(b) in the case of an imported drug, the names of the manufacturer and importer;

(c) the quantity of the drug manufactured or imported;

(d) the quantity of the drug distributed;

(e) the quantity of the drug remaining on the premises of the manufacturer or importer;

(f) the reasons for initiating the recall; and

(g) a description of any other action taken by the manufacturer or importer with respect to the recall.

SOR/82-524, s. 2; SOR/93-202, s. 11.

C.01.052. [Repealed, SOR/82-524, s. 2]

C.01.055. and C.01.056. [Repealed, SOR/82-524, s. 2]

Limits of Variability

C.01.061. (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.

(2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain a number of units such that, when determined by that official method,

(a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label;

(b) no package contains less than the number of dosage units shown on the label except as provided in the table; and

(c) where the drug is a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.

TABLE

Column I Column II

Item Labelled Number of Dosage Permitted Variation from the Labelled NumberUnits Per Package

Column I Column II

Item Labelled Number of Dosage Permitted Variation from the Labelled NumberUnits Per Package 1. 50 or less 0

More than 50, but less than2. 1101 the greater of one unit or 0.75% of the labelled number,3. 101 or more rounded up to the next whole number

SOR/82-429, s. 4; SOR/89-455, s. 4; SOR/97-228, s. 3.

C.01.062. (1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is

(a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or

(b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label.

(2) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be

(a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and

(b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.

(3) Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.

(4) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item.

(5) Subsections (1) to (4) do not apply in respect of

(a) a drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01;

(b) [Repealed, SOR/98-423, s. 8]

(c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act;

(d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or

(e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which

(i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug,

(ii) all labels, package inserts, product brochures and file cards to be used in connection with the drug make proper claims in respect of the drug,

(iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and

(iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer.

TABLE

Column I Column II Column III Column IV Limits of variation when the Limits of variation when recommended daily dose the recommended dailyRecommendedItem Vitamin shown on label is equal to or dose shown on label isdaily dose less then amount set out in greater than amount set out column II in column II

vitamin A (or 1. as B- 10 000 I.U. 90.0 - 165.0 % 90.0 - 115.0 %

carotene) 2. thiamine 4.5 mg 90.0 - 145.0 % 90.0 - 125.0 % 3. riboflavin 7.5 mg 90.0 - 125.0 % 90.0 - 125.0 %

niacin or4. 45 mg 90.0 - 125.0 % 90.0 - 125.0 %niacinamide 5. pyridoxine 3 mg 90.0 - 125.0 % 90.0 - 125.0 %

d-pantothenic6. 15 mg 90.0 - 135.0 % 90.0 - 125.0 %acid 7. folic acid 0.4 mg 90.0 - 135.0 % 90.0 - 115.0 % 8. vitamin B12 14 µg 90.0 - 135.0 % 90.0 - 125.0 % 9. vitamin C 150 I.U. 90.0 - 145.0 % 90.0 - 125.0 % 10. vitamin D 400 I.U. 90.0 - 145.0 % 90.0 - 115.0 % 11. vitamin E 25 I.U. 90.0 - 125.0 % 90.0 - 125.0 % 12. vitamin K 0.0 mg 90.0 - 115.0 % 13. biotin 0.0 mg 90.0 - 135.0 %

SOR/92-131, s. 1; SOR/92-591, s. 2; SOR/94-689, s. 2(E); SOR/95-530, s. 2; SOR/98-423, s. 8; SOR/2011-88, s. 5. Previous Version C.01.063. [Repealed, SOR/96-399, s. 2]

C.01.064. Where a drug is prepared for ophthalmic or parenteral use and contains a preservative ingredient, that ingredient

(a) shall be present only in an amount necessary to obtain the intended action and that does not pose undue risk to humans or animals; and

(b) shall not interfere with the therapeutic properties of the drug.

SOR/90-586, s. 2.

C.01.065. No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container

(a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name;

(b) is tested by an acceptable method for sterility, except

(i) for living vaccines, or

(ii) where the manufacturer has submitted evidence, satisfactory to the Director to prove that processing controls ensure the sterility of the drug in its immediate container,

and the drug is found to be sterile; and

(c) is subjected to such further tests satisfactory to the Director to ensure that the drug is safe to use according to directions.

SOR/86-552, s. 1; SOR/90-586, s. 3; SOR/93-202, s. 12; SOR/96-399, s. 3.

C.01.066. No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis.

C.01.067. (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container

(a) is tested by an acceptable method for the presence of pyrogens; and

(b) when so tested, is found to be non-pyrogenic.

(2) Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic.

SOR/81-335, s. 1; SOR/96-399, s. 4.

C.01.068. Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug.

SOR/85-715, s. 5; SOR/92-654, s. 3.

C.01.069. The packaging of a drug that is prepared for parenteral use shall meet the following requirements:

(a) the immediate container shall be of such material and construction that

(i) no deleterious substance is yielded to the drug,

(ii) it is non-reactive with the drug,

(iii) visual or electronic inspection of the drug is possible,

(iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and

(v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and

(b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii).

SOR/96-399, s. 5.

C.01.070. No person shall sell a drug that is a hypodermic tablet that does not completely dissolve in and form a clear solution with water.

Mercuric Chloride Tablets

C.01.071. No person shall sell mercuric chloride tablets for household use that are packaged in lots of 200 or less, unless

(a) such tablets are

(i) of an irregular or angular shape,

(ii) coloured blue, and

(iii) packed in an immediate container that is readily distinguishable by touch; and

(b) the principal display panel of both the inner and the outer labels carries in prominent type and in a colour contrasting to that of such labels

(i) the design of a skull and cross-bones, and

(ii) the word “Poison”.

SOR/2001-181, s. 2.

C.01.081. [Repealed, SOR/80-544, s. 4]

C.01.085. [Repealed, SOR/80-544, s. 5]

Synthetic Sweeteners

C.01.101. (1) [Repealed, SOR/78-422, s. 3]

(2) [Repealed, SOR/78-800, s. 1]

(3) [Repealed, SOR/78-422, s. 3]

C.01.121. and C.01.122. [Repealed, SOR/80-544, s. 6]

Aminopyrine and Dipyrone

C.01.131. No person shall sell Aminopyrine or Dipyrone (a derivative of Aminopyrine) for oral or parenteral use, unless

(a) the inner label carries the statement:

“WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and

(b) the outer label or the package insert carries the following statements:

“WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective.

PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).”

C.01.132. No person shall disseminate to a practitioner promotional literature about Aminopyrine or Dipyrone unless the statements set out in section C.01.131 are included in such literature.

C.01.133. The provisions of sections C.01.131 and C.01.132 do not apply to preparations containing Aminopyrine or Dipyrone that are

(a) dispensed by a pharmacist pursuant to a prescription; or

(b) sold for veterinary use only.

Coated Potassium Salts

C.01.134. No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label thereof or the package insert carries the following statement:

“WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur.”

C.01.135. No person shall disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics, unless the statement set out in section C.01.134 is included in such literature.

C.01.136. The provisions of sections C.01.134 and C.01.135 do not apply to coated tablets containing potassium salts with or without thiazide diuretics that

(a) are sold for veterinary use only;

(b) are dispensed by a pharmacist pursuant to a prescription; or

(c) contain 100 milligrams or less of elemental potassium per tablet.

Antibiotics

C.01.401. Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label the potency of the drug, expressed in terms of International Units where established or, if no International Unit has been established, in terms of units, milligrams, micrograms or fractions of a gram,

(a) per gram in the case of solids or viscous liquids;

(b) per millilitre in the case of other liquids; and

(c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form.

SOR/80-544, s. 7; SOR/92-654, s. 4.

C.01.402. [Repealed, SOR/92-654, s. 4]

C.01.410. to C.01.412. [Repealed, SOR/80-544, s. 8]

C.01.420. to C.01.422. [Repealed, SOR/80-544, s. 8]

Chloramphenicol

C.01.430. to C.01.432. [Repealed, SOR/80-544, s. 8]

C.01.433. No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless

(a) the inner label carries a warning statement to the effect that

(i) bone marrow depression has been associated with the use of chloramphenicol, and

(ii) the enclosed warnings and precautions should be read carefully; and

(b) the outer label or the package insert carries the following:

(i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and

(ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies

may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia.

C.01.434. The provisions of section C.01.433 do not apply to chloramphenicol and its salts or derivatives sold by a registered pharmacist.

C.01.435. No person shall disseminate to a practitioner promotional literature about chloramphenicol and its salts or derivatives for oral or parenteral use unless the statements set out in paragraph C.01.433(b) are included in such literature.

C.01.436. The provisions of sections C.01.433 and C.01.435 do not apply to a drug sold solely for veterinary use.

C.01.440. to C.01.442. [Repealed, SOR/80-544, s. 8]

C.01.450. to C.01.452. [Repealed, SOR/80-544, s. 8]

C.01.460. to C.01.462. [Repealed, SOR/80-544, s. 8]

C.01.470. to C.01.472. [Repealed, SOR/80-544, s. 8]

C.01.480. [Repealed, SOR/80-544, s. 8]

C.01.490. to C.01.497. [Repealed, SOR/80-544, s. 8]

C.01.510. to C.01.513. [Repealed, SOR/80-544, s. 8]

C.01.520. to C.01.522. [Repealed, SOR/80-544, s. 8]

C.01.530. to C.01.532. [Repealed, SOR/80-544, s. 8]

C.01.540. to C.01.542. [Repealed, SOR/80-544, s. 8]

C.01.550. to C.01.552. [Repealed, SOR/80-544, s. 8]

C.01.560. to C.01.563. [Repealed, SOR/80-544, s. 8]

C.01.570. to C.01.572. [Repealed, SOR/80-544, s. 8]

C.01.580. [Repealed, SOR/80-544, s. 8]

C.01.590. to C.01.592. [Repealed, SOR/80-544, s. 8]

Veterinary Drugs

C.01.600. No person shall sell for veterinary use a drug listed in the Table of Limits of Drug Dosage for Adults, other than a drug in a form not suitable for human use, unless both the inner and outer labels carry the statement “For Veterinary Use Only” or “Veterinary Use Only”.

SOR/80-543, s. 5.

C.01.601. [Repealed, SOR/93-407, s. 6]

C.01.602. The provisions of sections C.01.401 and C.01.402 do not apply to an antibiotic in amounts less than 50 parts per million contained in an animal food.

C.01.603. The provisions of paragraphs C.01.401 (b) and (c) and section C.01.402 do not apply to an antibiotic in amounts greater than 50 parts per million contained in an animal food.

C.01.604. Both the inner and outer labels of a veterinary drug represented as containing a vitamin shall carry

(a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name only of the vitamin in

(i) International Units per gram or per millilitre for vitamin A, provitamin A, vitamin D, and vitamin E,

(ii) milligrams per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for thiamine, riboflavin, niacin, niacinamide, pyridoxine, d-pantothenic acid, d­ panthenol, folic acid, ascorbic acid, and vitamin K,

(iii) micrograms per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for biotin, and vitamin B12,

(iv) Oral Units for vitamin B12 with intrinsic factor concentrate, or

(v) for vitamin products put up in individual dosage or dispensing form, the specified units per individual dosage or dispensing form;

(b) except for drugs in a form not suitable for human use, the statement “For Veterinary Use Only” or “Veterinary Use Only”.

SOR/80-543, s. 6.

C.01.605. An antibiotic for parenteral use that is recommended for veterinary use only shall carry on both the inner and outer labels

(a) the potency of the drug expressed in terms of International Units where established, or, if no International Unit has been established, in terms of units, milligrams or fractions of a gram, per gram in the case of solids or viscous liquids, per millilitre in the case of other liquids, or per individual dosage or dispensing form for antibiotic preparations put up in individual dosage or dispensing form; and

(b) [Repealed, SOR/92-654, s. 5]

(c) the statement “For Veterinary Use Only” or “Veterinary Use Only”.

SOR/80-543, s. 7; SOR/92-654, s. 5.

C.01.606. No person shall sell an antibiotic preparation for the treatment of animals, other than an antibiotic preparation that is a new drug sold pursuant to section C.08.013, unless,

(a) where the preparation is not to be used for lactating animals providing milk to be consumed as food, the inner and outer labels of the preparation carry a statement to that effect; or

(b) where the preparation may be used for lactating animals providing milk to be consumed as food,

(i) there has been submitted, on request, to the Director, acceptable evidence to show the period of time, not exceeding 96 hours, that must elapse after the last treatment with the preparation in order that the milk from treated lactating animals will contain no residue of antibiotics that would cause injury to human health, and

(ii) the principal display panel of the outer label of the preparation, the inner label and the packaging insert, if any, describing the antibiotic preparation carry the warning “WARNING: MILK TAKEN FROM TREATED ANIMALS DURING TREATMENT AND WITHIN ... HOURS AFTER THE LATEST TREATMENT MUST NOT BE USED AS FOOD”, where the number of hours to be inserted is determined according to evidence submitted pursuant to subparagraph (i).

SOR/88-378, s. 1; SOR/92-664, s. 2; SOR/93-467, s. 1.

C.01.606.1. No person shall sell a product intended for the prevention or treatment of foot rot of cattle if that product contains Ethylenediamine Dihydroiodide (EDDI).

SOR/90-327, s. 1.

C.01.607. Notwithstanding subparagraph C.01.004(1)(c)(ii), the declaration of a lot number is not required on the label of an animal feeding-stuff containing a drug.

SOR/80-543, s. 8.

C.01.608. The provisions of section C.01.604 do not apply to medicated feeds registered under the Feeds Act.

C.01.609. Notwithstanding the provisions of section C.01.401(a), the potency of an antibiotic in in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per ton.

C.01.610. No person shall sell any substance having oestrogenic activity for administration to poultry that may be consumed as food.

C.01.610.1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains

(a) chloramphenicol or its salts or derivatives;

(b) a 5-nitrofuran compound;

(c) clenbuterol or its salts or derivatives;

(d) a 5-nitroimidazole compound; or

(e) diethylstilbestrol or other stilbene compounds.

SOR/85-539, s. 1; SOR/85-685, s. 2; SOR/91-546, s. 1; SOR/94-568, s. 2; SOR/97-510, s. 2; SOR/2003-292, s. 3.

C.01.610.2 No person shall sell an antibiotic preparation containing chloramphenicol, its salts or derivatives, for administration to animals that do not produce food and that are not intended for consumption as food unless

(a) both the inner label and outer label of the preparation carry the words “WARNING: FEDERAL LAW PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD/MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS”;

(b) where the preparation is for parenteral use, the preparation contains, in the form of chloramphenicol sodium succinate, not more than one gram of chloramphenicol per vial;

(c) where the preparation is for ophthalmic use, the preparation contains not more than one per cent chloramphenicol; and

(d) where the preparation is for oral use, the preparation

(i) is in tablet or capsule form and contains not more than one gram of chloramphenicol per tablet or capsule, or

(ii) is in the form of a chloramphenicol palmitate suspension and contains not more than three grams of chloramphenicol per container.

SOR/91-546, s. 1.

C.01.611. (1) The Director may, in writing, from time to time require the manufacturer of a drug recommended for administration to animals that may be consumed as food

(a) to file with him in respect of that drug a submission, in form and content satisfactory to the Director, describing in detail tests carried out to determine that no residues of the drug, except residues within the limits prescribed by these Regulations, remain in meat, meat by- products, eggs or milk; and

(b) to print on the principal display panel of the outer label, the inner label and the packaging insert, if any, that describes the drug, a warning that meat, meat by-products, eggs or milk from animals to which the drug has been administered cannot be sold for consumption as food unless there has elapsed since the administration of the drug a period of time specified by the Director, based on a review of the available data with respect to drug residue.

(2) No manufacturer shall sell a drug in respect of which the Director has required a warning to be printed pursuant to paragraph (1)(b) unless the manufacturer has complied with that request.

SOR/93-467, s. 2.

C.01.612. [Repealed, SOR/94-568, s. 3]

Contraceptive Drugs

C.01.625. Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not listed in Schedule F may be advertised to the general public.

Division 1A

Establishment Licences Interpretation

C.01A.001. (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.

“antimicrobial agent” means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that

(a) are not invasive devices as defined in those Regulations; and

(b) are intended to come into contact with intact skin only. (agent antimicrobien)

“batch certificate” means a certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator

(a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;

(b) provides a detailed description of the drug, including

(i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and

(ii) a statement of tolerances for the properties and qualities of the drug;

(c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;

(d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and

(e) certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards. (certificat de lot)

“class monograph” means a document prepared by the Department of Health that

(a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and

(b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)

“dilute drug premix” means a drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué)

“dosage form class” means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)

“drug premix” means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux)

“fabricate” means to prepare and preserve a drug for the purposes of sale. (manufacturer)

“import” means to import into Canada a drug for the purpose of sale. (importer)

“MRA country” means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)

“mutual recognition agreement” means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaisance mutuelle)

“package/label” means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter)

“pharmaceutical” means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)

“recognized building” means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu)

“regulatory authority” means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire)

“site”[Repealed, SOR/2002-368, s. 1]

“wholesale” means to sell any of the following drugs, other than at retail sale, where the seller’s name does not appear on the label of the drugs:

(a) a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001(1); or

(b) a narcotic as defined in the Narcotic Control Regulations. (vendre en gros)

(2) In this Division and in Division 2, “drug” means a drug in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act or in Schedule D to the Act that is of biological origin. It does not include a dilute drug premix, a medicated feed as defined section 2 of the Feeds Regulations, 1983, a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 or a drug listed in Schedule H to the Act.

(3) Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request.

SOR/97-12, s. 5; SOR/98-7, s. 1; SOR/2000-120, s. 1; SOR/2002-368, s. 1; SOR/2004-282, s. 1.

Application

C.01A.002. (1) This Division does not apply to

(a) wholesaling a drug premix;

(b) importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons, namely,

(i) a pharmacist,

(ii) a practitioner, and

(iii) a person who compounds a drug under the supervision of a practitioner;

(c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005,

(d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A to the Act, namely,

(i) homeopathic drugs,

(ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and

(iii) drugs that

(A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and

(B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and

(e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.

(2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

SOR/97-12, s. 5; SOR/98-7, s. 2; SOR/2001/-203, s. 1; SOR/2004-282, s. 2.

C.01A.003. This Division and Divisions 2 to 4 apply to the following distributors:

(a) a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations, a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, who does not hold the drug identification number for the drug or narcotic; and

(b) a distributor of a drug for which that distributor holds the drug identification number.

SOR/97-12, s. 5; SOR/2002-368, s. 2.

Prohibition

C.01A.004. (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or

(b) perform the tests, including examinations, required under Division 2.

(2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

(3) No person shall carry on an activity referred to in subsection (1) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.

SOR/97-12, s. 5; SOR/2002-368, s. 3.

Application

[SOR/2011-81, s. 1(E)]

C.01A.005. A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents:

(a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any;

(b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;

(c) each activity set out in Table I to section C.01A.008 for which the licence is requested;

(d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;

(e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;

(f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;

(g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category,

(i) the dosage form classes, and whether any drugs will be in a sterile dosage form, and

(ii) whether any drugs will be bulk process intermediates;

(h) the address of each building in Canada at which records will be maintained;

(i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;

(j) the drug identification number, if any, or a name that clearly identifies the drug,

(i) for each narcotic as defined in the Narcotic Control Regulations or each controlled drug as defined in subsection G.01.001(1) for which the licence is requested, and

(ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale;

(k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;

(l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;

(m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building,

(i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building at which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drug and

(A) the dosage form class and whether the drug is in a sterile dosage form, and

(B) whether the drug is a bulk process intermediate,

(ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and

(iii) in respect of any other activities,

(A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

(B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4;

(n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building at which the drugs will be fabricated, packaged/labelled and tested, specifying for

each building which of those activities and for which category of drugs and, for each category,

(i) the dosage form classes and whether any drugs will be in a sterile dosage form, and

(ii) whether any drugs will be bulk process intermediates; and

(o) in the case of an importer referred to in paragraph (n),

(i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

(ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.

SOR/97-12, s. 5; SOR/2000-120, s. 2; SOR/2002-368, s. 4; SOR/2011-81, s. 2. Previous Version C.01A.006. (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment.

(2) An establishment licence must be amended where the licensee proposes

(a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;

(b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;

(c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and

(d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,

(i) to add a fabricator, packager/labeller or tester of a drug,

(ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and

(iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.

SOR/97-12, s. 5; SOR/2011-81, s. 3. Previous Version C.01A.007. (1) The Minister may, on receipt of an application for an establishment licence, an amendment to an establishment licence or the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision.

(2) When considering an application, the Minister may require that

(a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and

(b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.

SOR/97-12, s. 5; SOR/2011-81, s. 4. Previous Version

Issuance

C.01A.008. (1) Subject to section C.01A.010, the Minister shall, on receipt of the information and material required by sections C.01A.005 to C.01A.007, issue or amend an establishment licence.

(2) The establishment licence shall indicate

(a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, specifying for each activity and category whether sterile dosage forms are authorized;

(b) the address of each building in Canada at which a category of drugs is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and

(c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer,

(i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and

(ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs that are authorized, and whether sterile dosage forms are authorized.

(d) [Repealed, SOR/2002-368, s. 5]

(3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.

(4) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions respecting

(a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and

(b) any other matters necessary to prevent injury to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.

TABLE I

Item Activities 1. Fabricate 2. Package/label 3. Perform the tests, including any examinations, required under Division 2 4. Distribute as set out in paragraph C.01A.003(a) 5. Distribute as set out in paragraph C.01A.003(b) 6. Import 7. Wholesale

TABLE II

Item Categories of drugs 1. Pharmaceuticals 2. Vaccines 3. Whole blood and its components

Drugs listed in Schedule D to the Act, other than vaccines or whole blood and its4. components 5. Drugs listed in Schedule C to the Act

Drugs listed in Schedule F to these Regulations, controlled drugs as defined in6. subsection G.01.001(1) and narcotics as defined in the Narcotic Control Regulations

SOR/97-12, s. 5; SOR/2000-120, s. 3; SOR/2002-368, s. 5.

Annual Licence Review

C.01A.009. (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005.

(2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

SOR/97-12, s. 5; SOR/97-298, s. 1; SOR/2011-81, s. 5. Previous Version

Refusal to Issue

C.01A.010. (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if

(a) the applicant has made a false or misleading statement in relation to the application for the licence; or

(b) the applicant has had an establishment licence suspended in respect of the matter.

(2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.

(3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall

(a) notify the applicant in writing of the reasons for the refusal; and

(b) give the applicant an opportunity to be heard.

SOR/97-12, s. 5.

Terms and Conditions

C.01A.011. (1) Every person who holds an establishment licence shall comply with

(a) the requirements and the terms and conditions of the establishment licence; and

(b) the applicable requirements of Divisions 2 to 4.

(2) [Repealed, SOR/2000-120, s. 4]

SOR/97-12, s. 5; SOR/2000-120, s. 4.

C.01A.012. (1) The Minister may amend the terms and conditions of an establishment licence if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to the health of the consumer.

(2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for the amendment and its effective date.

SOR/97-12, s. 5.

Notification

C.01A.013. Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

(a) there is any change to the information referred to in any of paragraphs C.01A.005(a),(b),(e),(f),(h) and (i), and subparagraphs C.01A.005(g)(i) and (ii); or

(b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.

SOR/97-12, s. 5.

C.01A.014. (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless

(a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and

(b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.

(2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:

(a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;

(b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;

(c) changes to the practices or procedures; and

(d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.

SOR/97-12, s. 5; SOR/2000-120, s. 5; SOR/2002-368, s. 6.

C.01A.015. (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.

(2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester.

SOR/97-12, s. 5; SOR/2000-120, s. 6; SOR/2002-368, s. 7.

Suspension

C.01A.016. (1) Subject to subsection (3), the Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that

(a) the licensee has contravened any provision of the Act or these Regulations; or

(b) the licensee has made a false or misleading statement in the application for the establishment licence.

(2) Before suspending an establishment licence, the Minister shall consider

(a) the licensee’s history of compliance with the Act and these Regulations; and

(b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.

(3) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until

(a) an inspector has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

(b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

(c) the licensee has been given an opportunity to be heard in respect of the suspension.

SOR/97-12, s. 5.

C.01A.017. (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension.

(2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.

(3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.

SOR/97-12, s. 5.

C.01A.018. The Minister may reinstate an establishment licence after it has been suspended.

SOR/97-12, s. 5.

Cancellation

C.01A.018.1 The Minister shall cancel an establishment licence in either of the following circumstances:

(a) the licence has been suspended for a period of more than 12 months, or

(b) the licence holder has failed to submit an application for the review of their licence in accordance with subsection C.01A.009(1).

SOR/2011-81, s. 6.

Designation

C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the table to this section is hereby designated in respect of the activities set out in column 3 for the drug or category of drugs set out in column 2.

(2) Whole blood and its components are excluded from the drugs and categories of drugs set out in column 2 of the table to this section.

(3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the table to this section.

TABLE

DESIGNATED REGULATORY AUTHORITIES

Column 1 Column 2 Column 3

Item Regulatory authority Drug or category ofdrugs Activities

1. Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland

Pharmaceuticals for human or veterinary use Drugs listed in

Fabricating, packaging/labelling, testing

Column 1 Column 2 Column 3 Drug or category ofItem Regulatory authority Activitiesdrugs Schedules C and D to the Act Pharmaceuticals for human or veterinaryRegional Medicines Inspectorate of Fabricating,use2. Northwestern Switzerland (RFS-NW), packaging/labelling, Drugs listed inBasel, Switzerland testing Schedules C and D to the Act Pharmaceuticals for human or veterinaryRegional Medicines Inspectorate of Fabricating,use3. Eastern and Central Switzerland (RFS- packaging/labelling, Drugs listed inOZ), Zurich, Switzerland testing Schedules C and D to the Act Pharmaceuticals for human or veterinaryRegional Medicines Inspectorate of Fabricating,use4. Southern Switzerland (RFS-S), packaging/labelling, Drugs listed inTicino, Switzerland testing Schedules C and D to the Act Pharmaceuticals for human or veterinaryRegional Medicines Inspectorate of Fabricating,use5. Western Switzerland (RFS-W), packaging/labelling, Drugs listed inLausanne, Switzerland testing Schedules C and D to the Act

SOR/97-12, s. 5; SOR/2000-120, s. 7; SOR/2002-368, s. 8.

Division 2

Good Manufacturing Practices C.02.001. [Repealed, SOR/97-12, s. 5.1]

C.02.002. In this Division,

“drug”[Repealed, SOR/97-12, s. 6]

“importer”[Repealed, SOR/97-12, s. 6]

“medical gas” means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

“packaging material” includes a label; (matériel d’emballage)

“produce”[Repealed, SOR/97-12, s. 6]

“quality control department”[Repealed, SOR/2010-95, s. 1]

“specifications” means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

(a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

(b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

(c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

SOR/82-524, s. 3; SOR/85-754, s. 1; SOR/89-174, s. 1; SOR/97-12, s. 6; SOR/2010-95, s. 1. Previous Version C.02.002.1. This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

SOR/2004-282, s. 3.

Sale

C.02.003. No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

SOR/82-524, s. 3; SOR/97-12, s. 7; SOR/2000-120, s. 8; SOR/2010-95, s. 2(F). Previous Version

Premises

C.02.004. The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that

(a) permits the operations therein to be performed under clean, sanitary and orderly conditions;

(b) permits the effective cleaning of all surfaces therein; and

(c) prevents the contamination of the drug and the addition of extraneous material to the drug.

SOR/82-524, s. 3; SOR/97-12, s. 8; SOR/2010-95, s. 3. Previous Version

Equipment

C.02.005. The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that

(a) permits the effective cleaning of its surfaces;

(b) prevents the contamination of the drug and the addition of extraneous material to the drug; and

(c) permits it to function in accordance with its intended use.

SOR/82-524, s. 3; SOR/97-12, s. 9.

Personnel

C.02.006. Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser.

SOR/82-524, s. 3; SOR/85-754, s. 2; SOR/97-12, s. 52.

Sanitation

C.02.007. (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

(2) The sanitation program referred to in subsection (1) shall include

(a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and

(b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.

SOR/82-524, s. 3; SOR/97-12, ss. 10, 53.

C.02.008. (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.

(2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person

(a) is affected with or is a carrier of a disease in a communicable form; or

(b) has an open lesion on any exposed surface of the body.

SOR/82-524, s. 3; SOR/97-12, s. 11.

Raw Material Testing

C.02.009. (1) Each lot or batch of raw material shall be tested against the specifications for that raw material prior to its use in the fabrication of a drug.

(2) No lot or batch of raw material shall be used in the fabrication of a drug unless that lot or batch of raw material complies with the specifications for that raw material.

(3) Notwithstanding subsection (1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug.

(4) Where any property of a raw material is subject to change on storage, no lot or batch of that raw material shall be used in the fabrication of a drug after its storage unless the raw material is retested after an appropriate interval and complies with its specifications for that property.

(5) Where the specifications referred to in subsections (1), (2) and (4) are not prescribed, they shall

(a) be in writing;

(b) be acceptable to the Director who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and

(c) be approved by the person in charge of the quality control department.

SOR/82-524, s. 3; SOR/97-12, s. 59.

C.02.010. (1) The testing referred to in section C.02.009 shall be performed on a sample taken

(a) after receipt of each lot or batch of raw material on the premises of the fabricator; or

(b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if

(i) the fabricator

(A) has evidence satisfactory to the Director to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and

(B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and

(ii) the raw material has not been transported or stored under conditions that may affect its compliance with the specifications for that raw material.

(2) After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity.

SOR/82-524, s. 3; SOR/97-12, ss. 12, 60.

Manufacturing Control

C.02.011. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug.

(2) Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures.

SOR/82-524, s. 3; SOR/97-12, s. 13.

C.02.012. (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain

(a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and

(b) a program of self-inspection.

(2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system designed to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.

(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsection (2) in respect of that drug.

(4) If a drug is fabricated or packaged/labelled in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of the drug is not required to comply with the requirements of subsection (2) in respect of that activity for that drug if

(a) the address of the building is set out in that person’s establishment licence; and

(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.

SOR/82-524, s. 3; SOR/97-12, s. 13; SOR/2000-120, s. 9; SOR/2002-368, s. 9.

Quality Control Department

C.02.013. (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

(2) Except in the case of a wholesaler, the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, s. 55; SOR/2000-120, s. 10; SOR/2010­ 95, s. 4. Previous Version C.02.014. (1) Except in the case of a wholesaler, no lot or batch of a drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.

(2) A drug that is returned to the fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.

(3) No lot or batch of raw material or of packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the material is approved for that use by the person in charge of the quality control department.

(4) No lot or batch of a drug shall be reprocessed without the approval of the person in charge of the quality control department.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, ss. 14, 55; SOR/2010-95, s. 5. Previous Version C.02.015. (1) All fabrication, packaging/labelling, testing, storage and transportation methods and procedures that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation.

(2) The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control.

(2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity.

(3) The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory.

SOR/82-524, s. 3; SOR/97-12, s. 15; SOR/2010-95, s. 6. Previous Version

Packaging Material Testing

C.02.016. (1) Each lot or batch of packaging material shall, prior to its use in the packaging of a drug, be examined or tested against the specifications for that packaging material.

(2) No lot or batch of packaging material shall be used in the packaging of a drug unless the lot or batch of packaging material complies with the specifications for that packaging material.

(3) The specifications referred to in subsections (1) and (2) shall

(a) be in writing;

(b) be acceptable to the Director who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and

(c) be approved by the person in charge of the quality control department.

SOR/82-524, s. 3; SOR/89-174, s. 8(F).

C.02.017. (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken

(a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or

(b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if

(i) that person

(A) has evidence satisfactory to the Director to demonstrate that packaging materials sold to him by the vendor of that lot or batch of packaging material are consistently manufactured in accordance with and consistently comply with the specifications for those packaging materials, and

(B) undertakes periodic complete confirmatory examination or testing with a frequency satisfactory to the Director,

(ii) the packaging material has not been transported or stored under conditions that may affect its compliance with the specifications for that packaging material.

(2) After a lot or batch of packaging material is received on the premises of the person who packages a drug,

(a) the lot or batch of the packaging material shall be examined or tested for identity; and

(b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels.

SOR/82-524, s. 3; SOR/89-174, ss. 2(F), 8(F); SOR/97-12, s. 56(F).

Finished Product Testing

C.02.018. (1) Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug.

(2) No lot or batch of a drug shall be available for sale unless it complies with the specifications for that drug.

(3) The specifications referred to in subsections (1) and (2) shall

(a) be in writing;

(b) be approved by the person in charge of the quality control department; and

(c) comply with the Act and these Regulations.

SOR/82-524, s. 3.

C.02.019. (1) Subject to subsections (3) and (4), in the case of a packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer, the testing referred to in section C.02.018 shall be performed on a sample taken

(a) after receipt of each lot or batch of the drug on the premises in Canada of the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of the drug; or

(b) subject to subsection (2), before receipt of each lot or batch of the drug on the premises described in paragraph (a), if

(i) the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer

(A) has evidence satisfactory to the Director to demonstrate that drugs sold to him by the vendor of that lot or batch of the drug are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and

(B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and

(ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(2) Where the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of a drug receives a lot or batch of the drug on their premises in Canada, and the useful life of the drug is more than 30 days, the lot or batch shall be tested for identity, and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.

(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsections (1) and (2) in respect of that drug.

(4) If a drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of that drug is not required to comply with the requirements of subsections (1) and (2) in respect of that drug if

(a) the address of the building is set out in that person’s establishment licence; and

(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, ss. 16, 57; SOR/2000-120, s. 11; SOR/2002-368, s. 10.

Records

C.02.020. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain on their premises in Canada, for each drug sold,

(a) master production documents for the drug;

(b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;

(c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;

(d) evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug; and

(e) adequate evidence of the testing referred to in section C.02.018.

(2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Director, on request, the results of testing performed on raw materials and packaging/labelling material for each lot or batch of a drug sold.

(3) Every fabricator shall maintain on his premises

(a) the written specifications for the raw material; and

(b) adequate evidence of the testing of the raw materials referred to in section C.02.009.

(4) Every person who packages a drug shall maintain on his premises

(a) the written specifications for the packaging material; and

(b) adequate evidence of the packaging material examination or testing referred to in section C.02.016.

(5) Every fabricator shall maintain on their premises in Canada

(a) detailed plans and specifications of each building in Canada at which they fabricate, package/label or test; and

(b) a description of the design and construction of those buildings.

(6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each person’s title, responsibilities, qualifications, experience and training.

SOR/82-524, s. 3; SOR/89-174, ss. 3(F), 8(F); SOR/97-12, ss. 17, 52, 60.

C.02.021. (1) Subject to subsection (2), all records and evidence on the fabrication, packaging/labelling, testing and storage of a drug that are required to be maintained under this Division shall be retained for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the person’s establishment licence.

(2) All records and evidence on the testing of raw materials and packaging/labelling materials that are required to be maintained under this Division shall be retained for a period of at least five years after the materials were last used in the fabrication or packaging/labelling of a drug, unless otherwise specified in the person’s establishment licence.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/92-654, s. 6; SOR/97-12, s. 18.

C.02.022. Every distributor referred to in section C.01A.003, wholesaler and importer of a drug shall retain records of the sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for a period of at least one year after the expiration date of that lot or batch, unless otherwise specified in their establishment licence.

SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18.

C.02.023. (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall

(a) in the case of a complaint or information described in subsection C.02.015(2), make a record of the complaint or information, its investigation and, if applicable, any corrective action taken; and

(b) in the case of a complaint or information described in subsection C.02.015(2.1), make a record of the complaint or information, the name and business address of the person in charge of the quality control department to whom it was forwarded and the date on which it was forwarded.

(2) The fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall retain the record for a period of at least one year after the expiration date of the lot or batch of that drug, unless their establishment licence specifies otherwise.

SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18; SOR/2010-95, s. 7. Previous Version C.02.024. (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall

(a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and

(b) retain those records for a period of at least three years.

(2) Every person who fabricates or packages/labels a drug shall

(a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and

(b) retain those records for a period of at least three years.

SOR/82-524, s. 3; SOR/97-12, ss. 19, 53.

Samples

C.02.025. (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the distributor’s or importer’s establishment licence.

(2) The fabricator shall retain a sample of each lot or batch of raw materials used in the fabrication of a drug for a period of at least two years after the materials were last used in the fabrication of the drug, unless otherwise specified in the fabricator’s establishment licence.

SOR/82-524, s. 3; SOR/89-174, s. 4(F); SOR/92-654, s. 8; SOR/97-12, s. 20.

C.02.026. The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.

SOR/82-524, s. 3.

Stability

C.02.027. Every distributor referred to in paragraph C.01A.003(b) and importer shall establish the period of time during which each drug in the package in which it is sold will comply with the specifications.

SOR/82-524, s. 3; SOR/97-12, s. 58.

C.02.028. Every distributor referred to in paragraph C.01A.003(b) and importer shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

SOR/82-524, s. 3; SOR/97-12, s. 58.

Sterile Products

C.02.029. In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled

(a) in separate and enclosed areas;

(b) under the supervision of personnel trained in microbiology; and

(c) by a method scientifically proven to ensure sterility.

SOR/82-524, s. 3; SOR/97-12, s. 21.

Medical Gases

C.02.030. The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases.

SOR/85-754, s. 3.

Division 3 Schedule C Drugs

C.03.001. In this Division,

“drug” means a drug listed in Schedule C to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act that is of biological origin; (drogue)

“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 22]

“manufacturer”[Repealed, SOR/97-12, s. 22]

“master lot” means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; (maître-lot)

“radionuclide generator” means a radioactive parent and daughter

(a) contained in an ion-exchange column, or

(b) dissolved in a suitable solvent in a liquid-liquid extraction system

where the radioactive daughter is separated from its parent by

(c) elution from the ion exchange column, or

(d) a solvent extraction procedure. (générateur de radionucléide)

SOR/97-12, s. 22.

C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

SOR/97-12, s. 23.

C.03.002. to C.03.005. [Repealed, SOR/97-12, s. 24]

C.03.006. [Repealed, SOR/97-12, s. 67]

C.03.007. to C.03.011 [Repealed, SOR/97-12, s. 26]

C.03.012. On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations.

SOR/97-12, s. 27.

C.03.013. No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease.

SOR/97-12, s. 27.

C.03.014. (1) Section C.01.004 does not apply to a drug.

(2) and (3) [Repealed, SOR/97-12, s. 28]

SOR/79-236, s. 1; SOR/93-202, s. 15; SOR/97-12, s. 28.

C.03.015. Every package of a drug listed or described in Schedule F in the Regulations, other than

(a) a drug sold to a drug fabricator,

(b) a drug dispensed pursuant to a prescription,

(c) a radiopharmaceutical as defined in section C.03.201, or

(d) a component or kit as defined in section C.03.205,

shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.

SOR/80-543, s. 9; SOR/97-12, s. 61; SOR/2001-181, s. 4.

C.03.030. to C.03.045. [Repealed, SOR/81-335, s. 2]

Radiopharmaceuticals

C.03.201. In these Regulations, “radiopharmaceutical” means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons.

SOR/97-12, s. 29.

C.03.202. (1) Every package containing a radiopharmaceutical, other than a radionuclide generator, shall carry,

(a) on both the inner and the outer labels,

(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name,

(ii) the name of the distributor referred to in paragraph C.01A.003(b), and

(iii) the lot number; and

(b) on the outer label

(i) the address of the distributor referred to in paragraph C.01A.003(b),

(ii) the standard that the drug professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act,

(iii) a statement of the pharmaceutical form or the route of administration of the drug,

(iv) a statement of the recommended use and the recommended radioactivity to be administered for that use, or a reference to an accompanying package insert that shows such information,

(v) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,

(vi) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution — Radioactive Material” “Attention — Produit radioactif”,

(vii) the names and a statement of the amounts of any preservatives or stabilizing agents contained in the drug,

(viii) the names and a statement of the amounts of all other non-radioactive contents of the drug,

(ix) a statement of the total radioactivity content of the drug including overfill,

(x) a statement of the total volume of the drug including overfill, except where its contents are entirely in gaseous, capsule or lyophilized form,

(xi) a statement of the concentration of radioactive material in the drug expressed as

(A) units of radioactivity per capsule or

(B) units of radioactivity per unit volume,

except where the contents of the drug are entirely in gaseous or lyophilized form,

(xii) a statement of the specific activity of the drug expressed as units of radioactivity per unit weight of carrier present or the statement “carrier-free” or “sans entraîneur”, whichever is applicable,

(xiii) a statement of the reference time in respect of the radioactivity values mentioned in subparagraphs (ix), (xi) and (xii), the name of the month being written or designated by letter abbreviation,

(xiv) a statement of the recommended useful life or the date after which the drug is not recommended for use, the name of the month being written or designated by letter abbreviation, and

(xv) a statement of the special storage requirements with reference to temperature and light.

(2) [Repealed, SOR/2001-203, s. 2]

(3) Subparagraph (1)(b)(viii) of this section does not apply where the information referred to in that subparagraph is shown on a package insert that accompanies the drug.

(4) Section C.01.005 does not apply to a radiopharmaceutical.

SOR/79-236, s. 2; SOR/93-202, s. 16; SOR/97-12, ss. 54, 58, 62; SOR/2001-203, s. 2.

C.03.203. (1) Every radionuclide generator shall carry on the inner label

(a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name;

(b) the name and address of the distributor referred to in paragraph C.01A.003(b);

(c) the lot number;

(d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act;

(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

(f) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution — Radioactive Material” “Attention — Produit radioactif”;

(g) a statement of the total parent radioactivity contained in the radionuclide generator;

(h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation;

(i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation;

(j) a statement of the recommended useful life of the drug after removal from the radionuclide generator;

(k) a statement of special storage requirements with reference to temperature or shielding;

(l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and

(m) a statement cautioning against the dismantling of the radionuclide generator.

(2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator.

SOR/79-236, s. 3; SOR/93-202, s. 17; SOR/97-12, ss. 54, 58, 62.

C.03.204. (1) No person shall sell a drug containing technetium-99m at any time during the useful life of the drug if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.

(2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc­ 99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.

SOR/97-12, s. 30.

Drugs, other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals

C.03.205. For the purposes of sections C.03.206 to C.03.209,

“component” means

(a) a unit of a drug, other than a radionuclide, separately packaged in a kit for use in the preparation of a radiopharmaceutical, or

(b) an empty vial or other accessory item in a kit; (constituants)

“kit” means a package

(a) that contains one or more separately packaged units of a drug, other than a radionuclide, and

(b) that may contain empty vials or other accessory items, for use in the preparation of radiopharmaceuticals. (trousse)

SOR/79-236, s. 4.

C.03.206. Sections C.01.005 and C.04.019 do not apply to a component or kit.

SOR/79-236, s. 4.

C.03.207. Every component shall be labelled to show

(a) adequate identification of the component and an adequate description of its function;

(b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;

(c) the name of the distributor referred to in paragraph C.01A.003(b);

(d) the lot number;

(e) a statement of any special storage requirements with respect to temperature and light;

(f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and

(g) adequate directions for use or a reference to the accompanying package insert that shows such directions.

SOR/79-236, s. 4; SOR/97-12, s. 58.

C.03.208. Every kit shall be labelled to show

(a) its proper name;

(b) its brand name, if any;

(c) a list of its contents;

(d) the name and address of the distributor referred to in paragraph C.01A.003(b);

(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

(f) the lot number;

(g) a statement of any special storage requirements with respect to temperature and light;

(h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation;

(i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component;

(j) a statement of the sterility and apyrogenicity of the components;

(k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions;

(l) a statement of the duration of the useful life of the prepared radiopharmaceutical;

(m) a statement of the storage requirements for the prepared radiopharmaceutical;

(n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and

(o) a statement of the route of administration of the prepared radiopharmaceutical.

(p) [Repealed, SOR/2001-203, s. 3]

SOR/79-236, s. 4; SOR/93-202, s. 18; SOR/97-12, ss. 58, 62; SOR/2001-203, s. 3.

C.03.209. A package insert shall be included in every kit and shall show

(a) the proper name and the brand name, if any, of the kit and a description of its use;

(b) a list of the contents of the kit;

(c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit;

(d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;

(e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

(f) a statement of the duration of the useful life of the prepared radiopharmaceutical;

(g) a description of the biological actions of the prepared radiopharmaceutical;

(h) indications and contraindications in respect of the prepared radiopharmaceutical;

(i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;

(j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;

(k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;

(l) the radiation dosimetry in respect of the prepared radiopharmaceutical;

(m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;

(n) a statement of the route of administration of the prepared radiopharmaceutical; and

(o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.

SOR/79-236, s. 4; SOR/93-202, s. 19; SOR/97-12, s. 58.

Division 4 Schedule D Drugs

C.04.001. In this Division,

“date of manufacture” means

(a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test,

(b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and

(c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication)

“drug” means a drug listed in Schedule D to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule D to the Act; (drogue)

“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 31]

“manufacturer” [Repealed, SOR/97-12, s. 31]

SOR/97-12, s. 31.

C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

SOR/97-12, s. 32.

C.04.002. This Division does not apply to a drug in oral dosage form that contains micro­ organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.

SOR/97-12, s. 33.

C.04.003. The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than

(a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;

(b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or

(c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.

C.04.004. to C.04.006. [Repealed, SOR/97-12, s. 34]

C.04.007. [Repealed, SOR/97-12, s. 67]

C.04.008. to C.04.012 [Repealed, SOR/97-12, s. 36]

C.04.013. Every fabricator and packager/labeller shall safely segregate all work with spore- bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.

SOR/97-12, s. 63.

C.04.014. No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.

SOR/97-12, s. 37.

C.04.015. On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.

SOR/97-12, s. 37.

C.04.016. All animals from which drugs are prepared and preserved shall be

(a) under the direct supervision of competent medical or veterinary personnel;

(b) kept in quarantine by the fabricator for at least seven days before use; and

(c) healthy and free from infectious disease.

SOR/97-12, s. 38.

C.04.017. A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.

SOR/97-12, s. 61.

C.04.018. A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.

SOR/97-12, s. 61.

C.04.019. The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry

(a) on both the inner and the outer labels

(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,

(ii) the name of the distributor referred to in paragraph C.01A.003(b),

(iii) the potency of the drug, where applicable,

(iv) the recommended dose of the drug,

(v) the lot number,

(vi) the expiration date except upon the inner label of a single-dose container, and

(vii) adequate direction for use; and

(b) on the outer label

(i) the address of the distributor referred to in paragraph C.01A.003(b),

(ii) for whole blood and its components, the establishment licence number of the distributor referred to in paragraph C.01A.003(b), preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,

(iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,

(iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required,

(v) a statement of the net contents in terms of weight, measure, or number, and

(vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.

SOR/78-424, s. 7; SOR/93-202, s. 21; SOR/97-12, ss. 39, 54, 58; SOR/2011-88, s. 6. Previous Version C.04.020. Except in the case of the following drugs, every package of a drug listed in Schedule F of these Regulations shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label:

(a) a drug sold to a person who holds an establishment licence; and

(b) a drug dispensed pursuant to a prescription.

SOR/80-543, s. 10; SOR/97-12, s. 40; SOR/2001-181, s. 4.

Bacterial Vaccines, Products Analogous to Bacterial Vaccines

C.04.050. Except as provided in this Division, a bacterial vaccine shall be a sterile suspension of killed cultures of bacteria, with or without the addition of other medication, and shall not include an autogenous vaccine.

C.04.051. No person shall sell a bacterial vaccine unless the culture that has been used in its preparation has been tested by an acceptable method for identity and purity and when so tested it shall be true to name and a pure strain, and a record of the culture shall be maintained which shall include a statement of its origin, properties and characteristics.

C.04.052. No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum.

SOR/97-12, s. 61.

C.04.053. A fabricator of a bacterial vaccine prepared from a bacterium that does not grow readily in ordinary culture media shall test its sterility in media which are specially favourable to the growth of such bacterium, and it shall be sterile.

SOR/97-12, s. 61.

C.04.054. Except as provided in sections C.04.083, C.04.084 and C.04.090, both the inner and outer labels of every multiple-dose container and the outer label of every single-dose container of a bacterial vaccine shall carry a statement of

(a) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre,

(b) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, of each species or immunogenic type for a vaccine that contains a number of different species or immunogenic types of bacteria,

(c) the exact nature and amount of any substance, other than a simple diluent, combined with such vaccine, and

(d) the recommended dose,

and the inner label of a single-dose container shall carry a statement that it contains only one dose.

C.04.055. The expiration date of a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue.

Typhoid Vaccine

C.04.060. Cultures of Salmonella typhosa used in the preparation of typhoid vaccine shall be smooth, motile, and in the Vi form, with the following antigenic structure IX,XII,Vi; d.-.

C.04.061. No person shall sell any lot of typhoid vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.

Pertussis Vaccine

C.04.065. A fabricator shall, in the preparation of pertussis (whooping cough) vaccine, use only strains of Bordetella pertussis that meet the requirements of an antigenic test made by an acceptable method.

SOR/90-217, s. 1; SOR/97-12, s. 61.

C.04.066. No person shall sell any lot of pertussis (whooping cough) vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.

B.C.G. (Bacille Calmette-Guerin) Vaccine

C.04.070. B.C.G. vaccine shall be prepared from living B.C.G. organisms that

(a) have been obtained directly from a source approved by the Director;

(b) are proved to be non-pathogenic by an acceptable method; and

(c) have a history of successful use in the production of B.C.G. vaccine.

C.04.071. No fabricator shall employ any person in the manufacture of B.C.G. vaccine unless such person

(a) has been and remains free from all forms of tuberculous infection,

(b) undergoes every six months a medical examination, that shall include an X-ray examination of the chest, for the presence of tuberculosis, such examination being made by a qualified, practising physician who shall sign a certificate of such person’s freedom from tuberculosis, and such certificate shall be kept on file and be available at all times, and

(c) resides in a household that is at all times free from active tuberculosis,

nor shall a fabricator employ such person in any other laboratory position.

SOR/97-12, s. 61.

C.04.072. The preparation, preservation and packaging/labelling of B.C.G. vaccine shall be conducted under the direct supervision of an experienced bacteriologist who has

(a) not less than three years postgraduate training in bacteriology and immunology;

(b) specialized in the field of bacteriology; and

(c) at least one year of practical experience in the manufacture of B.C.G. vaccine.

SOR/97-12, s. 41.

C.04.073. No fabricator shall permit any culture that is not a B.C.G. culture to be at any time on any premises that are used for the manufacture of B.C.G. vaccine.

SOR/97-12, s. 61.

C.04.074. A packager/labeller shall test by an acceptable method, after filling of the final container, each lot of B.C.G. vaccine for the presence of contaminating micro-organisms and when so tested it shall be free therefrom.

SOR/97-12, s. 65.

C.04.075. Notwithstanding section C.04.074, a fluid B.C.G. vaccine may be released for sale if no growth has appeared upon the test culture medium after an incubation of 24 hours, but if there is evidence of the presence of contaminating micro-organisms in any lot during the test period of 10 days the packager/labeller shall at once recall such lot.

SOR/97-12, s. 65.

C.04.076. Every fabricator and packager/labeller shall determine the number of viable B.C.G. organisms in each lot of vaccine by an acceptable method and shall keep a record of the number.

SOR/97-12, s. 63.

C.04.077. A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months,

(a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and

(b) not less than six vials of the final product

from each lot thereof.

SOR/97-12, s. 61.

C.04.078. Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans.

SOR/97-12, s. 63.

C.04.079. A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals.

SOR/97-12, s. 61.

C.04.080. The expiration date for B.C.G. vaccine shall be not more than

(a) 10 days after harvesting in the case of fluid vaccine;

(b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or

(c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C.

C.04.081. No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.

C.04.082. No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.

C.04.083. The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

(a) the weight of bacteria per millilitre; and

(b) the route of administration of the vaccine.

C.04.084. The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

(a) the amount of bacteria per vial or per dose; and

(b) the route of administration of the vaccine.

C.04.085. The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.

Products Analogous to Bacterial Vaccines

C.04.090. A product analogous to a bacterial vaccine shall be

(a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or

(b) an extract prepared from a bacterial culture,

and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054.

C.04.091. The expiration date of a product analogous to a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue, but for dried tuberculin and tuberculin containing at least 50 per cent glycerin the expiration date shall be not later than five years after the date of manufacture or the date of issue, and for all other tuberculins not more than 12 months after the date of manufacture or the date of issue.

Virus and Rickettsial Vaccines

C.04.100. A virus vaccine, rickettsial vaccine, shall be a suspension of, or prepared from, living or killed viruses or rickettsiae.

C.04.101. No person shall sell a virus or a rickettsial vaccine unless the fabricator has submitted to the Minister details of the source of the strains of viruses or rickettsiae used, the method of their propagation, the method of fabrication of the vaccine, the methods employed for determining sterility, safety, identity and potency and any other tests required by these Regulations.

SOR/95-411, s. 2; SOR/97-12, s. 42.

C.04.102. Upon written request from the Director every fabricator and packager/labeller shall submit with respect to each lot of virus or rickettsial vaccine, when ready for sale, detailed protocols of sterility, safety, identity, potency, and of any other tests required by these Regulations.

SOR/97-12, s. 63.

Smallpox Vaccine

C.04.110. Smallpox vaccine

(a) shall be a virus vaccine;

(b) shall be the living virus of vaccinia or its derivatives obtained from

(i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus,

(ii) specifically infected membranes of chick embryos, or

(iii) suitable tissue culture infected with vaccinia virus or its derivatives; and

(c) shall be in fluid or dried form.

SOR/2006-2, s. 1.

C.04.111. Every fabricator and packager/labeller shall fabricate and package/label smallpox vaccine only in an independent unit that is isolated from all other laboratory activities, and in or about which no extraneous materials are permitted or stored.

SOR/97-12, s. 43.

C.04.112. A fabricator shall exclude the personnel who care for the vaccine animals from horse stables and paddocks and from contact with horses while smallpox vaccine is being propagated.

SOR/97-12, s. 61.

C.04.113. Every fabricator and packager/labeller shall dispense smallpox vaccine only in sterile glass containers that are sealed under aseptic conditions.

SOR/97-12, s. 63.

C.04.114. Every fabricator and packager/labeller shall test smallpox vaccine to establish that it is free from

(a) spore-forming anaerobic micro-organisms;

(b) coagulase positive staphylococci;

(c) haemolytic streptococci; and

(d) any other contaminating pathogenic micro-organisms.

SOR/97-12, s. 63.

C.04.115. Smallpox vaccine, when tested by acceptable methods,

(a) shall be free from extraneous micro-organisms, in the case of vaccine prepared for use by jet gun; and

(b) shall contain not more than 500 viable non-pathogenic bacteria per millilitre, in the case of vaccine prepared for use by the multiple pressure technique or by scarification.

C.04.116. Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that

(a) is known to prevent human to human transmission of smallpox; and

(b) meets the potency of equal to or greater than 108 pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes.

SOR/2006-2, s. 2.

C.04.117. No person shall sell smallpox vaccine unless

(a) in the case of fluid vaccine, it has been stored at a temperature below -10°C;

(b) in the case of dried vaccine, it has been stored at a temperature below 10°C; and

(c) the outer label carries a statement that it shall be stored at a temperature of not more than 5°C.

SOR/97-12, s. 44.

C.04.118. Notwithstanding the provisions of section C.04.003, the date of issue of smallpox vaccine shall be not later than

(a) in the case of fluid vaccine, nine months after the date of manufacture; and

(b) in the case of dried vaccine, 24 months after the date of manufacture.

C.04.119. The expiration date of smallpox vaccine shall not exceed the following, unless supported by evidence of stability satisfactory to the Minister:

(a) in the case of fluid vaccine, 3 months after the date of issue; or

(b) in the case of dried vaccine, 12 months after the date of issue.

SOR/2006-2, s. 3.

C.04.120. No inner label shall be required for smallpox vaccine in single-dose containers or when dispensed in capillary tubes.

C.04.121. No person shall sell smallpox vaccine to which an antibiotic has been added.

Poliomyelitis Vaccine

C.04.122. Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III.

C.04.123. Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency.

C.04.124. Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.

C.04.125. No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.

C.04.126. The outer label shall carry a statement of any antibiotic present in the vaccine.

C.04.127. The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Director, is presented that a longer period is appropriate.

SOR/85-715, s. 6.

Poliovirus Vaccine, Live, Oral

C.04.128. Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that

(a) have been obtained directly from a source acceptable to the Director;

(b) are shown to be genetically stable by an acceptable method;

(c) are shown to be non-pathogenic when given orally to humans;

(d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and

(e) have a history of successful use in the production of polio-virus vaccine, live, oral.

C.04.129. Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains not employed in the fabrication, packaging/labelling and testing of poliovirus vaccine, live, oral, are carried out.

SOR/97-12, s. 45.

C.04.130. No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral.

SOR/97-12, s. 61.

C.04.131. Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if

(a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and

(b) the fabricator has received written permission from the Director to carry out such manufacture.

SOR/97-12, s. 61.

C.04.132. Poliovirus vaccine, live, oral shall be prepared only

(a) in a tissue culture,

(b) in a medium, and

(c) by methods

acceptable to the Director.

C.04.133. No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom.

SOR/97-12, s. 61.

C.04.134. A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Director, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Director.

SOR/97-12, s. 61.

C.04.135. No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person

(a) is free from infectious disease;

(b) has been vaccinated successfully against poliomyelitis by poliovirus vaccine, live, oral; and

(c) has been proved by periodic tests to be a non-carrier of poliomyelitis virus.

SOR/97-12, s. 61.

C.04.136. A fabricator of poliovirus vaccine, live, oral shall not permit the entry to a building in which the vaccine is manufactured of any person who

(a) is not directly concerned with the manufacturing processes; or

(b) has been working on the same day with experimental animals or with infectious agents.

SOR/97-12, s. 61.

Bacteriophage

C.04.137. Bacteriophage shall be a virus preparation with specific lytic action against micro­ organisms actually or potentially pathogenic.

C.04.138. The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue.

Toxins, Toxoids

Schick Test Reagents

C.04.140. Schick test reagents for the diagnosis of susceptibility to diphtheria shall be

(a) diphtheria toxin for Schick test;

(b) Schick control; and

(c) diphtheria toxin for Schick test with control.

C.04.141. Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method.

C.04.142. Schick control shall be suitably diluted

(a) diphtheria toxoid; or

(b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes.

C.04.143. The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by

(a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and

(b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.

C.04.144. The human test dose of diphtheria toxin for Schick test, when fresh toxin containing no preservative is used, shall be determined by

(a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction, but mixed with 1/1,500 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and

(b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/100 of one test dose must not cause, and 1/50 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.

C.04.145. The human test dose for the Schick control shall give a negative Schick reaction when injected intracutaneously into normal guinea pigs.

C.04.146. No person shall sell diphtheria toxin for Schick test unless both the inner and the outer labels carry a statement of the number of human test doses it contains together with the name of any stabilizer.

C.04.147. The expiration date of Schick test reagents for the diagnosis of susceptibility to diphtheria shall be not later than 12 months after the date of manufacture or the date of issue.

Diphtheria Toxoid

C.04.160. Liquid diphtheria toxoid shall be sterile, formalized, detoxified diphtheria toxin and shall not contain more than 0.02 per cent free formaldehyde.

C.04.161. Diphtheria toxoid alum precipitated shall be prepared from diphtheria toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C.04.162. The alum used in the preparation of diphtheria toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO4)2,12H2O.

C.04.163. No fabricator shall use a culture medium for the production of diphtheria toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.

SOR/97-12, s. 61.

C.04.164. Diphtheria toxin from which diphtheria toxoid is prepared shall have a toxicity, as indicated by an L+dose, of not more than 0.20 millilitre or by an M.L.D. of not more than 0.0025 millilitre.

C.04.165. A fabricator shall test each bulk container of diphtheria toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non­ toxic.

SOR/97-12, s. 61.

C.04.166. No person shall sell any lot of diphtheria toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.

C.04.167. A fabricator shall fill diphtheria toxoid aseptically into clear glass containers and where preservative is not added shall seal the containers by fusion.

SOR/97-12, s. 61.

C.04.168. No person shall sell diphtheria toxoid that contains phenol.

C.04.169. No person shall sell diphtheria toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.

C.04.170. The expiration date of diphtheria toxoid shall be not later than two years after the date of manufacture or the date of issue.

Tetanus Toxoid

C.04.180. Liquid tetanus toxoid shall be sterile, formalized, detoxified tetanus toxin, and shall not contain more than 0.02 per cent free formaldehyde.

C.04.181. Tetanus toxoid alum precipitated shall be prepared from tetanus toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C.04.182. The alum used in the preparation of tetanus toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO4)2, 12H2O.

C.04.183. No fabricator shall use a culture medium for the production of tetanus toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.

SOR/97-12, s. 61.

C.04.184. Tetanus toxin from which tetanus toxoid is prepared shall have a toxicity as indicated by an M.L.D. for the guinea pig of not more than 0.0001 millilitre.

C.04.185. A packager/labeller shall test each bulk container of tetanus toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non­ toxic.

SOR/97-12, s. 65.

C.04.186. No person shall sell any lot of tetanus toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.

C.04.187. No person shall sell tetanus toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.

C.04.188. A fabricator shall fill tetanus toxoid aseptically into clear glass containers and where a preservative is not added shall seal the container by fusion.

SOR/97-12, s. 61.

C.04.189. No person shall sell tetanus toxoid that contains phenol.

C.04.190. The expiration date of tetanus toxoid shall be not later than two years after the date of manufacture or the date of issue.

Antitoxins, Antisera

C.04.210. An antitoxin or antiserum shall be the serum or fraction thereof separated from the blood of animals that have been artificially immunized against the by-products or antigenic fractions of specific cultures of micro-organisms, or against specific venoms.

C.04.211. The potency of an antitoxin or antiserum shall be determined by an acceptable method and where applicable the unit of potency shall be the International Unit.

C.04.212. Liquid diphtheria antitoxin shall have a potency of not less than 500 International Units per millilitre.

C.04.213. Liquid tetanus antitoxin shall have a potency of not less than 400 International Units per millilitre.

C.04.214. A liquid antitoxin or antiserum shall contain not more than 20 per cent solids.

C.04.215. A dried antitoxin shall be prepared from a liquid antitoxin and, when reconstituted to the original volume of the liquid antitoxin, shall have a potency not less than that prescribed for such liquid antitoxin.

C.04.216. A dried antitoxin or antiserum shall not contain more than one per cent moisture when determined by an acceptable method.

C.04.217. Each lot of antitoxin or antiserum shall be tested by an acceptable method for pyrogenicity and it shall be pyrogen-free, and, after filling into the final containers, for identity and it shall be true to name.

C.04.218. No person shall sell an antitoxin or antiserum unless both the inner and the outer labels carry a statement of the species of animal used, when other than the horse, and the net contents in millilitres or the number of units in the container.

C.04.219. In respect of antitoxins, the expiration date shall be

(a) for liquid antitoxins with standards of potency, not later than five years after the date of manufacture;

(b) for dried antitoxins with standards of potency, not later than five years after the date of manufacture;

(c) for liquid antioxins with no standards of potency, not later than 12 months after the date of manufacture; and

(d) for dried antitoxins with no standards of potency, not later than five years after the date of manufacture.

C.04.220. In respect of antisera, the expiration date shall be

(a) for liquid antisera with standards of potency, not later than three years after the date of manufacture;

(b) for dried antisera with standards of potency, not later than five years after the date of manufacture;

(c) for liquid antisera with no standards of potency, not later than 12 months after the date of manufacture; and

(d) for dried antisera with no standards of potency, not later than five years after the date of manufacture.

Preparations from Human Sources

C.04.230. Preparations from human sources shall be pooled blood plasma, or pooled blood serum, or fractions of either separated by a method satisfactory to the Minister.

C.04.231. A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy.

SOR/97-12, s. 61.

C.04.232. A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria.

SOR/97-12, s. 61.

C.04.233. The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator.

SOR/97-12, s. 61.

C.04.234. A fabricator shall obtain human placenta and cord used in the manufacture of preparations from human sources only from women confined in public hospitals, and the donor of such placenta and cord shall have been free from the toxaemias of pregnancy, and the placenta and cord shall not show gross evidence of any pathological condition.

SOR/97-12, s. 61.

C.04.235. (1) Subject to subsections (2) and (3), dried human serum, dried human plasma or dried fractions of either shall not contain more than one per cent moisture when determined by an acceptable method.

(2) Dried Rho(D) Immune Human globulin shall not contain more than three per cent moisture when determined by an acceptable method.

(3) Dried Antihemophilic Factor Human shall not contain more than two per cent moisture when determined by an acceptable method.

SOR/81-334, s. 3.

C.04.236. A fabricator shall provide directions or means for the removal of particles of such size as to be dangerous to the recipient from preparations from human sources that are issued in fluid form or that are reconstituted from the dried form.

SOR/97-12, s. 61.

C.04.237. A fabricator of preparations from human sources shall maintain complete records of all donors, which records shall include the medical certificate required by section C.04.231.

SOR/97-12, s. 61.

C.04.238. A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms:

(a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent;

(b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma;

(c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and

(d) dried products prepared from any of these.

SOR/97-12, s. 46.

C.04.239. No person shall sell a preparation from human sources unless both the inner and the outer labels clearly indicate that the preparation is derived from human sources.

C.04.240. The expiration date for preparations from human sources issued in fluid or dried form shall be not later than five years after the date of filling the immediate container.

C.04.241. The date of manufacture of preparations from human sources shall be the date of bleeding the donor.

C.04.300. and C.04.301. [Repealed, SOR/81-335, s. 3]

Human Plasma Collected by Plasmapheresis

Interpretation

C.04.400. The following definitions apply in this section and in sections C.04.401 to C.04.423.

“accident” means an unexpected event that is not attributable to a deviation from a fabricator’s procedures or applicable laws and that could adversely affect the safety of a donor or the safety, efficacy or quality of plasma. (accident)

“donor” means a person aged 17 years or older who has given their name to a fabricator for the purpose of participating in plasmapheresis with that fabricator. (donneur)

“error” means a deviation from a fabricator’s procedures or applicable laws that could adversely affect the safety of a donor or the safety, efficacy or quality of plasma. (manquement)

“fabricator” means a person who is the holder of an establishment licence issued under these Regulations that authorizes the person to fabricate source plasma. (manufacturier)

“personal identifier” means a unique group of letters, numbers or symbols, or any combination of them, that is assigned to a donor by a fabricator. (identificateur personnel)

“physician” means a person who is entitled to practise the profession of medicine under the laws of the province in which the person provides medical service in connection with plasmapheresis or specific immunization. (médecin)

“physician substitute” means a person who

(a) acts under the general supervision and direction of a physician; and

(b) is authorized to provide the services that may be provided by a physician substitute under sections C.04.401 to C.04.423, according to the applicable laws of the province in which the person provides any of those services. (substitut)

“plasmapheresis” means a process during which:

(a) blood is taken from a donor from which plasma is separated; and

(b) red blood cells and formed elements from the blood are returned to the donor. (plasmaphérèse)

“plasmapheresis session” means a meeting between a fabricator and a donor held for the purpose of proceeding with plasmapheresis. (séance de plasmaphérèse)

“serious adverse reaction” means an unexpected and undesirable response in a donor, associated with plasmapheresis or specific immunization, that results in any of the following consequences for the donor:

(a) hospitalization;

(b) persistent or significant disability or incapacity;

(c) a medical or surgical intervention to preclude a persistent or significant disability or incapacity;

(d) a life-threatening condition; or

(e) death. (effet indésirable grave)

“source plasma” means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use. (plasma destiné au fractionnement)

“specific immunization” means the administration of an immunogen to a donor with the intention of eliciting an immune response in their blood for the purpose of plasmapheresis. (immunisation spécifique)

“unique identifier” means a unique group of letters, numbers or symbols, or any combination of them, that is assigned by a fabricator to source plasma or red blood cells to be used in specific immunization. (identificateur unique)

SOR/78-545, s. 1; SOR/85-1022, s. 1; SOR/2006-353, s. 1. Previous Version Prohibitions

C.04.401. No person shall

(a) sell source plasma unless it has been fabricated, tested, packaged/labelled and stored in accordance with sections C.04.402 to C.04.423; or

(b) fabricate source plasma from blood collected from a person who is not suitable to participate in plasmapheresis according to sections C.04.402 to C.04.423.

SOR/78-545, s. 1; SOR/85-1022, s. 2; SOR/2006-353, s. 1. Previous Version

Fabricator’s Responsibility

C.04.402. (1) A fabricator shall ensure that a person who provides services to them in connection with plasmapheresis or specific immunization is qualified by education and by training or experience to provide the services.

(2) The fabricator shall ensure that the premises used for donor screening, plasmapheresis or specific immunization are designed, constructed and maintained in a manner that permits medical information to be communicated in confidence.

SOR/78-545, s. 1; SOR/85-1022, s. 2; SOR/97-12, s. 47; SOR/2006-353, s. 1. Previous Version Consent and Preliminary Evaluation

C.04.403. (1) A fabricator shall not begin plasmapheresis with a donor unless

(a) the fabricator has informed the donor of what is involved with plasmapheresis, including the risks to the donor’s health associated with plasmapheresis and with participating in plasmapheresis more frequently than once every eight weeks; and

(b) after paragraph (a) has been satisfied, the fabricator obtains from the donor

(i) a written acknowledgement that the information specified in paragraph (a) has been provided to them, and

(ii) in accordance with the applicable laws governing consent, written informed consent to participate in plasmapheresis.

(2) A fabricator shall not begin the specific immunization of a donor unless

(a) a physician has selected the immunogen to be administered to the donor and informed the donor of

(i) the name and nature of the selected immunogen,

(ii) the proposed frequency and the maximum number of specific immunization injections the donor is expected to receive, and

(iii) what is involved with specific immunization, including the risks to the donor’s health associated with specific immunization and with receiving the selected immunogen; and

(b) after paragraph (a) has been satisfied, the fabricator obtains from the donor

(i) a written acknowledgement that the information specified in paragraph (a) has been provided to them, and

(ii) in accordance with the applicable laws governing consent, written informed consent to receive the selected immunogen.

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version C.04.404. (1) A fabricator shall not proceed with plasmapheresis or specific immunization unless a physician or physician substitute has determined the donor’s suitability to participate

in plasmapheresis more frequently than once every eight weeks based on the donor’s medical history and a medical examination of the donor.

(2) If the donor is determined to be suitable, the fabricator shall document the following information:

(a) the fact that the donor is suitable to participate in plasmapheresis more frequently than once every eight weeks;

(b) the donor’s name and personal identifier;

(c) the name and signature of the physician who makes the determination, or supervises the physician substitute making the determination; and

(d) the date of the determination.

(3) The fabricator shall not proceed with plasmapheresis or specific immunization if the most recent determination under subsection (1) in respect of the donor was made more than

(a) 30 days before the date set for the donor’s first participation in plasmapheresis or specific immunization; or

(b) one year before any other date set for the donor’s participation in plasmapheresis or specific immunization.

SOR/78-545, s. 1; SOR/85-1022, s. 3; SOR/2006-353, s. 1. Previous Version Specific Immunization

C.04.405. (1) No one other than a physician or physician substitute shall administer an immunogen to a donor for the purpose of specific immunization.

(2) A physician shall monitor the donor’s response to the immunogen to determine if the donor can continue to receive specific immunization.

(3) If the donor cannot continue to receive specific immunization, the fabricator shall cease to provide it to the donor until a physician determines that the donor can receive specific immunization using the same or another immunogen.

SOR/78-545, s. 1; SOR/85-1022, s. 3; SOR/2006-353, s. 1. Previous Version Evaluation Before Collection

C.04.406. (1) At the beginning of each plasmapheresis session, a physician or physician substitute shall determine if the donor is suitable to participate in plasmapheresis.

(2) If the donor is determined to be temporarily not suitable to participate in plasmapheresis based on the criteria set out in Table 1 or any other medical reason justifying a determination of temporary non-suitability, the fabricator shall cancel the session, inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

(3) If the donor is determined to be not suitable to participate in plasmapheresis for an indefinite period based on the exclusion criteria set out in Table 2 or any other medical reason justifying a determination of indefinite non-suitability, the fabricator shall cancel the session and inform the donor of the reason why they are not suitable to participate in plasmapheresis for an indefinite period.

TABLE 1

Item Criteria 1. Weight of less than 50 kg 2. Temperature outside of normal limits 3. Blood pressure above 100 mmHg diastolic or 180 mmHg systolic

Haemoglobin level of less than 125 g/L of blood or haematocrit value of less than4. 0.38 L/L of blood 5. Total protein level of less than 60 g/L of blood 6. Substantial blood loss 7. Prior donation of plasma or other blood components 8. Pregnancy 9. History of medical or surgical procedures 10. History of convulsions requiring medical treatment 11. Ability to answer questions compromised by alcohol or drug use

Prior transfusion of blood, blood components or a blood product, or prior transplantation12. of a cell, tissue or organ other than dura mater 13. Skin infection at the site of the phlebotomy 14. Sign or symptom of infection

Risk of infection with HIV, hepatitis B virus or hepatitis C virus based on, but not limited to, a history of acupuncture, skin piercing, tattooing, accidental needle-stick15. injury or occasional sexual relations with a person at risk of having any of those infections Current or past use of medication that poses a risk to a recipient of a product16. manufactured from source plasma

17. Receipt of a live attenuated vaccine Animal bite requiring prophylaxis for rabies or for which the need for post-exposure18. prophylaxis has not been assessed

TABLE 2

Item Exclusion Criteria 1. Abnormal cardiovascular function or serious or chronic cardiovascular disease 2. Abnormal respiratory function or serious or chronic respiratory disease 3. Bleeding disorder that poses a risk to the donor in relation to plasmapheresis

Serious disease or medical condition of the liver, kidneys, another organ, a system or4. blood 5. Persistent abnormal plasma proteins including monoclonal or polyclonal gammopathy

Current or past use of medication that poses an ongoing risk to a recipient of a product6. manufactured from source plasma

Item Exclusion Criteria 7. History of recurrent fainting associated with the donation of blood or plasma

History, signs or symptoms of injectable drug abuse such as skin punctures, scars or8. sharing needles to inject drugs 9. History, signs or symptoms of AIDS or HIV infection 10. Risk of HIV infection based on sexual practices

History, signs or symptoms of a chronic or persistent infection or parasitic disease11. transmissible by blood 12. History, signs or symptoms of hepatitis, other than hepatitis A 13. Cancer, other than non-melanoma skin cancer or in-situ cervical cancer

Risk factor for Creutzfeldt-Jacob disease (CJD) or its variant (vCJD) based on, but not 14. limited to, the receipt of dura mater transplant or a treatment using a human pituitary

hormone 15. Positive test result for any transmissible disease agent

SOR/78-545, s. 1; SOR/85-1022, s. 3; SOR/2006-353, s. 1. Previous Version Plasma Protein Composition

C.04.407. (1) Before beginning plasmapheresis with a donor, a fabricator shall take a blood sample from the donor to determine the plasma protein composition of the donor’s blood by means of a serum protein electrophoresis test or an equivalent test.

(2) A blood sample shall be taken within seven days before the donor’s first plasmapheresis session at which the fabricator proceeds with plasmapheresis.

(3) If 21 days have elapsed from the taking of the sample without a physician examining the test result, the fabricator may not proceed with plasmapheresis until a physician examines the test result.

(4) If a physician concludes that the plasma protein composition of the donor’s blood is not within normal limits, the fabricator may not proceed with plasmapheresis until a physician determines that the plasma protein composition of the donor’s blood is within normal limits.

(5) If the fabricator has not taken a blood sample from the donor as required under subsection (1) for more than four months, the fabricator may not proceed with plasmapheresis until the blood sample is taken from the donor.

SOR/78-545, s. 1; SOR/85-1022, s. 3; SOR/2006-353, s. 1. Previous Version Ongoing Review of Collection Records

C.04.408. (1) A physician shall determine if a donor is suitable to continue to participate in plasmapheresis more frequently than once every eight weeks, based on the test results and collection records for the donor that have been made or received by the fabricator within the preceding four months.

(2) The determination shall be made at least every four months after the date of the initial determination that the donor is suitable under section C.04.404.

(3) If the donor is determined to be temporarily not suitable to participate in plasmapheresis the fabricator shall inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

(4) If the donor is determined to be not suitable for an indefinite period, the fabricator may not proceed with plasmapheresis and shall inform the donor of the reason why they are not suitable.

(5) If the requirement of subsection (2) is not met, the fabricator may not proceed with plasmapheresis until the determination is made.

SOR/78-545, s. 1; SOR/85-1022, s. 3; SOR/2006-353, s. 1. Previous Version Plasmapheresis Procedures

C.04.409. A fabricator who conducts a plasmapheresis session shall

(a) use aseptic methods and a sterile collection system licensed under the Medical Devices Regulations;

(b) ensure that all surfaces intended to come into contact with blood or plasma are pyrogen free;

(c) ensure that the donor’s skin where the phlebotomy is to be made is

(i) determined to be free from lesion, rash or other source of infection, and

(ii) cleaned and disinfected; and

(d) ensure that emergency medical personnel are capable of attending to the medical needs of the donor within 10 minutes after being contacted by the fabricator.

SOR/78-545, s. 1; SOR/85-1022, s. 4; SOR/2006-353, s. 1. Previous Version Maximum Volumes and Minimum Intervals

C.04.410. (1) A fabricator shall not collect plasma from a donor in a total amount, excluding anticoagulant solution, that exceeds

(a) if the donor’s weight is 50 kg or more but less than 68 kg,

(i) 625 mL or 640 g in respect of a single plasmapheresis session, and

(ii) 11.5 L in respect of all plasmapheresis sessions during the preceding six months;

(b) if the donor’s weight is 68 kg or more but less than 80 kg,

(i) 750 mL or 770 g in respect of a single plasmapheresis session, and

(ii) 15.5 L in respect of all plasmapheresis sessions during the preceding six months; and

(c) if the donor’s weight is 80 kg or more,

(i) 800 Ml or 820 g in respect of a single plasmapheresis session, and

(ii) 18.5 L in respect of all plasmapheresis sessions during the preceding six months.

(2) The fabricator shall have written procedures that describe

(a) the minimum waiting period for a donor between donations of plasma and between a donation of plasma and a donation of blood or other blood components; and

(b) the maximum number of plasma donations a donor may make in a given period.

SOR/78-545, s. 1; SOR/85-1022, s. 5; SOR/95-203, s. 1; SOR/2006-353, s. 1. Previous Version Anticoagulant Solution

C.04.411. (1) During plasmapheresis, the fabricator shall mix an anticoagulant solution with the blood collected from the donor.

(2) The anticoagulant solution shall have a valid drug identification number under these Regulations that indicates the solution is suitable for use in plasmapheresis.

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version Samples for Testing

C.04.412. (1) During a plasmapheresis session, the fabricator shall take a sample of blood or plasma in a manner that does not contaminate the sample or the source plasma.

(2) When the sample is taken, the fabricator shall clearly and permanently label the sample container with the unique identifier assigned to the source plasma.

(3) The fabricator shall ensure that the person who labels the sample container is the same person who labels the container holding the source plasma under subsection C.04.416(2).

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version C.04.413. (1) The fabricator shall test a sample taken under section C.04.412 to detect evidence of the following disease agents:

(a) HIV types 1 and 2;

(b) hepatitis B virus;

(c) hepatitis C virus; and

(d) syphilis.

(2) The fabricator shall retain the source plasma collected at the plasmapheresis session until all the test results are determined to be negative or non-reactive.

(3) In the case of a positive or reactive test result for any disease agent referred to in subsection (1), the fabricator shall

(a) clearly and permanently label the container holding the source plasma collected at the session with

(i) the statement “Caution: Not for Manufacturing Use” or “Précaution : Non destiné à la fabrication”, and

(ii) the hazard symbol for Biohazardous Infectious Material set out in Schedule II to the Controlled Products Regulations; and

(b) segregate and dispose of the source plasma.

(4) In the case of a positive or reactive test result for syphilis, the fabricator may not proceed with plasmapheresis until a subsequent test shows that the donor is not infected with syphilis and a physician determines that the donor can continue to participate in plasmapheresis.

(5) In the case of a positive or reactive test result for a disease agent referred to in subsection (1), other than syphilis, the fabricator shall discontinue plasmapheresis and inform the donor of the reason why they are not suitable to participate in plasmapheresis for an indefinite period.

SOR/78-545, s. 1; SOR/97-12, s. 48; SOR/2006-353, s. 1. Previous Version Preservatives and Additives

C.04.414. No person shall add a preservative or additive to source plasma.

SOR/78-545, s. 1; SOR/85-1022, s. 6; SOR/2006-353, s. 1. Previous Version Containers

C.04.415. A fabricator shall place source plasma in a container

(a) in respect of which a medical device licence has been issued under the Medical Devices Regulations for the purpose of collecting and storing plasma;

(b) that permits visual, electronic or automated inspection of the plasma;

(c) that has been visually inspected at the plasmapheresis session and found to be intact; and

(d) that has not been previously used for any purpose, including holding source plasma from the same donor.

SOR/78-545, s. 1; SOR/85-1022, s. 6; SOR/2006-353, s. 1. Previous Version Labelling

C.04.416. (1) Sections C.01.004 and C.04.019 do not apply to source plasma.

(2) A fabricator shall clearly and permanently label the container used to hold source plasma with

(a) the unique identifier assigned to the source plasma in the container;

(b) the statement “Source Plasma” or “Plasma destiné au fractionnement”;

(c) the statement “Caution: For Manufacturing Use Only” or “Précaution : À utiliser uniquement pour la fabrication”;

(d) the quantity of the source plasma;

(e) the name and quantity of the anticoagulant solution used during the plasmapheresis;

(f) the expiry date of the source plasma, expressed in an unambiguous format;

(g) subject to subsection C.04.413(3), a statement indicating that the source plasma tests negative for the disease agents for HIV, hepatitis B and hepatitis C;

(h) if the source plasma was collected from a donor who has received specific immunization, a statement indicating the immunogen that was used;

(i) the name, address and establishment licence number of the fabricator; and

(j) a statement indicating that the source plasma must be stored at a temperature of -20°C or colder.

(3) The unique identifier shall be placed on the container at the time of collection.

SOR/78-545, s. 1; SOR/85-1022, s. 7; SOR/2006-353, s. 1. Previous Version Storage

C.04.417. (1) In respect of the storage of source plasma, including storage during transportation, a fabricator shall ensure that the storage environment

(a) is designed to maintain a temperature of -20°C or colder; and

(b) remains consistently at a temperature of -20°C or colder.

(2) If the temperature of the environment rises above -20°C, the fabricator shall record the following information:

(a) the reason for the elevated temperature;

(b) the source plasma affected; and

(c) the final disposition of the source plasma.

(3) If the temperature of the environment rises to between - 20°C and +10°C, the fabricator shall clearly and permanently label the container of the source plasma with the statement “Source Plasma — Salvaged” or “Plasma destiné au fractionnement — recyclé”.

(4) Subsection (3) does not apply if the temperature of the environment rises to between ­ 20°C and -5°C for a single period lasting less than 72 hours.

(5) If the temperature of the environment rises above +10°C, the fabricator shall dispose of the source plasma.

(6) Paragraph (1)(b) and subsections (2) to (5) do not apply in respect of the storage of source plasma during transportation, if the transportation is not conducted by the fabricator.

SOR/78-545, s. 1; SOR/85-1022, s. 8; SOR/2006-353, s. 1. Previous Version C.04.418. (1) A fabricator shall inspect each container of source plasma to determine if the container and its label are intact and if there are any indications that the source plasma has been subject to thawing.

(2) The fabricator shall dispose of the source plasma if the inspection shows that

(a) the container is defective or damaged to the extent that it does not provide protection against external factors that could result in deterioration or contamination of the source plasma;

(b) the unique identifier assigned to the source plasma is missing or illegible;

(c) any information required under paragraphs C.04.416(2)(b) to (i) is missing or illegible, unless the missing or illegible information can be retrieved from the fabricator’s records; or

(d) the source plasma has been subject to thawing.

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version Records

C.04.419. (1) A fabricator shall use and maintain a recordkeeping system according to which the fabricator shall

(a) assign a personal identifier to each donor;

(b) keep on the donor’s file a photograph of the donor or some other reliable means of identification; and

(c) assign a unique identifier to the source plasma collected by the fabricator at each plasmapheresis session.

(2) The system shall be structured so that a fabricator may, based on a personal identifier or a unique identifier, identify the donor and retrieve sufficient records to permit the traceability and recall of source plasma.

(3) The fabricator shall keep the records referred to in subsection (2) indefinitely.

SOR/78-545, s. 1; SOR/85-1022, s. 9; SOR/2006-353, s. 1. Previous Version C.04.420. (1) For each donor, the fabricator shall keep

(a) the original or a copy of the donor’s acknowledgement and consent under paragraphs C.04.403(1)(b) and (2)(b), if any;

(b) the original or a copy of any determinations, examinations, test results, reports and written notices made under sections C.04.401 to C.04.423;

(c) for each specific immunization given by the fabricator to the donor, a record indicating

(i) the date and location of the immunization,

(ii) the physician or physician substitute who administered the immunogen, and

(iii) for the immunogen injected, its name and manufacturer’s name, the quantity and expiry date and either the immunogen’s lot number and drug identification number or, if the immunogen is red blood cells, its unique identifier;

(d) for each plasmapheresis session held by the fabricator for the donor, a record indicating

(i) the date and location of the session,

(ii) the volume of source plasma collected,

(iii) the unique identifier assigned to the source plasma,

(iv) the volume of red blood cells collected that was not returned to the donor, including the volume of red blood cells collected during sampling,

(v) for the anticoagulant solution used, its name, its manufacturer’s name and its lot number and drug identification number, and

(vi) for the container used, the manufacturer’s name and the container’s lot number and expiry date.

(2) The fabricator shall maintain a summary of all accidents, errors, serious adverse reactions and recalls of source plasma involving the fabricator.

(3) The fabricator shall maintain temperature records made under subsection C.04.417(2).

SOR/78-545, s. 1; SOR/85-1022, s. 10; SOR/97-12, s. 61; SOR/2006-353, s. 1. Previous Version Information to the Minister

C.04.421. (1) A fabricator shall notify the Minister of any serious adverse reaction

(a) within 24 hours after the fabricator becomes aware of the occurrence, in the case of a fatality; and

(b) within 15 days after the fabricator becomes aware of the occurrence, in any other case.

(2) In the case of a verbal notice under subsection (1), the fabricator shall submit a written report of the serious adverse reaction to the Minister within 24 hours after submitting the notice.

(3) The notice, if in writing, or the written report shall include a description of the serious adverse reaction and any steps taken to address it.

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version C.04.422. If a fabricator recalls source plasma for a reason involving product safety, the fabricator shall provide the Minister with a written report stating the reason for the recall, the number of units involved and the location from which the units were recalled.

SOR/78-545, s. 1; SOR/2006-353, s. 1.

Previous Version C.04.423. In order to prevent injury to the health and safety of donors and recipients of products manufactured from source plasma, a fabricator shall, on request, provide the Minister with a copy of any record pertaining to plasmapheresis, specific immunization or source plasma that is required by sections C.04.401 to C.04.422 to be kept by the fabricator.

SOR/78-545, s. 1; SOR/2006-353, s. 1. Previous Version C.04.424. [Repealed, SOR/2006-353, s. 1] Previous Version C.04.425. [Repealed, SOR/2006-353, s. 1] Previous Version C.04.426. [Repealed, SOR/2006-353, s. 1] Previous Version C.04.427. [Repealed, SOR/97-12, s. 50]

C.04.428. [Repealed, SOR/2006-353, s. 1] Previous Version

Insulin Preparations

[SOR/82-769, s. 5]

C.04.550. (1) “Insulin” means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and that is of value in the treatment of diabetes mellitus.

(2) The Canadian Reference Standard for insulin shall be the International Standard therefor.

(3) The insulin preparations described in these Regulations shall contain insulin to which may be added only such ingredients as are prescribed in these Regulations.

(4) The potency of an insulin preparation shall be expressed in units per cubic centimetre and each unit per cubic centimetre shall provide one International Unit of insulin per cubic centimetre.

SOR/82-769, s. 4.

C.04.551. No person shall sell or dispense an insulin preparation that has not been stored by him continuously at a temperature between 35° and 50°F (2° and 10°C).

SOR/82-769, s. 4.

C.04.552. The zinc-insulin crystals used in an insulin preparation shall contain, as determined by an acceptable method,

(a) not less than 21 International Units of insulin per milligram, and

(b) on the dry basis, not less than 0.30 per cent and not more than 0.90 per cent zinc.

SOR/82-769, s. 4.

Insulin Injection or Insulin

C.04.553. The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain

(a) weight by volume,

(i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and

(ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 7.0 milligrams of nitrogen for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals,

(ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and

(iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash.

SOR/82-769, s. 4; SOR/85-715, s. 7.

C.04.554. No person shall sell Insulin Injection unless,

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres;

(b) the vial label indicates that each cubic centimetre has a potency equal to

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin; and

(c) each cubic centimetre thereof has an actual potency that is at least 95 per cent and does not exceed 105 per cent of the potency indicated on the label as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.555. (1) A fabricator shall not sell Insulin Injection unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Injection

(i) protocols of assay of its potency expressed in International Units per cubic centimetre, in the case of insulin, and in International Units per milligram, in the case of zinc-insulin crystals,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals,

(iii) a report of the ash content in the case of insulin, and

(iv) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the first finished lot of Insulin Injection prepared from each master lot of insulin or zinc-insulin crystals, a report on the amount of each component thereof; and

(c) for the first filling of the first finished lot of Insulin Injection from each master lot of insulin or zinc-insulin crystals,

(i) a report of assay of its nitrogen content in milligrams per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per 1,000 International Units of insulin, and

(iii) a report on the determination of its pH.

(iv) [Repealed, SOR/95-203, s. 2]

SOR/82-769, s. 4; SOR/95-203, s. 2; SOR/97-12, s. 61.

C.04.556. The expiration date printed on the inner and outer labels of every package of Insulin Injection shall be a date not later than two years after the date of removal for distribution from the fabricator’s place of storage.

SOR/82-769, s. 4; SOR/97-12, s. 61.

Insulin Zinc Suspension — Rapid

C.04.557. The insulin preparation “Insulin Zinc Suspension — Rapid” shall be a sterile suspension in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,

(a) weight by volume,

(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),

(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 7.0 milligrams of nitrogen; and

(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.

SOR/80-545, s. 1; SOR/82-769, s. 4; SOR/85-715, s. 8.

C.04.558. The insulin used in the preparation of Insulin Zinc Suspension — Rapid shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of Insulin Zinc Suspension-Rapid when the precipitate is suspended uniformly.

SOR/82-769, s. 4.

C.04.559. The clear supernatant liquid obtained from Insulin Zinc Suspension — Rapid shall contain not more than 1.0 International Unit of Insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.560. No person shall sell Insulin Zinc Suspension — Rapid unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin.

SOR/82-769, s. 4.

C.04.561. (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Rapid,

(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the first finished lot of Insulin Zinc Suspension — Rapid prepared from each master lot of insulin or zinc-insulin crystals

(i) a report on the amount of each component used in the preparation,

(ii) a report of assay of its nitrogen content per 1,000 International Units of insulin,

(iii) a report of assay of its zinc content per 1,000 International Units of insulin,

(iv) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,

(v) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,

(vi) a report on the determination of its pH, and

(vii) a report on the microscopic appearance of the suspended precipitate; and

(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Rapid from each master lot of insulin or zinc-insulin crystals,

(i) a report on the determination of its pH,

(ii) a report on the microscopic examination of the precipitate, and

(iii) a report on its identification, as determined by an acceptable method.

(iv) [Repealed, SOR/95-203, s. 3]

SOR/82-769, s. 4; SOR/95-203, s. 3; SOR/97-12, s. 61.

C.04.562. The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Rapid shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

Insulin Zinc Suspension — Medium

C.04.563. The insulin preparation “Insulin Zinc Suspension — Medium” shall be a sterile suspension, in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of a mixture of crystals and amorphous material

in an approximate ratio of seven parts of crystals to three parts of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,

(a) weight by volume,

(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),

(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 7.0 milligrams of nitrogen of which not less than 63 per cent and not more than 73 per cent shall be in the crystalline component, and

(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.

SOR/80-545, s. 2; SOR/82-769, s. 4; SOR/85-715, s. 9; SOR/88-323, s. 7.

C.04.564. The insulin used in the preparation of Insulin Zinc Suspension — Medium shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.

SOR/82-769, s. 4.

C.04.565. The clear supernatant liquid obtained from Insulin Zinc Suspension — Medium shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.566. No person shall sell Insulin Zinc Suspension-Medium unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin.

SOR/82-769, s. 4.

C.04.567. (1) A fabricator shall not sell Insulin Zinc Suspension-Medium unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension-Medium,

(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the first finished lot of Insulin Zinc Suspension-Medium prepared from each master lot of insulin or zinc-insulin crystals,

(i) a report on the amount of each component used in the preparation,

(ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate,

(v) a report on the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,

(vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,

(vii) a report on the determination of its pH, and

(viii) a report on the microscopic appearance of the suspended precipitate; and

(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Medium from each master lot of insulin or zinc-insulin crystals,

(i) a report on the determination of its pH,

(ii) a report on the microscopic examination of the precipitate, and

(iii) a report on its identification as determined by an acceptable method.

(iv) [Repealed, SOR/95-203, s. 4]

SOR/82-769, s. 4; SOR/95-203, s. 4; SOR/97-12, s. 61.

C.04.568. The expiration date printed on the inner and outer labels of Insulin Zinc Suspension — Medium shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

Insulin Zinc Suspension — Prolonged

C.04.569. The insulin preparation “Insulin Zinc Suspension — Prolonged” shall be a sterile suspension in a buffered aqueous medium of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of crystals with not more than a trace of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain

(a) weight by volume,

(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),

(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 7.0 milligrams of nitrogen, of which not less than 90 per cent shall be in the crystalline component, and

(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.

SOR/80-545, s. 3; SOR/82-769, s. 4; SOR/85-715, s. 10.

C.04.570. The insulin used in the preparation of Insulin Zinc Suspension — Prolonged shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.

SOR/82-769, s. 4.

C.04.571. The clear supernatant liquid obtained from Insulin Zinc Suspension — Prolonged shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.572. No person shall sell Insulin Zinc Suspension — Prolonged unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin.

SOR/82-769, s. 4.

C.04.573. (1) A fabricator shall not sell Insulin Zinc Suspension — Prolonged unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Prolonged,

(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

(iii) reports of assay of the nitrogen content in milligrams and of its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the first finished lot of Insulin Zinc Suspension — Prolonged prepared from each master lot of insulin or zinc-insulin crystals,

(i) a report on the amount of each component used in the preparation,

(ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate,

(v) a report of the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,

(vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,

(vii) a report on the determination of its pH, and

(viii) a report on the microscopic appearance of the suspended precipitate; and

(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Prolonged from each master lot of insulin or zinc-insulin crystals,

(i) a report on the determination of its pH,

(ii) a report on the microscopic examination of the precipitate, and

(iii) a report on its identification as determined by an acceptable method.

(iv) [Repealed, SOR/95-203, s. 5]

SOR/82-769, s. 4; SOR/95-203, s. 5; SOR/97-12, s. 61.

C.04.574. The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Prolonged shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

Globin Insulin with Zinc

C.04.575. The insulin preparation “Globin Insulin with Zinc” shall be a sterile solution of insulin modified by the addition of globin prepared from beef blood, in the form of globin hydrochloride, and zinc, shall be a clear, yellowish, or almost colourless liquid free from insoluble matter and acceptably free from turbidity, shall have a pH of not less than 3.4 and not more than 3.8 and shall contain,

(a) weight by volume, not less than 1.3 per cent and not more than 1.7 per cent glycerin, and either

(i) not less than 0.15 per cent and not more than 0.20 per cent cresol, or

(ii) not less than 0.20 per cent and not more than 0.26 per cent phenol, and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 15.0 milligrams of total nitrogen,

(ii) not less than 36.0 milligrams and not more than 40.0 milligrams of globin calculated as 6.0 times the nitrogen content of the globin, and

(iii) not less than 2.5 milligrams and not more than 3.5 milligrams of zinc.

SOR/82-769, s. 4.

C.04.576. The globin hydrochloride used in the preparation of Globin Insulin with Zinc shall contain not less than 16.0 per cent and not more than 17.5 per cent nitrogen calculated on a dry, ash-free and hydrochloric acid-free basis, and its ash content shall be not more than 0.3 per cent as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.577. The insulin used in the preparation of Globin Insulin with Zinc shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40 or 80 International Units of insulin in each cubic centimetre of the Globin Insulin with Zinc.

SOR/82-769, s. 4.

C.04.578. (1) The Canadian Reference Standard for Globin Insulin with Zinc shall be the standard adopted therefor by the Director from time to time.

(2) Upon application of a person who holds an establishment licence, the Director shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.

(3) The testing of the biological reaction of Globin Insulin with Zinc shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Director.

SOR/82-769, s. 4; SOR/97-12, s. 64.

C.04.579. No person shall sell Globin Insulin with Zinc unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides,

(i) 40 International Units of insulin, or

(ii) 80 International Units of insulin.

SOR/82-769, s. 4.

C.04.580. (1) A fabricator shall not sell Globin Insulin with Zinc unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Globin Insulin with Zinc,

(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the master lot of globin hydrochloride used in the preparation of Globin Insulin with Zinc, reports of assay of

(i) its nitrogen content in per cent calculated on a dry, ash-free and hydrochloric acid free basis,

(ii) its chloride content in per cent calculated as hydrochloride, and

(iii) its ash content in percentage;

(c) for the components used in the preparation of the trial mixture of Globin Insulin with Zinc, a report on the quantity of

(i) insulin in grams, or in International Units,

(ii) zinc in grams, or in milligrams, per 1,000 International Units of insulin,

(iii) globin hydrochloride in grams or in milligrams, per 1,000 International Units of insulin, and

(iv) the volume of the preparation in cubic centimetres or litres;

(d) for the trial mixture of Globin Insulin with Zinc,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iii) protocols of the biological reaction showing the retardation of the insulin effect, and

(iv) a report on the determination of its pH;

(e) for the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc, a report on the amount of each component in the preparation; and

(f) for the first filling of the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, and

(iii) a report on the determination of its pH.

(iv) [Repealed, SOR/95-203, s. 6]

SOR/82-769, s. 4; SOR/95-203, s. 6; SOR/97-12, s. 61.

C.04.581. The expiration date printed on the inner and outer labels of every package of Globin Insulin with Zinc shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

NPH Insulin or Isophane Insulin

C.04.582. The insulin preparation “NPH Insulin” or “Isophane Insulin” shall be a sterile preparation of rod-shaped crystals containing insulin, protamine and zinc, suspended in a buffered aqueous medium, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain

(a) weight by volume, not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate, and either

(i) not less than 1.4 per cent and not more than 1.8 per cent glycerin and not less than 0.15 per cent and not more than 0.17 per cent metacresol and not less than 0.06 and not more than 0.07 per cent phenol, or

(ii) not less than 0.40 per cent and not more than 0.45 per cent sodium chloride and not less than 0.7 per cent and not more than 0.9 per cent glycerin and not less than 0.18 per cent and not more than 0.22 per cent metacresol; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 8.5 milligrams of nitrogen,

(ii) not less than 3.0 milligrams and not more than 6.0 milligrams of protamine except that the ratio of the protamine to the insulin shall be not less than the isophane ratio and shall not exceed the isophane ratio by more than 10 per cent,

(iii) not less than 0.16 milligram and not more than 0.40 milligram of zinc, and

(iv) no protease activity significant for the stability of NPH insulin.

SOR/82-769, s. 4; SOR/85-715, s. 11.

C.04.583. The protamine used in preparing NPH Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhynchus Suckley, or Salmo Linne.

SOR/82-769, s. 4.

C.04.584. The “isophane ratio” means the minimum number of milligrams of protamine required to precipitate 100 International Units of insulin and shall be determined by an acceptable method.

SOR/82-769, s. 4.

C.04.585. The insulin used in the preparation of NPH Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.

SOR/82-769, s. 4.

C.04.586. The clear supernatant liquid obtained from NPH insulin shall contain not more than 0.4 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, not more than 0.6 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 80 units per cubic centimetre and not more than 0.7 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 100 units per cubic centimetre, as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.587. No person shall sell NPH Insulin unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides,

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin.

SOR/82-769, s. 4.

C.04.588. (1) A fabricator shall not sell NPH Insulin unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of zinc-insulin crystals employed in the manufacture of NPH Insulin,

(i) protocols of assay of its potency in International Units per milligram,

(ii) a report of its moisture content in per cent determined by drying to constant weight at 100°C, and

(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the master lot of protamine, a report of the isophane ratio for the insulin used in the preparation of the NPH Insulin;

(c) for the trial mixture of NPH Insulin,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iii) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,

(iv) a report on the determination of its pH, and

(v) a report on the microscopic examination of the precipitate;

(d) for the first finished lot of NPH Insulin from each trial mixture of NPH Insulin, a report on the amount of each component in the preparation; and

(e) for the first filling of the first finished lot of NPH Insulin from each trial mixture of NPH Insulin,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(iii) a report on the determination of its pH,

(iv) a report on the microscopic examination of the precipitate, and

(v) a report of its identification as determined by an acceptable method.

(vi) [Repealed, SOR/95-203, s. 7]

SOR/82-769, s. 4; SOR/95-203, s. 7; SOR/97-12, s. 61.

C.04.589. The expiration date printed on the inner and outer labels of NPH Insulin shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

Protamine Zinc Insulin

C.04.590. The insulin preparation “Protamine Zinc Insulin” shall be a sterile white suspension in a buffered aqueous medium, containing insulin modified by the addition of protamine and zinc, shall have a pH of not less than 7.1 and not more than 7.4, and shall contain,

(a) weight by volume,

(i) not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate,

(ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin, and

(iii) either not less than 0.18 per cent and not more than 0.22 per cent cresol, or not less than 0.22 per cent and not more than 0.28 per cent phenol; and

(b) as determined by an acceptable method, for each 1,000 International Units of insulin,

(i) not more than 12.5 milligrams of total nitrogen,

(ii) not less than 10.0 milligrams and not more than 15.0 milligrams of protamine,

(iii) not less than 1.7 milligrams and not more than 2.5 milligrams of zinc.

SOR/82-769, s. 4.

C.04.591. The protamine used in the preparation of Protamine Zinc Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhunchus Suckley or Salmo Linne.

SOR/82-769, s. 4.

C.04.592. The insulin used in the preparation of Protamine Zinc Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.

SOR/82-769, s. 4.

C.04.593. (1) The Canadian Reference Standard for Protamine Zinc Insulin shall be the standard adopted therefor by the Director from time to time.

(2) Upon application of a person who holds an establishment licence, the Director shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.

(3) The testing of the biological reaction of Protamine Zinc Insulin shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Director.

SOR/82-769, s. 4; SOR/97-12, s. 64.

C.04.594. No person shall sell Protamine Zinc Insulin unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

(b) each cubic centimetre thereof provides

(i) 40 International Units of insulin,

(ii) 80 International Units of insulin, or

(iii) 100 International Units of insulin.

SOR/82-769, s. 4.

C.04.595. (1) A fabricator shall not sell Protamine Zinc Insulin unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Protamine Zinc Insulin,

(i) protocols of assay of its potency in International Units per cubic centimetre in the case of insulin and in International Units per milligram in the case of zinc-insulin crystals,

(ii) a report on its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

(iii) reports of assay of its nitrogen content in milligrams, and its zinc content in milligrams per 1,000 International Units of insulin;

(b) for the components used in the preparation of the trial mixture of Protamine Zinc Insulin, a report on the quantity of

(i) insulin in grams or in International Units,

(ii) zinc in grams or in milligrams, per 1,000 International Units of insulin,

(iii) protamine in grams or in milligrams, per 1,000 International Units of insulin, and

(iv) the volume of the preparation in cubic centimetres or litres;

(c) for the trial mixture of Protamine Zinc Insulin,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre per 1,000 International Units of insulin,

(iii) protocols of its biological reaction showing retardation of the insulin effect, and

(iv) a report on the determination of its pH;

(d) for the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin, a report on the amount of each component in the preparation; and

(e) for the first filling of the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin,

(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units,

(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units, and

(iii) a report on the determination of its pH.

(iv) [Repealed, SOR/95-203, s. 8]

SOR/82-769, s. 4; SOR/95-203, s. 8; SOR/97-12, s. 61.

C.04.596. The expiration date printed on the inner and outer labels of every package of Protamine Zinc Insulin shall be a date not later than two years after the date of filling of the immediate container.

SOR/82-769, s. 4.

Sulphated Insulin

C.04.597. The insulin preparation “Sulphated Insulin” shall be a clear or slightly turbid, colourless or almost colourless, sterile, isotonic preparation of zinc-insulin crystals chemically modified by treatment with sulphuric acid, shall have a pH of not less than 6.0 and not more than 7.0, and shall contain,

(a) weight by volume,

(i) not less than 0.6 per cent and not more than 1.0 per cent sodium chloride, and

(ii) not less than 0.2 per cent and not more than 0.3 per cent phenol; and

(b) as determined by an acceptable method,

(i) not more than 200 milligrams protein for each 1,000 International Units of insulin, and

(ii) not less than 5.5 and not more than 6.5 sulphate groups per insulin molecule.

SOR/82-769, s. 4.

C.04.598. The “neutralization ratio” means the amount of anti-beef-insulin serum required to neutralize one unit of Sulphated Insulin divided by the amount required to neutralize one unit of beef insulin, and shall be determined by an acceptable method.

SOR/82-769, s. 4.

C.04.599. The neutralization ratio of Sulphated Insulin shall be not less than 4 to 1.

SOR/82-769, s. 4.

C.04.600. No person shall sell Sulphated Insulin unless

(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres, and

(b) each cubic centimetre thereof provides 100 International Units of insulin as determined by an acceptable method.

SOR/82-769, s. 4.

C.04.601. (1) A fabricator shall not sell Sulphated Insulin unless he

(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;

(b) has furnished the Director with such additional information as the Director may require; and

(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.

(2) A submission filed pursuant to subsection (1) shall include at least,

(a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin,

(i) protocols of assay of its potency in International Units per milligram,

(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and

(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and

(b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals,

(i) a report of the amount of each component,

(ii) a report of the protein content in milligrams per 1,000 International Units of insulin,

(iii) a report on the determination of the neutralization ratio,

(iv) a report on the determination of the number of sulphate groups per insulin molecule,

(v) protocols of assay of its potency expressed as International Units per cubic centimetre, and

(vi) a report on the determination of its pH.

(vii) [Repealed, SOR/95-203, s. 9]

SOR/82-769, s. 4; SOR/95-203, s. 9; SOR/97-12, s. 61.

C.04.602. The expiration date printed on the inner and outer labels of every package of Sulphated Insulin shall be a date not later than two years after the date of filling of the immediate container.

SOR/80-545, s. 4; SOR/82-769, s. 4.

Labelling of Insulin Preparations

[SOR/82-769, s. 8]

C.04.650. The packager/labeller of Insulin Injection may label that insulin preparation “Insulin made from Zinc-Insulin crystals” only when it has been prepared from zinc-insulin crystals.

SOR/82-769, s. 7; SOR/97-12, s. 65.

C.04.651. The packager/labeller of an insulin preparation shall print the information required by these Regulations to appear on both the inner and outer labels of every package of that insulin preparation as set out in the Table to this section.

TABLE

Column I Column II Column III Potency ofItem Insulin Preparation Special Printing Requirements for LabelPreparation

(a) 40 units1. (a) black ink on yellow stock.per cc. Insulin Injection, not labelled (b) 80 units (b) black ink on green stock.as set out in item 2. per cc.

(c) 100 units (c) black ink on white stock.per cc.

(a) 40 units2. (a) red ink on grey stock.per cc. Insulin Injection, labelled

(b) 80 units“Insulin made from Zinc- (b) green ink on grey stock.per cc.Insulin crystals.” (c) 100 units (c) black ink on white stock.per cc.

(a) 40 units (a) red ink on lavender stock plus a3. Insulin Zinc Suspension — per cc. distinguishing mark or design. Rapid, Insulin Zinc Suspension (b) 80 units (b) green ink on lavender stock plus a— Medium and Insulin Zinc per cc. distinguishing mark or design. Suspension — Prolonged.

(c) 100 units (c) black ink on white stock.per cc. red ink on brown stock except that the

(a) 40 units expression “40 units per cubic4. (a)per cc. centimetre” may be printed in white letters on a red background.Globin Insulin with Zinc. green ink on brown stock except that

(b) 80 units the expression “80 units per cubic(b)per cc. centimetre” may be printed in white letters on a green background.

(a) 40 units5. (a) red ink on blue stocks.per cc.

(b) 80 unitsNPH Insulin. (b) green ink on blue stock.per cc.

(c) 100 units (c) black ink on white stock.per cc.

(a) 40 units6. (a) red ink on white stock.per cc.

(b) 80 unitsProtamine Zinc Insulin. (b) green ink on white stock.per cc.

(c) 100 units (c) black ink on white stockper cc. black ink on white stock plus the100 units7. Sulphated Insulin. statement “Warning... Not forper cc. Ordinary Use... See Package Leaflet”.

SOR/82-769, s. 7; SOR/97-12, s. 65.

C.04.652. The packager/labeller of an insulin preparation shall print on the outer label of every package thereof instructions to store the preparation in a refrigerator at 35° to 50°F (2° to 10°C) and to avoid exposing it to freezing.

SOR/82-769, s. 7; SOR/97-12, s. 65.

C.04.653. The packager/labeller of an insulin preparation that consists of a precipitate suspended in a buffered aqueous medium shall print on the inner label of every package thereof the statement “Shake Carefully”.

SOR/82-769, s. 7; SOR/97-12, s. 65.

C.04.654. The packager/labeller of an insulin preparation may, in lieu of printing adequate directions for its use on both the inner and outer labels thereof as required by subparagraph C.04.019(a)(vii), print the descriptions for use in a descriptive circular prepared in accordance with section C.04.655, but in such case he shall

(a) enclose a copy of the circular in the package containing the preparation; and

(b) state on the outer label of the package that such a circular is enclosed therein.

SOR/82-769, ss. 7, 9; SOR/97-12, s. 65.

C.04.655. The descriptive circular referred to in section C.04.654 shall include, at least, the following information:

(a) a statement that

(i) the treatment of diabetes mellitus requires medical supervision and review,

(ii) insulin preparations should be used only as determined by a physician for each patient in the light of blood-sugar and urinary-sugar findings, and

(iii) the physician’s instructions concerning diet, dosage, rest and exercise should be followed carefully;

(b) an outline of the procedure to be followed in withdrawing the insulin preparation from the vial, including techniques for sterilization of the syringe and needle, vial-stopper and site of injection;

(c) a statement explaining that injections should be subcutaneous, and not intravenous or intramuscular, and a caution against successive injections in any one site;

(d) a statement that doses are specified in terms of Units of potency per cubic centimetre and that the volume of each dose will depend upon the potency in terms of units per cubic centimetre stated on the label of the insulin preparation and that, for these reasons, it is important that the patient understand the markings on syringes;

(e) a brief explanation of hypoglycemia together with emergency measures suitable for use by patients and those caring for patients in the event of hypoglycemic reactions;

(f) a statement indicating the possibility of undesirable reactions associated with illness or infection, with the omission or loss of a meal, and with a shortage of the insulin preparation;

(g) a statement warning against using any other type of insulin preparation than that prescribed by the physician;

(h) a statement that the use of a package should not be commenced after the expiration date printed on the package;

(i) a statement that the contents should be used as continuously as practicable and that any vial from which a part of the contents has been withdrawn should be discarded in the event of its being in disuse for several weeks’ time;

(j) a statement stressing the importance of visiting a physician regularly and of carefully following his instructions;

(k) in the case of insulin preparations consisting of a clear, colourless or almost colourless solution, free from turbidity and from insoluble matter, a statement that if the contents of the vial become cloudy or turbid, use of that vial should be discontinued;

(l) in the case of insulin preparations consisting of a precipitate suspended in a buffered aqueous medium, a statement explaining that it is necessary to shake the vial carefully before withdrawing a dose, noting that if the contents have become lumpy or granular in appearance or have formed a deposit of particles on the wall of the container, the use of that vial should be discontinued;

(m) instructions that the insulin preparation should be stored in a refrigerator at 35° to 50°F (2° to 10°C) and should not be exposed to freezing; and

(n) in the case of Sulphated Insulin, a statement explaining that this insulin preparation is not for ordinary use, but is a chemically modified insulin which may be more effective than the usual insulin preparations in certain insulin-resistant or insulin-allergic diabetic patients.

SOR/82-769, ss. 7, 10.

C.04.656. (1) Notwithstanding section C.04.554, a person who holds an establishment licence may sell Insulin Injection made from zinc-insulin crystals contained in vials of approximately 20 cubic centimetre capacity each of which vials

(a) contains an excess volume sufficient to permit withdrawal of 20 cubic centimetres, and

(b) provides 500 International Units of insulin per cubic centimetre,

if

(c) notwithstanding section C.04.651, both the inner and outer labels are printed in black ink on white stock and overprinted in narrow brown and white diagonal stripes, of which there shall be at least five but not more than 20 to each inch;

(d) both the inner and the outer labels carry the statement “Warning — High Potency — Not for Ordinary Use”; and

(e) each package contains a descriptive circular that conforms to the requirements of section C.04.655 and, in addition, includes,

(i) at the beginning of the circular the statement:

“Warning — This insulin preparation contains 500 International Units of insulin in each cubic centimetre. Extreme caution must be observed in the measurement of doses because inadvertent overdose may result in irreversible shock. Serious consequences may result if it is used other than under constant medical supervision. Unless specifically prescribed it should never be used by patients to replace use of any other insulin preparations.”,

(ii) a statement that Insulin made from Zinc-Insulin crystals 500 International Units per cubic centimetre should not be administered intravenously, and

(iii) a statement giving information for the safe and effective use by physicians of the drug in insulin shock therapy and in the treatment of diabetic patients with high insulin resistance (daily requirement more than 200 International Units of insulin).

(2) [Repealed, SOR/95-203, s. 10]

SOR/82-769, ss. 7, 11; SOR/95-203, s. 10; SOR/97-12, s. 64.

Anterior Pituitary Extracts

[SOR/82-769, s. 14]

C.04.675. Anterior pituitary extract shall include all natural products, prepared from the anterior lobe of the pituitary gland of animals, having physiological properties associated with the hormones of the anterior pituitary gland and their proper names shall be

(a) Adrenocorticotrophic Hormone, Corticotrophin,

(b) Thyrotrophic Hormone, Thyrotrophin,

(c) Growth Hormone Pituitary, Somatotrophin,

(d) Lactogenic Hormone, Prolactin,

(e) Gonadotrophic Hormone, Gonadotrophin, followed by qualifying words to indicate the gonadotrophic activity associated with the extract,

and if unpurified anterior pituitary extract

(f) Pituitary Extract Anterior Lobe followed by qualifying words to indicate the physiological properties associated with it.

SOR/82-769, s. 13.

C.04.676. Reference standards for anterior pituitary extract shall be

(a) the International Standard,

(b) where no International Standard exists, the Canadian Reference Standard shall be that established and kept by the Director from whom portions for comparative testing may be had upon application, and

(c) where neither an International Standard nor a Canadian Reference Standard exists, a provisional reference standard that shall be a suitable quantity of the product submitted by the distributor referred to in paragraph C.01A.003(b) to the Director for checking the uniformity of the product.

SOR/82-769, s. 13; SOR/97-12, s. 58.

C.04.677. Both the inner and outer labels of an anterior pituitary extract shall carry a statement of the potency in terms of the reference standard for anterior pituitary extract provided in section C.04.676 as determined by an acceptable method, except that where no reference standard for an anterior pituitary extract exists, the distributor referred to in paragraph C.01A.003(b) shall include, with every package of the anterior pituitary extract, an acceptable statement of the unit of potency and the method of assay used.

SOR/82-769, s. 13; SOR/97-12, s. 58; SOR/97-543, s. 6.

C.04.678. No person who holds an establishment licence shall sell corticotrophic hormones for subcutaneous or intramuscular use unless the preparation has been assayed by an acceptable method involving subcutaneous injection and, where the preparation is recommended for intravenous use, the label carries specific dosage instructions for that use.

SOR/82-769, s. 13; SOR/97-12, s. 64.

C.04.679. No person shall sell as such adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone, or gonadotrophic hormone that is not acceptable free from any anterior pituitary extract other than the one for which it is named.

SOR/82-769, s. 13.

C.04.680. The outer label of a mixture of two or more of adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone and gonadotrophic hormone, or a mixture of any of those with pituitary extract anterior lobe, shall carry a declaration of the proper name and the amount of each component of the mixture.

SOR/82-769, s. 13; SOR/93-202, s. 22.

C.04.681. The outer label of an anterior pituitary extract or mixture of anterior pituitary extracts shall carry a statement

(a) showing the species of animal from which the glands used in the preparation of the anterior pituitary extract were obtained,

(b) that it shall be stored at refrigerator temperature, and

(c) that, except in the case of gonadotrophic hormones, it is to be used only on the advice or on the prescription of a physician.

SOR/82-769, s. 13.

C.04.682. Both the inner and outer labels of adrenocorticotrophic hormone shall carry a statement indicating the route of administration, in addition to meeting the requirements of paragraphs C.04.681(a) and (b).

SOR/82-769, ss. 13, 15.

C.04.683. The expiration date for an anterior pituitary extract or mixture of anterior pituitary extracts shall be not more than two years after the date of passing a potency test.

SOR/82-769, s. 13.

Division 5

Drugs For Clinical Trials Involving Human Subjects Interpretation

C.05.001. The definitions in this section apply in this Division.

“adverse drug reaction” means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)

“adverse event” means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique)

“clinical trial” means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique)

“drug” means a drug for human use that is to be tested in a clinical trial. (drogue)

“good clinical practices” means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques)

“import” means to import a drug into Canada for the purpose of sale in a clinical trial. (importer)

“investigator’s brochure” means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). (brochure du chercheur)

“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole)

“qualified investigator” means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is

(a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and

(b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié)

“research ethics board” means a body that is not affiliated with the sponsor, and

(a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and

(b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least

(i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline,

(ii) one member knowledgeable in ethics,

(iii) one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,

(iv) one member whose primary experience and expertise are in a non-scientific discipline, and

(v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. (comité d’éthique de la recherche)

“serious adverse drug reaction” means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave à une drogue)

“serious unexpected adverse drug reaction” means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. (réaction indésirable grave et imprévue à une drogue)

“sponsor” means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur)

SOR/2001-203, s. 4; 2001, c. 27, s. 273.

Application

C.05.002. (1) Subject to subsection (2), this Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects.

(2) Except for paragraph C.05.003(a), subsections C.05.006(2) and (3), paragraphs C.05.010(a) to (i), section C.05.011, subsections C.05.012(1) and (2), paragraphs C.05.012(3)(a) to (d) and (f) to (h), subsection C.05.012(4) and sections C.05.013, C.05.016 and C.05.017, this Division does not apply to the sale or importation of a drug for the purposes of a clinical trial authorized under subsection C.05.006(2).

SOR/2001-203, s. 4.

Prohibition

C.05.003. Despite sections C.01.014, C.08.002, C.08.002.02 and C.08.003, no person shall sell or import a drug for the purposes of a clinical trial unless

(a) the person is authorized under this Division;

(b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and

(c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug.

SOR/2001-203, s. 4; SOR/2011-88, s. 7. Previous Version

General

C.05.004. Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being.

SOR/2001-203, s. 4.

Application for Authorization

C.05.005. An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer and shall contain the following information and documents:

(a) a copy of the protocol for the clinical trial;

(b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;

(c) a clinical trial attestation, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, containing

(i) the title of the protocol and the clinical trial number,

(ii) the brand name, the chemical name or the code for the drug,

(iii) the therapeutic and pharmacological classifications of the drug,

(iv) the medicinal ingredients of the drug,

(v) the non-medicinal ingredients of the drug,

(vi) the dosage form of the drug,

(vii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor,

(viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the drug,

(ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application,

(x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and

(xi) a statement

(A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and

(B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading;

(d) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;

(e) an investigator’s brochure that contains the following information, namely,

(i) the physical, chemical and pharmaceutical properties of the drug,

(ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested,

(iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested,

(iv) any toxicological effects in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the drug,

(v) any results of carcinogenicity studies in any animal species tested in respect of the drug,

(vi) any results of clinical pharmacokinetic studies of the drug,

(vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans, and

(viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

(f) if the drug contains a human-sourced excipient, including any used in the placebo,

(i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or

(ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient;

(g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and

(h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.

SOR/2001-203, s. 4; SOR/2011-88, s. 8. Previous Version

Authorization

C.05.006. (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if

(a) the sponsor has submitted to the Minister an application in accordance with section C.05.005;

(b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons:

(i) that the information and documents in respect of the application

(A) were not provided in accordance with these Regulations, or

(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or

(ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that

(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,

(B) the clinical trial is contrary to the best interests of a clinical trial subject, or

(C) the objectives of the clinical trial will not be achieved;

(c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and

(d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application.

(2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of

(a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or

(b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned.

(3) A sponsor may not sell or import a drug for the purposes of a clinical trial

(a) during the period of any suspension made under section C.05.016 or C.05.017; or

(b) after a cancellation made under section C.05.016 or C.05.017.

SOR/2001-203, s. 4.

Notification

C.05.007. If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change:

(a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and

(b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008.

SOR/2001-203, s. 4.

Amendment

C.05.008. (1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met:

(a) the sponsor has submitted to the Minister an application for amendment in accordance with subsection (3);

(b) the Minister does not, within 30 days after the date of receipt of the application for amendment, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug in accordance with the amendment for any of the following reasons, namely,

(i) that the information and documents in respect of the application for amendment

(A) were not provided in accordance with these Regulations, or

(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or

(ii) that based on an assessment of the application for amendment, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that

(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,

(B) the clinical trial is contrary to the best interests of a clinical trial subject, or

(C) the objectives of the clinical trial will not be achieved;

(c) before the sale or importation of the drug, the sponsor submits to the Minister

(i) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved any amended protocol submitted under paragraph (3)(a) or approved any amended statement submitted under paragraph (3)(c), and

(ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given;

(d) before the sale or importation of the drug, the sponsor maintains records concerning

(i) the information referred to in paragraph C.05.005(h), and

(ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted;

(e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and

(f) the sponsor conducts the clinical trial in accordance with the amended authorization.

(2) For the purposes of subsection (1), amendments are

(a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject;

(b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug;

(c) amendments to the protocol that alter the risk to the health of a clinical trial subject;

(d) amendments to the protocol that affect the safety evaluation of the drug;

(e) amendments to the protocol that extend the duration of the clinical trial; and

(f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug.

(3) The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information:

(a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment;

(b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data;

(c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the new information; and

(d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.

(4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment.

(5) A sponsor may not sell or import a drug for the purposes of a clinical trial

(a) during the period of any suspension made under section C.05.016 or C.05.017; or

(b) after a cancellation made under section C.05.016 or C.05.017.

SOR/2001-203, s. 4.

Additional Information and Samples

C.05.009. If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination.

SOR/2001-203, s. 4.

Sponsor’s Obligations

Good Clinical Practices

C.05.010. Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that

(a) the clinical trial is scientifically sound and clearly described in a protocol;

(b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division;

(c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;

(d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;

(e) at each clinical trial site, there is no more than one qualified investigator;

(f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;

(g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;

(h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of

(i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and

(ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;

(i) the requirements respecting information and records set out in section C.05.012 are met; and

(j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026.

SOR/2001-203, s. 4.

Labelling

C.05.011. Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:

(a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;

(b) the name, number or identifying mark of the drug;

(c) the expiration date of the drug;

(d) the recommended storage conditions for the drug;

(e) the lot number of the drug;

(f) the name and address of the sponsor;

(g) the protocol code or identification; and

(h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).

SOR/2001-203, s. 4.

Records

C.05.012. (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

(2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

(3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including

(a) a copy of all versions of the investigator’s brochure for the drug;

(b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;

(c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event;

(d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons;

(e) records respecting the shipment, receipt, disposition, return and destruction of the drug;

(f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that

(i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and

(ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;

(g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and

(h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

(4) The sponsor shall maintain all records referred to in this Division for a period of 25 years.

SOR/2001-203, s. 4.

Submission of Information and Samples

C.05.013. (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that

(a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;

(b) the clinical trial is contrary to the best interests of a clinical trial subject;

(c) the objectives of the clinical trial will not be achieved;

(d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or

(e) information submitted in respect of the drug or the clinical trial is false or misleading.

(2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.

SOR/2001-203, s. 4.

Serious Unexpected Adverse Drug Reaction Reporting

C.05.014. (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:

(a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and

(b) if it is fatal or life threatening, within seven days after becoming aware of the information.

(2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

(3) Sections C.01.016 and C.01.017 do not apply to drugs used for the purposes of a clinical trial.

SOR/2001-203, s. 4.

Discontinuance of a Clinical Trial

C.05.015. (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall

(a) inform the Minister no later than 15 days after the date of the discontinuance;

(b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor;

(c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and

(d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.

(2) If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h).

SOR/2001-203, s. 4.

Suspension and Cancellation

C.05.016. (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

(a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug;

(b) any information submitted in respect of the drug or clinical trial is false or misleading;

(c) the sponsor has failed to comply with good clinical practices; or

(d) the sponsor has failed to provide

(i) information or samples of the drug as required under section C.05.009 or C.05.013, or

(ii) information or a report under section C.05.014.

(2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless

(a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension;

(b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that

(i) the situation giving rise to the intended suspension did not exist, or

(ii) the situation giving rise to the intended suspension has been corrected; and

(c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b).

(3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the

authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(4) If the Minister has suspended an authorization, the Minister shall

(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or

(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

SOR/2001-203, s. 4.

C.05.017. (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.

(2) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(3) If the Minister has suspended an authorization, the Minister shall

(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension did not exist or that it has been corrected; or

(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).

SOR/2001-203, s. 4.

Division 6 CANADIAN STANDARD DRUGS

1. Conjugated Estrogens

2. Conjugated Estrogens for Injection

3. Conjugated Estrogens Tablets

4. Digitoxin

5. Digitoxin Tablets

6. Digoxin

7. Digoxin Elixir

8. Digoxin Injection

9. Digoxin Tablets

10. Esterified Estrogens

11. Esterified Estrogens Tablets

12. Gelatin

13. Thyroid

SOR/80-544, s. 11.

General

C.06.001. In this Division,

(a) solubility and specific gravity shall be determined at 25°C;

(b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and

(c) determination of physical and chemical constants shall be carried out by acceptable methods.

Conjugated Estrogens

C.06.002. [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

SOR/82-429, s. 5.

Conjugated Estrogens for Injection

C.06.003. [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

SOR/82-429, s. 6.

Conjugated Estrogens Tablets

C.06.004. [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that

(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

SOR/82-429, s. 7.

C.06.100. and C.06.101. [Repealed, SOR/80-544, s. 12]

Digitoxin

C.06.120. [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.

Digitoxin Tablets

C.06.121. [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.

Digoxin

C.06.130. [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.

Digoxin Elixir

C.06.131. [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.

Digoxin Injection

C.06.132. [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.

Digoxin Tablets

C.06.133. [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.

C.06.140. to C.06.142. [Repealed, SOR/80-544, s. 12]

C.06.150. to C.06.153. [Repealed, SOR/80-544, s. 12]

C.06.154. to C.06.156. [Repealed, SOR/80-544, s. 12]

C.06.157. to C.06.160. [Repealed, SOR/80-544, s. 12]

Esterified Estrogens

C.06.161. [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.

Esterified Estrogens Tablets

C.06.162. [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.

Gelatin

C.06.170. Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.

C.06.180. to C.06.183. [Repealed, SOR/80-544, s. 12]

C.06.230. to C.06.233. [Repealed, SOR/80-544, s. 12]

C.06.240. to C.06.242. [Repealed, SOR/80-544, s. 12]

Thyroid

C.06.250. Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and

(a) its characters are

Description, —

(i) General, — thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and

(ii) Microscopical, — when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin, some of these fragments containing granules, minute vacuoles, crystalloidal bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain, the individual cells more or less polygonal to rounded-angular or irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuraxons; numerous aggregates of particles of intercellular substance and slender, mostly straight connective tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid, the bundles of fibres often appearing reddish in Mallory’s stain; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and

(b) the tests for its purity are

(i) Inorganic iodine, — add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water, shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid, shaking after each addition: no blue colour is produced, and

(ii) Moisture, — thyroid loses not more than six per cent moisture.

C.06.251. Thyroid shall be

(a) assayed by official method DO-26, Thyroid, October 15, 1981; and

(b) stored in a cool place and in a tightly-closed container.

SOR/82-429, s. 8.

C.06.252. [Repealed, SOR/80-544, s. 12]

C.06.260. to C.06.264. [Repealed, SOR/80-544, s. 12]

C.06.270. to C.06.280. [Repealed, SOR/80-544, s. 12]

Division 7

Sale of Drugs for the Purposes of Implementing the General Council Decision Interpretation

C.07.001. The definitions in this section apply in this Division.

“Commissioner of Patents” means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)

“General Council Decision” has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)

SOR/2005-141, s. 1.

Application

C.07.002. This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.

SOR/2005-141, s. 1.

Application for Authorization

C.07.003. An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:

(a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;

(c) in respect of a drug that is not a new drug,

(i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or

(ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;

(d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;

(e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and

(f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).

SOR/2005-141, s. 1.

Authorization

C.07.004. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if

(a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

(b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;

(c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and

(d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.

SOR/2005-141, s. 1.

C.07.005. Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if

(a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and

(b) the manufacturer has received authorization under section 21.04 of the Patent Act.

SOR/2005-141, s. 1.

C.07.006. Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.

SOR/2005-141, s. 1.

Notice to Commissioner of Patents

C.07.007. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.

SOR/2005-141, s. 1.

Marking and Labelling

C.07.008. No person shall sell a drug under this Division unless

(a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;

(b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and

(c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”

SOR/2005-141, s. 1.

C.07.009. The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.

SOR/2005-141, s. 1.

Records

C.07.010. The manufacturer shall, with respect to a drug authorized to be sold under this Division,

(a) establish and maintain records, in a manner that enables an audit to be made, respecting the information described in section C.08.007; and

(b) provide to the Minister the reports referred to in section C.08.008.

SOR/2005-141, s. 1.

Notice to Minister

C.07.011. The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.

SOR/2005-141, s. 1.

Division 8 New Drugs

C.08.001. For the purposes of the Act and this Division, “new drug” means

(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;

(b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or

(c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.

SOR/95-172, s. 2.

C.08.001.1. For the purposes of this Division,

“Canadian reference product” means

(a) a drug in respect of which a notice of compliance is issued under section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug,

(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01 cannot be used for that purpose because it is no longer marketed in Canada, or

(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)

“pharmaceutical equivalent” means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)

“specifications” means a detailed description of a new drug and of its ingredients and includes

(a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,

(b) a detailed description of the methods used for testing and examining the ingredients, and

(c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications)

SOR/95-411, s. 3; SOR/2011-88, s. 9. Previous Version C.08.002. (1) No person shall sell or advertise a new drug unless

(a) the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister;

(b) the Minister has issued, under section C.08.004 or C.08.004.01, a notice of compliance to the manufacturer of the new drug in respect of the submission;

(c) the notice of compliance in respect of the submission has not been suspended pursuant to section C.08.006; and

(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.

(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;

(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;

(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;

(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;

(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;

(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;

(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;

(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;

(j) a draft of every label to be used in conjunction with the new drug;

(k) a statement of all the representations to be made for the promotion of the new drug respecting

(i) the recommended route of administration of the new drug,

(ii) the proposed dosage of the new drug,

(iii) the claims to be made for the new drug, and

(iv) the contra-indications and side effects of the new drug;

(l) a description of the dosage form in which it is proposed that the new drug be sold;

(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.

(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

(b) samples of the ingredients of the new drug;

(c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

(d) any additional information or material respecting the safety and effectiveness of the new drug.

SOR/85-143, s. 1; SOR/93-202, s. 24; SOR/95-411, s. 4; SOR/2011-88, s. 10. Previous Version C.08.002.01 (1) A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if

(a) the new drug is intended for

(i) emergency use in situations where persons have been exposed to a chemical, biological, radiological or nuclear substance and action is required to treat, mitigate or prevent a life- threatening or other serious disease, disorder or abnormal physical state, or its symptoms, that results, or is likely to result, from that exposure, or

(ii) preventative use in persons who are at risk of exposure to a chemical, biological, radiological or nuclear substance that is potentially lethal or permanently disabling; and

(b) the requirements set out in paragraphs C.08.002(2)(g) and (h) cannot be met because

(i) exposing human volunteers to the substance referred to in paragraph (a) would be potentially lethal or permanently disabling, and

(ii) the circumstances in which exposure to the substance occurs are sporadic and infrequent.

(2) Subject to subsections (3) and (5), an extraordinary use new drug submission shall contain

(a) an attestation, signed and dated by the senior executive officer in Canada of the manufacturer filing the submission and by the manufacturer’s senior medical or scientific officer, certifying that the conditions referred to in paragraphs (1)(a) and (b) are met, together with sufficient supporting information to enable the Minister to determine that those conditions are met; and

(b) sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

(i) the information and material described in paragraphs C.08.002(2)(a) to (f) and (i) to (m),

(ii) information respecting the pathophysiological mechanism for the toxicity of the chemical, biological, radiological or nuclear substance and describing the new drug’s ability to treat, mitigate or prevent that mechanism,

(iii) detailed reports of in vitro studies respecting the toxicity and activity of the new drug in relation to the recommended purpose,

(iv) detailed reports of studies, in an animal species that is expected to react with a response that is predictive for humans, establishing the safety of the new drug, and providing substantial evidence of its effect, when used for the purpose and under the conditions of use recommended,

(v) information confirming that the end point of animal studies is clearly related to the desired benefit in humans,

(vi) information demonstrating that there is a sufficient understanding of the pharmacokinetics and pharmacodynamics of the new drug in animals and in humans to enable inferences to be drawn in respect of humans so as to allow for the selection of an effective dose in humans,

(vii) information respecting the safety of the new drug in humans, including detailed reports of clinical trials, if any, establishing the safety of the new drug,

(viii) information, if any, respecting the effectiveness of the new drug in humans for the purpose or under the conditions of use recommended,

(ix) a plan for monitoring and establishing the safety and effectiveness of the new drug under the conditions of use recommended that includes procedures for gathering and analyzing data, and

(x) any available assessment reports regarding the new drug prepared by regulatory authorities in countries other than Canada.

(3) Reports referred to in subparagraph (2)(b)(iii) or information referred to in subparagraph (2)(b)(vi) may be omitted if the extraordinary use new drug submission includes a detailed scientific explanation as to why the reports are or the information is not available.

(4) Any information or material that is necessary to enable the Minister to assess the safety and effectiveness of the new drug shall, at the request of the Minister, be added to the extraordinary use new drug submission, including

(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed to be sold;

(b) samples of the ingredients of the new drug;

(c) samples of the new drug in the dosage form in which it is proposed to be sold; and

(d) any information omitted by virtue of subsection (3).

(5) If an extraordinary use new drug submission is in respect of a new purpose for a new drug for which a notice of compliance has been issued under section C.08.004, the information and material referred to in subparagraph (2)(b)(i) may be omitted unless any of it is different from that which was originally submitted.

SOR/2011-88, s. 11.

C.08.002.02 Despite sections C.08.002 and C.08.003, no manufacturer or importer shall sell a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 except to

(a) the Government of Canada or the government of a province for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative; or

(b) a municipal government, or an institution of such a government, on receipt of a written order signed by a senior official of the government or institution or by his or her duly authorized representative.

SOR/2011-88, s. 11.

C.08.002.1. (1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product,

(a) the new drug is the pharmaceutical equivalent of the Canadian reference product;

(b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;

(c) the route of administration of the new drug is the same as that of the Canadian reference product; and

(d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.

(2) An abbreviated new drug submission or an abbreviated extraordinary use new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

(a) the information and material described in

(i) paragraphs C.08.002(2)(a) to (f) and (j) to (l), in the case of an abbreviated new drug submission, and

(ii) paragraphs C.08.002(2)(a) to (f) and (j) to (l) and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission;

(b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;

(c) evidence from the comparative studies conducted in connection with the submission that the new drug is

(i) the pharmaceutical equivalent of the Canadian reference product, and

(ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;

(d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

(e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.

(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission or an abbreviated extraordinary use new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

(b) samples of the ingredients of the new drug;

(c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

(d) any additional information or material respecting the safety and effectiveness of the new drug.

(4) For the purposes of this section, in the case of an abbreviated new drug submission, a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 is not a Canadian reference product.

SOR/95-411, s. 5; SOR/2011-88, s. 12. Previous Version C.08.003. (1) Despite section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended under section C.08.006, if any of the matters specified in subsection (2) are

significantly different from the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary use new drug submission, unless

(a) the manufacturer of the new drug has filed with the Minister a supplement to that submission;

(b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement;

(c) the notice of compliance in respect of the supplement has not been suspended pursuant to section C.08.006; and

(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label.

(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:

(a) the description of the new drug;

(b) the brand name of the new drug or the identifying name or code proposed for the new drug;

(c) the specifications of the ingredients of the new drug;

(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;

(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;

(f) the tests applied to control the potency, purity, stability and safety of the new drug;

(g) the labels used in connection with the new drug;

(h) the representations made with regard to the new drug respecting

(i) the recommended route of administration of the new drug,

(ii) the dosage of the new drug,

(iii) the claims made for the new drug,

(iv) the contra-indications and side effects of the new drug, and

(v) the withdrawal period of the new drug; and

(i) the dosage form in which it is proposed that the new drug be sold.

(3) A supplement to a submission referred to in subsection (1), with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.

(4) If a supplement to an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission concerns a matter specified in subparagraph (2)(h)(iii), the supplement shall contain the attestation and supporting information referred to in paragraph C.08.002.01(2)(a).

SOR/85-143, s. 2; SOR/93-202, s. 25; SOR/95-411, s. 6; SOR/2011-88, s. 13. Previous Version C.08.003.1 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.

SOR/95-411, s. 6; SOR/2001-203, s. 5; SOR/2011-88, s. 14. Previous Version C.08.004. (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

(b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(2) Where a new drug submission or abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.

(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

(b) if that submission or supplement does not comply with the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

SOR/84-267, ss. 1 to 3; SOR/85-143, s. 3; SOR/86-1009, s. 1; SOR/86-1101, s. 1; SOR/88­ 42, s. 1; SOR/88-257, s. 1; SOR/95-411, s. 6.

C.08.004.01 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

(a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

(b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(2) Where an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.

(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

(a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

(b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.

(4) A notice of compliance issued in respect of a new drug for extraordinary use on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

SOR/2011-88, s. 15.

C.08.004.1 (1) The following definitions apply in this section.

“abbreviated new drug submission” includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle)

“innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)

“new drug submission” includes an extraordinary use new drug submission. (présentation de drogue nouvelle)

“pediatric populations” means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)

(2) This section applies to the implementation of Article 1711 of the North American Free Trade Agreement, as defined in the definition “Agreement” in subsection 2(1) of the North American Free Trade Agreement Implementation Act, and of paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the World Trade Organization Agreement, as defined in the definition “Agreement” in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,

(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and

(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

(4) The period specified in paragraph (3)(b) is lengthened to eight years and six months if

(a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and

(b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would there-by provide a health benefit to members of those populations.

(5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.

(6) Paragraph (3)(a) does not apply to a subsequent manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the subsequent manufacturer before the end of the period of six years specified in that paragraph.

(7) Paragraph (3)(a) does not apply to a subsequent manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

(8) Paragraph (3)(b) does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).

SOR/95-411, s. 6; SOR/2006-241, s. 1; SOR/2011-88, s. 16.

Previous Version C.08.005. (1) Subject to subsection (1.1) and notwithstanding sections C.08.002 and C.08.003, a manufacturer of a new drug may sell it to a qualified investigator to be used solely for the purpose of clinical testing to obtain evidence with respect to the safety, dosage and effectiveness of that new drug, when the following conditions are met:

(a) before the sale, the manufacturer has filed with the Minister, in compliance with section C.08.005.1, a preclinical submission containing information and material respecting

(i) the brand name of the new drug or the identifying name or code proposed for the new drug,

(ii) the chemical structure or other specific identification of the composition of the new drug,

(iii) the source of the new drug,

(iv) a detailed protocol of the clinical testing,

(v) the results of investigations made to support the clinical use of the new drug,

(vi) the contra-indications and precautions known in respect of the new drug and the suggested treatment of overdosage of the new drug,

(vii) all ingredients of the new drug, stated quantitatively,

(viii) the methods, equipment, plant and controls used in the manufacture, processing and packaging of the new drug,

(ix) the tests applied to control the potency, purity and safety of the new drug, and

(x) the names and qualifications of all investigators to whom the drug is to be sold and the names of all institutions in which the clinical testing is to be carried out;

(b) the Director has not, within 60 days after the date of receipt of the preclinical submission, sent by registered mail to the manufacturer a notice in respect of that new drug indicating that the preclinical submission is not satisfactory;

(c) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators carry the statements

(i) “Investigational Drug” or “Drogue de recherche”, and

(ii) “To Be Used By Qualified Investigators Only” or “Réservée uniquement à l’usage de chercheurs compétents”;

(d) before the sale, the manufacturer ascertains that every qualified investigator to whom the new drug is to be sold

(i) has the facilities for the clinical testing to be conducted by the investigator, and

(ii) has received the information and material referred to in subparagraphs (a)(i) to (vi); and

(e) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will

(i) not use the new drug or permit it to be used other than for clinical testing,

(ii) not permit the new drug to be used by any person other than the investigator except under the investigator’s direction,

(iii) report immediately to that manufacturer and, if so required by the Director, report to the Director all serious adverse reactions encountered during the clinical testing, and

(iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer.

(1.1) This section applies only in respect of a new drug for veterinary use.

(2) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator unless that manufacturer has, in respect of all previous sales of that new drug to any qualified investigator,

(a) kept accurate records of the distribution of that new drug and of the results of the clinical testing and has made those records available to the Director for inspection on the request of the Director; and

(b) immediately reported to the Director all information he has obtained with respect to serious adverse reactions.

(3) The Minister may notify the manufacturer of a new drug that sales of that new drug to qualified investigators are prohibited if, in the opinion of the Minister, it is in the interest of public health to do so.

(4) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited.

(5) Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205.

SOR/79-236, s. 5; SOR/85-143, s. 4; SOR/87-511, s. 1; SOR/93-202, s. 26; SOR/95-411, s. 7; SOR/2001-203, s. 6.

C.08.005.1. (1) Every manufacturer who files a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use shall, in addition to any information and material that is required under section C.08.002, C.08.002.01, C.08.002.1, C.08.003 or C.08.005, include in the submission or supplement

(a) a copy of all clinical case reports respecting any subject of a study included in the submission or supplement if that subject has died, suffered a serious adverse reaction or an unexpected adverse reaction, or the study, insofar as it relates to this subject, has not been completed;

(b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement;

(c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and

(d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement.

(2) A sectional report referred to in paragraph (1)(b) shall include

(a) a summary of each study included in the submission or supplement;

(b) a summary of any additional information or material filed to amend the submission or supplement; and

(c) where raw data is available to the manufacturer in respect of a study,

(i) a summary of the data,

(ii) a cross-referencing of the data to the relevant portions of the sectional report,

(iii) a description of the conditions under which the experiments from which the data were obtained were conducted,

(iv) the details of the data treatment process, and

(v) the results and conclusions of the study.

(3) The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports.

(4) The submission certificate referred to in paragraph (1)(d) shall

(a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and

(b) be signed and dated by

(i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and

(ii) the senior medical or scientific officer of the manufacturer.

(5) No person shall sign a submission certificate if a sectional report, comprehensive summary or any information or material included in the submission or supplement, or any additional information and material filed to amend the submission or supplement,

(a) is false or misleading; or

(b) contains omissions that may affect its accuracy and completeness.

(6) Every manufacturer who has filed a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing

of a new drug for veterinary use and who has any relating clinical case reports or raw data that were not included in the submission or supplement shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister.

SOR/85-143, s. 5; SOR/92-543, s. 1; SOR/94-689, s. 2(F); SOR/95-411, s. 8; SOR/2001-203, s. 7; SOR/2011-88, s. 17. Previous Version C.08.006. (1) For the purposes of this section, evidence or new information obtained by the Minister includes any information or material filed by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.

(2) The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if the Minister considers

(a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from

(i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or

(ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued;

(b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer;

(c) that the submission or supplement contained an untrue statement of material fact;

(d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records;

(e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug;

(f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Director specifying the respect in which the labelling is false or misleading or incomplete; or

(g) that, in the case of a new drug for extraordinary use, the manufacturer has not adhered to the plan referred to in subparagraph C.08.002.01(2)(b)(ix).

SOR/95-411, s. 9; SOR/2001-203, s. 8; SOR/2011-88, s. 18.

Previous Version C.08.007. (1) Where a manufacturer has received a notice of compliance issued in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

(a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

(b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

(c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

(d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

(e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

(f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

(g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

(h) any unusual failure in efficacy of that new drug.

(i) [Repealed, SOR/95-521, s. 3]

(2) A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled.

SOR/95-411, s. 10; SOR/95-521, s. 3; SOR/2011-88, s. 19. Previous Version C.08.008. No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

(a) on request, reports of all records respecting the information described in paragraphs C.08.007(a) to (c);

(b) immediately on receipt by the manufacturer, reports of all records respecting the information described in paragraphs C.08.007(d) to (f); and

(c) within 15 days after the receipt by the manufacturer of information referred to in paragraphs C.08.007(g) and (h), a report on the information received.

SOR/95-411, s. 11; SOR/95-521, s. 4.

C.08.008.1 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer

(a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and

(b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness.

SOR/2011-88, s. 20.

C.08.009. (1) Where the Minister has decided

(a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or

(b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01,

the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

(2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

(3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

(4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.

(4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

(5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

(6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

(7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.

(7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

(8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.

SOR/95-411, s. 12; SOR/2001-203, s. 9; SOR/2011-88, s. 21. Previous Version

Sale of New Drug for Emergency Treatment

C.08.010. (1) The Director may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if

(a) the practitioner has supplied to the Director information concerning

(i) the medical emergency for which the drug is required,

(ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,

(iii) the names of all institutions in which the drug is to be used, and

(iv) such other data as the Director may require; and

(b) the practitioner has agreed to

(i) report to the manufacturer of the new drug and to the Director on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and

(ii) account to the Director on request for all quantities of the drug received by him.

(2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state

(a) the name of the practitioner to whom the new drug may be sold;

(b) the medical emergency in respect of which the new drug may be sold; and

(c) the quantity of the new drug that may be sold to that practitioner for that emergency.

C.08.011. (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.

(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.

Sale of Medicated Feeds

C.08.012. (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if

(a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,

(i) the Director has assigned a drug identification number pursuant to section C.01.014.2, or

(ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013;

(b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;

(c) the medicated feed is for therapeutic purposes only; and

(d) the written prescription contains the following information:

(i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,

(ii) the species, production type and age or weight of the animals to be treated with the medicated feed,

(iii) the type and amount of medicated feed to be mixed,

(iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,

(v) any special mixing instructions, and

(vi) labelling instructions including

(A) feeding instructions,

(B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and

(C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

(2) For the purpose of this section, “medicated feed” has the same meaning as in the Feeds Regulations.

SOR/80-741, s. 1; SOR/92-130, s. 1; SOR/93-202, s. 27.

Experimental Studies

Conditions of Sale

C.08.013. (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Director for the purpose of conducting an experimental study in animals if

(a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and

(b) the drug is labelled in accordance with subsection C.08.016(1).

(2) For the purposes of this section and sections C.08.014 to C.08.018,

“experimental studies certificate” means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales)

“experimental studies investigator” means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales)

“experimental study” means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale)

SOR/81-333, s. 1.

Experimental Studies Certificate

C.08.014. (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Director, in writing, the following information and material:

(a) the brand name of the new drug or the identifying name or code proposed for the new drug;

(b) the objectives and an outline of the proposed experimental study of the new drug;

(c) the species, number and production type of animals in respect of which the new drug is to be administered;

(d) the name and address of the manufacturer of the new drug;

(e) the address of the premises in which the experimental study is to be conducted;

(f) a description of the facilities to be used to conduct the experimental study;

(g) the name, address and qualifications of the proposed experimental studies investigator;

(h) the chemical structure, if known, and the relevant compositional characteristics of the new drug;

(i) the proposed quantity of the new drug to be used for the experimental study;

(j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug;

(k) the written agreement referred to in subsection (2); and

(l) such other information and material as the Director may require.

(2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.

(3) The Director may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other

information that the Director requests and where such samples or information are not submitted, the Director may refuse to issue an experimental studies certificate.

SOR/81-333, s. 1; SOR/93-202, s. 28.

C.08.015. (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is satisfied that

(a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study,

(b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and

(c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals,

the Director shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.

(2) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he shall refuse to issue an experimental studies certificate.

SOR/81-333, s. 1.

Labelling

C.08.016. (1) The label of a new drug that is sold pursuant to section C.08.013 shall show

(a) the brand name of the new drug or the identifying name or code proposed for the new drug;

(b) a warning statement to the effect that the drug is for use only in an experimental study in animals;

(c) the lot number of the drug;

(d) the name and address of the manufacturer of the drug; and

(e) the name of the person to whom the drug has been supplied.

(2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1).

SOR/81-333, s. 1; SOR/88-378, s. 2; SOR/93-202, s. 29.

Conditions of Experimental Study

C.08.017. An experimental studies investigator shall

(a) use the new drug only in accordance with the outline of the experimental study;

(b) report immediately to the Director all serious adverse drug reactions associated with the use of the new drug;

(c) report promptly to the Director, on request, the results of the experimental study;

(d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

(e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;

(f) report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and

(g) account to the Director, on request, for all quantities of the new drug received by him.

SOR/81-333, s. 1; SOR/2001-203, s. 10.

Suspension or Cancellation of Experimental Studies Certificate

C.08.018. (1) Where the Director is of the opinion that it is necessary in order to safeguard animal health or public health or to promote public safety, he may suspend for a definite or indefinite period or cancel an experimental studies certificate.

(2) Without limiting the generality of subsection (1), the Director may suspend or cancel an experimental studies certificate if

(a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator;

(b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;

(c) the qualifications of the experimental studies investigator prove to be inadequate;

(d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or

(e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.

SOR/81-333, s. 1.

Division 9 Non-prescription Drugs

C.09.001. This Division does not apply to

(a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or

(b) a drug for use exclusively in animals.

SOR/84-145, s. 4.

Analgesics

General

C.09.010. No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of

(a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or

(b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide.

SOR/84-145, s. 4.

C.09.011. Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution

(a) to consult a physician if the underlying condition requires continued use for more than five days; and

(b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician.

SOR/84-145, s. 4; SOR/86-589, s. 1.

C.09.012. Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing.

SOR/84-145, s. 4.

Acetaminophen

C.09.020. (1) The adult standard dosage unit of acetaminophen shall be 325 mg.

(2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg.

SOR/84-145, s. 4; SOR/90-587, s. 4.

C.09.021. (1) In this Division, “acetaminophen product” means a drug that contains

(a) acetaminophen as a single medicinal ingredient; or

(b) acetaminophen in combination with caffeine.

(2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.

(3) [Repealed, SOR/90-587, s. 5]

SOR/84-145, s. 4; SOR/90-587, s. 5.

C.09.022. (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form.

(2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.

(4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.

(5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.

(6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.

(7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.

(8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product.

SOR/84-145, s. 4; SOR/85-966, s. 4; SOR/86-954, s. 1; SOR/99-441, s. 1.

Salicylates

C.09.030. (1) The adult standard dosage unit of a salicylate shall be

(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and

(b) in the case of choline salicylate, 435 mg.

(2) The children’s standard dosage unit of a salicylate shall be

(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and

(b) in the case of choline salicylate, 110 mg.

SOR/84-145, s. 4.

C.09.031. (1) In this Division, “salicylate product” means a drug that contains

(a) a salt or derivative of salicylic acid as a single medicinal ingredient;

(b) a salt or derivative of salicylic acid in combination with caffeine;

(c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or

(d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids.

(2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.

(3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.

SOR/84-145, s. 4; SOR/85-966, s. 5(E).

C.09.032. (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form.

(2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

(a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or

(b) 670 mg of choline salicylate

per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

(a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and

(b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.

SOR/84-145, s. 4; SOR/85-966, s. 6.

C.09.033. (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon.

(2) A salicylate product in the form of a liquid may contain

(a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and

(b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units.

SOR/84-145, s. 4.

C.09.034. A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate.

SOR/84-145, s. 4.

C.09.035. A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form.

SOR/84-145, s. 4.

Division 10

[Repealed, SOR/98-423, s. 9]

PART D VITAMINS, MINERALS AND AMINO ACIDS D.01.001. (1) In this Part,

“advertise” means to advertise to the general public; (faire de la publicité)

“brand name” means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

(a) that is assigned to the drug by its manufacturer,

(b) under which the drug is sold or advertised, and

(c) that is used to distinguish the drug; (marque nominative)

“common name” means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is

(a) commonly known, and

(b) designated in scientific or technical journals; (nom usuel)

“prepackaged product” means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)

“reasonable daily intake”, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)

“recommended daily intake” means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in

(a) column II of Table I to Division 1 and column II of Table I to Division 2, for foods intended for persons 2 years of age or older, and

(b) column III of Table I to Division l and column III of Table I to Division 2, for foods intended for infants and children less than 2 years of age; (apport quotidien recommandé)

“testimonial”, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

“weighted recommended nutrient intake” means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)

(2) For the purposes of this Part, a serving of stated size of a food shall be

(a) based on the food as offered for sale; and

(b) expressed

(i) in grams, if

(A) the net quantity of the food is declared on the label by weight or by count, or

(B) the food is set out in column 1 of item 78, 149 or 150 of Schedule M, and

(ii) in millilitres, if the net quantity of the food is declared on the label by volume, except in the case of a food referred to in clause (i)(B).

(3) A serving of stated size shall be the net quantity of the food in the package if

(a) the quantity of food can reasonably be consumed by one person at a single eating occasion;

(b) the reference amount, as defined in section B.01.001, of the food is less than 100 g or 100 mL and the package contains less than 200% of that amount; or

(c) the reference amount, as defined in section B.01.001, of the food is 100 g or 100 mL or more and the package contains 150% or less of that amount.

SOR/88-559, s. 31; SOR/93-202, s. 31; SOR/96-259, s. 3; SOR/2003-11, s. 27.

Division 1

Vitamins In Foods D.01.002. (1) In this Division, “vitamin” means any of the following vitamins:

(a) vitamin A;

(b) vitamin D;

(c) vitamin E;

(d) vitamin K;

(e) vitamin C;

(f) thiamin, thiamine or vitamin B1;

(g) riboflavin or vitamin B2;

(h) niacin;

(i) vitamin B6;

(j) folacin or folate;

(k) vitamin B12;

(l) pantothenic acid or pantothenate; and

(m) biotin. (vitamin)

(2) For the purposes of this Division, no expression, other than an expression set out in subsection (1), shall be used to declare the vitamin content of a food.

(3) This Division applies only in respect of foods represented as containing a vitamin for use in human nutrition.

SOR/88-559, s. 32; SOR/2003-11, s. 28.

D.01.003. (1) For the purposes of these Regulations, the vitamin content of a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, shall be determined

(a) in the case of vitamin A, in terms of the content of retinol and its derivatives and beta- carotene, expressed as retinol equivalents (RE) on the basis of the following relationships:

(i) 1 RE = 1 microgram retinol, and

(ii) 1 RE = 6 micrograms beta-carotene;

(b) in the case of vitamin D, in terms of the content of cholecalciferol and ergocalciferol, expressed in micrograms;

(c) in the case of vitamin E, in terms of the content of d-alpha-tocopherol and dl-alpha­ tocopherol and their derivatives, expressed in milligrams on the basis of the following relationships:

(i) one milligram d-alpha-tocopherol = one milligram vitamin E, and

(ii) one milligram dl-alpha-tocopherol = 0.74 milligram vitamin E;

(d) in the case of vitamin K, in terms of the content of phylloquinone and menaquinones, expressed in micrograms;

(e) in the case of vitamin C, in terms of the content of L-ascorbic acid and L-dehydroascorbic acid and their derivatives, calculated in milligram equivalents of L-ascorbic acid and expressed in milligrams;

(f) in the case of thiamin, thiamine or vitamin B1, and its derivatives, in terms of the content of thiamin, expressed in milligrams;

(g) in the case of riboflavin or vitamin B2 and its derivatives, in terms of the content of riboflavin, expressed in milligrams;

(h) in the case of niacin, in terms of the content of niacin and its derivatives, calculated in milligrams of nicotinic acid, plus the content of tryptophan, calculated in milligrams and divided by 60, with the total expressed as niacin equivalents (NE);

(i) in the case of vitamin B6, in terms of the content of pyridoxine, pyridoxal and pyridoxamine and their derivatives, calculated in milligram equivalents of pyridoxine and expressed in milligrams;

(j) in the case of folacin, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated in microgram equivalents of folic acid and expressed in micrograms;

(k) in the case of vitamin B12, in terms of the content of cyanocobalamin and related compounds exhibiting the biological activity of cyanocobalamin, calculated in microgram equivalents of cyanocobalamin and expressed in micrograms;

(l) in the case of pantothenic acid or pantothenate, in terms of the content of d-pantothenic acid, expressed in milligrams; and

(m) in the case of biotin, in terms of the content of biotin, expressed in milligrams.

(2) For the purpose of paragraph (1)(h), the content of tryptophan may be calculated

(a) where the protein originates from a food that contains protein from more than one source or from a source other than milk, meat, poultry, fish or eggs, as constituting 1.1 per cent of the protein;

(b) where the protein originates from milk, meat, poultry or fish, as constituting 1.3 per cent of the protein; and

(c) where the protein originates from eggs, as constituting 1.5 per cent of the protein.

SOR/88-559, s. 32; SOR/90-830, s. 7.

D.01.004. (1) No person shall, on the label of or in any advertisement for a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the vitamin content of the food unless

(a) the vitamin is set out in column I of Table I to this Division;

(b) the percentage of the recommended daily intake of the vitamin, per serving of stated size, is 5% or more; and

(c) the vitamin content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.

(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,

(a) in the case of an advertisement, other than a radio or television advertisement, be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or

(c) in the case of a television advertisement, be communicated

(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or

(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(4) Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table.

(5) Paragraph (1)(c) does not apply in respect of a declaration of the biotin content as required by subparagraph B.24.202(a)(v).

SOR/84-300, s. 57(E); SOR/88-559, s. 32; SOR/90-830, s. 8; SOR/96-259, s. 9; SOR/2003­ 11, s. 29.

D.01.005. [Repealed, SOR/2003-11, s. 29]

D.01.006. No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a vitamin contained in the food, except to the effect that the vitamin

(a) is a factor in the maintenance of good health; and

(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

SOR/88-559, s. 32.

D.01.007. (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a vitamin, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the vitamin as a component of that ingredient unless

(a) despite subsection B.01.008(6), the vitamin is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and

(b) all components of the ingredient are declared.

(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).

SOR/84-300, s. 59(E); SOR/88-559, s. 32; SOR/2003-11, s. 30.

D.01.008. [Repealed, SOR/88-559, s. 32]

D.01.009. Subject to section D.01.010, no person shall sell a food to which any of the following vitamins have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,

(a) in the case of vitamin A, 1,600 International Units;

(b) in the case of thiamine, 0.6 milligram;

(c) in the case of riboflavin, 1.0 milligram;

(d) in the case of niacin or niacinamide, six milligrams;

(e) in the case of ascorbic acid, 20 milligrams; and

(f) in the case of vitamin D, 300 International Units.

D.01.010. Where a food to which a vitamin has been added is represented as being solely for use in the feeding of children under two years of age, no person shall sell such food unless a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than,

(a) in the case of vitamin A, 1,000 International Units;

(b) in the case of thiamine, 0.4 milligram;

(c) in the case of riboflavin, 0.6 milligram;

(d) in the case of niacin or niacinamide, four milligrams;

(e) in the case of pyridoxine, 0.6 milligram;

(f) in the case of ascorbic acid, 20 milligrams;

(g) in the case of vitamin D, 300 International Units; and

(h) in the case of vitamin E, five International Units.

D.01.011. No person shall sell a food to which any of the following vitamins have been added if a reasonable daily intake of that food by a person would result in the daily intake by such person of more than,

(a) in the case of vitamin A, 2,500 International Units;

(b) in the case of thiamine, two milligrams;

(c) in the case of riboflavin, three milligrams;

(d) in the case of niacin or niacinamide, 20 milligrams;

(e) in the case of pyridoxine, 1.5 milligrams;

(f) in the case of ascorbic acid, 60 milligrams;

(g) in the case of vitamin D, 400 International Units; and

(h) in the case of vitamin E, 15 International Units.

D.01.012. No person shall, in advertising a food that is represented as containing a vitamin or on a label of such food,

(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the vitamin to a person’s diet; or

(b) refer to, reproduce or quote any testimonial.

D.01.013. [Repealed, SOR/2003-11, s. 31]

TABLE I

RECOMMENDED DAILY INTAKE

Column I Column II Column III

Units* Intake of persons 2 years Intake of infants or childrenItem Vitamin of age or older less than 2 years of age 1. Vitamin A (RE) 1000 400 2. Vitamin D (µg) 5 10 3. Vitamin E (mg) 10 3 4. Vitamin C (mg) 60 20

Thiamin, thiamine or5. (mg) 1.3 0.45vitamin B1 Riboflavin or vitamin6. (mg) 1.6 0.55B2

7. Niacin (NE) 23 8 8. Vitamin B6 (mg) 1.8 0.7 9. Folacin or folate (µg) 220 65 10. Vitamin B12 (µg) 2 0.3

Pantothenic acid or11. (mg) 7 2pantothenate 12. Vitamin K (µg) 80 30

Column I Column II Column III

Units* Intake of persons 2 years Intake of infants or childrenItem Vitamin of age or older less than 2 years of age 13. Biotin (µg) 30 8 * RE = retinol equivalents

mg = milligrams µg = micrograms NE = niacin equivalents

SOR/88-559, s. 33; SOR/96-259, s. 4; SOR/2003-11, ss. 32, 33.

TABLE II

WEIGHTED RECOMMENDED NUTRIENT INTAKE

Column I Column II Column III Item Vitamin Units Amount 1. Biotin micrograms 90 2. Folacin micrograms 195 3. Niacin niacin equivalents 16 4. Pantothenic Acid milligrams 5.0 5. Riboflavin milligrams 1.2 6. Thiamine milligrams 1.0 7. Vitamin A retinol equivalents 870 8. Vitamin B6 milligrams 1.0 9. Vitamin B12 micrograms 1.0 10. Vitamin C milligrams 34 11. Vitamin D micrograms 3.0 12. Vitamin E milligrams 7.0

SOR/96-259, s. 5.

Division 2

Mineral Nutrients In Foods D.02.001. (1) In this Division, “mineral nutrient” means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:

(a) sodium;

(b) potassium;

(c) calcium;

(d) phosphorus;

(e) magnesium;

(f) iron;

(g) zinc;

(h) iodide;

(i) chloride;

(j) copper;

(k) fluoride;

(l) manganese;

(m) chromium;

(n) selenium;

(o) cobalt;

(p) molybdenum;

(q) tin;

(r) vanadium;

(s) silicon; and

(t) nickel. (minéral nutritif)

(2) This Division applies only in respect of foods that are represented as containing a mineral nutrient for use in human nutrition.

SOR/88-559, s. 34; SOR/90-830, s. 9(F).

D.02.002. (1) No person shall, on the label of or in any advertisement for a food, other than salt for table or general household use containing added iodide, prepackaged water and ice, a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the mineral nutrient content of the food unless

(a) the mineral nutrient is set out in column I of Table I to this Division;

(b) the percentage of the recommended daily intake of the mineral nutrient, per serving of stated size, is 5% or more; and

(c) the mineral nutrient content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.

(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,

(a) in the case of an advertisement, other than a radio or television advertisement, be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or

(c) in the case of a television advertisement, be communicated

(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or

(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(4) Subsection (1) does not apply to a statement or claim made in respect of the sodium or potassium content.

(5) Paragraphs (1)(a) and (c) do not apply in respect of a declaration of the total fluoride ion content as required by sections B.12.002 and B.12.008.

(6) Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table.

(7) Paragraph (1)(c) does not apply in respect of a declaration of the chromium, copper, manganese, molybdenum and selenium content as required by subparagraph B.24.202(a)(v).

SOR/84-300, s. 60(E); SOR/88-559, s. 34; SOR/90-830, s. 10; SOR/96-259, s. 9; SOR/2003­ 11, s. 34.

D.02.003. [Repealed, SOR/2003-11, s. 34]

D.02.004. No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a mineral nutrient contained in the food, except to the effect that the mineral nutrient

(a) is a factor in the maintenance of good health; and

(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

SOR/84-300, s. 61(E); SOR/88-559, s. 34.

D.02.005. (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a mineral nutrient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the mineral nutrient as a component of that ingredient unless

(a) despite subsection B.01.008(6), the mineral nutrient is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and

(b) all components of the ingredient are declared.

(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).

SOR/88-559, s. 34; SOR/2003-11, s. 35.

D.02.006. [Repealed, SOR/2003-11, s. 35]

TABLE I

RECOMMENDED DAILY INTAKE

Column I Column II Column III

Item Mineral Units* Intake of persons 2 years of Intake of infants and children lessNutrient age or older than 2 years of age 1. Calcium (mg) 1100 500 2. Phosphorus (mg) 1100 500 3. Magnesium (mg) 250 55 4. Iron (mg) 14 7 5. Zinc (mg) 9 4 6. Iodide (µg) 160 55 7. Selenium (µg) 50 15 8. Copper (mg) 2 0.5 9. Manganese (mg) 2 1.2 10. Chromium (µg) 120 12 11. Molybdenum (µg) 75 15 12. Chloride (mg) 3400 1000 * mg = milligrams

µg = micrograms

SOR/88-559, s. 34; SOR/96-259, s. 6; SOR/2003-11, s. 36.

TABLE II

WEIGHTED RECOMMENDED NUTRIENT INTAKE

Column I Column II Column III Item Mineral Nutrient Units Amount 1. Calcium milligrams 780 2. Iodide micrograms 155 3. Iron milligrams 10 4. Phosphorus milligrams 885 5. Magnesium milligrams 210 6. Zinc milligrams 10

SOR/96-259, s. 7.

D.02.007. [Repealed, SOR/88-559, s. 34]

D.02.008. No person shall, in advertising a food that is represented as containing a mineral nutrient or on a label of such food,

(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the mineral nutrient to a person’s diet; or

(b) refer to, reproduce or quote any testimonial.

D.02.009. No person shall sell a food to which any of the following mineral nutrients have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,

(a) in the case of calcium, 300 milligrams;

(b) in the case of phosphorus, 300 milligrams;

(c) in the case of iron, four milligrams; and

(d) in the case of iodine, 0.10 milligram.

D.02.010. (1) No person shall sell elemental iron powder for use in foods as a source of iron as a mineral nutrient unless

(a) subject to paragraph (b), the powder meets the specifications for

(i) Iron, Carbonyl,

(ii) Iron, Electrolytic, or

(iii) Iron, Reduced,

as set out in the Food Chemicals Codex, Third Edition, 1981, published by the National Academy of Sciences of the United States of America; and

(b) in the case of Iron, Reduced, 100 per cent by weight of the particles pass through a 100 mesh sieve and at least 95 per cent by weight of the particles pass through a 325 mesh sieve.

(2) No person shall sell a food to which elemental iron powder has been added as a source of iron as a mineral nutrient unless the powder meets the requirements referred to in paragraphs (1)(a) and (b).

SOR/84-303, s. 1.

D.02.011. No person shall sell a food to which sodium iron pyrophosphate has been added as a source of iron as a mineral nutrient unless

(a) the bioavailability of the iron in the food is not less than 50 per cent of the bioavailability of ferrous sulphate as determined by official method FO-42, Determination of Bioavailability of Iron, December 15, 1982; and

(b) that person retains documentary evidence showing that the bioavailability of the iron in the food has been determined by the official method referred to in paragraph (a) and, on request by the Director, submits such evidence to the Director.

SOR/84-303, s. 1.

Division 3

Addition Of Vitamins, Mineral Nutrients Or Amino Acids To Foods D.03.001. (1) In this Division, the expressions “vitamin” and “mineral nutrient” have the same meaning as in Divisions 1 and 2.

(2) This Division applies only in respect of foods that are represented as containing a vitamin, mineral nutrient or amino acid for use in human nutrition.

SOR/88-559, s. 35.

D.03.002. (1) Subject to section D.03.003, no person shall sell a food to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II of the Table.

(2) No milk or milk product or derivative listed in Column I of the Table to this section applies to the lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion unless that animal is identified therein.

TABLE

Column I Column II Food Vitamin, Mineral Nutrient or Amino Acid

Thiamine, niacin, vitamin B6, folic acid,1. Breakfast cereals pantothenic acid, magnesium, iron and zinc. Fruit nectars, vegetable drinks, bases and

2. mixes for vegetable drinks and a mixture of Vitamin C. vegetable juices

2.1 Fruit flavoured drinks that meet all the Vitamin C, folic acid, thiamine, iron,requirements of section B.11.150 potassium.

2.2 Bases, concentrates and mixes that are used Vitamin C, folic acid, thiamine, iron,for making fruit flavoured drinks and that potassium.

Column I Food meet all the requirements of section B.11.151

3. Infant cereal products

Margarine and other similar substitutes for4. butter

5. Alimentary pastes

6. Infant formulas and formulated liquid diets

6.1 Foods represented for use in a very lowenergy diet

Flavoured beverage mixes and bases7. recommended for addition to milk

Simulated meat products, simulated poultry 8. meat products, meat product extenders and

poultry product extenders

Meal replacements and nutritional9. supplements

Column II Vitamin, Mineral Nutrient or Amino Acid

Thiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine.

Vitamin A, Vitamin D, alpha-tocopherol

Thiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium Amino acids — alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; Minerals — calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc; Vitamins — alpha-tocopherol, biotin, d­ pantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K. Vitamins — alpha-tocopherol, biotin, d­ pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc Vitamin A, thiamine, niacin or niacinamide, vitamin C, iron. Thiamine, riboflavin, niacin, pyridoxine, d­ pantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine. Vitamins — alpha-tocopherol, biotin, d­ pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D Minerals — calcium, chloride, chromium,

Column I Food

Ready breakfast, instant breakfast and other 9.1 similar breakfast replacement foods

however described

10. Condensed milk, milk, milk powder,sterilized milk, (naming the flavour) milk Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming11. the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk, partly skimmed milk, skim milk powder

12. Evaporated milk Evaporated skim milk, concentrated skim

13. milk, evaporated partly skimmed milk, concentrated partly skimmed milk Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple14. and (naming the fruit) juice as described in section B.11.132, concentrated fruit juice except frozen concentrated orange juice

15. Flour, White Flour, Enriched Flour orEnriched White Flour

16. [Repealed, SOR/94-689, s. 2] 17. Table salt, table salt substitutes 18. Dehydrated potatoes

19. Products simulating whole egg

20. [Repealed, SOR/90-830, s. 11] 21. Goat’s milk, goat’s milk powder

Partly skimmed goat’s milk, skimmed 22. goat’s milk, partly skimmed goat’s milk

powder, skimmed goat’s milk powder 23. Evaporated goat’s milk

24. Evaporated partly skimmed goat’s milk,evaporated skimmed goat’s milk

Column II Vitamin, Mineral Nutrient or Amino Acid copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc

Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron

Vitamin D.

Vitamin A, vitamin D.

Vitamin C, vitamin D.

Vitamin A, vitamin C, vitamin D.

Vitamin C.

Thiamine, riboflavin, niacin, vitamin B6, folic acid, d-pantothenic acid, calcium, iron, magnesium.

Iodine. Vitamin C. Vitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin B6, d-pantothenic acid, folic acid, vitamin B12, alphatocopherol, calcium, iron, zinc, potassium.

Vitamin D

Vitamins A and D

Vitamins C, D, folic acid

Vitamins A, C, D, folic acid

Column I Column II Food Vitamin, Mineral Nutrient or Amino Acid

25. Pre-cooked rice as defined in subsection Thiamine, niacin, vitamin B6, folic acid,B.13.010.1(1) pantothenic acid, iron

26. Mineral water, spring water, water in sealed Fluorinecontainers, prepackaged ice Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen Vitamin A, Vitamin D, Vitamin E, thiamine,yolk, liquid egg-white, (liquid albumen), riboflavin, niacin, vitamin B6, folacin,dried egg-white (dried albumen), frozen27. vitamin B12, pantothenic acid, calcium,egg-white (frozen albumen), liquid whole phosphorus, magnesium, potassium, iron,egg mix, dried whole egg mix, frozen zincwhole egg mix, liquid yolk mix, dried yolk mix, frozen yolk mix

SOR/78-64, s. 8; SOR/78-403, s. 29; SOR/78-478, s. 3; SOR/78-637, s. 11(E); SOR/78-698, s. 10; SOR/79-6, s. 1; SOR/81-60, s. 14; SOR/83-858, s. 2; SOR/84-300, s. 62; SOR/85-623, s. 4; SOR/86-320, s. 2; SOR/87-640, s. 10; SOR/88-559, s. 36; SOR/89-145, s. 3; SOR/89­ 198, s. 18; SOR/90-830, s. 11; SOR/94-35, s. 5; SOR/94-689, s. 2; SOR/95-474, s. 6; SOR/96-259, s. 8; SOR/2010-143, s. 39(E). Previous Version D.03.003. Section D.03.002 does not apply to a food when all of the following conditions are met:

(a) the food is

(i) a gluten-free food referred to in paragraph B.24.003(1)(g), or

(ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i);

(b) no standard is prescribed in these Regulations for the food; and

(c) the food is not advertised.

SOR/78-64, s. 9; SOR/84-334, s. 2; SOR/90-830, s. 12; SOR/95-444, s. 3.

Division 4

[Repealed, SOR/2003-196, s. 105]

Division 5

Minerals In Drugs D.05.001. to D.05.007 [Repealed, SOR/2003-196, s. 106]

D.05.008. (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.

(2) Subsection (1) does not apply to a drug sold by prescription.

SOR/81-196, s. 2.

D.05.009. Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result.

D.05.010. [Repealed, SOR/2003-196, s. 107]

PART E CYCLAMATE AND SACCHARIN SWEETENERS E.01.001. (1) In this Part,

“cyclamate sweetener” means

(a) cyclohexyl sulfamic acid or a salt thereof, or

(b) any substance containing cyclohexyl sulfamic acid or a salt thereof

that is sold as a sweetener; (édulcorant au cyclamate)

“saccharin sweetener” means

(a) saccharin or a salt thereof, or

(b) any substance containing saccharin or a salt thereof

that is sold as a sweetener. (édulcorant à la saccharine)

(2) Part B of these Regulations does not apply to any cyclamate sweetener or saccharin sweetener.

SOR/78-422, s. 4.

Sale E.01.002. No person shall

(a) sell a cyclamate sweetener or saccharin sweetener that is not labelled as required by this Part; or

(b) commencing June 15, 1978, sell any saccharin sweetener to the general public except on the premises of a pharmacy.

SOR/78-422, s. 4.

Advertising

E.01.003. No person shall, in advertising to the general public a cyclamate sweetener or saccharin sweetener, make any representation other than with respect to the name, price and quantity of the sweetener.

SOR/78-422, s. 4.

Labelling E.01.004. (1) Every cyclamate sweetener that is not also a saccharin sweetener shall be labelled to state that such sweetener should be used only on the advice of a physician.

(2) Commencing June 1, 1979, every saccharin sweetener shall be labelled to state that

(a) continued use of saccharin may be injurious to health; and

(b) it should not be used by pregnant women except on the advice of a physician.

SOR/78-422, s. 4.

E.01.005. Commencing June 1, 1979, every cyclamate sweetener or saccharin sweetener shall be labelled to show

(a) a list of all the ingredients and, in the case of

(i) cyclohexyl sulfamic acid,

(ii) a salt of cyclohexyl sulfamic acid,

(iii) saccharin,

(iv) a saccharin salt, or

(v) carbohydrates,

the quantity thereof contained in the sweetener; and

(b) the energy value of the sweetener expressed in calories

(i) per teaspoonful, drop, tablet or other measure used in the directions for use, and

(ii) per 100 grams or 100 millilitres

of the sweetener.

SOR/78-422, s. 4.

PART G CONTROLLED DRUGS Division 1 General

G.01.001. (1) In this Part,

“agricultural implant” means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency; (implant agricole)

“common name” with reference to a controlled drug means the name in English or French by which the controlled drug is commonly known; (nom usuel)

“competent authority” means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of controlled drugs into or from the country; (autorité compétente)

“controlled drug” means a drug set out in the schedule to this Part and includes a preparation; (drogue contrôlée)

“hospital” means a facility

(a) that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness, or

(b) that is owned or operated by the Government of Canada or the government of a province and that provides health services; (hôpital)

“international obligation” means an obligation in respect of a controlled drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale)

“licence”[SOR/2004-238, s. 1]

“licensed dealer” means the holder of a licence issued under section G.02.003.2; (distributeur autorisé)

“parenteral use” with reference to a controlled drug means administration by means of a hypodermic syringe, needle or other instrument through or into the skin of mucous membrane; (usage parentéral)

“permit” means a permit issued under section G.02.008; (permis)

“pharmacist”

(a) means a person who is registered and entitled under the laws of a province

(i) to practise pharmacy, and

(ii) to operate a pharmacy or dispensary

and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and

(b) includes, for the purposes of sections G.01.002, G.01.003, G.03.002 to G.03.008, G.03.014, G.03.015 and G.03.017 and subsections G.05.003(3) and (4), a person who is

registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)

“practitioner”[Repealed, SOR/97-228, s. 7]

“preparation” means a drug that contains a controlled drug and one or more active medicinal ingredients, in a recognized therapeutic dose, other than a controlled drug; (préparation)

“prescription” means a direction given by a practitioner that a stated amount of a specified controlled drug be dispensed for the person named therein; (ordonnance)

“proper name” with reference to a controlled drug means the name in English or French

(a) assigned to the drug in section C.01.002,

(b) that appears in bold face type for the drug in the Regulations and where the drug is dispensed in a form other than that described in Part C, the name of the dispensing form, or

(c) assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b) of this definition; (nom propre)

“qualified person in charge” means the individual with the qualifications specified in subsection G.02.001.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)

“test kit” means an apparatus

(a) that contains reagent systems or buffering agents or both,

(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and

(c) the contents of which are not intended for administration to humans; (nécessaire d’essai)

“verbal order” means an order given orally. (commande verbale)

“written order”[Repealed, SOR/85-550, s. 1]

(2) The definitions in this subsection apply in this Part and Part J.

“Act” means the Controlled Drugs and Substances Act (Loi)

“advertisement” has the same meaning as in section 2 of the Food and Drugs Act. (publicité ou annonce)

“Department” has the same meaning as in section 2 of the Food and Drugs Act. (ministère)

“designated criminal offence” means

(a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code;

(b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code;

(c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;

(d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or

(e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (d). (infraction désignée en matière criminelle)

“designated drug offence” means

(a) an offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act, as those provisions read immediately before May 14, 1997,

(b) an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997,

(c) an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1), or

(d) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (c); (infraction désignée en matière de drogue)

“label” has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

“package” has the same meaning as in section 2 of the Food and Drugs Act. (emballage)

“Security Directive” means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time. (Directive en matière de sécurité)

(3) Unless otherwise provided, the definitions in subsection 2(1) of the Controlled Drugs and Substances Act apply in this Part and Part J.

SOR/78-220, s. 1; SOR/85-550, s. 1; SOR/86-91, s. 1; SOR/90-261, s. 1(F); SOR/92-386, s. 1; SOR/97-228, s. 7; SOR/97-515, s. 2; SOR/2003-135, s. 2; SOR/2004-238, s. 1.

G.01.002. (1) A person is authorized to have a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part in his or her possession where the person has obtained the controlled drug under these Regulations, in the course of activities performed in connection with the enforcement or administration of an Act or regulation, or from a person who is exempt under section 56 of the Controlled Drugs and Substances Act from the application of subsection 5(1) of that Act with respect to that controlled drug, and the person

(a) requires the controlled drug for his business or profession and is

(i) a licensed dealer,

(ii) a pharmacist, or

(iii) a practitioner who is registered and entitled to practise in the province in which he has such possession;

(b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;

(c) is a hospital employee or a practitioner in a hospital;

(d) has obtained the controlled drug for his own use from a practitioner or pursuant to a prescription that is not issued or obtained in contravention of these Regulations;

(e) is a practitioner of medicine who received the controlled drug under subsection G.06.001(3) or (4) and whose possession is for a purpose referred to in subsection G.06.001(5);

(f) is an agent of a practitioner of medicine who received the controlled drug under subsection G.06.001(3) and whose possession is for the purpose of complying with subsection G.06.001(4);

(g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or member of the technical or scientific staff of any department of the Government of Canada or of a province or university and such possession is for the purposes of and in connection with such employment;

(h) is a person other than a person referred to in paragraph (e) or (f), is exempted under section 56 of the Controlled Drugs and Substances Act with respect to possession of that controlled drug and whose possession is for a purpose set out in the exemption; or

(i) is a person referred to in paragraph G.06.001(5)(b).

(2) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where the person is acting as the agent for any person referred to in paragraph (1)(a) to (e), (h) or (i).

(3) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where

(a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(g); and

(b) the possession of the controlled drug is for the purpose of assisting that person in the enforcement or administration of an Act or a regulation.

SOR/97-515, s. 3; SOR/99-125, s. 1; SOR/2003-34, s. 1; SOR/2003-413, s. 1.

G.01.002.1. Section C.01.004 does not apply to a test kit that contains a controlled drug where a registration number has been issued for the test kit pursuant to section G.06.002.3 and has not been cancelled pursuant to section G.06.002.4.

SOR/80-543, s. 11.

G.01.003. In the case of a controlled drug that is dispensed by a pharmacist pursuant to a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained shall carry the following:

(a) the name and address of the pharmacy or pharmacist;

(b) the date and number of the prescription;

(c) the name of the person for whom the controlled drug is dispensed;

(d) the name of the practitioner;

(e) directions for use; and

(f) any other information that the prescription requires be shown on the label.

SOR/80-543, s. 11; SOR/2004-238, s. 2(F).

G.01.004. The Controlled Drugs and Substances Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.

SOR/92-386, s. 2; SOR/97-228, s. 8.

G.01.005. [Repealed, SOR/80-543, s. 12]

G.01.006. Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.

G.01.007. No person shall

(a) advertise a controlled drug to the general public; or

(b) issue or publish any other written advertisement respecting a controlled drug unless that

advertisement carries the symbol in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement.

G.01.008. [Repealed, SOR/80-543, s. 12]

Prescribed Manner of Notice of Application for an Order of Restoration

G.01.010. (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.

(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application for an order of restoration is to be made to the magistrate and shall specify

(a) the magistrate to whom the application is to be made;

(b) the time and place where the application is to be heard;

(c) the controlled drug or other thing in respect of which the application is to be made; and

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the controlled drug or other thing referred to in paragraph (c).

SOR/97-228, s. 9.

Division 2

Licences And Licensed Dealers G.02.001. Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug.

SOR/2004-238, s. 3.

G.02.001.1. To be eligible for a dealer’s licence, a person must be

(a) an individual who ordinarily resides in Canada;

(b) a corporation that has its head office in Canada or operates a branch office in Canada; or

(c) the holder of a position that includes responsibility for controlled drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

SOR/2004-238, s. 3.

G.02.001.2. (1) A licensed dealer

(a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

(b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent.

(2) The qualified person in charge and, if applicable, the alternate qualified person in charge

(a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

(b) shall be a pharmacist or a practitioner registered with a provincial professional licensing authority or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

(c) shall not have been convicted, as an adult, within the preceding 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

SOR/2004-238, s. 3; SOR/2010-222, ss. 1(E), 34. Previous Version G.02.002. No licensed dealer may import or export a controlled drug without a permit.

G.02.002.1 A licensed dealer is authorized to have a controlled drug in his possession for the purpose of exporting the controlled drug from Canada if he has obtained the controlled drug pursuant to these Regulations.

SOR/97-515, s. 4.

G.02.003. (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing

(a) if the licence is sought for

(i) an individual, the individual’s name,

(ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and

(iii) the holder of a position mentioned in paragraph G.02.001.1(c), the applicant’s name and the title of the position;

(b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;

(c) the name, date of birth and gender of the individual in charge of the premises;

(d) with respect to the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge,

(i) their name, date of birth and gender,

(ii) their academic qualifications, training and work experience relevant to their duties,

(iii) their hours of work at the premises,

(iv) their title at the premises,

(v) the name and title of their immediate supervisor at the premises, and

(vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;

(e) the name and gender of the individuals authorized to place an order for a controlled drug on behalf of the applicant;

(f) in the case of a product or compound that contains a controlled drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out

(i) the brand name, if any, of each product or compound,

(ii) the controlled drug in each product or compound,

(iii) the strength per unit of the controlled drug in each product or compound,

(iv) the quantity or package sizes of each product or compound, and

(v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer’s licence number of the other dealer;

(g) the activities referred to in section G.02.001 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

(h) if the licence is sought to produce a controlled drug other than a product or compound that contains a controlled drug,

(i) the name of the controlled drug to be produced,

(ii) the quantity that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and

(iii) if the controlled drug would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other dealer;

(i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;

(j) a detailed description of the method that the applicant proposes to use for recording their controlled drug transactions; and

(k) for any activity referred to in section G.02.001, other than the activities described in paragraphs (f) and (h), the controlled drug and the purpose for carrying out the activity.

(2) An application for a dealer’s licence must

(a) be signed by the individual in charge of the premises to which the licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual has the authority to bind the applicant.

(3) An application for a dealer’s licence must be accompanied by

(a) declarations signed by the individual in charge of the premises to which the application applies, the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge, stating that they have not been convicted, as an adult, within the previous 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years, of a designated drug offence or a designated criminal offence;

(c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;

(d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge have the knowledge and experience required under paragraph G.02.001.2(2)(a);

(e) if the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge is not a pharmacist or a practitioner registered with a provincial professional licensing authority, a copy of the person’s degree required under paragraph G.02.001.2(2)(b) and a copy of the course transcript for that degree;

(f) if the applicant’s name appears on the label of a product or compound that contains a controlled drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and

(g) if the applicant is a corporation, a copy of

(i) the certificate of incorporation or other constituting instrument, and

(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.

(4) The method proposed by the applicant under paragraph (1)(j) must

(a) allow for the recording of controlled drug transactions in accordance with section G.02.014; and

(b) permit the Minister to audit the activities of the licensed dealer with respect to controlled drugs.

(5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing

(a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;

(b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and

(c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.

SOR/2004-238, s. 4; SOR/2010-222, s. 2. Previous Version G.02.003.1. The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

SOR/2004-238, s. 4.

G.02.003.2. Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under sections G.02.003 and G.02.003.1, issue a dealer’s licence that contains

(a) the licence number;

(b) the name of the holder of the licence or the title of the position they hold, as the case may be, or, if the holder is a corporation, its corporate name;

(c) a list of the activities that are permitted;

(d) the address of the premises at which the licensed dealer may carry on the permitted activities;

(e) the name of the controlled drug for which the activities are permitted;

(f) the security level at the premises, determined in accordance with the Security Directive;

(g) the effective date of the licence;

(h) the expiry date of the licence, which may not be later than three years after its effective date;

(i) any conditions to be met by the holder of the licence to

(i) ensure that an international obligation is respected,

(ii) provide the security level referred to in paragraph (f), or

(iii) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use;

(j) in the case of a producer of a controlled drug, the quantity of the controlled drug that may be produced under the licence and the period during which that quantity may be produced; and

(k) in the case of the maker or assembler of a product or compound that contains a controlled drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

(i) the licence number,

(ii) the brand name, if any, of each product or compound,

(iii) the controlled drug in each product or compound,

(iv) the strength per unit of the controlled drug in each product or compound, and

(v) the quantity or package sizes of each product or compound.

SOR/2004-238, s. 4; SOR/2010-222, ss. 3, 35(F). Previous Version G.02.003.3. (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if

(a) the applicant is not an eligible person under section G.02.001.1;

(b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section G.02.015;

(c) false or misleading information or false or falsified documents were submitted in or with the application;

(d) an activity for which the licence is requested would not be in compliance with an international obligation;

(e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

(f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

(g) the applicant is in contravention of or has contravened during the preceding 10 years

(i) a provision of the Act or the regulations made or continued under it, or

(ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;

(h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a controlled drug being diverted to an illicit market or use;

(i) the individual in charge of the premises, the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge has been convicted, as an adult, within the preceding 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(j) the proposed method referred to in paragraph G.02.003(1)(j) is not capable of recording controlled drug transactions as required under section G.02.014 or permitting the Minister to audit the applicant’s activities with respect to controlled drugs in a timely manner; or

(k) the additional information required under section G.02.003.1 has not been provided or is insufficient to process the application.

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing a controlled drug from being diverted to an illicit market or use, the Minister shall not refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

(a) does not have a history of non compliance with the Act or any regulation made or continued under it; and

(b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

SOR/2004-238, s. 4; SOR/2010-222, ss. 4, 35(F). Previous Version G.02.003.4. (1) To apply to renew a dealer’s licence, a licensed dealer shall submit to the Minister

(a) the information referred to in paragraphs G.02.003(1)(a) to (k); and

(b) the following documents, namely,

(i) the documents referred to in paragraphs G.02.003(3)(a) and (d) and, subject to subsection G.02.003(5), the document referred to in paragraph G.02.003(3)(b),

(ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph G.02.003(3)(e), and

(iii) the original dealer’s licence that is to be renewed.

(2) An application for renewal must

(a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual in charge has the authority to bind the applicant.

(3) Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section G.02.003.1, issue a renewed dealer’s licence that contains the information specified in paragraphs G.02.003.2(a) to (k).

SOR/2004-238, s. 4.

G.02.003.5. (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister

(a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section G.02.003 that are relevant to the proposed amendment; and

(b) the original dealer’s licence.

(2) An application for amendment must

(a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual in charge has the authority to bind the applicant.

(3) Subject to section G.02.003.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the holder of the licence to

(a) ensure that an international obligation is respected;

(b) provide for the security level referred to in paragraph G.02.003.2(f) or the new level required as a result of the amendment being implemented; or

(c) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.

SOR/2004-238, s. 4; SOR/2010-222, ss. 5(F), 35(F). Previous Version G.02.003.6. (1) A licensed dealer shall

(a) obtain the Minister’s approval before making any of the following changes, namely,

(i) a change relating to the security at the premises referred to in the dealer’s licence, or

(ii) the replacement or addition of

(A) the individual in charge of the premises to which the dealer’s licence applies,

(B) the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises to which the dealer’s licence applies, and

(C) an individual authorized to place an order for a controlled drug on behalf of the licensed dealer;

(b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in

(i) the application for the dealer’s licence under section G.02.003,

(ii) the application to renew the dealer’s licence under section G.02.003.4, or

(iii) the request for approval under paragraph (a); and

(c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in

(i) the application for the dealer’s licence under section G.02.003,

(ii) the application to renew the dealer’s licence under section G.02.003.4, or

(iii) the request for approval under paragraph (a).

(2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:

(a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,

(i) the information specified in paragraph G.02.003(1)(c), and

(ii) the declarations specified in paragraph G.02.003(3)(a) and, subject to subsection G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c);

(b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,

(i) the information specified in paragraph G.02.003(1)(d), and

(ii) the documents specified in paragraphs G.02.003(3)(a), (d) and (e) and, subject to section G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c); and

(c) in the case of the replacement or addition of an individual who is authorized to place an order for a controlled drug on behalf of the licensed dealer, the individual’s name and gender.

SOR/2004-238, s. 4.

G.02.003.7. The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

SOR/2004-238, s. 4.

G.02.003.8. (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section G.02.003.91 if

(a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

(b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;

(c) the licensed dealer is no longer an eligible person under section G.02.001.1;

(d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the preceding 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or

(e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use.

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing a controlled drug from being diverted to an illicit market or use, the Minister shall not revoke a dealer’s licence under paragraph (1)(a) or (b) if the licensed dealer

(a) has no history of non-compliance with the Act and the regulations made or continued under it; and

(b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

SOR/2004-238, s. 4; SOR/2010-222, ss. 6, 35(F). Previous Version G.02.003.9. The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a controlled drug from being diverted to an illicit market or use.

SOR/2004-238, s. 4; SOR/2010-222, s. 35(F). Previous Version G.02.003.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under this Part, the Minister shall

(a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and

(b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation.

(2) The suspension of a dealer’s licence under this Part takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.

(3) A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension of the licence is unfounded.

SOR/2004-238, s. 4.

G.02.004. A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the controlled drugs specified in their dealer’s licence.

SOR/2004-238, s. 4.

G.02.005. to G.02.007 [Repealed, SOR/2004-238, s. 4]

G.02.008. The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a controlled drug.

G.02.009. An application for a permit shall be in a form approved by the Minister.

G.02.010. Every licence or permit issued under this Part is subject to the condition that the licensed dealer will comply with the provisions of this Part.

G.02.011. The Minister shall revoke a permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

SOR/2004-238, s. 5; SOR/2010-222, s. 7. Previous Version G.02.011.1. (1) Subject to subsection (2), the Minister shall revoke a permit by taking the same measures as those set out in subsection G.02.003.91(1) if

(a) any of paragraphs G.02.003.8(1)(a) to (e) applies with respect to the dealer’s licence as it pertains to the controlled drug to be imported or exported; or

(b) the import or export permit was issued on the basis of false or misleading information or false or falsified documents submitted in support of the application.

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing a controlled drug from being diverted to an illicit market or use, the Minister shall not revoke a permit under paragraph G.02.003.8(1)(a) or (b) or G.02.011.1(1)(b) if the holder meets the conditions set out in paragraphs G.02.003.8(2)(a) and (b).

(3) The Minister may revoke a permit if the holder fails to comply with the decision of the Minister to suspend the permit under section G.02.011.2 or if the situation giving rise to the suspension is not rectified.

SOR/2010-222, s. 7.

G.02.011.2. (1) The Minister shall suspend a permit without prior notice if

(a) the dealer’s licence as it pertains to the controlled drug to be imported or exported has expired or has been suspended or revoked;

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety or security;

(c) the Minister has reasonable grounds to believe that the continuation of the permit would present a risk of a controlled drug being diverted to an illicit market or use; or

(d) the import or export would contravene the laws of the country of export or import or a country of transit or transhipment.

(2) A decision of the Minister to suspend a permit takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.

(3) A person whose permit is suspended under subsection (1) may, within 10 days after receiving the notice of suspension, provide the Minister with reasons why the suspension is unfounded.

SOR/2010-222, s. 7.

G.02.012. A dealer’s licence is valid until the earlier of

(a) the expiry date set out in the licence, and

(b) the revocation or suspension of the licence under section G.02.003.7, G.02.003.8 or G.02.003.9.

SOR/2004-238, s. 5.

G.02.013. A permit issued under section G.02.008 is valid only for the particular importation or exportation in respect of which it was issued.

G.02.014. (1) Every licensed dealer shall keep a record of the following:

(a) the name and quantity of any controlled drug received by the licensed dealer, the name and address of the person who sold or provided it and the date it was received;

(b) the name, quantity and form of any controlled drug sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

(c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

(c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock; and

(d) the name and quantity of any controlled drug he had in stock at the end of each month.

(2) The record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made;

(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs; and

(c) for any period of at least two years on the premises described in the licence of the licensed dealer.

(3) The record of information referred to in paragraphs (1)(a), (b) and (d) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).

SOR/78-427, s. 1; SOR/97-228, s. 10; SOR/2004-238, s. 6; SOR/2010-222, s. 8(E). Previous Version G.02.015. (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

(a) the premises used or intended to be used in producing, making, assembling or storing a controlled drug; and

(b) the process and conditions of the producing, making, assembling or storing.

(2) [Repealed, SOR/2010-222, s. 9]

SOR/78-427, s. 2; SOR/2004-238, s. 7; SOR/2010-222, s. 9. Previous Version G.02.016. Every licensed dealer shall

(a) furnish such information respecting the dealings of such person in any controlled drug in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required to be kept by this Part;

(c) permit an inspector to make copies of or to take extracts from such books, records and documents; and

(d) permit an inspector to check all stock of controlled drugs located on the premises described in the licence of the licensed dealer.

G.02.017. [Repealed, SOR/78-427, s. 3]

G.02.018. Every licensed dealer shall notify the Minister promptly of changes in the following:

(a) [Repealed, SOR/2010-222, s. 10]

(b) the premises in which a controlled drug is produced, made, assembled or stored; and

(c) the process and conditions of the producing, making, assembling or storing.

SOR/2004-238, s. 8; SOR/2010-222, s. 10. Previous Version G.02.019. Every licensed dealer shall

(a) provide such protection against loss or theft of any controlled drug in his possession as may be required by the Minister;

(b) report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof; and

(c) securely pack a controlled drug in its immediate container and seal it in such a manner that it cannot be opened without breaking the seal.

SOR/88-482, s. 2(F).

G.02.020. A licensed dealer may only import into or export out of Canada a controlled drug at the place specified in his permit.

G.02.021. A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any controlled drug intended for export out of Canada.

G.02.022. A licensed dealer shall in taking delivery of a controlled drug imported by him or in making delivery of a controlled drug

(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and

(b) use such method of transportation as will ensure an accurate record being kept of the drug and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

G.02.023. Notwithstanding section G.02.022, a preparation may be delivered by common carrier.

G.02.024. A licensed dealer shall not sell or provide a controlled drug to any person other than a

(a) licensed dealer;

(b) pharmacist;

(c) practitioner;

(d) hospital employee or a practitioner in a hospital;

(e) [Repealed, SOR/2010-222, s. 11]

(f) a person who has been granted an exemption under section 56 of the Controlled Drugs and Substances Act with respect to the possession of a controlled drug.

SOR/78-220, s. 3; SOR/85-550, s. 2; SOR/99-125, s. 2; SOR/2004-238, s. 9; SOR/2010-222, s. 11. Previous Version G.02.024.1. Subject to section G.02.024.2 and notwithstanding sections G.02.024 and G.02.025, no licensed dealer shall

(a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(c) sell or provide a controlled drug, other than a preparation, to a practitioner named in a notice given by the Minister under section G.04.004.2; or

(d) sell or provide a preparation to a practitioner named in a notice given by the Minister under section G.04.004.2.

SOR/2003-135, ss. 7, 8; SOR/2004-238, s. 10.

G.02.024.2. Section G.02.024.1 does not apply to a licensed dealer to whom the Minister has issued a notice of retraction of the notice

(a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or

(b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.

SOR/2003-135, s. 3.

G.02.025. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer’s licence, sell or provide a controlled drug to a person referred to in section G.02.024 if

(a) [Repealed, SOR/2010-222, s. 12]

(b) the licensed dealer has received, on the premises described in the licence,

(i) a written order,

(ii) an order sent through a computer from a remote input device, or

(iii) a verbal order for a controlled drug listed in Part II or III of the schedule to this Part

that specifies the name and quantity of the drug to be supplied.

(2) A licensed dealer who has received an order referred to in subparagraph (1)(b)(i) and verified the signature on the order may sell or provide a controlled drug to a person referred to in section G.02.024, if the order is signed and dated by one of the following persons:

(a) if the controlled drug is to be sold or provided to a person referred to in paragraph G.02.024(a), (b), (c) or (f), by that person; or

(b) if the controlled drug is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order.

(3) A licensed dealer may sell or provide a controlled drug pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (5) and (6).

(3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) may provide a controlled drug to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.

(3.2) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii) may provide a controlled drug listed in Part II or III of the schedule to this Part to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.

(4) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii), and has provided a controlled drug listed in Part II or III of the schedule to this Part to a person referred to in paragraphs G.02.024(b) to (d), shall immediately record

(a) the name of the person to whom the controlled drug was sold or provided;

(b) if the drug was provided to a hospital employee or a practitioner in a hospital, the name of the pharmacist in charge of the dispensary of the hospital or the name of the practitioner authorized by the person in charge of the hospital to sign the order; and

(c) the date that the order is received.

(5) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that

(a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) is in the possession and care of that pharmacist or practitioner; and

(c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.

(6) For the purposes of this section, a computer program shall be able to

(a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) identify the pharmacist or practitioner placing the order by means of an identifying code unique to that pharmacist or practitioner;

(c) process separately and identify controlled drugs by the segregation of the orders for those drugs;

(d) detect unusual orders and thereby necessitate manual intervention by the licensed dealer; and

(e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.

(7) Where a licensed dealer has received, from a pharmacist or practitioner, an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) or a verbal order referred to in subparagraph (1)(b)(iii), he shall, within five working days of filling the order for a controlled drug, obtain and keep a receipt that includes

(a) the signature of the pharmacist or the practitioner who received the controlled drug;

(b) the date the pharmacist or practitioner received the controlled drug; and

(c) the name and the quantity of the controlled drug.

(8) If a licensed dealer has not received a receipt from a pharmacist or practitioner under subsection (7) within the time prescribed by that subsection, the dealer shall not, until after receiving the receipt, sell or provide a controlled drug to the pharmacist or practitioner pursuant to a further

(a) order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii); or

(b) verbal order referred to in subparagraph (1)(b)(iii).

from that pharmacist or practitioner.

SOR/78-220, s. 4; SOR/78-427, s. 4; SOR/85-550, s. 3; SOR/88-482, s. 3(F); SOR/90-261, s. 2(F); SOR/97-228, s. 11; SOR/2004-238, s. 11; SOR/2010-222, s. 12. Previous Version

G.02.026. A licensed dealer shall not sell or provide a controlled drug more than once in respect of one order unless

(a) the order for the drug states that the quantity of the drug is to be sold or provided

(i) in specified portions,

(ii) in separate deliveries not exceeding four deliveries, and

(iii) at specified intervals; or

(b) at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later in accordance with the order.

SOR/2004-238, s. 12; SOR/2010-222, s. 13(F). Previous Version G.02.027. [Repealed, SOR/80-543, s. 12]

Division 3

Pharmacists G.03.001. (1) A pharmacist, on receipt of a controlled drug from a licensed dealer or from another pharmacist, shall keep a record of the name and quantity of the controlled drug received by them, the name and address of the person who sold or provided it and the date it was received.

(2) The record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made; and

(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs.

(3) The record of information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).

SOR/78-427, s. 5; SOR/85-550, s. 4; SOR/86-91, s. 2(F); SOR/90-261, s. 3(F); SOR/97-228, s. 12; SOR/2004-238, s. 13; SOR/2010-222, s. 14(E). Previous Version G.03.002. No pharmacist shall, except as otherwise provided in this Part, sell or provide a controlled drug to any person unless the pharmacist has first been provided with a prescription for it, and

(a) if the prescription is in writing, it has been signed and dated by the practitioner issuing the same and the signature of the practitioner where not known to the pharmacist, has been verified by him; or

(b) if the prescription is given verbally, the pharmacist has taken reasonable precaution to satisfy himself that the person giving the prescription is a practitioner.

SOR/2004-238, s. 14.

G.03.002.1. Subject to section G.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall

(a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or

(d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2.

SOR/2003-135, ss. 7, 8; SOR/2004-238, s. 15.

G.03.002.2. Section G.03.002.1 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice

(a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or

(b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.

SOR/2003-135, s. 4.

G.03.003. A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice

(a) upon a written order, signed and dated by that practitioner, that has been verified if the signature of the practitioner is unknown to the pharmacist; or

(b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner.

SOR/85-550, s. 5; SOR/2004-238, s. 16.

G.03.004. A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided.

SOR/2004-238, s. 17.

G.03.005. A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in

charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified.

SOR/85-550, s. 6; SOR/2004-238, s. 18(E).

G.03.006. A pharmacist shall not refill a prescription for a controlled drug unless

(a) the practitioner, at the time that he issued the prescription, directed in writing, in the case of a controlled drug listed in Part I of the schedule to this Part, or directed in writing or orally, in the case of a controlled drug listed in Part II or III of the schedule to this Part, that the prescription be refilled, the number of times that it may be refilled and the dates for or the intervals between refills; and

(b) the pharmacist keeps a record of each refilling of a prescription.

SOR/78-427, s. 6; SOR/97-228, s. 13.

G.03.007 A pharmacist who dispenses, pursuant to an order or prescription, a controlled drug listed in Part I of the schedule to this Part, other than a preparation, shall forthwith enter in a book, register or similar record maintained for such purposes

(a) the name and address of the person named in the order or prescription;

(b) the name, initials and address of the practitioner who issued the order or prescription;

(c) the name or initials of the pharmacist who dispensed the controlled drug;

(d) the name, quantity and form of the controlled drug dispensed;

(e) the date on which the controlled drug was sold or provided; and

(f) the number assigned to the order or prescription.

SOR/78-427, s. 7; SOR/81-359, s. 1(F); SOR/97-228, s. 14; SOR/2004-238; s. 19.

G.03.008. A pharmacist shall, before dispensing a controlled drug pursuant to a prescription given orally or a verbal order, make a written record thereof, setting forth,

(a) the name and address of the person named in the prescription;

(b) the name, quantity and form of such controlled drug;

(c) the directions for use given therewith;

(d) the name, initials and address of the practitioner who issued the prescription;

(e) the name or initials of the pharmacist who dispensed such controlled drug;

(f) the date on which the controlled drug was sold or provided; and

(g) the number assigned to the prescription.

SOR/85-550, s. 7; SOR/2004-238, s. 20.

G.03.009. A pharmacist shall maintain a special prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions in writing for controlled

drugs dispensed and the written record of all controlled drugs dispensed pursuant to a prescription or order verbally given.

G.03.010. A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part.

G.03.011. A pharmacist shall

(a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require;

(b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep;

(c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and

(d) permit an inspector to check all stocks of controlled drugs on his premises.

G.03.012. A pharmacist shall take all reasonable steps that are necessary to protect controlled drugs on his premises or under his control against loss or theft.

SOR/85-550, s. 8.

G.03.013. A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

G.03.014. A pharmacist may, upon receiving a written order for a controlled drug signed and dated by

(a) the licensed dealer who sold or provided that drug to them, return that drug to that dealer;

(b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes;

(c) a Regional Director of the Department, sell or provide to or in accordance with the order of that Director any quantity of that drug, specified in the order, that is required by the Director in connection with their duties; and

(d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order.

SOR/81-359, s. 2; SOR/85-550, s. 9; SOR/99-125, s. 3; SOR/2004-238, s. 21.

G.03.015. A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions.

SOR/85-550, s. 10; SOR/2004-238, s. 22.

G.03.016. A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details.

G.03.017. The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the registration or authorization of the person to practise their profession

(a) in the province in which the pharmacist is registered or entitled to practise if

(i) the authority submits a written request that states the name and address of the pharmacist, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

(ii) the Minister has reasonable grounds to believe that the pharmacist has

(A) contravened a rule of conduct established by the authority,

(B) been found guilty in a court of law of a designated drug offence or of a contravention of this Part, or

(C) contravened a provision of this Part; or

(b) in a province in which the pharmacist is not registered or entitled to practise, if the authority submits to the Minister

(i) a written request for information that states

(A) the name and address of the pharmacist, and

(B) a description of the information being sought, and

(ii) documentation that shows that the pharmacist has applied to that authority to practise in that province.

SOR/86-881, s. 1; SOR/97-228, s. 15; SOR/2003-135, s. 5; SOR/2010-222, s. 15. Previous Version G.03.017.1. A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection G.03.017.2(3) a notice, issued under section G.03.017.2, advising them that recipients of the notice must not sell or provide a controlled drug other than a preparation, a preparation, or both, to that pharmacist.

SOR/2003-135, s. 5.

G.03.017.2. (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the pharmacist named in the notice a controlled drug other than a preparation, a preparation, or both.

(2) The notice must be issued if the pharmacist named in the notice has

(a) made a request to the Minister in accordance with section G.03.017.1 to issue the notice;

(b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the pharmacist is practising and that authority has requested the Minister in writing to issue the notice; or

(c) been found guilty in a court of law of a designated drug offence or of an offence under this Part.

(3) The notice must be issued to

(a) all licensed dealers;

(b) all pharmacies within the province in which the pharmacist named in the notice is registered and practising;

(c) the provincial professional licensing authority of the province in which the pharmacist named in the notice is registered or entitled to practise; and

(d) any interested provincial professional licensing authority in another province that has made a request to the Minister to issue the notice.

(4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the pharmacist named in the notice

(a) has contravened any of the provisions of sections G.03.001 to G.03.016;

(b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, contrary to accepted pharmaceutical practice;

(c) has, on more than one occasion, self-administered a preparation, contrary to accepted pharmaceutical practice;

(d) has, on more than one occasion, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice;

(e) has, on more than one occasion, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or

(f) is unable to account for the quantity of controlled drug for which the pharmacist was responsible under this Part.

(5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has

(a) consulted with the provincial professional licensing authority of the province in which the pharmacist to whom the notice relates is registered or entitled to practise;

(b) given that pharmacist an opportunity to present reasons why the notice should not be issued and considered those reasons; and

(c) considered

(i) the compliance history of the pharmacist in respect of the Act and the regulations made or continued under it, and

(ii) whether the actions of the pharmacist pose a significant security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.

SOR/2003-135, s. 5; SOR/2010-222, ss. 16, 35(F). Previous Version G.03.017.3. The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were issued a notice under subsection G.03.017.2(1) with a notice of retraction of that notice if

(a) in the circumstance described in paragraph G.03.017.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or

(b) in a circumstance described in any of paragraphs G.03.017.2(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has

(i) requested in writing that a retraction of the notice be issued, and

(ii) provided a letter from the provincial professional licensing authority of the province in which the pharmacist is registered or entitled to practise, in which the authority consents to the retraction of the notice.

SOR/2003-135, s. 5; SOR/2010-222, s. 17. Previous Version G.03.017.4. and G.03.017.5. [Repealed, SOR/2003-135, s. 5]

Division 4

Practitioners G.04.001. (1) In this section,

“administer” includes to prescribe, sell or provide; (administrer)

“designated drug” means any of the following controlled drugs:

(a) amphetamine and its salts,

(b) benzphetamine and its salts,

(c) methamphetamine and its salts,

(d) phenmetrazine and its salts, or

(e) phendimetrazine and its salts. (drogue désignée)

(2) Subject to subsections (3) and (4) and to an exemption granted under section 56 of the Controlled Drugs and Substances Act with respect to the administration of the controlled drug specified in the exemption, no practitioner shall administer a controlled drug to any person or animal.

(3) A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if

(a) that person or animal is a patient under his professional treatment; and

(b) the controlled drug is required for the condition for which the patient is receiving treatment.

(4) A practitioner may administer a designated drug to an animal or a person who is a patient under his professional treatment where the designated drug is for the treatment of any of the following conditions:

(a) in humans

(i) narcolepsy,

(ii) hyperkinetic disorders in children,

(iii) mental retardation (minimal brain dysfunction),

(iv) epilepsy,

(v) parkinsonism, or

(vi) hypotensive states associated with anesthesia; or

(b) in animals, depression of cardiac and respiratory centres.

SOR/99-125, s. 4; SOR/2004-238, s. 23.

G.04.002. (1) A practitioner who sells or provides a controlled drug to a person for self- administration or for administration to an animal shall, whether or not the practitioner charges for the drug, keep a record showing the name and quantity of the controlled drug sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided if the quantity of the controlled drug exceeds

(a) three times the maximum daily dosage recommended by the producer, maker or assembler of the controlled drug; or

(b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the producer, maker or assembler has not recommended a maximum daily dosage.

(2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it.

SOR/88-482, s. 4(F); SOR/2004-238, s. 24.

G.04.002A. A practitioner shall

(a) furnish to the Minister on request such information respecting

(i) the use by the practitioner of controlled drugs received — including the administering, selling or providing of the drugs to a person — , and

(ii) the prescriptions for controlled drugs issued by the practitioner,

as the Minister may require;

(b) produce to an inspector on request any records that these Regulations require the practitioner to keep;

(c) permit an inspector to make copies of such records or to take extracts therefrom;

(d) permit an inspector to check all stocks of controlled drugs on the practitioner’s premises;

(e) retain in his possession for at least two years any record that these Regulations require him to keep;

(f) take adequate steps to protect controlled drugs in his possession from loss or theft; and

(g) report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner’s discovery of the loss or theft.

SOR/2004-238, s. 25.

G.04.003. [Repealed, SOR/2010-222, s. 18] Previous Version G.04.004. The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the registration or authorization of the person to practise their profession

(a) in the province in which the practitioner is registered or entitled to practise if

(i) the authority submits a written request that states the name and address of the practitioner, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

(ii) the Minister has reasonable grounds to believe that the practitioner has

(A) contravened a rule of conduct established by the authority,

(B) been found guilty in a court of law of a designated drug offence or of a contravention of this Part, or

(C) contravened a provision of this Part; or

(b) in a province in which the practitioner is not registered or entitled to practise, if the authority submits to the Minister

(i) a written request for information that states

(A) the name and address of the practitioner, and

(B) a description of the information being sought, and

(ii) documentation that shows that the practitioner has applied to that authority to practise in that province.

SOR/86-881, s. 2; SOR/97-228, s. 17; SOR/2003-135, s. 6; SOR/2010-222, s. 19. Previous Version G.04.004.1. A practitioner may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section G.04.004.2, advising them of one or more of the following requirements:

(a) recipients of the notice must not sell or provide a controlled drug, other than a preparation, to that practitioner;

(b) recipients of the notice must not sell or provide a preparation to that practitioner;

(c) pharmacists practising in the notified pharmacies must not fill a prescription or order for a controlled drug, other than a preparation, from that practitioner; and

(d) pharmacists practising in the notified pharmacies must not fill a prescription or order for a preparation from that practitioner.

SOR/2003-135, s. 6.

G.04.004.2. (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that

(a) licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the practitioner named in the notice a controlled drug other than a preparation, a preparation, or both; or

(b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a controlled drug other than a preparation, a preparation, or both.

(2) The notice must be issued if the practitioner named in the notice has

(a) made a request to the Minister in accordance with section G.04.004.1 to issue the notice;

(b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the practitioner is practising and that authority has requested the Minister in writing to issue the notice; or

(c) been found guilty in a court of law of a designated drug offence or of an offence under this Part.

(3) The notice must be issued to

(a) all licensed dealers;

(b) all pharmacies within the province in which the practitioner named in the notice is registered and practising;

(c) the provincial professional licensing authority of the province in which the practitioner named in the notice is registered or entitled to practise;

(d) any interested provincial professional licensing authority in another province that has made a request to the Minister to issue the notice; and

(e) all pharmacies in an adjacent province in which a prescription or order from the practitioner named in the notice may be filled.

(4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the practitioner named in the notice

(a) has contravened any of the provisions of sections G.04.001 to G.04.002A;

(b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;

(c) has, on more than one occasion, self-administered a preparation, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;

(d) has, on more than one occasion, prescribed, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice;

(e) has, on more than one occasion, prescribed, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice; or

(f) is unable to account for the quantity of controlled drug for which the practitioner was responsible under this Part.

(5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has

(a) consulted with the provincial professional licensing authority of the province in which the practitioner to whom the notice relates is registered or entitled to practise;

(b) given that practitioner an opportunity to present reasons why the notice should not be issued and considered those reasons; and

(c) considered

(i) the compliance history of the practitioner in respect of the Act and the regulations made or continued under it, and

(ii) whether the actions of the practitioner pose a significant security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.

SOR/2003-135, s. 6; SOR/2010-222, ss. 20, 35(F). Previous Version G.04.004.3. The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were issued a notice under subsection G.04.004.2(1) with a notice of retraction of that notice if

(a) in the circumstance described in paragraph G.04.004.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or

(b) in a circumstance described in any of paragraphs G.04.004.2(2)(b) and (c) and (4)(a) to (f), the practitioner named in the notice has

(i) requested in writing that a retraction of the notice be issued, and

(ii) provided a letter from the provincial professional licensing authority of the province in which the practitioner is registered or entitled to practise, in which the authority consents to the retraction of the notice.

SOR/88-482, s. 5(F); SOR/2003-135, s. 6; SOR/2010-222, s. 21. Previous Version G.04.004.4. and G.04.004.5. [Repealed, SOR/2003-135, s. 6]

Division 5

Hospitals G.05.001. (1) A person who is in charge of a hospital shall keep or cause to be kept a record of the following information:

(a) the name and quantity of any controlled drug received for the hospital by a hospital employee or a practitioner in the hospital;

(b) the name and address of the person from whom any controlled drug was received and the date on which it was received;

(c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

(c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock;

(d) the name of the patient for whom a controlled drug was dispensed;

(e) the name of the practitioner ordering or prescribing a controlled drug; and

(f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof.

(2) Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept

(a) in a manner that permits an audit to be made;

(b) in a book, register or similar record maintained exclusively for controlled drugs; and

(c) for a period of at least two years.

(3) The information referred to in paragraphs (1)(d) to (f) may, with respect to a preparation, be kept in a form other than that specified in paragraph (2)(b).

(4) The information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).

SOR/78-427, s. 8; SOR/85-550, s. 11; SOR/88-482, s. 6; SOR/97-228, s. 18; SOR/2004-238, s. 27.

G.05.002. A person who is in charge of a hospital shall

(a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required by these Regulations to be kept;

(c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and

(d) permit an inspector to check all stocks of controlled drugs in the hospital.

G.05.003. (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section.

(2) On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal.

(3) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

(4) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

(5) The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research.

(6) No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified.

SOR/85-550, s. 12; SOR/88-482, s. 7; SOR/2004-238, s. 28; SOR/2010-222, s. 22(F). Previous Version G.05.004. A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

SOR/78-427, s. 9.

Division 6 Authority and Penalty

G.06.001. (1) and (2) [Repealed, SOR/99-125, s. 5]

(3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a controlled drug in their possession, provide or deliver the drug to

(a) a practitioner of medicine; or

(b) an agent of a practitioner of medicine, where the agent has been exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug.

(4) If an agent of a practitioner of medicine receives a controlled drug under subsection (3), they shall immediately provide or deliver it

(a) to the practitioner of whom he is the agent; or

(b) to the Minister or his agent.

(5) A practitioner of medicine who receives a controlled drug under subsection (3) or (4) shall immediately provide or deliver it

(a) for the purpose of identification or analysis thereof, to a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug for that purpose; or

(b) to the Minister or his agent.

SOR/99-125, s. 5; SOR/2004-238, s. 29.

G.06.002. Every person who is exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession or administration, as the case may be, of a controlled drug shall

(a) keep and retain for a period of two years from the date of the making of the record, a record of

(i) the kind, date and quantity of any controlled drug purchased or received by him,

(ii) the name and address of the person from whom the controlled drug was received, and

(iii) particulars of the use to which the controlled drug was put; and

(b) furnish such information respecting such controlled drugs as the Minister may require, and shall permit access to the records required to be kept by this Part.

SOR/85-550, s. 13; SOR/88-482, s. 8(F); SOR/99-125, s. 6.

Test Kits Containing Controlled Drugs

G.06.002.1. Any person may sell, possess or otherwise deal in a test kit that contains a controlled drug if

(a) a registration number has been issued for the test kit pursuant to section G.06.002.3;

(b) the test kit bears, on its external surface,

(i) the name of the producer, maker or assembler,

(ii) the trade name or trade mark, and

(iii) the registration number issued therefor pursuant to section G.06.002.3;

(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

(d) the registration number has not been cancelled pursuant to section G.06.002.4.

SOR/2004-238, s. 30.

G.06.002.2. The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Director an application containing

(a) particulars of the design and construction of the test kit;

(b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

(c) a statement of the proposed use of the test kit; and

(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

G.06.002.3. Where, on application under section G.06.002.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

(a) contains a controlled drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

(b) contains such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.

SOR/81-21, ss. 1, 2; SOR/86-91, s. 3(F).

G.06.002.4. The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,

(a) it is necessary to cancel the registration number in the interest of public health; or

(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

G.06.003. Any person who violates any provision of this Part is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both such fine and imprisonment.

Division 7

General

G.07.001. (1) In this section,

“member” means any person who is registered, certified or otherwise licensed by a nursing statutory body for the practice of nursing; (membre)

“nursing statutory body” means any provincial professional licensing authority that, pursuant to the laws of that province, registers, certifies or otherwise licenses a person for the practice of nursing. (organisme de nursing)

(2) The Minister may provide to a nursing statutory body any information obtained under the Controlled Drugs and Substances Act, the Food and Drugs Act or these Regulations that involves any member of that body.

SOR/82-120, s. 1; SOR/97-228, s. 19.

G.07.002 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.

SOR/97-228, s. 20.

SCHEDULE

(Sections G.01.001 and G.01.004, subsection G.02.014(3), subparagraph G.02.025(1)(b)(iii), subsections G.02.025(3.2) and (4) and G.03.001(3), paragraph G.03.006(a), section G.03.007 and subsection G.05.001(4))

PART I Amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives,

1. isomers and analogues, excluding those substances set out in item 1 of the schedule to Part J but including: (1) amphetamine (α-methylbenzeneethanamine) (2) methamphetamine (N,α-dimethylbenzeneethanamine) (3) Benzphetamine (N-benzyl-N,α-dimethylbenzeneethanamine)

2. Methylphenidate (α-phenyl-2-piperidineacetic acid methyl ester) and any salt thereof 3. Methaqualone (2-methyl-3-(2-methylphenyl)-4(3H)quinazolinone) and any salt thereof 4. Phendimetrazine (d-3,4-dimethyl-2-phenylmorpholine) and any salt thereof 5. Phenmetrazine (3-methyl-2-phenylmorpholine) and any salt thereof 6. Pentobarbital (5-ethyl-5-(1-methylbutyl)barbituric acid) 7. Secobarbital (5-allyl-5-(1-methylbutyl)barbituric acid) 8. 4-hydroxybutanoic acid (GHB) and any salt thereof 9. Aminorex (4,5-dihydro-5-phenyl-2-oxazolamine) and any salt thereof

10. Fenetylline (d,l-3,7-dihydro-1,3-dimethyl-7-(2-[(1-methyl-2-phenethyl)amino]ethyl)-1H­purine-2,6-dione) and any salt thereof

11. Glutethimide (2-ethyl-2-phenylglutarimide) 12. Lefetamine ((-)-N,N-dimethyl-α-phenylbenzeneethanamine) and any salt thereof 13. Mecloqualone (2-methyl-3-(2-chlorophenyl)-4(3H)-quinazolinone) and any salt thereof

14. Mesocarb (3-(α-methylphenethyl)-N-(phenylcarbamoyl)sydnone imine) and any saltthereof 15. Pemoline (2-amino-5-phenyl-oxazolin-4-one) and any salt thereof

16. Zipeprol (4-(2-methoxy-2-phenylethyl)-α-(methoxyphenylmethyl)-1-piperazineethanol)and any salt thereof

17. Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid)and any salt thereof

PART II 1. Barbiturates, their salts and derivatives, excluding the substances set out in items 6 and 7 ofPart I but including:

(1) Allobarbital (5,5-diallylbarbituric acid) (2) Alphenal (5-allyl-5-phenylbarbituric acid) (3) Amobarbital (5-ethyl-5-(3-methylbutyl)barbituric acid) (4) Aprobarbital (5-allyl-5-isopropylbarbituric acid) (5) Barbital (5,5-diethylbarbituric acid) (6) Barbituric Acid (2,4,6(1H,3H,5H)-pyrimidinetrione) (7) Butabarbital (5-sec-butyl-5-ethylbarbituric acid) (8) Butalbital (5-allyl-5-isobutylbarbituric acid) (9) Butallylonal (5-(2-bromoallyl)-5-sec-butylbarbituric acid) (10) Butethal (5-butyl-5-ethylbarbituric acid) (11) Cyclobarbital (5-(1-cyclohexen-1-yl)-5-ethylbarbituric acid) (12) Cyclopal (5-allyl-5-(2-cyclopenten-1-yl)barbituric acid) (13) Heptabarbital (5-(1-cyclohepten-1-yl)-5-ethylbarbituric acid) (14) Hexethal (5-ethyl-5-hexylbarbituric acid) (15) Hexobarbital (5-(1-cyclohexen-1-yl)-1,5-dimethylbarbituric acid) (16) Mephobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid) (17) Methabarbital (5,5-diethyl-1-methylbarbituric acid) (18) Methylphenobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid) (19) Propallylonal (5-(2-bromoallyl)-5-isopropyl-barbituric acid) (20) Phenobarbital (5-ethyl-5-phenylbarbituric acid) (21) Probarbital (5-ethyl-5-isopropylbarbituric acid) (22) Phenylmethylbarbituric Acid (5-methyl-5-phenylbarbituric acid) (23) Sigmodal(5-(2-bromoallyl)-5-(1-methylbutyl)- barbituric acid) (24) Talbutal (5-allyl-5-sec-butylbarbituric acid) (25) Vinbarbital (5-ethyl-5-(1-methyl-1-butenyl)barbituric acid) (26) Vinylbital (5-(1-methylbutyl)-5-vinylbarbituric acid)

2. Thiobarbiturates, their salts and derivatives, including: (1) Thialbarbital (5-allyl-5-(2-cyclohexen-1-yl)-2-thiobarbituric acid)

(2) Thiamylal (5-allyl-5-(1-methylbutyl)-2-thiobarbituric acid) (3) Thiobarbituric Acid (2-thiobarbituric acid) (4) Thiopental(5-ethyl-5-(1-methylbutyl)-2- thiobarbituric acid)

3. Chlorphentermine (1-(p-chlorophenyl)-2-methyl-2-aminopropane) and any salt thereof 4. Diethylpropion (2-(diethylamino)propiophenone) and any salt thereof 5. Phentermine (α,α-dimethylbenzeneethanamine) and any salt thereof 6. Butorphanol (1-N-cyclobutylmethyl-3,14-dihydroxy-morphinan) and any salt thereof 7. Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and any salt thereof 8. Pyrovalerone (4′-methyl-2-(1-pyrrolidinyl)valerophenone) and any salt thereof

PART III 1. Anabolic steroids and their derivatives, including:

(1) Androisoxazole (17ß-hydroxy-17α-methylandrostano[3,2-c]isoxazole) (2) Androstanolone (17ß-hydroxy-5α-androstan-3-one) (3) Androstenediol (androst-5-ene-3ß,17ß-diol) (4) Bolandiol (estr-4-ene-3b,17ß-diol) (5) Bolasterone (17ß-hydroxy-7α,17-dimethylandrost-4-en-3-one) (6) Bolazine (17ß-hydroxy-2α-methyl-5α-androstan-3-one azine) (7) Boldenone (17ß-hydroxyandrosta-1,4-dien-3-one) (8) Bolenol (19-nor-17α-pregn-5-en-17-ol) (9) Calusterone (17ß-hydroxy-7b,17-dimethylandrost-4-en-3-one) (10) Clostebol (4-chloro-17ß-hydroxyandrost-4-en-3-one) (11) Drostanolone (17ß-hydroxy-2α-methyl-5α-androstan-3-one) (12) Enestebol (4,17ß-dihydroxy-17-methylandrosta-1,4-dien-3-one) (13) Epitiostanol (2α, 3α-epithio-5α-androstan-17ß-ol) (14) Ethylestrenol (19-nor-17α-pregn-4-en-17-ol) (15) 4-Hydroxy-19-nor testosterone (16) Fluoxymesterone (9-fluoro-11ß,17ß-dihydroxy—17-methylandrost-4-en-3-one)

(17) Formebolone (11α,17ß-dihydroxy-17-methyl-3-oxoandrosta-1,4-dien-2­carboxaldehyde) (18) Furazabol (17-methyl-5α-androstano[2,3-c]furazan-17ß-ol) (19) Mebolazine (17ß-hydroxy-2α,17-dimethyl-5α-androstan-3-one azine) (20) Mesabolone (17ß-[(1-methoxycyclohexyl)oxy]-5α-androst-1-en-3-one) (21) Mesterolone (17ß-hydroxy-1α-methyl-5α-androstan-3-one) (22) Metandienone (17ß-hydroxy-17-methylandrosta-1,4-dien-3-one) (23) Metenolone (17ß-hydroxy-1-methyl-5α-androst-1-en-3-one) (24) Methandriol (17α-methylandrost-5-ene-3ß,17ß-diol) (25) Methyltestosterone (17ß-hydroxy-17-methyl-androst-4-en-3-one) (26) Metribolone (17ß-hydroxy-17-methylestra-4,9,11-trien-3-one) (27) Mibolerone (17ß-hydroxy-7α,17-dimethylestr-4-en-3-one) (28) Nandrolone (17ß-hydroxyestr-4-en-3-one)

(29) Norboletone (13-ethyl-17ß-hydroxy-18,19-dinorpregn-4-en-3-one) (30) Norclostebol (4-chloro-17ß-hydroxyestr-4-en-3-one) (31) Norethandrolone (17α-ethyl-17ß-hydroxyestr-4-en-3-one) (32) Oxabolone (4,17ß-dihydroxyestr-4-en-3-one) (33) Oxandrolone (17ß-hydroxy-17-methyl-2-oxa-5α-androstan-3-one) (34) Oxymesterone (4,17ß-dihydroxy-17-methylandrost-4-en-3-one) (35) Oxymetholone (17ß-hydroxy-2-(hydroxymethylene)-17-methyl-5α-androstan-3-one) (36) Prasterone (3ß-hydroxyandrost-5-en-17-one) (37) Quinbolone (17ß-(1-cyclopenten-1-yloxy)androsta-1,4-dien-3-one) (38) Stanozolol (17ß-hydroxy-17-methyl-5α-androstano[3,2-c]pyrazole) (39) Stenbolone (17ß-hydroxy-2-methyl-5α-androst-1-en-3-one) (40) Testosterone (17ß-hydroxyandrost-4-en-3-one) (41) Tibolone ((7α,17α)-17-hydroxy-7-methyl-19-norpregn-5(10)en-20-yn-3-one) (42) Tiomesterone (1α,7α-bis(acetylthio)-17ß-hydroxy-17-methylandrost-4-en-3-one) (43) Trenbolone (17ß-hydroxyestra-4,9,11-trien-3-one)

2. Zeranol (3,4,5,6,7,8,9,10,11,12-decahydro-7,14,16-trihydroxy-3-methyl-1H-2­benzoxacyclotetradecin-1-one)

SOR/78-427, s. 10; SOR/79-753, s. 1; SOR/81-84, s. 1; SOR/85-550, s. 14(F); SOR/86-678, s. 1; SOR/89-381, s. 1; SOR/92-386, s. 3; SOR/97-228, s. 21; SOR/99-425, s. 1; SOR/2003­ 34, ss. 2, 3; SOR/2003-413, s. 2.

PART J RESTRICTED DRUGS Division 1 General

J.01.001. In this Part,

“competent authority” means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country; (autorité compétente)

“institution” means any institution engaged in research on drugs and includes a hospital that is licensed by a province, a university, a department or agency of the Government of Canada or of a province or any part thereof; (établissement)

“international obligation” means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale)

“licence”[Repealed, SOR/2004-238, s. 31]

“licensed dealer” means the holder of a licence issued under section J.01.007.2; (distributeur autorisé)

“permit” means a permit issued under section J.01.005; (permis)

“practitioner” means a person who is registered and entitled under the laws of a province to practise the profession of medicine; (praticien)

“qualified investigator” means, in respect to a restricted drug, a person who

(a) is employed by or is connected with an institution, or

(b) is engaged in research in an institution in respect of that drug,

and whose use and possession of that drug is authorized by the Minister pursuant to section J.01.018; (chercheur compétent)

“qualified person in charge” means the individual with the qualifications specified in subsection J.01.003.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)

“restricted drug” means a drug set out in the schedule to this Part; (drogue d’usage restreint)

“test kit” means an apparatus

(a) that contains reagent systems or buffering agents or both,

(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and

(c) the contents of which are not intended for administration to humans. (nécessaire d’essai)

SOR/97-228, s. 22; SOR/2004-238, s. 31.

Possession

J.01.002. (1) The following persons may have a restricted drug in their possession:

(a) a licensed dealer;

(b) a qualified investigator if he has possession for the purpose of and in connection with research in an institution;

(c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of Health or officer of a court, if such person has possession for the purpose of and in connection with his employment; and

(d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that restricted drug.

(2) A person is authorized to have a restricted drug in his possession if the person is acting as the agent for a person referred to in paragraph (1)(a), (b) or (d).

(2.1) A person is authorized to have a restricted drug in his possession where

(a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(c); and

(b) the possession of the restricted drug is for the purpose of assisting that person in the enforcement or administration of an Act or regulation.

SOR/97-228, s. 23; SOR/99-125, s. 7; SOR/2010-222, s. 23. Previous Version

Licences, Permits and Licensed Dealers

J.01.003. Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a restricted drug.

SOR/2004-238, s. 32.

J.01.003.1. To be eligible for a dealer’s licence, a person must be

(a) an individual who ordinarily resides in Canada;

(b) a corporation that has its head office in Canada or operates a branch office in Canada; or

(c) the holder of a position that includes responsibility for restricted drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

SOR/2004-238, s. 32.

J.01.003.2. (1) A licensed dealer

(a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to restricted drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

(b) may designate an alternate qualified person in charge who must work at the premises set out in the licence and have authority to replace the qualified person in charge when that person is absent.

(2) The qualified person in charge and, if applicable, the alternate qualified person in charge

(a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

(b) shall be a pharmacist or a practitioner registered with a provincial professional licensing authority or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

(c) shall not have been convicted, as an adult, within the previous 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

SOR/2004-238, s. 32; SOR/2010-222, ss. 24(E), 34. Previous Version J.01.004. No licensed dealer shall import or export a restricted drug without a permit.

J.01.004.1 A licensed dealer is authorized to have a restricted drug in his possession for the purpose of exporting the restricted drug from Canada if he has obtained the restricted drug pursuant to these Regulations.

SOR/97-515, s. 5.

J.01.005. The Minister may, upon application therefor, after such investigation as he deems proper and subject to such terms and conditions as he deems proper, issue to any licensed dealer a permit for the importation or exportation of a restricted drug.

J.01.006. An application for a permit shall be in a form approved by the Minister.

J.01.007. (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing

(a) if the licence is sought for

(i) an individual, the individual’s name,

(ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and

(iii) the holder of a position mentioned in paragraph J.01.003.1(c), the applicant’s name and the title of the position;

(b) the address, telephone number and, if applicable, the facsimile transmission number and e- mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;

(c) the name, date of birth and gender of the individual in charge of the premises;

(d) with respect to the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge,

(i) their name, date of birth and gender,

(ii) their academic qualifications, training and work experience relevant to their duties,

(iii) their hours of work, at the premises,

(iv) their title at the premises,

(v) the name and title of their immediate supervisor at the premises, and

(vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;

(e) the name and gender of the individuals authorized to place an order for a restricted drug on behalf of the applicant;

(f) the activities referred to in section J.01.003 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

(g) in the case of a product or compound that contains a restricted drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out

(i) the name, number or identifying mark, if any, of each product or compound,

(ii) the restricted drug in each product or compound,

(iii) the strength per unit of the restricted drug in each product or compound,

(iv) the quantity or package sizes of each product or compound, and

(v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer’s licence number of the other dealer;

(h) if the licence is sought to produce a restricted drug other than a product or compound that contains a restricted drug

(i) the restricted drug to be produced,

(ii) the quantity that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and

(iii) if the restricted drug would be produced for another licensed dealer under a custom order, the name, address and licence number of the other dealer;

(i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;

(j) a detailed description of the method that the applicant proposes to use for recording their restricted drug transactions; and

(k) for any activity referred to in section J.01.003, other than the activities described in paragraphs (g) and h), the restricted drug and the purpose for carrying out the activity.

(2) An application for a dealer’s licence must

(a) be signed by the individual in charge of the premises to which the licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual in charge has the authority to bind the applicant.

(3) An application for a dealer’s licence must be accompanied by

(a) declarations signed by the individual in charge of the premises to which the application applies, the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge, stating that they have not been convicted, as an adult, within the preceding 10 years of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years of a designated drug offence or a designated criminal offence;

(c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;

(d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge have the knowledge and experience required under paragraph J.01.003.2(2)(a);

(e) if the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge is not a pharmacist or a practitioner registered with a provincial professional licensing authority, a copy of the person’s degree required under paragraph J.01.003.2(2)(b) and a copy of the course transcript for that degree;

(f) if the applicant’s name appears on the label of a product or compound that contains a restricted drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and

(g) if the applicant is a corporation, a copy of

(i) the certificate of incorporation or other constituting instrument, and

(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.

(4) The method proposed by the applicant under paragraph (1)(j) must

(a) allow for the recording of restricted drug transactions in accordance with section J.01.021; and

(b) permit the Minister to audit the activities of the licensed dealer with respect to restricted drugs.

(5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing

(a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;

(b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and

(c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.

SOR/2004-238, s. 33; SOR/2010-222, s. 25. Previous Version J.01.007.1. The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

SOR/2004-238, s. 33.

J.01.007.2. Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under sections J.01.007 and J.01.007.1, issue a dealer’s licence that contains

(a) the licence number;

(b) the name of the holder of the licence or the title of the position they hold, as the case may be, or, if the holder is a corporation, its corporate name;

(c) a list of the activities that are permitted;

(d) the address of the premises at which the licensed dealer may carry on the permitted activities;

(e) the name of the restricted drug for which the activities are permitted;

(f) the security level at the premises, determined in accordance with the Security Directive;

(g) the effective date of the licence;

(h) the expiry date of the licence, which may not be later than three years after its effective date;

(i) any conditions to be met by the holder of the licence to

(i) ensure that an international obligation is respected,

(ii) provide the security level referred to in paragraph (f), or

(iii) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use;

(j) in the case of a producer of a restricted drug, the quantity of the restricted drug that may be produced under the licence and the period during which that quantity may be produced; and

(k) in the case of the maker or assembler of a product or compound that contains a restricted drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

(i) the licence number,

(ii) the name, number or identifying mark, if any, of each product or compound,

(iii) the restricted drug in each product or compound,

(iv) the strength per unit of the restricted drug in each product or compound, and

(v) the quantity or package sizes of each product or compound.

SOR/2004-238, s. 33; SOR/2010-222, ss. 26, 35(F). Previous Version J.01.007.3. (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if

(a) the applicant is not eligible under section J.01.003.1;

(b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section J.01.025;

(c) false or misleading information or false or falsified documents were submitted in or with the application;

(d) an activity for which the licence is requested would not be in compliance with an international obligation;

(e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

(f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

(g) the applicant is in contravention of or has contravened during the preceding 10 years

(i) a provision of the Act or any regulations made or continued under the Act, or

(ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;

(h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a restricted drug being diverted to an illicit market or use;

(i) the individual in charge of the premises, the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge has been convicted, as an adult, within the preceding 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(j) the proposed method referred to in paragraph J.01.007(1)(j) is not capable of recording the applicant’s restricted drug transactions as required under section J.01.023 or permitting the Minister to audit the applicant’s activities with respect to restricted drugs in a timely manner; or

(k) the additional information required under section J.01.007.1 has not been provided or is insufficient to process the application.

(2) Unless it is necessary to do so to protect public health, safety, or security, including preventing a restricted drug from being diverted to an illicit market or use, the Minister shall not refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

(a) does not have a history of non compliance with the Act or any regulation made or continued under it; and

(b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

SOR/2004-238, s. 33; SOR/2010-222, ss. 27, 35(F). Previous Version J.01.007.4. (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister

(a) the information required under paragraphs J.01.007(1)(a) to (k); and

(b) the following documents, namely,

(i) the documents referred to in paragraphs J.01.007(3)(a) and (d) and, subject to subsection J.01.007(5), the document specified in paragraph J.01.007(3)(b),

(ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph J.01.007(3)(e), and

(iii) the original dealer’s licence that is to be renewed.

(2) An application for renewal must

(a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual in charge has the authority to bind the applicant.

(3) Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section J.01.007.1, issue a renewed dealer’s licence that contains the information specified in paragraphs J.01.007.2(a) to (k).

SOR/2004-238, s. 33.

J.01.007.5. (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister

(a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section J.01.007 that are relevant to the proposed amendment; and

(b) the original dealer’s licence.

(2) An application for amendment must

(a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and

(b) be accompanied by a statement signed by the individual in charge indicating that

(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

(ii) the individual in charge has the authority to bind the applicant.

(3) Subject to section J.01.007.3, the Minister shall, after examining the request for amendment and the supporting documentation, amend the dealer’s licence in accordance with the request and may add any conditions to be met by the holder of the licence to

(a) ensure that an international obligation is respected;

(b) provide for the security level referred to in paragraph J.01.007.2(f) or the new level required as a result of the amendment being implemented; or

(c) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use.

SOR/2004-238, s. 33; SOR/2010-222, ss. 28(F), 35(F). Previous Version J.01.007.6. (1) A licensed dealer shall

(a) obtain the Minister’s approval before making any of the following changes, namely,

(i) a change relating to the security at the premises referred to in the dealer’s licence, or

(ii) the replacement or the addition of

(A) an individual in charge of the premises to which the dealer’s licence applies,

(B) a qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer’s licence applies, and

(C) an individual authorized to place an order for a restricted drug on behalf of the licensed dealer;

(b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in

(i) the application for a dealer’s licence under section J.01.007,

(ii) the application to renew a dealer’s licence under section J.01.007.4, or

(iii) the request for approval under paragraph (a); and

(c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in

(i) the application for a dealer’s licence under section J.01.007,

(ii) the application to renew a dealer’s licence under section J.01.007.4, or

(iii) the request for approval under paragraph (a).

(2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:

(a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,

(i) the information specified in paragraph J.01.007(1)(c), and

(ii) the declarations specified in paragraph J.01.007(3)(a) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c);

(b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,

(i) the information specified in paragraph J.01.007(1)(d), and

(ii) the documents specified in paragraphs J.01.007(3)(a), (d) and (e) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c); and

(c) in the case of the replacement or addition of an individual who is authorized to place an order for a restricted drug on behalf of the licensed dealer, the individual’s name and gender.

SOR/2004-238, s. 33.

J.01.007.7. The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

SOR/2004-238, s. 33.

J.01.007.8. (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section J.01.007.91 if

(a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

(b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;

(c) the licensed dealer is no longer an eligible person under section J.01.003.1;

(d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the previous 10 years, of

(i) a designated drug offence,

(ii) a designated criminal offence, or

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or

(e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use.

(2) Unless it is necessary to do so to protect public health, safety, or security, including preventing a restricted drug from being diverted to an illicit market or use, the Minister shall not revoke a dealer’s licence under paragraph (1)(a) or (b) if the licensed dealer

(a) has no history of non-compliance with the Act and the regulations made or continued under it; and

(b) has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

SOR/2004-238, s. 33; SOR/2010-222, ss. 29, 35(F). Previous Version J.01.007.9. The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a restricted drug from being diverted to an illicit market or use.

SOR/2004-238, s. 33; SOR/2010-222, s. 35(F). Previous Version J.01.007.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a licence under this Part, the Minister shall

(a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and

(b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation.

(2) The suspension of a licence under this Part takes effect as soon as the Minister informs the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.

(3) A person who receives a notice of suspension referred to in subsection (2) may, in the 10 days following the receipt of the notice, provide the Minister with reasons why the suspension of the licence is unfounded.

SOR/2004-238, s. 33.

J.01.008. [Repealed, SOR/2004-238, s. 33]

J.01.009. The Minister may impose such restrictions and conditions on a licensed dealer as he deems necessary for the control of a restricted drug.

J.01.010. A licensed dealer may at any time make an application to the Minister to amend his licence in order to become a licensed dealer in respect of a restricted drug other than a restricted drug specified in his licence or to change the terms or conditions of his licence.

J.01.011. A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the restricted drugs specified in their dealer’s licence.

SOR/2004-238, s. 34.

J.01.012. The Minister shall revoke a permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

SOR/2004-238, s. 34; SOR/2010-222, s. 30. Previous Version J.01.012.1. (1) Subject to subsection (2), the Minister shall revoke a permit by taking the same measures as those set out in subsection J.01.007.91(1) if

(a) any of paragraphs J.01.007.8(1)(a) to (e) applies with respect to the dealer’s licence as it pertains to the restricted drug to be imported or exported; or

(b) the import or export permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application.

(2) Unless it is necessary to do so to protect public health, safety, or security, including preventing a restricted drug from being diverted to an illicit market or use, the Minister shall not revoke a permit under paragraph J.01.007.8(1)(a) or (b) or J.01.012.1(1)(b) if the holder meets the conditions set out in paragraphs J.01.007.8(2)(a) and (b).

(3) The Minister may revoke a permit if the holder fails to comply with the decision of the Minister to suspend the permit under section J.01.012.2 or if the situation giving rise to the suspension is not rectified.

SOR/2010-222, s. 30.

J.01.012.2. (1) The Minister shall suspend a permit without prior notice if

(a) the dealer’s licence as it pertains to the restricted drug to be imported or exported has expired or has been suspended or revoked;

(b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health, safety, or security;

(c) the Minister has reasonable grounds to believe that the continuation of the permit would present a risk of a restricted drug being diverted to an illicit market or use; or

(d) the import or export would contravene the laws of the country of export or import or a country of transit or transhipment.

(2) A decision of the Minister to suspend a permit takes effect as soon as the Minister notifies the holder of the decision and provides a written report of the reasons for the suspension.

(3) A person whose permit is suspended under subsection (1) may, within 10 days after receiving the notice of suspension, provide the Minister with reasons why the suspension is unfounded.

SOR/2010-222, s. 30.

J.01.013. A dealer’s licence is valid until the earlier of

(a) the expiry date set out in the licence, and

(b) the revocation or suspension of the licence under section J.01.007.7, J.01.007.8 or J.01.007.9.

SOR/2004-238, s. 34.

J.01.014. A permit is valid only for the particular importation or exportation in respect of which it was issued.

Sale of a Restricted Drug

J.01.015. An institution may, in a form approved by the Minister, make an application to a licensed dealer or to the Minister with respect to the purchase of a restricted drug

(a) for clinical use in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or

(b) for laboratory research in the institution by qualified investigators.

J.01.016. Where a licensed dealer receives an application made pursuant to section J.01.015, he shall, before selling a restricted drug to the institution that made the application

(a) supply the Minister with a copy of the application; and

(b) obtain the written authority of the Minister to make the proposed sale of the restricted drug.

J.01.017. An application made pursuant to section J.01.015 shall contain

(a) the name and the address of the institution seeking to purchase the drug;

(b) the names and qualifications of the qualified investigators who will use and be in possession of the drug;

(c) the details of the proposed use of the drug;

(d) the quantity of the drug required;

(e) the dosage form of the drug required by the institution; and

(f) the name of the licensed dealer from whom the purchase of the drug will be made.

J.01.018. Where the Minister receives from an institution an application or a copy of an application made pursuant to section J.01.015, he may, subject to such qualifications and limitations as he deems proper, authorize

(a) the sale to the institution by a licensed dealer of the restricted drug applied for in such quantity and such dosage form as he deems proper; and

(b) qualified investigators to make clinical use of the restricted drug in the institution or to carry out laboratory research with the restricted drug in the institution and to possess the restricted drug for the purposes of such use or research.

J.01.019. An institution shall use a restricted drug only for the purpose and in accordance with the protocol therefor set out in the application respecting that restricted drug made pursuant to section J.01.015.

J.01.020. Where a licensed dealer is authorized under section J.01.018 to sell a restricted drug, he may, notwithstanding section C.08.002, sell that drug subject to any qualifications or limitations imposed by the Minister.

Records and Inspection

J.01.021. Every institution shall keep and retain for a period of two years from the date of the making of the record, a record of

(a) the amount of every restricted drug received by the institution;

(b) details of the use of restricted drugs in the institution;

(c) the names and qualifications of every person who makes use of a restricted drug in the institution; and

(d) full clinical data with respect to the use of every restricted drug received by the institution.

SOR/85-550, s. 15.

J.01.022. Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.

J.01.023. Every licensed dealer shall maintain a record of

(a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received;

(b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

(c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

(d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and

(e) the name, quantity and form of any restricted drug he has in stock.

SOR/2004-238, s. 35; SOR/2010-222, s. 31(F). Previous Version

J.01.024. Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

J.01.025. (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

(a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and

(b) the process and conditions of the producing, making, assembling or storing.

(2) [Repealed, SOR/2010-222, s. 32]

SOR/2004-238, s. 36; SOR/2010-222, s. 32. Previous Version J.01.026. Every person who sells or provides a restricted drug shall

(a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;

(b) produce to an inspector any books, records or documents required to be kept under this Part;

(c) permit an inspector to make copies of or to take extracts from any books, records and documents; and

(d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.

SOR/2004-238, s. 37.

J.01.027. Every licensed dealer shall notify the Minister forthwith of any change

(a) [Repealed, SOR/2010-222, s. 33]

(b) in the premises in which a restricted drug is produced, made, assembled or stored; and

(c) in the process and conditions of producing, making, assembly or storage of a restricted drug.

SOR/2004-238, s. 38; SOR/2010-222, s. 33. Previous Version J.01.028. Every person who is in possession of a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister shall

(a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and

(b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.

J.01.029. Where a licensed dealer delivers a restricted drug, he shall

(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and

(b) use such methods of transportation as will ensure that an accurate record is kept of the drug while in transit and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

Packaging and Labelling

J.01.030. Every restricted drug that is sold to an institution shall be securely packed by the licensed dealer who sells the drug in such a manner that the package cannot be opened without breaking the seal.

J.01.031. The provisions of section C.01.004 do not apply to a restricted drug.

J.01.032. Every package that contains a restricted drug shall be labelled so that the inner and outer labels thereon show

(a) the proper name or, if there is no proper name, the common name of the drug;

(b) the net contents of the package;

(c) the unit strength of the drug where it is in unit form;

(d) the lot number of the drug;

(e) the words “Restricted Drug”; and

(f) the name and address of the producer, maker or assembler of the drug.

SOR/2004-238, s. 39.

J.01.032.1. Section J.01.032 does not apply to a test kit that contains a restricted drug where a registration number has been issued for the test kit pursuant to section J.01.033.3 and has not been cancelled pursuant to section J.01.033.4.

J.01.033. (1) and (2) [Repealed, SOR/99-125, s. 8]

(3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver the restricted drug that they have in their possession to

(a) a practitioner; or

(b) an agent of a practitioner, where the agent has been exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that restricted drug for that purpose.

(4) if an agent of a practitioner has received a restricted drug under subsection (3), the agent shall immediately provide or deliver it

(a) to the practitioner of whom he is the agent; or

(b) to the Minister or his agent.

(5) A practitioner who has received a restricted drug under subsection (3) or (4) shall immediately provide or deliver it

(a) for the purpose of identification or analysis thereof, to a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that restricted drug for that purpose; or

(b) to the Minister.

(6) Sections J.01.021 and J.01.022 apply with such modifications as the circumstances may require to every person who has received a restricted drug pursuant to this section other than a person to whom a restricted drug has been administered pursuant to an exemption granted under section 56 of the Controlled Drugs and Substances Act with respect to the administration of that drug.

SOR/99-125, s. 8; SOR/2004-238, s. 40.

Test Kits Containing Restricted Drugs

J.01.033.1. Any person may sell, possess or otherwise deal in a test kit that contains a restricted drug if

(a) a registration number has been issued for the test kit pursuant to section J.01.033.3;

(b) the test kit bears, on its external surface,

(i) the name of the producer, maker or assembler,

(ii) the trade name or trade mark, and

(iii) the registration number issued therefor pursuant to section J.01.033.3;

(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

(d) the registration number has not been cancelled pursuant to section J.01.033.4.

SOR/2004-238, s. 41.

J.01.033.2. The manufacturer of a test kit that contains a restricted drug may apply for a registration number therefor by submitting to the Director an application containing

(a) particulars of the design and construction of the test kit;

(b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

(c) a statement of the proposed use of the test kit; and

(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

J.01.033.3. Where, on application under section J.01.033.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

(a) contains a restricted drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

(b) contains such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.

SOR/81-21, ss. 3, 4; SOR/86-91, s. 4(F).

J.01.033.4. The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,

(a) it is necessary to cancel the registration number in the interest of public health; or

(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

Prescribed Manner of Notice of Application for an Order of Restoration

J.01.035. (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.

(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application is to be made to the magistrate and shall specify

(a) the magistrate to whom the application is to be made;

(b) the time and place where the application is to be heard;

(c) the restricted drug or other thing in respect of which the application is to be made; and

(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the restricted drug or other thing referred to in paragraph (c).

SOR/97-228, s. 24.

J.01.036 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.

SOR/97-228, s. 25.

SCHEDULE

(Section J.01.001)

The following amphetamines, their salts, derivatives, isomers and analogues and salts of1. derivatives, isomers and analogues: (1) N-ethylamphetamine (N-ethyl-α-methylbenzeneethanamine)

4-methyl-2,5-dimethoxyamphetamine (STP) (2,5-dimethoxy-4,α ­(2) dimethylbenzeneethanamine) 3,4-methylenedioxyamphetamine (MDA) (α-methyl-1,3-benzodioxole-5­(3) ethanamine)

(4) 2,5-dimethoxyamphetamine(2,5-dimethoxy-α-methylbenzeneethanamine) (5) 4-methoxyamphetamine (4-methoxy-α-methylbenzeneethanamine) (6) 2,4,5-trimethoxyamphetamine (2,4,5-trimethoxy-α-methylbenzeneethanamine)

N-methyl-3,4-methylenedioxyamphetamine (N,α-dimethyl-1,3-benzodioxole-5­(7) ethanamine) 4-ethoxy-2,5-dimethoxyamphetamine (4-ethoxy-2,5-dimethoxy-α ­(8) methylbenzeneethanamine) 5-methoxy-3,4-methylenedioxyamphetamine (7-methoxy-α-methyl-1,3­(9) benzodioxole-5-ethanamine)

(10) N,N-dimethyl-3,4-methylenedioxyamphetamine (N,N, α-trimethyl-1,3-benzodioxole­5-ethanamine)

(11) N-ethyl-3,4-methylenedioxyamphetamine (N-ethyl-α-methyl-1,3-benzodioxole-5­ethanamine)

(12) 4-ethyl-2,5-dimethoxyamphetamine (DOET) (4-ethyl-2,5-dimethoxy-α ­methylbenzeneethanamine)

(13) 4-bromo-2,5-dimethoxyamphetamine (4-bromo-2,5-dimethoxy-α ­methylbenzeneethanamine)

(14) 4-chloro-2,5-dimethoxyamphetamine (4-chloro-2,5-dimethoxy-α ­methylbenzeneethanamine) (15) 4-ethoxyamphetamine (4-ethoxy-α-methyl-benzeneethanamine)

(16) N-Propyl-3,4-methylenedioxyamphetamine (α-methyl-N-propyl-1,3-benzodioxole-5­ethanamine)

(17) N-hydroxy-3,4-methylenedioxyamphetamine (N-[α-methyl-3,4­(methylenedioxy)phenethyl]hydroxylamine) (18) 3,4,5-trimethoxyamphetamine (3,4,5-trimethoxy-α-methylbenzeneethanamine)

2. Lysergic acid diethylamide (LSD) (N,N-diethyllysergamide) and any salt thereof 3. N,N-Diethyltryptamine (DET) (3-[(2-diethylamino)ethyl]indole) and any salt thereof 4. N,N-Dimethyltryptamine (DMT) (3-[(2-dimethylamino)ethyl]indole) and any salt thereof

N-Methyl-3-piperidyl benzilate (LBJ) (3-[(hydroxydiphenylacetyl)oxy]-1­5. methylpiperidine) and any salt thereof 6. Harmaline (4,9-dihydro-7-methoxy-1-methyl-3H-pyrido(3,4-b)indole) and any salt thereof 7. Harmalol (4,9-dihydro-1-methyl-3H-pyrido(3,4-ß)indol-7-ol) and any salt thereof 8. Psilocin (3-[2-(dimethylamino)ethyl]-4-hydroxyindole) and any salt thereof 9. Psilocybin (3-[2-(dimethylamino)ethyl]-4-phosphoryloxyindole) and any salt thereof 10. N-(1-phenylcyclohexyl)ethylamine (PCE) and any salt thereof 11. 1-[1-(2-Thienyl)cyclohexyl]piperidine (TCP) and any salt thereof 12. 1-Phenyl-N-propylcyclohexanamine and any salt thereof

13. Mescaline (3,4,5-trimethoxybenzeneethanamine) and any salt thereof, but not peyote(lophophora) 14. 4-Methylaminorex (4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) and any salt thereof

15. 2-Methylamino-1-phenyl-1-propanone and any salt thereof 16. 1-[1-(Phenylmethyl)cyclohexyl]piperidine and any salt thereof 17. 1-[1-(4-Methylphenyl)cyclohexyl]piperidine and any salt thereof 18. Etryptamine (3-(2-aminobutyl)indole) and any salt thereof 19. Rolicyclidine (1-(1-phenylcyclohexyl) pyrrolidine) and any salt thereof

SOR/97-228, s. 25; SOR/2003-34, ss. 4, 5.

SCHEDULE F

(Sections C.01.001, C.01.041 to C.01.047, C.01.601 and C.10.005)

PART I Abacavir and its salts

Abacavir et ses sels

Abatacept

Abatacept

Abciximab

Abciximab

Acamprosate and its salts

Acamprosate et ses sels

Acarbose and its derivatives

Acarbose et ses dérivés

Acebutolol and its salts

Acébutolol et ses sels

Acetazolamide

Acétazolamide

Acetohexamide

Acétohexamide

Acetylcarbromal

Acétylcarbromal

Acetylcholine Chloride

Acétylcholine (chlorure d’)

Acitretin and its salts and derivatives

Acitrétine, ses sels et dérivés

Aconiazide and its salts

Aconiazide et ses sels

Acyclovir and its salts

Acyclovir et ses sels

Adalimumab

Adalimumab

Adapalene and its salts and derivatives

Adapalène, ses sels et dérivés

Adefovir and its salts and derivatives

Adéfovir, ses sels et dérivés

Adenosine and its salts, when sold or recommended for administration by intravenous injection

Adénosine et ses sels, s’il est vendu ou recommandé pour administration par injection intraveineuse

Agalsidase alfa

Agalsidase alfa

Alatrofloxacin and its salts and derivatives

Alatrofloxacine et ses sels et dérivés

Aldesleukin

Aldésleukine

Alefacept

Aléfacept

Alemtuzumab

Alemtuzumab

Alendronic acid and its salts

Alendronique (acide) et ses sels

Alfacalcidol

Alfacalcidol

Alfuzosin and its salts

Alfuzosine et ses sels

Alglucosidase alfa

Alglucosidase alfa

Aliskiren and its salts

Aliskirène et ses sels

Alkyl nitrites

Alkyle (nitrites d’)

Allopurinol

Allopurinol

Allylisopropylacetylurea

Allylisopropylacétylurée

Almotriptan and its salts

Almotriptan et ses sels

Alpha-chloralose

Alpha-chloralose

Alphadolone and its salts

Alphadolone et ses sels

Alphaxalone

Alfaxalone

Alteplase and its salts and derivatives

Altéplase, ses sels et dérivés

Altrenogest

Altrénogest

Altretamine

Altrétamine

Amantadine and its salts

Amantadine et ses sels

Ambenonium Chloride

Ambénonium (chlorure d’)

Ambrisentan

Ambrisentan

Amifostine and its salts

Amifostine et ses sels

Amikacin and its salts and derivatives

Amikacine, ses sels et dérivés

Amiloride and its salts

Amiloride et ses sels

Aminocaproic acid

Aminocaproïque (acide)

Aminoglutethimide

Aminoglutéhimide

Aminolevulinic acid and its salts and derivatives

Aminolévulinique (acide), ses sels et dérivés

Aminophylline

Aminophylline

Aminopterin and its salts

Aminoptérine et ses sels

4-Amino-pteroyl aspartic acid and its salts

Amino-4-ptéroyl aspartique (acide) et ses sels

5-Aminosalicylic acid

Amino-5-salicylique (acide)

4-Aminosalicylic Acid and its salts

Amino-4 salicylique (acide) et ses sels

Amiodarone and its salts

Amiodarone et ses sels

Amitraz

Amitraz

Amitriptyline and its salts

Amitriptyline et ses sels

Amlexanox and its salts and derivatives

Amlexanox, ses sels et dérivés

Amlodipine and its salts

Amlodipine et ses sels

Ammonium bromide

Bromure d’ammonium

Amoxapine

Amoxapine

Amoxicillin and its salts and derivatives

Amoxicilline, ses sels et dérivés

Amphotericin B and its salts and derivatives

Amphotéricine B, ses sels et dérivés

Ampicillin and its salts and derivatives

Ampicilline, ses sels et dérivés

Amprenavir and its salts and derivatives

Amprénavir et ses sels et dérivés

Amrinone and its salts

Amrinone et ses sels

Amsacrine and its salts

Amsacrine et ses sels

Anagrelide and its salts

Anagrélide et ses sels

Anakinra and its salts and derivatives

Anakinra, ses sels et dérivés

Anastrozole

Anastrozole

Ancestim

Ancestim

Anidulafungin

Anidulafungine

Anti-thymocyte globulin

Sérum antithymocytes

Apiol, oil of

Apiol (huile d’)

Apraclonidine and its salts

Apraclonidine et ses sels

Aprepitant and its derivatives

Aprépitant et ses dérivés

Aprotinin

Aprotinine

Argatroban and its salts and derivatives

Argatroban, ses sels et dérivés

L-Asparaginase

L-Asparaginase

Astemizole and its salts

Astémizole et ses sels

Atazanavir and its salts

Atazanavir et ses sels

Atenolol and its salts

Aténolol et ses sels

Atipamezole and its salts

Atipamézole et ses sels

Atomoxetine and its salts

Atomoxétine et ses sels

Atorvastatin and its salts

Atorvastatine et ses sels

Atovaquone

Atovaquone

Atracurium besilate

Atracurium (bésilate d’)

Atropine and its salts in ophthalmic or parenteral preparations only

Atropine et ses sels dans les préparations pour usage ophtalmique ou parentéral seulement

Auranofin

Auranofine

Aurothioglucose

Aurothioglucose

Azacyclonol and its salts

Azacyclonol et ses sels

Azaribine

Azaribine

Azathioprine and its salts

Azathioprine et ses sels

Azatidine and its salts

Azatadine et ses sels

Azelaic acid

Acide azélaïque

Azlocillin and its salts and derivatives

Azlocilline, ses sels et dérivés

Aztreonam and its salts

Aztréonam et ses sels

Baclofen and its salts

Baclofène et ses sels

Bambuterol and its salts

Bambutérol et ses sels

Becaplermin

Bécaplermine

Basiliximab

Basiliximab

Bemegride

Bémégride

Benactyzine and its salts

Benactyzine et ses sels

Benazepril and its salts and derivatives

Bénazépril, ses sels et dérivés

Bendazac and its salts

Bendazac et ses sels

Benoxaprofen and its salts

Benoxaprofène et ses sels

Benserazide and its salts

Bensérazide et ses sels

Benzathine penicillin and its salts and derivatives

Benzathine pénicilline, ses sels et dérivés

Benzoyl peroxide in concentrations greater than 5 per cent or when sold in combination with another medicinal ingredient

Benzoyle (peroxyde de) lorsqu’il constitue plus de cinq pour cent d’un mélange ou qu’il est vendu en association avec un autre ingrédient médicinal

Benztropine and its salts

Benzatropine et ses sels

Benzydamine and its salts

Benzydamine et ses sels

Beractant

Béractant

Betahistine and its salts

Bétahistine et ses sels

Betaine and its salts when sold or recommended for the treatment of homocystinuria

Bétaïne et ses sels s’ils sont vendus ou recommandés pour le traitement de l’homocystinurie

Betaxolol and its salts

Betaxolol et ses sels

Bethanechol chloride

Béthanéchol (chlorure de)

Bethanidine and its salts

Béthanidine et ses sels

Bevacizumab

Bévacizumab

Bezafibrate and its salts and derivatives

Bezafibrate, ses sels et dérivés

Bicalutamide

Bicalutamide

Bimatoprost and its derivatives

Bimatoprost et ses dérivés

Biperiden and its salts

Bipéridène et ses sels

Bishydroxycoumarin and its salts and derivatives

Bishydroxycoumarine, ses sels et dérivés

Bisoprolol and its salts

Bisoprolol et ses sels

Bitolterol and its salts

Bitoltérol et ses sels

Bivalirudin

Bivalirudine

Bleomycin

Bléomycine

Bortezomib

Bortézomib

Bosentan and its salts and derivatives

Bosentan et ses sels et dérivés

Botulinum toxin Type A

Toxine botulinique, type A

Botulinum Toxin Type B

Toxine botulinique, type B

Bretylium tosylate

Brétylium (tosylate de)

Brimonidine and its salts

Brimonidine et ses sels

Bromal

Bromal

Bromal hydrate

Bromal (hydrate de)

Brometone

Brométone

Bromisoval

Bromisoval

Bromocriptine and its salts

Bromocriptine et ses sels

Bromoform

Bromoforme

Bumetanide and its salts and derivatives

Bumétanide, ses sels et dérivés

Buproprion and its salts

Buproprione et ses sels

Buserelin and its salts

Buséréline et ses sels

Buspirone and its salts

Buspirone et ses sels

Busulfan

Busulfan

Butaperazine and its salts

Butapérazine et ses sels

Butoconazole and its salts

Butoconazole et ses sels

Butyl chloral hydrate

Butylchloral (hydrate de)

Cabergoline and its salts

Cabergoline et ses sels

Calcipotriol

Calcipotriol

Calcitonin

Calcitonine

Calcitriol

Calcitriol

Calcium bromide

Bromure de calcium

Calcium bromolactobionate

Bromolactobionate de calcium

Calcium carbimide

Calcium (carbimide de)

Candesartan and its salts and derivatives

Candésartan et ses sels et dérivés

Candicidin and its salts and derivatives

Candicidine, ses sels et dérivés

Capecitabine and its salts and derivatives

Capécitabine et ses sels et dérivés

Capreomycin and its salts and derivatives

Capréomycine, ses sels et dérivés

Captodiamine and its salts

Captodiamine et ses sels

Captopril and its salts

Captopril et ses sels

Carbachol

Carbachol

Carbamazepine

Carbamazépine

Carbenicillin and its salts and derivatives

Carbénicilline, ses sels et dérivés

Carbenoxolone and its salts

Carbenoxolone et ses sels

Carbetocin and its salts

Carbétocine et ses sels

Carbidopa and its salts

Carbidopa et ses sels

Carbimazole

Carbimazole

Carbocisteine

Carbocistéine

Carbomycin and its salts and derivatives

Carbomycine, ses sels et dérivés

Carboplatin

Carboplatine

Carbromal

Carbromal

Carisoprodol

Carisoprodol

Carmustine

Carmustine

Carphenazine and its salts

Carphénazine et ses sels

Carprofen and its salts and derivatives

Carprofène, ses sels et dérivés

Carvedilol and its salts

Carvédilol et ses sels

Caspofungin and its salts and derivatives

Caspofungine et ses sels et dérivés

Cefdinir and its salts and derivatives

Cefdinir et ses sels et dérivés

Cefepime and its salts and derivatives

Céfépime, ses sels et dérivés

Cefonicide and its salts

Céfonicide et ses sels

Cefoperazone and its salts and derivatives

Céfopérazone, ses sels et dérivés

Cefprozil and its salts and derivatives

Cefprozil, ses sels et dérivés

Ceftibuten and its salts and derivatives

Ceftibutène, ses sels et dérivés

Celecoxib and its salts

Célécoxib et ses sels

Cephalosporin C and its salts and derivatives

Céphalosporine C, ses sels et dérivés

Cerivastatin and its salts

Cérivastatine et ses sels

Cetirizine and its salts when sold in concentrations greater than 8.5 mg cetirizine per unit dose

Cétirizine et ses sels lorsque vendues en concentration supérieure à 8,5 mg de cétirizine par unité posologique

Cetrorelix and its salts

Cétrorélix et ses sels

Cetuximab

Cétuximab

Chloral

Chloral

Chloral hydrate

Chloral (hydrate de)

Chloralformamide

Chloralformamide

Chloralimide

Chloralimide

Chlorambucil and its salts and derivatives

Chlorambucil, ses sels et dérivés

Chloramphenicol and its salts and derivatives

Chloramphénicol, ses sels et dérivés

Chlorcyclizine and its salts (except in preparations for external use only)

Chlorcyclizine et ses sels (sauf dans les préparations pour usage externe seulement)

Chlorisondamine and its salts

Chlorisondamine et ses sels

Chlormezanone

Chlormézanone

Chloroquine and its salts

Chloroquine et ses sels

Chlorpropamide

Chlorpropamide

Chlorprothixene and its salts

Chlorprothixène et ses sels

Choline salicylate, when sold in combination with magnesium salicylate

Choline (salicylate de) s’il est vendu en association avec le salicylate de magnésium

Choline theophyllinate

Choline (théophyllinate de)

Choriogonadotropin alfa

Choriogonadotropine alfa

Ciclopirox and its salts

Ciclopirox et ses sels

Cilastatin and its salts

Cilastatine et ses sels

Cilazapril and its salts and derivatives

Cilazapril, ses sels et dérivés

Cimetidine and its salts, except when sold in concentrations of 200 mg or less per oral dosage unit and indicated for the treatment of heartburn

Cimétidine et ses sels, sauf s’ils sont vendus en une concentration de 200 mg ou moins par unité posologique orale pour le traitement des brûlures d’estomac

Cinacalcet and its salts

Cinacalcet et ses sels

Cinchophene and its salts

Cinchophène et ses sels

Cinoxacin

Cinoxacine

Ciprofloxacin and its salts

Ciprofloxacine et ses sels

Cisapride and its salts

Cisapride et ses sels

Cisatracurium besilate

Cisatracurium (bésilate de)

Cisplatin

Cisplatine

Citalopram and its salts

Citalopram et ses sels

Cladribine and its salts

Cladribine et ses sels

Clenbuterol and its salts

Clenbutérol et ses sels

Clindamycin and its salts and derivatives

Clindamycine et ses sels et dérivés

Clodronic acid and its salts

Clodronique (acide) et ses sels

Clofibrate

Clofibrate

Clomiphene and its salts

Clomiphène et ses sels

Clomipramine and its salts

Clomipramine et ses sels

Clonidine and its salts

Clonidine et ses sels

Clopidogrel and its salts

Clopidogrel et ses sels

Cloprostenol and its salts and derivatives

Cloprosténol, ses sels et dérivés

Clorazepic acid and its salts

Clorazépique (acide) et ses sels

Clotrimazole and its salts (except in preparations for topical and vaginal use)

Clotrimazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Cloxacillin and its salts and derivatives

Cloxacilline, ses sels et dérivés

Clozapine and its salts

Clozapine et ses sels

Colchicine

Colchicine

Colestipol and its salts

Colestipol et ses sels

Colfosceril and its derivatives

Colfoscéril et ses dérivés

Colistin and its salt and derivatives

Colistine, ses sels et dérivés

Cromoglicic acid and its salts (except sodium cromoglicate in solutions for ophthalmic or nasal use in concentrations of 2% or less)

Cromoglicique (acide) et ses sels (sauf le cromoglicate de sodium dans les solutions pour usage ophtalmique ou nasal en concentration de 2 % ou moins)

Cyclobenzaprine and its salts

Cyclobenzaprine et ses sels

Cyclopentolate and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada

Cyclopentolate et ses sels dans les préparations pour usage parentéral ou ophtalmique, sauf lorsqu’ils sont vendus pour usage diagnostique à un optométriste agréé dans une province du Canada

Cyclophosphamide

Cyclophosphamide

Cycloserine

Cyclosérine

Cyclosporine

Cyclosporine

Cyproterone acetate

Cyprotérone (acétate de)

Cytarabine and its salts

Cytarabine et ses sels

Dabigatran and its salts and derivatives

Dabigatran et ses sels et dérivés

Dacarbazine

Dacarbazine

Daclizumab

Daclizumab

Dactinomycin

Dactinomycine

Dalfopristin and its salts

Dalfopristine et ses sels

Dalteparin and its salts

Daltéparine et ses sels

Danaparoid and its salts and derivatives

Danaparoïde, ses sels et dérivés

Danazol

Danazol

Danofloxacin and its salts

Danofloxacine et ses sels

Dantrolene and its salts

Dantrolène et ses sels

Dapiprazole and its salts

Dapiprazole et ses sels

Daptomycin

Daptomycine

Darifenacin and its salts

Darifénacine et ses sels

Darunavir

Darunavir

Dasatinib

Dasatinib

Daunorubicin and its salts

Daunorubicine et ses sels

Deanol, and its salts and derivatives

Déanol, ses sels et dérivés

Debrisoquin and its salts

Debrisoquine et ses sels

Deferasirox

Déférasirox

Deferoxamine and its salts

Déféroxamine et ses sels

Delavirdine and its salts

Délavirdine et ses sels

Deracoxib

Déracoxib

Deserpidine and its alkaloids and salts

Déserpidine, ses alcaloïdes et sels

Desflurane

Desflurane

Desipramine and its salts

Désipramine et ses sels

Desmopressin and its salts

Desmopressin et ses sels

Detomidine and its salts

Détomidine et ses sels

Dexfenfluramine and its salts

Dexfenfluramine et ses sels

Dexrazoxane and its salts

Dexrazoxane et ses sels

Diazoxide and its salts

Diazoxide et ses sels

Dichloroacetic Acid

Dichloroacétique (acide)

Diclofenac and its salts, except when sold as a single medicinal ingredient in a concentration equivalent to 1% or less diclofenac in preparations for topical use on the skin

Diclofénac et ses sels sauf s’ils sont vendus comme ingrédient médicinal unique en une concentration maximale de 1 % dans les préparations pour usage topique sur la peau

Dicloxacillin and its salts and derivatives

Dicloxacilline, ses sels et dérivés

Didanosine and its salts and derivatives

Didanosine, ses sels et dérivés

Diethylbromacetamide

Diéthylbromacétamide

Diethylcarbamazine and its salts

Diéthylcarbamazine et ses sels

Diethylstilbestrol and its salts and derivatives

Diéthylstilbestrol, ses sels et dérivés

Difloxacin and its salts and derivatives

Difloxacine et ses sels et dérivés

Diflunisal and its salts

Diflunisal et ses sels

Digitalis lanata and its glycosides

Digitalis lanata et ses glycosides

Digitalis purpurea and its glycosides

Digitalis purpurea et ses glycosides

Digoxin immune Fab (ovine)

Digoxine [Fragments d’anticorps spécifiques de la digoxine Fab (ovins)]

Dihydrotachysterol

Dihydrotachystérol

Diiodohydroxyquin (except in preparations for topical use on the skin)

Diiodohydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)

Diltiazem and its salts

Diltiazem et ses sels

Dimercaprol

Dimercaprol

Dimethyl sulfoxide

Diméthylsulfoxide

2,4-Dinitrophenol and its salts and derivatives

Dinitro-2,4-phénol, ses sels et dérivés

Dinoprostone and its salts and derivatives

Dinoprostone, ses sels et dérivés

Diphenidol and its salts

Diphénidol et ses sels

Diphenylhydantoin (phenytoin) and its salts

Diphénylhydantoine (phénytoïne) et ses sels

Dipivefrin and its salts

Dipivefrine et ses sels

Diprophylline and its salts

Diprophylline et ses sels

Dipyridamole

Dipyridamole

Disopyramide and its salts

Disopyramide et ses sels

Disulfiram

Disulfirame

Dobutamine and its salts

Dobutamine et ses sels

Docetaxel and its derivatives

Docétaxel et ses dérivés

Dolasetron and its salts

Dolasétron et ses sels

Domperidone

Dompéridone

Donepezil and its salts

Donépézil et ses sels

Dopamine and its salts

Dopamine et ses sels

Dornase alfa

Dornase alfa

Dorzolamide and its salts

Dorzolamide et ses sels

Doxacurium chloride

Doxacurium (cholure de)

Doxapram

Doxapram

Doxazosin and its salts

Doxazosine et ses sels

Doxepin and its salts

Doxépine et ses sels

Doxercalciferol and its derivatives

Doxercalciférol et ses dérivés

Doxorubicin and its salts

Doxorubicine et ses sels

Doxycycline and its salts and derivatives, when sold for intramuscular administration in caged birds

Doxycycline, ses sels et dérivés, lorsque vendue pour administration intramusculaire aux oiseaux en cage

Doxylamine and its salts, when sold or recommended for use in the nausea or vomiting of pregnancy

Doxylamine et ses sels lorsque vendus ou recommandés contre les nausées ou vomissements de la grossesse

Droperidol and its salts

Dropéridol et ses sels

Drotrecogin

Drotrécogine

Duloxetine and its salts

Duloxétine et ses sels

Dutasteride

Dutastéride

Econazole and its salts

Éconazole et ses sels

Ecothiophate and its salts

Écothiophate et ses sels

Ectylurea and its salts

Ectylurée et ses sels

Eculizumab

Éculizumab

Edrophonium chloride

Édrophonium (chlorure d’)

Efalizumab

Éfalizumab

Efavirenz

Éfavirenz

Eflornithine and its salts and derivatives

Éflornithine, ses sels et dérivés

Eletriptan and its salts

Élétriptan et ses sels

Embutramide

Embutramide

Emedastine and its salts

Émédastine et ses sels

Emtricitabine

Emtricitabine

Emylcamate

Émylcamate

Enalaprilat and its salts and derivatives

Énalaprilate, ses sels et dérivés

Enflurane

Enflurane

Enfuvirtide

Enfuvirtide

Enoxaparin and its salts

Énoxaparine et ses sels

Enrofloxacin

Enrofloxacine

Entacapone

Entacapone

Entecavir

Entécavir

Epirubicine and its salts

Épirubicine et ses sels

Epoprostenol and its salts

Époprosténol et ses sels

Eprosartan and its salts and derivatives

Éprosartan et ses sels et dérivés

Epsiprantel

Epsiprantel

Eptifibatide and its salts

Eptifibatide et ses sels

Erlotinib and its salts

Erlotinib et ses sels

Ertapenem and its salts

Ertapénem et ses sels

Erythropoietin

Érythropoiétine

Escitalopram and its salts

Escitalopram et ses sels

Esmolol and its salts

Esmolol et ses sels

Esomeprazole and its salts

Ésoméprazole et ses sels

Estramustine and its salts

Estramustine et ses sels

Etanercept

Étanercept

Ethacrynic acid

Étacrynique (acide)

Ethambutol and its salts

Éthambutol et ses sels

Ethionamide and its salts

Éthionamide et ses sels

Ethomoxane and its salts

Éthomoxane et ses sels

Ethotoin and its salts

Éthotoine et ses sels

Ethyl trichloramate

Éthyle (trichloramate d’)

Etidronic acid and its salts

Étidronique (acide) et ses sels

Etodolac and its salts and derivatives

Étodolac, ses sels et dérivés

Etoposide and its derivatives

Étoposide et ses dérivés

Etravirine and its salts

Étravirine et ses sels

Etretinate

Étrétinate

Etymemazine and its salts

Étymémazine et ses sels

Exemestane

Exémestane

Ezetimibe

Ézétimibe

Famciclovir and its salts

Famciclovir et ses sels

Famotidine and its salts, except when sold in concentrations of 20 mg or less per oral dosage unit and indicated for the treatment of heartburn

Famotidine et ses sels, sauf s’ils sont vendus en une concentration de 20 mg ou moins par unité posologique orale et indiqués pour le traitement des brûlures d’estomac

Felodipine and its salts

Félodipine et ses sels

Fenfluramine and its salts

Fenfluramine et ses sels

Fenofibrate

Fénofibrate

Fenoprofen and its salts

Fénoprofène et ses sels

Fenoterol and its salts

Fénotérol et ses sels

Filgrastim

Filgrastime

Finasteride

Finastéride

Flavoxate and its salts

Flavoxate et ses sels

Flecainide and its salts

Flécaïnide et ses sels

Fleroxacin and its salts and derivatives

Fléroxacine, ses sels et dérivés

Floctafenine

Floctafénine

Florfenicol and its derivatives

Florfénicol et ses dérivés

Fluconazole, except when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis

Fluconazole, sauf s’il est vendu en une concentration de 150 mg par unité posologique orale pour le traitement des candidoses vaginales

Flucytosine

Flucytosine

Fludarabine and its salts and derivatives

Fludarabine, ses sels et dérivés

Flunarizine and its salts

Flunarizine et ses sels

Flunixin and its salts and derivatives

Flunixine, ses sels et dérivés

Fluorouracil and its derivatives

Fluorouracile et ses dérivés

Fluoxetine and its salts

Fluoxétine et ses sels

Flupentixol and its salts and derivatives

Flupentixol, ses sels et dérivés

Fluphenazine and its salts

Fluphénazine et ses sels

Fluprostenol and its salts and derivatives

Fluprosténol, ses sels et dérivés

Flurbiprofen and its salts

Flurbiprofène et ses sels

Fluspirilene

Fluspirilène

Flutamide

Flutamide

Fluvastatin and its salts and derivatives

Fluvastatine, ses sels et dérivés

Fluvoxamine and its salts

Fluvoxamine et ses sels

Folic acid in oral dosage form containing more than 1.0 mg of folic acid per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1.0 mg of folic acid

Acide folique présenté en unités posologiques orales contenant chacune plus de 1,0 mg d’acide folique ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion, par une personne, de plus de 1,0 mg d’acide folique

Follicle stimulating hormone

Folliculo-stimulante (hormone)

Fomepizole and its salts

Fomépizole et ses sels

Fondaparinux sodium

Fondaparinux sodique

Formestane and its derivatives

Formestane et ses dérivés

Formoterol and its salts

Formotérol et ses sels

Foscarnet sodium

Foscarnet sodique

Fosfomycin and its salts

Fosfomycine et ses sels

Fosinopril and its salts

Fosinopril et ses sels

Fosphenytoin and its salts

Fosphénytoïne et ses sels

Frovatriptan and its salts

Frovatriptan et ses sels

Fulvestrant

Fulvestrant

Fusidic acid and its salts

Fusidique (acide) et ses sels

Gabapentin and its salts and derivatives

Gabapentin, ses sels et dérivés

Galantamine and its salts and derivatives

Galantamine et ses sels et dérivés

Gallamine triethiodide

Gallamine (triéthiodure de)

Gallium and its salts

Gallium et ses sels

Ganciclovir and its salts

Ganciclovir et ses sels

Ganirelix and its salts and derivatives

Ganirélix, ses sels et dérivés

Gatifloxacin and its salts and derivatives

Gatifloxacine, ses sels et dérivés

Gefitinib

Géfitinib

Gemcitabine and its salts

Gemcitabine et ses sels

Gemfibrozil and its salts

Gemfibrozil et ses sels

Gemifloxacin and its salts

Gémifloxacine et ses sels

Gentamicin and its salts and derivatives

Gentamicine, ses sels et dérivés

Glatiramer and its salts

Glatiramère et ses sels

Gliclazide

Gliclazide

Glimepiride

Glimépiride

Glipizide

Glipizide

Glyburide and its salts and derivatives

Glyburide, ses sels et dérivés

Gold and its salts

Or et ses sels

Golimumab

Golimumab

Gonadorelin and its salts

Gonadoréline et ses sels

Gonadotropin, chorionic (human)

Gonadotropine chorionique (humain)

Gonadotropins, serum (human)

Gonadotropines sériques (humains)

Goserelin and its salts

Goséréline et ses sels

Granisetron and its salts

Granisetron et ses sels

Grepafloxacin and its salts and derivatives

Grépafloxacine et ses sels et dérivés

Guanethidine and its salts

Guanéthidine et ses sels

Halofantrine and its salts

Halofantrine et ses sels

Haloperidol

Halopéridol

Halothane

Halothane

Hetacillin and its salts and derivatives

Hétacilline, ses sels et dérivés

Hetastarch and its derivatives

Hetastarch et ses dérivés

Hexachlorophene and its salts

Hexachlorophène et ses sels

Hexacyclonate sodium

Hexacyclonate sodique

Hexamethonium and its salts

Hexaméthonium et ses sels

Histrelin and its salts

Histréline et ses sels

Hyaluronic acid and its salts, when sold or recommended for administration by intra-articular injection to horses

Hyaluronique (acide) et ses sels, s’il est vendu ou recommandé pour administration par injection intra-articulaire aux chevaux

Hydralazine and its salts

Hydralazine et ses sels

Hydroxychloroquine and its salts

Hydroxychloroquine et ses sels

4-Hydroxycoumarin and its derivatives when sold or recommended as anticoagulants

Hydroxy-4 coumarine et ses dérivés, s’ils sont vendus ou recommandés comme anticoagulants

Hydroxyurea

Hydroxyurée

Hydroxyzine and its salts and derivatives

Hydroxyzine, ses sels et dérivés

Ibandronic acid and its salts

Acide ibandronique et ses sels

Ibuprofen and its salts except when sold for oral administration in a concentration of 400 mg or less per dosage unit.

Ibuprofène et ses sels, sauf s’ils sont vendus pour administration par voie orale en une concentration de 400 mg ou moins par unité posologique

Ibutilide and its salts and derivatives

Ibutilide et ses sels et dérivés

Idarubicin and its salts

Idarubicine et ses sels

Idoxuridine

Idoxuridine

Ifosfamide

Ifosfamide

Imatinib and its salts

Imatinib et ses sels

Imiglucerase

Imiglucérase

Imipenem and its salts and derivatives

Imipénem, ses sels et dérivés

Imipramine and its salts

Imipramine et ses sels

Imiquimod and its salts

Imiquimod et ses sels

Indapamide and its salts

Indapamide et ses sels

Indinavir and its salts

Indinavir et ses sels

Indomethacin

Indométhacine

Infliximab

Infliximab

Inhaled human insulin

Insuline humaine inhalée

Inosiplex

Inosiplex

Interferon

Interféron

Iodochlorohydroxyquin (except in preparations for topical use on the skin)

Iodochlorhydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)

Ipratropium and its salts

Ipratropium et ses sels

Iproniazid and its salts

Iproniazide et ses sels

Irbesartan and its salts

Irbésartan et ses sels

Irinotecan and its salts

Irinotécan et ses sels

Isocarboxazid and its salts

Isocarboxazide et ses sels

Isoflurane

Isoflurane

Isoniazid

Isoniazide

Isoproterenol (Isoprenaline) and its salts

Isoprotérénol (Isoprénaline) et ses sels

Isotretinoin and its salts

Isotrétinoïne et ses sels

Isoxsuprine and its salts

Isoxsuprine et ses sels

Isradipine and its salts

Isradipine et ses sels

Itraconazole and its salts

Itraconazole et ses sels

Ivermectin and its derivatives, for human use or for veterinary use when sold for intramuscular injection into horses or for oral administration to dogs and cats

Ivermectine et ses dérivés, destinés à l’usage humain ou à l’usage vétérinaire, s’ils sont vendus pour injection intramusculaire aux chevaux ou pour administration par voie orale aux chiens et aux chats

Ketanserin and its salts

Kétansérine et ses sels

Ketoconazole and its salts (except in preparations for topical use as a shampoo)

Kétoconazole et ses sels (excepté pour les préparations pour usage topique sous la forme d’un shampooing)

Ketoprofene and its salts

Kétoprofène et ses sels

Ketorolac and its salts

Kétorolac et ses sels

Ketotifen and its salts

Kétotifène et ses sels

Labetalol and its salts

Labétalol et ses sels

Lactic acid, when recommended for parenteral use as a tissue sclerosing agent

Acide lactique, s’il est recommandé pour usage parentéral comme agent sclérosant

Lamivudine and its salts

Lamivudine et ses sels

Lamotrigine and its salts

Lamotrigue et ses sels

Lanreotide and its salts

Lanréotide et ses sels

Lansoprazole and its salts

Lansoprazole et ses sels

Lanthanum salts, when sold for the treatment of hyperphosphatemia

Sels de lanthane vendus pour le traitement de l’hyperphosphatémie

Lapatinib and its salts

Lapatinib et ses sels

Laronidase

Laronidase

Latanoprost

Latanoprost

Leflunomide and its salts

Léflunomide et ses sels

Lenalidomide

Lénalidomide

Letrozole

Létrozole

Leucovorin and its salts

Acide folinique et ses sels

Leuprolide and its salts

Leuproréline et ses sels

Levetiracetam

Lévétiracétam

Levobunolol and its salts

Levobunolol et ses sels

Levocabastine and its salts and derivatives

Lévocabastine, ses sels et dérivés

Levocarnitine and its salts and derivatives

Lévocarnitine et ses sels et dérivés

Levodopa and its salts

Lévodopa et ses sels

Linezolid and its salts

Linézolide et ses sels

Lisinopril and its salts and derivatives

Lisinopril, ses sels et dérivés

Lithium and its salts

Lithium et ses sels

Lodoxamide and its salts and derivatives

Lodoxamide, ses sels et dérivés

Lomefloxacin and its salts

Loméfloxacine et ses sels

Lomustine

Lomustine

Lopinavir

Lopinavir

Loracarbef and its salts and derivatives

Loracarbef, ses sels et dérives

Losartan and its salts

Losartan et ses sels

Losoxantrone and its salts

Losoxantrone et ses sels

Lovastatin

Lovastatine

Loxapine and its salts

Loxapine et ses sels

Lumiracoxib

Lumiracoxib

Lutropin alfa

Lutropine alfa

Magnesium glutamate hydrobromide

Bromhydrate de glutamate de magnésium

Maprotiline and its salts

Maprotiline et ses sels

Maraviroc

Maraviroc

Marbofloxacin and its salts and derivatives

Marbofloxacine et ses sels et dérivés

Mecamylamine and its salts

Mécamylamine et ses sels

Mechlorethamine and its salts

Méchloréthamine et ses sels

Mecillinam and its salts and derivatives

Mécillinam, ses sels et dérivés

Meclofenamic acid and its salts

Méclofénamique (acide) et ses sels

Medetomidine and its salts

Médétomidine et ses sels

Mefenamic acid and its salts

Méfénamique (acide) et ses sels

Mefloquine and its salts and derivatives

Méfloquine, ses sels et dérivés

Megestrol and its salts

Mégestrol et ses sels

Melanoma therapeutic vaccine

Vaccin thérapeutique contre le mélanome

Melarsomine and its salts, when sold for the treatment of heartworm in dogs

Mélarsomine et ses sels, s’ils sont vendus pour le traitement du ver du coeur chez le chien

Meloxicam and its salts and derivatives

Méloxicam et ses sels et dérivés

Melphalan

Melphalan

Memantine and its salts

Mémantine et ses sels

Menotropins (human)

Ménotropines (humains)

Mepacrine and its salts

Mépacrine et ses sels

Mepazine and its salts

Mépazine et ses sels

Mephenoxalone

Méphenoxalone

Mephentermine and its salts

Méphentermine et ses sels

Mercaptopurine

Mercaptopurine

Meropenem and its salts and derivatives

Méropénem, ses sels et dérivés

Mesna

Mesna

Mesoridazine and its salts

Mésoridazine et ses sels

Metaldehyde

Métaldéhyde

Metformin and its salts and derivatives

Metformine, ses sels et dérivés

Methacholine chloride

Méthacholine (chlorure de)

Methazolamide and its salts

Méthazolamide et ses sels

Methicillin and its salts and derivatives

Méthicilline, ses sels et dérivés

Methimazole

Méthimazole

Methisazone

Méthisazone

Methoin (Mephenytoin) and its salts

Méthoïne (méphénytoine) et ses sels

Methotrexate and its salts

Méthotrexate et ses sels

Methotrimeprazine and its salts

Méthotriméprazine et ses sels

Methoxamine and its salts

Méthoxamine et ses sels

Methoxsalen

Méthoxsalène

Methoxy polyethylene glycol-epoetin beta

Méthoxy polyéthylèneglycol-époétine bêta

Methyldopa and its salts

Méthyldopa et ses sels

Methylparafynol

Méthylparafynol

Methysergide and its salts and derivatives

Méthysergide, ses sels et dérivés

Metoclopramide

Métoclopramide

Metolazone and its salts

Métolazone et ses sels

Metomidate and its salts

Métomidate et ses sels

Metopimazine and its salts

Métopimazine et ses sels

Metoprolol and its salts

Métoprolol et ses sels

Metronidazole

Métronïdazole

Metyrapone and its salts

Métyrapone et ses sels

Mexiletine and its salts

Mésiletine et ses sels

Mezlocillin and its salts and derivatives

Mézlocilline, ses sels et dérivés

Micafungin and its salts

Micafungine et ses sels

Miconazole and its salts (except in preparations for topical and vaginal use)

Miconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Midodrine and its salts

Midodrine et ses sels

Miglustat

Miglustat

Milbemycin and its derivatives

Milbémycine et ses dérivés

Milrinone and its salts

Milrinone et ses sels

Minoxidil (except in solutions for topical use in concentrations of 2% or less)

Minoxidil (sauf dans les solutions pour usage topique où sa concentration est de 2 % ou moins)

Mirtazapine and its salts

Mirtazapine et ses sels

Mitomycin and its salts

Mitomycine et ses sels

Mitotane (o,p’-DDD)

Mitotane (o,p’-DDD)

Mitoxantrone and its salts

Mitoxantrone et ses sels

Mivacurium chloride

Mivacurium (chlorure de)

Modafinil and its salts

Modafinil et ses sels

Molgramostim

Molgramostim

Montelukast and its salts

Montélukast et ses sels

Moxidectin and its derivatives, when sold for the prevention of heartworm in dogs

Moxidectine et ses dérivés, s’ils sont vendus pour la prévention du ver du coeur chez le chien

Moxifloxacin and its salts and derivatives

Moxifloxacine, ses sels et dérivés

Muromonab-CD3

Muromonab-CD3

Mycophenolic acid and its salts and derivatives

Mycophénolique (acide) et ses sels et dérivés

Nabumetone

Nabumétone

Nadolol and its salts

Nadolol et ses sels

Nadroparin and its salts

Nadroparine et ses sels

Nafarelin and its salts and derivatives

Nafaréline, ses sels et dérivés

Nafcillin and its salts and derivatives

Nafcilline, ses sels et dérivés

Nalidixic acid

Nalidixique (acide)

Nalmefene and its salts

Nalméfène et ses sels

Naloxone and its salts

Naloxone et ses sels

Naltrexone and its salts and derivatives

Naltrexone, ses sels et ses dérivés

Naproxen and its salts, except when sold for oral use with a daily dosage of 440 mg

Naproxène et ses sels,sauf lorsque vendu pour administration par voie orale en dose quotidienne de 440 mg

Naratriptan and its salts

Naratriptan et ses sels

Natalizumab

Natalizumab

Nateglinide and its salts and derivatives

Natéglinide et ses sels et dérivés

Nedocromil and its salts

Nédocromil et ses sels

Nefazodone and its salts

Néfazodone et ses sels

Nelarabine

Nélarabine

Nelfinavir and its salts

Nelfinavir et ses sels

Neocinchophen and its salts

Néocinchophène et ses sels

Neostigmine salts

Néostigmine (les sels de)

Nepafenac

Népafénac

Netilmicin and its salts and derivatives

Nétilmicine, ses sels et dérivés

Nevirapine and its salts

Névirapine et ses sels

Nialamide and its salts

Nialamide et ses sels

Nicardipine and its salts

Nicardipine et ses sels

Nicotine and its salts, for human use, except

(a) in natural substances;

(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit;

(c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day;

(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit; or

(e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit

Nicotine et ses sels, destinés à l’usage humain, sauf :

a) dans les substances naturelles;

b) sous forme de gomme à mâcher contenant 4 mg ou moins de nicotine par unité posologique;

c) sous forme de timbre cutané ayant un taux de libération de 22 mg ou moins de nicotine par jour;

d) sous une forme destinée à être administrée par voie orale au moyen d’un inhalateur libérant 4 mg ou moins de nicotine par unité posologique;

e) sous forme de pastille contenant 4 mg ou moins de nicotine par unité posologique

Nicotinic acid when sold in

(a) a modified-release oral dosage form that provides 500 mg or more per dosage unit or per daily dose; or

(b) an immediate-release oral dosage form that provides more than 500 mg per dosage unit or per daily dose

Acide nicotinique vendu sous l’une des forme suivantes :

a) en forme posologique à libération modifiée fournissant, par unité posologique ou par dose quotidienne, 500 mg ou plus d’acide nicotinique administré par voie orale;

b) en forme posologique à libération immédiate fournissant, par unité posologique ou par dose quotidienne, plus de 500 mg d’acide nicotinique administré par voie orale

Nifedipine

Nifédipine

Nilotinib and its salts

Nilotinib et ses sels

Nilutamide

Nilutamide

Nimodipine and its salts

Nimodipine et ses sels

Nitric oxide

Oxyde nitrique

Nitroscanate

Nitroscanate

Nizatidine and its salts (except when sold in an oral dosage form containing not more than the equivalent of 75 mg of nizatidine)

Nizatidine et ses sels (sauf lorsque vendue sous une forme posologique orale contenant au plus l’équivalent de 75 mg de nizatidine)

Nomifensine and its salts

Nomifensine et ses sels

Norfloxacin

Norfloxacine

Nortriptyline and its salts

Nortriptyline et ses sels

Nylidrin and its salts

Nylidrine et ses sels

Octatropine methylbromide

Octatropine (méthylbromure d’)

Octreotide

Octréotide

Ofloxacin and its salts

Ofloxacine et ses sels

Olanzapine and its salts

Olanzapine et ses sels

Olmesartan and its salts and derivatives

Olmésartan, ses sels et dérivés

Olopatadine and its salts

Olopatadine et ses sels

Olsalazine and its salts

Olsalazine et ses sels

Omalizumab

Omalizumab

Omeprazole and its salts

Oméprazole et ses sels

Ondansetron and its salts

Ondansétron et ses sels

Orbifloxacin and its salts and derivatives

Orbifloxacine, ses sels et dérivés

Orciprenaline (Metaproterenol) and its salts

Orciprénaline (Métaprotérénol) et ses sels

Orlistat

Orlistat

Ormetoprim and its salts

Ormétoprime et ses sels

Ornidazole

Ornidazole

Oseltamivir and its salts

Oséltamivir et ses sels

Oxacillin, and its salts and derivatives

Oxacilline, ses sels et dérivés

Oxaliplatin

Oxaliplatine

Oxanamide

Oxanamide

Oxaprozin and its salts and derivatives

Oxaprozine, ses sels et dérivés

Oxcarbazepine

Oxcarbazépine

Oxolinic acid and its salts

Oxolinique (acide) et ses sels

Oxprenolol and its salts

Oxprénolol et ses sels

Oxybutynin and its salts

Oxybutynine et ses sels

Oxyphenbutazone and its salts

Oxyphenbutazone et ses sels

Oxytocin

Oxytocine

Paclitaxel and its derivatives

Paclitaxel et ses dérivés

Palifermin

Palifermine

Paliperidone and its salts and derivatives

Palipéridone, ses sels et ses dérivés

Palivizumab

Palivizumab

Pamidronic acid and its salts

Pamidronique (acide) et ses sels

Pancuronium and its salts

Pancuronium et ses sels

Panitumumab

Panitumumab

Pantoprazole and its salts

Pantoprazole et ses sels

Paraldehyde

Paraldéhyde

Paramethadione

Paraméthadione

Pargyline and its salts

Pargyline et ses sels

Paricalcitol

Paricalcitol

Paroxetine and its salts

Paroxétine et ses sels

Pegaptanib and its salts

Pegaptanib et ses sels

Pegfilgrastim

Pegfilgrastim

Pegvisomant

Pegvisomant

Pemetrexed and its salts

Pémétrexed et ses sels

Penciclovir and its salts

Penciclovir et ses sels

Penicillamine

Pénicillamine

Pentamidine and its salts

Pentamidine et ses sels

Pentolinium tartrate

Pentolinium (tartrate de)

Pentosan polysulfate and its salts

Pentosane polysulfate et ses sels

Pentostatin and its salts

Pentostatine et ses sels

Pentoxifylline and its salts

Pentoxifylline et ses sels

Perflutren

Perflutrène

Pergolide and its salts

Pergolide et ses sels

Pericyazine and its salts

Péricyazine et ses sels

Perindopril and its salts

Périndopril et ses sels

Perphenazine and its salts

Perphénazine et ses sels

Phacetoperane and its salts

Phacétopérane et ses sels

Phenacemide

Phénacémide

Phenacetin

Phénacétine

Phenaglycodol

Phénaglycodol

Phenazopyridine and its salts

Phénazopyridine et ses sels

Phenelzine and its salts

Phénelzine et ses sels

Phenformin and its salts

Phenformine et ses sels

Pheniprazine and its salts

Phéniprazine et ses sels

Phenthoxate and its salts

Phentoxate et ses sels

Phentolamine and its salts

Phentolamine et ses sels

Phenylbutazone and its salts

Phénylbutazone et ses sels

Phenylephrine and its salts in preparations for ophthalmic or parenteral use in concentrations greater than 2.5%

Phényléphrine et ses sels dans les préparations pour usage ophtalmique ou parentéral lorsqu’il constitue plus de 2,5% d’un mélange

Phenylindanedione and its derivatives

Phénylindanédione et ses dérivés

Phenylpropanolamine and its salts and derivatives for veterinary use

Phénylpropanolamine, ses sels et dérivés, destinés à l’usage vétérinaire

Pilocarpine and its salts

Pilocarpine et ses sels

Pimecrolimus

Pimécrolimus

Pimobendan

Pimobendan

Pimozide

Pimozide

Pinaverium bromide

Pinavérium (bromure de)

Pindolol and its salts

Pindolol et ses sels

Pioglitazone and its salts

Pioglitazone et ses sels

Pipecuronium bromide

Pipécuronium (bromure de)

Piperacetazine and its salts

Pipéracétazine et ses sels

Piperilate and its salts

Pipérilate et ses sels

Pipotiazine and its salts

Pipotiazine et ses sels

Pipobroman

Pipobroman

Pirbuterol and its salts

Pirbutérol et ses sels

Pirenzepine and its salts

Pirenzépine et ses sels

Pirlimycin and its salts

Pirlimycine et ses sels

Piroxicam and its salts

Piroxicam et ses sels

Pizotyline and its salts

Pizotyline et ses sels

Podophyllum and the following extracts and active principles, when sold or recommended for topical use:

(a) podophyllotoxin

(b) podophyllum resin

Podophyllum, ses extraits et principes actifs suivants lorsque vendus ou recommandés pour usage topique :

a) podophyllotoxine

b) podophyllum (résine de)

Polysulfated glycosaminoglycan

Glycosaminoglycan polysulfaté

Ponazuril

Ponazuril

Poractant alfa

Poractant alfa

Porfimer and its salts

Porfimère et ses sels

Posaconazole

Posaconazole

Potassium bromide

Bromure de potassium

Potassium gluconate, when sold or recommended for administration to cats

Potassium (gluconate de), lorsqu’il est vendu ou recommandé pour administration aux chats

Potassium para-aminobenzoate (except in preparations for topical use on the skin)

Potassium (para-aminobenzoate de) (sauf dans les préparations pour usage topique sur la peau)

Pralidoxime and its salts

Pralidoxime et ses sels

Pramipexole and its salts

Pramipexole et ses sels

Pravastatin and its salts

Pravastatine et ses sels

Praziquantel, except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses

Praziquantel, sauf s’il est vendu pour le traitement du ver solitaire Anoplocephala perfoliata chez les chevaux

Prazosin and its salts

Prazosine et ses sels

Pregabalin and its salts and derivatives

Prégabaline, ses sels et ses dérivés

Prenylamine and its salts

Prénylamine et ses sels

Primaquine and its salts

Primaquine et ses sels

Probenecid and its salts

Probénécide et ses sels

Probucol

Probucol

Procainamide and its salts

Procainamide et ses sels

Procarbazine and its salts

Procarbazine et ses sels

Procaterol and its salts

Procatérol et ses sels

Prochlorperazine and its salts

Prochlorpérazine et ses sels

Procyclidine and its salts

Procyclidine et ses sels

Prodilidine and its salts

Prodilidine et ses sels

Profenamine and its salts

Profénamine et ses sels

Proguanil and its salts

Proguanil et ses sels

Propafenone and its salts

Propafénone et ses sels

Propofol

Propofol

Propranolol and its salts

Propranolol et ses sels

Prostaglandins and their salts and derivatives

Prostaglandines, leurs sels et dérivés

Prothipendyl hydrochloride

Prothipendyl (chlorhydrate de)

Protirelin

Protireline

Protriptyline and its salts

Protriptyline et ses sels

Pyrazinamide

Pyrazinamide

Pyridostigmine bromide

Pyridostigmine (bromure de)

Pyrimethamine and its salts

Pyriméthamine et ses sels

Quetiapine and its salts

Quétiapine et ses sels

Quinagolide and its salts

Quinagolide et ses sels

Quinapril and its salts and derivatives

Quinapril, ses sels et dérivés

Quinupristin and its salts

Quinupristine et ses sels

Rabeprazole and its salts

Rabéprazole et ses sels

Raloxifene and its salts

Raloxifène et ses sels

Raltegravir and its salts

Raltégravir et ses sels

Raltitrexed and its salts and derivatives

Raltitrexed, ses sels et dérivés

Ramipril and its salts and derivatives

Ramipril, ses sels et dérivés

Ranibizumab

Ranibizumab

Ranitidine and its salts, except when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn

Ranitidine et ses sels, sauf s’ils sont vendus en une concentration de 150 mg ou moins par unité posologique orale et indiqués pour le traitement des brûlures d’estomac

Rasagiline and its salts

Rasagiline et ses sels

Rasburicase

Rasburicase

Raubasine and its salts

Raubasine et ses sels

Rauwolfia

Rauwolfia

Remoxipride and its salts

Rémoxipride et ses sels

Repaglinide and its salts and derivatives

Répaglinide et ses sels et dérivés

Rescinnamine and its salts

Rescinnamine et ses sels

Resocortol and its derivatives

Résocortol et ses dérivés

Retapamulin

Rétapamuline

Reviparin and its salts

Réviparine et ses sels

Ribavirin

Ribavirine

Rifabutin and its salts

Rifabutine et ses sels

Rifampin and its salts and derivatives

Rifampine, ses sels et dérivés

Riluzole and its salts

Riluzole et ses sels

Risedronic acid and its salts

Acide risédronique et ses sels

Risperidone and its salts

Rispéridone et ses sels

Ritodrine and its salts

Ritodrine et ses sels

Ritonavir

Ritonavir

Rituximab

Rituximab

Rivaroxaban

Rivaroxaban

Rivastigmine and its salts

Rivastigmine et ses sels

Rizatriptan and its salts

Rizatriptan et ses sels

Rocuronium bromide

Rocuronium (bromure de)

Rofecoxib

Rofécoxib

Romifidine and its salts

Romifidine et ses sels

Romiplostim

Romiplostim

Ropinirole and its salts

Ropinirole et ses sels

Rosiglitazone and its salts

Rosiglitazone et ses sels

Rosoxacin and its salts

Rosoxacine et ses sels

Rosuvastatin and its salts

Rosuvastatine et ses sels

Salbutamol and its salts

Salbutamol et ses sels

Salmeterol and its salts

Salmetérol et ses sels

Salsalate and its salts and derivatives

Salsalate, ses sels et dérivés

Saquinavir and its salts and derivatives

Saquinavir, ses sels et dérivés

Saralasin and its salts

Saralasine et ses sels

Sargramostim

Sargramostim

Selegiline and its salts

Sélégiline et ses sels

Sermorelin and its salts

Sermoréline et ses sels

Sertraline and its salts

Sertraline et ses sels

Sevelamer and its salts

Sévélamer et ses sels

Sibutramine and its salts

Sibutramine et ses sels

Sildenafil and its salts

Sildénafil et ses sels

Simvastatin

Simvastatine

Sirolimus and its derivatives

Sirolimus et ses dérivés

Sitagliptin and its salts

Sitagliptine et ses sels

Sitaxentan and its salts

Sitaxentan et ses sels

Sodium aurothiomalate

Aurothiomalate de sodium

Sodium bromide

Bromure de sodium

Sodium nitroprusside and its salts

Sodium (nitroprussiate de) et ses sels

Sodium polystyrene sulfonate

Sulfonate de polystyrène de sodium

Solifenacin and its salts

Solifénacine et ses sels

Somatostatin

Somatostatine

Somatrem

Somatrem

Somatropin

Somatropine

Sorafenib and its salts

Sorafénib et ses sels

Sotalol and its salts

Sotalol et ses sels

Spironolactone

Spironolactone

Stavudine

Stavudine

Streptozocin

Streptozocine

Strontium bromide

Bromure de strontium

Succinimide and its salts and derivatives (except those compounds used for decontaminating water)

Succinimide, ses sels et dérivés (sauf les produits utilisés pour décontaminer l’eau)

Sucralfate

Sucralfate

Sulconazole and its salts

Sulconazole et ses sels

Sulfinpyrazone and its salts

Sulfinpyrazone et ses sels

Sulindac and its salts

Sulindac et ses sels

Sulphones and their derivatives

Sulphones et leurs dérivés

Sumatriptan and its salts

Sumatriptan et ses sels

Sunitinib and its salts

Sunitinib et ses sels

Suprofen and its salts

Suprofène et ses sels

Suxamethonium chloride

Suxaméthonium (chlorure de)

Tacrolimus and its derivatives

Tacrolimus et ses dérivés

Tadalafil and its salts

Tadalafil et ses sels

Tamoxifen and its salts

Tamoxifène et ses sels

Tamsulosin and its salts

Tamsulosine et ses sels

Tazarotene

Tazarotène

Tazobactam and its salts and derivatives

Tazobactam, ses sels et dérivés

Teflubenzuron

Teflubenzuron

Tegafur and its salts

Tégafur et ses sels

Tegaserod and its salts

Tégasérod et ses sels

Telbivudine

Telbivudine

Telithromycin and its salts and derivatives

Télithromycine et ses sels et dérivés

Telmisartan and its salts and derivatives

Telmisartan et ses sels et dérivés

Temozolomide and its salts

Témozolomide et ses sels

Tenecteplase and its salts and derivatives

Ténectéplase et ses sels et dérivés

Teniposide

Téniposide

Tenofovir and its salts and derivatives

Ténofovir et ses sels et dérivés

Tenoxicam and its salts

Ténoxicam et ses sels

Terazosin and its salts

Térazosine et ses sels

Terbinafine and its salts

Terbinafine et ses sels

Terbutaline and its salts

Terbutaline et ses sels

Terconazole and its salts

Terconazole et ses sels

Terfenadine and its salts

Terfénadine et ses sels

Teriparatide and its salts

Tériparatide et ses sels

Terlipressin and its salts

Terlipressine et ses sels

Tetrabenazine and its salts

Tétrabénazine et ses sels

Thalidomide

Thalidomide

Theobromine and its salts

Théobromine et ses sels

Theophylline and its salts

Théophylline et ses sels

Thiethylperazine and its salts

Thiéthylpérazine et ses sels

Thiocarlide

Thiocarlide

Thioguanine

Thioguanine

Thiopropazate and its salts

Thiopropazate et ses sels

Thioproperazine and its salts

Thiopropérazine et ses sels

Thioridazine and its salts

Thioridazine et ses sels

Thiotepa

Thiotépa

Thiothixene and its salts

Thiothixène et ses sels

Thiouracil and its derivatives

Thiouracile et ses dérivés

Thyrotropin alfa

Thyrotropine alfa

Thyroxin and its salts

Thyroxine et ses sels

Tiaprofenic acid and its salts

Tiaprofénique (acide) et ses sels

Ticarcillin and its salts and derivatives

Ticarcilline, ses sels et dérivés

Ticlopidine and its salts

Ticlopidine et ses sels

Tigecycline

Tigécycline

Tilmicosin, except in preparations for veterinary use to be administered orally

Tilmicosine, sauf dans les préparations pour usage vétérinaire destinées à être administrées par voie orale

Tiludronic acid and its salts

Tiludronique (acide) et ses sels

Timolol and its salts

Timolol et ses sels

Tinidazole

Tinidazole

Tinzaparin and its salts

Tinzaparine et ses sels

Tioconazole and its salts (except in preparations for topical and vaginal use)

Tioconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Tiotropium bromide

Tiotropium (bromure de)

Tipranavir and its salts

Tipranavir et ses sels

Tirofiban and its salts and derivatives

Tirofiban et ses sels et dérivés

Tizanidine and its salts

Tizanidine et ses sels

Tobramycin and its salts and derivatives

Tobramycine, ses sels et dérivés

Tocainide and its salts

Tocaïnide et ses sels

Tolazamide

Tolazamide

Tolazoline and its salts

Tolazoline et ses sels

Tolbutamide

Tolbutamide

Tolcapone

Tolcapone

Tolfenamic acid and its salts and derivatives

Tolfénamique (acide), ses sels et dérivés

Tolmetin and its salts

Tolmétine et ses sels

Tolterodine and its salts

Toltérodine et ses sels

Topiramate

Topiramate

Topotecan and its salts

Topotécane et ses sels

Torasemide and its salts

Torasémide et ses sels

Toremifene and its salts

Torémifène et ses sels

Trandolaprilat and its salts and derivatives

Trandolaprilat et ses sels et dérivés

Tranexamic acid

Tranexamique (acide)

Tranylcypromine

Tranylcypromine

Trastuzumab

Trastuzumab

Trazodone and its salts

Trazodone et ses sels

Treosulfan

Tréosulfan

Treprostinil and its salts

Tréprostinil et ses sels

Tretamine

Trétamine

Tretinoin and its salts and derivatives

Trétinoïne, ses sels et dérivés

Tretinoin (Vitamin A acid)

Trétinoïne (acide de vitamine A)

Triamterene and its salts

Triamtérène et ses sels

Tricaine and its salts

Tricaïne et ses sels

Trifluoperazine and its salts

Trifluopérazine et ses sels

Triflupromazine and its salts

Triflupromazine et ses sels

Trifluridine

Trifluridine

Trihexyphenidyl and its salts

Trihexyphénidyle et ses sels

Triiodothyropropionic acid

Triiodothyropropionique (acide)

Trilostane

Trilostane

Trimebutine and its salts

Trimébutine et ses sels

Trimethadione

Triméthadione

Trimethaphan camsylate

Trimétaphan (camsilate de)

Trimethoprim and its salts

Triméthoprime et ses sels

Trimetrexate and its salts

Trimétrexate et ses sels

Trimipramine and its salts

Trimipramine et ses sels

Trioxsalen

Trioxysalène

Troglitazone

Troglitazone

Tropicamide and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada

Tropicamide et ses sels dans les préparations pour usage ophtalmique ou parentéral, sauf lorsque vendu pour usage diagnostique à un optométriste enregistré dans une province du Canada

Trospium chloride

Trospium (chlorure de)

Trovafloxacin and its salts and derivatives

Trovafloxacine et ses sels et dérivés

L-Tryptophan, when sold as a single ingredient

L-Tryptophane, s’il est vendu comme seul ingrédient

Tubocurarine chloride

Tubocurarine (chlorure de)

Tybamate

Tybamate

Tylosin and its salts and derivatives, when sold for the treatment of chronic colitis in dogs

Tylosine, ses sels et dérivés, lorsque vendu pour le traitement de la colite chronique chez le chien

Unoprostone and its salts and derivatives

Unoprostone, ses sels et dérivés

Uracil and its salts

Uracile et ses sels

Uracil mustard and its salts

Uracile (moutarde à l’) et ses sels

Ursodeoxycholic acid and its salts

Ursodéoxycholique (acide) et ses sels

Ustekinumab

Ustekinumab

Valaciclovir and its salts

Valaciclovir et ses sels

Valdecoxib and its salts

Valdécoxib et ses sels

Valganciclovir and its salts and derivatives

Valganciclovir, ses sels et dérivés

Valproic acid and its salts

Valproïque (acide) et ses sels

Valrubicin and its derivatives

Valrubicine et ses dérivés

Valsartan and its salts and derivatives

Valsartan et ses sels et dérivés

Vancomycin and its salts and derivatives

Vancomycine, ses sels et dérivés

Vardenafil and its salts

Vardénafil et ses sels

Varenicline and its salts

Varénicline et ses sels

Vasopressin and its salts

Vasopressine et ses sels

Vecuronium bromide

Vecuronium (bromure de)

Vedaprofen and its salts and derivatives

Védaprofène et ses sels et dérivés

Venlafaxine and its salts

Venlafaxine et ses sels

Verapamil and its salts

Vérapamil et ses sels

Verteporfin and its salts and derivatives

Vertéporfine et ses sels et dérivés

Vidarabine

Vidarabine

Vigabatrin and its salts and derivatives

Vigabatrine, ses sels et dérivés

Vinblastine and its salts

Vinblastine et ses sels

Vincristine and its salts

Vincristine et ses sels

Vindesine and its salts

Vindésine et ses sels

Vinorelbine and its salts

Vinorelbine et ses sels

Viomycin and its salts and derivatives

Viomycine, ses sels et dérivés

Vitamin A in oral dosage form containing more than 10,000 International Units of Vitamin A per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 10,000 International Units ofVitamin A

Vitamine A présentée en unités posologiques orales contenant chacune plus de 10 000 unités internationales de vitamine A ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion,par une personne, de plus de 10 000 unités internationales de vitamine A

Vitamin B12 with Intrinsic Factor Concentrate

Vitamine B12 avec concentré de facteur intrinsèque

Vitamin D in oral dosage form containing more than 1,000 International Units of Vitamin D per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1,000 International Units ofVitamin D

Vitamine D présentée en unités posologiques orales contenant chacune plus de 1 000 unités internationales de vitamine D ou dont la plus forte dose quotidienne recommandée sur

l’étiquette résulte en l’ingestion,par une personne, de plus de 1 000 unités internationales de vitamine D

Voriconazole

Voriconazole

Vorinostat

Vorinostat

Xanthinol nicotinate

Xantinol (nicotinate de)

Xylazine and its salts

Xylazine et ses sels

Yohimbine and its salts

Yohimbine et ses sels

Zafirlukast and its salts

Zafirlukast et ses sels

Zalcitabine and its salts

Zalcitabine et ses sels

Zanamivir and its salts and derivatives

Zanamivir et ses sels et dérivés

Zidovudine

Zidovudine

Ziprasidone and its salts

Ziprasidone et ses sels

Zoledronic acid and its salts and derivatives

Acide zolédronique et ses sels et dérivés

Zomepirac and its salts

Zomépirac et ses sels

Zopiclone and its salts

Zopiclone et ses sels

Zuclopenthixol and its salts and derivatives

Zuclopenthixol, ses sels et dérivés

PART II Acepromazine and its salts

Acépromazine et ses sels

Acetanilide

Acétanilide

Adrenocortical hormones and their salts and derivatives, except

(a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 0.5% hydrocortisone in preparations for topical use on the skin; and

(b) clobetasone butyrate, when sold in a concentration of 0.05% clobetasone butyrate in cream preparations for topical use on the skin

Hormones corticosurrénales, leurs sels et dérivés sauf les suivants :

(a) l’hydrocortisone et l’acétate d’hydrocortisone vendus en tant qu’ingrédient médicinal unique dont la concentration permet un apport en hydrocortisone de 0,5 % dans les préparations pour usage topique sur la peau;

(b) le butyrate de clobétasone vendu sous forme de crème contenant 0,05 % de butyrate de clobétasone pour usage topique sur la peau

Aminopyrine and its derivatives

Aminopyrine et ses dérivés

Amprolium and its salts

Amprolium et ses sels

Antipyrine (except preparations for topical use)

Antipyrine (sauf dans les préparations pour usage topique)

Apramycin and its salts

Apramycine et ses sels

Azithromycin and its salts and derivatives

Azithromycine, ses sels et dérivés

Calcium salts when sold for the treatment of hyperphosphatemia

Calcium (sels de) vendus pour le traitement de l’hyperphosphatémie

Centella asiatica extract and active principles thereof

Centella asiatica (extrait de) et ses principes actifs

Chlorhexidine and its salts, when used as a topical oral preparation

Chlorhexidine et ses sels, dans les préparations pour usage oral topique

Chlorothiazide and its salts and derivatives

Chlorothiazide, ses sels et dérivés

Chlorpromazine and its salts

Chlorpromazine et ses sels

Cholestyramine resin

Colestyramine (résine de)

Clarithromycin and its salts and derivatives

Clarithromycine, ses sels et dérivés

Cyclizine

Cyclizine

Dihydrostreptomycin and its salts and derivatives

Dihydrostreptomycine, ses sels et dérivés

Dirithromycin

Dirithromycine

Ergot alkaloids and their salts

Ergot (alcaloïdes d’) et leurs sels

Erythromycin and its salts and derivatives

Érythromycine, ses sels et dérivés

Folic acid

Acide folique

Framycetin and its salts and derivatives

Framycétine, ses sels et dérivés

Furaltadone and its salts

Furaltadone et ses sels

Furazolidone and its salts

Furazolidone et ses sels

Furosemide

Furosémide

Griseofulvin and its salts and derivatives

Griséofulvine, ses sels et dérivés

Iron derivatives for parenteral use only

Fer, ses dérivés pour usage parentéral seulement

Kanamycin and its salts and derivatives

Kanamycine, ses sels et dérivés

Levamisole and its salts

Lévamisole et ses sels

Lincomycin and its salts and derivatives

Lincomycine, ses sels et dérivés

Liothyronine and its salts

Liothyronine et ses sels

Mebendazole

Mébendazole

Meclizine and its salts when sold in concentrations greater than 25 mg per dosage unit

Méclizine et ses sels s’ils sont vendus en une concentration supérieure à 25 mg par unité posologique

Neomycin and its salts and derivatives

Néomycine, ses sels et dérivés

Nicarbazin

Nicarbazin

Nitrofurantoin and its salts

Nitrofurantoine et ses sels

Novobiocin and its salts and derivatives

Novobiocine, ses sels et dérivés

Nystatin (except preparations for topical use on the skin) and its salts and derivatives

Nystatine (sauf dans les préparations pour usage topique sur la peau), ses sels et dérivés

Oleandomycin and its salts and derivatives

Oléandomycine, ses sels et dérivés

Penicillin and its salts and derivatives, (except amoxicillin, ampicillin, azlocillin, benzathine penicillin, carbenicillin, cloxacillin, dicloxacillin, hetacillin, mecillinam, methicillin, mezlocillin, nafcillin, oxacillin and ticarcillin and their salts and derivatives)

Pénicilline, ses sels et dérivés, (sauf amoxicilline, ampicilline, azlocilline, benzathine pénicilline, carbénicilline, cloxacilline, dicloxacilline, hétacilline, mécillinam, méthicilline, mezlocilline, nafcilline, oxacilline et ticarcilline, leurs sels et dérivés)

Physostigmine salicylate (except preparations for oral or topical use only)

Physostigmine (salicylate de), (sauf dans les préparations pour usage oral et topique seulement)

Polymyxin B and its salts and derivatives, (except for topical use or for local action in the oral cavity or nasal passages)

Polymyxine B, ses sels et dérivés, (sauf pour usage topique ou local dans la cavité buccale ou dans les voies nasales)

Primidone

Primidone

Promazine and its salts

Promazine et ses sels

Reserpine and its salts

Réserpine et ses sels

Ronidazole and its salts and derivatives

Ronidazole, ses sels et dérivés

Sex hormones, except the following:

Hormones sexuelles, sauf :

Androisoxazole

Androisoxazole

Androstanolone

Androstanolone

Androstenediol and its derivatives

Androstènediol et ses dérivés

Bolandiol and its derivatives

Bolandiol et ses dérivés

Bolasterone

Bolastérone

Bolazine

Bolazine

Boldenone and its derivatives

Boldénone et ses dérivés

Bolenol

Bolénol

Calusterone

Calustérone

Clostebol and its derivatives

Clostébol et ses dérivés

Cyproterone and its derivatives

Cyprotérone et ses dérivés

Diethylstilbestrol and its derivatives

Diéthylstilbestrol et ses dérivés

Drostanolone and its derivatives

Drostanolone et ses dérivés

Enestebol

Énestébol

Epitiostanol

Épitiostanol

Ethylestrenol

Éthylestrénol

Fluoxymesterone

Fluoxymestérone

Formebolone

Formébolone

Furazabol

Furazabol

4-Hydroxy-19-nortestosterone and its derivatives

Hydroxy-4-nor-19 testostérone et ses dérivés

Levonorgestrel, when sold in concentrations of 0.75 mg per oral dosage unit

Lévonorgestrel, s’il est vendu en une concentration de 0,75 mg par unité posologique orale

Mebolazine

Mébolazine

Megestrol and its derivatives

Mégestrol et ses dérivés

Mesabolone

Mésabolone

Mesterolone

Mestérolone

Metandienone

Métandiénone

Metenolone and its derivatives

Méténolone et ses dérivés

Methandriol

Méthandriol

Methyltestosterone and its derivatives

Méthyltestostérone et ses dérivés

Metribolone

Métribolone

Mibolerone

Mibolérone

Nandrolone and its derivatives

Nandrolone et ses dérivés

Norboletone

Norbolétone

Norclostebol and its derivatives

Norclostébol et ses dérivés

Norethandrolone

Noréthandrolone

Oxabolone and its derivatives

Oxabolone et ses dérivés

Oxandrolone

Oxandrolone

Oxymesterone

Oxymestérone

Oxymetholone

Oxymétholone

Prasterone

Prastérone

Quinbolone

Quinbolone

Stanozolol

Stanozolol

Stenbolone and its derivatives

Stenbolone et ses dérivés

Testosterone and its derivatives

Testostérone et ses dérivés

Tibolone

Tibolone

Tiomesterone

Tiomestérone

Trenbolone and its derivatives

Trenbolone et ses dérivés

Zeranol

Zéranol

Sodium fluoride (in solid oral dosage forms containing more than one milligram of fluoride ion)

Sodium (fluorure de) (sous forme posologique solide orale contenant plus d’un milligramme d’ion fluor)

Spectinomycin and its salts and derivatives

Spectinomycine, ses sels et dérivés

Spiramycin and its salts and derivatives

Spiramycine, ses sels et dérivés

Streptomycin and its salts and derivatives

Streptomycine, ses sels et dérivés

Sulphonamides and their salts and derivatives

Sulfamides, leurs sels et dérivés

Tetracycline and its salts and derivatives (except doxycycline when sold for intramuscular administration in caged birds)

Tétracycline, ses sels et dérivés (sauf doxycycline si elle est vendue pour administration intramusculaire aux oiseaux en cage)

Thiabendazole

Thiabendazole

Thyroid

Thyroïde

Tioconazole and its salts

Tioconazole et ses sels

Trimeprazine and its salts

Triméprazine et ses sels

Tylosin and its salts and derivatives (except when sold for the treatment of chronic colitis in dogs)

Tylosine, ses sels et dérivés (sauf lorsque vendu pour le traitement de la colite chronique chez le chien)

Veratrum album and its alkaloids and their salts

Veratrum album, ses alcaloïdes et leurs sels

Veratrum viride and its alkaloids and their salts

Veratrum viride, ses alcaloïdes et leurs sels

Virginiamycin and its salts and derivatives

Virginiamycine, ses sels et dérivés

Vitamin A

Vitamine A

Vitamin D

Vitamine D

Vitamin K, except Vitamin K1 and Vitamin K2 sold

(a) for external use in humans; or

(b) in an oral dosage form for use in humans if the maximum recommended daily dose is 0.120 mg or less

Vitamine K, sauf la vitamine K1 et la vitamine K2 vendues :

(a) soit pour usage externe destiné aux humains;

(b) soit sous une forme posologique orale destinée aux humains si la dose quotidienne maximale recommandée est de 0,120 mg ou moins

SOR/78-423, s. 5; SOR/78-427, s. 11; SOR/79-754, s. 1; SOR/80-279, s. 1; SOR/81-334, s. 6; SOR/81-358, s. 2; SOR/82-1072, s. 1; SOR/85-551, s. 2; SOR/86-91, s. 5; SOR/86-955, s. 1; SOR/87-332, s. 1; SOR/87-447, s. 1; SOR/87-496, ss. 1 to 18; SOR/87-669, ss. 1, 2; SOR/88­ 351, ss. 1 to 11; SOR/88-511, ss. 1 to 11; SOR/89-195, s. 1; SOR/89-454, ss. 1 to 4; SOR/89­ 504, ss. 1 to 4; SOR/89-572, ss. 1 to 45; SOR/90-119, ss. 1 to 10; SOR/90-173, s. 2(F); SOR/90-443, ss. 1(F) to 4 (F), 5, 6(F) to 15(F); SOR/90-585, ss. 1 to 5; SOR/91-197, ss. 1, 2(F); SOR/91-521, ss. 1 to 15; SOR/92-95, ss. 1 to 9; SOR/92-386, ss. 4 to 8; SOR/92-591, s. 2; SOR/92-647, ss. 1 to 15; SOR/92-724, s. 1; SOR/93-110, ss. 1 to 3, 4(E), 5(E), 6 to 11; SOR/93-243, s. 2; SOR/93-435, ss. 1 to 38; SOR/94-166, ss. 1 to 17, 18(E), 19 to 30; SOR/94-286, ss. 1, 2; SOR/94-458, ss. 1 to 13; SOR/94-462, s. 1; SOR/94-557, ss. 1 to 9; SOR/94-461, s. 1; SOR/95-59, s. 1; SOR/95-172, s. 2; SOR/95-201, s. 1; SOR/95-546, s. 1; SOR/96-253, ss. 1, 2; SOR/96-306, s. 1; SOR/97-140, s. 1; SOR/97-407, s. 1; SOR/97-410, ss. 1, 2; SOR/97-414, s. 1; SOR/97-543, ss. 8, 9; SOR/97-544, s. 1; SOR/97-567, s. 1; SOR/98-291, ss. 1 to 7; SOR/98-292, s. 1; SOR/98-293, s. 1; SOR/98-294, s. 1; SOR/99-370, ss. 1, 2(F), 3, 4(F); SOR/99-373, s. 1; SOR/99-374, ss. 1(F), 2; SOR/99-412, s. 1; SOR/2000­ 119, s. 1; SOR/2000-124, s. 1; SOR/2000-197, ss. 1, 2; SOR/2000-219, s. 2; SOR/2000-403, ss. 1, 2; SOR/2001-95, s. 1; SOR/2001-531, s. 1; SOR/2002-53, s. 1; SOR/2002-418, s. 1; SOR/2003-34, ss. 6 to 8; SOR/2003-36, s. 1; SOR/2003-80, ss. 1, 2; SOR/2003-248, s. 1; SOR/2003-327, s. 1; SOR/2004-108, ss. 1 to 6; SOR/2005-105, s. 1; SOR/2005-167, s. 1; SOR/2005-270, s. 1; SOR/2005-307, s. 1; SOR/2006-143, s. 1; SOR/2006-144, ss. 1, 2; SOR/2006-211, s. 1; SOR/2006-212, s. 1; SOR/2006-213, s. 1; SOR/2006-214, s. 1; SOR/2006-215, s. 1; SOR/2006-251, s. 1; SOR/2007-36, s. 1; SOR/2007-37, s. 1; SOR/2007­ 38, s. 1; SOR/2007-39, s. 1; SOR/2007-40, s. 1; SOR/2007-41, s. 1; SOR/2007-42, ss. 1, 2; SOR/2007-83, s. 1; SOR/2007-224, s. 1; SOR/2007-234, s. 1; SOR/2008-35, s. 1; SOR/2008­ 100, s. 1; SOR/2008-101, ss. 1, 2; SOR/2008-108, s. 1; SOR/2008-204, s. 1; SOR/2008-205, s. 1; SOR/2008-206, s. 1; SOR/2008-207, s. 1; SOR/2008-260, s. 1; SOR/2009-116, s. 1; SOR/2009-117, s. 1; SOR/2009-118, s. 1; SOR/2009-119, s. 1; SOR/2009-120, s. 1;

SOR/2009-279, ss. 1, 2; SOR/2009-305, s. 1; SOR/2010-114, s. 1; SOR/2011-58, s. 1; SOR/2011-93, s. 1. Previous Version SCHEDULE K

REASONABLE DAILY INTAKE FOR VARIOUS FOODS

Column I Column II Item Name and Description R.D.I.No. 1. Alimentary Pastes, dry ....... 3.0 oz. 85 g

Bacon (side) simulated meat product that resembles side bacon,2. 1.0 oz. 28 g(cooked) ....... Beverage Bases and Mixes, Flavoured, for Addition to Milk 16.03. 454 ml(ready to serve) ....... fl.oz.

4. Bread, 5 slices ....... 5.3 oz. 150 g 5. Butter ....... 2.0 oz. 57 g

30.06. Buttermilk ....... 852 mlfl.oz. 7. Cereals, Breakfast or Infant ....... 1.0 oz. 28 g 8. Cereals, puffed ....... 0.5 oz. 14 g 9. Cheese (other than Cottage Cheese) ....... 2.0 oz. 57 g 10. Cheese, Cottage ....... 3.5 oz. 100 g

15.011. Condensed Milk ....... 426 mlfl.oz. 12. Cream, whipping ....... 2.0 oz. 57 g 13. Egg, yolk-replaced egg ....... 3.5 oz. 100 g

15.0 852 mlfl.oz. Evaporated Milk, Evaporated Skim Milk, Evaporated Partly 30.014. Skimmed Milk ....... fl.oz.

(reconstituted to original volume)

15. Fish, Shell Fish ....... 3.5 oz. 100 g 16. Fruits, dried ....... 2.0 oz. 57 g 17. Fruits, (other than banana, lemon, lime, watermelon) ....... 3.5 oz. 100 g 18. Fruits, Banana ....... 5.3 oz. 150 g 19. Fruits, Lemon ....... 1.8 oz. 50 g 20. Fruits, Lime ....... 1.8 oz. 50 g 21. Fruits, Watermelon ....... 7.0 oz. 200 g 22. Fruit Drinks, Fruit Nectars (ready to serve) ....... 4.0 fl.oz. 114 ml

Fruit Drink Bases, Mixes and Concentrates (ready to serve)23. 4.0 fl.oz. 114 ml....... 24. Fruit Juices (other than lemon juice and lime juice) ....... 4.0 fl.oz. 114 ml

Column I Column II Item Name and Description R.D.I.No. 25. Fruit Juices, Lemon ....... 1.0 fl.oz. 28 ml 26. Fruit Juices, Lime ....... 1.0 fl.oz. 28 ml 27. Ice Cream, Ice Milk ....... 3.5 oz. 100 g 28. Infant Formulas, Prepared (ready to serve) ....... As directed by Label 29. Instant Breakfast, Ready Breakfast (ready to serve) ....... As directed by Label 30. Margarine ....... 2.0 oz. 57 g 31. Meat Products ....... 3.5 oz. 100 g 32. Meat Product Extenders ....... 3.5 oz. 100 g 33. Extended Meat Products ....... 3.5 oz. 100 g

30.034. Milk, whole ....... 852 mlfl.oz. 30.035. Milk Powder (reconstituted and ready to serve) ....... 852 mlfl.oz. 30.036. (naming the flavour) Milk ....... 852 mlfl.oz.

37. Molasses ....... 1.5 oz. 43 g 38. Nuts ....... 1.0 oz. 28 g 39. Peanut Butter ....... 1.0 oz. 28 g 40. Poultry Products ....... 3.5 oz. 100 g 41. Extended Poultry Products ....... 3.5 oz. 100 g 42. Poultry Product Extenders ....... 3.5 oz. 100 g

Simulated Meat Products excluding a simulated meat product43. 3.5 oz. 100 gthat resembles side bacon ....... 44. Simulated Poultry Products ....... 3.5 oz. 100 g

30.045. Skim Milk, Partly Skimmed Milk ....... 852 mlfl.oz. (naming the flavour) Skim Milk, (naming the flavour) Partly 30.046. 852 mlSkimmed Milk ....... fl.oz. Skim Milk Powder, Partly Skimmed Milk Powder 30.047. 852 ml(reconstituted and ready to serve) ....... fl.oz. Skim Milk with Added Milk Solids, Partly Skimmed Milk with 30.048. 852 mlAdded Milk Solids ....... fl.oz. (naming the flavour) Skim Milk with Added Milk Solids, 30.049. (naming the flavour) Partly Skimmed Milk with Added Milk 852 mlfl.oz.Solids .......

50. Soup (ready to serve) ....... 7.0 fl.oz. 200 ml 30.051. Sterilized Milk ....... 852 mlfl.oz.

52. Vegetable Juices ....... 4.0 fl.oz. 114 ml 53. Vegetable Drinks ....... 4.0 fl.oz. 114 ml

__________

Column I Column II Item Name and Description R.D.I.No.

Vegetable Drink Concentrates, Mixes and Bases (ready to54. 4.0 fl.oz. 114 mlserve) ....... 55. Vegetable (other than baked beans and cooked potatoes) ....... 3.5 oz. 100 g 56. Vegetables, baked beans ....... 8.5 oz. 250 g 57. Vegetables, cooked potatoes ....... 7.0 oz. 200 g 58. Yeast ....... 0.5 oz. 14 g 59. Yogurt, plain ....... 5.0 oz. 150 g

SOR/78-64, s. 10; SOR/84-300, s. 63(E).

APPENDICES I AND II [Repealed, SOR/81-935, s. 2] APPENDIX III FORMS Export Certificate (Under the Food and Drugs Act*—R.S.C. 1970, c. F-27)

The undersigned exporter hereby certifies that the (description of article)

packaged and labelled as follows: __________ and marked in distinct overprinting with the word “Export”

1. is not manufactured for consumption in Canada,

2. is not sold for consumption in Canada, and

3. packages and the contents of such packages do not contravene any known requirement of the law of

to which it is or is about to be consigned.

(name of country or countries)

Dated at the day of 19 .

Canada : In the matter of an Export Certificate under the Food and Drugs Act,

__________

Province of

To Wit : I, __________

of the of __________

in the of __________

do solemnly declare:

1. that I am the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me,

or

I am the of __________

the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me (describe position of declarant as the agent of the “Exporter” in case of a Corporation issuing the certificate),

2. that the information set out in the said certificate is true,

3. that all information relevant to the purpose of the said certificate is set out herein and no information relevant thereto has knowingly been withheld.

And I make this solemn declaration conscientiously believing it to be true, and knowing that it is of the same force and effect as if made under oath, and by virtue of The Canada Evidence Act.

Declared before me at this __________

day of 19 .

A Commissioner for Taking Oaths

*See section 32 of the Food and Drugs Act and Appendix III of the Food and Drug Regulations

SOR/80-318, s. 2.

SCHEDULE L

(Sections B.01.402, B.01.403, B.01.450 and B.01.454 to B.01.465)

NUTRITION FACTS TABLE FORMATS

GRAPHICS ARE NOT DISPLAYED, SEE SOR/2003-11, S. 37; ERR., VOL. 137, NO. 5

SOR/2003-11, s. 37; err., Vol. 137, No. 5.

SCHEDULE M

(Sections B.01.001, B.01.002A and D.01.001)

REFERENCE AMOUNTS

Column 1 Column 2 ReferenceItem Food amount1

Bakery Products 1. Bread, excluding sweet quick-type rolls 50 g

Bagels, tea biscuits, scones, rolls, buns, croissants, tortillas, soft bread2. 55 gsticks, soft pretzels and corn bread 3. Brownies 40 g

Heavy weight cake: 10 g or more per 2.5 cm cube, such as cheese cake, 4. pineapple upside-down cake, cake with at least 35% of the finished 125 g

weight as fruit, nuts or vegetables, or any of these combined Medium weight cake: 4 g or more per 2.5 cm cube but less than 10 g per 2.5 cm cube, such as cake with or without icing or filling, cake

5. with less than 35% of the finished weight as fruit, nuts or vegetables or 80 g any of these combined, light weight cake with icing, Boston cream pie, cupcakes, eclairs or cream puffs Light weight cake: less than 4 g per 2.5 cm cube, such as angel food,6. 55 gchiffon or sponge cake, without icing or filling Coffee cakes, doughnuts, danishes, sweet rolls, sweet quick-type7. 55 gbreads and muffins

8. Cookies, with or without coating or filling, and graham wafers 30 g 9. Crackers, hard bread sticks and melba toast 20 g 10. Dry breads, matzo and rusks 30 g 11. Flaky type pastries, with or without filling or icing 55 g 12. Toaster pastries 55 g 13. Ice cream cones 5 g 14. Croutons 7 g 15. French toast, pancakes and waffles 75 g 16. Grain-based bars, with filling or partial or full coating 40 g 17. Grain-based bars, without filling or coating 30 g 18. Rice cakes and corn cakes 15 g 19. Pies, tarts, cobblers, turnovers and other pastries 110 g 20. Pie crust 1/6 of 20 cm

Column 1 Column 2 ReferenceItem Food amount1

crust or 1/8 of 23 cm crust

21. Pizza crust 55 g 22. Taco shell, hard 30 g

Beverages 23. Carbonated and non-carbonated beverages, iced tea and wine coolers 355 mL 24. Sports drinks and water 500 mL

Coffee: regular, instant and specialty, including espresso, café au lait,25. 175 mLflavoured and sweetened 26. Tea and herbal tea

(a) regular and instant (hot) 175 mL (b) flavoured and sweetened, prepared from mixes 250 mL

27. Cocoa and chocolate beverages (hot) 175 mL Cereals and Other Grain Products

40 g dry 28. Hot breakfast cereals, such as oatmeal or cream of wheat 250 mL

prepared Ready-to-eat breakfast cereals, puffed and uncoated (less than 20 g per29. 15 g250 mL) Ready-to-eat breakfast cereals, puffed and coated, flaked, extruded,

30. without fruit or nuts (20 g to 42 g per 250 mL), very high fibre cereals 30 g (with 28 g or more fibre per 100 g) Ready-to-eat breakfast cereals, fruit and nut type, granola (43 g or31. 55 gmore per 250 mL) and biscuit type cereals

32. Bran and wheat germ 15 g 33. Flours, including cornmeal 30 g

45 g dry34. Grains, such as rice or barley 140 g cooked 85 g dry35. Pastas without sauce 215 g cooked

36. Pastas, dry and ready-to-eat, such as fried canned chow mein noodles 25 g 37. Starch, such as cornstarch, potato starch, tapioca starch or wheat starch 10 g 38. Stuffing 100 g

Dairy Products and Substitutes Cheese, including cream cheese and cheese spread, except those listed39. 30 gas a separate item

40. Cottage cheese 125 g Cheese used as an ingredient, such as dry cottage cheese or ricotta41. 55 gcheese

42. Hard cheese, grated, such as parmesan or romano 15 g

Column 1 Column 2 ReferenceItem Food amount1

43. Quark, fresh cheese and fresh dairy desserts 100 g 44. Cream and cream substitute, except those listed as a separate item 15 mL 45. Cream and cream substitute, powder 2 g 46. Cream and cream substitute, aerosol or whipped 15 g 47. Eggnog 125 mL 48. Milk, evaporated or condensed 15 mL

Plant-based beverages, milk, buttermilk and milk-based drinks, such as49. 250 mLchocolate milk 50. Shakes and shake substitutes, such as dairy shake mix 250 mL 51. Sour cream 30 mL 52. Yogurt 175 g

Desserts 53. Ice cream, ice milk, frozen yogurt and sherbet 125 mL 54. Dairy desserts, frozen, such as cakes, bars, sandwiches or cones 125 mL

Non-dairy desserts, frozen, such as flavoured and sweetened ice or55. 75 mLpops, or frozen fruit juices in bars or cups 56. Sundaes 250 mL 57. Custard, gelatin and pudding 125 mL

Dessert Toppings and Fillings 58. Dessert toppings, such as maple butter and marshmallow cream 30 g 59. Cake frostings and icings 35 g 60. Pie fillings 75 mL

Eggs and Egg Substitutes 61. Egg mixtures, such as egg foo young, scrambled eggs or omelets 110 g 62. Eggs 50 g 63. Egg substitutes 50 g

Fats and Oils 64. Butter, margarine, shortening and lard 10 g 65. Vegetable oil 10 mL 66. Butter replacement, powder 2 g 67. Dressings for salad 30 mL 68. Mayonnaise, sandwich spread and mayonnaise-type dressing 15 mL 69. Oil, spray type 0.5 g

Marine and Fresh Water Animals 70. Canned anchovies, anchovy paste and caviar 15 g2

Marine and fresh water animals with sauce, such as fish with cream71. 140 g cookedsauce or shrimp with lobster sauce Marine and fresh water animals without sauce, such as plain or fried 125 g raw72. fish or shellfish, or fish or shellfish cakes, with or without breading or 100 g cooked

Column 1 Column 2 ReferenceItem Food amount1

batter 73. Marine and fresh water animals, canned 55 g2

74. Marine and fresh water animals, smoked or pickled, or spreads 55 g2

Fruit and Fruit Juices 140 g75. Fruit, fresh, canned or frozen, except those listed as a separate item 150 mL canned2

76. Candied or pickled fruit 30 g2

77. Dried fruit, such as raisins, dates or figs 40 g 78. Fruit for garnish or flavour, such as maraschino cherries 4 g2

79. Fruit relishes 60 mL 80. Avocado, used as an ingredient 30 g 81. Cranberries, lemons and limes, used as ingredients 55 g 82. Watermelon, cantaloupe, honeydew and other melons 150 g

Juices, nectars and fruit drinks represented for use as substitutes for83. 250 mLfruit juices 84. Juices, used as ingredients, such as lemon juice or lime juice 5 mL

Legumes 85. Bean curd (tofu) and tempeh 85 g2

100 g dryBeans, peas and lentils, such as white beans, kidney beans, romano86. 250 mL cookedbeans, soybeans or chick peas or canned2

Meat, Poultry, Their Products and Substitutes3

54 g uncooked87. Pork rinds and bacon 15 g cooked 30 g uncooked88. Beef, pork and poultry breakfast strips 15 g cooked

Dried meat and poultry, such as jerky, dried beef or parma ham, as well 89. as sausage products with a water activity of 0.90 or less, such as 30 g

salami, dried thuringer or cervelat Luncheon meats, such as bologna, blood pudding, minced luncheon 75 g uncooked roll, liver sausage, mortadella, ham and cheese loaf or headcheese;90. pâté; sandwich spread; potted meat food product; taco fillings; meat pie 55 g cooked fillings and cretons Sausage products, such as linked sausage, Vienna sausage, wieners, 75 g uncooked breakfast sausage, frankfurters, pork sausage, bratwurst, kielbasa,91. Polish sausage, summer sausage, smoked sausage, smoked country 55 g cooked sausage, pepperoni, knackwurst, thuringer or cervelat Cuts of meat and poultry without sauce, and ready-to-cook cuts, with 125 g raw

92. or without breading or batter, including marinated, tenderized and 100 g cookedinjected cuts

Column 1

Item Food

Patties, cutlettes, chopettes, steakettes, meatballs, sausage meat and93. ground meat, with or without breading or batter Cured meat products, such as cured ham, dry cured ham, back bacon, cured pork back, dry cured cappicolo, corned beef, pastrami, country94. ham, cured pork shoulder picnic, cured poultry ham products, smoked meat or pickled meat

95. Canned meat and poultry Meat and poultry with sauce, such as meat in barbecue sauce or turkey96. with gravy, but excluding combination dishes Miscellaneous

97. Baking powder, baking soda and pectin 98. Baking decorations, such as coloured sugars or sprinkles for cookies 99. Bread crumbs and batter mixes 100. Cooking wine 101. Cocoa powder 102. Non-alcoholic drink mixers, such as pina colada or daiquiri 103. Chewing gum

104. Salad and potato toppers, such as salad crunchies, salad crispins orsubstitutes for bacon bits 105. Salt and salt substitutes, as well as seasoned salt, such as garlic salt 106. Spices and herbs

Combination Dishes Measurable with a cup, such as casserole, hash, macaroni and cheese with or without meat, pot pie, spaghetti with sauce, stir fry, meat or poultry casserole, baked or refried beans, wieners and beans, meat107. chili, chili with beans, creamed chipped beef, beef or poultry ravioli in sauce, beef stroganoff, poultry à la king, Brunswick stew, goulash, stew, ragout or poutine Not measurable with a cup, such as burritos, egg rolls, enchiladas, pizza, pizza rolls, sausage rolls, pastry rolls, cabbage rolls, quiche, sandwiches, crackers and meat or poultry lunch-type packages, gyros,

108. burger on a bun, frank on a bun, calzones, tacos, pockets stuffed with meat, lasagna, chicken cordon bleu, stuffed vegetables with meat or poultry, shish kabobs, empanadas, fajitas, souvlaki, meat pie or tourtière

109. Hors d’oeuvres Nuts and Seeds

110. Nuts and seeds, not for use as snacks: whole, chopped, sliced, sliveredor ground 111. Butters, pastes and creams, other than peanut butter 112. Peanut butter

Column 2 Reference amount1

100 g raw 60 g cooked 85 g raw

55 g cooked

55 g2

140 g

0.6 g 4 g 30 g 30 mL 5 g 250 mL 3 g

7 g

1 g 0.5 g

250 mL

140 g without gravy or sauce

195 g with gravy or sauce

50 g

30 g shelled

30 g 15 g

Column 1 Column 2 ReferenceItem Food amount1

113. Flours, such as coconut flour 15 g Potatoes, Sweet Potatoes and Yams

85 g frozen 114. French fries, hash browns, skins and pancakes French fries

70 g prepared 115. Mashed, candied, stuffed or with sauce 140 g

110 g fresh or frozen

116. Plain, fresh, canned or frozen 125 g vacuum packed 160 g canned2

Salads

117. Salads, such as egg, fish, shellfish, bean, fruit, vegetable, meat, ham or 100 gpoultry salad, except those listed as a separate item 118. Gelatin salad 120 g 119. Pasta or potato salad 140 g

Sauces, Dips, Gravies and Condiments

120. Sauces for dipping, such as barbecue, hollandaise, tartar, mustard or 30 mLsweet and sour sauce 121. Dips, such as legume or dairy-based 30 g 122. Major main entree sauce, such as spaghetti sauce 125 mL

Minor main entree sauce, such as pizza sauce, pesto sauce or other 123. sauces used as toppings, such as white sauce, cheese sauce, salsa, 60 mL

cocktail sauce or gravy

124. Major condiments, such as ketchup, steak sauce, soy sauce, vinegar, 15 mLteriyaki sauce or marinades

125. Minor condiments, such as horseradish, hot sauce, mustard or 5 mLworcestershire sauce Snacks

126. Chips, pretzels, popcorn, extruded snacks, grain-based snack mixes and 50 gfruit-based snacks, such as fruit chips 127. Nuts or seeds for use as snacks 50 g shelled 128. Meat or poultry snack food sticks 20 g

Soups 129. All varieties 250 mL

Sugars and Sweets

130. Candies, including chocolate bars and other chocolate products, except 40 gthose listed as a separate item 131. Hard candies, except those listed as a separate item 15 g 132. Baking candies, such as chocolate chips 15 g

Column 1 Column 2 ReferenceItem Food amount1

133. Breath mints 2 g

134. Roll-type hard candies and mini size hard candies in dispenser 5 gpackages 135. Confectioner’s or icing sugar 30 g

136. Bread spreads, except those listed as a separate item, honey and 20 gmolasses 137. Jams, jellies, marmalades, fruit butters and spreads 15 mL 138. Marshmallows 30 g 139. Sugars, except those listed as a separate item 4 g

amount equivalent in140. Sugar substitute sweetness to 4 g of sugar 30 mL as ingredient141. Syrups, including chocolate, maple and corn syrup 60 mL other uses

Vegetables Vegetables without sauce, including cream style corn and stewed 85 g fresh or

142. tomatoes, but not including vegetables without sauce listed as a frozen separate item 125 mL canned2

110 g fresh or 143. Vegetables with sauce frozen

125 mL canned

144. Vegetables primarily used for garnish or flavouring, fresh, canned or 4 gfrozen, but not dried, such as parsley or garlic 145. Chili pepper and green onion 30 g 146. Seaweed 15 g 147. Lettuce and sprouts 65 g 148. Vegetable juice and vegetable drink 250 mL 149. Olives 15 g2

150. Pickles 30 g2

151. Relish 15 mL 152. Vegetable pastes, such as tomato paste 30 mL 153. Vegetable sauce or purée, such as tomato sauce or tomato purée 60 mL 1Unless otherwise noted, the reference amounts are for the ready-to-serve or almost ready-to­ serve form of the food. If not listed separately, the reference amount for the unprepared form, such as dry mixes, concentrates, dough, batter, and fresh or frozen pasta, is the amount required to make one reference amount of the prepared form.

2Excludes any liquid in which the solid food may be packed or canned, unless the liquid is customarily consumed with the solid food. 3Meat and poultry substitutes include extended and simulated meat and poultry products.

SOR/2003-11, s. 37; SOR/2010-94, s. 7(F). Previous Version

RELATED PROVISIONS

 — SOR/97-12

66. Packages of drugs that are labelled in accordance with Part C of the Food and Drug Regulations, as those Regulations read on December 31, 1996, are not required to comply with the labelling requirements in these Regulations until January 1, 1999.

 — SOR/98-423

10. For the purposes of sections 11 to 13, “Director” has the same meaning as in section A.01.010 of the Food and Drugs Regulations.

 — SOR/98-423

11. Despite sections 1 and 7 to 9, if a numbered certificate of registration has been issued in respect of a drug but a drug identification number has not been assigned under section C.01.014.2 of the Food and Drug Regulations, as amended by section 4 of these Regulations, or under section 12 of these Regulations, then section C.01.001A, paragraphs C.01.015(2)(b) and C.01.062(5)(b) and Division 10 and the schedule and the table to Division 10 of Part C of the Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, remain in force in respect of that drug until October 1, 1998, except to the extent that they require information that is not required by those provisions as amended by these Regulations.

 — SOR/98-423

12. (1) Despite these Regulations and subject to subsection (3), if the conditions set out in subsection (2) are satisfied, the Director shall, until October 1, 1998, provide to a manufacturer or importer referred to in paragraph (2)( c),

(a) if the information referred to in section C.01.014.3 of the Food and Drug Regulations as amended by section 5 of these Regulations has not been submitted in respect of the drug, the document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations, as amended by section 4 of these Regulations; or

(b) in any other case,

(i) a drug identification number for the drug preceded by the letters “DIN”, or

(ii) where there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”.

(2) The conditions referred to in subsection (1) are:

(a) a numbered certificate of registration has been issued for the drug under subsection C.10.004(1) of the Food and Drug Regulations as it read before the coming into force of these Regulations;

(b) the numbered certificate of registration has not been cancelled under section C.10.008 of the Food and Drug Regulations as it read immediately before the coming into force of these Regulations; and

(c) prior to September 1, 1998, the manufacturer or importer has submitted to the Director

(i) the name of the drug for which a drug identification number is to be issued, and

(ii) the information referred to in subsection C.01.014.1(2) of the Food and Drug Regulations.

(3) If more than one numbered certificate of registration has been issued for a drug on the sole basis of a difference in colour, flavour or fragrance, a single drug identification number shall be assigned in respect of the drug.

 — SOR/98-423

13. Despite section 4 of these Regulations and subject to section C.10.005 of the Food and Drug Regulations as that section read immediately before the coming into force of these Regulations, the Director may, until September 30, 1998, issue a numbered certificate of registration, if

(a) the manufacturer expressly requests that a numbered certificate of registration be issued for the drug; and

(b) its application was accepted by the Director for review before the coming into force of these Regulations.

 — SOR/98-423

14. Despite section 2, a manufacturer may, until September 30, 2000, label a drug with the label that was in use on September 30, 1998.

 — SOR/2001-203

11. An application concerning the sale of a drug for human use for the purposes of a clinical trial that is received under Division 8 of the Food and Drug Regulations before September 1, 2001 is subject to those Regulations and any procedures established under those Regulations as they read at the time the application was received.

 — SOR/2003-11

38. (1) The following definitions apply in this section.

“former Regulations” means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

“manufacturer” has the same meaning as in section A.01.010 of the Food and Drug Regulations. (fabricant)

“prepackaged product” has the same meaning as in section B.01.001 of the Food and Drug Regulations. (produit préemballé)

(2) Despite sections 1 to 37 and subject to subsection (3), the former Regulations continue to apply to a prepackaged product that is labelled in accordance with the former Regulations until the day that is three years after the day on which these Regulations come into force, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains

(a) a statement or claim set out in column 4 of any of items 15, 16 and 22 to 26 of the table following section B.01.513 of the Food and Drug Regulations, as enacted by section 20 of these Regulations;

(b) a statement or claim set out in column 1 of the table following section B.01.603 of the Food and Drug Regulations, as enacted by section 20 of these Regulations; or

(c) the expression “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

(3) In applying subsection (2) to a prepackaged product that is sold by a manufacturer who had gross revenues from sales in Canada of food of less than $1,000,000 for the 12-month period immediately prior to the day on which these Regulations come into force, the reference to “three years” in that subsection shall be read as a reference to “five years”.

 — SOR/2006-241

2. Section C.08.004.1 of the Food and Drug Regulations, as it read immediately before the coming into force of these Regulations, applies to a drug in respect of which a notice of compliance was issued before June 17, 2006.

 — SOR/2007-302, s. 12

12. Sections 1 to 6 and 11 of these Regulations do not apply to cheese that is made before these Regulations come into force.

AMENDMENTS NOT IN FORCE

 — SOR/2010-105, s. 1

1. Subsection C.01.001(1) of the Food and Drug Regulations1 is amended by adding the following in alphabetical order: 1C.R.C., c. 870

“flavour” means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; (saveur)

“fragrance” means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; (parfum)

“non-medicinal ingredient” means a substance — other than the pharmacologically active drug — that is added during the manufacturing process and that is present in the finished drug product; (ingrédient non médicinal)

“pharmaceutical ink” means a non-medicinal ingredient or combination of non- medicinal ingredients used to imprint the drug with marks or symbols; (encre pharmaceutique)

 — SOR/2010-105, s. 2

2. (1) Section C.01.004 of the Regulations is amended by adding the following after subsection (1):

(1.1) In addition to the requirements of subsection (1), when a drug is intended for human use, its outer label must contain a list of all non-medicinal ingredients, or, if the outer label is too small, the list must appear on a tag, tape or card that is attached to the package.

(1.2) The non-medicinal ingredients must be listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients.

(1.3) In the case of flavour, fragrance or pharmaceutical ink, the expressions “flavour/saveur”, “fragrance/parfum” and “pharmaceutical ink/encre pharmaceutique”, respectively, may be included in the list to indicate that such ingredients have been added to the drug, instead of listing those ingredients or combinations of them individually.

(1.4) When the composition of the drug varies from one lot to another, the outer label must include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or/ou” or “may contain/peut contenir”.

(1.5) Subsections (1.1) to (1.4) do not apply to

(a) a drug that is required to be sold pursuant to a prescription;

(b) a drug that is not required to be sold pursuant to a prescription but is administered only under the supervision of a practitioner;

(c) a drug that is represented as being solely for use as a disinfectant on hard non­ porous surfaces; or

(d) a drug for veterinary use.

(2) The portion of subsection C.01.004(2) of the Regulations before paragraph (a) is replaced by the following:

(2) In addition to the requirements of subsection (1) and, if applicable, subsections (1.1) to (1.4), the outer label of a drug must show all of the following information:

 — SOR/2011-28, s. 1

1. Paragraph B.01.008(5)(a) of the Food and Drug Regulations1 is replaced by the following:

1C.R.C., c. 870

(a) immediately after the ingredient of which they are components in such a manner as to indicate that they are components of the ingredient, except that if a source of a food allergen or gluten is required by paragraph B.01.010.1(8)(a) to be shown immediately after that ingredient, they shall instead be shown immediately after that source; and

 — SOR/2011-28, s. 2

2. (1) Item 30 of the table to subsection B.01.009(1) of the English version of the Regulations is replaced by the following:

Item Ingredient 30. hydrolyzed plant protein

(2) Paragraph B.01.009(3)(c) of the Regulations is replaced by the following:

(c) hydrolyzed plant protein;

(3) Subsection B.01.009(5) of the Regulations is repealed.

 — SOR/2011-28, s. 3

3. (1) Item 8 of the table to paragraph B.01.010(3)(a) of the Regulations is replaced by the following:

Column I Column II

Item Ingredient or Common NameComponent hydrolyzed plant hydrolyzed plus the name of the plant plus protein or8. protein hydrolysed plus the name of the plant plus protein

(2) The table to paragraph B.01.010(3)(a) of the Regulations is amended by adding the following after item 19:

Column I Column II Item Ingredient or Component Common Name 20. starch the name of the plant plus starch 21. modified starch modified plus the name of the plant plus starch 22. lecithin the name of the source of the lecithin plus lecithin 23. crustacean the name of the crustacean 24. shellfish the name of the shellfish

(3) Item 21 of the table to paragraph B.01.010(3)(b) of the Regulations is replaced by the following:

Column I Column II Item Ingredient or Component Common Name

one or more of the following food additives, namely, sulfites, sulfitingpotassium bisulphite, potassium metabisulphite, sodium21. agents, sulphites orbisulphite, sodium dithionite, sodium metabisulphite, sulphiting agentssodium sulphite, sulphur dioxide and sulphurous acid

 — SOR/2011-28, s. 4

4. The Regulations are amended by adding the following after section B.01.010:

B.01.010.1 (1) The following definitions apply in this section and in section B.01.010.3.

“food allergen” means any protein from any of the following foods, or any modified protein, including any protein fraction, that is derived from any of the following foods:

(a) almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts;

(b) peanuts;

(c) sesame seeds;

(d) wheat or triticale;

(e) eggs;

(f) milk;

(g) soybeans;

(h) crustaceans;

(i) shellfish;

(j) fish; or

(k) mustard seeds. (allergène alimentaire)

“gluten” means

(a) any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals:

(i) barley,

(ii) oats,

(iii) rye,

(iv) triticale,

(v) wheat; or

(b) any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in paragraph (a) or from the grain of a hybridized strain referred to in that paragraph. (gluten)

(2) If a food allergen or gluten is present in a prepackaged product, the source of the food allergen or gluten, as the case may be, must be shown on the label of the product in

(a) the list of ingredients; or

(b) in a statement entitled “Contains” that complies with the requirements of subsection B.01.010.3(1).

(3) Subsection (2) does not apply to a food allergen or gluten that is present in a prepackaged product as a result of cross-contamination.

(4) Subsection (2) does not apply to a to a food allergen or gluten that is present in a prepackaged product referred to in paragraphs B.01.008(2)(a) to (e) unless a list of ingredients is shown on the product’s label.

(5) Subsection (2) does not apply to a food allergen or gluten that is present in a prepackaged product for which a standard is prescribed by section B.02.130 or B.02.131 unless a list of ingredients is shown on the product’s label.

(6) The source of a food allergen required to be shown under subsection (2) must be shown

(a) for a food allergen from a food referred to in one of paragraphs (a), (b) and (e) of the definition “food allergen” in subsection (1) or derived from that food, by the name of the food as shown in the applicable paragraph, expressed in the singular or plural;

(b) for a food allergen from the food referred to in paragraph (c) of the definition “food allergen” in subsection (1) or derived from that food, by the name “sesame”, “sesame seed” or “sesame seeds”;

(c) for a food allergen from a food referred to in one of paragraphs (d) and (f) of the definition “food allergen” in subsection (1) or derived from that food, by the name of the food as shown in the applicable paragraph;

(d) for a food allergen from the food referred to in paragraph (g) of the definition “food allergen” in subsection (1) or derived from that food, by the name “soy”, “soya”, “soybean” or “soybeans”;

(e) for a food allergen from a food referred to in one of paragraphs (h) to (j) of the definition “food allergen” in subsection (1) or derived from that food, by the common name of the food referred to in column II of item 6, 23 or 24 of the table to paragraph B.01.010(3)(a), whichever is applicable; and

(f) for a food allergen from the food referred to in paragraph (k) of the definition “food allergen” in subsection (1) or derived from that food, by the name “mustard”, “mustard seed” or “mustard seeds”.

(7) The source of gluten required to be shown under subsection (2) must be shown

(a) for gluten from the grain of a cereal referred to in one of subparagraphs (a)(i) to (v) of the definition “gluten” in subsection (1) or derived from that grain, by the name of the cereal as shown in the applicable subparagraph; and

(b) for gluten from the grain of a hybridized strain created from one or more of the cereals referred to in subparagraphs (a)(i) to (v) of the definition “gluten” in subsection (1) or derived from that grain, by the names of the cereals as shown in the applicable subparagraphs.

(8) For the purpose of paragraph (2)(a), the source of the food allergen or gluten must be shown in the list of ingredients, in parentheses, as follows:

(a) immediately after the ingredient that is shown in that list, if the food allergen or gluten

(i) is that ingredient,

(ii) is present in that ingredient, but is not a component of or present in a component of that ingredient, or

(iii) is, or is present in, a component of that ingredient and the component is not shown in the list of ingredients; or

(b) immediately after the component that is shown in the list of ingredients, if the food allergen or gluten is that component or is present in that component.

(9) Despite subsection (2), the source of the food allergen or gluten must be shown on the label of the product in the “Contains” statement if the food allergen or gluten

(a) is, or is present in, an ingredient that is not shown in the list of ingredients, but is not a component of that ingredient or present in a component of that ingredient; or

(b) is, or is present in, a component and neither the component nor the ingredient in which it is present is shown in the list of ingredients.

(10) Despite subsection (8), the source of the food allergen or gluten is not required to be shown in parentheses immediately after the ingredient or component, as the case may be, if the source of the food allergen or gluten appears

(a) in the list of ingredients

(i) as part of the common name of the ingredient or component, or

(ii) in parentheses, under subsection (8), immediately after another ingredient or component; or

(b) in the “Contains” statement.

(11) For greater certainty, nothing in subsection (8) affects how an ingredient or component may be shown in the list of ingredients under paragraph B.01.010(3)(b).

B.01.010.2 (1) In this section and in section B.01.010.3, “sulphites” means one or more food additives that are listed exclusively in column I of item 21 of the table to paragraph B.01.010(3)(b) and are present in a prepackaged product.

(2) For greater certainty, the definition “sulphites” in subsection (1) includes only sulphites that are present in the prepackaged product as a result of being added.

(3) If sulphites are present in a prepackaged product in a total amount of 10 parts per million or more and none are required to be shown in the list of ingredients under section B.01.008 or B.01.009, the sulphites must be shown on the label of the product in

(a) the list of ingredients; or

(b) a statement entitled “Contains” that complies with the requirements of subsection B.01.010.3(1).

(4) Subsection (3) does not apply to sulphites present in the prepackaged products referred to in paragraphs B.01.008(2)(a) to (e) unless a list of ingredients is shown on the product’s label.

(5) Subsection (3) does not apply to sulphites present in a prepackaged product for which a standard is prescribed by section B.02.130 or B.02.131 unless a list of ingredients is shown on the product’s label.

(6) Sulphites that are shown on a label of the product under subsection (3) must be shown as follows:

(a) if the sulphites are shown in the list of ingredients,

(i) by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, or

(ii) individually by the applicable name set out in column I of item 21 of the table to paragraph B.01.010(3)(b), except that the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid” must be followed, in parentheses, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”; or

(b) if the sulphites are shown in a “Contains” statement, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

(7) Sulphites that are shown in the list of ingredients under paragraph (6)(a) must be shown as follows:

(a) sulphites that are a component of an ingredient that is shown in the list of ingredients must be shown either in parentheses immediately after the ingredient or at the end of that list where they may be shown in any order with the other ingredients that are shown at the end of that list under subsection B.01.008(4);

(b) in all other cases, the sulphites must be shown at the end of the list of ingredients where they may be shown in any order with the other ingredients that are shown at the end of that list under subsection B.01.008(4).

(8) If sulphites are present in a prepackaged product in a total amount of 10 parts per million or more and any of them are required to be shown in the list of ingredients under section B.01.008 or B.01.009, in the case of sulphites shown individually by the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid”, that name must be followed, in parentheses, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

(9) If the total amount of sulphites present in the prepackaged product is 10 parts per million or more, sulphites that are required to be shown in a list of ingredients under section B.01.008 or B.01.009 may also be shown on the label of the product in a “Contains” statement that complies with the requirements of subsection B.01.010.3(1).

(10) Despite subparagraph (6)(a)(ii) and subsection (8), if sulphites are shown individually in a list of ingredients, by the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid”, that name is not required to be followed, in

parentheses, by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” if

(a) in the list of ingredients,

(i) the term “sulfite” or “sulphite” appears in the common name of another sulphite, or

(ii) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is shown in parentheses following another sulphite; or

(b) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is shown in a “Contains” statement on the label of the product.

B.01.010.3 (1) If a “Contains” statement is included on the label of a prepackaged product under any of subsections B.01.010.1(2), B.01.010.1(9), B.01.010.2(3) or B.01.010.2(9), that statement must

(a) appear after the list of ingredients for the product, if any, without any intervening printed, written or graphic material; and

(b) include all of the following information, even if all or part of that information is also shown in the list of ingredients for the product:

(i) the source for each food allergen that is present in the product,

(ii) each source for the gluten that is present in the product, and

(iii) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, if the total amount of sulphites present in the product is 10 parts per million or more.

(2) Despite paragraph (1)(b), the following information is not required to be shown in the statement more than once:

(a) the same source of a food allergen;

(b) the same source of gluten; and

(c) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

 — SOR/2011-28, s. 5

5. Section B.13.011 of the Regulations is replaced by the following:

B.13.011. [S]. Corn starch shall be starch made from maize and shall contain not less than 84% starch.

 — SOR/2011-28, s. 6

6. Section B.24.018 of the Regulations is replaced by the following:

B.24.018. It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition “gluten” in subsection B.01.010.1(1).

 — SOR/2011-28, s. 7

7. Paragraph D.01.007(1)(a) of the Regulations is replaced by the following:

(a) despite subsection B.01.008(6), the vitamin is declared by its common name, and that common name is shown immediately after the ingredient in such a manner as to indicate that the vitamin is a component of that ingredient, except that if a source of a food allergen or gluten is required by paragraph B.01.010.1(8)(a) to be shown immediately after that ingredient, the common name of the vitamin is instead shown immediately after that source; and

 — SOR/2011-28, s. 8

8. Paragraph D.02.005(1)(a) of the Regulations is replaced by the following:

(a) despite subsection B.01.008(6), the mineral nutrient is declared by its common name, and that common name is shown immediately after the ingredient in such a manner as to indicate that the mineral nutrient is a component of that ingredient, except that if a source of a food allergen or gluten is required by paragraph B.01.010.1(8)(a) to be shown immediately after that ingredient, the common name of the mineral nutrient is instead shown immediately after that source; and

 Règlement sur les aliments et drogues

Règlement sur les aliments et drogues C.R.C., ch. 870

LOI SUR LES ALIMENTS ET DROGUES

Règlement concernant les aliments et drogues

PARTIE A ADMINISTRATION Dispositions générales A.01.001. Le présent règlement peut être cité sous le titre : Règlement sur les aliments et drogues.

A.01.002. Lorsqu’il y a lieu, les dispositions du présent règlement établissent les normes de composition, de concentration, d’activité, de pureté, de qualité ou autre propriété de la substance alimentaire ou de la drogue, auxquelles elles se rapportent.

A.01.003. [Abrogé, DORS/94-289, art. 1]

Interprétation A.01.010. Dans le présent règlement,

« centimètre cube » ou son abréviation « cc. » sont censées interchangeables avec le mot « millilitre » et son abréviation « ml. »; (cubic centimetre)

« conjoint de fait » La personne qui vit avec la personne en cause dans une relation conjugale depuis au moins un an. (common-law partner)

« Directeur » désigne le sous-ministre adjoint de la Direction générale des produits de santé et des aliments du ministère. (Director)

« emballage de sécurité » désigne un emballage doté d’un dispositif de sûreté qui offre au consommateur une assurance raisonnable que l’emballage n’a pas été ouvert avant l’achat; (security package)

« espace principal » S’entend au sens du Règlement sur l’emballage et l’étiquetage des produits de consommation. (principal display panel)

« étiquette extérieure » désigne l’étiquette sur l’extérieur d’un emballage d’aliment ou de drogue, ou y apposée; (outer laben( �/p>

« étiquette intérieure » désigne l’étiquette sur le récipient immédiat d’un aliment ou d’une drogue, ou y apposée; (inner label)

« fabricant »[Abrogée, DORS/97-12, art. 1]

« fabricant » ou « distributeur » Toute personne, y compris une association ou une société de personnes, qui, sous son propre nom ou sous une marque de commerce, un dessin­ marque, un logo, un nom commercial ou un autre nom, dessin ou marque soumis à son contrôle, vend un aliment ou une drogue. (manufactureroudistributor)

« Loi » Sauf pour l’application des parties G et J, la Loi sur les aliments et drogues. (Act)

« méthode acceptable » Méthode d’analyse ou d’examen désignée par le Directeur comme étant acceptable aux fins de l’application de la Loi et du présent règlement. (acceptable method)

« méthode officielle » signifie une méthode d’analyse ou d’examen désignée comme telle par le Directeur pour usage dans l’application de la Loi et du présent règlement; (official method)

« numéro de lot » désigne toute combinaison de lettres, de chiffres ou de lettres et de chiffres au moyen de laquelle tout aliment ou une drogue peut être retracé au cours de la fabrication et identifié au cours de la distribution. (Lot number)

DORS/84-300, art. 1(F); DORS/85-141, art. 1; DORS/89-455, art. 1; DORS/97-12, art. 1; DORS/2000-353, art. 1; DORS/2001-272, art. 5; DORS/2003-135, art. 1.

A.01.011. Le Directeur doit, sur demande, fournir des exemplaires des méthodes officielles.

A.01.012. Le Directeur doit, sur demande, indiquer si une méthode est acceptable ou non, lorsqu’on la lui présente en vue d’une décision.

A.01.013. Dans le présent règlement, la mention propre ou usuelle d’un aliment, d’une drogue ou d’une vitamine sous un de ses noms, renvoie à tous ses noms.

A.01.014. Quand, suivant le présent règlement, un numéro de lot doit paraître sur tout article, récipient, emballage ou étiquette, ce numéro doit être précédé de l’une des désignations suivantes :

a) « Numéro du Lot »;

b) « Lot no »;

c) « Lot »; ou

d) « (L) ».

A.01.015. (1) Sous réserve du paragraphe (2), toute mention, tout renseignement ou toute déclaration dont le présent règlement exige l’indication sur l’étiquette d’une drogue doit être soit en anglais soit en français, en plus de toute autre langue.

(2) Lorsqu’en vertu du sous-alinéa C.01.004(1)c)(iii), un mode d’emploi doit figurer sur les étiquettes intérieure et extérieure d’une drogue, ce mode d’emploi doit être en anglais et en français si cette drogue est disponible à la vente sans ordonnance à un point de vente libre-service.

DORS/85-140, art. 1.

A.01.016. Tout renseignement qui, selon que l’exige le présent règlement, doit figurer sur l’étiquette d’un aliment ou d’une drogue doit

a) être clairement formulé et placé bien en vue; et

b) être facile à apercevoir, pour l’acheteur ou le consommateur, dans les conditions ordinaires d’achat et d’usage.

Analystes; inspecteurs A.01.020. et A.01.021. [Abrogés, DORS/81-935, art. 1]

A.01.022. Les devoirs et fonctions des inspecteurs s’exercent au titre des aliments et drogues visés par la Loi et le présent règlement.

A.01.023. Les attributions d’un inspecteur s’étendent à tout le Canada.

A.01.024. Le certificat visé au paragraphe 22(2) de la Loi doit :

a) établir que la personne qui y est nommée est un inspecteur pour les fins de la Loi; et

b) être signé par

(i) le Directeur et la personne nommée au certificat, dans le cas d’un inspecteur du ministère.

(ii) [Abrogé, DORS/2000-184, art. 60]

DORS/80-500, art. 1; DORS/92-626, art. 1; DORS/95-548, art. 5; DORS/2000-184, art. 60.

A.01.025. Lorsque les règlements d’exécution de la Loi sur la radiodiffusion les y autorisent, les inspecteurs doivent agir en qualité d’agents du Conseil de la radiodiffusion et des télécommunications canadiennes aux fins d’appliquer les règlements édictés par le Conseil de la radiodiffusion et des télécommunications canadiennes, relativement à la publicité de tout article qui tombe sous le coup de la Loi sur les spécialités pharmaceutiques ou médicaments brevetés ou de la Loi des aliments et drogues, ou relativement à toute recommandation quant à la prévention, au traitement ou à la guérison d’une maladie ou affection.

A.01.026. Un inspecteur peut, pour l’application de la Loi ou du présent règlement, prendre des photographies

a) de tout article visé au paragraphe 23(2) de la Loi;

b) de tout lieu où il a des motifs raisonnables de croire qu’un article visé à l’alinéa a) y est fabriqué, préparé, conservé, empaqueté ou emmagasiné; et

c) de toute chose lorsqu’il a des motifs raisonnables de croire, qu’elle sert ou peut servir à la fabrication, la préparation, la conservation, l’empaquetage ou l’emmagasinage d’un article visé à l’alinéa a).

DORS/90-814, art. 1.

Importations A.01.040. Sous réserve de l’article A.01.044, il est interdit d’importer pour la vente des aliments ou des drogues dont la vente au Canada enfreindrait la Loi ou le présent règlement.

DORS/92-626, art. 2(F).

A.01.041. L’inspecteur peut examiner et prélever des échantillons de tout aliment ou drogue destinés à être importés au Canada.

A.01.042. L’inspecteur peut référer à un analyste, pour examen, les échantillons des aliments ou drogues examinés ou prélevés en vertu de l’article A.01.041.

A.01.043. L’inspecteur qui estime, après examen d’un échantillon de l’aliment ou de la drogue ou réception du rapport de l’analyste que la vente de l’aliment, de la drogue ou du cosmétique serait contraire à la Loi ou au présent règlement, doit en notifier par écrit le percepteur des douanes ainsi que l’importateur.

DORS/84-300, art. 2(A).

A.01.044. (1) Quiconque cherche à importer pour la vente un aliment ou une drogue dont la vente enfreindrait la Loi ou le présent règlement peut, dans les cas où un nouvel étiquetage ou une modification rendrait cette vente au Canada conforme à la Loi et au présent règlement, importer cet aliment ou cette drogue pour la vente aux conditions suivantes :

a) l’importateur avise l’inspecteur de l’importation proposée;

b) les aliments ou les drogues font l’objet d’un nouvel étiquetage ou d’une modification propre à rendre légale leur vente au Canada.

(2) Il est interdit de vendre un aliment ou une drogue importé au Canada en vertu du paragraphe (1), à moins qu’il n’ait fait l’objet d’un nouvel étiquetage ou d’une modification dans les trois mois suivant la date de l’importation ou dans le délai plus long fixé :

a) par le directeur, s’il s’agit d’une drogue;

b) par le directeur ou le président de l’Agence canadienne d’inspection des aliments, s’il s’agit d’un aliment.

DORS/92-626, art. 3; DORS/95-548, art. 5; DORS/2000-184, art. 61; DORS/2000-317, art. 18.

Exportation A.01.045. Le certificat visé à l’article 37 de la Loi doit revêtir la forme prévue à l’appendice III et être délivré et signé par l’exportateur.

DORS/80-318, art. 1; DORS/90-814, art. 2.

Échantillons A.01.050. L’inspecteur qui prélève un échantillon d’un article en application de l’alinéa 23(1)a) de la Loi doit aviser le propriétaire de l’article ou la personne de qui il a obtenu l’échantillon de son intention de soumettre tout ou partie de l’échantillon à un analyste pour analyse ou examen, et :

a) lorsque, de l’avis de l’inspecteur, la division de la quantité obtenue ne nuirait pas à l’examen ou à l’analyse, il doit

(i) diviser la quantité prélevée en trois parties,

(ii) identifier les trois parties comme la partie du propriétaire, l’échantillon et le double de l’échantillon, et si une partie seulement porte l’étiquette, cette partie doit constituer l’échantillon,

(iii) sceller chaque partie de manière qu’elle ne puisse être ouverte sans briser le sceau, et

(iv) remettre la partie identifiée comme la partie du propriétaire, au propriétaire ou à la personne chez qui l’échantillon a été prélevé et envoyer l’échantillon ainsi que le double à un analyste pour l’examen ou analyse; ou

b) lorsque, de l’avis de l’inspecteur, la division de la quantité prélevée nuirait à l’analyse ou à l’examen, il doit

(i) identifier la quantité entière de l’échantillon,

(ii) sceller l’échantillon de manière qu’il ne puisse être ouvert sans briser le sceau, et

(iii) envoyer l`échantillon à un analyste pour analyse ou examen.

DORS/90-814, art. 3.

A.01.051. Lorsque le propriétaire ou la personne chez qui l’échantillon est prélevé s’oppose à la méthode suivie par un inspecteur en vertu de l’article A.01.050 au moment où l’échantillon est prélevé, l’inspecteur doit suivre les deux méthodes énoncées dans ledit article si le propriétaire ou la personne chez qui l’échantillon a été prélevé lui fournit une quantité suffisante de l’objet en cause.

Honoraires d'analyse

A.01.060. Les honoraires d’analyse de tout échantillon, autrement qu’aux fins de la présente Loi ou pour le compte d’un autre ministère du gouvernement du Canada aux fins de poursuites judiciaires, sont de 15 $.

Étiquetage des contenants d'aliments et de drogues sous pression A.01.060.1. Les définitions qui suivent s’appliquent aux articles A.01.061 et A.01.062.

« espace principal »[Abrogée, DORS/2000-353, art. 2]

« projection de la flamme » Détermination de la longueur du jet enflammé du contenu sous pression expulsé d’un contenant aérosol lorsque celui-ci est soumis à un essai selon la méthode officielle DO-30, intitulée Détermination de la projection de la flamme, en date du 15 octobre 1981. (flame projection)

« retour de flamme » Partie de la projection de la flamme qui va du point d’inflammation jusqu’au contenant aérosol lorsque celui-ci est soumis à un essai selon la méthode officielle DO-30, intitulée Détermination de la projection de la flamme, en date du 15 octobre 1981. (flashback)

DORS/92-15, art. 1; DORS/2000-353, art. 2; DORS/2001-272, art. 6.

A.01.061. (1) Sous réserve de l’article A.01.063, l’étiquette intérieure et l’étiquette extérieure d’un aliment ou d’une drogue emballés dans un contenant métallique non réutilisable, conçu pour permettre de libérer le contenu sous pression au moyen d’une valve actionnée à la main et faisant partie intégrante du contenant, doivent porter dans leur espace principal, conformément aux articles 15 à 18 du Règlement sur les produits chimiques et contenants destinés aux consommateurs, dans sa version en vigueur le 30 septembre 2001 :

a) le signal de danger figurant à la colonne II de l’article 10 de l’annexe II de ce règlement et le mot indicateur « ATTENTION / CAUTION »;

b) la mention de danger principale suivante : « CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ. / CONTAINER MAY EXPLODE IF HEATED. ».

(2) Sous réserve de l’article A.01.063, l’étiquette intérieure et l’étiquette extérieure d’un aliment ou d’une drogue visés au paragraphe (1) doivent porter dans un espace quelconque, selon les dimensions prévues à l’alinéa 19(1)b) du Règlement sur les produits chimiques et contenants destinés aux consommateurs, dans sa version en vigueur le 30 septembre 2001, la mention de danger additionnelle suivante :

« Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50 °C.

Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C. »

(3) Les dispositions des paragraphes (1) et (2) ne s’appliquent pas lorsque,

a) de l’avis du Directeur, s’il s’agit d’une drogue, ou

b) de l’avis du ministre de la Consommation et des Corporations, s’il s’agit d’un aliment,

la conception du contenant, les matériaux utilisés pour sa fabrication ou la présence d’un dispositif de sécurité éliminent le danger éventuel que présente ledit contenant.

DORS/81-616, art. 1; DORS/85-1023, art. 1; DORS/92-15, art. 2; DORS/2001-272, art. 7.

A.01.062. (1) Sous réserve de l’article A.01.063, l’étiquette intérieure et l’étiquette extérieure d’un aliment ou d’une drogue qui est emballé dans un contenant visé au paragraphe A.01.061(1) et qui présente une projection de la flamme d’une longueur visée à la colonne I de l’un des articles 1 à 3 du tableau du présent paragraphe ou un retour de flamme indiqué à la colonne I de l’article 4 de ce tableau, déterminés selon la méthode officielle DO-30, intitulée Détermination de la projection de la flamme, en date du 15 octobre 1981, doivent porter dans leur espace principal, conformément aux articles 15 à 18 du Règlement sur les produits chimiques et contenants destinés aux consommateurs, dans sa version en vigueur le 30 septembre 2001 :

a) le signal de danger correspondant qui figure à la colonne II;

b) dans les deux langues officielles, le mot indicateur correspondant qui est précisé à la colonne III;

c) dans les deux langues officielles, la mention de danger principale correspondante qui est prévue à la colonne IV.

CE GRAPHIQUE N’EST PAS EXPOSÉ, VOIR DORS/81-616, ART. 2; DORS/92-15, ART. 3

(2) En plus des exigences énoncées au paragraphe (1), l’étiquette intérieure et l’étiquette extérieure d’un aliment ou d’une drogue visés à ce paragraphe doivent porter dans un espace quelconque, selon les dimensions prévues à l’alinéa 19(1)b) du Règlement sur les produits chimiques et contenants destinés aux consommateurs, dans sa version en vigueur le 30 septembre 2001, la mention de danger additionnelle suivante :

« Ne pas utiliser en présence d’une flamme nue ou d’étincelles.

Do not use in presence of open flame or spark. »

DORS/81-616, art. 2; DORS/82-429, art. 1; DORS/85-1023, art. 2; DORS/92-15, art. 3; DORS/2001-272, art. 8.

A.01.063. (1) Lorsque le contenu net étiqueté d’un contenant d’un aliment ou d’une drogue visés aux paragraphes A.01.061(1) ou A.01.062(1) ne dépasse pas 60 millilitres ou 60 grammes, l’étiquette intérieure peut ne porter que les renseignements exigés à l’alinéa A.01.061(1)a) ou aux alinéas A.01.062(1)a) et b), selon le cas.

(2) Lorsque le contenu net étiqueté d’un contenant d’un aliment ou d’une drogue visés aux paragraphes A.01.061(1) ou A.01.062(1) est supérieur à 60 millilitres ou 60 grammes mais ne dépasse pas 120 millilitres ou 120 grammes, l’étiquette intérieure peut ne porter que les renseignements exigés aux paragraphes A.01.061(1) ou A.01.062(1), selon le cas.

(3) Lorsque la quantité nette figurant sur l’étiquette d’un contenant d’un aliment ou d’une drogue visés aux paragraphes A.01.061(1) ou A.01.062(1) est inférieure à 30 mL ou à 30 g, le signal de danger doit être d’une taille telle qu’il peut être circonscrit par un cercle ayant un diamètre d’au moins 6 mm.

(4) Lorsqu’un contenant d’un aliment ou d’une drogue décrit aux paragraphes (1) ou (2) est vendu dans un emballage, l’étiquette extérieure peut ne porter que les renseignements exigés au paragraphe A.01.061(2) et, s’il y a lieu, au paragraphe A.01.062(2).

DORS/81-616, art. 2; DORS/92-15, art. 4.

A.01.064. [Abrogé, DORS/93-243, art. 2]

Emballage de sécurité A.01.065. (1) Pour l’application du présent article, « drogue pour usage humain » s’entend d’une drogue destinée à la consommation humaine, qu’elle soit sous forme de :

a) rince-bouche;

b) drogue pour usage par inhalation, ingestion ou insertion;

c) drogue pour usage ophtalmique.

(2) Sous réserve du paragraphe (3), il est interdit de vendre ou d’importer une drogue pour usage humain qui est emballée et qui est offerte à un point de vente libre-service accessible au public, à moins qu’elle ne soit contenue dans un emballage de sécurité.

(3) Le paragraphe (2) ne s’applique pas aux pastilles.

(4) Sous réserve du paragraphe (5), une mention ou une illustration qui attire l’attention sur le dispositif de sûreté de l’emballage visé au paragraphe (2) doit figurer :

a) d’une part, sur l’étiquette intérieure de l’emballage;

b) d’autre part, sur l’étiquette extérieure de l’emballage si le dispositif fait partie de l’emballage extérieur.

(5) Le paragraphe (4) ne s’applique pas dans le cas où le dispositif est évident et fait partie intégrante du récipient immédiat de la drogue.

DORS/85-141, art. 2; DORS/88-323, art. 1; DORS/92-664, art. 1.

Exemptions Application

A.01.066. Les articles A.01.067 et A.01.068 ne s’appliquent pas aux drogues suivantes :

a) toute drogue qui est inscrite aux annexes I, II, III, IV ou V de la Loi réglementant certaines drogues et autres substances;

b) toute drogue qui est énumérée ou décrite à l’annexe F, autre qu’une drogue énumérée ou décrite à la partie II de cette annexe qui est :

(i) soit présentée sous une forme impropre à l’usage humain,

(ii) soit étiquetée de la façon prévue à l’alinéa C.01.046b).

DORS/2007-288, art. 1.

Publicité

A.01.067. Est exemptée de l’application du paragraphe 3(1) de la Loi toute drogue dont la publicité est faite, auprès du grand public, à titre de mesure préventive — mais non à titre de traitement ou de moyen de guérison — d’une maladie, d’un désordre ou d’un état physique anormal énuméré à l’annexe A de la Loi.

DORS/2007-288, art. 1.

Vente

A.01.068. Est exemptée de l’application du paragraphe 3(2) de la Loi, en ce qui concerne sa vente par une personne, à titre de mesure préventive — mais non à titre de traitement ou de moyen de guérison — d’une maladie, d’un désordre ou d’un état physique anormal énuméré à l’annexe A de la Loi, toute drogue qui est représentée par une étiquette ou dont la publicité auprès du grand public est faite par la personne en cause.

DORS/2007-288, art. 1.

PARTIE B ALIMENTS Titre 1 Dispositions générales

B.01.001. (1) Dans la présente partie,

« acides gras monoinsaturés », « graisses monoinsaturées », « gras monoinsaturés », « lipides monoinsaturés » ou « monoinsaturés » Acides gras cis-monoinsaturés. (monounsaturated fatty acids, monounsaturated fat, monounsaturatesormonounsaturated)

« acides gras polyinsaturés », « graisses polyinsaturées », « gras polyinsaturés », « lipides polyinsaturés » ou « polyinsaturés » Acides gras polyinsaturés à interruption cis ­ méthylénique. (polyunsaturated fatty acids, polyunsaturated fat, polyunsaturatesorpolyunsaturated)

« acides gras polyinsaturés oméga-3 », « graisses polyinsaturées oméga-3 », « gras polyinsaturés oméga-3 », « lipides polyinsaturés oméga-3 », « polyinsaturés oméga-3 » ou « oméga-3 » Selon le cas :

a) acide 9-cis, 12-cis, 15-cis octadécatriénoïque ou acide α-linolénique;

b) acide 8-cis, 11-cis, 14-cis, 17-cis éicosatétraénoïque;

c) acide 5-cis, 8-cis, 11-cis, 14-cis, 17-cis éicosapentaénoïque ou AEP;

d) acide 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosapentaénoïque;

e) acide 4-cis, 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosahexaénoïque ou ADH. (omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fat, omega-3 polyunsaturates, omega-3 polyunsaturatedoromega-3)

« acides gras polyinsaturés oméga-6 », « graisses polyinsaturées oméga-6 », « gras polyinsaturés oméga-6 », « lipides polyinsaturés oméga-6 », « polyinsaturés oméga-6 » ou « oméga-6 » Selon le cas :

a) acide 9-cis, 12-cis octadécadiénoïque ou acide linoléique;

b) acide 6-cis, 9-cis, 12-cis octadécatriénoïque;

c) acide 8-cis, 11-cis, 14-cis éicosatriénoïque ou acide di-homo-γ-linolénique;

d) acide 5-cis, 8-cis, 11-cis, 14-cis éicosatétraénoïque ou acide arachidonique;

e) acide 7-cis, 10-cis, 13-cis, 16-cis docosatétraénoïque;

f) acide 4-cis, 7-cis, 10-cis, 13-cis, 16-cis docosapentaénoïque. (omega-6 polyunsaturated fatty acids, omega-6 polyunsaturated fat, omega-6 polyunsaturates, omega-6 polyunsaturatedoromega-6)

« acides gras saturés », « graisses saturées », « gras saturés », « lipides saturés » ou « saturés » Acides gras ne contenant aucune liaison double. (saturated fatty acids, saturated fat, saturatesor saturated)

« acides gras trans », « graisses trans », « gras trans », « lipides trans » ou « trans » Acides gras insaturés qui contiennent une ou plusieurs liaisons doubles isolées ou non conjuguées de configuration trans. (trans fatty acids, trans fator trans)

« additif alimentaire » s’entend de toute substance dont l’emploi est tel ou peut vraisemblablement être tel que cette substance ou ses sous-produits sont intégrés à un aliment ou en modifient les caractéristiques, à l’exclusion de ce qui suit :

a) toute substance nutritive qui est employée, reconnue ou vendue couramment comme substance alimentaire ou comme ingrédient d’un aliment,

b) vitamines, minéraux nutritifs et acides aminés, autres que ceux qui sont énumérés aux tableaux du Titre 16,

c) épices, assaisonnements, préparations aromatisantes, essences, oléorésines et extraits naturels,

d) produits chimiques agricoles autres que ceux visés aux tableaux du titre 16,

e) matériaux d’emballage des aliments ou toute substance qui entre dans leur composition, et

f) produits pharmaceutiques recommandés pour les animaux dont la chair peut être consommée par l’homme; (food additive)

« agent édulcorant » Vise notamment tout aliment qui fait l’objet d’une norme énoncée dans le titre 18, mais non les additifs alimentaires visés aux tableaux du titre 16. (sweetening agent)

« agent gélatinisant » désigne la gélatine, l’agar-agar et la carragénine; (gelling agent)

« aliment non normalisé » désigne tout aliment pour lequel la présente partie ne prescrit pas de norme; (unstandardized food)

« allongeur de produit de viande » désigne un aliment qui est source de protéines et qui est présenté comme devant servir à augmenter le volume de produits de viande; (meat product extender)

« allongeur de produit de volaille » désigne un aliment qui est source de protéines et qui est présenté comme devant servir à augmenter le volume de produits de volaille; (poultry product extender)

« apport nutritionnel recommandé pondéré » Relativement à une vitamine ou à un minéral nutritif figurant à la colonne I du tableau II du titre 1 de la partie D ou à la colonne I du tableau II du titre 2 de cette partie, la quantité indiquée dans la colonne III. (weighted recommended nutrient intake)

« apport quotidien recommandé » Relativement à une vitamine ou à un minéral nutritif figurant à la colonne I du tableau I du titre 1 de la partie D ou à la colonne I du tableau I du titre 2 de cette partie :

a) dans le cas d’un produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans, la quantité indiquée dans la colonne III;

b) dans les autres cas, la quantité indiquée dans la colonne II. (recommended daily intake)

« à proximité », appliqué au nom usuel, signifie adjacent au nom usuel sans qu’aucun texte imprimé ou écrit, ni aucun signe graphique, ne soit intercalé entre les deux; (close proximity)

« colorant alimentaire » désigne les matières colorantes que le titre 6 permet d’employer dans ou sur les produits alimentaires; (food colour)

« constituant » désigne une unité alimentaire alliée, en tant qu’élément alimentaire individuel, à une ou plusieurs autres unités alimentaires pour former un ingrédient; (component)

« date limite de conservation » désigne la date où la durée de conservation d’un produit préemballé prend fin; (durable life date)

« durée de conservation » désigne la période, commençant le jour de l’emballage pour la vente au détail, pendant laquelle un produit préemballé qui est en stockage dans des conditions qui conviennent audit produit, retiendra, sans détérioration appréciable, la nature saine, le caractère agréable au goût et la valeur nutritive que possède ordinairement ce produit, ainsi que toute autre qualité revendiquée par le fabricant; (durable life)

« édulcorant » Additif alimentaire désigné comme édulcorant au tableau IX de l’article B.16.100. (sweetener)

« emballage décoratif » désigne un emballage sur lequel ne figure, sauf sur le dessous, aucune indication promotionnelle ou publicitaire autre qu’une marque de commerce ou un nom usuel et qui, à cause d’un dessin figurant sur sa surface ou à cause de sa forme ou de son apparence, semble être décoratif et est vendu à titre d’objet décoratif en plus d’être vendu comme emballage du produit; (ornamental container)

« espace principal » Malgré la définition de ce terme à l’article A.01.010, vise :

a) dans le cas d’une étiquette apposée sur un produit préemballé visé par la Loi sur l’emballage et l’étiquetage des produits de consommation, l’espace principal défini dans le Règlement sur l’emballage et l’étiquetage des produits de consommation,

b) dans le cas d’une étiquette apposée sur un produit préemballé non visé par la Loi sur l’emballage et l’étiquetage des produits de consommation, la portion de l’étiquette apposée sur tout ou partie de la face ou de la surface de l’emballage qui est exposée ou visible dans les conditions normales ou habituelles de vente ou d’utilisation, et dans les cas où l’emballage ne possède pas une telle face ou surface, la portion de l’étiquette apposée sur toute partie de l’emballage, à l’exclusion du dessous de l’emballage, le cas échéant, et

c) dans le cas d’une étiquette apposée sur un aliment qui n’est pas un produit préemballé, la portion de l’étiquette apposée sur tout ou partie de la face ou de la surface de l’aliment qui est exposée ou visible dans les conditions normales ou habituelles de vente ou d’utilisation; (principal display panen( �/p>

« ingrédient » désigne une unité alimentaire alliée, en tant qu’élément alimentaire, à une ou plusieurs autres unités alimentaires pour former une denrée alimentaire intégrale vendue comme produit préemballé; (ingredient)

« nom usuel », en ce qui a trait à un aliment, désigne

a) le nom de l’aliment imprimé en caractères gras dans le présent règlement,

b) le nom prescrit par un autre règlement, ou

c) si le nom de l’aliment n’est pas ainsi imprimé ou prescrit, le nom sous lequel l’aliment est généralement connu; (common name)

« norme de référence » Relativement à un élément nutritif figurant à la colonne 1 du tableau de l’article B.01.001.1, la quantité indiquée dans la colonne 2. (reference standard)

« oeuf à jaune substitué » désigne un aliment qui

a) ne contient pas de jaune d’oeuf mais qui contient de l’albumen d’oeuf liquide, en poudre ou congelé ou un mélange de ces trois formes,

b) est destiné à servir de substitut à l’oeuf entier, et

c) est conforme aux exigences de l’article B.22.032; (yolk-replaced egg)

« parties par million »[Abrogée, DORS/2010-94, art. 1]

« parties par million » ou « p.p.m. » S’entend de parties par million en poids, à moins d’indication contraire. (parts per million or p.p.m.)

« pour cent » ou « % » Pourcentage en poids, à moins d’indication contraire; (per cent ou %)

« préparation aromatisante » s’applique à tout aliment qui fait l’objet d’une norme du titre 10; (flavouring preparation)

« produit chimique agricole » Toute substance utilisée ou présentée comme étant utilisable dans un aliment, ou sur sa surface, pendant sa production, son entreposage ou son transport et dont l’utilisation donne lieu, ou dont on peut raisonnablement s’attendre à ce qu’elle donne lieu, à un résidu ou à un composant ou dérivé de la substance dans l’aliment ou sur sa surface, y compris tout produit antiparasitaire au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires, régulateur de croissance des végétaux, fertilisant ou tout adjuvant ou véhicule utilisé avec la substance. Sont toutefois exclus les produits suivants :

a) les additifs alimentaires visés aux tableaux de l’article B.16.100 et utilisés conformément à ces tableaux;

b) les substances nutritives utilisées, reconnues ou couramment vendues comme aliments ou comme ingrédients d’un aliment;

c) les vitamines, minéraux nutritifs et acides aminés;

d) les assaisonnements, épices, extraits naturels, huiles essentielles, oléorésines et préparations aromatisantes;

e) les matériaux d’emballage des aliments ou toute substance qui entre dans leur composition;

f) les drogues recommandées pour administration aux animaux pouvant être consommés comme aliments. (agricultural chemical)

« produit de poisson » désigne du poisson ou du poisson préparé; (fish product)

« produit de viande » désigne de la viande, des sous-produits de viande, de la viande préparée ou des sous-produits de viande préparée; (meat product)

« produit de viande avec allongeur » désigne un produit de viande auquel un allongeur de produit de viande a été ajouté; (extended meat product)

« produit de volaille » désigne de la viande de volaille, de la viande de volaille préparée, des sous-produits de viande de volaille ou des sous-produits de viande de volaille préparée; (poultry product)

« produit de volaille avec allongeur » désigne un produit de volaille auquel un allongeur de produit de volaille a été ajouté; (extended poultry product)

« produit préemballé » désigne un aliment contenu dans un emballage de manière à être normalement vendu, utilisé ou acheté par une personne; (prepackaged product)

« quantité de référence » Relativement à un aliment figurant à la colonne 1 de l’annexe M, la quantité de cet aliment indiquée dans la colonne 2. (reference amount)

« ration quotidienne raisonnable », appliquée à un aliment énuméré à un poste de la colonne I de l’annexe K, désigne la quantité de cet aliment indiquée dans la colonne II de ladite annexe; (reasonable daily intake)

« repas préemballé » Choix préemballé d’aliments destiné à une seule personne, qui ne requiert aucune autre préparation que le réchauffage et qui contient au moins les portions suivantes, selon la description qui en est donnée dans la publication intitulée Guide alimentaire canadien pour manger sainement, autorisée par le ministre de la Santé nationale et du Bien-être social et publiée en 1992 par le ministère des Approvisionnements et Services :

a) une portion de viande, poisson, volaille, légumineuses, noix, graines, oeufs ou lait ou produits du lait autres que le beurre, la crème, la crème sure, la crème glacée, le lait glacé et le sorbet laitier;

b) une portion de légumes, fruits ou produits céréaliers. (prepackaged mean( �/p>

« simili-produit de viande » désigne un aliment qui ne contient aucun produit de viande, produit de volaille ni produit de poisson mais qui a l’apparence d’un produit de viande; (simulated meat product)

« simili-produit de volaille » désigne un aliment qui ne contient aucun produit de volaille, produit de viande ni produit de poisson mais qui a l’apparence d’un produit de volaille; (simulated poultry product)

« substitut de repas » Préparation alimentaire qui, à elle seule, peut remplacer au moins un repas quotidien. (meal replacement)

« sucres » désigne tous les monosaccharides et les disaccharides; (sugars)

« supplément nutritif » Aliment vendu ou présenté comme supplément à un régime alimentaire dont l’apport en énergie et en éléments nutritifs essentiels peut ne pas être suffisant. (nutritional supplement)

« surface exposée disponible » Relativement à un produit préemballé, les surfaces suivantes :

a) le dessous de tout emballage décoratif ou la totalité de la surface des deux côtés d’une étiquette mobile attachée à l’emballage décoratif, la plus grande surface étant à retenir;

b) la totalité de la surface des deux côtés de toute étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat;

c) la totalité de la surface de tout autre emballage, à l’exclusion de son dessous si son contenu fuit ou est endommagé lorsque l’emballage est retourné.

Sont toutefois exclus :

d) toute surface de l’emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat;

e) toute partie d’un emballage, autre que l’emballage d’un aliment destiné à être consommé par une personne en une seule fois, qui est conçue pour être détruite lors de l’ouverture de celui-ci;

f) tout espace occupé par le code universel des produits. (available display surface)

« surtitrage » Quantité d’une vitamine ou d’un minéral nutritif ajoutée à un aliment, dans les limites des bonnes pratiques industrielles, en sus de la quantité déclarée sur l’étiquette, afin d’assurer le maintien de cette dernière pendant toute la durée de conservation. (overage)

« tableau de la valeur nutritive » Tableau que porte l’étiquette d’un produit préemballé conformément au paragraphe B.01.401(1). (nutrition facts table)

« valeur énergétique » s’entend, dans le cas d’un aliment, de la quantité d’énergie que peut recevoir une personne lorsqu’elle ingère l’aliment et que les constituants chimiques de cet aliment, dont les protéines, les matières grasses, les glucides et l’alcool, sont métabolisés. (energy value)

« valeur quotidienne » Selon le cas :

a) relativement à une vitamine ou à un minéral nutritif mentionné dans la définition de « apport quotidien recommandé », l’apport quotidien recommandé de cette vitamine ou de ce minéral nutritif;

b) relativement à un élément nutritif mentionné dans la définition de « norme de référence », la norme de référence de cet élément. (daily value)

(2) Les termes ci-après sont définis comme il suit pour l’application de la Loi.

« additif alimentaire » S’entend au sens du paragraphe (1). (food additive)

« produit chimique agricole » S’entend au sens du paragraphe (1). (agricultural chemical)

DORS/78-403, art. 1(F); DORS/79-23, art. 1; DORS/81-83, art. 1; DORS/81-617, art. 1; DORS/88-336, art. 1; DORS/88-559, art. 1; DORS/89-175, art. 1; DORS/91-124, art. 1; DORS/91-527, art. 1; DORS/93-276, art. 1; DORS/95-474, art. 1; DORS/98-580, art. 1(F); DORS/2000-353, art. 3; DORS/2003-11, art. 1; err.(A), Vol. 137, no 5; DORS/2005-98, art. 1; DORS/2008-181, art. 1; DORS/2008-182, art. 1; DORS/2010-94, art. 1. Version précédente B.01.001.1 (1) Dans le présent article, « lipides » s’entend de tous les acides gras exprimés sous forme de triglycérides.

(2) La norme de référence d’un élément nutritif figurant à la colonne 1 du tableau du présent article est la quantité indiquée dans la colonne 2.

TABLEAU

NORMES DE RÉFÉRENCE

Colonne 1 Colonne 2 Article Élément nutritif Quantité 1. Lipides 65 g 2. La somme des acides gras saturés et des acides gras trans 20 g 3. Cholestérol 300 mg 4. Glucides 300 g 5. Fibres 25 g 6. Sodium 2 400 mg 7. Potassium 3 500 mg

DORS/2003-11, art. 2.

B.01.002. Dans la présente partie, la présence du symbole [N] entre le numéro d’une disposition et le nom de l’aliment visé indique que la disposition prescrit la norme de composition, de concentration, d’activité, de pureté, de qualité ou de toute autre propriété à observer pour cet aliment; l’absence de ce symbole indique qu’aucune norme n’est prescrite à l’égard de l’aliment visé.

DORS/79-752, art. 1.

B.01.002A. (1) Pour l’application de la présente partie, toute portion déterminée d’un aliment est :

a) établie en fonction de l’aliment tel qu’il est vendu;

b) exprimée, selon le cas :

(i) en grammes, dans l’un ou l’autre des cas suivants :

(A) la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette,

(B) l’aliment figure à la colonne 1 des articles 78, 149 ou 150 de l’annexe M,

(ii) en millilitres, dans le cas où la quantité nette de l’aliment, autre qu’un aliment visé à la division (i)(B), est mentionnée en volume sur l’étiquette.

(2) Une portion déterminée est la quantité nette de l’aliment dans l’emballage, dans l’un ou l’autre des cas suivants :

a) la quantité de l’aliment peut être raisonnablement consommée par une personne en une seule fois;

b) la quantité de référence de l’aliment est inférieure à 100 g ou à 100 mL et l’emballage contient moins de 200 % de cette quantité;

c) la quantité de référence de l’aliment est d’au moins 100 g ou 100 mL et l’emballage contient au plus 150 % de cette quantité.

DORS/88-559, art. 2; DORS/2003-11, art. 3.

B.01.003. (1) Doivent porter une étiquette lorsqu’ils sont offerts en vente les aliments suivants :

a) tous les produits préemballés sauf

(i) les confiseries préemballées, appelées couramment bonbons d’une bouchée, qui sont vendues individuellement, et

(ii) les fruits ou légumes frais préemballés qui sont emballés dans une enveloppe ou bande ayant moins de 1/2 pouce de largeur;

b) les viandes et sous-produits de la viande cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail;

c) les volailles, viandes de volaille ou sous-produits de la viande de volaille cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail;

d) la viande de cheval ou ses sous-produits;

e) toute substance ou tout mélange de substances à utiliser comme additif alimentaire ou préparation d’additif alimentaire; et

f) la farine et la farine de blé complet traitées aux rayons gamma provenant d’une source de cobalt 60.

(2) [Abrogé, DORS/79-23, art. 2]

DORS/79-23, art. 2.

B.01.004. (1) L’étiquette visée à l’article B.01.003 doit être apposée en tout ou en partie

a) dans le cas d’un produit préemballé, sur l’emballage dans lequel le produit est vendu; et

b) dans le cas d’un aliment qui n’est pas un produit préemballé, sur l’aliment même.

(2) L’étiquette doit être apposée de manière que l’emballage du produit préemballé ou de l’aliment, selon le cas, porte l’étiquette au moment de la vente.

DORS/84-300, art. 3.

B.01.005. (1) Sous réserve des paragraphes (2) à (5), les renseignements qui doivent figurer sur l’étiquette ne peuvent figurer sur la portion de l’étiquette qui est apposée sur le dessous de l’emballage ou du produit alimentaire, le cas échéant.

(2) Les renseignements dont l’indication sur l’étiquette est prescrite peuvent figurer sur la portion de l’étiquette apposée sur le dessous d’un emballage ou d’un produit alimentaire, le cas échéant, si lesdits renseignements figurent aussi sur les portions de l’étiquette qui ne sont pas apposées sur le dessous de l’emballage ou du produit alimentaire.

(3) Nonobstant le paragraphe (2), lorsque l’emballage d’un produit préemballé est un emballage décoratif et que l’étiquette est apposée sur le dessous de l’emballage, les renseignements dont l’indication est prescrite peuvent figurer sur l’étiquette apposée sur le dessous de l’emballage.

(4) Par dérogation au paragraphe (2), les renseignements exigés par le sous-alinéa B.01.007(1.1)b)(i) ou les alinéas B.24.103g), B.25.057(1)f) ou (2)f) peuvent figurer sur la partie de l’étiquette qui est apposée sur le dessous de l’emballage, s’il est dit clairement ailleurs sur l’étiquette que ces renseignements figurent à cet endroit.

(5) Malgré le paragraphe (2), le tableau de la valeur nutritive peut figurer sur la portion de l’étiquette qui est apposée sur le dessous de l’emballage ou du produit alimentaire, si la surface exposée disponible comprend le dessous.

DORS/79-529, art. 1; DORS/92-626, art. 4; DORS/2003-11, art. 4.

B.01.006. (1) Le nom usuel de l’aliment doit figurer sur l’espace principal.

(2) Par dérogation au paragraphe (1), le nom usuel des fruits ou légumes frais qui sont préemballés de manière à être visibles et reconnaissables dans leur emballage n’a pas à être indiqué sur l’étiquette.

DORS/79-23, art. 3; DORS/92-626, art. 5.

B.01.007. (1) Dans le présent article, « date d’emballage » désigne :

a) soit la date à laquelle l’aliment est emballé pour la première fois dans l’emballage dans lequel il sera offert en vente aux consommateurs;

b) soit la date à laquelle le produit préemballé est pesé par le détaillant dans l’emballage dans lequel il sera offert en vente aux consommateurs pour la première fois.

(1.1) L’étiquette doit comporter les renseignements suivants :

a) le nom et l’adresse du principal établissement de la personne par qui ou pour qui l’aliment a été fabriqué ou produit;

b) dans le cas où le produit préemballé a une durée de conservation de 90 jours ou moins et est emballé ailleurs que sur les lieux de vente au détail où il sera vendu :

(i) la date limite de conservation,

(ii) le mode d’entreposage du produit préemballé, s’il requiert des conditions d’entreposage différentes des conditions ambiantes normales;

c) dans le cas où le produit préemballé a une durée de conservation de 90 jours ou moins et est emballé sur les lieux de vente au détail où il sera vendu :

(i) la date d’emballage,

(ii) la durée de conservation de l’aliment, sauf si elle est affichée près de l’aliment.

(1.2) La date d’emballage visée à l’alinéa (1.1)c) doit répondre aux exigences des paragraphes (4) et (5) sauf en ce qui concerne les expressions « best before » et « meilleur avant » qui doivent être remplacées par celles de « packaged on » et « empaqueté le ».

(2) L’alinéa (1.1)a) ne s’applique pas aux fruits ou légumes frais qui sont sur les lieux de vente au détail, sont préemballés de façon à être visibles et identifiables dans l’emballage.

(3) Les alinéas (1.1)b) et c) ne s’appliquent pas :

a) aux produits préemballés qui sont des fruits ou légumes frais préemballés;

b) aux portions individuelles préemballées d’aliments qui sont servies avec des repas ou des casse-croûte par un restaurant ou une autre entreprise commerciale;

c) aux portions individuelles préemballées d’aliments qui sont préparées dans un dépôt de vivres et vendues au moyen de distributeurs automatiques ou d’une cantine mobile;

d) aux beignets préemballés.

(4) La date limite de conservation doit être indiquée de la manière suivante :

a) les mots « meilleur avant » et « best before » doivent être regroupés avec la date limite de conservation à moins que cette date ne soit clairement expliquée ailleurs sur l’étiquette;

b) lorsqu’il est nécessaire, pour des raisons de clarté, d’indiquer l’année de la date limite de conservation, l’année doit être indiquée en premier et doit comprendre au moins les deux derniers chiffres;

c) le mois doit figurer en toutes lettres après l’année, si l’année est indiquée, et peut être abrégé comme le paragraphe (5); et

d) le jour du mois doit être indiqué après le mois et en chiffres.

(5) Le mois de la date limite de conservation, lorsqu’il est abrégé, doit être abrégé de la manière suivante, et une seule abréviation doit être utilisée pour la langue anglaise et la langue française :

JA pour JANVIER JL pour JUILLET FE pour FÉVRIER AU pour AOÛT MR pour MARS SE pour SEPTEMBRE AV pour AVRIL OC pour OCTOBRE MA pour MAI NO pour NOVEMBRE JN pour JUIN DE pour DÉCEMBRE

(6) Sauf indication contraire du présent règlement, nul ne doit utiliser, pour marquer une date limite de conservation sur l’étiquette d’un produit préemballé, une autre méthode que la méthode indiquée dans le présent article.

(7) L’alinéa (1.1)b) ne s’applique pas à la levure fraîche préemballée si

a) la date à laquelle il est prévu que le produit perd son efficacité est indiquée sur l’étiquette de la manière et selon la forme prescrites pour la date limite de conservation en vertu des paragraphes (4) et (5); et

b) les termes « best before » et « meilleur avant » sont remplacés par les termes « use by » et « employez avant ».

DORS/79-23, art. 4; DORS/79-529, art. 2; DORS/88-291, art. 1; DORS/92-626, art. 6.

B.01.008. (1) Les renseignements suivants doivent être groupés ensemble, sur n’importe quelle partie de l’étiquette :

a) les renseignements exigés par le présent règlement, autres que ceux qui doivent figurer sur l’espace principal ou dans le tableau de la valeur nutritive, et ceux exigés par les articles B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 et B.01.601;

b) lorsqu’un produit préemballé se compose de plus d’un ingrédient, une liste de tous les ingrédients, y compris, sous réserve de l’article B.01.009, les constituants, le cas échéant.

(2) L’alinéa (1)b) ne s’applique pas

a) aux produits préemballés, sauf les noix assorties, dont l’emballage se fait sur les lieux de vente au détail à partir du produit en vrac;

b) aux portions individuelles préemballées d’aliment, servies par un restaurant ou une autre entreprise commerciale avec les repas ou casse-croûte;

c) aux portions individuelles préemballées d’aliment, préparées dans un dépôt de vivres et vendues au moyen de distributeurs automatiques ou d’une cantine mobile;

d) aux viandes et sous-produits de la viande préemballés, cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail;

e) aux volailles, viandes de volaille, ou sous-produits de la viande de volaille cuits à la broche, rôtis ou grillés sur les lieux de la vente au détail;

f) au bourbon et aux produits préemballés régis par les normes de composition énoncées au titre 2;

g) aux produits préemballés régis par les normes de composition du titre 19.

(3) Les ingrédients d’un produit préemballé doivent figurer dans l’ordre décroissant de leurs proportions respectives dans le produit ou être indiqués avec mention du pourcentage de chacun par rapport au produit, l’ordre d’importance ou le pourcentage devant être celui des ingrédients avant qu’ils soient combinés pour former le produit préemballé.

(4) Nonobstant le paragraphe (3), les ingrédients ci-après peuvent figurer dans n’importe quel ordre s’ils sont indiqués immédiatement après les autres ingrédients :

a) épices, assaisonnements et fines herbes, sauf le sel;

b) substances aromatisantes et substances aromatisantes artificielles;

c) substances qui rehaussent le goût;

d) additifs alimentaires, sauf les ingrédients de préparation d’additifs alimentaires ou les mélanges de substances devant être utilisés comme additifs alimentaires;

e) vitamines;

f) sels ou dérivés de vitamines;

g) minéraux nutritifs; et

h) sels de minéraux nutritifs.

(5) Les constituants doivent figurer

a) immédiatement après l’ingrédient dont ils sont des constituants de manière à indiquer qu’ils sont des constituants de cet ingrédient; et

b) dans l’ordre décroissant de leurs proportions respectives dans l’ingrédient.

(6) Par dérogation à l’alinéa (1)b) et au paragraphe (5) et sous réserve de l’article B.01.009, dans les cas où le présent règlement exige l’indication d’un ou de plusieurs constituants d’un ingrédient dans la liste des ingrédients figurant sur l’étiquette d’un produit préemballé, le nom de cet ingrédient n’a pas à être inclus dans la liste si tous ses constituants y sont désignés par leur nom usuel avec les autres ingrédients du produit :

a) dans l’ordre décroissant de leur proportion du produit, ou

b) comme un pourcentage du produit,

l’ordre ou le pourcentage, selon le cas, étant basé

c) dans le cas des constituants, sur la quantité totale de chacun des constituants avant qu’ils soient combinés pour former les ingrédients du produit; et

d) dans le cas des ingrédients, sur la quantité de chacun des ingrédients avant qu’ils soient combinés pour former le produit.

(7) Par dérogation à l’alinéa (1)b), les composés d’enduits de cire et leurs constituants n’ont pas à être indiqués comme ingrédients ou constituants sur l’étiquette des fruits ou légumes frais préemballés.

(8) Par dérogation à l’alinéa (1)b), les boyaux de saucisse n’ont pas à être indiqués comme ingrédients ou constituants sur l’étiquette des saucisses préemballées.

(9) Par dérogation à l’alinéa (1)b), l’hydrogène utilisé pour l’hydrogénation n’a pas à être indiqué comme ingrédient ou constituant sur l’étiquette des produits préemballés.

(10) Par dérogation à l’alinéa (1)b), les constituants des ingrédients d’un sandwich fait avec du pain n’ont pas à être indiqués comme ingrédients sur l’étiquette du sandwich.

DORS/79-23, art. 5; DORS/88-559, art. 3; DORS/92-626, art. 7; DORS/93-145, art. 1; DORS/2003-11, art. 5.

B.01.009. (1) Les constituants des ingrédients ou groupes d’ingrédients énumérés dans le tableau du présent paragraphe n’ont pas à être indiqués sur l’étiquette d’un produit.

TABLEAU

Article Ingrédient

Article Ingrédient 1. beurre 2. margarine 3. shortening 4. saindoux 5. saindoux de panne 6. monoglycérides 7. diglycérides 8. riz 9. amidons ou amidons modifiés

pains régis par les normes de composition énoncées aux articles B.13.021 à10. B.13.029 11. farine 12. farine de soya 13. farine Graham 14. farine de blé entier 15. levure artificielle (poudre à pâte)

laits régis par les normes de composition énoncées aux articles B.08.003 à16. B.08.027 17. base de gomme à mâcher

agents édulcorants régis par les normes de composition énoncées aux articles18. B.18.001 à B.18.018 19. cacao, cacao faible en gras 20. sel

vinaigres régis par les normes de composition énoncées aux articles B.19.003 à21. B.19.007 bourbon et boissons alcooliques régies par les normes de composition énoncées22. aux articles B.02.001 à B.02.134 fromage faisant l’objet d’une norme prévue au titre 8 et qui, dans un produit23. préemballé, constitue au total moins de 10 pour cent de celui-ci confitures, marmelades et gelées régies par les normes de composition énoncées

24. aux articles B.11.201 à B.11.241, lorsque la quantité totale de ces ingrédients constitue moins de 5 pour cent du produit préemballé olives, marinades, achards (relish) et raifort, lorsque la quantité totale de ces25. ingrédients constitue moins de 10 pour cent du produit préemballé une ou plusieurs graisses ou huiles végétales ou animales faisant l’objet d’une norme prévue au titre 9 et graisses ou huiles végétales ou animales hydrogénées,26. modifiées ou interestérifiées, qui, dans un produit préemballé, constituent au total moins de 15 pour cent de celui-ci

27. viande, poisson, viande de volaille, sous-produit de viande ou de viande de

Article Ingrédient volaille, préparé ou conservé, lorsque la quantité totale de ces ingrédients constitue moins de 10 pour cent d’un produit préemballé qui est un aliment non normalisé pâte alimentaire qui ne contient aucun oeuf sous quelque forme que ce soit, ni28. aucune farine autre que de la farine de blé

29. culture bactérienne 30. protéine végétale hydrolysée 31. eau gazéifiée

lactosérum (petit-lait), poudre de lactosérum (petit-lait), lactosérum (petit-lait) 32. concentré, beurre de lactosérum (petit-lait) et huile de beurre de lactosérum (petit­

lait) 33. culture de moisissures 34. eau chlorée et eau fluorée 35. gélatine

chapelure de blé grillée utilisée dans ou comme liant, agent de remplissage ou36. d’enrobage dans ou sur un produit alimentaire

(2) Sous réserve du paragraphe (3), lorsqu’une préparation ou un mélange figurant au tableau du présent paragraphe est ajouté à un aliment, les ingrédients et les constituants de la préparation ou du mélange n’ont pas à être indiqués sur l’étiquette de l’aliment.

TABLEAU

Article Préparation ou mélange 1. préparation de colorants alimentaires 2. préparation aromatisante 3. préparation aromatisante artificielle 4. mélange d’épices 5. assaisonnement ou mélange de fines herbes 6. préparation vitaminée 7. préparation minérale 8. préparation d’additif alimentaire 9. préparation de présure 10. préparation de rehausseur de saveur 11. préparation de levure pressée, sèche, active ou instantanée

(3) Les ingrédients ou les constituants suivants d’une préparation ou d’un mélange figurant au tableau du paragraphe (2) qui a été ajouté à un aliment doivent figurer sous leur nom usuel dans la liste des ingrédients de l’aliment, comme s’ils étaient des ingrédients de celui-ci :

a) sel;

b) acide glutamique ou ses sels;

c) protéines végétales hydrolysées;

d) aspartame;

e) chlorure de potassium;

f) les ingrédients ou les constituants qui remplissent une fonction dans l’aliment ou qui ont un effet sur celui-ci.

(4) Malgré les paragraphes (1) et (2), les constituants suivants, lorsqu’ils sont contenus dans un des ingrédients énumérés au tableau de ces paragraphes, doivent figurer dans la liste des ingrédients :

a) l’huile d’arachide;

b) l’huile d’arachide hydrogénée ou partiellement hydrogénée;

c) l’huile d’arachide modifiée.

(5) Par dérogation au paragraphe B.01.008(10) et à l’article 23 du tableau du paragraphe (1), si du lysozyme de blanc d’oeuf est ajouté à un aliment visé aux articles B.08.033 ou B.08.034, la mention « lysozyme de blanc d’oeuf » doit figurer dans la liste des ingrédients de l’étiquette de l’aliment, de la même façon que l’exigent les paragraphes B.01.008(4) et (5), selon le cas.

DORS/78-728, art. 1; DORS/79-23, art. 6; DORS/79-662, art. 1; DORS/88-559, art. 4; DORS/92-626, art. 8; DORS/93-145, art. 2; DORS/93-465, art. 1; DORS/95-548, art. 5(F); DORS/97-263, art. 1; DORS/2000-417, art. 1; DORS/2010-143, art. 39(A). Version précédente B.01.010. (1) Dans le présent article, « nom usuel » comprend un nom indiqué dans la colonne II des tableaux du paragraphe (3).

(2) Un ingrédient ou constituant doit figurer dans la liste des ingrédients sous son nom usuel.

(3) Aux fins du paragraphe (2),

a) l’ingrédient ou constituant indiqué à l’un des articles du tableau ci-après, dans la colonne I, doit figurer dans la liste d’ingrédients sous le nom usuel indiqué à cet article, dans la colonne II :

TABLEAU

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

suif, graisse ou huile mentionnés à l’expression « suif de », « huile de » ou 1. l’article B.09.002 du Titre 9, sauf le « graisse de » suivie du nom de la

saindoux, le saindoux de panne, ou le viande d’où est tiré le corps gras

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

suif de boeuf shortening ou margarine contenant des corps gras, sauf le shortening et la margarine contenant de l’huile de copra,2. de l’huile de palme, de l’huile de palmiste, de l’huile d’arachide ou du beurre de cacao shortening ou margarine contenant de l’huile de copra, de l’huile de palme, de3. l’huile de palmiste, de l’huile d’arachide ou du beurre de cacao

4. viande 5. viande de volaille 6. poisson

7. produit protéique végétal

protéine végétale hydrolysée produite8. par procédé enzymatique

9. tout isolat protéique

tout sous-produit de viande mentionné à 10. l’article B.14.003, à l’exception de la

gélatine

tout sous-produit de viande de volaille11. mentionné à l’article B.22.003

huile ou graisse visée à l’article B.09.002, hydrogéné ou partiellement12. hydrogéné, y compris le suif mais à l’exception du saindoux

huile ou graisse visée à l’article B.09.002 du Titre 9, y compris le suif, qui a été13. modifié par l’extraction complète ou partielle d’un acide gras

l’expression « shortening de » ou « margarine de » suivie de l’expression « huile végétale » ou « huile marine » ou par le nom usuel du corps gras ou de l’huile végétale, animale ou marine utilisée l’expression « shortening de » ou « margarine de » suivie du nom usuel de corps gras ou de l’huile végétale utilisée le nom de la viande le nom de la volaille le nom du poisson l’expression « produit protéique de » suivie du nom de la plante l’expression « protéine hydrolysée de » suivie du nom de la plante l’expression « protéine de » suivie du nom de la source de la protéine ou le nom usuel de l’isolat protéique l’expression « sous-produit de » suivie du nom de la viande, ou le nom du sous-produit de la viande accompagné du nom de la viande l’expression « sous-produit de » suivie du nom de la volaille, ou le nom du sous-produit de viande de volaille accompagné du nom de la volaille « huile de », « graisse de » ou « suif de » suivie du nom de la viande d’où est tirée l’huile, la graisse ou le suif, lui­ même suivi du terme « hydrogéné » l’expression « huile de », « graisse de » ou « suif de » suivie du nom de la viande d’où est tirée l’huile, la graisse ou le suif, lui-même suivi du terme « modifié » ou « modifiée »

une ou plusieurs graisses ou huiles l’expression « huile végétale 14. végétales, sauf l’huile de copra, l’huile hydrogénée », « graisse végétale

de palme, l’huile de palmiste, l’huile hydrogénée » ou le nom spécifique de

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

d’arachide et le beurre de cacao, qui ont l’huile ou de la graisse, lui-même suivi été hydrogénées ou partiellement du terme « hydrogéné » ou hydrogénées « hydrogénée » huile de copra, huile de palme, huile de palmiste, huile d’arachide ou beurre de15. cacao qui ont été hydrogénés ou partiellement hydrogénés

huiles ou graisses d’animaux marins 16. hydrogénées ou partiellement

hydrogénées

une ou plusieurs graisses ou huiles végétales, sauf l’huile de copra, l’huile de palme, l’huile de palmiste, l’huile17. d’arachide et le beurre de cacao, qui ont été modifiées par extraction complète ou partielle d’un acide gras huile de copra, huile de palme, huile de palmiste, huile d’arachide ou beurre de18. cacao qui ont été modifiés par extraction complète ou partielle d’un acide gras huiles ou graisses d’animaux marins

19. modifiées par extraction complète ou partielle d’un acide gras

le nom spécifique de l’huile ou de la graisse suivi du terme « hydrogéné » ou « hydrogénée »

« huile marine hydrogénée » ou « graisse marine hydrogénée » ou le nom spécifique de l’huile ou de la graisse suivi du terme « hydrogéné »

« huile végétale modifiée » ou « graisse végétale modifiée » ou le nom spécifique de l’huile ou de la graisse suivi du terme « modifié »

le nom spécifique de l’huile ou de la graisse suivi du terme « modifié » ou « modifiée »

« huile marine modifiée » ou le nom spécifique de l’huile ou de la graisse, suivi du terme « modifié »

b) les ingrédients ou constituants d’un aliment qui figurent à la colonne I du tableau du présent alinéa peuvent être désignés collectivement, dans la liste des ingrédients, par le nom usuel indiqué à la colonne II, sauf dans les cas où l’un d’eux est désigné séparément dans la liste par son nom usuel :

TABLEAU

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

une ou plusieurs graisses ou huiles végétales, sauf « huile végétale » ou « graisse1. l’huile de copra, l’huile de palme, l’huile de végétale »palmiste, l’huile d’arachide et le beurre de cacao une ou plusieurs graisses ou huiles d’animaux2. « huile marine »marins un ou plusieurs colorants compris dans le tableau III du titre 16, sauf le rocou lorsqu’il est utilisé3. colorantconformément à l’alinéa B.14.031i) ou à la division B.14.032d)(xvi)(A) et sauf le rouge

Colonne I Article Ingrédient ou constituant

allura et le jaune soleil FCF lorsqu’ils sont utilisés conformément aux divisions B.14.032d)(xvi)(B) et (C) respectivement une ou plusieurs substances ayant des propriétés aromatisantes, préparées à partir de matières

4. premières d’origine animale ou végétale ou de constituants alimentaires tirés uniquement de matières premières d’origine animale ou végétale

une ou plusieurs substances ayant des propriétés aromatisantes préparées en tout ou en partie à5. partir de constituants obtenus par synthèse chimique

un ou plusieurs épices, assaisonnements, ou fines6. herbes, sauf le sel

toute forme liquide, concentrée, séchée, congelée ou reconstituée, des produits suivants : beurre, babeurre, huile de beurre, matière grasse de lait, crème, lait, lait partiellement écrémé, lait écrémé7. et tout autre constituant du lait dont la composition chimique n’a pas été modifiée et dont l’état chimique est celui dans lequel il se trouve dans le lait toute forme liquide, concentrée, séchée, congelée ou reconstituée, des produits suivants : lait écrémé à teneur réduite en calcium (obtenu par procédé d’échange d’ions), caséine, caséinates, produits du lait de culture, protéines

7.1 lactosériques, lait ultrafiltré, lactosérum (petit­ lait), beurre de lactosérum (petit-lait), crème de lactosérum (petit-lait) et tout autre constituant du lait dont l’état chimique a été modifié de façon à différer de celui dans lequel il se trouve dans le lait un ou plusieurs ingrédients ou constituants mentionnés à l’article 7 combinés avec un ou7.2 plusieurs ingrédients ou constituants mentionnés à l’article 7.1 toute combinaison de phosphate disodique,8. phosphate monosodique, hexamétaphosphate de

Colonne II Nom usuel

« parfum », « essence » ou « substance aromatisante »

« substance aromatisante artificielle », « essence synthétique », « essence artificielle », « arôme artificiel » ou « parfum artificiel » « épices », « condiments », « assaisonnements » ou « fines herbes »

substances laitières

substances laitières modifiées

substances laitières modifiées

phosphate de sodium ou phosphates de sodium

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

sodium, tripolyphosphate sodique, pyrophosphate tétrasodique et pyrophosphate acide de sodium

9. une ou plusieurs espèces de bactéries « culture bactérienne » 10. une ou plusieurs espèces de moisissures « culture de moisissure » 11. préparation contenant du labferment « présure »

enzymes coagulant le lait qui proviennent de Aspergillus oryzae RET-1 (pBoel777), Endothia

12. parasitica, Rhizomucor miehei (Cooney et Emerson) (précédemment nomméMucor miehei (Cooney et Emerson)) ou Mucor pusillus Lindt une ou plusieurs substances qui ont pour fonction le mot « arôme » suivi du nomde donner un arôme et qui sont tirées uniquement13. de la source végétale oude la source végétale ou animale d’après laquelle animalel’arôme est nommé chapelure de blé grillée, obtenue par cuisson d’une pâte préparée avec de la farine et de l’eau sans levain ou levée à l’aide de produits14. chapelure de blé grilléechimiques ou de levure et qui autrement est conforme à la norme énoncée aux articles B.13.021 ou B.13.022 les éléments de la gomme à mâcher, sauf

15. l’enrobage, qui ne donnent pas de saveur douce, base de gomme à mâcher d’arôme ou de coloration sucre, sucre liquide, sucre inverti ou sucre inverti16. sucreliquide, seul ou combiné sirop de glucose ou sirop de glucose isomérisé

17. contenant au plus 60 pour cent de fructose en glucose-fructose poids sec, seul ou combiné sirop de glucose ou sirop de glucose isomérisé

18. contenant plus de 60 pour cent de fructose en sirop de fructose poids sec, seul ou combiné

19. sucre ou glucose-fructose, seul ou combiné sucre/glucose-fructose eau à laquelle de l’anhydride carbonique a été20. eau gazéifiéeajouté un ou plusieurs des additifs alimentaires suivants : bisulfite de potassium, métabisulfite de

21. potassium, bisulfite de sodium, métabisulfite de agents de sulfitage ou sulfites sodium, sulfite de sodium, dithionite de sodium, acide sulfureux et anhydride sulfureux eau fluorée, eau chlorée ou eau déminéralisée ou22. eauautrement traitée de façon à en éliminer la dureté

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

ou les impuretés vinaigre de vin, vinaigre d’alcool, vinaigre blanc,

23. vinaigre de grain, vinaigre de malt, vinaigre de vinaigre cidre ou vinaigre de pommes, seul ou combiné

(4) Nonobstant le paragraphe (2) et le paragraphe B.01.008(5), lorsqu’un aliment contient des ingrédients de la même catégorie, ceux-ci peuvent être indiqués par un nom de catégorie si

a) ils sont formés de plus d’un constituant et ne sont pas énumérés au tableau du paragraphe B.01.009(1); et

b) leurs constituants sont indiqués

(i) immédiatement après le nom de catégorie des ingrédients dont ils sont des constituants de manière à indiquer qu’ils sont des constituants de ces ingrédients, et

(ii) par ordre décroissant de leur proportion collective de ces ingrédients.

DORS/79-23, art. 7 et 8(F); DORS/79-529, art. 3; DORS/80-632, art. 1; DORS/84-300, art. 4(A) et 5(F); DORS/91-124, art. 2; DORS/92-626, art. 9; DORS/92-725, art. 1; DORS/93-243, art. 2(F); DORS/93-465, art. 2; DORS/95-548, art. 5(F); DORS/97-516, art. 1; DORS/98-458, art. 1 et 7(F) DORS/2005-98, art. 7; DORS/2007-302, art. 4(F). Version précédente B.01.011. (1) Lorsqu’il est reconnu comme une pratique industrielle acceptable pour un fabricant

a) de ne pas inclure dans un produit préemballé un aliment qui est normalement un ingrédient ou constituant de son produit préemballé, ou

b) de remplacer en tout ou en partie un aliment qui est normalement un ingrédient ou constituant de son produit préemballé par un autre aliment,

la liste des ingrédients, pour la période de 12 mois à partir du moment où l’étiquette est apposée sur le produit préemballé, peut indiquer comme ingrédients ou constituants les aliments qui peuvent être omis et les aliments utilisables comme aliments de substitution

c) si tous les aliments utilisables comme ingrédients ou constituants pendant toute la période de 12 mois sont compris dans la liste d’ingrédients;

d) s’il est clairement énoncé dans la liste d’ingrédients que l’aliment indiqué comme ingrédient ou constituant peut être omis du produit préemballé ou qu’un autre aliment peut être substitué à l’aliment figurant comme ingrédient ou constituant; et

e) si les aliments qui peuvent être omis ou remplacés sont groupés avec la même catégorie d’aliments utilisés comme ingrédients ou constituants, et si les aliments compris

dans chacun de ces groupes sont énumérés dans l’ordre décroissant des proportions respectives dans lesquelles ils seront probablement utilisés au cours de ladite période de 12 mois.

(2) Lorsqu’il est reconnu comme une pratique industrielle acceptable pour un fabricant de varier les proportions des ingrédients ou constituants dans un produit préemballé, la liste d’ingrédients, pour la période de 12 mois à compter du moment où l’étiquette est apposée sur le produit préemballé, peut indiquer les ingrédients ou constituants dans les mêmes proportions pendant toute la période de 12 mois

a) s’il est clairement énoncé dans la liste d’ingrédients que les proportions indiquées sont susceptibles de modification; et

b) si les ingrédients ou constituants sont indiqués dans l’ordre décroissant des proportions respectives dans lesquelles ils seront probablement utilisés au cours de ladite période de 12 mois.

B.01.012. (1) Dans le présent article,

« aliment spécial » désigne un aliment qui est

a) un aliment ayant un caractère religieux particulier et utilisé pour les cérémonies religieuses, ou

b) un aliment importé

(i) dont l’usage n’est pas largement répandu chez la population du Canada en général, et

(ii) dont il n’existe aucun succédané facilement accessible, qui soit fabriqué, transformé, produit ou emballé au Canada et qui soit généralement reconnu comme un succédané valable; (specialty food)

« collectivité locale » désigne une cité, un territoire d’un gouvernement métropolitain, une ville, un village, une municipalité ou tout autre territoire d’un gouvernement local mais ne comprend pas une collectivité locale située dans un district bilingue établi sous le régime de la Loi sur les langues officielles; (local government unit)

« langue maternelle » désigne la première langue qu’ont apprise dans leur enfance des personnes vivant dans une région du Canada et qu’elles comprennent encore, tel qu’il a été établi par le dernier recensement décennal qui a précédé la date à laquelle l’aliment visé au paragraphe (3) est vendu au consommateur; (mother tongue)

« langues officielles » désigne la langue française et la langue anglaise; (official languages)

« produit alimentaire d’essai » désigne un aliment qui, avant la date de l’avis d’intention concernant cet aliment et dont il est question au paragraphe (5), n’était pas vendu au Canada et qui diffère considérablement de tout autre aliment vendu au Canada par sa composition, sa fonction, son état ou la forme de son emballage, et comprend un aliment visé à l’article B.01.054; (test market food)

« produit alimentaire local » désigne un aliment qui est fabriqué, transformé, produit ou emballé dans une collectivité locale et vendu seulement

a) dans la collectivité locale où il est fabriqué, transformé, produit ou emballé,

b) dans une ou plusieurs collectivités locales situées dans le voisinage immédiat[ement] de la collectivité où il est fabriqué, transformé, produit ou emballé, ou

c) dans la collectivité locale où il est fabriqué, transformé, produit ou emballé et dans une ou plusieurs collectivités locales situées dans le voisinage immédiat de ladite collectivité. (local food)

(2) Sous réserve des paragraphes (9), (10) et (11), tous les renseignements devant être indiqués sur l’étiquette d’un aliment en vertu du présent règlement doivent l’être dans les deux langues officielles.

(3) Sous réserve des paragraphes (4) à (6), un produit alimentaire local ou un produit alimentaire d’essai est exempté de l’application des dispositions du paragraphe (2)

a) s’il est vendu dans une collectivité locale où l’une des langues officielles est la langue maternelle de moins de 10 pour cent de la population résidente de la collectivité locale; et

b) si les renseignements devant figurer sur l’étiquette d’un aliment aux termes du présent règlement sont indiqués dans la langue officielle qui est la langue maternelle d’au moins 10 pour cent de la population résidente de la collectivité locale.

(4) Lorsqu’une des langues officielles est la langue maternelle de moins de 10 pour cent de la population résidente de la collectivité locale et que l’autre langue officielle est la langue maternelle de moins de 10 pour cent de la population résidente de la même collectivité locale, le paragraphe (3) ne s’applique pas.

(5) Le paragraphe (3) ne s’applique pas à un produit alimentaire d’essai, sauf si la personne qui a l’intention de sonder le marché du produit a déposé, auprès du président de l’Agence canadienne d’inspection des aliments, six semaines avant de sonder le marché, un avis d’intention établi en une forme que celui-ci juge acceptable.

(6) Aux fins de l’application du paragraphe (3), un produit alimentaire d’essai cesse d’en être un à la fin d’une période de 12 mois après la date à laquelle il a été pour la première fois offert en vente à titre de produit d’essai, mais un produit alimentaire d’essai acheté pour la revente par une autre personne que celle qui a déposé l’avis d’intention dont il est question au paragraphe (5), avant la fin de ladite période demeure un produit d’essai aux fins du paragraphe (3) jusqu’à ce qu’il soit vendu à un consommateur.

(7) Un produit alimentaire spécial est exempté de l’application du paragraphe (2) si les renseignements devant figurer sur son étiquette selon ce règlement sont indiqués dans l’une des langues officielles.

(8) Lorsque l’étiquette d’un produit préemballé comporte une ou plusieurs surfaces qui sont de même dimension et de même importance que l’espace principal, les renseignements devant figurer dans l’espace principal, aux termes du présent règlement

peuvent y figurer dans une langue officielle seulement s’ils figurent dans l’autre langue officielle sur l’une des autres surfaces.

(9) Le paragraphe (2) ne s’applique pas au nom et au principal établissement de la personne par ou pour qui l’aliment a été fabriqué, transformé, produit ou emballé pour la revente si ces renseignements sont indiqués dans l’une des langues officielles.

(10) Le paragraphe (2) ne s’applique pas aux noms usuels suivants si un de ceux-ci est indiqué de la manière suivante sur l’espace principal :

Scotch Whisky Akvavit Irish Whisky Aquavit Highland Whisky Armagnac Dry Gin Marc Bourbon Grappa Tennessee Whisky Calvados Tequila Poire William Mezcal Crème de Bleuets Rye Whisky Curaçao Orange Crème de Menthe Liqueur de Fraise Crème de Cacao Mandarinette Crème de Cassis Prunelle de Bourgogne Crème de Banane Chartreuse Triple Sec Pastis Anisette Fior d’Alpe Crème de Noyau Strega Brandy Campari Sake or Saki Americano Advocaat or Advokaat Apricot Brandy Liqueur Kirsch Peach Brandy Liqueur Slivovitz Sloe Gin Ouzo Manhattan Cherry Brandy Liqueur Martini Kummel

(11) Le paragraphe (2) ne s’applique pas à l’étiquette d’un contenant d’expédition destiné à une entreprise ou institution commerciale ou industrielle si

a) le contenant d’expédition et son contenu ne sont pas revendus comme produit préemballé individuel à un consommateur au niveau du commerce de détail; et

b) tous les renseignements devant être indiqués sur l’étiquette d’un aliment en vertu du présent règlement le sont dans l’une des langues officielles.

DORS/79-23, art. 9; DORS/79-529, art. 4; DORS/84-300, art. 6; DORS/93-603, art. 1; DORS/95-548, art. 5; DORS/2000-184, art. 62.

B.01.013. (1) Sauf disposition contraire de la Loi ou du présent règlement, il est interdit de faire mention, directement ou indirectement, de la Loi ou du présent règlement sur l’étiquette ou dans l’annonce d’un aliment.

(2) Par dérogation au paragraphe (1), l’étiquette ou l’annonce d’un aliment peut contenir une mention indiquant que l’aliment est « conforme à la norme établie dans le Règlement sur les aliments et drogues pour (nom usuel de l’aliment visé) », si l’aliment satisfait à la norme applicable établie par le présent règlement et si le fabricant de l’aliment le prouve à l’aide des résultats d’essais effectués avant l’inscription de la mention ou le justifie par toute autre preuve existant avant cette inscription.

DORS/92-626, art. 10; DORS/95-548, art. 5(F).

B.01.014. L’étiquette d’un aliment autre qu’un édulcorant et qui contient de l’aspartame doit porter les renseignements suivants :

a) sous réserve de l’alinéa b), une déclaration sur l’espace principal indiquant que l’aliment contient de l’aspartame ou est édulcoré avec de l’aspartame et ce, en caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans la portion numérique que la déclaration de la quantité nette, comme l’exige l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) dans le cas où d’autres édulcorants sont utilisés avec l’aspartame, une déclaration sur l’espace principal indiquant que l’aliment

(i) contient de l’aspartame et (nom des autres édulcorants), ou

(ii) est édulcoré avec de l’aspartame et (nom des autres édulcorants),

et ce, en caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans la portion numérique de la déclaration de la quantité nette, comme l’exige l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

c) sur la surface de l’étiquette, une déclaration indiquant que l’aspartame contient de la phénylalanine; et

d) une déclaration indiquant la teneur en aspartame, exprimée en milligrammes, par portion déterminée.

DORS/81-617, art. 2; DORS/88-559, art. 5; DORS/2003-11, art. 6.

B.01.015. (1) L’étiquette d’un édulcorant qui contient de l’aspartame doit porter les renseignements suivants :

a) une déclaration sur l’espace principal indiquant que l’aliment contient de l’aspartame ou est édulcoré avec de l’aspartame et ce, en caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans la portion numérique de la déclaration

de la quantité nette, comme l’exige l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) sur la surface de l’étiquette, une déclaration indiquant que l’aspartame contient de la phénylalanine;

c) sur la surface de l’étiquette, une déclaration sur le pouvoir édulcorant d’une portion exprimé en fonction de la quantité de sucre requise pour produire un degré d’édulcoration équivalent; et

d) une déclaration indiquant la teneur en aspartame, exprimée en milligrammes, par portion déterminée.

(2) [Abrogé, DORS/2007-176, art. 1]

DORS/81-617, art. 2; DORS/88-559, art. 6; DORS/2003-11, art. 7; DORS/2007-176, art. 1. Version précédente B.01.016. L’étiquette d’un aliment, autre qu’un édulcorant de table, qui contient du sucralose doit porter les renseignements suivants :

a) sous réserve de l’alinéa b), une mention sur l’espace principal indiquant que l’aliment contient du sucralose ou est édulcoré avec du sucralose, en caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans les données numériques de la déclaration de quantité nette, conformément à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) dans le cas où le sucralose est utilisé en combinaison avec un autre édulcorant ou un agent édulcorant, ou les deux, le nom de ceux-ci figurant dans une mention sur l’espace principal qui indique, en caractères conformes aux exigences de l’alinéa a), que l’aliment contient du sucralose et cet autre édulcorant ou cet agent édulcorant, ou les deux, selon le cas, ou est édulcoré avec ceux-ci;

c) une mention indiquant la teneur en sucralose, exprimée en milligrammes, par portion déterminée.

DORS/91-527, art. 2; DORS/94-625, art. 1; DORS/2003-11, art. 8.

B.01.017. (1) L’étiquette d’un aliment qui est un édulcorant de table contenant du sucralose doit porter les renseignements suivants :

a) une mention sur l’espace principal indiquant que l’aliment contient du sucralose ou est édulcoré avec du sucralose, en caractères de dimensions au moins égales et aussi bien en vue que les caractères utilisés dans les données numériques de la déclaration de quantité nette, conformément à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) sur toute partie de l’étiquette, une mention de la capacité édulcorante d’une portion, exprimée en fonction de la quantité de sucre nécessaire pour produire un degré d’édulcoration équivalent;

c) une mention indiquant la teneur en sucralose, exprimée en milligrammes, par portion déterminée.

(2) [Abrogé, DORS/2007-176, art. 2]

DORS/91-527, art. 2; DORS/94-625, art. 2; DORS/2003-11, art. 9; DORS/2007-176, art. 2. Version précédente B.01.018. L’étiquette d’un aliment qui contient du polydextrose en indique la teneur, exprimée en grammes, par portion déterminée.

DORS/93-276, art. 2; DORS/94-779, art. 1; DORS/97-512, art. 1; DORS/2003-11, art. 10.

B.01.019. L’étiquette d’un aliment, autre qu’un édulcorant de table, qui contient de l’acésulfame-potassium doit porter les renseignements suivants :

a) sous réserve de l’alinéa b), une mention sur l’espace principal indiquant que l’aliment contient de l’acésulfame- potassium ou est édulcoré avec de l’acésulfame-potassium, en caractères dont les dimensions sont au moins égales à celles des caractères utilisés pour les données numériques de la déclaration de quantité nette conformément à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation, et qui sont aussi en évidence que ceux-ci;

b) dans le cas où l’acésulfame-potassium est utilisé en combinaison avec un autre édulcorant ou un agent édulcorant, ou les deux, le nom de ceux-ci figurant dans une mention sur l’espace principal qui indique, en caractères conformes aux exigences de l’alinéa a), que l’aliment contient de l’acésulfame-potassium et cet autre édulcorant ou cet agent édulcorant, ou les deux, selon le cas, ou est édulcoré avec ceux-ci;

c) une mention indiquant la teneur en acésulfame-potassium, exprimée en milligrammes, par portion déterminée.

DORS/94-625, art. 3; DORS/2003-11, art. 11.

B.01.020. (1) L’étiquette d’un aliment qui est un édulcorant de table contenant de l’acésulfame-potassium doit porter les renseignements suivants :

a) une mention sur l’espace principal indiquant que l’aliment contient de l’acésulfame­ potassium ou est édulcoré avec de l’acésulfame-potassium, en caractères dont les dimensions sont au moins égales à celles des caractères utilisés pour les données numériques de la déclaration de quantité nette conformément à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation et qui sont aussi en évidence que ceux-ci;

b) sur toute partie de l’étiquette, une mention de la capacité édulcorante d’une portion, exprimée en fonction de la quantité de sucre nécessaire pour produire un degré d’édulcoration équivalent;

c) une mention indiquant la teneur en acésulfame-potassium, exprimée en milligrammes, par portion déterminée.

(2) [Abrogé, DORS/2007-176, art. 3]

DORS/94-625, art. 3; DORS/2003-11, art. 12; DORS/2007-176, art. 3. Version précédente B.01.021. (1) À moins qu’elle ne porte un tableau de la valeur nutritive, l’étiquette d’un aliment qui contient de l’érythritol doit porter une mention indiquant la teneur en érythritol de l’aliment, exprimée en grammes, par portion déterminée.

(2) La mention indiquant la teneur en érythritol et celle indiquant la teneur en tout autre polyalcool et en polydextrose doivent être regroupées.

DORS/2004-261, art. 1.

B.01.022. L’étiquette d’un aliment, autre qu’un édulcorant de table, qui contient du néotame doit porter les renseignements suivants :

a) sous réserve de l’alinéa b), une mention sur l’espace principal indiquant que l’aliment contient du néotame ou est édulcoré avec du néotame, et ce, en caractères de dimensions au moins égales et aussi bien en vue que les caractères prévus pour les données numériques de la déclaration de la quantité nette à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) dans le cas où d’autres édulcorants ou des agents édulcorants sont utilisés en combinaison avec le néotame, une mention sur l’espace principal indiquant, en caractères de dimensions au moins égales et aussi bien en vue que les caractères prévus pour les données numériques de la déclaration de la quantité nette à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation, que l’aliment, selon le cas :

(i) contient du néotame et (noms des autres édulcorants et des agents édulcorants),

(ii) est édulcoré avec du néotame et (noms des autres édulcorants et des agents édulcorants);

c) si l’étiquette de l’aliment porte un tableau de la valeur nutritive, une mention indiquant la teneur en néotame, exprimée en milligrammes, par portion déterminée;

d) si l’étiquette de l’aliment ne porte pas un tableau de la valeur nutritive, une mention indiquant, sur toute partie de l’étiquette, la valeur énergétique et les teneurs ci-après de l’aliment par portion déterminée, regroupées et en caractères d’égale importance :

(i) la valeur énergétique exprimée en Calories (Calories ou Cal) et en kilojoules (kilojoules ou kJ),

(ii) la teneur en protéines, en matières grasses et en glucides, exprimée en grammes,

(iii) la teneur en néotame exprimée en milligrammes.

DORS/2007-176, art. 4.

B.01.023. L’étiquette d’un aliment qui est un édulcorant de table contenant du néotame doit porter les renseignements suivants :

a) une mention sur l’espace principal indiquant que l’aliment contient du néotame ou est édulcoré avec du néotame, et ce, en caractères de dimensions au moins égales et aussi bien en vue que les caractères prévus pour les données numériques de la déclaration de la quantité nette à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation;

b) sur toute partie de l’étiquette, une mention sur le pouvoir édulcorant d’une portion exprimé en fonction de la quantité de sucre requise pour produire un degré d’édulcoration équivalent;

c) si l’étiquette de l’aliment porte un tableau de la valeur nutritive, une mention indiquant la teneur en néotame, exprimée en milligrammes, par portion déterminée;

d) si l’étiquette de l’aliment ne porte pas un tableau de la valeur nutritive, une mention indiquant, sur toute partie de l’étiquette, la valeur énergétique et les teneurs ci-après de l’aliment par portion déterminée, regroupées et en caractères d’égale importance :

(i) la valeur énergétique exprimée en Calories (Calories ou Cal) et en kilojoules (kilojoules ou kJ),

(ii) la teneur en protéines, en matières grasses et en glucides, exprimée en grammes,

(iii) la teneur en néotame exprimée en milligrammes.

DORS/2007-176, art. 4.

B.01.033. (1) À l’exception des préparations pour nourrisson ou pour régime liquide, il est interdit de vendre un aliment représenté de quelque manière que ce soit comme contenant du collagène, de la gélatine ou de la caséine, totalement ou partiellement hydrolisés, à moins que son étiquette ne porte sur l’espace principal, en caractères de même dimension que le nom usuel, l’expression :

« ATTENTION À NE PAS UTILISER COMME SOURCE UNIQUE D’ALIMENTATION ».

(2) On entend par « préparation pour régime liquide » un aliment visé aux articles B.24.101 à B.24.103.

DORS/78-65, art. 1.

B.01.034. [Abrogé, DORS/88-559, art. 7]

B.01.035. (1) Sous réserve du paragraphe (8), dans le cas d’un aliment irradié visé à la colonne I du tableau du titre 26 qui est un produit préemballé offert en vente, l’espace principal de l’étiquette apposée sur l’emballage doit porter le symbole prévu au paragraphe (5).

(2) Dans le cas d’un aliment irradié visé à la colonne I du tableau du titre 26, autre qu’un produit préemballé, qui est offert pour la vente, un écriteau portant le symbole prévu au paragraphe (5) doit être placé à côté de l’aliment.

(3) Le symbole devant, selon les paragraphes (1) ou (2), figurer sur l’espace principal de l’étiquette ou sur un écriteau doit être accompagné de l’une des mentions suivantes ou d’une mention ayant le même sens :

a) « traité par radiation »;

b) « traité par irradiation »;

c) « irradié ».

(4) Il est interdit de vendre un aliment visé à la colonne I du tableau du titre 26 qui a été irradié de la façon prévue au paragraphe B.26.003(2) à moins que les exigences des paragraphes (1) à (3) ne soient respectées.

(5) Pour l’application des paragraphes (1) à (3), le symbole désignant l’aliment irradié doit :

a) avoir un diamètre extérieur :

(i) dans le cas visé au paragraphe (1), égal ou supérieur à la hauteur des données numériques de la déclaration de quantité nette visée à l’article 14 du Règlement sur l’emballage et l’étiquetage des produits de consommation,

(ii) dans le cas visé au paragraphe (2), d’au moins 5 cm;

b) revêtir la forme suivante :

CE GRAPHIQUE N’EST PAS EXPOSÉ, VOIR DORS/89-172, ART. 1

(6) Nonobstant le paragraphe B.01.009(1), tout aliment visé à la colonne I du tableau du titre 26 qui sert d’ingrédient ou de constituant dans un produit préemballé et qui a été irradié doit, s’il représente 10 pour cent ou plus de ce produit, figurer dans la liste des ingrédients avec la mention « irradié ».

(7) L’étiquette apposée sur le contenant d’expédition de tout aliment visé à la colonne I du tableau du titre 26 et irradié selon la dose absorbée permise maximale indiquée à la colonne IV de ce tableau doit porter la mention exigée par le paragraphe (3) ainsi que la mention « Ne pas irradier de nouveau ».

(8) Dans le cas où le contenant d’expédition constitue l’emballage du produit préemballé, l’étiquette qui y est apposée doit porter les mentions visées au paragraphe (7); le symbole prévu au paragraphe (5) n’est pas obligatoire.

(9) Toute annonce concernant un aliment irradié visé à la colonne I du tableau du titre 26 doit indiquer que cet aliment a été irradié.

(10) Les mentions visées aux paragraphes (3) et (6) à (8) doivent figurer dans les deux langues officielles, conformément au paragraphe B.01.012(2).

DORS/89-172, art. 1.

B.01.037. [Abrogé, DORS/88-559, art. 8]

B.01.040. [Abrogé, DORS/88-559, art. 9]

B.01.042. Lorsque la présente partie prescrit une norme pour un aliment,

a) l’aliment ne doit renfermer que les ingrédients nommés dans la norme pour cet aliment;

b) chacun des ingrédients doit être incorporé dans les limites de quantités, s’il en est, fixées pour tel ingrédient; et

c) l’ingrédient, si la norme comprend un ingrédient qui peut s’utiliser comme additif alimentaire à une fin particulière, doit être un additif alimentaire nommé à l’un des tableaux de l’article B.16.100 comme additif alimentaire utilisable dans cet aliment et à cette fin particulière.

B.01.043. Sous réserve de l’article B.25.062, lorsque la présente partie ne prévoit pas de norme pour un aliment :

a) l’aliment ne doit renfermer aucun additif alimentaire autre que les additifs alimentaires nommés à l’un des tableaux de l’article B.16.100, comme additifs utilisables dans ledit aliment aux fins précisées audit tableau; et

b) chacun desdits additifs alimentaires doit être incorporé dans l’aliment en quantité telle qu’il reste dans les limites, s’il en est, fixées pour cet aliment et pour cet additif alimentaire audit tableau.

DORS/87-640, art. 1.

B.01.044. Lorsque la limite de tolérance d’un additif alimentaire à tout tableau de l’article B.16.100 est fixée par les mots « Bonnes pratiques industrielles », la quantité d’additif alimentaire, ajoutée à l’aliment en cours de fabrication et de conditionnement, ne doit pas dépasser la quantité requise pour arriver aux fins pour lesquelles l’additif est autorisé pour ledit aliment.

B.01.045. Un additif alimentaire doit,

a) lorsque des spécifications sont énoncées pour cet additif dans la présente partie, répondre à ces spécifications;

b) lorsque des spécifications pour cet additif ne sont pas prévues dans la présente partie mais le sont dans la publication de la National Academy of Sciences, Washington, D.C.,

États-Unis, intitulée Food Chemicals Codex, quatrième édition, publiée en 1996, compte tenu de ses modifications successives, satisfaire à ces spécifications;

c) dans le cas du lactitol et du maltitol, satisfaire aux spécifications établies par le Comité mixte FAO/OMS d’experts des additifs alimentaires et énoncées dans la publication de l’Organisation des Nations Unies pour l’alimentation et l’agriculture, Rome, intitulée Specifications for identity and purity of certain food additives—FAO Food and Nutrition Paper 38, publiée en 1988;

d) [Abrogé, DORS/2010-142, art. 1]

e) [Abrogé, DORS/97-512, art. 2]

f) dans le cas de l’isomalt, satisfaire aux spécifications établies par le Comité mixte FAO/OMS d’experts sur les additifs alimentaires et énoncées dans la publication de l’Organisation des Nations Unies pour l’alimentation et l’agriculture, Rome, intitulée Compendium of food additive specifications, Addendum 4 — FAO Food and Nutrition Paper 52, publiée en 1996.

g) [Abrogé, DORS/97-512, art. 2]

DORS/82-383, art. 1; DORS/91-527, art. 3; DORS/92-93, art. 1; DORS/92-551, art. 1; DORS/93-276, art. 3; DORS/94-625, art. 4; DORS/94-779, art. 2; DORS/95-172, art. 2; DORS/97-512, art. 2; DORS/2010-142, art. 1. Version précédente B.01.046. (1) Un aliment est falsifié s’il contient ou si on y a ajouté l’une des substances ou catégories de substances suivantes :

a) de l’huile minérale, de la paraffine, de la vaseline, ou l’une de leurs préparations;

b) de la coumarine, un extrait de fèves tonka, des graines de Dipteryx odorata Willd., ou de Dipteryx oppositifolia Willd.;

c) édulcorants non nutritifs;

d) de la farine de graine de cotonnier qui renferme plus de 450 parties par million de gossypol libre;

e) des acides gras et leurs sels qui renferment le facteur de l’oedème du poussin ou un autre facteur toxique;

f) du dihydrosafrole;

g) de l’isosafrole;

h) de l’essence de sassafras américaine obtenue du Sassafras albidum (Nutt). Nees;

i) de l’essence de sassafras brésilienne obtenue de l’Ocotea cymbarum H.B.K.;

j) de l’essence camphrée de sassafras obtenue du Cinnamomum camphorum Sieb.;

k) de l’essence de micranthum obtenue du Cinnamomum micranthum Hayata;

l) du safrole;

m) de l’essence de l’extrait ou de la racine de calamus obtenue de l’Acorus calamus L.;

n) des noix et des produits de noix qui contiennent plus de 15 parties par milliard d’aflatoxine;

o) de l’éthylène-thiourée;

p) dibenzo-p-dioxines chlorées, ou

q) anthranilate de cinnamyle.

(2) Aux fins de l’alinéa (1)n), le contenu d’aflatoxine d’une noix ou d’un produit de noix doit être calculé en fonction de la graine comestible.

DORS/79-358, art. 1; DORS/80-501, art. 1; DORS/82-1071, art. 1; DORS/83-857, art. 1; DORS/84-300, art. 7; DORS/88-534, art. 1.

B.01.047. Nonobstant l’article B.01.046,

a) la présence, dans tout aliment sauf le boyau de saucisse, d’huile minérale en quantité ne dépassant pas 0,3 pour cent, si conforme aux bonnes pratiques industrielles, ne constitue pas en soi une falsification;

b) la seule présence de la paraffine dans la gomme à mâcher ne constitue pas, en soi, une falsification;

c) la présence sur les fruits et légumes frais, les navets exceptés, d’une couche de paraffine ou de vaseline ne dépassant pas 0,3 pour cent, si l’emploi d’un tel enrobage est requis par une bonne pratique industrielle, ne constitue pas en soi une falsification;

d) la présence, sur le fromage ou les navets, d’une couche de paraffine conforme aux bonnes pratiques industrielles, ne constitue pas en soi une falsification;

e) la présence, dans un boyau de saucisse, d’huile minérale en quantité ne dépassant pas cinq pour cent en poids, si conforme aux bonnes pratiques industrielles, ne constitue pas en soi une falsification;

f) la seule présence de 20 parties par billion (1012) ou moins de 2,3,7,8­ tétrachlorodibenzoparadioxin dans le poisson ne constitue pas, en soi, une falsification;

g) la présence, dans les produits de boulangerie et les confiseries, de vaseline en quantité ne dépassant pas 0,15 pour cent, si conforme aux bonnes pratiques industrielles, ne constitue pas en soi une falsification;

h) la présence, dans un succédané de sel, d’huile minérale en quantité ne dépassant pas 0,6 pour cent, si conforme aux bonnes pratiques industrielles, ne constitue pas en soi une falsification;

i) la présence, dans les fruits, les légumes et les céréales, d’éthylènethio-urée en quantité ne dépassant pas 0,05 partie par million ne constitue pas en soi une falsification.

DORS/81-934, art. 1; DORS/82-122, art. 1; DORS/82-1071, art. 2; DORS/83-932, art. 1; DORS/84-17, art. 1; DORS/92-76, art. 1.

B.01.047.1 (1) Les définitions qui suivent s’appliquent au présent article.

« ESB » Encéphalopathie spongiforme bovine. (BSE)

« matériel à risque spécifié » S’entend de ce qui suit :

a) le crâne, la cervelle, les ganglions trigéminés, les yeux, les amygdales, la moelle épinière et les ganglions de la racine dorsale des boeufs âgés de 30 mois ou plus;

b) l’iléon distal des boeufs de tous âges. (specified risk material)

(2) Il est interdit de vendre ou d’importer pour la vente tout aliment qui contient du matériel à risque spécifié.

(3) Le paragraphe (2) ne s’applique pas à l’égard de l’aliment qui provient d’un pays désigné comme exempt d’ESB en conformité avec l’article 7 du Règlement sur la santé des animaux.

(4) Le paragraphe (2) ne s’applique pas à l’égard de l’aliment emballé pour la vente ou importé pour la vente avant l’entrée en vigueur du présent paragraphe.

DORS/2003-265, art. 1.

B.01.048. (1) Il est interdit de vendre :

a) des animaux qui sont destinés à être consommés comme aliments et auxquels a été administré un produit contenant une drogue mentionnée au paragraphe (2);

b) de la viande, des sous-produits de viande, des oeufs ou du lait qui sont destinés à être consommés comme aliments et qui proviennent d’un animal auquel a été administré un produit contenant une drogue mentionnée au paragraphe (2);

c) de la viande, des sous-produits de viande, des oeufs ou du lait contenant des résidus d’une drogue mentionnée au paragraphe (2).

(2) Les drogues visées au paragraphe (1) sont :

a) le chloramphénicol, ses sels et ses dérivés;

b) un composé de 5-nitrofurane;

c) le clenbutérol, ses sels et ses dérivés;

d) un composé de 5-nitro-imidazole;

e) le diéthylstilbestrol et d’autres composés de stilbène.

DORS/85-685, art. 1; DORS/87-626, art. 1; DORS/94-568, art. 1; DORS/97-510, art. 1; DORS/2003-292, art. 1.

B.01.049. Il est interdit d’employer sur l’étiquette ou l’emballage, dans la réclame ou pour la vente d’un produit alimentaire qui ne répond pas aux prescriptions du « kashruth » qui s’y applique, le mot « kascher » une lettre de l’alphabet hébreu ou tout autre mot, expression, illustration, signe, symbole, marque, véhicule ou autre représentation indiquant ou risquant de donner l’impression que ce produit est « kascher ».

DORS/84-300, art. 8.

B.01.053. Il est interdit de vendre un produit présenté comme déjeuner prêt à manger ou déjeuner instantané, ou sous toute autre appellation semblable, à moins qu’il n’y ait dans chaque portion déterminée :

a) au moins 4,0 mg de fer;

b) de la vitamine A, de la thiamine, de la riboflavine, de la niacine ou de la niacinamide et de la vitamine C;

c) une bonne source alimentaire de protéines; et

d) si le produit est consommé de la façon indiquée, au moins 300 calories.

DORS/2003-11, art. 13.

B.01.054. (1) Afin de recueillir des renseignements à l’appui d’une modification au présent règlement, le Directeur peut délivrer au fabricant ou au distributeur d’un aliment, lorsque l’aliment ou l’emballage, l’étiquetage ou l’annonce de celui-ci ne sont pas conformes aux exigences du présent règlement, une lettre d’autorisation de mise en marché temporaire permettant la vente, l’emballage, l’étiquetage ou l’annonce de l’aliment décrit dans la lettre pour une période déterminée, dans une région désignée, en quantité définie et de la manière précisée dans la lettre si

a) le fabricant ou le distributeur lui a fourni les renseignements suivants :

(i) la raison pour laquelle une autorisation de mise en marché temporaire de l’aliment est requise,

(ii) une description de l’aliment, y compris un échantillon et un projet d’étiquette,

(iii) une description de toute modification proposée aux exigences du présent règlement,

(iv) des données suffisantes à prouver que la consommation de l’aliment ne sera pas nuisible à la santé de l’acheteur ni à celle du consommateur,

(v) la quantité proposée d’aliment à vendre,

(vi) la période projetée qui est requise pour une telle vente,

(vii) la région proposée qui est désignée pour une telle vente, et

(viii) toutes les autres données que le Directeur pourrait lui demander; et

b) le fabricant ou le distributeur de l’aliment a consenti

(i) à décrire l’aliment sur une étiquette ou dans une réclame d’une manière qui ne soit ni fausse, ni trompeuse, ni mensongère,

(ii) à se servir sur l’étiquette ou dans toute annonce des marques ou déclarations que le Directeur pourrait exiger,

(iii) à faire part au Directeur, sur demande, des résultats de la mise en marché temporaire, et

(iv) à retirer le produit du marché, sur demande, si de l’avis du Directeur, il est de l’intérêt public de le faire.

(2) Le Directeur doit, dans toute lettre d’autorisation de mise en marché temporaire délivrée conformément au paragraphe (1), préciser

a) le nom usuel et une description de l’aliment qui doit être vendu;

b) le nom et l’adresse du fabricant ou du distributeur de l’aliment;

c) la raison pour laquelle la mise en marché temporaire de l’aliment est autorisée;

d) la quantité de l’aliment dont la vente est autorisée;

d.1) le genre d’emballage, d’étiquetage ou d’annonce autorisé à l’égard de l’aliment lorsque la lettre a pour objet d’autoriser une modification aux exigences du règlement traitant de l’emballage, de l’étiquetage ou de l’annonce;

e) la période où l’aliment peut être vendu; et

f) la région désignée dans laquelle l’aliment peut être vendu.

DORS/81-566, art. 1; DORS/85-275, art. 1.

B.01.055. (1) Le fabricant ou le distributeur mentionné dans une lettre d’autorisation de mise en marché temporaire délivrée conformément au paragraphe B.01.054(1) peut, aux fins visées dans la lettre, vendre, emballer, étiqueter ou annoncer l’aliment pour la période déterminée, dans la région désignée, en quantité définie et de la manière autorisée dans la lettre.

(2) L’aliment ou l’emballage, l’étiquetage ou l’annonce d’un aliment à l’égard desquels une lettre d’autorisation de mise en marché temporaire a été délivrée en application du paragraphe B.01.054(1) sont soustraits à l’application des dispositions du présent règlement prises en vertu de l’alinéa 30(1)b) de la Loi auxquelles ils ne sont pas conformes, s’ils respectent les modalités de la lettre d’autorisation.

DORS/81-566, art. 1; DORS/85-275, art. 2; DORS/90-814, art. 4.

B.01.056. (1) Le présent article s’applique aux autorisations de mise en marché provisoire que le ministre peut accorder en vertu du paragraphe 30.2(1) de la Loi.

(2) Au présent article, « aliment à usage diététique spécial » s’entend au sens de l’article B.24.001.

(3) Le fabricant d’un aliment ou de produits chimiques agricoles, de drogues pour usage vétérinaire, d’additifs alimentaires, de vitamines, de minéraux nutritifs ou d’acides aminés présents dans un aliment ou sur sa surface peut présenter par écrit au ministre une demande d’autorisation de mise en marché provisoire pour l’aliment, à l’égard de l’un des sujets mentionnés au paragraphe 30.2(2) de la Loi.

(4) La demande est accompagnée des renseignements suivants :

a) le nom usuel et une description de l’aliment;

b) les motifs à l’appui de la demande;

c) le détail de toute demande, à l’égard de l’aliment, d’exemption de l’application de tout ou partie des articles 5 à 6.1 de la Loi et des dispositions réglementaires applicables;

d) des données suffisantes, y compris les résultats de tests et d’analyses scientifiques, démontrant que l’aliment ne serait pas nuisible à la santé de l’acheteur ou du consommateur;

e) dans le cas d’une demande qui porte sur l’ajout de vitamines, de minéraux nutritifs ou d’acides aminés à l’aliment, une mention, avec documents à l’appui, indiquant que l’ajout proposé vise un ou plusieurs des objectifs suivants :

(i) ramener la quantité de vitamines ou de minéraux nutritifs à celle présente dans l’aliment avant son traitement ou, dans le cas d’acides aminés, fournir des protéines d’une qualité nutritionnelle équivalente à celle de l’aliment avant son traitement,

(ii) rendre l’aliment destiné à être vendu comme substitut d’un autre aliment nutritionnellement équivalent à l’aliment qu’il est destiné à remplacer dans l’alimentation, au regard des éléments suivants :

(A) la quantité de vitamines et minéraux nutritifs ajoutés,

(B) la qualité des protéines fournies par l’ajout d’acides aminés,

(iii) prévenir ou corriger une carence en vitamines ou en minéraux nutritifs dans la population ou dans des groupes particuliers de celle-ci,

(iv) modifier la quantité de vitamines, de minéraux nutritifs ou d’acides aminés dans l’aliment à usage diététique spécial;

f) dans le cas d’une demande qui porte sur l’utilisation d’un additif alimentaire dans l’aliment ou sur sa surface, les renseignements visés à l’article B.16.002.

(5) Outre les éléments pouvant être prévus aux termes des paragraphes 30.2(2) et (4) de la Loi, l’autorisation de mise en marché provisoire indique :

a) le nom usuel et une description de l’aliment en cause;

b) les motifs pour lesquels elle est accordée;

c) les dispositions de la Loi et du présent règlement desquelles l’aliment est exempté.

(6) Toute autorisation de mise en marché provisoire peut être abrogée par le ministre s’il conclut, après examen des renseignements additionnels portés à sa connaissance, que l’aliment faisant l’objet de l’autorisation est ou peut être nuisible à la santé de l’acheteur ou du consommateur.

DORS/97-313, art. 1; DORS/2008-181, art. 2. Version précédente B.01.060. à B.01.066. [Abrogés, DORS/88-559, art. 10]

B.01.070. [N]. Des noix mélangées ou un mélange de noix doivent être un mélange de noix qui comporte un pourcentage, en poids, d’au moins cinq pour cent de chaque type de noix.

B.01.071. Pour tout produit préemballé qui est un mélange de noix, le pourcentage et le nom usuel du type de noix prédominant en poids doivent figurer sur l’espace principal de l’emballage, à proximité du nom usuel du produit.

DORS/88-336, art. 3; DORS/92-626, art. 11.

B.01.072. Par dérogation à toute autre disposition de la partie B, peut être qualifié de « fumé » tout produit alimentaire qui a été exposé à la chaleur en présence d’une solution de fumée liquide vaporisée et tirée du bois dur, de la sciure de bois dur ou des épis de maïs.

DORS/92-626, art. 11.

B.01.080. (1) Dans le présent article, « congelés » s’entend d’un produit conservé à la température de congélation et n’inclut pas une congélation de surface qui aurait pu se produire durant la manutention et le transport.

(2) Lorsque de la viande ou un de ses sous-produits, de la volaille ou un de ses sous­ produits, du poisson ou de la chair de tout autre animal marin ou d’eau douce qui a été congelé est décongelé avant la vente, la mention « produit décongelé » doit figurer

a) sur l’espace principal de l’étiquette, à proximité du nom usuel du produit, et en lettres au moins aussi lisibles et en évidence que celles du nom usuel;

b) n’importe où sur l’espace principal de l’étiquette en lettres d’au moins 1/4 de pouce (6,4 millimètres) de hauteur; ou

c) sur un écriteau placé tout près du produit alimentaire, en lettres que tout acheteur éventuel peut voir et lire facilement.

(3) Lorsqu’une partie d’un produit alimentaire mentionné au paragraphe (2) a été congelée et décongelée avant la vente, la mention « Provenance : parties fraîches et congelées » ou « Provenance : parties de (d’) (nom du produit) fraîches et congelées » doit figurer à l’endroit précisé et comme il est indiqué à l’alinéa (2)a), b) ou c).

DORS/88-336, art. 3.

B.01.090. (1) Est interdite la mise en vente au détail de toute viande coupée solide ou de toute viande de volaille coupée solide à laquelle ont été ajoutés des sels de phosphate ou de l’eau, à moins que la viande ne soit contenue dans un emballage et ne porte une étiquette.

(2) L’étiquette visée au paragraphe (1) doit inclure une mention de la teneur minimale en protéines de la viande, incorporée au nom usuel du produit sur l’espace principal de l’emballage, en caractères aussi lisibles et visibles que tous les autres caractères figurant dans le même espace et de dimension au moins égale à la moitié de la taille des lettres utilisées pour le nom usuel du produit, sans être d’une hauteur inférieure à 1,6 mm.

DORS/94-262, art. 1.

B.01.091. L’étiquette de toute pièce de viande ou de toute pièce de viande de volaille à laquelle ont été ajoutés des sels de phosphate ou de l’eau, qui est non traitée par salaison et qui est préemballée chez le détaillant, indique les ingrédients de cet aliment conformément aux paragraphes B.01.008(3) à (5).

DORS/94-262, art. 1; DORS/2003-11, art. 14.

B.01.092. Les articles B.01.090 et B.01.091 ne s’appliquent pas au bacon de flanc, au bacon Wiltshire, aux bajoues de porc, ni au porc et au boeuf salés.

DORS/94-262, art. 1.

B.01.100. (1) Le nom usuel d’un simili-produit de viande ou d’un simili-produit de volaille est formé du nom usuel du produit de viande ou de volaille dont l’apparence est imitée, auquel s’ajoute le préfixe « simili ».

(2) Le préfixe « simili » mentionné au paragraphe (1) doit figurer en caractères au moins aussi gros et aussi en évidence que ceux du reste du nom usuel du simili-produit.

(3) Lorsqu’un simili-produit de viande ou un simili-produit de volaille n’est pas un produit préemballé, doivent être indiqués, en caractères lisibles, sur une inscription placée bien en évidence sur le produit ou à proximité, le nom usuel du produit et les autres renseignements qui, aux termes du présent article, doivent figurer sur l’étiquette d’un simili-produit de viande ou d’un simili-produit de volaille.

(4) La mention

a) « sans teneur en viande », dans le cas d’un simili-produit de viande, et

b) « sans teneur en volaille », dans le cas d’un simili-produit de volaille,

doit figurer sur l’espace principal de l’étiquette d’un simili-produit de viande ou d’un simili-produit de volaille à proximité du nom usuel et en caractères au moins aussi gros et aussi visibles que ceux du reste du nom usuel.

(5) à (7) [Abrogés, DORS/88-559, art. 11]

DORS/88-336, art. 3; DORS/88-559, art. 11.

B.01.101. (1) Aux fins du présent article et de l’article B.01.102, « source de protéines » s’entend de tout aliment à teneur en protéines, à l’exclusion des produits suivants : épices, assaisonnements, parfums ou arômes, parfums ou arômes artificiels, exhausteurs de goût (substances qui rehaussent le goût), additifs alimentaires et produits analogues qui ne contiennent que de petites quantités de protéines.

(2) Le nom usuel d’un allongeur de produit de viande est formé du mot « allongeur » suivi de « au », « à la » ou « aux », selon le cas, du nom usuel de l’aliment qui est contenu dans l’allongeur de produit de viande et qui est source de protéines et

a) de l’expression « pour viande »; ou

b) du nom usuel du produit de viande dont le volume est augmenté.

(3) Le nom usuel d’un allongeur de produit de volaille est formé du mot « allongeur » suivi de « au », « à la » ou « aux », selon le cas, du nom usuel de l’aliment qui est contenu dans l’allongeur de produit de volaille et qui est source de protéines et

a) de l’expression « pour volaille »; ou

b) du nom usuel du produit de volaille dont le volume est augmenté.

(4) Les aliments qui sont sources de protéines dans l’allongeur de produits de viande ou dans l’allongeur de produits de volaille doivent figurer dans le nom usuel de cet allongeur, où ils sont désignés par leur nom usuel,

a) dans l’ordre décroissant de la proportion de l’allongeur qu’ils représentent; et

b) en caractères au moins aussi gros et aussi en évidence que ceux du reste du nom usuel de l’allongeur de produits de viande ou de volaille.

(5) et (6) [Abrogés, DORS/88-559, art. 12]

DORS/88-559, art. 12.

B.01.102. (1) Le nom usuel d’un produit de viande avec allongeur ou d’un produit de volaille avec allongeur est formé du nom usuel du produit de viande ou de volaille dont le volume est augmenté, auquel s’ajoute le nom usuel de chacun des aliments qui sont

sources de protéines dans le produit de viande avec allongeur ou dans le produit de volaille avec allongeur.

(2) Par dérogation au paragraphe (1),

a) les mots « viande », « produit de viande », « volaille », « viande de volaille » ou « sous-produit de viande de volaille », selon le cas, peuvent être employés dans le nom usuel d’un produit de viande avec allongeur ou d’un produit de volaille avec allongeur comme étant le nom usuel de l’aliment incorporé qui est une source de protéines dérivée d’un produit de viande ou d’un produit de volaille; et

b) lorsque, suivant une pratique industrielle reconnue, le fabricant n’inclut pas dans l’allongeur de produit de viande ou dans l’allongeur de produit de volaille une source quelconque de protéines qui est dérivée d’une plante et qui est généralement un ingrédient de cet allongeur de produit de viande ou de cet allongeur de produit de volaille, ou qu’il remplace en tout ou en partie, dans l’allongeur de produit de viande ou dans l’allongeur de produit de volaille, une source de protéines qui est généralement un ingrédient de ce produit par une source quelconque de protéines dérivée d’une plante, le terme « plante » peut être employé dans le nom usuel d’un produit de viande avec allongeur ou d’un produit de volaille avec allongeur comme étant le nom usuel de l’aliment incorporé qui est une source de protéines dérivée d’une plante.

(3) Les aliments qui sont sources de protéines dans un produit de viande avec allongeur ou dans un produit de volaille avec allongeur doivent figurer dans le nom usuel de ce produit, où ils sont désignés par leur nom usuel,

a) dans l’ordre décroissant de la proportion du produit de viande ou de volaille avec allongeur qu’ils représentent; et

b) en caractères au moins aussi gros et aussi en évidence que ceux du reste du nom usuel de ce produit.

(4) Lorsqu’un produit de viande avec allongeur ou un produit de volaille avec allongeur n’est pas un produit préemballé, doivent être indiqués, en caractères lisibles, sur une inscription placée bien en évidence sur le produit ou à proximité, le nom usuel du produit et les autres renseignements qui, aux termes du présent article, doivent figurer sur l’étiquette d’un produit de viande avec allongeur ou d’un produit de volaille avec allongeur.

(5) à (7) [Abrogés, DORS/88-559, art. 13]

DORS/84-300, art. 9; DORS/88-559, art. 13.

B.01.103. (1) Le nom usuel d’un oeuf à jaune substitué est « oeuf à jaune substitué ».

(2) à (4) [Abrogés, DORS/88-559, art. 14]

DORS/88-559, art. 14.

B.01.300. [Abrogé, DORS/2003-11, art. 15]

B.01.301. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, ailleurs que dans le tableau de la valeur nutritive, le cas échéant, toute indication de la valeur énergétique de l’aliment ou de sa teneur en un élément nutritif, à moins qu’elle soit exprimée de la façon ci-après, par portion déterminée :

a) dans le cas de la valeur énergétique, en Calories;

b) dans le cas d’une vitamine figurant à la colonne I du tableau I du titre 1 de la partie D ou d’un minéral nutritif figurant à la colonne I du tableau I du titre 2 de cette partie, selon l’unité indiquée dans cette colonne;

c) dans le cas du sodium, du potassium et du cholestérol, en milligrammes;

d) dans le cas de la teneur en ions minéraux de l’eau ou de la glace préemballées, en parties par million;

e) dans les autres cas, en grammes.

(2) Malgré le paragraphe (1), est permise, sur l’étiquette ou dans l’annonce d’un aliment, ailleurs que dans le tableau de la valeur nutritive, le cas échéant, toute indication du pourcentage de la valeur quotidienne d’un élément nutritif contenu dans l’aliment, si les conditions suivantes sont réunies :

a) l’élément nutritif figure à la colonne 1 du tableau de l’article B.01.401 ou du tableau de l’article B.01.402;

b) le pourcentage de la valeur quotidienne de l’élément nutritif doit ou peut être déclaré dans le tableau de la valeur nutritive;

c) le pourcentage de la valeur quotidienne de l’élément nutritif est déclaré par portion déterminée.

(3) Toute indication visée aux paragraphes (1) ou (2) paraissant sur l’étiquette d’un aliment figure :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

DORS/88-559, art. 15; DORS/2003-11, art. 16.

B.01.302. à B.01.304 [Abrogés, DORS/2003-11, art. 17]

B.01.305. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, relativement aux protéines, à moins que l’aliment réponde aux critères mentionnés à la colonne 2 de l’article 8 du tableau suivant l’article B.01.513 en regard du sujet « source de protéines » visé à la colonne 1.

(2) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, relativement aux acides aminés, à moins que :

a) l’aliment réponde aux critères mentionnés à la colonne 2 de l’article 8 du tableau suivant l’article B.01.513 en regard du sujet « source de protéines » visé à la colonne 1;

b) sa teneur en histidine, en isoleucine, en leucine, en lysine, en méthionine, en phénylalanine, en thréonine, en tryptophane et en valine soit exprimée en grammes par portion déterminée sur l’étiquette ou dans l’annonce.

(3) Les paragraphes (1) et (2) ne s’appliquent pas :

a) à une préparation pour régime liquide, à un succédané de lait humain ou à un aliment présenté comme contenant un succédané de lait humain;

b) à un aliment présenté comme étant destiné à un régime sans gluten, à teneur réduite en protéines, à faible teneur en (nom de l’acide aminé) ou sans (nom de l’acide aminé);

c) au mot « protéines » utilisé dans le nom usuel d’un ingrédient dans la liste d’ingrédients;

d) à la déclaration des acides aminés dans la liste d’ingrédients;

e) aux noms usuels visés à la colonne II des articles 7 à 9 du tableau de l’alinéa B.01.010(3)a), lorsqu’ils figurent dans la liste des ingrédients conformément à cet alinéa;

f) au nom usuel d’une préparation contenant un seul acide aminé qui peut être vendue comme aliment;

g) aux déclarations exigées aux alinéas B.01.014c) et B.01.015(1)b);

h) à toute mention ou allégation figurant à la colonne 4 de l’article 7 du tableau suivant l’article B.01.513 en regard du sujet « faible teneur en protéines » visé à la colonne 1;

i) à la déclaration de la teneur en protéines dans le tableau de la valeur nutritive;

j) à une mention de la teneur en protéines d’un aliment tel que l’exigent l’alinéa B.24.103c), le sous-alinéa B.24.202a)(ii), les alinéas B.24.304b) ou B.25.057(1)a) ou les sous-alinéas B.25.057(2)c)(i) ou d)(i);

k) à la déclaration selon laquelle un aliment n’est pas une source de protéines.

(4) Toute déclaration visée aux paragraphes (1) ou (2) paraissant sur l’étiquette d’un aliment figure :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

DORS/88-559, art. 15; DORS/90-830, art. 3(F); DORS/2003-11, art. 18.

B.01.306. à B.01.310 [Abrogés, DORS/2003-11, art. 19]

B.01.311. (1) Sous réserve des paragraphes (2) et (3), est interdite, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, concernant l’action ou les effets de la valeur énergétique de l’aliment ou de tout élément nutritif contenu dans l’aliment.

(2) Toute mention ou allégation figurant à la colonne 1 du tableau suivant l’article B.01.603 est permise sur l’étiquette ou dans l’annonce d’un aliment.

(3) Sous réserve de l’article B.01.312, est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute mention ou allégation indiquant que la valeur énergétique de l’aliment ou un de ses éléments nutritifs est généralement reconnu comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé et à la croissance et au développement normaux.

(4) Si une mention ou allégation visée au paragraphe (3) porte sur un élément nutritif qui ne figure pas à la colonne 1 des tableaux des articles B.01.401 et B.01.402, la teneur de l’aliment en cet élément est indiquée sur l’étiquette, exprimée en grammes par portion déterminée.

(5) Toute mention ou allégation visée aux paragraphes (2) ou (3) paraissant sur l’étiquette d’un aliment figure :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

DORS/88-559, art. 15; DORS/2003-11, art. 20.

B.01.312. (1) Si une mention ou une allégation visée au paragraphe B.01.311(3) est faite sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique les renseignements ci-après qui font l’objet de la mention ou de l’allégation, par portion déterminée :

a) la valeur énergétique;

b) la teneur en l’élément nutritif.

(2) Si une mention ou une allégation est faite dans l’annonce d’un aliment, autre qu’une annonce radiophonique ou télévisée, les renseignements visés au paragraphe (1), à la fois :

a) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

b) figurent en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

(3) Si une mention ou une allégation est faite dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée, les renseignements visés au paragraphe (1) précèdent ou suivent immédiatement la mention ou l’allégation.

(4) Si une mention ou une allégation est faite dans une annonce télévisée, les renseignements visés au paragraphe (1) sont communiqués, selon le cas :

a) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou, à la fois des composantes audio et visuelle de celle-ci;

b) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(5) Les renseignements visés au paragraphe (1) qui sont communiqués en mode visuel dans une annonce télévisée, à la fois :

a) paraissent en même temps et pendant au moins la même durée que la mention ou l’allégation;

b) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

c) figurent en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

DORS/2003-11, art. 20.

Interprétation

B.01.400. Les définitions qui suivent s’appliquent aux articles B.01.401 à B.01.603.

« lipides » Tous les acides gras exprimés sous forme de triglycérides. (fat)

« point » Unité de mesure de la force du corps des caractères connu comme point anglo­ américain et qui équivaut à 0,3514598 mm. (point)

DORS/2003-11, art. 20.

Étiquetage nutritionnel

Renseignements principaux

B.01.401. (1) Sauf disposition contraire du présent article et des articles B.01.402 à B.01.406 et B.01.467, l’étiquette de tout produit préemballé porte un tableau de la valeur nutritive indiquant exclusivement les renseignements visés à la colonne 1 du tableau du présent article, exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4.

(2) Le paragraphe (1) ne s’applique pas à un produit préemballé dans les cas suivants :

a) tous les renseignements visés à la colonne 1 du tableau du présent article, autres que l’article 1 (« portion déterminée »), peuvent être exprimés par « 0 » au tableau de la valeur nutritive conformément au présent article;

b) le produit est, selon le cas :

(i) une boisson dont la teneur en alcool est de plus de 0,5 %,

(ii) un légume frais, un fruit frais ou un mélange quelconque de légumes frais ou de fruits frais sans ingrédient ajouté ainsi qu’une orange à laquelle un colorant a été ajouté et un légume frais ou un fruit frais enrobé de paraffine ou de vaseline,

(iii) de la viande, un sous-produit de viande, de la viande de volaille ou un sous-produit de viande de volaille, cru et composé d’un seul ingrédient,

(iv) un produit d’animaux marins ou d’animaux d’eau douce cru et composé d’un seul ingrédient,

(v) un produit vendu uniquement dans l’établissement de détail où il est préparé et transformé à partir de ses ingrédients, y compris un pré-mélange si un ingrédient autre que de l’eau est ajouté au pré-mélange lors de la préparation et de la transformation du produit,

(vi) un produit vendu uniquement dans un éventaire routier, une exposition d’artisanat, un marché aux puces, une foire, un marché d’agriculteurs ou une érablière par l’individu qui l’a transformé et préparé,

(vii) une portion individuelle qui est vendue pour consommation immédiate et qui n’a fait l’objet d’aucun procédé pour en prolonger la durée de conservation, notamment l’utilisation d’un emballage spécial,

(viii) un produit vendu uniquement dans l’établissement de détail où il est emballé, si l’étiquette du produit est un autocollant et que la surface exposée disponible du produit est de moins de 200 cm2;

c) le produit est, selon le cas :

(i) une confiserie préemballée, appelée couramment bonbon d’une bouchée, qui est vendue individuellement,

(ii) une portion individuelle préemballée d’un aliment, destinée uniquement à être servie par un restaurant ou une autre entreprise commerciale avec les repas ou casse-croûte,

(iii) du lait, du lait partiellement écrémé, du lait écrémé, du lait de chèvre, du lait de chèvre partiellement écrémé, du lait de chèvre écrémé, du lait (indication de l’arôme), du lait partiellement écrémé (indication de l’arôme), du lait écrémé (indication de l’arôme) ou de la crème, vendu dans un contenant réutilisable en verre.

(3) Malgré les alinéas (2)a) et b), le paragraphe (1) s’applique dans les cas suivants :

a) le produit contient une vitamine ou un minéral nutritif ajoutés;

b) une vitamine ou un minéral nutritif est déclaré comme constituant d’un ingrédient du produit, sauf si l’ingrédient est de la farine;

c) le produit contient de l’acésulfame-potassium, de l’aspartame, du néotame ou du sucralose ajoutés;

d) le produit est de la viande, un sous-produit de viande, de la viande de volaille ou un sous-produit de viande de volaille hachés;

e) l’étiquette du produit ou encore l’annonce faite par le fabricant du produit ou sous ses ordres comporte, selon le cas :

(i) une mention de la valeur énergétique, d’un élément nutritif figurant à la colonne 1 du tableau du présent article ou à la colonne 1 du tableau de l’article B.01.402 ou une mention d’un composant de l’élément nutritif, autre qu’un renseignement prévu au titre 12 ou qu’une mention du nom usuel de l’ingrédient dans la liste des ingrédients du produit,

(ii) une déclaration indiquant expressément ou implicitement que le produit a des propriétés particulières liées à la nutrition ou à la santé, notamment une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513, à la colonne 1 du tableau suivant l’article B.01.603 ou aux articles B.01.311, D.01.006 ou D.02.004,

(iii) un nom, une mention, un logo, un symbole, un sceau d’approbation ou toute autre marque concernant la santé,

(iv) les expressions « valeur nutritive », « valeurs nutritives » ou « nutrition facts ».

(4) Le paragraphe (1) ne s’applique pas à une préparation pour régime liquide, à un succédané de lait humain ou à un aliment présenté comme contenant un succédané de lait humain, à un substitut de repas, à un supplément nutritif ou à un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie.

(5) L’étiquette ou l’annonce d’une préparation pour régime liquide, d’un succédané de lait humain ou d’un aliment présenté comme contenant un succédané de lait humain, d’un substitut de repas, d’un supplément nutritif ou d’un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie ne peut comporter un tableau de la valeur nutritive ou les expressions « valeur nutritive », « valeurs nutritives » ou « nutrition facts ».

(6) Si au moins sept des renseignements relatifs à la valeur énergétique et aux éléments nutritifs visés à la colonne 1 des articles 2 à 5 et 7 à 13 du tableau du présent article peuvent être exprimés, conformément au présent article, par « 0 » au tableau de la valeur nutritive d’un produit préemballé, autre qu’un produit destiné exclusivement aux enfants âgés de moins de deux ans, le tableau peut ne contenir que les renseignements suivants :

a) la portion déterminée;

b) la valeur énergétique;

c) la teneur en lipides;

d) la teneur en glucides;

e) la teneur en protéines;

f) la teneur en tout élément nutritif qui fait l’objet d’une déclaration visée au sous-alinéa (3)e)(ii);

g) la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit, à l’exclusion de l’iodure ajouté à du sel de table ou à du sel d’usage domestique général et du fluorure ajouté à de l’eau ou à de la glace préemballées;

h) la teneur en une vitamine ou en un minéral nutritif déclaré comme constituant d’un ingrédient du produit, à l’exclusion de la farine;

i) la teneur en tout élément nutritif visé à la colonne 1 des articles 4, 5, 7, 8, 10, 11 et 13 du tableau du présent article qui ne peut être exprimée par « 0 » au tableau de la valeur nutritive;

j) la mention « Source négligeable de (désignation de tout élément nutritif omis conformément au présent paragraphe) » ou, si le produit remplit les conditions du paragraphe B.01.455(3), la mention « Source négligeable d’autres éléments nutritifs ».

(7) Le paragraphe (1) ne s’applique pas aux produits préemballés suivants :

a) tout produit destiné uniquement à être utilisé comme ingrédient dans la fabrication d’autres produits préemballés destinés à être vendus au consommateur au niveau du commerce de détail ou comme ingrédient dans la préparation d’aliments par une entreprise ou une institution commerciale ou industrielle;

b) tout produit à portion multiple prêt à servir destiné uniquement à être servi par une entreprise ou une institution commerciale ou industrielle.

TABLEAU

RENSEIGNEMENTS PRINCIPAUX

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

1. Portion « Portion (1) La portion est (1) La portion exprimée

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

déterminée exprimée en l’une en unité métrique est ou l’autre des unités arrondie :

(portion déterminée) », « pour (portion déterminée) » ou « par (portion déterminée) »

Valeur2. énergétique « Calories » ou « Calories totales »

suivantes : a) dans le cas de l’aliment qui est a) lorsqu’elle esthabituellement inférieure à 10 g ouséparé en morceaux 10 mL : au plus prochetel du gâteau, de la multiple de 0,1 g outarte ou de la pizza, 0,1 mL;une fraction de l’aliment; b) dans le cas de b) lorsqu’elle est égale l’aliment visé au ou supérieure à 10 g ou paragraphe 10 mL : au plus proche B.01.002A(2), le multiple de 1 g ou contenant; 1 mL. c) dans les autres cas, en unité courante dont la (2) La portion exprimée quantité est en fraction est mesurable à l’oeil représentée par un nu, telle que numérateur et un millilitre, tasse, dénominateur séparés cuillère à soupe ou d’une barre. « (nom de l’unité de l’aliment) ».

(3) La portion(2) La portion comprend le termeexprimée « assortis » lorsque leconformément au tableau de la valeurparagraphe (1) est nutritive du produitsuivie de la portion préemballé qui contientexprimée en un assortimentgrammes ou en d’aliments indique lesmillilitres, tel qu’il renseignements quiest prévu à l’alinéa correspondent à uneB.01.002A(1)b). valeur composée. La valeur est arrondie :

La valeur est a) lorsqu’elle est exprimée en inférieure à 5 Calories : Calories par portion déterminée. (i) si le produit répond

aux critères mentionnés

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

à la colonne 2 de l’article 1 du tableau suivant l’article B.01.513 en regard du sujet « sans énergie » visé à la colonne 1 : à 0 Calorie,

(ii) dans les autres cas : au plus proche multiple de 1 Calorie;

b) lorsqu’elle est égale ou supérieure à 5 Calories sans dépasser 50 Calories : au plus proche multiple de 5 Calories; c) lorsqu’elle est supérieure à 50 Calories : au plus proche multiple de 10 Calories.

3. Teneur en lipides

« Lipides » ou « Total des lipides »

La teneur est exprimée : a) en grammes par portion déterminée;

(1) La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g :

(i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 11 du tableau suivant l’article B.01.513 en regard du

b) en pourcentage de sujet « sans lipides » la valeur visé à la colonne 1 et si quotidienne par les teneurs en acides portion déterminée. gras saturés et en acides

gras trans sont exprimées par « 0 g » au tableau de la valeur nutritive, ou sont omises de ce tableau conformément au

Colonne 1 Colonne 2 Colonne 3 Article Renseignements Nomenclature Unité

4. La teneur est Teneur en acides gras saturés

exprimée en grammes par portion déterminée.

« Acides gras saturés », « Lipides saturés » ou « saturés »

Colonne 4 Règles d’écriture paragraphe B.01.401(6), et qu’aucun autre acide gras n’est exprimé par une valeur supérieure à 0 g : à 0 g,

(ii) dans les autres cas : au plus proche multiple de 0,1 g;

b) lorsqu’elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. La teneur est arrondie :

a) lorsqu’elle est inférieure à 0,5 g :

(i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 18 du tableau suivant l’article B.01.513 en regard du sujet « sans acides gras saturés » visé à la colonne 1 : à 0 g,

(ii) dans les autres cas :

Colonne 1 Article Renseignements

5.

Teneur en acides gras trans

Somme des6. acides gras saturés et des acides gras trans

Colonne 2 Nomenclature

« Acides gras trans », « Lipides trans » ou « trans »

« Acides gras saturés + acides gras trans », « Lipides saturés

Colonne 3 Unité

La teneur est exprimée en grammes par portion déterminée.

La somme est exprimée en pourcentage de la valeur quotidienne

Colonne 4 Règles d’écriture au plus proche multiple de 0,1 g;

b) lorsqu’elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. La teneur est arrondie :

a) lorsqu’elle est inférieure à 0,5 g :

(i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 22 du tableau suivant l’article B.01.513 en regard du sujet « sans acides gras trans » visé à la colonne 1 : à 0 g,

(ii) dans les autres cas : au plus proche multiple de 0,1 g;

b) lorsqu’elle est égale ou supérieure à 0,5 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. Le pourcentage est arrondi : a) lorsque les teneurs en acides gras saturés et en

Colonne 1 Colonne 2 Article Renseignements Nomenclature

+ lipides trans » ou « saturés + trans »

7.

Teneur en « Cholestérol »cholestérol

Teneur en8. « Sodium »sodium

Colonne 3 Unité par portion déterminée.

La teneur est exprimée en milligrammes par portion déterminée et peut aussi être exprimée en pourcentage de la valeur quotidienne par portion déterminée.

La teneur est exprimée : a) en milligrammes par portion déterminée;

b) en pourcentage de la valeur quotidienne par portion déterminée.

Colonne 4 Règles d’écriture acides gras trans déclarées sont « 0 g » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. (1) La teneur est arrondie : a) si le produit répond aux critères mentionnés à la colonne 2 de l’article 27 du tableau suivant l’article B.01.513 en regard du sujet « sans cholestérol » visé à la colonne 1 : à 0 mg; b) dans les autres cas : au plus proche multiple de 5 mg. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. (1) La teneur est arrondie :

a) lorsqu’elle est inférieure à 5 mg :

(i) si le produit répond aux critères mentionnés à la colonne 2 de l’article 31 du tableau suivant l’article B.01.513 en regard du sujet « sans sodium ou sans sel » visé à la

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

colonne 1 : à 0 mg,

(ii) dans les autres cas : au plus proche multiple de 1 mg;

b) lorsqu’elle est égale ou supérieure à 5 mg sans dépasser 140 mg : au plus proche multiple de 5 mg; c) lorsqu’elle est supérieure à 140 mg : au plus proche multiple de 10 mg. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

9. Teneur en glucides

« Glucides » ou « Total des glucides »

La teneur est exprimée :

a) en grammes par portion déterminée;

(1) La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g;

b) en pourcentage de la valeur quotidienne par portion déterminée.

b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %.

10. Teneur en fibres « Fibres » ou« Fibres La teneur est exprimée :

(1) La teneur est arrondie :

Colonne 1 Colonne 2 Article Renseignements Nomenclature

alimentaires »

11. Teneur en sucres « Sucres »

Teneur en12. « Protéines »protéines

13. Teneur en :

a) « Vitaminea) vitamine A A » ou « Vit A »

b) « Vitamineb) vitamine B C » ou « Vit C »

Colonne 3 Unité

a) en grammes par portion déterminée;

b) en pourcentage de la valeur quotidienne par portion déterminée.

La teneur est exprimée en grammes par portion déterminée.

La teneur est exprimée en grammes par portion déterminée.

La teneur est exprimée en pourcentage de la valeur quotidienne par portion déterminée

Colonne 4 Règles d’écriture a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 g » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. Le pourcentage est arrondi : a) lorsqu’il est inférieur à 2 % :

(i) si le produit contient moins de 1 % de la valeur quotidienne par quantité de référence et par portion déterminée :

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

à 0 %,

c) calcium c) « Calcium » (ii) dans les autres cas :à 2 %;

b) lorsqu’il est égal ou

d) fer d) « Fer » supérieur à 2 % sansdépasser 10 % : au plus proche multiple de 2 %; c) lorsqu’il est supérieur à 10 % sans dépasser 50 % : au plus proche multiple de 5 %; d) lorsqu’il est supérieur à 50 % : au plus proche multiple de 10 %.

DORS/2003-11, art. 20; DORS/2007-176, art. 5. Version précédente Renseignements complémentaires

B.01.402. (1) Le tableau de la valeur nutritive peut également indiquer les renseignements visés à la colonne 1 du tableau du présent article.

(2) Les renseignements visés à la colonne 1 du tableau du présent article qui sont présentés dans le tableau de la valeur nutritive sont exprimés au moyen de la nomenclature indiquée dans la colonne 2, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4.

(3) Le tableau de la valeur nutritive indique la teneur en acides gras polyinsaturés oméga­ 6, en polyinsaturés oméga-3 et en monoinsaturés dans l’un ou l’autre des cas suivants :

a) la teneur en un de ces groupes d’acides gras ou la teneur en acides gras polyinsaturés est indiquée dans le tableau ou sur l’étiquette du produit préemballé ou encore dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres;

b) la teneur en un acide gras est indiquée sur l’étiquette du produit préemballé ou encore dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres.

(4) Lorsqu’une déclaration expresse ou implicite incluant des renseignements visés à la colonne 1 du tableau du présent article est faite sur l’étiquette du produit préemballé ou encore dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres, ces renseignements sont aussi mentionnés dans le tableau de la valeur nutritive.

(5) Le tableau de la valeur nutritive du produit préemballé indique la teneur en potassium si le produit contient des sels de potassium ajoutés et si l’étiquette du produit ou encore l’annonce du produit faite par le fabricant du produit ou sous ses ordres contient une mention ou une allégation figurant à la colonne 4 des articles 31 à 36 du tableau suivant l’article B.01.513 en regard des sujets « sans sodium ou sans sel », « faible teneur en sodium ou en sel », « teneur réduite en sodium ou en sel », « moins de sodium ou de sel », « non additionné de sel ou de sodium » ou « légèrement salé » visés à la colonne 1.

(6) Le tableau de la valeur nutritive du produit préemballé indique la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit préemballé, à l’exclusion de l’iodure ajouté à du sel de table ou d’usage domestique général et du fluorure ajouté à de l’eau ou à de la glace préemballées.

(7) Le tableau de la valeur nutritive de tout produit préemballé dont un ingrédient, autre que de la farine, contient une vitamine ou un minéral nutritif déclaré comme constituant de cet ingrédient en indique la teneur.

(8) Malgré le paragraphe (1) et l’article 1 du tableau du présent article, le tableau de la valeur nutritive ne peut contenir de renseignements concernant la quantité de portions par contenant si la portion déterminée est exprimée en tasses ou en cuillères à soupe.

(9) Si les renseignements visés à la colonne 1 du tableau du présent article paraissent dans le tableau de la valeur nutritive, ils figurent :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette du produit aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

TABLEAU

RENSEIGNEMENTS COMPLÉMENTAIRES

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

1. « Portions par La quantité est (1) La quantité est arrondie :

Portions par contenant

contenant » ou « (nombre d’unités) par contenant »

exprimée en nombre de portions.

a) lorsqu’elle est inférieure à 2, au plus proche multiple de 1; b) lorsqu’elle est égale ou supérieure à 2 sans dépasser 5 : au plus proche multiple de 0,5;

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

c) lorsqu’elle est supérieure à 5 : au plus proche multiple de 1. (2) Si la quantité est arrondie, elle est précédée du mot « environ ». (3) Si le poids du produit varie, la quantité peut être déclarée « variable ».

La valeur est La valeur estexprimée enValeur arrondie au plus2. « kilojoules » ou « kJ » kilojoules parénergétique proche multiple deportion 10 kilojoules.déterminée. La valeur est3. arrondie : a) lorsqu’elle est« Calories provenant La valeur est inférieure àValeur des lipides », exprimée en 5 Calories :énergétique « Calories provenant Calories parprovenant des du total des lipides » portion (i) si la teneur enlipides ou « Calories des déterminée. lipides déclarée danslipides » le tableau de la valeur nutritive est « 0 g » : à 0 Calorie,

(ii) dans les autres cas : au plus proche multiple de 1 Calorie;

b) lorsqu’elle est égale ou supérieure à 5 Calories sans dépasser 50 Calories : au plus proche multiple de 5 Calories; c) lorsqu’elle est

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

supérieure à 50 Calories : au plus proche multiple de 10 Calories. La valeur est arrondie :

4.

Valeur énergétique provenant de la somme des acides gras saturés et des acides gras trans

« Calories des acides gras saturés et trans », « Calories des lipides saturés et trans » ou « Calories des saturés et des trans »

La valeur est exprimée en Calories par portion déterminée.

a) lorsqu’elle est inférieure à 5 Calories :

(i) si la teneur en acides gras saturés et en acides gras trans déclarée dans le tableau de la valeur nutritive est « 0 g » : à 0 Calorie,

(ii) dans les autres cas : au plus proche multiple de 1 Calorie;

b) lorsqu’elle est égale ou supérieure à 5 Calories sans dépasser 50 Calories : au plus proche multiple de 5 Calories; c) lorsqu’elle est supérieure à 50 Calories : au plus proche multiple de 10 Calories. La teneur est

5. Teneur en acidesgras polyinsaturés

« Acides gras polyinsaturés », « Lipides polyinsaturés » ou « polyinsaturés »

La teneur est exprimée en grammes par portion déterminée.

arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

1 g sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. La teneur est

(1) Si le tableau de la arrondie : valeur nutritive indique a) lorsqu’elle estla teneur en acides gras La teneur est inférieure à 1 g : aupolyinsaturés :Teneur en acides exprimée en plus proche multiple« oméga-6 », « Acides6. gras polyinsaturés grammes par de 0,1 g;gras polyinsaturésoméga-6 portionoméga-6 », « Lipides b) lorsqu’elle est polyinsaturés oméga- déterminée. égale ou supérieure à 6 » ou « polyinsaturés 1 g sans dépasser oméga-6 » 5 g : au plus proche

multiple de 0,5 g; (2) Dans les autres cas : « Acides gras c) lorsqu’elle estpolyinsaturés oméga­ supérieure à 5 g : au6 », « Lipides plus proche multiplepolyinsaturés oméga­ de 1 g.6 » ou « polyinsaturés oméga-6 »

La teneur est (1) Si le tableau de la arrondie : valeur nutritive indique a) lorsqu’elle estla teneur en acides gras La teneur est inférieure à 1 g : aupolyinsaturés :Teneur en acides exprimée en plus proche multiple« oméga-3 », « Acides7. gras polyinsaturés grammes par de 0,1 g;gras polyinsaturésoméga-3 portionoméga-3 », « Lipides b) lorsqu’elle est polyinsaturés oméga- déterminée. égale ou supérieure à 3 » ou « polyinsaturés 1 g sans dépasser oméga-3 » 5 g : au plus proche

multiple de 0,5 g; (2) Dans les autres cas : « Acides gras c) lorsqu’elle est polyinsaturés oméga- supérieure à 5 g : au 3 », « Lipides plus proche multiple polyinsaturés oméga- de 1 g. 3 » ou « polyinsaturés

Colonne 1 Article Renseignements

Teneur en acides 8. gras

monoinsaturés

Teneur en9. potassium

Colonne 2 Colonne 3 Nomenclature Unité oméga-3 »

« Acides gras La teneur est monoinsaturés », exprimée en « Lipides grammes par monoinsaturés » ou portion « monoinsaturés » déterminée.

La teneur est exprimée :

« Potassium » a) en milligrammes par portion déterminée;

b) en pourcentage de la valeur quotidienne par portion déterminée.

Colonne 4 Règles d’écriture

La teneur est arrondie : a) lorsqu’elle est inférieure à 1 g : au plus proche multiple de 0,1 g; b) lorsqu’elle est égale ou supérieure à 1 g, sans dépasser 5 g : au plus proche multiple de 0,5 g; c) lorsqu’elle est supérieure à 5 g : au plus proche multiple de 1 g. (1) La teneur est arrondie :

a) lorsqu’elle est inférieure à 5 mg :

(i) si le produit contient moins de 5 mg de potassium par quantité de référence et par portion déterminée : à 0 mg,

(ii) dans les autres cas : au plus proche multiple de 1 mg;

b) lorsqu’elle est égale ou supérieure à 5 mg sans dépasser 140 mg : au plus proche multiple de 5 mg; c) lorsqu’elle est supérieure à

Colonne 1 Article Renseignements

10. Teneur en fibres solubles

11. Teneur en fibres insolubles

12.

Teneur en polyalcools

Colonne 2 Nomenclature

« Fibres solubles »

« Fibres insolubles »

(1) Si l’aliment ne contient qu’un polyalcool : « Polyalcool », « Polyol » ou « (Nom du polyalcool) »;

(2) Dans les autres cas : « Polyalcools » ou « Polyols »

Colonne 3 Unité

La teneur est exprimée en grammes par portion déterminée.

La teneur est exprimée en grammes par portion déterminée.

La teneur est exprimée en grammes par portion déterminée.

Colonne 4 Règles d’écriture 140 mg : au plus proche multiple de 10 mg. (2) Le pourcentage est arrondi : a) lorsque la teneur déclarée est « 0 mg » : à 0 %; b) dans les autres cas : au plus proche multiple de 1 %. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g.

Colonne 3 Unité La teneur est exprimée en grammes par portion déterminée.

La teneur est exprimée en pourcentage de la valeur quotidienne par portion déterminée.

Colonne 4 Règles d’écriture La teneur est arrondie : a) lorsqu’elle est inférieure à 0,5 g : à 0 g; b) lorsqu’elle est égale ou supérieure à 0,5 g : au plus proche multiple de 1 g. Le pourcentage est arrondi :

a) lorsqu’il est inférieur à 2 % :

(i) si le produit contient moins de 1 % de la valeur quotidienne par quantité de référence et par portion déterminée : à 0 %,

(ii) dans les autres cas : au plus proche multiple de 2 %;

b) lorsqu’il est égal ou supérieur à 2 % sans dépasser 10 % : au plus proche multiple de 2 %; c) lorsqu’il est supérieur à 10 % sans dépasser 50 % : au plus proche multiple de 5 %; d) lorsqu’il est supérieur à 50 % : au plus proche multiple

Colonne 1 Colonne 2 Article Renseignements Nomenclature

13. Teneur en amidon « Amidon »

14. Teneur en :

a) vitamine D

b) vitamine E

c) vitamine K

d) thiamine

e) riboflavine

f) niacine

g) vitamine B6

a) « Vitamine D » ou « Vit D »

b) « Vitamine E » ou « Vit E »

c) « Vitamine K » ou « Vit K »

d) « Thiamine », « Thiamine (vitamine B1) » ou « Thiamine (vit B1) »

e) « Riboflavine », « Riboflavine (vitamine B2) » ou « Riboflavine (vit B2) »

f) « Niacine »

g) « Vitamine B6 » ou « Vit B6 »

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

de 10 %. h) folate h) « Folate »

i) vitamine B12 i) « Vitamine B12 » ou « Vit B12 »

j) biotine j) « Biotine »

k) acide pantothénique

k) « Acide pantothénique » ou « Pantothénate »

l) phosphore l) « Phosphore »

m) iodure m) « Iodure » ou« Iode » n) magnésium n) « Magnésium » o) zinc o) « Zinc » p) sélénium p) « Sélénium » q) Cuivre q) « Cuivre » r) Manganèse r) « Manganèse » s) Chrome s) « Chrome » t) Molybdène t) « Molybdène » u) Chlorure u) « Chlorure »

Dans la version de la note complémentaire qui énumère les éléments nutritifs :

15.

Base des pourcentages des valeurs quotidiennes

Une des quatre notes complémentaires du sous-titre « Valeur quotidienne » dans les figures 18.1(F) et (A) de l’annexe L.

a) la valeur quotidienne de potassium n’est indiquée que si la teneur en potassium est déclarée dans le tableau de la valeur nutritive; b) la valeur quotidienne de cholestérol n’est indiquée que si la teneur en cholestérol est déclarée dans le tableau de la valeur nutritive en pourcentage de la

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Article Renseignements Nomenclature Unité Règles d’écriture

valeur quotidienne par portion déterminée.

16. Facteurs de conversion d’énergie

« Calories par gramme », « Lipides 9 », « Glucides 4 » et « Protéines 4 »

DORS/2003-11, art. 20; err., Vol. 137, no 5; DORS/2005-98, art. 2(F).

Aliments pour enfants âgés de moins de deux ans

B.01.403. (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans.

(2) Le tableau de la valeur nutritive du produit préemballé ne peut indiquer les renseignements suivants :

a) le pourcentage de la valeur quotidienne des lipides, du cholestérol, du sodium, du potassium, des glucides ou des fibres ou de la somme des acides gras saturés et des acides gras trans;

b) la valeur énergétique provenant des lipides ou de la somme des acides gras saturés et des acides gras trans;

c) toute note complémentaire du sous-titre « % valeur quotidienne » paraissant dans les figures 18.1(F) et (A) de l’annexe L.

(3) Les teneurs en acides gras saturés, en acides gras trans et en cholestérol peuvent être omises du tableau de la valeur nutritive.

(4) Malgré le paragraphe (3), le tableau de la valeur nutritive qui indique la teneur en cholestérol doit également indiquer la teneur en acides gras saturés et la teneur en acides gras trans.

(5) Si au moins six des renseignements relatifs à la valeur énergétique et aux éléments nutritifs visés à la colonne 1 des articles 2, 3 et 8 à 13 du tableau de l’article B.01.401 peuvent être exprimés, conformément à cet article, par « 0 » au tableau de la valeur nutritive du produit préemballé, le tableau peut ne contenir que les renseignements suivants :

a) la portion déterminée;

b) la valeur énergétique;

c) la teneur en lipides;

d) la teneur en glucides;

e) la teneur en protéines;

f) la teneur en tout élément nutritif qui fait l’objet d’une des déclarations visées au sous­ alinéa B.01.401(3)e)(ii);

g) la teneur en un polyalcool, en une vitamine ou en un minéral nutritif ajoutés au produit, à l’exclusion du fluorure ajouté à de l’eau ou à de la glace préemballées;

h) la teneur en une vitamine ou en un minéral nutritif déclaré comme constituant d’un ingrédient du produit, à l’exclusion de la farine;

i) la teneur en tout élément nutritif visé à la colonne 1 des articles 8, 10, 11 et 13 du tableau de l’article B.01.401 qui ne peut être exprimée par « 0 » au tableau de la valeur nutritive;

j) sauf dans le cas mentionné à l’alinéa k), la mention « Source négligeable de (désignation de tout élément nutritif omis conformément au présent paragraphe) »; la mention peut toutefois être omise en ce qui concerne les acides gras saturés, les acides gras trans et le cholestérol;

k) si le produit remplit les conditions du paragraphe B.01.462(3), la mention « Source négligeable d’autres éléments nutritifs » ou la mention visée à l’alinéa j).

DORS/2003-11, art. 20.

Aliments utilisés dans la fabrication d'autres aliments

B.01.404. (1) Le présent article s’applique à tout produit préemballé qui est destiné uniquement à être utilisé comme ingrédient dans la fabrication d’autres produits préemballés destinés à être vendus au consommateur au niveau du commerce de détail ou comme ingrédient dans la préparation d’aliments par une entreprise ou une institution commerciale ou industrielle.

(2) Il est interdit de vendre le produit préemballé à moins que des renseignements nutritionnels écrits concernant le produit l’accompagnent lors de sa livraison à l’acheteur.

(3) Les renseignements nutritionnels :

a) comprennent ceux que le tableau de la valeur nutritive indiquerait, n’eût été le paragraphe B.01.401(7), aux termes des articles B.01.401 et B.01.402;

b) peuvent comprendre ceux que le tableau de la valeur nutritive peut indiquer aux termes de l’article B.01.402;

c) sont présentés conformément aux articles B.01.401 et B.01.402, sous réserve des modifications suivantes :

(i) les renseignements concernant les vitamines figurant à la colonne I du tableau I du titre 1 de la partie D et les minéraux nutritifs figurant à la colonne I du tableau I du titre 2 de cette partie sont exprimés au moyen de l’unité applicable indiquée dans cette colonne :

(A) par gramme ou 100 grammes de l’aliment, dans le cas où la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette,

(B) par millilitre ou 100 millilitres de l’aliment, dans le cas où la quantité nette de l’aliment est mentionnée en volume sur l’étiquette,

(ii) les renseignements concernant les autres éléments nutritifs ainsi que la valeur énergétique, figurant à la colonne 1 des tableaux des articles B.01.401 ou B.01.402 sont exprimés au moyen d’une unité visée à la colonne 3 :

(A) par gramme ou 100 grammes de l’aliment, dans le cas où la quantité nette de l’aliment est mentionnée en poids ou en nombre sur l’étiquette,

(B) par millilitre ou 100 millilitres de l’aliment, dans le cas où la quantité nette de l’aliment est mentionnée en volume sur l’étiquette,

(iii) le pourcentage de la valeur quotidienne et les renseignements concernant la portion déterminée peuvent être omis,

(iv) les renseignements nutritionnels sont indiqués avec un degré de précision qui correspond à la précision des méthodes analytiques utilisées pour produire ces renseignements.

DORS/2003-11, art. 20.

Aliments pour entreprise ou institution

B.01.405. (1) Le présent article s’applique à tout produit préemballé à portion multiple prêt à servir destiné uniquement à être servi par une entreprise ou une institution commerciale ou industrielle.

(2) Il est interdit de vendre le produit préemballé à moins que des renseignements nutritionnels écrits concernant le produit l’accompagnent lors de sa livraison à l’acheteur.

(3) Les renseignements nutritionnels :

a) comprennent ceux que le tableau de la valeur nutritive indiquerait, n’eût été le paragraphe B.01.401(7), aux termes des articles B.01.401 et B.01.402;

b) peuvent comprendre ceux que le tableau de la valeur nutritive peut indiquer en vertu de l’article B.01.402;

c) sont présentés conformément aux articles B.01.401 et B.01.402.

DORS/2003-11, art. 20.

Objet des renseignements

B.01.406. (1) Sous réserve des paragraphes (2) à (8), le tableau de la valeur nutritive indique les renseignements uniquement en fonction du produit préemballé tel qu’il est vendu.

(2) Le tableau de la valeur nutritive de tout produit préemballé qui comprend des ingrédients ou des aliments emballés séparément et destinés à être consommés ensemble indique les renseignements en fonction soit de chaque ingrédient ou aliment, soit du produit dans son ensemble.

(3) Le tableau de la valeur nutritive de tout produit préemballé qui contient un assortiment d’aliments du même type et dont la portion typique ne comprend qu’un de ces aliments indique les renseignements en fonction :

a) de chaque aliment dans le produit, lorsque les renseignements nutritionnels figurant à la colonne 1 du tableau de l’article B.01.401 sont différents pour chaque aliment;

b) d’un aliment dans le produit, lorsque les renseignements nutritionnels figurant à la colonne 1 du tableau de l’article B.01.401 sont les mêmes pour chaque aliment.

(4) Le tableau de la valeur nutritive de tout produit préemballé qui contient un assortiment d’aliments du même type et dont la portion typique comprend plus d’un de ces aliments indique les renseignements qui correspondent soit à la valeur de chaque aliment, soit à une valeur composée.

(5) Le tableau de la valeur nutritive de tout produit préemballé contenant un aliment à préparer selon des instructions fournies dans ou sur l’emballage, ou qui est normalement combiné avec d’autres ingrédients ou aliments ou cuit avant d’être consommé, peut également indiquer les renseignements en fonction de l’aliment une fois préparé, auquel cas :

a) le tableau indique les renseignements ci-après en fonction de l’aliment préparé :

(i) sauf dans le cas visé au sous-alinéa (ii), la quantité de l’aliment exprimée en une unité indiquée dans la colonne 3 des alinéas 1(1)a) ou c) du tableau de l’article B.01.401, soit « environ (la portion déterminée) » ou « environ (la portion déterminée) préparé », et, s’il y a lieu, au moyen des règles d’écriture indiquées dans la colonne 4 des paragraphes 1(1) et (2),

(ii) si l’aliment est normalement combiné avec un autre aliment, la quantité de l’autre aliment exprimée en une unité indiquée dans la colonne 3 des alinéas 1(1)c) du tableau de l’article B.01.401 et, s’il y a lieu, au moyen des règles d’écriture indiquées dans la colonne 4 du paragraphe 1(1),

(iii) la valeur énergétique exprimée au moyen de la nomenclature indiquée dans la colonne 2 de l’article 2 du tableau de l’article B.01.401, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4,

(iv) si elle est déclarée dans le tableau de la valeur nutritive de l’aliment tel qu’il est vendu, la valeur énergétique provenant des lipides, exprimée au moyen de la

nomenclature indiquée dans la colonne 2 de l’article 3 du tableau de l’article B.01.402, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4,

(v) les renseignements visés à la colonne 1 des articles 3, 6 à 10 et 13 du tableau de l’article B.01.401 et à la colonne 1 des articles 9 et 14 du tableau de l’article B.01.402 et qui sont indiqués en pourcentage de la valeur quotidienne dans le tableau de la valeur nutritive en fonction de l’aliment tel qu’il est vendu, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en pourcentage de la valeur quotidienne par portion déterminée et au moyen des règles d’écriture indiquées dans la colonne 4;

b) le tableau peut également indiquer les renseignements ci-après en fonction des ingrédients ajoutés ou de l’autre aliment, s’ils sont déclarés dans le tableau de la valeur nutritive de l’aliment tel qu’il est vendu :

(i) les renseignements visés à la colonne 1 des articles 3 à 5 et 7 à 12 du tableau de l’article B.01.401, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 des articles 7 et 8 et en grammes pour ceux visés à la colonne 1 des articles 3 à 5 et 9 à 12, et au moyen des règles d’écriture indiquées dans la colonne 4,

(ii) les renseignements visés à la colonne 1 des articles 5 à 13 du tableau de l’article B.01.402, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 de l’article 9 et en grammes pour ceux visés à la colonne 1 des articles 5 à 8 et 10 à 13, et au moyen des règles d’écriture indiquées dans la colonne 4.

(6) Le paragraphe (5) ne s’applique pas aux produits préemballés destinés exclusivement aux enfants âgés de moins de deux ans.

(7) Sous réserve du paragraphe (8), le tableau de la valeur nutritive peut aussi indiquer les renseignements en fonction d’autres quantités de l’aliment qui correspondent à différents usages ou unités de mesure de l’aliment, auquel cas :

a) le tableau indique les renseignements ci-après pour chacune des autres quantités de l’aliment :

(i) la quantité exprimée au moyen d’une unité indiquée dans la colonne 3 du paragraphe 1(1) du tableau de l’article B.01.401 et, s’il y a lieu, des règles d’écriture indiquées dans la colonne 4 des paragraphes 1(1) et (2),

(ii) la valeur énergétique, exprimée au moyen de la nomenclature indiquée dans la colonne 2 de l’article 2 du tableau de l’article B.01.401, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4,

(iii) si elle est déclarée dans le tableau de la valeur nutritive à l’égard de la première quantité d’aliment pour laquelle des renseignements sont déclarés, la valeur énergétique provenant des lipides, exprimée au moyen de la nomenclature indiquée dans la colonne 2 de l’article 3 du tableau de l’article B.01.402, de l’unité indiquée dans la colonne 3 et des règles d’écriture indiquées dans la colonne 4,

(iv) les renseignements visés à la colonne 1 des articles 3, 6 à 10 et 13 du tableau de l’article B.01.401 et à la colonne 1 des articles 9 et 14 du tableau de l’article B.01.402 et qui sont indiqués en pourcentage de la valeur quotidienne dans le tableau de la valeur nutritive à l’égard de la première quantité d’aliment pour laquelle des renseignements sont déclarés, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en pourcentage de la valeur quotidienne par portion déterminée et au moyen des règles d’écriture indiquées dans la colonne 4;

b) si le tableau est présenté selon l’une des versions du modèle double prévu à l’article B.01.458, il peut également indiquer, pour chacune des autres quantités de l’aliment, la quantité exprimée en l’unité indiquée dans la colonne 3 du paragraphe 1(2) du tableau de l’article B.01.401 et selon les règles d’écriture indiquées dans la colonne 4 du paragraphe 1(1), si ces renseignements sont déclarés dans le tableau de la valeur nutritive à l’égard de la première quantité d’aliment pour laquelle des renseignements sont déclarés;

c) si le tableau est présenté selon l’une des versions du modèle composé prévu aux articles B.01.459 ou B.01.464, il indique également les renseignements ci-après pour chacune des autres quantités de l’aliment, s’ils sont déclarés dans le tableau de la valeur nutritive à l’égard de la première quantité d’aliment pour laquelle des renseignements sont déclarés :

(i) la quantité de l’aliment exprimée au moyen de l’unité indiquée dans la colonne 3 du paragraphe 1(2) du tableau de l’article B.01.401 et des règles d’écriture indiquées dans la colonne 4 du paragraphe 1(1),

(ii) les renseignements visés à la colonne 1 des articles 3 à 5 et 7 à 12 du tableau de l’article B.01.401, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 des articles 7 et 8 et en grammes pour ceux visés à la colonne 1 des articles 3 à 5 et 9 à 12, et au moyen des règles d’écriture indiquées dans la colonne 4,

(iii) les renseignements visés à la colonne 1 des articles 5 à 13 du tableau de l’article B.01.402, exprimés au moyen de la nomenclature indiquée dans la colonne 2, en milligrammes pour ceux visés à la colonne 1 de l’article 9 et en grammes pour ceux visés à la colonne 1 des articles 5 à 8 et 10 à 13, et au moyen des règles d’écriture indiquées dans la colonne 4.

(8) Le tableau de la valeur nutritive d’un produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans qui indique des renseignements conformément au paragraphe (7) indique les renseignements visés aux sous-alinéas (7)a) et c).

DORS/2003-11, art. 20.

[B.01.407 à B.01.449 réservés]

Présentation du tableau de la valeur nutritive

B.01.450. (1) Sous réserve des paragraphes (2) à (6), le tableau de la valeur nutritive est présenté selon le modèle de la figure applicable de l’annexe L, compte tenu notamment

de l’ordre de présentation, des dimensions, des espacements et de l’emploi des majuscules, des minuscules et des caractères gras.

(2) Les caractères et les filets du tableau de la valeur nutritive sont monochromes et équivalent visuellement à de l’imprimerie noire en aplat de 100 % sur un fond blanc ou de couleur de teinte neutre et uniforme d’au plus 5 %.

(3) Les caractères dans le tableau de la valeur nutritive :

a) sont normalisés, sans empattement, non décoratifs et inscrits de manière à ce qu’ils ne se touchent pas et ne touchent pas les filets;

b) peuvent être de dimensions plus grandes que ceux indiqués dans la figure applicable de l’annexe L si tous les caractères sont agrandis de façon uniforme.

(4) Un filet de un ou deux points visé à la figure applicable de l’annexe L peut avoir une force de corps plus grande dans le tableau de la valeur nutritive.

(5) Le tableau de la valeur nutritive indique les renseignements conformément aux articles B.01.400 à B.01.403 et B.01.406.

(6) L’ordre de la langue indiqué dans la figure applicable de l’annexe L peut être inversé lorsque le tableau de la valeur nutritive est composé d’un tableau en français et en anglais.

DORS/2003-11, art. 20.

Emplacement du tableau de la valeur nutritive

B.01.451. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive est présenté sur l’étiquette du produit préemballé :

a) dans un tableau en français et un tableau en anglais sur le même espace continu de la surface exposée disponible;

b) dans un tableau en français et en anglais sur tout espace continu de la surface exposée disponible;

c) dans un tableau en français sur tout espace continu de la surface exposée disponible et un tableau en anglais sur tout autre espace continu de cette surface de même grandeur et de même importance que le premier espace.

(2) Si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette d’un produit préemballé aux termes du présent règlement peuvent l’être uniquement en français ou uniquement en anglais et qu’ils y figurent dans la langue en cause, le tableau de la valeur nutritive du produit peut être présenté sur l’étiquette du produit uniquement dans cette langue sur tout espace continu de la surface exposée disponible.

DORS/2003-11, art. 20.

Orientation du tableau de la valeur nutritive

B.01.452. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive est orienté dans le même sens que les autres renseignements figurant sur l’étiquette du produit préemballé.

(2) Dans le cas où une version du tableau de la valeur nutritive ne peut être orientée dans le même sens que les autres renseignements figurant sur l’étiquette du produit préemballé, elle est orientée dans un autre sens s’il y a suffisamment d’espace et si le contenu ne fuit pas ou n’est pas endommagé lorsque l’emballage est retourné.

(3) Le paragraphe (1) ne s’applique pas au tableau de la valeur nutritive présenté sur le dessus ou le dessous du produit préemballé.

DORS/2003-11, art. 20.

Application

B.01.453. (1) Les articles B.01.454 à B.01.460 s’appliquent aux produits préemballés autres que ceux destinés exclusivement aux enfants âgés de moins de deux ans.

(2) Les articles B.01.461 à B.01.465 s’appliquent aux produits préemballés destinés exclusivement aux enfants âgés de moins de deux ans.

DORS/2003-11, art. 20.

Modèles standard et horizontal

B.01.454. (1) Le présent article s’applique à tout produit préemballé à moins que l’un des articles B.01.455 à B.01.459 s’y applique.

(2) Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(3) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une ou l’autre des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une des façons suivantes :

a) selon le modèle standard bilingue prévu aux figures 3.5(B), 3.6(B) ou 3.7(B) de l’annexe L;

b) selon le modèle horizontal bilingue prévu aux figures 4.3(B), 4.4(B) ou 4.5(B) de l’annexe L;

c) selon le modèle linéaire prévu aux figures 16.1(F) et (A) ou 16.2(F) et (A) de l’annexe L;

d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

e) d’une façon prévue à l’article B.01.466.

(4) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement.

(5) Malgré les paragraphes (2) et (3), si le produit préemballé, dont l’étiquette est un autocollant et dont la surface exposée disponible est de 200 cm2 ou plus, est vendu uniquement dans l’établissement de détail où il est emballé, le tableau de la valeur nutritive est présenté selon l’une des versions figurant à la colonne 1 des articles 1 à 3 des parties 1 à 3 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

(6) Malgré les paragraphes (2) et (3), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues aux alinéas (3)a), b) et c) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1 MODÈLE STANDARD

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 1.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 1.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points)

Colonne 1

Article Figure de l’annexe L(version) 1.3(F) et (A) (caractères étroits de3. 7 points avec interligne de 11 points) 1.4(F) et (A) (caractères étroits de4. 7 points avec interligne de 10 points) 1.5(F) et (A) (caractères étroits de5. 6 points avec interligne de 10 points) 1.6(F) et (A) (caractères étroits de6. 6 points avec interligne de 9 points)

PARTIE 2

Colonne 2

Condition d’utilisation

Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

MODÈLE STANDARD ÉTROIT Colonne 1

Article Figure de l’annexe L(version) 2.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 2.2(F) et (A) (caractères de 7 points2. avec interligne de 11 points) 2.3(F) et (A) (caractères étroits de3. 7 points avec interligne de 11 points)

Colonne 2

Condition d’utilisation

La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

2.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être 4. présentées conformément au présent règlement sur

(caractères étroits de 15 % ou moins de la surface exposée disponible.

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 6 points avec interligne de 10 points)

PARTIE 3 MODÈLE STANDARD BILINGUE

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 3.1(B) (caractères de 8 points1. avec interligne de 12 points) 3.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 3.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 3.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

PARTIE 4 MODÈLE HORIZONTAL BILINGUE

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 4.1(B) Les versions des parties 1 à 3 ne peuvent être présentées (caractères étroits de1. conformément au présent règlement sur 15 % ou moins 7 points avec interligne de la surface exposée disponible. de 11 points)

Colonne 1 Colonne 2

Article Figure de l’annexe L(version) Condition d’utilisation

2.

4.2(B) (caractères étroits de

Les versions des parties 1 à 3 et de l’article 1 ne peuvent être présentées conformément au présent règlement sur

6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèles simplifiés

B.01.455. (1) Le présent article s'applique à tout produit préemballé qui remplit la condition du paragraphe B.01.401(6) et dont le tableau de la valeur nutritive ne contient que les renseignements visés aux alinéas B.01.401(6)a) à j).

(2) Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l'une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(3) Si le tableau de la valeur nutritive qui ne contient que les renseignements visés aux alinéas B.01.401(6)a) à j) ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l'une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l'une des façons suivantes :

a) selon le modèle standard simplifié bilingue prévu aux figures 6.5(B) ou 6.6(B) de l'annexe L;

b) selon le modèle horizontal simplifié bilingue prévu aux figures 7.3(B) ou 7.4(B) de l'annexe L;

c) selon le modèle linéaire simplifié prévu aux figures 17.1(F) et (A) ou 17.2(F) et (A) de l'annexe L;

d) selon l'une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

e) d'une façon prévue à l'article B.01.466.

(4) Malgré les paragraphes (2) et (3), si le produit préemballé, dont l'étiquette est un autocollant et dont la surface exposée disponible est de 200 cm2 ou plus, est vendu uniquement dans l'établissement de détail où il est emballé, le tableau de la valeur nutritive est présenté selon l'une des versions figurant à la colonne 1 des articles 1 à 3 des parties 1 et 2 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

(5) Malgré les paragraphes (2) et (3), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l'acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d'achat, il est présenté selon l'une des versions prévues aux alinéas (3)a), b) et c) ou selon l'une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1 MODÈLE STANDARD SIMPLIFIÉ

Colonne 1 Colonne 2

Article Figure de l'annexe L Condition d'utilisation(version) 5.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 5.2(F) et (A) La version de l'article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 5.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 5.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 5.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 5.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE STANDARD SIMPLIFIÉ BILINGUE

Colonne 1 Colonne 2

Article Figure de l'annexe L Condition d'utilisation(version) 6.1(B) (caractères de 8 points1. avec interligne de 12 points) 6.2(B) La version de l'article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 6.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 6.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

PARTIE 3 MODÈLE HORIZONTAL SIMPLIFIÉ BILINGUE

Colonne 1 Colonne 2

Article Figure de l'annexe L Condition d'utilisation(version) 7.1(B) Les versions des parties 1 et 2 ne peuvent être présentées (caractères étroits de1. conformément au présent règlement sur 15 % ou moins 7 points avec interligne de la surface exposée disponible. de 11 points) 7.2(B) Les versions des parties 1 et 2 et de l'article 1 ne peuvent2. (caractères étroits de être présentées conformément au présent règlement sur

Colonne 1 Colonne 2

Article Figure de l'annexe L Condition d'utilisation(version) 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle double — aliments à préparer

B.01.456. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui indique les renseignements visés au paragraphe B.01.406(5) est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) soit selon le modèle double bilingue prévu aux figures 9.5(B) ou 9.6(B) de l’annexe L;

b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement ainsi que des renseignements visés au paragraphe B.01.406(5).

(4) Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues à l’alinéa (2)a) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1

MODÈLE DOUBLE — ALIMENTS À PRÉPARER

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 8.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 8.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 8.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 8.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 8.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 8.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE DOUBLE BILINGUE — ALIMENTS À PRÉPARER

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 1. 9.1(B)

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) (caractères de 8 points avec interligne de 12 points) 9.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 9.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 9.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle composé — différents types d'aliments

B.01.457. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui indique des renseignements distincts en fonction de chaque ingrédient ou aliment, tel qu’il est prévu au paragraphe B.01.406(2), à l’alinéa B.01.406(3)a) ou au paragraphe B.01.406(4), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) dans le cas de tout produit visé aux paragraphes B.01.406(2) ou (4) :

(i) soit selon le modèle composé bilingue prévu aux figures 11.5(B) ou 11.6(B) de l’annexe L,

(ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

b) dans le cas de tout produit visé à l’alinéa B.01.406(3)a) :

(i) soit selon le modèle composé bilingue prévu aux figures 11.5(B) ou 11.6(B) de l’annexe L,

(ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible,

(iii) soit d’une façon prévue à l’article B.01.466.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque ingrédient ou aliment pour lequel des renseignements distincts y sont indiqués.

(4) Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues au sous-alinéa (2)a)(i) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1 MODÈLE COMPOSÉ — DIFFÉRENTS TYPES D’ALIMENTS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 10.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 10.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points)

3. 10.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) (caractères étroits de 7 points avec interligne de 11 points) 10.4(F) et (A) (caractères étroits de4. 7 points avec interligne de 10 points) 10.5(F) et (A) (caractères étroits de5. 6 points avec interligne de 10 points) 10.6(F) et (A) (caractères étroits de6. 6 points avec interligne de 9 points)

PARTIE 2

présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 3 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 4 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 à 5 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

MODÈLE COMPOSÉ BILINGUE — DIFFÉRENTS TYPES D’ALIMENTS

Colonne 1

Article Figure de l’annexe L(version) 11.1(B) (caractères de 8 points1. avec interligne de 12 points) 11.2(B) (caractères de 7 points2. avec interligne de 11 points) 11.3(B) (caractères étroits de3. 7 points avec interligne de 11 points)

Colonne 2

Condition d’utilisation

La version de l’article 1 ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

Les versions des articles 1 et 2 ne peuvent être présentées conformément au présent règlement sur 15 % ou moins de la surface exposée disponible.

11.4(B) Les versions des articles 1 à 3 ne peuvent être4. (caractères étroits de présentées conformément au présent règlement sur

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle double — différentes quantités d'aliments

B.01.458. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui indique des renseignements distincts en fonction de différentes quantités de l’aliment, tel qu’il est prévu à l’alinéa B.01.406(7)a), sans indiquer les renseignements visés au sous-alinéa B.01.406(7)c), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) soit selon le modèle double bilingue prévu aux figures 13.5(B) ou 13.6(B) de l’annexe L;

b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués.

(4) Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues à l’alinéa (2)a) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1

MODÈLE DOUBLE — DIFFÉRENTES QUANTITÉS D’ALIMENTS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 12.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 12.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 12.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 12.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 12.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 12.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE DOUBLE BILINGUE — DIFFÉRENTES QUANTITÉS D’ALIMENTS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 13.1(B) (caractères de 8 points1. avec interligne de 12 points) 13.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 13.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 13.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle composé — différentes quantités d'aliments

B.01.459. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé qui indique des renseignements distincts en fonction de différentes quantités de l’aliment, tel qu’il est prévu aux alinéas B.01.406(7)a) et c), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) soit selon le modèle composé bilingue prévu aux figures 15.5(B) ou 15.6(B) de l’annexe L;

b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués.

(4) Malgré les paragraphes (1) et (2), si le tableau de la valeur nutritive du produit préemballé est placé sur une étiquette mobile attachée à un emballage décoratif ou sur une étiquette mobile attachée à un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat, il est présenté selon l’une des versions prévues à l’alinéa (2)a) ou selon l’une des versions figurant à la colonne 1 du tableau du présent article, sans égard à toute condition prévue à la colonne 2.

TABLEAU PARTIE 1 MODÈLE COMPOSÉ — DIFFÉRENTES QUANTITÉS D’ALIMENTS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 14.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 14.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 14.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 14.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 14.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 14.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE COMPOSÉ BILINGUE — DIFFÉRENTES QUANTITÉS D’ALIMENTS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 15.1(B) (caractères de 8 points1. avec interligne de 12 points) 15.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 15.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 15.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Présentation des renseignements complémentaires

B.01.460. (1) Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 qui sont indiqués dans la version du tableau de la valeur nutritive se composant d’un tableau en anglais et d’un tableau en français ou d’un tableau en anglais ou en français sont présentés :

a) selon l’ordre, les retraits et les notes complémentaires indiqués aux figures 18.1(F) et (A) de l’annexe L;

b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable de l’annexe L.

(2) Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 indiqués dans la version du tableau de la valeur nutritive se composant d’un tableau en anglais et en français sont présentés :

a) selon l’ordre, les retraits et les notes complémentaires indiqués à la figure 19.1(B) de l’annexe L;

b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable de l’annexe L.

(3) Malgré l’alinéa (1)a), les retraits indiqués aux figures 18.1(F) et (A) de l’annexe L ne s’appliquent pas si les renseignements visés à la colonne 1 du tableau de l’article B.01.402 sont présentés selon le modèle linéaire visé à l’alinéa B.01.454(3)c) ou le modèle linéaire simplifié visé à l’alinéa B.01.455(3)c).

DORS/2003-11, art. 20.

Modèles standard et horizontal — enfants âgés de moins de deux ans

[DORS/2003-11, art. 20; err.(A), Vol. 137, no 5]

B.01.461. (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans, à moins que l’un des articles B.01.462, B.01.463 et B.01.464 s’y applique.

(2) Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(3) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une des façons suivantes :

a) selon le modèle standard bilingue prévu aux figures 22.5(B), 22.6(B) ou 22.7(B) de l’annexe L;

b) selon le modèle horizontal bilingue prévu aux figures 23.3(B) ou 23.4(B) de l’annexe L;

c) selon le modèle linéaire prévu aux figures 31.1(F) et (A) ou 31.2(F) et (A) de l’annexe L;

d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

e) d’une façon prévue à l’article B.01.466.

(4) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement.

TABLEAU PARTIE 1 MODÈLE STANDARD — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 20.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 20.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 20.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 20.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 20.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

6. 20.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) (caractères étroits de présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE STANDARD ÉTROIT — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 21.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 21.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 21.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 21.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

PARTIE 3 MODÈLE STANDARD BILINGUE — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 22.1(B) (caractères de 8 points1. avec interligne de 12 points) 22.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 22.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 22.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

PARTIE 4 MODÈLE HORIZONTAL BILINGUE — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 23.1(B) Les versions des parties 1 à 3 ne peuvent être présentées (caractères étroits de1. conformément au présent règlement sur 15 % ou moins 7 points avec interligne de la surface exposée disponible. de 11 points) 23.2(B) Les versions des parties 1 à 3 et de l’article 1 ne peuvent (caractères étroits de2. être présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèles simplifiés — enfants âgés de moins de deux ans

B.01.462. (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans qui remplit la condition du paragraphe B.01.403(5) et dont le tableau de la valeur nutritive ne contient que les renseignements visés aux alinéas B.01.403(5)a) à k).

(2) Sous réserve du paragraphe (3), le tableau de la valeur nutritive du produit préemballé est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(3) Si le tableau de la valeur nutritive qui ne contient que les renseignements visés aux alinéas B.01.403(5)a) à k) ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté de l’une ou l’autre des façons suivantes :

a) selon le modèle standard simplifié bilingue prévu aux figures 25.5(B) ou 25.6(B) de l’annexe L;

b) selon le modèle horizontal simplifié bilingue prévu aux figures 26.3(B) ou 26.4(B) de l’annexe L;

c) selon le modèle linéaire simplifié prévu aux figures 32.1(F) et (A) ou 32.2(F) et (A) de l’annexe L;

d) selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

e) d’une façon prévue à l’article B.01.466.

TABLEAU PARTIE 1 MODÈLE STANDARD SIMPLIFIÉ — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 24.1(F) et (A)

1. (caractères de 8 points avec interligne de

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 12 points) 24.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 24.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 24.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 24.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 24.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE STANDARD SIMPLIFIÉ BILINGUE — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 25.1(B) (caractères de 8 points1. avec interligne de 12 points) 25.2(B) La version de l’article 1 ne peut être présentée2. (caractères de 7 points conformément au présent règlement sur 15 % ou moins

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) avec interligne de de la surface exposée disponible. 11 points) 25.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 25.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

PARTIE 3 MODÈLE HORIZONTAL SIMPLIFIÉ BILINGUE — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 26.1(B) Les versions des parties 1 et 2 ne peuvent être présentées (caractères étroits de1. conformément au présent règlement sur 15 % ou moins 7 points avec interligne de la surface exposée disponible. de 11 points) 26.2(B) Les versions des parties 1 et 2 et de l’article 1 ne peuvent (caractères étroits de2. être présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle composé — différents types d'aliments — enfants âgés de moins de deux ans

B.01.463. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans qui indique des renseignements distincts en fonction de chaque ingrédient ou aliment, tel qu’il est prévu au paragraphe B.01.406(2), à l’alinéa B.01.406(3)a) ou au paragraphe B.01.406(4), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) dans le cas de tout produit visé aux paragraphes B.01.406(2) ou (4) :

(i) soit selon le modèle composé bilingue prévu aux figures 28.5(B) ou 28.6(B) de l’annexe L,

(ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

b) dans le cas de tout produit visé à l’alinéa B.01.406(3)a) :

(i) soit selon le modèle composé bilingue prévu aux figures 28.5(B) ou 28.6(B) de l’annexe L,

(ii) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible;

(iii) soit d’une façon prévue à l’article B.01.466.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque ingrédient ou aliment pour lequel des renseignements distincts y sont indiqués.

TABLEAU PARTIE 1 MODÈLE COMPOSÉ — DIFFÉRENTS TYPES D’ALIMENTS — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 27.1(F) et (A)1. (caractères de 8 points

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) avec interligne de 12 points) 27.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 27.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 27.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 27.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 27.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2 MODÈLE COMPOSÉ BILINGUE — DIFFÉRENTS TYPES D’ALIMENTS — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 28.1(B)

1. (caractères de 8 points avec interligne de

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 12 points) 28.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 28.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 28.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Modèle composé — différentes quantités d'aliments — enfants âgés de moins de deux ans

B.01.464. (1) Sous réserve du paragraphe (2), le tableau de la valeur nutritive de tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans qui indique les renseignements distincts en fonction de différentes quantités de l’aliment, tel qu’il est prévu au paragraphe B.01.406(8), est présenté selon l’une des versions figurant à la colonne 1 du tableau du présent article, si la condition prévue à la colonne 2 est remplie.

(2) Si le tableau de la valeur nutritive ne peut être présenté conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé selon l’une des versions figurant à la colonne 1 du tableau du présent article, il est présenté :

a) soit selon le modèle composé bilingue prévu aux figures 30.5(B) ou 30.6(B) de l’annexe L;

b) soit selon l’une des versions figurant à la colonne 1 du tableau du présent article, même si le tableau de la valeur nutritive devrait être présenté sur plus de 15 % de la surface exposée disponible.

(3) Pour l’application du présent article, afin d’établir si une version du tableau de la valeur nutritive ne peut être présentée conformément au présent règlement sur 15 % ou moins de la surface exposée disponible du produit préemballé, il n’est tenu compte, dans le tableau, que des renseignements exigés par le présent règlement pour chaque quantité d’aliment pour laquelle des renseignements distincts y sont indiqués.

TABLEAU PARTIE 1 MODÈLE COMPOSÉ — DIFFÉRENTES QUANTITÉS D’ALIMENTS — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 29.1(F) et (A) (caractères de 8 points1. avec interligne de 12 points) 29.2(F) et (A) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 29.3(F) et (A) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 29.4(F) et (A) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 29.5(F) et (A) Les versions des articles 1 à 4 ne peuvent être (caractères étroits de5. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points) 29.6(F) et (A) Les versions des articles 1 à 5 ne peuvent être (caractères étroits de6. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 9 points)

PARTIE 2

MODÈLE COMPOSÉ BILINGUE — DIFFÉRENTES QUANTITÉS D’ALIMENTS — ENFANTS ÂGÉS DE MOINS DE DEUX ANS

Colonne 1 Colonne 2

Article Figure de l’annexe L Condition d’utilisation(version) 30.1(B) (caractères de 8 points1. avec interligne de 12 points) 30.2(B) La version de l’article 1 ne peut être présentée (caractères de 7 points2. conformément au présent règlement sur 15 % ou moins avec interligne de de la surface exposée disponible. 11 points) 30.3(B) Les versions des articles 1 et 2 ne peuvent être (caractères étroits de3. présentées conformément au présent règlement sur 7 points avec interligne 15 % ou moins de la surface exposée disponible. de 11 points) 30.4(B) Les versions des articles 1 à 3 ne peuvent être (caractères étroits de4. présentées conformément au présent règlement sur 6 points avec interligne 15 % ou moins de la surface exposée disponible. de 10 points)

DORS/2003-11, art. 20.

Présentation des renseignements complémentaires — enfants âgés de moins de deux ans

B.01.465. (1) Le présent article s’applique à tout produit préemballé destiné exclusivement aux enfants âgés de moins de deux ans.

(2) Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 qui sont indiqués dans une version du tableau de la valeur nutritive se composant d’un tableau en anglais et d’un tableau en français ou d’un tableau en anglais ou en français, sont présentés :

a) selon l’ordre et les retraits indiqués aux figures 33.1(F) et (A) de l’annexe L;

b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable de l’annexe L.

(3) Les renseignements visés à la colonne 1 du tableau de l’article B.01.402 qui sont indiqués dans une version du tableau de la valeur nutritive se composant d’un tableau en anglais et en français sont présentés :

a) selon l’ordre et les retraits indiqués à la figure 34.1(B) de l’annexe L;

b) quant aux autres caractéristiques de présentation, selon le modèle prévu à la figure applicable de l’annexe L.

(4) Malgré l’alinéa (2)a), les retraits indiqués aux figures 33.1(F) et (A) de l’annexe L ne s’appliquent pas si les renseignements visés à la colonne 1 du tableau de l’article B.01.402 sont présentés selon le modèle linéaire visé à l’alinéa B.01.461(3)c) ou le modèle linéaire simplifié visé à l’alinéa B.01.462(3)c).

DORS/2003-11, art. 20.

Autres modes de présentation

B.01.466. (1) Malgré l’article A.01.016, le tableau de la valeur nutritive d’un produit préemballé qui répond aux critères mentionnés aux paragraphes B.01.454(3) ou B.01.455(3), à l’alinéa B.01.457(2)b), aux paragraphes B.01.461(3) ou B.01.462(3) ou à l’alinéa B.01.463(2)b) peut être placé sur, selon le cas :

a) une étiquette mobile attachée à l’emballage;

b) un encart inséré dans l’emballage;

c) le verso d’une étiquette;

d) une étiquette dépliante;

e) un manchon, une surenveloppe ou un collier.

(2) Si le tableau de la valeur nutritive est placé conformément aux alinéas (1)b) ou c), le recto de l’étiquette en indique l’endroit en caractères d’au moins 8 points.

(3) Si le tableau de la valeur nutritive est placé conformément au paragraphe (1), il est présenté :

a) dans le cas de tout produit visé au paragraphe B.01.454(3), selon l’une des versions prévues aux alinéas B.01.454(3)a), b) et c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.454;

b) dans le cas de tout produit visé au paragraphe B.01.455(3), selon l’une des versions prévues aux alinéas B.01.455(3)a), b) et c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.455;

c) dans le cas de tout produit visé à l’alinéa B.01.457(2)b), selon l’une des versions prévues au sous-alinéa B.01.457(2)b)(i) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.457;

d) dans le cas de tout produit visé au paragraphe B.01.461(3), selon l’une des versions prévues aux alinéas B.01.461(3)a), b) et c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.461;

e) dans le cas de tout produit visé au paragraphe B.01.462(3), selon l’une des versions prévues aux alinéas B.01.462(3)a), b) et c) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.462;

f) dans le cas de tout produit visé à l’alinéa B.01.463(2)b), selon l’une des versions prévues au sous-alinéa B.01.463(2)b)(i) ou selon l’une des versions figurant à la colonne 1 du tableau de l’article B.01.463.

DORS/2003-11, art. 20.

Petits emballages

B.01.467. (1) Malgré l’article A.01.016 et sous réserve du paragraphe (2), l’étiquette de tout produit préemballé dont la surface exposée disponible est de moins de 100 cm2 peut ne pas porter le tableau de la valeur nutritive si son recto comporte des indications sur la manière dont l’acheteur ou le consommateur peut obtenir les renseignements qui devraient figurer dans le tableau.

(2) Le paragraphe (1) ne s’applique pas :

a) aux produits préemballés visés aux alinéas B.01.401(3)a), b), c) ou e);

b) aux produits préemballés contenus dans un emballage sur lequel aucune étiquette ne peut être apposée ou sur lequel les renseignements ne peuvent être indiqués lisiblement et de façon que l’acheteur ou le consommateur puisse les voir aisément dans les conditions habituelles d’achat.

(3) Les indications visées au paragraphe (1) répondent aux critères suivants :

a) elles sont présentées en caractères d’au moins 8 points;

b) elles comportent une adresse postale ou un numéro de téléphone sans frais;

c) elles figurent :

(i) soit en français et en anglais,

(ii) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette du produit aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

(4) Le fabricant du produit préemballé fournit les renseignements visés au paragraphe (1) à l’acheteur ou au consommateur sur demande :

a) sans frais;

b) de la façon suivante :

(i) soit dans la langue officielle dans laquelle les renseignements sont demandés ou, à la demande de l’acheteur ou du consommateur, dans les deux langues officielles,

(ii) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette du produit aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci;

c) sous forme d’un tableau de la valeur nutritive qui est présenté, à la fois :

(i) selon un modèle — autre qu’un modèle horizontal — qui est prévu à l’un des articles B.01.454 à B.01.459 et B.01.461 à B.01.464 et qui, autrement, figurerait sur l’étiquette du produit conformément au présent règlement,

(ii) selon l’une des versions de ce modèle figurant à la colonne 1 de l’article 1 de toute partie du tableau de l’article applicable visé au sous-alinéa (i).

(5) Dans le présent article, « langues officielles » s’entend du français et de l’anglais.

DORS/2003-11, art. 20.

[B.01.468 à B.01.499 réservés]

Allégations relatives à la teneur nutritive

Définitions

B.01.500. (1) Les définitions qui suivent s’appliquent au présent article et au tableau suivant l’article B.01.513.

« aliment de référence du même groupe alimentaire » Aliment qui peut être substitué, dans l’alimentation, à l’aliment auquel il est comparé et qui appartient, selon le cas :

a) au même groupe alimentaire que l’aliment auquel il est comparé, tel que le fromage comme aliment de référence pour le lait, ou le poulet comme aliment de référence pour le tofu;

b) à la catégorie des autres aliments, si l’aliment auquel il est comparé appartient aussi à cette catégorie, tel que les bretzels comme aliment de référence pour les croustilles;

c) à la catégorie des aliments composés, si l’aliment auquel il est comparé appartient aussi à cette catégorie, tel que la pizza comme aliment de référence pour la lasagne. (reference food of the same food group)

« aliment de référence similaire » Aliment du même type que l’aliment auquel il est comparé et qui n’a pas été transformé, formulé, reformulé ou autrement modifié de manière à augmenter ou à diminuer la valeur énergétique ou la teneur en l’élément nutritif qui fait l’objet de la comparaison, tel que le lait entier comme aliment de référence similaire pour le lait partiellement écrémé, ou les biscuits aux brisures de

chocolat ordinaires comme aliment de référence similaire pour les biscuits aux brisures de chocolat à teneur réduite en matières grasses. (similar reference food)

« aliments composés » Catégorie comprenant les aliments qui contiennent, comme ingrédients, des aliments appartenant à plus d’un groupe alimentaire ou appartenant à un ou plusieurs groupes alimentaires et mélangés avec des aliments provenant de la catégorie des autres aliments, tels que la pizza ou la lasagne. (combination foods)

« autres aliments » Catégorie comprenant les aliments qui n’appartiennent à aucun des groupes alimentaires, notamment :

a) les aliments contenant surtout des matières grasses, tels que le beurre, la margarine, l’huile ou le saindoux;

b) les aliments contenant surtout des sucres, tels que les confitures, le miel, le sirop ou les confiseries;

c) les grignotines, telles que les croustilles ou les bretzels;

d) les boissons, telles que l’eau, le thé, le café ou les boissons gazeuses;

e) les fines herbes, épices et condiments, tels que les marinades, la moutarde ou le ketchup. (other foods)

« groupe alimentaire » L’une des catégories d’aliments suivantes :

a) les produits du lait et leurs substituts dont les boissons végétales enrichies;

b) la viande, la volaille et le poisson ainsi que leurs substituts, dont les légumineuses, les oeufs, le tofu et le beurre d’arachide;

c) le pain et les produits céréaliers;

d) les légumes et les fruits. (food group)

(2) L’aliment de référence similaire visé à la colonne 3 de l’article 45 du tableau suivant l’article B.01.513 en regard du sujet « léger (énergie ou lipides) » figurant à la colonne 1 a une valeur nutritionnelle représentative d’aliments du même type qui n’ont pas été transformés, formulés, reformulés ou autrement modifiés de manière à augmenter la valeur énergétique ou la teneur en lipides.

DORS/2003-11, art. 20; DORS/2007-302, art. 4(F). Version précédente Langues

B.01.501. Les déclarations prévues aux articles B.01.503 à B.01.513 faites sur l’étiquette d’un aliment figurent :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

DORS/2003-11, art. 20.

Mentions ou allégations

B.01.502. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, caractérisant la valeur énergétique de l’aliment ou sa teneur en un élément nutritif.

(2) Le paragraphe (1) ne s’applique pas :

a) aux déclarations prévues par le présent règlement;

b) aux déclarations prévues à l’article 35 du Règlement sur les produits transformés;

c) aux déclarations prévues au paragraphe 94(4) du Règlement de 1990 sur l’inspection des viandes;

d) aux déclarations caractérisant la teneur en lactose d’un aliment;

e) aux déclarations caractérisant l’adjonction de sel dans un aliment, autres que les mentions ou les allégations figurant à la colonne 4 du tableau suivant l’article B.01.513;

f) aux déclarations caractérisant l’adjonction de sucres dans un aliment, autres que les mentions ou les allégations figurant à la colonne 4 du tableau suivant l’article B.01.513;

g) aux déclarations caractérisant la teneur en amidon d’un aliment destiné exclusivement aux enfants âgés de moins de deux ans;

h) aux déclarations « (nom de l’aliment) dégraissé », « (nom de l’aliment) déminéralisé », « (nom du sirop) à forte/haute teneur en (nom du monosaccharide ou du disaccharide) » et « (nom du sirop) à teneur élevée en (nom du monosaccharide ou du disaccharide) »;

i) aux déclarations caractérisant la teneur en un acide gras d’une huile végétale qui font partie du nom usuel de celle-ci;

j) aux déclarations caractérisant la teneur en alcool des boissons contenant plus de 0,5 % d’alcool;

k) à la déclaration « légèrement salé » faite à l’égard du poisson;

l) à la déclaration anglaise « lean » faite à l’égard d’un repas préemballé présenté comme étant conçu pour un régime amaigrissant ou un régime de maintien du poids.

DORS/2003-11, art. 20.

B.01.503. (1) Est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute mention ou toute allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 en regard de l’un des sujets figurant à la colonne 1, si les conditions suivantes sont réunies :

a) l’aliment répond aux critères mentionnés à la colonne 2;

b) s’il y a lieu, l’étiquette ou l’annonce de l’aliment répond aux critères mentionnés à la colonne 3 conformément aux articles B.01.504 à B.01.506;

c) s’il s’agit d’un aliment qui n’est pas un produit préemballé ou d’un produit préemballé pour lequel une annonce est faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique, par portion déterminée et, le cas échéant, conformément aux articles B.01.505 ou B.01.506 :

(i) soit la valeur énergétique, si l’objet de la mention ou de l’allégation est la valeur énergétique,

(ii) soit la teneur en l’élément nutritif en cause, si l’objet de la mention ou de l’allégation est un élément nutritif.

(2) Malgré le paragraphe (1), est interdite, sur l’étiquette ou dans l’annonce d’un aliment destiné exclusivement aux enfants âgés de moins de deux ans, toute mention ou toute allégation figurant à la colonne 4 du tableau suivant l’article B.01.513, sauf si la mention ou l’allégation est faite à l’égard de l’un des sujets ci-après figurant à la colonne 1 :

a) « source de protéines » visé à l’article 8;

b) « excellente source de protéines » visé à l’article 9;

c) « plus de protéines » visé à l’article 10;

d) « non additionné de sel ou de sodium » visé à l’article 35;

e) « non additionné de sucres » visé à l’article 40.

(3) Lorsqu’une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 est faite sur l’étiquette ou dans l’annonce d’un aliment, tous les mots, chiffres, signes ou symboles constituant cette mention ou allégation ont la même taille et figurent aussi bien en vue les uns que les autres.

(4) Dans la version anglaise des mentions ou des allégations, le terme « fibre » peut aussi s’orthographier « fiber ».

DORS/2003-11, art. 20.

B.01.504. Lorsqu’une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 est faite sur l’étiquette d’un aliment, les renseignements requis en vertu des critères mentionnés à la colonne 3, à la fois :

a) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé :

(i) soit la mention ou l’allégation ne paraissant qu’une seule fois,

(ii) soit, si la mention ou l’allégation est répétée, celle qui est la plus en évidence sur l’espace principal ou, à défaut, celle qui est la plus en évidence ailleurs sur l’étiquette;

b) figurent en caractères d’une taille qui est au moins égale et aussi bien en vue que :

(i) ceux de la mention ou de l’allégation ne paraissant qu’une seule fois,

(ii) si la mention ou l’allégation est répétée, ceux de celle qui est la plus en évidence sur l’espace principal ou, à défaut, ceux de celle qui est la plus en évidence ailleurs sur l’étiquette.

DORS/2003-11, art. 20.

B.01.505. Si une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 est faite dans l’annonce d’un aliment autre qu’une annonce radiophonique ou télévisée, les renseignements requis en vertu des critères mentionnés à la colonne 3 et, le cas échéant, les renseignements requis par l’alinéa B.01.503(1)c), à la fois :

a) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

b) figurent en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

DORS/2003-11, art. 20.

B.01.506. (1) Si une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 est faite dans une annonce radiophonique ou télévisée, les renseignements requis en vertu des critères mentionnés à la colonne 3 et, le cas échéant, les renseignements requis par l’alinéa B.01.503(1)c) figurent dans l’annonce, à l’exception des renseignements requis en vertu des critères mentionnés à l’alinéa a) de la colonne 3, à l’égard des sujets ci-après figurant à la colonne 1, qui peuvent être mentionnés sur l’étiquette de l’aliment :

a) « énergie réduite » visé à l’article 3;

b) « teneur réduite en lipides » visé à l’article 13;

c) « teneur réduite en acides gras saturés » visé à l’article 20;

d) « teneur réduite en acides gras trans » visé à l’article 23;

e) « teneur réduite en cholestérol » visé à l’article 29;

f) « teneur réduite en sodium ou en sel » visé à l’article 33;

g) « légèrement salé » visé à l’article 36;

h) « teneur réduite en sucres » visé à l’article 38;

i) « léger (énergie ou lipides) » visé à l’article 45.

(2) Malgré le paragraphe (1), si la mention ou l’allégation est faite dans une annonce radiophonique ou télévisée par une personne autre que le fabricant de l’aliment ou une personne agissant sous ses ordres, les renseignements requis en vertu des critères mentionnés à l’alinéa a) de la colonne 3 du tableau suivant l’article B.01.513 à l’égard des sujets visés aux alinéas (1)a) à i) sont mentionnés dans l’annonce.

(3) Si les renseignements requis en vertu des critères mentionnés à la colonne 3 du tableau suivant l’article B.01.513 et les renseignements requis par l’alinéa B.01.503(1)c) sont mentionnés dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée, ils précèdent ou suivent immédiatement la mention ou l’allégation.

(4) Dans le cas d’une annonce télévisée, les renseignements requis en vertu des critères mentionnés à la colonne 3 du tableau suivant l’article B.01.513 et, le cas échéant, les renseignements requis par l’alinéa B.01.503(1)c) sont communiqués, selon le cas :

a) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou à la fois des composantes audio et visuelle de celle-ci;

b) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(5) Les renseignements requis en vertu des critères mentionnés à la colonne 3 du tableau suivant l’article B.01.513 et les renseignements requis par l’alinéa B.01.503(1)c) qui sont communiqués en mode visuel dans une annonce télévisée, à la fois :

a) paraissent en même temps et pendant au moins la même durée que la mention ou l’allégation;

b) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

c) figurent en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

DORS/2003-11, art. 20.

B.01.507. Est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, selon laquelle l’aliment est conçu pour un régime à teneur réduite en énergie si une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 en regard de l’un des sujets ci-après figurant à la colonne 1 est faite sur l’étiquette ou dans l’annonce conformément à l’article B.01.503 :

a) « sans énergie » visé à l’article 1;

b) « peu d’énergie » visé à l’article 2;

c) « énergie réduite » visé à l’article 3;

d) « moins d’énergie » visé à l’article 4;

e) « sans sucres » visé à l’article 37.

DORS/2003-11, art. 20.

B.01.508. Est permise, sur l’étiquette ou dans l’annonce d’un aliment, toute déclaration, expresse ou implicite, selon laquelle l’aliment est conçu pour un régime à teneur réduite en sodium si une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 en regard de l’un des sujets ci-après figurant à la colonne 1 est faite sur l’étiquette ou dans l’annonce conformément à l’article B.01.503 :

a) « sans sodium ou sans sel » visé à l’article 31;

b) « faible teneur en sodium ou en sel » visé à l’article 32;

c) « teneur réduite en sodium ou en sel » visé à l’article 33;

d) « moins de sodium ou de sel » visé à l’article 34.

DORS/2003-11, art. 20.

B.01.509. Est permise, sur l’étiquette ou dans l’annonce d’un aliment, la mention ou l’allégation « non sucré » si l’aliment répond aux critères mentionnés à la colonne 2 de l’article 40 du tableau suivant l’article B.01.513 en regard du sujet « non additionné de sucres » figurant à la colonne 1 et s’il ne contient aucun des édulcorants mentionnés à la colonne 1 du tableau IX de l’article B.16.100.

DORS/2003-11, art. 20.

B.01.510. Toute mention ou toute allégation figurant à la colonne 4 du tableau suivant l’article B.01.513 en regard des sujets ci-après figurant à la colonne 1, faite sur l’étiquette ou dans l’annonce de céréales à déjeuner avec du lait, est accompagnée d’une indication que la mention ou l’allégation est faite à l’égard de 30 g de céréales à déjeuner combinées avec 125 mL de lait :

a) « source de protéines » visé à l’article 8;

b) « excellente source de protéines » visé à l’article 9;

c) « plus de protéines » visé à l’article 10.

DORS/2003-11, art. 20.

B.01.511. (1) Sous réserve des paragraphes (2) à (4), il est entendu que toute mention ou toute allégation figurant à la colonne 4 du tableau suivant l’article B.01.513, faite sur

l’étiquette ou dans l’annonce d’un aliment, ne peut être entrecoupée d’autres mots, chiffres, signes ou symboles, mais peut en être précédée ou suivie.

(2) Les mots « très », « ultra » et « extra », et tout autre mot, chiffre, signe ou symbole modifiant la nature de la mention ou de l’allégation, ne peuvent précéder ou suivre celle­ ci.

(3) Toute mention ou toute allégation faite sur l’étiquette ou dans l’annonce d’un aliment qui n’a pas été transformé, formulé, reformulé ou autrement modifié afin de répondre aux critères mentionnés à la colonne 2 du tableau suivant l’article B.01.513 ne peut être accompagnée de la marque de l’aliment.

(4) Tout mot, chiffre, signe ou symbole qui précède ou suit la mention ou l’allégation visée au paragraphe (3) fait en sorte que la mention ou l’allégation caractérise tous les aliments du même type que l’aliment en cause et non seulement celui-ci en particulier.

DORS/2003-11, art. 20.

B.01.512. Si un aliment répond aux critères mentionnés à la colonne 2 du tableau suivant l’article B.01.513 en regard de plusieurs sujets figurant à la colonne 1, la répétition de l’élément commun, dans les mentions ou les allégations figurant à la colonne 4 faites sur l’étiquette ou dans l’annonce de l’aliment, n’est pas nécessaire et les éléments dissemblables peuvent être unis au moyen d’une conjonction ou d’un signe de ponctuation, selon le cas.

DORS/2003-11, art. 20.

Caractéristique organoleptique

B.01.513. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, la mention ou l’allégation « léger » ou « light », de même que toute mention ou toute allégation ayant la même consonance que celle-ci, à l’égard d’une caractéristique organoleptique de l’aliment, à moins que les conditions suivantes soient réunies :

a) si la mention ou l’allégation « léger » ou « light » est faite sur l’étiquette d’un aliment, la caractéristique organoleptique, à la fois :

(i) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé :

(A) la mention ou l’allégation ne paraissant qu’une seule fois,

(B) si la mention ou l’allégation est répétée, celle qui est la plus en évidence sur l’espace principal ou, à défaut, celle qui est la plus en évidence ailleurs sur l’étiquette,

(ii) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que :

(A) ceux de la mention ou de l’allégation ne paraissant qu’une seule fois,

(B) si la mention ou l’allégation est répétée, ceux de celle qui est la plus en évidence sur l’espace principal ou, à défaut, ceux de celle qui est la plus en évidence ailleurs sur l’étiquette;

b) si la mention ou l’allégation « léger » ou « light » est faite dans l’annonce d’un aliment autre qu’une annonce radiophonique ou télévisée, la caractéristique organoleptique, à la fois :

(i) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si une telle mention ou allégation est répétée, celle qui est la plus en évidence,

(ii) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence;

c) si la mention ou l’allégation « léger » ou « light » est faite dans une annonce radiophonique ou dans la composante audio d’une annonce télévisée, la caractéristique organoleptique précède ou suit immédiatement la mention ou l’allégation;

d) si la mention ou l’allégation « léger » ou « light » est faite dans la composante visuelle d’une annonce télévisée, la caractéristique organoleptique, à la fois :

(i) paraît en même temps et pendant la même durée que la mention ou l’allégation,

(ii) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence,

(iii) figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

(2) Le paragraphe (1) ne s’applique pas :

a) à la mention ou à l’allégation anglaise « light » faite conformément au paragraphe 12(1) du Règlement sur les produits de l’érable;

b) à la mention ou à l’allégation « léger » ou « light » faite à l’égard du rhum.

TABLEAU

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

L’aliment fournit « sans énergie »,

1. Sans énergie moins de 5 Caloriesou 21 kilojoules par « 0 énergie », « zéro énergie », « aucune

quantité de référence énergie », « ne fournit

Colonne 1 Colonne 2

Article Sujet Critères — aliments

et par portion déterminée.

Peu d’énergie L’aliment fournit,2. selon le cas : a) au plus 40 Calories ou 167 kilojoules par quantité de référence et par portion déterminée et, dans le cas d’un aliment autre qu’un édulcorant de table, par 50 g si la quantité de référence est 30 g ou 30 mL ou moins; b) au plus 120 Calories ou 500 kilojoules par 100 g, si l’aliment est un repas préemballé. (1) L’aliment présente, après transformation, formulation,

3. Énergie reformulation ouréduite autre modification, une diminution d’au moins 25 % de sa valeur énergétique, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence similaire; b) par 100 g, par

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de

Colonne 4

Mention ou allégation

pas d’énergie », « sans Calories », « 0 Calorie », « zéro Calorie », « aucune Calorie » ou « ne fournit pas de Calories »

« peu d’énergie », « peu de Calories », « faible valeur énergétique », « pauvre en énergie », « pauvre en Calories », « fournit seulement (quantité) Calories par portion », « fournit moins de (quantité) Calories par portion », « hypocalorique » ou « peu calorique »

« énergie réduite », « valeur énergétique réduite », « moins d’énergie », « plus faible valeur énergétique », « plus pauvre en énergie », « moins de Calories » ou « plus pauvre en Calories »

Colonne 1

Article Sujet

Moins4. d’énergie

Colonne 2

Critères — aliments

rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 en regard du sujet « peu d’énergie » figurant à la colonne 1.

La valeur énergétique de l’aliment est d’au moins 25 % inférieure, selon le cas : a) par quantité de référence, à celle de l’aliment de référence du même groupe alimentaire;

b) par 100 g, à celle de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de

Colonne 3 Critères — étiquette ou annonce l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de valeur énergétique, par portion déterminée, exprimée en pourcentage, en fraction ou en Calories, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de valeur énergétique, par portion déterminée, exprimée en pourcentage, en

Colonne 4

Mention ou allégation

« moins d’énergie », « plus faible valeur énergétique », « plus pauvre en énergie », « moins de Calories » ou « plus pauvre en Calories »

Colonne 1

Article Sujet

Source5. d’énergie

6. Plus d’énergie

Colonne 2

Critères — aliments

l’article 2 en regard du sujet « peu d’énergie » figurant à la colonne 1.

L’aliment fournit au moins 100 Calories ou 420 kilojoules par quantité de référence et par portion déterminée. L’aliment fournit au moins 25 % plus d’énergie, soit au moins 100 Calories ou 420 kilojoules de plus, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce fraction ou en Calories, par rapport à l’aliment de référence du même groupe alimentaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire ou de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de valeur énergétique, par portion déterminée, exprimée en pourcentage, en

Colonne 4

Mention ou allégation

« source d’énergie », « fournit de l’énergie », « source de Calories » ou « fournit des Calories »

« plus de Calories », « fournit plus de Calories »

Colonne 1

Article Sujet

Faible teneur7. en protéines

Source de8. protéines

Excellente 9. source de

protéines

Colonne 2

Critères — aliments

L’aliment contient, par 100 g, au plus 1 g de protéines.

L’aliment a une cote protéique d’au moins 20, déterminée selon la méthode officielle FO-1 intitulée Détermination de cote protéique, du 15 octobre 1981, selon le cas : a) par ration quotidienne raisonnable; b) par 30 g, combiné avec 125 mL de lait, s’il s’agit de céréales à déjeuner. L’aliment a une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1 intitulée Détermination de cote protéique, du 15 octobre 1981, selon le cas :

Colonne 3 Critères — étiquette ou annonce fraction ou en Calories, par rapport à l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire.

Colonne 4

Mention ou allégation

« faible teneur en protéines », « pauvre en protéines », « contient seulement (quantité) g de protéines par portion » ou « contient moins de (quantité) g de protéines par portion »

« source de protéines », « contient des protéines », « bonne source de protéines » ou « teneur élevée en protéines »

« excellente source de protéines », « très bonne source de protéines », « teneur très élevée en protéines » ou « riche en protéines »

Colonne 1

Article Sujet

Plus de10. protéines

Colonne 2

Critères — aliments

a) par ration quotidienne raisonnable; b) par 30 g, combiné avec 125 mL de lait, s’il s’agit de céréales à déjeuner.

L’aliment a, à la fois :

a) une cote protéique d’au moins 20, déterminée selon la méthode officielle FO-1, intitulée Détermination de cote protéique du 15 octobre 1981, selon le cas :

(i) par ration quotidienne raisonnable,

(ii) par 30 g, combiné avec 125 mL de lait, s’il s’agit de céréales à déjeuner;

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire ou de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en protéines, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence du même groupe

Colonne 4

Mention ou allégation

« plus de protéines »

Colonne 1

Article Sujet

11. Sans lipides

12. Faible teneur en lipides

Colonne 2

Critères — aliments

b) une teneur en protéines supérieure d’au moins 25 %, soit au moins 7 g de plus, par ration quotidienne raisonnable par rapport à l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire. L’aliment contient, selon le cas : a) moins de 0,5 g de lipides par quantité de référence et par portion déterminée;

b) moins de 0,5 g de lipides par portion déterminée, si l’aliment est un repas préemballé.

L’aliment contient, selon le cas :

a) au plus 3 g de lipides par quantité de référence et par

Colonne 3 Critères — étiquette ou annonce alimentaire ou l’aliment de référence similaire.

Colonne 4

Mention ou allégation

« sans lipides », « 0 lipide », « zéro lipide », « aucun lipide », « ne contient pas de lipides », « sans matières grasses », « 0 matière grasse », « zéro matière grasse », « aucune matière grasse », « ne contient pas de matières grasses », « sans gras », « 0 gras », « zéro gras », « aucun gras », « ne contient pas de gras », « sans graisses », « 0 graisse », « zéro graisse », « aucune graisse » ou « ne contient pas de graisses » « faible teneur en lipides », « pauvre en lipides », « contient seulement (quantité) g de lipides par portion »,

Colonne 1

Article Sujet

Teneur 13. réduite en

lipides

Colonne 2

Critères — aliments

portion déterminée, et par 50 g si la quantité de référence est 30 g ou 30 mL ou moins;

b) au plus 3 g de lipides par 100 g, 30 % ou moins de l’énergie provenant des lipides, si l’aliment est un repas préemballé.

(1) L’aliment présente, après transformation, formulation, reformulation ou autre modification, une diminution d’au moins 25 % de la teneur en lipides, selon le cas :

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

Colonne 4

Mention ou allégation

« contient moins de (quantité) g de lipides par portion », « peu de lipides », « faible teneur en matières grasses », « pauvre en matières grasses », « contient seulement (quantité) g de matières grasses par portion », « contient moins de (quantité) g de matières grasses par portion », « peu de matières grasses », « faible teneur en gras », « pauvre en gras », « contient seulement (quantité) g de gras par portion », « contient moins de (quantité) g de gras par portion », « peu de gras », « faible teneur en graisses », « pauvre en graisses », « contient seulement (quantité) g de graisses par portion », « contient moins de (quantité) g de graisses par portion » ou « peu de graisses » « teneur réduite en lipides », « moins de lipides », « teneur plus faible en lipides », « plus pauvre en lipides », « teneur réduite en matières grasses », « moins de matières grasses », « teneur plus faible en

Colonne 1

Article Sujet

Moins de14. lipides

Colonne 2

Critères — aliments

a) par quantité de référence, par rapport à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 12 en regard du sujet « faible teneur en lipides » figurant à la colonne 1.

(1) La teneur en lipides de l’aliment est d’au moins 25 % inférieure, selon le cas : a) par quantité de référence, à celle de l’aliment de référence du même groupe alimentaire;

b) par 100 g, à celle de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en lipides, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent;

Colonne 4

Mention ou allégation

matières grasses », « plus pauvre en matières grasses », « teneur réduite en gras », « moins de gras », « teneur plus faible en gras », « plus pauvre en gras », « teneur réduite en graisses », « moins de graisses », « teneur plus faible en graisses » ou « plus pauvre en graisses »

« moins de lipides », « teneur plus faible en lipides », « plus pauvre en lipides », « moins de matières grasses », « teneur plus faible en matières grasses », « plus pauvre en matières grasses », « moins de gras », « teneur plus faible en gras », « plus pauvre en gras », « moins de graisses », « teneur plus faible en graisses » ou « plus pauvre en graisses »

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

100 % sans15. lipides

(Pourcentage)16. sans lipides

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 12 en regard du sujet « faible teneur en lipides » figurant à la colonne 1.

L’aliment, à la fois :

a) contient moins de 0,5 g de lipides par 100 g; b) ne contient pas de lipides ajoutés; c) répond aux critères mentionnés à la colonne 2 de l’article 11 en regard du sujet « sans lipides » figurant à la colonne 1.

L’aliment répond aux est faite :

c) la différence de teneur en lipides, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence du même groupe alimentaire.

L’une des mentions ou allégations ci-après

« 100 % sans lipides », « 100 % sans matières grasses », « 100 % sans gras » ou « 100 % sans graisses »

« (pourcentage) sans lipides », « (pourcentage) sans matières grasses », « (pourcentage) sans gras » ou « (pourcentage) sans graisses »

critères mentionnés à la colonne 2 de l’article 12 en regard du sujet « faible teneur en lipides » figurant à la colonne 1.

« faible teneur en lipides », « faible teneur en matières grasses », « faible teneur en gras », « faible teneur en graisses », « pauvre en lipides », « pauvre en matières

Colonne 1

Article Sujet

Non additionné de17. matières grasses

18.

Sans acides gras saturés

Colonne 2

Critères — aliments

(1) Aucune graisse ou huile visée au titre 9, ni aucun beurre, ghee ou ingrédient additionné de graisse ou d’huile, de beurre ou de ghee n’a été ajouté à l’aliment. (2) L’aliment de référence similaire est additionné de graisse ou d’huile visée au titre 9, de beurre ou de ghee. L’aliment contient, selon le cas : a) moins de 0,2 g d’acides gras saturés et moins de 0,2 g d’acides gras trans par quantité de référence et par portion déterminée;

b) moins de 0,2 g d’acides gras saturés et moins de 0,2 g d’acides gras trans par portion déterminée si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce grasses », « pauvre en gras » ou « pauvre en graisses »

Colonne 4

Mention ou allégation

« non additionné de matières grasses », « sans matières grasses ajoutées » ou « aucune addition de matières grasses »

« sans acides gras saturés », « 0 acide gras saturé », « zéro acide gras saturé », « aucun acide gras saturé », « ne contient pas d’acides gras saturés », « sans lipides saturés », « 0 lipide saturé », « zéro lipide saturé », « aucun lipide saturé », « ne contient pas de lipides saturés », « sans gras saturés », « 0 gras saturé », « zéro gras saturé », « aucun gras saturé », « ne contient pas de gras saturés », « sans graisses saturées », « 0 graisse saturée », « zéro graisse saturée », « aucune graisse saturée », « ne

Colonne 1

Article Sujet

Faible teneur 19. en acides gras

saturés

Colonne 2

Critères — aliments

(1) La somme des acides gras saturés et des acides gras trans que contient l’aliment n’excède pas 2 g, selon le cas : a) par quantité de référence et par portion déterminée; b) par 100 g, si l’aliment est un repas préemballé.

(2) L’aliment fournit au plus 15 % d’énergie provenant de la somme des acides gras saturés et des acides gras trans.

Colonne 3 Critères — étiquette ou annonce

Colonne 4

Mention ou allégation

contient pas de graisses saturées », « sans saturés », « 0 saturé », « zéro saturé », « aucun saturé » ou « ne contient pas de saturés » « faible teneur en acides gras saturés », « pauvre en acides gras saturés », « contient seulement (quantité) g d’acides gras saturés par portion », « contient moins de (quantité) g d’acides gras saturés par portion », « peu d’acide gras saturés », « faible teneur en lipides saturés », « pauvre en lipides saturés », « contient seulement (quantité) g de lipides saturés par portion », « contient moins de (quantité) g de lipides saturés par portion », « peu de lipides saturés », « faible teneur en gras saturés », « pauvre en gras saturés », « contient seulement (quantité) g de gras saturés par portion », « contient moins de (quantité) g de gras saturés par portion », « peu de gras saturés », « faible teneur en graisses saturées », « pauvre en graisses

Colonne 1

Article Sujet

Teneur réduite en20. acides gras saturés

Colonne 2

Critères — aliments

(1) L’aliment présente, après transformation, formulation, reformulation ou autre modification, une diminution d’au moins 25 % de la teneur en acides gras saturés — sans augmentation de la teneur en acides gras trans, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent;

Colonne 4

Mention ou allégation

saturées », « contient seulement (quantité) g de graisses saturées par portion », « contient moins de (quantité) g de graisses saturées par portion », « peu de graisses saturées », « faible teneur en saturés », « pauvre en saturés », « contient seulement (quantité) g de saturés par portion », « contient moins de (quantité) g de saturés par portion » ou « peu de saturés » « teneur réduite en acides gras saturés », « moins d’acides gras saturés », « teneur plus faible en acides gras saturés », « plus pauvre en acides gras saturés », « teneur réduite en lipides saturés », « moins de lipides saturés », « teneur plus faible en lipides saturés », « plus pauvre en lipides saturés », « teneur réduite en gras saturés », « moins de gras saturés », « teneur plus faible en gras saturés », « plus pauvre en gras saturés », « teneur réduite en graisses saturées », « moins de graisses saturées », « teneur plus

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

Moins 21. d’acides gras

saturés

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1.

(1) La teneur en acides gras saturés de l’aliment est d’au moins 25 % inférieure et sa teneur en acides gras trans n’est pas supérieure, selon le cas : a) par quantité de référence, à celles de l’aliment de référence du même groupe alimentaire;

b) par 100 g, à celles de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras

c) la différence de teneur en acides gras saturés, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en acides gras saturés, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment

faible en graisses saturées », « plus pauvre en graisses saturées », « teneur réduite en saturés », « moins de saturés », « teneur plus faible en saturés » ou « plus pauvre en saturés »

« moins d’acides gras saturés », « teneur plus faible en acides gras saturés », « plus pauvre en acides gras saturés », « moins de lipides saturés », « teneur plus faible en lipides saturés », « plus pauvre en lipides saturés », « moins de gras saturés », « teneur plus faible en gras saturés », « plus pauvre en gras saturés », « moins de graisses saturées », « teneur plus faible en graisses saturées », « plus pauvre en graisses saturées », « moins de saturés », « teneur plus faible en saturés » ou « plus pauvre en saturés »

Colonne 1

Article Sujet

22. Sans acides gras trans

23. Teneur réduite en acides gras trans

Colonne 2

Critères — aliments

saturés » figurant à la colonne 1.

L’aliment, à la fois : a) contient moins de 0,2 g d’acides gras trans, selon le cas :

(i) par quantité de référence et par portion déterminée,

(ii) par portion déterminée si l’aliment est un repas préemballé;

b) répond aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1.

(1) L’aliment présente, après transformation, formulation, reformulation ou autre modification, une diminution d’au moins 25 % de la teneur en acides gras

Colonne 3 Critères — étiquette ou annonce de référence du même groupe alimentaire.

Les renseignements suivants sont mentionnés :

Colonne 4

Mention ou allégation

« sans acides gras trans », « 0 acide gras trans », « zéro acide gras trans », « aucun acide gras trans », « ne contient pas d’acides gras trans », « sans lipides trans », « 0 lipide trans », « zéro lipide trans », « aucun lipide trans », « ne contient pas de lipides trans », « sans gras trans », « 0 gras trans », « zéro gras trans », « aucun gras trans », « ne contient pas de gras trans », « sans graisses trans », « 0 graisse trans », « zéro graisse trans », « aucune graisse trans », « ne contient pas de graisses trans », « sans trans », « 0 trans », « zéro trans », « aucun trans » ou « ne contient pas de trans » « teneur réduite en acides gras trans », « moins d’acides gras trans », « teneur plus faible en acides gras trans », « plus pauvre en acides gras trans », « teneur réduite en lipides trans », « moins

Colonne 1

Article Sujet

Moins 24. d’acides gras

trans

Colonne 2

Critères — aliments

trans — sans augmentation de la teneur en acides gras saturés, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1.

(1) La teneur en acides gras trans de l’aliment est d’au moins 25 % inférieure et sa teneur en acides gras saturés n’est pas supérieure, selon le cas : a) par quantité de référence, à celles de l’aliment de référence du même groupe alimentaire;

b) par 100 g, à celles

Colonne 3 Critères — étiquette ou annonce

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en acides gras trans, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de

Colonne 4

Mention ou allégation

de lipides trans », « teneur plus faible en lipides trans », « plus pauvre en lipides trans », « teneur réduite en gras trans », « moins de gras trans », « teneur plus faible en gras trans », « plus pauvre en gras trans », « teneur réduite en graisses trans », « moins de graisses trans », « teneur plus faible en graisses trans », « plus pauvre en graisses trans », « teneur réduite en trans », « moins de trans », « teneur plus faible en trans » ou « plus pauvre en trans »

« moins d’acides gras trans », « teneur plus faible en acides gras trans », « plus pauvre en acides gras trans », « moins de lipides trans », « teneur plus faible en lipides trans », « plus pauvre en lipides trans », « moins de gras trans », « teneur plus faible en gras trans », « plus pauvre en gras trans », « moins de graisses trans »,

Colonne 1

Article Sujet

25.

Source d’acides gras polyinsaturés oméga-3

Colonne 2

Critères — aliments

de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1.

L’aliment contient, selon le cas : a) au moins 0,3 g d’acides gras polyinsaturés oméga­ 3 par quantité de référence et par portion déterminée;

b) au moins 0,3 g d’acides gras polyinsaturés oméga­ 3 par 100 g si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en acides gras trans, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence du même groupe alimentaire.

Colonne 4

Mention ou allégation

« teneur plus faible en graisses trans », « plus pauvre en graisses trans », « moins de trans », « teneur plus faible en trans » ou « plus pauvre en trans »

« source d’acides gras polyinsaturés oméga­ 3 », « contient des acides gras polyinsaturés oméga­ 3 », « source de lipides polyinsaturés oméga­ 3 », « contient des lipides polyinsaturés oméga-3 », « source de gras polyinsaturés oméga-3 », « contient des gras polyinsaturés oméga-3 », « source de graisses polyinsaturées oméga-3 », « contient des graisses polyinsaturées oméga­ 3 », « source de polyinsaturés oméga­ 3 » ou « contient des polyinsaturés oméga­

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

3 »

26. L’aliment contient,selon le cas : « source d’acides gras polyinsaturés oméga-

Source d’acides gras polyinsaturés oméga-6

a) au moins 2 g d’acides gras polyinsaturés oméga­ 6 par quantité de référence et par portion déterminée;

6 », « contient des acides gras polyinsaturés oméga­ 6 », « source de lipides polyinsaturés oméga­ 6 », « contient des lipides polyinsaturés oméga-6 », « source de gras polyinsaturés oméga-6 », « contient

b) au moins 2 g d’acides gras polyinsaturés oméga­ 6 par 100 g, si l’aliment est un repas préemballé.

des gras polyinsaturés oméga-6 », « source de graisses polyinsaturées oméga-6 », « contient des graisses polyinsaturées oméga­ 6 », « source de polyinsaturés oméga­ 6 » ou « contient des polyinsaturés oméga­ 6 »

27. Sanscholestérol L’aliment, à la fois :

a) contient moins de 2 mg de cholestérol, selon le cas :

« sans cholestérol », « 0 cholestérol », « zéro cholestérol », « aucun cholestérol » ou « ne

(i) par quantité de référence et par

contient pas de cholestérol »

portion déterminée,

(ii) par portion déterminée, si l’aliment est un repas préemballé;

b) répond aux critères mentionnés à la colonne 2 de l’article

Colonne 1

Article Sujet

28. Faible teneur en cholestérol

Teneur 29. réduite en

cholestérol

Colonne 2

Critères — aliments

19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1. L’aliment, à la fois : a) contient au plus 20 mg de cholestérol, selon le cas :

(i) par quantité de référence et par portion déterminée, et par 50 g si la quantité de référence est 30 g ou 30 mL ou moins,

(ii) par 100 g, si l’aliment est un repas préemballé;

b) répond aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1. (1) L’aliment présente, après transformation, formulation, reformulation ou autre modification, une diminution d’au moins 25 % de la teneur en cholestérol, selon le cas : a) par quantité de référence, par rapport

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

Colonne 4

Mention ou allégation

« faible teneur en cholestérol », « pauvre en cholestérol », « contient seulement (quantité) mg de cholestérol par portion », « contient moins de (quantité) mg de cholestérol par portion » ou « peu de cholestérol »

« teneur réduite en cholestérol », « moins de cholestérol », « teneur plus faible en cholestérol » ou « plus pauvre en cholestérol »

Colonne 1

Article Sujet

Moins de30. cholestérol

Colonne 2

Critères — aliments

à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 28 en regard du sujet « faible teneur en cholestérol » figurant à la colonne 1.

(3) L’aliment répond aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1. (1) La teneur en cholestérol de l’aliment est d’au moins 25 % inférieure, selon le cas : a) par quantité de référence, à celle de l’aliment de référence du même groupe alimentaire;

Colonne 3 Critères — étiquette ou annonce

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en cholestérol, par portion déterminée, exprimée en pourcentage, en fraction ou en milligrammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

Colonne 4

Mention ou allégation

« moins de cholestérol », « teneur plus faible en cholestérol » ou « plus pauvre en cholestérol »

Colonne 1

Article Sujet

31.

Sans sodium ou sans sel

Colonne 2

Critères — aliments

b) par 100 g, à celle de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 28 en regard du sujet « faible teneur en cholestérol » figurant à la colonne 1.

(3) L’aliment répond aux critères mentionnés à la colonne 2 de l’article 19 en regard du sujet « faible teneur en acides gras saturés » figurant à la colonne 1. L’aliment contient, selon le cas : a) moins de 5 mg de sodium par quantité de référence et par portion déterminée; b) moins de 5 mg de sodium par portion déterminée, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en cholestérol, par portion déterminée, exprimée en pourcentage, en fraction ou en milligrammes, par rapport à l’aliment de référence du même groupe alimentaire.

Colonne 4

Mention ou allégation

« sans sodium », « 0 sodium », « zéro sodium », « aucun sodium », « ne contient pas de sodium », « sans sel », « 0 sel », « zéro sel », « aucun sel » ou « ne contient pas de sel »

Colonne 1

Article Sujet

32.

Faible teneur en sodium ou en sel

Teneur réduite en33. sodium ou en sel

Colonne 2

Critères — aliments

L’aliment contient, selon le cas : a) au plus 140 mg de sodium par quantité de référence et par portion déterminée, et par 50 g si la quantité de référence est 30 g ou 30 mL ou moins;

b) au plus 140 mg de sodium par 100 g, si l’aliment est un repas préemballé.

(1) L’aliment présente, après transformation, formulation, reformulation ou autre modification, une diminution d’au moins 25 % de la teneur en sodium, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence similaire, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent;

Colonne 4

Mention ou allégation

« faible teneur en sodium », « pauvre en sodium », « contient seulement (quantité) mg de sodium par portion », « contient moins de (quantité) mg de sodium par portion », « peu de sodium », « hyposodique », « faible teneur en sel », « pauvre en sel », « contient seulement (quantité) mg de sel par portion », « contient moins de (quantité) mg de sel par portion », « peu de sel » ou « peu salé »

« teneur réduite en sodium », « moins de sodium », « teneur plus faible en sodium », « plus pauvre en sodium », « teneur réduite en sel », « moins de sel », « moins salé », « teneur plus faible en sel » ou « plus pauvre en sel »

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

Moins de 34. sodium ou de

sel

(2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 32 en regard du sujet « faible teneur en sodium ou en sel » figurant à la colonne 1.

(1) La teneur en sodium de l’aliment est d’au moins 25 % inférieure, selon le cas : a) par quantité de référence, à celle de l’aliment de référence du même groupe alimentaire;

b) par 100 g, à celle de l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

(2) L’aliment de référence du même groupe alimentaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 32 en regard du sujet « faible teneur en sodium ou en sel » figurant à la colonne 1.

c) la différence de teneur en sodium, par portion déterminée, exprimée en pourcentage, en fraction ou en milligrammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en sodium, par portion déterminée, exprimée en pourcentage, en fraction ou en milligrammes, par rapport à l’aliment de référence du même groupe alimentaire.

« moins de sodium », « teneur plus faible en sodium », « plus pauvre en sodium », « moins de sel », « moins salé », « teneur plus faible en sel » ou « plus pauvre en sel »

Colonne 1

Article Sujet

Non additionné de35. sel ou de sodium

Légèrement36. salé

Colonne 2

Critères — aliments

(1) L’aliment ne contient aucun sel ajouté, aucun autre sel de sodium ni ingrédient contenant du sodium et ayant le même effet que du sel ajouté. (2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 32 en regard du sujet « faible teneur en sodium ou en sel » figurant à la colonne 1, et contient du sel ajouté ou d’autres sels de sodium. (1) L’aliment présente une diminution d’au moins 50 % de la teneur en sodium ajouté par rapport à l’aliment de référence similaire. (2) L’aliment de référence similaire ne répond pas aux critères mentionnés à la colonne 2 de l’article 32 en regard du sujet « faible teneur en sodium ou en sel » figurant à la colonne 1.

Colonne 3 Critères — étiquette ou annonce

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent;

c) la différence de teneur en sodium,

Colonne 4

Mention ou allégation

« non additionné de sel », « sans sel ajouté », « aucune addition de sel », « non salé », « aucun sel ajouté », « non additionné de sodium », « sans sodium ajouté », « aucune addition de sodium » ou « aucun sodium ajouté »

« légèrement salé » ou « salé légèrement »

Colonne 1

Article Sujet

37. Sans sucres

Teneur 38. réduite en

sucres

Colonne 2

Critères — aliments

L’aliment, à la fois : a) contient moins de 0,5 g de sucres par quantité de référence et par portion déterminée; b) à l’exception de la gomme à mâcher, répond aux critères mentionnés à la colonne 2 de l’article 1 en regard du sujet « sans énergie » figurant à la colonne 1. La teneur en sucres de l’aliment, après transformation, formulation, reformulation ou autre modification, est inférieure d’au moins 25 %, soit d’au moins 5 g, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence similaire; b) par 100 g, par rapport à l’aliment de

Colonne 3 Critères — étiquette ou annonce par portion déterminée, exprimée en pourcentage, en fraction ou en milligrammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle

Colonne 4

Mention ou allégation

« sans sucre », « 0 sucre », « zéro sucre », « aucun sucre » ou « ne contient pas de sucre »

« teneur réduite en sucre », « moins de sucre », « moins sucré », « teneur plus faible en sucre » ou « plus pauvre en sucre »

Colonne 1

Article Sujet

Moins de39. sucres

Colonne 2

Critères — aliments

référence similaire, si l’aliment est un repas préemballé.

La teneur en sucres de l’aliment est inférieure d’au moins 25 %, soit d’au moins 5 g, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence du même groupe alimentaire;

b) par 100 g, par rapport à l’aliment de référence du même groupe alimentaire, si l’aliment est un repas préemballé.

Colonne 3 Critères — étiquette ou annonce de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en sucres, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence du même groupe alimentaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en sucres, par portion déterminée, exprimée en pourcentage, en fraction ou en

Colonne 4

Mention ou allégation

« moins de sucre », « moins sucré », « teneur plus faible en sucre » ou « plus pauvre en sucre »

Colonne 1

Article Sujet

Non 40. additionné de

sucres

Source de41. fibres

Colonne 2

Critères — aliments

(1) L’aliment ne contient aucun sucre ajouté, aucun ingrédient additionné de sucres, ni aucun ingrédient contenant des sucres ayant un pouvoir édulcorant. (2) Pas d’augmentation délibérée de la teneur en sucres par d’autres moyens; l’augmentation peut toutefois résulter d’un traitement effectué à d’autres fins. (3) L’aliment de référence similaire contient des sucres ajoutés. (1) L’aliment contient au moins 2 g, selon le cas : a) de fibres par quantité de référence et par portion déterminée lorsque ni le type ni l’origine des fibres ne sont précisés dans la mention ou l’allégation;

b) de fibres de

Colonne 3 Critères — étiquette ou annonce grammes, par rapport à l’aliment de référence du même groupe alimentaire.

Colonne 4

Mention ou allégation

« non additionné de sucre », « sans sucre ajouté » ou « aucune addition de sucre »

« source de fibres », « contient des fibres », « source de fibres alimentaires », « contient des fibres alimentaires », « source de fibres (désignation du type de fibres) », « contient des fibres (désignation du type de fibres) », « source de fibres (désignation de l’origine des fibres) » ou « contient des fibres

Colonne 1

Article Sujet

Source élevée42. de fibres

Colonne 2

Critères — aliments

chaque type ou origine précisé, par quantité de référence et par portion déterminée, lorsque le type ou l’origine des fibres est précisé dans la mention ou l’allégation. (2) L’aliment contient au moins un ingrédient qui répond à l’un des critères mentionnés au paragraphe (1), si l’aliment est un repas préemballé. (1) L’aliment contient au moins 4 g, selon le cas : a) de fibres par quantité de référence et par portion déterminée lorsque ni le type ni l’origine des fibres ne sont précisés dans la mention ou l’allégation; b) de fibres de chaque type ou origine précisé, par quantité de référence et par portion déterminée, lorsque le type ou l’origine des fibres est précisé dans la mention ou l’allégation. (2) L’aliment contient au moins un

Colonne 3 Critères — étiquette ou annonce

Colonne 4

Mention ou allégation

(désignation de l’origine des fibres) »

« source élevée de fibres », « teneur élevée en fibres », « source élevée de fibres alimentaires », « teneur élevée en fibres alimentaires », « source élevée de fibres (désignation du type de fibres) », « teneur élevée en fibres (désignation du type de fibres) », « source élevée de fibres (désignation de l’origine des fibres) » ou « teneur élevée en fibres (désignation de l’origine des fibres) »

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce

ingrédient qui répond à l’un des critères mentionnés au paragraphe (1), si l’aliment est un repas préemballé.

Source très (1) L’aliment 43. élevée de contient au moins « source très élevée de

fibres 6 g, selon le cas : fibres », « teneur très a) de fibres par élevée en fibres », quantité de référence « riche en fibres », et par portion « source très élevée de déterminée lorsque ni le type ni l’origine des fibres ne sont

fibres (désignation du type de fibres) », « teneur très élevée en

précisés dans la mention ou l’allégation;

fibres (désignation du type de fibres) », « riche en fibres

b) de fibres de chaque type ou origine précisé, par quantité de référence et par portion déterminée, lorsque le type ou l’origine des fibres est précisé dans la mention ou

(désignation du type de fibres) », « source très élevée de fibres (désignation de l’origine des fibres) », « teneur très élevée en fibres (désignation de l’origine des fibres) », « riche en fibres

l’allégation. (2) L’aliment contient au moins un ingrédient qui répond à l’un des critères mentionnés au paragraphe (1), si l’aliment est un repas

(désignation de l’origine des fibres) », « source très élevée de fibres alimentaires », « teneur très élevée en fibres alimentaires » ou « riche en fibres alimentaires »

préemballé. « plus de fibres », « teneur plus élevée en

44. Plus de fibres (1) La teneur en fibres de l’aliment, lorsque le type ou

Les renseignements suivants sont

fibres », « plus de fibres (désignation du type de fibres) », « teneur plus

l’origine des fibres ne mentionnés : sont pas précisés

Colonne 1

Article Sujet

Colonne 2

Critères — aliments

dans la mention ou l’allégation, ou, dans le cas contraire, la teneur en fibres de chaque type ou origine de fibres précisé, est supérieure d’au moins 25 %, soit d’au moins 1 g, selon le cas : a) par quantité de référence, par rapport à l’aliment de référence du même groupe alimentaire ou à l’aliment de référence similaire;

b) par 100 g, par rapport à l’aliment de référence du même groupe alimentaire ou à l’aliment de référence similaire, si l’aliment est un repas préemballé.

(2) L’aliment contient, selon le cas : a) au moins 2 g de fibres par quantité de référence et par portion déterminée, lorsque ni le type ni l’origine des fibres ne sont précisés dans la mention ou l’allégation, ou au moins 2 g de fibres

Colonne 3 Critères — étiquette ou annonce

a) l’aliment de référence du même groupe alimentaire ou l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence du même groupe alimentaire ou de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de teneur en fibres, par portion déterminée, exprimée en pourcentage, en fraction ou en grammes, par rapport à l’aliment de référence du même groupe alimentaire ou à l’aliment de

Colonne 4

Mention ou allégation

élevée en fibres (désignation du type de fibres) », « plus de fibres (désignation de l’origine des fibres) », « teneur plus élevée en fibres (désignation de l’origine des fibres) », « plus de fibres alimentaires » ou « teneur plus élevée en fibres alimentaires »

Colonne 1

Article Sujet

Léger 45. (énergie ou

lipides)

Colonne 2

Critères — aliments

de chaque type ou origine précisé par quantité de référence et par portion déterminée, lorsque le type ou l’origine des fibres est précisé dans la mention ou l’allégation; b) au moins un ingrédient qui répond aux critères mentionnés à la colonne 2 de l’article 41 en regard du sujet « source de fibres » figurant à la colonne 1, si l’aliment est un repas préemballé. L’aliment répond aux critères mentionnés à la colonne 2 de l’un ou l’autre des articles suivants : a) l’article 3 en regard du sujet « énergie réduite » figurant à la colonne 1;

b) l’article 13 en regard du sujet « teneur réduite en lipides » figurant à la colonne 1.

Colonne 3 Critères — étiquette ou annonce référence similaire.

Les renseignements suivants sont mentionnés :

a) l’aliment de référence similaire;

b) la quantité de l’aliment et celle de l’aliment de référence similaire utilisées aux fins de comparaison si elles diffèrent; c) la différence de valeur énergétique ou de teneur en lipides, par portion

Colonne 4

Mention ou allégation

« léger » ou « allégé »

Colonne 1 Colonne 2 Colonne 3 Colonne 4 Critères —

Article Sujet Critères — aliments étiquette ou Mention ou allégation annonce déterminée, exprimée en pourcentage, en fraction, en Calories ou en grammes, par rapport à l’aliment de référence similaire.

46. Maigre L’aliment, à la fois : « maigre » a) est une viande ou une volaille qui n’est pas hachée, un animal marin, un animal d’eau douce ou un produit de l’un de ces aliments; b) contient au plus 10 % de matières grasses.

47. Extra maigre L’aliment, à la fois : « extra maigre » a) est une viande ou une volaille qui n’est pas hachée, un animal marin, un animal d’eau douce ou un produit de l’un de ces aliments; b) contient au plus 7,5 % de matières grasses.

DORS/2003-11, art. 20; err.(F), Vol. 137, no 5; DORS/2007-176, art. 6. Version précédente [B.01.514 à B.01.599 réservés]

Allégations relatives à la santé

Langues

B.01.600. Toute mention ou allégation mentionnée à la colonne 1 du tableau suivant l’article B.01.603 faite sur l’étiquette d’un aliment figure :

a) soit en français et en anglais;

b) soit dans l’une de ces langues, si, conformément aux paragraphes B.01.012(3) ou (7), les renseignements devant être indiqués sur l’étiquette de l’aliment aux termes du présent règlement peuvent l’être uniquement dans la langue en cause et qu’ils y figurent dans celle-ci.

DORS/2003-11, art. 20.

Mentions ou allégations

B.01.601. (1) L’aliment dont l’étiquette ou l’annonce comporte une mention ou allégation figurant à la colonne 1 du tableau suivant l’article B.01.603 est exempté de l’application des dispositions de la Loi et de ses règlements relatives aux drogues et des paragraphes 3(1) et (2) de la Loi, si les conditions suivantes sont réunies :

a) il répond aux critères applicables mentionnés à la colonne 2;

b) son étiquette ou annonce répond aux critères applicables mentionnés à la colonne 3;

c) il n’est :

(i) ni destiné exclusivement aux enfants âgés de moins de deux ans,

(ii) ni un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie.

(2) Le paragraphe (1) ne s’applique pas à l’aliment qui satisfait à la définition de « drogue », à l’article 2 de la Loi, pour une raison autre que la présence, sur son étiquette ou annonce, d’une mention ou allégation visée à ce paragraphe.

(3) Le paragraphe (1) s’applique même si le terme « lipides » est substitué au terme « graisses » dans la version française de la mention ou de l’allégation.

DORS/2003-11, art. 20.

B.01.602. (1) Les renseignements requis en vertu des critères mentionnés à la colonne 3 du tableau suivant l’article B.01.603 qui figurent dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres répondent aux critères suivants :

a) dans le cas d’une annonce autre qu’une annonce radiophonique ou télévisée :

(i) d’une part, ils précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou allégation figurant à la colonne 1 ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence,

(ii) d’autre part, ils figurent en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence;

b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, ils précèdent ou suivent immédiatement la mention ou l’allégation figurant à la colonne 1;

c) dans le cas d’une annonce télévisée, ils sont communiqués :

(i) en mode audio, si la mention ou l’allégation figurant à la colonne 1 fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci,

(ii) en mode audio ou en mode visuel, si la mention ou l’allégation figurant à la colonne 1 fait partie uniquement de la composante visuelle de l’annonce.

(2) Les renseignements qui sont communiqués en mode visuel dans une annonce télévisée conformément au sous-alinéa (1)c)(ii), à la fois :

a) paraissent en même temps et pendant au moins la même durée que la mention ou l’allégation;

b) précèdent ou suivent, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

c) figurent en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

DORS/2003-11, art. 20.

B.01.603. Il est entendu que toute mention ou allégation figurant à la colonne 1 du tableau suivant le présent article, faite sur l’étiquette ou dans l’annonce d’un aliment, ne peut être entrecoupée d’autres mots, chiffres, signes ou symboles, mais peut en être

a) autre qu’un légume ou un

précédée ou suivie.

TABLEAU

Colonne 1 Colonne 2 Colonne 3

Article Mention ou allégation Critères — aliments Critères — étiquette ouannonce

(1) « Une alimentation L’aliment : (1) Si la mention ou saine comprenant des l’allégation figure sur aliments à teneur élevée en l’étiquette d’un produit1. potassium et pauvres en fruit, ne répond pas aux préemballé ou encore sodium peut réduire le critères mentionnés à la dans l’annonce d’un tel risque d’hypertension, colonne 2 de l’article 2 du produit faite par le

Colonne 1

Article Mention ou allégation

facteur de risque d’accident cérébrovasculaire et de maladie du coeur. (Nom de l’aliment) ne contient pas de sodium. »

(2) « Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du coeur. (Nom de l’aliment) est pauvre en sodium. »

(3) « Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du coeur. (Nom de l’aliment) est une bonne source de potassium et ne contient pas de sodium. »

(4) « Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de

Colonne 2

Critères — aliments

tableau suivant l’article B.01.513 en regard du sujet « peu d’énergie » visé à la colonne 1;

b) contient au moins 10 % de l’apport nutritionnel recommandé pondéré d’une vitamine ou d’un minéral nutritif, selon le cas :

(i) par quantité de référence et portion déterminée,

(ii) par portion déterminée, si l’aliment est un repas préemballé;

c) répond aux critères mentionnés à la colonne 2 de l’article 19 du tableau suivant l’article B.01.513 en regard du sujet « faible teneur en acides gras saturés » visé à la colonne 1;

d) contient au plus 0,5 % d’alcool;

e) dont l’étiquette ou l’annonce comporte les mentions ou allégations (1), (3) ou (5) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 31 du tableau suivant l’article B.01.513 en regard du sujet « sans sodium ou sans sel » visé à la colonne 1;

f) dont l’étiquette ou l’annonce comporte les mentions ou allégations (2),

Colonne 3 Critères — étiquette ou annonce fabricant du produit ou sous ses ordres, le tableau de la valeur nutritive indique la teneur en potassium, conformément au paragraphe B.01.402(2).

(2) Si la mention ou l’allégation figure sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique la teneur en sodium et en potassium par portion déterminée et, le cas échéant, conformément à l’article B.01.602.

Colonne 1

Article Mention ou allégation

maladie du coeur. (Nom de l’aliment) est une bonne source de potassium et est pauvre en sodium. »

(5) « Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du coeur. (Nom de l’aliment) est une source élevée de potassium et ne contient pas de sodium. »

(6) « Une alimentation saine comprenant des aliments à teneur élevée en potassium et pauvres en sodium peut réduire le risque d’hypertension, facteur de risque d’accident cérébrovasculaire et de maladie du coeur. (Nom de l’aliment) a une teneur élevée en potassium et est pauvre en sodium. »

(1) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D

2. et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de

Colonne 2

Critères — aliments

(4) ou (6) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 32 du tableau suivant l’article B.01.513 en regard du sujet « faible teneur en sodium ou en sel » visé à la colonne 1;

g) dont l’étiquette ou l’annonce comporte les mentions ou allégations (3), (4), (5) ou (6) figurant à la colonne 1 du présent article, contient 350 mg ou plus de potassium, selon le cas :

(i) par quantité de référence et portion déterminée,

(ii) par portion déterminée, si l’aliment est un repas préemballé.

L’aliment :

a) autre qu’un légume ou un fruit, ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 du tableau suivant l’article B.01.513 en regard du sujet « peu d’énergie » visé à la

Colonne 3 Critères — étiquette ou annonce

(1) Si la mention ou l’allégation figure sur l’étiquette d’un produit préemballé ou encore dans l’annonce d’un tel produit faite par le fabricant du produit ou sous ses ordres, le tableau de la valeur

Colonne 1

Article Mention ou allégation

l’aliment) est une bonne source de calcium. »

(2) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une source élevée de calcium. »

(3) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une excellente source de calcium. »

(4) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une source très élevée de calcium. »

(5) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D

Colonne 2

Critères — aliments

colonne 1;

b) ne contient pas plus de phosphore, à l’exclusion de celui qui est fourni par le phytate, que de calcium;

c) contient au plus 0,5 % d’alcool;

d) dont l’étiquette ou l’annonce comporte les mentions ou allégations (1) ou (2) figurant à la colonne 1 du présent article, contient, selon le cas :

(i) 200 mg ou plus de calcium par quantité de référence et par portion déterminée,

(ii) 300 mg ou plus de calcium par portion déterminée, si l’aliment est un repas préemballé;

e) dont l’étiquette ou l’annonce comporte les mentions ou allégations (3), (4), (5) ou (6) figurant à la colonne 1 du présent article, contient, selon le cas :

(i) 275 mg ou plus de calcium par quantité de référence et par portion déterminée,

(ii) 400 mg ou plus de calcium par portion déterminée, si l’aliment est un repas préemballé;

Colonne 3 Critères — étiquette ou annonce nutritive indique la teneur en vitamine D et en phosphore, conformément au paragraphe B.01.402(2).

(2) Si la mention ou l’allégation figure sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique la teneur en vitamine D, en calcium et en phosphore par portion déterminée et, le cas échéant, conformément à l’article B.01.602.

Colonne 1

Article Mention ou allégation

et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une excellente source de calcium et de vitamine D. »

(6) « Une alimentation saine comprenant une quantité adéquate de calcium et de vitamine D et une activité physique régulière favorisent la formation d’os solides et peuvent réduire le risque d’ostéoporose. (Nom de l’aliment) est une source très élevée de calcium et de vitamine D. »

(1) « Une alimentation saine pauvre en graisses saturées et en graisses trans peut réduire le risque de maladie du coeur. (Nom de l’aliment) ne contient pas de graisses saturées ni de graisses trans. »3. (2) « Une alimentation saine pauvre en graisses saturées et en graisses trans peut réduire le risque de maladie du coeur. (Nom de l’aliment) est pauvre en graisses saturées et en graisses trans. »

Colonne 2

Critères — aliments

f) dont l’étiquette ou l’annonce comporte les mentions ou allégations (5) ou (6) figurant à la colonne 1 du présent article, contient 1,25 µg ou plus de vitamine D, selon le cas :

(i) par quantité de référence et portion déterminée,

(ii) par portion déterminée, si l’aliment est un repas préemballé.

L’aliment :

a) autre qu’un légume ou un fruit, ne répond pas aux critères mentionnés à la colonne 2 de l’article 2 du tableau suivant l’article B.01.513 en regard du sujet « peu d’énergie » visé à la colonne 1;

b) contient au moins 10 % de l’apport nutritionnel recommandé pondéré d’une vitamine ou d’un minéral nutritif, selon le cas :

(i) par quantité de référence et portion déterminée,

Colonne 3 Critères — étiquette ou annonce

Si la mention ou l’allégation figure sur l’étiquette ou dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, l’étiquette ou l’annonce indique la teneur en acides gras saturés et en acides gras trans par portion déterminée et, le cas échéant,

Colonne 1

Article Mention ou allégation

Colonne 2

Critères — aliments

(ii) par portion déterminée, si l’aliment est un repas préemballé;

c) contient au plus 100 mg de cholestérol par portion de 100 g de l’aliment;

d) contient au plus 0,5 % d’alcool;

e) s’il est une graisse ou une huile, répond à l’un ou l’autre des critères suivants :

(i) ceux mentionnés à la colonne 2 de l’article 25 du tableau suivant l’article B.01.513 en regard du sujet « source d’acides gras polyinsaturés oméga-3 » visé à la colonne 1,

(ii) ceux mentionnés à la colonne 2 de l’article 26 du tableau suivant l’article B.01.513 en regard du sujet « source d’acides gras polyinsaturés oméga-6 » visé à la colonne 1,

(iii) ceux prévus aux sous­ alinéas (i) et (ii);

f) contient, selon le cas :

(i) au plus 480 mg de sodium par quantité de référence, par portion déterminée et, si la quantité de référence est d’au plus 30 g ou 30 mL, par 50 g,

(ii) au plus 960 mg de sodium par portion

Colonne 3 Critères — étiquette ou annonce conformément à l’article B.01.602.

Colonne 1 Colonne 2 Colonne 3 Critères — étiquette ouArticle Mention ou allégation Critères — aliments annonce

déterminée, si l’aliment est un repas préemballé;

g) dont l’étiquette ou l’annonce comporte la mention ou l’allégation (1) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 18 du tableau suivant l’article B.01.513 en regard du sujet « sans acides gras saturés » visé à la colonne 1;

h) dont l’étiquette ou l’annonce comporte la mention ou l’allégation (2) figurant à la colonne 1 du présent article, répond aux critères mentionnés à la colonne 2 de l’article 19 du tableau suivant l’article B.01.513 en regard du sujet « faible teneur en acides gras saturés » visé à la colonne 1.

L’aliment :

a) est un des légumes, fruits ou jus ci-après et ne peut contenir que des agents

« Une alimentation saine édulcorants, les additifs comportant une grande alimentaires permis par le variété de légumes et de4. présent règlement, du sel,fruits peut aider à réduire des fines herbes, des épices, le risque de certains types des assaisonnements ou de de cancer. » l’eau :

(i) un légume frais, congelé, en conserve ou déshydraté,

(ii) un fruit frais, congelé, en

Colonne 1 Colonne 2 Colonne 3

Article Mention ou allégation Critères — aliments Critères — étiquette ouannonce conserve ou sec,

(iii) un jus de légume ou de fruit,

(iv) une combinaison des aliments mentionnés aux sous-alinéas (i) à (iii);

b) n’est pas :

(i) une pomme de terre, une igname, du manioc, une banane plantain, du maïs, un champignon, une légumineuse mature ou leur jus,

(ii) un légume ou un fruit utilisé comme condiment, garniture ou aromatisant, notamment une cerise au marasquin, un fruit glacé ou confit ou de l’oignon en flocons,

(iii) une confiture ou une tartinade de type confiture, une marmelade, une conserve de fruit ou une gelée,

(iv) une olive;

(v) un légume ou fruit en poudre;

c) contient au plus 0,5 % d’alcool.

(1) « Ne cause pas la carie Si la mention ou dentaire. » l’allégation figure sur

l’étiquette d’un produit5. (2) « Ne favorise pas la L’aliment est une gomme à préemballé ou encore carie dentaire. » mâcher, un bonbon dur ou dans l’annonce d’un tel

un rafraîchisseur d’haleine qui répond à l’un ou l’autre

Colonne 1 Colonne 2 Colonne 3

Article Mention ou allégation Critères — aliments Critères — étiquette ouannonce des critères suivants :

a) il ne contient, au total, pas plus de 0,25 % d’amidon, de dextrines, de monosaccharides, de disaccharides, d’oligosaccharides ou d’autres glucides produit faite par le fermentescibles; fabricant du produit ou

sous ses ordres, le (3) « Ne favorise pas les b) il contient plus de 0,25 % tableau de la valeur caries dentaires. » de glucides fermentescibles nutritive indique la

et il ne réduit pas le pH de la teneur en polyalcools,(4) « Non cariogène. » plaque à moins de 5,7 par s’il y en a, fermentation bactérienne conformément au pendant 30 minutes après paragraphe B.01.402(2). avoir été consommé, le pH étant mesuré selon le test « indwelling plaque pH » décrit dans « Identification of Low Caries Risk Dietary Components », Monographs in Oral Science, T.N. Imfeld, Volume 11, 1983.

DORS/2003-11, art. 20; err.(F), Vol. 137, no 5; DORS/2010-142, art. 2. Version précédente

Titre 2

Boissons alcooliques B.02.001. L’expression boissons alcooliques vise notamment les aliments mentionnés dans le présent titre.

DORS/93-145, art. 3(F).

B.02.002. Les définitions qui suivent s’appliquent au présent titre.

« âge » Période durant laquelle une boisson alcoolique est conservée dans les conditions d’emmagasinage nécessaires pour développer sa saveur et son bouquet caractéristiques. (age)

« agent édulcorant » Le glucose-fructose, le sirop de fructose ou tout aliment qui fait l’objet d’une norme énoncée au titre 18, ou une combinaison de ces produits. (sweetening agent)

« alcool » Alcool éthylique. (alcohol)

« alcool absolu » Alcool à 100 pour cent. (absolute alcohol)

« esprit de grain » Distillat alcoolique obtenu à partir d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt ou par d’autres enzymes et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes, et dont les substances naturellement présentes, autres que l’alcool et l’eau, ont été complètement ou presque complètement éliminées. (grain spirit)

« esprit de malt » Distillat alcoolique obtenu, par distillation à l’alambic chauffé à feu nu, à partir d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro­ organismes. (malt spirit)

« esprit de mélasse » Distillat alcoolique obtenu à partir de la canne à sucre ou de produits de la canne à sucre fermentés au moyen de levure ou d’un mélange de levure et d’autres micro-organismes, et dont les substances naturellement présentes, autres que l’alcool et l’eau, ont été complètement ou presque complètement éliminées. (molasses spirit)

« petit fût » Barrique ou baril de bois d’une capacité ne dépassant pas 700 L. (small wood)

« substance aromatique » À l’égard d’un spiritueux, tout autre spiritueux ou vin, domestique ou importé, qui est ajouté comme substance aromatique en vertu de la Loi sur l’accise. (flavouring)

DORS/84-300, art. 10; DORS/93-145, art. 4.

B.02.003. Lorsqu’une boisson alcoolique a une teneur en alcool de 1,1 pour cent ou plus par volume, ce pourcentage, suivi de la mention « alcool en volume » ou « alc./vol. », doit être indiqué dans l’espace principal.

DORS/88-418, art. 1; DORS/93-145, art. 5(F).

Whisky

B.02.010. [N]. Le whisky ou whiskey, à l’exclusion du whisky de malt, du whisky écossais, du whisky irlandais, du whisky canadien, du whisky Highland, du bourbon ou whisky bourbon et du whisky Tennessee :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu à partir d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt ou par d’autres enzymes et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes;

b) peut contenir du caramel et des substances aromatiques.

DORS/93-145, art. 6; DORS/93-603, art. 2.

B.02.011. et B.02.012. [Abrogés, DORS/93-145, art. 7]

B.02.013. [N]. Le whisky de malt:

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation d’un moût de grain malté qui a été fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes;

b) doit posséder l’arôme, le goût et les caractéristiques communément attribués au whisky de malt;

c) peut contenir du caramel et des substances aromatiques.

DORS/93-145, art. 8.

B.02.014. et B.02.015. [Abrogés, DORS/93-145, art. 9]

B.02.016. [N]. Le whisky écossais doit être du whisky qui a été distillé en Écosse comme whisky écossais pour la consommation domestique, conformément aux lois du Royaume- Uni.

B.02.017. Est interdit tout mélange ou toute modification de whisky écossais importé en vrac aux fins d’embouteillage et de vente au Canada comme whisky écossais, sauf

a) le mélange avec d’autre whisky écossais;

b) l’addition d’eau distillée ou autrement purifiée pour porter le whisky au degré alcoolique requis; ou

c) l’addition de caramel.

B.02.018. [N]. Le whisky irlandais doit être du whisky distillé en Irlande du Nord ou dans la République d’Irlande pour la consommation domestique, conformément aux lois de l’Irlande du Nord ou de la République d’Irlande.

B.02.019. Est interdit tout mélange ou toute modification de whisky irlandais importé en vrac aux fins d’embouteillage et de vente au Canada comme whisky irlandais, sauf

a) le mélange avec d’autre whisky irlandais;

b) l’addition d’eau distillée ou autrement purifiée pour porter le whisky au degré alcoolique requis; ou

c) l’addition de caramel.

B.02.020. [N]. (1) Le whisky canadien:

a) doit :

(i) être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu à partir d’un moût de céréales ou de produits de céréales saccharifié par la diastase du malt ou par d’autres enzymes et fermenté au moyen de levure ou d’un mélange de levure et d’autres micro-organismes,

(ii) être vieilli en petit fût durant au moins trois ans,

(iii) posséder l’arôme, le goût et les caractéristiques communément attribués au whisky canadien,

(iv) être fabriqué conformément aux exigences de la Loi sur l’accise et de ses règlements d’application,

(v) être trempé, distillé et vieilli au Canada,

(vi) contenir au moins 40 pour cent d’alcool en volume;

b) peut contenir du caramel et des substances aromatiques.

(2) Sous réserve du paragraphe (3), il est interdit de faire une allégation concernant l’âge du whisky canadien, sauf pour la période durant laquelle le whisky a été conservé en petit fût.

(3) Dans le cas du whisky canadien vieilli en petit fût durant au moins trois ans, toute période ne dépassant pas six mois durant laquelle le whisky canadien a été conservé dans d’autres récipients peut être comptée dans l’âge allégué du whisky.

DORS/93-145, art. 10; DORS/2000-51, art. 1.

B.02.021. [N]. Le whisky Highland:

a) doit être une boisson alcoolique potable mélangée au Canada à partir :

(i) d’une part, d’au moins 25 pour cent de whisky de malt calculé en alcool absolu distillé au Canada ou en Écosse,

(ii) d’autre part, de whisky;

b) s’il contient au moins 51 pour cent de whisky de malt distillé en Écosse, peut être étiqueté et annoncé comme contenant de ce whisky.

DORS/93-145, art. 10.

B.02.022. (1) Sous réserve du paragraphe (2), il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment en tant que bourbon, ou d’une manière qui peut laisser croire qu’il s’agit de bourbon, à moins que cet aliment ne soit du whisky fabriqué aux États-Unis en tant que bourbon conformément aux lois de ce pays applicables au bourbon préparé pour consommation à l’intérieur du pays.

(2) Il est permis de modifier du bourbon importé pour être embouteillé et vendu au Canada en tant que bourbon, en y ajoutant de l’eau distillée ou autrement purifiée pour ramener le bourbon au degré alcoolique requis.

DORS/89-59, art. 2; DORS/93-145, art. 11(F).

B.02.022.1. (1) Sous réserve du paragraphe (2), il est interdit d’étiqueter, d’emballer ou de vendre un aliment — ou d’en faire la publicité — en tant que whisky Tennessee ou de manière qu’il puisse être confondu avec le whisky Tennessee, à moins que cet aliment ne soit du bourbon ou whisky bourbon pur produit dans l’État du Tennessee et fabriqué aux États-Unis en tant que whisky Tennessee conformément aux lois de ce pays applicables au whisky Tennessee préparé pour consommation à l’intérieur du pays.

(2) Il est permis de modifier du whisky Tennessee importé pour être embouteillé et vendu au Canada en tant que whisky Tennessee, en y ajoutant de l’eau distillée ou autrement purifiée pour ramener le whisky au degré alcoolique voulu.

DORS/93-603, art. 3.

B.02.023. (1) Sous réserve des articles B.02.022 et B.02.022.1, il est interdit de vendre pour consommation au Canada du whisky qui n’a pas été vieilli en petit fût durant au moins trois ans.

(2) Le paragraphe (1) ne s’applique pas aux substances aromatiques contenues dans le whisky; toutefois, il est interdit de vendre pour consommation au Canada du whisky contenant des substances aromatiques, autres que du vin, qui n’ont pas été vieillies en petit fût durant au moins deux ans.

DORS/93-145, art. 12; DORS/93-603, art. 4.

Rhum

B.02.030. [N]. Le rhum:

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu à partir de la canne à sucre ou des produits de la canne à sucre fermentés au moyen de levure ou d’un mélange de levure et d’autres micro-organismes;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes.

DORS/93-145, art. 13.

B.02.031. (1) Il est interdit de vendre pour consommation au Canada du rhum qui n’a pas été vieilli en petit fût durant au moins un an.

(2) Le paragraphe (1) ne s’applique pas aux substances aromatiques contenues dans le rhum; toutefois, il est interdit de vendre pour consommation au Canada du rhum contenant des substances aromatiques, autres que du vin, qui n’ont pas été vieillies en petit fût durant au moins un an.

DORS/84-657, art. 1; DORS/93-145, art. 13.

B.02.032. [Abrogé, DORS/93-145, art. 14]

B.02.033. Est interdit tout mélange ou toute modification de rhum importé en vrac aux fins d’embouteillage et de vente au Canada comme du rhum importé, sauf

a) le mélange avec d’autres rhums importés;

b) l’addition d’eau distillée ou autrement purifiée pour ramener le rhum au degré alcoolique indiqué sur l’étiquette apposée sur le contenant;

c) l’addition de caramel.

DORS/89-127, art. 1.

B.02.034. (1) Par dérogation à l’article B.02.033, est interdit tout mélange ou toute modification de rhum obtenu des produits de la canne à sucre d’un pays des Antilles du Commonwealth, qui a été distillé et fermenté dans un tel pays et importé en vrac d’un tel pays aux fins d’embouteillage et de vente au Canada comme du rhum provenant des Antilles, sauf :

a) le mélange avec d’autres rhums d’un pays des Antilles du Commonwealth;

b) le mélange avec du rhum canadien de telle sorte que la proportion de rhum canadien dans le produit final soit entre un et 1,5 pour cent par volume;

c) l’addition d’eau distillée ou autrement purifiée pour ramener le rhum au degré alcoolique indiqué sur l’étiquette apposée sur le contenant;

d) l’addition de caramel.

(2) Dans le présent article, « pays des Antilles du Commonwealth » désigne : Anguilla, Antigua et Barbuda, Barbade, Bahamas, Belize, Bermudes, Îles Vierges britanniques, Îles Caïmanes, Dominique, Grenade, Guyane, Jamaïque, Montserrat, Saint-Christophe-et- Nevis, Sainte-Lucie, Saint-Vincent-et-Grenadines, Trinité et Tobago et Îles Turques et Caïques.

DORS/89-127, art. 2.

Gin

B.02.040. [N]. Le genièvre Hollands, genièvre, gin type hollandais ou gros gin:

a) doit être une boisson alcoolique potable obtenue :

(i) soit par la redistillation de l’esprit de malt avec ou sur des baies de genièvre ou par le mélange des produits de plus d’une telle redistillation,

(ii) soit par la redistillation d’un mélange d’esprit de malt et d’au plus quatre fois le même volume d’esprit de grain en alcool absolu avec ou sur des baies de genièvre, ou par le mélange des produits de plus d’une telle redistillation,

(iii) soit par le mélange d’esprit de malt redistillé avec ou sur des baies de genièvre et d’au plus quatre fois le même volume d’esprit de grain ou d’esprit de mélasse en alcool absolu, ou par une combinaison de plus d’un tel mélange;

b) peut contenir :

(i) d’autres substances végétales aromatiques ajoutées pendant la redistillation,

(ii) du caramel;

c) ne peut contenir plus de deux pour cent d’agent édulcorant;

d) peut être étiqueté ou annoncé comme étant distillé lorsque l’un des sous-alinéas a)(i) ou (ii) est respecté;

e) doit être désigné comme genièvre mélangé sur l’espace principal de l’étiquette et dans la publicité lorsque le sous-alinéa a)(iii) est respecté.

DORS/93-145, art. 15.

B.02.041. [N]. Le gin, à l’exclusion du genièvre Hollands, genièvre, gin type hollandais ou gros gin :

a) doit être une boisson alcoolique potable obtenue :

(i) soit par la redistillation d’alcool dérivé de matières premières alimentaires avec ou sur des baies de genièvre, ou par le mélange des produits de plus d’une telle redistillation,

(ii) soit par le mélange d’alcool dérivé de matières premières alimentaires redistillé avec ou sur des baies de genièvre et d’alcool dérivé de matières premières alimentaires, ou par une combinaison de plus d’un tel mélange;

b) peut contenir :

(i) d’autres substances végétales aromatiques ajoutées pendant la redistillation,

(ii) un agent édulcorant,

(iii) des préparations aromatisantes pour assurer un profil aromatique uniforme;

c) peut être étiqueté et annoncé comme Dry Gin ou London Dry Gin lorsqu’aucun agent édulcorant n’y a été ajouté.

DORS/93-145, art. 15.

B.02.042. [Abrogé, DORS/93-145, art. 15]

B.02.043. Est interdite toute déclaration sur l’âge du genièvre, mais dans le cas du genièvre qui a été conservé dans des récipients appropriés, l’étiquette peut porter une déclaration à cet effet.

Eau-de-vie

B.02.050. [N]. L’eau-de-vie de vin (brandy), à l’exclusion de l’armagnac, du brandy canadien, du brandy de fruits, du brandy de fruits secs, du brandy de lies, du cognac, de la grappa et du marc :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation du vin;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes.

DORS/84-300, art. 12; DORS/93-145, art. 16.

B.02.051. [N]. L’armagnac doit être de l’eau-de-vie de vin (brandy) fabriquée dans la région d’Armagnac, en France, conformément aux lois de la République française pour la consommation en France.

DORS/93-145, art. 16.

B.02.052. [N]. Le brandy canadien :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation de vin qui a été fermenté au Canada;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes.

DORS/93-145, art. 16.

B.02.053. [N]. Le cognac doit être de l’eau-de-vie de vin (brandy) fabriquée dans la région de Cognac, en France, conformément aux lois de la République française pour la consommation en France.

DORS/93-145, art. 16.

B.02.054. [N]. Le brandy de fruits secs :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu à partir de fruits secs et sains;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes.

DORS/93-145, art. 16.

B.02.055. [N]. Le brandy de fruits :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation :

(i) soit du vin de fruit ou d’un mélange de vins de fruit,

(ii) soit d’un moût fermenté, ou d’un mélange, de fruits mûrs et sains autres que des raisins;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes;

c) peut être désigné sur l’étiquette comme « brandy de (désignation du fruit) » lorsque la totalité des fruits ou du vin de fruit qui ont servi à la fabrication du brandy proviennent du fruit désigné.

DORS/93-145, art. 16.

B.02.056. [N]. La grappa :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation du marc provenant de raisins mûrs et sains après extraction du jus ou du vin;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes.

DORS/93-145, art. 16.

B.02.057. [N]. Le brandy de lies :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation des lies de vin ou du vin de fruit;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes;

c) peut être désigné sur l’étiquette comme « brandy de lies de (désignation du fruit) » lorsque la totalité des lies qui ont servi à la fabrication du brandy proviennent du fruit désigné.

DORS/93-145, art. 16.

B.02.058. [N]. Le marc :

a) doit être un distillat alcoolique potable ou un mélange de distillats alcooliques potables obtenu par la distillation de la peau et de la pulpe de fruits mûrs et sains après extraction du jus de fruit, du vin ou du vin de fruit;

b) peut contenir :

(i) du caramel,

(ii) des fruits et d’autres substances végétales,

(iii) des substances aromatiques et des préparations aromatisantes;

c) peut être désigné sur l’étiquette comme « marc de (désignation du fruit) » lorsque la totalité de la peau et de la pulpe qui ont servi à la fabrication du brandy proviennent du fruit désigné.

DORS/93-145, art. 16.

B.02.059. Il est interdit de mélanger ou de modifier toute eau-de-vie de vin (brandy) importée en vrac pour être embouteillée et vendue au Canada comme eau-de-vie de vin (brandy) importée, autrement que :

a) par mélange avec d’autres eaux-de-vie de vin (brandy) importées;

b) par addition de caramel;

c) par addition d’eau distillée ou autrement purifiée en vue de porter l’eau-de-vie de vin (brandy) au degré alcoolique requis.

DORS/93-145, art. 16.

B.02.060. Lorsqu’une eau-de-vie de vin (brandy) est entièrement distillée dans un pays autre que le Canada, le pays d’origine doit être inscrit sur l’étiquette.

DORS/84-300, art. 13(F); DORS/93-145, art. 16.

B.02.061. (1) Il est interdit de vendre de l’eau-de-vie de vin (brandy) qui n’a pas été vieillie dans des récipients de bois durant au moins un an ou vieillie en petit fût durant au moins six mois.

(2) Le paragraphe (1) ne s’applique pas aux substances aromatiques contenues dans l’eau-de-vie de vin (brandy); toutefois, il est interdit de vendre de l’eau-de-vie de vin (brandy) contenant des substances aromatiques, autres que du vin, qui n’ont pas été vieillies dans des récipients de bois durant au moins un an ou vieillies en petit fût durant au moins six mois.

(3) Les paragraphes (1) et (2) ne s’appliquent pas à l’eau-de-vie de vin (brandy) qui satisfait aux normes applicables prévues aux articles B.02.051 à B.02.058.

(4) Il est interdit de faire toute allégation concernant l’âge de l’eau-de-vie de vin (brandy), sauf pour la période durant laquelle celle-ci a été conservée dans des récipients de bois ou conservée en petit fût.

DORS/93-145, art. 16.

Liqueurs et cordiaux spiritueux

B.02.070. [N]. La liqueur ou le cordial spiritueux:

a) doit être un produit obtenu par le mélange ou la distillation d’alcool dérivé de matières premières alimentaires avec ou sur des fruits, des fleurs, des feuilles ou d’autres substances végétales ou leurs jus, ou avec des extraits obtenus par infusion, percolation ou macération de ces substances végétales;

b) doit être additionné, au cours de la fabrication, d’un agent édulcorant en quantité d’au moins 2,5 pour cent du produit fini;

c) doit contenir au moins 23 pour cent d’alcool absolu en volume;

d) peut contenir :

(i) des préparations aromatisantes naturelles et artificielles,

(ii) des colorants.

DORS/93-145, art. 16.

Vodka

B.02.080. [N]. La vodka doit être une boisson alcoolique potable obtenue par le traitement de l’esprit de grain ou de pommes de terre avec du charbon de bois, de manière que le produit n’ait ni caractère ni arôme ni goût distinctifs.

DORS/93-145, art. 16.

Tequila

B.02.090. (1) Sous réserve du paragraphe (2), il est interdit d’étiqueter, d’emballer ou de vendre un aliment—ou d’en faire la publicité—en tant que Tequila ou de manière qu’il puisse être confondu avec la tequila, à moins que cet aliment ne soit de la tequila fabriquée au Mexique en tant que tequila conformément aux lois de ce pays applicables à la tequila préparée pour consommation à l’intérieur du pays.

(2) Il est permis de modifier de la tequila importée pour être embouteillée et vendue au Canada en tant que tequila, en y ajoutant de l’eau distillée ou autrement purifiée pour ramener la tequila au degré alcoolique voulu.

DORS/93-603, art. 5.

Mezcal

B.02.091. (1) Sous réserve du paragraphe (2), il est interdit d’étiqueter, d’emballer ou de vendre un aliment — ou d’en faire la publicité — en tant que Mezcal ou de manière qu’il puisse être confondu avec le mezcal, à moins que cet aliment ne soit du mezcal fabriqué au Mexique en tant que mezcal conformément aux lois de ce pays applicables au mezcal préparé pour consommation à l’intérieur du pays.

(2) Il est permis de modifier du mezcal importé pour être embouteillé et vendu au Canada en tant que mezcal, en y ajoutant de l’eau distillée ou autrement purifiée pour ramener le mezcal au degré alcoolique voulu.

DORS/93-603, art. 6.

Vin

B.02.100. [N]. Le vin

a) doit être une boisson alcoolique produite par la fermentation alcoolique complète ou partielle de raisins frais, de moût de raisin, de produits dérivés uniquement de raisins frais ou d’un mélange de plusieurs de ces ingrédients;

b) peut être additionné, en cours de fabrication,

(i) de levure,

(ii) de jus de raisin concentré,

(iii) de dextrose, de fructose, de glucose, de solides du glucose, de sucre, de sucre inverti ou d’une solution aqueuse de l’une ou l’autre de ces substances,

(iv) de nourriture pour les levures, en conformité avec le tableau XIV de l’article B.16.100,

(v) de sulfate de calcium en quantité telle que la teneur en sulfates solubles de vin fini ne dépasse pas 0,2 pour cent en poids par volume, calculée en sulfate de potassium,

(vi) de carbonate de calcium en quantité telle que la teneur en acide tartrique du vin fini ne soit pas inférieure à 0,15 pour cent en poids par volume,

(vii) d’anhydride sulfureux, y compris ses sels, en quantité telle que sa teneur dans le vin fini ne dépasse pas

(A) 70 parties par million à l’état libre, ou

(B) 350 parties par million à l’état combiné, calculé en anhydride sulfureux,

(viii) de l’une ou plusieurs des substances suivantes :

(A) acide citrique, acide fumarique, acide lactique, acide malique, acide tartrique, bicarbonate de potassium, carbonate de potassium et citrate de potassium, selon les limites de tolérance conformes aux bonnes pratiques industrielles,

(B) acide métatartrique, selon une limite de tolérance de 0,01 pour cent,

(C) tartrate acide de potassium, selon une limite de tolérance de 0,42 pour cent,

(ix) d’amylase et de pectinase, selon les limites de tolérance conformes aux bonnes pratiques industrielles,

(x) d’acide ascorbique ou de ses sels ou d’acide érythorbique ou de ses sels, selon les limites de tolérance conformes aux bonnes pratiques industrielles,

(xi) d’agent antimousse, en conformité avec le tableau VIII de l’article B.16.100,

(xii) de l’un ou plusieurs des agents de collage suivants :

(A) albumine, argile, bioxyde de silicium, blanc d’œuf, caséine, charbon activé, colle de poisson, polyvinylpolypyrrolidone et terre de diatomées,

(B) agar-agar, ferrocyanure de potassium, gélatine et gomme arabique, selon les limites de tolérance conformes aux bonnes pratiques industrielles,

(C) acide tannique, selon une limite de tolérance de 200 parties par million,

(D) polyvinylpyrrolidone, en une quantité ne dépassant pas 2 parties par million dans le produit fini,

(xiii) de caramel, selon une limite de tolérance conforme aux bonnes pratiques industrielles,

(xiv) d’eau-de-vie de vin (brandy), d’eau-de-vie de fruits, ou d’alcool obtenu par fermentation alcoolique de substances alimentaires puis par distillation jusqu’à production d’alcool titrant au moins 94 pour cent en volume,

(xv) de l’une ou plusieurs des substances suivantes :

(A) anhydride carbonique et ozone, selon les limites de tolérance conformes aux bonnes pratiques industrielles,

(B) oxygène,

(xvi) d’acide sorbique ou de ses sels, n’excédant pas 500 parties par million, calculé en acide sorbique,

(xvii) de bactéries malolactiques des genres Lactobacillus, Leuconostoc et Pediococcus,

(xviii) de sulfate de cuivre en quantité telle que la teneur en cuivre du produit fini ne dépasse pas 0,0001 pour cent,

(xix) d’azote,

(xx) de rognures et de particules de chêne;

c) peut, avant la dernière filtration, être traité avec

(i) une résine fortement acide échangeuse de cations sous forme d’ions sodium, ou

(ii) une résine faiblement basique échangeuse d’anions sous forme d’ions hydroxyl.

DORS/78-402, art. 1; DORS/81-565, art. 1; DORS/84-300, art. 14(F) et 15(A); DORS/2006-91, art. 1; DORS/2008-142, art. 1(F); DORS/2010-143, art. 39(A). Version précédente B.02.101. Est interdite la vente de vin qui contient plus de 0,24 pour cent en poids par volume d’acidité volatile, calculée en acide acétique selon la méthode officielle FO-2, Détermination d’acidité volatile dans le vin, le cidre et le cidre champagne, 15 octobre 1981.

DORS/82-768, art. 2; DORS/2006-91, art. 2. Version précédente B.02.102. [N]. L’eau-de-vie de fruits doit être un distillat alcoolique obtenu du vin, du vin de fruits, de la pulpe de raisins ou de la pulpe de fruits.

B.02.103. [N]. Le vin de fruits, ou vin de (désignation du fruit) doit être un produit de la fermentation alcoolique du jus de fruits mûrs et sains autres que le raisin, et doit être conforme, en tous points, aux exigences de la norme du vin prescrite à l’article B.02.100.

B.02.104. [N]. Le vermouth doit être du vin auquel ont été ajoutés des amers, des aromates ou autres substances végétales ou une préparation aromatisante et ne peut contenir plus de 20 pour cent d’alcool absolu en volume.

DORS/93-145, art. 17(F).

B.02.105. [N]. Le vin aromatisé, le cocktail au vin ou le vin apéritif est du vin additionné d’herbes, d’épices, d’autres substances végétales, de jus de fruits ou de préparations aromatisantes, et renferme au plus 20 pour cent d’alcool absolu en volume.

B.02.105A. [N]. Le vin aromatisé (désignation de fruit), le cocktail au vin (désignation du fruit) ou le vin apéritif (désignation du fruit) est du vin de fruits, un mélange de vins de fruits ou un mélange de vins de fruits et de vin additionné d’herbes, d’épices, d’autres substances végétales, de jus de fruits ou de préparations aromatisantes, et renferme au plus 20 pour cent d’alcool absolu en volume.

B.02.106. [N]. Le vin de miel:

a) est le produit de la fermentation alcoolique d’une solution aqueuse du miel;

b) peut, au cours de sa fabrication, être additionné d’une ou de plusieurs des substances suivantes :

(i) levure,

(ii) nourriture pour les levures,

(iii) anhydride sulfureux, y compris ses sels, en quantité telle que la teneur dans le vin fini ne dépasse pas

(A) 70 parties par million à l’état libre, ou

(B) 350 parties par million à l’état combiné, calculé en anhydride sulfureux,

(iv) acide tartrique ou citrique,

(v) tartrate acide de potassium,

(vi) arômes naturels, d’origine botanique,

(vii) eau-de-vie de fruits, ou alcool obtenu par fermentation alcoolique de substances alimentaires puis par distillation jusqu’à production d’alcool titrant au moins 94 pour cent en volume,

(viii) caramel,

(ix) gaz carbonique,

(x) n’importe lequel des agents de collage suivants : charbon activé, argile ou acide tannique;

(xi) acide sorbique, ainsi que ses sels — calculés en acide sorbique —, en quantité telle que la teneur dans le vin fini ne dépasse pas 500 parties par million.

DORS/96-241, art. 1; DORS/2010-94, art. 9(A).

Version précédente B.02.107. [N]. Le vin de mai doit être du vin auquel a été ajoutée une préparation aromatisante artificielle d’aspérule odorante.

B.02.108. Le pays d’origine doit être clairement indiqué sur l’espace principal de l’étiquette d’un vin.

DORS/84-300, art. 16(A).

Cidre

B.02.120. [N]. Le cidre

a) doit

(i) être le produit de la fermentation alcoolique du jus de pomme, et

(ii) renfermer au moins 2,5 pour cent et au plus 13,0 pour cent d’alcool absolu en volume; et

b) peut, en cours de fabrication, être additionné

(i) de levure,

(ii) de jus de pomme concentré,

(iii) de sucre, de dextrose, de sucre inverti, de glucose, de solides de glucose ou de solutions aqueuses de n’importe lequel de ces sucres,

(iv) de nourriture pour les levures,

(v) d’acide sulfureux, y compris ses sels, en quantité telle que leur concentration dans le cidre fini ne dépasse pas

(A) 70 parties par million à l’état libre, ou

(B) 350 parties par million à l’état combiné, calculée en anhydride sulfureux,

(vi) d’acide tartrique et de tartrate de potassium,

(vii) d’acide citrique,

(viii) d’acide lactique,

(ix) de pectinase et amylase,

(x) d’acide ascorbique ou érythorbique ou leurs sels,

(xi) de n’importe lequel des agents de clarification suivants :

(A) le charbon activé,

(B) l’argile,

(C) la terre d’infusoires,

(D) la gélatine,

(E) l’albumine,

(F) le chlorure de sodium,

(G) le gel de silice,

(H) la caséine,

(I) l’acide tannique en concentration ne dépassant pas 200 parties par million, ou

(J) la polyvinylpyrrolidone en concentration ne dépassant pas deux parties par million dans le produit fini,

(xii) de caramel,

(xiii) d’eau-de-vie de vin (brandy), d’eau-de-vie de fruits ou d’alcool obtenu par fermentation alcoolique de substances alimentaires puis par distillation jusqu’à production d’alcool tirant au moins 94 pour cent en volume,

(xiv) d’anhydride carbonique,

(xv) d’oxygène,

(xvi) d’ozone, ou

(xvii) d’acide sorbique ou de ses sels, en quantité d’au plus 500 parties par million, calculé en acide sorbique.

DORS/81-565, art. 2; DORS/84-300, art. 17(A).

B.02.122. [N]. Le cidre champagne doit être du cidre imprégné de gaz carbonique sous pression, en effectuant

a) le dernier stade de la fermentation en vase clos, ou

b) une fermentation secondaire en vase clos avec ou sans l’addition de sucre, de dextrose, de sucre inverti, de glucose, de solides de glucose ou de solutions aqueuses de n’importe lequel de ces sucres,

et il doit contenir au moins sept pour cent d’alcool absolu en volume.

DORS/84-300, art. 18.

B.02.123. Est interdite la vente de cidre ou de cidre champagne qui possède une acidité volatile de plus de 0,2 pour cent en poids par volume, calculée en acide acétique selon la

méthode officielle FO-2, Détermination d’acidité volatile dans le vin, le cidre et le cidre champagne, 15 octobre 1981.

DORS/82-768, art. 3.

Bière

B.02.130. [N]. La bière

a) doit être le produit de la fermentation alcoolique, au moyen de levure, d’une infusion de malt d’orge ou de malt de blé et de houblon ou d’extrait de houblon dans de l’eau potable et être brassée de manière à avoir l’arôme, le goût et les caractéristiques communément attribués à la bière;

b) peut, au cours de sa fabrication, être additionnée d’un ou de plusieurs des ingrédients suivants :

(i) grains de céréale,

(ii) matières glucidiques,

(iii) sel,

(iv) essence de houblon,

(v) extrait de houblon, à condition qu’il soit ajouté au moût avant ou pendant la cuisson,

(vi) extrait de houblon pré-isomérisé,

(vi.1) extrait de houblon isomérisé réduit,

(vii) carragheen (algue rouge de l’espèce Chondrus crispus),

(viii) dioxyde de carbone,

(ix) caramel,

(x) dextrine,

(xi) enzymes alimentaires,

(xii) agents stabilisants,

(xiii) rajusteurs de pH et agents correcteurs de l’eau,

(xiv) agents de conservation de la catégorie I,

(xv) agents de conservation de la catégorie II,

(xvi) agents séquestrants,

(xvii) nourriture de levures,

(xviii) un ou plusieurs des agents de collage suivants : bentonite, cellulose, charbon activé, colle de poisson, copeaux de cerisier, de chêne, de hêtre et de noisetier, gélatine, gel de silice, gomme arabique, kaolin, nylon 66, polyvinylpolypyrrolidone, silicate d’aluminium, silicate de calcium, silicate de magnésium et terre de diatomées,

(xix) polyvinylpyrrolidone,

(xx) persulfate d’ammonium,

(xxi) dans le cas du moût, diméthylpolysiloxane,

(xxii) dans le cas de la pâte, peroxyde d’hydrogène.

DORS/88-418, art. 2; DORS/92-92, art. 1; DORS/96-483, art. 1; DORS/2006-91, art. 3. Version précédente B.02.131. [N]. L’ale, le stout, le porter ou la liqueur de malt

a) doit être le produit de la fermentation alcoolique, au moyen de levure, d’une infusion de malt d’orge ou de malt de blé et de houblon ou d’extrait de houblon dans de l’eau potable et être brassé de manière à avoir l’arôme, le goût et les caractéristiques communément attribués à l’ale, au stout, au porter ou à la liqueur de malt, selon le cas;

b) peut, au cours de sa fabrication, être additionné d’un ou de plusieurs des ingrédients mentionnés à l’alinéa B.02.130b).

DORS/88-418, art. 2.

B.02.132. Les noms à employer pour désigner la bière, l’ale, le stout, le porter ou la liqueur de malt dans la publicité qui s’y rapporte ou sur leur étiquette sont les noms usuels, avec ou sans qualificatif, selon le cas, indiqués à la colonne II du tableau, suivant la teneur en alcool mentionnée à la colonne I.

TABLEAU

Colonne I Colonne II

Article Pourcentage d’alcool par Nom usuelvolume bière extra-légère, ale extra-légère, stout extra-léger,1. de 1,1 à 2,5 porter extra-léger

2. de 2,6 à 4,0 bière légère, ale légère, stout léger, porter léger 3. de 4,1 à 5,5 bière, ale, stout, porter

bière forte, ale forte, stout fort, porter fort, liqueur de4. de 5,6 à 8,5 malt bière extra-forte, ale extra-forte, stout extra-fort, porter5. 8,6 et plus extra-fort, liqueur de malt forte

DORS/88-418, art. 2.

B.02.133. [N]. Dans le présent titre, « extrait de houblon » désigne un extrait de cones de houblon obtenu par extraction

a) à l’hexane, au méthanol ou au chlorure de méthylène de telle façon que l’extrait de houblon contienne au plus 2,2 pour cent du solvant employé; ou

b) au dioxyde de carbone ou à l’alcool éthylique, en quantité conforme aux bonnes pratiques industrielles.

DORS/86-89, art. 1; DORS/88-418, art. 3.

B.02.134. [N]. (1) Dans le présent titre, « extrait de houblon pré-isomérisé » désigne un extrait de houblon obtenu :

a) par utilisation d’un des dissolvants suivants :

(i) l’hexane,

(ii) le dioxyde de carbone,

(iii) l’éthanol;

b) par isolation subséquente des acides alpha et leur conversion en acides alpha isomérisés par utilisation d’un alcali dilué et application de chaleur.

(2) Aux fins de l’alinéa (1)b), la quantité de résidus d’hexane dans l’extrait de houblon pré-isomérisé ne doit pas dépasser 1,5 partie par million pour chaque un pour cent d’acide iso-alpha contenu dans l’extrait.

DORS/88-418, art. 4.

B.02.135. [N]. Dans le présent titre, « extrait de houblon isomérisé réduit » s’entend :

a) des tétrahydroisohumulones obtenues du houblon :

(i) soit par isomérisation et réduction des humulones (acides alpha) au moyen d’hydrogène et d’un catalyseur,

(ii) soit par réduction des lupulones (acides bêta) au moyen d’hydrogène et d’un catalyseur, suivie d’une oxydation et d’une isomérisation;

b) des hexahydroisohumulones obtenues du houblon par réduction des tétrahydroisohumulones au moyen du borohydrure de sodium;

c) des dihydroisohumulones obtenues du houblon par réduction des acides isoalpha au moyen du borohydrure de sodium.

DORS/96-483, art. 2; DORS/2000-352, art. 1.

Titre 3

Poudre à pâte B.03.001. Au présent Titre, « substance à réaction acide » désigne l’une ou n’importe quelle association des substances suivantes :

a) l’acide lactique ou ses sels;

b) l’acide tartrique ou ses sels;

c) les sels acides de l’acide phosphorique; et

d) les composés acides de l’aluminium.

B.03.002. [N]. La levure artificielle ou poudre à pâte est une combinaison de bicarbonate de sodium ou de potassium, d’une substance à réaction acide, d’amidon ou autre substance neutre; elle peut contenir un agent anti-agglomérant et doit dégager une quantité de gaz carbonique représentant au moins 10 pour cent de son poids, déterminée selon la méthode officielle FO-3, Détermination de gaz carbonique dégagé par la poudre à pâte, 15 octobre 1981.

DORS/82-768, art. 4; DORS/92-626, art. 12.

Titre 4

Produits du cacao et produits de chocolat B.04.001. Les définitions qui suivent s’appliquent au présent titre.

« ingrédient édulcorant » Un agent édulcorant ou une combinaison d’agents édulcorants, à l’exception du sucre à glacer. (sweetening ingredient)

« ingrédient laitier » Un des produits suivants ou toute combinaison de ceux-ci :

a) les produits suivants faisant l’objet d’une norme établie dans la présente partie :

(i) lait ou lait entier,

(ii) lait écrémé,

(iii) lait partiellement écrémé ou en partie écrémé,

(iv) lait stérilisé,

(v) lait condensé ou lait condensé sucré,

(vi) lait évaporé,

(vii) lait écrémé évaporé ou écrémé concentré,

(viii) lait évaporé partiellement écrémé ou lait concentré partiellement écrémé,

(ix) poudre de lait, poudre de lait entier, lait entier desséché ou lait entier en poudre,

(x) lait écrémé en poudre, poudre de lait écrémé ou lait écrémé desséché,

(xi) lait écrémé additionné de solides du lait,

(xii) lait partiellement écrémé additionné de solides du lait ou lait en partie écrémé additionné de solides du lait,

(xiii) lait malté, lait malté en poudre ou poudre de lait malté,

(xiv) beurre,

(xv) crème;

b) les produits suivants ne faisant pas l’objet d’une norme établie dans la présente partie :

(i) lait ou lait entier reconstitué,

(ii) lait écrémé reconstitué,

(iii) lait partiellement écrémé reconstitué,

(iv) lait partiellement écrémé en poudre,

(v) babeurre,

(vi) huile de beurre,

(vii) crème reconstituée. (milk ingredient)

« produit de chocolat » Produit dérivé d’un ou de plusieurs produits du cacao, y compris le chocolat, le chocolat mi-amer, le chocolat mi-sucré, le chocolat noir, le chocolat sucré, le chocolat au lait et le chocolat blanc. (chocolate product)

« produit du cacao » Produit dérivé des fèves de cacao, y compris les fèves de cacao décortiquées, la liqueur de cacao, la pâte de cacao, le chocolat non sucré, le chocolat amer, la liqueur de chocolat, le cacao, le cacao faible en gras, la poudre de cacao et la poudre de cacao faible en gras. (cocoa product)

DORS/97-263, art. 2.

B.04.002. [N]. Les fèves de cacao sont les graines de Theobroma cacao L. ou d’une espèce très proche.

DORS/97-263, art. 2.

B.04.003. [N]. Les fèves de cacao décortiquées sont le produit préparé par décorticage des fèves de cacao nettoyées. Leur teneur en écale résiduelle ne peut excéder 1,75 pour cent en masse — exempte d’alcali lorsque celui-ci a été utilisé pour le traitement des fèves décortiquées ou des fèves de cacao dont elles proviennent —, déterminée conformément à la méthode prévue dans la publication de l’Association of Official

Analytical Chemists, de Washington, intitulée Official Methods of Analysis of the Association of Official Analytical Chemists, 12e éd. (1975), aux articles 13.010 à 13.014 sous la rubrique « Shell in Cacao Nibs — Official Final Action ».

DORS/97-263, art. 2.

B.04.004. [N]. La liqueur de cacao, la pâte de cacao, le chocolat non sucré, le chocolat amer ou la liqueur de chocolat :

a) est le produit obtenu par la désagrégation mécanique de la fève de cacao décortiquée, avec ou sans extraction ou addition de l’un de ses constituants;

b) contient au moins 50 pour cent de beurre de cacao.

DORS/97-263, art. 2.

B.04.005. (1) Les produits du cacao peuvent être traités au moyen de l’un ou plusieurs des rajusteurs du pH ou agents alcalinisants suivants :

a) hydroxydes d’ammonium, carbonates d’ammonium, bicarbonates d’ammonium, hydroxydes de sodium, carbonates de sodium, bicarbonates de sodium, hydroxydes de potassium, carbonates de potassium et bicarbonates de potassium;

b) carbonates de magnésium ou hydroxydes de magnésium;

c) carbonates de calcium.

(2) La quantité de tout rajusteur du pH mentionné aux alinéas (1)a) à c) ne peut dépasser les limites de tolérance prévues à la colonne III du tableau X de l’article B.16.100.

(3) La valeur neutralisante de l’ensemble des rajusteurs du pH visés aux alinéas (1)a) à c), calculée d’après la masse respective de chacun, ne peut dépasser la valeur neutralisante de cinq parties, en masse, de carbonate anhydre de potassium par 100 parties, en masse, de produit du cacao, sans matières grasses.

(4) Les produits du cacao peuvent être traités au moyen de l’un ou plusieurs des rajusteurs du pH ou agents neutralisants suivants, ajoutés tels quels ou en solution aqueuse :

a) acide phosphorique;

b) acide citrique;

c) acide L-tartarique.

(5) La valeur neutralisante de l’ensemble des rajusteurs du pH visés au paragraphe (4), calculée d’après la masse respective de chacun, ne peut dépasser les limites de tolérance applicables prévues à la colonne III du tableau X de l’article B.16.100.

(6) Pour l’application du paragraphe (5) :

a) la quantité totale d’acide phosphorique, en masse, ne peut dépasser 0,5 partie, exprimée en P2O5, par 100 parties, en masse, du produit du cacao sans matières grasses;

b) la quantité totale — seule ou en combinaison — d’acide citrique et d’acide L­ tartarique, en masse, ne peut dépasser 1,0 partie par 100 parties, en masse, du produit du cacao sans matières grasses.

DORS/97-263, art. 2.

B.04.006. [N]. Le chocolat, le chocolat mi-amer, le chocolat mi-sucré ou le chocolat noir :

a) est constitué d’un ou de plusieurs des éléments suivants, en combinaison avec un ingrédient édulcorant :

(i) liqueur de cacao,

(ii) liqueur de cacao et beurre de cacao,

(iii) beurre de cacao et poudre de cacao;

b) contient au moins 35 pour cent de solides du cacao totaux dont :

(i) au moins 18 pour cent sont du beurre de cacao,

(ii) au moins 14 pour cent sont des solides du cacao dégraissés;

c) peut contenir :

(i) moins de 5 pour cent de solides du lait totaux provenant d’ingrédients laitiers,

(ii) des épices,

(iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iv) du sel,

(v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés,

(D) esters polyglycériques d’acides gras d’huile de ricin transestérifiée,

(E) monostéarate de sorbitan.

DORS/79-664, art. 2; DORS/97-263, art. 2.

B.04.007. [N]. Le chocolat sucré :

a) est constitué d’un ou de plusieurs des éléments suivants, en combinaison avec un ingrédient édulcorant :

(i) liqueur de cacao,

(ii) liqueur de cacao et beurre de cacao,

(iii) beurre de cacao et poudre de cacao;

b) contient au moins 30 pour cent de solides du cacao totaux dont :

(i) 18 pour cent sont du beurre de cacao,

(ii) 12 pour cent sont des solides du cacao dégraissés;

c) peut contenir :

(i) moins de 12 pour cent de solides du lait totaux provenant d’ingrédients laitiers,

(ii) des épices,

(iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iv) du sel,

(v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés,

(D) esters polyglycériques d’acides gras d’huile de ricin transestérifiée,

(E) monostéarate de sorbitan.

DORS/97-263, art. 2.

B.04.008. [N]. Le chocolat au lait :

a) est constitué d’un ou de plusieurs des éléments suivants, en combinaison avec un ingrédient édulcorant :

(i) liqueur de cacao,

(ii) liqueur de cacao et beurre de cacao,

(iii) beurre de cacao et poudre de cacao;

b) contient au moins :

(i) 25 pour cent de solides du cacao totaux dont :

(A) au moins 15 pour cent sont du beurre de cacao,

(B) au moins 2,5 pour cent sont des solides du cacao dégraissés,

(ii) 12 pour cent de solides du lait totaux provenant d’ingrédients laitiers,

(iii) 3,39 pour cent de matières grasses du lait;

c) peut contenir :

(i) moins de 5 pour cent de petit-lait ou de produits du petit-lait,

(ii) des épices,

(iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iv) du sel,

(v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés,

(D) esters polyglycériques d’acides gras d’huile de ricin transestérifiée,

(E) monostéarate de sorbitan.

DORS/97-263, art. 2.

B.04.009. [N]. Le chocolat blanc :

a) est constitué des éléments suivants :

(i) au moins 20 pour cent de beurre de cacao,

(ii) au moins 14 pour cent de solides du lait totaux provenant d’ingrédients laitiers,

(iii) au moins 3,5 pour cent de matières grasses du lait;

b) peut contenir :

(i) moins de 5 pour cent de petit-lait ou de produits du petit-lait,

(ii) des épices,

(iii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iv) du sel,

(v) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit de chocolat :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés,

(D) esters polyglycériques d’acides gras d’huile de ricin transestérifiée,

(E) monostéarate de sorbitan.

DORS/97-263, art. 2.

B.04.010. [N]. Le cacao ou la poudre de cacao :

a) est le produit :

(i) qui est obtenu par pulvérisation de ce qui reste de la liqueur de cacao qui a été partiellement dégraissée par moyen mécanique,

(ii) dont la teneur en beurre de cacao est d’au moins 10 pour cent;

b) peut contenir :

(i) des épices,

(ii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iii) du sel,

(iv) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit du cacao :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés.

DORS/82-768, art. 5; DORS/97-263, art. 2.

B.04.011. [N]. Le cacao faible en gras ou la poudre de cacao faible en gras :

a) est le produit :

(i) qui est obtenu par pulvérisation de ce qui reste de la liqueur de cacao qui a été partiellement dégraissée par moyen mécanique,

(ii) dont la teneur en beurre de cacao est de moins de 10 pour cent;

b) peut contenir :

(i) des épices,

(ii) des préparations aromatisantes pour équilibrer la saveur, sauf celles qui imitent la saveur du chocolat ou du lait,

(iii) du sel,

(iv) les agents émulsifiants suivants, en quantité n’excédant pas, pour chacun de ces agents, les limites de tolérance prévues à la colonne III du tableau IV de l’article B.16.100 et, pour toute combinaison de ces agents, 1,5 pour cent en masse du produit du cacao :

(A) monoglycérides et mono- et diglycérides,

(B) lécithine et lécithine hydroxylée,

(C) sels d’ammonium de glycérides phosphorylés.

DORS/82-768, art. 6; DORS/97-263, art. 2.

B.04.012. Il est interdit de vendre des produits du cacao ou des produits de chocolat, à moins qu’ils ne soient exempts de bactéries du genre Salmonella d’après les résultats de l’analyse selon la méthode officielle MFO-11, Examen microbiologique du cacao et du chocolat, du 30 novembre 1981.

DORS/97-263, art. 2.

Titre 5

Café B.05.001. [N]. Le café vert, café brut ou café non torréfié doit être la graine de Coffea arabica L., de C. liberia Hiern ou de C. robusta Chev., presque complètement débarrassée de son spermoderme.

B.05.002. [N]. Le café torréfié ou café doit être du café vert torréfié, doit renfermer au moins 10 pour cent de matière grasse et peut renfermer au plus six pour cent de cendres totales.

B.05.003. [N]. Le (indication du type de café) décaféiné :

a) est le café de ce type duquel a été extraite de la caféine et qui, par suite d’une telle extraction, contient au plus :

(i) 0,1 pour cent de caféine, s’il s’agit de café brut décaféiné ou de café décaféiné,

(ii) 0,3 pour cent de caféine, s’il s’agit de café instantané décaféiné;

b) peut avoir été décaféiné au moyen des solvants d’extraction mentionnés au tableau XV du titre 16.

DORS/90-443, art. 1.

Titre 6 Colorants pour aliments

B.06.001. Dans le présent Titre,

« colorant synthétique » désigne un colorant organique, autre que le caramel, qui est produit par synthèse chimique, qui n’a pas son équivalent dans la nature et qui est assujetti à une norme prévue aux articles B.06.041 à B.06.053; (synthetic colour)

« diluant » désigne une substance, autre qu’un colorant synthétique, qui est présente dans une préparation colorante ou un mélange colorant; (diluent)

« mélange » désigne un mélange de deux colorants synthétiques ou plus, ou un mélange d’un ou de plusieurs colorants synthétiques avec un ou plusieurs diluants; (mixture)

« méthode officielle FO-7 » désigne la méthode officielle FO-7, Détermination de la teneur en pigment dans les colorants synthétiques pour aliments, 15 mars 1984; (official method FO-7)

« méthode officielle FO-8 » désigne la méthode officielle FO-8, Dosage des matières insolubles dans l’eau dans les colorants synthétiques pour aliments, 15 mars 1984; (official method FO-8)

« méthode officielle FO-9 » désigne la méthode officielle FO-9, Dosage des extraits d’éther réunis dans les colorants synthétiques pour aliments, 15 mars 1984; (official method FO-9)

« méthode officielle FO-10 » désigne la méthode officielle FO-10, Dosage des pigments accessoires dans les colorants synthétiques pour aliments, 15 mars 1984; (official method FO-10)

« méthode officielle FO-11 » désigne la méthode officielle FO-11, Dosage des composés intermédiaires dans les colorants synthétiques pour aliments, 15 mars 1984; (official method FO-11)

« méthode officielle FO-12 » désigne la méthode officielle FO-12, Dosage des matières volatiles dans le rouge citrin no 2, 15 mars 1984; (official method FO-12)

« méthode officielle FO-13 » désigne la méthode officielle FO-13, Dosage des cendres sulfatées dans le rouge citrin no 2, 15 mars 1984; (official method FO-13)

« méthode officielle FO-14 » désigne la méthode officielle FO-14, Dosage des matières solubles dans l’eau dans le rouge citrin no 2, 15 mars 1984; (official method FO-14)

« méthode officielle FO-15 » désigne la méthode officielle FO-15, Dosage des matières insolubles dans le tétrachlorure de carbone dans le rouge citrin no 2, 15 mars 1984; (official method FO-15)

« pigment » désigne le pigment principal et tout pigment associé, isomère ou accessoire, présents dans un colorant synthétique; (dye)

« préparation » désigne une préparation faite d’un ou de plusieurs colorants synthétiques, qui renferme moins de trois pour cent de pigment et est vendue pour usage domestique. (preparation)

DORS/80-500, art. 2; DORS/84-440, art. 1.

B.06.002. Il est interdit de vendre un aliment, à l’exclusion d’un colorant synthétique, d’un mélange, d’une préparation ou d’une préparation aromatisante, qui est destiné à la consommation selon le mode d’emploi figurant sur l’étiquette et qui renferme

a) plus de 300 parties par million d’amaranthe, d’érythrosine, d’indigotine, de jaune soleil FCF, de rouge allura, de tartrazine ou d’un mélange de ces colorants, à moins qu’une limite de tolérance plus élevée soit indiquée dans la colonne III de l’article 3 du tableau III de l’article B.16.100;

b) plus de 100 parties par million de vert solide FCF, de bleu brillant FCF, ou d’un mélange de ces colorants;

c) plus de 300 parties par million d’un mélange des colorants synthétiques visés aux alinéas a) et b) dans les limites qui y sont prévues; ou

d) plus de 150 parties par million de ponceau SX.

DORS/80-500, art. 2; DORS/84-440, art. 2; DORS/86-178, art. 1(F); DORS/2007-75, art. 1. Version précédente B.06.003. Il est interdit de vendre un colorant pour aliments qui renferme

a) plus de trois parties par million d’arsenic, calculé en arsenic selon la méthode officielle FO-4, Détermination d’arsenic dans les colorants alimentaires, 15 octobre 1981;

b) plus de 10 parties par million de plomb, calculé en plomb selon la méthode officielle FO-5, Détermination de plomb dans les colorants alimentaires, 15 octobre 1981; ou

c) plus de 40 parties par million de métaux lourds, exception faite de l’oxyde de fer, du bioxyde de titane, de l’aluminium et de l’argent.

DORS/80-500, art. 2; DORS/82-768, art. 7.

B.06.004. Il est interdit de vendre un colorant synthétique pour aliments sans respecter les conditions suivantes :

a) l’étiquette doit porter le numéro de lot et le nom usuel du colorant synthétique et les mots « colorant pour aliments »;

b) le Directeur ou un organisme jugé compétent par ce dernier doit avoir certifié que chaque lot est conforme à l’article B.06.003 et répond à la norme prescrite pour le colorant aux articles B.06.041 à B.06.053; et

c) lorsque la certification est accordée par un organisme, une copie doit en être présentée au Directeur pour acceptation.

DORS/80-500, art. 2.

B.06.005. Il est interdit d’importer un colorant synthétique pour aliments sans respecter les conditions suivantes :

a) le Directeur ou un organisme jugé compétent par ce dernier doit avoir certifié que chaque lot est conforme à l’article B.06.003 et répond à la norme prescrite pour ce colorant aux articles B.06.041 à B.06.053; et

b) lorsque la certification est accordée par un organisme, une copie doit en être présentée au Directeur pour acceptation.

DORS/80-500, art. 2.

B.06.006. Il est interdit de vendre un mélange pour aliments s’il ne porte, sur son étiquette, le numéro de lot et les mots « colorant pour aliments ».

DORS/80-500, art. 2.

B.06.007. Il est interdit de vendre une préparation pour aliments sans respecter les conditions suivantes :

a) les mots « préparation colorante pour aliments » doivent figurer dans l’espace principal de l’étiquette; et

b) s’il s’agit d’une préparation liquide, la capacité maximale du contenant doit être d’au plus 60 millilitres et le liquide ne doit pouvoir être versé que goutte à goutte.

DORS/80-500, art. 2.

B.06.008. Il est interdit d’importer ou de vendre un mélange ou une préparation pour aliments sans respecter les conditions suivantes :

a) le Directeur ou un organisme jugé compétent par ce dernier doit avoir certifié que les colorants synthétiques contenus sont conformes à l’article B.06.003 et répondent à la norme prescrite aux articles B.06.041 à B.06.053; ou

b) les colorants synthétiques contenus doivent avoir été certifiés et cette certification doit avoir été acceptée conformément aux articles B.06.004 et B.06.005.

DORS/80-500, art. 2.

B.06.009. à B.06.013. [Abrogés, DORS/80-500, art. 2]

Colorants naturels

B.06.021. [N]. Le rocou soluble dans l’huile, le rocou à colorer le beurre, ou le rocou à colorer la margarine,

a) doit être un extrait des graines de Bixa orellana

(i) dissous dans l’huile végétale, l’huile de ricin, les monoglycérides et les diglycérides, le propylèneglycol ou les monoesters et diesters de propylèneglycol et d’acides gras lipogènes, avec ou sans adjonction de un pour cent d’hydroxide de potassium, ou

(ii) absorbé sur du sucre, du lactose, de l’amidon ou du silicate de calcium hydraté, avec ou sans phosphate de calcium, phosphate double d’aluminium et de potassium, bicarbonate de sodium ou sel ordinaire; et

b) doit renfermer au moins 0,30 pour cent de pigments totaux, calculés en bixine (cis) naturelle, et les pigments totaux doivent être de la bixine (cis) naturelle dans la proportion de 40 pour cent au moins.

B.06.022. [N]. Le ß-carotène doit être le colorant alimentaire chimiquement connu comme ß-carotène et manufacturé synthétiquement et doit se conformer aux spécifications suivantes :

a) solution de un pour cent dans le chloroforme .......limpide;

b) perte de poids à la dessiccation .......au plus 0,2 pour cent;

c) cendre .......au plus 0,2 pour cent; et

d) dosage (spectrophotométrique) .......de 96 à 101 pour cent.

B.06.023. [N]. Le ß-Apo-8′-caroténal doit être le colorant alimentaire chimiquement connu comme ß-apo-8′-caroténal et doit se conformer aux spécifications suivantes :

a) solution de un pour cent dans le chloroforme .......limpide;

b) point de fusion (décomposition) .......136 °C à 140 °C (corrigé);

c) perte de poids à la dessiccation .......au plus 0,2 pour cent;

d) cendre .......au plus 0,2 pour cent; et

e) dosage (spectrophotométrique) .......de 96 à 101 pour cent.

B.06.024. [N]. Canthaxanthine doit être le colorant alimentaire chimiquement connu comme canthaxanthine et doit se conformer aux spécifications suivantes :

a) solution de un pour cent dans le chloroforme .......limpide;

b) perte de poids à la dessiccation .......au plus 0,2 pour cent;

c) analyse (spectrophotométrique) .......de 96 à 101 pour cent.

B.06.025. [N]. L’ester éthylique de l’acide ß-apo-8′-caroténoïque doit être le colorant alimentaire chimiquement connu sous le nom d’ester éthylique de l’acide ß-apo-8′­ caroténoïque et doit être conforme aux spécifications suivantes :

a) solution à un pour cent dans le chloroforme .......limpide;

b) perte de poids à la dessiccation .......au plus 0,2 pour cent; et

c) dosage (spectrophotométrique) .......96 à 101 pour cent.

DORS/84-300, art. 19(F).

Colorants non organiques

B.06.031. [N]. Le noir de fumée doit être du carbone préparé à partir de gaz naturel par le procédé à l’impinger ou à la filière, et ne doit renfermer ni hydrocarbure aromatique supérieur ni matière bitumineuse, après analyse selon la méthode officielle FO-6, Détermination d’hydrocarbures aromatiques supérieurs et de matières bitumineuses dans le noir de fumée et le charbon de bois, 15 octobre 1981.

DORS/82-768, art. 8.

B.06.032. [N]. Le charbon de bois doit être du carbone préparé par combustion incomplète de matière végétale et ne doit renfermer ni hydrocarbure aromatique supérieur ni matière bitumineuse, après analyse selon la méthode officielle FO-6, Détermination d’hydrocarbures aromatiques supérieurs et de matières bitumineuses dans le noir de fumée et le charbon de bois, 15 octobre 1981.

DORS/82-768, art. 8.

B.06.033. [N]. Le dioxyde de titane doit être la substance chimique connue sous le nom de dioxyde de titane et ne doit pas contenir moins de 99 pour cent de dioxyde de titane et, nonobstant l’article B.06.006, ne doit pas contenir plus de 50 parties par million d’antimoine total exprimé en métal et déterminé selon une méthode acceptable.

Colorants synthétiques

B.06.041. [N]. L’amaranthe doit être le sel trisodique de l’acide 1-(4-sulfo-1­ naphtylazo)-2-naphtol-3,6-disulfonique; elle doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) quatre pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 9; DORS/84-440, art. 3.

B.06.042. [N]. L’érythrosine doit être le sel disodique de la 2,4,5,7­ tétraiodofluorescéine; elle doit renfermer au moins 85 pour cent de pigment calculé en monohydrate selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) cinq pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 9; DORS/84-440, art. 3.

B.06.043. [N]. Le ponceau SX doit être le sel disodique de l’acide 2-(5-sulfo-2,4­ xylylazo)-1-naphtol-4-sulfonique; il doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) un pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 9; DORS/84-440, art. 3.

B.06.044. [N]. Le rouge allura doit être le sel disodique de l’acide 6-hydroxy-5-[(2­ méthoxy-5-méthyl-4-sulfophényl) azo]-2-naphtalène sulfonique; il doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) quatre pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/84-440, art. 3.

B.06.045. [N]. La tartrazine doit être le sel trisodique du 3-carboxy-5-hydroxy-1-p­ sulfophényl-4-p-sulfophénylazopyrazole; elle doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) un pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 10; DORS/84-440, art. 3.

B.06.046. [N]. Le jaune soleil FCF doit être le sel disodique de l’acide 1-p­ sulfophénylazo-2-naphtol-6-sulfonique; il doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle F6-8;

b) 0,2 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) cinq pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 10; DORS/84-440, art. 3.

B.06.049. [N]. Le vert solide FCF doit être le sel disodique du 4,4′-di(N-éthyl-m­ sulfobenzylamino)-2″-sulfo-4″-hydroxy-triphénylméthanol anhydride; il doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,4 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) cinq pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) un pour cent de composés intermédiaires, déterminé selon la méthode officielle FO-11.

DORS/82-768, art. 11; DORS/84-440, art. 3.

B.06.050. [N]. L’indigotine doit être le sel disodique de l’acide indigotine-5,5′ ­ disulfonique; elle doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,4 pour cent d’extrait d’éther réunis, déterminé selon la méthode officielle FO-9;

c) un pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) 0,5 pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 11; DORS/84-440, art. 3.

B.06.051. [N]. Le bleu brillant FCF doit être le sel disodique du 4,4′-di(N-éthyl-m­ sulfobenzylamino)-2″-sulfotriphénylméthanol anhydride; il doit renfermer au moins 85 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,2 pour cent de matière insoluble dans l’eau, déterminé selon la méthode officielle FO-8;

b) 0,4 pour cent d’extraits d’éther réunis, déterminé selon la méthode officielle FO-9;

c) cinq pour cent de pigments accessoires, déterminé selon la méthode officielle FO-10; et

d) deux pour cent de composés intermédiaires, déterminé selon la méthode officielle FO­ 11.

DORS/82-768, art. 11; DORS/84-440, art. 3.

B.06.053. [N]. Le rouge citrin no 2 doit être le 1-(2,5-diméthoxyphénylazo)-2-naphtol; il doit renfermer au moins 98 pour cent de pigment, déterminé selon la méthode officielle FO-7, et peut renfermer au plus

a) 0,5 pour cent de matières volatiles (à 100 °C), déterminé selon la méthode officielle FO-12;

b) 0,3 pour cent de cendres sulfatées, déterminé selon la méthode officielle FO-13;

c) 0,3 pour cent de matière soluble dans l’eau, déterminé selon la méthode officielle FO­ 14;

d) 0,5 pour cent de matière insoluble dans le tétrachlorure de carbone, déterminé selon la méthode officielle FO-15;

e) 0,05 pour cent de composés intermédiaires non combinés; et

f) deux pour cent de pigments accessoires.

DORS/82-768, art. 12; DORS/84-440, art. 3.

B.06.061. La laque de tout colorant synthétique soluble dans l’eau pour lequel une norme est prévue aux articles B.06.041, B.06.042, B.06.043, B.06.044, B.06.045, B.06.046, B.06.049, B.06.050 ou B.06.051 doit être le sel de calcium ou d’aluminium du colorant en cause, absorbé sur alumine.

DORS/82-1071, art. 3; DORS/84-300, art. 20; DORS/87-640, art. 2.

B.06.062. [Abrogé, DORS/82-768, art. 13]

Titre 7

Épices, condiments et assaisonnements B.07.001. [N]. Le myrte-piment, pimenta, piment de la Jamaïque, piment des Anglais ou toute-épice, entier ou moulu, doit être la baie complète et non mûrie du Pimenta dioica (L) Merr. et doit renfermer

a) au plus

(i) 25 pour cent de cellulose,

(ii) 5,5 pour cent de cendres totales,

(iii) 0,4 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iv) 12 pour cent d’humidité; et

b) au moins 2,5 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.002. [N]. L’anis ou la graine d’anis, entier ou moulu, doit être le fruit desséché du Pimpinella anisum L. et doit renfermer

a) au plus

(i) neuf pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins deux millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.003. [N]. Le basilic ou le basilic odorant, entier ou moulu, doit être la feuille desséchée de l’Ocimum basilicum L. et doit renfermer

a) au plus

(i) 15 pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins 0,2 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.004. [N]. Les feuilles de laurier, entières ou moulues, doivent être les feuilles desséchées du Laurus nobilis L. et doivent renfermer

a) au plus

(i) 4,5 pour cent de cendres totales,

(ii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) sept pour cent d’humidité; et

b) au moins un millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.005. [N]. Le carvi ou la graine de carvi, entier ou moulu, doit être le fruit desséché du carvi, Carum carvi L. et doit renfermer

a) au plus

(i) huit pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 11,5 pour cent d’humidité; et

b) au moins deux millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.006. [N]. La cardamome ou la graine de cardamome, décolorée ou verte, entière ou moulue, doit être le fruit mûr et desséché de l’Elettaria cardamomum Maton et doit renfermer

a) au plus

(i) huit pour cent de cendres totales,

(ii) trois pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 13 pour cent d’humidité; et

b) au moins trois millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.007. [N]. Le poivre de cayenne ou le cayenne, entier ou moulu,

a) est le fruit mûr et desséché du Capsicum frutescens L., du Capsicum baccatum L. ou d’autres espèces de Capsicum portant de petits fruits et doit renfermer au plus

(i) 1,5 pour cent d’amidon,

(ii) 28 pour cent de cellulose,

(iii) 10 pour cent de cendres totales,

(iv) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(v) 10 pour cent d’humidité; et

b) peut renfermer au plus deux pour cent de bioxyde de silicium en tant qu’agent anti­ agglomérant.

DORS/79-659, art. 1; DORS/84-17, art. 2.

B.07.008. [N]. Le sel de céleri

a) doit être un mélange

(i) de graines de céleri moulu ou de céleri déshydraté moulu, et

(ii) de sel en une quantité n’excédant pas 75 pour cent; et

b) peut renfermer au plus 0,5 pour cent de bioxyde de silicium comme agent anti­ agglomérant.

DORS/79-659, art. 1.

B.07.009. [N]. La graine de céleri, entière ou moulue, doit être la graine mûre et desséchée de l’Apium graveolens L. et doit renfermer

a) au plus

(i) 12 pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins 1,5 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.010. [N]. Le poivre de céleri

a) doit être un mélange

(i) de graines de céleri moulu ou de céleri déshydraté moulu, et

(ii) de poivre noir moulu en une quantité n’excédant pas 70 pour cent; et

b) peut renfermer au plus 0,5 pour cent de bioxyde de silicium comme agent anti­ agglomérant.

DORS/79-659, art. 1.

B.07.011. [N]. La cannelle ou la cannelle bâtarde (ou fausse cannelle), entière ou moulue, doit être l’écorce desséchée des arbres du genre Cinnamomum des espèces C. burmanni Blume, C. loureirii Nees ou C. Cassia Blume et doit renfermer

a) au plus

(i) six pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 13 pour cent d’humidité; et

b) au moins 1,2 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.012. [N]. La cannelle de Ceylan, entière ou moulue, doit être la cannelle obtenue exclusivement du Cinnamomum zeylanicum Nees.

DORS/79-659, art. 1.

B.07.013. [N]. Le clou de girofle, entier ou moulu, doit être le bouton clos et desséché de la fleur de l’Eugenia caryophyllus (Spreng) et doit renfermer

a) au plus

(i) cinq pour cent de tiges de clou de girofle,

(ii) six pour cent de cendres totales,

(iii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique,

(iv) 10 pour cent de cellulose, et

(v) huit pour cent d’humidité; et

b) au moins 13 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.014. [N]. La coriandre ou la graine de coriandre, entière ou moulue, doit être la graine desséchée du Coriandrum sativum L. et doit renfermer

a) au plus

(i) sept pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins 0,3 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.015. [N]. Le cumin ou la graine de cumin, entier ou moulu, doit être la graine desséchée du Cuminum cyminum L. et doit renfermer

a) au plus

(i) 9,5 pour cent de cendres totales,

(ii) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins 2,5 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.016. [N]. La poudre de cari doit être un mélange

a) de curcuma avec des épices et des condiments; et

b) de sel en une quantité n’excédant pas cinq pour cent.

DORS/79-659, art 1.

B.07.017. [N]. La graine d’aneth, entière ou moulue, doit être la graine desséchée de l’Anethum graveolens L., ou de l’Anethum sowa D.C. et doit renfermer

a) au plus

(i) 10 pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins deux millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.018. [N]. Le fenouil ou la graine de fenouil, entier ou moulu, doit être la graine mûre et desséchée du Foeniculum vulgare Mill. et doit renfermer

a) au plus

(i) 10 pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins un millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.019. [N]. Le fenugrec, entier ou moulu, doit être la graine mûre et desséchée du Trigonella foenumgraecum L. et doit renfermer au plus

a) cinq pour cent de cendres totales;

b) un pour cent de cendres insolubles dans l’acide chlorhydrique; et

c) 10 pour cent d’humidité.

DORS/79-659, art. 1.

B.07.020. [N]. Le sel d’ail

a) doit être un mélange

(i) d’ail déshydraté en poudre, et

(ii) de sel en une quantité n’excédant pas 75 pour cent; et

b) peut renfermer les agents anti-agglomérants suivants pour une quantité totale n’excédant pas deux pour cent :

silicate double d’aluminium et de calcium, phosphate tricalcique, silicate de calcium, stéarate de calcium, carbonate de magnésium, silicate de magnésium, stéarate de magnésium, bioxyde de silicium, en une quantité n’excédant pas un pour cent et silicate double de sodium et d’aluminium.

DORS/79-659, art. 1.

B.07.021. [N]. Le gingembre, entier ou moulu, doit être le rhizome lavé et desséché ou décortiqué du Zingiber officinale Roscoe et doit renfermer

a) au plus

(i) sept pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 12,5 pour cent d’humidité; et

b) au moins 1,5 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.022. [N]. Le macis, entier ou moulu, doit être l’arille desséchée du Myristica fragrans Houttyn et doit renfermer

a) au plus

(i) 3,5 pour cent de cendres totales,

(ii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) huit pour cent d’humidité; et

b) au moins 11 millilitres d’huile volatile par 100 grammes d’épice,

la somme des extraits non volatils qui pourraient en être extraits au moyen

c) d’éther éthylique, doit constituer de 20 pour cent à 35 pour cent du produit; et

d) d’éther éthylique, après extraction préliminaire avec l’éther de pétrole, doit représenter au plus cinq pour cent du produit.

DORS/79-659, art. 1.

B.07.023. [N]. La marjolaine, entière ou moulue, doit être la feuille desséchée, avec ou sans une faible proportion des fleurs de la plante de la Marjorana hortensis Moench et doit renfermer

a) au plus

(i) 10 pour cent des tiges et de matières étrangères d’origine végétale,

(ii) 13,5 pour cent de cendres totales,

(iii) 4,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iv) 10 pour cent d’humidité; et

b) au moins 0,7 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.024. [N]. La graine de moutarde doit être la graine du Sinapis alba, du Brassica hirta Moench, du Brassica juncea (L) Cosson ou du Brassica nigra et doit renfermer

a) au plus

(i) sept pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 11 pour cent d’humidité; et

b) au moins 25 pour cent d’extrait d’éther non volatil.

DORS/79-659, art. 1.

B.07.025. [N]. La moutarde, farine de moutarde ou moutarde moulue doit être la poudre qui provient de la graine de moutarde

a) de laquelle

(i) a été enlevée une majeure partie de la balle, et

(ii) peut avoir été enlevée une partie de l’huile fixe; et

b) qui renferme au plus

(i) 1,5 pour cent d’amidon, et

(ii) huit pour cent de cendres totales, sur la matière dégraissée.

DORS/79-659, art. 1; DORS/2010-142, art. 3(F). Version précédente B.07.026. [N]. La muscade, entière ou moulue, doit être la graine desséchée du Myristica fragrans Houttyn, peut, avant la mouture, porter une mince couche de chaux et doit renfermer

a) au plus

(i) trois pour cent de cendres totales,

(ii) 0,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) huit pour cent d’humidité; et

b) au moins

(i) 25 pour cent d’extrait d’éther non volatil, et

(ii) 6,5 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.027. [N]. Le sel d’oignon

a) doit être un mélange

(i) d’oignons déshydratés en poudre, et

(ii) de sel en une quantité n’excédant pas 75 pour cent; et

b) peut renfermer les agents anti-agglomérants suivants pour une quantité totale n’excédant pas deux pour cent :

silicate double d’aluminium et de calcium, phosphate tricalcique, silicate de calcium, stéarate de calcium, carbonate de magnésium, silicate de magnésium, stéarate de magnésium, bioxyde de silicium en une quantité n’excédant pas un pour cent et silicate double de sodium et d’aluminium.

DORS/79-659, art. 1.

B.07.028. [N]. L’origan, entier ou moulu, doit être la feuille desséchée de l’Origanum vulgar L. ou de l’Origanum Spp. et doit renfermer

a) au plus

(i) 10 pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins 2,5 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.029. [N]. Le paprika est le fruit mûr desséché et moulu du Capsicum annuum L. et

a) doit renfermer au plus

(i) 23 pour cent de cellulose,

(ii) 8,5 pour cent de cendres totales,

(iii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iv) 12 pour cent d’humidité; et

b) peut renfermer au plus deux pour cent de bioxyde de silicium en tant qu’agent anti­ agglomérant.

DORS/79-659, art. 1; DORS/84-17, art. 3.

B.07.030. [N]. Le poivre noir ou le poivre en grain, entier ou moulu, doit être la baie non mûrie et desséchée du Piper nigrum L. et doit renfermer

a) au plus

(i) sept pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 12 pour cent d’humidité;

b) au moins

(i) six pour cent d’extrait de chlorure de méthylène non volatil,

(ii) 30 pour cent d’amidon de poivre, et

(iii) 2,0 millilitres d’huile volatile par 100 grammes d’épice; et

c) une fois moulu, les diverses parties de la baie dans leurs proportions normales.

DORS/79-659, art. 1.

B.07.031. [N]. Le poivre blanc, entier ou moulu, doit être la baie mûre et desséchée du Piper nigrum L. débarrassée de son enveloppe extérieure et dont l’enveloppe intérieure peut être enlevée, il doit renfermer

a) au plus

(i) cinq pour cent de cellulose,

(ii) 2,5 pour cent de cendres totales,

(iii) 0,3 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iv) 15 pour cent d’humidité; et

b) au moins

(i) six pour cent d’extrait de chlorure de méthylène non volatil,

(ii) 52 pour cent d’amidon de poivre, et

(iii) un millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.032. [N]. La graine de pavot doit être la graine desséchée du Papaver somniferum L. et doit renfermer

a) au plus

(i) sept pour cent de cendres totales, et

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique; et

b) au moins 40 pour cent d’extrait d’éther non volatil.

DORS/79-659, art. 1.

B.07.033. [N]. Le romarin, entier ou moulu, doit être la feuille desséchée du Rosemarinus officinalis L. et doit renfermer

a) au plus

(i) 7,5 pour cent de cendres totales,

(ii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins 1,2 millilitre d’huile volatile par 100 grammes d’épice.

DORS/78-637, art. 1; DORS/79-659, art. 1.

B.07.034. [N]. La sauge, entière ou moulue, doit être la feuille desséchée du Salvia officinalis L., du Salvia triloba L. ou du Salvia lavandulaefolia Vahl. et doit renfermer

a) au plus

(i) 12 pour cent de tiges, pétioles non compris, et de matières étrangères d’origine végétale,

(ii) 10 pour cent de cendres totales,

(iii) un pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iv) 10 pour cent d’humidité; et

b) au moins un millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.035. [N]. La sarriette, entière ou moulue, doit être la feuille et la fleur desséchées du Satureja hortensis L. ou du Satureja montana L. et doit renfermer

a) au plus

(i) 11 pour cent de cendres totales,

(ii) deux pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 14 pour cent d’humidité; et

b) au moins 0,8 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.036. [N]. La graine de sésame doit être la graine à balles desséchées du Sesamum indicum L. et doit renfermer

a) au plus huit pour cent d’humidité; et

b) au moins 50 pour cent d’extrait d’éther non volatil.

DORS/79-659, art. 1; DORS/2010-142, art. 4(F). Version précédente B.07.037. [N]. L’estragon, entier ou moulu, doit être la feuille et la fleur desséchées de l’Artemisia dracunculus L. et doit renfermer

a) au plus

(i) 15 pour cent de cendres totales,

(ii) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins 0,3 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.038. [N]. Le thym, entier ou moulu, doit être la feuille et la fleur desséchées du Thymus vulgaris L. ou du Thymus zygis L. et doit renfermer

a) au plus

(i) 12 pour cent de cendres totales,

(ii) cinq pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) neuf pour cent d’humidité; et

b) au moins 0,9 millilitre d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.039. [N]. Le curcuma, entier ou moulu, doit être le rhizome desséché du Curcuma longa L. et doit renfermer

a) au plus

(i) sept pour cent de cendres totales,

(ii) 1,5 pour cent de cendres insolubles dans l’acide chlorhydrique, et

(iii) 10 pour cent d’humidité; et

b) au moins 3,5 millilitres d’huile volatile par 100 grammes d’épice.

DORS/79-659, art. 1.

B.07.040. [N]. La mayonnaise, sauce mayonnaise ou sauce mayonnaise à salade

a) doit être un mélange

(i) d’huile végétale,

(ii) d’oeufs entiers ou de jaunes d’oeufs, à l’état liquide, congelés ou desséchés, et

(iii) de vinaigre ou de jus de citron;

b) peut renfermer

(i) de l’eau,

(ii) du sel,

(iii) un agent édulcorant,

(iv) des épices ou autres condiments, excepté le curcuma et le safran,

(v) de l’acide citrique, tartrique ou lactique, et

(vi) un agent séquestrant; et

c) doit renfermer au moins 65 pour cent d’huile végétale.

DORS/79-659, art. 1.

B.07.041. [N]. La sauce française ou sauce vinaigrette

a) doit être un mélange

(i) d’huile végétale, et

(ii) de vinaigre ou de jus de citron;

b) peut renfermer

(i) de l’eau,

(ii) du sel,

(iii) un agent édulcorant,

(iv) des épices, des tomates ou d’autres condiments,

(v) un émulsif,

(vi) des oeufs entiers ou des jaunes d’oeufs, à l’état liquide, congelés ou desséchés,

(vii) de l’acide citrique, tartrique ou lactique, et

(viii) un agent séquestrant; et

c) doit renfermer au moins 35 pour cent d’huile végétale.

DORS/79-659, art. 1.

B.07.042. [N]. La sauce à salade ou sauce genre mayonnaise

a) doit être un mélange

(i) d’huile végétale,

(ii) d’oeufs entiers ou de jaunes d’oeufs, à l’état liquide, congelés ou desséchés,

(iii) de vinaigre ou de jus de citron, et

(iv) d’amidon, de farine, de farine de seigle ou de tapioca, ou un mélange de ces produits;

b) peut renfermer

(i) de l’eau,

(ii) du sel,

(iii) un agent édulcorant,

(iv) des épices ou autres condiments,

(v) un émulsif,

(vi) de l’acide citrique, tartrique ou lactique, et

(vii) un agent séquestrant; et

c) doit renfermer au moins 35 pour cent d’huile végétale.

DORS/79-659, art. 1.

B.07.043. Est interdite la vente d’une sauce d’assaisonnement qui contient plus de cinq pour cent d’acide gras monoénoïques en C22 par rapport aux acides totaux qu’elle renferme.

DORS/79-659, art. 1.

Titre 8

Produits laitiers B.08.001. Les aliments mentionnés dans le présent Titre sont des produits laitiers.

B.08.001.1 Les définitions qui suivent s’appliquent au présent titre.

« produit du lait »

a) Dans le cas du beurre ou du beurre de petit-lait, l’un ou l’autre des produits suivants :

(i) le lait partiellement écrémé, le lait écrémé, la crème, le babeurre ou la crème de petit- lait,

(ii) le lait sous forme concentrée, desséchée ou reconstituée ou tout produit visé au sous­ alinéa (i) sous forme concentrée, desséchée ou reconstituée;

b) dans le cas du fromage, l’un ou l’autre des produits suivants :

(i) le lait partiellement écrémé, le lait écrémé, la crème, le babeurre, le petit-lait ou la crème de petit-lait,

(ii) le lait sous forme concentrée, desséchée, congelée ou reconstituée ou tout produit visé au sous-alinéa (i) sous forme concentrée, desséchée, congelée ou reconstituée,

(iii) le beurre, l’huile de beurre et le beurre de petit-lait,

(iv) tout composant du lait — sauf l’eau —, pris seul ou en combinaison avec d’autres,

(v) le concentré protéique de petit-lait;

c) dans le cas du fromage à la crème à tartiner, du fromage à la crème à tartiner (avec indication des ingrédients ajoutés), du fromage fondu à tartiner, du fromage fondu à tartiner (avec indication des ingrédients ajoutés), d’une préparation de fromage conditionné à froid, d’une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés), d’une préparation de fromage fondu ou d’une préparation de fromage fondu (avec indication des ingrédients ajoutés), l’un ou l’autre des produits suivants :

(i) le beurre, le beurre de petit-lait et le petit-lait,

(ii) le concentré protéique de petit-lait,

(iii) tout produit visé au sous-alinéa (i) sous forme concentrée ou desséchée;

d) dans le cas d’un mélange à lait glacé, d’un mélange à crème glacée et du sorbet laitier, les produits visés aux sous-alinéas a)(i) ou (ii) ou c)(i) ou (ii). (milk product)

« ultrafiltré » Se dit du lait, du lait partiellement écrémé ou du lait écrémé qu’on fait passer à travers une ou plusieurs membranes semi-perméables pour partiellement en soustraire l’eau, le lactose, les minéraux et les vitamines hydrosolubles sans en altérer le

rapport protéines de petit-lait à la caséine et qui résulte en un produit liquide. (ultrafiltered)

DORS/92-400, art. 1; DORS/97-543, art. 1(F); DORS/98-580, art. 1(F); DORS/2007­ 302, art. 1; DORS/2010-94, art. 2. Version précédente B.08.002. Sauf l’exception prévue dans le présent règlement, tout produit laitier qui contient du gras autre que du gras de lait est falsifié.

B.08.002.1. Les articles B.08.003 à B.08.028, ne s’appliquent pas à la sécrétion lactée des glandes mammaires d’un animal autre qu’une vache, genre Bos, ni aux produits ou dérivés de cette sécrétion.

DORS/85-623, art. 1.

B.08.002.2 (1) Il est interdit de vendre la sécrétion lactée normale provenant des glandes mammaires d’une vache, genre Bos, ou d’un autre animal, ou tout produit laitier fabriqué à partir de cette sécrétion, à moins que la sécrétion ou le produit laitier n’aient été pasteurisés à une température et pendant une période qui assurent la réduction de l’activité de la phosphatase alcaline de façon que la limite de tolérance spécifiée dans la méthode officielle MFO-3, Détermination de l’activité phosphatasique des produits laitiers, en date du 30 novembre 1981, soit respectée.

(2) Le paragraphe (1) ne s’applique pas :

a) aux fromages;

b) aux aliments vendus pour être soumis à d’autres étapes de fabrication ou de transformation en vue de leur pasteurisation de la façon prévue au paragraphe (1).

DORS/91-549, art. 1; DORS/95-499, art. 1.

Lait

B.08.003. [N]. Le lait ou lait entier

a) doit être la sécrétion lactée normale des glandes mammaires de la vache, genre Bos;

b) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

DORS/95-499, art. 2.

B.08.004. [N]. Le lait écrémé

a) doit être un lait qui ne contient pas plus de 0,3 pour cent de gras de lait;

b) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A; et

c) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

DORS/78-656, art. 1.

B.08.005. [N]. Le lait partiellement écrémé ou en partie écrémé

a) doit provenir d’un lait dont la teneur en gras a été réduite par séparation mécanique ou ajustée par l’addition de crème, de lait ou de lait écrémé ou partiellement écrémé seuls ou en association;

b) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A; et

c) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

DORS/78-656, art. 2.

B.08.006. [N]. Le gras de lait ou gras de beurre doit être la matière grasse du lait de vache et doit avoir

a) une densité d’au moins 0,905 à la température de 40 °C,

b) une teneur en tocophérols d’au plus 50 microgrammes par gramme, déterminée selon la méthode officielle FO-16, Détermination de la teneur en tocophérols du gras de lait ou du gras de beurre, 15 octobre 1981,

c) un indice de Reichert-Meissl d’au moins 24, et

d) un indice de Polenske ne dépassant pas 10 pour cent de l’indice de Reichert-Meissl et ne dépassant 3,5 en aucun cas, et

si la teneur en tocophérols dépasse 50 microgrammes par gramme ou si l’indice de Polenske dépasse 10 pour cent de l’indice de Reichert-Meissl, le gras de lait sera censé avoir été additionné d’une matière grasse autre que celle du lait de vache.

DORS/82-768, art. 14.

B.08.007. [N]. Le lait stérilisé

a) et b) [Abrogés, DORS/97-148, art. 1]

c) doit renfermer au moins

(i) 11,75 pour cent de solides du lait, et

(ii) 3,25 pour cent de gras de lait; et

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

DORS/97-148, art. 1.

B.08.008. Le pourcentage de matière grasse du lait contenu dans

a) du lait partiellement écrémé ou en partie écrémé,

b) du lait partiellement écrémé additionné de solides du lait ou du lait en partie écrémé additionné de solides du lait, ou

c) du lait évaporé partiellement écrémé ou du lait concentré partiellement écrémé

doit être indiqué sur l’espace principal suivi de l’expression « matière grasse du lait » ou de l’abréviation « M.G. ».

B.08.009. [N]. Le lait condensé ou lait condensé sucré doit être du lait dont l’eau a été évaporée et auquel on a ajouté du sucre, du dextrose, du glucose, des solides du glucose ou du lactose, ou un mélange quelconque de ces substances; il peut renfermer de la vitamine D ajoutée et doit renfermer au moins

a) 28 pour cent de solides du lait; et

b) huit pour cent de gras de lait.

B.08.010. [N]. Le lait évaporé

a) doit être du lait dont de l’eau a été évaporée;

b) doit contenir au moins

(i) 25,0 pour cent de solides du lait,

(ii) 7,5 pour cent de matière grasse du lait;

c) doit, nonobstant les articles D.01.009 à D.01.011, contenir de la vitamine C ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 60 milligrammes et au plus 75 milligrammes de vitamine C;

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier renferme au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

e) peut renfermer

(i) du phosphate disodique ou du citrate de sodium ajoutés, ou les deux, et

(ii) un agent émulsifiant.

DORS/78-656, art. 3; DORS/92-400, art. 2.

B.08.011. [N]. Le lait écrémé évaporé ou écrémé concentré

a) doit être un lait qui a été concentré à la moitié au moins de son volume primitif par déshydratation;

b) doit contenir

(i) au plus 0,3 pour cent de gras de lait, et

(ii) au moins 17,0 pour cent de solides du lait autres que le gras;

c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

d) doit, nonobstant les articles D.01.009 à D.01.011, contenir de la vitamine C en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 60 milligrammes et au plus 75 milligrammes de vitamine C;

e) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

f) peut contenir du phosphate disodique ou du citrate de sodium ajoutés, ou les deux.

B.08.012. [N]. Le lait évaporé partiellement écrémé ou lait concentré partiellement écrémé

a) doit être un lait dont une partie du gras a été enlevé;

b) doit être concentré à la moitié au moins de son volume primitif par déshydratation;

c) doit contenir au moins 17,0 pour cent de solides du lait autres que le gras;

d) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

e) doit, nonobstant les articles D.01.009 à D.01.011, contenir de la vitamine C ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 60 milligrammes et au plus 75 milligrammes de vitamine C;

f) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

g) peut contenir

(i) un agent émulsifiant, et

(ii) du phosphate disodique ou du citrate de sodium ajoutés, ou les deux.

B.08.013. [N]. La poudre de lait, la poudre de lait entier, lait entier desséché ou lait entier en poudre

a) doit être du lait desséché;

b) doit renfermer au moins

(i) 95 pour cent de solides du lait, et

(ii) 26 pour cent de gras de lait;

c) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

d) peut contenir l’agent émulsifiant lécithine en quantité n’excédant pas 0,5 pour cent.

DORS/78-656, art. 4; DORS/83-932, art. 2.

B.08.014. [N]. Le lait écrémé en poudre, la poudre de lait écrémé, ou le lait écrémé desséché

a) doivent être du lait écrémé desséché;

b) doivent contenir au moins 95 pour cent des solides du lait;

c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

e) peut contenir un agent anti-mousse.

DORS/78-656, art. 5; DORS/80-501, art. 2(F).

B.08.014A. Est interdite la vente de poudre de lait, de poudre de lait entier, de lait entier desséché, de lait entier en poudre, de poudre de lait écrémé ou de lait écrémé desséché, à moins qu’ils ne soient, selon la méthode officielle MFO-12, Examen microbiologique de la poudre de lait, 30 novembre 1981, trouvés exempts de bactéries du genre Salmonella.

DORS/78-656, art. 6; DORS/82-768, art. 15.

B.08.015. Est interdite la vente de lait, de lait écrémé, de lait partiellement écrémé, de lait (indication de l’arôme), de lait écrémé (indication de l’arôme), de lait partiellement écrémé (indication de l’arôme), de lait écrémé additionné de solides du lait, de lait

partiellement écrémé additionné de solides du lait, de lait écrémé (indication de l’arôme) additionné de solides du lait, de lait partiellement écrémé (indication de l’arôme) additionné de solides du lait, de lait condensé, de lait évaporé, de lait écrémé et évaporé, de lait évaporé partiellement écrémé, de poudre de lait, ou de poudre de lait écrémé, dont la teneur en vitamines a été accrue par irradiation ou par addition, à moins que

a) dans le cas de l’addition de vitamine D, le dissolvant contenant ladite vitamine ne fournisse au lait au plus 0,01 pour cent de gras étranger au lait; et

b) dans les cas où la teneur en vitamine D est accrue par irradiation, l’espace principal de l’étiquette ne porte l’inscription « vitamine D accrue » précédant ou suivant immédiatement le nom de l’aliment sans interposition d’écrit, d’imprimé ou d’illustration.

DORS/88-336, art. 3.

B.08.016. [N]. Le lait (indication de l’arôme)

a) doit être le produit fabriqué

(i) soit exclusivement de lait, de lait en poudre, de lait écrémé, de lait écrémé en poudre, de lait partiellement écrémé, de lait évaporé, de lait évaporé partiellement écrémé, de lait écrémé évaporé ou de crème, soit d’un mélange quelconque de ces produits,

(ii) d’une préparation aromatisante, et

(iii) d’un agent édulcorant;

b) doit renfermer au moins trois pour cent de gras de lait;

c) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D;

d) peut contenir du sel, un colorant alimentaire, de la lactase, un agent stabilisant et au plus 0,5 pour cent d’amidon; et

e) peut contenir au plus 50 000 bactéries aérobies totales par centimètre cube, déterminées selon la méthode officielle MFO-7, Examen microbiologique du lait, 30 novembre 1981.

DORS/78-656, art. 7; DORS/82-768, art. 16; DORS/84-762, art. 1.

B.08.017. [N]. Le lait écrémé (indication de l’arôme)

a) doit être le produit fabriqué

(i) soit exclusivement de lait écrémé en poudre ou de lait écrémé évaporé, soit d’un mélange quelconque de ces produits,

(ii) d’une préparation aromatisante, et

(iii) d’un agent édulcorant;

b) doit renfermer au plus 0,3 pour cent de gras de lait; et

c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

e) peut contenir du sel, un colorant alimentaire, de la lactase, un agent stabilisant et au plus 0,5 pour cent d’amidon.

DORS/78-656, art. 8; DORS/84-762, art. 2.

B.08.018. [N]. Le lait partiellement écrémé (indication de l’arôme) ou le lait en partie écrémé (indication de l’arôme)

a) doit être le produit fabriqué

(i) soit exclusivement de lait, de lait en poudre, de lait écrémé, de lait écrémé en poudre, de lait partiellement écrémé, de lait évaporé, de lait évaporé partiellement écrémé, de lait écrémé évaporé ou de crème, soit d’un mélange quelconque de ces produits,

(ii) d’une préparation aromatisante, et

(iii) d’un agent édulcorant;

b) doit renfermer plus de 0,3 pour cent et moins de trois pour cent de gras de lait;

c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D;

e) peut contenir du sel, un colorant alimentaire, de la lactase, un agent stabilisant et au plus 0,5 pour cent d’amidon; et

f) peut contenir au plus 50 000 bactéries aérobies totales par centimètre cube, déterminées selon la méthode officielle MFO-7, Examen microbiologique du lait, 30 novembre 1981.

DORS/78-656, art. 9; DORS/82-768, art. 17; DORS/84-762, art. 3.

B.08.019. [N]. Le lait écrémé additionné de solides du lait

a) doit être du lait écrémé auquel a été ajouté du lait écrémé en poudre ou du lait écrémé évaporé, ou les deux;

b) doit renfermer au moins 10 pour cent de solides du lait;

c) doit renfermer au plus 0,3 pour cent de gras de lait;

d) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A; et

e) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

DORS/78-656, art. 10.

B.08.020. [N]. Le lait partiellement écrémé additionné de solides du lait ou le lait en partie écrémé additionné de solides du lait

a) doit être du lait partiellement écrémé auquel a été ajouté du lait écrémé en poudre, du lait en poudre, du lait évaporé, du lait évaporé partiellement écrémé ou du lait écrémé évaporé, ou un mélange quelconque de ces produits;

b) doit renfermer au moins 10 pour cent de solides du lait autres que le gras; et

c) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A; et

d) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D.

B.08.021. [N]. Le lait malté, le lait malté en poudre ou la poudre de lait malté

a) doit être le produit fabriqué en mélangeant du lait avec le liquide séparé d’un moût de malt d’orge moulue et de farine d’orge;

b) peut renfermer, de manière à assurer la pleine action enzymatique, du sel et du bicarbonate de sodium ou du bicarbonate de potassium ajoutés;

c) peut être débarrassé d’eau; et

d) doit renfermer

(i) au moins 7,5 pour cent de gras de lait, et

(ii) au plus 3,5 pour cent d’humidité.

B.08.022. [N]. Le lait malté (indication de l’arôme) ou lait malté en poudre (indication de l’arôme)

a) doit être du lait malté ou du lait malté en poudre qui renferme une préparation aromatisante; et

b) peut contenir de la lactase.

DORS/84-762, art. 4.

B.08.023. [N]. Le lait écrémé (indication de l’arôme) additionné de solides du lait

a) doit être le produit fabriqué

(i) soit exclusivement de lait écrémé, de lait écrémé en poudre ou de lait écrémé évaporé, soit d’un mélange quelconque de ces produits,

(ii) d’une préparation aromatisante, et

(iii) d’un agent édulcorant;

b) doit renfermer au moins 10 pour cent de solides du lait autres que le gras;

c) doit renfermer au plus 0,3 pour cent de gras de lait;

d) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de vitamine A;

e) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D; et

f) peut contenir du sel, un colorant alimentaire, de la lactase, un agent stabilisant et au plus 0,5 pour cent d’amidon.

DORS/78-656, art. 11; DORS/84-762, art. 5.

B.08.024. Est interdite la vente de lait aux fins de la fabrication de produits laitiers, si ce lait renferme plus de

a) deux millions de bactéries aérobies totales par millilitre, déterminées selon la méthode officielle MFO-7, Examen microbiologique du lait, 30 novembre 1981; ou

b) deux milligrammes de sédiments par 16 onces liquides, déterminés selon la méthode officielle MFO-8, Détermination de sédiments dans le lait, 30 novembre 1981.

DORS/82-768, art. 18.

B.08.025. Il est interdit à un fabricant d’acheter du lait aux fins de fabriquer des produits laitiers, et de fabriquer d’autres produits laitiers avec du lait, si le fabricant a lieu de croire que ce lait n’est pas conforme aux dispositions de l’article B.08.024.

B.08.026. [N]. Le lait partiellement écrémé (indication de l’arôme) additionné de solides du lait ou le lait en partie écrémé (indication de l’arôme) additionné de solides du lait

a) doit être le produit fabriqué

(i) soit exclusivement de lait, de lait en poudre, de lait écrémé, de lait écrémé en poudre, de lait partiellement écrémé, de lait évaporé, de lait évaporé partiellement écrémé, de lait écrémé évaporé ou de crème, soit d’un mélange quelconque de ces produits,

(ii) d’une préparation aromatisante, et

(iii) d’un agent édulcorant;

b) doit renfermer au moins 10 pour cent de solides du lait autres que le gras;

c) doit renfermer plus de 0,3 pour cent et moins de trois pour cent de gras de lait;

d) doit, nonobstant les articles D.01.009 et D.01.010, contenir de la vitamine A ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 1 200 unités internationales et au plus 2 500 unités internationales de la vitamine A;

e) doit contenir de la vitamine D ajoutée en quantité telle qu’une ration quotidienne raisonnable du produit laitier contienne au moins 300 unités internationales et au plus 400 unités internationales de vitamine D;

f) peut contenir du sel, un colorant alimentaire, de la lactase, un agent stabilisant et au plus 0,5 pour cent d’amidon; et

g) peut contenir au plus 50 000 bactéries aérobies totales par centimètre cube, déterminées selon la méthode officielle MFO-7, Examen microbiologique du lait, 30 novembre 1981.

DORS/78-656, art. 12; DORS/82-768, art. 19; DORS/84-300, art. 21(F); DORS/84-762, art. 6.

B.08.027. Il n’est pas obligatoire d’ajouter des vitamines aux produits laitiers suivants qui sont utilisés ou vendus pour la fabrication d’autres produits alimentaires : lait; lait partiellement écrémé; lait en partie écrémé; lait écrémé; lait stérilisé; lait évaporé; lait écrémé évaporé; lait écrémé concentré; lait évaporé partiellement écrémé; lait concentré partiellement écrémé; la poudre de lait; lait entier desséché; lait entier en poudre; la poudre de lait écrémé; lait écrémé desséché; la poudre de lait partiellement écrémé; la poudre de lait en partie écrémé; lait écrémé additionné de solides du lait; lait partiellement écrémé additionné de solides du lait et lait en partie écrémé additionné de solides du lait.

DORS/78-656, art. 13.

B.08.028. (1) Doit être indiqué sur l’espace principal et être suivi de l’expression « matière grasse du lait » ou de l’abréviation « M.G. » le pourcentage de matière grasse contenue dans

a) le lait (nom de l’arôme);

b) le lait partiellement écrémé (nom de l’arôme);

c) le lait partiellement écrémé additionné de solides du lait (nom de l’arôme);

d) la crème;

e) la crème sure.

(2) En plus de la mention exigée au paragraphe (1), il peut être indiqué sur l’étiquette d’un aliment mentionné à ce paragraphe sa teneur en matières grasses exprimée en grammes par portion déterminée.

DORS/79-23, art. 10; DORS/88-559, art. 16; DORS/2010-94, art. 3(F). Version précédente

Lait de chèvre

B.08.028.1. La sécrétion lactée des glandes mammaires de tout animal autre que la vache, genre Bos, de même que tout produit ou dérivé de cette sécrétion doivent être étiquetés de façon qu’il soit fait mention du nom de l’animal.

DORS/85-623, art. 2.

B.08.029. (1) Nonobstant les articles D.01.009 à D.01.011, il est interdit de vendre du lait de chèvre ou du lait de chèvre en poudre additionnés de vitamine D, à moins qu’ils ne contiennent au moins 35 et au plus 45 unités internationales de vitamine D par 100 mL de l’aliment prêt à servir.

(2) Nonobstant les articles D.01.009 à D.01.011, il est interdit de vendre du lait de chèvre partiellement écrémé, du lait de chèvre écrémé, du lait de chèvre partiellement écrémé en poudre ou du lait de chèvre écrémé en poudre auxquels on a ajouté des vitamines, à moins qu’ils ne contiennent, par 100 mL de l’aliment prêt à servir, au moins 35 et au plus 45 unités internationales de vitamine D et au moins 140 et au plus 300 unités internationales de vitamine A.

(3) Nonobstant les articles D.01.009 à D.01.011, il est interdit de vendre du lait de chèvre concentré auquel on a ajouté des vitamines, à moins que, une fois reconstitué selon le mode d’emploi, il ne contienne par quantité de 100 mL au moins sept et au plus neuf milligrammes de vitamine C, au moins 35 et au plus 45 unités internationales de vitamine D et au moins 10 et au plus 20 microgrammes d’acide folique.

(4) Nonobstant les articles D.01.009 à D.01.011, il est interdit de vendre du lait de chèvre concentré partiellement écrémé ou du lait de chèvre concentré écrémé auxquels on a ajouté des vitamines, à moins que, une fois reconstitués selon le mode d’emploi, ils ne

contiennent par quantité de 100 mL au moins 140 et au plus 300 unités internationales de vitamine A, au moins sept et au plus neuf milligrammes de vitamine C, au moins 35 et au plus 45 unités internationales de vitamine D et au moins 10 et au plus 20 microgrammes d’acide folique.

DORS/85-623, art. 2.

Fromage

B.08.030. (1) Dans le présent titre, lorsqu’il s’agit de fromage,

« cornichons et achards » désigne les aliments qui répondent à la norme prescrite à l’article B.11.051; (pickles and relishes)

« entier » se dit du produit ayant conservé la grosseur et la forme primitives qu’il avait lors de sa fabrication; (whole)

« entreposé » se dit du produit conservé à une température d’au moins 2 °C durant 60 jours ou plus après la date du début de la fabrication; (stored)

« matière première pasteurisée » désigne le lait, le lait écrémé, la crème, le lait reconstitué à partir de sa poudre, le lait écrémé reconstitué à partir de sa poudre ou un mélange de ces produits, qui a été pasteurisé à une température d’au moins 61,6 °C durant une période minimale de 30 minutes, ou à une température et durant une période équivalentes dans le cas de la destruction de la phosphatase, déterminées selon la méthode officielle MFO-3, Détermination de l’activité phosphatasique des produits laitiers, 30 novembre 1981; (pasteurized source)

« produit laitier »[Abrogée, DORS/92-400, art. 3]

(2) Dans le texte anglais des règlements, le mot « process » peut être utilisé au lieu du mot « processed » dans les noms usuels suivants : processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, and processed cheese spread with (naming the added ingredients).

DORS/79-752, art. 2; DORS/82-768, art. 20; DORS/92-400, art. 3.

B.08.031. Un fromage fabriqué avec du lait qui est le produit de la sécrétion lactée normale des glandes mammaires d’animaux autres que les vaches genre Bos doit

a) être conforme à toutes les exigences du présent titre s’appliquant à la variété; et

b) porter l’origine du lait sur l’espace principal de son étiquette.

DORS/79-752, art. 2.

B.08.032. (1) Pour chacun des aliments suivants à l’égard desquels une norme est prescrite, à savoir

a) le fromage (indication de la variété),

b) le fromage cheddar,

c) le fromage à la crème,

d) le fromage de petit-lait,

e) le fromage de petit-lait (indication de la variété),

f) le fromage à la crème (avec indication des ingrédients ajoutés),

g) le fromage à la crème à tartiner,

h) le fromage à la crème à tartiner (avec indication des ingrédients ajoutés),

i) le fromage fondu (indication de la variété),

j) le fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés),

k) une préparation de fromage fondu,

l) une préparation de fromage fondu (avec indication des ingrédients ajoutés),

m) le fromage fondu à tartiner,

n) le fromage fondu à tartiner (avec indication des ingrédients ajoutés),

o) le fromage conditionné à froid (indication de la variété),

p) le fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés),

q) une préparation de fromage conditionné à froid, et

r) une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés),

il doit être indiqué, dans l’espace principal de l’étiquette, le pourcentage de matière grasse de lait suivi soit de l’expression « matière grasse de lait », soit de l’abréviation « M.G. », ainsi que le pourcentage d’humidité de l’aliment suivi soit du mot « humidité », soit du mot « eau ».

(2) Sous réserve du paragraphe (3), est interdite sur l’étiquette d’un aliment visé au paragraphe (1) toute mention expresse ou implicite de la teneur en matière grasse de lait ou de la teneur en humidité qui n’est pas conforme au paragraphe (1).

(3) En plus des mentions exigées au paragraphe (1), il peut être indiqué sur l’étiquette d’un aliment mentionné à ce paragraphe sa teneur en matières grasses exprimée en grammes par portion déterminée.

DORS/79-752, art. 2; DORS/88-559, art. 17; DORS/94-689, art. 2(A); DORS/2010-94, art. 8(A). Version précédente

B.08.033. (1) [N]. Le fromage (indication de la variété) autre que le fromage cheddar, le fromage à la crème, le fromage de petit-lait, le fromage à la crème (avec indication des ingrédients ajoutés), le fromage à la crème à tartiner, le fromage à la crème à tartiner (avec indication des ingrédients ajoutés), le fromage fondu (indication de la variété), le fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés), une préparation de fromage fondu, une préparation de fromage fondu (avec indication des ingrédients ajoutés), le fromage fondu à tartiner, le fromage fondu à tartiner (avec indication des ingrédients ajoutés), le fromage conditionné à froid (indication de la variété), le fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés), une préparation de fromage conditionné à froid, une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés), le fromage cottage et le fromage cottage en crème,

a) doit

(i) être le produit de la coagulation, à l’aide de bactéries, de lait, de produits du lait ou d’un mélange de ceux-ci, en vue de former, après égouttement du petit-lait, une masse homogène de caillé,

(i.1) sauf pour le fromage Féta, avoir une teneur en caséine dérivée du lait ou du lait ultrafiltré, du lait partiellement écrémé, du lait partiellement écrémé ultrafiltré, du lait écrémé, du lait écrémé ultrafiltré ou de la crème, plutôt que de tout autre produit du lait, au moins équivalente aux pourcentages ci-après de la teneur totale en protéines du fromage :

(A) 63 %, dans le cas du fromage Pizza mozzarella ou Pizza mozzarella partiellement écrémé,

(B) 83 %, dans le cas du fromage de lait écrémé, Brick, Brick canadien, Colby, Farmer’s, Jack, Monterey (Monterey Jack), Mozzarella (Scamorza), Mozzarella partiellement écrémé (Scamorza partiellement écrémé), Munster canadien, Pizza partiellement écrémé ou Pizza et des autres variétés de fromage non mentionnées aux divisions (A) ou (C),

(C) 95 %, dans le cas des autres variétés de fromage visées au tableau du présent article,

(i.2) avoir un rapport protéines de petit-lait à la caséine qui ne dépasse pas celui du lait,

(ii) posséder les propriétés physiques, chimiques et organoleptiques typiques de la variété,

(iii) s’il s’agit d’une variété de fromage nommée dans le tableau du présent article, ne pas contenir plus que le pourcentage maximal d’humidité indiqué pour cette variété dans la colonne II de ce tableau,

(iv) s’il s’agit d’une variété de fromage nommée dans la partie I du tableau du présent article, contenir au moins le pourcentage minimal de matière grasse de lait indiqué pour cette variété dans la colonne III de ce tableau, et

(v) s’il s’agit d’une variété de fromage nommée dans la partie II du tableau du présent article, ne pas contenir plus que le pourcentage maximal de matière grasse de lait indiqué pour cette variété dans la colonne III de ce tableau; et

b) peut contenir

(i) du sel, des assaisonnements, des condiments et des épices,

(ii) des préparations aromatisantes autres que les aromatisants de fromage,

(iii) des micro-organismes favorisant l’affinage,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma,

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits, et

(C) en quantité n’excédant pas 0,10 partie par million, le bleu brillant FCF seulement dans le Feta,

(v) du chlorure de calcium comme agent d’affermissement, en quantité n’excédant pas 0,02 pour cent du lait et des produits du lait utilisés,

(vi) de la cire de paraffine comme enrobage, en quantité conforme aux bonnes pratiques industrielles,

(vii) en quantité n’excédant pas 50 parties par million, des résidus de nitrate de potassium, de nitrate de sodium ou d’un mélange de ces produits utilisés aux fins et de la manière prévues au paragraphe (2),

(viii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles,

(ix) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium, ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique,

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique, ou

(D) la natamycine appliquée à la surface du fromage, en une quantité n’excédant pas 20 parties par million ou, si le fromage est râpé fin ou en filaments, 10 parties par million,

(x) s’il est râpé fin ou en filaments, du silicate de calcium, de la cellulose microcristalline, de la cellulose ou un mélange de ces produits, utilisé comme agent anti-agglomérant, en quantité totale n’excédant pas 2,0 pour cent,

(xi) du dioxyde de carbone comme rajusteur du pH dans le lait pour la fabrication du fromage, en quantité conforme aux bonnes pratiques industrielles.

(1.1) Le fromage d’une variété visée à la colonne I de la partie I du tableau du présent article peut contenir plus que le pourcentage maximal d’humidité indiqué dans la colonne II et moins que le pourcentage minimal de matière grasse du lait indiqué dans la colonne III, si les conditions suivantes sont réunies :

a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du tableau suivant l’article B.01.513 est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci;

b) le fromage a la saveur et la texture caractéristiques de la variété de fromage visée.

(1.2) La mention « 83 % » dans la division (1)a)(i.1)(B) vaut mention de « 78 % » et la mention « 95 % » dans la division (1)a)(i.1)(C) vaut mention de « 90 % », dans le cas des variétés de fromage visées, si les conditions suivantes sont réunies :

a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du tableau suivant l’article B.01.513 est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci;

b) le fromage a la saveur et la texture caractéristiques de la variété de fromage visée.

(2) Le nitrate de potassium, le nitrate de sodium ou un mélange de ces produits peuvent être utilisés comme agents de conservation dans le fromage, pourvu que

a) la quantité de sel ou le mélange de sels ne dépasse pas 200 parties par million du lait et des produits du lait utilisés;

b) le fromage soit

(i) du fromage affiné aux moisissures conservé dans un contenant hermétique, ou

(ii) du fromage affiné

(A) qui contient au plus 68 pour cent d’humidité à l’état dégraissé, et

(B) dont la fermentation lactique et la salaison ont été faites plus de 12 heures après la coagulation du caillé par enzymes; et

c) la salaison soit, dans le cas du fromage visé au sous-alinéa b)(ii), appliquée à l’extérieur du fromage sous forme de sel ou de saumure.

(3) Il est interdit d’utiliser un enzyme qui n’est pas compris parmi les suivants :

a) l’aminopeptidase provenant de Lactococcus lactis, la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS105), l’enzyme coagulant le lait provenant de Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)), de Mucor pusillus Lindt par fermentation de culture pure ou de Aspergillus oryzae RET-1 (pBoel777), la lipase provenant de Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var.; Tissus comestibles des préestomacs d’agneaux, de chevreaux ou de veaux; Tissus pancréatiques d’animaux ou de Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)); Rhizopus niveus, la pepsine provenant de la muqueuse glandulaire de l’estomac de porc, la phospholipase provenant de Aspergillus oryzae (pPFJo142), la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, la présure de bovin provenant de l’extrait aqueux du 4e (véritable) estomac de bovins, de moutons et de chèvres adultes et la protéase provenant de Micrococcus caseolyticus var., dans la fabrication d’un fromage visé au paragraphe (1);

b) [Abrogé, DORS/2010-143, art. 1]

c) l’enzyme coagulant le lait provenant d’Endothia parasitica et les enzymes mentionnés à l’alinéa a) dans la fabrication du fromage Emmentaler (Emmenthal, suisse), du fromage Mozzarella (Scamorza) et du fromage Mozzarella partiellement écrémé (Scamorza partiellement écrémé);

d) l’enzyme coagulant le lait provenant d’Endothia parasitica et les enzymes mentionnés à l’alinéa a), dans la fabrication du fromage Parmesan et du fromage Romano;

e) la protéase provenant d’Aspergillusoryzae var., Aspergillus niger var. ou Bacillus subtilis var., dans la fabrication du fromage Colby;

f) le lysozyme provenant de blanc d’oeuf.

(3.1) Il est interdit d’utiliser une enzyme visée au paragraphe (3) en quantité supérieure à celle conforme aux bonnes pratiques industrielles.

(4) Lorsqu’une préparation aromatisante, autre qu’une préparation aromatisante habituellement utilisée dans la variété de fromage, est ajoutée à un fromage conformément au paragraphe (1), l’expression « (avec indication de la préparation aromatisante) » doit être ajoutée au nom usuel sur l’étiquette.

(5) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(6) Dans les cas visés au paragraphe (5), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

TABLEAU PARTIE I

Colonne I Colonne II Colonne III Pourcentage Pourcentage minimal deArticle Variété de fromage maximal d’humidité matière grasse du lait

1. Asiago 40,0 30,0 2. Petit Édam 47,0 21,0 3. Petit Gouda 45,0 26,0 4. Bleu 47,0 27,0 5. Fromage beurre (Butterkäse) 46,0 27,0 6. Bra 36,0 26,0 7. Brick 42,0 29,0 8. Brie 54,0 23,0 9. Caciocavallo 45,0 24,0 10. Camembert (Carré de l’est) 56,0 22,0 11. Brick canadien 42,0 29,0 12. Munster canadien 46,0 27,0 13. Colby 42,0 29,0 14. Danbo 46,0 25,0 15. Édam 46,0 22,0 16. Elbo 46,0 25,0 17. Emmenthal (Suisse) 40,0 27,0 18. Esrom 50,0 23,0 19. Farmer’s 44,0 27,0 20. Féta 55,0 22,0 21. Fontina 46,0 27,0 22. Fynbo 46,0 25,0 23. Gouda 43,0 28,0 24. Gournay 55,0 33,0 25. Gruyère 38,0 28,0 26. Havarti 50,0 23,0 27. Jack 50,0 25,0 28. Kasseri 44,0 25,0 29. Limburger 50,0 25,0 30. Maribo 43,0 26,0 31. Montasio 40,0 28,0 32. Monterey (Monterey Jack) 44,0 28,0

Colonne I Colonne II Colonne III Pourcentage Pourcentage minimal deArticle Variété de fromage maximal d’humidité matière grasse du lait

33. Mozzarella (Scamorza) 52,0 20,0 34. Muenster (Munster) 50,0 25,0 35. Neufchâtel 60,0 20,0 36. Parmesan 32,0 22,0

Mozzarella partiellement écrémé37. 52,0 15,0(Scamorza partiellement écrémé) 38. Pizza partiellement écrémé 48,0 15,0

Pizza mozzarella partiellement38.1 61,0 11,0écrémé 39. Pizza 48,0 20,0 39.1 Pizza mozzarella 58,0 15,0 40. Provolone 45,0 24,0 41. Romano (Sardo) 34,0 25,0 42. St. Jorge 40,0 27,0 43. Saint-Paulin 50,0 25,0 44. Samsoë 44,0 26,0 45. Tilsiter (Tilsit) 45,0 25,0 46. Tybo 46,0 25,0

PARTIE II

Colonne I Colonne II Colonne III Pourcentage maximal Pourcentage maximal deArticle Variété de fromage d’humidité matière grasse du lait

Harzkase (Harzer Käse,1. 55,0 3,0Mainzer Käse) 2. Lait écrémé 55,0 7,0

DORS/79-752, art. 2; DORS/80-632, art. 2; DORS/82-383, art. 2 et 3; DORS/82-566, art. 1; DORS/84-302, art. 1; DORS/86-89, art. 2; DORS/87-640, art. 3; DORS/88-534, art. 2; DORS/89-198, art. 1; DORS/90-469, art. 1; DORS/91-88, art. 1; DORS/92-197, art. 1; DORS/92-400, art. 4; DORS/93-477, art. 1; DORS/94-212, art. 1; DORS/94-417, art. 1; DORS/95-183, art. 1; DORS/97-191, art. 1; DORS/98-458, art. 2; DORS/2000-336, art. 1; DORS/2000-353, art. 4; DORS/2000-417, art. 2; DORS/2001-94, art. 1; DORS/2005­ 98, art. 7; DORS/2007-302, art. 2 et 4(F); DORS/2010-94, art. 8(A); DORS/2010-143, art. 1 et 39(A). Version précédente B.08.034. (1) [N]. Le fromage cheddar

a) doit

(i) être le produit de la coagulation — à l’aide de bactéries — du lait, de produits du lait ou d’un mélange de ceux-ci, en vue de former un caillé soumis par la suite soit au procédé cheddar, soit à tout autre procédé qui donne du fromage possédant les mêmes propriétés physiques, chimiques et organoleptiques que le fromage produit par le procédé cheddar,

(i.1) avoir une teneur en caséine dérivée du lait ou du lait ultrafiltré, du lait partiellement écrémé, du lait partiellement écrémé ultrafiltré, du lait écrémé, du lait écrémé ultrafiltré ou de la crème, plutôt que de tout autre produit du lait, d’au moins 83 % de la teneur totale en protéines du fromage,

(i.2) avoir un rapport protéines de petit-lait à la caséine qui ne dépasse pas celui du lait,

(ii) contenir

(A) au plus 39 pour cent d’humidité, et

(B) au moins 31 pour cent de matière grasse de lait, et

b) peut contenir

(i) du sel,

(ii) des préparations aromatisantes autres que les aromatisants de fromage,

(iii) des cultures bactériennes favorisant l’affinage,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) du chlorure de calcium comme agent d’affermissement, en quantité n’excédant pas 0,02 pour cent du lait et des produits du lait utilisés,

(vi) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles,

(vii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium, ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique,

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique, ou

(D) la natamycine appliquée à la surface du fromage, en une quantité n’excédant pas 20 parties par million ou, si le fromage est râpé fin ou en filaments, 10 parties par million,

(viii) s’il est râpé fin ou en filaments, du silicate de calcium, de la cellulose microcristalline, de la cellulose ou un mélange de ces produits, utilisé comme agent anti­ agglomérant, en quantité totale n’excédant pas 2,0 pour cent.

c) ne peut être étiqueté et annoncé comme étant un fromage cheddar qui a été vieilli que s’il remplit les conditions suivantes :

(i) il est fait uniquement de lait, de lait ultrafiltré, de lait partiellement écrémé, de lait partiellement écrémé ultrafiltré, de lait écrémé, de lait écrémé ultrafiltré, de crème ou d’un mélange de ceux-ci,

(ii) il a été vieilli pendant au moins neuf mois et la période pendant laquelle il a été vieilli est mentionnée sur l’espace principal de l’étiquette ou dans l’annonce.

(1.1) Le fromage cheddar peut contenir plus que le pourcentage maximal d’humidité prévu à la division (1)a)(ii)(A) et moins que le pourcentage minimal de matière grasse de lait prévu à la division (1)a)(ii)(B), si les conditions suivantes sont réunies :

a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du tableau suivant l’article B.01.513 est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci;

b) le fromage a la saveur et la texture caractéristiques du fromage cheddar.

(1.2) la mention « 83 % » au sous-alinéa (1)a)(i.1) vaut mention de « 78 % », si les conditions suivantes sont réunies :

a) la mention ou l’allégation figurant à la colonne 4 de l’un des articles 12 à 14, 16, 20, 21 et 45 du tableau suivant l’article B.01.513 est indiquée sur l’étiquette du produit dans le nom usuel de celui-ci;

b) le fromage a la saveur et la texture caractéristiques du fromage cheddar.

(2) Dans la fabrication du fromage cheddar, il est interdit d’utiliser une enzyme qui n’est pas comprise parmi les suivantes :

a) l’aminopeptidase provenant de Lactococcus lactis, la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS105), l’enzyme coagulant le lait provenant de Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)), de Mucor pusillus Lindt par fermentation de culture pure ou de Aspergillus oryzae RET-1 (pBoel777), la lipase provenant de Aspergillus niger var.; Aspergillus oryzae var.;

Rhizopus oryzae var.; Tissus comestibles des préestomacs d’agneaux, de chevreaux ou de veaux; Tissus pancréatiques d’animaux ou de Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)); Rhizopus niveus, la pepsine provenant de la muqueuse glandulaire de l’estomac de porc, la phospholipase provenant de Aspergillus oryzae (pPFJo142) et la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux;

b) la protéase provenant d’Aspergillus oryzae;

c) le lysozyme provenant de blanc d’oeuf.

(2.1) Il est interdit d’utiliser une enzyme visée au paragraphe (2) en quantité supérieure à celle conforme aux bonnes pratiques industrielles.

(3) Lorsqu’une préparation aromatisante est ajoutée à un fromage conformément au paragraphe (1), l’expression « (avec indication de la préparation aromatisante) » doit être ajoutée au nom usuel sur l’étiquette.

(4) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(5) Dans les cas visés au paragraphe (4), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/82-383, art. 4; DORS/83-617, art. 1; DORS/84-302, art. 2; DORS/84-762, art. 7; DORS/88-534, art. 3; DORS/89-244, art. 1; DORS/90-469, art. 2; DORS/91-88, art. 2; DORS/92-197, art. 2; DORS/93-477, art. 2; DORS/94-212, art. 2; DORS/95-183, art. 2; DORS/97-191, art. 2; DORS/98-458, art. 3; DORS/2000-336, art. 2; DORS/2000-417, art. 3; DORS/2005-98, art. 7; DORS/2007-302, art. 3 et 4(F); DORS/2010-143, art. 2 et 39(A). Version précédente B.08.035. (1) [N]. Le fromage à la crème

a) doit

(i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former, après égouttement du petit-lait, une masse homogène de caillé, et

(ii) contenir

(A) au plus 55 pour cent d’humidité, et

(B) au moins 30 pour cent de matière grasse de lait; et

b) peut contenir

(i) de la crème ajoutée pour modifier la teneur en matière grasse de lait,

(ii) du sel,

(iii) de l’azote pour améliorer la tartinabilité, en quantité conforme aux bonnes pratiques industrielles,

(iv) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

en quantité ne dépassant pas 0,5 pour cent, la carragénine d’ammonium, la carragénine de calcium, la gomme de caroube (fève de l’acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carragénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, et

(v) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) Il est interdit d’utiliser un enzyme

a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication du fromage à la crème;

b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles.

DORS/79-752, art. 2; DORS/92-197, art. 3; DORS/94-212, art. 3; DORS/95-183, art. 3; DORS/2010-143, art. 3. Version précédente B.08.036. (1) [N]. Le fromage de petit-lait ou le fromage de petit-lait (indication de la variété)

a) doit être le produit de la coagulation, à l’aide d’une source de chaleur, du petit-lait ou du petit-lait concentré en vue de former un caillé auquel une forme est donnée; et

b) peut contenir

(i) des micro-organismes favorisant l’affinage,

(ii) du lait et des produits du lait ajoutés, et

(iii) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, de l’acide tartrique, du bicarbonate de potassium, du bicarbonate de sodium, du carbonate de calcium, du carbonate de potassium, du carbonate de sodium et de l’hydroxyde de sodium comme rajusteurs du pH.

(2) Il est interdit d’utiliser, pour favoriser la coagulation du petit-lait dans la fabrication du fromage de petit-lait, une substance autre que du vinaigre ou du petit-lait sûr.

DORS/79-752, art. 2; DORS/2007-302, art. 4(F); DORS/2010-142, art. 5. Version précédente B.08.037. (1) [N]. Le fromage à la crème (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former, après égouttement du petit-lait, une masse homogène de caillé,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage à la crème, tout en conservant sa nature fondamentale, les ingrédients suivants :

(A) du fromage autre que du fromage à la crème,

(B) des assaisonnements, des épices, des préparations aromatisantes, des condiments ou du chocolat,

(C) des fruits, des légumes, des cornichons, des achards ou des noix,

(D) de la viande préparée ou conservée, ou

(E) du poisson préparé ou conservé, et

(iii) contenir

(A) au plus 60 pour cent d’humidité, et

(B) au moins 26 pour cent de matière grasse de lait; et

b) peut contenir

(i) de la crème ajoutée pour modifier la teneur en matière grasse de lait,

(ii) du sel,

(iii) de l’azote pour améliorer la tartinabilité, en une quantité conforme aux bonnes pratiques industrielles,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

en quantité ne dépassant pas 0,5 pour cent, la carragénine d’ammonium, la carragénine de calcium, la gomme de caroube (fève de l’acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carragénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, et

(vi) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) Il est interdit d’utiliser un enzyme

a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication d’un produit visé au paragraphe (1);

b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles.

DORS/79-752, art. 2; DORS/92-197, art. 4; DORS/94-212, art. 4; DORS/95-183, art. 4; DORS/2010-143, art. 4. Version précédente B.08.038. (1) [N]. Le fromage à la crème à tartiner

a) doit

(i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former, après égouttement du petit-lait, une masse homogène de caillé, et

(ii) contenir

(A) du lait et des produits du lait ajoutés,

(B) au moins 51 pour cent de fromage à la crème,

(C) au plus 60 pour cent d’humidité, et

(D) au moins 24 pour cent de matière grasse de lait; et

b) peut contenir

(i) de la crème ajoutée pour modifier la teneur en matière grasse de lait,

(ii) du sel, du vinaigre et des agents édulcorants,

(iii) de l’azote pour améliorer la tartinabilité, en quantité conforme aux bonnes pratiques industrielles,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carragénine d’ammonium, la carragénine de calcium, la gomme de caroube (fève de l’acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carragénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, et

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétophosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de

l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartarique comme rajusteurs du pH, et

(vii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) Il est interdit d’utiliser un enzyme

a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication d’un produit visé au paragraphe (1);

b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles.

DORS/79-752, art. 2; DORS/92-197, art. 5; DORS/94-212, art. 5; DORS/95-183, art. 5; DORS/2007-302, art. 4(F); DORS/2010-143, art. 5. Version précédente B.08.039. (1) [N]. Le fromage à la crème à tartiner (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit de la coagulation de la crème à l’aide de bactéries, en vue de former une masse homogène de caillé après égouttement du petit-lait,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage à la crème à tartiner, tout en conservant sa nature fondamentale, les ingrédients ajoutés suivants :

(A) du fromage autre que du fromage à la crème,

(B) des assaisonnements, des épices, des préparations aromatisantes, des condiments ou du chocolat,

(C) des fruits, des légumes, des cornichons, des achards ou des noix,

(D) de la viande préparée ou conservée, ou

(E) du poisson préparé ou conservé, et

(iii) contenir

(A) du lait et des produits du lait ajoutés,

(B) au plus 60 pour cent d’humidité, et

(C) au moins 24 pour cent de matière grasse de lait; et

b) peut contenir

(i) de la crème ajoutée pour modifier la teneur en matière grasse de lait,

(ii) du sel, du vinaigre et des agents édulcorants,

(iii) de l’azote pour améliorer la tartinabilité, en une quantité conforme aux bonnes pratiques industrielles,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-carothénoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stalibisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carragénine d’ammonium, la carragénine de calcium, la gomme de caroube (fève de l’acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carragénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits, et

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas de sels de phosphate, et 4,0 pour cent en tout,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du

bicarbonate de sodium, du carbonate de sodium et de l’acide tartarique comme rajusteurs du pH, et

(vii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) Il est interdit d’utiliser un enzyme

a) autre que la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), la pepsine provenant de la muqueuse glandulaire de l’estomac de porc ou la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, dans la fabrication d’un produit visé au paragraphe (1);

b) en quantité supérieure à ce qui est conforme aux bonnes pratiques industrielles.

DORS/79-752, art. 2; DORS/92-197, art. 6; DORS/94-212, art. 6; DORS/95-183, art. 6; DORS/2007-302, art. 4(F); DORS/2010-143, art. 6. Version précédente B.08.040. (1) [N]. Le fromage fondu (indication de la variété)

a) doit

(i) sous réserve du sous-alinéa (ii), être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, des variétés de fromage nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) dans le cas du fromage cheddar fondu, être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, des fromages suivants en vue de former une masse homogène :

(A) fromage cheddar,

(B) fromage à caillé brassé,

(C) fromage à caillé granuleux, ou

(D) fromage à caillé lavé,

(iii) s’il est fait

(A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est inférieur à 40 pour cent, ou

(B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximaux d’humidité permise est inférieure à 40 pour cent,

contenir un pourcentage d’humidité non supérieur de plus de cinq pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de trois pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés,

(iv) sous réserve du sous-alinéa (v), s’il est fait

(A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est d’au moins 40 pour cent, ou

(B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximaux d’humidité permise est d’au moins 40 pour cent,

contenir un pourcentage d’humidité non supérieur de plus de trois pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de deux pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés, et

(v) dans le cas du fromage de lait écrémé fondu, contenir au plus

(A) 55 pour cent d’humidité, et

(B) sept pour cent de matière grasse de lait; et

b) peut contenir

(i) de l’eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) s’il s’agit de fromage de lait écrémé fondu, du lait écrémé en poudre, du lait de beurre en poudre et du petit-lait en poudre ajoutés,

(iv) du sel, du vinaigre et des agents édulcorants,

(v) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(vi) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose),

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine en quantité n’excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(vi.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent,

(vii) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l’acide tartarique comme rajusteurs du pH,

(viii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(ix) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/91-409, art. 1.

B.08.041. (1) [N]. Le fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, des variétés de fromage nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage fondu (indication de la variété), tout en conservant la nature fondamentale, les ingrédients suivants :

(A) des préparations aromatisantes autres que celles qui ressemblent à l’arôme des variétés de fromage utilisées,

(B) des assaisonnements, des épices, des condiments ou du chocolat,

(C) des fruits, des légumes, des cornichons, des achards ou des noix,

(D) de la viande préparée ou conservée, ou

(E) du poisson préparé ou conservé,

(iii) s’il est fait

(A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est inférieur à 40 pour cent, ou

(B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximaux d’humidité permise est inférieure à 40 pour cent,

contenir un pourcentage d’humidité non supérieur de plus de cinq pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de trois pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés, et

(iv) s’il est fait

(A) d’une seule variété de fromage dont le pourcentage maximal d’humidité permise est d’au moins 40 pour cent, ou

(B) de plusieurs variétés de fromage dont la moyenne des pourcentages maximaux d’humidité permise est d’au moins 40 pour cent,

contenir un pourcentage d’humidité non supérieur de plus de trois pour cent au pourcentage maximal visé à la disposition (A) ou (B), selon le cas, et un pourcentage de matière grasse de lait non inférieur de plus de deux pour cent au pourcentage minimal ou à la moyenne des pourcentages minimaux permis pour cette ou ces variétés; et

b) peut contenir

(i) de l’eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose),

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine en quantité n’excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l’acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/91-409, art. 2; DORS/92-400, art. 5; DORS/2010-94, art. 4(A). Version précédente B.08.041.1. (1) [N]. Une préparation de fromage fondu

a) doit

(i) être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, et

(ii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au moins 51 pour cent de fromage,

(C) au plus 46 pour cent d’humidité, et

(D) au moins 23 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l’eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou d’un mélange de ces produits.

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose),

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l’acide propionique, la propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, la sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/91-409, art. 3; DORS/92-400, art. 6; DORS/2007-302, art. 4(F). Version précédente B.08.041.2. (1) [N]. Une préparation de fromage fondu (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer de la préparation de fromage fondu, tout en conservant sa nature fondamentale, les ingrédients suivants :

(A) des assaisonnements, des épices, des préparations aromatisantes, des condiments ou du chocolat,

(B) des fruits, des légumes, des cornichons, des achards ou des noix,

(C) de la viande préparée ou conservée, ou

(D) du poisson préparé ou conservé, et

(iii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au plus 46 pour cent d’humidité, et

(C) au moins 22 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l’eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-apo-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose),

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/91-409, art. 4; DORS/92-400, art. 7; DORS/2007-302, art. 4(F). Version précédente B.08.041.3. (1) [N]. Le fromage fondu à tartiner

a) doit

(i) être le produit du mélange et du malaxage, à l’aide d’une source de chaleur, d’une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène, et

(ii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au moins 51 pour cent de fromage,

(C) au plus 60 pour cent d’humidité, et

(D) au moins 20 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l’eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n’excédant pas 35 parties par million, le ß-8po-8′-caroténal, l’ester éthylique de l’acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n’excédant pas 0,5 pour cent, la carraghénine d’ammonium, la carraghénine de calcium, la gomme de caroube (gomme de caroubier), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d’Irlande, la carraghénine de potassium, l’alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine de sodium, la gomme adragante, la gomme xanthane ou un mélange de ces produits,

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d’aluminium et de sodium, l’hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le

phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine, en quantité n’excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n’excédant pas 1 pour cent,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l’acide acétique, du carbonate de calcium, de l’acide citrique, de l’acide lactique, de l’acide malique, de l’acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l’acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l’acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n’exédant pas 2 000 parties par million, calculée en acide propionique,

(B) l’acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n’excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n’excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L’étiquette d’un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l’espace principal de l’étiquette.

DORS/79-752, art. 2; DORS/82-1071, art. 4; DORS/91-409, art. 5; DORS/2007-302, art. 4(F). Version précédente B.08.041.4. (1) [N]. Le fromage fondu à tartiner (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit du mélange et du malaxage, à l'aide d'une source de chaleur, d'une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage fondu à tartiner, tout en conservant sa nature fondamentale, les ingrédients suivants :

(A) des assaisonnements, des épices, des préparations aromatisantes, des condiments ou du chocolat,

(B) des fruits, des légumes, des cornichons, des achards ou des noix,

(C) de la viande préparée ou conservée, ou

(D) du poisson préparé ou conservé, et

(iii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au plus 60 pour cent d'humidité, et

(C) au moins 20 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l'eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conformant aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n'excédant pas 35 parties par million, le ß-apo-8′-caroténal, l'ester éthylique de l'acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

(A) en quantité n'excédant pas 0,5 pour cent, la carraghénine d'ammonium, la carraghénine de calcium, la gomme de caroube (gomme de caroubier), la carraghénine, la gélatine, la gomme de guar, la gélose de mousse d'Irlande, la carraghénine de potassium, l'alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carraghénine de sodium, la gomme adragante, la gomme xanthane ou un mélange de ces produits,

(B) le phosphate de calcium dibasique, le phosphate de potassium dibasique, le pyrophosphate acide de sodium, le phosphate d'aluminium et de sodium, l'hexamétaphosphate de sodium, le phosphate disodique, le phosphate monosodique, le phosphate trisodique, le pyrophosphate tétrasodique, le citrate de calcium, le citrate de potassium, le citrate de sodium, le tartrate double de sodium et de potassium, le tartrate de sodium, le gluconate de sodium ou un mélange de ces produits, en quantité qui, calculée en sels anhydres, ne dépasse pas 3,5 pour cent, dans le cas des sels de phosphate, et 4,0 pour cent en tout,

(C) de la lécithine, en quantité n'excédant pas 0,2 pour cent, et

(D) en quantité ne dépassant pas 0,5 pour cent, des monoglycérides et des mono- et diglycérides ou un mélange de ces produits,

(v.1) du phosphate tricalcique comme agent pour améliorer la couleur, la texture, la consistance et la tartinabilité, en quantité n'excédant pas 1 pour cent,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l'acide acétique, du carbonate de calcium, de l'acide citrique, de l'acide lactique, de l'acide malique, de l'acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium, et de l'acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l'acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n'excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l'acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n'excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n'excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L'étiquette d'un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l'espace principal de l'étiquette.

DORS/79-752, art. 2; DORS/82-1071, art. 5; DORS/91-409, art. 6; DORS/2007-302, art. 4(F). Version précédente B.08.041.5. (1) [N]. Le fromage conditionné à froid (indication de la variété)

a) doit

(i) sous réserve du sous-alinéa (ii), être le produit du mélange et du malaxage, sans l'aide d'une source de chaleur, des variétés de fromage nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) dans le cas du fromage cheddar conditionné à froid, être le produit du mélange et du malaxage, sans l'aide d'une source de chaleur, des fromages suivants, en vue de former une masse homogène :

(A) fromage cheddar,

(B) fromage à caillé brassé,

(C) fromage à caillé granuleux, ou

(D) fromage à caillé lavé,

(iii) s'il est fait

(A) d'une seule variété de fromage, ne pas contenir plus d'humidité que le pourcentage maximal permis pour cette variété, et ne pas contenir moins de matière grasse de lait que le pourcentage minimal permis pour cette variété, ou

(B) de plusieurs variétés de fromage, ne pas contenir plus d'humidité que la moyenne des pourcentages maximaux permis pour ces variétés, et ne pas contenir moins de matière grasse de lait que la moyenne des pourcentages minimaux permis pour ces variétés; et

b) peut contenir

(i) de l'eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n'excédant pas 35 parties par million, le ß-apo-8′-caroténal, l'ester éthylique de l'acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) en quantité conforme aux bonnes pratiques industrielles, de l'acide acétique, du carbonate de calcium, de l'acide citrique, de l'acide lactique, de l'acide malique, de l'acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l'acide tartarique comme rajusteurs du pH,

(vi) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(vii) les agents de conservation suivants :

(A) l'acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n'excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l'acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n'excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n'excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L'étiquette d'un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l'espace principal de l'étiquette.

DORS/79-752, art. 2; DORS/92-400, art. 8.

B.08.041.6. (1) [N]. Le fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit du mélange et du malaxage, sans l'aide d'une source de chaleur, des variétés de fromage nommées, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer du fromage conditionné à froid (indication de la variété), tout en conservant sa nature fondamentale, les ingrédients suivants :

(A) des préparations aromatisantes autres que celles qui ressemblent à l'arôme des variétés de fromage utilisées dans le produit,

(B) des assaisonnements, des épices, des condiments ou du chocolat,

(C) des fruits, des légumes, des cornichons, des achards ou des noix,

(D) de la viande préparée ou conservée, ou

(E) du poisson préparé ou conservé, et

(iii) s'il est fait

(A) d'une seule variété de fromage, avoir un pourcentage d'humidité non supérieur au maximum permis pour cette variété, et un pourcentage de matière grasse de lait non inférieur de plus de un pour cent au minimum permis pour cette variété, ou

(B) de plusieurs variétés de fromage, avoir un pourcentage d'humidité non supérieur à la moyenne des maximums permis pour ces variétés, et un pourcentage de matière grasse de lait non inférieur de plus de un pour cent à la moyenne des minimums permis pour ces variétés; et

b) peut contenir

(i) de l'eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n'excédant pas 35 parties par million, le ß-apo-8′-caroténal, l'ester éthylique de l'acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

en quantité ne dépassant pas 0,5 pour cent, la carragénine d'ammonium, la carragénine de calcium, la gomme de caroube (fève de l'acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme du guar, la gélose de mousse d'Irlande, la carragénine de potassium, l'alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l'acide acétique, du carbonate de calcium, de l'acide citrique, de l'acide lactique, de l'acide malique, de l'acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l'acide tartarique comme rajusteurs du pH, et

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l'acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n'excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l'acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n'excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n'excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L'étiquette d'un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l'espace principal de l'étiquette.

DORS/79-752, art. 2; DORS/92-400, art. 9; DORS/2010-94, art. 5(A). Version précédente B.08.041.7. (1) [N]. Une préparation de fromage conditionné à froid

a) doit

(i) être le produit du mélange et du malaxage, sans l'aide d'une source de chaleur, d'une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au moins 51 pour cent de fromage,

(C) au plus 46 pour cent d'humidité, et

(D) au moins 23 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l'eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) du sel, du vinaigre et des agents édulcorants,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n'excédant pas 35 parties par million, le ß-apo-8′-caroténal, l'ester éthylique de l'acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

en quantité ne dépassant pas 0,5 pour cent, la carragénine d'ammonium, la carragénine de calcium, la gomme de caroube (fève de l'acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d'Irlande, la carragénine de potassium, l'alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l'acide acétique, du carbonate de calcium, de l'acide citrique, de l'acide lactique, de l'acide malique, de l'acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l'acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l'acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n'excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l'acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n'excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n'excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L'étiquette d'un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l'espace principal de l'étiquette.

DORS/79-752, art. 2; DORS/2007-302, art. 4(F). Version précédente B.08.041.8. (1) [N]. Une préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

a) doit

(i) être le produit du mélange et du malaxage, sans l'aide d'une source de chaleur, d'une ou de plusieurs variétés de fromage, autre que le fromage à la crème, le fromage cottage ou le fromage de petit-lait, en vue de former une masse homogène,

(ii) contenir, en quantité suffisante pour pouvoir se distinguer de la préparation de fromage conditionné à froid, tout en conservant sa nature fondamentale, les ingrédients suivants :

(A) des assaisonnements, des épices, des préparations aromatisantes, des condiments ou du chocolat,

(B) des fruits, des légumes, des cornichons, des achards ou des noix,

(C) de la viande préparée ou conservée, ou

(D) du poisson préparé ou conservé, et

(iii) contenir

(A) du lait ou des produits du lait ajoutés,

(B) au plus 46 pour cent d'humidité, et

(C) au moins 22 pour cent de matière grasse de lait; et

b) peut contenir

(i) de l'eau ajoutée pour modifier la teneur en humidité,

(ii) de la matière grasse de lait ajoutée,

(iii) des agents édulcorants, du sel et du vinaigre,

(iv) les colorants suivants :

(A) en quantité conforme aux bonnes pratiques industrielles, le rocou, le ß-carotène, la chlorophylle, le paprika, la riboflavine, le curcuma, et

(B) en quantité n'excédant pas 35 parties par million, le ß-apo-8′-caroténal, l'ester éthylique de l'acide ß-apo-8′-caroténoïque ou un mélange de ces produits,

(v) les agents émulsifiants, gélatinisants, stabilisants et épaississants qui suivent :

en quantité ne dépassant pas 0,5 pour cent, la carragénine d'ammonium, la carragénine de calcium, la gomme de caroube (fève de l'acacia vulgaire ou faux acacia), la carragénine, la gélatine, la gomme de guar, la gélose de mousse d'Irlande, la carragénine de potassium, l'alginate de propylèneglycol, la carboxyméthylcellulose sodique (carboxyméthylcellulose, gomme de cellulose, glycolate sodique de cellulose), la carragénine sodique, la gomme adragante, la gomme xanthane ou un mélange de ces produits,

(vi) en quantité conforme aux bonnes pratiques industrielles, de l'acide acétique, du carbonate de calcium, de l'acide citrique, de l'acide lactique, de l'acide malique, de l'acide phosphorique, du bicarbonate de potassium, du carbonate de potassium, du bicarbonate de sodium, du carbonate de sodium et de l'acide tartarique comme rajusteurs du pH,

(vii) de la fumée de bois comme agent de conservation, en quantité conforme aux bonnes pratiques industrielles, et

(viii) les agents de conservation suivants :

(A) l'acide propionique, le propionate de calcium, le propionate de sodium ou un mélange de ces produits, en quantité n'excédant pas 2 000 parties par million, calculée en acide propionique,

(B) l'acide sorbique, le sorbate de calcium, le sorbate de potassium, le sorbate de sodium ou un mélange de ces produits, en quantité n'excédant pas 3 000 parties par million, calculée en acide sorbique, ou

(C) un mélange des agents de conservation visés aux dispositions (A) et (B), en quantité n'excédant pas 3 000 parties par million, calculée respectivement en acide propionique et en acide sorbique.

(2) L'étiquette d'un fromage ne doit porter le terme « fumé » que si de la fumée de bois a été ajoutée au fromage conformément au paragraphe (1).

(3) Dans les cas visés au paragraphe (2), le terme « fumé » doit paraître dans l'espace principal de l'étiquette.

DORS/79-752, art. 2; DORS/2007-302, art. 4(F). Version précédente B.08.042. Est interdite à tout fabricant la vente de fromage entier qui n’a pas été fabriqué à partir d’une matière première pasteurisée, à moins que la date du début de la fabrication ne soit

a) marquée ou timbrée sur ledit fromage dans les trois jours; ou

b) marquée sur l’étiquette au moment de l’empaquetage, si ledit fromage est d’un type tel qu’il soit difficile, en raison de sa texture, de sa consistance ou de sa structure physique, d’y marquer ou timbrer ladite date.

B.08.043. Est interdite à tout fabricant la vente de tout fromage qui n’a pas été fabriqué à partir d’une matière première pasteurisée, si ledit fromage a été subdivisé en petites portions, à moins

a) que ledit fromage n’ait été dûment entreposé; ou

b) que chaque portion du fromage découpé ne porte la date du début de sa fabrication marquée, timbrée ou imprimée.

B.08.044. (1) Est interdite la vente d’un fromage, y compris le caillé de fromagerie, qui n’a pas été fabriqué à partir d’une matière première pasteurisée sauf s’il a été entreposé.

(2) Le fromage, y compris le caillé de fromagerie, qui n’est pas fait d’une matière première pasteurisée, peut être utilisé comme ingrédient dans un aliment si celui-ci est

fabriqué ou traité de façon à pasteuriser le fromage selon la méthode prévue dans la définition de « matière première pasteurisée » au paragraphe B.08.030(1).

DORS/78-405, art. 1; DORS/79-752, art. 3.

B.08.045. Nonobstant l’article B.08.044, le fromage qui n’a pas été fabriqué à partir d’une matière première pasteurisée et qui n’a pas été entreposé, mais qui porte marquée ou timbrée la date du début de sa fabrication, peut être vendu à

a) un grossiste;

b) un intermédiaire; ou

c) en quantité d’au moins 900 livres, à un détaillant.

B.08.046. Est interdite la vente de tout fromage entier n’ayant pas été fabriqué à partir d’une matière première pasteurisée, à moins que la date du début de la fabrication ne soit timbrée sur ledit fromage.

B.08.047. Tout fabricant, grossiste, ou intermédiaire, qui vend du fromage n’ayant pas été fabriqué à partir d’une matière première pasteurisée et qui n’a pas été entreposé, doit tenir un registre

a) du numéro d’inscription de la fromagerie,

b) de la date de fabrication dudit fromage,

c) du ou des numéros de cuvées,

d) du nom et de l’adresse de la personne à laquelle le fromage est vendu, et

e) du poids vendu de fromage provenant de chaque cuvée,

pour chaque lot de fromage vendu.

B.08.048. (1) Sous réserve de l’article B.08.054, est interdite la vente d’un fromage, y compris le caillé de fromagerie, fabriqué à partir d’une matière première pasteurisée s’il renferme plus de

a) 100 Escherichia coli, ou

b) 100 Staphylococcus aureus

par gramme, après analyse selon la méthode officielle MFO-14, « Examen microbiologique du fromage », 30 novembre 1983.

(2) Est interdite la vente d’un fromage fabriqué à partir d’une matière première non pasteurisée, s’il renferme plus de

a) 500 Escherichia coli, ou

b) 1 000 Staphylococcus aureus

par gramme, après analyse selon la méthode officielle MFO-14, « Examen microbiologique du fromage », 30 novembre 1983.

DORS/78-405, art. 2; DORS/82-768, art. 21; DORS/84-17, art. 4.

B.08.049. [N]. Le petit-lait:

a) est le produit qui reste après que le caillé a été extrait du lait lors de la fabrication du fromage;

b) peut contenir :

(i) de la catalase, s’il s’agit de petit-lait liquide qui a été traité avec du peroxyde d’hydrogène,

(ii) de la lactase,

(iii) du peroxyde d’hydrogène, s’il s’agit de petit-lait liquide destiné à la fabrication de produits de petit-lait séché,

(iv) du peroxyde de benzoyle et du phosphate tricalcique comme véhicule du peroxyde de benzoyle, s’il s’agit de petit-lait liquide destiné à la fabrication de produits de petit-lait séché autres que ceux entrant dans les préparations pour nourrissons,

(v) de l’hexamétaphosphate de sodium, s’il s’agit de petit-lait liquide destiné à la fabrication de produits de petit-lait concentré ou séché.

DORS/79-752, art. 4; DORS/89-555, art. 1; DORS/2010-40, art. 1. Version précédente B.08.050. [Abrogé, DORS/95-281, art. 1]

B.08.051. [N]. Le fromage cottage:

a) doit être le produit, sous forme de petits grumeaux, préparé à partir de lait écrémé, de lait écrémé évaporé ou de lait écrémé en poudre et de cultures bactériennes anodines qui produisent un acide;

b) doit contenir au plus 80 pour cent d’humidité;

c) peut contenir au plus 0,5 pour cent d’agent stabilisant;

d) peut contenir :

(i) du lait,

(ii) de la crème,

(iii) du lait en poudre,

(iv) de la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux,

(v) l’enzyme coagulant le lait provenant de Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)), de Mucor pusillus Lindt par fermentation de culture pure ou de Aspergillus oryzae RET-1 (pBoel777), en quantité conforme aux bonnes pratiques industrielles,

(vi) de la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), en quantité conforme aux bonnes pratiques industrielles,

(vi.1) de la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), en quantité conforme aux bonnes pratiques industrielles,

(vi.2) pepsine provenant de la muqueuse glandulaire de l’estomac de porc,

(vii) du sel,

(viii) du chlorure de calcium,

(ix) du lactose ajouté,

(x) des rajusteurs de pH,

(xi) des achards (relish),

(xii) des fruits,

(xiii) des légumes,

(xiv) du dioxyde de carbone.

DORS/81-60, art. 4; DORS/92-197, art. 7; DORS/94-212, art. 7; DORS/95-183, art. 7; DORS/98-458, art. 4; DORS/2001-94, art. 2; DORS/2005-98, art. 7; DORS/2010-143, art. 7 et 39(A). Version précédente B.08.052. [N]. Le fromage cottage en crème doit être du fromage cottage qui renferme de la crème, ou un mélange de crème et de lait ou de lait écrémé, ou les deux, en quantité telle que le produit fini doit renfermer

a) au moins quatre pour cent de gras de lait; et

b) pas plus de 80 pour cent d’humidité et peut renfermer des agents émulsifiants, gélatinisants, stabilisants ou épaississants.

B.08.053. Tout produit laitier employé dans la préparation du fromage cottage doit avoir été pasteurisé.

B.08.054. Est interdite la vente du fromage cottage et du fromage cottage en crème dont la teneur bactérienne dépasse 10 bactéries coliformes par gramme, déterminée selon la méthode officielle MFO-4, Examen microbiologique du fromage cottage, 30 novembre 1981.

DORS/82-768, art. 22.

Beurre

B.08.056. [N]. Le beurre:

a) doit :

(i) être l’aliment préparé, conformément aux bonnes pratiques industrielles, à partir du lait ou des produits du lait,

(ii) contenir au moins 80 pour cent de la matière grasse du lait;

b) peut contenir :

(i) des solides du lait,

(ii) des cultures bactériennes,

(iii) du sel,

(iv) un colorant alimentaire.

DORS/92-400, art. 10.

B.08.057. [N]. Le beurre de petit-lait doit être du beurre fabriqué de crème de petit-lait.

DORS/92-400, art. 10.

Crème glacée

B.08.061. [N]. Le mélange pour crème glacée

a) est un mélange pasteurisé, mais non congelé, de crème, de lait ou d’autres produits du lait, édulcoré avec du sucre, du sucre liquide, du sucre inverti, du miel, du dextrose, du glucose, du sirop de maïs, des solides du sirop de maïs ou avec un mélange de n’importe lesquels de ces édulcorants;

b) peut renfermer

(i) des oeufs,

(ii) une préparation aromatisante,

(iii) du cacao ou du sirop de chocolat,

(iv) un colorant pour aliments,

(v) des rajusteurs de pH,

(vi) de la cellulose microcristalline ou un agent stabilisant, ou les deux, en quantité telle que la crème glacée, faite du mélange, n’en contiendra pas plus de 0,5 pour cent,

(vii) un chélateur ou agent séquestrant,

(viii) du sel,

(ix) au plus un pour cent de caséine comestible ou de caséinates comestibles ajoutés,

(x) des esters monoacides gras de propylèneglycol en quantité telle que la crème glacée, faite du mélange, n’en contiendra pas plus de 0,35 pour cent et du tristéarate de sorbitan en quantité telle que la crème glacée, faite du mélange, n’en contiendra pas plus de 0,035 pour cent;

c) doit renfermer au moins

(i) 36 pour cent de solides, et

(ii) 10 pour cent de gras de lait ou, si du cacao ou du sirop de chocolat ont été ajoutés, huit pour cent de gras de lait.

DORS/92-400, art. 11; DORS/97-543, art. 2(F); DORS/2007-75, art. 2; DORS/2007-302, art. 4(F); DORS/2010-142, art. 6(F). Version précédente B.08.062. [N]. La crème glacée

a) est l’aliment congelé obtenu par congélation d’un mélange à crème glacée, avec ou sans incorporation d’air;

b) peut renfermer du cacao ou du sirop de chocolat, des fruits, des noix et des confiseries;

c) doit renfermer au moins

(i) 36 pour cent de solides,

(ii) 10 pour cent de gras de lait ou, si du cacao ou du sirop de chocolat, des fruits, des noix ou des confiseries ont été ajoutés, huit pour cent de gras de lait, et

(iii) 180 grammes de solides au litre dont au moins 50 grammes doivent être de la matière grasse du lait, ou, si du cacao ou du sirop de chocolat, des fruits, des noix ou des confiseries ont été ajoutés, 180 grammes de solides au litre, dont au moins 40 grammes doivent être de la matière grasse du lait;

d) doit renfermer au plus

(i) 100 000 bactéries par gramme, et

(ii) 10 organismes coliformes par gramme,

déterminés selon la méthode officielle MFO-2, Examen microbiologique de la crème glacée ou du lait glacé, 30 novembre 1981.

DORS/82-768, art. 23; DORS/92-400, art. 12.

Sorbet laitier

[DORS/98-580, art. 1(F)]

B.08.063. [N]. Le sorbet laitier

a) doit être l’aliment congelé, autre que la crème glacée ou le lait glacé, fabriqué à partir d’un produit du lait;

b) peut renfermer

(i) de l’eau,

(ii) un agent édulcorant,

(iii) des fruits ou jus de fruits,

(iv) de l’acide citrique ou tartrique,

(v) une préparation aromatisante,

(vi) un colorant pour aliments,

(vii) au plus 0,75 pour cent d’agent stabilisant,

(viii) un chélateur ou agent séquestrant,

(ix) du lactose,

(x) au plus, 0,5 pour cent de cellulose microcristalline,

(xi) au plus un pour cent de caséine comestible ou de caséinates comestibles ajoutés;

c) doit renfermer

(i) au plus cinq pour cent de solides du lait, y compris le gras de lait, et

(ii) au moins 0,35 pour cent d’acide, déterminé par titration et exprimé en acide lactique.

DORS/92-400, art. 13; DORS/97-543, art. 3(F); DORS/98-580, art. 1(F); DORS/2007­ 302, art. 4(F). Version précédente

Lait glacé

B.08.071. [N]. Le mélange pour lait glacé

a) est un mélange pasteurisé, mais non congelé, de crème, de lait ou d’autres produits du lait, édulcoré avec du sucre, du sucre liquide, du sucre inverti, du miel, du dextrose, du glucose, du sirop de maïs, des solides du sirop de maïs ou avec un mélange de n’importe lesquels de ces édulcorants;

b) peut renfermer

(i) des oeufs,

(ii) une préparation aromatisante,

(iii) du cacao ou du sirop de chocolat,

(iv) un colorant pour aliments,

(v) un rajusteur de pH,

(vi) un agent stabilisant en quantité telle que la teneur dans le lait glacé sera d’au plus 0,5 pour cent,

(vii) un chélateur ou agent séquestrant,

(viii) du lactose ajouté,

(ix) au plus, 1,5 pour cent de cellulose microcristalline,

(x) du sel,

(xi) au plus un pour cent de caséine comestible ou de caséinates comestibles ajoutés;

c) doit renfermer

(i) au moins 33 pour cent de solides, et

(ii) au moins trois pour cent et au plus cinq pour cent de gras de lait.

DORS/92-400, art. 14; DORS/97-543, art. 4(F); DORS/2007-302, art. 4(F). Version précédente B.08.072. [N]. Le lait glacé

a) est l’aliment congelé obtenu par congélation d’un mélange à lait glacé, avec ou sans incorporation d’air;

b) peut renfermer du cacao ou du sirop de chocolat, des fruits, des noix et des confiseries;

c) doit renfermer

(i) au moins 33 pour cent de solides,

(ii) au moins trois pour cent et au plus cinq pour cent de gras de lait, et

(iii) au moins 160 grammes de solides au litre, dont au moins 14 grammes doivent être de la matière grasse du lait;

d) doit renfermer au plus

(i) 100 000 bactéries par gramme, et

(ii) 10 organismes coliformes par gramme,

déterminés selon la méthode officielle MFO-2, Examen microbiologique de la crème glacée ou du lait glacé, 30 novembre 1981.

DORS/82-768, art. 24; DORS/92-400, art. 15.

B.08.073. [Abrogé, DORS/92-626, art. 13]

B.08.074. (1) Le pourcentage de la matière grasse du lait contenu dans

a) le yogourt,

b) le fromage cottage, et

c) le fromage cottage en crème,

doit être indiqué sur l’espace principal et suivi de l’expression « matière grasse du lait » ou de l’abréviation « M.G. ».

(2) En plus de la mention exigée au paragraphe (1), il peut être indiqué sur l’étiquette d’un aliment mentionné à ce paragraphe sa teneur en matières grasses exprimée en grammes par portion déterminée.

DORS/88-559, art. 18.

Crème

B.08.075. [N]. La crème

a) doit être le liquide gras obtenu par séparation des éléments du lait, de manière à élever la teneur du liquide en gras de lait; et

b) peut contenir :

(i) un agent rajusteur de pH,

(ii) un agent stabilisant,

(iii) dans le cas de la crème à fouetter qui a été thermisée à une chaleur supérieure à 100 °C, les ingrédients et les additifs alimentaires suivants :

(A) du lait écrémé en poudre en quantité n’excédant pas 0,25 pour cent,

(B) des solides de glucose en quantité n’excédant pas 0,1 pour cent,

(C) du sulfate de calcium en quantité n’excédant pas 0,005 pour cent,

(D) de la gomme xanthane en quantité n’excédant pas 0,02 pour cent,

(E) [Abrogée, DORS/2010-142, art. 7]

(iv) dans le cas de la crème à fouetter, de la cellulose microcristalline en quantité n’excédant pas 0,2 pour cent.

DORS/79-662, art. 2; DORS/82-1071, art. 6; DORS/88-419, art. 1; DORS/2010-142, art. 7. Version précédente B.08.076. (1) Le pourcentage de la matière grasse du lait contenue dans la crème en conserve doit être indiqué sur l’espace principal de l’étiquette et suivi de l’expression « matière grasse du lait » ou de l’abréviation « M.G. ».

(2) En plus de la mention exigée au paragraphe (1), il peut être indiqué sur l’étiquette de la crème en conserve sa teneur en matières grasses exprimée en grammes par portion déterminée.

DORS/88-559, art. 19.

B.08.077. [N]. La crème sure

a) est préparée à partir de crème pasteurisée surie au moyen d’une culture bactérienne productrice d’acide et doit renfermer au moins 14 pour cent de gras de lait; et

b) peut renfermer

(i) des solides de lait,

(ii) des solides de petit-lait,

(iii) du lait de beurre,

(iv) de l’amidon en quantité ne dépassant pas un pour cent,

(v) du sel,

(vi) de la présure provenant de l’extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux, en quantité conforme aux bonnes pratiques industrielles,

(vii) les additifs alimentaires suivants faisant fonction d’agents émulsifiants, gélatinisants, stabilisants et épaississants :

(A) algine, gomme de caroube, carraghénine, gélatine, gomme de guar, pectine, alginate de propylèneglycol ou un mélange de ces substances, en quantité ne dépassant pas 0,5 pour cent,

(B) monoglycérides, mono et diglycérides, seuls ou combinés, en quantité ne dépassant pas 0,3 pour cent, et

(C) phosphate disodique en quantité ne dépassant pas 0,05 pour cent,

(viii) du citrate de sodium en tant que précurseur de saveur en quantité ne dépassant pas 0,1 pour cent,

(ix) l’enzyme coagulant le lait provenant de Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)), de Mucor pusillus Lindt

par fermentation de culture pure ou de Aspergillus oryzae RET-1 (pBoel777), en quantité conforme aux bonnes pratiques industrielles,

(x) de la chymosine A provenant de Escherichia coli K-12, GE81 (pPFZ87A), en quantité conforme aux bonnes pratiques industrielles,

(xi) de la chymosine B provenant de Aspergillus niger var. awamori, GCC0349 (pGAMpR) ou de Kluyveromyces marxianus var lactis, DS1182 (pKS 105), en quantité conforme aux bonnes pratiques industrielles.

DORS/78-876, art. 1; DORS/80-500, art. 3; DORS/81-60, art. 5; DORS/92-197, art. 8; DORS/94-212, art. 8; DORS/95-183, art. 8; DORS/98-458, art. 5; DORS/2005-98, art. 7; DORS/2010-143, art. 8 et 39(A). Version précédente

Titre 9

Graisses et huiles B.09.001. [N]. Les graisses et les huiles végétales doivent être entièrement obtenues de la source végétale d’où elles tirent leur nom et posséder une saveur et une odeur douces; elles peuvent, à l’exception de l’huile d’olive, contenir des agents émulsifiants, des agents de conservation de la catégorie IV, un agent antimousse et du carotène-B en quantité suffisante pour compenser la perte subie pendant le traitement, pourvu qu’une telle addition soit déclarée sur l’étiquette.

DORS/85-179, art. 1.

B.09.002. [N]. Les graisses et les huiles d’origine animale doivent être entièrement obtenues d’animaux sains au moment de l’abattage, posséder une saveur et une odeur douces et peuvent contenir,

a) à l’exception du gras de lait et du suif, des agents de conservation de la catégorie IV; et

b) à l’exception du saindoux, du gras de lait et du suif, un agent antimousse.

B.09.003. [N]. L’huile d’olive ou huile douce

a) doit être l’huile obtenue du fruit de l’olivier (Olea europaea L);

b) doit avoir la composition en acides gras

(i) d’au moins 56,0 et d’au plus 83,0 pour cent d’acide oléique,

(ii) d’au moins 7,5 et d’au plus 20,0 pour cent d’acide palmitique,

(iii) d’au moins 3,5 et d’au plus 20,0 pour cent d’acide linoléique,

(iv) d’au moins 0,5 et d’au plus 3,5 pour cent d’acide stéarique,

(v) d’au moins 0,3 et d’au plus 3,5 pour cent d’acide palmitoléique,

(vi) d’au plus 1,5 pour cent d’acide linolénique, et

(vii) d’au plus 0,05 pour cent d’acide myristique, calculé en esters méthyliques;

c) doit contenir en quantités minimes seulement l’acide arachidique, l’acide béhénique, l’acide gadoléique ou l’acide lignocérique;

d) doit avoir

(i) une densité relative (gravité spécifique), calculée lorsque l’huile est à 20 °C et l’eau à 20 °C (20 °C/eau à 20 °C), d’au moins 0,910 et d’au plus 0,916,

(ii) un indice de réfraction, lorsqu’on utilise la raie D du sodium comme source lumineuse et que l’huile d’olive est à 20 °C (nD20 °C), d’au moins 1,4677 et d’au plus 1,4705,

(iii) un indice d’iode, en utilisant l’épreuve de Wijs, d’au moins 75 et d’au plus 94,

(iv) un indice de saponification, exprimé en milligrammes d’hydroxyde de potassium par gramme d’huile, d’au moins 184 et d’au plus 196,

(v) un indice d’acidité d’au plus 6,6 mg d’hydroxyde de potassium par gramme d’huile,

(vi) une acidité libre d’au plus 3,3 pour cent exprimée en tant qu’acide oléique,

(vii) un indice de peroxyde d’au plus 20 milliéquivalents d’oxygène des peroxydes par kilogramme d’huile,

(viii) une teneur en substances insaponifiables d’au plus 15 g/kg, et

(ix) un indice de Bellier d’au plus 17;

e) doit donner des résultats négatifs pour les épreuves des huiles semi-siccatives, de l’huile de résidu d’olive, de l’huile de coton, de l’huile de thé et de l’huile de sésame; et

f) nonobstant l’article B.09.001, peut contenir de l’alphatocophérol en quantités suffisantes pour remplacer la quantité perdue au cours du raffinage, pourvu qu’une telle addition soit déclarée sur l’étiquette.

DORS/78-655, art. 1.

B.09.004. [N]. L’huile de coton

a) est l’huile des graines de l’espèce cultivée de Gossypium;

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,918 et d’au plus 0,926,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,458 et d’au plus 1,466,

(iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 189 et d’au plus 198,

(iv) un indice d’iode (Wijs) d’au moins 99 et d’au plus 119,

(v) une teneur en substances insaponifiables d’au plus 15 grammes par kilogramme,

(vi) un test Halphen positif,

(vii) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(viii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile; et

c) peut renfermer de l’oxystéarine.

B.09.005. [N]. Le beurre de cacao est la matière grasse extraite de fèves de cacao décortiquées, avant ou après torréfaction, ou de la liqueur de cacao et possède les caractéristiques suivantes :

a) un indice de réfraction (à 40 °C) d’au moins 1,453 et d’au plus 1,458;

b) un indice de saponification d’au moins 188 et d’au plus 202;

c) un indice d’iode (Hanus) d’au moins 32 et d’au plus 41; et

d) un indice d’acidité d’au plus cinq.

DORS/97-263, art. 3.

B.09.006. [N]. L’huile de maïs ou huile de blé d’inde

a) est l’huile du germe ou de l’embryon de Zea mays L.; et

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,917 et d’au plus 0,925,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,465 et d’au plus 1,468,

(iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 187 et d’au plus 195,

(iv) un indice d’iode (Wijs) d’au moins 103 et d’au plus 128,

(v) une teneur en substances insaponifiables d’au plus 28 grammes par kilogramme,

(vi) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(vii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile.

B.09.007. [N]. L’huile d’arachide

a) est l’huile des graines d’Arachis hypogaea L.;

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,914 et d’au plus 0,917,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,460 et d’au plus 1,465,

(iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 187 et d’au plus 196,

(iv) un indice d’iode (Wijs) d’au moins 80 et d’au plus 106,

(v) une teneur en substances insaponifiables d’au plus 10 grammes par kilogramme,

(vi) une proportion d’acide arachidique ou d’acides gras supérieurs, d’au moins 48 grammes par kilogramme,

(vii) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(viii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile; et

c) peut renfermer de l’oxystéarine.

DORS/84-300, art. 22(A).

B.09.008. [N]. L’huile de fève de soya, l’huile de soja ou l’huile de soya

a) est l’huile des graines de Glycine max (L.) Merr.;

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,919 et d’au plus 0,925,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,466 et d’au plus 1,470,

(iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 189 et d’au plus 195,

(iv) un indice d’iode (Wijs) d’au moins 120 et d’au plus 143,

(v) une teneur en substances insaponifiables d’au plus 15 grammes par kilogramme,

(vi) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(vii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile; et

c) peut renfermer de l’oxystéarine.

DORS/84-300, art. 23(A).

B.09.009. [N]. L’huile de graine de tournesol ou l’huile de tournesol

a) est l’huile des graines de Helianthus annuus L.; et

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,918 et d’au plus 0,923,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,467 et d’au plus 1,469,

(iii) un indice d’iode (Wijs) d’au moins 110 et d’au plus 143,

(iv) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 188 et d’au plus 194,

(v) une teneur en substances insaponifiables d’au plus 15 grammes par kilogramme,

(vi) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(vii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile.

B.09.009A. [N]. L’huile de graines de carthame ou l’huile de carthame

a) est l’huile des graines de Carthamus tinctorius L.; et

b) doit avoir

(i) une densité relative (20 °C/eau à 20 °C) d’au moins 0,922 et d’au plus 0,927,

(ii) un indice de réfraction (nD40 °C) d’au moins 1,467 et d’au plus 1,470,

(iii) un indice de saponification (milligrammes d’hydroxyde de potassium par gramme d’huile) d’au moins 186 et d’au plus 198,

(iv) un indice d’iode (Wijs) d’au moins 135 et d’au plus 150,

(v) une teneur en substances insaponifiables d’au plus 15 grammes par kilogramme,

(vi) un indice d’acidité d’au plus 0,6 milligramme d’hydroxyde de potassium par gramme d’huile, et

(vii) un indice de peroxyde d’au plus 10 milliéquivalents d’oxygène dégagé par kilogramme d’huile.

B.09.010. Nonobstant l’article 1 du tableau de l’alinéa B.01.010(3)b), lorsqu’elle est un ingrédient de toute huile à friture ou de table, la graisse ou l’huile végétale doit être désignée dans la liste d’ingrédients par son nom usuel.

DORS/98-458, art. 7(F).

B.09.011. [N]. Le shortening autre que le beurre et le saindoux, doit être l’aliment mi­ solide préparé à partir de matières grasses, d’huile ou d’un mélange de matières grasses et d’huiles, soumis ou non à l’hydrogénation, et peut renfermer,

a) des agents de conservation de la catégorie IV,

b) un agent anti-mousse,

c) du monoglycéride citrate de stéaryle,

d) des monoglycérides, ou un mélange de monoglycérides et de diglycérides des acides gras lipogènes, le poids des monoglycérides ne dépassant pas 10 pour cent, et le poids global des monoglycérides et des diglycérides ne dépassant pas 20 pour cent du poids du shortening,

e) des monoglycérides lactylés, ou un mélange de monoglycérides et de diglycérides lactylés des acides gras lipogènes, le poids global ne dépassant pas huit pour cent du poids du shortening, et

f) tristéarate de sorbitan,

sauf que le poids global des ingrédients permis aux alinéas d) et e) ne doit pas dépasser 20 pour cent du poids du shortening.

B.09.012. [Abrogé, DORS/97-148, art. 2]

B.09.013. [N]. Le saindoux

a) doit être la graisse fondue provenant du porc;

b) doit avoir

(i) une densité relative (gravité spécifique) calculée lorsque le saindoux est à 40 °C et l’eau à 20 °C (40 °C/eau à 20 °C), d’au moins 0,894 et d’au plus 0,906,

(ii) un indice de réfraction, lorsqu’on utilise la raie D du sodium comme source lumineuse et que le saindoux est à 40 °C (nD40 °C), d’au moins 1,448 et d’au plus 1,461,

(iii) un titrage d’au moins 32 °C et d’au plus 45 °C,

(iv) un indice de saponification, exprimé en milligrammes d’hydroxyde de potassium par gramme de matière grasse, d’au moins 192 et d’au plus 203,

(v) un indice d’iode, en utilisant l’épreuve de Wijs, d’au moins 45 et d’au plus 70,

(vi) une teneur en substances insaponifiables d’au plus 12 g/kg,

(vii) un indice d’acidité d’au plus 2,5 mg d’hydroxyde de potassium par gramme de matière grasse, et

(viii) un indice de peroxyde d’au plus 16 milliéquivalents d’oxygène de peroxydes par kilogramme de matière grasse; et

c) peut contenir

(i) de la stéarine de saindoux ou du saindoux hydrogéné,

(ii) un agent de conservation de la catégorie IV, et

(iii) au plus un pour cent de substances provenant de la fonte de lard, autres que les acides gras ou des matières grasses.

DORS/78-401, art. 1(F); DORS/84-300, art. 25(F).

B.09.014. [N]. Le saindoux de panne doit être la graisse fondue à la température modérée, provenant du tissu adipeux interne de l’abdomen du porc, à l’exclusion de la graisse adhérant aux intestins, et doit avoir un indice d’iode (Hanus) d’au plus 65.

B.09.015. [N]. Le suif

a) doit être de matière grasse de l’aloyau ou de rognons, ou la graisse de la coiffe, obtenue d’une carcasse de boeuf;

b) doit avoir

(i) une densité relative (gravité spécifique), calculée lorsque le suif est à 40 °C et l’eau à 20 °C (40 °C/eau à 20 °C), d’au moins 0,893 et d’au plus 0,898,

(ii) un indice de réfraction, lorsqu’on utilise la raie D du sodium comme source lumineuse et que le suif est à 40 °C (nD40 °C), d’au moins 1,448 et d’au plus 1,460,

(iii) un titrage d’au moins 42,5 °C et d’au plus 47 °C,

(iv) un indice de saponification, exprimé en milligrammes d’hydroxyde de potassium par gramme de matière grasse, d’au moins 190 et d’au plus 200,

(v) un indice d’iode, en utilisant l’épreuve de Wijs, d’au moins 32 et d’au plus 47,

(vi) une teneur en substances insaponifiables d’au plus 10 g/kg,

(vii) un indice d’acidité d’au plus 2 mg d’hydroxyde de potassium par gramme de matière grasse, et

(viii) un indice de peroxyde d’au plus 10 milliéquivalents, d’oxygène de peroxydes par kilogramme de matière grasse; et

c) doit renfermer au plus trois pour cent de céréales et un pour cent de sel lorsqu’il est vendu sous forme de suif haché.

DORS/78-655, art. 2(F).

B.09.016. [N]. La margarine

a) doit être une émulsion plastique ou liquide d’eau dans de la graisse, de l’huile ou des graisses et des huiles ne provenant pas du lait et qui peuvent avoir été soumises à l’hydrogénation;

b) doit renfermer

(i) au moins 80 pour cent de graisse, d’huile, ou de graisse et d’huile comptées en gras, et

(ii) nonobstant l’article D.01.009, au moins

(A) 3 300 U.I. de vitamine A, et

(B) 530 U.I. de vitamine D

par 100 g; et

c) peut renfermer :

(i) de la poudre de lait écrémé, du babeurre en poudre ou du babeurre liquide,

(ii) du petit-lait ou des solides de petit-lait modifié,

(iii) des protéines,

(iv) de l’eau,

(v) de la vitamine E, si celle-ci est ajoutée en une quantité telle que le produit final contienne au moins 0,6 unité internationale d’alphatocophérol par gramme d’acide linoléique présent dans la margarine,

(vi) un agent aromatisant,

(vii) un agent édulcorant,

(viii) du chlorure de potassium et du chlorure de sodium,

(ix) les colorants pour aliments suivants : ß-apo-8′- caroténal, canthaxanthine, carotène, curcuma, ester éthylique de l’acide ß-apo-8′-caroténoïque et rocou, selon les limites de tolérance prévues au tableau III de l’article B.16.100,

(x) les émulsifs suivants : lécithine, mono- et diglycérides, monoglycérides et tristéarate de sorbitan, selon les limites de tolérance prévues au tableau IV de l’article B.16.100,

(xi) les rajusteurs du pH suivants : acide citrique, acide lactique, acide tartrique, bicarbonate de potassium, bicarbonate de sodium, carbonate de potassium, carbonate de sodium, citrate de potassium, citrate de sodium, hydroxyde de potassium, hydroxyde de sodium, lactate de potassium, lactate de sodium et tartrate double de sodium et de potassium, selon les limites de tolérance prévues au tableau X de l’article B.16.100,

(xii) les agents de conservation suivants : acide benzoïque, acide sorbique, benzoate de potassium, benzoate de sodium, citrate de monoglycéride, citrate de monoisopropyle, gallate de propyle, hydroxyanisole butylé, hydroxytoluène butylé, palmitate d’ascorbyle,

sorbate de calcium, sorbate de potassium, sorbate de sodium et stéarate d’ascorbyle, selon les limites de tolérance prévues au tableau XI de l’article B.16.100,

(xiii) les agents séquestrants suivants : citrate de stéaryle et versénate (éthylènediamine tétracétate) de calcium disodique, selon les limites de tolérance prévues au tableau XII de l’article B.16.100.

DORS/81-60, art. 6; DORS/84-300, art. 26(F); DORS/93-466, art. 1.

B.09.017. [N]. La margarine réduite en calories

a) doit être conforme à la norme pour la margarine, sauf qu’elle ne doit pas renfermer plus de

(i) 40 pour cent de gras, d’huile ou de graisse et d’huile compté en gras,

(ii) 50 pour cent des calories qui seraient normalement présentes dans le produit s’il n’était pas réduit en calories;

b) sous réserve de l’alinéa c), peut renfermer l’un ou plusieurs des ingrédients suivants, en une quantité totale d’au plus 0,5 pour cent :

(i) de la gomme arabique,

(ii) de l’agar,

(iii) de l’algine,

(iv) de la gomme de caroube,

(v) de la carragénine,

(vi) du furcelleran,

(vii) de la gomme gellane,

(viii) de la gomme de guar,

(ix) de la gomme de sterculia,

(x) de l’alginate de propylèneglycol,

(xi) de la gomme adragante,

(xii) de la gomme xanthane;

c) peut contenir des esters polyglycéroliques d’acides gras :

(i) soit seuls, en une quantité d’au plus 0,2 pour cent,

(ii) soit en combinaison avec tout ingrédient visé à l’alinéa b), en une quantité d’au plus 0,2 pour cent pourvu que la quantité de cette combinaison de tels esters et d’ingrédients n’excède pas au total 0,5 pour cent;

d) malgré le sous-alinéa B.09.016c)(x), peut contenir de la lécithine en une quantité d’au plus 0,5 pour cent;

e) peut renfermer :

(i) de l’amidon végétal,

(ii) de l’amidon végétal modifié,

(iii) de la maltodextrine.

DORS/94-38, art. 1; DORS/95-350, art. 1; DORS/96-160, art. 1.

B.09.020. et B.09.021. [Abrogés, DORS/88-559, art. 20]

B.09.022. Est interdite la vente d’huile de cuisson, de margarine, d’huile à salade, de simili-produits laitiers, de shortening, ou d’un aliment qui rappelle la margarine ou le shortening, s’ils contiennent plus de cinq pour cent d’acides gras monoénoïques en C22 par rapport aux acides gras totaux renfermés dans le produit.

Titre 10

Préparations aromatisantes B.10.003. [N]. L’extrait de (nom de l’arôme) ou l’essence de (nom de l’arôme), doit être une solution de principes sapides ou odorants, ou doués de ces deux propriétés, et extraits de la plante d’où l’extrait ou l’essence aromatique tire son nom, dans l’alcool éthylique, le glycérol, le propylène glycol, seuls ou en mélange, et peut renfermer de l’eau, un agent édulcorant, un colorant pour aliments, et un agent de conservation de la catégorie II ou de la catégorie IV.

B.10.004. [N]. L’extrait artificiel de (nom de l’arôme), l’essence artificielle de (nom de l’arôme), l’extrait imitation de (nom de l’arôme), l’essence imitation de (nom de l’arôme), doivent être des extraits ou essences aromatiques, sauf que les principes aromatiques doivent provenir en tout ou en partie de sources autres que la plante aromatique dont ils tirent leur nom et, si ledit extrait ou essence sont définis dans le présent règlement, le pouvoir aromatisant de l’extrait ou de l’essence, artificiel ou imitation, doit être au moins égal à celui de l’extrait ou de l’essence.

B.10.005. [N]. Une préparation aromatisante de (nom de l’arôme)

a) doit être une préparation, autre qu’une préparation aromatisante définie à l’article B.10.003, de principes sapides ou odorants, ou des deux, extraits de la plante aromatique dont la préparation tire son nom;

b) peut contenir un édulcorant, un colorant alimentaire, un agent de conservation de la catégorie II, du thaumatin, un agent de conservation de la catégorie IV ou un agent émulsifiant; et

c) ne peut contenir que les liquides ajoutés suivants :

(i) eau,

(ii) un ou un mélange quelconque des liquides suivants : 1,3-butylèneglycol, acétate d’éthyle, alcool éthylique, glycérol, diacétate de glycéryle, triacétate de glycéryle, tributyrate de glycéryle, alcool isopropylique, monoglycérides et diglycérides; 1,2­ propylèneglycol ou citrate d’éthyl,

(iii) huile végétale comestible, et

(iv) acétate isobutyrate de sucrose, huile végétale bromée ou un mélange de ces produits, si la préparation aromatisante est utilisée dans les boissons contenant des huiles d’agrumes ou d’épinette.

DORS/84-300, art. 27(A); DORS/86-1112, art. 1; DORS/2010-142, art. 8. Version précédente B.10.006. [N]. Une préparation aromatisante artificielle de (nom de l’arôme) ou une préparation aromatisante imitation de (nom de l’arôme) doit être une préparation aromatisante, sauf que les principes aromatiques peuvent provenir en tout ou en partie de sources autres que la plante aromatique dont la préparation tire son nom et, si ladite préparation aromatisante est définie dans le présent règlement, le pouvoir aromatisant de ladite préparation aromatisante artificielle ou imitation doit être au moins égal à celui de ladite préparation aromatisante.

B.10.007. [N]. Nonobstant les articles B.10.003 et B.10.005, un extrait de (nom du fruit) naturellement fortifié, une essence de (nom du fruit) naturellement fortifiée, une préparation aromatisante de (nom du fruit) naturellement fortifiée doivent être un extrait, une essence, ou une préparation aromatisante obtenus du fruit nommé, auxquels ont été ajoutés d’autres extraits naturels et dont 51 pour cent du pouvoir aromatisant doit provenir du fruit nommé.

B.10.008. Sur toute étiquette ou dans toute réclame d'une préparation aromatisante artificielle ou d'une imitation d'une préparation aromatisante, le mot « artificiel » ou « imitation » doit faire partie intégrante du nom de ladite préparation aromatisante, être imprimé en caractères identiques à ceux dudit nom et être disposé de façon identique.

DORS/84-300, art. 28.

B.10.009. [N]. L’essence d’amande, l’extrait d’amande et la préparation aromatisante à l’amande, doivent être extraits du noyau de l’amande amère, de l’abricot ou de la pêche, et doivent renfermer au moins un pour cent en volume de l’huile volatile ainsi obtenue, exempte d’acide cyanhydrique.

B.10.010. [N]. L’essence d’anis, l’extrait d’anis et la préparation aromatisante à l’anis, doivent être l’essence, l’extrait ou la préparation aromatisante, préparés à partir d’huile d’anis, naturelle ou déterpénée, et leur pouvoir aromatisant doit correspondre à celui d’une solution alcoolique qui renferme au moins trois pour cent en volume d’huile d’anis, huile volatile extraite du fruit de Pimpinella anisum L. ou d’Illicium Verum Hook.

B.10.011. [N]. L’essence de graine de céleri, l’extrait de graine de céleri et la préparation aromatisante à la graine de céleri, doivent être l’essence, l’extrait ou la préparation aromatisante, préparés à partir de graine de céleri, huile de graine de céleri, ou huile de graine de céleri déterpénée, et leur pouvoir aromatisant doit correspondre à celui d’une solution alcoolique qui renferme au moins 0,3 pour cent en volume d’huile volatile de graine de céleri.

B.10.012. [N]. L’essence de fausse cannelle (ou cannelle bâtarde), l’extrait de fausse cannelle et la préparation aromatisante à la fausse cannelle, doivent être l’essence, l’extrait ou la préparation aromatisante, obtenus de l’huile, naturelle ou déterpénée, extraite des feuilles et des rameaux de Cinnamomum cassia L., doivent renfermer au moins 80 pour cent d’aldéhyde cinnamique, et leur pouvoir aromatisant doit correspondre à celui d’une solution alcoolique qui renferme au moins deux pour cent en volume d’huile volatile de fausse cannelle ou cannelle bâtarde.

B.10.013. [N]. L'essence de cannelle de Ceylan, l'extrait de cannelle de Ceylan et la préparation aromatisante à la cannelle de Ceylan, doivent être l'essence, l'extrait ou la préparation aromatisante obtenue de l'huile volatile extraite de l'écorce de Cinnamomum zeylanicum Nees, et doivent renfermer

a) au moins deux pour cent en volume d'huile de cannelle de Ceylan;

b) au moins 65 pour cent d'aldéhyde cinnamique; et

c) au plus 10 pour cent d'eugénol.

B.10.014. [N]. L’essence de clou de girofle, l’extrait de clou de girofle et la préparation aromatisante au clou de girofle, doivent être l’essence, l’extrait ou la préparation aromatisante obtenus de l’huile volatile extraite du bouton de girofle, et doivent renfermer au moins deux pour cent en volume d’huile de clou de girofle.

B.10.015. [N]. L’essence de gingembre, l’extrait de gingembre et la préparation aromatisante au gingembre, doivent être l’essence, l’extrait ou la préparation aromatisante obtenus du gingembre, et doivent renfermer, dans 100 millilitres, les matières solubles dans l’alcool d’au moins 20 grammes de gingembre.

B.10.016. [N]. L’essence de citron, l’extrait de citron et la préparation aromatisante au citron, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir d’huile de citron, naturelle ou déterpénée, ou de zeste de citron, et doivent renfermer au moins 0,2 pour cent de citral dérivé de l’huile de citron.

B.10.017. [N]. L'essence de muscade, l'extrait de muscade et la préparation aromatisante à la muscade, doivent être l'essence, l'extrait ou la préparation aromatisante préparés à partir d'huile de muscade, naturelle ou déterpénée, et leur pouvoir aromatisant doit correspondre à celui d'une solution alcoolique qui renferme au moins deux pour cent en volume d'huile de muscade.

B.10.018. [N]. L’essence d’orange, l’extrait d’orange et la préparation aromatisante à l’orange, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à

partir de zeste d’oranges douces, d’huile d’oranges douces, ou d’huile d’oranges douces déterpénée, et leur pouvoir aromatisant doit correspondre à celui d’une solution alcoolique qui renferme cinq pour cent en volume d’huile d’oranges douces, c’est-à-dire l’huile volatile extraite du zeste frais de Citrus auranlium L. et ayant, dans un tube à essai de 100 millimètres de longueur, et à 25 °C, un pouvoir rotatoire de +95° au moins.

B.10.019. [N]. L’essence de menthe poivrée, l’extrait de menthe poivrée et la préparation aromatisante à la menthe poivrée, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de menthe poivrée ou d’huile de menthe poivrée, obtenue des feuilles et des fleurs de Mentha piperata L., ou de Mentha arvensis De. C., var piperascens Holmes, et leur pouvoir aromatisant doit correspondre à celui d’une solution alcoolique qui renferme au moins trois pour cent en volume d’huile de menthe poivrée, huile qui renferme au moins 50 pour cent de menthol, à l’état libre et à l’état combiné.

B.10.020. [N]. L’essence de rose, l’extrait de rose et la préparation aromatisante à la rose, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de l’huile volatile obtenue des pétales de Rosa damascena Mill., de R. centajolia L., ou de R. moschata Herrm, et doivent renfermer au moins 0,4 pour cent en volume d’huile de rose.

B.10.021. [N]. L’essence de sarriette, l’extrait de sarriette et la préparation aromatisante à la sarriette, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de sarriette ou d’huile de sarriette, et renfermer au moins 0,35 pour cent en volume d’huile de sarriette.

B.10.022. [N]. L’essence de menthe verte, l’extrait de menthe verte et la préparation aromatisante à la menthe verte, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de menthe verte ou d’huile de menthe verte, obtenue des feuilles et des fleurs de Mentha spicata L., et doivent renfermer au moins trois pour cent en volume d’huile de menthe verte.

B.10.023. [N]. L’essence de basilic (odorant), l’extrait de basilic et la préparation aromatisante au basilic, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de basilic ou d’huile de basilic, obtenue des feuilles et des fleurs d’Ocymum basilicum L., et doivent renfermer au moins 0,1 pour cent en volume de basilic odorant.

B.10.024. [N]. L’essence de marjolaine, l’extrait de marjolaine et la préparation aromatisante à la marjolaine, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de marjolaine ou d’huile de marjolaine et doivent renfermer au moins un pour cent en volume d’huile de marjolaine.

B.10.025. [N]. L’essence de thym, l’extrait de thym et la préparation aromatisante au thym, doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de thym ou d’huile de thym, et doivent renfermer au moins 0,2 pour cent en volume d’huile de thym.

B.10.026. [N]. L’essence de vanille, l’extrait de vanille et la préparation aromatisante à la vanille

a) doivent être l’essence, l’extrait ou la préparation aromatisante préparés à partir de la gousse de vanille, fruit desséché et traité de Vanilla planifolia Andrews ou de Vanilla tahitensia J. W. Moore;

b) doivent contenir par 100 ml, quelle que soit la méthode d’extraction, une quantité de substances solubles, dans leurs proportions naturelles, au moins égale à celle extraite des quantités suivantes de gousses de vanille selon la méthode officielle FO-17, Extraction de substances solubles de gousses de vanille, en date du 15 septembre 1989 :

(i) au moins 10 g de gousses de vanille, dans le cas de gousses ayant une teneur en humidité d’au plus 25 pour cent,

(ii) au moins 7,5 g de gousses de vanille à l’état desséché, dans le cas de gousses ayant une teneur en humidité de plus de 25 pour cent;

c) ne doivent pas, nonobstant les articles B.10.003 et B.10.005, renfermer de matière colorante ajoutée.

DORS/82-768, art. 25; DORS/84-300, art. 29(F); DORS/91-149, art. 1.

B.10.027. [N]. L’essence de gaulthérie, de thé du Canada ou de wintergreen, l’extrait de gaulthérie, la préparation aromatisante à la gaulthérie, doivent être l’essence, l’extrait ou la préparation aromatisante, préparés à partir d’huile de gaulthérie, huile volatile distillée des feuilles de Gaultheria procumbens L. ou de Betula lenta L., et doivent renfermer au moins trois pour cent en volume d’huile de gaulthérie ou de thé des bois.

Titre 11

Fruits, légumes, leurs produits et succédanés [DORS/78-478, art. 1]

B.11.001. Dans le présent titre,

« ingrédient acide » désigne

a) l’acide citrique, malique ou tartrique,

b) le jus de citron ou de limette, ou

c) le vinaigre; (acid ingredient)

« ingrédient édulcorant » désigne le sucre, le sucre inverti, le miel, le dextrose, le glucose ou les solides du glucose, ou un mélange quelconque de ces produits, à l’état sec ou liquide; (sweetening ingredient)

« jus de fruit » désigne le liquide non fermenté, exprimé de fruits mûrs, sains et frais qui peut être traité par la chaleur et refroidi. (fruit juice)

B.11.001.1. Est interdite la vente de fruits ou de légumes frais destinés à être consommés crus, à l’exception de raisins frais, s’ils sont additionnés d’anhydride sulfureux ou de ses sels.

DORS/87-374, art. 1.

Légumes

B.11.002. [N]. Le ou les (nom du légume) en conserve

a) doivent être le produit obtenu par traitement thermique du légume frais qui est nommé, après préparation appropriée;

b) doivent être conditionnés en récipients hermétiquement scellés;

c) peuvent renfermer

(i) un ingrédient édulcorant,

(ii) du sel,

(iii) de l’eau, et

(iv) un agent raffermissant; et

d) peuvent contenir

(i) pour les haricots verts en conserve et les haricots jaunes en conserve, une quantité de morceaux de poivron vert, de poivron rouge et de tomate représentant au plus 15 pour cent du produit final, ainsi que des assaisonnements à l’aneth et du vinaigre,

(ii) pour les pois en conserve, des garnitures composées d’un ou de plusieurs des éléments suivants : laitue, oignons, carottes, morceaux de poivron vert ou rouge, dont la quantité représente au plus 15 pour cent de l’ensemble de l’ingrédient végétal égoutté, des herbes aromatiques, des épices et des assaisonnements, du bouillon ou du jus de légumes et des herbes aromatiques, une quantité d’hydroxyde de calcium d’au plus 0,01 pour cent du produit final et une quantité d’hydroxyde de magnésium d’au plus 0,05 pour cent du produit final,

(iii) pour

(A) les asperges en conserve, une quantité d’acide acétique, d’acide citrique, d’acide malique et d’acide tartrique conforme aux bonnes pratiques industrielles,

(B) les asperges blanches en conserve, une quantité d’acide acétique, d’acide citrique, d’acide malique, d’acide tartrique et d’acide ascorbique conforme aux bonnes pratiques industrielles,

(C) les piments forts en conserve, une quantité d’acide citrique conforme aux bonnes pratiques industrielles,

(iv) pour les asperges conservées dans des contenants en verre ou des contenants métalliques vernis sur toute leur surface intérieure, une quantité de chlorure stanneux d’au plus 2,5 [25] parties par million, calculée en étain,

(v) pour les artichauts en conserve, les fèves germées en conserve et les oignons en conserve, une quantité d’acide citrique conforme aux bonnes pratiques industrielles, devant servir de rajusteur du pH,

(vi) pour les haricots de Lima mûrs (haricots beurre) en conserve et les haricots pinto en conserve, une quantité d’éthylènediaminetétracétate disodique d’au plus 130 parties par million,

(vi.1) pour les conserves de fèves gourganes, une quantité de versénate (éthylènediaminetétracétate) de calcium disodique d’au plus 365 parties par million,

(vii) pour les haricots nains rouges en conserve, les pois chiches (Garbanzos) en conserve et les pois à hile noir en conserve, une quantité d’éthylènediaminetétracétate disodique d’au plus 150 parties par million, et

(viii) pour les asperges en conserve, les haricots verts en conserve, les haricots jaunes en conserve et les pois en conserve,

(A) une quantité de beurre représentant au moins trois pour cent du produit final, ou d’autres graisses ou huiles animales ou végétales comestibles,

(B) des amidons naturels ou modifiés de façon enzymatique ou physique s’ils sont utilisés avec du beurre ou d’autres graisses ou huiles animales ou végétales comestibles,

(C) une quantité d’un ou de plusieurs des éléments suivants : gomme de caroubier, algine, caragénine, furcelleran gomme de guar et alginate de propylèneglycol, qui, utilisée avec du beurre ou d’autres graisses ou huiles animales ou végétales comestibles, représente au plus un pour cent du produit final, et

(D) des sauces, des assaisonnements ou des agents aromatisants caractéristiques s’ils figurent dans le nom usuel du produit.

DORS/79-660, art. 1; DORS/84-300, art. 30; DORS/95-435, art. 1; DORS/97-561, art. 1.

B.11.003. [N]. Les champignons en conserve

a) doivent être le produit obtenu par traitement thermique de champignons cultivés convenablement préparés;

b) doivent être conditionnés en récipients hermétiquement scellés; et

c) peuvent contenir de l’acide ascorbique, de l’acide citrique et du sel.

DORS/84-300, art. 31.

B.11.003A. [N]. Les champignons congelés

a) doivent être le produit obtenu par congélation de champignons cultivés convenablement préparés; et

b) peuvent contenir du métabisulfite de sodium, du phosphate dibasique de sodium, du sulfate de sodium et du sel.

B.11.004. [N]. Le (nom du légume) congelé doit être le produit obtenu par la congélation de ce légume, auquel on a pu ajouter du sel, à l’état frais, après qu’il a été préparé convenablement et soumis au blanchiment.

B.11.005. [N]. Les tomates ou tomates en conserve

a) doivent être le produit obtenu par traitement thermique de tomates mûres, fraîches et convenablement préparées;

b) peuvent renfermer

(i) un ingrédient édulcorant à l’état sec,

(ii) du sel,

(iii) un agent raffermissant,

(iv) de l’acide citrique,

(v) des épices et autres condiments; et

c) doivent renfermer au moins 50 pour cent de solides de tomates égouttés, déterminé selon la méthode officielle FO-18, Détermination de solides de tomates égouttés, 15 octobre 1981.

DORS/82-768, art. 26.

B.11.007. [N]. Le jus de tomates doit être le liquide, pasteurisé mais non concentré, renfermant une proportion substantielle de fine pulpe de tomates, obtenu de tomates saines, mûres et entières, débarrassées des queues et autres parties impropres à la consommation, par n’importe quel procédé qui n’ajoute pas d’eau au liquide, et il peut renfermer du sel et un ingrédient édulcorant à l’état sec.

B.11.009. [N]. La pâte de tomates doit être le produit obtenu, par l’évaporation d’une partie de l’eau de tomates ou de parures saines de tomates; elle peut renfermer du sel et des agents de conservation de la catégorie II et doit renfermer au moins 20 pour cent de solides de tomates, déterminé selon la méthode officielle FO-19, Détermination de solides de tomates, 15 octobre 1981.

DORS/82-768, art. 27.

B.11.010. [N]. La pâte de tomates concentrée ou pâte concentrée de tomates doit être de la pâte de tomates qui renferme au moins 30 pour cent de solides de tomates,

déterminé selon la méthode officielle FO-19, Détermination de solides de tomates, 15 octobre 1981.

DORS/82-768, art. 27.

B.11.011. [N]. La pulpe de tomates doit être le produit obtenu par traitement thermique de tomates saines, mûres et entières, ou de parures saines de tomates, concentrées jusqu’à une densité d’au moins 1,050 (à 20 °C/20 °C), et elle peut renfermer du sel et un agent de conservation de la catégorie II.

B.11.012. [N]. La purée de tomates doit être le produit en conserve obtenu par traitement thermique de tomates mûres et entières, débarrassé des pelures et des graines et concentré à une densité d’au moins 1,050 (à 20 °C/20 °C); elle peut renfermer du sel et un agent de conservation de la catégorie II.

B.11.014. [N]. Le catsup de tomates, le catsup et les produits dont le nom usuel est une variante du mot catsup

a) doivent être le produit obtenu par traitement thermique du jus de tomates rouges à maturité, ou de parures saines de tomates débarrassées des pelures et des graines;

b) doivent renfermer

(i) du vinaigre,

(ii) du sel,

(iii) des condiments, et

(iv) un ingrédient édulcorant; et

c) peuvent renfermer

(i) un agent de conservation de la catégorie II, et

(ii) un colorant pour aliments.

B.11.015. [Abrogé, DORS/97-151, art. 19]

B.11.016. Est interdite la vente de tomates en conserve, de jus de tomates ou d’un jus de légume qui renferme des filaments de moisissures dans plus de 25 pour cent du champ microscopique, à l’examen selon la méthode officielle MFO-5, Examen de tomates en conserve, de jus de tomates et de jus de légumes, de purée de tomates, de pâte de tomates, de pulpe de tomates et de catsup de tomates pour la détermination des filaments de moisissures, 30 novembre 1981.

DORS/82-768, art. 28.

B.11.017. Est interdite la vente de purée de tomates, de pâte de tomates, de pulpe de tomates ou de catsup de tomates qui renferme des filaments de moisissures dans plus de 50 pour cent du champ microscopique, à l’examen selon la méthode officielle MFO-5,

Examen de tomates en conserve, de jus de tomates et de jus de légumes, de purée de tomates, de pâte de tomates, de pulpe de tomates et de catsup de tomates pour la détermination des filaments de moisissures, 30 novembre 1981.

DORS/82-768, art. 28.

B.11.025. Est interdite la vente de pommes de terre, de patates (sucrées) ou patates douces, qui ont été colorées artificiellement.

B.11.040. [N]. Les fèves au lard doivent être l’aliment préparé avec des haricots secs et du lard; elles peuvent renfermer une sauce, des condiments, des épices et un agent édulcorant et doivent renfermer au moins 60 pour cent de solides égouttés, déterminé selon la méthode officielle FO-20, Détermination de solides égouttés dans le cas de fèves au lard ou fèves de régime végétarien, 15 octobre 1981.

DORS/82-768, art. 29.

B.11.041. [N]. Les fèves ou haricots ou les fèves de régime végétarien doivent être l’aliment préparé avec des haricots secs; elles peuvent renfermer une sauce, des condiments, des épices et un agent édulcorant et doivent renfermer au moins 60 pour cent de solides égouttés, déterminé selon la méthode officielle FO-20, Détermination de solides égouttés dans le cas de fèves au lard ou fèves de régime végétarien, 15 octobre 1981.

DORS/82-768, art. 29.

B.11.050. [N]. Les olives doivent être le fruit, nature ou farci, de l’olivier, et peuvent renfermer

a) du vinaigre;

b) du sel;

c) un ingrédient édulcorant;

d) des épices;

e) des condiments;

f) de l’acide lactique;

g) de l’acide sorbique ou son sel de potassium ou de sodium;

h) du chlorure de calcium;

i) de l’acide citrique;

j) dans le cas des olives mûres, du gluconate ferreux.

DORS/97-561, art. 2.

B.11.051. [N]. Les pickles, cornichons, achards (relish), ou marinades, doivent être le produit préparé à partir de légumes et de fruits, avec du sel et du vinaigre, et peuvent renfermer

a) des épices;

b) des condiments;

c) du sucre, du sucre inverti, du dextrose ou du glucose, à l’état sec ou à l’état liquide;

d) un colorant pour aliments;

e) un agent de conservation de la catégorie II;

f) un agent raffermissant;

g) du monooléate polyoxyéthylénique (20) de sorbitan, en quantité d’au plus 0,05 pour cent;

h) de l’acide lactique;

i) des huiles végétales; et

j) dans le cas des achards, des cornichons ou des marinades à la moutarde, un agent épaississant.

DORS/84-300, art. 32.

Fruits

B.11.101. [N]. Le ou les (nom du fruit) en conserve

a) doivent être le produit préparé par traitement thermique du fruit frais qui est nommé, après qu’il a été convenablement préparé;

b) doivent être conditionnés en récipients hermétiquement scellés; et

c) peuvent contenir

(i) un ingrédient édulcorant,

(ii) de l’eau,

(iii) du jus de fruits, du jus de fruits fait de concentré, du jus de fruits concentré ou un mélange quelconque de ces produits,

(iv) dans le cas des poires en conserve, de l’acide citrique, de l’acide malique, de l’acide tartrique de la série L ou de l’acide lactique en quantité suffisante pour maintenir le pH entre 4,2 et 4,5, du jus de citron, des épices, des huiles d’épices, de la menthe et une préparation aromatisante autre que celle qui simule l’arôme des poires en conserve,

(v) dans le cas des pommes en conserve, un agent raffermissant,

(vi) dans le cas de la compote de pommes en conserve, de l’acide citrique et de l’acide malique en quantité suffisante pour maintenir le pH entre 4,2 et 4,5; de l’acide ascorbique et de l’acide isoascorbique à condition que le total n’excède pas 150 parties par million, des épices, du sel et une préparation aromatisante autre que celle qui simule l’arôme de la compote de pommes en conserve,

(vii) dans le cas des pamplemousses en conserve, de l’acide citrique en quantité suffisante pour maintenir le pH entre 4,2 et 4,5, du jus de citron, du chlorure de calcium et du lactate de calcium, à condition que la teneur totale en calcium, qu’il soit naturellement présent ou ajouté, n’excède pas 0,035 pour cent, des épices et une préparation aromatisante autre que celle qui simule l’arôme des pamplemousses en conserve,

(viii) dans le cas des mandarines en conserve, de l’acide citrique, en quantité suffisante pour maintenir le pH entre 4,2 et 4,5,

(ix) dans le cas des pêches en conserve, de l’acide ascorbique de la série L à une teneur ne dépassant pas 550 parties par million, des épices, des noyaux de pêches et des graines de pêches pour rehausser la saveur et une préparation aromatisante autre que celle qui simule l’arôme des pêches en conserve,

(x) dans le cas de l’ananas en conserve, de l’acide citrique en quantité suffisante pour maintenir le pH entre 4,2 et 4,5, des épices, des huiles d’épices, de la menthe, du diméthylpolysiloxane à une teneur ne dépassant pas 10 parties par million lorsque le jus d’ananas est utilisé comme véhicule de conditionnement et une préparation aromatisante autre que celle qui simule l’arôme de l’ananas en conserve,

(xi) dans le cas des prunes en conserve, une préparation aromatisante autre que celle qui simule l’arôme des prunes en conserve, et

(xii) dans le cas des fraises en conserve, de l’acide citrique, de l’acide lactique, de l’acide malique ou de l’acide tartrique de la série L en quantité suffisante pour maintenir le pH entre 4,2 et 4,5.

DORS/84-300, art. 33.

B.11.102. [N]. Le ou les (nom du fruit) congelés doivent être le produit obtenu par congélation du fruit frais qui est nommé, après qu’il a été convenablement préparé, et ils peuvent renfermer

a) un ingrédient édulcorant;

b) de l’eau;

c) du jus de fruit, du jus de fruit préparé à partir de concentré, du jus de fruit concentré ou un mélange quelconque de ces produits;

d) de l’acide ascorbique, de l’acide citrique, de l’acide érythorbique ou de l’acide malique pour prévenir la décoloration;

e) dans le cas des pommes tranchées, congelées,

(i) un agent raffermissant, et

(ii) de l’acide sulfureux.

DORS/84-300, art. 34; DORS/95-436, art. 1.

B.11.103. et B.11.104. [Abrogés, DORS/79-252, art. 1]

B.11.105. [Abrogé, DORS/97-151, art. 20]

Jus de fruits

B.11.120. [N]. Le jus de (nom du fruit):

a) doit être le jus du fruit qui est nommé;

b) peut renfermer un ingrédient édulcorant à l’état sec, un agent de conservation de la catégorie II, de l’amylase, de la cellulase et de la pectinase.

DORS/78-402, art. 2; DORS/84-300, art. 35; DORS/90-87, art. 1; DORS/92-591, art. 2.

B.11.121. Nonobstant l’article B.11.120, le jus de fruit préparé, à partir de n’importe quel fruit nommé dans les articles B.11.123 à B.11.128A inclusivement, doit être conforme à la norme prescrite pour ledit jus de fruit audit article.

B.11.123. [N]. Le jus de pommes

a) doit être le jus de fruit exprimé des pommes;

b) peut contenir un agent de conservation de la catégorie II, de la vitamine C, de l’amylase, de la cellulase et de la pectinase;

c) doit avoir une densité d’au moins 1,041 et d’au plus 1,065 (à 20 °C/20 °C); et

d) doit, dans 100 millilitres mesurés à 20 °C, renfermer au moins 0,24 gramme et au plus 0,60 gramme de cendres, dont au moins 50 pour cent doit être du carbonate de potassium.

DORS/90-87, art. 2.

B.11.124. [N]. Le jus de raisin

a) doit être le jus de fruit obtenu de raisin frais;

b) doit avoir une densité d’au moins 1,040 et d’au plus 1,124 (à 20 °C/20 °C);

c) doit, avant que soit ajouté un ingrédient édulcorant, renfermer dans 100 millilitres mesurés à 20 °C,

(i) au moins 0,20 gramme et au plus 0,55 gramme de cendres, et

(ii) au moins 0,015 gramme et au plus 0,070 gramme d’acide phosphorique calculé en pentoxyde de phosphore; et

d) peut contenir un agent rajusteur du pH, un ingrédient édulcorant à l’état sec, un agent de conservation de la catégorie II, de la vitamine C, de l’amylase, de la cellulase et de la pectinase.

DORS/84-300, art. 36(A); DORS/86-1112, art. 2; DORS/90-87, art. 3.

B.11.125. [N]. Le jus de pamplemousse

a) doit être le jus de fruit exprimé de pamplemousses propres, sains et mûrs;

b) doit

(i) renfermer au moins 1,15 milliéquivalents d’aminoacides libres pour 100 millilitres, déterminés selon la méthode officielle FO-21, Détermination d’aminoacides dans le jus de pamplemousse et le jus d’orange, 15 octobre 1981,

(ii) renfermer au moins 70 milligrammes de potassium pour 100 millilitres, déterminés selon la méthode officielle FO-22, Détermination de potassium dans le jus de pamplemousse et le jus d’orange, 15 octobre 1981, et

(iii) pour les composés-polyphénoliques totaux, avoir une densité optique d’au moins 0,310, déterminée selon la méthode officielle FO-23, Détermination de densité optique pour les composés polyphénoliques totaux du jus de pamplemousse et du jus d’orange, 15 octobre 1981;

c) doit, avant que soient ajoutées le sucre, le sucre inverti, le dextrose ou les solides de glucose,

(i) avoir un degré Brix d’au moins 9,3°, déterminé selon la méthode officielle FO-24, Détermination de degré Brix pour le jus de pamplemousse et le jus d’orange, 15 octobre 1981, et

(ii) renfermer au moins 0,7 pour cent et au plus 2,1 pour cent d’acide, en poids, calculé en acide citrique anhydre selon la méthode officielle FO-25, Détermination d’acide dans le jus de pamplemousse ou le jus d’orange, 15 octobre 1981; et

d) peut contenir du sucre, du sucre inverti, du dextrose à l’état sec, des solides de glucose, un agent de conservation de la catégorie II, de l’amylase, de la cellulase et de la pectinase.

DORS/82-768, art. 30; DORS/90-87, art. 4.

B.11.126. [N]. Le jus de citron

a) doit être le jus de fruit exprimé du citron;

b) doit, avant l’addition d’un ingrédient édulcorant, renfermer, dans 100 millilitres mesurés à 20 °C, au moins

(i) 8,0 grammes de solides solubles, déterminés selon la méthode officielle FO-26, Détermination de solides solubles dans le jus de citron, le jus de lime ou le jus de limette, 15 octobre 1981, et

(ii) 5,0 grammes d’acide, calculé en acide citrique anhydre selon la méthode officielle FO-27, Détermination d’acide dans le jus de citron, le jus de lime ou le jus de limette, 15 octobre 1981;

c) peut renfermer du chlorure stanneux; et

d) peut contenir un édulcorant à l’état sec, un agent de conservation de la catégorie II, de l’amylase, de la cellulase et de la pectinase.

DORS/82-768, art. 31; DORS/90-87, art. 5.

B.11.127. [N]. Le jus de lime ou le jus de limette

a) doit être le jus de fruit exprimé de limes;

b) doit avoir

(i) une densité d’au moins 1,030 et d’au plus 1,040 (à 20 °C/20 °C),

(ii) un pouvoir rotatoire entre +0,5 et -1,5 degré Ventzke déterminé à 20 °C, et dans un tube à essai de 200 millimètres de longueur;

c) doit, avant l’addition d’un ingrédient édulcorant, renfermer, dans 100 millilitres mesurés à 20 °C, au moins

(i) 8,0 grammes de solides solubles, déterminés selon la méthode officielle FO-26, Détermination de solides solubles dans le jus de citron, le jus de lime ou le jus de limette, 15 octobre 1981, et

(ii) 5,5 grammes d’acide, calculé en acide citrique anhydre selon la méthode officielle FO-27, Détermination d’acide dans le jus de citron, le jus de lime ou le jus de limette, 15 octobre 1981;

d) peut renfermer du chlorure stanneux; et

e) peut contenir un édulcorant à l’état sec, un agent de conservation de la catégorie II, de l’amylase, de la cellulase et de la pectinase.

DORS/82-768, art. 32; DORS/90-87, art. 6.

B.11.128. [N]. Le jus d’orange

a) doit être le jus de fruit exprimé d’oranges propres, saines et mûres;

b) doit

(i) renfermer au moins 1,20 milliéquivalents d’aminoacides libres pour 100 millilitres, déterminés selon la méthode officielle FO-21, Détermination d’aminoacides dans le jus de pamplemousse et le jus d’orange, 15 octobre 1981,

(ii) renfermer au moins 115 milligrammes de potassium pour 100 millilitres, déterminés selon la méthode officielle FO-22, Détermination de potassium dans le jus de pamplemousse et le jus d’orange, 15 octobre 1981, et

(iii) pour les composés polyphénoliques totaux, avoir une densité optique d’au moins 0,380, déterminée selon la méthode officielle FO-23, Détermination de densité optique pour les composés polyphénoliques totaux du jus de pamplemousse et du jus d’orange, 15 octobre 1981;

c) doit avant que soient ajoutés le sucre, le sucre inverti, le dextrose ou les solides de glucose,

(i) avoir un degré Brix d’au moins 9,7°, déterminé selon la méthode officielle FO-24, Détermination de degré Brix pour le jus de pamplemousse et le jus d’orange, 15 octobre 1981, et

(ii) renfermer au moins 0,5 pour cent et au plus 1,8 pour cent d’acide, en poids, calculé en acide citrique anhydre selon la méthode officielle FO-25, Détermination d’acide dans le jus de pamplemousse ou le jus d’orange, 15 octobre 1981;

d) peut renfermer des essences d’orange, des huiles d’orange et de la pulpe d’orange, dont la teneur est rectifiée conformément aux bonnes pratiques industrielles; et

e) peut contenir du sucre, du sucre inverti, du dextrose à l’état sec, des solides de glucose, un agent de conservation de la catégorie II, de l’amylase, de la cellulase et de la pectinase.

DORS/82-768, art. 33; DORS/90-87, art. 7.

B.11.128A. [N]. Le jus d’ananas

a) doit être le jus de fruit exprimé des ananas; et

b) peut renfermer un ingrédient édulcorant à l’état sec, un agent de conservation de la catégorie II, de la vitamine C, de l’amylase, de la cellulase, de la pectinase et un agent anti-mousse.

DORS/90-87, art. 8; DORS/91-90, art. 1.

B.11.129. [N]. Le jus de (nom du fruit) gazeux ou le jus de (nom du fruit) mousseux, doit être le jus du fruit nommé, qui a été imprégné d’anhydride carbonique sous pression.

B.11.130. [N]. (1) Le jus de (nom du fruit) concentré :

a) doit être du jus de fruit qui est concentré à la moitié au moins de son volume original par élimination d’eau;

b) peut contenir :

(i) de la vitamine C,

(ii) un colorant pour aliments,

(iii) du chlorure stanneux,

(iv) un édulcorant,

(v) un agent de conservation de la catégorie II;

c) peut être additionné, à des fins de normalisation et conformément aux bonnes pratiques industrielles, de l’une ou plusieurs des substances suivantes :

(i) essence, huile ou pulpe du fruit désigné,

(ii) eau.

(2) Les sous-alinéas (1)b)(i), (ii), (iii) et (v) ne s’appliquent pas au jus d’orange concentré congelé.

DORS/89-198, art. 2; DORS/91-124, art. 3.

B.11.131. [N]. Le jus de (noms des fruits) doit être un mélange de jus de fruits dont chacun est conforme à la norme prescrite pour ce jus de fruit au présent titre.

B.11.132. [N]. Le jus de pomme et de (nom du fruit)

a) doit être un mélange de jus de pomme et de jus d’un autre fruit, où chacun des deux est conforme aux normes prescrites pour ce jus de fruit au présent titre, s’il y a lieu; et

b) peut renfermer de la vitamine C ajoutée.

B.11.133. [N]. Le jus de (nom du fruit) reconstitué, le jus de concentré de (nom du fruit) ou le jus de (nom du fruit) fait de concentré

a) doit être le jus de fruit qui a été préparé par l’adjonction d’eau au jus de fruit du même nom dont l’eau avait été enlevée;

b) peut renfermer du jus, de la pulpe, des huiles et des esters naturels du fruit nommé ainsi qu’un ingrédient édulcorant;

c) doit être conforme aux normes des jus de fruits nommés telles qu’elles sont prescrites au présent titre; et

d) peut renfermer, quant au jus de citron reconstitué ou du jus de lime reconstitué, au plus 10 parties par million de diméthylpolysiloxane.

DORS/78-637, art. 2.

B.11.134. [N]. Le nectar d’abricot, le nectar de pêche ou le nectar de poire

a) doit être le produit pulpeux non fermenté mais fermentable, destiné à une consommation directe et obtenu par le mélange de toute la partie comestible de pêches, de poires ou d’abricots sains et mûrs, sous forme concentrée ou non concentrée, avec de l’eau et, sous réserve de l’alinéa e)(i), un ingrédient édulcorant;

b) doit être composé

(i) dans le cas du nectar de pêche et du nectar de poire, d’au moins 40 pour cent de fruit en poids ou de l’équivalent obtenu du concentré de fruit, et

(ii) dans le cas du nectar d’abricot, d’au moins 35 pour cent de fruit en poids ou de l’équivalent obtenu du concentré de fruit;

c) doit comprendre au moins 13 pour cent de solides solubles en poids exprimé en °Brix selon l’échelle internationale prévue pour la saccharose et calculé à l’aide d’un réfractomètre à 20 °C et non corrigé pour l’acidité;

d) doit comprendre au plus 3 g/kg (3000 p.p.m.) d’éthanol et 10 mg/kg (10 p.p.m.) de furfurol hydroxyméthylique; et

e) peut comprendre

(i) du miel si aucun autre ingrédient édulcorant n’est utilisé,

(ii) une quantité d’acide citrique et d’acide malique conforme aux bonnes pratiques industrielles,

(iii) du jus de citron, et

(iv) de la vitamine C.

DORS/79-660, art. 2; DORS/2010-94, art. 9(A). Version précédente

Boissons à arôme de fruit

B.11.150. Il est interdit d’étiqueter, d’empaqueter, de vendre ou d’annoncer une boisson à arôme de fruit de façon à créer l’impression qu’elle contient une vitamine ou présente toute autre valeur nutritive normalement attribuée à un jus de fruits à moins que les exigences suivantes ne soient respectées :

a) qu’elle soit vendue comme succédané d’un jus de fruits ou comme boisson pour le petit déjeuner;

b) qu’elle ne soit pas gazeuse;

c) qu’elle ne soit pas offerte ni habituellement connue comme

(i) une boisson gazeuse, ou

(ii) une boisson désaltérante ou rafraîchissante; et

d) qu’elle contienne, nonobstant les articles D.01.009, D.01.011 et D.02.009, lorsque la boisson est prête à servir, par 100 ml,

(i) de la vitamine C en quantité d’au moins 24 µg et d’au plus 48 µg, et

(ii)

(A) de l’acide folique, si ajouté, en quantité d’au moins 40 µg et d’au plus 80 µg,

(B) de la thiamine, si ajoutée, en quantité d’au moins 0,08 mg et d’au plus 0,11 mg,

(C) du fer, si ajouté, en quantité d’au moins 0,56 mg et d’au plus 0,80 mg, ou

(D) du potassium, si ajouté, en quantité d’au moins 100 mg et d’au plus 200 mg.

DORS/78-478, art. 2.

B.11.151. Il est interdit d’étiqueter, d’empaqueter, de vendre ou d’annoncer une base, un concentré ou un mélange pour préparer une boisson à arôme de fruit de façon à créer l’impression qu’il contient une vitamine ou qu’il présente toute autre valeur nutritive normalement attribuée à un jus de fruits à moins que les exigences suivantes ne soient respectées :

a) qu’une telle base, concentré ou mélange

(i) soit vendu pour faire une boisson pour le petit déjeuner ou un succédané de jus de fruits,

(ii) ne soit pas offert ni habituellement connu comme un produit pour faire une boisson gazeuse ou une boisson désaltérante ou rafraîchissante; et

b) que la boisson préparée à partir d’eux soit conforme aux exigences prescrites à l’alinéa B.11.150d).

DORS/78-478, art. 2.

Confiture

B.11.201. [N]. La confiture de (nom du fruit)

a) doit être le produit obtenu en traitant des fruits, de la pulpe de fruits ou des fruits en conserve, par ébullition jusqu’à une consistance convenable, avec de l’eau et un agent édulcorant;

b) doit renfermer au moins

(i) 45 pour cent du fruit nommé,

(ii) 66 pour cent de solides solubles dans l’eau, déterminés au réfractomètre;

c) peut renfermer

(i) la quantité ajoutée de pectine, de préparation pectique ou d’ingrédient acide, requise pour compenser raisonnablement toute déficience en pectine ou en acidité naturelle du fruit nommé,

(ii) un agent de conservation de la catégorie II,

(iii) un agent rajusteur du pH, et

(iv) un agent anti-mousse; et

d) ne doit renfermer ni pommes ni rhubarbe.

DORS/92-400, art. 16.

B.11.202. [N]. La confiture de (nom du fruit) avec pectine

a) doit être le produit obtenu en traitant des fruits, de la pulpe de fruits ou des fruits en conserve, par ébullition jusqu’à une consistance convenable, avec de l’eau et un agent édulcorant;

b) doit renfermer

(i) au moins 27 pour cent du fruit nommé,

(ii) au moins 66 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et

(iii) de la pectine ou une préparation pectique;

c) peut renfermer

(i) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle du fruit nommé,

(ii) un colorant pour aliments,

(iii) un agent de conservation de la catégorie II,

(iv) un agent rajusteur du pH, et

(v) un agent anti-mousse; et

d) ne doit renfermer ni pommes ni rhubarbe.

DORS/92-400, art. 17.

B.11.203. [N]. La confiture de pommes (ou de rhubarbe) et de (nom du fruit)

a) doit être le produit obtenu en traitant des fruits, de la pulpe de fruits ou des fruits en conserve, par ébullition jusqu’à une consistance convenable, avec de l’eau et un agent édulcorant;

b) doit renfermer au moins

(i) 12,5 pour cent du fruit nommé, sauf que si le fruit nommé est la fraise, elle doit renfermer au moins 15 pour cent de fraises,

(ii) 20 pour cent de pulpe de pommes ou de rhubarbe, et

(iii) 66 pour cent de solides solubles dans l’eau, déterminés au réfractomètre; et

c) peut renfermer

(i) de la pectine ou une préparation pectique,

(ii) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle du fruit utilisé dans la préparation,

(iii) un colorant pour aliments,

(iv) un agent de conservation de la catégorie II,

(v) un agent rajusteur du pH, et

(vi) un agent anti-mousse.

B.11.204. Lorsqu’une confiture visée par une norme établie à l’article B.11.203 contient une addition de pectine ou de préparation pectique, l’addition de pectine ou de préparation pectique, l’addition mentionnée sur l’espace principal de l’étiquette.

Marmelade

B.11.220. [N]. La marmelade de (nom de l’agrume) doit être le produit alimentaire à consistance de gelée, préparé à partir de tout mélange de zeste ou d’écorce, de pulpe, et de jus de l’agrume nommé, par ébullition avec de l’eau et un agent édulcorant; elle doit renfermer au moins 65 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et peut renfermer

a) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle des agrumes nommés;

b) un agent rajusteur du pH; et

c) un agent anti-mousse.

B.11.221. [N]. La marmelade de (nom de l’agrume) avec pectine

a) doit être le produit alimentaire à consistance de gelée, préparé à partir de tout mélange de zeste ou d’écorce, de pulpe, et de jus de l’agrume nommé, par ébullition avec de l’eau et un agent édulcorant;

b) doit renfermer

(i) au moins 27 pour cent de tout mélange de zeste ou d’écorce, de pulpe et de jus de l’agrume nommé,

(ii) au moins 65 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et

(iii) de la pectine ou une préparation pectique; et

c) peut renfermer

(i) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle de l’agrume utilisé dans sa préparation,

(ii) un agent de conservation de la catégorie II,

(iii) un agent rajusteur du pH, et

(iv) un agent anti-mousse.

B.11.222. [N]. La marmelade d’ananas et la marmelade de figues

a) doivent être le produit alimentaire à consistance de gelée, préparé à partir de la pulpe et du jus de fruit nommé, par ébullition avec de l’eau et un agent édulcorant;

b) doivent renfermer

(i) au moins 45 pour cent du fruit nommé, et

(ii) 65 pour cent de solides solubles dans l’eau, déterminés au réfractomètre;

c) peuvent renfermer la quantité ajoutée de pectine, de préparation pectique ou d’ingrédient acide, qui est requise pour compenser raisonnablement toute déficience en pectine naturelle ou en acidité naturelle du fruit nommé;

d) un agent rajusteur du pH; et

e) un agent anti-mousse.

B.11.223. [N]. La marmelade d’ananas avec pectine ou la marmelade de figues avec pectine

a) doivent être le produit alimentaire à consistance de gelée, préparé à partir de la pulpe et du jus du fruit nommé, par ébullition avec de l’eau et un agent édulcorant;

b) doivent renfermer

(i) au moins 27 pour cent du fruit nommé,

(ii) au moins 65 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et

(iii) de la pectine ou une préparation pectique; et

c) peuvent renfermer

(i) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle du fruit nommé,

(ii) un colorant pour aliments,

(iii) un agent de conservation de la catégorie II,

(iv) un agent rajusteur du pH, et

(v) un agent anti-mousse.

DORS/84-300, art. 37(A).

B.11.224. [N]. Les conserves (nom du fruit) doivent être le produit alimentaire fabriqué en traitant des fruits autres que les pommes ou la rhubarbe avec un ingrédient édulcorant, et doivent renfermer au moins

a) 45 parties en poids du fruit nommé pour 55 parties en poids de la matière desséchée de l’ingrédient édulcorant; et

b) 60 pour cent de solides solubles dans l’eau, déterminés au réfractomètre.

Gelée

B.11.240. [N]. La gelée de (nom du fruit) doit être l’aliment gélatineux, exempt de graines et de pulpe, fabriqué avec le fruit nommé, le jus du fruit nommé, ou un concentré du jus du fruit nommé, par ébullition avec de l’eau et un agent édulcorant; elle doit renfermer au moins 62 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et elle peut renfermer

a) la quantité ajoutée de pectine, de préparation pectique, ou d’ingrédient acide, requise pour compenser raisonnablement toute déficience en pectine naturelle ou en acidité du fruit nommé;

b) un agent rajusteur du pH; et

c) un agent anti-mousse.

B.11.241. [N]. La gelée de (nom du fruit) avec pectine

a) doit être l’aliment gélatineux, exempt de graines et de pulpe, fabriqué avec le fruit nommé, le jus du fruit nommé ou un concentré du jus du fruit nommé, par ébullition avec de l’eau et un agent édulcorant;

b) doit renfermer

(i) au moins l’équivalent de 32 pour cent de jus du fruit nommé,

(ii) au moins 62 pour cent de solides solubles dans l’eau, déterminés au réfractomètre, et

(iii) de la pectine ou une préparation pectique; et

c) peut renfermer

(i) la quantité d’ingrédient acide requise pour compenser raisonnablement toute déficience en acidité naturelle du fruit nommé,

(ii) le jus d’un autre fruit,

(iii) un agent gélatinisant,

(iv) un colorant pour aliments,

(v) un agent de conservation de la catégorie II,

(vi) un agent rajusteur du pH, et

(vii) un agent anti-mousse.

B.11.242. Les normes prescrites dans le présent règlement ne s’appliquent ni à la sauce aux canneberges (ou atocas), ni à la gelée de canneberges, ni aux canneberges en gelée, ni à la gelée de menthe ni à la menthe en gelée.

Mince-Meat ou Mince

B.11.250. [N]. Le mince, mince-meat ou fruit-mince

a) doit être le produit alimentaire préparé avec

(i) des fruits frais ou des fruits secs,

(ii) du suif,

(iii) du sel,

(iv) des épices, et

(v) un agent édulcorant; et

b) peut renfermer

(i) du vinaigre,

(ii) du jus de fruits frais, concentré ou fermenté,

(iii) un spiritueux,

(iv) des noix,

(v) de la viande cuite,

(vi) un agent de conservation de la catégorie II,

(vii) un agent épaississant,

(viii) de l’acide citrique, et

(ix) du caramel.

DORS/84-300, art. 38(F).

Cidre bouilli

B.11.260. [N]. Le cidre bouilli doit être le liquide exprimé de pommes entières, de coeurs, de parures, ou de rebuts de pommes, concentré par ébullition.

Titre 12

Eau et glace préemballées [DORS/80-633, art. 1]

B.12.001. [N]. Une eau dite eau minérale ou eau de source

a) doit être de l’eau potable obtenue d’une source souterraine et non d’un réseau de distribution publique;

b) ne doit contenir aucune bactérie coliforme, après analyse selon la méthode officielle MFO-9, Examen microbiologique de l’eau minérale, 30 novembre 1981;

c) ne doit pas être modifiée dans sa composition par l’emploi de substances chimiques; et

d) peut contenir, nonobstant le sous-alinéa c),

(i) de l’anhydride carbonique ajouté,

(ii) du fluorure ajouté, si la teneur totale en ion fluorure n’excède pas une partie par million, et

(iii) de l’ozone ajouté.

DORS/80-633, art. 2; DORS/82-768, art. 34.

B.12.002. L’espace principal de l’étiquette d’un récipient contenant une eau dite eau minérale ou eau de source doit indiquer

a) la position géographique de la source souterraine dont provient l’eau;

b) la teneur totale en sels minéraux dissous, exprimée en parties par million;

c) la teneur totale en ion fluorure, exprimée en parties par million; et

d) si du fluor ou de l’ozone a été ajouté.

DORS/84-300, art. 39(F); DORS/88-336, art. 3; DORS/92-626, art. 14(F).

B.12.003. Lorsque de l’anhydride carbonique a été ajouté à une eau dite eau minérale ou eau de source, le qualificatif « gazéifiée » (« carbonated ») doit figurer sur l’espace

principal de l’étiquette du récipient et doit être placé en dernier dans le nom usuel, si l’anhydride carbonique ajouté

a) ne provient pas du dégazage de l’eau à l’émergence de la source souterraine; ou

b) est en quantité supérieure à celle qui se trouvait à l’origine dans l’eau.

DORS/84-300, art. 40(F); DORS/88-336, art. 3.

B.12.004. Il est interdit de vendre de l’eau en contenants scellés, à l’exclusion de l’eau minérale et de l’eau de source, qui contient

a) des bactéries coliformes, après analyse selon la méthode officielle MFO-15, Examen microbiologique de l’eau présentée dans des contenants hermétiques (à l’exclusion de l’eau minérale et de l’eau de source) et de la glace pré-emballée, 30 novembre 1981;

b) plus de 100 bactéries aérobies totales par millilitre après analyse selon la méthode officielle MFO-15, Examen microbiologique de l’eau présentée dans des contenants hermétiques (à l’exclusion de l’eau minérale et l’eau de source) et de la glace pré­ emballée, 30 novembre 1981;

c) une quantité d’ion fluorure présent à l’état naturel qui dépasse la quantité normale; ou

d) une quantité de fluorure ajouté telle que la teneur totale en fluorure ajouté et en ion fluorure présent à l’état naturel dépasse une partie par million.

DORS/80-633, art. 3; DORS/82-768, art. 35.

B.12.005. (1) Il est interdit de vendre de la glace préemballée qui contient

a) des bactéries coliformes, après analyse selon la méthode officielle MFO-15, Examen microbiologique de l’eau présentée dans des contenants hermétiques (à l’exclusion de l’eau minérale et de l’eau de source) et de la glace pré-emballée, 30 novembre 1981;

b) une quantité d’ion fluorure présent à l’état naturel qui dépasse la quantité normale; ou

c) une quantité de fluorure ajouté telle que la teneur totale en fluorure ajouté et en ion fluorure présent à l’état naturel dépasse une partie par million.

(2) Il est interdit de fabriquer de la glace préemballée en vue de la vente, faite à partir d’eau qui contient

a) des bactéries coliformes, après analyse selon la méthode officielle MFO-15, Examen microbiologique de l’eau présentée dans des contenants hermétiques (à l’exclusion de l’eau minérale et de l’eau de source) et de la glace pré-emballée, 30 novembre 1981;

b) une quantité d’ion fluorure présent à l’état naturel qui dépasse la quantité normale; ou

c) une quantité de fluorure ajoutée telle que la teneur totale en fluorure ajouté et en ion fluorure présent à l’état naturel dépasse une partie par million.

DORS/80-633, art. 3; DORS/82-768, art. 36.

B.12.006. Le nom usuel de l’eau en contenants scellés, à l’exclusion de l’eau minérale et de l’eau de source, est « eau », qualifiée du mot

a) « distillée » si elle a été évaporée et condensée;

b) « déminéralisée » si sa teneur en sels minéraux a été réduite autrement que par distillation, à moins de 10 parties par million; et

c) « gazéifiée » si elle contient de l’anhydride carbonique ajouté.

DORS/80-633, art. 3.

B.12.007. Nonobstant l’article B.01.008, si du chlore ou de ses composés

a) ont été utilisés dans le traitement de l’eau en contenants scellés, à l’exclusion de l’eau minérale et de l’eau de source, et

b) ont été par la suite éliminés avec tout chlore ou composé de chlore produit dans l’eau,

il n’est pas nécessaire de les déclarer dans la liste des ingrédients sur l’étiquette du contenant.

DORS/80-633, art. 3.

B.12.008. La teneur totale en ion fluorure doit être indiquée, en parties par million, dans l’espace principal de l’étiquette de l’eau vendue en contenants scellés, à l’exclusion de l’eau minérale et de l’eau de source, ainsi que sur l’étiquette de la glace préemballée.

DORS/80-633, art. 3; DORS/2000-353, art. 5(A).

B.12.009. L’espace principal de l’étiquette de l’eau vendue en contenants scellés, à l’exclusion de l’eau minérale et de l’eau de source, doit porter une indication des traitements qu’elle a subis, à l’exception des suivants :

a) l’addition d’un ingrédient qui est déclaré dans la liste d’ingrédients;

b) la chlorination suivie de l’élimination de l’agent de chlorination utilisé, ainsi que tout chlore ou composé de chlore produit dans l’eau;

c) la décantation; et

d) la filtration.

DORS/80-633, art. 3; DORS/2000-353, art. 5(A).

Titre 13

Céréales et produits de boulangerie

B.13.001. [N]. La farine, farine blanche, farine enrichie ou farine blanche enrichie

a) est le produit alimentaire obtenu par mouture et blutage de blé nettoyé de qualité à farine à l’aide d’un tamis dont l’ouverture de maille ne dépasse pas celle de la toile métallique de « 149 microns (no 100) »;

b) doit être débarrassée de son et de germe au point que son pourcentage de cendres, avant l’addition d’une autre matière permise par cet article, calculée sur la matière desséchée, ne dépasse pas 1,20 pour cent;

c) doit avoir une teneur en humidité d’au plus 15 pour cent;

d) doit renfermer, par 100 grammes de farine :

(i) 0,64 milligramme de thiamine,

(ii) 0,40 milligramme de riboflavine,

(iii) 5,30 milligrammes de niacine ou de niacinamide,

(iv) 0,15 milligramme d’acide folique,

(v) 4,4 milligrammes de fer;

e) peut renfermer

(i) de la farine de blé malté,

(ii) de la farine d’orge malté, en quantité d’au plus 0,50 pour cent du poids de la farine,

(iii) de l’amylase, de l’amylase maltogène, de la broméline, de la glucoamylase, de la glucose-oxydase, de la lactase, de la lipase, de la lipoxydase, de la pentosanase, de la protéase, de la pullulanase ou de la xylanase,

(iv) du chlore,

(v) du bioxyde de chlore,

(vi) du peroxyde de benzoyle, en quantité d’au plus 150 parties en poids par million de parties de farine, avec ou sans véhicule constitué d’au plus 900 parties en poids par million de parties de farine de l’une ou d’un mélange des substances suivantes : carbonate de calcium, sulfate de calcium, phosphate bicalcique, carbonate de magnésium, sulfate double d’aluminium et de potassium, sulfate double d’aluminium et de sodium, amidon et phosphate tricalcique,

(vii) [Abrogé, DORS/94-227, art. 1]

(viii) du persulfate d’ammonium, en quantité d’au plus 250 parties en poids par million de parties de farine,

(ix) du chlorure d’ammonium, en quantité d’au plus 2 000 parties en poids par million de parties de farine,

(x) du peroxyde d’acétone,

(xi) de l’azodicarbonamide, en quantité d’au plus 45 parties en poids par million de parties de farine,

(xii) de l’acide ascorbique, en quantité d’au plus 200 parties en poids par million de parties de farine,

(xiii) du l-cystéine (chlorhydrate), en quantité d’au plus 90 parties en poids par million de parties de farine,

(xiv) du phosphate monocalcique en quantité d’au plus 7 500 parties en poids par million de parties de farine, et

(xv) par 100 grammes de farine :

(A) 0,31 milligramme de vitamine B6,

(B) 1,3 milligramme d’acide-d-pantothénique,

(C) 190 milligrammes de magnésium;

f) peut contenir du carbonate de calcium, de la farine d’os comestible, de la craie (B.P.), du calcaire broyé ou du sulfate de calcium, en quantité suffisante pour que 100 grammes de farine contiennent au moins 140 milligrammes de calcium.

g) [Abrogé, DORS/97-151, art. 21]

DORS/78-402, art. 3; DORS/78-698, art. 2; DORS/80-632, art. 3; DORS/82-383, art. 5; DORS/84-300, art. 41(A); DORS/89-145, art. 1; DORS/92-63, art. 1; DORS/92-94, art. 1; DORS/94-227, art. 1; DORS/94-689, art. 2; DORS/96-527, art. 1; DORS/97-122, art. 1; DORS/97-151, art. 21; DORS/97-558, art. 1; DORS/98-550, art. 1; DORS/2003-130, art. 1.

B.13.002. Malgré l’article B.13.001, il n’est pas nécessaire que la farine, la farine blanche, la farine enrichie ou la farine blanche enrichie utilisée ou vendue pour la fabrication de gluten ou d’amidon renferme de la thiamine, de la riboflavine, de la niacine, de l’acide folique ou du fer ajoutés.

DORS/98-550, art. 2.

B.13.003. [N]. La farine blanche à vitamine B (Approuvée-Canada)

a) doit être de la farine qui a été moulue de façon à conserver une forte proportion des vitamines naturelles du grain de blé original;

b) doit correspondre à un taux d’extraction d’au moins 70 pour cent du blé dont elle provient;

c) doit être blutée sur au moins un tamis ayant une ouverture de maille ne dépassant pas celle de la toile métallique dite 149 microns (tamis no 100); et

d) doit, sur la matière desséchée, renfermer

(i) par livre, une quantité de complexe vitaminique B fournissant au moins 1,2 milligramme de thiamine, et

(ii) au plus 0,70 pour cent et au moins 0,61 pour cent de cendres.

B.13.004. [Abrogé, DORS/79-252, art. 1]

B.13.005. [N]. La farine de blé entier, farine de blé complet,

a) doit être le produit alimentaire obtenu par mouture et blutage de blé nettoyé de qualité à farine, dont une partie de la couche externe du son ou épiderme, a été enlevée;

b) doit renfermer les constituants naturels du grain de blé dans la proportion d’au moins 95 pour cent du poids total du blé dont elle provient;

c) doit avoir

(i) une teneur en cendres, calculée sur la matière desséchée, d’au moins 1,25 pour cent et d’au plus 2,25 pour cent,

(ii) une teneur en humidité d’au plus 15 pour cent, et

(iii) un degré de finesse tel qu’au moins 90 pour cent passe librement au travers d’un tamis no 8 (2 380 microns), et au moins 50 pour cent, au travers d’un tamis no 20 (840 microns); et

d) peut renfermer

(i) de la farine de blé maltée,

(ii) de la farine d’orge maltée, en quantité d’au plus 0,50 pour cent du poids de la farine,

(iii) de l’amylase, de l’amylase maltogène, de la broméline, de la glucoamylase, de la glucose-oxydase, de la lactase, de la lipase, de la lipoxydase, de la pentosanase, de la protéase, de la pullulanase ou de la xylanase,

(iv) du chlore,

(v) du bioxyde de chlore,

(vi) du peroxyde de benzoyle, en quantité d’au plus 150 parties en poids par million de parties de farine, avec ou sans véhicule constitué d’au plus 900 parties en poids par million de parties de farine de l’une ou d’un mélange des substances suivantes : carbonate de calcium, sulfate de calcium, phosphate bicalcique, carbonate de magnésium, sulfate double d’aluminium et de potassium, sulfate double d’aluminium et de sodium, amidon et phosphate tricalcique,

(vii) [Abrogé, DORS/94-227, art. 2]

(viii) du persulfate d’ammonium, en quantité d’au plus 250 parties en poids par million de parties de farine,

(ix) du chlorure d’ammonium, en quantité d’au plus 2 000 parties en poids par million de parties de farine,

(x) de l’azodicarbonamide, en quantité d’au plus 45 parties en poids par million de parties de farine,

(xi) de peroxyde d’acétone,

(xii) de l’acide ascorbique, en quantité d’au plus 200 parties en poids par million de parties de farine, et

(xiii) du l-cystéine (chlorhydrate), en quantité d’au plus 90 parties en poids par million de parties de farine.

e) [Abrogé, DORS/97-151, art. 22]

DORS/78-402, art. 4; DORS/80-632, art. 4; DORS/82-383, art. 6; DORS/92-63, art. 2; DORS/92-94, art. 2; DORS/94-227, art. 2; DORS/94-689, art. 2; DORS/97-122, art. 2; DORS/97-151, art. 22; DORS/97-558, art. 2; DORS/2000-184, art. 63(F); DORS/2003­ 130, art. 2.

B.13.006. [N]. La farine Graham doit être de la farine à laquelle a été ajoutée une partie du son et autres constituants du grain de blé, et doit avoir une teneur en cendres, calculée sur la matière desséchée, d’au moins 1,20 pour cent et d’au plus 2,25 pour cent.

B.13.007. [N]. La farine de gluten doit être le produit alimentaire obtenu en enlevant de la farine une partie de l’amidon, et elle doit renfermer au plus

a) 10 pour cent d’humidité, et

b) 44 pour cent d’amidon, calculé sur la matière desséchée, selon la méthode officielle FO-28, Détermination d’amidon dans la farine de gluten, 15 octobre 1981.

DORS/82-768, art. 37.

B.13.008. [N]. Le blé broyé, blé de mouture grossière, doit être le produit alimentaire préparé par mouture de blé nettoyé, de façon que 40 pour cent ou plus passe au travers d’un tamis no 8 (2 380 microns) et moins de 50 pour cent au travers d’un tamis no 20 (840 microns), sans modifier les proportions des constituants naturels dudit blé, à part l’humidité, et doit avoir

a) une teneur en cendres, calculée sur la matière desséchée, d’au moins 1,50 pour cent et d’au plus 2,25 pour cent; et

b) une teneur en humidité d’au plus 15,5 pour cent.

B.13.009. [N]. Le blé concassé doit être le produit alimentaire obtenu par concassage ou par coupage de blé nettoyé en fragments anguleux, de sorte qu’au moins 90 pour cent

passe au travers d’un tamis no 8 (2 380 microns) et au plus 20 pour cent au travers d’un tamis no 20 (840 microns), sans modifier les proportions des constituants naturels dudit blé, sauf l’humidité, et doit avoir

a) une teneur en cendres, calculée sur la matière desséchée, d’au moins 1,50 pour cent et d’au plus 2,25 pour cent; et

b) une teneur en humidité d’au plus 15,5 pour cent.

B.13.010. [N]. Le riz doit être le grain du riz, décortiqué, ou décortiqué et poli, et, dans le cas de grains décortiqués et polis, il peut porter un enrobage de silicate de magnésium, de talc et de glucose.

DORS/78-403, art. 3.

B.13.010.1 (1) Aux fins du présent titre, le terme « riz précuit » s’entend du riz poli qui a été cuit à l’eau ou à la vapeur et séché de façon que les grains de riz conservent leur caractère poreux et leur structure ouverte.

(2) Nonobstant les articles D.01.009, D.01.011 et D.02.009, il est interdit de vendre du riz précuit auquel a été ajouté une vitamine ou un minéral nutritif mentionné à la colonne I du tableau du présent article ou une combinaison de ceux-ci, en une quantité autre que celle prévue à la colonne II de ce tableau par 100 g de riz précuit.

TABLEAU

Colonne I Colonne II Article Vitamine ou minéral nutritif Quantité par 100 g de riz précuit 1. Thiamine 0,45 mg 2. Niacine 4,2 mg 3. Vitamine B6 0,6 mg 4. Acide folique 0,016 mg 5. Acide pantothénique 1,2 mg 6. Fer 1,6 mg

(3) Il est interdit de présenter du riz précuit comme étant « enrichi » à moins qu’il n’ait été additionné de thiamine, de niacine et de fer.

DORS/86-320, art. 1; DORS/98-458, art. 7(F).

B.13.011. [N]. L’amidon de maïs (fécule de maïs) doit être l’amidon extrait du maïs et doit avoir une teneur en amidon d’au moins 84 pour cent.

DORS/84-300, art. 42.

B.13.014. Aux fins du présent titre, la teneur en humidité, la teneur en cendres et le degré de finesse doivent être déterminés selon la méthode officielle applicable suivante :

a) FO-29, Détermination d’humidité dans les céréales, 15 octobre 1981;

b) FO-30, Détermination de cendres dans les céréales, 15 octobre 1981; ou

c) FO-31, Détermination de degré de finesse des produits de céréales, 15 octobre 1981.

DORS/82-768, art. 38.

B.13.015. [N]. La farine de graine de coton ou les produits analogues à base de graine de coton seront tirés de graines décortiquées, dégraissées ou partiellement dégraissées, cuites et moulues, et ils renfermeront au plus 450 parties par million de gossypol libre.

B.13.020. Dans le présent titre, « solides de lait » s’entend de la quantité totale des solides provenant du lait, du lait partiellement écrémé, du lait écrémé ou de l’un de ceux­ ci sous forme concentrée, desséchée ou reconstituée, seul ou dans une combinaison quelconque.

DORS/89-170, art. 1.

Pain

B.13.021. [N]. Le pain ou pain blanc, doit être l’aliment fabriqué par cuisson d’une pâte à levain, préparée avec de la farine et de l’eau, et il peut renfermer

a) du sel;

b) du shortening, du saindoux, du beurre, ou de la margarine;

c) du lait ou un produit du lait;

d) des oeufs, du blanc d’oeuf, du jaune d’oeuf (à l’état frais, en poudre ou congelé);

e) un agent édulcorant;

f) du sirop de malt, de l’extrait de malt, ou de la farine maltée;

g) de la levure sèche inactive de l’espèce Saccharomyces cerevisiae, en quantité d’au plus deux parties en poids par 100 parties de farine employée;

h) de l’amylase, de l’amylase maltogène, de la broméline, de la glucoamylase, de la glucose-oxydase, de la lactase, de la lipase, de la lipoxydase, de la pentosanase, de la protéase, de la pullulanase ou de la xylanase;

i) sous réserve de l’article B.13.029, un ou plusieurs des ingrédients suivants, en quantité d’au plus cinq parties en poids par 100 parties de farine employée : farine de blé complet, farine blé entier, farine Graham, farine de gluten, farine de blé, amidon de blé, farine autre que le blé ou amidon autre que le blé, chacun pouvant être entièrement ou partiellement dextrinisé;

j) d’autres parties du grain de blé;

k) de la lécithine ou un glycéride phosphorylé d’ammonium;

l) des monoglycérides et des diglycérides des acides gras qui entrent dans la composition des matières grasses;

m) du chlorure d’ammonium, du sulfate d’ammonium, du carbonate de calcium, du lactate de calcium, du phosphate diammonique, du phosphate dicalcique, du phosphate monoammonique, ou un mélange quelconque desdits, en quantité n’excédant pas, pour l’ensemble des additifs, 0,25 parties en poids par 100 parties de farine employée;

n) du phosphate monocalcique en quantité d’au plus 0,75 parties en poids par 100 parties de farine employée;

o) du peroxyde de calcium, du persulfate d’ammonium, du persulfate de potassium ou une combinaison de ces additifs, en quantité n’excédant pas, pour l’ensemble de ces additifs, 0,01 partie en poids pour 100 parties de farine employée;

p) du peroxyde d’acétone;

q) du vinaigre;

r) un agent de conservation de la catégorie III;

s) un colorant pour aliments;

t) du stéaroyl-2-lacylate de calcium ou stéaroyl-2-lactylate de sodium en quantité d’au plus 0,375 partie, en poids, par 100 parties de farine employée;

u) du l-cystéine (chlorhydrate), en quantité d’au plus 0,009 partie en poids par 100 parties de farine employée;

v) du sulfate de calcium, en quantité d’au plus 0,5 partie en poids par 100 parties de farine employée;

w) du stéaryl-fumarate de sodium, en quantité d’au plus 0,5 partie en poids par 100 parties de farine employée;

x) de l’acide ascorbique, en quantité d’au plus 0,02 partie en poids par 100 parties de farine employée;

y) de l’acide lactique;

z) de l’azodicarbonamide en quantité d’au plus 45 parties en poids par million de parties de farine;

aa) de l’iodate de calcium, de l’iodate de potassium ou un mélange quelconque desdits, en quantité n’excédant pas, pour l’ensemble des additifs 45 parties en poids par million de parties de farine employée; et

bb) des esters tartriques des mono- et diglycérides acétylés, en une quantité n’exdédant pas au poids 0,6 partie par 100 parties de farine employée.

DORS/78-402, art. 5; DORS/79-251, art. 2; DORS/82-383, art. 7 et 8; DORS/84-300, art. 43(A); DORS/92-63, art. 3; DORS/92-94, art. 3; DORS/94-227, art. 3; DORS/97-122, art. 3; DORS/97-558, art. 3; DORS/2003-130, art. 3; DORS/2007-302, art. 4(F). Version précédente B.13.022. [N]. Le pain enrichi ou le pain blanc enrichi:

a) doit être du pain fabriqué à partir d’une pâte dans laquelle la farine de blé enrichi est la seule farine de blé utilisée;

b) doit contenir :

(i) par 100 parties de farine employée, au moins :

(A) soit deux parties en poids de solides de lait écrémé,

(B) soit quatre parties en poids de poudre de petit-lait,

(C) soit la quantité d’un produit protéique à base de pois (Pisum sativum) ou de fèves de soja (Glycine max) qui donnera 0,5 partie en poids de protéine,

(ii) par 100 grammes de pain, au moins :

(A) 0,40 milligramme de thiamine,

(B) 0,24 milligramme de riboflavine,

(C) 3,3 milligrammes de niacine ou de niacinamide,

(D) 0,10 milligramme d’acide folique,

(E) 2,76 milligrammes de fer;

c) peut contenir par 100 grammes de pain au moins :

(i) 0,14 milligramme de vitamine B6,

(ii) 0,6 milligramme d’acide d-pantothénique,

(iii) 90 milligrammes de magnésium,

(iv) 66 milligrammes de calcium;

d) peut être désigné par le nom usuel « pain au lait » s’il contient au moins six parties en poids de solides de lait par 100 parties de farine enrichie employée.

DORS/78-698, art. 3; DORS/87-704, art. 1; DORS/89-170, art. 2; DORS/89-198, art. 3; DORS/98-550, art. 3.

B.13.023. et B.13.024. [Abrogés, DORS/79-252, art. 1]

B.13.025. [N]. Le pain aux raisins ou pain de raisin, doit être du pain qui renferme, par 100 parties de la farine employée, au moins 50 parties en poids de raisin sec épépiné, ou

sans pépins, ou de raisin sec et de raisin de Corinthe, dont au moins 35 parties doivent être du raisin, et il peut renfermer des épices et des écorces ou zeste de fruits.

B.13.026. [N]. Le pain à (indication du pourcentage) de blé entier :

a) doit :

(i) être du pain pour lequel le pourcentage indiqué de farine représente le pourcentage de farine de blé entier employée,

(ii) contenir au moins 60 pour cent de farine de blé entier par rapport à la quantité totale de farine employée;

b) peut :

(i) contenir du caramel,

(ii) être désigné par le nom usuel « pain au lait à (indication du pourcentage) de blé entier » s’il contient au moins six parties en poids de solides de lait par 100 parties de la quantité totale de farine enrichie et de farine de blé entier employées.

DORS/89-170, art. 3.

B.13.027. [N]. Le pain brun ou pain bis, doit être du pain coloré au moyen de farine de blé entier, de farine graham, de son, de mélasse ou de caramel.

B.13.028. [Abrogé, DORS/97-151, art. 23]

B.13.029. Les pains de composition spéciale peuvent être composés

a) d’un ou de plusieurs ingrédients à l’alinéa B.13.021i) en quantité supérieure à celle spécifiée dans cet alinéa; et

b) de fruits, de noix, de graines et d’ingrédients aromatisants.

DORS/79-251, art. 3.

Pâtes alimentaires

B.13.051. Est interdite la vente de macaroni, de spaghetti, de nouilles et toute pâte alimentaire semblable, sous la désignation de macaroni aux oeufs, spaghetti aux oeufs, nouilles aux oeufs, ou pâtes alimentaires aux oeufs, respectivement, à moins que ces aliments ne contiennent, sur la matière desséchée, au moins quatre pour cent de solides du jaune d’oeufs provenant d’oeufs entiers, d’oeufs séchés, d’oeufs congelés ou de jaune d’oeuf congelé.

B.13.052. (1) Par dérogation aux articles D.01.009, D.01.011 et D.02.009, il est interdit de vendre une pâte alimentaire à laquelle a été ajouté une vitamine ou un minéral nutritif énuméré à la colonne I du tableau du présent article, à moins que chaque portion de 100 g de la pâte alimentaire ne renferme au moins la quantité minimale de vitamine ou de

minéral nutritif ajouté qui est prévue à la colonne II et au plus la quantité maximale prévue à la colonne III.

(2) Il est interdit de présenter une pâte alimentaire comme « enrichie » à moins qu’elle ne renferme une quantité ajoutée de thiamine, de riboflavine, de niacine, d’acide folique et de fer conforme au tableau du présent article.

TABLEAU

Colonne I Colonne II Colonne III

Article Vitamine ou minéral Quantité minimale par 100 g Quantité maximale parnutritif ajouté de la pâte alimentaire 100 g de la pâte alimentaire 1. Thiamine 0,63 mg 1,50 mg 2. Riboflavine 0,11 mg 0,60 mg 3. Niacine 5,90 mg 7,50 mg 4. Acide folique 0,20 mg 0,27 mg 5. Acide pantothénique 1,00 mg 2,00 mg 6. Vitamine B6 0,40 mg 0,80 mg 7. Fer 2,90 mg 4,30 mg 8. Magnésium 150,00 mg 300,00 mg

DORS/94-37, art. 1; DORS/94-689, art. 2; DORS/96-527, art. 2; DORS/98-550, art. 4 et 5.

Céréales à déjeuner

B.13.060. Nonobstant les articles D.01.009, D.01.011 et D.02.009, il est interdit de vendre une céréale à déjeuner à laquelle ont été ajoutés un ou plusieurs des vitamines ou minéraux nutritifs énumérés à la colonne I du tableau du présent article, à moins que chaque portion de 100 g de la céréale ne renferme la quantité de vitamines ou de minéraux nutritifs ajoutés qui est prévue à la colonne II de ce tableau.

TABLEAU

Colonne I Colonne II Article Vitamine ou minéral nutritif Quantité par 100 g de la céréale à déjeuner 1. Thiamine 2,0 mg 2. Niacine 4,8 mg 3. Vitamine B6 0,6 mg 4. Acide folique 0,06 mg 5. Acide pantothénique 1,6 mg 6. Magnésium 160,0 mg 7. Fer 13,3 mg 8. Zinc 3,5 mg

DORS/83-858, art. 1; DORS/89-145, art. 2; DORS/98-458, art. 7(F).

Titre 14

Viande, préparations et produits de la viande B.14.001. Dans le présent titre,

« agent de remplissage » désigne toute substance végétale, (à l’exception de la tomate et de la pulpe de betterave), le lait, les oeufs, la levure, ou tout dérivé ou combinaison de ces produits qui serait acceptable comme aliment; (filler)

« animal » comprend les animaux utilisés comme aliments, mais ne comprend ni les animaux marins ni les animaux d’eau douce. (animal)

« remplissage »[Abrogée, DORS/86-875, art. 1]

DORS/82-768, art. 39; DORS/86-875, art. 1.

B.14.002. [N]. La viande doit être la portion comestible du muscle squelettique d’un animal sain au moment de l’abattage, ou du muscle que l’on trouve dans la langue, le diaphragme, le coeur ou l’oesophage; elle peut renfermer la graisse qui y adhère ou le recouvre, ainsi que les portions d’os, de peau, de tendons, de nerfs ou de vaisseaux sanguins, qui accompagnent normalement le tissu musculaire et n’en sont pas séparés au moment de l’habillage, mais ne comprend pas le muscle trouvé dans les lèvres, le groin ou le museau, la peau de la tête ou les oreilles.

B.14.003. [N]. Les sous-produits de viande doivent être toute portion comestible d’un animal, autre que la viande, qui provient d’un ou de plusieurs animaux sains au moment de l’abattage.

B.14.004. [N]. La viande, les sous-produits de viande ou leurs préparations, sont falsifiés s’ils renferment ou si on leur a ajouté l’une des substances ou catégories de substances nommées ci-dessous :

a) des muqueuses, des organes ou des parties d’organes de l’appareil génital, du caecum, de la rate, du pis, des poumons, ou tout autre organe ou partie d’un animal qui ne sont pas vendus d’habitude comme article d’alimentation;

b) un agent de conservation autre que ceux qui sont prévus au présent titre; ou

c) un colorant autre que le rocou, le rouge allura et le jaune soleil FCF, visés par le présent titre, ainsi que le caramel.

DORS/92-725, art. 2; DORS/97-516, art. 2.

B.14.005. [N]. La viande préparée et les sous-produits de viande préparée doivent être, respectivement, de la viande ou des sous-produits de viande, hachés ou non, auxquels a été ajouté tout ingrédient permis par le présent règlement, ou qui ont subi un procédé de conservation, qui ont été placés dans un contenant hermétiquement fermé ou qui ont été cuits, et peuvent renfermer :

a) dans le cas de jambons, d’épaules, de socs de porc, de jambons pique-nique et de jambons de longe préparés : de la gélatine;

b) dans le cas des tissus gras de porc ou de boeuf partiellement dégraissés : un agent de conservation de la catégorie IV;

c) lorsque le présent titre prescrit une teneur totale minimale en protéines ou une teneur minimale en protéines de viande, un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 :

(i) du pyrophosphate acide de sodium,

(ii) de l’hexamétaphosphate de sodium,

(iii) du phosphate disodique,

(iv) du phosphate monosodique,

(v) du pyrophosphate tétrasodique,

(vi) du tripolyphosphate de sodium,

(vii) du phosphate monopotassique,

(viii) du phosphate dipotassique,

(ix) du pyrophosphate tétrapotassique;

d) dans le cas de rôtis de boeuf tranchés emballés sous vide et de jambons cuits tranchés emballés sous vide : du Carnobacterium maltaromaticum CB1.

DORS/94-262, art. 2; DORS/2010-264, art. 1. Version précédente B.14.006. De l’huile de coton hydrogénée en poudre peut être appliquée, dans une proportion qui ne dépasse pas 0,25 pour cent du produit, comme agent de démoulage sur la surface de la viande, des sous-produits de viande, des viandes préparées, des sous­ produits de viande préparés, des produits de viande avec allongeur et des simili-produits de viande.

DORS/2010-142, art. 59(F). Version précédente B.14.007. [N]. Le liant à viande ou le liant à (désignation du produit de viande) est un agent de remplissage contenant une combinaison quelconque de sel, d’agents édulcorants, d’épices ou d’autres condiments (sauf la tomate), d’oeufs, de blancs d’oeufs, et

a) lorsqu’il est vendu pour servir dans les viandes conditionnées ou conservées et dans les sous-produits de viande conditionnés ou conservés, il peut renfermer de l’acide ascorbique, de l’acide érythorbique, de l’acide isoascorbique, de l’ascorbate de calcium,

de l’ascorbate de sodium, du carbonate de sodium, de l’érythorbate de sodium, de l’iso­ ascorbate de sodium, du nitrate de potassium, du nitrite de potassium, du nitrate de sodium ou du nitrite de sodium, pourvu que ces nitrates et nitrites, le cas échéant, soient emballés séparément des épices et condiments;

b) lorsque le liant est vendu pour servir dans la viande conditionnée ou dans les sous­ produits de viande conditionnée dans lesquels il est permis d’ajouter un agent gélatinisant, il peut renfermer un tel agent gélatinisant;

c) lorsque le liant est vendu pour servir dans la saucisse fraîche, crue, il peut contenir un arôme artificiel d’érable; et

d) peut contenir un agent anti-agglomérant.

DORS/80-13, art. 1; DORS/82-913, art. 1; DORS/86-875, art. 2(F); DORS/2010-143, art. 9. Version précédente B.14.008. Est interdite la vente d’un liant à viande, d’un agent de remplissage ou de préparations pour marinades, saumures ou mélanges de salaison à sec, présentés comme devant servir dans les produits de viande, à moins que l’étiquette ne donne un mode d’emploi qui, s’il est suivi, produira un aliment conforme aux dispositions de l’article B.14.030 touchant l’agent de remplissage et que l’aliment ne contienne au maximum que la quantité d’additifs alimentaires correspondant aux limites de tolérance prescrites dans le présent règlement.

DORS/84-300, art. 44(A).

B.14.009. [N]. La marinade, la saumure et le mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés peuvent renfermer

a) des agents de conservation de la catégorie I, si les nitrates ou les nitrites, ou les deux, d’une part, et les épices et condiments, d’autre part, sont emballés séparément;

b) de l’acide citrique, du citrate de sodium ou du vinaigre;

c) des agents édulcorants, y compris le sucre d’érable et le sirop d’érable;

d) un arôme de fumée liquide, un arôme de fumée liquide concentré, du sel, des assaisonnements, des épices, des extraits d’épice, des huiles d’épice ou des oléorésines d’épice;

e) du bicarbonate de sodium, de l’hydroxyde de sodium ou de l’hydroxyde de potassium;

f) dans la marinade servant à la salaison de coupes de porc, de boeuf, ou d’agneau : du phosphate disodique, du phosphate monosodique, de l’hexamétaphosphate de sodium, du tripolyphosphate de sodium, du pyrophosphate tétrasodique et du pyrophosphate acide de sodium, en telle quantité, calculée en phosphate disodique, que le produit fini renferme au plus 0,5 pour cent de phosphate ajouté;

g) dans le cas de marinade servant à la salaison de parties de boeufs, des enzymes, si l’espace principal de l’étiquette du boeuf salé porte, immédiatement avant ou après le nom ordinaire, la mention « Attendri par...(nom de l’enzyme ou des enzymes protéolytiques) »;

h) dans le cas du mélange de salaison à sec : un agent anti-agglomérant ou un agent humidifiant; et

i) dans le cas de la marinade servant à la salaison

(i) de jambon, d’épaules et de dos de porc, de l’arôme artificiel d’érable, et

(ii) de poitrines de porc : de l’arôme artificiel d’érable, et un arôme d’orange conforme à la norme prescrite à l’article B.10.005.

DORS/79-251, art. 4; DORS/80-13, art. 2; DORS/82-596, art. 1; DORS/88-336, art. 3; DORS/94-567, art. 1; DORS/2010-143, art. 10(F). Version précédente B.14.010. Est interdite la vente comme aliment d’un animal mort ou de n’importe quelle partie d’un tel animal.

B.14.011. Est interdite la vente comme aliment de la viande, des sous-produits de la viande, des préparations contenant de la viande ou des dérivés de la viande, obtenus, préparés ou fabriqués à partir d’un animal mort.

B.14.012. Aux fins des articles B.14.010 et B.14.011, « animal mort » signifie un animal mort qui

a) n’a pas été abattu pour servir comme aliment, conformément aux pratiques acceptées couramment d’abattre les animaux pour utiliser comme aliment, et qui doit comprendre la saignée; ou

b) était atteint de maladie au moment de l’abattre.

B.14.013. et B.14.014. [Abrogés, DORS/97-148, art. 3]

Viande, sous-produits de la viande

B.14.015. [N]. Le boeuf haché ordinaire doit être de la viande de boeuf hachée finement et doit contenir tout au plus 30 pour cent de gras de boeuf, déterminé selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981.

DORS/82-768, art. 40.

B.14.015A. [N]. Le boeuf haché mi-maigre doit être de la viande de boeuf hachée finement et doit contenir tout au plus 23 pour cent de gras de boeuf, déterminé selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981.

DORS/82-768, art. 40.

B.14.015B. [N]. Le boeuf haché maigre doit être de la viande de boeuf hachée finement et doit contenir tout au plus 17 pour cent de gras de boeuf, déterminé selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981.

DORS/82-768, art. 40.

B.14.015C. Est interdite la vente de boeuf haché contenant plus de 30 pour cent de gras de boeuf, déterminé selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981.

DORS/82-768, art. 40.

B.14.016. Est interdite la vente de viande de cheval, de sous-produits de viande de cheval, ou de tout aliment en contenant, à moins

a) qu’ils ne soient étiquetés comme tels, lorsqu’ils sont offerts ou exposés en vente; et

b) lorsqu’ils sont sous forme d’emballages, que l’espace principal de l’étiquette ne porte une déclaration de la présence de viande de cheval ou d’un sous-produit de viande de cheval en caractères au moins aussi lisibles et aussi en évidence que n’importe quels autres caractères sur ledit espace principal.

DORS/88-336, art. 3.

B.14.017. [Abrogé, DORS/2003-292, art. 2.

B.14.018. (1) Sous réserve du paragraphe (2), l’annonce pour la vente d’une carcasse de boeuf ou de veau ou d’une partie de celle-ci pesant au moins 7 kg doit indiquer :

a) s’il s’agit d’une carcasse autre qu’une carcasse importée, la catégorie qui a été attribuée à la carcasse par l’autorité responsable constituée en vertu de la Loi sur les produits agricoles au Canada ou d’une loi provinciale;

b) s’il s’agit d’une carcasse de boeuf importée, la catégorie qui a été attribuée à la carcasse par l’autorité responsable constituée en vertu de la Loi sur les produits agricoles au Canada ou d’une loi provinciale ou la catégorie qui a été attribuée à la carcasse par l’autorité responsable constituée en vertu des lois du pays d’origine;

c) s’il s’agit d’une carcasse de veau importée, la catégorie qui a été attribuée à la carcasse par l’autorité responsable constituée en vertu des lois du pays d’origine;

d) s’il s’agit d’une carcasse de boeuf, la catégorie de rendement qui a été attribuée à la carcasse, le cas échéant, par l’autorité responsable constituée en vertu de la Loi sur les produits agricoles au Canada.

(2) Si la carcasse visée au paragraphe (1) n’a fait l’objet d’aucune classification et que toute la carcasse ou partie de celle-ci pesant au moins 7 kilogrammes est annoncée pour la vente, l’annonce doit indiquer clairement que la carcasse n’a pas été classée.

DORS/92-626, art. 15; DORS/2003-6, art. 79.

B.14.019. (1) L’annonce, pour la vente, d’une carcasse de boeuf, de veau, de porc ou d’agneau ou d’une partie de celle-ci pesant au moins 7 kilogrammes qui indique le prix de vente doit :

a) contenir la mention « le prix au kilogramme est établi en fonction du poids de la carcasse avant le débitage, le désossage et le parage » ou la mention « le prix au kilogramme est établi en fonction du poids de la viande après le débitage, le désossage et le parage », selon le cas;

b) si, en sus du prix de vente, des frais sont exigibles pour le débitage, le désossage, le parage, l’emballage ou la congélation de la carcasse ou de la partie de carcasse :

(i) préciser le montant de ces frais,

(ii) lorsque ces frais sont établis d’après un prix unitaire au poids, préciser s’ils sont calculés selon le poids avant ou après le débitage, le désossage et le parage de la carcasse.

(2) Les renseignements exigés au paragraphe (1) doivent figurer juste à côté du prix de vente, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique soient intercalés entre les deux.

DORS/92-626, art. 15; DORS/95-548, art. 5(F).

B.14.020. [N]. La viande coupée solide doit consister :

a) soit en une pièce de viande entière;

b) soit en un produit constitué de morceaux de viande dont plus de 80 pour cent pèsent au moins 25 g chacun.

DORS/94-262, art. 3.

B.14.021. (1) Est interdite la vente de viande coupée solide à laquelle ont été ajoutés des sels de phosphate ou de l’eau, à moins que les conditions suivantes ne soient réunies :

a) la viande, à l’exception du bacon de flanc, du bacon Wiltshire, des bajoues de porc, et du porc et du boeuf salés, a :

(i) si elle est cuite, une teneur minimale en protéines de viande de 12 pour cent,

(ii) si elle n’est pas cuite, une teneur minimale en protéines de viande de 10 pour cent;

b) la viande contient un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 :

(i) du pyrophosphate acide de sodium,

(ii) de l’hexamétaphosphate de sodium,

(iii) du phosphate disodique,

(iv) du phosphate monosodique,

(v) du pyrophosphate tétrasodique,

(vi) du tripolyphosphate de sodium,

(vii) du phosphate monopotassique,

(viii) du phosphate dipotassique,

(ix) du pyrophosphate tétrapotassique.

(2) Aux fins du calcul de la teneur en protéines de viande visée à l’alinéa (1)a), les os et les couches de gras visible ne doivent pas être pris en compte.

DORS/94-262, art. 3.

Viandes préparées, sous-produits de viande préparés

B.14.030. (1) Sous réserve des paragraphes (2) et (3) et de l’article B.14.030A, il est interdit de vendre de la viande préparée ou un sous-produit de viande préparée dont la teneur en protéines est de moins de 1,5 point de pourcentage inférieure à la teneur totale en protéines exigée pour cet aliment.

(2) Le paragraphe (1) ne s’applique pas à un produit de viande avec allongeur.

(3) Dans le cas où la viande préparée ou le sous-produit de viande préparée contient de la gélatine, cet ingrédient ne doit pas être pris en compte dans le calcul de la teneur totale en protéines de cet aliment.

DORS/78-637, art. 3; DORS/79-251, art. 5(F); DORS/80-13, art. 3; DORS/82-768, art. 41; DORS/86-875, art. 3.

B.14.030A. Pour l’application des articles B.14.030, B.14.032, B.14.033, B.14.035, B.14.074, B.14.075, B.14.076 et B.14.077, dans le cas où l’un ou l’autre des ingrédients non carnés énumérés aux sous-alinéas B.14.032Aa) à g) est présent dans une viande préparée ou un sous-produit de viande préparée, en morceaux identifiables et en quantité suffisante pour différencier ces ingrédients de la viande préparée ou du sous-produit de viande préparée, cet ingrédient ne doit pas être pris en compte dans le calcul de la quantité totale de gras ou de protéines.

DORS/86-875, art. 3.

B.14.031. [N]. La viande conditionnée ou conservée et les sous-produits de viande conditionnés ou conservés sont faits de viande crue ou cuite ou d’un sous-produit de viande crue ou cuite, qui ont été salés, asséchés, marinés, saumurés ou fumés et peuvent être garnis d’une glace et renfermer

a) un agent de conservation de la catégorie I;

b) des agents édulcorants;

c) des épices et des condiments, sauf la tomate;

d) du vinaigre;

e) de l’alcool;

f) de l’arôme de fumée ou de l’arôme artificiel de fumée;

g) dans le cas de jambons, d’épaules, de dos et de poitrines de porc fumés : de l’arôme artificiel d’érable;

gg) dans le cas des poitrines de porc de salaison : un arôme d’orange conforme à la norme prescrite à l’article B.10.005;

h) dans le cas des coupes de porc, de boeuf ou d’agneau de salaison préparées à l’aide de marinade, du phosphate disodique, du phosphate monosodique, de l’hexamétaphosphate de sodium, du tripolyphosphate de sodium, du pyrophosphate tétrasodique et du phyrophosphate acide de sodium, en telle quantité, calculée en phosphate disodique, que le produit fini renferme au plus 0,5 pour cent de phosphate ajouté;

i) dans le cas du tocino, du rocou en telle quantité que le produit fini renferme au plus 0,1 pour cent de rocou si la présence de rocou est indiquée dans la liste des ingrédients sur l’étiquette par « rocou »;

j) dans le cas de jambons cuits tranchés emballés sous vide : du Carnobacterium maltaromaticum CB1.

DORS/79-251, art. 6; DORS/80-13, art. 4; DORS/82-596, art. 2; DORS/84-300, art. 45(A); DORS/88-336, art. 2 et 3; DORS/92-725, art. 3; DORS/97-151, art. 24; DORS/2010-264, art. 2. Version précédente B.14.032. [N]. La saucisse, chair à saucisse ou viande à saucisse

a) est faite de viande hachée, fraîche ou conservée;

b) peut être renfermée dans des boyaux;

c) peut être mouillée de vinaigre, fumée, cuite ou asséchée;

d) peut renfermer

(i) de la graisse animale,

(ii) un agent de remplissage,

(iii) de la tripe de boeuf,

(iv) du foie,

(v) du sang de boeuf ou de porc, frais ou congelé,

(vi) des agents édulcorants,

(vii) du sel et des épices,

(viii) des condiments autres que la tomate,

(ix) un pied-de-cuve produisant de l’acide lactique,

(x) du liant à viande,

(xi) du plasma sanguin de boeuf et de porc,

(xii) dans le cas de la viande hachée, en conserve : de l’arôme de fumée ou de l’arôme artificiel de fumée,

(xiii) si elle est cuite,

(A) de la glucono-delta-lactone,

(B) des tissus gras de boeuf ou de porc partiellement dégraissés, et

(C) un produit de lait écrémé desséché obtenu du lait écrémé par la réduction de sa teneur en calcium et une augmentation correspondante de sa teneur en sodium, dans une proportion ne dépassant pas trois pour cent du produit fini,

(xiv) dans le cas de la saucisse fraîche, crue : de l’arôme artificiel d’érable, et de la poudre de pomme comme aromatisant,

(xv) dans le cas de la saucisse sèche ou de la chair à saucisse sèche, de la glucono-delta­ lactone,

(xvi) dans le cas du longaniza :

(A) du rocou en une quantité telle que le produit fini renferme au plus 1 000 parties par million de rocou, si la présence du rocou est indiquée par « rocou » dans la liste des ingrédients sur l’étiquette,

(B) du rouge allura en une quantité telle que le produit fini renferme au plus 80 parties par million de rouge allura, si la présence du rouge allura est indiquée par « rouge allura » dans la liste des ingrédients sur l’étiquette,

(C) du jaune soleil FCF en une quantité telle que le produit fini renferme au plus 20 parties par million de jaune soleil FCF, si la présence du jaune soleil FCF est indiquée par « jaune soleil FCF » dans la liste des ingrédients sur l’étiquette,

(xvii) dans le cas de la saucisse fumée emballée sous vide : du Carnobacterium maltaromaticum CB1;

e) doit contenir, dans le cas d’un produit vendu comme saucisse fraîche, au plus 40 pour cent de matières grasses, déterminé selon la méthode officielle FO-33, Détermination de

matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981;

f) doit avoir, si elle est cuite, une teneur totale en protéines d’au moins 11 pour cent;

g) doit avoir, dans le cas de la saucisse fraîche crue et de la chair ou viande à saucisse fraîche crue, une teneur totale en protéines d’au moins neuf pour cent.

DORS/80-13, art. 5; DORS/82-768, art. 42; DORS/88-336, art. 3; DORS/92-725, art. 4; DORS/97-151, art. 25; DORS/97-516, art. 3; DORS/2010-264, art. 3. Version précédente B.14.032A. [N]. (Nom de la viande préparée ou du sous-produit de viande préparée) avec (nom des ingrédients non carnés) doit être de la viande préparée à laquelle sont ajoutés d’autres ingrédients non carnés, notamment

a) des fruits;

b) des légumes;

c) des noix;

d) du fromage ou du fromage fondu;

e) du macaroni;

f) des cornichons; ou

g) des olives.

DORS/84-300, art. 46.

B.14.032AA. Lorsque les ingrédients non carnés visés à l’article B.14.032A sont ajoutés à de la viande préparée de façon telle qu’ils ne sont pas présents en morceaux identifiables et en quantité suffisante dans le produit fini, ce dernier doit renfermer les quantités de protéines établies pour (nom de la viande préparée ou du sous-produit de viande préparée) que mentionne l’article B.14.032A.

DORS/86-875, art. 4.

B.14.033. [N]. La viande en pot, le pâté de viande ou la viande à tartiner sont faits de viande fraîche ou conservée, hachée finement et cuite et peuvent renfermer un liant à viande, du sel, des agents édulcorants, des épices ou d’autres condiments ainsi qu’un agent gélatinisant; leur teneur totale en protéines doit être d’au moins neuf pour cent.

DORS/80-13, art. 6.

B.14.034. [N]. Les sous-produits de viande en pot, les sous-produits de viande en pâte et les sous-produits de viande à tartiner doivent

a) consister, au moins en partie, de sous-produits de viande et être conformes à la norme relative à la viande en pot; et

b) dans le cas du pâté de foie ou du saucisson de foie à tartiner, peuvent contenir du germe de blé et de la levure.

DORS/78-637, art. 4; DORS/80-13, art. 7; DORS/86-875, art. 5.

B.14.035. [N]. Le pain de viande, la viande en pain, la viande en brique ou en rouleau et la viande à lunch sont faits de viande fraîche ou conservée, hachée finement, cuite ou pressée; ils peuvent renfermer, dans une proportion d’au plus trois pour cent du produit fini, un produit de lait écrémé desséché obtenu par la réduction de la quantité de calcium à laquelle est substituée une quantité égale de sodium, et contenir un agent de remplissage, un liant à viande, du sel, des agents édulcorants, de la glucono-delta-lactone, des épices ou d’autres condiments, du lait, des oeufs, un agent gélatinisant et des tissus gras de boeuf ou de porc partiellement dégraissés; leur teneur totale en protéines doit être d’au moins 11 pour cent.

DORS/80-13, art. 8.

B.14.036. [N]. Le pain de sous-produits de viande ou sous-produits de viande en pain, et le pain de viande et de sous-produits de viande ou viande et sous-produits de viande en pain, doivent être l’aliment qui consiste, en tout ou en partie, de sous-produits de viande, et être autrement conformes en tous points à la norme prescrite pour le pain de viande.

B.14.037. [N]. La tête en fromage ou tête fromagée

a) doit être de la viande cuite hachée finement, ou de la viande conservée cuite et hachée finement,

b) ne doit pas renfermer

(i) moins de 50 pour cent de viande de tête, ni

(ii) aucune peau autre que celle qui adhère naturellement à la viande de porc employée,

c) peut renfermer la peau de la tête, du groin de porc, de la tripe de boeuf, du sel, des épices, des condiments et un agent gélatinisant ajouté, et

d) peut renfermer

(i) de l’acide ascorbique ou son sel de sodium, ou

(ii) de l’acide érythorbique ou son sel de sodium,

et, aux fins du présent article, la peau de tête et le groin sont considérés comme de la viande de tête.

DORS/80-500, art. 5.

B.14.038. [N]. Le fromage de porc ou fromage de hure doit être de la tête en fromage, sauf qu’il peut renfermer moins de 50 pour cent de viande de tête.

B.14.039. Lorsqu’un gélifiant (agent gélatinisant) a été ajouté à une viande préparée ou à un sous-produit de viande préparée, l’addition du gélifiant doit être mentionnée sur l’espace principal de l’étiquette; sinon, l’expression « en gelée » doit figurer comme partie intégrante du nom usuel de l’aliment.

B.14.040. Sous réserve de l’article B.14.032 et des articles B.14.033 à B.14.036, est interdite la vente d’un aliment qui consiste en un mélange de viande hachée et d’agent de remplissage, de sous-produit de viande hachée et d’agent de remplissage ou de viande hachée, de sous-produit de viande hachée et d’agent de remplissage, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 13 pour cent;

b) n’ait une teneur en matières grasses d’au plus 40 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, dans le cas d’un mélange contenant de la viande de porc ou de sous-produit de porc, ou les deux; et

c) n’ait une teneur en matières grasses d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, dans le cas de tout autre mélange de viande.

DORS/79-251, art. 7(F); DORS/82-768, art. 43.

B.14.041. Sous réserve de l’article B.14.032 et des articles B.14.033 à B.14.036, est interdite la vente d’un aliment qui consiste en un mélange de viande hachée, d’épices et de condiments, de sous-produit de viande hachée, d’épices et de condiments, de viande hachée, de sous-produit de viande hachée, d’épices et de condiments, ou de viande hachée et de sous-produit de viande hachée, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 16 pour cent;

b) n’ait une teneur en matières grasses d’au plus 40 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, dans le cas d’un mélange contenant de la viande de porc, ou de sous-produit de porc, ou les deux; et

c) n’ait une teneur en matières grasses d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, dans le cas de tout autre mélange de viande.

DORS/79-251, art. 7(F); DORS/82-768, art. 44.

Dérivés de la viande

B.14.061. [N]. La farine d’os comestible doit être le produit alimentaire provenant du broyage d’os secs et dégraissés d’animaux sains au moment de l’abattage, et elle doit

a) renfermer au moins 85 pour cent de cendres, déterminé selon la méthode officielle FO­ 34, Détermination de cendres dans la farine d’os comestible, 15 octobre 1981.

b) et c) [Abrogés, DORS/97-148, art. 4]

DORS/82-768, art. 45; DORS/97-148, art. 4.

B.14.062. [N]. (1) La gélatine ou gélatine comestible

a) est un aliment purifié, obtenu par le traitement de la peau, des ligaments ou des os d’animaux;

b) contient au moins 82 pour cent de solides exempts de cendres, déterminé selon la méthode officielle FO-35, Détermination de solides exempts de cendres dans la gélatine, 15 octobre 1981;

c) qui est exempt de goût ou d’odeur désagréable lorsque 2,5 grammes sont dissous dans 100 millilitres d’eau tiède;

d) [Abrogé, DORS/97-148, art. 5]

e) ne contient aucun résidus de peroxyde d’hydrogène lorsqu’utilisé au cours de la fabrication; et

f) peut contenir

(i) au plus 2,6 pour cent de cendres rapportées à la matière desséchée,

(ii) au plus 500 parties par million d’acide sulfureux, y compris ses sels, calculé en anhydride sulfureux, et

(iii) lorsque destinée à la fabrication de guimauves, de l’hexamétaphosphate de sodium ou du lauryl sulfate de sodium.

(2) Il est interdit d’utiliser, au cours de la fabrication de la gélatine ou de la gélatine comestible,

a) des composés acides ou basiques autres que l’acide acétique, l’hydroxyde d’ammonium, l’acide citrique, l’acide fumarique, l’acide chlorhydrique, la chaux, l’hydroxyde de magnésium, l’acide phosphorique, le carbonate de sodium, l’hydroxyde de sodium, le sulfure de sodium, l’acide sulfurique, l’acide sulfureux ou l’acide tartique; ou

b) des agents de filtration et de clarification autre que le charbon activé, l’alumine, le sulfate d’aluminium, le phosphate dicalcique, la cellulose, la terre de diatomées, la perlite, une résine échangeuse de cations de forte acidité sous forme d’ions hydrogènes, ou une résine échangeuse d’anions basiques sous forme d’ions de chlorure ou d’ions basiques libres.

DORS/78-401, art. 2(A); DORS/78-874, art. 1; DORS/80-501, art. 3; DORS/82-768, art. 46; DORS/97-148, art. 5.

Ragoûts de viande

B.14.063. Aux fins des articles B.14.064 à B.014.068, on entend par viande pour ragoûts de la viande contenant lorsque crue, au plus

a) 25 pour cent de gras, dans le cas de ragoût de boulettes, et

b) 20 pour cent de gras, dans le cas de tout autre ragoût.

DORS/78-874, art. 2.

B.14.064. [N]. Le ragoût de légumes avec (nom de la viande)

a) doit contenir des légumes et (le nom de la viande) dans les quantités suivantes, calculées et d’après les aliments crus :

(i) au moins 12 pour cent de viande pour ragoût, et

(ii) au moins 38 pour cent de légumes, et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 2.

B.14.065. [N]. Le ragoût de (nom de la viande)

a) doit contenir des légumes et (le nom de la viande) dans les quantités suivantes, calculées d’après les aliments crus :

(i) au moins 20 pour cent de viande pour ragoût, et

(ii) au moins 30 pour cent de légumes, et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 2.

B.14.066. [N]. Le ragoût irlandais

a) doit contenir du mouton, de l’agneau ou du boeuf, seul ou en association, et des légumes dans les quantités suivantes, calculées d’après les aliments crus :

(i) au moins 20 pour cent de viande pour ragoût,

(ii) au moins 30 pour cent de légumes, et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 2.

B.14.067. [N]. Les boulettes de viande avec légumes en sauce

a) doivent contenir des légumes et des boulettes dans les quantités suivantes, calculées d’après les aliments crus :

(i) au moins 22 pour cent de boulettes de viande,

(ii) au moins 30 pour cent de légumes, et

b) peuvent contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 2.

B.14.068. [N]. Le ragoût spécial de viande

a) doit contenir de la viande et des légumes dans les quantités suivantes, calculés d’après les aliments crus :

(i) au moins 25 pour cent de viande pour ragoût,

(ii) au moins 30 pour cent de légumes, et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 2.

Spécialités de viande

B.14.070. [N]. Les saucisses fumées (wieners ou saucissons de Francfort) avec haricots ou les saucisses aux fèves doivent être l’aliment préparé avec des haricots secs et des saucisses fumées; elles peuvent renfermer une sauce, des condiments, des épices et un agent édulcorant et doivent renfermer au moins 25 pour cent de saucisses fumées, déterminé selon la méthode officielle FO-36, Détermination de la teneur en saucisses fumées dans des spécialités de viande telles que les saucisses fumées avec haricots, 15 octobre 1981.

DORS/82-768, art. 47.

B.14.071. [N]. Les haricots aux saucisses fumées ou fèves aux saucisses fumées (haricots avec saucisses fumées, ou haricots avec wieners) doivent être l’aliment préparé avec des haricots secs et des saucisses fumées; ils peuvent renfermer une sauce, des condiments, des épices et un agent édulcorant et doivent renfermer au moins 10 pour cent de saucisses fumées, déterminé selon la méthode officielle FO-36, Détermination de la teneur en saucisses fumées dans des spécialités de viande telles que les saucisses fumées avec haricots, 15 octobre 1981.

DORS/82-768, art. 47.

Vente de viandes ou de sous-produits de la viande cuits à la broche, rôtis ou grillés

B.14.072. Est interdite la vente de viande ou de sous-produits de la viande cuits à la broche, rôtis ou grillés et prêts à la consommation à moins que la viande ou le sous­ produit de la viande cuits

a) n’aient constamment

(i) indiqué une température de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus, ou

(ii) été conservés à une température ambiante de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus; et

b) ne portent, sur l’espace principal de l’étiquette, mention qu’ils doivent être conservés à une température de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus.

DORS/78-403, art. 4(F); DORS/88-336, art. 3.

Allongeur de produits de viande

B.14.073. Est interdite la vente d’un allongeur de produits de viande pour usage dans un aliment qui consiste en un mélange décrit aux articles B.14.074, B.14.075, B.14.076, B.14.077 ou B.14.078, à moins que cet allongeur

a) n’ait, à l’état réhydraté,

(i) une teneur totale en protéines d’au moins 16 pour cent, et

(ii) une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

b) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés au tableau du présent Titre, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que,

c) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités non supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 48.

Produits de viande avec allongeur

B.14.074. Sous réserve des articles B.14.075 à B.14.079, est interdite la vente d’un aliment qui consiste en un mélange de produit de viande et d’allongeur de produits de viande, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 16 pour cent;

b) n’ait une teneur en matières grasses d’au plus 25 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981; et que,

c) en ce qui a trait à l’allongeur de produits de viande, il ne satisfasse aux exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 49.

B.14.075. Est interdite la vente d’un aliment qui consiste en un mélange de produit de viande et d’allongeur de produits de viande et qui rappelle la saucisse fraîche, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins neuf pour cent;

b) n’ait une teneur en matières grasses d’au plus 40 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981; et que,

c) en ce qui a trait à l’allongeur de produit de viande, il ne satisfasse aux exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 50; DORS/84-300, art. 47(F).

B.14.076. Est interdite la vente d’un aliment qui consiste en un mélange de produit de viande et d’allongeur de produits de viande et qui rappelle la saucisse cuite, le pain de viande, le pain de sous-produit de viande, la viande en brique ou en rouleau ou la viande à lunch, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 11 pour cent;

b) n’ait une teneur en matières grasses d’au plus 25 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981; et que,

c) en ce qui a trait à l’allongeur de produits de viande, il ne satisfasse aux exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 51.

B.14.077. Est interdite la vente d’un aliment qui consiste en un mélange de produit de viande et d’allongeur de produits de viande et qui rappelle la viande en pot, un sous­ produit de viande en pot, le pâté de viande, le pâté de sous-produit de viande, la viande à tartiner ou un sous-produit de viande à tartiner, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins neuf pour cent;

b) n’ait une teneur en matières grasses d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981; et que,

c) en ce qui a trait à l’allongeur de produits de viande, il ne satisfasse aux exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 52; DORS/84-300, art. 48(A).

B.14.078. Est interdite la vente d’un aliment qui consiste en un mélange de produit de viande et d’allongeur de produits de viande et qui rappelle le boeuf haché ordinaire, le boeuf haché mi-maigre ou le boeuf haché maigre, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 16 pour cent;

b) n’ait une teneur en matières grasses

(i) d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant ordinaire,

(ii) d’au plus 23 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant mi-maigre, ou

(iii) d’au plus 17 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant maigre; et que,

c) en ce qui a trait à l’allongeur de produit de viande, il ne rencontre les exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 53.

B.14.079. Est interdite la vente d’un aliment qui consiste en un mélange de produit de viande, d’un agent de remplissage, et d’un allongeur de produit de viande, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 13 pour cent;

b) n’ait une teneur en matières grasses d’au plus 25 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981; et que,

c) en ce qui a trait à l’allongeur de produit de viande, il ne rencontre les exigences des alinéas B.14.073a) à c).

DORS/82-768, art. 54.

Simili-produits de viande

B.14.085. Sous réserve des articles B.14.086 à B.14.090, est interdite la vente d’un simili-produit de viande, à moins que ce produit

a) n’ait, à l’état réhydraté,

(i) une teneur totale en protéines d’au moins 16 pour cent,

(ii) une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981, et

(iii) une teneur en matières grasses d’au plus 25 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981;

b) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et minéraux nutritifs énumérés au tableau du présent titre, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

c) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités non supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 55.

B.14.086. Est interdite la vente d’un simili-produit de viande qui rappelle la saucisse fraîche à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins neuf pour cent;

b) n’ait une cote protéique d’au moins 23, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) n’ait une teneur en matières grasses d’au plus 40 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981;

d) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés au tableau du présent titre, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

e) lorsque des acides aminés essentiels isolés ont été ajoutés, ne contienne ces acides en quantités non supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 56.

B.14.087. Est interdite la vente d’un simili-produit de viande qui rappelle la saucisse cuite, le pain de viande, le pain de sous-produit de viande, la viande en brique ou en rouleau ou la viande à lunch, à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins 11 pour cent;

b) n’ait une cote protéique d’au moins 28, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) n’ait une teneur en matières grasses d’au plus 25 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981;

d) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés au tableau du présent titre, à la colonne I, en quantité

au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

e) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 57.

B.14.088. Est interdite la vente d’un simili-produit de viande qui rappelle la viande en pot, un sous-produit de viande en pot, le pâté de viande, le pâté de sous-produit de viande, la viande à tartiner ou un sous-produit de viande à tartiner, à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins neuf pour cent;

b) n’ait une cote protéique d’au moins 23, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) n’ait une teneur en matières grasses d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981;

d) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés au tableau du présent titre, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

e) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 58.

B.14.089. Est interdite la vente d’un simili-produit de viande qui rappelle le boeuf haché ordinaire, le boeuf haché mi-maigre ou le boeuf haché maigre, à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins 16 pour cent;

b) n’ait une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) n’ait une teneur en matières grasses

(i) d’au plus 30 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant ordinaire,

(ii) d’au plus 23 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant mi-maigre, ou

(iii) d’au plus 17 pour cent, déterminée selon la méthode officielle FO-33, Détermination de matières grasses dans des produits de viande et des simili-produits de viande, 15 octobre 1981, lorsque le produit est présenté comme étant maigre;

d) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés à la colonne I du tableau du présent titre, en quantité au moins égale à celle indiquée à la colonne II de ce tableau, pour chacune de ces vitamines et chacun de ces minéraux nutritifs; et que

e) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides aminés en quantité non supérieure à celle qui améliore la qualité nutritive de la protéine.

DORS/82-768, art. 59.

B.14.090. Est interdite la vente d’un simili-produit de viande qui rappelle le bacon de flanc, à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins 25 pour cent;

b) n’ait une cote protéique d’au moins 20, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs énumérés au tableau du présent titre, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

d) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 60.

TABLEAU

Colonne I Colonne II Article Vitamines ou minéraux nutritifs Quantité par gramme de protéines C.1 ....... Cuivre ....... 4,4 microgrammes F.1 ....... Acide folique ....... 0,45 microgramme I.1 ....... Fer ....... 0,25 milligramme M.1 ....... Magnésium ....... 1,1 milligramme N.1 ....... Niacine ....... 0,34 milligramme P.1 ....... Acide pantothénique ....... 0,04 milligramme P.2 ....... Potassium ....... 20 milligrammes P.3 ....... Pyridoxine ....... 0,02 milligramme R.1 ....... Riboflavine ....... 0,01 milligramme T.1 ....... Thiamine ....... 0,02 milligramme V.1 ....... Vitamine B12....... 0,08 microgramme

Colonne I Colonne II Article Vitamines ou minéraux nutritifs Quantité par gramme de protéines Z.1 ....... Zinc ....... 0,20 milligramme

DORS/98-458, art. 7(F).

Titre 15

Falsification des produits alimentaires B.15.001. Un aliment visé au tableau I n’est falsifié que s’il contient l’une des substances inscrites en regard dans des proportions supérieures à celles prévues.

DORS/78-404, art. 1; DORS/79-249, art. 1.

B.15.002. (1) Sous réserve du paragraphe (2), un aliment est falsifié dans l’un ou l’autre des cas suivants :

a) des produits antiparasitaires au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires ou leurs composants ou dérivés, pour lesquels aucune limite maximale de résidus n’a été fixée en vertu des articles 9 ou 10 de cette loi pour l’aliment, sont présents — seuls ou en combinaison — dans l’aliment ou sur sa surface en une quantité supérieure à 0,1 partie par million;

b) des produits chimiques agricoles ou des composants ou dérivés de ceux-ci, autres que les produits antiparasitaires au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires ou leurs composants ou dérivés, sont présents — seuls ou en combinaison — dans l’aliment ou sur sa surface en une quantité supérieure à 0,1 partie par million.

(2) L’aliment est exempté de l’application de l’alinéa 4(1)d) de la Loi si les produits chimiques agricoles ci-après ou leurs composants ou dérivés — seuls ou en combinaison — sont les seuls produits chimiques agricoles ou composants ou dérivés de ces produits présents dans l’aliment ou sur sa surface :

a) un produit fertilisant;

b) un adjuvant ou un véhicule de produit chimique agricole;

c) un sel de bromure inorganique;

d) du dioxyde de silicium;

e) du soufre;

f) des spores viables de Bacillus thuringiensis Berliner ou

g) du kaolin.

(3) Le paragraphe (2) ne s’applique pas à l’aliment si est présent dans celui-ci, ou sur sa surface, tout produit chimique agricole visé à ce paragraphe, ou un de ses composants ou

dérivés, qui est un produit antiparasitaire au sens du paragraphe 2(1) de la Loi sur les produits antiparasitaires ou un de ses composants ou dérivés pour lequel une limite maximale de résidus a été fixée en vertu des articles 9 ou 10 de cette loi pour l’aliment.

(4) [Abrogé, DORS/2008-181, art. 3]

DORS/78-404, art. 1; DORS/79-249, art. 1; DORS/81-83, art. 2; DORS/97-313, art. 2; DORS/98-98, art. 1; DORS/2005-67, art. 1; DORS/2008-181, art. 3; DORS/2008-182, art. 2. Version précédente B.15.003. Les aliments énumérés à la colonne IV du tableau III du présent titre, dans lesquels se trouve une drogue mentionnée à la colonne I qui correspond, après analyse, à la substance nommée à la colonne II, sont exemptés de l’application de l’alinéa 4d) de la Loi si la quantité de drogue présente ne dépasse pas la limite maximale de résidu prévue à la colonne III.

DORS/78-404, art. 1; DORS/79-249, art. 1; DORS/91-255, art. 1.

TABLEAU I

I II III

Article Substance Tolérance Alimentsp.p.m. 1. Arsenic (1) 3,5 (1) Protéines de poisson

(2) 1 (2) Farine d’os comestible (3) Jus de fruits, nectar de fruits, boissons, lorsque prêtes

(3) 0,1 à servir, et eaux vendues dans des contenants scellés, sauf l’eau minérale et l’eau de source

2. Fluorure (1) 650 (1) Farine d’os comestible (2) 150 (2) Protéines de poisson

3. Plomb (1) 10 (1) Farine d’os comestible (2) 1,5 (2) Pâte de tomates et sauce tomate (3) 0,5 (3) Protéines de poisson et tomates entières

(4) Jus de fruits, nectar de fruits, boissons, lorsque prêtes (4) 0,2 à servir, et eaux vendues dans des contenants scellés, sauf

l’eau minérale et l’eau de source (5) Lait évaporé, lait condensé et préparation pour(5) 0,15 nourrisson, concentrée

(6) 0,08 (6) Préparation pour nourrisson, lorsque prête à servir 4. Étain (1) 250 (1) Aliments en conserve

DORS/78-404, art. 2; DORS/79-249, art. 2; DORS/86-258, art. 1; DORS/89-243, art. 1 et 2; DORS/91-149, art. 2(A); DORS/94-689, art. 2(F).

TABLEAU II [Abrogé, DORS/2008-182, art. 3] TABLEAU III

DROGUES POUR USAGE VÉTÉRINAIRE

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

albendazole-2­A.01 albendazole 0,2 Foie de bovinaminosulfone Tissus comestibles deA.1 ampicilline ampicilline 0,01 porc et de bovin; lait Muscles de

A.2 amprolium amprolium 0,5 poulet et de dinde Foie et rognons

1,0 de poulet et de dinde

7,0 Oeufs Rognons deA.3 apramycine apramycine 0,1 porc Muscles de porc, de poulet0,5 et de dinde;

A.4 acide arsanilique arsenic oeufs Foie de porc, de

2,0 poulet et de dinde Muscles de0,1 poulet

B.1 buquinolate buquinolate Foie, rognons, 0,4 peau et gras de

poulet C.01 ceftiofur 0,1 Lait

Muscles dedesfuroyl-ceftiofur (DFC) 1,0 bovin, de

mouton et de

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

porc Foie et gras de bovin, de2,0 mouton et de porc Rognons de5,0 porc Rognons de

6,0 bovin et de mouton

C.1 céfapirine céfapirine 0,02 Lait Tissus

0,1 comestibles de bovin Rognons, foie et muscles deC.2 chlortétracycline chlortétracycline 0,1 bovin; muscles de mouton

0,2 Gras de porc 0,5 Foie de mouton

Muscles, foie, peau et gras de poulet et de dinde; muscles

1,0 de porc; muscles et gras de veau; rognons de mouton

2,0 Foie de porc Rognons de porc, de poulet

4,0 et de dinde; foie et rognons de veau Muscles de

5,0 poulet et deC.3 clopidol clopidol dinde 15,0 Foie et rognons

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

de poulet et de dinde Muscles de bovin, de1,0 chèvre et de poulet Rognons, foieD.1 décoquinate décoquinate et gras de bovin et de chèvre;2,0 rognons, foie, peau et gras de poulet Muscle de

D.1.1 diclazuril diclazuril 0,5 dinde et de poulet Gras et peau de

1,0 dinde et de poulet Foie de dinde et3,0 de poulet

D.2 dihydrostreptomycine dihydrostreptomycine 0,125 Lait D.3 2,0 Gras de poulet

dinitolmide, y compris le Muscles de dinitolmide (zoalène) métabolite amino-3 nitro-5 poulet et de3,0o-toluamide dinde; foie et

gras de dinde Foie et rognons6,0 de poulet

D.4 doramectine doramectine 0,01 Muscle de porc Muscle de0,03 bovin

0,035 Foie de porc 0,07 Foie de bovin

Muscle deE.01 enrofloxacine desethylene ciprofloxacine 0,02 bovin 0,07 Foie de bovin

E.02 eprinomectine eprinomectine Bla 0,02 Lait 0,1 Muscle de

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

bovin 1,0 Foie de bovin

E.1 érythromycine érythromycine 0,05 Lait Tissus

0,1 comestibles de porc Tissus comestibles de0,125 poulet et de dinde

F.1 fenbendazole fenbendazole 0,45 Foie de bovin 4,5 Foie de porc

Muscle deF.2 florfénicol florfénicol-amine 0,8 salmonidé 2 Foie de bovin

flunixine sous forme Muscle deF.3 flunixine 0,02d’acide bovin 0,08 Foie de bovin

Tissus G.1 gentamicine gentamicine 0,1 comestibles de

dinde Rognons de0,4 porc

H.01 halofuginone halofuginone 0,1 Foie de poulet H.1 hydrocortisone hydrocortisone 0,01 Lait I.1 ivermectine dihydro-22,23 avermectine 0,015 Foie de porc

B1a 0,03 Foie de mouton 0,07 Foie de bovin

K.1 kétoprofène kétoprofène 0,05 Lait 0,1 Muscle de porc

Muscle de0,25 bovin Rognons de0,5 porc Rognons de0,8 bovin

L.01 lasalocide lasalocide 0,35 Peau et gras de

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

poulet 0,65 Foie de bovin 0,1 Tissus (calculé comestibles dechlorhydrate de commeL.1 lévamisole bovin, delévamisole chlorhydrate mouton et de de porc lévamisole)

Muscle de porcL.2 lincomycine lincomycine 0,1 et de poulet Foie de porc et0,5 de poulet Peau et gras deM.01 maduramicine maduramicine 0,4 poulet

M.1 monensin monensin 0,01 Lait Tissus comestibles de0,05 bovin, de dinde et de poulet

M.2 N-méthyl-1,3-propane- 0,1 Laittartrate de morantel diamine 0,5 Foie de bovin M.3 moxidectine moxidectine 0,55 Gras de bovin

Muscle de porc N.01 narasin narasin 0,05 et de poulet;

foie de porc 0,5 Gras de poulet

Tissus N.1 néomycine néomycine 0,25 comestibles de

veau Muscles, foie,N,N1-bis(nitro-4 phényn( �.2 nicarbazine 4,0 rognons et peauurée de poulet Muscles deN.3 nitarsone arsenic 0,5 dinde

2,0 Foie de dinde Tissus

N.4 novobiocine novobiocine 1,0 comestibles de bovin, de poulet

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

et de dinde Muscle de bovin, de dinde, de homard, deO.1 oxytétracycline oxytétracycline 0,2 mouton, de porc, de poulet et de salmonidé

0,3 Miel 0,4 Oeufs

Foie de bovin, de dinde, de

0,6 mouton, de porc et de poulet Rognons de bovin, de dinde, de mouton, de porc et de poulet; gras de1,2 bovin et de mouton; peau et gras de dinde, de porc et de poulet

0,01P.1 pénicilline G pénicilline G Lait U.I./mL

Tissus 0,01 comestibles de

dinde Tissus

0,05 comestibles de bovin et de porc Muscles deP.1.1 pirlimycine pirlimycine 0,3 bovin

0,4 Lait 0,5 Foie de bovin

P.2 polymyxine B polymyxine B 4,0 u/mL Lait P.3 tartrate de pyrantel N-méthylpropanediamine- 1,0 Muscles de

Colonne I Nom usuel (ou marque

Article nominative) de la drogue

chlorhydrate deR.1 robénidine

R.2 roxarsone

S.01 salinomycine

S.1 spectinomycine

S.2 streptomycine

S.3 sulfachlorpyridazine

S.3.1 sulfadiazine

Colonne II

Nom de la substance aux fins d’analyse de la drogue

1,3

robénidine

arsenic

salinomycine

spectinomycine

streptomycine

sulfachlorpyridazine

sulfadiazine

Colonne III Limite maximale de résidu p.p.m. (calculé comme tartrate de pyrantel) 10,0 (calculé comme tartrate de pyrantel) 0,1 (calculé comme chlorhydrate de robénidine) 0,2 (calculé comme chlorhydrate de robénidine)

0,5

2,0

0,35

0,1

0,125

0,1

0,1

Colonne IV

Aliments

porc

Foie et rognons de porc

Muscles, foie et rognons de poulet

Peau et gras de poulet

Muscles de porc, de poulet et de dinde; oeufs Foie de porc, de poulet et de dinde Foie de bovin et de porc; peau et gras de poulet Tissus comestibles de poulet Lait Tissus comestibles de bovin et de porc Muscle de

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

salmonidé S.4 sulfadiméthoxine sulfadiméthoxine 0,01 Lait

Tissus 0,1 comestibles de

bovin Tissus

S.5 sulfaéthoxypyridazine sulfaéthoxypyridazine 0,1 comestibles de bovin

S.6 sulfaméthazine sulfaméthazine 0,01 Lait Tissus comestibles de bovin, de dinde,0,1 de porc, de poulet et de veau Tissus

S.7 sulfathiazole sulfathiazole 0,1 comestibles de porc Muscle deT.01 teflubenzuron teflubenzuron 0,3 salmonidé Peau de3,2 salmonidé Tissus comestibles de veau, de porc,T.1 tétracycline tétracycline 0,25 de mouton, de poulet et de dinde

T.2 thiabendazole 0,05 Laitthiabendazole et tous ses Tissusmétabolites hydroxy-5 comestibles dethiabendazole (libres,

0,1 bovin, deconjugués glucuronides et chèvre et deconjugués sulfates) mouton

T.3 tiamuline hydroxy-8-alpha-mutiline 0,4 Foie de porc T.3.1 tilmicosine tilmicosine 1,6 Foie de bovin

Muscle deT.3.2 triméthoprime triméthoprime 0,1 salmonidé

Colonne I Colonne II Colonne III Colonne IV Nom usuel (ou marque LimiteNom de la substance auxArticle nominative) de la maximale de Alimentsfins d’analyse de la droguedrogue résidu p.p.m.

Muscles, foie, rognons et gras

T.4 tylosine tylosine 0,2 de bovin, de porc, de poulet et de dinde

DORS/84-300, art. 49(A); DORS/91-255, art. 2; DORS/92-591, art. 2; DORS/2002-52, art. 1 à 12; DORS/2005-396, art. 1 à 4; DORS/2008-274, art. 1 à 8; DORS/2010-39, art. 1(F) et (2)(F). Version précédente

Titre 16

Additifs alimentaires B.16.001. En ce qui concerne toute substance ou tout mélange de substances à utiliser comme additif alimentaire, l’indication, soit de la quantité de chacun des additifs présents, soit du mode d’emploi donnant comme résultat un aliment qui ne contient pas ces additifs dans une proportion supérieure aux limites de tolérance prescrites par le présent règlement, doit être groupée avec la liste d’ingrédients.

B.16.002. Toute demande tendant à ajouter un additif alimentaire, ou à modifier de quelque façon les tableaux qui suivent l’article B.16.100 doit être accompagnée d’une présentation au ministre, dans une forme, d’une teneur et d’une manière que le ministre jugera satisfaisantes, et doit comprendre

a) une description de l’additif alimentaire, y compris son nom chimique et le nom sous lequel on se propose de le vendre, la méthode de fabrication qui s’y applique, ses propriétés physiques et chimiques, sa composition, et ses caractères distinctifs, ou, lorsque ces renseignements ne sont pas disponibles, une explication détaillée;

b) la déclaration de la quantité d’additif alimentaire que l’on projette d’utiliser, les fins proposées pour son emploi, ainsi que le détail du mode d’emploi, des recommandations et conseils quant à son usage;

c) lorsque de l’avis du Directeur cela sera nécessaire, une méthode d’analyse acceptable qui convienne aux fins de contrôle et de réglementation, et qui permette de déterminer la quantité d’additif alimentaire et de toute autre substance résultant de son emploi, dans le produit alimentaire fini;

d) les données établissant que l’additif alimentaire aura l’effet physique, ou tout autre effet technique, qui est prévu;

e) les rapports détaillés de toutes les épreuves effectuées pour établir l’innocuité de l’additif alimentaire, dans les conditions recommandées pour son usage;

f) les données indiquant les quantités de résidus qui peuvent rester dans ou sur le produit alimentaire fini, lorsque l’additif est utilisé conformément aux bonnes pratiques industrielles;

g) une limite de tolérance proposée, pour les résidus de l’additif alimentaire dans ou sur le produit alimentaire fini;

h) des échantillons des étiquettes proposées pour l’additif alimentaire; et

i) un échantillon de l’additif alimentaire dans la forme définitive prévue pour son usage, un échantillon de l’ingrédient actif et, sur demande, un échantillon de l’aliment qui renferme ledit additif alimentaire.

B.16.003. Dans un délai d’au plus 90 jours après avoir reçu une présentation en vertu de l’article B.16.002, le ministre doit faire savoir à la personne qui a soumis la présentation s’il a ou non l’intention de recommander au gouverneur en conseil que ledit additif soit ajouté à la liste, ainsi que le détail de cette inscription à la liste.

B.16.004. [Abrogé, DORS/97-148, art. 6]

B.16.006. L’alinéa B.01.042c) et l’alinéa B.01.043a), ne s’appliquent pas aux épices, aux condiments, aux préparations aromatisantes, aux huiles essentielles, aux matières extractives naturelles, ni aux oléo-résines.

B.16.007. Il est interdit de vendre un aliment qui contient un additif alimentaire autre que l’un de ceux visés aux articles B.01.042, B.01.043 et B.25.062.

DORS/87-640, art. 5.

B.16.008. [Abrogé, DORS/88-418, art. 5]

B.16.100. Est interdite la vente de toute substance comme additif alimentaire, à moins que ledit additif ne soit nommé à l’un ou plusieurs des tableaux ci-après :

TABLEAU I

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS ANTI­ AGGLOMÉRANTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

1,0 % sauf pour le sel à fins

C.1 Silicate double d’aluminium et de calcium

(1) Sel

(2) Sel d’ail, sel d’oignon

(1) 2,0 %, conformément auxexigences de l’alinéa B.17.001(1)a).

(2) 2,0 % conformément auxexigences des alinéas

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

B.07.020b) et B.07.02b) respectivement.

(3) Mélanges secs nonnormalisés (3) Bonnes pratiques industrielles

1,0 %, sauf pour le sel à

C.2 Phosphatetricalcique (1) Sel (1) grains fins, 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a). 2,0 % conformément aux

(2) Sel d’ail, sel d’oignon (2) exigences des alinéasB.07.020b) et B.07.027b) respectivement.

(3) Mélanges de salaison àsec (3) Bonnes pratiques industrielles

(4) Mélanges secs nonnormalisés (4) Bonnes pratiques industrielles

(5) Rocou soluble dansl’huile (5) Bonnes pratiques industrielles

Si on l’emploie seul ou avec du silicate de calcium, du carbonate de magnésium, du silicate de magnésium, du

(6) Sucre à glacer (6) stéarate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 % 1,0 %, pour le sel à grains

C.3 Silicate decalcium (1) Sel (1) fins, 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a). 2,0 % conformément aux

(2) Sel d’ail, sel d’oignon (2) exigences des alinéasB.07.020b) et B.07.027b) respectivement.

(3) Poudre à pâte (3) 5,0 %

(4) Mélange de salaison àsec (4) Bonnes pratiques industrielles

(5) Mélanges secs nonnormalisés (5) Bonnes pratiques industrielles

(6) Sucre à glacer (6) Si on l’emploie seul ou avec

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

du phosphate tricalcique, du carbonate de magnésium, du silicate de magnésium, du stéarate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %

Liant à viande ou liant à (7) (désignation du produit (7) 1,0 %

de viande) Fromage râpé fin ou en filaments (indication de la variété); fromage Si on l’emploie seul ou avec

(8) cheddar râpé fin ou enfilaments; préparations (8) la cellulose microcrystalline ou la cellulose, la quantité

de fromage râpé fin ou totale n’excédant pas 2,0 % en filaments non normalisées Mélange de poudre de jaunes d’oeufs; mélange de poudre d’oeufs

(9) entiers; poudre de blancd’oeuf (poudre (9) 2,0 %

d’albumen); poudre de jaune d’oeuf; poudre d’oeuf entier

1,0 %, sauf pour le sel à

C.4 Stéarate decalcium (1) Sel (1) grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a). 2,0 % conformément aux

(2) Sel d’ail, sel d’oignon (2) exigences des alinéasB.07.020b) et B.07.027b) respectivement.

(3) Mélanges secs nonnormalisés (3) Bonnes pratiques industrielles

Fromage râpé fin ou en Si on l’emploie seul ou avec filaments (indication de le silicate de calcium ou la

C.5 Cellulose la variété); fromage cellulose microcristalline, la cheddar râpé fin ou en quantité totale n’excédant pas filaments; préparations 2,0 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de fromage râpé fin ou en filaments non normalisées

M.1 Carbonate demagnésium (1)

Sel (sauf si employé dans les préparations de viande et de sous­ produits de viande du Titre 14)

(1)

1,0 % pour le sel à grains fins 2,0 %, conformément aux exigences de l’alinéa B.17.001(1)a).

Sel d’ail, sel d’oignon 2,0 % conformément aux(sauf si employé dans les exigences des alinéas(2) préparations de viande et (2) B.07.020b) et B.07.027b)de sous-produits de respectivement.viande du Titre 14) Mélanges secs non normalisés (sauf lorsqu’il est utilisé dans

(3) les préparations de (3) Bonnes pratiques industrielles viande et de sous­ produits de la viande du Titre 14)

Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du silicate de magnésium, du stéarate de

(4) Sucre à glacer (4) magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %

Mélanges secs non normalisés (sauf lorsqu’il est utilisé dansOxyde deM.2 les préparations de Bonnes pratiques industriellesmagnésium viande et de sous­ produits de la viande du Titre 14)

1,0 %, sauf pour le sel à Silicate de grains fins 2,0 %,M.3 (1) Sel (1)magnésium conformément aux exigences

de l’alinéa B.17.001(1)a).

(2) 2,0 % conformément aux(2) Sel d’ail et d’oignon exigences des alinéas

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

B.07.020b) et B.07.027b) respectivement.

(3) Mélanges secs non (3) Bonnes pratiques industriellesnormalisés Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du

(4) Sucre à glacer (4) stéarate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 % 1,0 %, sauf pour le sel à

Stéarate de grains fins 2,0 %,M.4 (1) Sel (1)magnésium conformément aux exigences de l’alinéa B.17.001(1)a). 2,0 % conformément aux exigences des alinéas(2) Sel d’ail, sel d’oignon (2) B.07.020b) et B.07.027b) respectivement.

(3) Mélanges secs non (3) Bonnes pratiques industriellesnormalisés Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du

(4) Sucre à glacer (4) silicate de magnésium, du dioxyde de silicium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %

Fromage râpé fin ou en filaments (indication de la variété); fromage Si on l’emploie seul ou avec

Cellulose cheddar râpé fin ou en le silicate de calcium ou laM.5 microcristalline filaments; préparations cellulose, la quantité totale de fromage râpé fin ou n’excédant pas 2,0 % en filaments non normalisées

P.1 Propylèneglycol Sel 0,035 % S.1 Bioxyde de (1) Sel d’ail; sel d’oignon (1) 1,0 % conformément aux

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

silicium exigences des alinéas B.07.020b) et B.07.027b) respectivement.

(2) Sel de céleri; poivre de (2) 0,5 %.céleri

(3) Mélanges secs non (3) Bonnes pratiquesnormalisés industrielles. Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du

(4) Sucre à glacer (4) silicate de magnésium, du stéarate de magnésium ou du silicate double d’aluminium et de sodium, le total ne doit pas dépasser 1,5 %.

(5) Aliments vendus sous (5) Bonnes pratiquesforme de comprimés industrielles. Poivre de cayenne; chili;

(6) assaisonnement au chili; (6) 2,0 %. paprika; poivre rouge

1,0 % (sauf pour le sel à grains fins : 2,0 %)(7) Sel (7) conformément aux exigences de l’alinéa B.17.001(1)a) 1,0 %, sauf pour le sel àSilicate double grains fins 2,0 %,S.2 d’aluminium et (1) Sel (1) conformément aux exigencesde sodium de l’alinéa B.17.001(1)a). Si on l’emploie seul ou avec du phosphate tricalcique, du silicate de calcium, du carbonate de magnésium, du(2) Sucre à glacer (2) silicate de magnésium, du stéarate de magnésium ou du dioxyde de silicium, le total ne doit pas dépasser 1,5 %.

Mélange de poudre de jaunes d’oeufs; mélange

(3) de poudre d’oeufs (3) 2,0 % entiers; poudre de blanc d’oeuf (poudre

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

d’albumen); poudre de jaune d’oeuf; poudre d’oeuf entier

2,0 %, conformément aux exigences des alinéas(4) Sel d’ail, sel d’oignon (4) B.07.020b) et B.07.027b) respectivement.

(5) Mélanges secs non (5) Bonnes pratiquesnormalisés industrielles. Decahydrate 13 p.p.m. calculé en

S.3 ferrocyanure de Sel ferrocyanure de sodium sodium anhydre

DORS/79-662, art. 3 à 13; DORS/82-913, art. 4; DORS/83-410, art. 2; DORS/84-17, art. 5; DORS/84-801, art. 2; DORS/86-1125, art. 1; DORS/88-534, art. 4; DORS/91-88, art. 3 et 4; DORS/93-477, art. 3 à 5; DORS/94-689, art. 2(F); DORS/97-191, art. 3; DORS/2010-94, art. 8(A); DORS/2010-143, art. 11 et 12.

TABLEAU II

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE BLANCHIMENT, DE MATURATION, OU POUR CONDITIONNER LES PÂTES

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(1) Farine; farine de blé (1) Bonnes pratiquesA.1 Peroxyde d’acétone entier; pain industrielles

(2) Produits de boulangerie (2) Bonnes pratiquesnon normalisés industrielles A.1A [Abrogé, DORS/79-660, art. 3]

(1) Farine; farine de bléA.2 (1) 250 p.p.m.Persulfate d’ammonium entier (2) Pain (2) 100 p.p.m. de farine

(3) Produits de boulangerie (3) Bonnes pratiquesnon normalisés industrielles

(1) Farine; farine de bléA.2A Acide ascorbique (1) 200 p.p.m. de farineentier; pain

(2) Produits de boulangerie (2) 200 p.p.m. de farinenon normalisés A.3 [Abrogé, DORS/79-660, art. 4] A.3A [Abrogé, DORS/79-660, art. 4] A.4 Azodicarbonamide Farine; farine de blé 45 p.p.m. de farine

S.1

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

B.1 Peroxyde de benzoyle

C.1 Iodate de calcium

C.2 Peroxyde de calcium

C.3 Stéaroyl-2-lactylate de calcium

C.4 Chlore

C.5 Bioxyde de chlore

C.6 Chlorhydrate de L­ cystéine

entier; pain Farine; farine de blé entier

(1) Pain

(2) Produits de boulangerienon normalisés (1) Pain

(2) Produits de boulangerienon normalisés (1) Pain

(2) Produits de boulangerienon normalisés

(3) Mélanges à gâteaux

Farine; farine de blé entier Farine; farine de blé entier

(1) Farine; farine de bléentier; pain

(2) Produits de boulangerienon normalisés P.1 [Abrogé, DORS/94-227, art. 4] P.2 Iodate de potassium (1) Pain

(2) Produits de boulangerienon normalisés P.3 Persulfate de potassium (1) Pain

Stéaroyl-2-lactylate de sodium

S.2 Stéaryl-fumarate de

(2) Produits de boulangerienon normalisés (1) Pain

(2) Produits de boulangerienon normalisés

(3) Crêpes et mélanges àcrêpes

(4) Gaufres et mélanges àgaufres

(5) Mélanges à gâteaux

(1) Pain

150 p.p.m.

(1) 45 p.p.m. de farine

(2) 45 p.p.m. de farine

(1) 100 p.p.m. de farine

(2) Bonnes pratiquesindustrielles (1) 3 750 p.p.m. de farine

(2) 3 750 p.p.m. de farine

(3) 0,5 % du poids sec dumélange Bonnes pratiques industrielles Bonnes pratiques industrielles

(1) 90 p.p.m.

(2) Bonnes pratiquesindustrielles

(1) 45 p.p.m. de farine

(2) 45 p.p.m. de farine

(1) 100 p.p.m. de farine

(2) Bonnes pratiquesindustrielles (1) 3 750 p.p.m. de farine

(2) 3 750 p.p.m. de farine

(3) 0,3 % du poids desingrédients secs

(4) 0,3 % du poids desingrédients secs

(5) 0,5 % du poids sec dumélange (1) 5 000 p.p.m. de farine

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

sodium (2) Produits de boulangerie (2) 5 000 p.p.m. de farinenon normalisés 500 p.p.m., calculé enS.3 Sulfite de sodium Pâte à biscuit bioxyde de soufre

DORS/79-660, art. 3 et 4; DORS/87-640, art. 6; DORS/92-591, art. 2; DORS/94-227, art. 4; DORS/94-689, art. 2(F); DORS/2005-98, art. 3; DORS/2005-98, art. 8(F); DORS/2010-41, art. 9(A).

TABLEAU III

ADDITIFS ALIMENTAIRES AUTORISÉS COMME COLORANTS POUR ALIMENTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Aluminium Confiture de pommes (1) Bonnes pratiques1. (1)métallique (ou de rhubarbe) et de industrielles Orcanette (nom du fruit); pain;

beurre; jus de fruitRocou concentré sauf le jus Anthocyanines d’orange concentré Rouge de congelé; marmelade de betterave figues avec pectine; Canthaxanthine mélange pour crème

glacée; mélange pour laitNoir actif glacé; sucre à glacer;Carotène confiture de (nom du

Charbon de bois fruit) avec pectine; gelée Chlorophylle de (nom du fruit) avec Cochenille pectine; liqueurs et

cordiaux alcoolisés; laitOxyde de fer (indication de l’arôme);

Orseille marinades et achards Paprika (relish); marmelade Riboflavine d’ananas avec pectine;

sorbet laitier; lait écréméSafran (indication de l’arôme);Bois de santal lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de

Argent l’arôme) additionné de métallique solides du lait; lait

partiellement écrémé (indication de l’arôme)

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

additionné de solides du lait; poisson fumé; pâte de homard et oeufs de poisson (caviar); ketchup de tomates; poisson et viande emballés, marinés ou conditionnés à froid par une autre méthode analogue (Titre 21)

Bioxyde de titane (2) Jaune d’oeuf congelé; (2) Curcuma jaune d’oeuf liquide; Bonnes pratiques

oeuf entier congelé; oeuf industrielles selon les entier liquide; poudre de alinéas B.22.034b) et

Xanthophylle jaune d’oeuf; poudre B.22.035b) d’oeuf entier

(3) Aliments non normalisés (3) Bonnes pratiquesindustrielles Bonnes pratiques

(4) Les graisses et huiles (4) industrielles selon l’articlevégétales B.09.001

(5) Bonnes pratiques(5) Margarine industrielles Fromage (indication de la variété); fromage cheddar; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à Bonnes pratiques tartiner, fromage à la industrielles, conformément crème à tartiner (avec aux exigences des articles indication des B.08.033, B.08.034, ingrédients ajoutés); B.08.037, B.08.038,

(6) fromage fondu (6) B.08.039, B.08.040, (indication de la variété); B.08.041, B.08.041.1, fromage fondu B.08.041.2, B.08.041.3, (indication de la variété) B.08.041.4, B.08.041.5, (avec indication des B.08.041.6, B.08.041.7, et ingrédients ajoutés); B.08.041.8. préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés);

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Mélange de poisson et de

(7) Bonnes pratiques(7) viande préparés visé à industriellesl’alinéa B.21.006n) 0,1 % conformément aux exigences de l’alinéa(8) Longaniza; Tocino (8) B.14.031i) ou du sous­ alinéa B.14.032d)(xvi)

Pellicule de collagène (9) Bonnes pratiques(9) comestible (oxyde de fer industriellesseulement)

1,0 % (les résidus de rocou

(10) Boyaux de saucisse dans les saucisses préparées(10)(rocou seulement) avec ces boyaux ne doivent pas dépasser 100 p.p.m.) 0,75 % (les résidus de cochenille dans les

(11) Boyaux de saucisse (11) saucisses préparées avec(cochenille seulement) ces boyaux ne doivent pas dépasser 75 p.p.m.)

Confiture de pommesß-apo-8′- (ou de rhubarbe) et deCaroténal Ester (nom du fruit); pain;1A. éthylique de (1) (1) 35 p.p.m.beurre; jus de fruitl’acide ß-apo-8′ ­ concentré sauf le juscaroténoique d’orange concentré

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

congelé; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; sucre à glacer; confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; liqueurs et cordiaux alcooliques; margarine; lait (indication de l’arôme); marinades et achards (relish); marmelade d’ananas avec pectine; sorbet laitier; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; poisson fumé; pâte de homard et oeufs de poisson (caviar); ketchup de tomates

(2) Aliments non normalisés (2) 35 p.p.m. Fromage (indication de la variété); fromage 35 p.p.m., conformémentcheddar; fromage à la aux exigences des articlescrème (avec indication B.08.033, B.08.034,des ingrédients ajoutés); B.08.037, B.08.038,fromage à la crème à B.08.039, B.08.040,(3) tartiner; fromage à la (3) B.08.041, B.08.041.1,crème à tartiner (avec B.08.041.2, B.08.041.3,indication des B.08.041.4, B.08.041.5,ingrédients ajoutés); B.08.041.6, B.08.041.7 etfromage fondu B.08.041.8(indication de la variété); fromage fondu

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Mélange de poisson et de

(4) viande préparés visé à (4) 35 p.p.m. l’alinéa B.21.006n) Ale; confiture de pommes (ou de rhubarbe) et de (nom du fruit); bière; eau-de-vie de vin; pain; pain brun; beurre; cidre; vinaigre de cidre; jus de fruit

(1) Bonnes pratiques2. Caramel (1) concentré sauf le jus industriellesd’orange concentré congelé; marmelade de figues avec pectine; genièvre Hollands; mélange pour crème glacée; mélange pour lait glacé; sucre à glacer;

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; bière légère; liqueurs et cordiaux alcoolisés; liqueur de malt; vinaigre de malt; lait (indication de l’arôme); mincemeat; marinades et achards (relish); marmelade d’ananas avec pectine; porter; rhum; sorbet laitier; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; poisson fumé; pâte de homard et oeufs de poisson (caviar); stout; ketchup de tomates; whisky; vin; vinaigre de vin; vin de miel

(2) Aliments non normalisés (2) Bonnes pratiquesindustrielles Mélange de poisson et de

(3) Bonnes pratiques(3) viande préparés visé à industriellesl’alinéa B.21.006n) 15 % (les résidus de caramel dans les saucisses

(4) Boyaux de saucisse (4) préparées avec ces boyaux ne doivent pas dépasser 0,15 %)

3. Rouge allura (1) Confiture de pommes (1) 300 p.p.m., isolément ou en (ou de rhubarbe) et de mélange, en conformité de

Amaranthe (nom du fruit); pain; l’article B.06.002 Erythrosine beurre; jus de fruit

Colonne I Article Additifs

Indigotine Jaune soleil FCF

Tartrazine

Colonne II Colonne III Permis dans ou sur Limites de tolérance

concentré sauf le jus d’orange concentré congelé; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; sucre à glacer; confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; liqueurs et cordiaux alcoolisés; lait (indication de l’arôme); marinades et achards (relish); marmelade d’ananas avec pectine; sorbet laitier; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; poisson fumé; pâte de homard et oeufs de poisson (caviar); ketchup de tomates

(2) Aliments non normalisés (2)

Mélange de poisson et de (3) viande préparés visé à (3)

l’alinéa B.21.006n)

(4) Anchois salé, chinchard (4)salé et crevette salée

(5) Longaniza (5)

300 p.p.m., isolément ou en mélange, en conformité de l’article B.06.002 300 p.p.m., isolément ou en mélange, en conformité avec l’article B.06.002 125 p.p.m. conformément aux exigences de l’alinéa B.21.021d) 80 p.p.m. de rouge allura conformément aux exigences de la division B.14.032d)(xvi)(B) et

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

20 p.p.m. de jaune soleil FCF conformément aux exigences de la division B.14.032d)(xvi)(C)

(6) Boyaux de saucisse (jaune soleil FCF seulement)

(6)

0,15 % (les résidus de jaune soleil FCF dans les saucisses préparées avec ces boyaux ne doivent pas dépasser 15 p.p.m.) 600 p.p.m. isolément. Si combiné avec d’autres colorants nommés à la

Grignotines de maïs à colonne I du présent article (7) saveur de fromage (jaune (7) et de l’article 4 du présent

soleil FCF seulement) tableau, la limite de tolérance permise est de 300 p.p.m. conformément à l’alinéa B.06.002c)

4. Bleu brillant FCF (1) Confiture de pommes (1) (ou de rhubarbe) et de (nom du fruit); pain; beurre; jus de fruit concentré sauf le jus d’orange concentré congelé; marmelade de figues avec pectine; mélange pour crème glacée; mélange pour lait glacé; sucre à glacer; confiture de (nom du 100 p.p.m., isolément ou en fruit) avec pectine; gelée mélange, en conformité de

Vert solide FCF de (nom du fruit) avec l’article B.06.002 pectine; liqueurs et cordiaux alcoolisés; lait (indication de l’arôme); marinades et achards (relish); marmelade d’ananas avec pectine; sorbet laitier; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; poisson fumé; pâte de homard et oeufs de poisson (caviar); ketchup de tomates

100 p.p.m., isolément ou en (2) Aliments non normalisés (2) mélange, en conformité de

l’article B.06.002 Mélange de poisson et de 100 p.p.m., isolément ou en

(3) viande préparés visé à (3) mélange, en conformité l’alinéa B.21.006n) avec l’article B.06.002

(4) Feta (bleu brillant FCF (4) 0,10 p.p.m.seulement) Écorce des oranges5. Rouge citrin no 2 2 p.p.m.entières Écorce de fruits; fruits

6. Ponceau SX glacés; cerises glacées; 150 p.p.m. marasques

Bonnes pratiques7. Or Boissons alcooliques industrielles

DORS/79-752, art. 5; DORS/80-500, art. 6; DORS/82-596, art. 3; DORS/84-440, art. 4; DORS/84-602, art. 1; DORS/89-198, art. 6 à 10; DORS/92-725, art. 5; DORS/93-466, art. 2; DORS/94-689, art. 2(F); DORS/95-434, art. 1; DORS/95-493, art. 1; DORS/97­ 516, art. 4; DORS/98-580, art. 1(F); DORS/99-96, art. 1; DORS/2000-50, art. 1; DORS/2000-146, art. 1 à 3; DORS/2007-75, art. 3; DORS/2010-94, art. 8(A); DORS/2010-143, art. 13.

TABLEAU IV

ADDITIFS ALIMENTAIRES AUTORISÉS COMME ÉMULSIFS, AGENTS GÉLATINISANTS, STABILISANTS OU ÉPAISSISSANTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Achards (relish); cornichons à la

(1) Bonnes pratiquesA.1 Gomme arabique (1) moutarde; crème; lait industrielles(indication de l’arôme); lait écrémé (indication

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; sauce à salade; sauce française Crème glacée; mélange pour crème glacée; lait(2) (2) 0,5 %glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

0,5 % selon les (5) Margarine réduite en (5) exigences de l’articlecalories B.09.017

Asperges en conserve, 1,0 % selon lesharicots jaunes en exigences de la(6) conserve; haricots verts (6) dispositionen conserve; pois en B.11.002d)(viii)(C).conserve

A.2 Monoglycéridesacétylés Aliments non normalisés

Bonnes pratiques industrielles

A.3 (1) Pain (1) 6 000 p.p.m. de farine

Esters tartriques des (2) Aliments non normalisés (2)

Bonnes pratiques industrielles

mono- et diglycérides acétylés

(3)

Préparations pour nourrissons à base d’acides aminés (3)

240 p.p.m. prête à consommer

cristallisés Fromage de porc; (nom de la volaille) en

A.4 Agar-agar (1) conserve; crème; fromage de tête ou tête fromagée; gelée de

(1) Bonnes pratiquesindustrielles

(nom du fruit) avec pectine; liant à viande

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(quand il est vendu pour servir dans les viandes ou dans les sous-produits de la viande conditionnés dans lesquels un agent gélatinisant est autorisé); sous-produits de la viande en pain; pain de viande; lait (indication de l’arôme); cornichons à la moutarde; viande en pot; sous-produits de la viande en pot; poisson ou viande conditionnés (Titre 21); achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Crème glacée; mélange pour crème glacée; lait(2) (2) 0,5 %glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

0,5 % selon les (5) Margarine réduite en (5) exigences de l’articlecalories B.09.017

Ale; bière; crème; (1) Bonnes pratiquesA.5 Algine (1) sauce vinaigrette; bière industrielleslégère; liqueur de malt;

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

lait (indication de l’arôme); cornichons à la moutarde; porter; achards (relish); sauce à salade; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé; stout

0,03 % de la préparation pour nourrissons prête à consommer. Si l’on

(2) Préparations pour (2) emploie aussi lanourrissons carraghénine ou la gomme de guar, ou les deux, le total ne doit pas dépasser 0,03 %

Fromage cottage; fromage cottage en crème; crème glacée;

(3) mélange pour crème (3) 0,5 % glacée; lait glacé; mélange pour le lait glacé

(4) Sorbet laitier (4) 0,75 % Aliments non (5) Bonnes pratiques(5) normalisés industrielles

0,5 % selon les (6) Margarine réduite en (6) exigences de l’articlecalories B.09.017

0,5 % selon les (7) Crème sure (7) exigences de la

disposition

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

B.08.077b)(vii)(A) Asperges en conserve; 1,0 % selon lesharicots jaunes en exigences de la(8) conserves; haricots (8) dispositionverts en conserves; pois B.11.002d)(viii)(C)en conserve

0,1 % de la préparation

(9)

Préparations pour nourrissons à base d’acides aminés isolés ou d’hydrolysats de protéines, ou des deux

(9)

pour nourrissons prête à consommer. Si l’on emploie aussi la carraghénine ou la gomme de guar, ou les deux, le total ne doit pas dépasser 0,1 % 0,05 % de la préparation pour

(10)

Préparations pour nourrissons sans lactose, à base de protéines du lait

(10)

nourrissons prête à consommer. Si l’on emploie aussi la carraghénine ou la gomme de guar, ou les deux, le total ne doit pas dépasser 0,05 %

A.6 Acide alginique Mêmes aliments quepour l’algine

Mêmes limites de tolérance que pour l’algine

A.7 Alginate d’ammonium Mêmes aliments quepour l’algine

Mêmes limites de tolérance que pour l’algine

A.8 Carraghénineammoniacale Mêmes aliments que pour la carragénine

Mêmes limites de tolérance que pour la carraghénine.

A.9 Furcellerand’ammonium Mêmes aliments que pour le furcelleran

Mêmes limites de tolérance que pour le furcelleran

Pain; crème; lait (indication de l’arôme);

A.9A Sel d’ammonium deglycéride phosphorylé (1) cornichons à la moutarde; achards (relish); lait écrémé

(1) Bonnes pratiquesindustrielles

(indication de l’arôme); lait partiellement

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Crème glacée; mélange pour crème glacée; lait(2) (2) 0,5 %glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

(5) Produits de chocolat; (5) 0,7 %produits du cacao Huiles essentielles; sauces non normalisées; mélanges Bonnes pratiquesA.10 Arabinogalactane à poudings; base ou industriellesmélanges pour breuvage et mélanges de garniture à tarte

Levure de boulanger Aliments non Bonnes pratiquesB.1 Glycan normalisés industrielles Mêmes limites deMêmes aliments queC.1 Alginate de calcium tolérance que pourpour l’algine l’algine

Aliments non (1) Bonnes pratiquesC.2 Carbonate de calcium (1) normalisés industrielles Mélange de poisson et

(2) Bonnes pratiques(2) de viande préparés visé industriellesà l’alinéa B.21.006n) Mêmes limites deMêmes aliments queC.3 Carraghénine calcique tolérance que pour lapour la carraghénine carraghénine

(1) Fromage à la crème à (1) 4,0 %, conformémentC.4 Citrate de calcium tartiner; fromage à la aux exigences des

Colonne I Article Additifs

C.5 Furcelleran de calcium

C.6 Gluconate de calcium

Glycérophosphate deC.7 calcium Hypophosphite deC.8 calcium

C.9 Phosphate bicalcique

Colonne II Permis dans ou sur

crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

Mêmes aliments que pour le furcelleran

Aliments non normalisés Mélanges à desserts non normalisés Mélanges à desserts non normalisés Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la(1) variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de

Colonne III Limites de tolérance

articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

Mêmes limites de tolérance que pour le furcelleran Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

3,5 %, conformément aux exigences des articles B.08.038,

(1) B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Aliments non (2) Bonnes pratiques(2) normalisés industrielles Aliments non Bonnes pratiquesC.10 Phosphate tricalcique normalisés industrielles Crème glacée; mélange pour crème glacée; laitC.11 Sulfate de calcium (1) (1) 0,5 %glacé; mélange pour lait glacé

(2) Sorbet laitier (2) 0,75 % Aliments non (3) Bonnes pratiques(3) normalisés industrielles

(4) Fromage cottage en (4) 0,05 %crème Crème à fouetter

(5) thermisée à une chaleur (5) 0,005 % supérieure à 100 °C Mélange de poisson et

(6) de viande préparés visé (6) 0,06 % à l’alinéa B.21.006n) Aliments non Bonnes pratiquesC.12 Tartrate de calcium normalisés industrielles Mêmes aliments que Mêmes limites de pour la tolérance que pour laC.13 Carboxyméthylcellulose carboxyméthylcellulose carboxyméthylcellulose sodique sodique Crème, sauce vinaigrette; (indication de l’arôme) lait; cornichons à la (1) Bonnes pratiquesC.14 Gomme de caroube (1) moutarde; achards industrielles. (relishes); sauce à salade; (indication de l’arôme) lait écrémé;

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(indication de l’arôme) lait partiellement écrémé; (indication de l’arôme) lait écrémé additionné de solides du lait; (indication de l’arôme) lait partiellement écrémé additionné de solides du lait; fromage fondu de lait écrémé Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

0,5 % selon les (3) Margarine (3) exigences de l’alinéahypocalorique B.09.017b) (4) Sorbet laitier (4) 0,75 %

0,5 % selon les exigences de la(5) Crème sure (5) disposition B.08.077b)(vii)(A)

Aliments non (6) Bonnes pratiques(6) normalisés industrielles. Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); 0,5 %, conformémentfromage à la crème à aux exigences destartiner; fromage à la articles B.08.035,crème à tartiner (avec B.08.037, B.08.038,(7) indication des (7) B.08.039, B.08.041.3,ingrédients ajoutés); B.08.041.4,fromage fondu à B.08.041.6, B.08.041.7tartiner; fromage fondu et B.08.041.8à tartiner (avec indication des ingrédients ajoutés); fromage (indication de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Ale; bière; fromage de porc; (nom de la volaille) en conserve; crème; sauce vinaigrette; fromage de tête ou tête fromagée; gelée à (nom du fruit) avec pectine; bière légère; liqueur de malt; liant à viande (quand il est vendu pour servir dans les viandes ou dans les sous-produits de la viande conditionnés dans lesquels un agent gélatinisant est

(1) Bonnes pratiquesC.15 Carraghénine (1) autorisé); sous-produits industriellesde la viande en pain; pain de viande; lait (indication de l’arôme); cornichons à la moutarde; porter; viande en pot; sous­ produits de la viande en pot; poisson ou viande conditionnés (Titre 21); achards (relish); sauce à salade; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; stout Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Lait évaporé (3) 0,015 % (4) Sorbet laitier (4) 0,75 %

Lait évaporé partiellement écrémé;(5) (5) 0,01 %lait concentré partiellement écrémé

0,1 % de la préparation Préparations pour pour nourrissons prête nourrissons à base à consommer. Si l’on

(6) d’acides aminés isolés (6) emploie aussi l’algine ou d’hydrolysats de ou la gomme de guar, protéines, ou les deux ou les deux, le total ne

doit pas dépasser 0,1 % 0,03 % de la préparation pour nourrissons prête à consommer. Si l’on

(7) Préparations pour (7) emploie aussi l’alginenourrissons ou la gomme de guar ou les deux, le total ne doit pas dépasser 0,03 %

Aliments non (8) Bonnes pratiques(8) normalisés industrielles 0,5 % selon les

(9) Margarine réduite en (9) exigences de l’articlecalories B.09.017 0,5 % selon les exigences de la(10) Crème sure (10) disposition B.08.077b)(vii)(A)

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(11)

(12)

(13)

C.17 Gomme de cellulose

Asperges en conserve; haricots jaunes en conserve, haricots verts en conserve, pois en conserve Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

Préparations pour nourrissons sans lactose, à base de protéines du lait

Mêmes aliments que pour la carboxyméthylcellulose sodique

(11)

(12)

(13)

1,0 % selon les exigences de la disposition B.11.022d)(viii)(C)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8

0,05 % de la préparation pour nourrissons prête à consommer. Si l’on emploie aussi l’algine ou la gomme de guar, ou les deux, le total ne doit pas dépasser 0,05 % Mêmes limites de tolérance que pour la carboxyméthylcellulose sodique

F.1 Furcelleran (1) Ale; bière; bière légère; (1) Bonnes pratiques

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

G.1 Gélatine

liqueur de malt; porter; stout Aliments non(2) normalisés

(3) Margarine réduite encalories

Asperges en conserve; haricots jaunes en

(4) conserve; haricots verts en conserve; pois en conserve Fromage de porc; (nom de la volaille) en conserve; crème; fromage de tête ou tête fromagée; gelée de (nom du fruit) avec pectine; liant à viande (quand il est vendu pour servir dans les sous-produits de la viande conditionnés dans lesquels un agent gélatinisant est autorisé); sous-produits de la viande en pain;

(1) pain de viande; lait (indication de l’arôme); cornichons à la moutarde; viande en pot; sous-produits de la viande en pot; poisson ou viande conditionnés (Titre 21); jambons, épaules, soc de porc et épaules de porc genre pique-nique préparés; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme);

industrielles

(2) Bonnes pratiquesindustrielles

(3)

(4)

0,5 % selon les exigences de l’article B.09.017

1,0 % selon les exigences de la disposition B.11.002d)(viii)(C)

(1) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Crème sure de la

(4) 0,5 % selon les(4) disposition exigencesB.08.077b)(vii)(A) Aliments non (5) Bonnes pratiques(5) normalisés industrielles. Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des 0,5 %, conformémentingrédients ajoutés); aux exigences desfromage fondu à articles B.08.035,tartiner; fromage fondu B.08.037, B.08.038,(6) à tartiner (avec (6) B.08.039, B.08.041.3,indication des B.08.041.4,ingrédients ajoutés); B.08.041.6, B.08.041.7fromage conditionné à et B.08.041.8froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(avec indication des ingrédients ajoutés) Confiseries non

G.2 Gomme gellan (1) normalisées; produits de glaçage Tartinades de fruits; aspics; produits de fruits transformés;

(2) (sauf pour l’un de ces produits visé par une norme dans le présent règlement) Margarine réduite en calories; tartinades(3) réduites en matière grasse Produits laitiers (sauf pour l’un de ces

(4) produits visé par une norme dans le présent règlement) Sauce vinaigrette; sauce à salade; sauces d’assaisonnements (sauf pour l’un de ces(5) produits visé par une norme dans le présent règlement); gélatines; poudings; garnitures Mélanges pour pâtisseries; produits de boulangerie; (sauf pour

(6) l’un de ces produits visé par une norme dans le présent règlement) Sauces; glaçages; sirops de table; (sauf pour l’un de ces(7) produits visé par une norme dans le présent règlement)

(1) 0,5 %

(2) 0,3 %

(3) 0,25 %

(4) 0,15 %

(5) 0,1 %

(6) 0,1 % du mélange sec

(7) 0,05 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

G.3 Gomme de guar

(8)

(9)

(1)

(2)

Boissons (sauf pour l’un de ces produits visé par une norme dans le présent règlement) Grignotines (sauf pour l’un de ces produits visé par une norme dans le présent règlement) Crème; sauce vinaigrette; lait (indication de l’arôme); mincemeat; cornichons à la moutarde; achards (relish); sauce à salade; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Fromage cottage; fromage cottage en crème; crème glacée; mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Préparations pournourrissons

(4) Sorbet laitier

(8) 0,08 %

(9) 0,1 %

(1) Bonnes pratiquesindustrielles

(2) 0,5 %

0,03 % de la préparation pour nourrissons prête à consommer. Si l’on(3) emploie aussi l’algine ou la carragénine ou les deux, le total ne doit pas dépasser 0,03 %

(4) 0,75 %

Colonne I Colonne II Article Additifs Permis dans ou sur

Aliments non(5) normalisés

(6) Margarine réduite encalories

(7)

(8)

(9)

(10)

Crème sure de la disposition B.08.077b)(vii)(A) Asperges en conserve; haricots jaunes en conserve; haricots verts en conserve; pois en conserve Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

Préparations pour nourrissons à base d’acides aminés isolés ou d’hydrolysats de protéines, ou des deux

Colonne III Limites de tolérance

(5) Bonnes pratiquesindustrielles 0,5 % selon les

(6) exigences de l’article B.09.017

(7) 0,5 % selon lesexigences

(8)

(9)

(10)

1,0 % selon les exigences de la disposition B.11.002d)(viii)(C)

0,5 %, conformément aux exigences des articles B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8

0,1 % de la préparation pour nourrissons prête à consommer. Si l’on emploie aussi l’algine ou la carraghénine, ou les deux, le total ne doit

Colonne I Article Additifs

G.4 Gomme sénégal

H.1 Hydroxylécithine

HydroxypropylH.1A cellulose

HydroxypropylH.2 méthylcellulose

Gélose de mousseI.1 d’Irlande

Gomme sterculiaK.1 (Karaya)

Colonne II Permis dans ou sur

Préparations pour nourrissons sans(11) lactose, à base de protéines du lait

Mêmes aliments que pour la gomme arabique

(1) Produits de chocolat;produits du cacao Aliments non(2) normalisés Aliments non normalisés Sauce vinaigrette; lait (indication de l’arôme); cornichons à la moutarde; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de(1) l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; sauce à salade Aliments non(2) normalisés

Mêmes aliments que pour la carraghénine

Sauce vinaigrette; lait (1) (indication de l’arôme);

cornichons à la

Colonne III Limites de tolérance

pas dépasser 0,1 % 0,05 % de la préparation pour nourrissons prête à consommer. Si l’on(11) emploie aussi l’algine ou la carraghénine, ou les deux, le total ne doit pas dépasser 0,05 % Mêmes limites de tolérance que pour la gomme arabique

(1) 1,0 %

(2) Bonnes pratiquesindustrielles Bonnes pratiques industrielles

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles Mêmes limites de tolérance que pour la carraghénine

(1) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

moutarde; achards (relish); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

0,5 % selon les (5) Margarine réduite en (5) exigences de l’articlecalories B.09.017

8,0 % (sauf que le total des mono- et des diglycérides et desMono- et diglycéridesL.1 (1) Shortening (1) mono- et diglycérideslactylés lactylés, ne doit pas dépasser 20,0 % du shortening)

Aliments non (2) 8,0 % de la teneur en(2) normalisés gras Esters lactyliques Aliments non Bonnes pratiquesL.1A d’acides gras normalisés industrielles

Pain; crème; lait (indication de l’arôme); cornichons à la (1) Bonnes pratiquesL.2 Lécithine (1) moutarde; achards industrielles (relish); lait écrémé (indication de l’arôme);

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait Crème glacée; mélange 0,5 %, seul ou en pour crème glacée; lait combinaison avec(2) (2)glacé; mélange pour d’autres agents lait glacé émulsifiants

0,03 % de la

(3) Préparations pour préparation pour(3)nourrissons nourrissons prête à consommer

(4) Sorbet laitier (4) 0,75 % Aliments non (5) Bonnes pratiques(5) normalisés industrielles

(6) Margarine (6) 0,2 %

(7) Margarine réduite en (7) 0,5 %calories Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage

(8) fondu; préparation de (8) 0,2 % fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(9) Poudre de lait (9) 0,5 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(10) Produits de chocolat; (10) 1,0 %produits du cacao Mêmes aliments que Mêmes limites de

L.3 Gomme de caroubier pour la gomme de tolérance que pour la caroube gomme de caroube.

0,3 %, calculé en selM.1 Chlorure de magnésium Tofu anhydre Ale; bière; sauce vinaigrette; bière

(1) Bonnes pratiquesM.2 Méthylcellulose (1) légère; liqueur de malt; industriellesporter; sauce à salade; stout Aliments non (2) Bonnes pratiques(2) normalisés industrielles

Cellulose méthyl- Aliments non Bonnes pratiquesM.3 éthylique normalisés industrielles

(1) Pain; crème; pâte de (1) Bonnes pratiquesM.4 Monoglycérides poisson industrielles

(2) Produits de chocolat; (2) 1,5 %produits du cacao Stabilisants dans la proportion totale deMélange pour crème 0,5 %, conformément(3) glacée; mélange pour (3) aux sous-alinéaslait glacé B.08.061b)(vi) et B.08.071b)(vi)

(4) Fromage cottage en (4) Bonnes pratiquescrème industrielles 0,25 % de la

(5) Préparations pour préparation pour(5)nourrissons nourrissons prête à consommer

(6) Boyaux de saucisse (6) 0,35 % du boyau (7) Margarine (7) 0,5 % (8) Sorbet laitier (8) 0,75 %

10,0 % (sauf que le total des mono et diglycérides et des(9) Shortening (9) mono et diglycérides lactylés ne doit pas dépasser 20,0 % du

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

shortening) (10) Crème sure (10) 0,3 %

(11) Aliments non (11) Bonnes pratiquesnormalisés industrielles Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des 0,5 % conformémentingrédients ajoutés); aux exigences despréparation de fromage articles B.08.040,(12) fondu; préparation de (12) B.08.041, B.08.041.1,fromage fondu (avec B.08.041.2, B.08.041.3indication des et B.08.041.4ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

(1) Pain; crème; pâte de (1) Bonnes pratiquesM.5 Mono- et diglycérides poisson industrielles

(2) Produits de chocolat; (2) 1,5 %produits du cacao Stabilisants dans la proportion totale deMélange pour crème 0,5 %, conformément(3) glacée; mélange pour (3) aux sous-alinéaslait glacé B.08.061b)(vi) et B.08.071b)(vi)

Fromage cottage; (4) Bonnes pratiques(4) Fromage cottage en industriellescrème

0,25 % de la

(5) Préparations pour préparation pour(5)nourrissons nourrissons prête à consommer

(6) Boyaux de saucisse (6) 0,35 % du boyau (7) Margarine (7) 0,5 % (8) Sorbet laitier (8) 0,75 %

Colonne I Article Additifs

Sels monosodiques de M.6 mono- et diglycérides

phosphorylés

O.1 Gomme d’avoine

P.1 Pectine

Colonne II Permis dans ou sur

(9) Shortening

(10) Crème sure

(11) Aliments nonnormalisés Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage

(12) fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Émulsions à base d’huiles végétales

(1) comestibles servant d’enduits pour batterie de cuisine Aliments non(1) normalisés Confiture de pommes (ou de rhubarbe) et de (nom du fruit); crème, marmelade de figues;(1) marmelade de figues avec pectine; sauce vinaigrette; confiture de (nom du fruit);

Colonne III Limites de tolérance

10,0 % (sauf que le total des mono et diglycérides et des

(9) mono et diglycérides lactylés ne doit pas dépasser 20,0 % du shortening)

(10) 0,3 %

(11) Bonnes pratiquesindustrielles

0,5 % conformément aux exigences des articles B.08.040,(12) B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(1) 4,0 %

(1) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

confiture de (nom du fruit) avec pectine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade de (nom de l’agrume) avec pectine; lait (indication de l’arôme); mincemeat; cornichons à la moutarde; marmelade d’ananas; marmelade d’ananas avec pectine; achards (relish); sauce à salade; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait Crème glacée; mélange pour crème glacée; lait(2) (2) 0,5 %glacé; mélange pour lait glacé

0,5 % conformément à (3) Crème sure (3) la disposition

B.08.077b)(vii)(A) (4) Sorbet laitier (4) 0,75 %

Aliments non (5) Bonnes pratiques(5) normalisés industrielles Aliments non (1) Bonnes pratiques(1) normalisés industrielles

Esters P.1A polyglycéroliques (2) Huiles végétales (2) 0,025 %

0,2 % conformémentd’acides gras (3) Margarine réduite en (3) aux exigences decalories l’alinéa B.09.017c)

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(1) Produits de chocolat (1) 0,5 % Enrobages de confiserie non(2) (2) 0,25 %normalisés à saveur deEsters polyglycériques chocolatP.1B d’acides gras d’huile de Émulsions à basericin transestérifiés d’huiles végétales

(3) comestibles pour (3) 2,0 % enduire les moules à cuisson

0,1 %. Si l’on emploie Mono-oélate Crème glacée; mélange le tristéarate polyoxyéthylénique pour crème glacée; lait polyoxyéthyléniqueP.2 (1) (1)(20) de sorbitan glacé; mélange pour (20) de sorbitan, le Polysorbate 80 lait glacé; sorbet laitier total ne doit pas

dépasser 0,1 %

(2) Desserts congelés non (2) 0,1 %normalisés

(3) Achards (relish) et (3) 0,05 %cornichons 0,05 % du breuvage. Si l’on emploie aussi le

(4) Bases ou mélanges monostéarate de(4)pour breuvages sorbitan, le total ne doit pas dépasser 0,05 % du breuvage 0,1 %. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan, le tristéarate

(5) Mélange imitation de (5) polyoxyéthyléniquecrème en poudre (20) de sorbitan ou le monostéarate de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,4 % 0,05 %. Si l’on emploie aussi le monostéarateGarnitures fouettées à(6) (6) polyoxyéthyléniquel’huile végétale (20) de sorbitan, le tristéarate

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

polyoxyéthylénique (20) de sorbitan ou le monostéarate de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,4 % 0,5 % de la glace à gâteau finie. Si l’on emploie aussi le monostéarate polyoxyéthyléniqueGlaces à gâteaux; (20) de sorbitan ou le(7) mélanges pour glaces à (7) monostéarate degâteaux sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % de la glace à gâteau finie

(8) Sel (8) 10 parties par million (9) Crème fouettée (9) 0,1 %

(10) Rafraîchisseurs (10) 100 p.p.m.d’haleine

(11) Fromage cottage en (11) 80 p.p.m.crème Huiles d’épice et oléorésines d’épice utilisées dans le mélange de salaison

(12) pour mariner des (12) 0,2 % de la marinade viandes de salaison ou des sous-produits de viande de salaison (Titre 14)

(13) Boyaux de saucisse (13) 0,15 % de boyau Bonnes pratiques industrielles. Les

(14) Agents aromatisants à résidus de polysorbate(14)saveur de fumée 80 ne doivent pas dépasser 275 p.p.m. dans le produit fini.

(15) Huiles végétales (15) 0,125 % (16) Préparations de rocou (16) 25 % de la préparation

Colonne I Colonne II Article Additifs Permis dans ou sur

(17) Préparations decurcuma

(18) Arômes de fuméeliquide concentrés

(19) Sauce à salade nonnormalisée

Mélange imitation de crème en poudre; agents de crémage àMonostéarate l’huile végétale;polyoxyéthyléniqueP.3 (1) garnitures fouettées à(20) de sorbitan l’huile végétale;Polysorbate 60 mélange pour garnitures à l’huile végétale

(2) Gâteaux

Colonne III Limites de tolérance

colorante totale

(17) 50 % de la préparationcolorante totale Bonne pratiques industrielles. Les résidus de polysorbate(18) 80 ne peuvent dépasser 0,3 % dans le produit fini.

(19) 0,25 %

0,4 %. Si l’on emploie aussi le tristéarate polyoxyéthylénique (20) de sorbitan, le monostéarate de sorbitan, ou le mono­ oléate polyoxyéthylénique (20) de sorbitan, soit séparément, soit ensemble, le total ne doit pas dépasser 0,4 %, sauf que, dans les garnitures fouettées renfermant de l’huile(1) végétale, on peut employer une combinaison de polysorbate (60) et de monostéarate de sorbitan de plus de 0,4 %, si la proportion de polysorbate (60) ne dépasse pas 0,77 % et celle du monostéarate de sorbitan ne dépasse pas 0,27 % de la garniture fouettée renfermant de l’huile végétale

(2) 0,5 % du poids à l’étatsec. Si l’on emploie

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

aussi le tristéarate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,5 % du poids sec 0,5 % du poids à l’état sec. Si l’on emploie

(3) Gâteaux; mélanges àgâteaux (3) aussi le monostéarate de sorbitan, le total ne doit pas dépasser 0,7 % du poids à l’état sec 0,5 %. Si l’on emploie aussi un mélange de

(4)

Enrobages de confiserie non normalisés et produits de confiserie moulés non normalisés utilisés comme confiserie ou pour la cuisson

(4)

l’un quelconque des ingrédients suivants : tristéarate polyoxyéthymique [polyoxyéthylénique] (20) de sorbitan, monostéarate de sorbitan ou tristéarate de sorbitan, le total ne doit pas dépasser 1,0 % 0,5 % de la glace à gâteau finie. Si l’on emploie aussi le monostéarate de

(5) Glaces à gâteaux; mélange pour glaces à gâteaux

(5)

sorbitan ou le mono­ oléate polyoxyéthylénique (20) de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % de la glace à gâteau finie

(6) Poudings; garnitures àtarte (6) 0,5 % du poids à l’état sec 0,05 % du breuvage. Si

(7) Bases ou mélangespour breuvages (7) l’on emploie aussi le monostéarate de sorbitan, le total ne doit pas dépasser 0,05 % du

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

breuvage Substitut de crème sure(8) (8) 0,1 %(aigre) Sauces à salade non normalisées; sauces(9) (9) 0,3 %cuisinées, non normalisées, en boîte Base de matière grasse

(10) pour l’auto-arrosage de (10) 0,25 % la volaille par injection Tartinades à sandwich non normalisées;(11) (11) 0,2 %trempettes non normalisées

(12) Bases ou mélanges secs (12) 250 p.p.m. de soupepour soupes prête à consommer

(13) Mélange sec de pâte à (13) 0,5 % du mélange secfrire d’enrobage 120 p.p.m. dans la

(14) Cocktails alcoolisés (14) boisson prête àpréparés consommer Lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de

Polyoxyéthylène (20) l’arôme); lait écrémé P.4 Tristéarate de sorbitan; (1) (indication de l’arôme) (1) 0,5 %

Polysorbate 65 additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait

0,1 %. Si l’on emploie Crème glacée; mélange aussi le mono-oléate pour crème glacée; lait polyoxyéthylénique(2) (2)glacé; mélange pour (20) de sorbitan, le lait glacé; sorbet laitier total ne doit pas

dépasser 0,1 %

(3) Desserts congelés non (3) 0,1 %normalisés

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

0,3 % du poids à l’état sec. Si l’on emploie aussi le monostéarate polyoxyéthylénique(4) Gâteaux (4) (20) de sorbitan, le total ne doit pas dépasser 0,5 % du poids sec 0,5 %. Si l’on emploie aussi un mélange de l’un quelconque des ingrédients suivants :

Enrobages de monostéarate (5) confiserie non (5) polyoxyéthylénique

normalisés (20) de sorbitan, monostéarate de sorbitan ou tristéarate de sorbitan, le total ne doit pas dépasser 1,0 % 0,05 % du breuvage. Si l’on emploie aussi le

(6) Bases ou mélanges monostéarate de(6)pour breuvages sorbitan, le total ne doit pas dépasser 0,05 % du breuvage 0,4 %. Si l’on emploie aussi le monostéarateMélange imitation de polyoxyéthyléniquecrème en poudre; (20) de sorbitan, leagents de crémage à monostéarate del’huile végétale;(7) (7) sorbitan ou le mono-garnitures fouettées à oléatel’huile végétale; polyoxyéthyléniquemélange pour garniture (20) de sorbitan, seulsà l’huile végétale ou mélangés, le total ne doit pas dépasser 0,4 %

Rafraîchisseurs(8) (8) 200 p.p.m.d’haleine Stéarate Produits de boulangerieP.5 0,4 %polyoxyéthylénique (8) non normalisés

Mêmes aliments que Mêmes limites deP.6 Alginate de potassium pour l’algine tolérance que pour

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

l’algine

P.7 Carragénine potassique

P.8 Chlorure de potassium

P.9 Citrate de potassium (1)

Furcelleran deP.10 potassium

P.11 Phosphate dipotassique (1)

Mêmes aliments que pour la carraghénine

Aliments non normalisés Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des (1)ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés)

Mêmes aliments que pour le furcelleran

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (1)(indication de la variété); fromage fondu (indication de la variété) (avec

Mêmes limites de tolérance que pour la carraghénine Bonnes pratiques industrielles

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

Mêmes limites de tolérance que pour le furcelleran

3,5 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

indication des ingrédients ajoutés);

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Ale; bière; sauce vinaigrette; bière légère; liqueur de malt; cornichons à laAlginate de (1) Bonnes pratiquesP.12 (1) moutarde; porter;propylèneglycol industriellesfromage fondu; fromage à la crème fondu; achards (relish); sauce à salade; stout Fromage cottage; fromage cottage en

(2) crème; crème glacée; (2) 0,5 % mélange pour crème glacée;

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

0,5 % selon les (5) Margarine réduite en (5) exigences de l’articlecalories B.09.017

0,5 % selon les exigences de la(6) Crème sure (6) disposition B.08.077b)(vii)(A)

Asperges et conserve; 1,0 % selon lesharicots jaunes en exigences de la(7) conserve; haricots verts (7) dispositionen conserve; pois en B.11.002d)(viii)(C)conserve Fromage à la crème; 0,5 %, conformément

(8) fromage à la crème (8) aux exigences des (avec indication des articles B.08.035,

Colonne I Article Additifs

Ether P.13 propylèneglycolique de

méthylcellulose

Esters monoacides grasP.14 de propylèneglycol

Pyrophosphate acide deS.1 sodium

Colonne II Permis dans ou sur

ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

Mêmes aliments que l’hydroxypropyl méthylcellulose

(1) Mélange pour crèmeglacée Aliments non(2) normalisés Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la(1) variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de

Colonne III Limites de tolérance

B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 et B.08.041.8

Mêmes limites de tolérance que pour l’hydroxypropyl méthylcellulose

(1) 0,35 % de la crèmeglacée faite du mélange

(2) Bonnes pratiquesindustrielles

3,5 %, conformément aux exigences des articles B.08.038,

(1) B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner avec (indication des ingrédients ajoutés)

Mêmes limites de (1) Mêmes aliments queS.2 Alginate de sodium (1) tolérance que pourpour l’algine l’algine (2) Gros cristaux de sel (2) 15 p.p.m.

(3) Lustre de poisson (3) Bonnes pratiquescongelé industrielles Fromage à la crème à tartiner; fromage à la crème à tartiner avec (indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu 3,5 %, conformément(indication de la aux exigences desvariété) (avecPhosphate double articles B.08.038,indication desS.2A d’aluminium et de (1) (1) B.08.039, B.08.040,ingrédients ajoutés);sodium B.08.041, B.08.041.1,préparation de fromage B.08.041.2, B.08.041.3fondu; préparation de et B.08.041.4fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Crème; sauce vinaigrette; lait (indication de l’arôme);Carboxyméthylcellulose (1) Bonnes pratiquesS.3 (1) cornichons à lasodique industriellesmoutarde; achards (relish); sauce à salade; lait écrémé (indication

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de l’arôme); lait partiellement écrémé (indication de l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % Aliments non (4) Bonnes pratiques(4) normalisés industrielles

(5) Lustre de poisson (5) Bonnes pratiquescongelé industrielles Fromage (indication de la variété) fondu; fromage (indication de la variété) fondu (avec indication des

(6) ingrédients ajoutés); (6) 0,5 % préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés) Fromage à la crème; 0,5 %, conformémentfromage à la crème aux exigences des(avec indication des articles B.08.035,ingrédients ajoutés); B.08.037, B.08.038,(7) fromage à la crème à (7) B.08.039, B.08.041.3,tartiner; fromage à la B.08.041.4,crème à tartiner (avec B.08.041.6, B.08.041.7indication des et B.08.041.8ingrédients ajoutés);

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

Mêmes limites deMêmes aliments queS.4 Carraghénine sodique tolérance que pour lapour la carraghénine carraghénine Mêmes aliments que Mêmes limites de

Glycolate sodique de pour la tolérance que pour laS.5 cellulose carboxyméthylcellulose carboxyméthylcellulose sodique sodique Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu 4,0 %, conformément (indication de la aux exigences des variété) (avec articles B.08.038,

S.6 Citrate de sodium (1) indication des (1) B.08.039, B.08.040, ingrédients ajoutés); B.08.041, B.08.041.1, préparation de fromage B.08.041.2, B.08.041.3 fondu; préparation de et B.08.041.4 fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des

Colonne I Article Additifs

S.7 Furcelleran sodique

S.8 Gluconate de sodium

Hexamétaphosphate de sodium

Colonne II Permis dans ou sur

ingrédients ajoutés) Lait évaporé; lait écrémé évaporé ou lait écrémé concentré; lait

(2) évaporé partiellement écrémé ou lait concentré partiellement écrémé Crème glacée; mélange pour crème glacée; lait(3) glacé; mélange pour lait glacé

(4) Sorbet laitier

(1)

(1)

Mêmes aliments que pour le furcelleran

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Cornichons à la moutarde; achards (relish);

Colonne III Limites de tolérance

(2) 0,1 % seul ou associé àdu phosphate disodique

(3) 0,5 %

(4) 0,75 %

(1)

Mêmes limites de tolérance que pour le furcelleran

4,0 %, conformément aux exigences des articles B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 et B.08.041.4

(1) Bonnes pratiquesindustrielles

(2) Crème glacée; mélange (2) 0,5 %

S.9

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

pour crème glacée; lait glacé; mélange pour lait glacé

0,05 % de la

(3) Préparations pour préparation pour(3)nourrissons nourrissons prête à consommer

(4) Sorbet laitier (4) 0,75 % Aliments non (5) Bonnes pratiques(5) normalisés industrielles Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu 3,5 %, conformément(indication de la aux exigences desvariété) (avec articles B.08.038,indication des(6) (6) B.08.039, B.08.040,ingrédients ajoutés); B.08.041, B.08.041.1,préparation de fromage B.08.041.2, B.08.041.3fondu; préparation de et B.08.041.4fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Mélange de poisson et

(7) de viande préparés visé (7) 0,1 % à l’alinéa B.21.006n) Lait (indication de l’arôme); cornichons à la moutarde; achards

(1) Bonnes pratiquesS.11 Phosphate disodique (1) (relish); lait écrémé industrielles(indication de l’arôme); lait partiellement écrémé (indication de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

l’arôme); lait écrémé (indication de l’arôme) additionné de solides du lait; lait partiellement écrémé (indication de l’arôme) additionné de solides du lait; fromage fondu au lait écrémé Fromage cottage;

(2) fromage cottage en (2) 0,5 % crème Lait évaporé; lait écrémé évaporé ou lait écrémé concentré; lait

(3) 0,1 % seul ou associé à(3) évaporé partiellement du citrate de sodiumécrémé ou lait concentré partiellement écrémé

0,05 % selon les exigences de la(4) Crème sure (4) disposition B.08.077b)(vii)(C)

Aliments non (5) Bonnes pratiques(5) normalisés industrielles Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu 3,5 %, conformément(indication de la aux exigences desvariété); fromage fondu articles B.08.038,(indication de la(6) (6) B.08.039, B.08.040,variété) (avec B.08.041, B.08.041.1,indication des B.08.041.2, B.08.041.3ingrédients ajoutés); et B.08.041.4préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu 3,5 %, conformément(indication de la aux exigences desvariété) (avec articles B.08.038,indication desS.12 Phosphate monosodique (1) (1) B.08.039, B.08.040,ingrédients ajoutés); B.08.041, B.08.041.1,préparation de fromage B.08.041.2, B.08.041.3fondu; préparation de et B.08.041.4fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Aliments non (2) Bonnes pratiques(2) normalisés industrielles Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); 3,5 %, conformément fromage fondu aux exigences des (indication de la articles B.08.038,

S.13 Phosphate trisodique (1) variété); fromage fondu (1) B.08.039, B.08.040, (indication de la B.08.041, B.08.041.1, variété) (avec B.08.041.2, B.08.041.3 indication des et B.08.041.4 ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Aliments non (2) Bonnes pratiques(2) normalisés industrielles Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu 4,0 %, conformément(indication de la aux exigences desvariété) (avec articles B.08.038,Tartrate double de indication desS.14 (1) B.08.039, B.08.040,potassium et de sodium (1) ingrédients ajoutés); B.08.041, B.08.041.1,préparation de fromage B.08.041.2, B.08.041.3fondu; préparation de et B.08.041.4fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Aliments non (2) Bonnes pratiques(2) normalisés industrielles Fromage à la crème à tartiner; fromage à la 3,5 %, conformémentcrème à tartiner (avec aux exigences desindication des articles B.08.038,Pyrophosphate ingrédients ajoutés);S.15 (1) (1) B.08.039, B.08.040,tétrasodique fromage fondu B.08.041, B.08.041.1,(indication de la B.08.041.2, B.08.041.3variété); fromage fondu et B.08.041.4(indication de la variété) (avec

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indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Aliments non (2) Bonnes pratiques(2) normalisés industrielles Mélange de poisson et

(3) de viande préparés visé (3) 0,1 % à l’alinéa B.21.006n)

S.15A Stéaroyl-2-lactylate de (1) Glaces et mélanges à (1) 0,4 % du poids dessodium glaces ingrédients secs

(2) Garnitures et mélanges (2) 0,5 % du poids despour garnitures ingrédients secs

(3) Poudings et mélanges à (3) 0,2 % du produit finipoudings Substituts de crème (4) 1,0 % du poids des(4) sure (aigre) ingrédients secs

(5) Agents de crémage à (5) 2,0 % du poids desl’huile végétale ingrédients secs

(6) Mélange de pâte à frire (6) 0,75 % du poids desingrédients secs

(7) Spiritueux à base de (7) 0,35 % dans le produitcrème non normalisés fini

(8) Sauce à salade; sauce (8) 0,4 % du produit finivinaigrette (9) Soupes (9) 0,2 % du produit fini

Fromage à la crème à 4,0 %, conformément tartiner; fromage à la aux exigences des crème à tartiner (avec articles B.08.038,

S.16 Tartrate de sodium (1) indication des (1) B.08.039, B.08.040, ingrédients ajoutés); B.08.041, B.08.041.1, fromage fondu B.08.041.2, B.08.041.3 (indication de la et B.08.041.4

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variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Mélange de poisson et

S.16A Tripolyphosphate de de viande préparés visé 0,1 %sodium à l’alinéa B.21.006n) 0,4 %. Si l’on emploie aussi le tristéarate polyoxyéthylénique (20) de sorbitan, le polysorbate (60) ou le mono-oléate polyoxyéthylénique (20) de sorbitan, soit

Mélange imitation de séparément, soit crème en poudre; ensemble, le total ne agents de crémage à doit pas dépasser l’huile végétale; 0,4 %, sauf que, dansMonostéarate deS.18 (1) garnitures fouettées à (1) les garnitures fouettéessorbitan l’huile végétale; renfermant de l’huile mélange pour végétale, on peut garnitures à l’huile employer une végétale combinaison de

monostéarate de sorbitan et de polysorbate (60) de plus de 0,4 %, si la proportion de monostéarate de sorbitan ne dépasse pas 0,27 % et celle du

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polysorbate (60) ne dépasse pas 0,77 % du poids de la garniture fouettée renfermant de l’huile végétale 0,6 % du poids à l’état sec. Si l’on emploie aussi le monostéarate

(2) Gâteaux; mélanges à polyoxyéthylénique(2)gâteaux (20) de sorbitan le total ne doit pas dépasser 0,7 % du poids à l’état sec 1,0 %. Si l’on emploie aussi un mélange de l’un quelconque des

Enrobages de ingrédients suivants : confiserie non monostéarate normalisés et produits polyoxyéthylénique

(3) de confiserie moulés (3) (20) de sorbitan, non normalisés utilisés tristéarate comme confiserie ou polyoxyéthylénique pour la cuisson (20) de sorbitan ou

tristéarate de sorbitan, le total ne doit pas dépasser 1,0 % 0,5 % de la glace à gâteau finie. Si l’on emploie aussi le mono­ oléate polyoxyéthylénique

Glaces à gâteaux; (20) de sorbitan ou le (4) mélanges pour glaces à (4) monostéarate

gâteaux polyoxyéthylénique (20) de sorbitan, seuls ou mélangés, le total ne doit pas dépasser 0,5 % de la glace à gâteau finie 0,05 % dans le

(5) Bases ou mélanges breuvage. Si l’on(5)pour breuvages emploie aussi le mono­ oléate

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polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,05 % dans le breuvage. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,05 % dans le breuvage

(6) Bases ou mélanges secs (6) 250 p.p.m. de soupepour soupes prête à consommer 1,5 % (les résidus de monostéarate de sorbitan dans le pain et

(7) Levure sèche (7) les autres produits de boulangerie au levain ne doivent pas dépasser 0,05 %).

(8) Produits de chocolat (8) 1,0 % (9) Poudings (9) 0,5 %

S.18A Trioléate de sorbitan Boyaux de saucisse 0,35 % de boyau S.18B Tristéarate de sorbitan (1) Margarine; shortening (1) 1 %

1 %, si l’on emploie aussi un mélange de n’importe quel des

Enrobages de ingrédients suivants : confiserie non monostéarate normalisés et produits polyoxyéthylénique

(2) de confiserie moulés (2) (20) de sorbitan, non normalisés utilisés tristéarate comme confiserie ou polyoxyéthylénique pour la cuisson (20) de sorbitan ou

monostéarate de sorbitan, le total ne doit pas dépasser 1 %

(3) Mélange pour crème (3) 0,035 % de la crèmeglacée glacée faite du mélange

(4) Desserts congelés non (4) 0,035 %normalisés

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Monoglycéryl- citrate Bonnes pratiquesS.19 Shorteningde stéaryle industrielles Esters saccharosiques (1) Préparations colorantesS.20 (1) 1,5 %d’acides gras de caroténoïdes

Confiseries non normalisées; enrobages(2) (2) 0,5 %de confiserie non normalisés

T.2 [Abrogé, DORS/2006-91, art. 5] Sauce vinaigrette; cornichons à la (1) Bonnes pratiquesT.3 Gomme adragante (1) moutarde; sauce à industrielles salade; achards (relish) Fromage cottage; fromage cottage en crème; crème glacée;(2) (2) 0,5 %mélange pour crème glacée; lait glacé; mélange pour lait glacé

(3) Sorbet laitier (3) 0,75 % (4) Caviar de lump (4) 1,0 %

Aliments non (5) Bonnes pratiques(5) normalisés industrielles 0,5 % selon les

(6) Margarine réduite en (6) exigences de l’articlecalories B.09.017 Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à 0,5 %, conformément tartiner; fromage à la aux exigences des crème à tartiner (avec articles B.08.035, indication des B.08.037, B.08.038,(7) (7)ingrédients ajoutés); B.08.039, B.08.041.3, fromage (indication de B.08.041.4, la variété) conditionné B.08.041.6, B.08.041.7 à froid (avec indication et B.08.041.8 des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de

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fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Poisson et viande préparés déchiquetés, sauf le caviar de lompe;

(8) poisson de salaison et (8) 0,75 % chair de poisson de salaison déchiquetés (Titre 21) Sauce vinaigrette; sauce à salade; (1) Bonnes pratiquesX.1 Gomme xanthane (1) aliments non industrielles normalisés

0,5 %. Si l’on emploieFromage cottage; aussi d’autres(2) fromage cottage en (2) stabilisants, le total necrème doit pas dépasser 0,5 % 0,5 % selon les

(3) Margarine réduite en (3) exigences de l’articlecalories B.09.017 Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à 0,5 %, conformémenttartiner; fromage à la aux exigences descrème à tartiner (avec articles B.08.035,indication des B.08.037, B.08.038,(4) ingrédients ajoutés); (4) B.08.039, B.08.041.3,fromage fondu à B.08.041.4,tartiner; fromage fondu B.08.041.6, B.08.041.7à tartiner (avec et B.08.041.8indication des ingrédients ajoutés); fromage (indication de la variété) conditionné à froid (avec indication

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des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Cornichons à la

(5) moutarde; achards (5) 0,1 % (relish)

0,1 %. Si l’on emploie aussi de la cellulose

(6) Mélange pour crème mycrocristalline et(6)glacée d’autres stabilisants, le total ne doit pas dépasser 0,5 % 0,1 %. Si l’on emploi aussi d’autres(7) Mélange pour lait glacé (7) stabilisants, le total ne doit pas dépasser 0,5 % 0,1 %. Si l’on emploie aussi d’autres

(8) Sorbet laitier (8) stabilisants, le total ne doit pas dépasser 0,75 %

Crème à fouetter (9) thermisée à une chaleur (9) 0,02 %

supérieure à 100 °C

DORS/78-403, art. 5(F) à 13(F), 14 à 16, 17(F) à 21(F) et 22; DORS/78-656, art. 14 et 15; DORS/78-876, art. 2; DORS/79-660, art. 5 à 10; DORS/79-752, art. 6; DORS/80­ 501, art. 4; DORS/81-60, art. 7 à 10; DORS/81-565, art. 4 et 5; DORS/81-934, art. 2 à 6; DORS/82-383, art. 9; DORS/82-1071, art. 9 à 16; DORS/83-932, art. 3 et 4; DORS/84­ 300, art. 50(A); DORS/84-602, art. 2; DORS/84-801, art. 3; DORS/85-179, art. 2 à 4; DORS/85-623, art. 3(A); DORS/88-99, art. 3; DORS/88-419, art. 2 et 3; DORS/90-87, art. 9; DORS/91-710, art. 1; DORS/92-64, art. 1; DORS/92-93, art. 2; DORS/92-344, art. 1; DORS/93-466, art. 3 et 4; DORS/94-38, art. 2; DORS/94-567, art. 2; DORS/94-689, art. 2(F); DORS/96-160, art. 2; DORS/96-376, art. 1; DORS/96-497, art. 1; DORS/96­ 499, art. 1; DORS/97-29, art. 1; DORS/97-263, art. 4 à 10; DORS/98-580, art. 1(F); DORS/2000-353, art. 7(F); DORS/2005-316, art. 1; DORS/2005-395, art. 1(F), 2 à 4 et 5(F); DORS/2006-91, art. 4 et 5; DORS/2007-75, art. 4 à 6; DORS/2007-76, art. 1 et 2; DORS/2010-41, art. 9(A); DORS/2010-94, art. 8(A) et 9(A); DORS/2010-142, art. 9, 10(F), 11 à 13, 14(F), 15(F) et 16.

TABLEAU V

ADDITIFS ALIMENTAIRES AUTORISÉS COMME ENZYMES DANS LES ALIMENTS

Colonne I Colonne II Colonne III Colonne IV

Article Additifs Source permise Permis dans ou sur Limites detolérance Bonnes

A.01 (1) Moût de bière (1) pratiques α-Acétolactate Bacillus subtilis ToC46 industrielles décarboxylase (pUW235)

(2) Moût dedistillerie (2) Bonnes pratiques industrielles

Fromage cheddar; Bonnes

A.02 (1) fromage (1) pratiques (indication de la industrielles

Aminopeptidase Lactococcus lactis variété)

(2)

Préparations aromatisantes à base de produits laitiers

(2) Bonnes pratiques industrielles

Protéines hydrolysées d’origine Bonnes

(3) animale, (3) pratiques végétale ou industrielles provenant du lait

A.1 Amylase (1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1) Bonnes pratiques industrielles

Aspergillus niger var.; Aspergillus oryzae var.; Bacillus subtilis var.;

(2) Farine; farine deblé entier; pain (2) Bonnes pratiques industrielles

Rhizopus oryzae var.; Bonnes Malt d’orge (3) Cidre; vin (3) pratiques

industrielles

(4) Sirop auchocolat (4) Bonnes pratiques industrielles

(5) Moût dedistillerie (5) Bonnes pratiques

Colonne I Colonne II Colonne III

Article Additifs Source permise Permis dans ou sur

Céréales

(6) séchées de petitdéjeuner à saveur de malt

(7) Jus de fruits nonconcentrés

Céréales (8) précuites

(instantanées) Amidon utilisé dans la production des dextrines, du maltose, du

(9) dextrose, duglucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté) Produits de

(10) boulangerie non normalisés

(11) Boissonsvégétales

Produits (12) céréaliers pour

bébés Ale; bière; bière

(1) légère; liqueurde malt; porter;

Aspergillus niger STz18­ stout

9 (pHUda7) (2) Moût dedistillerie

(3) Amidon utilisédans la

Colonne IV Limites de tolérance

industrielles

Bonnes (6) pratiques

industrielles

Bonnes (7) pratiques

industrielles Bonnes

(8) pratiques industrielles

Bonnes (9) pratiques

industrielles

Bonnes (10) pratiques

industrielles Bonnes

(11) pratiques industrielles Bonnes

(12) pratiques industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles Bonnes(3) pratiques

Colonne I

Article Additifs

Colonne II

Source permise

Bacillus amyloliquefaciens EBA 20 (pUBH2); Bacillus licheniformis; Bacillus licheniformis BML 592 (pAmyAmp); Bacillus licheniformis BML 730 (pAmyAmp); Bacillus licheniformis LA 57 (pDN1981); Bacillus licheniformis LAT8(pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1346); Bacillus licheniformis PL 1303 (pPL1117); Bacillus licheniformis MOL2083 (pCA164-LE399)

Bacillus licheniformis LA 57 (pDN1981); Bacillus licheniformis PL 1303 (pPL1117)

Colonne III

Permis dans ou sur

production des dextrines, du dextrose, du glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté), du maltose

Moût de(1) distillerie

Amidon utilisé dans la production des dextrines, du maltose, du dextrose, du(2) glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté)

Colonne IV Limites de tolérance

industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

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Article Additifs Source permise Permis dans ou sur Limites detolérance Bonnes

(3) Moût de bière (3) pratiques industrielles

Amidon utilisé dans la production des dextrines, du

(1)

maltose, du dextrose, du glucose (sirop de glucose) ou

(1) Bonnes pratiques industrielles

de solides de glucose (sirop de glucose déshydraté)

(2) Moût dedistillerie

Bacillus licheniformis 3253 (plCatH-3253); Bacillus licheniformis 3266 (plCatH-3266ori1); Bacillus stearothermophilus; Bacillus subtilis B1.109

(2) Bonnes pratiques industrielles

(pCPC800) Bonnes (3) Moût de bière (3) pratiques

industrielles Bonnes

(4) Farine; farine de (4) pratiquesblé entier; pain industrielles Produits de Bonnes

(5) boulangerie non (5) pratiques normalisés industrielles Amidon utilisé dans la production des dextrines, du maltose, duBacillus subtilis B1.109 Bonnesdextrose, du(pCPC720) (ATCC 39, (1) (1) pratiquesglucose (sirop705) industriellesde glucose) ou de solides de glucose (sirop de glucose déshydraté)

Bacillus subtilis BRG-1 A.2 Amylase maltogène (pBRG1); Bacillus (1) Amidon utilisé (1) Bonnes

dans la pratiques

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Article Additifs Source permise Permis dans ou sur Limites detolérance production des industrielles dextrines, du maltose, du dextrose, du glucose, (sirop

subtilis DN1413 de glucose) ou (pDN1413); Bacillus subtilis LFA 63

de solides de glucose (sirop

(pLFA63); Bacillus subtilis RB-147

de glucose déshydraté)

(pRB147) (2) Farine; farine deblé entier; pain (2)

Bonnes pratiques industrielles

Produits de Bonnes (3) boulangerie non (3) pratiques

normalisés industrielles Fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients

B.1 Présure de bovin

Extrait aqueux du 4e (véritable) estomac de bovins, de moutons et de chèvres adultes

ajoutés); fromage à la crème (avec indication des ingrédients

Bonnes pratiques industrielles

ajoutés); fromage cheddar; fromage cottage; fromage (indication de la variété) Ale; bière; bièreLes ananas Ananas Bonneslégère; liqueurB.2 Broméline comosus et Ananas (1) (1) pratiquesde malt; porter;bracteatus industriellesstout

(2) Farine; farine de (2) Bonnes

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Article Additifs Source permise Permis dans ou sur Limites detolérance blé entier; pain pratiques

industrielles

(3) Boyaux desaucisse (3) Bonnes pratiques industrielles

Protéine hydrolysée d’origine Bonnes

(4) animale, (4) pratiques végétale ou industrielles provenant du lait

Bonnes (5) Pièces de viande (5) pratiques

industrielles Produits pour Bonnes

(6) attendrir la (6) pratiques viande industrielles

Bonnes Marinade pratiques

(7) employée dansla salaison de (7) industrielles selon

parties de boeuf l’alinéa B.14.009g)

Gaufrettes Bonnes (8) sucrées, gaufres, (8) pratiques

crêpes industrielles

C.1 Catalase (1)

Boissons préparées (gazeuses et non gazeuses)

(1) Bonnes pratiques industrielles

Blanc d’oeuf Aspergillus niger var.; Micrococcus lysodeikticus; Foie de boeuf (Bos taurus) (2)

liquide (albumen liquide), jaune d’oeuf liquide ou oeuf entier

(2) Bonnes pratiques industrielles

liquide, destinés au séchage

(3) Petit-lait liquide Bonnes(3)traité au pratiques

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Article Additifs Source permise Permis dans ou sur Limites detolérance peroxyde industrielles d’hydrogène, conformément à l’article H.1, du tableau VIII

C.2 Cellulase (1) Moût dedistillerie (1) Bonnes pratiques industrielles

Aspergillus niger var. (2) Concentré decafé liquide

Extraits

(2) Bonnes pratiques industrielles

(3)

d’épices; préparations aromatisantes naturelles et

(3) Bonnes pratiques industrielles

colorants

Trichoderma reesei QM 9414

(1)

(2)

Jus de fruits non concentrés (1)

Feuilles de thé destinées à la production de solides de thé

(2)

Bonnes pratiques industrielles

Bonnes pratiques industrielles

C.3 Chymosine Fromage cheddar; fromage (indication de la variété); fromage

(i) Chymosine A Escherichia coli K-12,GE81 (pPFZ87A) (1)

cottage; fromage à la crème; fromage à la crème (avec

(1) Bonnes pratiques industrielles

indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la

Colonne I Colonne II Colonne III Colonne IV

Article Additifs Source permise Permis dans ou sur Limites detolérance crème à tartiner (avec indication des ingrédients ajoutés); crème sure

(2)

Produits pour desserts à base de lait non normalisés

(2) Bonnes pratiques industrielles

Fromage cheddar; fromage (indication de la variété); fromage cottage;

(ii) Chymosine B

Aspergillus niger var. awamori, GCC0349 (pGAMpR); Kluyveromyces marxianus var. lactis, DS1182 (pKS105)

(1)

fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la

(1) Bonnes pratiques industrielles

crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); crème sure

(2)

Produits pour desserts à base de lait non normalisés

(2) Bonnes pratiques industrielles

Ale; bière; bière Bonneslégère; liqueurF.1 Ficine (1) (1) pratiquesde malt; porter;Latex de figuier (Ficus industriellesstoutsp.) Bonnes

(2) Boyaux de (2) pratiquessaucisse industrielles

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Source permise Permis dans ou sur tolérance

Protéine hydrolysée d’origine Bonnes

(3) animale, (3) pratiques végétale ou industrielles provenant du lait

Bonnes (4) Pièces de viande (4) pratiques

industrielles Produits pour Bonnes

(5) attendrir la (5) pratiques viande industrielles

Bonnes Marinade pratiques employée dans industrielles(6) (6)la salaison de selon parties de boeuf l’alinéa

B.14.009g) Ale; bière; bièreGlucoamylase Bonneslégère; liqueurG.1 (Amyloglucosidase; (1) (1) pratiquesde malt; porter;maltase) industriellesstout

Aspergillus niger var.; BonnesAspergillus oryzae var.; (2) Farine; farine de (2) pratiquesRhizopus oryzae var. blé entier; pain industrielles Bonnes

(3) Sirop au (3) pratiqueschocolat industrielles BonnesMoût de(4) (4) pratiquesdistillerie industrielles

Céréales Bonnes (5) précuites (5) pratiques

(instantanées) industrielles Amidon employé dans la Bonnesproduction des(6) (6) pratiquesdextrines, du industriellesmaltose, du dextrose, du

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Article Additifs Source permise Permis dans ou sur Limites detolérance glucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté) Produits de Bonnes

(7) boulangerie non (7) pratiques normalisés industrielles

Aspergillus niger STz18­ 9 (pHUda7)

(1)

(2)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1)

Moût de distillerie (2)

Bonnes pratiques industrielles

Bonnes pratiques industrielles

Amidon utilisé dans la production des dextrines, du

(3)

dextrose, du glucose (sirop de glucose) ou de solides de

(3) Bonnes pratiques industrielles

glucose (sirop de glucose déshydraté), du maltose

Rhizopus niveus var.

(1) Moût dedistillerie

Moût servant à

(1) Bonnes pratiques industrielles Bonnes

(2) la fabrication du (2) pratiques vinaigre industrielles

Bonnes (1) Moût de bière (1) pratiques

Rhizopus delemar var.; Multiplici sporus (2) Moût dedistillerie (2)

industrielles Bonnes pratiques industrielles

(3) Moût servant à (3) Bonnes

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Article Additifs Source permise Permis dans ou sur Limites detolérance la fabrication du pratiques vinaigre industrielles Amidon employé dans la production des dextrines, du

(4)

maltose, du dextrose, du glucose (sirop de glucose) ou

(4) Bonnes pratiques industrielles

de solides de glucose (sirop de glucose déshydraté)

G.2 Glucanase (1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1) Bonnes pratiques industrielles

Aspergillus niger var.; Bacillus subtilis var. (2) Maïs pourégrenage (2)

Bonnes pratiques industrielles

(3) Moût dedistillerie (3) Bonnes pratiques industrielles

Moût servant à Bonnes (4) la fabrication du (4) pratiques

vinaigre industrielles Produits de Bonnes

(5) boulangerie non (5) pratiques normalisés industrielles

Humicola insolens var.

(1)

Ale; bière; bière légère; liqueur de malt; porter; stout

(1) Bonnes pratiques industrielles

(2) Moût dedistillerie (2) Bonnes pratiques industrielles

G.3 Glucose-oxydase Aspergillus niger var.; Aspergillus oryzae Mtl­ 72 (pHUda107)

(1)

Boissons préparées (gazeuses et non gazeuses)

(1) Bonnes pratiques industrielles

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Source permise Permis dans ou sur tolérance

BonnesBlanc d’oeuf pratiquesliquide industrielles(albumen selon lesliquide), jaune(2) (2) alinéasd’oeuf liquide B.22.034b),ou oeuf entier B.22.035b)liquide, destinés au séchage etB.22.036b)

(3) Farine; farine deblé entier; pain (3) Bonnes pratiques industrielles

Produits de Bonnes (4) boulangerie non

normalisés (4) pratiques

industrielles

G.4 Glucose-isomérase

Bacillus coagulans var.; Streptomyces olivochromogenes var.; Actinoplanes missouriensis var.; Streptomyces olivaceus var.; Microbacterium arborescens NRRL B­ 11022; Streptomyces murinus DSM 3252; Streptomyces rubiginosus ATCC No. 21,175; Streptomyces rubiginosus SYC 5406 (pSYC5239)

(1)

Glucose (sirop de glucose) à être partiellement ou complètement transformé en fructose par isomérisation

(1) Bonnes pratiques industrielles

H.1 Hemicellulase (1) Moût dedistillerie (1) Bonnes pratiques industrielles

Bacillus subtilis var. (2) Concentré decafé liquide (2) Bonnes pratiques industrielles

Moût destiné à Bonnes (3) la fabrication du (3) pratiques

vinaigre industrielles

I.01 Inulinase Aspergillus niger var.Tieghem Inuline Bonnes pratiques industrielles

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Article Additifs Source permise Permis dans ou sur Limites detolérance Saccharose utilisé dans la Bonnes

I.1 Invertase Aspergillus japonicus production de pratiques fructo­ industrielles oligosaccharides

Saccharomyces sp.

(1)

Confiseries non normalisées avec centre mou ou liquide

(1) Bonnes pratiques industrielles

Produits de Bonnes (2) boulangerie non (2) pratiques

normalisés industrielles Produits enzymatiques Bonnes

L.1 Lactase (1) pour la (1) pratiques réduction du industrielles lactose Lait destiné à la Bonnesfabrication du(2) (2) pratiquesmélange pour la industriellescrème glacée

Aspergillus niger var.; Aspergillus oryzae var.;Kluyveromyces fragilis (Kluyveromyces Marxianus var.

(3) Farine; farine deblé entier; pain (3)

Lait (indication de l’arôme); lait

Bonnes pratiques industrielles

marxianus); Kluyveromyces lactis (Kluyveromyces Marxianus var. lactis); Saccharomyces sp.

écrémé (indication de l’arôme); lait partiellement écrémé (indication de Bonnes

(4) l’arôme); lait (4) pratiques malté industrielles (indication de l’arôme); lait écrémé additionné de solides du lait (indication de l’arôme); lait

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Article Additifs Source permise Permis dans ou sur Limites detolérance partiellement écrémé additionné de solides du lait (indication de l’arôme); Lait destiné à la Bonnesfabrication du(1) (1) pratiquesmélange pour laExtraits acellulaires de industriellescrème glacéeCandida pseudotropicalis

Bonnes (2) Yogourt (2) pratiques

industrielles Bonnes

(3) Petit-lait (3) pratiques industrielles

Lait (indication de l’arôme); lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); lait malté (indication de Bonnes

(4) l’arôme); lait (4) pratiques écrémé industrielles additionné de solides du lait (indication de l’arôme); lait partiellement écrémé additionné de solides du lait (indication de l’arôme)

Aspergillus niger var.; Aspergillus oryzae var.;L.2 Lipase (1) Préparations (1) BonnesRhizopus oryzaevar.; aromatisantes à pratiques

base de produits industrielles

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Article Additifs Source permise Permis dans ou sur Limites detolérance laitiers Blanc d’oeuf liquide (albumen Bonnes

Tissus comestibles des (2) liquide); poudre

de blanc d’oeuf (2) pratiques

industrielles préestomacs d’agneaux, de chevreaux ou de veaux; Tissus pancréatiques d’animaux

(poudre d’albumen) Fromage cheddar; fromage fondu Bonnes

(3) cheddar; (3) pratiques fromage industrielles (indication de la variété)

(4) Farine; farine deblé entier; pain (4) Bonnes pratiques industrielles

Produits de Bonnes (5) boulangerie non (5) pratiques

normalisés industrielles Protéines hydrolysées d’origine Bonnes

(6) animale, (6) pratiques végétale ou industrielles provenant du lait

(1) Graisses ethuiles modifiées (1) Bonnes pratiques industrielles

Aspergillus oryzae Fromage(MLT-2) (pRML 787) cheddar; Bonnes(p3SR2); Rhizomucor (2) fromage (2) pratiquesmiehei (Cooney et (indication de la industriellesEmerson) (précédemment variété)nommé Mucor miehei Préparations(Cooney et Emerson)); Bonnesaromatisantes àRhizopus niveus (3) (3) pratiquesbase de produits industrielleslaitiers

(4) Protéines (4) Bonnes

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hydrolysées pratiques d’origine industrielles animale, végétale ou provenant du lait

BonnesAspergillus oryzae AI-11 (1) Farine; farine de (1) pratiques(pBoel 960) blé entier; pain industrielles Produits de Bonnes

(2) boulangerie non (2) pratiques normalisés industrielles

BonnesGraisses et(3) pratiqueshuiles modifiées (3) industrielles Aspergillus oryzae BonnesBECh2#3 (pCaHj559); (1) Farine; farine de (1) pratiquesAspergillus oryzae blé entier; pain industrielles(MStr115) (pMStr20)

Produits de Bonnes (2) boulangerie non (2) pratiques

normalisés industrielles BonnesLécithine(3) (3) pratiquesmodifiée industrielles

Produits des Bonnes (4) oeufs non (4) pratiques

normalisés industrielles BonnesAspergillus niger Graisses et pratiques(pCaHj600/MBin118#11) huiles modifiées industrielles

Graisses et Bonnes Penicillium camembertii (1) huiles (1) pratiques

comestibles industrielles BonnesGrumeaux ou farine de (1) Farine; farine deL.3 Lipoxydase (1) pratiquesfine Soja blé entier; pain industrielles

Fromage Bonnes L.4 Lysozyme Blanc d’oeuf cheddar; pratiques

fromage industrielles

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(indication de la variété) Crème sure; fromage cheddar; BonnesEnzyme coagulant fromageM.1 (1) (1) pratiquesle lait cottage;

Rhizomucor miehei industriellesfromage (Cooney et Emerson) (indication de la (précédemment nommé variété) Mucor miehei (Cooney et PréparationsEmerson)) ou Mucor Bonnesaromatisantes àpusillus Lindt par (2) (2) pratiquesbase de produitsfermentation de culture industrielleslaitierspure ou Aspergillus oryzae RET-1 Protéines (pBoel777) hydrolysées

d’origine Bonnes (3) animale, (3) pratiques

végétale ou industrielles provenant du lait Fromage BonnesEmmentaler(1) (1) pratiques(Emmental ou industriellesSuisse)

Bonnes (2) FromageEndothia parasitica par (2) pratiquesParmesanfermentation de culture industrielles

pure Bonnes (3) Fromage (3) pratiquesRomano industrielles

Fromage Bonnes (4) Mozzarella (4) pratiques

(Scamorza) industrielles Fromage Mozzarella partiellement Bonnes

(5) écrémé (5) pratiques (Scamorza industrielles partiellement écrémé)

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Article Additifs Source permise Permis dans ou sur

Blanc d’oeuf liquide (albumen

P.1 Pancréatine (1) liquide); poudre de blanc d’oeuf (poudre d’albumen) Céréales

(2) précuites

Pancréas de porc (Sus scrofa) ou de boeuf (Bos taurus)

(instantanées) Amidon utilisé dans la production des dextrines, du maltose, du

(3) dextrose, duglucose (sirop de glucose) ou de solides de glucose (sirop de glucose déshydraté) Protéines hydrolysées d’origine

(4) animale ou végétale ou provenant du lait Ale; bière; bière

P.2 Papaïne (1) légère; liqueurde malt; porter; stout

Fruit du papayer Carica papaya L. (Fam. du Caricaceae)

(2) Boeuf avantl’abattage

Boyaux de saucisse;

(3) pellicules de collagène hydrosolubles

Colonne IV Limites de tolérance

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

Bonnes (3) pratiques

industrielles

Bonnes (4) pratiques

industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

Bonnes (3) pratiques

industrielles

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Article Additifs Source permise Permis dans ou sur Limites detolérance comestibles Protéine hydrolysée d’origine Bonnes

(4) animale, (4) pratiques végétale ou industrielles provenant du lait

Bonnes (5) Pièces de viande (5) pratiques

industrielles Produits pour Bonnes

(6) attendrir la (6) pratiques viande industrielles Céréales Bonnes

(7) précuites (7) pratiques (instantanées) industrielles

(8)

Marinade employée dans la salaison de parties de boeuf

(8) Bonnes pratiques industrielles

Produits de Bonnes (9) boulangerie non (9) pratiques

normalisés industrielles Bonnes

P.3 Pectinase (1) Cidre; vin (1) pratiques industrielles

Aspergillus niger var.; Rhizopus oryzae var. (2)

Moût de distillerie (2)

Bonnes pratiques industrielles

(3) Jus de fruits nonconcentrés (3) Bonnes pratiques industrielles

(4)

Préparations naturelles aromatisantes et colorants

(4) Bonnes pratiques industrielles

Pelures Bonnes (5) d’agrumes (5) pratiques

destinées à la industrielles

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Source permise Permis dans ou sur tolérance

fabrication de confiture, de marmelade et de fruits confits Bouillon de

(6) légume employé dans les soupes Feuilles de thé destinées à la(7) production de solides de thé

(1) Cidre; vin

Aspergillus oryzae Km-1- (2) 1 (pA2PEI)

(3)

P.4 Pentosanase (1)

Aspergillus niger var.;

Jus de fruits non concentrés

Produits à base de fruits et de légumes non normalisés Ale; bière; bière légère; liqueur de malt; porter; stout

(2) Maïs pourBacillus subtilis var. égrenage

(3)

(4)

(5)

Moût de distillerie

Moût destiné à la fabrication du vinaigre Produits de boulangerie non normalisés

(6) Farine; farine deblé entier, pain

(6)

(7)

(1)

(2)

(3)

(1)

(2)

(3)

(4)

(5)

(6)

Bonnes pratiques industrielles

Bonnes pratiques industrielles

Bonnes pratiques industrielles Bonnes pratiques industrielles

Bonnes pratiques industrielles

Bonnes pratiques industrielles

Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

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Article Additifs Source permise Permis dans ou sur

(1) Farine; farine deblé entier, pain

Trichoderma reesei (QM9414) (2)

Moût de distillerie

Produits de (3) boulangerie non

normalisés Ale; bière; bière

P.5 Pepsine (1) légère; liqueurde malt; porter; stout Fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication

Muqueuse glandulaire de l’estomac de porc

des ingrédients ajoutés); fromage à la

(2) crème (avec indication des ingrédients ajoutés); fromage cheddar; fromage cottage; fromage (indication de la variété)

(3) Farine de sojadégraissée

Céréales (4) précuites

(instantanées) (5) Protéines

Colonne IV Limites de tolérance

Bonnes (1) pratiques

industrielles Bonnes

(2) pratiques industrielles Bonnes

(3) pratiques industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

Bonnes (3) pratiques

industrielles Bonnes

(4) pratiques industrielles

(5) Bonnes

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Article Additifs Source permise Permis dans ou sur

hydrolysées d’origine animale ou végétale ou provenant du lait

P.5A Phospholipase Streptomycesviolaceoruber (1) Lécithine modifiée

Produits des (2) oeufs non

normalisés Fromage

Aspergillus oryzae (pPFJo142)

cheddar; fromage (indication de la variété) Ale; bière; bière

P.6 Protéase (1) légère; liqueurde malt; porter; stout

Aspergillus oryzae var.; (2) Farine; farine de blé entier; pain

Aspergillus niger var.; Bacillus subtilis var.

(3)

Préparations aromatisantes à base de produits laitiers

(4) Moût dedistillerie

(5) Boyaux desaucisses

Protéines hydrolysées d’origine

(6) animale, végétale, ou provenant du lait

Colonne IV Limites de tolérance

pratiques industrielles

Bonnes (1) pratiques

industrielles Bonnes

(2) pratiques industrielles

Bonnes pratiques industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

Bonnes (3) pratiques

industrielles

Bonnes (4) pratiques

industrielles Bonnes

(5) pratiques industrielles

Bonnes (6) pratiques

industrielles

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Poudre de fromage de Bonnes

(7) pulvérisation (7) pratiques sèche industrielles industrielle

Bonnes (8) Pièces de viande (8) pratiques

industrielles Produits pour Bonnes

(9) attendrir la (9) pratiques viande industrielles Céréales Bonnes

(10) précuites (10) pratiques (instantanées) industrielles Produits de Bonnes

(11) boulangerie non (11) pratiques normalisés industrielles Fromage cheddar; fromage cheddar destiné à la transformation Bonnes

(12) (fromage à (12) pratiques caillé brassé; industrielles fromage à caillé granuleux; fromage à caillé lavé); fromage Colby

Bonnes (13) Boissons (13) pratiquesvégétales industrielles

Fromage BonnesMicrococcus caseolyticus (1) (indication de la (1) pratiquesvar. variété) industrielles Protéines hydrolysées BonnesBacillus licheniformis (1) d’origine (1) pratiques(Cx) animale, industrielles végétale ou

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Article Additifs Source permise Permis dans ou sur Limites detolérance provenant du lait

P.7 Pullulanase (1) Farine; farine deblé entier; pain (1) Bonnes pratiques industrielles

Amidon utilisé dans la

Bacillus acidopullulyticus NCIB 11647; Bacillus licheniformis SE2-Pul­ int211 (pUBCDEBRA11DNSI)

(2)

production des dextrines, du dextrose, du glucose (sirop de glucose), de solides de glucose (sirop

(2) Bonnes pratiques industrielles

de glucose déshydraté) ou de sirops et de solides de fructose, du maltose Produits de Bonnes

(3) boulangerie non (3) pratiques normalisés industrielles

(1) Farine; farine deblé entier; pain (1) Bonnes pratiques industrielles Bonnes

(2) Moût de bière (2) pratiques industrielles

Amidon utilisé dans la

Bacillus licheniformis BMP 139 (pR11Amp)

production des dextrines, du

(3)

dextrose, du glucose (sirop de glucose), de solides de

(3) Bonnes pratiques industrielles

glucose (sirop de glucose déshydraté) ou de sirops et de

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Article Additifs Source permise Permis dans ou sur Limites detolérance solides de fructose, du maltose Produits de Bonnes

(4) boulangerie non (4) pratiques normalisés industrielles

(1) Farine; farine deblé entier; pain (1) Bonnes pratiques industrielles

Bacillus subtilis B1-163 (pEB301) (2) Moût de bière (2)

Bonnes pratiques industrielles

(3) Moût dedistillerie (3) Bonnes pratiques industrielles

Amidon utilisé dans la production des dextrines, du dextrose, du glucose (sirop de glucose), de Bonnes

(4) solides de (4) pratiques glucose (sirop industrielles de glucose déshydraté) ou de sirops et de solides de fructose, du maltose Produits de Bonnes

(5) boulangerie non (5) pratiques normalisés industrielles

Bonnes (1) Moût de bière (1) pratiques

industrielles Bacillus subtilis RB121 (pDG268) (2) Moût dedistillerie (2)

Bonnes pratiques industrielles

(3) Amidon utilisédans la (3) Bonnes pratiques

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Article Additifs Source permise Permis dans ou sur Limites detolérance production des industrielles dextrines, du dextrose, du glucose (sirop de glucose), du maltose ou de solides de glucose (sirop de glucose déshydraté) Crème sure; fromage à la crème; fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients

R.1 Présure

Extrait aqueux du 4e (véritable) estomac de veaux, de chevreaux ou d’agneaux

(1)

ajoutés); fromage à la crème (avec indication des

(1) Bonnes pratiques industrielles

ingrédients ajoutés); fromage cheddar; fromage cottage; fromage (indication de la variété)

(2)

Produits pour desserts à base de lait non normalisés

(2) Bonnes pratiques industrielles

Produits de Bonnes T.01 Transglutaminase Streptoverticillium

mobaraense souche S­ 8112

(1) poisson préparé non normalisés

(2) Simili-produitsde viande

(1)

(2)

pratiques industrielles Bonnes pratiques industrielles

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Produits de Bonnes (3) fromage non (3) pratiques

normalisés industrielles Produits de Bonnes

(4) fromage fondu (4) pratiques non normalisés industrielles Produits de Bonnesfromage à la(5) (5) pratiquescrème non industriellesnormalisés

Bonnes (6) Yogourt (6) pratiques

industrielles Desserts laitiers Bonnes

(7) congelés non (7) pratiques normalisés industrielles Protéines hydrolysées d’origine BonnesPancreas de porc (SusT.1 Trypsine (1) animale ou (1) pratiquesscrofa) végétale ou industrielles provenant du lait

Bonnes (1) Farine; farine deX.1 Xylanase (1) pratiquesblé entier; painAspergillus oryzae Fa 1– industrielles

1 (pA2X1TI) Produits de Bonnes (2) boulangerie non (2) pratiques

normalisés industrielles Bonnes

(1) Farine; farine deAspergillus oryzae JaL (1) pratiquesblé entier; pain339 (pJaL537); Bacillus industrielles subtilis DIDK 0115 Produits de Bonnes (pUB110 OIS2) (2) boulangerie non (2) pratiques

normalisés industrielles

DORS/78-402, art. 6; DORS/78-876, art. 3; DORS/79-662, art. 14 à 17; DORS/80-501, art. 4; DORS/80-632, art. 5; DORS/81-60, art. 11; DORS/81-934, art. 7 à 10; DORS/82­ 383, art. 10; DORS/82-566, art. 2; DORS/82-1071, art. 17; DORS/84-302, art. 4; DORS/84-762, art. 8 et 9; DORS/84-801, art. 4; DORS/86-89, art. 4 à 6; DORS/86-1112, art. 4; DORS/87-254, art. 2; DORS/87-640, art. 7; DORS/88-281, art. 1; DORS/90-24,

art. 1 à 3; DORS/90-87, art. 10 à 12; DORS/90-469, art. 3; DORS/91-124, art. 5(F); DORS/91-487, art. 1; DORS/91-691, art. 1; DORS/92-63, art. 4; DORS/92-94, art. 4; DORS/92-195, art. 1; DORS/92-197, art. 9; DORS/92-231, art. 1; DORS/92-518, art. 1; DORS/92-591, art. 2(F); DORS/94-29, art. 1; DORS/94-182, art. 1; DORS/94-212, art. 9; DORS/94-417, art. 2; DORS/94-552, art. 1; DORS/94-689, art. 2; DORS/94-712, art. 1; DORS/95-65, art. 1; DORS/95-183, art. 9; DORS/95-525, art. 1 et 2; DORS/96-375, art. 1; DORS/97-81, art. 1; DORS/97-82, art. 1; DORS/97-122, art. 4(F) et 5; DORS/97-508, art. 1 et 2; DORS/97-513, art. 1; DORS/97-558, art. 4; DORS/98-454, art. 1; DORS/98­ 458, art. 6 et 7(F); DORS/2000-336, art. 3 à 5; DORS/2000-417, art. 4; DORS/2003-130, art. 4; DORS/2004-84, art. 1; DORS/2005-98, art. 3 à 7 et 8(F); DORS/2005-394, art. 1 à 6; DORS/2007-225, art. 1; DORS/2010-41, art. 1 à 6 et 9(A); DORS/2010-42, art. 1 à 4; DORS/2010-94, art. 8(A); DORS/2010-142, art. 17; DORS/2010-143, art. 14 à 26.

TABLEAU VI

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS RAFFERMISSANTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Crabe; homard; saumon; Sulfate crevettes et thon en (1) Bonnes pratiquesA.1 (1)d’aluminium conserve; cornichons et industrielles

achards (relish)

(2) Bonnes pratiques(2) Aliments non normalisés industrielles

(1) Cornichons et achards (1) Bonnes pratiquesA.2 Sulfate double (relish) industrielles d’aluminium et (2) Bonnes pratiques(2) Aliments non normalisésd’ammonium industrielles

(1) 0,026 %, calculé enC.1 (1) Pommes en conserve calciumChlorure de 0,035 %, calculé encalcium

(2) Pamplemousses en (2) calcium conformément auconserve sous-alinéa B.11.101c)(vii)

(3) Fromage (indication de lavariété); fromage cheddar (3) 0,02 % du lait et des produits du lait utilisés

(4) Bonnes pratiques(4) Fromage cottage industrielles

(5) Glaçage de poisson (5) Bonnes pratiquescongelé industrielles (6) Olives (6) 1,5 % de la saumure

(7) Cornichons et achards (7) 0,4 %(relish)

(8) Tomates; légumes en (8) 0,026 %, calculé enconserve (nom du calcium et, dans le cas des

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

légume); pommes pois en conserve, 0,035 %, congelées calculé en calcium

(9) Bonnes pratiques(9) Aliments non normalisés industrielles Tomates; légumes en conserve; pommes (1) 0,026 %, calculé enC.2 Citrate de calcium (1) congelées; pommes calcium tranchées congelées

(2) 0,026 %, calculé en(2) Pommes en conserve calcium

(3) Bonnes pratiques(3) Aliments non normalisés industrielles Gluconate de Bonnes pratiquesC.3 Aliments non normaliséscalcium industrielles

0,035 %, calculé en C.3A Lactate de calcium (1) Pamplemousses en (1) calcium, selon le sous­conserve alinéa B.11.101c)(vii)

(2) Pois en conserve (2) 0,035 % calculé en calcium Phosphate Bonnes pratiquesC.4 Aliments non normalisésbicalcique industrielles

Tomates; légumes enPhosphate (1) 0,026 %, calculé enC.5 (1) conserve; pommesmonocalcique calciumcongelées

(2) 0,026 %, calculé en(2) Pommes en conserve calcium

(3) Bonnes pratiques(3) Aliments non normalisés industrielles Tomates; légumes en

(1) 0,026 %, calculé enC.6 Sulfate de calcium (1) conserve; pommes calciumcongelées

(2) 0,026 %, calculé en(2) Pommes en conserve calcium

(1) Cornichons et achards (1) Bonnes pratiquesP.1 Sulfate double (relish) industriellesd’aluminium et de potassium (2) Bonnes pratiques(2) Aliments non normalisés industrielles

(1) Cornichons et achards (1) Bonnes pratiquesS.1 Sulfate double (relish) industriellesd’aluminium et de (2) Bonnes pratiquessodium (2) Aliments non normalisés industrielles

DORS/78-402, art. 7; DORS/79-660, art. 11 et 12; DORS/79-752, art. 7; DORS/93-445, art. 1; DORS/94-689, art. 2(F); DORS/2007-302, art. 4(F); DORS/2010-94, art. 8(A).

TABLEAU VII

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE SATINAGE OU DE GLAÇAGE

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance A.1 (1) Confiseries non normalisées (1) 0,4 %Monoglycérides

acétylés (2) Bonnes pratiques(2) Poisson congelé industrielles B.1 Cire d’abeilles Confiseries non normalisées 0,4 % C.1 Cire de carnauba Confiseries non normalisées 0,4 % C.2 Cire de candélilla Confiseries non normalisées 0,4 % G.1 Gomme arabique Confiseries non normalisées 0,4 % G.2 Résine de benjoin Confiseries non normalisées 0,4 %

Silicate deM.1 Confiseries non normalisées 0,4 %magnésium M.2 Huile minérale Confiseries non normalisées 0,15 % P.1 Vaseline Confiseries non normalisées 0,15 %

Confiseries non normalisées;S.1 Gomme laque 0,4 %décorations à gâteaux S.2 Spermaceti Confiseries non normalisées 0,4 % Z.1 Zéine Confiseries non normalisées 1,0 %

DORS/94-689, art. 2(F); DORS/2010-142, art. 18 à 29.

TABLEAU VIII

ADDITIFS ALIMENTAIRES DIVERS

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

Ale; bière; bière légère; liqueur de Bonnes pratiquesA.01 Gomme arabique Agent de collagemalt; porter; stout; industrielles vin

A.1 Mono-glycéridesacétylés Aliments non normalisés

Couverture; agent de démoulage

Bonnes pratiques industrielles

A.1.01 Agar-agar Vin Agent de collage Bonnes pratiquesindustrielles A.1.1 Sulphate d’aluminium Blanc d’oeuf Pour stabiliser 0,036 %

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

congelé (albumen l’albumen durant congelé); blanc la pasteurisation d’oeuf liquide (albumen liquide); jaune d’oeuf congelé; jaune d’oeuf liquide; oeuf entier congelé; oeuf entier liquide; poudre de blanc d’oeuf (poudre d’albumen); poudre de jaune d’oeuf; poudre d’oeuf entier

Persulfate Agent anti-A.2 Levure de bière 0,1 %d’ammoniaque microbien A.3 [Abrogé, DORS/93-276, art. 4] A.4 [Abrogé, DORS/93-276, art. 5]

Aliments nonB.2 Cire d’abeilles Agent anticollant 0,4 %normalisés Petit-lait liquide destiné à la fabrication de produits de petit-laitB.2.1 Peroxyde de benzoyle Décolorer 100 p.p.m.séché autres que ceux entrant dans les préparations pour nourrissons Préparation aromatisante de 15 p.p.m. dans les (nom de l’arôme) boissons contenantAgentpour utilisation dans des huiles d’agrumesB.3 Huile végétale bromée modificateur deles boissons ou d’épinette sousla densitécontenant des huiles leur forme d’agrumes ou consommable d’épinette Enduits aux casseroles, à base d’huile végétale Agent de Bonnes pratiquesB.4 n-Butane comestible, de propulsion industrielles lécithine ou d’un mélange des deux

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

C.1 Caféine Breuvages de typecola Caractéristique du produit

200 p.p.m. dans le produit fini 200 p.p.m., calculéBreuvages de type CaractéristiqueC.2 Citrate de caféine en caféine, dans lecola du produit produit fini 900 p.p.m.,

Véhicule du conformément aux (1) Farine; farine de bléC.3 Carbonate de calcium (1) peroxyde de (1) sous-alinéasentier benzoyle B.13.001e)(vi) et

B.13.005d)(vi) (2) [Abrogé, DORS/94-227, art. 5]

Confiseries non (3) Bonnes pratiques(3) (3) Crémer et fixernormalisées industrielles

(4) Agent de (4) Bonnes pratiques(4) Gomme à mâcher remplissage industrielles Véhicule etAliments non (5) Bonnes pratiques(5) (5) agent denormalisés industriellessaupoudrage

Bonnes pratiques industrielles (la

Restauration des quantité de calciumAlbumine de l’oeufC.3A Lactate de calcium (1) (1) propriétés (1) ajoutée ne doit pas(délysozymisée) fonctionnelles excéder celle perdue lors du processus de transformation)

Mélange de poisson et de viande préparés Modifier la (2) Bonnes pratiques(2) (2)visé à l’alinéa texture industrielles B.21.006n)

C.4 Oxyde de calcium (1) Crustacés etmollusques congelés (1)

Faciliter l’enlèvement des matières étrangères et réduire la déperdition d’humidité pendant la cuisson

(1)

Lorsque employé en combinaison avec le chlorure de sodium (sel) et l’hydroxyde de sodium en solution, l’oxyde de calcium ne doit pas dépasser 30 p.p.m.

(2)

Mélange de poisson et de viande préparés visés à l’alinéa (2)

Modifier la texture (2)

Bonnes pratiques industrielles

B.21.006n)

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

900 p.p.m. Véhicule du conformément aux

(1) Farine; farine de bléC.5 Phosphate bicalcique (1) peroxyde de (1) sous-alinéasentier benzoyle B.13.001e)(vi) et B.13.005d)(vi)

(2) [Abrogé, DORS/94-227, art. 6] 900 p.p.m.

Véhicule du conformément aux (1) Farine; farine de bléC.6 Phosphate tricalcique (1) peroxyde de (1) sous-alinéasentier benzoyle B.13.001e)(vi) et

B.13.005d)(vi) (2) [Abrogé, DORS/94-227, art. 7]

Petit-lait liquide destiné à la fabrication de Véhicule duproduits de petit-lait (3) 0,04 % des produits(3) (3) peroxyde deséché autres que de petit-lait séchébenzoyleceux entrant dans les préparations pour nourrissons Fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); Améliorer lapréparation de couleur, lafromage fondu;(4) (4) texture, la (4) 1,0 %préparation de consistance et lafromage fondu (avec tartinabilitéindication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés) Rocou soluble dans Bonnes pratiquesC.7 Silicate de calcium Véhiculel’huile industrielles Confiseries non Agent de Bonnes pratiquesC.8 Stéarate de calcium normalisées démoulage industrielles

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

C.9

C.10

C.11

C.12

C.13

C.13.1

Blanc d’oeuf

Stéaroyl-2- lactylate de calcium (1)

congelé (albumen congelé); blanc d’oeuf liquide

(1) Faire monter enneige (1) 0,05 %

(albumen liquide)

(2) Poudre de blanc d’oeuf (poudre d’albumen)

(2) Faire monter enneige (2) 0,5 %

(3) Garnitures de graissevégétale (3) Faire mousser (3) 0,3 %

Pommes de terre (4) Agent deconditionnement (4) 0,2 % du poids à(4) déshydratées l’état sec 900 p.p.m.

Véhicule du conformément aux (1) Farine; farine de bléSulfate de calcium (1) peroxyde de (1) sous-alinéasentier benzoyle B.13.001e)(vi) et

B.13.005d)(vi) (2) [Abrogé, DORS/94-227, art. 8]

(3) Remplissage (3) Bonnes pratiques(3) Poudre à pâte neutre industrielles Ale; bière; jus de (nom du fruit) gazeux; bière légère; liqueur de malt; Rendre (1) Bonnes pratiquesAnhydride carbonique (1) (1)porter; cidre; stout; mousseux industrielles vins; eau dite eau minérale ou eau de source

Agent pulseur ouAliments non (2) Bonnes pratiques(2) (2) pour rendrenormalisés industriellesmousseux Fromage cottage; Prolonger la

(3) Bonnes pratiques(3) fromage cottage en (3) durée de industriellescrème conservation Confiseries non Agent de Bonnes pratiquesHuile de ricin normalisées démoulage industrielles

[Abrogé, DORS/2010-142, art. 35] Pâte à frire et (1) Agent de(1) (1) 1 %chapelure remplissageCellulose en poudre

(2) Agent de(2) Biscottes (2) 2 %remplissage

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

Confiseries non normalisées qui répondent aux critères mentionnés à la colonne 2 de

(3) Agent de(3) l’article 3 du tableau (3) 25 %remplissagesuivant l’article B.01.513 en regard du sujet « énergie réduite » visé à la colonne 1 Glaces comestibles (4) Agent de(4) (4) 3 %non normalisées remplissage

(5) Agent de(5) Garnitures (5) 0,5 %remplissage Aliments vendus

(6) Agent de(6) sous forme de (6) 50 %remplissagecomprimés

(7) Agent de(7) Glaçages (7) 1 %remplissage

(8) Agent de(8) Assaisonnements (8) 3 %remplissage Produits de (9) Agent de(9) (9) 8 %boulangerie sucrés remplissage Aliments non Agent pulseur et Bonnes pratiquesC.14A Chloropentafluoréthane normalisés agent d’aération industrielles

(1) Bonnes pratiquesC.15 Acide citrique (1) Sang de boeuf (1) Anticoagulant industrielles Aliments non Nourrir les (2) Bonnes pratiques(2) (2)normalisés cultures industrielles Rafraîchisseurs CaractéristiqueC.16 Gluconate de cuivre 50 p.p.m.d’haleine du produit

0,0001 % calculé en C.17 Sulfate de cuivre Vin Agent de collage cuivre dans le produit

fini Confiture de (nom du fruit); confiture

Formules à base de de (nom du fruit) (1) Agent (1) 10 p.p.m. deD.1 diméthyl-polysiloxane (1) avec pectine; antimousse diméthylpolysiloxane confiture de pommes (ou de rhubarbe) et

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; huiles et graisses; jus de citron reconstitué; jus de lime reconstitué; lait écrémé en poudre; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; shortening; vin Jus d’ananas; Mélanges de jus d’ananas avec

(2) d’autres jus de fruits; ananas en conserve (lorsque le jus

(2) Agent anti-mousse (2) 10 p.p.m. de diméthylpolysiloxane

d’ananas est utilisé comme véhicule de conditionnement)

Bonnes pratiques industrielles. (Les

(3) Surfaces entrant en contact avec les aliments

(3) Agent dedémoulage (3) résidus de diméthylpolysiloxane dans l’aliment ne doivent pas excéder 10 p.p.m.)

(4) Aliments nonnormalisés (4) Agent antimousse (4)

10 p.p.m. de diméthylpolysiloxane

(5) Moût utilisé dans lafabrication d’ale, de (5) Agent antimousse (5)

10 p.p.m. de diméthylpolysiloxane

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

bière, de bière légère, de liqueur de malt, de porter et de stout Bases sèches de

(1) Agent (1) 10 p.p.m. dans laD.3 (1) boissons, acidulées àDioctyl sulfo-succinate humidifiant boisson finiel’acide fumariquesodique (2) Réduit la rupture(2) Boyaux de saucisse (2) 200 p.p.m. du boyaudu boyau

Pour favoriser laPaprika; pimentE.1 Ethoxyquin conservation de 100 p.p.m.rouge moulu la couleur Bonnes pratiques

Épices entières ou industrielles (résidus moulues (sauf les d’éthylèneE.2 Oxyde d’éthylène Fumigationmélanges contenant chlorophydrine du sel) n’excédant pas 1 500

p.p.m.) Bonnes pratiquesF.1 Gluconate ferreux Olives mûres Fixer la couleur industrielles Bonnes pratiquesG.1 Gélatine Bière; cidre; vin Agent de collage industrielles

G.2 [Abrogé, DORS/89-175, art. 2] Activer la

(1) Saucisse cuite;G.2A Glucono-delta-lactone (1) fixation de la (1) 0,5 %viande en pain couleur Faciliter le (2) Bonnes pratiques(2) Saucisse sèche (2) séchage industrielles

Mélanges de (1) Bonnes pratiquesG.3 Glycérol (1) salaison des viandes; (1) Humidifier industriellesboyaux à saucisse

Viandes de salaison Glacer la surface (2) Bonnes pratiques(2) (2)(Titre 14) de ces viandes industrielles Aliments non (3) Humidifier; (3) Bonnes pratiques(3) normalisés lustrer industrielles Boissons contenant AgentEster glycérique de laG.4 des huiles d’agrumes modificateur de 100 p.p.m.colophane ou d’épinette la densité

(1) Adjuvant de (1) 135 p.p.m. dans leH.1 Peroxyde d’hydrogène (1) Moût de bière clarification moût

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

Petit-lait liquide destiné à la 100 p.p.m. (voirPour décolorer et(2) fabrication de (2) (2) aussi le paragraphemaintenir le pHproduits de petit-lait C.1(3) du tableau V) séché Balle d’avoine utilisée dans la (3) Agent de (3) Bonnes pratiques(3) fabrication de fibre blanchiment industrielles de balle d’avoine Enduits pour casseroles à base d’huile végétale Agent de Bonnes pratiquesI. Isobutane comestible, de propulsion industrielles lécithine ou d’un mélange des deux

Esters lactyliques Aliments non Bonnes pratiquesL.1 Agent plastifiantd’acides gras normalisés industrielles Bonnes pratiquesL.2 Lanoline Gomme à mâcher Agent plastifiant industrielles

Surfaces entrant en Agent de Bonnes pratiquesL.3 Lécithine contact avec les démoulage industriellesaliments Édulcorant de table Lubrifiant utilisé sous forme de dans la 3 % du poids duL.4 L-Leucine comprimé contenant fabrication des comprimé de l’aspartame comprimés

Silicate d’aluminium et Agent de Bonnes pratiquesM.1 Gomme à mâcherde magnésium saupoudrage industrielles 900 p.p.m.

Véhicule du conformément auxCarbonate de (1) Farine; farine de bléM.2 (1) peroxyde de (1) sous-alinéasmagnésium entier benzoyle B.13.001e)(vi) et B.13.005d)(vi)

(2) [Abrogé, DORS/94-227, art. 9] Confiseries non (3) Agent de (3) Bonnes pratiques(3) normalisées démoulage industrielles

Bonnes pratiques Restauration des industrielles (laChlorure de Albumine de l’oeufM.2A propriétés quantité demagnésium (délysozymisée) fonctionnelles magnésium ajoutée

ne doit pas excéder

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

celle perdue lors du processus de transformation)

Confiseries non (1) Agent de (1) Bonnes pratiquesM.3 Silicate de magnésium (1) normalisées démoulage industrielles

(2) Agent de (2) Bonnes pratiques(2) Gomme à mâcher saupoudrage industrielles

(3) Bonnes pratiques(3) Riz (3) Enrober industrielles Confiseries non (1) Agent de (1) Bonnes pratiquesM.4 Stéarate de magnésium (1) normalisées démoulage industrielles Aliments vendus

(2) Bonnes pratiques(2) sous forme de (2) Liant industriellescomprimés Bonnes pratiques industrielles (la quantité deRestauration desAlbumine de l’oeuf magnésium ajoutéeM.4A Sulfate de magnésium propriétés(délysozymisée) ne doit pas excéderfonctionnelles celle perdue lors du processus de transformation)

M.5A [Abrogé, DORS/93-276, art. 6] Cellulose méthyl- Aliments non Bonnes pratiquesM.5C Agent d’aérationéthylique normalisés industrielles Cellulose (1) Mélange pour lait (1) Agent texturantM.6 (1) 1,5 %microcristalline glacé et épaississant

(2) Agent texturant(2) Sorbet laitier (2) 0,5 %et épaississant Aliments non normalisés qui répondent aux critères mentionnés à la colonne 2 de

(3) Agent de (3) Bonnes pratiques(3) l’article 3 du tableau remplissage industriellessuivant l’article B.01.513 en regard du sujet « énergie réduite » visé à la colonne 1

(4) Garniture fouettée à (4) Agent texturant (4) 1,5 %

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

l’huile végétale et épaississant

(5) Desserts congelés (5) Agent texturant (5) 0,5 %non normalisés et épaississant Tartinades à sandwich non

(6) Agent texturant(6) normalisées; (6) 3,0 %et épaississanttrempettes non normalisées Aliments non normalisés autres que les aliments non (7) Agent texturant(7) (7) 2,0 %normalisés et épaississant mentionnés au présent article

0,5 % ou, s’il est employé en association avec des

(8) Mélange pour crème (8) Agent texturant agents stabilisants, la(8)glacée et épaississant quantité totale ne doit pas dépasser 0,5 % de la crème glacée faite du mélange

Édulcorant de table sous forme de (9) Désagrégation(9) (9) 2,2 %comprimé contenant des comprimés de l’aspartame

(10) Agent stabilisant(10) Crème à fouetter (10) 0,2 %et épaississant

(11) Rafraîchisseurs (11) Agent texturant (11) 9,0 %d’haleine et épaississant 0,3 %, conformément à l’article B.01.047. Si la vaseline est également utiliséeConfiseries non dans les produits denormalisées;

(1) Agent de boulangerie, commeM.7 Huile minérale (1) produits de (1)démoulage agent de démoulage,boulangerie; raisins la quantité totale desecs épépinés toute combinaison de vaseline et d’huile minérale ne doit pas dépasser 0,15 %

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

(2) Fruits et légumesfrais (2) Badigeonner (2) 0,3 % conformément à l’article B.01.047 5 % conformément à l’alinéa B.01.047e) (les résidus d’huile minérale dans les saucisses crues

(3) Boyaux de saucisse (3) Lubrifiant (3) préparées avec ces boyaux ne doivent pas dépasser 200 p.p.m.; dans les saucisses cuites, 30 p.p.m.)

(4) Succédané de sel (4) Agent liant et enrobage protecteur

(4) 0,6 %, conformémentà l’alinéa B.01.047h)

M.8 Monoacétine Produits de boulangerie non normalisés

Agent plastifiant Bonnes pratiquesindustrielles

Confiture de pommes (ou de rhubarde) et de (nom du fruit); huiles et graisses; marmelade de figues; marmelade de figues avec pectine; confiture de (nom du fruit); confiture de

M.9 Mono- et diglycérides (1) (nom du fruit) avec pectine; gelée de (nom du fruit); gelée

(1) Agentantimousse (1) Bonnes pratiques industrielles

de (nom du fruit) avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade d’ananas; marmelade d’ananas avec pectine

(2) Aliments non (2) Agent (2) Bonnes pratiques

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

normalisés antimousse; industrielles humidifiant; agent de démoulage Agent antimousse;Aliments non Bonnes pratiquesM.10 Mono-glycérides humidifiant;normalisés industriellesagent de démoulage

Fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); Pour améliorer la (1) Bonnes pratiquesN.1 Azote (1) fromage à la crème à (1) tartinabilité industriellestartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés)

Pour améliorer la (2) Bonnes pratiques(2) Margarine (2) tartinabilité industrielles Aliments non (3) Bonnes pratiques(3) (3) Agent pulseurnormalisés industrielles Aliments non Bonnes pratiquesN.2 Oxyde d’azote Agent pulseurnormalisés industrielles Aliments non Agent pulseur et Bonnes pratiquesO.1 Octafluoro-cyclobutane normalisés agent d’aération industrielles Huile de graines de Empêcher lacotonnier; huileO.2 Oxystéarine formation de 0,125 %d’arachides; huile de cristauxsoja

O.3 Ozone (1) Cidre (1) Agent dematuration (1) Bonnes pratiques industrielles

(2) Eau dite eau minérale ou eau de source

(2) Stérilisantchimique (2) Bonnes pratiques industrielles

(3) Vin (3) Agent dematuration (3) Bonnes pratiques industrielles

Cultures

P.1 Extrait de pancréas bactériennesproductrices Pour enrayer les bactériophages

Bonnes pratiques industrielles

d’acides

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

(1) Fruits et légumes (1) 0,3 % conformémentP.1A Paraffine (1) Enroberfrais à l’article B.01.047 Bonnes pratiques industrielles(2) Fromage et navets (2) Enrober (2) conformément à l’article B.01.047 0,15 %, conformément à l’article B.01.047. Si on utilise également une huile minérale

Produits de (1) Agent de comme agent deP.2 Vaseline (1) (1)boulangerie démoulage démoulage, la quantité totale de toute combinaison de vaseline et d’huile minérale ne doit pas dépasser 0,15 %

(2) Fruits et légumes (2) 0,3 %, conformément(2) Enroberfrais à l’article B.01.047

(1) AgentP.2A (1) Boissons gazeuses (1) 10 p.p.m.Polyéthylèneglycol antimousse (gamme de poids Édulcorant de table moléculaires de 3 000 à sous forme de(2) (2) Lubrifiant (2) 1,0 %9 000) comprimé contenant

de l’aspartame

(3) Comprimés de L- (3) Agent liant pour (3) 7,0 %lysine comprimés Aliments non Agent texturant Bonnes pratiquesP.2B Polydextrose normalisés et épaississant industrielles Ale; bière; bière légère; cidre; liqueurP.3 Polyvinyl-pyrrolidone (1) (1) Agent de collage (1) 2 p.p.m. dans lede malt; porter; produit fini stout; vin Édulcorant de table sous forme de (2) Liant pour(2) (2) 0,3 %comprimé contenant comprimés de l’aspartame Dispersions de Agent réducteur Bonnes pratiques pigment laqué de de la viscosité et industrielles (les(3) (3) (3)colorant pour stabilisant dans résidus de utilisation dans les les dispersions polyvinylpyrrolidone

Colonne I Article Additifs

Sulfate double P.4 d’aluminium et de

potassium

Ferrocyanure deP.4.1 potassium

P.5 Stéarate de potassium

P.6 Propane

P.7 Propylène-glycol

Q.1 Essence de quillaja

S.1 Saponine

S.1.01 Dioxyde de silicium

Pyrophosphate acide de sodium

Colonne II Permis dans ou sur

confiseries non normalisées sous forme de comprimé

Farine; farine de blé entier

Vin

(1) Gomme à mâcher

Préparations émulsifiantes

(2) contenant des mono- esters de propylèneglycol Aliments non normalisés Rocou soluble dans(1) l’huile Aliments non(2) normalisés Bases de boissons; mélanges pour boissons; liqueurs douces Bases de boissons; mélanges pour boissons; liqueurs douces Émulsions à base d’huiles végétales comestibles servant d’enduits pour batterie de cuisine Filets de poisson congelés; poisson haché congelé; homard congelé; crabe congelé; clams

Colonne III Colonne IV But de l’emploi Limites de tolérance

de pigment laqué ne doivent pas de colorant dépasser 100 p.p.m.

dans le produit fini) 900 p.p.m.,

Véhicule du conformément aux peroxyde de sous-alinéas benzoyle B.13.001e)(vi) et

B.13.005d)(vi) Bonnes pratiquesAgent de collage industrielles

(1) Agent plastifiant (1) Bonnes pratiquesindustrielles

(2) Agent stabilisant (2) 2 %

Agent pulseur et Bonnes pratiques agent d’aération industrielles

(1) Bonnes pratiques(1) Solvant industrielles

(2) Bonnes pratiques(2) Humidifiant industrielles

Bonnes pratiquesFaire mousser industrielles

Bonnes pratiquesFaire mousser industrielles

Agent de 2,0 % de la suspension préparation

Réduire les Si employé en pertes dues au association avec le traitement et la tripolyphosphate de formation sodium et le d’exsudat lors de pyrophosphate

S.1.1

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

congelés; crevettes la décongélation tétrasodique, la congelées quantité totale de

phosphate ajouté, calculé en phosphate dibasique de sodium, ne doit pas dépasser 0,5 % 900 p.p.m.

Véhicule du conformément auxSulfate d’aluminium et Farine; farine de bléS.2 peroxyde de sous-alinéasde sodium entier benzoyle B.13.001e)(vi) et B.13.005d)(vi)

Confiseries nonS.3 Bicarbonate de sodium (1) (1) Agent d’aération (1) Bonnes pratiquesnormalisées industrielles Stabilisant de

(2) Bonnes pratiques(2) Sel ordinaire (2) l’iodure de industriellespotassium Mélangé avec l’hexamétaphosphate 15 % du mélange dede sodium, filets de Pour empêcher carbonate de sodiumpoisson congelés,S.3A Carbonate de sodium de suinter en ethomard congelé, dégelant d’hexamétaphosphatecrabe congelé, clams de sodiumcongelés et crevettes congelées

Enrobage pourCarboxyméthylS.3B Boyaux de saucisse faciliter 0,25 % de boyauxcellulose de sodium l’épluchage S.4 (1) Sang de boeuf (1) Anticoagulant (1) 0,5 %

Citrate de sodium Précurseur de(2) Crème sure (2) (2) 0,1 %saveur Mélange de poisson et de viande préparés Modifier la (3) Bonnes pratiques(3) (3)visé à l’alinéa texture industrielles B.21.006n)

Adjuvant dans la 13 p.p.m. calculé enDécahydrate de production deS.5 Sel dendritique ferrocyanure anhydreferrocyanure de sodium cristaux de sel de sodiumdendritique S.6 Hexamétaphosphate de (1) Sang de boeuf (1) Anticoagulant (1) 0,2 %

sodium (2) Filets de poisson (2) Empêcher de (2) 0,5 % de phosphate

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

congelés; homards congelés; crabe congelé; clams congelés et crevettes congelées

suinter en dégelant

ajouté total, calculé en phosphate dibasique de sodium

(3) Gélatine qui entre dans la composition des guimauves

(3) Agent defouettage (3) 2 %

Faciliter Lorsque employé enl’enlèvement des combinaison avec lematières chlorure de sodiumétrangères etCrustacés et (sel) et l’oxyde deS.6A Hydroxyde de sodium réduire lamollusques congelés calcium en solution,déperdition l’hydroxyde ded’humidité sodium ne doit paspendant la dépasser 70 p.p.m.cuisson

S.6.1 Lauryl­sulfate de sodium (1) Poudre de blanc d’oeuf (poudre d’albumen)

(1) Faire monter enneige (1) 0,1 %

Blanc d’oeuf

(2) congelé (albumen congelé); blanc d’oeuf liquide

(2) Faire monter enneige (2) 0,0125 %

(albumen liquide)

(3) Gélatine qui entre dans la composition des guimauves

(3) Agent defouettage (3) 0,5 %

S.6.2 Chlorophylline de sodium, potassium et cuivre

Rafraîchisseurs d’haleine

Caractéristique du produit 700 p.p.m.

EmpêcherPhosphate dibasique de (1) Bonnes pratiquesS.7 (1) Poisson congelé (1) l’éclatement desodium industriellesla glace

(2) Champignons (2) Empêcher la (2) Bonnes pratiquescongelés décoloration industrielles Filets de poisson Réduire les Si employé en congelés; poisson pertes dues au association avec le

Pyrophosphate haché congelé; traitement et la tripolyphosphate deS.7.1 tétrasodique homard congelé; formation sodium et le crabe congelé; clams d’exsudat lors de pyrophosphate acide congelés; crevettes la décongélation de sodium, la

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

congelées quantité totale de phosphate ajouté, calculé en phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

Eau potable en Bonnes pratiquesS.8 Silicate de sodium Anticorrosifboîtes industrielles Bonnes pratiquesS.9 Stéarate de sodium Gomme à mâcher Agent plastifiant industrielles

Blanc d’oeuf congelé (albumenStéaroyl-2-lactylate de Faire monter enS.9A (1) congelé); blanc (1) (1) 0,05 %sodium neiged’oeuf liquide (albumen liquide) Poudre de blanc Faire monter en(2) d’oeuf (poudre (2) (2) 0,5 %neiged’albumen) Garnitures à l’huile

(3) ou mélanges pour (3) Faire mousser (3) 0,3 % garnitures Pommes de terre (4) Agent deconditionnement (4)

0,2 % du poids à(4) déshydratées l’état sec Champignons Empêcher la Bonnes pratiquesS.9B Sulfate de sodium congelés décoloration industrielles

S.9C Sulfite de sodium Miettes de thon enconserve Empêcher la décoloration 300 p.p.m.

S.10 Thiosulfate de sodium Sel Stabilisant de l’iodure de potassium

Bonnes pratiques industrielles

S.11 Tripolyphosphate desodium

Clams congelés; crabe congelé; crevettes congelées; filets de poisson congelés; homard congelé; poisson haché congelé et poisson haché menu congelé

Réduire les pertes dues au traitement et la formation d’exsudat lors de la décongélation

Si employé seul ou en association avec le pyrophosphate acide de sodium et le pyrophosphate tétrasodique, la quantité totale de phosphate ajouté, calculé en phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

Colonne I Colonne II Article Additifs Permis dans ou sur S.12 [Abrogé, DORS/93-276, art. 8]

Asperges conservées dans des contenants en verre ou des

S.13 Chlorure stanneux (1) contenants métalliques vernis sur toute leur surface intérieure Boissons gazeuses en boîtes; jus de citron; jus de fruit(2) concentré sauf le jus d’orange concentré congelé; jus de lime Confiseries nonS.14 Acide stéarique (1) normalisées

(2) Gomme à mâcher

Aliments vendus (3) sous forme de

comprimés

Sulfate de méthyle etS.15 Pectinede sodium

S.15A [Abrogé, DORS/93-276, art. 9] Préparation aromatisante de

Acétate isobutyrate de (nom de l’arôme)S.16 sucrose pour utilisation dans les boissons contenant des huiles

Colonne III Colonne IV But de l’emploi Limites de tolérance

Stabiliser la (1) 25 p.p.m. calculé en(1) couleur et la étainsaveur

Stabiliser la (2) Bonnes pratiques(2) couleur et la industriellessaveur

(1) Agent de (1) Bonnes pratiquesdémoulage industrielles

(2) Agent plastifiant (2) Bonnes pratiquesindustrielles Agent de

(3) Bonnes pratiques(3) démoulage et industrielleslubrifiant Aider au conditionnement, comme résultat de la méthylation de la pectine par l’action de l’acide 0,1 % de pectinesulfurique et de l’alcool méthylique, le bicarbonate de sodium agissant comme neutralisant

300 p.p.m. dans les boissons contenantAgent des huiles d’agrumesmodificateur de ou d’épinette sousla densité leur forme consommable

Colonne I Colonne II Colonne III Colonne IV Article Additifs Permis dans ou sur But de l’emploi Limites de tolérance

d’agrumes ou d’épinette

Améliorer le rendement de Bonnes pratiquesS.17 Acide sulfurique Grains de café l’extraction des industrielles solides de café

(1) Bonnes pratiquesT.1 Talc (1) Riz (1) Enrobage industrielles

(2) Base de gomme à (2) Bonnes pratiques(2) Remplissagemâcher industrielles

(3) Agent de (3) Bonnes pratiques(3) Gomme à mâcher saupoudrage industrielles Pour diminuer (1) Bonnes pratiquesT.2 Acide tannique (1) Gomme à mâcher (1) l’adhérence industrielles

Cidre; vin; vin de(2) (2) Agent de collage (2) 200 p.p.m.miel T.2A [Abrogé, DORS/93-276, art. 10]

Agent Bonnes pratiquesT.3 Triacétine Mélanges à gâteau humidifiant indrustrielles Blanc d’oeuf congelé (albumen congelé); blanc d’oeuf liquide Faire monter enT.4 Triéthylcitrate 0,25 %(albumen liquide); neige poudre de blanc d’oeuf (poudre d’albumen)

X.1 [Abrogé, DORS/93-276, art. 11]

DORS/78-401, art. 3; DORS/78-403, art. 23 à 25; DORS/78-876, art. 4; DORS/79-660, art. 13; DORS/79-752, art. 8; DORS/80-632, art. 6 à 13; DORS/81-83, art. 4; DORS/81­ 617, art. 3; DORS/81-934, art. 11 et 12; DORS/82-566, art. 3 et 4; DORS/82-1071, art. 18 à 20; DORS/83-410, art. 3; DORS/83-584, art. 1; DORS/83-932, art. 5 et 6; DORS/84-17, art. 6; DORS/84-441, art. 1; DORS/84-602, art. 3; DORS/84-762, art. 10; DORS/84-801, art. 5 et 6; DORS/86-1112, art. 5; DORS/86-1125, art. 2; DORS/87-469, art. 1; DORS/87-640, art. 8; DORS/88-419, art. 4; DORS/88-534, art. 5 et 6; DORS/89­ 175, art. 2; DORS/89-197, art. 1; DORS/89-198, art. 11; DORS/89-555, art. 2 et 3; DORS/91-90, art. 2; DORS/91-124, art. 6 à 9; DORS/91-149, art. 3; DORS/91-186, art. 1; DORS/91-409, art. 7; DORS/91-527, art. 4; DORS/92-229, art. 1; DORS/92-344, art. 2 à 4; DORS/93-276, art. 4 à 11; DORS/94-416, art. 1; DORS/94-227, art. 5 à 10; DORS/94-689, art. 2(F); DORS/94-723, art. 1; DORS/96-260, art. 1; DORS/96-378, art. 1; DORS/97-509, art. 1; DORS/98-580, art. 1(F); DORS/99-97, art. 1; DORS/99-420, art.

11(F); DORS/2000-353, art. 8(F); DORS/2001-94, art. 3; DORS/2005-316, art. 2(F) et 3; DORS/2006-91, art. 6 à 12; DORS/2007-75, art. 7; DORS/2010-41, art. 9(A); DORS/2010-94, art. 8(A); DORS/2010-142, art. 30(F), 31 à 39, 40(F), 41 à 45, 46(F), 47 à 51 et 59(F); DORS/2010-143, art. 27 à 31.

TABLEAU IX

ADDITIFS ALIMENTAIRES QUI PEUVENT ÊTRE UTILISÉS COMME ÉDULCORANTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

A.01 Acésulfame­potassium (1) Édulcorants de table (1) Bonnes pratiques industrielles 0,025 % dans les

(2) Boissons gazéifiées (2) boissons, sousleur forme consommable

Boissons; concentrés de boisson; 0,05 % dans lesmélanges pour boisson; boissons boissons, sous(3) laitières; (sauf pour ceux de ces (3) leur formeproduits visés par une norme dans consommablele présent règlement) Desserts; mélanges pour desserts; glaçages; mélanges pour glaçages; 0,1 % dans les garnitures; mélanges pour produits, sous(4) (4)garnitures; (sauf pour ceux de ces leur forme produits visés par une norme dans consommable le présent règlement)

(5) Gomme à mâcher; rafraîchisseurs (5) 0,35 %d’haleine Tartinades de fruit (sauf pour ceux

(6) de ces produits visés par une (6) 0,1 % norme dans le présent règlement) Sauces à salade (sauf pour ceux de

(7) ces produits visés par une norme (7) 0,05 % dans le présent règlement)

(8) Confiseries non normalisées (8) 0,25 % Mélanges pour pâtisseries; produits 0,1 % dans les de boulangerie; (sauf pour ceux de produits, sous(9) (9)ces produits visés par une norme leur forme dans le présent règlement) consommable

(1) Bonnes pratiquesA.1 Aspartame (1) Édulcorants de table industrielles (2) Céréales pour petit déjeuner (2) 0,5 %

Colonne I Article Additifs

Aspartame, en capsules, pour prévenir saA.2 dégradation pendant la cuisson

E.1 Érythritol

Colonne II Permis dans ou sur

Boissons; concentrés de boisson; mélanges pour boisson; (sauf pour(3) l’un de ces produits visés par une norme dans le présent règlement) Desserts; mélanges pour desserts; glaçages; mélanges pour glaçages; garnitures; mélanges pour(4) garnitures; (sauf pour l’un de ces produits visés par une norme dans le présent règlement)

(5) Gomme à mâcher; rafraîchisseursd’haleine Tartinades de fruit; purées et sauces; sirops de table; (sauf pour(6) l’un de ces produits visés par une norme dans le présent règlement) Sauces à salade; tartinades d’arachides et autres tartinades de

(7) noix; (sauf pour l’un de ces produits visés par une norme dans le présent règlement) Condiments (sauf pour l’un de ces

(8) produits visés par une norme dans le présent règlement) Shellacs de confiserie pour les friandises; assaisonnements sucrés(9) ou mélanges pour enrobage des friandises Confiseries non normalisées;

(10) enrobages de confiserie non normalisés

Produits de boulangerie et mélanges pour pâtisseries (sauf pour l’un de ces produits visés par une norme dans le présent règlement)

(1) Édulcorants de table

Colonne III Limites de tolérance

0,1 % dans les boissons, sous(3) leur forme consommable

0,3 % dans les produits, sous(4) leur forme consommable

(5) 1,0 %

(6) 0,2 %

(7) 0,05 %

(8) 0,2 %

(9) 0,1 %

(10) 0,3 %

0,4 % dans les produits, sous leur forme consommable

(1) Bonnes pratiquesindustrielles (2) Boissons diététiques (2) 3,5 % (3) Garnitures et glaçages à la crème (3) 60 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

faits à base de gras (4) Biscuits et gaufrettes diététiques (4) 7 % (5) Bonbons mous (5) 40 % (6) Bonbons durs (6) 50 % (7) Gomme à mâcher (7) 60 %

Hydrolysat Bonnes pratiquesH.1 d’amidon Aliments non normalisés industrielleshydrogéné Bonnes pratiquesI.1 Isomalt Aliments non normalisés industrielles Bonnes pratiquesL.1 Lactitol Aliments non normalisés industrielles Bonnes pratiquesM.1 Maltitol Aliments non normalisés industrielles Bonnes pratiquesM.2 Sirop de maltitol Aliments non normalisés industrielles Bonnes pratiquesM.3 Mannitol Aliments non normalisés industrielles

(1) Bonnes pratiquesN.1 Néotame (1) Édulcorants de table industrielles (2) Céréales à déjeuner (2) 0,016 %

0,003 % dans lesBoissons non normalisées; boissons, sous(3) concentrés de boisson non (3) leur formenormalisés; mélanges pour boisson consommable Desserts non normalisés; 0,01 % dans lesgarnitures; glaçages; mélanges produits, sous(4) pour desserts; mélanges pour (4) leur formegarnitures; mélanges pour consommableglaçages; yogourt

(5) Gomme à mâcher; rafraîchisseurs (5) 0,032 %d’haleine Purées et sauces non normalisées;

(6) sirops de table non normalisés; (6) 0,007 % tartinades de fruit non normalisées Sauces à salade non normalisées;

(7) tartinades d’arachides et autres (7) 0,002 % tartinades de fruits à écale

(8) Condiments non normalisés; (8) 0,007 % (9) Assaisonnements sucrés ou (9) 0,0032 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

mélanges pour enrobage des friandises; glaçages à confiserie pour friandises;

(10) Confiseries non normalisées; enrobages de confiserie non normalisés

(10) 0,01 %

(11) Produits de boulangerie non normalisés et mélanges pour pâtisseries

(11)

0,013 % dans les produits, sous leur forme consommable

(1) Mélange de poisson et de viandeS.1 Sorbitol préparés visé à l’alinéa B.21.006n) (1) 6,0 %

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Bonnes pratiquesS.1.1 Sirop de sorbitol Aliments non normalisés industrielles

(1) Bonnes pratiquesS.2 Sucralose (1) Édulcorants de table industrielles (2) Céréales pour petit déjeuner (2) 0,1 %

Boissons; concentrés de boisson; 0,025 % dans lesmélanges pour boisson; boissons boissons, sous(3) laitières; (sauf pour l’un de ces (3) leur formeproduits visés par une norme dans consommablele présent règlement) Desserts; mélanges pour desserts; glaçages; mélanges pour glaçages; 0,025 % dans lesdesserts laitiers; desserts congelés; produits, sous(4) garnitures; mélanges pour (4) leur formegarnitures; (sauf pour l’un de ces consommableproduits visés par une norme dans le présent règlement)

(5) Gomme à mâcher; rafraîchisseurs (5) 0,15 %d’haleine Tartinades de fruit (sauf pour l’un

(6) de ces produits visés par une (6) 0,045 % norme dans le présent règlement) Sauces à salade; condiments; (sauf pour l’un de ces produits visés par(7) (7) 0,04 %une norme dans le présent règlement)

(8) Assaisonnements sucrés ou (8) 0,07 %

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

mélanges pour enrobage des friandises; confiseries non normalisées; enrobages de confiserie non normalisés; glaçages à confiserie pour friandises Mélanges pour pâtisseries; produits 0,065 % dans les de boulangerie; (sauf pour l’un de produits, sous(9) (9)ces produits visés par une norme leur forme dans le présent règlement) consommable Produits de fruits et légumes transformés (sauf pour l’un de ces(10) (10) 0,015 %produits visés par une norme dans le présent règlement) Boissons alcooliques (sauf pour

(11) l’un de ces produits visés par une (11) 0,07 % norme dans le présent règlement)

0,04 % dans les produits, sous(12) Poudings; mélanges pour poudings (12) leur forme consommable

Sirops de table (sauf pour l’un de (13) ces produits visés par une norme (13) 0,15 %

dans le présent règlement)

(1) Gommes à mâcher; rafraîchisseursT.1 Thaumatin (1) 500 p.p.m.d’haleine (2) Succédanés du sel (2) 400 p.p.m.

Une préparation aromatisante de (nom de l’arôme) visée à l’article(3) (3) 100 p.p.m.B.10.005; préparations aromatisantes non normalisées

Bonnes pratiquesX.1 Xylitol Aliments non normalisés industrielles

DORS/93-276, art. 12; DORS/94-625, art. 5; DORS/94-689, art. 2(F); DORS/94-779, art. 3; DORS/97-512, art. 3 et 4; DORS/2004-261, art. 2; DORS/2007-76, art. 3; DORS/2007-176, art. 7; DORS/2010-142, art. 52 à 55.

TABLEAU X

ADDITIFS ALIMENTAIRES AUTORISÉS COMME RAJUSTEURS DU PH, RÉACTIFS DES ACIDES ET DES AGENTS CORRECTEURS DE L’EAU

Colonne I Colonne II Colonne III

Article Additifs Permis dans ou sur Limites de tolérance Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à (1) Bonnes pratiquesA.1 Acide acétique (1) tartiner (avec indication des industrielles ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(2) Bonnes pratiques(2) Asperges en conserve industrielles

(3) Bonnes pratiques(3) Gélatine industrielles

(4) Bonnes pratiques(4) Aliments non normalisés industrielles Bonnes pratiquesA.2 Acide adipique Aliments non normalisés industrielles

(1) Bonnes pratiquesA.3 Sulfate double (1) Poudre à pâte industriellesd’aluminium et (2) Bonnes pratiquesd’ammonium (2) Aliments non normalisés industrielles

En quantité suffisante pour

Bicarbonate traiter les produitsA.4 (1) Produits du cacao (1)d’ammonium du cacao conformément à l’article B.04.005

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(2) Bonnes pratiques(2) Aliments non normalisés industrielles En quantité suffisante pour

Carbonate traiter les produitsA.5 (1) Produits du cacao (1)d’ammonium du cacao conformément à l’article B.04.005

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Citrate d’ammonium Bonnes pratiquesA.6 Aliments non normalisésdibasique industrielles Citrate d’ammonium Bonnes pratiquesA.7 Aliments non normalisésmonobasique industrielles

En quantité suffisante pour

Hydroxyde traiter les produitsA.8 (1) Produits du cacao (1)d’ammonium du cacao conformément à l’article B.04.005

(2) Bonnes pratiques(2) Gélatine industrielles

(3) Bonnes pratiques(3) Aliments non normalisés industrielles

A.9 Phosphate d’ammonium dibasique

(1)

Ale; cultures bactériennes; poudre à pâte; bière; bière légère; liqueur de malt; porter; stout

(1) Bonnes pratiquesindustrielles

(2) Produits de boulangerie nonnormalisés (2) Bonnes pratiques industrielles

A.10 Phosphate d’ammonium monobasique

(1)

Ale; cultures bactériennes; poudre à pâte; bière; bière légère; liqueur de malt; porter; stout

(1) Bonnes pratiquesindustrielles

(2) Produits de boulangerie nonnormalisés (2) Bonnes pratiques industrielles

(3) Lait de beurre sans culture (3) 0,1 %

C.1 Acétate de calcium (1) Ale; bière; bière légère; liqueurde malt; porter; stout (1) Bonnes pratiques industrielles

(2) Aliments non normalisés (2) Bonnes pratiquesindustrielles

C.2

Colonne I Article Additifs

Carbonate de calcium

C.3 Chlorure de calcium

Colonne II Permis dans ou sur

(1) Mélange pour crème glacée;mélange pour lait glacé; vin Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à(2) tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3) Jus de raisin

(4) Aliments non normalisés

(5) Produits du cacao

(1) Ale; bière; bière légère; liqueurde malt; porter; stout

(2) Aliments non normalisés

Colonne III Limites de tolérance

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles En quantité suffisante pour traiter les produits(5) du cacao conformément à l’article B.04.005

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(1) Bonnes pratiquesC.4 (1) Préparations pour nourrissons industriellesCitrate de calcium (2) Bonnes pratiques(2) Aliments non normalisés industrielles

Bonnes pratiquesC.5 Fumarate de calcium Aliments non normalisés industrielles Gluconate de Bonnes pratiquesC.6 Aliments non normaliséscalcium industrielles

Ale; bière; mélange pour crème Hydroxyde de glacée; mélange pour lait glacé; (1) Bonnes pratiquesC.7 (1)calcium bière légère; liqueur de malt; industrielles

porter; stout (2) Pois en conserve (2) 0,01 %

(3) Bonnes pratiques(3) Préparations pour nourrissons industrielles

(4) Bonnes pratiques(4) Jus de raisin industrielles

(5) Bonnes pratiques(5) Aliments non normalisés industrielles

(1) Bonnes pratiquesC.8 (1) Poudre à pâte industriellesLactate de calcium (2) Bonnes pratiques(2) Aliments non normalisés industrielles

Ale; bière; mélange pour crème glacée; mélange pour lait glacé; (1) Bonnes pratiquesC.9 Oxyde de calcium (1) bière légère; liqueur de malt; industrielles porter; stout

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Bonnes pratiquesC.10 Phosphate bicalcique Aliments non normalisés industrielles

Ale; poudre à pâte; bière; bièrePhosphate (1) Bonnes pratiquesC.11 (1) légère; liqueur de malt; porter;monocalcique industriellesstout

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Bonnes pratiquesC.12 Phosphate tricalcique Aliments non normalisés industrielles

Ale; bière; bière légère; liqueur Bonnes pratiquesC.13 Sulfate de calcium de malt; porter; stout; vin industrielles

Colonne I Article Additifs

C.13A Dioxyde de carbone

C.14 Acide citrique

Colonne II Permis dans ou sur

Fromage (indication de la variété) Ale; artichauts en conserve; asperges en conserve; bière; bière légère; blanc d’oeuf (albumen) et jaune d’oeuf; champignons en conserve; cidre; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); crevettes cuites congelées; fromage cottage; fromage cottage en crème; gélatine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; germes de haricots en conserve; jus de raisin; liqueur de malt; maquereau de printemps en conserve; marmelade d’ananas;

(1) marmelade d’ananas avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; mayonnaise; mélange pour crème glacée; mélange pour lait glacé; mincemeat; mollusques en conserve; nectar d’abricot; nectar de pêche; nectar de poire; (nom du fruit) congelé; oeuf entier à l’état liquide; en poudre ou congelé; oignons en conserve; olives; piments forts en conserve; poires en conserve; porter; sauce à salade; sauce vinaigrette; sorbet laitier; stout; tomates; vin de miel

(2) Compote de pommes enconserve; pamplemousses en

Colonne III Limites de tolérance

Bonnes pratiques industrielles

(1) Bonnes pratiquesindustrielles

(2) En quantitésuffisante pour

Colonne I Article Additifs

C.15 Crème de tartre

Colonne II Permis dans ou sur

conserve; mandarines en conserve; poires en conserve; ananas en conserve; fraises en conserve

(3) Préparation pour nourrissons

(4) Margarine

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à(5) tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(6) Aliments non normalisés

(7) Produits du cacao

Mêmes aliments que pour le

Colonne III Limites de tolérance

maintenir le pH entre 4,2 et 4,5

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles

(5) Bonnes pratiquesindustrielles

(6) Bonnes pratiquesindustrielles 1,0 %, seul ou en combinaison avec

(7) de l’acide tartarique, sans matières grasses Mêmes limites de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

tartrate acide de potassium tolérance que pour le tartrate acide de potassium

(1) Bonnes pratiquesF.1 (1) Gélatine industriellesAcide fumarique (2) Bonnes pratiques(2) Aliments non normalisés industrielles

(3) Bonnes pratiques(3) Vin industrielles Bonnes pratiquesG.1 Acide gluconique Aliments non normalisés industrielles

Glucono-delta- Bonnes pratiquesG.2 Aliments non normaliséslactone industrielles Ale; bière; gélatine; bière

(1) Bonnes pratiquesH.1 Acide chlorhydrique (1) légère; liqueur de malt; porter; industriellesstout

(2) Bonnes pratiques(2) Préparations pour nourrissons industrielles Ale; achards (relish); bière; blanc d’oeuf congelé (albumen congelé); blanc d’oeuf liquide (albumen liquide); cidre; cornichons; fromage cottage; fromage cottage en crème; jaune d’oeuf congelé; jaune d’oeuf liquide; liqueur de malt; mayonnaise; mélange pour (1) Bonnes pratiquesL.1 Acide lactique (1) crème glacée; mélange pour lait industrielles glacé; oeuf entier congelé; oeuf entier liquide; olives; pain; porter; poudre à pâte; poudre de blanc d’oeuf (poudre d’albumen); poudre de jaune d’oeuf; poudre d’oeuf entier; sauce à salade; sauce vinaigrette; sorbet laitier; stout

En quantité

(2) Poires en conserve; fraises en suffisante pour(2)conserve maintenir le pH entre 4,2 et 4,5

(3) Bonnes pratiques(3) Margarine industrielles

Colonne I Article Additifs

Carbonate deM.2 magnésium

Citrate deM.3 magnésium

Colonne II Permis dans ou sur

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à(4) tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(5) Aliments non normalisés

(6) Vin

(1) Produits du cacao

(2) Mélange pour crème glacée;mélange pour lait glacé

(3) Aliments normalisés

Liqueurs douces

Colonne III Limites de tolérance

(4) Bonnes pratiquesindustrielles

(5) Bonnes pratiquesindustrielles

(6) Bonnes pratiquesindustrielles En quantité suffisante pour traiter les produits(1) du cacao conformément à l’article B.04.005

(2) Bonnes pratiquesindustrielles

(3) Bonnes pratiquesindustrielles Bonnes pratiques industrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Fumarate de Bonnes pratiquesM.4 Aliments non normalisésmagnésium industrielles M.5 (1) Pois en conserve (1) 0,05 %

En quantité suffisante pourHydroxyde de traiter les produitsmagnésium (2) Produits du cacao (2) du cacao conformément à l’article B.04.005

(3) Gélatine; mélange pour crèmeglacée; mélange pour lait glacé (3) Bonnes pratiques industrielles

(4) Bonnes pratiques(4) Cultures bactériennes industrielles Oxyde de Mélange pour crème glacée; Bonnes pratiquesM.6 magnésium mélange pour lait glacé industrielles Phosphate de Bonnes pratiquesM.6A Cultures bactériennesmagnésium industrielles Sulfate de (1) Ale; bière; bière légère; liqueur (1) Bonnes pratiquesM.7 magnésium de malt; porter; stout industrielles

(2) Bonnes pratiques(2) Cultures bactériennes industrielles Asperges en conserve; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade d’ananas;

(1) Bonnes pratiquesM.8 Acide malique (1) marmelade d’ananas avec industriellespectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; nectar d’abricot; nectar de pêche; nectar de poire; (nom du fruit) congelé

En quantitéCompote de pommes en suffisante pour(2) conserve; poires en conserve; (2) maintenir le pHfraises en conserve entre 4,2 et 4,5

Colonne I Colonne II Article Additifs Permis dans ou sur

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à(3) tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4) Aliments non normalisés

(5) Vin

Sulfate deM.8A Cultures bactériennesmanganèse M.9 Acide métatartrique Vin

Ale; bière; bière légère; fromage cottage; fromage cottage en crème; gélatine;P.1 Acide phosphorique (1) liqueur de malt; monoglycérides et mono- et diglycérides; porter; stout Fromage à la crème à tartiner;

(2) fromage à la crème à tartiner (avec indication des ingrédients

Colonne III Limites de tolérance

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles

(5) Bonnes pratiquesindustrielles Bonnes pratiques industrielles 0,01 %

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

P.2

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3) Bonnes pratiques(3) Protéines de poisson industrielles

(4) Bonnes pratiques(4) Aliments non normalisés industrielles 0,5 %, en P2O5,

(5) Produits du cacao (5) sans matières grasses

(1) Poudre à pâte; hydromel vineux (1) Bonnes pratiquesTartrate acide de industrielles potassium

(2) Bonnes pratiques(2) Aliments non normalisés industrielles (3) Vin (3) 0,42 %

P.3 Sulfate double d’aluminium et de potassium

(1)

Ale; poudre à pâte; bière; bière légère; liqueur de malt; rocou soluble dans l’huile; porter; stout

(1) Bonnes pratiquesindustrielles

(2) Aliments non normalisés (2) Bonnes pratiquesindustrielles P.4 Bicarbonate de (1) Lait malté; poudre à pâte; (1) Bonnes pratiques

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

potassium poudre de lait malté; industrielles En quantité suffisante pour traiter les produits(2) Produits du cacao (2) du cacao conformément à l’article B.04.005

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à (3) Bonnes pratiques(3) tartiner (avec indication des industrielles ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4) Bonnes pratiques(4) Préparations pour nourrissons industrielles

(5) Bonnes pratiques(5) Margarine industrielles

(6) Bonnes pratiques(6) Aliments non normalisés industrielles

(7) Bonnes pratiques(7) Vin industrielles P.5 Carbonate de (1) Produits du cacao (1) En quantité

Colonne I Colonne II Article Additifs Permis dans ou sur

potassium

(2)

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(3) Margarine

(4) Aliments non normalisés

(5) Mélange de poisson et de viande préparés visé à l’alinéa B.21.006n)

(6) Vin

P.6 Chlorure depotassium Ale; bière; bière légère; liqueur de malt; porter; stout

Colonne III Limites de tolérance

suffisante pour traiter les produits du cacao conformément à l’article B.04.005

(2) Bonnes pratiquesindustrielles

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles

(5) Bonnes pratiquesindustrielles

(6) Bonnes pratiquesindustrielles Bonnes pratiques industrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(1) Bonnes pratiquesP.7 (1) Préparations pour nourrissons industriellesCitrate de potassium (2) Bonnes pratiques(2) Margarine industrielles

(3) Bonnes pratiques(3) Aliments non normalisés industrielles

(4) Bonnes pratiques(4) Vin industrielles Fumarate de Bonnes pratiquesP.8 Aliments non normaliséspotassium industrielles

P.9 (1) Rocou soluble dans l’huile (1) 1,0 % En quantité suffisante pourHydroxyde de traiter les produitspotassium (2) Produits du cacao (2) du cacao conformément à l’article B.04.005

Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et (3) Bonnes pratiques(3) des sous-produits de viande industrielles conditionnés ou conservés; mélange pour crème glacée; mélange pour lait glacé

(4) Bonnes pratiques(4) Préparation pour nourrissons industrielles

(5) Bonnes pratiques(5) Margarine industrielles

(6) Bonnes pratiques(6) Jus de raisin industrielles

(7) Bonnes pratiques(7) Aliments non normalisés industrielles Bonnes pratiquesP.9A Lactate de potassium Margarine industrielles

Phosphate Bonnes pratiquesP.10 Aliments non normalisésbipotassique industrielles Ale; bière; bière légère; liqueur Bonnes pratiquesP.11 Sulfate de potassium de malt; porter; boissons non industriellesalcoolisées; stout

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Tartrate de Bonnes pratiquesP.12 Cidrepotassium industrielles Bonnes pratiquesS.1 Acétate de sodium Aliments non normalisés industrielles

(1) Bonnes pratiquesS.2 (1) Poudre à pâtePyrophosphate acide industrielles de sodium

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Tartrate acide de Bonnes pratiquesS.3 Poudre à pâtesodium industrielles Phosphate Bonnes pratiquesS.4 d’aluminium et de Aliments non normalisés industriellessodium

(1) Bonnes pratiquesS.5 Sulfate double (1) Poudre à pâte industriellesd’aluminium et de (2) Bonnes pratiquessodium (2) Aliments non normalisés industrielles

Blanc d’oeuf congelé (albumen congelé); blanc d’oeuf liquide (albumen liquide); confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; jaune d’oeuf congelé; jaune d’oeuf liquide; marinade, saumure et mélange de salaisonBicarbonate de (1) Bonnes pratiquesS.6 (1) à sec employés dans lesodium industriellesmarinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés; marmelade d’ananas; marmelade d’ananas avec pectine; marmalade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; mélange pour crème glacée;

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

mélange pour lait glacé; oeuf entier congelé; oeuf entier liquide; poudre à pâte; poudre de blanc d’oeuf (poudre d’albumen); poudre de jaune d’oeuf; poudre de lait malté; poudre d’oeuf entier; rocou soluble dans l’huile

En quantité suffisante pour traiter les produits(2) Produits du cacao (2) du cacao conformément à l’alinéa B.04.005

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à (3) Bonnes pratiques(3) tartiner (avec indication des industrielles ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4) Bonnes pratiques(4) Préparations pour nourrissons industrielles (5) Margarine (5) Bonnes pratiques

Colonne I Colonne II Article Additifs Permis dans ou sur

(6) Aliments non normalisés

(1) Ale; bière; bière légère; liqueurS.7 Bisulfate de sodium de malt; porter; stout

(2) Produits de boulangerie nonnormalisés

S.8 Carbonate de sodium (1)

Blanc d’oeuf congelé (albumen congelé); blanc d’oeuf liquide (albumen liquide); confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confiture de pommes (ou de rhubarbe) et de (nom du fruit); gélatine; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; jaune d’oeuf congelé; jaune d’oeuf liquide; liant à viande ou liant à (désignation du produit de viande) lorsqu’il est vendu pour servir dans les viandes conditionnées ou conservées et dans les sous-produits de viande conditionnés ou conservés; marmelade d’ananas; marmelade d’ananas avec pectine; marmelade de figues; marmelade de figues avec pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; mélange pour crème glacée; mélange pour lait glacé; oeuf entier congelé; oeuf entier liquide; poudre de blanc d’oeuf (poudre d’albumen); poudre de jaune d’oeuf; poudre d’oeuf entier

(2) Produits du cacao

Colonne III Limites de tolérance

industrielles

(6) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

En quantité suffisante pour(2) traiter les produits du cacao

Colonne I Colonne II Article Additifs Permis dans ou sur

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à(3) tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4) Margarine

(5) Aliments non normalisés

Confitures de (nom du fruit); confitures de (nom du fruit) avec pectine; confitures de pommes (ou de rhubarbe) et de (nom du fruit); crème; fromage

S.9 Citrate de sodium (1) cottage; fromage cottage à la crème; gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; marmelade d’ananas ou de figues; marmelade d’ananas ou de figues avec pectine;

Colonne III Limites de tolérance

conformément à l’article B.04.005

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles

(5) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

marmelade de (nom des agrumes); marmelade de (nom des agrumes) avec pectine; mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(2) Bonnes pratiques(2) Préparations pour nourrissons industrielles

(3) Bonnes pratiques(3) Aliments non normalisés industrielles

(4) Bonnes pratiques(4) Margarine industrielles Bonnes pratiquesS.12 Fumarate de sodium Aliments non normalisés industrielles Bonnes pratiquesS.13 Gluconate de sodium Aliments non normalisés industrielles

Hexamétaphosphate Bonnes pratiquesS.14 Aliments non normalisésde sodium industrielles En quantité suffisante pour

Hydroxyde de traiter les produitsS.15 (1) Produits du cacao (1)sodium du cacao conformément à l’article B.04.005

Gélatine; lait écrémé (indication de l’arôme); lait partiellement écrémé (indication de l’arôme); marinade, saumure et mélange de salaison à sec employés dans

(2) Bonnes pratiques(2) le marinage des viandes industriellesconditionnées ou conservées et des sous-produits de viande conditionnés ou conservés; mélange pour crème glacée; mélange pour lait glacé

(3) Bonnes pratiques(3) Préparations pour nourrissons industrielles

(4) Bonnes pratiques(4) Margarine industrielles

(5) Bonnes pratiques(5) Aliments non normalisés industrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Fromage de petit-lait; fromage (6) Bonnes pratiques(6) de petit-lait (indication de la industriellesvariété)

(1) Bonnes pratiquesS.16 (1) Margarine industriellesLactate de sodium (2) Bonnes pratiques(2) Aliments non normalisés industrielles

Ale; culture bactérienne; bière; (1) Bonnes pratiquesS.17 Phosphate bisodique (1) crème; bière légère; liqueur de industriellesmalt; porter; stout

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Phosphate (1) Ale; bière; bière légère; liqueur (1) Bonnes pratiquesS.18 monosodique de malt; porter; stout industrielles

(2) Bonnes pratiques(2) Aliments non normalisés industrielles

Phosphate trisodique (1) Ale; bière; bière légère; liqueur (1) Bonnes pratiquesS.19 de malt; porter; stout industrielles

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Confitures de pommes (ou de rhubarbe) et de (nom du fruit); confitures de (nom du fruit) avec pectine; gelée de (nom du

Tartrate double de fruit); gelée de (nom du fruit) (1) Bonnes pratiquesS.20 sodium et de (1) avec pectine; marmelade de industriellespotassium (nom des agrumes); marmelade

de (nom des agrumes) avec pectine; marmelade d’ananas ou de figues; marmelade d’ananas ou de figues avec pectine

(2) Bonnes pratiques(2) Aliments non normalisés industrielles

(3) Bonnes pratiques(3) Margarine industrielles Pyrophosphate Bonnes pratiquesS.21 Aliments non normaliséstétrasodique industrielles Polyphosphate Bonnes pratiquesS.22 Aliments non normaliséstrisodique industrielles

Ale; bière; bière légère; liqueur Bonnes pratiquesS.23 Acide sulfurique de malt; porter; stout industrielles

Colonne I Colonne II Article Additifs Permis dans ou sur

S.24 Acide sulfureux Gélatine

Ale; asperges en conserve; bière; bière légère; cidre; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; confitures de pommes (ou de rhubarbe) et de (nom de fruit); gelée de (nom du fruit); gelée de (nom du fruit) avec pectine; liqueur de malt; marmelade d’ananas; marmelade d’ananas avecT.1 Acide tartrique (1) pectine; marmelade de (nom de l’agrume); marmelade de (nom de l’agrume) avec pectine; marmelade de figues; marmelade de figues avec pectine; mayonnaise; mélange pour crème glacée; mélange pour lait glacé; porter; poudre à pâte; sauce à salade; sauce vinaigrette; sorbet laitier; stout; vin; vin de miel;

(2) Poires en conserve; fraises enconserve

Fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu

(3) (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation

Colonne III Limites de tolérance

Bonnes pratiques industrielles, pourvu que le produit fini contienne au plus 500 p.p.m. exprimées en anhydride sulfureux

(1) Bonnes pratiquesindustrielles

En quantité suffisante pour(2) maintenir le pH entre 4,2 et 4,5

(3) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés); fromage de petit-lait (indication de la variété)

(4) Bonnes pratiques(4) Margarine industrielles

(5) Bonnes pratiques(5) Aliments non normalisés industrielles 1,0 %, seul ou en combinaison avec

(6) Produits du cacao (6) de l’acide citrique, sans matières grasses

DORS/78-874, art. 4; DORS/79-660, art. 14 à 17; DORS/79-664, art. 3 à 13; DORS/79­ 752, art. 9; DORS/80-501, art. 4; DORS/86-1112, art. 6 à 8; DORS/92-106, art. 1; DORS/92-344, art. 5; DORS/94-689, art. 2(F); DORS/95-281, art. 2 à 5; DORS/95-436, art. 2 et 3; DORS/97-263, art. 11 à 25; DORS/97-561, art. 3; DORS/98-580, art. 1(F); DORS/2001-94, art. 3; DORS/2006-91, art. 13 à 20; DORS/2007-75, art. 8; DORS/2010­ 41, art. 9(A); DORS/2010-94, art. 8(A); DORS/2010-142, art. 56; DORS/2010-143, art. 32 à 36.

TABLEAU XI PARTIE I

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE CONSERVATION DE LA CATÉGORIE I

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Colonne I Article Additifs

AcideA.1 acétique

AcideA.2 ascorbique

Colonne II Permis dans ou sur

Poisson de salaison; viandes de salaison; sous-produits de viande de salaison; viande de volaille de salaison; sous­ produits de viande de volaille

(1) de salaison; marinade; saumure et mélange de salaison à sec, employés dans l’apprêt des viandes de salaison ou des sous-produits de viande de salaison

(2) Aliments non normalisés

Ale; asperges blanches en conserve; bière; bière légère; champignons en conserve; cidre; fruits congelés; glaçage pour poisson congelé; tête en fromage ou tête fromagée; liant à viande pour viandes conservées et sous-produits de viande conservée (titre 14 seulement); liqueur de malt; marinade injectable; poisson déchiqueté congelé; poisson

(1) conservé; poisson haché congelé; porter; saumure et mélange de salaison à sec employés dans le conditionnement des viandes ou des sous-produits de viande; sous-produits de viande conservés; sous­ produits de viande de volaille conservés; stout; thon en conserve; viande conservée; viande de volaille conservée; vin

(2) Compote de pommes enconserve

Colonne III Limites de tolérance

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

S’il est utilisé seul ou en combinaison avec l’acide

(2) isoascorbique, la quantité totale n’excède pas 150 p.p.m.

Colonne I Article Additifs

Ascorbate deC.1 calcium

AcideE.1 érythorbique

AcideI.1 isoascorbique

Nitrate deP.1 potassium

Colonne II Permis dans ou sur (3) Pêches en conserve

(4) Aliments non normalisés

Mêmes aliments que pour l’acide ascorbique Ale; bière; cidre; fruits congelés; tête en fromage ou tête fromagée; bière légère; liqueur de malt; liant à viande pour viandes de salaison et sous-produits de la viande de salaison (Titre 14 seulement); porter; poisson de salaison; poisson haché congelé; poisson déchiqueté congelé; glaçage pour poisson congelé;(1) viande de salaison; sous­ produits de la viande de salaison; viande de volaille de salaison; sous-produits de la viande de volaille de salaison; marinade; saumure et mélange de salaison à sec employés dans le conditionnement des viandes ou des sous-produits de la viande de salaison; stout; vin

(2) Compote de pommes enconserve

(3) Aliments non normalisés

Mêmes aliments que pour l’acide érythorbique

Liant à viande pour saucisse séchée; saucisse semi-séchée; viande conservée et sous­(1) produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

Colonne III Limites de tolérance (3) 550 p.p.m.

(4) Bonnes pratiquesindustrielles Mêmes limites de tolérance que pour l’acide ascorbique

(1) Bonnes pratiquesindustrielles

S’il est utilisé seul ou en combinaison avec l’acide(2) ascorbique, la quantité totale n’excède pas 150 p.p.m.

(3) Bonnes pratiquesindustrielles Mêmes limites de tolérance que pour l’acide érythorbique Si le liant à viande est utilisé selon le mode d’emploi donné sur l’étiquette, que le(1) nitrate de potassium soit ajouté seul ou avec du nitrate de sodium, la

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

quantité totale de tels nitrates ainsi ajoutée à chaque lot de saucisse séchée, de saucisse semi­ séchée, de viande conservée, ou de sous­ produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si la saumure ou le mélange de salaison à sec est utilisé selon le mode d’emploi donné sur l’étiquette, que le nitrate de potassium soit ajouté seul ou avec duSaumure et mélange de nitrate de sodium, lasalaison à sec employés dans quantité totale de telsle marinage des viandes nitrates ainsi ajouté à(2) conservées et des sous- (2) chaque lot de viandeproduits de viande conservée, conservée ou de sous­préparés selon des méthodes produits de viandede salaison lente (Titre 14) conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrate de potassium est ajouté seul ou avec du nitrate de sodium, la

Saucisse séchée; saucisse quantité totale de tels semi-séchée; viande conservée nitrates ajoutée à chaque lot et sous-produits de viande de saucisse séchée, de(3) (3)conservée, préparés selon des saucisse semi-séchée, de méthodes de salaison lente viande conservée, ou de (Titre 14) sous-produits de viande

conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

Fromage mûri, ne contenant pas plus de 68 % d’humidité calculée sur la matière non- S’il est utilisé seul ou avecgrasse, et dans la fabrication du nitrate de sodium, leduquel la fermentation de produit contiendra unel’acide lactique et le salage quantité maximale de 200(4) sont complétés plus de 12 (4) p.p.m. (basée sur le lait). Leheures après la coagulation de résidu dans le fromage finila caillebotte par des enzymes ne devra pas excéder 50alimentaires, et à l’extérieur p.p.m.duquel on applique du sel, soit à l’état sec ou sous forme de saumure

S’il est utilisé seul ou avec du nitrate de sodium, le produit contiendra une

(5) Fromage mûri; moulé; quantité maximale de 200(5)empaqueté à vide p.p.m. (basée sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m. Si le liant à viande, la saumure ou le mélange de salaison à sec est utilisé selon le mode d’emploi donné sur l’étiquette, que le nitrite de potassium soit

Liant à viande; marinade; ajouté seul ou avec du saumure et mélange de nitrite de sodium, la quantité

Nitrite de salaison à sec, utilisés dans le totale de tels nitrites ajoutéeP.2 (1) (1)potassium marinage de la viande à chaque lot de viande conservée et des sous-produits conservée ou de sous­ de viande conservée (Titre 14) produits de viande

conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

(2) Viande conservée, sauf le (2) Si le nitrite de potassium est

Colonne I Article Additifs

Ascorbate deS.1 sodium

ErythorbateS.2 de sodium

Colonne II Permis dans ou sur

bacon de flanc, et sous­ produits de viande conservée (Titre 14)

(3) Bacon de flanc

Viande de volaille conservée (4) et sous-produits de viande de

volaille conservée (Titre 22)

Mêmes aliments que pour l’acide ascorbique

(1) Mêmes aliments que pourl’acide érythorbique

Colonne III Limites de tolérance

ajouté seul ou avec du nitrite de sodium, la quantité totale de tels nitrites ajoutée à chaque lot de viande conservée, sauf le bacon de flanc, ou de sous-produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrite de potassium est ajouté seul ou avec du nitrite de sodium, la quantité totale de tels nitrites ajoutée à chaque lot de bacon de

(3) flanc ne doit pas excéder 0,19 once par 100 livres ou 120 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrite de potassium est ajouté seul ou avec du nitrite de sodium, la quantité totale de tels nitrites ajouté à chaque lot de viande de volaille conservée et de

(4) sous-produits de viande de volaille conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Mêmes limites de tolérance que pour l’acide ascorbique Mêmes limites de tolérance

(1) que pour l’acide érythorbique

(2) Clams en conserve (2) 350 p.p.m.

S.3

S.4

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Iso-ascorbate de sodium

Nitrate de sodium

Mêmes aliments que pour l’acide érythorbique

Liant à viande pour saucisse séchée; saucisse semi-séchée; viande conservée et sous­(1) produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

Saumure et mélange de salaison à sec utilisés dans le marinage de viande conservée

(2) et de sous-produits de viande conservée, préparés selon des méthodes de salaison lente (Titre 14)

Saucisse séchée; saucisse semi-séchée; viande conservée et sous-produits de viande(3) conservée, préparés selon des méthodes de salaison lente (Titre 14)

Mêmes limites de tolérance que pour l’acide érythorbique Si le liant à viande est utilisé selon le mode d’emploi donné sur l’étiquette, que le nitrate de sodium soit ajouté seul ou avec du nitrate de potassium, la quantité totale de tels nitrates ainsi ajoutée à chaque lot de saucisse

(1) séchée, de saucisse semi­ séchée, de viande conservée ou de sous-produits de viande conservée, ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si la saumure ou le mélange de salaison à sec est utilisé selon le mode d’emploi donné sur l’étiquette, que le nitrate de sodium soit ajouté seul ou avec du nitrate de potassium, la quantité totale de tels nitrates ainsi ajoutée

(2) à chaque lot de viande conservée ou de sous­ produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrate de sodium est ajouté seul ou avec du nitrate de potassium, la(3) quantité totale de tels nitrates ajoutée à chaque lot de saucisse séchée, de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

saucisse semi-séchée, de viande conservée ou de sous-produits de viande conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté.

Fromage mûri, ne contenant pas plus de 68 % d’humidité calculée sur la matière non- S’il est utilisé seul ou avecgrasse, et dans la fabrication du nitrate de potassium, leduquel la fermentation de produit contiendra unel’acide lactique et le salage quantité maximale de 200(4) sont complétés plus de 12 (4) p.p.m. (basée sur le lait). Leheures après la coagulation de résidu dans le fromage finila caillebotte par des enzymes ne devra pas excéder 50alimentaires et à l’exception p.p.m.duquel on applique du sel, soit à l’état sec ou sous forme de saumure

S’il est utilisé seul ou avec du nitrate de potassium, le produit contiendra une

(5) Fromage mûri; moulé; quantité maximale de 200(5)empaqueté à vide p.p.m. (basée sur le lait). Le résidu dans le fromage fini ne devra pas excéder 50 p.p.m. Si le liant à viande, la marinade, la saumure ou le mélange de salaison à sec est utilisé selon le modeLiant à viande; marinade; d’emploi donné sursaumure et mélange de l’étiquette, que le nitrite deNitrite de salaison à sec utilisés pour leS.5 (1) (1) sodium soit ajouté seul ousodium marinage de viande conservée avec du nitrite de potassium,et de sous-produits de viande la quantité totale de telsconservée (Titre 14) nitrites ainsi ajoutée à chaque lot de viande conservée ou de sous­ produits de viande

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrite de sodium est ajouté seul ou avec du nitrite de potassium, la quantité totale de tels nitrites ajoutée à chaque lot

(2) Viande conservée, sauf le bacon, et sous-produits de viande conservée (Titre 14)

(2)

de viande conservée, sauf le bacon de flanc, ou de sous­ produits de viande conservée, ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrite de sodium est ajouté seul ou avec du nitrite de potassium, la quantité totale de tels nitrites ajoutée à chaque lot

(3) Bacon de flanc (3) de bacon de flanc ne doit pas excéder 0,19 once par 100 livres ou 120 parties par million, calculée avant que le produit ne soit fumé, cuit ou fermenté. Si le nitrite de sodium est ajouté seul ou avec du nitrite de potassium, la quantité totale de tels

(4) Viande de volaille conservée et sous-produits de viande de volaille conservée (Titre 22)

(4)

nitrites ajoutée à chaque lot de viande de volaille conservée ou de sous­ produits de viande de volaille conservée ne doit pas excéder 0,32 once par 100 livres ou 200 parties par million, calculée avant que

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

le produit ne soit fumé, cuit ou fermenté.

Fromage (indication de la variété); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avecFumée de (1) Bonnes pratiquesW.1 (1) indication des ingrédientsbois industriellesajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Poisson conservé; viande conservée (titres 14 et 21); sous-produits de viande

(2) Bonnes pratiques(2) conservés (titres 14 et 21); industriellesviande de volaille conservée; sous-produits de viande de volaille conservés; saucisses

(3) Bonnes pratiques(3) Aliments non normalisés industrielles

PARTIE II

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE CONSERVATION DE LA CATÉGORIE II

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Confiture de pommes (ou de rhubarbe) et de (nom du fruit); marmelade de figues avec pectine; jus de fruit sauf le jus d’orange concentré congelé; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; poisson et viande emballés,

B.1 Acide benzoïque (1) marinés ou conditionnés à (1) 1 000 p.p.m. froid par une autre méthode analogue (Titre 21); marmelade de (nom de l’agrume) avec pectine; mincemeat; cornichons et achards (relish); marmelade d’ananas avec pectine; ketchup de tomates; pâte de tomates; pulpe de tomates; purée de tomates Aliments non normalisés, [à

(2) l’exception des préparations (2) 1 000 p.p.m. non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

Si utilisé seul ou en association avec de l’acide sorbique; la(3) Margarine (3) quantité totale ne doit pas excéder 1 000 p.p.m. Mêmes limites deSorbate de Mêmes aliments que pourC.1 tolérance que pourcalcium l’acide sorbique l’acide sorbique

Carnobacterium Saucisse fumée emballée (1) Bonnes pratiquesC.2 (1)maltaromaticum sous vide industrielles CB1

(2) Rôti de boeuf tranché emballé (2) Bonnes pratiques

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

H.1 4-Hexylrésorcine

(3)

(4)

M.1 Benzoate de p­hydroxyméthyle (1)

(2)

sous vide conformément à l’article B.14.005 Jambon cuit tranché emballé sous vide conformément à l’article B.14.005 ou B.14.031 Dinde cuite tranchée emballée sous vide conformément à l’article B.22.006 ou B.22.021

Crustacés

Confiture de pommes (ou de rhubarbe) et de (nom du fruit); marmelade de figues avec pectine; jus de fruit sauf le jus d’orange concentré congelé; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; poisson et viande emballés, marinés ou conditionnés à froid par une autre méthode analogue (Titre 21); marmelade de (nom de l’agrume) avec pectine; mincemeat; cornichons et achards (relish); marmelade d’ananas avec pectine; ketchup de tomates; pâte de tomates; pulpe de tomates; purée de tomates Aliments non normalisés, [à l’exception des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21);

industrielles

(3) Bonnes pratiquesindustrielles

(4) Bonnes pratiquesindustrielles

Bonnes pratiques industrielles. Les résidus dans la partie comestible du produit non cuit ne doivent pas dépasser 1,0 p.p.m.

(1) 1 000 p.p.m.

(2) 1 000 p.p.m.

Colonne I Article Additifs

M.2 Méthylparabène

Benzoate deP.1 potassium

Bisulfite deP.2 potassium

Métabisulfite deP.3 potassium

Sorbate deP.4 potassium

Benzoate de p­P.5 hydroxypropyle

Colonne II Permis dans ou sur

b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

Mêmes aliments que pour le benzoate de p­ hydroxyméthyle

Mêmes aliments que pour l’acide benzoïque

Mêmes aliments que pour l’anhydride sulfureux

Mêmes aliments que pour l’anhydride sulfureux

Mêmes aliments que pour l’acide sorbique

Confiture de pommes (ou de rhubarbe) et de (nom du fruit); marmelade de figues avec pectine; jus de fruit sauf le jus d’orange concentré congelé; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; poisson et viande emballés,

(1) marinés ou conditionnés à froid par une autre méthode analogue (Titre 21); marmelade de (nom de l’agrume) avec pectine; mincemeat; cornichons et achards (relish); marmelade d’ananas avec pectine; ketchup de tomates; pâte de tomates; pulpe de tomates; purée de tomates

(2) Aliments non normalisés, [àl’exception des préparations

Colonne III Limites de tolérance

Mêmes limites de tolérance que pour le benzoate de p­ hydroxyméthyle 1 000 p.p.m., calculé en acide benzoïque Mêmes limites de tolérance que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’acide sorbique

(1) 1 000 p.p.m.

(2) 1 000 p.p.m.

Colonne I Article Additifs

P.6 Propylparabène

Benzoate deS.1 sodium

Bisulfite deS.2 sodium

Métabisulfite deS.3 sodium

Sel sodique de l’acide p­S.4 hydroxyméthyl benzoïque Sel sodique de

S.5 l’acide p­ hydroxypropyl

Sorbate deS.6 sodium

S.7 Sulfite de sodium

Dithionite deS.8 sodium

S.9 Acide sorbique

Colonne II Permis dans ou sur

non normalisées de a) viande et de sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

Mêmes aliments que pour le benzoate de p­ hydroxypropyle

Mêmes aliments que pour l’acide benzoïque

Mêmes aliments que pour l’anhydride sulfureux

Mêmes aliments que pour l’anhydride sulfureux

Mêmes aliments que pour le benzoate de p­ hydroxyméthyle

Mêmes aliments que pour le benzoate de p­ hydroxypropyle

Mêmes aliments que pour l’acide sorbique

Mêmes aliments que pour l’anhydride sulfureux

Mêmes aliments que pour l’anhydride sulfureux

Confiture de pommes (ou de rhubarbe) et de (nom du fruit); marmelade de figues(1) avec pectine; jus de fruit sauf le jus d’orange concentré congelé; confiture de (nom du

Colonne III Limites de tolérance

Mêmes limites de tolérance que pour le benzoate de p­ hydroxypropyle 1 000 p.p.m., calculé en acide benzoïque Mêmes limites de tolérance que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux

1 000 p.p.m., calculé en benzoate de p­ hydroxyméthyle

1 000 p.p.m., calculé en benzoate de p­ hydroxypropyle Mêmes limites de tolérance que pour l’acide sorbique Mêmes limites de tolérance que pour l’anhydride sulfureux Mêmes limites de tolérance que pour l’anhydride sulfureux

(1) 1 000 p.p.m.

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; marinades et achards (relish); marmelade d’ananas avec pectine; poisson desséché, fumé ou salé; pâte de poisson fumé ou salé; sirop (nom de la source de glucose); ketchup de tomates; pâte de tomates; pulpe de tomates; purée de tomates Aliments non normalisés [à

(2) l’exception des préparations (2) 1 000 p.p.m. non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

(3) Saumure d’olive (3) 300 p.p.m. Si utilisé seul ou en association avec de l’acide benzoïque, la(4) Margarine (4) quantité totale ne doit pas excéder 1 000 p.p.m.

(5) Vinaigrettes non normalisées (5) 3 350 p.p.m. 70 p.p.m. à l’état libre,

Anhydride ou 350 p.p.m. enS.10 (1) Cidre; vin de miel; vin (1)sulfureux combinaison, calculé en anhydride sulfureux

(2) Ale; bière; bière légère; (2) 15 p.p.m., calculé enliqueur de malt; porter; stout anhydride sulfureux Confiture de pommes (ou de rhubarbe) et de (nom du (3) 500 p.p.m., calculé en(3) fruit); mélasse qualité anhydride sulfureux fantaisie; marmelade de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

figues avec pectine; pommes tranchées et congelées; jus de fruit sauf le jus d’orange concentré congelé; gélatine; confiture de (nom du fruit); confiture de (nom du fruit) avec pectine; gelée de (nom du fruit) avec pectine; marmelade de (nom de l’agrume) avec pectine; mincemeat; cornichons et achards (relish); marmelade d’ananas avec pectine; sirop (nom de la source de glucose); mélasse de raffinerie; mélasse de table; ketchup de tomates; pâte de tomates; pulpe de tomates; purée de tomates

(4) 100 p.p.m., calculé en(4) Boissons anhydride sulfureux

(5) 2 500 p.p.m., calculé(5) Fruits et légumes desséchés en anhydride sulfureux Aliments non normalisés, [à l’exception des aliments

(6) 500 p.p.m., calculé en(6) reconnus comme sources de anhydride sulfureuxthiamine et des préparations non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

(7) 90 p.p.m, calculé en(7) Champignons congelés anhydride sulfureux

(8) Dextrose anhydre; (8) 20 p.p.m., calculé enmonohydrate de dextrose anhydride sulfureux 40 p.p.m., sauf pour le glucose ou le sirop de(9) Glucose ou sirop de glucose (9) glucose utilisés pour la fabrication des

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

confiseries, pas plus de 400 p.p.m. calculé en anhydride sulfureux 40 p.p.m., sauf pour les solides de glucose ou le sirop de glucose

(10) Solides de glucose ou sirop déshydraté utilisés(10)de glucose déshydraté pour la fabrication des confiseries, pas plus de 150 p.p.m. calculé en anhydride sulfureux Bonnes pratiques industrielles. Les résidus dans la partie comestible du produit(11) Crustacés (11) non cuit ne doivent pas dépasser 100 p.p.m., calculé en anhydride sulfureux.

PARTIE III

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE CONSERVATION DE LA CATÉGORIE III

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Propionate (1) Mêmes aliments que pour (1) 2 000 p.p.m., calculé sousC.1 de calcium l’acide propionique forme d’acide propionique (2) Tortillas molles (2) 4 000 p.p.m.

Sorbate de Mêmes aliments que pour Mêmes limites de toléranceC.2 calcium l’acide sorbique que pour l’acide sorbique La surface du fromage 20 p.p.m., conformément aux

N.1 Natamycine (1) (indication de la variété) et du (1) exigences des articles fromage cheddar B.08.033 et B.08.034 La surface du fromage râpé fin ou en filaments (indication de 10 p.p.m., conformément aux

(2) la variété) et du fromage (2) exigences des articles cheddar râpé fin ou en B.08.033 et B.08.034 filaments

Sorbate de (1) Mêmes aliments que pour (1) Mêmes limites de tolérancepotassium l’acide sorbique que pour l’acide sorbique (2) Tortillas molles (2) 5 000 p.p.m.

P.1

P.2

Colonne I Colonne II Article Additifs Permis dans ou sur

Acide propionique (1) Pain

Fromage (indication de la variété); fromage cheddar; fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des(2) ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés) Aliments non normalisés, à

(3) l’exception des préparations non normalisées a) de viande et de sous­ produits de viande (titres 14 et 21); b) de poisson; et c) de viande de volaille et de sous-produits de viande de

Colonne III Limites de tolérance

(1) 2 000 p.p.m.

2 000 p.p.m. ou 3 000 p.p.m., suivant le cas, conformément aux exigences des articles B.08.033, B.08.034, B.08.035, B.08.037,

(2) B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 et B.08.041.8

(3) 2 000 p.p.m.

S.1

Colonne I Article Additifs

Diacétate de sodium

PropionateS.2 de sodium Sorbate deS.3 sodium AcideS.4 sorbique

Colonne II Permis dans ou sur

volaille

(1) Pain;

Aliments non normalisés, [à (2) l’exception des préparations

non normalisées de a) viande et sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille] Mêmes aliments que pour l’acide propionique Mêmes aliments que pour l’acide sorbique

(1) Pain

Fromage (indication de la variété); fromage cheddar; fromage à la crème; fromage à la crème (avec indication des ingrédients ajoutés); fromage à la crème à tartiner; fromage à la crème à tartiner (avec indication des ingrédients ajoutés); fromage fondu (indication de la variété); fromage fondu (indication de la variété) (avec indication des

(2) ingrédients ajoutés); préparation de fromage fondu; préparation de fromage fondu (avec indication des ingrédients ajoutés); fromage fondu à tartiner; fromage fondu à tartiner (avec indication des ingrédients ajoutés); fromage conditionné à froid (indication de la variété); fromage conditionné à froid (indication de la variété) (avec indication des

Colonne III Limites de tolérance

(1) 3 000 p.p.m.

(2) 3 000 p.p.m.

2 000 p.p.m., calculé en acide propionique Mêmes limites de tolérance que pour l’acide sorbique

(1) 1 000 p.p.m.

3 000 p.p.m., conformément aux exigences des articles B.08.033, B.08.034, B.08.035, B.08.037, B.08.038, B.08.039,(2) B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 et B.08.041.8

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

ingrédients ajoutés); préparation de fromage conditionné à froid; préparation de fromage conditionné à froid (avec indication des ingrédients ajoutés)

(3) Cidre; vin; vin de miel (3) 500 p.p.m. Aliments non normalisés, à

(4) l’exception des préparations (4) 1 000 p.p.m. non normalisées a) de viande et de sous­ produits de viande (titres 14 et 21), b) de poisson; et c) de viande de volaille et de sous-produits de viande de volaille

PARTIE IV

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS DE CONSERVATION DE LA CATÉGORIE IV

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Huiles et graisses; saindoux;

(1) Bonnes pratiquesA.1 Acide ascorbique (1) monoglycérides et industriellesdiglycérides; shortening Aliments non (2) Bonnes pratiques(2) normalisés industrielles Huiles et graisses; saindoux;

(1) Bonnes pratiquesA.2 Palmitate d’ascorbyle (1) monoglycérides et industriellesdiglycérides; shortening Aliments non normalisés, [à

(2) Bonnes pratiques(2) l’exception des industriellespréparations non normalisées de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

0,02 % de la teneur en gras. Si on emploie aussi le

(3) Margarine (3) stéarate d’ascorbyle, laquantité totale ne doit pas excéder 0,02 % de la teneur en gras

(4) Préparations pournourrissons (4) 0,001% de la préparation pour nourrissons prête à consommer

Graisses et huiles;

A.3 Stéarate d’ascorbyle (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening 0,02 % de la teneur en gras. Si on emploie aussi le

(2) Margarine (2) palmitate d’ascorbyle, laquantité totale ne doit pas excéder 0,02 % de la teneur en gras

Hydroxyanisole 0,02 %. Si on emploie aussi

B.1

butylé (mélange de 2­ tertiobutyl-4­ hydroxyanisole et de 3-tertiobutyl-4­

(1) Graisses et huiles, saindoux, shortening

(1)

l’hydroxytoluène butylé, l’hydroquinone de butyle tertiaire ou le gallate de propyle, la quantité totale ne

hydroxyanisole) doit pas dépasser 0,02 % 0,005 %. Si on emploieCéréales à déjeuner aussi l’hydroxytoluènesèches; produits(2) (2) butylé ou le gallate dedéshydratés de propyle, la quantité ne doitpommes de terre pas en dépasser 0,005 % 0,02 %. Si on emploie aussi

(3) Gomme à mâcher (3) l’hydroxytoluène butylé ou le gallate de propyle, la

Colonne I Colonne II Article Additifs Permis dans ou sur

Huiles essentielles; essences à base

(4) d’huile d’agrumes; substances aromatiques sèches

(5) Huiles d’agrumes

(6)

(7)

(8)

(9)

(10)

Tissus gras de porc ou de boeuf partiellement dégraissés Liquides renfermant de la vitamine A et devant servir d’additifs alimentaires Mélanges en poudre pour boissons; mélanges en poudre pour desserts et sucreries Levure active séchée Autres aliments non normalisés, [à l’exception des préparations non normalisées de

a) viande et sous­ produits de viande (Titres 14 et 21);

b) poisson; et c) viande de volaille et sous­ produits de viande

Colonne III Limites de tolérance

(4)

(5)

(6)

quantité ne doit pas en dépasser 0,02 % 0,125 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, la quantité ne doit pas en dépasser 0,125 % 0,5 %. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, la quantité ne doit pas en dépasser 0,5 % 0,0065 %. Si on emploie aussi l’hydroxytoluène butylé, la quantité ne doit pas en dépasser 0,0065 %

(7) 5 mg/1 000 000 unitésinternationales

(8) 0,009 %

(9) 0,1 %

(10)

0,02 % de la teneur de l’aliment en gras ou en huile. Si on emploie aussi l’hydroxytoluène butylé ou le gallate de propyle, la quantité ne doit pas en dépasser 0,02 % de la teneur de l’aliment en gras ou en huile

B.2

Colonne I Article Additifs

Hydroxytoluène butylé (3,5­ ditertiobutyl-4­ hydroxytoluène)

Colonne II Permis dans ou sur

de volaille] Préparations sèches de vitamine D(11) devant être ajoutées aux aliments

(12) Margarine

(13) Viande de volaillecuite et séchée

Graisses et huiles, (1) saindoux,

shortening

Céréales à déjeuner sèches; produits de(2) pommes de terre déshydratés

(3) Gomme à mâcher

Huiles essentielles; essences à base

(4) d’huiles d’agrumes; substances aromatiques sèches

(5) Huiles d’agrumes

Colonne III Limites de tolérance

(11) 10 mg/1 000 000 unitésinternationales

0,01 % de la teneur en gras. Si on emploie aussi l’hydroxytoluène butylé ou

(12) le gallate de propyle ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras 0,015 % de la teneur en gras. Si on emploie aussi le gallate de propyle ou l’acide

(13) citrique, ou les deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras. 0,02 %. Si on emploie aussi l’hydroxyanisole butylée, l’hydroquinone de butyle(1) tertiaire ou le gallate de propyle, la quantité totale ne doit pas dépasser 0,02 % 0,005 %. Si on emploie aussi l’hydroxyanisole

(2) butylé ou le gallate de propyle, la quantité ne doit pas en dépasser 0,005 % 0,02 %. Si on emploie aussi l’hydroxyanisole butylé ou

(3) le gallate de propyle, la quantité ne doit pas en dépasser 0,02 % 0,125 %. Si on emploie aussi l’hydroxyanisole

(4) butylé, ou le gallate de propyle, la quantité ne doit pas en dépasser 0,125 %

(5) 0,5 %. Si on emploie aussil’hydroxyanisole butylé ou

Colonne I Colonne II Article Additifs Permis dans ou sur

Tissus gras de porc ou de boeuf,(6) partiellement dégraissés Liquides renfermant de la vitamine A et(7) devant servir d’additifs alimentaires

(8) Riz à demi cuit Autres aliments non normalisés, [à

(9) l’exception des préparations non normalisées de a) viande et de sous-produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille] Préparations sèches de vitamine D à(10) ajouter aux aliments

(11) Margarine

Graisses et huiles; C.1 Acide citrique (1) saindoux;

monoglycérides et

Colonne III Limites de tolérance

le gallate de propyle, la quantité ne doit pas en dépasser 0,5 % 0,0065 %. Si on emploie aussi l’hydroxyanisole(6) butylé, la quantité ne doit pas en dépasser 0,0065 %

(7) 5 mg/1 000 000 unitésinternationales

(8) 0,0035 % 0,02 % de la teneur des aliments en gras ou en huile.

(9) Si on emploie aussi l’hydroxyanisole butylé ou le gallate de propyle, la quantité ne doit pas en dépasser 0,02 % de la teneur de l’aliment en gras ou en huile

(10) 10 mg/1 000 000 unitésinternationales

0,01 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ou

(11) le gallate de propyle ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras

(1) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

diglycérides; shortening Aliments non normalisés, [à

(2) Bonnes pratiques(2) l’exception des industriellespréparations non normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

0,015 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ouViande de volaille(3) (3) le gallate de propyle, ou lescuite et séchée deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras.

Suppléments Bonnes pratiquesC.1.1 L-cystéine nutritifs conformes industriellesà l’article B.24.201 Formules de remplacement desChlorhydrate de L- Bonnes pratiquesC.2 sulfites pour lescystéine industriellesfruits et les légumes préparés Graisses et huiles; saindoux;

(1) Bonnes pratiquesG.1 Résine de gaïac (1) monoglycérides et industriellesdiglycérides; shortening Aliments non normalisés, [à

(2) Bonnes pratiques(2) l’exception des industriellespréparations non normalisées de a) viande et sous­ produits de viande

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille] Graisses et huiles;

L.1 Lécithine (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening Aliments non

(2) normalisés, [à l’exception des préparations non

(2) Bonnes pratiquesindustrielles

normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille] Graisses et huiles;

L.2 Citrate de lécithine (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening Aliments non

(2) normalisés, [à l’exception des préparations non

(2) Bonnes pratiquesindustrielles

normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

de volaille] Graisses et huiles;

M.1 Citrate demonoglycéride (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening Aliments non

(2) normalisés, [à l’exception des préparations non

(2) Bonnes pratiquesindustrielles

normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

0,01 % de la teneur en gras. Si on emploie aussi le citrate de monoisopropyle

(3) Margarine (3) ou le citrate de stéaryle ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras

Graisses et huiles;

M.2 Citrate demonoisopropyle (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening Aliments non

(2) normalisés, [à l’exception des préparations non

(2) Bonnes pratiquesindustrielles

normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

volaille et sous­ produits de viande de volaille]

0,01 % de la teneur en gras. Si on emploie aussi le citrate de monoglycéride ou

(3) Margarine (3) le citrate de stéaryle ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras 0,02 %. Si on emploie aussi

P.1 Gallate de propyle (1) Graisses et huiles, saindoux, shortening

(1)

l’hydroxyanisole butylée, l’hydroxytoluène butylé, l’hydroquinone de butyle tertiaire, la quantité totale ne doit pas dépasser 0,02 % 0,005 %. Si on emploieCéréales à déjeuner aussi l’hydroxyanisolesèches; produits(2) (2) butylé ou l’hydroxytoluènedéshydratés de butylé, la quantité ne doitpommes de terre pas en dépasser 0,005 % 0,02 %. Si on emploie aussi l’hydroxyanisole butylé ou

(3) Gomme à mâcher (3) l’hydroxytoluène butylé, la quantité ne doit pas en dépasser 0,02 % 0,125 %. Si on emploie

Huiles essentielles; aussi l’hydroxyanisole (4) substances (4) butylé ou l’hydroxytoluène

aromatiques sèches butylé la quantité ne doit pas en dépasser 0,125 % 0,5 %. Si on emploie aussi l’hydroxyanisole butylé ou

(5) Huiles d’agrumes (5) l’hydroxytoluène butylé, la quantité ne doit pas en dépasser 0,5 %

Autres aliments non 0,02 % de la teneur de normalisés, [à l’aliment en gras ou en

(6) l’exception des (6) huile. Si on emploie aussi préparations non l’hydroxyanisole butylé ou normalisées de l’hydroxytoluène butylé, la a) viande et sous- quantité ne doit pas en

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

produits de viande dépasser 0,02 % de la teneur (Titres 14 et 21); de l’aliment en gras ou en

huile. b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

0,01 % de la teneur en gras. Si on emploie aussi l’hydroxyanisole butylé ou

(7) Margarine (7) l’hydroxytoluène butylé ou les deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras 0,015 % de la teneur en gras. Si on emploie aussi

(8) Viande de volaillecuite et séchée (8) l’hydroxyanisole butylé ou l’acide citrique, ou les deux, la quantité totale ne doit pas excéder 0,015 % de la teneur en gras.

Graisses et huiles;

T.1 Acide tartrique (1) saindoux; monoglycérides et diglycérides;

(1) Bonnes pratiquesindustrielles

shortening Aliments non

(2) normalisés, [à l’exception des préparations non

(2) Bonnes pratiquesindustrielles

normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

T.1A Hydroquinone debutyle tertiaire Graisses et huiles, saindoux,

0,02 %. Si on emploie aussi l’hydroxyanisole butylée,

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

shortening l’hydroxytoluène butylé ou le gallate de propyle, la quantité totale ne doit pas dépasser 0,02 %

T.2

Tocophérols (alphatocophérol; concentré de tocophérols mixtes)

(1)

Graisses et huiles; saindoux; monoglycérides et diglycérides; shortening

(1) Bonnes pratiquesindustrielles

Aliments non normalisés, [à

(2) Bonnes pratiques(2) l’exception des industriellespréparations non normalisées de a) viande et sous­ produits de viande (Titres 14 et 21); b) poisson; et c) viande de volaille et sous­ produits de viande de volaille]

0,001% de la préparation (3) Préparations pour (3) pour nourrissons prête ànourrissons consommer

DORS/79-285, art. 1 à 4; DORS/79-660, art. 18; DORS/79-752, art. 10; DORS/80-500, art. 7; DORS/81-565, art. 6; DORS/81-934, art. 13 à 15; DORS/82-383, art. 11; DORS/86-89, art. 7; DORS/86-1020, art. 1; DORS/87-138, art. 1 et 2; DORS/87-469, art. 2; DORS/89-198, art. 12 à 16; DORS/91-124, art. 10 à 12; DORS/92-226, art. 1; DORS/92-591, art. 2(F); DORS/94-689, art. 2(F); DORS/95-592, art. 1; DORS/96-241, art. 2; DORS/97-148, art. 7; DORS/97-191, art. 4; DORS/98-459, art. 1; DORS/99-289, art. 1 à 4; DORS/2003-156, art. 1; DORS/2005-316, art. 4 à 6; DORS/2010-94, art. 8(A); DORS/2010-141, art. 1 et 2; DORS/2010-264, art. 4.

TABLEAU XII

ADDITIFS ALIMENTAIRES AUTORISÉS COMME CHÉLATEURS OU AGENTS SÉQUESTRANTS

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

A.1 Citrate diammonique Aliments non normalisés Bonnes pratiquesindustrielles

Colonne I Article Additifs

A.2 Citrate monoammonique

C.1 Citrate de calcium

C.2 Versenate (Éthylènediaminetétracétate, ou EDTA) de calcium disodique

Colonne II Permis dans ou sur

Aliments non normalisés

Aliments non normalisés

Ale; bière; bière légère; (1) liqueur de malt; porter;

stout Sauce vinaigrette; mayonnaise; sauce à salade;(2) sauces et mayonnaises non normalisées Salade de pommes de terre;

(3) tartinades à sandwich non normalisées

(4) Crevettes en conserve; thonen conserve Crabe en conserve; homard

(5) en conserve; saumon en conserve

(6) Margarine

(7) Palourdes en conserve

Haricots de Lima mûrs (haricots beurre) en(8) conserve; haricots pinto en conserve Escargots en conserve;

(9) escargots de mer en conserve

(10) Fèves gourganes enconserve

(11) Boissons gazeuses; thésprêts à boire

(12) Pommes de terrepasteurisées sous vide

Colonne III Limites de tolérance

Bonnes pratiques industrielles Bonnes pratiques industrielles

(1) 25 p.p.m., sous formeanhydre

(2) 75 p.p.m., sous formeanhydre

(3) 100 p.p.m., sous formeanhydre

(4) 250 p.p.m., sous formeanhydre

(5) 275 p.p.m., sous formeanhydre

(6) 75 p.p.m., sous formeanhydre

(7) 340 p.p.m., sous formeanhydre 130 p.p.m., sous forme anhydre et conformément(8) aux exigences du sous­ alinéa B.11.002d)(vi)

(9) 300 p.p.m., sous formeanhydre

365 p.p.m., sous forme anhydre et conformément(10) aux exigences du sous­ alinéa B.11.002d)(vi.1)

(11) 33 p.p.m., sous formeanhydre 100 p.p.m., seul ou en association avec l’EDTA

(12) disodique, calculé sous forme d’EDTA disodique anhydre

Colonne I Article Additifs

C.3 EDTA de calcium disodique

C.4 Phosphate monocalcique

C.5 Phosphate tricalcique

C.6 Phytate de calcium

C.7 Acide citrique

D.1 Versenate (éthylènediamine­ tétracétate) disodique

Colonne II Permis dans ou sur

Mêmes aliments que pour le versenate (éthylènediaminetétracétate) de calcium disodique Mélange pour crème glacée;

(1) mélange pour lait glacé; sorbet laitier Produits laitiers non(2) normalisés Mélange pour crème glacée; mélange pour lait glacé

Fruits glacés ou confits

Marinade, saumure et mélange de salaison à sec employés dans le marinage

(1) des viandes conditionnées ou conservées et des sous­ produits de viande conditionnés ou conservés

(2) Aliments non normalisés

Filets de poisson congelés; poisson haché congelé;(3) poisson haché menu congelé

(1) Sauces et condiments Tartinades à sandwich non(2) normalisées Haricots à hile noir; haricots nains rouges en

(3) conserve; pois chiches (Garbanzos) en conserve B.11.002d)(vii) Produits à base de bananes(4) séchées Préparation de colorant laque en suspension

(5) aqueuse pour utilisation dans l’enrobage de tablettes de confiseries

Colonne III Limites de tolérance

Mêmes limites de tolérance que pour le versenate (éthylènediaminetétracétate) de calcium disodique

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles Bonnes pratiques industrielles Bonnes pratiques industrielles

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

(3) 0,1 %

(1) 70 p.p.m.

(2) 90 p.p.m.

150 p.p.m. conformément (3) aux exigences du sous­

alinéa B.11.002d)(vii)

(4) 265 p.p.m.

(5) 1 % de la préparation decolorant

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

100 p.p.m., seul ou en association avec l’EDTA dePommes de terre(6) (6) calcium disodique, calculépasteurisées sous vide sous forme d’EDTA disodique anhydre Mêmes limites de toléranceMêmes aliments que pour leD.2 EDTA disodique que pour le versenateversenate disodique disodique

G.1 Glycine Mono- et diglycérides 0,02 % P.1 Acide phosphorique Mono- et diglycérides 0,02 %

Mélange pour crème glacée; (1) Bonnes pratiquesP.2 (1) mélange pour lait glacé; industriellesPhosphate mono-potassique sorbet laitier

(2) Bonnes pratiques(2) Aliments non normalisés industrielles Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

(3) viande de volaille coupée (3) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée

(1) Produits pour attendrir la (1) Bonnes pratiquesP.3 viande industrielles Viande coupée solide; viande préparée; sous-Pyrophosphate produit de viande préparée; 0,5 % en phosphates totauxtétrapotassique

(2) viande de volaille coupée (2) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

P.4 Phosphate dipotassique (1) viande de volaille coupée (1) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée

Si employé seul ou en Pyrophosphate acide de association avec leS.1 (1) Fruits de mer en conserve (1)sodium hexamétaphosphate de

sodium ou le

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

tripolyphosphate de sodium, ou les deux, la quantité totale de phosphate ajouté, calculé sous forme de phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

(2) Mélange pour crème glacée; (2) Bonnes pratiquesmélange pour lait glacé industrielles Solution d’injection ou Bonnes pratiquesd’immersion servant à la(3) (3) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

Bonnes pratiquesMarinade servant à la industrielles et(4) salaison de coupes de porc, (4) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(5) Aliments non normalisés (5) Bonnes pratiquesindustrielles

(6)

Viande coupée solide; viande préparée; sous­ produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée

(6) 0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique

Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées

S.2 Citrate de sodium (1) ou conservées et des sous­produits de viande conditionnés ou conservés; mélange pour crème glacée; mélange pour lait glacé; sorbet laitier

(1) Bonnes pratiquesindustrielles

(2) Aliments non normalisés (2) Bonnes pratiquesindustrielles

S.3 Hexamétaphosphate desodium (1) Fruits de mer en conserve (1)

Si employé seul ou en association avec le pyrophosphate acide de sodium ou le

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

tripolyphosphate de sodium, ou les deux, la quantité totale de phosphate ajouté, calculé sous forme de phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

(2) Mélange pour crème glacée; (2) Bonnes pratiquesmélange pour lait glacé industrielles Solution d’injection ou Bonnes pratiquesd’immersion servant à la(3) (3) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

Bonnes pratiquesMarinade servant à la industrielles et(4) salaison de coupes de porc, (4) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(5) Bonnes pratiques(5) Aliments non normalisés industrielles Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

(6) viande de volaille coupée (6) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée Petit-lait liquide destiné à la 800 p.p.m. dans les produits

(7) fabrication de produits de (7) de petit-lait concentré ou petit-lait concentré ou séché séché Mélange pour crème glacée;

(1) Bonnes pratiquesS.4 Phosphate disodique (1) mélange pour lait glacé; industriellessorbet laitier Solution d’injection ou Bonnes pratiquesd’immersion servant à la(2) (2) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

Bonnes pratiquesMarinade servant à la industrielles et(3) salaison de coupes de porc, (3) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(4) Bonnes pratiques(4) Aliments non normalisés industrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

(5) viande de volaille coupée (5) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée Mélange pour crème glacée;

(1) Bonnes pratiquesS.5 (1) mélange pour lait glacé; industriellessorbet laitier Phosphate monosodique Solution d’injection ou Bonnes pratiquesd’immersion servant à la(2) (2) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

Bonnes pratiquesMarinade servant à la industrielles et(3) salaison de coupes de porc, (3) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(4) Bonnes pratiques(4) Aliments non normalisés industrielles Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

(5) viande de volaille coupée (5) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée Mélange pour crème glacée;

(1) Bonnes pratiquesS.6 (1) mélange pour lait glacé; industriellesPyrophosphate tétrasodique sorbet laitier

(2) Produits pour attendrir la (2) Bonnes pratiquesviande industrielles Solution d’injection ou Bonnes pratiquesd’immersion servant à la(3) (3) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

Bonnes pratiquesMarinade servant à la industrielles et(4) salaison de coupes de porc, (4) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(5) Bonnes pratiques(5) Aliments non normalisés industrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

Viande coupée solide; viande préparée; sous­ produit de viande préparée; 0,5 % en phosphates totaux

(6) viande de volaille coupée (6) ajoutés, calculés en solide; viande de volaille phosphate disodique préparée; sous-produit de viande de volaille préparée Solution d’injection ou Bonnes pratiquesd’immersion servant à laS.7 Tripolyphosphate de sodium (1) (1) industrielles etsalaison de la volaille ou de conformément à B.22.021e)la viande de volaille

(2) Produits pour attendrir la (2) Bonnes pratiquesviande industrielles Bonnes pratiquesMarinade servant à la industrielles et(3) salaison de coupes de porc, (3) conformément à B.14.009f)de boeuf ou d’agneau et B.14.031h)

(4) Aliments non normalisés (4) Bonnes pratiquesindustrielles

(5)

Viande coupée solide; viande préparée; sous­ produit de viande préparée; viande de volaille coupée solide; viande de volaille préparée; sous-produit de viande de volaille préparée

(5) 0,5 % en phosphates totaux ajoutés, calculés en phosphate disodique

Si employé seul ou en association avec le pyrophosphate acide de sodium ou le

(6) Fruits de mer en conserve (6) hexamétaphosphate de sodium, ou les deux, la quantité totale de phosphate ajouté, calculé sous forme de phosphate dibasique de sodium, ne doit pas dépasser 0,5 %

S.8 Citrate de stéaryle Margarine

0,01 % de la teneur en gras. Si on emploie aussi le citrate de monoglycéride ou le citrate de monoisopropyle ou les

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

deux, la quantité totale ne doit pas excéder 0,01 % de la teneur en gras

DORS/79-660, art. 19 et 20; DORS/80-501, art. 4; DORS/82-596, art. 4 à 9; DORS/94­ 141, art. 1; DORS/94-262, art. 4 à 12; DORS/94-689, art. 2; DORS/95-435, art. 2; DORS/97-30, art. 1; DORS/97-562, art. 1; DORS/98-580, art. 1(F); DORS/2005-316, art. 7 à 11; DORS/2010-40, art. 2; DORS/2010-142, art. 57 et 58; DORS/2010-143, art. 37(F) et 38.

TABLEAU XIII

ADDITIFS ALIMENTAIRES AUTORISÉS COMME AGENTS MODIFIANTS DE L’AMIDON

Colonne I Colonne II Colonne III Permis dansArticle Additifs Limites de toléranceou sur

A.1 Anhydride acétique Amidon Bonnes pratiques industrielles A.2 Acide adipique Amidon Bonnes pratiques industrielles A.3 Sulfate d’aluminium Amidon Bonnes pratiques industrielles E.1 Épichlorhydrine Amidon Bonnes pratiques industrielles H.1 Acide chlorhydrique Amidon Bonnes pratiques industrielles H.2 Peroxyde d’hydrogène Amidon Bonnes pratiques industrielles M.1 Sulfate de magnésium Amidon 0,4 % N.1 Acide nitrique Amidon Bonnes pratiques industrielles

AnhydrideO.1 Amidon Bonnes pratiques industriellesocténylsuccinique P.1 Peracide acétique Amidon Bonnes pratiques industrielles

Oxychlorure deP.2 Amidon Bonnes pratiques industriellesphosphore Permanganate de 50 p.p.m. de sulfate de manganèse calculéP.3 Amidonpotassium en manganèse

P.4 Oxyde de propylène Amidon 25 % S.1 Acétate de sodium Amidon Bonnes pratiques industrielles S.2 Bicarbonate de sodium Amidon Bonnes pratiques industrielles S.3 Carbonate de sodium Amidon Bonnes pratiques industrielles S.4 Chlorite de sodium Amidon Bonnes pratiques industrielles S.5 Hydroxyde de sodium Amidon Bonnes pratiques industrielles

Hypochlorite deS.6 Amidon Bonnes pratiques industriellessodium

Colonne I

Article Additifs

Trimétaphosphate deS.7 sodium Tripolyphosphate deS.7A sodium

S.8 Anhydride succinique S.9 Acide sulfurique

DORS/94-689, art. 2(F).

TABLEAU XIV

Colonne II Permis dans ou sur

Amidon

Amidon

Amidon Amidon

Colonne III

Limites de tolérance

400 p.p.m., calculé en phosphore

Phosphate résiduel total ne devant pas dépasser 0,4 % (calculé en phosphore) Bonnes pratiques industrielles Bonnes pratiques industrielles

ADDITIFS ALIMENTAIRES AUTORISÉS COMME NOURRITURE DES LEVURES

Colonne I Article Additifs A.1

Chlorure d’ammonium

A.2 Phosphate diammonique

A.3 Phosphate monoammonique

SulfateA.4 d’ammonium

Colonne II Permis dans ou sur (1) Farine; farine de blé entier

(2) Pain

(3) Aliments non normalisés

(1) Pain

(2) Cidre; vin de miel; vin

(3) Produits de boulangerie nonnormalisés

(1) Pain

Ale; bière; cidre; vin de (2) miel; bière légère; liqueur

de malt; porter; stout; vin

(3) Produits de boulangerie nonnormalisés

(1) Pain

(2) Cidre; vin de miel; vin

Colonne III Limites de tolérance (1) 2 000 p.p.m. de farine

2 500 p.p.m. de farine. (2) Pour les mélanges, voir

l’alinéa B.13.021m)

(3) Bonnes pratiquesindustrielles 2 500 p.p.m. de farine.

(1) Pour les mélanges, voir l’alinéa B.13.021m)

(2) Bonnes pratiquesindustrielles

(3) Bonnes pratiquesindustrielles 2 500 p.p.m. de farine.

(1) Pour les mélanges, voir l’alinéa B.13.021m)

(2) Bonnes pratiquesindustrielles

(3) Bonnes pratiquesindustrielles 2 500 p.p.m. de farine.

(1) Pour les mélanges, voir l’alinéa B.13.021m)

(2) Bonnes pratiquesindustrielles

Colonne I Colonne II Colonne III Article Additifs Permis dans ou sur Limites de tolérance

(3) Produits de boulangerie non (3) Bonnes pratiquesnormalisés industrielles 2 500 p.p.m. de farine.Carbonate deC.1 (1) Pain (1) Pour les mélanges, voircalcium l’alinéa B.13.021m)

(2) Produits de boulangerie non (2) Bonnes pratiquesnormalisés industrielles Chlorure de Produits de boulangerie non Bonnes pratiquesC.2 calcium normalisés industrielles

Produits de boulangerie non Bonnes pratiquesC.3 Citrate de calcium normalisés industrielles 2 500 p.p.m. de farine.

C.4 Lactate de calcium (1) Pain (1) Pour les mélanges, voir l’alinéa B.13.021m)

(2) Produits de boulangerie non (2) Bonnes pratiquesnormalisés industrielles 2 500 p.p.m. de farine.PhosphateC.5 (1) Pain (1) Pour les mélanges, voirbicalcique l’alinéa B.13.021m)

(2) Produits de boulangerie non (2) Bonnes pratiquesnormalisés industrielles 7 500 p.p.m. de farine.PhosphateC.6 (1) Pain (1) Pour les mélanges, voirmonocalcique l’alinéa B.13.021m)

(2) Farine (2) 7 500 p.p.m. de farine

(3) Produits de boulangerie non (3) Bonnes pratiquesnormalisés industrielles Phosphate Produits de boulangerie non Bonnes pratiquesC.7 tricalcique normalisés industrielles

C.8 Sulfate de calcium (1) Pain (1) 5 000 p.p.m. de farine

(2) Produits de boulangerie non (2) Bonnes pratiquesnormalisés industrielles Bonnes pratiquesF.1 Sulfate ferreux Cultures bactériennes industrielles

Ale; bière; bière légère;Sulfate de Bonnes pratiquesM.1 liqueur de malt; porter;manganèse industriellesstout Ale; bière; bière légère;Acide Bonnes pratiquesP.1 liqueur de malt; porter;phosphorique industriellesstout

Colonne I Article Additifs

P.2 Chlorure de potassium

P.4 Phosphate bipotassique

PhosphateP.5 monopotassique

S.1 Sulfate de sodium normalisés U.1 [Abrogé, DORS/87-5, art. 1]

Ale; bière; bière légère; Z.1 Sulfate de zinc (1) liqueur de malt; porter;

stout

(2) Cultures bactériennes

Colonne II Permis dans ou sur

Ale; bière; bière légère; (1) liqueur de malt; porter;

stout

(2) Produits de boulangerie nonnormalisés Ale; bière; cidre; vin de

(1) miel; bière légère; liqueur de malt; porter; stout; vin

(2) Produits de boulangerie nonnormalisés Ale; bière; cidre; vin de miel; bière légère; liqueur de malt; porter; stout; vin Produits de boulangerie non

Colonne III Limites de tolérance

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

Bonnes pratiques industrielles

Bonnes pratiques industrielles

(1) Bonnes pratiquesindustrielles

(2) Bonnes pratiquesindustrielles

DORS/87-5, art. 1; DORS/94-689, art. 2(F); DORS/95-281, art. 6 et 7; DORS/2010-41, art. 7(A) et 9(A).

TABLEAU XV

ADDITIFS ALIMENTAIRES AUTORISÉS COMME SOLVANTS DE SUPPORT OU D’EXTRACTION

Colonne I

Article Additifs

1. Acétone

Alcool2. benzylique

Colonne II Colonne III

Permis dans ou sur Résidu maximal

(1) Extraits d’épices; (1) 30 p.p.m.extractifs naturels

(2) Encres à marquer laviande et les oeufs

Préparation (1) aromatisante de (nom

de l’arôme) (Titre 10) (2) Préparations

Colonne IV Limites de tolérance

Bonnes (2) pratiques

industrielles Bonnes

(1) pratiques industrielles

(2) Bonnes

3.1

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Permis dans ou sur Résidu maximal tolérance

1,3-Butylène-3. glycol

Dioxyde de carbone

4. Huile de ricin

5. Acétate d’éthyle (1)

(1)

(2)

(1)

(2)

aromatisantes non normalisées Préparation aromatisante de (nom de l’arôme) (Titre 10) Préparations aromatisantes non normalisées Graines de café vertes et feuilles de thé destinées à la décaféination Extraits d’épices; extractifs naturels; préparation aromatisante de (nom de l’arôme) (titre 10); extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133b); extrait de houblon pré­ isomérisé, conformément au sous-alinéa B.02.134(1)a)(ii)

(3) Produits des oeufs

(4) Poudre de cacao

Rocou soluble dans l’huile; rocou, colorant pour le beurre; rocou, colorant pour la margarine Extraits d’épices; extractifs naturels; préparation

pratiques industrielles Bonnes

(1) pratiques industrielles Bonnes

(2) pratiques industrielles

Bonnes (1) pratiques

industrielles

Bonnes (2) pratiques

industrielles

Bonnes (3) pratiques

industrielles Bonnes

(4) pratiques industrielles

Bonnes pratiques industrielles

Bonnes (1) pratiques

industrielles

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Permis dans ou sur Résidu maximal tolérance

aromatisante de (nom de l’arôme) (Titre 10) Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles

10 p.p.m. dans les cafés faits deGraines de café vertes graines rôties(3) destinées à la (3) et les cafésdécaféination décaféinés solubles (instantanés)

Feuilles de thé (4) destinées à la (4) 50 p.p.m.

décaféination Extraits d’épices; extractifs naturels; BonnesAlcool éthylique6. (1) préparation (1) pratiques(éthanol) aromatisante de (nom industrielles de l’arôme) (Titre 10) Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles Mélanges colorants et Bonnes

(3) préparations (3) pratiques colorantes (Titre 6) industrielles

Bonnes (4) Encres à marquer la (4) pratiquesviande et les oeufs industrielles

Bonnes (5) Préparations d’additifs (5) pratiquesalimentaires industrielles

Extrait de houblon, conformément au sous-alinéa BonnesB.02.130b)(v) et à(6) (6) pratiquesl’alinéa B.02.133b); industriellesextrait de houblon pré­ isomérisé, conformément au

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Permis dans ou sur Résidu maximal tolérance

sous-alinéa B.02.134(1)a)(iii)

Alcool éthylique Farine de graines 10 p.p.m. de6.A dénaturé avec végétales oléagineuses methanolméthanol 7. [Abrogé, DORS/82-406, art. 1]

Extrait de (nom de l’arôme); essence de BonnesGlycérol (nom de l’arôme);8. (1) (1) pratiques(glycérine) préparation industriellesaromatisante de (nom de l’arôme) (Titre 10) Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles Mélanges colorants et Bonnes

(3) préparations (3) pratiques colorantes (Titre 6) industrielles

Bonnes (4) Préparations d’additifs (4) pratiquesalimentaires industrielles

Préparation BonnesDiacétate de9. (1) aromatisante de (nom (1) pratiquesglycéryle de l’arôme) (Titre 10) industrielles Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles

Triacétate de Préparation Bonnes 10. glycéryle (1) aromatisante de (nom (1) pratiques

(triacétine) de l’arôme) (Titre 10) industrielles Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles

Tributyrate de Préparation Bonnes 11. glycéryle (1) aromatisante de (nom (1) pratiques

(tributyrine) de l’arôme) (Titre 10) industrielles Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles

12. Hexane (1) Extraits d’épices; (1) 25 p.p.m.

Colonne I Colonne II Colonne III Colonne IV

Article Additifs Permis dans ou sur Résidu maximal Limites detolérance extractifs naturels Extrait de houblon, conformément au

(2) sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133a)

(2) 2,2 %

(3) Graisses et huilesvégétales (3) 10 p.p.m.

(4) Farine de grainesvégétales oléagineuses (4) 10 p.p.m.

(5)

Extrait de houblon pré-isomérisé, conformément au sous-alinéa B.02.134(1)a)(i) et au paragraphe B.02.134(2)

(5)

1,5 p.p.m., par rapport à la teneur, exprimée en pourcentage, d’acide iso­ alpha dans l’extrait de houblon pré­ isomérisé.

13. Alcool isopropylique) (Isopropanol)

(1) Extraits d’épices;extractifs naturels (2) Protéines de poisson

(3) Préparation aromatisante de (nom de l’arôme) (Titre 10)

(1) 50 p.p.m.

(2) 0,15 %

(3) Bonnes pratiques industrielles

(4) Préparations aromatisantes non normalisées

(4) Bonnes pratiques industrielles

(5) Encres à marquer laviande et les oeufs (5) Bonnes pratiques industrielles

14. (1) Extraits d’épices;extractifs naturels (1) 50 p.p.m.

Alcool méthylique (méthanol) (2)

Extrait de houblon, conformément au sous-alinéa B.02.130b)(v) et à l’alinéa B.02.133a)

(2) 2,2 %

(3) Encres à marquer la (3) Bonnes

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Permis dans ou sur Résidu maximal tolérance

viande et les oeufs pratiques industrielles

Méthyléthyl- Extraits d’épices;14.1 cétone (2- 50 p.p.m.extractifs naturelsButanone)

(1) Extraits d’épices;15. (1) 30 p.p.m.extractifs naturelsChlorure de Extrait de houblon,méthylène conformément au 2,2 % dans(Dichloro­

(2) sous-alinéa (2) l’extrait deméthane) B.02.130b)(v) et à houblon l’alinéa B.02.133a)

10 p.p.m. dans le café décaféiné torréfié, le café

Grains de café vert et soluble (3) feuilles de thé devant (3) instantané

être décaféinés décaféiné, les feuilles de thé décaféiné et le thé instantané décaféiné.

Préparation BonnesMonoglycérides16. (1) aromatisante de (nom (1) pratiqueset diglycérides de l’arôme) (Titre 10) industrielles Rocou soluble dans l’huile; rocou, Bonnes

(2) colorant pour le (2) pratiques beurre; rocou, colorant industrielles pour la margarine Préparations Bonnes

(3) aromatisantes non (3) pratiques normalisées industrielles

Bonnes (4) Préparations d’additifs (4) pratiquesalimentaires industrielles

Bonnes (1) Extraits d’épices;17. Citrate de (1) pratiquesextractifs naturelsmonoglycérides industrielles (2) Préparations (2) Bonnes

Colonne I Colonne II Colonne III Colonne IV Limites deArticle Additifs Permis dans ou sur Résidu maximal tolérance

aromatisantes non pratiques normalisées industrielles

18. 2-Nitropropane Huiles végétales 0,5 p.p.m. Extrait de (nom de l’arôme); essence de1,2-Propylène- Bonnes(nom de l’arôme);19. glycol (1,2- (1) (1) pratiquespréparationpropanédiol) industriellesaromatisante de (nom de l’arôme) (Titre 10) Rocou soluble dans l’huile; rocou, Bonnes

(2) colorant pour le (2) pratiques beurre; rocou, colorant industrielles pour la margarine Préparations Bonnes

(3) aromatisantes non (3) pratiques normalisées industrielles Mélanges colorants et Bonnes

(4) préparations (4) pratiques colorantes (Titre 6) industrielles

Bonnes (5) Préparations d’additifs (5) pratiquesalimentaires industrielles

Mono et diesters Rocou soluble dans de propylène- l’huile; rocou, Bonnes

20. glycol et colorant pour le pratiques d’acides gras beurre; rocou, colorant industrielles lipogènes pour la margarine

Préparation BonnesCitrate de21. (1) aromatisante de (nom (1) pratiquestriéthyle de l’arôme) (Titre 10) industrielles Préparations Bonnes

(2) aromatisantes non (2) pratiques normalisées industrielles

DORS/78-403, art. 26 et 27; DORS/82-383, art. 12; DORS/82-406, art. 1; DORS/82-913, art. 5; DORS/82-1071, art. 21 et 22; DORS/84-541, art. 1; DORS/86-89, art. 8 et 9; DORS/86-178, art. 4 à 7; DORS/86-1112, art. 9; DORS/90-667, art. 1; DORS/94-689, art. 2; DORS/96-259, art. 1; DORS/96-377, art. 1. Version précédente

Titre 17

Sel B.17.001. (1) [N]. Le sel, autre que le sel gemme à l’état brut, doit être du chlorure de sodium cristallisé et peut renfermer

a) un ou plusieurs des agents anti-agglomérants suivants :

(i) silicate double d’aluminium et de calcium, phosphate tricalcique, silicate de calcium, stéarate de calcium, carbonate de magnésium, silicate de magnésium, stéarate de magnésium, bioxyde de silicium et silicate double d’aluminium et de sodium, le total ne devant pas dépasser un pour cent et, dans le cas du sel à grains fins, ne devant pas dépasser deux pour cent,

(ii) propylèneglycol en une quantité n’excédant pas 0,035 pour cent, et

(iii) décahydrate de ferrocyanure de sodium, en une quantité n’excédant pas 13 parties par million, calculée en ferrocyanure de sodium anhydre;

b) au plus

(i) 1,4 pour cent, séparément ou ensemble, de sulfate de calcium ou de chlorure de potassium,

(ii) 13 parties par million de ferrocyanure de sodium anhydre lorsqu’il est ajouté comme décahydrate de ferrocyanure de sodium dans la fabrication de cristaux dendritiques de sel;

(iii) 10 parties par million de monooléate polyoxyéthylénique (2) de sorbitan lorsqu’il est employé dans la fabrication de gros cristaux de sel,

(iv) 15 parties par million d’alginate de sodium lorsqu’il est employé dans la production de gros cristaux de sel, et

(v) 0,1 pour cent d’autres ingrédients; et

c) nonobstant les alinéas a) et b), la quantité totale de décahydrate de ferrocyanure de sodium, qu’il soit ajouté à titre d’agent anti-agglomérant ou d’adjuvant dans la production de sel dendritique, ne doit pas dépasser 13 parties par million, calculée en ferrocyanure de sodium anhydre.

(2) [Abrogé, DORS/97-151, art. 26]

DORS/79-662, art. 18; DORS/86-1125, art. 3; DORS/97-151, art. 26.

B.17.002. [Abrogé, DORS/79-662, art. 18]

B.17.003. Nonobstant l’article B.17.001, le sel de table ou à usage domestique général doit contenir 0,01 pour cent d’iodure de potassium, avec ou sans dextrose, du

thiosulphate de sodium ou du bicarbonate de sodium comme stabilisant de l’iodure, la présence de l’iodure devant être indiquée sur l’espace principal de l’étiquette.

Titre 18 Agents édulcorants

B.18.001. [N]. Le sucre

a) doit être le produit alimentaire connu en chimie sous le nom de sucrose ou saccharose; et

b) doit renfermer au moins 99,8 pour cent de saccharose.

B.18.002. [N]. Le sucre liquide doit être le produit alimentaire obtenu par la dissolution du sucre dans de l’eau.

B.18.003. [N]. Le sucre inverti doit être le produit alimentaire obtenu par l’hydrolyse complète ou partielle du sucre.

B.18.004. [N]. Le sucre inverti liquide doit être le produit alimentaire obtenu par une solution de sucre inverti dans de l’eau.

B.18.005. [N]. Est interdite la vente de sucre liquide ou de sucre inverti liquide à moins que l’étiquette ne déclare le pourcentage de sa teneur en sucre ou en sucre inverti.

B.18.006. [N]. Le sucre à glacer

a) doit être du sucre en poudre; et

b) peut renfermer

(i) un colorant pour aliments, et

(ii) soit au plus cinq pour cent d’amidon, ou un agent anti-agglomérant.

B.18.007. [N]. La cassonade, le sucre brun ou sucre doré

a) doit être le produit alimentaire obtenu des sirops provenant du raffinage du sucre;

b) peut renfermer au plus

(i) 4,5 pour cent d’humidité, et

(ii) 3,5 pour cent de cendres sulfatées; et

c) doit renfermer au moins 90 pour cent de sucre et de sucre inverti.

B.18.008. [N]. Le sirop de sucre raffiné, le sirop de raffineur ou le sirop doré

a) doit être le produit alimentaire fait du sirop obtenu au cours du raffinage du sucre;

b) peut être hydrolysé; et

c) doit renfermer au plus

(i) 35 pour cent d’humidité, et

(ii) 2,5 pour cent de cendres sulfatées.

B.18.009. [N]. La mélasse qualité fantaisie

a) doit être le produit alimentaire sirupeux obtenu par évaporation et inversion partielle du jus de la canne à sucre, clarifié ou non, et dont aucun sucre n’a été extrait auparavant;

b) peut renfermer de l’acide sulfureux ou ses sels;

c) doit contenir au plus

(i) 25 pour cent d’humidité, et

(ii) trois pour cent de cendres sulfatées.

B.18.010. [N]. la mélasse de table

a) doit être le produit alimentaire liquide obtenu dans la fabrication du sucre brut ou raffiné;

b) peut renfermer de l’acide sulfureux ou ses sels;

c) doit contenir au plus

(i) 25 pour cent d’humidité, et

(ii) trois pour cent de cendres sulfatées.

B.18.011. [N]. La mélasse de raffineur, la mélasse verte ou la mélasse de cuisine ou la mélasse pour cuisson

a) doit être le liquide résiduaire obtenu dans la fabrication du sucre brut ou raffiné;

b) peut renfermer de l’acide sulfureux ou ses sels;

c) doit contenir au plus

(i) 25 pour cent d’humidité, et

(ii) 12 pour cent de cendres sulfatées.

B.18.015. [N]. (1) Le dextrose anhydre, aux fins de la partie B du présent règlement

a) doit être l’aliment connu en chimie sous le nom de dextrose;

b) doit contenir au moins 99,5 pour cent de D-glucose sous sa forme déshydratée;

c) doit contenir au plus 0,25 pour cent de cendres sulfatées, calculées sur la matière desséchée;

d) doit renfermer au moins 98 pour cent, au total, de solides; et

e) peut contenir de l’acide sulfureux ou ses sels.

(2) Le monohydrate de dextrose, au fins de la partie B du présent règlement,

a) doit être l’aliment connu en chimie sous le nom de dextrose;

b) doit contenir au moins 99,5 pour cent de D-glucose sous sa forme déshydratée;

c) doit renfermer au plus 0,25 pour cent de cendres sulfatées, calculées sur la matière desséchée;

d) doit renfermer au moins 90 pour cent, au total, de solides; et

e) peut contenir de l’acide sulfureux ou ses sels.

DORS/84-300, art. 51.

B.18.016. [N]. Le glucose ou sirop de glucose

a) doit être la solution concentrée purifiée de saccharides nutritifs obtenus par l’hydrolyse incomplète, au moyen d’un acide ou d’enzymes, de l’amidon ou d’une substance amylacée;

b) doit contenir au moins 70 pour cent, au total, de solides;

c) doit contenir au plus 1,0 pour cent de cendres sulfatées, calculées sur la matière desséchée;

d) doit contenir au moins 20 pour cent de sucres réducteurs (équivalent du dextrose) calculés en D-glucose sur la matière desséchée; et

e) peut contenir de l’acide sulfureux ou ses sels.

DORS/78-402, art. 8.

B.18.017. [N]. Les solides de glucose ou sirop de glucose déshydraté

a) doivent être le glucose ou le sirop de glucose dont on a partiellement retiré l’eau;

b) doivent contenir au moins 93 pour cent, au total, de solides;

c) doivent contenir au plus 1,0 pour cent de cendres sulfatées, calculées sur la matière desséchée;

d) doivent contenir au moins 20 pour cent de sucres réducteurs (équivalent au dextrose) calculés en D-glucose sur la matière desséchée; et

e) peuvent contenir de l’acide sulfureux ou ses sels.

B.18.018. [N]. Le sirop (nom de la source de glucose)

a) doit être du glucose;

b) peut renfermer

(i) un agent édulcorant,

(ii) une préparation aromatisante,

(iii) de l’acide sorbique,

(iv) de l’acide sulfureux ou ses sels,

(v) du sel,

(vi) de l’eau;

c) doit renfermer au plus

(i) 35 pour cent d’humidité, et

(ii) trois pour cent de cendres.

DORS/94-83, art. 1.

B.18.019. [N]. Le lactose

a) doit être l’hydrate de carbone normalement obtenu à partir du petit-lait et il peut

(i) être anhydre,

(ii) contenir une molécule d’eau de cristallisation, ou

(iii) être un mélange des deux types mentionnés aux sous-alinéas (i) et (ii);

b) doit contenir au moins 99,0 pour cent de lactose anhydre, sans aucune trace d’humidité;

c) ne doit pas contenir plus de 0,3 pour cent de cendres sulfatées sans aucune trace d’humidité;

d) ne doit pas subir une perte de poids de plus de 6,0 pour cent à la dessiccation; et

e) doit avoir, dans une solution à 10 pour cent, un pH d’au moins 4,5 et d’au plus 7,0.

Miel

B.18.025. [N]. Le miel est l’aliment produit par l’abeille et provenant

a) du nectar de fleurs,

b) de sécrétions produites par des plantes vivantes, ou

c) de sécrétions présentes sur des plantes vivantes,

il doit présenter les caractéristiques suivantes :

d) une consistance fluide, visqueuse, soit partiellement soit entièrement cristallisée;

e) une activité diastasique, déterminée après conditionnement et mélange, exprimée par un indice d’au moins huit sur l’échelle de Gothe, si sa teneur en hydroxyméthylfurfural ne dépasse pas 0,004 pour cent; ou

f) une activité diastasique, déterminée après conditionnement et mélange, exprimée par un indice d’au moins trois sur l’échelle de Gothe, si sa teneur en hydroxyméthylfurfural ne dépasse pas 0,0015 pour cent.

B.18.026. (1) Sous réserve des dispositions du paragraphe (2), le miel obtenu principalement du nectar de fleurs doit

a) avoir une teneur apparente en sucres réducteurs, exprimée en sucre inverti, d’au moins 65 pour cent;

b) avoir une teneur en eau d’au plus 20 pour cent;

c) avoir une teneur apparente en saccharose d’au plus cinq pour cent;

d) contenir au plus 0,1 pour cent d’extrait sec insoluble dans l’eau, sauf pour le miel de presse, qui ne doit pas en contenir plus de 0,5 pour cent;

e) contenir au plus 0,6 pour cent de cendres; et

f) contenir au plus 40 milliéquivalents d’acide par 1 000 grammes.

(2) Le miel obtenu principalement du nectar de lavande, de robinier, de luzerne ou de Banksia menziesii, doit satisfaire aux exigences des alinéas (1)a), b) et d) à f); sa teneur apparente en saccharose ne doit pas dépasser 10 pour cent.

B.18.027. Le miel produit à partir de sécrétions provenant des plantes ou se trouvant sur les plantes doit

a) avoir une teneur apparente en sucres réducteurs, exprimée en sucre inverti, d’au moins 60 pour cent;

b) avoir une teneur en eau d’au plus 20 pour cent;

c) avoir une teneur apparente en saccharose d’au plus 10 pour cent;

d) contenir au plus 0,1 pour cent d’extrait sec insoluble dans l’eau, sauf pour le miel de presse, qui ne doit pas en contenir plus de 0,5 pour cent;

e) contenir au plus 1,0 pour cent de cendres; et

f) contenir au plus 40 milliéquivalents d’acide par 1 000 grammes.

DORS/84-300, art. 52.

Titre 19

Vinaigre B.19.001. Le vinaigre doit être le liquide obtenu par la fermentation acétique d’un liquide alcoolique et contenir au moins 4,1 pour cent et au plus 12,3 pour cent d’acide acétique.

DORS/92-626, art. 16; DORS/93-243, art. 2.

B.19.002. Le pourcentage du volume d’acide acétique contenu dans tout vinaigre mentionné au Titre 19 doit figurer sur l’espace principal de l’étiquette suivi de l’expression « acide acétique ».

B.19.003. [N]. Le vinaigre de vin doit être du vinaigre obtenu du vin, et il peut renfermer du caramel.

B.19.004. [N]. Le vinaigre d’alcool, vinaigre blanc ou vinaigre de grain, doit être du vinaigre obtenu d’alcool distillé et dilué.

B.19.005. [N]. Le vinaigre de malt doit être du vinaigre obtenu d’une infusion de malt, non distillé avant la fermentation acétique, il peut renfermer d’autres céréales ou du caramel, il doit être dextrogyre et renfermer, dans 100 millilitres mesurés à la température de 20 °C, au moins

a) 1,8 gramme de solides; et

b) 0,2 gramme de cendres.

B.19.006. [N]. Le vinaigre de cidre ou vinaigre de pommes doit être du vinaigre obtenu du liquide exprimé de pommes entières, de morceaux de pommes ou de rebuts de pommes, et il peut renfermer du caramel.

B.19.007. [N]. Le vinaigre mélangé doit être un mélange de deux ou plusieurs variétés de vinaigre, et dans ce mélange, le vinaigre d’alcool ne doit pas fournir plus de 55 pour cent de l’acide acétique total.

B.19.008. Il est interdit de nommer une des variétés de vinaigre entrant dans la composition d’un vinaigre mélangé, à moins que l’étiquette dudit mélange de vinaigres ne porte une liste complète des variétés de vinaigre présentes, par ordre décroissant de leurs proportions respectives, basées sur leur teneur en acide acétique.

B.19.009. La limite maximale de la teneur en acide acétique d’un vinaigre visé à l’article B.19.001 ne s’applique pas au vinaigre vendu uniquement à des fins de fabrication si la mention « Réservé à la fabrication » ou « Aux fins de fabrication seulement » figure sur l’espace principal de l’étiquette et sur tous les documents relatifs à ce vinaigre.

Titre 20

Thé B.20.001. [N]. Le thé doit être les feuilles et les bourgeons desséchés de Thea sinensis (L.) Sims, préparés selon les procédés ordinaires du commerce.

B.20.002. [N]. Le thé noir doit être du thé noir ou un mélange de deux ou plusieurs thés noirs, et doit renfermer, sur la matière desséchée, au moins 30 pour cent d’extrait soluble dans l’eau, déterminé selon la méthode officielle FO-37, Détermination d’extraits solubles dans l’eau dans le thé, 15 octobre 1981, et au moins quatre pour cent et au plus sept pour cent de cendres totales.

DORS/82-768, art. 61.

B.20.003. Les dispositions de l’article B.20.002 ne s’appliquent pas au thé noir nature non mélangé, emballé selon une bonne pratique commerciale dans le pays d’origine, et qui contient, sur la matière desséchée, au moins 25 pour cent d’extrait soluble dans l’eau, déterminé selon la méthode officielle FO-37, Détermination d’extraits solubles dans l’eau dans le thé, 15 octobre 1981, et au moins quatre pour cent et au plus sept pour cent de cendres totales.

DORS/82-768, art. 61.

B.20.004. [N]. Le thé vert doit renfermer, sur la matière desséchée, au moins 33 pour cent d’extrait soluble dans l’eau, déterminé selon la méthode officielle FO-37, Détermination d’extraits solubles dans l’eau dans le thé, 15 octobre 1981, et au moins quatre pour cent et au plus sept pour cent de cendres totales.

DORS/82-768, art. 61.

B.20.005. [N]. Le (indication du type de thé) décaféiné :

a) est le thé de ce type duquel a été extraite de la caféine et qui, par suite d'une telle extraction, contient au plus 0,4 pour cent de caféine;

b) peut avoir été décaféiné au moyen des solvants d'extraction mentionnés au tableau XV du titre 16.

DORS/90-429, art. 2.

Titre 21

Produits d'animaux marins et d'animaux d'eau douce B.21.001. Les aliments mentionnés dans le présent titre sont compris dans le terme produits d'animaux marins et d'animaux d'eau douce.

B.21.002. Dans le présent titre,

« remplissage » désigne

a) de la farine ou une semoule de céréales ou de pommes de terre, mais non de légumineuses,

b) de la farine de blé conditionnée, qui renferme au moins l'équivalent de 80 pour cent de dextrose, déterminé selon la méthode officielle FO-32, Détermination des remplissages, des liants et de l'équivalent de dextrose, 15 octobre 1981,

c) du pain, des biscuits ou autre produit de boulangerie, mais non des produits qui renferment une légumineuse ou sont fabriqués à base de légumineuses,

d) du lait en poudre, du lait écrémé en poudre, du babeurre en poudre et du petit-lait en poudre; et

e) de l'amidon; (filler)

« animaux marins et animaux d'eau douce » comprend

a) le poisson,

b) les mollusques et crustacés, et autres invertébrés marins,

c) les mammifères marins, et

d) les grenouilles. (Marine and fresh water animal)

DORS/82-768, art. 62.

B.21.003. [N]. Le poisson doit consister en sa partie comestible, propre et habillée, avec ou sans sel ou condiment, et peut

a) dans le cas de filets congelés, contenir de l’acide ascorbique ou son sel de sodium, de l’acide citrique ou de l’acide érythorbique ou son sel de sodium, ainsi que :

(i) du tripolyphosphate de sodium, de l’hexamétaphosphate de sodium ou une combinaison de tripolyphosphate de sodium, de pyrophosphate acide de sodium et de pyrophosphate tétrasodique, ou

(ii) un mélange d’hexamétaphosphate de sodium et de carbonate de sodium;

b) s’il est congelé, être enrobé d’un lustre se composant d’eau, de monoglycérides acétyles, de chlorure de calcium, d’alginate de sodium, de carboxyméthycellulose de sodium, de phosphate disodique, de sirop de maïs de dextrose, de glucose, de solides du glucose, d’acide ascorbique ou de son sel de sodium, ou d’acide érythorbique ou de son sel de sodium; et

c) s’il est haché et congelé, contenir du tripolyphosphate de sodium, de l’hexamétaphosphate de sodium, de l’acide ascorbique ou son sel de sodium, de l’acide citrique, de l’acide érythorbique ou son sel de sodium, ou une combinaison de tripolyphosphate de sodium, de pyrophosphate acide de sodium et de pyrophosphate trétrasodique.

DORS/84-300, art. 53; DORS/88-534, art. 7; DORS/91-149, art. 4; DORS/97-562, art. 2; DORS/2000-353, art. 9(F).

B.21.004. [N]. Dans le présent titre, la « chair » doit être la chair propre et habillée des crustacés, des mollusques, des autres invertébrés marins ou des mammifères marins, hachés ou non, avec ou sans sel ou d’autres condiments, et, dans le cas du homard congelé, du crabe congelé, des crevettes congelées et des clams congelés, peut contenir du tripolyphosphate de sodium ou de l’hexamétaphosphate de sodium ou une combinaison d’hexamétaphosphate de sodium et de carbonate de sodium ou une combinaison de tripolyphosphate de sodium, de pyrophosphate acide de sodium et de pyrophosphate tétrasodique.

DORS/88-534, art. 8; DORS/91-149, art. 5.

B.21.005. Le poisson, à l’exception des protéines de poisson, la chair d’animaux marins ou d’animaux d’eau douce ou leurs préparations sont falsifiées si l’une des substances ci­ dessous ou une substance de l’une des catégories suivantes s’y trouve ou y a été ajoutée :

a) muqueuses, tout organe ou toute partie de l’appareil génital, ou tout organe ou toute partie d’un animal marin ou d’un animal d’eau douce qui ne se vend par d’ordinaire comme article d’alimentation;

b) un agent de conservation autre que ceux qui sont prévus au présent titre, sauf

(i) l’acide sorbique ou ses sels, dans le poisson desséché qui a été salé ou fumé et dans la pâte de poisson fumé et salé conditionnée à froid, et

(ii) l’acide benzoïque ou ses sels, le benzoate de p-hydroxyméthyle et le benzoate de p­ hydroxypropyle, dans les produits de poisson ou de chair de poisson empaquetés, marinés ou conditionnés à froid par une autre méthode; et

c) un colorant pour aliments autre que ceux qui sont prévus au présent titre.

B.21.006. [N]. Le poisson et la viande préparés doivent être l’aliment entier ou déchiqueté préparé à partir du poisson ou de la viande, selon le cas, frais ou en conserve; ils peuvent être cuits ou en conserve et peuvent,

a) dans le cas de pâte de homard et d’oeufs de poisson (caviar), contenir un colorant pour aliments;

b) dans le cas des crevettes cuites congelées, des crustacés en conserve, des maquereaux en conserve et des mollusques en conserve, contenir de l’acide citrique ou du jus de citron;

c) dans le cas de pâte de poisson, contenir un remplissage, un liant à poisson, des monoglycérides ou des mono et diglycérides;

d) dans le cas des conserves de saumon, de thon, de homard, de chair de crabe et de crevettes, contenir de l’éthylènediaminetétracétate disodique de calcium (EDTA disodique de calcium) et du sulfate d’aluminium;

e) dans le cas du thon en conserve, contenir de l’acide ascorbique;

f) dans le cas des fruits de mer en conserve, contenir de l’hexamétaphosphate de sodium, du pyrophosphate acide de sodium ou du tripolyphosphate de sodium, seul ou en association, la quantité totale de phosphate ajouté, calculé sous forme de phosphate dibasique de sodium, ne devant pas dépasser 0,5 %;

g) contenir un arôme de fumée liquide ou un arôme de fumée liquide concentré;

h) contenir de l’huile comestible, un bouillon végétal, de la sauce tomate ou de la purée de tomates;

i) contenir un gélifiant (agent gélatinisant), si l’expression « en gelée » figure, comme partie intégrante du nom usuel, sur l’espace principal de l’étiquette;

j) contenir du sel;

k) dans le cas des conserves d’escargots, des conserves d’escargots de mer et des conserves de palourdes, contenir du versénate (éthylènediamine tétracétate) de calcium disodique;

l) dans le cas de miettes de thon en conserve, contenir du sulfite de sodium;

m) dans le cas du caviar de lompe, contenir de la gomme adragante;

n) dans le cas d’un mélange de poisson et de viande préparés qui a l’apparence et le goût de la chair d’animaux marins ou d’animaux d’eau douce, contenir du remplissage, un liant à poisson, de l’oeuf entier, du blanc d’oeuf, du jaune d’oeuf, un colorant alimentaire, des agents gélatinisants ou stabilisants, des agents modifiant la texture, des préparations aromatisantes naturelles, des préparations aromatisantes artificielles, des agents rajusteurs du pH, de l’édulcorant et, dans une proportion ne dépassant pas deux pour cent du mélange, des légumineuses;

o) dans le cas des crustacés, contenir du bisulfite de potassium, du bisulfite de sodium, du dithionite de sodium, du métabisulfite de potassium, du métabisulfite de sodium, du sulfite de sodium ou de l’anhydride sulfureux;

p) dans le cas des crustacés et mollusques congelés, contenir de l’oxyde de calcium et de l’hydroxyde de sodium;

q) dans le cas de produits congelés de poisson pré-cuit pané, contenir de l’acide citrique en une quantité n’excédant pas la limite de tolérance de 0,1 pour cent;

r) dans le cas des clams en conserve, contenir de l’érythorbate de sodium en une quantité n’excédant pas la limite de tolérance de 350 parties par million;

s) dans le cas des produits déchiquetés, sauf le caviar de lompe, contenir de la gomme adragante en une quantité n’excédant pas la limite de tolérance de 0,75 pour cent.

DORS/80-13, art. 9; DORS/81-60, art. 12; DORS/84-602, art. 4; DORS/86-1020, art. 2; DORS/89-197, art. 2; DORS/92-344, art. 6; DORS/93-276, art. 13; DORS/94-141, art. 2;

DORS/94-567, art. 3; DORS/94-689, art. 2(A); DORS/97-151, art. 27; DORS/97-562, art. 3; DORS/2005-316, art. 12; DORS/2007-76, art. 4. Version précédente B.21.007. [N]. Le liant à poisson devant servir dans ou sur le poisson ou la viande conditionnés doit être du remplissage auquel on a ajouté n'importe quel mélange de sel, de sucre, de dextrose, de glucose, d'épices ou d'autres condiments.

B.21.008. Est interdite la vente de remplissage ou de liant à poisson représenté, sur l’étiquette ou dans une réclame, comme devant servir dans les produits de poisson, à moins que l’étiquette ne porte des instructions appropriées pour que l’emploi du produit soit conforme aux dispositions de l’article B.21.020.

B.21.009. De l’huile de coton hydrogénée en poudre peut être appliquée, dans une proportion qui ne dépasse pas 0,25 pour cent du produit, comme agent de démoulage sur la surface de produits d’animaux marins et d’animaux d’eau douce.

DORS/2010-142, art. 59(F). Version précédente

Poisson préparé

B.21.020. Est interdite la vente de poisson préparé ou de chair de poisson préparée qui renferme

a) plus que la quantité de remplissage, de liant à poisson, ou d’autres ingrédients, que représente quatre pour cent de sucres réducteurs, calculés en dextrose selon la méthode officielle FO-32, Détermination des remplissages, des liants et de l’équivalent de dextrose, 15 octobre 1981; et

b) plus de 70 pour cent d’humidité, lorsque ledit poisson préparé contient du remplissage.

DORS/82-768, art. 63.

B.21.021. [N]. Le poisson de salaison et la chair de poisson de salaison doivent être du poisson ou de la chair de poisson, à l'état cru ou cuit, qui ont été desséchés, salés, marinés, saumurés ou fumés; ils peuvent renfermer un agent de conservation de la catégorie I, du dextrose, du glucose, des épices, du sucre et du vinaigre, et

a) le poisson desséché qui a été salé ou fumé et la pâte de poisson fumé et salé conditionnée à froid peuvent renfermer de l'acide sorbique et ses sels;

b) le poisson fumé peut renfermer un colorant pour aliments;

c) les produits de poisson ou de chair de poisson emballés, marinés ou conditionnés à froid par une autre méthode peuvent renfermer du bois de santal, de l'acide benzoïque ou ses sels, du méthyl-p-hydroxy-bensoate et du propyl-p-hydroxy-bensoate;

d) l'anchois salé, le chinchard salé et la crevette salée peuvent contenir de l'érythrosine en telle quantité que le produit fini renferme au plus 125 parties par million d'érythrosine;

e) les produits déchiquetés peuvent contenir de la gomme adragante en une quantité n’excédant pas la limite de tolérance de 0,75 pour cent.

DORS/95-493, art. 2; DORS/97-562, art. 4(F); DORS/2007-76, art. 5. Version précédente B.21.022. et B.21.023. [Abrogés, DORS/79-252, art. 1]

B.21.024. Nonobstant l’article B.21.020, la pâte de homard doit renfermer au plus deux pour cent de remplissage ou de liant à poisson.

B.21.025. Il est interdit de vendre des animaux marins et des animaux d’eau douce et des produits de ces animaux, qui sont fumés ou qui renferment un arôme de fumée liquide ou un arôme de fumée liquide concentré et qui sont emballés dans un contenant hermétiquement scellé, à moins que l’une ou l’autre des conditions suivantes ne soit remplie :

a) le contenant a été traité, après son scellement, par chaleur à une température et pendant un temps suffisants pour détruire toutes les spores de Clostridium botulinum;

b) le contenu contient au moins neuf pour cent de sel, déterminé selon la méthode officielle FO-38 intitulée Détermination de sel dans le poisson fumé du 15 mars 1985;

c) le contenu est habituellement cuit avant la consommation;

d) le contenu est congelé et l’espace principal de l’étiquette du contenant porte, en caractères identiques à ceux du nom usuel du contenu, l’inscription « Garder congelé jusqu’à utilisation ».

DORS/80-13, art. 10; DORS/82-566, art. 5; DORS/82-768, art. 64; DORS/89-198, art. 17; DORS/94-567, art. 4.

B.21.027. [N]. Les protéines de poisson

a) constituent l’aliment préparé,

(i) en extrayant, à l’aide d’alcool isopropylique, l’eau, la graisse et les autres éléments solubles des poissons comestibles, entiers et frais, de l’ordre des clupéiformes, familles des clupéidés et des osméridés, et de l’ordre des gadiformes, famille des gadidés, ou des parures qui restent après avoir enlevé les filets de ces poissons éviscérés, et

(ii) en séchant et broyant le concentré de protéines résultant de l’opération décrite au sous-alinéa (i);

b) peuvent contenir un agent rectificateur du pH; et

c) ne doivent pas contenir

(i) moins de 75 pour cent de protéines d’une qualité non inférieure à celle de la caséine, après analyse selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981.

(ii) et (iii) [Abrogés, DORS/97-148, art. 8]

DORS/82-768, art. 65; DORS/97-148, art. 8.

Cuisses de grenouille

B.21.031. Est interdite la vente de cuisses de grenouille, fraîches ou congelées, à moins qu’elles ne soient trouvées exemptes de bactéries du genre Salmonella selon la méthode officielle MFO-10, Examen microbiologique de cuisses de grenouille, 30 novembre 1981.

DORS/82-768, art. 66.

Titre 22

Volaille, viande de volaille, leurs préparations et leurs produits B.22.001. [N]. Le terme « volaille » désigne tout oiseau communément utilisé dans la consommation humaine.

B.22.002. [N]. La viande de volaille est la chair propre et apprêtée, coeur et gésier compris, d'une volaille éviscérée qui était saine au moment de l'abattage.

DORS/80-13, art. 11.

B.22.003. [N]. Les sous-produits de volaille sont les parties propres de la volaille, à l’exclusion de la viande ordinairement utilisée comme aliment, et comprennent le foie et la peau mais non l’oesophage, les pattes et la tête.

DORS/80-13, art. 12.

B.22.004. [N]. Les abats doivent être le coeur, le foie et le gésier de la volaille.

B.22.005. La viande de volaille, les sous-produits de viande de volaille ou leurs préparations sont falsifiés, s’ils renferment ou si l’on y a ajouté l’une des substances ci­ dessous ou une substance de l’une des catégories suivantes :

a) tout organe ou toute partie de volaille qui ne se vend pas d’ordinaire comme partie comestible;

b) un agent de conservation autre que ceux qui sont prévus au présent titre; ou

c) un colorant autre que le caramel.

B.22.006. [N]. La viande de volaille préparée et les sous-produits de viande de volaille préparée doivent être, respectivement, de la viande de volaille ou des sous­ produits de viande de volaille, hachés ou non, auxquels a été ajouté tout ingrédient permis par le présent règlement, ou qui ont subi un procédé de conservation, qui ont été placés dans un contenant hermétiquement fermé ou qui ont été cuits, et peuvent renfermer :

a) lorsque le présent titre prescrit une teneur totale minimale en protéines ou une teneur minimale en protéines de viande, un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 :

(i) du pyrophosphate acide de sodium,

(ii) de l’hexamétaphosphate de sodium,

(iii) du phosphate disodique,

(iv) du phosphate monosodique,

(v) du pyrophosphate tétrasodique,

(vi) du tripolyphosphate de sodium,

(vii) du phosphate monopotassique,

(viii) du phosphate dipotassique,

(ix) du pyrophosphate tétrapotassique;

b) s’il s’agit de viande de volaille cuite et séchée, un agent de conservation de la catégorie IV;

c) s’il s’agit de dinde cuite tranchée emballée sous vide, du Carnobacterium maltaromaticum CB1.

DORS/81-934, art. 16; DORS/94-262, art. 13; DORS/2010-264, art. 5. Version précédente B.22.008. Dans le présent titre, « agent de remplissage » désigne toute matière végétale, (à l’exclusion de la tomate et de la pulpe de betterave), le lait, les oeufs, la levure, ou tout dérivé ou combinaison de ces produits qui serait acceptable comme aliment.

DORS/82-768, art. 67; DORS/84-300, art. 54(A); DORS/86-875, art. 6.

B.22.009. Est interdite la vente

a) de la volaille qui est destinée à être consommée comme aliment et à laquelle a été administré un produit ayant un pouvoir oestrogène; ou

b) de viande de volaille ou de sous-produits de viande de volaille, renfermant quelque résidu que ce soit de substances exogènes à action oestrogène.

DORS/87-626, art. 2.

B.22.010. De l’huile de coton hydrogénée en poudre peut être appliquée, dans des proportions qui ne dépassent pas 0,25 pour cent du produit, comme agent de démoulage sur la surface de la viande de volaille, des sous-produits de volaille, de la viande de

volaille préparée, des sous-produits de viande de volaille préparés, des produits de volaille avec allongeur et des simili-produits de volaille.

DORS/2010-142, art. 59(F). Version précédente B.22.011. [N]. La viande de volaille coupée solide doit consister :

a) soit en une pièce de viande de volaille entière;

b) soit en un produit constitué de morceaux de viande de volaille, dont au moins 80 pour cent pèsent au moins 25 g chacun.

DORS/94-262, art. 14.

B.22.012. (1) Est interdite la vente de viande de volaille coupée solide à laquelle ont été ajoutés des sels de phosphate ou de l’eau, à moins que les conditions suivantes ne soient réunies :

a) la viande a :

(i) si elle est cuite, une teneur minimale en protéines de viande de 12 pour cent,

(ii) si elle n’est pas cuite, une teneur minimale en protéines de viande de 10 pour cent;

b) la viande contient un ou plusieurs des sels de phosphate suivants, en une proportion n’excédant pas la limite de tolérance calculée en phosphate disodique conformément au tableau XII de l’article B.16.100 :

(i) du pyrophosphate acide de sodium,

(ii) de l’hexamétaphosphate de sodium,

(iii) du phosphate disodique,

(iv) du phosphate monosodique,

(v) du pyrophosphate tétrasodique,

(vi) du tripolyphosphate de sodium,

(vii) du phosphate monopotassique,

(viii) du phosphate dipotassique,

(ix) du pyrophosphate tétrapotassique.

(2) Aux fins du calcul de la teneur en protéines de viande visée à l’alinéa (1)a), les os et les couches de gras visible ne doivent pas être pris en compte.

DORS/94-262, art. 14.

B.22.013. Est interdite la vente de la volaille habillée, entière ou en morceaux, qui a été refroidie dans un réservoir refroidisseur contenant un liquide additionné de sels de phosphate.

DORS/94-262, art. 14.

Ragoûts de poulet

B.22.016. Aux fins des articles B.22.017 à B.22.019, on entend par « viande de volaille pour ragoût » de la viande de volaille contenant au plus 15 % de gras, calculés d’après le poids de la viande crue.

DORS/78-874, art. 3.

B.22.017. [N]. Le ragoût de légumes avec (nom de la viande de volaille)

a) doit contenir des légumes et (le nom de la viande de volaille) dans les quantités suivantes :

(i) si de la viande crue est utilisée, au moins 12 % de viande de volaille pour ragoût,

(ii) si de la viande cuite est utilisée, au moins 6 % de viande de volaille pour ragoût,

(iii) au moins 38 % de légumes et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 3.

B.22.018. [N]. Le ragoût de (nom de la viande de volaille)

a) doit contenir des légumes et de la viande de volaille pour ragoût, dans les quantités suivantes :

(i) si de la viande crue est utilisée, au moins 20 % de viande de volaille pour ragoût,

(ii) si de la viande cuite est utilisée, au moins 10 % de viande de volaille pour ragoût,

(iii) au moins 30 % de légumes et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 3.

B.22.019. [N]. Le ragoût spécial de viande de volaille

a) doit contenir de la viande de volaille et des légumes dans les quantités suivantes :

(i) si de la viande crue est utilisée, au moins 25 % de viande de volaille pour ragoût,

(ii) si de la viande cuite est utilisée, au moins 15 % de viande de volaille pour ragoût,

(iii) au moins 30 % de légumes et

b) peut contenir de la sauce, du sel, des assaisonnements et des épices.

DORS/78-874, art. 3.

Viandes de volaille préparées, sous-produits de viande de volaille préparés

B.22.020. [Abrogé, DORS/86-875, art. 7]

B.22.021. [N]. La viande de volaille conditionnée ou conservée et les sous-produits de viande de volaille conditionnée ou conservée sont la viande de volaille ou des sous­ produits de viande de volaille crus ou cuits, qui ont été salés ou fumés et qui peuvent renfermer

a) des agents de conservation de la catégorie I;

b) un arôme de fumée liquide, un arôme de fumée liquide concentré ou des épices;

c) des agents édulcorants;

d) du vinaigre;

e) dans le cas de la volaille et de la viande de volaille de salaison préparées à l’aide d’une solution d’injection ou d’immersion, du phosphate disodique, du phosphate monosodique, de l’hexamétaphosphate de sodium, du tripolyphosphate de sodium, du pyrophosphate tétrasodique et du pyrophosphate acide de sodium, en telle quantité calculée en phosphate disodique, que le produit fini renferme au plus 0,5 pour cent de phosphate ajouté;

f) dans le cas de la dinde cuite tranchée emballée sous vide, du Carnobacterium maltaromaticum CB1.

DORS/80-13, art. 13; DORS/82-596, art. 10; DORS/94-567, art. 5; DORS/2010-264, art. 6. Version précédente B.22.022. [N]. La (nom de la volaille) en conserve doit être préparée avec de la viande de volaille et peut renfermer

a) les os ou parties d’os adhérant aux morceaux de viande de la volaille mise en conserve;

b) du bouillon;

c) du sel;

d) des assaisonnements;

e) des agents gélatinisants; et

f) de petites quantités de gras.

DORS/84-300, art. 55.

B.22.023. [N]. Le bouillon utilisé dans la (nom de la volaille) en conserve doit être le liquide dans lequel on a fait cuire la viande de volaille.

B.22.024. Lorsqu’un gélifiant (agent gélatinisant) a été ajouté à de la volaille en conserve, la mention de l’addition du gélifiant doit figurer sur l’espace principal de l’étiquette; sinon, l’expression « en gelée » doit figurer comme partie intégrante du nom usuel de l’aliment.

B.22.025. [N]. La (nom de la volaille) désossée doit être de la viande de volaille en conserve, débarrassée des os et de la peau; elle doit renfermer au moins 50 pour cent de viande de la volaille nommée, déterminé selon la méthode officielle FO-39, Détermination de viande dans la volaille désossée, 15 octobre 1981, et elle peut renfermer du bouillon dont la densité est d’au moins 1,000 à la température de 50 °C.

DORS/82-768, art. 69.

B.22.026. Est interdite la vente de volaille, de viande de volaille ou de sous-produits de viande de volaille cuits à la broche, rôtis ou grillés et prêts à la consommation à moins que la volaille, la viande de volaille ou le sous-produit de viande de volaille cuits

a) n’aient constamment

(i) indiqué une température de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus, ou

(ii) été conservés à une température ambiante de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus; et

b) ne portent, sur l’espace principal de l’étiquette, mention qu’ils doivent être conservés à une température de 40 °F (4,4 °C) ou moins, ou de 140 °F (60 °C) ou plus.

DORS/78-403, art. 28(F); DORS/88-336, art. 3.

Allongeur de produits de volaille

B.22.027. Est interdite la vente d’un allongeur de produits de volaille, à moins que cet allongeur

a) n’ait, à l’état réhydraté,

(i) une teneur totale en protéines d’au moins 16 pour cent, et

(ii) une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

b) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs figurant au tableau du titre 14, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de chacun de ces minéraux nutritifs; et que

c) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités non supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 70.

Produits de volaille avec allongeur

B.22.028. Est interdite la vente d’un aliment qui consiste en un mélange de produit de volaille et d’allongeur de produits de volaille, à moins que cet aliment

a) n’ait une teneur totale en protéines d’au moins 16 pour cent, et

b) n’ait une teneur en matières grasses d’au plus 15 pour cent, et que

l’allongeur de produits de volaille ne satisfasse aux exigences des alinéas B.22.027a) à c).

Simili-produits de volaille

B.22.029. Est interdite la vente d’un simili-produit de volaille, à moins que ce produit

a) n’ait une teneur totale en protéines d’au moins 16 pour cent;

b) n’ait une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) n’ait une teneur en matières grasses d’au plus 15 pour cent;

d) par dérogation aux articles D.01.009 et D.02.009, ne contienne toutes les vitamines et tous les minéraux nutritifs figurant au tableau du titre 14, à la colonne I, en quantité au moins égale à celle indiquée audit tableau, à la colonne II, au regard de chacune de ces vitamines et de ces minéraux nutritifs; et que

e) lorsque des acides aminés essentiels isolés ont été ajoutés, il ne contienne ces acides en quantités non supérieures aux quantités qui améliorent la qualité nutritive de la protéine.

DORS/82-768, art. 71.

Produits des oeufs

B.22.032. Est interdite la vente d’un produit imitant l’oeuf, sauf si ce produit

a) provient d’albumine d’oeuf, en poudre, à l’état liquide ou congelé, ou d’un mélange quelconque de ces produits;

b) a une cote protéique d’au moins 40, déterminée selon la méthode officielle FO-1, Détermination de cote protéique, 15 octobre 1981;

c) nonobstant les articles D.01.009 et D.02.009, contient par 100 grammes de produits prêt à utiliser

(i) au moins

(A) 50 milligrammes de calcium,

(B) 2,3 milligrammes de fer,

(C) 1,5 milligramme de zinc,

(D) 130 milligrammes de potassium,

(E) 1 000 unités internationales de vitamine A,

(F) 0,10 milligramme de thiamine,

(G) 0,30 milligramme de riboflavine,

(H) 3,60 milligrammes de niacine,

(I) 1,60 milligramme d’acide pantothénique,

(J) 0,20 milligramme de vitamine B6′

(K) 0,50 microgramme de vitamine B12′

(L) 0,02 milligramme d’acide folique, et

(M) 2,0 unités internationales d’alpha tocophérol, et

(ii) au plus trois milligrammes de cholestérol;

d) contient du calcium et du phosphore dans une proportion d’au moins une partie de calcium pour quatre parties de phosphore; et

e) contient, dans le gras total de toute graisse ou huile utilisée, au moins 40 pour cent d’acides gras polyinsaturés à groupe cis-cis méthylène et au plus 20 pour cent d’acides gras saturés.

DORS/82-768, art. 72; DORS/84-300, art. 56.

B.22.033. Est interdite la vente de produits des oeufs visés aux articles B.22.032, B.22.034, B.22.035, B.22.036 et B.22.037, destinés à la consommation humaine, sauf s’ils sont trouvés exempts de bactéries de l’espèce Salmonella selon la méthode officielle MFO-6, Examen microbiologique des produits des oeufs et des oeufs à l’état liquide, 30 novembre 1981.

DORS/82-768, art. 73.

B.22.034. [N]. L’oeuf entier liquide, la poudre d’oeuf ou l’oeuf entier congelé

a) est le produit obtenu en débarrassant de leur coquille des oeufs frais sains ou des oeufs entreposés sains, et

(i) dans le cas de la poudre d’oeuf entier, en la séchant, ou

(ii) dans le cas de l’oeuf entier congelé, en le congelant; et

b) peut renfermer

(i) du sulfate d’aluminium, des agents rajusteurs de pH ou du colorant bêta-carotène,

(ii) dans le cas de l’oeuf entier liquide destiné au séchage, de l’autolysat de levure et peut être traité avec du peroxyde d’hydrogène et de la catalase, de la glucose-oxydase et de la catalase, de la levure ou une culture bactérienne appropriée fermentant le glucose, et

(iii) dans le cas de la poudre d’oeuf entier, des agents anti-agglomérants.

B.22.035. [N]. Le jaune d’oeuf liquide, la poudre de jaune d’oeuf ou le jaune d’oeuf congelé

a) est le produit obtenu en débarrassant de leur coquille et de leur blanc des oeufs frais sains ou des oeufs entreposés sains, et

(i) dans le cas de la poudre de jaune d’oeuf, en la séchant, ou

(ii) dans le cas du jaune d’oeuf congelé, en le congelant; et

b) peut renfermer

(i) du sulfate d’aluminium, des agents rajusteurs du Ph ou du colorant bêta-carotène,

(ii) dans le cas du jaune d’oeuf liquide destiné au séchage, de l’autolysat de levure et peut être traité avec du peroxyde d’hydrogène et de la catalase, de la glucose-oxydase et de la catalase, de la levure ou une culture bactérienne appropriée fermentant le glucose, et

(iii) dans le cas de la poudre de jaune d’oeuf, des agents anti-agglomérants.

B.22.036. [N]. Le blanc d’oeuf liquide (albumen liquide), la poudre de blanc d’oeuf (poudre d’albumen) ou le blanc d’oeuf congelé (albumen congelé)

a) est le produit obtenu en débarrassant de leur coquille et de leur jaune des oeufs frais sains ou des oeufs entreposés sains, et

(i) dans le cas de la poudre de blanc d’oeuf, en la séchant, ou

(ii) dans le cas du blanc d’oeuf congelé, en le congelant; et

b) peut renfermer

(i) des agents favorisant la montée en neige, du sulfate d’aluminium et des agents rajusteurs du Ph,

(ii) dans le cas du blanc d’oeuf liquide destiné au séchage de l’autolysat de levure et peut être traité avec du peroxyde d’hydrogène et de la catalase, de la glucose-oxydase et de la catalase, de la levure ou une culture bactérienne appropriée fermentant le glucose,

(iii) dans le cas du blanc d’oeuf liquide et de la poudre de blanc d’oeuf, de la lipase ou de la pancréatine, et

(iv) dans le cas de la poudre de blanc d’oeuf, des agents anti-agglomérants.

B.22.037. [N]. Le mélange liquide d’oeufs entier, le mélange de poudre d’oeufs entiers, le mélange congelé d’oeufs entiers, le mélange liquide de jaunes d’oeufs, le mélange de poudre de jaunes d’oeufs ou le mélange congelé de jaunes d’oeufs

a) est le produit obtenu en ajoutant du sel, des agents édulcorants, ou les deux, aux oeufs entiers liquides, à la poudre d’oeuf entier, aux oeufs entiers congelés, aux jaunes d’oeufs liquides, à la poudre de jaune d’oeuf ou aux jaunes d’oeufs congelés; et

b) dans le cas du mélange de poudre d’oeufs entiers ou du mélange de poudre de jaunes d’oeufs, peut renfermer des agents anti-agglomérants.

B.22.038. (1) Il est interdit d’utiliser un nom usuel mentionné aux articles B.22.034 à B.22.037 à l’égard d’un produit des oeufs qui a fait l’objet d’un traitement non mentionné à l’un de ces articles si celui-ci a entraîné une réduction de la quantité d’une vitamine ou d’un minéral nutritif présent dans le produit en une concentration représentant, par 100 g du produit, 10 pour cent ou plus de l’apport nutritionnel recommandé pondéré, à moins que la quantité ainsi réduite n’ait été ramenée à ce qu’elle était avant le traitement.

(2) Malgré les articles D.01.009, D.01.011 et D.02.009, il est permis d’ajouter une vitamine ou un minéral nutritif mentionné à la colonne II de l’article 27 du tableau de l’article D.03.002 à un produit des oeufs visé aux articles B.22.034 à B.22.037 afin de ramener la concentration de cette vitamine ou de ce minéral à ce qu’elle était avant le traitement.

(3) Pour l’application du présent article, « apport nutritionnel recommandé pondéré » s’entend au sens du paragraphe D.01.001(1).

DORS/96-259, art. 2.

Titre 23

Matériaux à emballer les denrées alimentaires B.23.001. Est interdite la vente d’un aliment dont l’emballage peut transmettre à son contenu une substance pouvant être nuisible à la santé d’un consommateur de l’aliment.

B.23.002. Sous réserve de l’article B.23.003, est interdite la vente d’un aliment dont l’emballage a été fabriqué à l’aide d’un chlorure de polyvinyle renfermant un produit chimique à base d’étain octylique.

B.23.003. Est permise, sauf dans le cas du lait, du lait écrémé, du lait partiellement écrémé, du lait stérilisé, des boissons maltées et des boissons gazeuses non alcoolisées, la vente d’un aliment dont l’emballage a été fabriqué à partir de polychlorure de vinyle contenant l’un ou plusieurs des produits chimiques suivants à base d’étain octylique, soit le S,S;-bis(isooctylmercaptoacétate) de di(n-octyl)étain, le polymère maltéate de di(n­ octyl)étain ou le S,S;, S:-tris(isooctylmercaptoacétate) de (n-octyl) étain, si la quantité de ce produit ou de la combinaison de ces produits ne dépasse pas trois pour cent de la

quantité de résine et si l’aliment en contact avec l’emballage ne contient pas plus de une partie par million d’étain octylique total.

DORS/81-60, art. 13; DORS/86-1125, art. 4.

B.23.004. (1) Le S,S;-bis(isooctylmercaptoacétate) de di(n-octyl)étain est l’étain octylique obtenu à partir du bichlorure de di(n-octyl)étain et contenant au moins 15,1 et au plus 16,4 pour cent d’étain et au moins 8,1 et au plus 8,9 pour cent de soufre thiolique.

(2) Aux fins du présent titre, le bichlorure de di(n-octyl)étain est un organo-étain contenant au moins 95 pour cent de bichlorure de di(n-octyl)étain et au plus :

a) cinq pour cent de trichlorure de (n-octyl)étain ou de chlorure de tri(n-octyl)étain ou de la combinaison des deux;

b) 0,2 pour cent de toute combinaison d’autres alkyl-étains isomères à groupement alkyl renfermant huit atomes de carbone;

c) 0,1 pour cent de toute combinaison d’alkyl-étains homologues supérieurs et inférieurs.

DORS/86-1125, art. 5.

B.23.005. Le polymère maléate de di(n-octyl)étain est l’étain octylique obtenu à partir du bichlorure de di(n-octyl)étain, dont la formule est ((C8H17)2 SnC4H2O4)n (dans laquelle n est d’au moins 2 et d’au plus 4), dont l’indice de saponification est d’au moins 225 et d’au plus 255, et qui contient au moins 25,2 et au plus 26,6 pour cent d’étain.

DORS/86-1125, art. 6(F).

B.23.006. (1) Le S,S;,S:-tris(isooctylmercaptoacétate) de (n-octyl)étain est l’étain octylique possédant la formule n-C8HSn(SCH2CO2 C8H17)3, qui est obtenu à partir du trichlorure de (n-octyl)étain et qui contient au moins 13,4 et au plus 14,8 pour cent d’étain et au moins 10,9 et au plus 11,9 pour cent de soufre thiolique.

(2) Aux fins du présent titre, le trichlorure de (n-octyl)étain est un organo-étain contenant au moins 95 pour cent de trichlorure de (n-octyl)étain et au plus :

a) cinq pour cent de bichlorure de di(n-octyl)étain, de chlorure de tri(n-octyl)étain ou de chlorures d’alkyl-étains supérieurs (à groupement alkyl renfermant plus de huit atomes de carbone) ou de toute combinaison de ceux-ci;

b) 0,2 pour cent de toute combinaison d’alkyl-étains;

c) 0,1 pour cent de toute combinaison d’alkyl-étains homologues inférieurs (à groupement alkyl renfermant moins de huit atomes de carbone).

DORS/86-1125, art. 7.

B.23.007. Est interdite la vente d’un aliment dont l’emballage peut transmettre à son contenu une quantité de chlorure de vinyle, déterminée selon la méthode officielle FO-40, Détermination de chlorure de vinyle dans les aliments, 15 octobre 1981, pour cet aliment.

DORS/82-768, art. 74.

B.23.008. Est interdite la vente d’un aliment dont l’emballage peut transmettre à son contenu une quantité quelconque d’acrylonitrile, telle que déterminée selon la méthode officielle FO-41, Détermination d’acrylonitrile dans les aliments (16 février 1982).

DORS/82-541, art. 1.

Titre 24 Aliments à usage diététique spécial

B.24.001. Dans ce titre,

« aliment à usage diététique spécial » désigne un aliment qui a été spécialement transformé ou formulé pour satisfaire les besoins alimentaires particuliers d’une personne

a) manifestant un état physique ou physiologique particulier suite à une maladie, une blessure ou un désordre fonctionnel, ou

b) chez qui l’on cherche à obtenir un résultat particulier, y compris, sans s’y limiter, une perte de poids, grâce au contrôle de sa ration alimentaire; (food for special dietary use)

« changement majeur » S’entend, dans le cas d’un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie, de tout changement d’un des éléments suivants qui pourrait, selon l’expérience du fabricant ou la théorie généralement admise, avoir un effet indésirable sur les concentrations ou la disponibilité des éléments nutritifs de l’aliment ou sur l’innocuité microbiologique ou chimique de celui-ci :

a) un ingrédient ou la quantité d’un ingrédient dans l’aliment;

b) le procédé de fabrication ou l’emballage de l’aliment;

c) le mode de préparation et le mode d’emploi de l’aliment. (major change)

« date limite d’utilisation » Relativement à une préparation pour régime liquide, un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie, un substitut de repas ou un supplément nutritif, la date :

a) après laquelle le fabricant n’en recommande plus la consommation;

b) jusqu’à laquelle le produit conserve sa stabilité microbiologique et physique de même que la valeur nutritive indiquée sur l’étiquette. (expiration date)

« hôpital »

a) Établissement qui fait l’objet d’un permis délivré par une province ou qui a été approuvé ou désigné par elle à ce titre en conformité avec ses lois en vue d’assurer des soins ou des traitements aux personnes atteintes de toute forme de maladie ou d’affection;

b) établissement qui assure des soins de santé et qui appartient au gouvernement du Canada ou d’une province ou qui est exploité par lui. (hospital)

« médecin » Personne qui, en vertu des lois d’une province, est inscrite à titre de médecin et est autorisée à pratiquer la médecine et qui exerce cette profession en vertu de ces lois dans cette province. (physician)

« pharmacien » Personne qui, en vertu des lois d’une province, est inscrite à titre de pharmacien et est autorisée à exercer cette profession et qui l’exerce en vertu de ces lois dans cette province. (pharmacist)

« poids corporel cible » Poids corporel visé à la fin d’un régime amaigrissant que fixe le médecin avant le début du régime. (target body weight)

« préparation pour régime liquide » désigne un aliment qui

a) est vendu pour consommation sous forme liquide, et

b) est vendu ou présenté comme régime alimentaire complet pris par voie orale ou administré à la sonde stomacale à une personne visée à l’alinéa a) de la définition d’« aliment à usage diététique spécial »; (formulated liquid diet)

« régime à très faible teneur en énergie » Régime amaigrissant qui, lorsqu’il est suivi selon les indications, fournit moins de 900 kilocalories par jour. (very low energy diet)

« repas préemballé »[Abrogée, DORS/95-474, art. 3]

« substitut de repas »[Abrogée, DORS/95-474, art. 3]

DORS/78-64, art. 1; DORS/78-698, art. 4; DORS/94-35, art. 1; DORS/95-474, art. 3.

B.24.003. (1) Il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment de manière à donner l’impression qu’il est à usage diététique spécial, à moins que cet aliment ne soit

a) à e) [Abrogés, DORS/2003-11, art. 21]

f) une préparation pour régime liquide qui répond aux exigences des articles B.24.101 et B.24.102;

f.1) un substitut de repas à usage diététique spécial qui répond aux exigences de l’article B.24.200;

f.2) un supplément nutritif qui répond aux exigences de l’article B.24.201;

g) un aliment sans gluten répondant aux exigences de l’article B.24.018;

h) un aliment présenté comme étant destiné aux régimes à teneur réduite en protéines;

i) un aliment présenté comme étant destiné aux régimes à faible teneur en (nom de l’acide aminé);

j) un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui répond aux exigences mentionnées à l’article B.24.303.

(1.1) Malgré le paragraphe (1), il est permis d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment de manière à donner l’impression qu’il est à usage diététique spécial si son étiquette comporte une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513, conformément à l’article B.01.503, en regard de l’un des sujets ci-après visé à la colonne 1 :

a) « sans énergie », visé à l’article 1;

b) « peu d’énergie », visé à l’article 2;

c) « sans sodium ou sans sel », visé à l’article 31;

d) « faible teneur en sodium ou en sel », visé à l’article 32;

e) « sans sucres », visé à l’article 37.

(2) Le paragraphe (1) ne s’applique pas aux préparations pour nourrissons.

(3) Il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment de manière à donner l’impression qu’il est conçu pour les régimes amaigrissants, à moins que cet aliment ne soit

a) un substitut de repas dont la composition répond aux exigences de l’article B.24.200;

b) un repas préemballé;

c) un aliment vendu par une clinique d’amaigrissement à ses clients pour être consommé dans le cadre d’un programme d’amaigrissement supervisé par le personnel de la clinique;

d) un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie et dont la composition répond aux exigences de l’article B.24.303.

(4) Sauf disposition contraire du présent règlement, il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un aliment, en le présentant comme étant « diététique » ou « diète » ou d’inclure l’un ou l’autre de ces mots dans sa marque à moins que son étiquette comporte une mention ou une allégation figurant à la colonne 4 du tableau suivant l’article B.01.513, conformément à l’article B.01.503, en regard de l’un des sujets ci-après visé à la colonne 1 :

a) « sans énergie », visé à l’article 1;

b) « peu d’énergie », visé à l’article 2;

c) « énergie réduite », visé à l’article 3;

d) « moins d’énergie », visé à l’article 4;

e) « sans sucres », visé à l’article 37.

DORS/78-64, art. 2; DORS/78-698, art. 5; DORS/84-334, art. 1; DORS/86-178, art. 8(A); DORS/94-35, art. 2; DORS/95-444, art. 1; DORS/95-474, art. 4; DORS/2003-11, art. 21.

B.24.004. à B.24.014 [Abrogés, DORS/2003-11, art. 22]

B.24.015. et B.24.016. [Abrogés, DORS/88-559, art. 26]

B.24.017. (1) Lorsque le Directeur demande par écrit au fabricant d’une préparation pour régime liquide, d’un substitut de repas ou d’un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie de soumettre, à une date précise ou avant celle­ ci, des preuves relatives à ce produit, le fabricant doit cesser de vendre ce produit le lendemain de cette date à moins d’avoir déposé les preuves demandées.

(2) Si le directeur est d’avis que les preuves présentées par le fabricant selon le paragraphe (1) sont insuffisantes, il doit l’en informer par écrit.

(3) Lorsque, aux termes du paragraphe (2), un fabricant est informé que les preuves relatives à la préparation pour régime liquide, au substitut de repas ou à l’aliment présenté comme étant conçu pour un régime à très faible teneur en énergie sont insuffisantes, il doit cesser de vendre ce produit à moins qu’il ne présente des preuves supplémentaires et que le Directeur ne l’informe par écrit qu’elles sont suffisantes.

(4) Dans le présent article, les preuves relatives à une préparation pour régime liquide, à un substitut de repas ou à un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie s’entendent des preuves permettant d’établir que l’aliment possède les qualités nutritives voulues pour être utilisé comme source nutritive unique qui répond aux besoins nutritifs des personnes à qui il est destiné lorsqu’il est consommé suivant le mode d’emploi.

DORS/78-698, art. 6; DORS/94-35, art. 3.

B.24.018. Il est interdit d’étiqueter, d’emballer ou de vendre un aliment ou d’en faire la publicité de manière à donner l’impression qu’il est sans gluten, sauf s’il s’agit d’un aliment qui ne contient ni blé — dont l’épeautre et le kamut —, ni avoine, ni orge, ni seigle, ni triticale, ni aucun élément de ces grains.

DORS/95-444, art. 2.

B.24.019. [Abrogé, DORS/2003-11, art. 23]

Préparations pour régime liquide

B.24.100. Est interdite la publicité au grand public d’une préparation pour régime liquide.

DORS/78-64, art. 7; DORS/78-698, art. 7.

B.24.101. Il est interdit de vendre une préparation pour régime liquide à moins que l’aliment,

a) s’il est vendu prêt à servir, ou

b) s’il n’est pas vendu prêt à servir, lorsque dilué avec de l’eau, du lait, ou les deux,

ne soit un succédané complet du régime total en ce qu’il satisfait aux besoins nutritionnels d’une personne.

DORS/78-64, art. 7.

B.24.102. (1) Sous réserve du paragraphe (4), une préparation pour régime liquide doit, lorsqu’elle est prête à servir :

a) contenir :

(i) soit au moins 20 g de protéines d’une qualité nutritive équivalente à la caséine, après analyse selon la méthode officielle FO-1, Détermination de cote protéique, du 15 octobre 1981,

(ii) soit une quantité et une qualité de protéines, y compris les protéines additionnées d’acides aminés, dont, lorsque la qualité des protéines est exprimée comme une fraction de la qualité de la caséine :

(A) la fraction ne sera pas inférieure à 85/100,

(B) le résultat de la multiplication de la fraction et du poids en grammes de la protéine ne sera pas inférieur à 20;

b) contenir au moins l g d’acide linoléique sous forme de glycéride.

(2) Par dérogation aux articles D.01.009, D.01.011 et D.02.009, une préparation pour régime liquide doit contenir, lorsqu’elle est prête à servir, les vitamines et les minéraux mentionnés dans la colonne I du tableau du présent article :

a) lorsque l’apport recommandé est de 2 500 kcal par jour ou moins, en quantités non inférieures à celles visées à la colonne II et non supérieures à celles visées à la colonne III;

b) lorsque l’apport recommandé est supérieur à 2 500 kcal par jour, en quantités non inférieures à celles visées à la colonne IV et non supérieures à celles visées à la colonne V.

(3) Les quantités d’éléments nutritifs visées aux alinéas (1)a) et b) et au paragraphe (2) doivent être calculées :

a) par 1 000 kcal disponibles, lorsque l’apport recommandé est de 2 500 kcal par jour ou moins;

b) par 1 500 kcal disponibles, lorsque l’apport recommandé est supérieur à 2 500 kcal par jour.

(4) L’alinéa (1)a) ne s’applique pas à une préparation pour régime liquide recommandée pour un régime à teneur réduite en protéines ou à faible teneur en (nom de l’acide aminé).

TABLEAU

Par 1 000 kcal disponibles Par 1 500 kcal disponibles Colonne I Colonne II Colonne III Colonne IV Colonne V

Quantité Quantité Quantité QuantitéVitamines minimale maximale minimale maximale Vitamine A 2 000 U.I. 5 000 U.I 2 000 U.I. 3 000 U.I. Vitamine D 100 U.I. 400 U.I. 100 U.I. 200 U.I. Vitamine E (a­ tocophérol) 5 U.I. 5 U.I.

Acide ascorbique 20 mg 20 mg Thiamine 0,5 mg 0,6 mg Riboflavine 0,7 mg 0,84 mg Niacine 6,6 mg 7,9 mg Vitamine B6 0,9 mg 0,9 mg Vitamine B12 1,5 µg 1,5 µg Acide folique 100 µg 100 µg Acide d-pantothénique 2,5 mg 2,5 mg Minéraux Calcium 400 mg 400 mg Phosphore 400 mg 400 mg Fer 8 mg 8 mg Iode 50 µg 50 µg Magnésium 150 mg 150 mg Cuivre 1 mg 1 mg Zinc 7 mg 7 mg

DORS/78-64, art. 7; DORS/78-698, art. 8; DORS/82-768, art. 75; DORS/87-640, art. 9(F); DORS/90-830, art. 6(F).

B.24.103. L’étiquette d’une préparation pour régime liquide doit porter les renseignements suivants :

a) une mention indiquant que l’aliment est destiné à être consommé par voie orale ou administré à la sonde stomacale;

b) une mention de la valeur énergétique de l’aliment, exprimée en Calories :

(i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale,

(ii) par unité de l’aliment prêt à servir;

c) une mention de la teneur de l’aliment en protéines ou en équivalent de protéines, en matières grasses, en acide linoléique, en glucides disponibles et, s’il y a lieu, en fibres brutes, exprimée en grammes :

(i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale,

(ii) par unité de l’aliment prêt à servir;

d) une mention de la teneur en vitamines et en minéraux nutritifs énumérés au tableau de l’article B.24.102, exprimée en unités internationales ou en milligrammes :

(i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale,

(ii) par unité de l’aliment prêt à servir;

e) une mention de la teneur en une vitamine ou un minéral nutritif autres ceux énumérés au tableau de l’article B.24.102, exprimée en milligrammes :

(i) par 100 grammes ou par 100 millilitres de l’aliment sous sa forme commerciale,

(ii) par unité de l’aliment prêt à servir;

f) un mode complet de préparation et d’emploi, ainsi que les indications nécessaires à sa conservation après l’ouverture du contenant et

g) la date limite de son utilisation.

DORS/78-64, art. 7; DORS/88-559, art 27.

Substituts de repas, suppléments nutritifs, repas préemballés et aliments vendus par les cliniques d'amaigrissement

B.24.200. (1) Il est interdit de vendre ou d’annoncer un substitut de repas à moins que, dans son état prêt à servir ou une fois préparé, selon le mode d’emploi, avec de l’eau, du lait, du lait partiellement écrémé, du lait écrémé ou une combinaison de ces produits, il ne réponde aux exigences suivantes :

a) il procure au moins 225 Kcal ou 945 kJ par portion;

b) au moins 15 pour cent et au plus 40 pour cent de l’énergie utilisable provient de sa teneur en protéines, sauf dans le cas d’un substitut de repas pour régimes amaigrissants, où au moins 20 pour cent de l’énergie utilisable provient de sa teneur en protéines;

c) sous réserve du paragraphe (2), au plus 35 pour cent de l’énergie utilisable provient de sa teneur en lipides;

d) au moins 3,0 pour cent de l’énergie utilisable provient de l’acide linoléique sous forme de glycéride et au moins 0,5 pour cent de l’énergie utilisable provient de l’acide linolénique n-3 sous forme de glycéride, et le rapport entre l’acide linoléique et l’acide linolénique n-3 est d’au moins 4 à 1 et d’au plus 10 à 1;

e) les protéines qu’il contient sont :

(i) soit d’une qualité nutritive équivalente à celle de la caséine,

(ii) soit de qualité nutritive et en quantité suffisantes pour donner un résultat d’au moins 15 pour cent, ou d’au moins 20 pour cent dans le cas d’un substitut de repas pour régimes amaigrissants, lorsque la qualité nutritive de ces protéines est divisée par la qualité nutritive de la caséine et ensuite multipliée par le pourcentage de l’énergie utilisable provenant de la teneur en protéines;

f) toute portion de celui-ci contient chacune des vitamines et chacun des minéraux nutritifs énumérés dans la colonne I du tableau du présent article, en une quantité :

(i) sous réserve du paragraphe (3), non inférieure à la quantité minimale indiquée à la colonne II,

(ii) sous réserve des paragraphes (4) et (5), non supérieure, compte tenu du surtitrage, à la quantité maximale indiquée à la colonne III.

(2) Il est interdit de vendre ou d’annoncer un substitut de repas présenté comme étant le substitut de tous les repas de la journée, à moins que, dans son état prêt à servir ou une fois préparé, selon le mode d’emploi, avec de l’eau, du lait, du lait partiellement écrémé, du lait écrémé ou une combinaison de ces produits, il ne réponde aux exigences suivantes :

a) au plus 30 pour cent de l’énergie utilisable provient de sa teneur en lipides;

b) au plus 10 pour cent de l’énergie utilisable provient de sa teneur en acides gras saturés.

(3) Le substitut de repas qui n’est pas présenté comme étant le substitut de tous les repas de la journée est soustrait à l’application du sous-alinéa (1)f)(i) quant à la quantité minimale de sélénium, de chrome ou de molybdène, s’il ne contient aucune quantité ajoutée de ce minéral nutritif.

(4) Il est fait abstraction, pour l’application du sous-alinéa (1)f)(ii), des vitamines et des minéraux nutritifs qui ne sont pas des ingrédients ajoutés dans le substitut de repas.

(5) La quantité maximale de vitamine C indiquée à la colonne III du tableau du présent article n’inclut pas le surtitrage.

TABLEAU

COLONNE I COLONNE II COLONNE III Éléments nutritifs Quantité minimale par portion Quantité maximale par portion VITAMINES

COLONNE I COLONNE II COLONNE III Éléments nutritifs Quantité minimale par portion Quantité maximale par portion Vitamine A 250 ER 630 ER Vitamine D 1,25 µg 2,50 µg Vitamine E 2,5 mg 5,0 mg Vitamine C 10 mg 20 mg Thiamine 300 µg 750 µg Riboflavine 400 µg 800 µg Niacine 6 EN 12 EN Vitamine B6 400 µg 750 µg Vitamine B12 0,25 µg 0,75 µg Folacine 60 µg 120 µg Acide pantothénique 1,25 mg 2,50 mg Biotine 25 µg 75 µg MINÉRAUX NUTRITIFS Calcium 200 mg 400 mg Phosphore 250 mg 500 mg Fer 2,5 mg 5,0 mg Iode 40 µg 120 µg Magnésium 60 mg 120 mg Cuivre 0,5 mg 1,0 mg Zinc 3 mg 6 mg Potassium 375 mg Sodium 250 mg Manganèse 1 mg 2 mg Sélénium 10 µg 20 µg Chrome 10 µg 20 µg Molybdène 20 µg 40 µg

DORS/78-698, art. 9; DORS/80-13, art. 14; DORS/95-474, art. 5.

B.24.201. (1) Il est interdit de vendre ou d’annoncer un supplément nutritif qui contient moins de 225 Kcal ou 945 kJ par portion, à moins qu’il ne réponde aux exigences suivantes :

a) il contient au moins 150 Kcal ou 630 kJ par portion;

b) au moins 15 pour cent et au plus 40 pour cent de l’énergie utilisable provient de sa teneur en protéines;

c) les protéines qu’il contient sont :

(i) soit d’une qualité nutritive équivalente à celle de la caséine,

(ii) soit de qualité nutritive et en quantité suffisantes pour donner un résultat d’au moins 15 pour cent lorsque la qualité nutritive de ces protéines est divisée par la qualité nutritive de la caséine et ensuite multipliée par le pourcentage de l’énergie utilisable provenant de sa teneur en protéines;

d) il contient, par 100 Kcal ou 420 kJ, chacune des vitamines et chacun des minéraux nutritifs énumérés dans la colonne I du tableau du présent article, en une quantité :

(i) sous réserve du paragraphe (3), non inférieure à la quantité minimale indiquée à la colonne II,

(ii) sous réserve des paragraphes (4) et (5), non supérieure, compte tenu du surtitrage, à la quantité maximale indiquée à la colonne III.

(2) Il est interdit de vendre ou d’annoncer un supplément nutritif qui procure 225 Kcal ou 945 kJ ou plus par portion, à moins que, dans son état prêt à servir ou une fois préparé, selon le mode d’emploi, avec de l’eau, du lait, du lait partiellement écrémé, du lait écrémé ou une combinaison de ces produits, il ne réponde aux exigences suivantes :

a) il procure au moins 225 Kcal ou 945 kJ par portion;

b) au plus 35 pour cent de l’énergie utilisable provient de sa teneur en lipides;

c) au moins 3,0 pour cent de l’énergie utilisable provient de l’acide linoléique sous forme de glycéride et au moins 0,5 pour cent de l’énergie utilisable provient de l’acide linolénique n-3 sous forme de glycéride, et le rapport entre l’acide linoléique et l’acide linolénique n-3 est d’au moins 4 à 1 et d’au plus 10 à 1;

d) au moins 15 pour cent et au plus 40 pour cent de l’énergie utilisable provient de sa teneur en protéines;

e) les protéines qu’il contient sont :

(i) soit d’une qualité nutritive équivalente à celle de la caséine,

(ii) soit de qualité nutritive et en quantité suffisantes pour donner un résultat d’au moins 15 pour cent lorsque la qualité nutritive de ces protéines est divisée par la qualité nutritive de la caséine et ensuite multipliée par le pourcentage de l’énergie utilisable provenant de sa teneur en protéines;

f) il contient, par 100 Kcal ou 420 kJ, chacune des vitamines et chacun des minéraux nutritifs énumérés dans la colonne I du tableau du présent article, en une quantité :

(i) sous réserve du paragraphe (3), non inférieure à la quantité minimale indiquée à la colonne II,

(ii) sous réserve des paragraphes (4) et (5), non supérieure, compte tenu du surtitrage, à la quantité maximale indiquée à la colonne III.

(3) Est soustrait à l’application des sous-alinéas (1)d)(i) et (2)f)(i) quant à la quantité minimale de sélénium, de chrome ou de molybdène, le supplément nutritif qui ne contient aucune quantité ajoutée de ce minéral nutritif.

(4) Il est fait abstraction, pour l’application des sous-alinéas (1)d)(ii) et (2)f)(ii), des vitamines et des minéraux nutritifs qui ne sont pas des ingrédients ajoutés dans le supplément nutritif.

(5) La quantité maximale de vitamine C indiquée à la colonne III du tableau du présent article n’inclut pas le surtitrage.

TABLEAU

COLONNE I COLONNE II COLONNE III Éléments Quantité minimale par 100 Kcal ou Quantité maximale par 100 Kcal nutritifs 420 kJ utilisables ou 420 kJ utilisables VITAMINES Vitamine A 100 ER 250 ER Vitamine D 0,25 µg 1 µg Vitamine E 1,0 mg 2,0 mg Vitamine C 5 mg 10 mg Thiamine 140 µg 350 µg Riboflavine 180 µg 360 µg Niacine 3 EN 6 EN Vitamine B6 180 µg 350 µg Vitamine B12 0,1 µg 0,3 µg Folacine 30 µg 60 µg Acide 0,6 mg 1,2 mgpantothénique Biotine 12 µg 35 µg MINÉRAUX NUTRITIFS Calcium 100 mg 175 mg Phosphore 100 mg 175 mg Fer 1,0 mg 2,0 mg Iode 15 µg 45 µg Magnésium 20 mg 40 mg Cuivre 0,15 mg 0,30 mg Zinc 1,4 mg 2,0 mg Potassium 175 mg Manganèse 0,45 mg 0,90 mg Sélénium 4 µg 8 µg Chrome 4 µg 8 µg

COLONNE I COLONNE II COLONNE III Éléments Quantité minimale par 100 Kcal ou Quantité maximale par 100 Kcal nutritifs 420 kJ utilisables ou 420 kJ utilisables Molybdène 8 µg 15 µg

DORS/78-698, art. 9; DORS/95-474, art. 5.

B.24.202. L’étiquette d’un substitut de repas ou d’un supplément nutritif doit porter :

a) les renseignements suivants, par portion déterminée et par quantité spécifiée de l’aliment lorsque celui-ci est préparé selon le mode d’emploi :

(i) la valeur énergétique de l’aliment, exprimée en Calories (Calories ou Cal) et en kilojoules (kilojoules ou kJ),

(ii) sa teneur en protéines, en matières grasses, en acide linoléique, en acide linolénique n-3, en acides gras saturés et en glucides, exprimée en grammes,

(iii) sa teneur en vitamine A, en vitamine D, en vitamine E, en vitamine C, en thiamine ou vitamine B1, en riboflavine ou vitamine B2, en niacine, en vitamine B6, en vitamine B12, en folacine et en acide pantothénique ou pantothénate, exprimée, dans le cas du substitut de repas, en pourcentage de l’apport quotidien recommandé qui est indiqué à la colonne II du tableau du titre 1 de la partie D et, dans le cas du supplément nutritif, en équivalents de rétinol (ER) pour la vitamine A, en équivalents de niacine (EN) pour la niacine et en milligrammes pour la vitamine D, la vitamine E, la vitamine C, la thiamine ou vitamine B1, la riboflavine ou vitamine B2, la vitamine B6, la vitamine B12, la folacine et l’acide pantothénique ou pantothénate,

(iv) sa teneur en calcium, en phosphore, en fer, en iode, en magnésium et en zinc, exprimée, dans le cas du substitut de repas, en pourcentage de l’apport quotidien recommandé qui est indiqué à la colonne II du tableau du titre 2 de la partie D et, dans le cas du supplément nutritif, en milligrammes,

(v) sa teneur en biotine, en cuivre, en potassium, en sodium, en manganèse, en sélénium, en chrome et en molybdène, exprimée en milligrammes;

b) dans le cas du substitut de repas ou du supplément nutritif auquel il faut ajouter du lait, du lait partiellement écrémé ou du lait écrémé, une mention indiquant que la teneur nutritive de l’aliment a été établie compte tenu du lait, du lait partiellement écrémé ou du lait écrémé qui sera ajouté selon le mode d’emploi;

c) dans le cas du substitut de repas vendu ou annoncé comme étant le substitut de tous les repas de la journée dans un régime amaigrissant, le mode d’emploi qui assurera au consommateur un apport énergétique quotidien d’au moins 900 Kcal ou 3 780 kJ;

d) la date limite d’utilisation du substitut de repas ou du supplément nutritif;

e) dans le cas du substitut de repas pour régimes amaigrissants, la mention « UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À

TENEUR RÉDUITE EN ÉNERGIE / USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET », inscrite bien en évidence dans l’espace principal de l’étiquette;

f) dans le cas du substitut de repas pour régimes amaigrissants qui n’est pas présenté comme étant le substitut de tous les repas de la journée, les renseignements requis à l’article B.24.204.

DORS/78-698, art. 9; DORS/88-559, art. 28; DORS/95-474, art. 5.

B.24.203. L’étiquette d’un repas préemballé pour régimes amaigrissants ou d’un aliment destiné à être vendu dans une clinique d’amaigrissement doit porter :

a) [Abrogé, DORS/2003-11, art. 24]

b) la mention « UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE / USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET », inscrite bien en évidence dans l’espace principal de l’étiquette;

c) les renseignements requis à l’article B.24.204.

DORS/78-698, art. 9; DORS/88-559, art. 29; DORS/95-474, art. 5; DORS/2003-11, art. 24.

B.24.204. L’étiquette du repas préemballé ou du substitut de repas, autre que le substitut de repas présenté comme étant le substitut de tous les repas de la journée, qui sont emballés, vendus ou annoncés comme étant pour des régimes amaigrissants, ou l’étiquette d’un aliment destiné à être vendu dans une clinique d’amaigrissement, doit comprendre dans le mode d’emploi un menu type de sept jours dans lequel figure le repas préemballé, le substitut de repas ou l’aliment et qui répond aux exigences suivantes :

a) chaque repas quotidien comprend au moins une portion, selon la description qui en est donnée dans la publication intitulée Guide alimentaire canadien pour manger sainement, autorisée par le ministre de la Santé nationale et du Bien-être social et publiée en 1992 par le ministère des Approvisionnements et Services, d’un aliment de chacun des groupes suivants :

(i) lait, produits du lait ou leurs substituts,

(ii) viande et substituts de viande,

(iii) pain et produits céréaliers,

(iv) légumes et fruits;

b) l’apport énergétique quotidien n’est pas inférieur à 1 200 Kcal ou 5 040 kJ;

c) au plus 30 pour cent de l’apport énergétique quotidien total provient de sa teneur en lipides et au plus 10 pour cent de l’apport énergétique quotidien total provient de sa teneur en acides gras saturés;

d) l’apport quotidien moyen de chacun des éléments nutritifs énumérés dans la colonne I du tableau du présent article n’est pas inférieur à la quantité indiquée à la colonne II, dans le cas d’un menu recommandé pour les hommes, ou à celle indiquée à la colonne III, dans le cas d’un menu recommandé pour les femmes;

e) le menu ne mentionne aucun supplément de vitamines ou de minéraux nutritifs.

TABLEAU

COLONNE I COLONNE II COLONNE III INGESTION QUOTIDIENNE MOYENNE

ÉLÉMENTS NUTRITIFS HOMMES FEMMES Protéines 65 g 55 g VITAMINES Vitamine A 1000 ER 800 ER Vitamine D 5 µg 5 µg Vitamine E 10 mg 7 mg Vitamine C 40 mg 30 mg Thiamine 1 mg 1 mg Riboflavine 1 mg 1 mg Niacine 14 EN 14 EN Vitamine B6 1,5 mg 1,5 mg Vitamine B12 1 µg 1 µg Folacine 230 µg 200 µg Acide pantothénique 5 mg 5 mg MINÉRAUX NUTRITIFS Calcium 800 mg 800 mg Phosphore 1000 mg 850 mg Fer 9 mg 13 mg Iode 160 µg 160 µg Magnésium 250 mg 210 mg Cuivre 2 mg 2 mg Zinc 12 mg 9 mg

DORS/78-698, art. 9; DORS/95-474, art. 5.

B.24.205. (1) Il est interdit d’étiqueter, d’emballer, de vendre ou d’annoncer un repas préemballé ou un substitut de repas pour régimes amaigrissants ou un aliment destiné à être vendu dans une clinique d’amaigrissement, de manière à donner l’impression que la consommation d’un supplément de vitamines ou de minéraux nutritifs doit faire partie des régimes amaigrissants.

(2) Il est interdit de mentionner, directement ou indirectement, un supplément de vitamines ou de minéraux nutritifs sur l’étiquette ou dans la publicité d’un repas

préemballé ou d’un substitut de repas pour régimes amaigrissants ou d’un aliment destiné à être vendu dans une clinique d’amaigrissement.

(3) Quiconque annonce un repas préemballé ou un substitut de repas pour régimes amaigrissants ou un aliment destiné à être vendu dans une clinique d’amaigrissement doit inclure dans la publicité la mention « UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE / USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET ».

DORS/78-698, art. 9; DORS/95-474, art. 5.

Aliments présentés comme étant conçus pour régimes à très faible teneur en énergie

B.24.300. Il est interdit d’annoncer au grand public un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie.

DORS/94-35, art. 4.

B.24.301. (1) Il est interdit de vendre un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie sans ordre écrit du médecin.

(2) Malgré le paragraphe (1), un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie peut être vendu, sans ordre écrit du médecin :

a) aux médecins;

b) aux grossistes en médicaments;

c) aux pharmaciens;

d) aux hôpitaux.

(3) Seuls les pharmaciens peuvent vendre au grand public un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie.

DORS/94-35, art. 4.

B.24.302. Le pharmacien doit conserver pendant au moins deux ans après la date d’exécution l’ordre écrit d’un médecin visant un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie.

DORS/94-35, art. 4.

B.24.303. (1) Un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie, qu’il soit prêt à servir ou dilué avec de l’eau selon les indications du fabricant, doit, par ration quotidienne recommandée par le fabricant :

a) fournir :

(i) soit au moins 60 g de protéines d’une qualité nutritive équivalente à celle de la caséine,

(ii) soit des protéines en une quantité et d’une qualité telles que, lorsque cette qualité est exprimée en fraction de la qualité de la caséine :

(A) cette fraction ne soit pas inférieure à 85/100,

(B) le produit de la fraction par le poids en grammes de la protéine ne soit pas inférieur à 60;

b) renfermer les vitamines et les minéraux nutritifs mentionnés dans la colonne I du tableau du présent paragraphe, en une quantité au moins égale à la quantité minimale par jour indiquée à la colonne II;

c) contenir toute substance nutritive, sauf celles mentionnées aux alinéas a) et b), en une quantité suffisante pour l’usage préconisé de la substance dans l’aliment, selon des essais cliniques.

TABLEAU

Colonne I Colonne II Article Vitamines et minéraux nutritifs Quantité minimale par jour 1. Thiamine 1,3 mg 2. Riboflavine 1,6 mg 3. Niacine 23 mg 4. Folacine 0,22 mg 5. Biotine 0,15 mg 6. Acide pantothénique 7,0 mg 7. Vitamine B6 1,5 mg 8. Vitamine B12 0,001 mg 9. Vitamine A 1000 ER 10. Vitamine D 0,005 mg 11. Vitamine E 10 mg 12. Vitamine C 40 mg 13. Calcium 800 mg 14. Phosphore 1000 mg 15. Magnésium 250 mg 16. Fer 13 mg 17. Iode 0,16 mg 18. Zinc 12 mg 19. Cuivre 2 mg 20. Manganèse 3,5 mg 21. Sélénium 0,07 mg

Colonne I Colonne II Article Vitamines et minéraux nutritifs Quantité minimale par jour 22. Chrome 0,05 mg 23. Molybdène 0,1 mg 24. Sodium 2000 mg 25. Potassium 3000 mg 26. Chlorure 1500 mg

(2) Malgré l’alinéa (1)a), tout aliment présenté comme étant conçu pour un régime à très faible teneur en énergie doit être accompagné d’un mode d’emploi qui, s’il est respecté, donnera un apport quotidien d’au moins 1,2 g de protéines par kilogramme de poids corporel cible.

DORS/94-35, art. 4.

B.24.304. L’étiquette d’un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie doit porter les renseignements suivants :

a) une mention de la valeur énergétique de l’aliment exprimée en Calories (Calories ou Cal) et en kilojoules (kilojoules ou kJ) par 100 g ou par 100 mL de l’aliment sous sa forme commerciale et par unité de l’aliment prêt à servir;

b) une mention de la teneur de l’aliment en protéines, en matières grasses, en glucides et, s’il y a lieu, en fibres, exprimée en grammes par 100 g ou par 100 mL de l’aliment sous sa forme commerciale et par unité de l’aliment prêt à servir;

c) une mention de la teneur de l’aliment en vitamines et en minéraux nutritifs mentionnés au tableau du paragraphe B.24.303(1) exprimée en milligrammes ou, dans le cas de la vitamine A, en équivalents de rétinol (ER), par 100 g ou par 100 mL de l’aliment sous sa forme commerciale et par unité de l’aliment prêt à servir;

d) une mention de la teneur de l’aliment en toute autre substance nutritive qui y est ajoutée selon la quantité prévue à l’alinéa B.24.303(1)c), exprimée en milligrammes ou en grammes par 100 g ou par 100 mL de l’aliment sous sa forme commerciale et par unité de l’aliment prêt à servir;

e) la mention « À UTILISER SEULEMENT SOUS SURVEILLANCE MÉDICALE » apposée bien en vue sur l’espace principal;

f) le mode d’emploi de l’aliment, y compris :

(i) un énoncé justificatif de l’emploi de l’aliment,

(ii) les critères de sélection des personnes auxquelles prescrire l’aliment,

(iii) les instructions pour la consultation, l’évaluation du patient et son suivi,

(iv) une mention concernant les précautions et les contre-indications voulues;

g) le mode de préparation de l’aliment, ainsi que les indications pour sa conservation avant et après l’ouverture du contenant;

h) la date limite d’utilisation de l’aliment.

DORS/94-35, art. 4.

B.24.305. (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie à moins que le fabricant n’ait donné au Directeur, au moins 90 jours avant la vente ou l’annonce, un avis écrit de son intention de vendre l’aliment ou de l’annoncer en vue de la vente.

(2) L’avis visé au paragraphe (1) est signé par le fabricant et contient, à l’égard de l’aliment présenté comme conçu pour un régime à très faible teneur en énergie, les renseignements suivants :

a) le nom sous lequel l’aliment sera vendu ou annoncé pour la vente;

b) les nom et adresse du principal établissement du fabricant;

c) les nom et adresse de chaque établissement où l’aliment est fabriqué;

d) la liste des ingrédients de l’aliment et la quantité de chacun d’eux;

e) les caractéristiques relatives à la qualité nutritive, microbiologique et physique des ingrédients et de l’aliment;

f) le détail des techniques de contrôle de la qualité appliquées aux essais des ingrédients et de l’aliment;

g) le détail du procédé de fabrication et des techniques de contrôle de la qualité appliquées au cours de la fabrication;

h) les résultats des essais effectués pour déterminer la date limite d’utilisation de l’aliment;

i) les preuves invoquées pour établir que l’aliment répond aux besoins nutritifs, autres que les besoins énergétiques, des personnes à qui il est destiné, lorsqu’il est consommé suivant le mode d’emploi;

j) une description du type d’emballage qui sera utilisé;

k) le mode d’emploi;

l) le texte des étiquettes, y compris les feuillets à insérer dans l’emballage, qui seront utilisées avec l’aliment;

m) les nom et titre du signataire de l’avis et la date de la signature.

(3) Malgré le paragraphe (1), il est permis de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie si le

Directeur, après avoir été avisé par le fabricant conformément à ce paragraphe, informe celui-ci par écrit que l’avis satisfait aux exigences visées au paragraphe (2).

DORS/94-35, art. 4.

B.24.306. (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur, à moins que le fabricant n’ait donné au Directeur, au moins 90 jours avant la vente ou l’annonce, un avis écrit de son intention de vendre cet aliment ou de l’annoncer en vue de la vente.

(2) L’avis visé au paragraphe (1) est signé par le fabricant et contient, à l’égard de l’aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur, les renseignements suivants :

a) le nom sous lequel l’aliment sera vendu ou annoncé en vue de la vente;

b) les nom et adresse du principal établissement du fabricant;

c) la description du changement majeur;

d) les preuves invoquées pour établir que l’aliment répond aux besoins nutritifs, autres que les besoins énergétiques, des personnes à qui il est destiné, lorsqu’il est consommé suivant le mode d’emploi;

e) les preuves invoquées pour établir que le changement majeur n’a pas d’effet indésirable sur l’aliment ou son utilisation;

f) le texte des étiquettes, y compris les feuillets à insérer dans l’emballage, qui seront utilisées avec l’aliment;

g) les nom et titre du signataire de l’avis et la date de la signature.

(3) Malgré le paragraphe (1), il est permis de vendre ou d’annoncer en vue de la vente un aliment présenté comme étant conçu pour un régime à très faible teneur en énergie qui a subi un changement majeur si le Directeur, après avoir été avisé par le fabricant conformément à ce paragraphe, a informé celui-ci par écrit que l’avis satisfait aux exigences visées au paragraphe (2).

DORS/94-35, art. 4.

Titre 25 Définitions

B.25.001. Dans le présent titre,

« aliment pour bébés » désigne un aliment présenté comme pouvant être consommé par des bébés; (infant food)

« bébé » désigne une personne de moins d’un an; (infant)

« changement majeur » désigne, dans le cas d’un succédané de lait humain, un changement d’ingrédient ou de la quantité d’un ingrédient, ou la modification du traitement ou de l’emballage du succédané de lait humain, qui pourrait, selon l’expérience du fabricant ou la théorie généralement admise, altérer les concentrations ou compromettre la disponibilité des éléments nutritifs du succédané de lait humain ou l’innocuité microbiologique ou chimique de celui-ci; (major change)

« date limite d’utilisation » s’entend, dans le cas d’un succédané de lait humain, de la date :

a) après laquelle le fabricant recommande de ne pas consommer le succédané de lait humain,

b) jusqu’à laquelle le succédané de lait humain conserve sa stabilité physique et microbiologique et la valeur nutritive indiquée sur l’étiquette; (expiration date)

« (nom d’un aliment) en purée ou tamisé » désigne l’aliment nommé qui est composé de particules d’une grosseur généralement uniforme et qui n’exige ni n’encourage la mastication avant d’être avalé par des bébés; (strained (naming a food))

« (nom d’un aliment) pour enfants en bas âge » désigne l’aliment nommé qui contient normalement des particules d’une grosseur encourageant la mastication, mais qui peut être facilement avalé par des bébés sans être mastiqué; (junior (naming a food))

« succédané de lait humain » désigne tout aliment présenté

a) comme un remplacement partiel ou total du lait humain et destiné à être consommé par des bébés, ou

b) comme pouvant être utilisé comme ingrédient d’un aliment visé à l’alinéa a); (human milk substitute)

« succédané de lait humain nouveau » désigne un succédané de lait humain :

a) soit qui est fabriqué pour la première fois,

b) soit qui est vendu au Canada pour la première fois,

c) soit qu’une personne fabrique pour la première fois. (new human milk substitute)

DORS/78-637, art. 5; DORS/83-933, art. 1; DORS/90-174, art. 1.

Aliments pour bébés

B.25.002. Est interdite la vente ou la publicité en vue de la vente d’un aliment pour bébés visé à la colonne I du tableau I du présent titre, si cet aliment contient plus que la quantité de sodium indiquée à la colonne II du tableau.

DORS/83-933, art. 1.

B.25.003. (1) Sous réserve du paragraphe (2), est interdite la vente des aliments pour bébés qui contiennent,

a) des fruits en purée,

b) des jus de fruit,

c) des boissons aux fruits, ou

d) des céréales

auxquels du chlorure de sodium a été ajouté.

(2) Le paragraphe (1) ne s’applique pas aux desserts en purée contenant un aliment visé aux alinéas (1)a) à d).

DORS/83-933, art. 1.

Succédanés de lait humain et aliments renfermant un succédané de lait humain

B.25.045. Le nom usuel d’un succédané de lait humain ou d’un succédané de lait humain nouveau est « préparation pour nourrissons ». (infant formula)

DORS/90-174, art. 2.

B.25.046. (1) Il est interdit de vendre ou d’annoncer pour la vente un succédané de lait humain nouveau, à moins que le fabricant n’ait donné au Directeur, au moins 90 jours avant la vente ou l’annonce de cet aliment, un avis écrit de son intention de vendre ou d’annoncer pour la vente le succédané de lait humain nouveau.

(2) L’avis visé au paragraphe (1) est signé et contient les renseignements suivants :

a) le nom sous lequel le succédané de lait humain nouveau sera vendu ou annoncé pour la vente;

b) le nom et l’adresse du principal établissement du fabricant;

c) les nom et adresse de chaque établissement où le succédané de lait humain nouveau est fabriqué;

d) la liste des ingrédients du succédané de lait humain nouveau et de la quantité de chacun d’eux;

e) les caractéristiques relatives à la qualité nutritionnelle, microbiologique et physique des ingrédients et du succédané de lait humain nouveau;

f) le détail des techniques de contrôle de la qualité appliquées à l’examen des ingrédients et du succédané de lait humain nouveau;

g) le détail du procédé de fabrication et des techniques de contrôle de la qualité appliquées au cours de la fabrication du succédané de lait humain nouveau;

h) les résultats des examens effectués pour déterminer la date limite d’utilisation du succédané de lait humain nouveau;

i) les preuves établissant que le succédané de lait humain nouveau a une valeur nutritive suffisante pour favoriser une croissance et un développement acceptables chez les bébés s’il est consommé conformément au mode d’emploi;

j) une description du type d’emballage qui sera utilisé pour le succédané de lait humain nouveau;

k) le mode d’emploi du succédané de lait humain nouveau;

l) le texte écrit des étiquettes, y compris les feuillets insérés dans l’emballage, qui seront utilisées pour le succédané de lait humain nouveau;

m) le nom et le titre du signataire de l’avis et la date de la signature.

(3) Nonobstant le paragraphe (1), il est permis de vendre ou d’annoncer pour la vente un succédané de lait humain nouveau si le fabricant en a avisé le Directeur conformément au paragraphe (1) et que celui-ci l’a informé par écrit que l’avis est satisfaisant.

DORS/90-174, art. 2.

B.25.047. Les succédanés de lait humain nouveaux sont assujettis aux exigences des articles B.25.051 à B.25.059.

DORS/90-174, art. 2; DORS/2003-11, art. 25.

B.25.048. (1) Il est interdit de vendre ou d’annoncer pour la vente un succédané de lait humain qui a fait l’objet d’un changement majeur, à moins que le fabricant n’ait donné au Directeur, au moins 90 jours avant la vente ou l’annonce de cet aliment, un avis écrit de son intention de vendre ou d’annoncer pour la vente le succédané de lait humain.

(2) L’avis visé au paragraphe (1) est signé et contient les renseignements suivants :

a) le nom sous lequel le succédané de lait humain sera vendu ou annoncé pour la vente;

b) le nom et l’adresse du principal établissement du fabricant;

c) une description du changement majeur;

d) la preuve établissant que le succédané de lait humain a une valeur nutritive suffisante pour favoriser une croissance et un développement acceptables chez les bébés s’il est consommé conformément au mode d’emploi;

e) la preuve établissant que le changement majeur n’a pas eu d’effet préjudiciable sur le succédané de lait humain;

f) le texte écrit des étiquettes, y compris les feuillets insérés dans l’emballage, qui seront utilisées pour le succédané de lait humain;

g) le nom et le titre du signataire de l’avis et la date de la signature.

(3) Nonobstant le paragraphe (1), il est permis de vendre ou d’annoncer pour la vente un succédané de lait humain qui a fait l’objet d’un changement majeur si le fabricant en a avisé le Directeur conformément au paragraphe (1) et que celui-ci l’a informé par écrit que l’avis est satisfaisant.

DORS/90-174, art. 2.

B.25.050. [Abrogé, DORS/90-174, art. 2]

B.25.051. (1) Est interdite la vente ou la publicité en vue de la vente d’un succédané de lait humain, à moins que celui-ci, préparé selon le mode d’emploi, ne soit conforme aux dispositions du présent titre concernant les succédanés de lait humain.

(2) Est interdite la vente ou la publicité en vue de la vente d’un aliment présenté comme contenant un succédané de lait humain, à moins que la portion de succédané de lait humain contenue dans l’aliment ne respecte les exigences en matière de nutrition établies dans le présent titre pour les succédanés de lait humain.

DORS/83-933, art. 1.

B.25.052. (1) Est interdite la vente ou la publicité en vue de la vente d’un succédané de lait humain, à moins que celui-ci ne réponde aux besoins nutritionnels normaux ou particuliers des bébés et qu’il ne soit d’une consistance telle que, lorsqu’il est prêt à servir, il coule librement à travers la tétine d’un biberon.

(2) Est interdite la vente ou la publicité en vue de la vente d’un aliment présenté comme contenant un succédané de lait humain, à moins que la portion de succédané de lait humain contenue dans l’aliment ne réponde aux besoins nutritionnels normaux ou particuliers des bébés.

DORS/78-637, art. 6; DORS/82-768, art. 76; DORS/83-933, art. 1.

B.25.053. (1) Est interdite la vente ou la publicité en vue de la vente d’un succédané de lait humain qui, lorsqu’il est préparé selon le mode d’emploi, exige l’addition d’une substance nutritive autre que de l’eau, ou d’une source de glucides, ou des deux.

(2) Est interdite la vente ou la publicité en vue de la vente d’un aliment présenté comme contenant un succédané de lait humain qui exige, lorsqu’il est préparé selon le mode d’emploi, l’addition d’une substance nutritive autre que l’eau.

DORS/78-637, art. 7; DORS/83-933, art. 1.

B.25.054. (1) Sauf les exceptions prévues dans le présent titre, est interdite la vente ou la publicité en vue de la vente d’un succédané de lait humain, à moins que celui-ci, préparé selon le mode d’emploi, ne contienne :

a) pour 100 kilocalories utilisables,

(i) au moins 3,3 et au plus 6 grammes de lipides,

(ii) au moins 500 milligrammes d’acide linoléique sous forme de glycéride,

(iii) au plus un kilocalorie provenant d’acides gras monoénoïques en C22,

(iv) au moins 1,8 et au plus 4 grammes de protéines,

(v) au moins 1,8 gramme de protéines d’une qualité nutritive équivalente à celle de la caséine, ou des protéines, y compris les protéines auxquelles des acides aminés sont ajoutés, en quantité et de qualité telles que, lorsque la qualité de la protéine est exprimée en fraction de celle de la caséine,

(A) la fraction n’est pas inférieure à 85/100, et

(B) le produit de la multiplication de la fraction par le poids en gramme de protéine n’est pas inférieur à 1,8,

(vi) nonobstant les articles D.01.010, D.01.011 et D.02.009, les vitamines et minéraux nutritifs visés à la colonne I du tableau II du présent titre, en quantité non inférieure à la quantité indiquée dans la colonne II du tableau et non supérieure à la quantité indiquée dans la colonne III du tableau, et

(vii) au moins 12 milligrammes de choline; et

b) les rapports suivants :

(i) au moins 0,6 unité internationale d’alphatocophérol par gramme d’acide linoléique,

(ii) au moins 1,2 gramme et au plus 2 grammes de calcium par gramme de phosphore, et

(iii) au moins 15 microgrammes de vitamine B6 par gramme de protéines.

(2) Est interdite la vente ou la publicité en vue de la vente d’un aliment présenté comme contenant un succédané de lait humain, à moins que la portion de succédané de lait humain contenue dans l’aliment ne respecte les dispositions du paragraphe (1).

DORS/78-637, art. 7; DORS/83-933, art. 1.

B.25.055. (1) Le sous-alinéa B.25.054(1)a)(i) ne s’applique pas au succédané de lait humain présenté comme étant utilisable dans un régime à teneur modifiée en lipides.

(2) Le sous-alinéa B.25.054(1)a)(iv), à l’exception de la partie qui prescrit la quantité maximale de protéines, ainsi que le sous-alinéa B.25.054(1)a)(v) ne s’appliquent pas à un succédané de lait humain présenté comme étant destiné à un régime pauvre en (nom de l’acide aminé).

(3) La partie du sous-alinéa B.25.054(1)a)(vi) qui prescrit les quantités minimales de vitamine D, de calcium et de phosphore, ainsi que le sous-alinéa B.25.054(1)b)(ii), ne

s’appliquent pas à un succédané de lait humain présenté comme étant destiné à un régime pauvre en (nom du minéral) ou en vitamine D, ou les deux.

DORS/83-933, art. 1.

B.25.056. Est interdite la vente d’un succédané de lait humain ou d’un aliment présenté comme contenant un succédané de lait humain

a) auquel on a ajouté une substance nutritive

(i) que l’on retrouve normalement dans le lait humain, et

(ii) qui n’est pas mentionnée à l’alinéa B.25.054(1)a),

sauf si la quantité de cette substance présente dans 100 kilocalories utilisables du succédané de lait humain ou dans la portion de succédané de lait humain contenue dans l’aliment, préparé selon le mode d’emploi, est égale à la quantité de ladite substance présente dans 100 kilocalories utilisables de lait humain; ou

b) auquel on a ajouté des acides aminés, sauf

(i) si ces acides aminés sont nécessaires pour améliorer la qualité de la fraction protéinique du succédané de lait humain ou de la portion de succédané de lait humain contenue dans l’aliment et n’excèdent pas la quantité requise pour cette amélioration, ou

(ii) si la fraction protéinique du succédané de lait humain ou de la portion de succédané de lait humain contenue dans l’aliment est constituée d’acides aminés isolés ou d’un hydrolysat de protéines ou les deux, et

si seulement des acides aminés de forme L ont été ajoutés.

DORS/78-637, art. 8; DORS/83-933, art. 1.

B.25.057. (1) L’étiquette d’un succédané de lait humain doit comporter les renseignements suivants :

a) une déclaration de la teneur en protéines, en matières grasses, en glucides disponibles, en cendres et, s’il y a lieu, en fibres brutes :

(i) en grammes par 100 grammes ou en grammes par 100 millilitres de succédané de lait humain sous sa forme commerciale, et

(ii) en grammes pour une quantité spécifiée de succédané de lait humain, prêt à servir;

b) une déclaration de la valeur énergétique

(i) en calories par 100 grammes ou en calories par 100 millilitres de succédané de lait humain sous sa forme commerciale, et

(ii) en calories pour une quantité spécifiée de succédané de lait humain, prêt à servir;

c) une déclaration de la quantité de toutes les vitamines et de tous les minéraux nutritifs énumérés au tableau II du présent titre

(i) en unités internationales ou en milligrammes par 100 grammes, ou en unités internationales ou en milligrammes par 100 millilitres de succédané de lait humain sous sa forme commerciale, et

(ii) en unités internationales ou en milligrammes pour une quantité spécifiée de succédané de lait humain, prêt à servir;

d) une déclaration de la quantité de choline et de la quantité de toute substance nutritive ajoutée et normalement contenue dans le lait humain mais non visée à l’alinéa B.25.054(1)a),

(i) en milligrammes ou en grammes par 100 grammes, ou en milligrammes ou en grammes par 100 millilitres du succédané de lait humain sous sa forme commerciale, et

(ii) en milligrammes ou en grammes pour une quantité spécifiée de succédané de lait humain, prêt à servir;

e) les instructions appropriées pour la préparation, l’utilisation et la conservation du succédané de lait humain une fois le contenant ouvert; et

f) la date limite d’utilisation du succédané de lait humain.

(2) L’étiquette d’un aliment présenté comme contenant un succédané de lait humain doit fournir les renseignements suivants :

a) une déclaration, dans l’espace principal, de la proportion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale, inscrite le plus près possible de toute déclaration concernant la présence d’un succédané de lait humain dans l’aliment, et d’une manière aussi évidente que cette déclaration;

b) dans la liste d’ingrédients du produit le nom usuel du succédané de lait humain, suivi d’une liste de tous les ingrédients contenus dans le succédané de lait humain;

c) une déclaration

(i) de la teneur en protéines, en matières grasses, en glucides disponibles, en cendres et, s’il y a lieu, en fibres brutes de la portion de succédané de lait humain que contient l’aliment, exprimée en grammes par 100 grammes ou par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale,

(ii) de la valeur énergétique de la portion de succédané de lait humain contenue dans l’aliment, exprimée en calories par 100 grammes ou en calories par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale,

(iii) de la quantité de toutes les vitamines et de tous les minéraux nutritifs indiqués au tableau II du présent titre et contenue dans la portion de succédané de lait humain que renferme l’aliment, exprimée en unités internationales ou en milligrammes par

100 grammes, ou en unités internationales ou en milligrammes par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciales, et

(iv) de la quantité de choline et de la quantité de toute substance nutritive ajoutée et normalement contenue dans le lait humain mais non visée à l’alinéa B.25.054(1)a) contenues dans la portion de succédané de lait humain que renferme l’aliment, exprimées en milligrammes ou en grammes par 100 grammes, ou en milligrammes ou en grammes par 100 millilitres de la portion de succédané de lait humain contenue dans l’aliment sous sa forme commerciale;

d) une déclaration

(i) de la teneur en protéines, en matières grasses, en glucides disponibles, en cendres et, s’il y a lieu, en fibres brutes, exprimée en grammes par 100 grammes ou par 100 millilitres d’aliment sous sa forme commerciale et en grammes par quantité spécifiée de l’aliment prêt à servir,

(ii) de la valeur énergétique, exprimée en calories par 100 grammes ou en calories par 100 millilitres d’aliment sous sa forme commerciale et en grammes pour une quantité spécifiée de l’aliment prêt à servir,

(iii) de la quantité de toutes les vitamines et de tous les minéraux nutritifs indiqués au tableau II du présent titre, exprimée en unités internationales ou en milligrammes par 100 grammes, ou en unités internationales ou en milligrammes par 100 millilitres d’aliment sous sa forme commerciale, et en unités internationales ou en milligrammes pour une quantité spécifiée de l’aliment prêt à servir, et

(iv) de la quantité de choline et de la quantité de toute substance nutritive ajoutée et normalement contenue dans le lait humain mais non visée à l’alinéa B.25.054(1)a), exprimées en milligrammes ou en grammes par 100 grammes, ou en milligrammes ou en grammes par 100 millilitres d’aliment sous sa forme commerciale, et en milligrammes ou en grammes pour une quantité spécifiée de l’aliment prêt à servir;

e) les instructions appropriées pour la préparation, l’utilisation et la conservation de l’aliment une fois le contenant ouvert; et

f) la date limite d’utilisation de l’aliment.

DORS/83-933, art. 1; DORS/88-559, art. 30.

B.25.058. Nonobstant l’article D.02.005, est interdite toute allégation relative à la teneur en fer d’un succédané de lait humain, sauf de la façon prescrite à l’alinéa B.25.057(1)c), à moins que le succédané de lait humain ne contienne au moins un milligramme de fer par 100 kilocalories utilisables.

DORS/78-637, art. 9(F); DORS/83-933, art. 1.

B.25.059. Est interdite, sur l’étiquette ou dans l’annonce d’un succédané de lait humain ou d’un aliment présenté comme contenant un succédané de lait humain, toute mention ou allégation relative à son contenu portant :

a) soit sur le pourcentage de la valeur quotidienne :

(i) de lipides,

(ii) d’acides gras saturés et d’acides gras trans,

(iii) de sodium,

(iv) de potassium,

(v) de glucides,

(vi) de fibres,

(vii) de cholestérol;

b) soit sur le nombre de Calories provenant :

(i) des lipides,

(ii) des acides gras saturés et des acides gras trans.

DORS/2003-11, art. 26.

B.25.060. (1) Lorsque le Directeur demande par écrit au fabricant de succédané de lait humain ou d’aliment présenté comme contenant ce succédané de fournir dans un délai précis des preuves concernant le succédané de lait humain, le fabricant, s’il n’a pas répondu à la demande dans le délai fixé, doit cesser, après l’expiration du délai, de vendre ce succédané ou cet aliment.

(2) Si le Directeur estime que les preuves présentées par le fabricant en vertu du paragraphe (1) sont insuffisantes, il en avise le fabricant par écrit.

(3) Lorsque le fabricant reçoit, en application du paragraphe (2), un avis portant que les preuves concernant le succédané de lait humain sont insuffisantes, il doit cesser la vente de ce succédané de lait humain ou des aliments présentés comme contenant ce succédané de lait humain jusqu’à ce qu’il ait présenté des preuves supplémentaires et que le Directeur l’ait avisé que ces preuves sont suffisantes.

(4) Pour l’application du présent article, « preuves concernant le succédané de lait humain » désigne :

a) d’une part, la preuve établissant que le succédané de lait humain a une valeur nutritive suffisante pour favoriser une croissance et un développement acceptables chez les bébés s’il est consommé conformément au mode d’emploi;

b) d’autre part, les résultats des examens effectués pour déterminer la date limite d’utilisation du succédané de lait humain.

DORS/83-933, art. 1; DORS/88-424, art. 2; DORS/90-174, art. 3.

B.25.061. (1) Sous réserve du paragraphe (2), est interdite l’inscription, sur l’étiquette d’un aliment, de toute indication concernant la consommation de l’aliment par un bébé âgé de moins de six mois.

(2) Le paragraphe (1) ne s’applique pas aux succédanés de lait humain et aux succédanés de lait humain nouveaux.

DORS/83-933, art. 1; DORS/90-174, art. 4.

B.25.062. (1) Sous réserve du paragraphe (2), est interdite la vente d’un aliment étiqueté et annoncé comme pouvant être consommé par des bébés, si ledit aliment contient un additif alimentaire.

(2) Le paragraphe (1) ne s’applique pas

a) aux produits de boulangerie étiquetés ou annoncés comme pouvant être consommés par des bébés;

b) à l’acide ascorbique utilisé dans les aliments ci-après qui sont étiquetés ou annoncés comme pouvant être consommés par des bébés :

(i) fruits en purée,

(ii) céréales contenant des bananes;

c) à la lécithine de soya utilisée dans les céréales de riz étiquetées ou annoncées comme pouvant être consommées par des bébés;

d) à l’acide citrique utilisé dans les aliments étiquetés ou annoncés comme pouvant être consommés par des bébés;

e) aux préparations pour nourrissons qui contiennent les additifs alimentaires figurant aux tableaux IV et X de l’article B.16.100 pour utilisation dans les préparations pour nourrissons;

f) aux préparations pour nourrissons qui contiennent des ingrédients fabriqués avec des additifs alimentaires figurant au tableau V de l’article B.16.100;

g) aux préparations pour nourrissons qui contiennent des produits de petit-lait concentré ou séché fabriqués avec du petit-lait liquide auquel de l’hexamétaphosphate de sodium a été ajouté;

h) aux produits céréaliers pour bébés qui contiennent de l’amylase conformément au tableau V de l’article B.16.100;

i) aux préparations pour nourrissons qui contiennent du palmitate d’ascorbyle ou des tocophérols;

j) aux préparations pour nourrissons qui contiennent des huiles dans lesquelles du palmitate d’ascorbyle ou des tocophérols ont été ajoutés.

DORS/83-933, art. 1; DORS/90-24, art. 4; DORS/91-149, art. 6; DORS/97-559, art. 1; DORS/2010-40, art. 3; DORS/2010-41, art. 8; DORS/2010-94, art. 6; DORS/2010-141, art. 3.

TABLEAU I

TENEUR EN SODIUM DES ALIMENTS POUR BÉBÉS

Colonne I Colonne II Sodium total en

Aliments grammes par 100 g de l’aliment

1. Desserts pour enfants en bas âge ....... 0,10 Viandes pour enfants en bas âge, repas de viande pour enfants

2. en bas âge, repas pour enfants en bas âge, petits déjeuners 0,25 pour enfants en bas âge .......

3. Légumes pour enfants en bas âge, soupes pour enfants en bas 0,20âge ....... 4. Desserts en purée ....... 0,05

5. Viandes en purée, repas de viande en purée, repas en purée, 0,15petits déjeuners en purée ....... 6. Légumes en purée, soupes tamisées ....... 0,10

DORS/78-637, art. 10; DORS/83-933, art. 1.

TABLEAU II

Colonne I Colonne II Colonne III

Article Vitamine ou minéral Quantité minimale par 100 Quantité maximale par 100nutritif kilocalories utilisables kilocalories utilisables B.1 Biotine 2 mcg — F.1 Acide folique 4 mcg — N.1 Niacine 250 mcg —

Acide d­P.1 300 mcg —pantothénique R.1 Riboflavine 60 mcg — T.1 Thiamine 40 mcg — T.2 Alpha-tocophérol 0,6 U.I — V.1 Vitamine A 250 U.I. 500 U.I.

Colonne I Colonne II Colonne III

Article Vitamine ou minéral Quantité minimale par 100 Quantité maximale par 100nutritif kilocalories utilisables kilocalories utilisables V.2 Vitamine B6 35 mcg — V.3 Vitamine B12 0,15 mcg — V.4 Vitamine C 8 mg — V.5 Vitamine D 40 U.I. 80 U.I. V.6 Vitamine K1 8 mcg — C.1 Calcium 50 mg — C.2 Chlorure 55 mg 150 mg C.3 Cuivre 60 mcg — L.1 Iode 5 mcg — L.2 Fer 0,15 mg — M.1 Magnésium 6 mg — M.2 Manganèse 5 mcg — P.2 Phosphore 25 mg — P.3 Potassium 80 mg 200 mg S.1 Sodium 20 mg 60 mg Z.1 Zinc 0,5 mg —

DORS/83-933, art. 1; DORS/98-458, art. 7(F). Version précédente

Titre 26

Irradiation des aliments Définitions

B.26.001. Les définitions qui suivent s’appliquent au présent titre.

« irradiation » Le traitement au moyen d’un rayonnement ionisant. (irradiation)

« rayonnement ionisant » Selon le cas :

a) rayons gamma provenant d’une source de cobalt 60 ou de césium 137;

b) rayons X provenant d’un appareil radiogène fonctionnant à un niveau d’énergie égal ou inférieur à 5 MeV;

c) électrons provenant d’un appareil radiogène fonctionnant à un niveau d’énergie égal ou inférieur à 10 MeV. (ionizing radiation)

DORS/89-175, art. 3.

Application

B.26.002. Le présent titre ne s’applique pas aux aliments exposés à un rayonnement ionisant émis par un instrument de mesure utilisé pour déterminer le poids, évaluer la quantité des solides en vrac ou mesurer la teneur en solides d’un liquide, ou à d’autres fins d’inspection.

DORS/89-175, art. 3.

Dispositions générales

B.26.003. (1) Sous réserve du paragraphe (2), il est interdit de vendre un aliment qui a été irradié.

(2) Il est permis de vendre un aliment irradié dont le nom figure à la colonne I du tableau du présent titre si les conditions suivantes sont réunies :

a) l’aliment a été irradié sous l’action d’un rayonnement provenant d’une source mentionnée à la colonne II aux fins précisées à la colonne III de ce tableau;

b) la dose de rayonnement ionisant absorbée par l’aliment ne dépasse pas la dose absorbée permise indiquée à la colonne IV de ce tableau.

DORS/89-175, art. 3.

Registres

B.26.004. (1) Le fabricant qui vend un aliment irradié doit conserver à son établissement, pour une période d’au moins deux ans après la date d’irradiation, un registre contenant les renseignements suivants :

a) l’aliment irradié ainsi que la quantité et les numéros de lot de celui-ci;

b) l’irradiation;

c) la date de l’irradiation;

d) la dose de rayonnement ionisant absorbée par l’aliment;

e) la source du rayonnement ionisant;

f) une mention indiquant si l’aliment a été irradié ou non avant l’irradiation faite par le fabricant et, dans l’affirmative, tous les renseignements visés aux alinéas a) à e) à l’égard de cette irradiation préalable.

(2) Quiconque importe, pour la vente au Canada, un aliment qui a été irradié doit conserver le registre visé au paragraphe (1) à son établissement, pour une période d’au moins deux ans après la date d’importation.

DORS/89-175, art. 3.

Modification du tableau

B.26.005. Toute demande visant la modification du tableau du présent titre ou l’adjonction d’un aliment à celui-ci doit être accompagnée d’une présentation au Directeur contenant les renseignements suivants :

a) le but et le détail de l’irradiation proposée, notamment la source du rayonnement ionisant et la fréquence proposée des doses minimale et maximale du rayonnement ionisant;

b) les données indiquant que la dose minimale du rayonnement ionisant proposé permettra d’atteindre le but visé par l’irradiation et que la dose maximale du rayonnement ionisant proposé n’excédera pas le niveau approprié à cette fin;

c) les renseignements sur la nature du dosimètre utilisé, la fréquence de la dosimétrie de l’aliment ainsi que des données relatives à la dosimétrie et aux fantômes utilisés afin de garantir que les relevés dosimétriques correspondent activement à la dose absorbée par l’aliment durant l’irradiation;

d) les données relatives aux effets, le cas échéant, dans les conditions envisagées, de l’irradiation et de tout autre traitement qui y est combiné sur la qualité nutritive de l’aliment, cru et prêt à servir;

e) les données établissant que les caractéristiques chimiques, physiques ou microbiologiques de l’aliment irradié n’ont pas été modifiées de façon à le rendre impropre à la consommation humaine;

f) si le Directeur le demande, les données établissant que l’irradiation proposée est sans danger dans les conditions envisagées;

g) les conditions recommandées pour l’emmagasinage et l’expédition de l’aliment irradié, notamment la durée, la température ainsi que l’emballage, et une comparaison avec les conditions recommandées pour le même aliment non irradié;

h) le détail de tout autre traitement que l’aliment doit subir avant ou après l’irradiation proposée;

i) toute autre donnée exigée par le Directeur qui établit que le consommateur ou l’acheteur de l’aliment irradié n’est pas déçu ou trompé quant à la nature, la valeur, la composition, les avantages et la sûreté de l’aliment irradié.

TABLEAU

Colonne I Colonne II Colonne III Colonne IV DoseSources permises deArticle Aliment But de l’irradiation absorbéerayonnement ionisant permise

Pommes de terre Inhibition de la au plus1. Cobalt 60(Solanum tuberosum germination durant 0,15 kGy

Colonne I Colonne II Colonne III Colonne IV DoseSources permises deArticle Aliment But de l’irradiation absorbéerayonnement ionisant permise

L.) l’emmagasinage Inhibition de laOignons (Allium au plus2. Cobalt 60 germination durantcepa) 0,15 kGyl’emmagasinage Prévention de

Blé, farine, farine de l’infestation par des au plus3. blé entier (Triticum Cobalt 60 insectes dans 0,75 kGysp.) l’aliment emmagasiné

au plus Épices entières ou Cobalt 60, Césium 137 ou 10 kGy, moulues électrons provenant de Réduction de la dose4. et assaisonnements sources radiogènes (au charge microbienne globale déshydratés plus 3 MeV) moyenne

totale

DORS/89-175, art. 3; DORS/98-458, art. 7(F).

Titre 27

Aliments peu acides emballés dans des récipients hermétiquement fermés B.27.001. Les définitions qui suivent s’appliquent au présent titre.

« activité de l’eau » Rapport de la pression de vapeur d’eau de l’aliment à la pression de vapeur de l’eau pure à la même température et à la même pression. (water activity)

« aliment peu acide » Aliment, à l’exception des boissons alcooliques, dont l’un des constituants a un pH supérieur à 4,6 et une activité de l’eau supérieure à 0,85. (low-acid food)

« contenant d’expédition » Récipient, emballage ou enveloppe dans lequel les contenants d’aliments sont placés aux fins de transport. (shipping container)

« récipient hermétiquement fermé » Contenant conçu pour protéger son contenu contre les microorganismes, y compris les spores. (hermetically sealed container)

« réfrigéré » Le fait d’être soumis à une température de 4 °C ou moins sans qu’il y ait congélation. (refrigeration)

« stérilité commerciale » État de l’aliment qui a subi un traitement thermique, seul ou en combinaison avec d’autres procédés, pour le rendre exempt de toute forme viable de

microorganismes, y compris les spores, susceptibles de se développer dans l’aliment aux températures auxquelles il est destiné à être normalement soumis durant la distribution et l’entreposage. (commercially sterile)

DORS/89-309, art. 1.

B.27.002. (1) Il est interdit de vendre un aliment peu acide emballé dans un récipient hermétiquement fermé à moins que cet aliment ne soit dans un état de stérilité commerciale.

(2) Le paragraphe (1) ne s’applique pas aux aliments peu acides emballés dans des récipients hermétiquement fermés lorsque, selon le cas :

a) ces aliments sont gardés réfrigérés et l’espace principal de l’étiquette du récipient et l’étiquette du contenant d’expédition portent la mention « Garder au froid » et « Keep Refrigerated »;

b) ces aliments sont gardés congelés et l’espace principal de l’étiquette du récipient et l’étiquette du contenant d’expédition portent la mention « Garder congelé » et « Keep Frozen ».

(3) Le paragraphe (1) ne s’applique pas aux tomates et aux produits de tomates dont le pH est égal ou inférieur à 4,7 après le traitement thermique, qui sont emballés dans des récipients hermétiquement fermés.

DORS/89-309, art. 1; DORS/91-149, art. 7.

B.27.003. Il est interdit de vendre un aliment peu acide emballé dans un récipient hermétiquement fermé qui, selon le cas :

a) est bombé;

b) n’est pas bien fermé;

c) comporte d’autres défauts susceptibles de compromettre l’herméticité du récipient.

DORS/89-309, art. 1.

B.27.004. (1) Lorsque le Directeur juge que la vente d’un aliment peu acide emballé dans un récipient hermétiquement fermé risque d’être en contravention avec les articles B.27.002 ou B.27.003, il peut, par avis écrit, demander au fabricant ou à l’importateur de l’aliment de lui présenter, au plus tard à la date précisée dans l’avis, la preuve que les procédés de fabrication, de transformation et d’emballage de l’aliment permettent d’atteindre et de maintenir la stérilité commerciale.

(2) Le fabricant ou l’importateur qui reçoit un avis émis en application du paragraphe (1) doit cesser la vente de l’aliment à compter de la date précisée dans l’avis jusqu’à ce qu’il ait présenté la preuve demandée.

(3) Si le Directeur juge insuffisante la preuve présentée par le fabricant ou l’importateur en application du paragraphe (1), il lui envoie un avis à cet effet.

(4) Le fabricant ou l’importateur qui reçoit l’avis mentionné au paragraphe (3) doit cesser immédiatement la vente de l’aliment et ce, jusqu’à ce qu’il ait présenté une autre preuve et que le Directeur l’ait avisé par écrit que cette preuve est suffisante.

DORS/89-309, art. 1.

B.27.005. Il est interdit de vendre un aliment peu acide qui est dans un état de stérilité commerciale et qui est emballé dans un récipient hermétiquement fermé, à moins que les conditions suivantes ne soient réunies :

a) l’étiquette ou le récipient de l’aliment porte un code ou un numéro de lot qui indique de façon permanente et lisible :

(i) l’établissement dans lequel le produit a atteint la stérilité commerciale,

(ii) le jour, le mois et l’année où l’aliment a atteint la stérilité commerciale;

b) un inspecteur peut obtenir à l’établissement, ou de l’importateur s’il s’agit d’un aliment importé, la signification exacte de chaque élément du code ou du numéro de lot mentionné à l’alinéa a).

DORS/89-309, art. 1.

Titre 28

Aliments nouveaux Définitions

B.28.001. Les définitions qui suivent s’appliquent au présent titre.

« aliment nouveau » Selon le cas :

a) substance, y compris un micro-organisme, qui ne présente pas d’antécédents d’innocuité comme aliment;

b) aliment qui a été fabriqué, préparé, conservé ou emballé au moyen d’un procédé qui :

(i) n’a pas été appliqué auparavant à l’aliment,

(ii) fait subir à l’aliment un changement majeur;

c) aliment dérivé d’un végétal, d’un animal ou d’un micro-organisme qui, ayant été modifié génétiquement, selon le cas :

(i) présente des caractères qui n’avaient pas été observés auparavant,

(ii) ne présente plus des caractères qui avaient été observés auparavant,

(iii) présente un ou plusieurs caractères qui ne se trouvent plus dans les limites prévues pour ce végétal, cet animal ou ce micro-organisme. (novel food)

« changement majeur » Changement apporté à un aliment à la suite duquel, selon l’expérience du fabricant ou la théorie généralement admise dans le domaine des sciences de la nutrition et de l’alimentation, les propriétés de celui-ci se situent en dehors des variations naturelles acceptables de l’aliment en ce qui a trait à l’un ou l’autre des éléments suivants :

a) la composition, la structure, la qualité nutritive ou les effets physiologiques généralement reconnus de l’aliment;

b) la manière dont l’aliment est métabolisé par le corps humain;

c) l’innocuité générale, microbiologique ou chimique de l’aliment. (major change)

« modifier génétiquement » Manipuler intentionnellement les caractères héréditaires d’un végétal, d’un animal ou d’un micro-organisme. (genetically modify)

DORS/99-392, art. 1.

Avis avant la vente

B.28.002. (1) Il est interdit de vendre ou d’annoncer en vue de la vente un aliment nouveau à moins que le fabricant ou l’importateur :

a) n’ait donné au Directeur un avis écrit de son intention de vendre l’aliment nouveau ou de l’annoncer en vue de la vente;

b) n’ait reçu du Directeur l’avis visé à l’alinéa B.28.003(1)a) ou au paragraphe B.28.003(2), selon le cas.

(2) L’avis visé à l’alinéa (1)a) est signé par le fabricant ou l’importateur, ou une personne autorisée à signer en son nom, et contient les renseignements suivants :

a) le nom commun sous lequel l’aliment nouveau sera vendu;

b) les nom et adresse du principal établissement du fabricant et, si l’adresse est à l’étranger, les nom et adresse du principal établissement de l’importateur;

c) la description de l’aliment nouveau, accompagnée :

(i) des renseignements sur son élaboration,

(ii) des renseignements détaillés sur son mode de fabrication, de préparation, de conservation, d’emballage et d’emmagasinage,

(iii) de la description du changement majeur, le cas échéant,

(iv) des renseignements sur son utilisation proposée et son mode de préparation,

(v) le cas échéant, des renseignements sur l’historique de son utilisation comme aliment dans un pays autre que le Canada,

(vi) de renseignements permettant d’établir son innocuité;

d) des renseignements sur les niveaux de consommation estimatifs chez les consommateurs de l’aliment nouveau;

e) le texte des étiquettes qui seront utilisées avec l’aliment nouveau;

f) les nom et titre du signataire de l’avis et la date de la signature.

DORS/99-392, art. 1.

B.28.003. (1) Dans les quarante-cinq jours suivant la réception de l’avis visé à l’alinéa B.28.002(1)a), le Directeur examine les renseignements contenus dans l’avis et :

a) si les renseignements établissent l’innocuité de l’aliment nouveau, il avise par écrit le fabricant ou l’importateur que ces renseignements sont suffisants;

b) si d’autres renseignements sont nécessaires sur le plan scientifique afin d’évaluer l’innocuité de l’aliment nouveau, il demande par écrit au fabricant ou à l’importateur de les lui fournir.

(2) Dans les quatre-vingt-dix jours suivant la réception des renseignements additionnels visés à l’alinéa (1)b), le Directeur les évalue et, s’ils établissent l’innocuité de l’aliment nouveau, il avise par écrit le fabricant ou l’importateur que ces renseignements sont suffisants.

DORS/99-392, art. 1.

PARTIE C DROGUES Titre 1 Dispositions générales

C.01.001. (1) Dans la présente partie,

« antibiotique » désigne toute drogue ou tout mélange de drogues, tels que ceux qui figurent aux articles C.01.410 à C.01.592, lesquels sont préparés à partir de certains microorganismes, ou l’ont été antérieurement, mais sont maintenant fabriqués par synthèse, et sont doués de propriétés inhibitrices de la croissance d’autres microorganismes; (antibiotic)

« cuillerée à thé » désigne, aux fins du calcul d’une dose, un volume de cinq centimètres cubes; (teaspoon)

« date limite d’utilisation » La plus rapprochée des dates suivantes :

a) la date, indiquée au moins par l’année et le mois, jusqu’à laquelle une drogue conserve l’activité, la pureté et les propriétés physiques précisées sur l’étiquette;

b) la date, indiquée au moins par l’année et le mois, après laquelle le fabricant recommande de ne plus employer la drogue. (expiration date)

« délai d’attente » Intervalle entre le moment de la dernière administration d’une drogue à un animal et le moment où la concentration de tout résidu de la drogue présent dans les tissus ou les produits prélevés chez l’animal pour servir d’aliment ne présente vraisemblablement plus de risques pour la santé de l’être humain. (withdrawal period)

« dose normale pour adultes » désigne, dans le cas d’une drogue, la dose prescrite au titre 9; (adult standard dosage unit)

« dose normale pour enfants » désigne, dans le cas d’une drogue, la dose prescrite au titre 9; (children’s standard dosage unit)

« drogue officielle » désigne toute drogue

a) pour laquelle une norme est fixée dans le présent règlement, ou

b) pour laquelle une norme est fixée dans l’une des publications mentionnées à l’annexe B de la Loi, et non dans le présent règlement; (official drug)

« emballage protège-enfants » désigne un emballage qui répond aux exigences du paragraphe (2); (child resistant package)

« fiche d’observation » Rapport détaillé renfermant les données pertinentes concernant l’utilisation d’une drogue chez un sujet. (case report)

« groupe d’essai » désigne un groupe qui répond aux exigences du paragraphe (3); (test group)

« marque nominative » Dans le cas d’une drogue, le nom en français ou en anglais, avec ou sans le nom d’un fabricant, d’une personne morale, d’une société de personnes ou d’un particulier :

a) qui lui a été attribué par le fabricant;

b) sous lequel elle est vendue ou fait l’objet de publicité;

c) qui sert à l’identifier. (brand name)

« nom propre » désigne, à l’égard d’une drogue, le nom en anglais ou en français

a) attribué à ladite drogue à l’article C.01.002,

b) figurant en caractères gras dans le présent règlement lorsqu’il est question de ladite drogue et, lorsque la drogue est distribuée sous une forme autre que celle qui est décrite dans la présente partie, le nom de la forme sous laquelle ladite drogue est distribuée,

c) spécifié dans la licence canadienne, dans le cas des drogues comprises à l’annexe C ou à l’annexe D de la Loi, ou

d) attribué, dans l’une des publications mentionnées à l’annexe B de la Loi, dans le cas des drogues non comprises aux alinéas a), b) ou c); (proper name)

« nom usuel » Dans le cas d’une drogue, le nom en français ou en anglais sous lequel elle est :

a) généralement connue;

b) désignée dans des revues scientifiques ou techniques autres que les publications dont le nom figure à l’annexe B de la Loi. (common name)

« ordonnance » désigne un ordre délivré par un praticien, spécifiant une quantité donnée de quelque drogue ou mélange de drogues à dispenser à la personne nommée dans ladite ordonnance; (prescription)

« pour cent » désigne le pourcentage en poids, à moins de précision contraire; (per cent)

« praticien » désigne toute personne autorisée par la loi d’une province du Canada à traiter les malades au moyen de n’importe quelle drogue mentionnée ou décrite à l’annexe F du présent règlement; (practitioner)

« produit d’acétaminophène » s’entend au sens du titre 9; (acetaminophen product)

« produit de salicylate » s’entend au sens du titre 9; (salicylate product)

« réaction indésirable à une drogue » Réaction nocive et non intentionnelle à une drogue qui survient lorsque la drogue est utilisée selon les doses normales ou selon des doses expérimentales, aux fins du diagnostic, du traitement ou de la prévention d’une maladie ou de la modification d’une fonction organique. (adverse drug reaction)

« réaction indésirable grave à une drogue » Réaction nocive et non intentionnelle à une drogue qui est provoquée par toute dose de celle-ci et qui nécessite ou prolonge l’hospitalisation, entraîne une malformation congénitale ou une invalidité ou incapacité persistante ou importante, met la vie en danger ou entraîne la mort. (serious adverse drug reaction)

« réaction indésirable grave et imprévue à une drogue » Réaction indésirable grave à une drogue, dont la nature, la gravité ou la fréquence n’est pas indiquée dans les mentions de risque figurant sur l’étiquette de la drogue. (serious unexpected adverse drug reaction)

« récipient immédiat » Récipient qui est en contact direct avec la drogue. (immediate container)

« usage interne » signifie l’absorption par la bouche ou l’application, en vue d’une action fonctionnelle, à toute partie du corps dans laquelle ladite drogue vient en contact avec une muqueuse; (internal use)

« usage parentéral » signifie l’administration d’une drogue au moyen d’une seringue hypodermique, d’une aiguille ou de quelque autre instrument, à travers ou dans la peau ou une muqueuse. (parenteral use)

(2) L’emballage protège-enfants est un emballage qui :

a) soit, lorsqu’il est soumis à un essai selon une méthode acceptable, répond aux exigences suivantes :

(i) dans le cas d’un groupe d’essai formé d’enfants, ne peut être ouvert :

(A) d’une part, par au moins 85 pour cent de ces enfants, sans démonstration préalable de la méthode d’ouverture,

(B) d’autre part, par au moins 80 pour cent de ces enfants, après démonstration de la méthode d’ouverture,

(ii) dans le cas d’un groupe d’essai formé d’adultes :

(A) peut être ouvert par au moins 90 pour cent de ces adultes,

(B) s’il s’agit d’un emballage conçu pour être refermé de façon à répondre aux exigences du sous-alinéa (i), peut être ainsi refermé par au moins 90 pour cent de ces adultes;

b) soit est conforme à l’une des normes suivantes :

(i) la norme CAN/CSA-Z76.1-M90 de l’Association canadienne de normalisation intitulée Emballages de sécurité réutilisables pour enfants, publiée en janvier 1990, compte tenu de ses modifications successives,

(ii) la norme européenne EN 28317 : 1992 intitulée Emballages à l’épreuve des enfants— Exigences et méthodes d’essai pour emballages refermables, adoptée par le Comité européen de normalisation le 30 octobre 1992 et homologuée par l’Association française de normalisation le 20 décembre 1992 et par la British Standards Institution le 15 février 1993, qui reproduit intégralement la norme internationale ISO 8317 : 1989, compte tenu de ses modifications successives,

(iii) l’article 1700.15 intitulé Poison prevention packaging standards, titre 16, du Code of Federal Regulations des États-Unis, compte tenu de ses modifications successives.

(3) Pour l’application du présent article, le groupe d’essai est constitué :

a) dans le cas des enfants, d’au moins 200 enfants qui :

(i) sont en santé et ne souffrent d’aucun handicap physique ou mental apparent,

(ii) sont âgés de 42 à 51 mois,

(iii) représentent dans une égale proportion, avec une marge de plus ou moins 10 pour cent, les divers âges, exprimés en mois, de 42 à 51 mois, calculés au mois près;

b) dans le cas des adultes, d’au moins 100 adultes qui :

(i) sont en santé et ne souffrent d’aucun handicap physique ou mental apparent,

(ii) sont âgés de 18 à 45 ans,

(iii) représentent dans une égale proportion, avec une marge de plus ou moins 10 pour cent, les divers âges, exprimés en années, de 18 à 45 ans, calculés à l’année près.

(4) Pour l’application du présent article, les modifications successives des normes visées à l’alinéa (2)b) entrent en vigueur à l’expiration du délai de 18 mois suivant la date désignée par l’autorité compétente comme étant celle de leur entrée en vigueur.

DORS/80-543, art. 1; DORS/85-966, art. 1; DORS/86-93, art. 1; DORS/87-484, art. 1; DORS/92-654, art. 1; DORS/93-202, art. 1; DORS/95-411, art. 1; DORS/95-521, art. 1; DORS/96-399, art. 1; DORS/96-240, art. 1; DORS/97-543, art. 5.

C.01.001A. [Abrogé, DORS/98-423, art. 1]

C.01.002. Le nom propre d’une drogue qui figure vis-à-vis d’un numéro de poste dans le tableau suivant, dans la colonne intitulée « Noms chimiques et synonymes » doit être le nom qui figure vis-à-vis dudit poste, dans la colonne intitulé « Noms Propres ».

TABLEAU

Poste o Noms propres Noms chimiques et synonymesn

A.1 Acépromazine ....... 2-acétyl-10-(3-diméthylaminopropyl) phénothiazine

Acétyminophène ....... p-acétaminophénol, paracétamol, p-hydroxyacétanilide: N­A.2 acétyl-p aminophénol A.3 Acétanilide ....... Acétylaminobenzone: antifébrine: phénylacétamide

AcideA.4 acétylsalicylique ....... Acide acétylsalicylique

1-H-Pyrazolo[3,4-d] pyrimidin-4-ol: 4­A.5 Allopurinol ....... Hydroxypyrazolo(3,4-d) pyrimidine A.6 Amantadine ....... 1-Adamantanamine

AcideA.7 aminocaproïque ....... 6-acide aminohexanoïque

N-4-(2,4-diamino-6-ptéridyl méthyl) amino-benzoyl-L-acideA.8 Aminoptérine ....... glutamique Aminopyrine: 1,5-diméthyl-2-phényl-4-diméthylamino-3-pyrazolone:A.9 amidopyrine ....... diméthylaminophénazone

3-(3-diméthylaminopropylidène)-1,2: 4,5­A.10 Amitriptyline ....... dibenzocyclohepta-1,4-diène A.11 Azacyclonol ....... α,α-diphényl-4-pipéridine carbinol B.1 Bémégride ....... 3-éthyl-3-méthylglutarimide B.2 Bénactyzine ....... Diméthylaminoéthyl-1,1-diphénylglycolate

3-benzyl-3,4-dihydro-6-(trifluorométhyl)-2H-1,2,4­BendrofluméthiazideB.3 benzothiadiazine-7-sulfonamide-1,1-dioxide:....... Bendrofluazide (B.A.N.) B.4 Bétahistine ....... 2-[2-(Méthylamino)éthyl]pyridine

Poste o Noms propres Noms chimiques et synonymesn

N-Benzyl-N′N″-diméthylguanidine: 1-Benzyl-2,3­B.5 Béthanidine ....... diméthylguanidine Tosylate de N-2-bromobenzyl-N-éthyl-N,N-Brétylium (TosylateB.6 diméthylammonium (acide tosylique est le nom vulgaire dede) ....... l’acide p-toluénesulphonique)

B.7 Bromisoval ....... 2-monobromo-isovalérylurée: bromisovalum: bromévalitone Calcium, carbimideC.1 Cyanamide de calciumde .......

Sulfure de 4-butylthio-α-phénylbenzyl-2­C.2 Captodiamine ....... diméthylaminoéthyl Dicarbamate de N-isopropyl-2-méthyl-2-propyl-1,3­C.3 Carisoprodol ....... propanediol 1-[10-(3[4-(2-hydroxyéthyl)-1-piperazinyl] propyn( �.4 Carphénazine ....... phénothiazine-2yl]-1-propapone 7-[2-Thiényl)acétamido]-3-(1-pyridylméthyl)-3-céphem-4­C.5 Céphaloridine ....... carboxylique acide betaïne 1-bioxyde de 2-(4-chlorophényl)-3-méthyl-4­C.6 Chlormézanone ....... métathiazanone-1: chlorméthazanone: chorméthazone

Chlorométhapyrilène N,N-diméthyl-N′-(2-pyridyl)-N′-(5-chloro-2-thényl)­C.7 ....... éthylénédiamine: chlorothène ChlorphènetermineC.8 4-chloro-α,α-diméthylphénéthylamine.......

2-butoxy-N-(2-diéthylaminoéthyl) cinchoninamide:C.9 Cinchocaïne ....... dibucaïne C.10 Cinchophène ....... Acide carboxylique de 2-phénylquinoléine-4-quinophane C.11 Clofibrate ....... Éthyl 2-(p-Chlorophénoxy)-2-méthylpropionate

1-Chloro-2-[4(2-diéthylaminoéthoxy)phényl]-1,2­ C.12 Clomiphène ....... diphényléthylène: 2-[p-(2-Chloro-1,2-diphénylvinyl)

phenoxy]triéthylamine 5-(3-méthylaminopropyl)-10,11-dihydro-5H­D.1 Désipramine ....... dibenz[b,f]azépine 7-chloro-1,3-dihydro-1-méthyl-5-phényl-2H-1,4­D.2 Diazépame ....... benzodiazépin-2-one

D.3 Diéthylpropion ....... 1-phényl-2-diéthylaminopropanone-1 D.4 Diphénidol ....... 1,1-Diphényl-4-piperidinobutan-1-ol D.5 Disulfiram ....... Bisulfure de tétraéthylthiurame E.1 Ectylurée ....... 2-éthyl-cis-crotonylurée E.2 Émylcamate ....... Carbamate de 1-éthyl-1-méthylpropyl E.3 Éthacrynique (Acide) [2,3-Dichloro-4-(2-méthylènebutyryl) phénoxy]acetique

Poste o Noms propres Noms chimiques et synonymesn

....... acide: 2,3-Dichloro-4-(2-éthylacryloyl)phénoxyacetique acide

E.4 Ethchlorvynol ....... 3-(2-chlorovynil)-1-pentyne-3-ol E.5 Éthinamate ....... Carbamate de 1-éthynylcyclohexyl E.6 Éthionamide ....... 2-éthylisonicotinthioamide E.7 Éthomoxane ....... 2-n-butylaminoéthyl-8-éthoxybenzo-1,4-dioxane

Éthyl (TrichloramateE.8 Carbamate d’éthyl n-[1-(2,2,2-trichloro-1-hydroxyéthyl)]d’) ....... E.9 Étryptamine ....... 3-(2-aminobutyl) indole E.10 Étymémazine ....... 10-(3-diméthylamino-2-méthylpropyl)-2-éthylphénothiazine

10-[3-[4-(2-hydroxyéthyl)pipérazine-1-yl]propyl]-2­F.1 Fluphénazine ....... trifluorométhylphénothiazine 4-Chloro-N-furfuryl-5-sulphamoylanthranilique acide:F.2 Furosémide ....... frusemide (B.A.N.) [[(chloro-5 méthoxy-2 benzamido)-2 éthyl]-4G.1 Glyburide ....... phénylsulfonyl]-1 cyclohexyl-3 urée: Glibenclamide 4-(4-Chlorophényl)-1-[3-(4-fluorobenzoyl) propyl]­

H.1 Halopéridol ....... pipéridine-4-ol:4-[4-(p-Chlorophényl)-4­ hydroxypipéridino]-4’-fluorobutyrophénone

Hydroxychloroquine 7-chloro-4[4-(N-éthyl-N-2-hydroxyéthylamino)-1­H.2 ....... méthylbutyl-amino] quinoline 1-(p-chloro-α-phénylbenzyl)-4-(2-hydroxy éthoxyéthyn( �.3 Hydroxyzine ....... pipérazine

I.1 Idoxuridine ....... 5-iodo-2′-déoxyuridine 5-(3-diméthylaminopropyl)-10,11-dihydro-5H­I.2 Imipramine ....... dibenz[b,f]azépine Acide acétique de 1-(p-chlorobenzoyl)-5-méthoxy-2­I.3 Indométhacine ....... méthylindole-3

I.4 Iproniazide ....... 1-isonicotinoyl-2-isopropylhydrazine I.5 Isocarboxazide ....... 3-N-benzylhydrazinocarbonyl-5-méthylisoxazole

Alcool benzylique de 3,4-dihydroxy-α­I.6 Isoprotérénol ....... [(isopropylamino)méthyl]:isoprénaline Acide propionique de L-α-amino-3-[(4-hydroxy-3­L.1 Liothyronine ....... iodophénoxy)-3,5-di-iodophényl]

Méfénamique (Acide)M.1 Acide anthranilique de N-(2,3-xylyl)....... M.2 Melphalan ....... 4-di-(2-chloréthyl)amino-L-phénylalanine M.3 Mépazine ....... 10-[(1-méthyl-3-pipéridyl)méthyl] phénothiazine M.4 Méphénésine ....... 3-o-toloxy-1,2-propanediol

Poste o Noms propres Noms chimiques et synonymesn

M.5 Méphénoxalone ....... 5-(o-méthoxyphénoxyméthyl)-2-oxazolidinone M.6 Méprobamate ....... 2,2-di(carbamoylméthyl) pentane

2-méthyl-3-o-tolyquinazoline-4-one: 2-méthyl-3-o-tolyl-4­M.7 Méthaqualone ....... quinazolone 1-Méthylindoline-2,3-dione-3-thiosémicarbazone: N­M.8 Méthisazone ....... Méthylisatin-ß-thiosémicarbazone

Méthotriméprazine 10-[3-(2-méthyl)diméthylamino propyl]-2­M.9 ....... méthoxyphénothiazine: lévomépromazine M.10 Méthyldopa ....... 1-3-(3,4-dihydroxyphényl)-2-méthylalanine M.11 Méthylparafynol ....... 3-méthyl-1-pentyne-3-ol: méthyl-pentynol M.12 Méthylphénidate ....... Acétate de méthyl-1-phényl-1-(2-pipéridyl) M.13 Méthyprylon ....... 3,3-diéthyl-5-méthyl-2,4-pipéridinedione

Acide 1-méthyl-d-lysergique de 1-(hydroxyméthyn( �.14 Méthysergide ....... propylamide M.15 Métyrapone ....... 2-méthyl-1,2-di(3-pyridyl)propane-1-one

Nalidixique (Acide) Acide carboxylique de 1-éthyl-7-méthyl-4-oxo-1,8­N.1 ....... naphthyridine-3 N.2 Nialamide ....... 1-[2-(benzylcarbamyl) éthyl]-2-isonicotinoylhydrazine

3-(3-méthylaminopropylidène)-1,2:4,5-dibenzocyclohepta­N.3 Nortriptyline ....... 1,4-diène O.1 Oxanimide ....... 2-éthyl-3-propyl-glycidamide

7-chloro-1,3-dihydro-3-hydroxy-5-phényl-1,4­O.2 Oxazépam ....... benzodiazépine-2-one Oxyphenbutazone 4-n-butyl-2(4-hydroxyphényl)-1-phénylpyrazolidine-3,5­O.3 ....... dione

P.1 Paraméthadione ....... 3,5-diméthyl-5-éthyl-2,4-oxazolidinedione P.2 Pargyline ....... N-benzyl-N-méthylprop-2-ynylamine P.3 Pémoline ....... 2-imino-5-phényloxazolidine-4-one

1,2,3,4,5,6-Hexahydro-8-hydroxy-6,11-diméthyl-3-(3­ méthylbut-2-ényl)-2,6-méthano-3-benzazocine: 1,2,3,4,5,6­P.4 Pentazocine ....... Hexahydro-6,11-diméthyl-3-(3-méthyl-2-butényl)-2,6­ méthano-3-benzazocine-8-ol

Pentolinium (Tartrate NN′-pentaméthylènedi-(tartrate d’hydrogène deP.5 de) ....... méthylpyrrolidinium) 2-chloro-10-[3-[1-(2-hydroxyéthyl)-4-pipérazinyl]propyl]P.6 Perphénazine ....... phénothiazine

P.7 Phacétopérane ....... l-1-phényl-1-(2′-pipéridyl)-1-acétoxyméthane P.8 Phénacémide ....... Phénylacétylurée P.9 Phénacétine ....... p-acétphénétidine:acétphénétidine: acétophénétidine:p­

Poste o Noms propres Noms chimiques et synonymesn

éthoxy-acétanilide P.10 Phènaglycodol ....... 2-p-chlorophényl-3-méthyl-2,3-butanediol

PhènedimétrazineP.11 3,4-diméthyl-2 phénylmorpholine....... P.12 Phénelzine ....... 2-phényléthylhydrazine P.13 Phèneformine ....... N′-ß-phénéthylformamidinyliminourée P.14 Phéniprazine ....... α-méthylphénéthylhydrazine

Tétrahydro-3-méthyl-2-phényl-1,4-oxazine: 3-méthyl-2­P.15 Phénemétrazine ....... phénylmorpholine P.16 Phènetermine ....... α,α-diméthylphénéthylamine: phényl-tert-butylamine

PhénylindanédioneP.17 2-phénylindane-1,3-dione....... PhényltoloxamineP.18 N,N-diméthyl-2-(α-phényl-o-tolyloxy) éthylamine.......

P.19 Pholédrine ....... p-(4-hydroxyphényl)-isopropylméthylamine P.20 Piperliate ....... Benzilate de 1-pipéridine-éthanol P.21 Pipradrol ....... Diphényl-2-pipéridylméthanol

P.22 Prochlorpérazine ....... 2-chloro-10-[3-(1-méthyl-4­pipérazinyl)propyl]phénothiazine P.23 Prodilidine ....... Propionate de 1,2-diméthyl-3-phényl-3-pyrrolidinyl P.24 Propranolol ....... 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol P.25 Prothipènedyl ....... 9-(3-diméthylaminopropyl)-10-thia-1,9-diaza-anthracène

7-(3-Méthylaminopropyl)-1,2:5,6­ P.26 Protriptyline ....... dibenzocycloheptatrien:N-Méthyl-5H-dibenzo [a,d]

cycloheptène-5-propylamine P.27 Pyrazinamide ....... Amide acido-pyrazinoïque

3-{[(4-méthyl-1-pipérazinyl)imino]méthyl} rifamycine R.1 Rifampin ....... SV:Rifampicine (I.N.N.) (Rifamycine SV, antibiotique

produit par le streptomyces mediterranei) Sel disodique de l’acide [(hydroxy-2 propanediyl-1,3) bis(oxy)]-5,5′ bis[oxo-4(4H) α-benzopyranne-carboxylique­ 2]: (Hydroxy-2 triméthylènedioxy)-5,5′ bis[oxo-4(4H) α-Cromoglicate sodiqueS.01 benzopyranne-carboxylate-2] disodique : Dioxo-4,4′....... (hydroxy-2 triméthylènedioxy)-5,5′ bis(chromène­ carboxylate-2) disodique : Cromolyn sodium (USP) : Cromoglicate disodique : bis(carboxylate-2 de sodium oxo-4 chroményl-5 oxy)-1,3 propanol-2:

S.1 Sulfameter ....... 2-(4-Aminobenzènesulphonamido)-5­

Poste o Noms propres Noms chimiques et synonymesn

méthoxypyrimidine:N′-(5-méthoxy-2-pyrimidinyl) sulfanilamide: Sulfaméthoxydiazine (B.A.N.) N′-(4,6-diméthyl-2-pyrimidyl) sulfanilamide: 2-(p­

S.2 Sulfaméthazine ....... aminobenzènesulfonamide)-4,6­ diméthylpyrimidine:sulfadimédine

S.3 Sulfinpyrazone ....... 1,2-diphényl-4-(2-phénylsufiniléthyl)-3,5-pyrazolidinedione S.4 Sulfisoxazole ....... 3,4-diméthyl-5-sulfanilamidoisoxazole: sulfafurazole T.1 Tétracaïne ....... 2-diméthylaminoéthyl-p-n-butylaminobenzoate:améthocaïne

Thiéthylpérazine ....... 2-éthylthio-10-[3-(4-méthylpipérazine-1-yl)propyl]T.2 phénothiazine 2-chloro-10-[3-[1-(2-acétoxyéthyl)-4-pipérazinyl]propyl]T.3 Thiopropazate ....... phénothiazine

Thiopropérazine ....... 2-diméthylsulphamoyl-10-[3-(4-méthylpipérazine-1-yl)­T.4 propyl]phénothiazine 10-[2-[2-(1-méthylpipéridyl)] éthyl]-2­T.5 Thioridazine ....... méthylthiophénothiazine

TranylcypromineT.6 Trans d, 1-2-phénylcyclopropylamine....... T.7 Triamtérène ....... 2,4,7-triamino-6-phénylptéridine

Triflupromazine ....... 10-(3-diméthylaminopropyl)-2­T.8 trifluorométhylphénothiazine : fluopromazine T.9 Triméprazine ....... 10-(3-diméthylamino-2-méthylpropyl)phénothiazine T.10 Triméthadione ....... 3,5,5-triméthyl-2,4-oxazolidinedione:troxidone

5-(3-diméthylamino-2-méthylpropyl)-10,11-dihydro-5H­ T.11 Trimipramine ....... dibenz [b,f]azépine : 5-(3′-diméthylamino-2′­

méthylpropyl)iminodibenzyl 2-méthyl-2-propyltriméthylène butylcarbamate:2­T.12 Tybamate ....... (hydroxyméthyl)-2-méthylpentyl butylcarbamate carbamate

V.1 Vinblastine ....... Alcaloïde dérivé du Vinca rosea V.2 Vincristine ....... Alcaloïde dérivé du Vinca rosea

DORS/87-565, art. 1; DORS/88-182, art. 1(F); DORS/88-482, art. 1; DORS/90-173, art. 1(F).

C.01.003. Il est interdit de vendre une drogue qui n’est pas étiquetée selon le présent règlement.

DORS/80-544, art. 1.

C.01.004. (1) Les étiquettes intérieure et extérieure d’une drogue doivent porter

a) sur l’espace principal :

(i) le nom propre, s’il y a lieu, de la drogue inscrit immédiatement avant ou après la marque nominative de celle-ci, le cas échéant, en caractères d’une taille au moins égale à la moitié de celle des caractères de la marque nominative,

(ii) le nom usuel de la drogue à défaut d’un nom propre,

(iii) si une norme est prescrite pour la drogue au titre 6 de la présente partie, une déclaration attestant que la drogue est conforme à la norme canadienne, pour laquelle l’abréviation D.N.C. peut être utilisée,

(iv) si une norme n’est pas prescrite pour la drogue au titre 6 de la présente partie mais figure dans une publication mentionnée à l’annexe B de la Loi, le nom de la publication qui contient cette norme, ou son abréviation donnée à l’annexe B de la Loi, ou, s’il s’agit d’une norme du fabricant, une déclaration en ce sens,

(v) en français et en anglais, la mention « stérile » « sterile » s’il s’agit d’une drogue dont l’état stérile est exigé par le présent règlement;

b) sur le quart supérieur gauche de l’espace principal :

(i) le symbole Pr, seulement s’il s’agit d’une drogue qui doit, en vertu de la présente partie ou de la partie D, être vendue sur ordonnance,

(ii) le symbole « C » inscrit clairement, d’une couleur et de dimensions bien visibles, s’il s’agit d’une drogue contrôlée autre qu’une drogue contrôlée contenue dans un implant agricole et mentionnée à la partie III de l’annexe de la partie G,

(iii) le symbole « N » d’une couleur faisant contraste avec le reste de l’étiquette ou en caractères d’au moins la moitié de la taille de toute autre lettre utilisée sur l’étiquette, s’il s’agit d’un stupéfiant au sens du Règlement sur les stupéfiants,

(iv) s’il s’agit d’une substance ciblée au sens du paragraphe 1(1) du Règlement sur les benzodiazépines et autres substances ciblées, le symbole suivant, d’une couleur contrastant avec le reste de l’étiquette et en caractères d’au moins la moitié de la taille de toute autre lettre utilisée sur l’espace principal :

CE GRAPHIQUE N’EST PAS EXPOSÉ, VOIR DORS/2000-219, ART. 1

c) sur une partie quelconque :

(i) le nom et l’adresse du fabricant de la drogue,

(ii) le numéro de lot de la drogue,

(iii) le mode d’emploi approprié de la drogue,

(iv) une liste quantitative de tous les ingrédients médicinaux de la drogue, désignés par leur nom propre ou, à défaut, par leur nom usuel,

(v) la date limite d’utilisation de la drogue,

(vi) dans le cas d’une drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01, la mention suivante, inscrite en majuscules et de façon lisible :

« SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.

HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS. ».

(2) Outre les exigences du paragraphe (1), l’étiquette extérieure d’une drogue doit indiquer

a) le contenu net du contenant de la drogue, en termes de poids, de volume ou de nombre;

b) dans le cas d’une drogue à usage parentéral, une liste quantitative de tous les agents de conservation incorporés à la drogue, désignés par leur nom propre ou, à défaut, par leur nom usuel; et

c) dans le cas d’une drogue pour usage humain qui contient du mercure ou l’un de ses sels ou dérivés utilisé comme agent de conservation, une liste quantitative de tous les agents de conservation mercuriels incorporés à la drogue, désignés par leur nom propre ou, à défaut, par leur nom usuel.

(3) Lorsque le contenant d’une drogue est trop petit pour avoir une étiquette intérieure conforme aux exigences du présent règlement, la drogue est soustraite à ces exigences d’étiquetage :

a) s’il y a une étiquette extérieure conforme aux dispositions d’étiquetage du présent règlement; et

b) si l’étiquette intérieure indique

(i) le nom propre de la drogue ou, à défaut, son nom usuel, ou la marque nominative s’il s’agit d’une drogue renfermant plus d’un ingrédient médicinal,

(ii) l’activité de la drogue, sauf si, dans le cas d’une drogue renfermant plus d’un ingrédient médicinal, le nom utilisé conformément au sous-alinéa (i) est unique en ce qui a trait à une activité particulière de la drogue,

(iii) le contenu net du récipient de la drogue, s’il ne s’agit pas d’une drogue sous une forme posologique déterminée,

(iv) la voie d’administration s’il ne s’agit pas de la voie orale,

(v) le numéro de lot de la drogue,

(vi) le nom du fabricant de la drogue,

(vii) la date limite d’utilisation de la drogue,

(viii) l’indication de caractéristiques spéciales de la forme posologique si elles ne sont pas manifestes d’après le nom de la drogue visé au sous-alinéa (i) ou (ii).

(4) [Abrogé, DORS/92-654, art. 2]

(5) Le présent article ne s’applique pas

a) à une drogue vendue à un fabricant de drogues; ni

b) à une drogue vendue sur ordonnance si l’étiquette de la drogue porte le mode d’emploi convenable de la drogue et est conforme à l’article C.01.005.

DORS/80-543, art. 2; DORS/81-334, art. 1(A); DORS/85-715, art. 2; DORS/89-229, art. 1; DORS/90-216, art. 1; DORS/90-586, art. 1; DORS/92-654, art. 2; DORS/93-202, art. 2; DORS/97-228, art. 1; DORS/97-515, art. 1; DORS/2000-219, art. 1; DORS/2001-181, art. 4; DORS/2011-88, art. 1. Version précédente C.01.004.1 (1) Il est interdit d’importer une drogue sous forme posologique en vue de la vente à moins qu’une personne ne soit responsable au Canada de la vente de cette drogue.

(2) Il est interdit à toute personne qui importe une drogue sous forme posologique de vendre un lot ou un lot de fabrication de cette drogue, à moins que son nom et l’adresse du principal établissement au Canada de la personne responsable de la vente de cette drogue ne figurent sur l’étiquette intérieure et sur l’étiquette extérieure de la drogue.

DORS/82-524, art. 1; DORS/93-475, art. 1; DORS/97-12, art. 2.

C.01.005. (1) L’espace principal des étiquettes intérieure et extérieure d’une drogue vendue sous forme posologique doit indiquer clairement et lisiblement l’identification numérique que lui a attribuée le Directeur conformément au paragraphe C.01.014.2(1), précédée de la mention « Drogue : identification numérique » ou de la mention « Drug Identification Number » ou des deux, ou de l’abréviation « DIN ».

(2) Le paragraphe (1) ne s’applique pas à une drogue

a) préparée par un pharmacien, conformément à une ordonnance, ou par un praticien; ou

b) vendue conformément à une ordonnance, si l’étiquette de cette drogue indique :

(i) le nom propre, le nom usuel ou la marque nominative de la drogue,

(ii) l’activité de la drogue, et

(iii) le nom du fabricant de la drogue.

(3) Aux fins du présent article et de l’article C.01.014, une « drogue sous sa forme posologique » s’entend d’une drogue prête pour la consommation sans autre transformation.

(4) et (5) [Abrogés, DORS/81-248, art. 1]

DORS/81-248, art. 1; DORS/93-202, art. 3; DORS/98-423, art. 2; DORS/2001-181, art. 4.

C.01.006. Lorsqu’un emballage d’une drogue ne porte qu’une seule étiquette, ladite étiquette doit montrer tous les renseignements que le présent règlement exige sur les étiquettes intérieure et extérieure.

C.01.007. Aucune mention, directe ou indirecte, de la Loi ou du présent règlement ne doit figurer sur une étiquette ou dans la publicité d’une drogue, à moins que ladite mention ne soit précisément requise par la Loi ou par le présent règlement.

C.01.008. [Abrogé, DORS/80-544, art. 2]

C.01.009. Lorsqu’un statut du Parlement du Canada ou un règlement édicté en vertu d’un tel statut fixe pour une drogue une norme de composition ou de qualité et que ledit statut ou règlement donne à la norme un nom ou une désignation, il est interdit de faire figurer ledit nom ou ladite désignation sur l’étiquette ou dans la publicité de ladite drogue, à moins que celle-ci ne soit conforme à ladite norme de composition ou de qualité.

C.01.010. Lorsqu’il est nécessaire d’indiquer le mode d’emploi approprié et sûr dans le cas d’une drogue d’usage parentéral ou de l’annexe F qui sert au traitement ou à la prophylaxie d’une maladie, d’un trouble ou d’un état physique anormal mentionné à l’annexe A de la Loi, les étiquettes et les feuillets insérés dans l’emballage de ladite drogue peuvent mentionner ladite maladie, ledit trouble ou ledit état physique anormal et ladite drogue est exemptée par les présentes des dispositions de l’article 3 de la Loi, sous ce rapport.

C.01.011. (1) Une drogue à laquelle s’applique le paragraphe 10(2) de la Loi doit être exemptée de la norme de toute drogue mentionnée dans toute publication de l’annexe B de la Loi, dans la mesure où cette drogue diffère de la norme quant à la couleur, à la saveur, à la forme et à la dimension, si ces différences ne perturbent pas toute méthode de dosage indiquée par l’une desdites publications.

(2) [Abrogé, DORS/93-243, art. 2]

(3) Lorsqu’une norme de fabricant est utilisée pour une drogue, le fabricant devra tenir à la disposition du Directeur général, à la demande de ce dernier, les détails relatifs à cette norme et à une méthode d’analyse de cette drogue qui soit acceptable au Directeur général.

(4) Il est interdit d’utiliser pour une drogue une norme de fabricant qui prévoit,

a) un degré de pureté inférieur au degré maximal de pureté,

b) un écart d’activité supérieur à l’écart minimal,

indiqués pour cette drogue dans les publications mentionnées à l’annexe B de la Loi.

DORS/93-243, art. 2.

C.01.012. Le fabricant qui fait une déclaration sur l’étiquette d’une drogue sous forme de posologie orale, ou dans sa publicité, relativement au siège, à la vitesse ou à l’étendue de libération d’un ingrédient médicinal de la drogue dans l’organisme, ou à la disponibilité d’un ingrédient médicinal de la drogue dans l’organisme, doit :

a) avant de faire la déclaration, effectuer, par une méthode acceptable, les investigations qui se révèlent nécessaires pour démontrer que le siège, la vitesse ou l’étendue de libération de l’ingrédient médicinal de la drogue dans l’organisme et la disponibilité de l’ingrédient médicinal de la drogue dans l’organisme correspondent à la déclaration;

b) soumettre, sur demande, le dossier de telles investigations au Directeur.

DORS/89-455, art. 2; DORS/94-36, art. 1.

C.01.013. (1) Lorsque le Directeur demande par écrit au fabricant d’une drogue de lui fournir, à ou avant une date donnée, des preuves concernant une drogue, le fabricant doit suspendre la vente de cette drogue après cette date, à moins qu’il n’ait fourni les preuves demandées.

(2) Lorsque le Directeur est d’avis que les preuves fournies par le fabricant, conformément au paragraphe (1), sont insuffisantes, il doit en aviser par écrit le fabricant.

(3) Lorsque, conformément au paragraphe (2), un fabricant est avisé que les preuves concernant une drogue donnée sont insuffisantes, il doit susprendre la vente de ladite drogue, à moins qu’il ne fournisse d’autres preuves et qu’il ne soit avisé par écrit par le Directeur que ces autres preuves sont suffisantes.

(4) Dans cet article « preuves concernant une drogue » signifie des preuves servant à établir l’innocuité de la drogue lorsqu’elle est utilisée dans les conditions d’emploi recommandées et son efficacité pour les indications recommandées.

Attribution et annulation de l'identification numérique des drogues

C.01.014. (1) Il est interdit à un fabricant de vendre, sous forme posologique, une drogue qui n’a pas fait l’objet d’une identification numérique, ou dont l’identification a été annulée selon l’article C.01.014.6.

(2) Le paragraphe (1) ne s’applique pas aux drogues visées à l’annexe C de la Loi ni au sang entier et ses composants ni aux aliments médicamentés au sens de l’article 2 du Règlement de 1983 sur les aliments du bétail.

DORS/81-248, art. 2; DORS/97-12, art. 3.

C.01.014.1. (1) Le fabricant d’une drogue, une personne autorisée par lui ou, dans le cas d’une drogue devant être importée au Canada, l’importateur de la drogue, peut présenter une demande d’identification numérique pour cette drogue.

(2) Une demande d’identification numérique doit être présentée au Directeur par écrit et doit contenir les renseignements suivants :

a) le nom du fabricant de la drogue, tel qu’il figurera sur l’étiquette;

b) la forme pharmaceutique sous laquelle la drogue doit être vendue;

c) dans le cas d’une drogue non visée à l’alinéa d), la voie d’administration recommandée;

d) dans le cas d’une drogue destinée à désinfecter des locaux, le genre de locaux où il est recommandé de l’utiliser;

e) une liste quantitative des ingrédients médicinaux contenus dans la drogue, désignés par leur nom propre ou, à défaut de celui-ci par leur nom usuel;

f) la marque nominative sous laquelle la drogue doit être vendue;

g) une indication portant qu’il s’agit d’une drogue à usage humain, à usage vétérinaire ou devant servir à désinfecter des locaux;

h) le nom de la quantité de chaque colorant de nature non médicinale;

i) l’usage ou les fins pour lesquels la drogue est recommandée;

j) la posologie recommandée;

k) l’adresse du fabricant visé à l’alinéa a) et, si cette adresse est à l’extérieur du pays, le nom et l’adresse de l’importateur de la drogue;

l) les nom et adresse du particulier, de l’entreprise ou de la société ou de la corporation, autres que les noms et adresses indiqués aux alinéas a) et k), qui paraîtront sur l’étiquette de la drogue;

m) le libellé des étiquettes et des dépliants accompagnant la drogue et de toute autre documentation supplémentaire disponible sur demande; et

n) le nom et le poste de la personne ayant signé la demande, ainsi que la date de signature.

(3) Dans le cas d’une drogue nouvelle, la présentation de drogue nouvelle, la présentation de drogue nouvelle pour usage exceptionnel, la présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel déposée en vertu des articles C.08.002, C.08.002.01 ou C.08.002.1 tient lieu de demande d’identification numérique.

DORS/81-248, art. 2; DORS/93-202, art. 4; DORS/98-423, art. 3; DORS/2011-88, art. 2. Version précédente

C.01.014.2. (1) Sous réserve du paragraphe (2), sur réception des renseignements visés au paragraphe C.01.014.1(2) ou aux articles C.08.002, C.08.002.01 ou C.08.002.1, selon le cas, le Directeur remet au fabricant ou à l’importateur un document qui :

a) indique :

(i) soit l'identification numérique attribuée à la drogue, précédée de l'abréviation « DIN »,

(ii) soit, si la drogue a deux marques nominatives ou plus, les identifications numériques attribuées à celle-ci par le Directeur, dont chacune correspond à une marque nominative et est précédée de l'abréviation « DIN »;

b) comporte les renseignements visés aux alinéas C.01.014.1(2)a) à f).

(2) Le Directeur peut refuser de remettre le document visé au paragraphe (1) s'il a de bonnes raisons de croire que le produit faisant l'objet d'une demande visée à l'article C.01.014.1

a) n'est pas une drogue; ou

b) est une drogue dont la vente nuirait à la santé du consommateur ou de l'acheteur ou enfreindrait la Loi ou le présent règlement.

(3) Lorsque le Directeur refuse, selon le paragraphe (2), de remettre le document, le requérant peut fournir des renseignements supplémentaires et lui demander de reconsidérer sa décision.

(4) Le Directeur doit reconsidérer sa décision de refuser de remettre le document, en fonction des renseignements supplémentaires fournis conformément au paragraphe (3).

DORS/81-248, art. 2; DORS/92-230, art. 1; DORS/98-423, art. 4; DORS/2011-88, art. 3. Version précédente C.01.014.3. Le fabricant ou l’importateur, ou la personne autorisée par l’un de ceux-ci, doit, dans les 30 jours suivant la mise en marché de la drogue, dater et signer le document qui lui est remis à l’égard de la drogue selon le paragraphe C.01.014.2(1) et le renvoyer :

a) avec une confirmation de l’exactitude des renseignements qu’il contient;

b) avec une indication de la date de la mise en marché de la drogue au Canada; et

c) avec des échantillons ou des facsimilés des étiquettes et des dépliants d’accompagnement, ainsi que les renseignements supplémentaires sur l’emploi du produit fournis sur demande.

DORS/81-248, art. 2; DORS/98-423, art. 5.

C.01.014.4. Dans le cas où les renseignements visés au paragraphe C.01.014.1(2) ne sont plus exacts :

a) en raison de la modification des renseignements visés aux alinéas C.01.014.1(2)a) à f) :

(i) qui se produit avant la mise en marché de la drogue, une nouvelle demande doit être présentée, ou

(ii) qui se produit après la mise en marché de la drogue, la vente doit être discontinuée jusqu’à ce qu’une nouvelle demande d’identification numérique soit présentée et qu’un numéro soit attribué; et

b) en raison de la modification des renseignements visés aux alinéas C.01.014.1(2)g) à k) :

(i) qui se produit avant la mise en marché de la drogue, tous les détails de la modification doivent être présentés en même temps que le document visé à l’article C.01.014.3, ou

(ii) qui se produit après la mise en marché de la drogue, la personne à qui l’identification numérique de la drogue a été attribuée doit en informer le Directeur dans les 30 jours suivant la modification.

DORS/81-248, art. 2; DORS/92-230, art. 2; DORS/98-423, art. 6.

C.01.014.5. Le fabricant d’une drogue doit fournir au Directeur, avant le premier octobre de chaque année et selon la forme autorisée par le Directeur, une déclaration signée par lui-même ou en son nom par une personne autorisée, attestant que tous les renseignements qu’il a présentés jusqu’alors au sujet de la drogue sont toujours exacts.

DORS/81-248, art. 2.

C.01.014.6. (1) Le Directeur annule l’identification numérique d’une drogue

a) si la personne à qui il l’a attribuée l’informe que la vente ou l’importation de la drogue concernée a été discontinuée;

b) si la drogue est une drogue nouvelle pour laquelle l’avis de conformité a été suspendu conformément à l’article C.08.006; ou

c) s’il a été décidé que le produit faisant l’objet de l’identification numérique n’est pas une drogue.

(2) Le Directeur peut annuler l’identification numérique d’une drogue

a) si le fabricant de la drogue ne s’est pas conformé à l’article C.01.014.5; ou

b) si le fabricant à qui l’identification numérique a été attribuée a été avisé, selon l’article C.01.013, que les preuves présentées au sujet de la drogue sont insuffisantes.

DORS/81-248, art. 2.

C.01.014.7. Lorsqu’une personne à qui l’identification numérique d’une drogue a été attribuée en discontinue la vente au Canada, elle doit informer le Directeur dans les 30 jours suivant la discontinuation.

DORS/81-248, art. 2.

Temps de désagrégation des comprimés

C.01.015. (1) Sous réserve du paragraphe (2), il est interdit de vendre une drogue pour usage humain se présentant sous forme de comprimé destiné à être avalé entier, à moins qu’elle ne présente les caractéristiques de désagrégation suivantes lorsqu’elle est soumise à l’épreuve décrite dans la méthode officielle DO-25 intitulée Détermination du temps de désagrégation des comprimés en date du 5 juillet 1989 :

a) dans le cas d’un comprimé non enrobé, le comprimé soumis à l’épreuve se désagrège en au plus 45 minutes;

b) dans le cas d’un comprimé enrobé ordinaire, le comprimé soumis à l’épreuve se désagrège en au plus 60 minutes;

c) dans le cas d’un comprimé désigné sur l’étiquette comme un comprimé à enrobage entéro-soluble ou à enrobage destiné à une fin semblable, le comprimé immergé pendant 60 minutes dans du suc gastrique simulé ne se désagrège pas et, lorsqu’il est immergé dans du suc intestinal simulé, il se désagrège en au plus 60 minutes.

(2) Le paragraphe (1) ne s’applique pas à la drogue sous forme de comprimé lorsque, selon le cas :

a) un avis de conformité a été délivré à l’égard de la drogue sous forme de comprimé en application des articles C.08.004 ou C.08.004.01;

b) [Abrogé, DORS/98-423, art. 7]

c) une épreuve de dissolution ou de désagrégation est prévue pour la drogue sous forme de comprimé au titre 6 de la présente partie;

d) l’étiquette de la drogue indique que celle-ci satisfait à une norme contenue dans l’une des publications mentionnées à l’annexe B de la Loi;

e) il est démontré, selon une méthode acceptable, que la drogue est libérée dans l’organisme;

f) une déclaration est faite sur l’étiquette, ou dans toute publicité, relativement au siège, à la vitesse ou à l’étendue de libération d’un ingrédient médicinal de la drogue dans l’organisme, ou à la disponibilité de l’ingrédient médicinal de la drogue dans l’organisme.

DORS/89-429, art. 2; DORS/89-455, art. 3; DORS/94-36, art. 2; DORS/98-423, art. 7; DORS/2011-88, art. 4. Version précédente

Interdiction

C.01.016. Il est interdit à tout fabricant de vendre une drogue, à moins qu’il se conforme aux conditions énoncées aux articles C.01.017 à C.01.019.

DORS/95-521, art. 2; DORS/2011-31, art. 1. Version précédente

Rapports sur les réactions indésirables graves aux drogues

C.01.017. Le fabricant, dans les quinze jours après avoir reçu communication de renseignements concernant toute réaction indésirable grave à une drogue, ou après en avoir pris connaissance, selon la première des deux éventualités à survenir, présente un rapport faisant état de ces renseignements au ministre dans les cas suivants :

a) il s’agit d’une réaction indésirable grave à la drogue survenue au Canada;

b) il s’agit d’une réaction indésirable grave et imprévue à la drogue survenue à l’extérieur du Canada.

DORS/95-521, art. 2; DORS/2011-31, art. 1. Version précédente

Rapport de synthèse annuel et fiches d’observation

C.01.018. (1) Le fabricant prépare un rapport de synthèse annuel sur les renseignements concernant les réactions indésirables à une drogue et les réactions indésirables graves à une drogue dont il a reçu communication ou a eu connaissance au cours des douze derniers mois.

(2) Le rapport de synthèse annuel comprend une analyse critique et concise des réactions indésirables à une drogue et des réactions indésirables graves à une drogue.

(3) Dans le cadre de la préparation du rapport de synthèse annuel, le fabricant évalue, en se fondant sur l’analyse visée au paragraphe (2), si ce qui est connu à propos des risques et avantages associés à la drogue a changé de façon importante durant la période visée par le rapport et fait état de ses conclusions à cet égard dans son rapport.

(4) Lorsque, dans le cadre de la préparation du rapport de synthèse annuel, le fabricant conclut à un changement important, il en informe sans tarder le ministre par écrit, si ce n’est déjà fait.

(5) Afin d’évaluer l’innocuité de la drogue et son efficacité, le ministre peut demander par écrit au fabricant de lui présenter l’un ou l’autre des documents suivants, ou les deux :

a) les rapports de synthèse annuels;

b) les fiches d’observation relatives aux réactions indésirables à la drogue et aux réactions indésirables graves à la drogue qui sont connues du fabricant.

(6) Après avoir donné au fabricant la possibilité de se faire entendre, le ministre précise un délai raisonnable, selon les circonstances, pour la présentation des rapports de synthèse annuels ou des fiches d’observation, ou des deux. Le fabricant présente les documents dans le délai imparti.

DORS/2011-31, art. 1. Version précédente

Rapport de synthèse relatif à un sujet de préoccupation

C.01.019. (1) Le ministre peut, aux fins d’évaluation de l’innocuité et de l’efficacité de la drogue, demander par écrit au fabricant de lui présenter un rapport de synthèse relatif à un sujet de préoccupation.

(2) Le rapport comprend une analyse critique et concise des réactions indésirables à la drogue et des réactions indésirables graves à la drogue, ainsi que les fiches d’observation portant sur tout ou partie des réactions indésirables à la drogue et réactions indésirables graves à la drogue connues du fabricant et associées au sujet de préoccupation que le ministre a demandé à celui-ci d’analyser dans le rapport.

(3) Après avoir donné au fabricant la possibilité de se faire entendre, le ministre précise un délai raisonnable, selon les circonstances, pour la présentation du rapport. Ce délai peut être de moins de trente jours si le ministre a besoin des renseignements contenus dans le rapport pour établir si la drogue présente un risque grave et imminent pour la santé humaine.

(4) Le fabricant présente le rapport dans le délai imparti.

DORS/2011-31, art. 1.

Tenue de dossiers

C.01.020. (1) Le fabricant tient les dossiers des rapports et fiches d’observations visés aux articles C.01.017 à C.01.019.

(2) Il conserve les dossiers pendant vingt-cinq ans après la date de leur création.

DORS/2011-31, art. 1.

Doses limites des drogues

C.01.021. Sauf disposition contraire du présent règlement, il est interdit de vendre pour administration humaine une drogue mentionnée au tableau ci-après, à moins qu’il ne soit indiqué sur les étiquettes intérieure et extérieure (sauf l’étiquette intérieure d’un récipient à dose simple),

a) la composition quantitative de ladite drogue; et

b) la dose simple et la dose quotidienne recommandées pour adultes et désignées comme telles, exception faite

(i) des préparations destinées uniquement à l’usage externe, et

(ii) des préparations destinées uniquement aux enfants; et

c) des directives convenables d’emploi, lorsque la drogue est recommandée pour les enfants, directives qui doivent soit

(i) consister en la déclaration : « POUR ENFANTS : selon les instructions du médecin », ou

(ii) fixer des doses maximums simple et quotidienne qui ne doivent pas dépasser les valeurs données ci-dessous :

Années d’âge Proportion de la dose adulte

10 à 14 la moitié 5 à 9 le quart 2 à 4 le sixième Moins de 2 ans Selon les instructions du médecins

TABLEAU

TABLEAU DES DOSES LIMITES DES DROGUES POUR ADULTES

Usage Usage interneexterne — —

Dose maximum enDrogue Dose milligrammes, sauf indicationmaximum contraire Dosepour cent Dose quotidiennesimple

Acétaminophène ....... — 650 4,0 g Acétanilide et dérivés (exception faite de N­ — 65 195acétyl-ρ-aminophénol ....... Acide acétylsalicylique ....... — 650 4,0 g Acide cyanhydrique (prussique) solution à 2 — 0,062 ml 0,31 mlpour cent ....... Acide tannique ....... — 150 1 000 Aconitine, ses préparations et dérivés ....... 0,2 0,1 0,1 Adonis vernalis ....... — 65 195 Amylocaïne, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage 0,0 0,0 0,0 ophtalmique ....... Antimoine (composés d’) ....... — 3,3 13

Usage externe —

Drogue Dose maximum

pour cent

Atropine, méthylatropine, et leurs sels ....... 1,0 Belladone et ses préparations, en alcaloïdes de la belladone ....... 0,375

Benzène (benzol) ....... — Benzocaïne ....... 8,0 Bêta-naphtol ....... — Bleu de méthylène ....... — Bromure d’aminoxyde d’hyoscine ....... 0,5 Butacaïne, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage 0,0 ophtalmique ....... Cadexomer Iode ....... 0,0 Cantharides, cantharidine et leurs préparations, basées sur la cantharidine, à 0,03 l’exception des vésicatoires ....... Cantharides, vésicatoires seulement ....... 0,2 Chlorate de potassium ....... — Chlorate de potassium (gargarisme) ....... 2,5 Chlorate de sodium ....... — Chlorhydrate d’amylocaïne, sauf lorsque vendu ou recommandé pour usage 1,0 ophtalmique ....... Chlorhydrate de cinchocaïne, à l’exception des suppositoires ....... 1,0

Chlorhydrate de cinchocaïne (suppositoires —seulement) ....... Chlorobutanol (à toutes les 4 heures au plus) —....... Colchicine et ses sels ....... — Colchique et ses préparations, en colchicine —....... Cyproheptadine et ses sels, lorsqu’ils sont —vendus ou recommandés pour augmenter le

Usage interne

— Dose maximum en milligrammes, sauf indication contraire Dose Dose quotidiennesimple 0,13 0,44

0,13 0,44

— — 195 585 195 585 130 390 0,325 0,975

0,0 0,0

0,0 0,0

0,0 0,0

0,0 0,0 325 975 — — 325 975

0,0 0,0

0,0 0,0

11 11

325 975

0,55 1,65

0,27 0,81

0,0 0,0

Usage externe —

Drogue Dose maximum

pour cent

poids....... Éphédrine et ses sels ....... — Éphédrine et ses sels (vaporisations) ....... 1,0 Épinéphrine et ses sels (vaporisations) ....... 1,0 Gelséminine (gelsémine) et ses sels (à toutes —les 4 heures au plus) ....... Gelsémium et ses préparations, en drogue —brute ....... Huile de cèdre ....... 25,0 Huile de croton ....... 10,0 Hydroquinone ....... 2,0 Hyoscine (scopolamine) et ses sels ....... 0,5 Hyoscyamine et ses sels ....... — Jusquiame et ses préparations, en alcaloïdes —de jusquiame ....... Lobélie et ses préparations, en drogue brute —....... Lobéline et ses sels ....... — Phénacétine ....... — Phénazone et ses composés ....... — Phénol ....... 2,0 Phénylpropanolamine, lorsqu’elle est vendue ou recommandée comme déprimant de — l’appétit ....... Phosphore ....... — Podophylline ....... 0,0 Procaïne et ses sels ....... — Proxymétacaïne, ses sels et dérivés, lorsqu’ils sont vendus ou recommandés pour usage 0,0 ophtalmique ....... Salicylamide ....... — Santonine ....... —

Usage interne

— Dose maximum en milligrammes, sauf indication contraire Dose Dose quotidiennesimple

11 —

32,5 —

— —

0,55 1,65

16,2 48,6

0,0 0,0 — 0,325 0,325

0,0 0,0 — 0,975 0,975

0,073 0,22

130 390

2,0 650 325 32,5

6,0 1,95 g 975 260

0,0 0,0

0,0 0,0 —

0,0 0,0 —

0,0 0,0

975 65

2,925 g 130

Usage Usage interneexterne — —

Dose maximum enDrogue Dose milligrammes, sauf indicationmaximum contraire Dosepour cent Dose quotidiennesimple

Scille et ses préparations, en drogue brute — 32,5 97,5....... Sélénium et ses composés ....... 2,5 0,0 0,0 Sodium (fluorure de) ....... — 0,1 0,1 Stramoïne et ses préparations, en alcaloïdes — 0,16 0,65de stramoïne ....... Strychnine et ses sels ....... — 0,0 0,0 Sulfate de butacaïne, sauf lorsque vendu ou 1,0 0,0 0,0recommandé pour usage ophtalmique ....... Tétracaïne, ses sels et dérivés lorsqu’ils sont vendus ou recommandés pour usage 0,0 0,0 0,0 ophtalmique ....... Thiocyanates ....... 0,0 0,0 0,0 Uréthane ....... 0,0 0,0 0,0

Quand des drogues douées de propriétés physiologiques semblables sont en mélange, la dose de chacune doit être réduite proportionnellement.

Les doses exactes peuvent être exprimées en unités métriques ou en unités impériales. Si la dose est exprimée en unités des deux systèmes, l’une des données peut n’être qu’approximative, mais cette valeur approximative doit précéder ou suivre la donnée exacte d’après laquelle le produit sera jugé, et elle doit être indiquée entre parenthèses.

DORS/78-422, art. 1; DORS/80-544, art. 3; DORS/84-145, art. 1; DORS/85-715, art. 3; DORS/85-966, art. 2; DORS/88-94, art. 1; DORS/89-229, art. 2; DORS/89-548, art. 1.

C.01.022. Nonobstant l’alinéa C.01.021b), la dose simple et la dose quotidienne recommandées, pour une drogue

a) destinée à être brûlée en vue de l’inhalation des fumées, peuvent être augmentées à 10 fois la dose orale; et

b) présentée en suppositoires, peuvent être augmentées à 33 1/3 pour cent en excédent de la dose orale.

C.01.024. (1) Les articles C.01.021 et C.01.022 ne s’appliquent pas

a) à une drogue vendue à un fabricant de drogues; ni

b) à une drogue vendue sur ordonnance.

(2) L’alinéa C.01.021c) ne s’applique pas

a) à l’acétaminophène;

b) à l’acide acétylsalicylique;

c) au salicylate de magnésium;

d) au salicylate de sodium; ni

e) au salicylate de choline.

(3) Lorsqu’une drogue mentionnée aux alinéas (2)a) à d) est recommandée pour les enfants, il est interdit de vendre cette drogue pour administration humaine à moins qu’il ne soit indiqué sur les étiquettes intérieure et extérieure

a) qu’il est recommandé de prendre cette drogue « selon les instructions du médecin »; ou

b) qu’il est recommandé de ne pas prendre de doses supérieures à celles indiquées dans le tableau ci-après et de ne pas administrer de doses simples à moins de quatre heures d’intervalle.

TABLEAU

DOSES MAXIMALES

Colonne Colonne ColonneColonne II Colonne III Colonne IV Colonne VI VI VII Dose maximale Dose Dose maximale Dosepour enfants en maximale pour enfants en maximale Dose Doseunités pour enfants unités pour adultes maximale maximaleArticle Âge posologiques de en unités posologiques en unités simple quotidienne80 mg posologiques de 160 mg posologiques (en mg) (en mg)d’acétaminophène de 80 mg d’acétaminophène de 325 mgen gouttes

11 ans

1. jusqu’à moins de

— 6 3 1,5 480 2 400

12 ans 9 ans

2. jusqu’à moins de

— 5 2,5 1,25 400 2 000

11 ans

3. 6 ansjusqu’à — 4 2 1 320 1 600

Colonne Colonne ColonneColonne II Colonne III Colonne IV Colonne VI VI VII Dose maximale Dose Dose maximale Dosepour enfants en maximale pour enfants en maximale Dose Doseunités pour enfants unités pour adultes maximale maximaleArticle Âge posologiques de en unités posologiques en unités simple quotidienne80 mg posologiques de 160 mg posologiques (en mg) (en mg)d’acétaminophène de 80 mg d’acétaminophène de 325 mgen gouttes

moins de 9 ans 4 ans

4. jusqu’àmoins — 3 1,5 — 240 1 200

de 6 ans 2 ans

5. jusqu’àmoins — 2 1 — 160 800

de 4 ans

6.

1 an jusqu’à moins de 2 ans

1,5 ou selon les instructions du médecin

— — — 120 600

7.

4 mois jusqu’à moins de 1 an

1 ou selon les instructions du médecin

— — — 80 400

0 mois jusqu’à 0,5 ou selon les

8. moins instructions du — — — 40 200 de médecin 4 mois

(4) Lorsque le salicylate de choline est recommandé pour les enfants, il est interdit de vendre cette drogue pour administration humaine à moins qu’il ne soit indiqué sur les étiquettes intérieure et extérieure

a) qu’il est recommandé de prendre cette drogue « selon les instructions du médecin »; ou

b) qu’il est recommandé de ne pas prendre de doses supérieures à celles indiquées dans le tableau ci-après et de ne pas administrer de doses simples à moins de quatre heures d’intervalle.

TABLEAU

DOSE MAXIMUM

Âge (Années) Unités posologiques adultes Dose simple Dose maximum(435 mg) (en mg) quotidienne (en mg) 11 à moins de 12 1 1/2 660 3 300

9 à moins de 11 1 1/4 550 2 750

6 à moins de 9 1 440 2 200

4 à moins de 6 3/4 330 1 650

2 à moins de 4 1/2 220 1 100

moins de 2 selon les instructions du médecinans

DORS/84-145, art. 2; DORS/90-587, art. 1.

C.01.025. Les étiquettes intérieure et extérieure d’une drogue portant une dose simple ou dose quotidienne recommandée, ou la déclaration d’une concentration dépassant les limites fixées à l’article C.01.021, doivent toutes deux porter une mise en garde signalant que le produit ne doit être employé que sur le conseil d’un médecin.

C.01.026. Les dispositions de l’article C.01.025 ne s’appliquent pas

a) à une drogue vendue sur ordonnance; ni

b) à l’étiquette intérieure d’un récipient à dose unique.

C.01.027. (1) Quiconque fait la publicité auprès du grand public d’une drogue pour administration humaine doit ne faire porter cette publicité que sur la marque nominative, le nom propre, le nom usuel, le prix et la quantité s’il s’agit d’une drogue :

a) qui contient une drogue mentionnée au tableau de l’article C.01.021;

b) dont l’étiquette fait état :

(i) soit d’une dose recommandée pour adultes, simple ou quotidienne, qui entraîne le dépassement de la dose maximum pour adultes, simple ou quotidienne, de la drogue visée à l’alinéa a) que prévoit le tableau de l’article C.01.021,

(ii) soit d’une concentration de la drogue visée à l’alinéa a) qui excède la dose maximum prévue au tableau de l’article C.01.021.

(2) Le paragraphe (1) ne s’applique pas aux produits contenant :

a) de l’acétaminophène;

b) de l’acide acétylsalicylique;

c) du salicylate de choline;

d) du salicylate de magnésium;

e) du salicylate de sodium.

(3) [Abrogé, DORS/94-409, art. 1]

(4) Quiconque fait la publicité auprès du grand public d’une drogue pour administration humaine qui contient de l’acide acétylsalicylique ne doit pas faire porter cette publicité sur son administration aux enfants ou aux adolescents ou sur son utilisation par eux.

DORS/81-358, art. 1; DORS/84-145, art. 3; DORS/85-715, art. 4(F); DORS/85-966, art. 3; DORS/93-202, art. 5; DORS/93-411, art. 1; DORS/94-409, art. 1.

Mises en garde et emballages protège-enfants

C.01.028. (1) Sous réserve du paragraphe (2), les étiquettes intérieure et extérieure d’une drogue qui contient l’un des ingrédients suivants :

a) de l’acide acétylsalicylique ou un de ses sels ou dérivés, de l’acide salicylique ou un de ses sels, ou de la salicylamide doivent porter, si la drogue est recommandée pour les enfants, une mise en garde spécifiant que la drogue ne doit pas être administrée à un enfant de moins de deux ans sauf sur l’avis d’un médecin;

b) de l’acide borique ou du borate de sodium comme ingrédient médicinal doivent porter une mise en garde spécifiant que la drogue ne doit pas être administrée à un enfant de moins de trois ans;

c) de l’hyoscine (scopolamine) ou un de ses sels, doivent porter une mise en garde spécifiant que la drogue ne doit pas être employée par des personnes atteintes de glaucome, ni si elle provoque une sensation douloureuse de tension dans l’oeil ou embrouille la vue;

d) de la phénacétine, seule ou en combinaison avec d’autres drogues, doivent porter la mise en garde suivante :

« MISE EN GARDE : Peut être dangereux à fortes doses ou pendant un temps prolongé. Ne pas dépasser la dose recommandée sans consulter un médecin. »;

e) de l’acide acétylsalicylique destiné à l’usage interne doivent porter une mise en garde précisant que la drogue ne doit pas être administrée aux enfants ou aux adolescents atteint de la varicelle ou ayant les symptômes de la grippe ni utilisée par eux, sauf après consultation d’un médecin ou d’un pharmacien au sujet du syndrome de Reye; la mise en garde doit également signaler que le syndrome de Reye est une maladie rare et grave.

(2) Le paragraphe (1) ne s’applique pas :

a) à une drogue destinée exclusivement à l’usage parentéral;

b) à une drogue délivrée sur ordonnance;

c) à une drogue qui doit être vendue sur ordonnance aux termes du présent règlement ou du Règlement sur les stupéfiants.

DORS/86-93, art. 2; DORS/88-323, art. 2(F); DORS/93-411, art. 2.

C.01.029. (1) Sous réserve des paragraphes C.01.031.2(1) et (2), une mise en garde spécifiant qu’il faut conserver la drogue hors de la portée des enfants doit figurer sur les étiquettes intérieure et extérieure d’une drogue :

a) qui contient l’un des ingrédients suivants :

(i) de l’acide salicylique, un de ses sels ou de la salicylamide,

(ii) de l’acide acétylsalicylique, un de ses sels ou dérivés,

(iii) de l’acétaminophène,

(iv) plus de cinq pour cent de salicylate d’alkyle; ou

b) qui est dans un emballage qui renferme :

(i) soit plus que l’équivalent de 250 mg de fer élément,

(ii) soit plus que l’équivalent de 120 mg d’ion fluorure, à moins que la drogue ne soit réservée à l’usage des cabinets de dentiste.

(2) Sous réserve des paragraphes C.01.031.2(1) et (2), une mise en garde spécifiant que la quantité de drogue contenue dans l’emballage est suffisante pour causer des torts sérieux à un enfant, doit figurer sur les étiquettes intérieure et extérieure d’un emballage qui renferme

a) plus de 1,5 g d’acide salicylique ou d’une quantité équivalente de l’un de ses sels ou de la salicylamide;

b) plus de 2,0 g d’acide acétylsalicylique ou d’une quantité équivalente de l’un de ses sels ou dérivés;

c) plus de 3,2 g d’acétaminophène;

d) plus de l’équivalent de 250 mg de fer élément; ou

e) plus que l’équivalent de 120 mg d’ion fluorure, à moins que la drogue ne soit réservée à l’usage des cabinets de dentiste.

(3) Les mises en garde exigées aux paragraphes (1) et (2) doivent être précédées d’un symbole bien en évidence de forme octogonale et de couleur frappante sur fond de couleur contrastante.

DORS/86-93, art. 2; DORS/87-484, art. 2; DORS/88-323, art. 3(F); DORS/90-587, art. 2; DORS/93-468, art. 1.

C.01.030. [Abrogé, DORS/2003-196, art. 104]

C.01.031. (1) Sous réserve de l’article C.01.031.2,

a) est interdite la vente d’une drogue mentionnée au paragraphe C.01.029(1) à moins

(i) qu’elle ne soit emballée dans un emballage protège-enfants lorsque la drogue est recommandée exclusivement pour les enfants,

(ii) qu’elle ne soit offerte dans au moins un format d’emballage protège-enfants lorsque la drogue n’est pas recommandée exclusivement pour les enfants;

b) lorsqu’une drogue mentionnée au paragraphe C.01.029(1) est emballée dans un emballage qui n’est pas un emballage protège-enfants, l’étiquette extérieure doit indiquer que la drogue est disponible dans un emballage protège-enfants.

(2) [Abrogé, DORS/93-468, art. 2]

DORS/86-93, art. 2; DORS/87-16, art. 1; DORS/93-468, art. 2.

C.01.031.1. [Abrogé, DORS/87-484, art. 3]

C.01.031.2. (1) Les articles C.01.029 à C.01.031 ne s’appliquent pas à :

a) une drogue qui doit être vendue sur ordonnance aux termes du présent règlement ou du Règlement sur les stupéfiants;

b) une drogue destinée exclusivement à l’usage parentéral;

c) une drogue sous forme de préparation effervescente ou de poudre;

d) une drogue sous forme de suppositoire;

e) une drogue destinée à l’usage topique, sauf s’il s’agit d’une préparation liquide contenant plus de cinq pour cent de salicylate d’alkyle;

f) une drogue emballée dans un emballage non refermable contenant au plus deux doses normales pour un adulte;

g) une drogue sous forme de pâte dentifrice.

(2) Les articles C.01.029 à C.01.031 ne s’appliquent pas à une drogue qui est remballée par un pharmacien ou un praticien au moment de la vente.

(3) L’article C.01.031 ne s’applique pas à :

a) une drogue vendue seulement dans un contenant muni d’un applicateur à bille ou d’un vaporisateur ou d’un applicateur à mèche fixé en permanence;

b) une drogue vendue exclusivement à l’intention des animaux autres que les animaux familiers;

c) une drogue réservée à l’usage des cabinets de dentiste ou présentée dans un emballage destiné uniquement aux hôpitaux.

DORS/86-93, art. 2; DORS/87-484, art. 4; DORS/88-323, art. 5(F); DORS/93-468, art. 3.

C.01.032. Est interdite la vente de toute drogue corticostéroïde pour usage ophtalmique, à moins

a) que l’étiquette extérieure ou le feuillet inséré dans l’emballage ne porte, comme partie du mode d’emploi, les déclarations ci-dessous :

« Contre-indications

Affections virales de la cornée et des conjonctives

Tuberculose des yeux

Affections fongiques des yeux

Infections purulentes aiguës et non traitées des yeux, qui, à l’instar des autres affections causées par des micro-organismes, peuvent être masquées ou stimulées par la présence du stéroïde.

Effets secondaires

L’usage ophtalmique prolongé des drogues corticostéroïdes peut causer un accroissement de la pression intra-oculaire chez certains sujets et, dans les affections causant l’amincissement de la cornée, on a vu des perforations se produire; »

et

b) que l’étiquette intérieure ne porte les déclarations requises par l’alinéa a) ou les instructions de lire l’étiquette extérieure ou le feuillet inséré dans l’emballage pour se renseigner sur les contre-indications et les effets secondaires.

C.01.033. L’article C.01.032 ne s’applique pas à une drogue corticostéroïde dispensée par un pharmacien inscrit qui remplit une ordonnance.

C.01.034. Est interdit l’envoi, à un praticien de, matières publicitaires relatives aux drogues corticostéroïdes pour usage ophtalmique à moins que les déclarations requises par l’alinéa C.01.032a) ne soient incluses dans ces matières.

C.01.035. Les articles C.01.032 et C.01.034 ne s’appliquent pas à une drogue vendue pour l’usage vétérinaire seulement.

Divers

C.01.036. (1) Il est interdit à un fabricant ou importateur de vendre

a) une drogue qui contient de la phénacétine associée à un sel ou à un dérivé de l’acide salicylique;

b) une drogue pour usage humain qui contient de l’oxyphénisatine, de l’acétate d’oxyphénisatine ou de la phénisatine; ou

c) une drogue pour usage humain qui contient du mercure ou l’un de ses sels ou dérivés, sauf s’il s’agit de l’une des drogues suivantes dans laquelle le mercure ou l’un de ses sels ou dérivés est utilisé comme agent de conservation et pour laquelle le fabricant ou l’importateur a soumis au Directeur des preuves démontrant que l’utilisation de cet agent de conservation est le seul moyen satisfaisant d’assurer la stérilité ou la stabilité de la drogue :

(i) une drogue mentionnée aux annexes C ou D de la Loi,

(ii) l’une des drogues suivantes :

(A) une drogue ophtalmique ou une drogue pour usage dans la région oculaire,

(B) une drogue pour administration par voie nasale,

(C) une drogue pour administration par voie otique,

(D) une drogue à usage parentéral emballée dans un contenant à doses multiples.

(2) Pour l’application de la division (1)c)(ii)(A), « région oculaire » désigne la région délimitée par les crêtes supraorbitale et infraorbitale et comprend les sourcils, la peau située sous les sourcils, les paupières, les cils, le sac conjonctival de l’oeil, le globe oculaire et le tissu mou situé sous l’oeil et à l’intérieur de la crête infraorbitale.

DORS/78-423, art. 2; DORS/86-93, art. 3; DORS/89-229, art. 3.

C.01.036.1. Est interdite la vente au grand public de l’oxyde nitreux ainsi que la publicité le concernant.

DORS/78-875, art. 1.

C.01.037. (1) Il est interdit de vendre au grand public une drogue recommandée exclusivement pour les enfants si l’emballage qui la contient renferme :

a) soit plus de 1,92 g de salicylamide ou d’acide salicylique ou de la quantité équivalente de l’un des sels d’acide salicylique;

b) soit plus de 1,92 g d’acide acétylsalicylique ou de la quantité équivalente de l’un de ses sels ou dérivés;

c) soit plus de 3,2 g en unités posologiques de 160 mg d’acétaminophène;

d) soit plus de 1,92 g en unités posologiques de 80 mg d’acétaminophène.

(2) Le paragraphe (1) ne s’applique pas à une drogue délivrée sur ordonnance.

DORS/86-93, art. 4; DORS/87-484, art. 5; DORS/88-323, art. 6; DORS/90-587, art. 3.

C.01.038. Une drogue destinée à l’usage des humains est adultérée si elle contient

a) de la strychnine ou l’un de ses sels;

b) des extraits ou des teintures de

(i) Strychnos nux vomica,

(ii) Strychnos Ignatti, ou

(iii) une espèce de Strychnos qui contient de la strychnine, autre que les espèces mentionnées aux sous-alinéas (i) et (ii),

c) du méthapyrilène ou l’un de ses sels;

d) de l’échimidine ou l’un de ses sels; ou

e) des plantes des espèces suivantes ou des extraits ou des teintures de :

(i) Symphytum asperum,

(ii) Symphytum x uplandicum, ou

(iii) toute autre espèce de plante qui contient de l’échimidine.

DORS/79-512, art. 1; DORS/88-173, art. 1.

C.01.039. Sont soustraits de l’application de la présente partie, les produits de diagnostic in vitro qui sont des drogues ou qui contiennent des drogues autres que celles visées à l’annexe E de la Loi ainsi que toute drogue visée à l’annexe D de la Loi dont l’étiquette porte qu’elle ne doit servir qu’en médecine vétérinaire.

DORS/97-12, art. 4.

C.01.040. Il est interdit à tout fabricant ou importateur de vendre une drogue pour usage humain qui contient l’un des ingrédients suivants :

a) du chloroforme;

b) de l’arsenic ou l’un de ses sels ou dérivés.

DORS/89-229, art. 4.

C.01.040.1. Il est interdit à tout fabricant d’utiliser du salicylate de méthyle comme ingrédient médicinal dans une drogue pour usage interne destinée aux humains.

DORS/78-422, art. 2; DORS/78-801, art. 1; DORS/81-334, art. 2(F); DORS/89-176, art. 1; DORS/92-662, art. 1.

Colorants

C.01.040.2. (1) Il est interdit à un fabricant d’employer dans une drogue un colorant qui n’est pas prévu aux paragraphes (3) et (4).

(2) Il est interdit à quiconque d’importer à des fins de vente une drogue qui contient un colorant non prévu aux paragraphes (3) et (4).

(2.1) Les définitions qui suivent s’appliquent aux paragraphes (3) et (4).

« C.I. (indication du numéro) » Désignation servant à identifier un colorant selon la publication intitulée Colour Index, publiée par The Society of Dyers and Colourists, avec ses modifications successives. (C.I. (indication of the number))

« D&C (indication de la couleur et du numéro) » Désignation servant à identifier un colorant pouvant être utilisé aux États-Unis dans les drogues et les cosmétiques, selon le Code of Federal Regulations des États-Unis. (D & C (indication of the colour and the number))

« FD&C (indication de la couleur et du numéro) » Désignation servant à identifier un colorant pouvant être utilisé aux États-Unis dans les aliments, les drogues et les cosmétiques, selon le Code of Federal Regulations des États-Unis. (FD & C (indication of the colour and the number))

(3) Les colorants qui peuvent être employés dans les drogues à usage interne ou externe sont les suivants :

a) AMARANTE (FD&C, Rouge no 2, radié; C.I. no 16185),

ANTHOCYANINE PROVENANT DE JUS EXPRIMÉ DE FRUITS OU DE LÉGUMES COMESTIBLES FRAIS,

ß-APO-8′-CAROTÉNAL (C.I. no 40820),

BLEU BRILLANT FCF, SEL D’AMMONIUM (D&C Bleu no 4, C.I. no 42090),

BLEU BRILLANT FCF, SEL SODIQUE (FD&C Bleu no 1, C.I. no 42090),

CANTHAXANTHINE (C.I. no 40850),

CARAMEL,

CARMINE (C.I. no 75470),

CARMOISINE (Ext. D&C Rouge no 10, radié : C.I. no 14720),

ß-CAROTÈNE (C.I. no 40800),

CHLOROPHYLLE (C.I. no 75810),

DIOXYDE DE TITANE (C.I. no 77891),

ÉOSINE YS, FORME ACIDE (D&C Rouge no 21; C.I. no 45380:2),

ÉOSINE YS, SEL SODIQUE (D&C Rouge no 22; C.I. no 45380),

ÉRYTHROSINE (FD&C Rouge no 3; C.I. no 45430),

FUSCHINE ACIDE D (D&C Rouge no 33 C.I. no 17200),

INDIGO (D&C Bleu no 6; C.I. no 73000),

INDIGOTINE (FD&C Bleu no 2; C.I. no 73015),

JAUNE DE QUINOLÉINE WS (D&C Jaune no 10; C.I. no 47005),

JAUNE SOLEIL FCF (FD&C Jaune no 6; C.I. no 15985),

LITHOL RUBINE B, SEL DE CALCIUM (D&C Rouge no 7, C.I. no 15850:1),

LITHOL RUBINE B, SEL SODIQUE (D&C Rouge no 6; C.I. no 15850),

NOIR DE FUMÉE (C.I. no 77266),

OXYDES DE FER (C.I. nos 77489, 77491, 77492 et 77499),

PHLOXINE B, FORME ACIDE (D&C Rouge no 27; C.I. no 45410:1),

PHLOXINE B, SEL SODIQUE (D&C Rouge no 28; C.I. no 45410),

PONCEAU SX (FD&C Rouge no 4; C.I. no 14700),

PONCEAU 4R (C.I. no 16255),

RIBOFLAVINE,

ROSE HÉLINDONE CN (D&C Rouge no 30; C.I. no 73360),

ROUGE ALLURA AC (FD&C Rouge no 40; C.I., no 16035),

ROUGE FEU (D&C Rouge no 36; C.I. no 12085),

TARTRAZINE (FD&C Jaune no 5; C.I. no 19140),

VERT D’ALIZARINE CYANINE F (D&C Vert no 5; C.I. no 61570),

VERT SOLIDE FCF (FD&C Vert no 3; C.I. no 42053);

b) les préparations effectuées par l’addition d’un des colorants énumérés à l’alinéa a) à un substrat

(i) d’alumine,

(ii) de blanc fixe,

(iii) de blanc lustré,

(iv) d’argile,

(v) d’oxyde de zinc,

(vi) de talc,

(vii) de colophane,

(viii) de benzoate d’aluminium,

(ix) de carbonate de calcium, ou

(x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix); et

c) les préparations effectuées par l’addition d’un sel de sodium, de potassium, d’aluminium, de baryum, de calcium, de strontium ou de zirconium d’un des colorants énumérés à l’alinéa a) à un substrat

(i) d’alumine,

(ii) de blanc fixe,

(iii) de blanc lustré,

(iv) d’argile,

(v) d’oxyde de zinc,

(vi) de talc,

(vii) de colophane,

(viii) de benzoate d’aluminium,

(ix) de carbonate de calcium, ou

(x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix).

(4) Les colorants suivants peuvent être employés uniquement dans les drogues à usage externe :

a) DIBROMOFLUORESCÉINE (ROUGE SOLVANT 72 (C.I. no 45370:1) ORANGE no 5 (D&C Orange no 5)),

FERROCYANURE FERRIQUE (C.I. no 77510),

GUANINE (C.I. no 75170),

MARRON FONCÉ (D&C Rouge no 34; C.I. no 15880:1),

MICA (C.I. no 77019),

ORANGE II (D&C Orange no 4; C.I. no 15510),

OXYCHLORURE DE BISMUTH (C.I. no 77163),

OXYDE DE ZINC (C.I. no 77947),

POURPRE D’ALIZUROL SS (D&C Violet no 2; C.I. no 60725),

PYRANINE CONCENTRÉE (D&C Vert no 8; C.I. no 59040),

ROCOU (C.I. no 75120),

ROUGE TONEY (D&C Rouge no 17; C.I. no 26100),

URANINE, FORME ACIDE (D&C Jaune no 7; C.I. no 45350:1),

URANINE, SEL SODIQUE (D&C Jaune no 8; C.I. no 45350),

VERT DE QUINIZARINE SS (D&C Vert no 6; C.I. no 61565),

VERT D’HYDROXYDE DE CHROME (PIGMENT VERT 18 (C.I. no 77289)),

VIOLET ACIDE 43 (Ext. D&C Violet no 2; C.I. no 60730),

VIOLET DE MANGANÈSE (C.I. no 77742);

b) les préparations effectuées par l’addition d’un des colorants énumérés à l’alinéa a) à un substrat

(i) d’alumine,

(ii) de blanc fixe,

(iii) de blanc lustré,

(iv) d’argile,

(v) d’oxyde de zinc,

(vi) de talc,

(vii) de colophane,

(viii) de benzoate d’aluminium,

(ix) de carbonate de calcium, ou

(x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix); et

c) les préparations effectuées par l’addition d’un sel de sodium, de potassium, d’aluminium, de baryum, de calcium, de strontium ou de zirconium d’un des colorants énumérés à l’alinéa a) à un substrat

(i) d’alumine,

(ii) de blanc fixe,

(iii) de blanc lustré,

(iv) d’argile,

(v) d’oxyde de zinc,

(vi) de talc,

(vii) de colophane,

(viii) de benzoate d’aluminium,

(ix) de carbonate de calcium, ou

(x) d’une combinaison des substances visées aux sous-alinéas (i) à (ix).

(5) Les paragraphes (1) et (2) ne s’appliquent pas à une drogue qui est présentée comme étant destinée exclusivement, aux fins de la prévention des maladies, à la désinfection :

a) des instruments médicaux;

b) des établissements de soins de santé;

c) des locaux où sont fabriqués, préparés ou gardés des aliments.

DORS/84-949, art. 1; DORS/86-590, art. 1(A); DORS/94-460, art. 1; DORS/95-431, art. 1; DORS/2002-369, art. 1; DORS/2005-95, art. 1.

Drogues de l'annexe F

C.01.041. (1) Dans le présent article et les articles C.01.041.1 à C.01.046, « drogue de l’annexe F » désigne une drogue énumérée ou décrite à l’annexe F du présent règlement.

(1.1) Sous réserve des articles C.01.043 et C.01.046, il est interdit de vendre une substance contenant une drogue de l’annexe F, à moins que :

a) le vendeur n’ait reçu une ordonnance écrite ou verbale;

b) dans le cas où l’ordonnance lui est transférée selon l’article C.01.041.1, les exigences de l’article C.01.041.2 n’aient été respectées.

(2) Quand l’ordonnance d’une drogue de l’annexe F est donnée par écrit, la personne qui vend ladite drogue doit conserver l’ordonnance pendant au moins deux ans après la date d’exécution de l’ordonnance.

(3) Quand l’ordonnance d’une drogue de l’annexe F est donnée verbalement, la personne à laquelle le praticien communique l’ordonnance consignera celle-ci par écrit et la personne qui vend la drogue conservera par écrit cette ordonnance pendant au moins deux ans après la date d’exécution de ladite ordonnance.

(4) La personne qui consigne par écrit une ordonnance verbale indiquera sur l’ordonnance écrite

a) la date et le numéro de l’ordonnance;

b) le nom et l’adresse de la personne en faveur de laquelle est donnée l’ordonnance;

c) le nom propre, le nom usuel ou la marque nominative et la quantité de la drogue prescrite;

d) son propre nom et celui du praticien qui a donné l’ordonnance; et

e) le mode d’emploi indiqué dans l’ordonnance, y compris si, suivant le praticien, l’ordonnance doit ou non être renouvelée et, dans le cas de l’affirmative, combien de fois.

(5) Les paragraphes (1.1) à (4) ne s’appliquent pas à une substance contenant

a) de l’hydrate de chloral, dans des préparations pour usage externe, lorsque celui-ci ne constitue pas plus d’un pour cent de la substance; ou

b) de l’hexachlorophène et ses sels, lorsqu’ils ne constituent pas plus de 0,75 pour cent de la substance, calculés en hexachlorophène.

DORS/78-424, art. 2; DORS/80-543, art. 3; DORS/93-202, art. 6; DORS/93-407, art. 2.

C.01.041.1. Un pharmacien peut transférer à un autre pharmacien une ordonnance portant sur une drogue de l’annexe F.

DORS/78-424, art. 3.

C.01.041.2. (1) Le pharmacien à qui est transférée une ordonnance ne peut vendre la drogue de l’annexe F qui y est prescrite, à moins que le pharmacien effectuant le transfert ne lui indique le nombre restant de renouvellements autorisés, la date du dernier renouvellement ainsi que ses nom et adresse, et ne lui transmette, selon le cas, une copie de l’ordonnance écrite ou une copie de la consignation écrite de l’ordonnance verbale visée au paragraphe C.01.041(4).

(2) Le pharmacien à qui est transférée une ordonnance ne peut vendre la drogue de l’annexe F qui y est prescrite lorsque l’ordonnance lui est transmise verbalement, à moins qu’il ne la consigne par écrit selon le paragraphe C.01.41(4) et que le pharmacien qui effectue le transfert ne lui indique le nombre restant de renouvellements autorisés, la date du dernier renouvellement ainsi que ses nom et adresse.

DORS/78-424, art. 3.

C.01.041.3. Le pharmacien à qui est transférée une ordonnance portant sur une drogue de l’annexe F conserve dans ses dossiers, durant deux ans, les renseignements et documents reçus selon l’article C.01.041.2.

DORS/78-424, art. 3.

C.01.041.4. Le pharmacien qui effectue un transfert selon le paragraphe C.01.041.1 inscrit, sur l’original de l’ordonnance ou dans un registre d’ordonnances tenu pour chaque patient, la date du transfert et ne peut faire aucune autre vente selon cette ordonnance ni transférer cette dernière à un autre pharmacien.

DORS/78-424, art. 3.

C.01.042. (1) Est interdit le renouvellement d’une ordonnance prescrivant une drogue de l’annexe F, à moins que le praticien ne l’autorise, et est interdit le renouvellement d’une telle ordonnance pour un plus grand nombre de fois que ne l’a prescrit le praticien.

(2) La personne qui exécute ou renouvelle une ordonnance portant sur une drogue de l’annexe F inscrit, sur l’original de l’ordonnance ou dans un registre d’ordonnances tenu pour chaque patient,

a) la date d’exécution de l’ordonnance;

b) la date de chaque renouvellement;

c) la quantité de drogue préparée lors de l’exécution et de chaque renouvellement; et

d) son propre nom.

DORS/78-424, art. 4.

C.01.043. (1) Est permise sans aucune ordonnance, la vente d’une drogue de l’annexe F à

a) un fabricant de drogues;

b) un praticien;

c) un pharmacien en gros;

d) un pharmacien inscrit;

e) un hôpital reconnu par le ministère de la Santé nationale et du Bien-être social;

f) un ministère d’un gouvernement, fédéral ou provincial, sur réception d’une commande écrite signée par le ministre en cause ou son représentant dûment autorisé; ou à

g) toute personne, sur réception d’une commande écrite signée par le Directeur.

(2) Quand une personne effectue une vente autorisée par les alinéas (1)f) ou g), elle doit conserver la commande écrite relative à la drogue durant une période minimum de deux ans à partir de l’exécution de ladite commande.

C.01.044. (1) Quiconque fait la publicité auprès du grand public d’une drogue mentionnée à l’annexe F doit ne faire porter la publicité que sur la marque nominative, le nom propre, le nom usuel, le prix et la quantité de la drogue.

(2) Le paragraphe (1) ne s’applique pas lorsque :

a) la drogue est mentionnée à la partie II de l’annexe F;

b) la drogue est :

(i) soit présentée sous une forme impropre à l’usage humain,

(ii) soit étiquetée de la façon prévue à l’alinéa C.01.046b).

DORS/78-424, art. 5; DORS/93-202, art. 7; DORS/93-407, art. 3.

C.01.045. (1) Sous réserve du paragraphe (2), est interdite l’importation d’une drogue de l’annexe F par toute personne autre qu’un

a) praticien;

b) fabricant de drogues;

c) pharmacien en gros;

d) pharmacien inscrit; ou

e) résident d’un pays étranger, durant son séjour au Canada.

(2) Toute personne peut importer une drogue de l’annexe F mentionnée à la partie II de celle-ci, si la drogue est importée sous une forme ou avec une étiquette telles que cette personne puisse vendre cette drogue en vertu de l’article C.01.046.

DORS/93-407, art. 4.

C.01.046. Est permise la vente, sans ordonnance, d’une drogue mentionnée ou décrite dans la partie II de l’annexe F du présent règlement,

a) si la drogue est présentée sous une forme impropre à l’usage humain; ou

b) si l’espace principal de l’étiquette intérieure et de l’étiquette extérieure porte, en français et en anglais, les mentions « Pour usage vétérinaire seulement/For Veterinary Use Only » ou « Usage vétérinaire seulement/Veterinary Use Only », immédiatement après ou avant la marque nominative, le nom propre ou le nom usuel, en caractères d’une taille au moins égale à la moitié de celle des plus gros caractères utilisés sur l’étiquette.

DORS/93-202, art. 8; DORS/93-407, art. 5; DORS/2001-181, art. 1(A).

C.01.047. [Abrogé, DORS/80-543, art. 4]

C.01.048. (1) Lorsqu’un médecin, un dentiste, un médecin-vétérinaire ou un pharmacien, dûment inscrit et autorisé à exercer sa profession dans une province, a signé une commande précisant la marque nominative, le nom propre ou le nom usuel et la quantité d’une drogue qui n’est pas :

a) un stupéfiant au sens du Règlement sur les stupéfiants,

b) une drogue contrôlée au sens du paragraphe G.01.001(1), ni

c) une drogue nouvelle pour laquelle l’avis de conformité prévu par l’article C.08.004 n’a pas été délivré,

la personne qui reçoit la commande peut distribuer la drogue, à titre d’échantillon, audit médecin, dentiste, médecin-vétérinaire ou pharmacien, si la drogue est étiquetée conformément au présent règlement.

(2) Une commande dont il est question au paragraphe (1) peut spécifier que ladite commande sera renouvelée à intervalles y indiqués pendant une période d’au plus six mois.

DORS/93-202, art. 9; DORS/97-228, art. 2.

C.01.049. Une personne qui, en vertu de l’article C.01.048, distribue une drogue, à titre d’échantillon, doit

a) tenir des dossiers indiquant

(i) le nom, l’adresse et les titres professionnels de toute personne à qui la drogue est distribuée,

(ii) la marque nominative, la quantité et la forme de présentation de cette drogue,

(iii) la date de distribution de ladite drogue; et

b) conserver lesdits dossiers, ainsi que toutes les commandes reçues en vertu de l’article C.01.048, pendant au moins deux ans, à compter de la date à laquelle la distribution inscrite aux dossiers a eu lieu.

DORS/93-202, art. 10.

Retrait du marché

C.01.051. Un fabricant qui vend une drogue sous une forme posologique ou une personne qui importe et vend au Canada une drogue sous une forme posologique doivent, s’ils décident de retirer la drogue du marché, fournir au Directeur les renseignements suivants dès le début du retrait :

a) le nom propre de la drogue ou, à défaut, son nom usuel, ainsi que la marque nominative de la drogue et le numéro du lot;

b) dans le cas d’une drogue importée, le nom du fabricant et de l’importateur;

c) la quantité de la drogue fabriquée ou importée;

d) la quantité de la drogue distribuée;

e) la quantité de la drogue qui reste dans les locaux du fabricant ou de l’importateur;

f) les raisons qui ont motivé le retrait; et

g) toute autre mesure prise par le fabricant ou l’importateur relativement au retrait.

DORS/82-524, art. 2; DORS/93-202, art. 11.

C.01.052. [Abrogé, DORS/82-524, art. 2]

C.01.055. et C.01.056. [Abrogés, DORS/82-524, art. 2]

Limites de variabilité

C.01.061. (1) Dans le cas d’une drogue dont la quantité nette contenue dans l’emballage est indiquée sur l’étiquette autrement qu’en nombre d’unités posologiques, la quantité nette moyenne, déterminée conformément à la méthode officielle DO-31 intitulée Détermination du contenu net en date du 7 décembre 1988, pour tout groupe de 10 emballages de cette drogue choisis selon cette méthode, ne peut être inférieure à la quantité nette indiquée sur l’étiquette.

(2) Dans le cas d’une drogue dont la quantité nette contenue dans l’emballage est indiquée sur l’étiquette en nombre d’unités posologiques, pour tout groupe de 10 emballages de cette drogue choisis conformément à la méthode officielle DO-31 intitulée Détermination du contenu net en date du 7 décembre 1988, lorsque le nombre d’unités posologiques de ce groupe est déterminé selon cette méthode :

a) le nombre moyen d’unités posologiques pour les 10 emballages ne peut être inférieur au nombre d’unités posologiques indiqué sur l’étiquette;

b) aucun emballage ne peut contenir un nombre d’unités posologiques inférieur à celui indiqué sur l’étiquette, sous réserve des écarts prévus au tableau du présent article;

c) dans le cas d’une drogue contrôlée au sens du paragraphe G.01.001(1) ou d’un stupéfiant au sens du Règlement sur les stupéfiants, aucun emballage ne peut contenir un nombre d’unités posologiques supérieur à celui indiqué sur l’étiquette, sous réserve des écarts prévus au tableau du présent article.

TABLEAU

Colonne I Colonne II Nombre d’unités Écart admissible par rapport au nombreArticle posologiques indiqué sur indiqué sur l’étiquettel’étiquette, par emballage

1. 50 ou moins 0 2. Plus de 50, mais moins de 101 1

le plus élevé des nombres suivants : une unité 3. 101 ou plus ou 0,75 % du nombre indiqué sur l’étiquette,

arrondi au nombre entier supérieur

DORS/82-429, art. 4; DORS/89-455, art. 4; DORS/97-228, art. 3.

C.01.062. (1) Sous réserve des paragraphes (2) à (5), le fabricant ne peut vendre une drogue sous forme posologique lorsque la quantité de tout ingrédient médicinal qu’elle contient, déterminée selon une méthode acceptable, représente :

a) moins de 90,0 pour cent de la quantité indiquée sur l’étiquette;

b) plus de 110,0 pour cent de la quantité indiquée sur l’étiquette.

(2) Sous réserve du paragraphe (5), lorsqu’une drogue sous forme posologique renferme un ingrédient médicinal qui est une substance volatile d’origine végétale ou son équivalent de synthèse, aucun écart par rapport à la quantité de l’ingrédient indiquée sur l’étiquette, déterminée selon une méthode acceptable, n’est permis en dehors de l’écart suivant :

a) au moins 85,0 pour cent de la quantité indiquée sur l’étiquette;

b) au plus 120,0 pour cent de la quantité indiquée sur l’étiquette.

(3) Sous réserve du paragraphe (5), lorsqu’une drogue sous forme de capsule renferme un ingrédient médicinal qui est une vitamine contenue dans une huile de foie de poisson, aucun écart par rapport à la quantité de l’ingrédient médicinal indiquée sur l’étiquette, déterminée selon une méthode acceptable, n’est permis, autre que l’écart précisé pour cette huile de foie de poisson dans une publication dont le nom figure à l’annexe B de la Loi.

(4) Sous réserve du paragraphe (5), lorsqu’une drogue sous forme posologique renferme un ingrédient médicinal qui est une vitamine, aucun écart par rapport à la quantité de l’ingrédient médicinal indiquée sur l’étiquette, déterminée selon une méthode acceptable, n’est permis, autre que l’écart précisé aux colonnes III ou IV du tableau du présent article en regard d’une vitamine figurant à la colonne I en la quantité indiquée à la colonne II.

(5) Les paragraphes de (1) à (4) ne s’appliquent pas à :

a) une drogue pour laquelle un avis de conformité a été délivré en application des articles C.08.004 ou C.08.004.01;

b) [Abrogé, DORS/98-423, art. 8]

c) une drogue pour laquelle une norme est contenue dans une publication dont le nom figure à l’annexe B de la Loi;

d) une drogue mentionnée aux annexes C ou D de la Loi ou au titre 6 de la partie C du présent règlement;

e) une drogue à laquelle une identification numérique a été attribuée aux termes du paragraphe C.01.014.2(1) et :

(i) dont les conditions de fabrication et de contrôle de la qualité permettent le contrôle de son identité, de sa qualité, de sa pureté, de sa stabilité, de son innocuité, de sa teneur et de son activité,

(ii) qui possède bien les propriétés que les encarts, étiquettes, brochures et fiches s’y rapportant lui attribuent,

(iii) qui peut, sans risque prévisible excessif pour l’être humain, être utilisée aux fins et dans les conditions d’emploi recommandées par le fabricant,

(iv) qui est efficace aux fins et dans les conditions d’emploi recommandées par le fabricant.

TABLEAU

Colonne I Colonne II Colonne III Colonne IV

Article Vitamine Dose quotidienne recommandée

Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est égale ou inférieure à celle de la colonne II

Écart admissible lorsque la dose quotidienne recommandée indiquée sur l’étiquette est supérieure à celle de la colonne II

vitamine A (ou 1. comme B- 10 000 U.I. 90,0 - 165,0 % 90,0 - 115,0 %

carotène) 2. thiamine 4,5 mg 90,0 - 145,0 % 90,0 - 125,0 % 3. riboflavine 7,5 mg 90,0 - 125,0 % 90,0 - 125,0 %

niacine ou4. 45 mg 90,0 - 125,0 % 90,0 - 125,0 %niacinamide 5. pyridoxine 3 mg 90,0 - 125,0 % 90,0 - 125,0 %

acide d­6. 15 mg 90,0 - 135,0 % 90,0 - 125,0 %pantothénique 7. acide folique 0,4 mg 90,0 - 135,0 % 90,0 - 115,0 % 8. vitamine B12 14 µg 90,0 - 135,0 % 90,0 - 125,0 % 9. vitamine C 150 mg 90,0 - 145,0 % 90,0 - 125,0 % 10. vitamine D 400 U.I. 90,0 - 145,0 % 90,0 - 115,0 % 11. vitamine E 25 U.I. 90,0 - 125,0 % 90,0 - 125,0 % 12. vitamine K 0,0 mg 90,0 - 115,0 % 13. biotine 0,0 mg 90,0 - 135,0 %

DORS/92-131, art. 1; DORS/92-591, art. 2; DORS/94-689, art. 2(A); DORS/95-530, art. 2; DORS/98-423, art. 8; DORS/2011-88, art. 5. Version précédente C.01.063. [Abrogé, DORS/96-399, art. 2]

C.01.064. Si une drogue est préparée pour usage ophtalmique ou usage parentéral et que l’un de ses ingrédients est un agent de conservation, cet ingrédient :

a) doit être limité à la quantité nécessaire pour produire l’effet prévu sans entraîner de risques indus pour les personnes ou les animaux;

b) ne doit pas nuire aux propriétés thérapeutiques de la drogue.

DORS/90-586, art. 2.

C.01.065. Il est interdit de vendre une drogue préparée pour usage ophtalmique ou usage parentéral, sauf si un échantillon représentatif de chaque lot de la drogue, dans son récipient immédiat :

a) est soumis, selon une méthode acceptable, à une épreuve d’identité qui démontre que la drogue correspond à son nom propre, ou à défaut, à son nom usuel;

b) est soumis, par une méthode acceptable, à une épreuve de stérilité qui démontre que la drogue est stérile, laquelle épreuve n’est pas effectuée :

(i) dans le cas des vaccins vivants, ou

(ii) dans le cas où le fabricant présente une preuve que le Directeur juge satisfaisante démontrant que les contrôles employés dans la transformation de la drogue en assurent la stérilité dans son récipient immédiat;

c) est soumis aux autres épreuves que le Directeur juge satisfaisantes pour démontrer que la drogue est sûre à l’usage suivant le mode d’emploi.

DORS/86-552, art. 1; DORS/90-586, art. 3; DORS/93-202, art. 12; DORS/96-399, art. 3.

C.01.066. Est interdite la vente des drogues en solution aqueuse, préparée pour usage parentéral, à moins qu’elles n’aient été préparées avec de l’eau apyrogène produite par distillation ou par osmose enverse.

C.01.067. (1) Sous réserve du paragraphe (2), il est interdit de vendre une drogue préparée pour usage parentéral, sauf si un échantillon représentatif de chaque lot de la drogue :

a) a été soumis, dans son récipient immédiat, à une épreuve de pyrogénicité selon une méthode acceptable;

b) a été trouvé apyrogène lors de l’épreuve visée à l’alinéa a).

(2) Le paragraphe (1) ne s’applique pas aux drogues qui ne se prêtent pas à une épreuve de pyrogénicité ni aux drogues de nature pyrogène.

DORS/81-335, art. 1; DORS/96-399, art. 4.

C.01.068. Le fabricant doit conserver des dossiers détaillés des épreuves exigées aux articles C.01.065 et C.01.067 pendant au moins un an après la date limite d’utilisation indiquée sur l’étiquette de la drogue.

DORS/85-715, art. 5; DORS/92-654, art. 3.

C.01.069. L’emballage d’une drogue préparée pour usage parentéral doit satisfaire aux exigences suivantes :

a) le récipient immédiat doit être fait d’un tel matériau et de telle façon :

(i) qu’il ne cède à son contenu aucune substance délétère,

(ii) qu’il ne présente aucune réaction au contact de la drogue,

(iii) qu’il permette l’inspection visuelle ou électronique de la drogue,

(iv) qu’il assure une protection contre les facteurs environnementaux causant la dégradation ou la contamination ou que, s’il ne peut assurer cette protection, celle-ci soit assurée par l’emballage secondaire,

(v) qu’il contienne une quantité suffisante de drogue pour permettre le retrait de la quantité indiquée sur l’étiquette;

b) le dispositif de fermeture immédiat et tout matériau qui entre en contact avec la drogue dans son récipient immédiat doivent répondre aux exigences des sous-alinéas a)(i) et (ii).

DORS/96-399, art. 5.

C.01.070. Est interdite la vente d’une drogue sous forme de comprimé hypodermique qui ne se dissout pas complètement dans l’eau pour y former une solution limpide.

Comprimés de bichlorure de mercure

C.01.071. Est interdite la vente de comprimés de bichlorure de mercure pour usage domestique, en emballages de 200 ou moins, à moins que

a) lesdits comprimés ne soient

(i) de forme irrégulière ou angulaire,

(ii) de couleur bleue, et

(iii) emballés dans un récipient immédiat facilement reconnaissable au toucher; et que

b) l’espace principal des étiquettes intérieure et extérieure ne porte, imprimés en caractères bien reconnaissables et d’une couleur faisant contraste avec celle desdites étiquettes,

(i) le dessin d’une tête de mort et de tibias croisés, et

(ii) le mot « Poison ».

DORS/2001-181, art. 2.

C.01.081. [Abrogé, DORS/80-544, art. 4]

C.01.085. [Abrogé, DORS/80-544, art. 5]

Édulcorants synthétiques

C.01.101. (1) [Abrogé, DORS/78-422, art. 3]

(2) [Abrogé, DORS/78-800, art. 1]

(3) [Abrogé, DORS/78-422, art. 3]

C.01.121. et C.01.122. [Abrogés, DORS/80-544, art. 6]

Aminopyrine et dipyrone

C.01.131. Est interdite la vente de l’aminopyrine ou de la dipyrone (dérivé de l’aminopyrine) pour usage oral ou parentéral, à moins que

a) l’étiquette intérieure ne porte la déclaration suivante :

« MISE EN GARDE : L’agranulocytose fatale peut être associée à l’emploi de l’aminopyrine et de la dipyrone. Des congrès sanguins appropriés sont essentiels. (Voir mises en garde et précautions à l’intérieur) »; et que

b) l’étiquette extérieure ou le dépliant compris dans l’emballage ne portent les déclarations suivantes :

« MISE EN GARDE : Il est établi qu’une agranulocytose grave et même fatale peut survenir après l’administration de l’aminopyrine ou de la dipyrone. Une agranulocytose fatale est apparue après qu’on eut employé ces drogues pour une thérapie de courte durée, une thérapie intermittente ou une thérapie prolongée. Par conséquent, l’emploi de ces drogues devrait être d’une durée aussi brève que possible. Étant donné la possibilité de telles réactions, l’aminopyrine et la dipyrone ne devraient s’employer que lorsque des agents moins virtuellement dangereux sont inefficaces.

PRÉCAUTIONS : Il est essentiel que se fassent fréquemment des numérations de leucocytes avec formule leucocytaire durant tout traitement avec ces drogues. Toutefois, il faut remarquer que l’agranulocytose peut se produire d’une façon subite sans aucun signe avant coureur. L’emploi de la drogue devrait être interrompu au premier signe d’un changement de la formule sanguine ou d’un symptôme d’agranulocytose, et il faudrait avertir le malade d’interrompre l’emploi de la drogue au premier signe du mal de gorge ou d’une autre infection de la bouche ou de la gorge (douleur, enflure, hyperesthésie, ulcération). »

C.01.132. Est interdit l’envoi, à un médecin praticien, de la documentation publicitaire sur l’aminopyrine ou la dipyrone à moins que les déclarations figurant à l’article C.01.131 ne soient comprises dans cette documentation.

C.01.133. Les dispositions des articles C.01.131 et C.01.132 ne s’appliquent pas aux préparations renfermant de l’aminopyrine ou de la dipyrone et qui sont

a) dispensées par un pharmacien d’après une ordonnance; ou

b) vendues pour usage vétérinaire seulement.

Sels de potassium enrobés

C.01.134. Est interdite la vente de comprimés enrobés contenant des sels de potassium, avec ou sans diurétiques de thiazide, à moins que l’étiquette intérieure ou le dépliant compris dans l’emballage ne portent la déclaration suivante :

« MISE EN GARDE : Il existe un lien probable entre l’emploi de comprimés enrobés contenant des sels de potassium avec ou sans diurétiques de thiazide et l’incidence de l’ulcération grave de l’intestin grêle. Ces préparations ne sont à utiliser que s’il n’est pas possible de suppléer convenablement au régime alimentaire; il faut en cesser l’emploi dès qu’apparaissent des douleurs abdominales, une distension abdominale, des nausées, des vomissements ou des hémorragies gastrointestinales. »

C.01.135. Est interdit l’envoi, à un médecin praticien, de la documentation publicitaire sur les dragées contenant des sels de potassium avec ou sans diurétiques de thiazide, à moins que la déclaration figurant à l’article C.01.134 ne soit comprise dans cette documentation.

C.01.136. Les dispositions des articles C.01.134 et C.01.135 ne s’appliquent pas aux dragées renfermant des sels de potassium avec ou sans diurétiques de thiazide et qui

a) sont vendues pour usage vétérinaire seulement;

b) sont dispensées par un pharmacien d’après une ordonnance; ou

c) renferment 100 milligrammes ou moins de potassium élémentaire par dragée.

Antibiotiques

C.01.401. Sauf disposition contraire du présent règlement, l’antibiotique qui n’est pas destiné à l’usage parentéral doit, en plus de satisfaire aux exigences de l’article C.01.004, porter sur l’étiquette intérieure et l’étiquette extérieure une indication de l’activité de la drogue exprimée en unités internationales si de telles unités existent ou, à défaut, en unités, milligrammes, microgrammes ou fractions de grammes :

a) par gramme, dans le cas des solides ou des liquides visqueux;

b) par millilitre, dans le cas des autres liquides;

c) par dose individuelle ou forme posologique, dans le cas de préparations antibiotiques présentées en doses individuelles ou sous forme posologique.

DORS/80-544, art. 7; DORS/92-654, art. 4.

C.01.402. [Abrogé, DORS/92-654, art. 4]

C.01.410. à C.01.412. [Abrogés, DORS/80-544, art. 8]

C.01.420. à C.01.422. [Abrogés, DORS/80-544, art. 8]

Chloramphénicol

C.01.430. à C.01.432. [Abrogés, DORS/80-544, art. 8]

C.01.433. Est interdite la vente du chloramphénicol, de ses sels et dérivés, pour usage oral ou parentéral, à moins que

a) l’étiquette intérieure ne porte un avertissement pour faire savoir

(i) qu’une diminution de l’activité de la moëlle osseuse a été associée à l’emploi de chloramphénicol, et

(ii) qu’il y a lieu de lire attentivement les avertissements et les précautions jointes; et

b) l’étiquette extérieure ou le prospectus d’emballage ne portent

(i) un avertissement pour faire savoir que le chloramphénicol ne devrait pas être employé dans le traitement ou la prévention des infections bénignes ou lorsqu’il n’est pas indiqué, comme pour les rhumes, la grippe, ou les infections des voies respiratoires supérieures; que deux types de diminution de l’activité de la moëlle osseuse sont associés à l’emploi de chloramphénicol; qu’une certaine diminution de l’activité de la moëlle osseuse est communément constatée durant le traitement, et qu’elle est fonction de la dose et potentiellement réversible; que des analyses de sang permettent de déceler les changements précoces; que l’autre forme de diminution de l’activité de la moëlle osseuse est très rare, se traduisant par une hypoplasie de la moëlle osseuse brutale, tardive et généralement fatale qui peut survenir sans avertissement, et

(ii) une déclaration des précautions à prendre précisant qu’il est indispensable de faire des analyses de sang appropriées au cours du traitement par le chloramphénicol et que, bien que les analyses de sang permettent de déceler les modifications sanguines périphériques précoces, il ne faut pas s’y fier pour déceler la forme rare et généralement irréversible de diminution de l’activité de la moëlle osseuse avant l’apparition d’une anémie aplastique.

C.01.434. Les dispositions de l’article C.01.433 ne s’appliquent pas au chloramphénicol, à ses sels ou dérivés, vendus par un pharmacien inscrit.

C.01.435. Est interdit l’envoi, à un médecin praticien, de la documentation publicitaire sur le chloramphénicol, ses sels ou dérivés, pour usage oral ou parentéral, à moins que les déclarations stipulées à l’alinéa C.01.433b) ne soient comprises dans cette documentation.

C.01.436. Les dispositions des articles C.01.433 et C.01.435 ne s’appliquent pas à un médicament vendu pour usage vétérinaire seulement.

C.01.440. à C.01.442. [Abrogés, DORS/80-544, art. 8]

C.01.450. à C.01.452. [Abrogés, DORS/80-544, art. 8]

C.01.460. à C.01.462. [Abrogés, DORS/80-544, art. 8]

C.01.470. à C.01.472. [Abrogés, DORS/80-544, art. 8]

C.01.480. [Abrogé, DORS/80-544, art. 8]

C.01.490. à C.01.497. [Abrogés, DORS/80-544, art. 8]

C.01.510. à C.01.513. [Abrogés, DORS/80-544, art. 8]

C.01.520. à C.01.522. [Abrogés, DORS/80-544, art. 8]

C.01.530. à C.01.532. [Abrogés, DORS/80-544, art. 8]

C.01.540. à C.01.542. [Abrogés, DORS/80-544, art. 8]

C.01.550. à C.01.552. [Abrogés, DORS/80-544, art. 8]

C.01.560. à C.01.563. [Abrogés, DORS/80-544, art. 8]

C.01.570. à C.01.572. [Abrogés, DORS/80-544, art. 8]

C.01.580. [Abrogé, DORS/80-544, art. 8]

C.01.590. à C.01.592. [Abrogés, DORS/80-544, art. 8]

Drogues d'application vétérinaire

C.01.600. Il est interdit de vendre pour usage vétérinaire une drogue énumérée au tableau des doses limites des drogues pour adultes, sauf une drogue présentée sous une forme impropre à l’usage humain, si les étiquettes intérieure et extérieure de cette drogue ne portent pas toutes deux la mention « Pour usage vétérinaire seulement » ou « Usage vétérinaire seulement ».

DORS/80-543, art. 5.

C.01.601. [Abrogé, DORS/93-407, art. 6]

C.01.602. Les dispositions des articles C.01.401 et de C.01.402 ne s’appliquent pas à un antibiotique présent dans un article d’alimentation animale en quantité inférieure à 50 parties par million.

C.01.603. Les dispositions des alinéas C.01.401b) et c), et de l’article C.01.402 ne s’appliquent pas à un antibiotique présent dans un article d’alimentation animale en quantité supérieure à 50 parties par million.

C.01.604. Les étiquettes intérieure et extérieure d’une drogue d’application vétérinaire représentée comme contenant une vitamine doivent toutes deux porter

a) la déclaration de la quantité de chaque vitamine présente dans la drogue, uniquement sous le nom propre de chaque vitamine

(i) en unités internationales par gramme ou par millilitre, dans le cas de la vitamine A, de la provitamine A, de la vitamine D et de la vitamine E,

(ii) en milligrammes par gramme, dans le cas des solides ou des liquides visqueux, ou par millilitre, dans le cas des autres liquides, lorsqu’il s’agit de la thiamine, de la riboflavine, de la niacine, de la niacinamide, de la pyridoxine, de l’acide d-pantothénique, du d­ panthénol, de l’acide folique, de l’acide ascorbique et de la vitamine K,

(iii) en microgrammes par gramme, dans le cas des solides ou des liquides visqueux, ou par millilitre, dans le cas des autres liquides, lorsqu’il s’agit de la biotine et de la vitamine B12,

(iv) en unités orales, dans le cas de la vitamine B12 avec concentré de facteur intrinsèque, ou,

(v) dans le cas des produits vitaminiques présentés sous forme posologique ou forme de distribution individuelle, en unités spécifiées par dose ou autre forme posologique individuelle;

b) sauf dans le cas des drogues présentées sous une forme qui ne convient pas à l’usage humain, la déclaration « Pour usage vétérinaire seulement » ou « Usage vétérinaire seulement ».

DORS/80-543, art. 6.

C.01.605. Un antibiotique d’administration parentérale, qui est recommandé uniquement pour usage vétérinaire, doit porter sur ses étiquettes intérieure et extérieure

a) l’activité de la drogue exprimée en unités internationales, lorsqu’il y a de telles unités établies, ou, si aucune unité internationale n’a été établie, en termes d’unités, de milligrammes ou de fractions de gramme, par gramme dans le cas des solides ou des liquides visqueux, par millilitre dans le cas des autres liquides, ou par dose individuelle ou forme posologique dans le cas de préparations antibiotiques présentées sous forme posologique ou forme de distribution individuelle;

b) [Abrogé, DORS/92-654, art. 5]

c) la déclaration « Pour usage vétérinaire seulement » ou « Usage vétérinaire seulement ».

DORS/80-543, art. 7; DORS/92-654, art. 5.

C.01.606. Il est interdit de vendre pour le traitement des animaux une préparation d’antibiotique, autre qu’une préparation d’antibiotique qui est une drogue nouvelle vendue conformément à l’article C.08.013, à moins que les conditions suivantes ne soient remplies :

a) dans le cas où la préparation ne peut être administrée aux animaux en période de lactation dont le lait est destiné à être consommé comme aliment, une mention à cet effet figure sur les étiquettes intérieure et extérieure de la préparation;

b) dans le cas où la préparation peut être administrée aux animaux en période de lactation dont le lait est destiné à être consommé comme aliment :

(i) il a été soumis au Directeur, sur demande, des preuves acceptables du délai ne dépassant pas 96 heures qui doit s’écouler après l’administration de la dernière dose de cette préparation pour que le lait des animaux traités ne contienne aucun résidu d’antibiotique qui soit dommageable à la santé de l’homme,

(ii) l’espace principal de l’étiquette extérieure de la préparation, l’étiquette intérieure et, le cas échéant, la notice jointe à l’emballage qui décrit la préparation d’antibiotique portent la mise en garde suivante : « MISE EN GARDE : LE LAIT PROVENANT DES ANIMAUX TRAITÉS QUI EST EXTRAIT PENDANT LE TRAITEMENT ET DANS LES ... HEURES APRÈS ADMINISTRATION DE LA DERNIÈRE DOSE NE DOIT PAS ÊTRE UTILISÉ COMME ALIMENT. », le nombre d’heures à indiquer étant celui du délai déterminé selon les preuves soumises aux termes du sous­ alinéa (i).

DORS/88-378, art. 1; DORS/92-664, art. 2; DORS/93-467, art. 1.

C.01.606.1. Il est interdit de vendre tout produit contenant du dihydroiodure d’éthylènediamine (DIED) qui est destiné à la prévention ou au traitement du panaris interdigité (piétin) chez les bovins.

DORS/90-327, art. 1.

C.01.607. Nonobstant le sous-alinéa C.01.004(1)c)(ii), la déclaration du numéro de lot n’est pas requise sur l’étiquette d’un aliment contenant une drogue et destiné aux animaux.

DORS/80-543, art. 8.

C.01.608. Les dispositions de l’article C.01.604 ne s’appliquent pas aux aliments médicamentés du bétail, enregistrés en vertu de la Loi relative aux aliments du bétail.

C.01.609. Nonobstant les dispositions de l’alinéa C.01.401a), l’activité d’un antibiotique en quantités dépassant 50 parties par million contenu dans un aliment médicamenté du bétail, enregistré en vertu de la Loi relative aux aliments du bétail, peut être déclarée en grammes par tonne.

C.01.610. Est interdite la vente de toute substance qui possède une action oestrogène, pour administration aux volailles pouvant être consommées comme aliment.

C.01.610.1 Il est interdit de vendre une drogue pour administration aux animaux qui produisent des aliments ou qui sont destinés à être consommés comme aliments si elle contient :

a) soit du chloramphénicol ou l’un de ses sels ou dérivés;

b) soit un composé de 5-nitrofurane;

c) soit du clenbutérol ou l’un de ses sels ou dérivés;

d) soit un composé de 5-nitro-imidazole;

e) soit du diéthylstilbestrol ou d’autres composés de stilbène.

DORS/85-539, art. 1; DORS/85-685, art. 2; DORS/91-546, art. 1; DORS/94-568, art. 2; DORS/97-510, art. 2; DORS/2003-292, art. 3.

C.01.610.2 Il est interdit de vendre toute préparation d’antibiotique contenant du chloramphénicol, ou l’un de ses sels ou dérivés, pour administration aux animaux qui ne produisent pas d’aliments et qui ne sont pas destinés à être consommés comme aliments, à moins que les conditions suivantes ne soient remplies :

a) l’étiquette intérieure et l’étiquette extérieure de cette préparation portent la mise en garde suivante : « MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS/WARNING: FEDERAL LAW PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD »;

b) s’il s’agit d’une préparation à usage parentéral, celle-ci contient au plus un gramme de chloramphénicol par ampoule sous forme de succinate sodique de chloramphénicol;

c) s’il s’agit d’une préparation pour usage ophtalmique, celle-ci contient au plus 1 pour cent de chloramphénicol;

d) s’il s’agit d’une préparation pour administration par voie orale, celle-ci, selon le cas :

(i) est sous forme de comprimé ou de capsule et contient au plus un gramme de chloramphénicol par comprimé ou capsule,

(ii) est sous forme de suspension de palmitate de chloramphénicol et contient au plus trois grammes de chloramphénicol par récipient.

DORS/91-546, art. 1.

C.01.611. (1) Le Directeur peut, par écrit, exiger de temps à autre du fabricant d’une drogue recommandée pour administration aux animaux qui peuvent servir d’aliment

a) une présentation relative à ladite drogue, dans une forme et une teneur à la satisfaction du Directeur, décrivant en détail les épreuves conduites pour déterminer qu’aucun résidu de cette drogue, sauf dans les limites prescrites par le présent règlement, ne demeure dans la viande, les sous-produits de la viande, les oeufs ou le lait; et

b) l’impression, dans l’espace principal de l’étiquette extérieure, sur l’étiquette intérieure et, le cas échéant, sur la notice jointe à l’emballage qui décrit la drogue, d’une mise en garde indiquant que la viande, les sous-produits de la viande, les oeufs ou le lait provenant d’animaux auxquels a été administrée cette drogue ne peuvent être vendus comme aliments que s’il s’est écoulé depuis cette administration le délai que fixe le Directeur en se fondant sur une étude des données connues sur les résidus de la drogue.

(2) Il est interdit à tout fabricant de vendre une drogue au sujet de laquelle le Directeur a exigé la mise en garde mentionnée à l’alinéa (1)b) si ledit fabricant n’a pas fait droit à ladite exigence.

DORS/93-467, art. 2.

C.01.612. [Abrogé, DORS/94-568, art. 3]

Drogues anticonceptionnelles

C.01.625. Les drogues anticonceptionnelles, fabriquées, vendues ou présentées pour la prévention de la conception et qui ne figurent pas à l’annexe F peuvent faire l’objet de publicité auprès du grand public.

Titre 1A

Licence d'établissement Définitions et interprétation

C.01A.001. (1) Les définitions qui suivent s’appliquent au présent titre et aux titres 2 à 4.

« accord de reconnaissance mutuelle » Accord international portant sur le reconnaissance mutuelle en matière de certification de la conformité aux bonnes pratiques de fabrication des drogues. (mutual recognition agreement)

« agent antimicrobien » Drogue pouvant détruire les micro-organismes pathogènes et dont l’étiquette indique qu’elle est destinée à être utilisée dans la désinfection des surfaces de l’environnement ou des instruments médicaux, au sens du Règlement sur les instruments médicaux, qui :

a) ne sont pas des instruments effractifs au sens de ce règlement;

b) sont destinés à entrer en contact uniquement avec une peau intacte. (antimicrobial agent)

« autorité réglementaire » Organisme public ou autre entité, dans un pays participant, qui est habilité à contrôler l’utilisation ou la vente de drogues dans ce pays et qui peut prendre des mesures d’exécution pour veiller à ce que les drogues commercialisées sur le territoire relevant de sa compétence satisfassent aux exigences légales. (regulatory authority)

« bâtiment reconnu » À l’égard de la manufacture, de l’emballage-étiquetage ou de l’analyse d’une drogue, bâtiment qu’une autorité réglementaire, désignée aux termes du paragraphe C.01A.019(1) à l’égard de cette activité pour cette drogue, a reconnu comme satisfaisant à ses normes de bonnes pratiques de fabrication à l’égard de cette activité pour cette drogue. (recognized building)

« certificat de lot » Certificat délivré par le manufacturier d’un lot ou lot de fabrication d’une drogue exporté dans le cadre d’un accord de reconnaissance mutuelle et dans lequel le manufacturier :

a) identifie le document-type de production pour la drogue et atteste que le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé conformément aux méthodes énoncées dans le document-type;

b) fournit une description détaillée de la drogue, y compris :

(i) la liste des propriétés et des qualités de la drogue, y compris l’identité, l’activité et la pureté de la drogue,

(ii) une indication des tolérances relatives aux propriétés et aux qualités de la drogue;

c) indique les méthodes d’analyse du lot ou lot de fabrication ainsi que les résultats analytiques détaillés obtenus;

d) indique les adresses des bâtiments où le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé;

e) atteste que le lot ou le lot de fabrication a été manufacturé, emballé-étiqueté et analysé conformément aux bonnes pratiques de fabrication de l’autorité réglementaire qui a reconnu les bâtiments comme satisfaisant à ses normes de bonnes pratiques de fabrication. (batch certificate)

« classe de forme posologique » S’entend des parentérales, comprimés, capsules, solutions, suspensions, aérosols, poudres, suppositoires, gaz médicaux, prémélanges médicamenteux ou de toute autre classe de forme posologique désignée par le ministre. (dosage form class)

« emballer-étiqueter » Emballer une drogue dans son récipient immédiat ou apposer l’étiquette intérieure ou extérieure sur la drogue. (package/label)

« importer » Importer une drogue au Canada en vue de la vente. (import)

« manufacturer » Préparer et conserver une drogue en vue de la vente. (fabricate)

« monographie de classe » Document établi par le ministère de la Santé qui :

a) présente la liste des types et concentrations d’ingrédients médicinaux qui peuvent être contenus dans les drogues d’une classe donnée;

b) énonce les exigences, notamment en matière d’étiquetage, applicables à ces drogues. (class monograph)

« pays participant » Pays participant à un accord de reconnaissance mutuelle avec le Canada. (MRA country)

« pays signataire »[Abrogée, DORS/2002-368, art. 1]

« prémélange médicamenteux » Drogue à usage vétérinaire qui a fait l’objet d’une identification numérique et dont l’étiquette porte qu’elle doit être combinée à un aliment au sens de l’article 2 de la Loi relative aux aliments du bétail. (drug premix)

« prémélange médicamenteux dilué » Drogue à usage vétérinaire résultant de la combinaison d’un prémélange médicamenteux à un aliment au sens de l’article 2 de la Loi relative aux aliments du bétail de sorte qu’au taux le plus bas des posologies approuvées pour cette drogue, au moins 10 kg de la combinaison soit nécessaire pour

médicamenter une tonne métrique d’un aliment complet au sens de l’article 2 du Règlement de 1983 sur les aliments du bétail. (dilute drug premix)

« produit pharmaceutique » Toute drogue non visée aux annexes C ou D de la Loi. (pharmaceutical)

« site »[Abrogée, DORS/2002-368, art. 1]

« vendre en gros » Vendre autrement qu’au détail une ou plusieurs des drogues suivantes sans que le nom du vendeur ne figure sur l’étiquette :

a) toute drogue visée aux annexes C ou D de la Loi, toute drogue visée à l’annexe F du présent règlement ou toute drogue contrôlée au sens du paragraphe G.01.001(1) de celui­ ci;

b) un stupéfiant au sens du Règlement sur les stupéfiants. (wholesale)

(2) Au présent titre et au titre 2, « drogue » s’entend de toute drogue sous forme posologique ou de toute drogue sous forme de produit intermédiaire en vrac pouvant être utilisée dans la préparation d’une drogue d’origine biologique visée aux annexes C ou D de la Loi. La présente définition ne comprend pas le prémélange médicamenteux dilué, l’aliment médicamenté au sens de l’article 2 du Règlement de 1983 sur les aliments du bétail, les drogues utilisées uniquement pour une étude expérimentale menée conformément au certificat délivré en vertu de l’article C.08.015 et les drogues visées à l’annexe H de la Loi.

(3) Lorsque le ministre désigne d’autres classes de formes posologiques, il met la liste de ces classes à la disposition de quiconque en fait la demande.

DORS/97-12, art. 5; DORS/98-7, art. 1; DORS/2000-120, art. 1; DORS/2002-368, art. 1; DORS/2004-282, art. 1.

Application

C.01A.002. (1) Le présent titre ne s’applique pas dans les cas suivants :

a) la vente en gros d’un prémélange médicamenteux;

b) l’importation ou la préparation, conformément à une ordonnance, d’une drogue qui n’est pas disponible sur le marché canadien par les personnes suivantes :

(i) le pharmacien,

(ii) le praticien,

(iii) la personne qui prépare une drogue sous la supervision d’un praticien;

c) toute activité à l’égard d’une drogue destinée exclusivement aux essais cliniques visée au paragraphe C.05.006(1) ou à l’article C.08.005;

d) les activités visant à manufacturer, emballer-étiqueter, analyser conformément au titre 2, distribuer à titre de distributeur visé à l’article C.01A.003, vendre en gros ou importer l’une ou l’autre des drogues suivantes vendues sans ordonnance et qui sont sous forme posologique et pour usage humain mais qui ne sont pas présentées comme traitement ou mesure préventive d’une maladie, d’un désordre ou d’un état physique anormal visés à l’annexe A de la Loi ou comme moyen de guérison :

(i) les drogues homéopathiques,

(ii) les drogues conformes aux exigences de la monographie de classe intitulée, selon le cas, « Suppléments vitaminiques », « Suppléments minéraux », « Suppléments vitaminiques alimentaires » ou « Suppléments minéraux alimentaires »,

(iii) toute drogue qui :

(A) d’une part, contient une substance végétale, minérale ou animale dont les propriétés sont présentées comme étant thérapeutiques ou préventives, notamment les herbes médicinales traditionnelles, les médicaments traditionnels chinois, ayurvédiques (Indiens d’Asie) et autochtones (Amérique du Nord),

(B) d’autre part, dont l’utilisation à des fins médicales est appuyée seulement de preuves historiques et ethnologiques tirées d’ouvrages de références relatifs à un système de médecine autre que celui fondé sur des normes scientifiques conventionnelles;

e) les activités visant à manufacturer, emballer-étiqueter, analyser, distribuer ou importer un agent antimicrobien.

(2) Le présent titre et les titres 2 à 4 ne s’appliquent pas dans le cas de l’activité visant à apposer une étiquette sur un récipient déjà étiqueté.

DORS/97-12, art. 5; DORS/98-7, art. 2; DORS/2001-203, art. 1; DORS/2004-282, art. 2.

C.01A.003. Le présent titre et les titres 2 à 4 s’appliquent au distributeur :

a) d’une drogue visée aux annexes C ou D de la Loi, d’une drogue visée à l’annexe F du présent règlement, d’une drogue contrôlée au sens du paragraphe G.01.001(1) de celui-ci ou d’un stupéfiant au sens du Règlement sur les stupéfiants dont il n’a pas obtenu l’identification numérique;

b) d’une drogue dont il a obtenu l’identification numérique.

DORS/97-12, art. 5; DORS/2002-368, art. 2.

Interdiction

C.01A.004. (1) Sous réserve du paragraphe (2), il est interdit, sauf conformément à une licence d’établissement :

a) de manufacturer, d’emballer-étiqueter, de distribuer à titre de distributeur visé à l’article C.01A.003, d’importer et de vendre en gros une drogue;

b) d’effectuer les analyses, y compris les examens, exigées au titre 2.

(2) Une personne n’est pas tenue d’être titulaire d’une licence d’établissement pour effectuer les analyses exigées au titre 2 si elle est autorisée par une licence d’établissement à manufacturer, emballer-étiqueter, distribuer à titre de distributeur visé à l’alinéa C.01A.003b) ou importer une drogue.

(3) Il est interdit d’exercer une activité visée au paragraphe (1) à l’égard d’un stupéfiant au sens du Règlement sur les stupéfiants ou d’une drogue contrôlée au sens du paragraphe G.01.001(1) du présent règlement à moins d’être titulaire de la licence prévue pour ce stupéfiant ou cette drogue dans le règlement applicable.

DORS/97-12, art. 5; DORS/2002-368, art. 3.

Demande

[DORS/2011-81, art. 1(A)]

C.01A.005. Toute demande de licence d’établissement est présentée au ministre, en la forme établie par celui-ci, et contient les renseignements et documents suivants :

a) les nom, adresse et numéro de téléphone du demandeur ainsi que, le cas échéant, son numéro de télécopieur et son adresse électronique;

b) les nom et numéro de téléphone d’une personne qu’il est possible de joindre en cas d’urgence ainsi que, le cas échéant, son numéro de télécopieur et son adresse électronique;

c) chaque activité visée par la demande et figurant au tableau I de l’article C.01A.008;

d) chaque catégorie de drogues visée par la demande et figurant au tableau II de l’article C.01A.008;

e) chaque classe de forme posologique à l’égard de laquelle le demandeur se propose d’exercer une activité visée par sa licence et une mention indiquant s’il s’agit d’une drogue sous forme posologique stérile;

f) une mention indiquant si le demandeur se propose d’exercer une activité visée par sa licence à l’égard d’une drogue sous forme de produit intermédiaire en vrac;

g) l’adresse de chacun des bâtiments au Canada où le demandeur se propose de manufacturer, d’emballer-étiqueter, d’effectuer les analyses exigées au titre 2 ou d’entreposer des drogues, avec indication, pour chaque bâtiment, de l’activité et de la catégorie de drogues ainsi que, pour chaque catégorie de drogues :

(i) la classe de forme posologique et une mention indiquant s’il s’agit d’une drogue sous forme posologique stérile,

(ii) une mention indiquant s’il s’agit d’une drogue sous forme de produit intermédiaire en vrac;

h) l’adresse de chacun des bâtiments au Canada où seront conservés les dossiers;

i) pour tout bâtiment visé aux alinéas g) ou h), une mention indiquant s’il s’agit d’une maison d’habitation;

j) l’identification numérique, le cas échéant, ou le nom qui identifie clairement la drogue s’il s’agit :

(i) d’un stupéfiant au sens du Règlement sur les stupéfiants ou d’une drogue contrôlée au sens du paragraphe G.01.001(1) du présent règlement, pour lequel la licence est demandée,

(ii) de toute autre drogue d’une catégorie visée par la demande, à moins que la licence ne vise les analyses effectuées conformément au titre 2, la distribution à titre de distributeur visé à l’alinéa C.01A.003a) ou la vente en gros;

k) la date de la dernière inspection des bâtiments visés à l’alinéa g), le cas échéant, effectuée aux termes de la Loi ou du présent règlement;

l) la preuve que les bâtiments, l’équipement et les méthodes et pratiques que le demandeur propose satisfont aux exigences applicables des titres 2 à 4;

m) dans le cas de l’importateur d’une drogue qui, dans un pays participant, est manufacturée, emballée-étiquetée ou analysée dans un bâtiment reconnu :

(i) les nom et adresse de chaque manufacturier, emballeur-étiqueteur et analyste ainsi que l’adresse de chaque bâtiment où la drogue est manufacturée, emballée-étiquetée ou analysée, avec indication, pour chaque bâtiment, de l’activité et de la catégorie de drogues ainsi que :

(A) la classe de forme posologique de la drogue et une mention indiquant s’il s’agit d’une drogue sous forme posologique stérile,

(B) une mention indiquant s’il s’agit d’une drogue sous forme de produit intermédiaire en vrac,

(ii) à l’égard de chaque activité qui, dans un pays participant, est effectuée dans un bâtiment reconnu, le nom de l’autorité réglementaire désignée aux termes du paragraphe C.01A.019(1) à l’égard de cette activité pour cette drogue, qui reconnaît ce bâtiment comme satisfaisant à ses normes de bonnes pratiques de fabrication qui ont trait à cette activité pour cette drogue,

(iii) à l’égard des autres activités, selon le cas :

(A) le certificat d’un inspecteur canadien indiquant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur ou de l’analyste satisfont aux exigences applicables des titres 2 à 4,

(B) toute autre preuve établissant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur ou de l’analyste satisfont aux exigences applicables des titres 2 à 4;

n) dans le cas de tout autre importateur, les nom et adresse du manufacturier, de l’emballeur-étiqueteur et de l’analyste de qui il se propose d’importer la drogue, l’adresse de chaque bâtiment où elle sera manufacturée, emballée-étiquetée et analysée, avec indication, pour chaque bâtiment, de l’activité et de la catégorie de drogues ainsi que, pour chaque catégorie de drogues :

(i) la classe de forme posologique et une mention indiquant s’il s’agit d’une drogue sous forme posologique stérile,

(ii) une mention indiquant s’il s’agit d’une drogue sous forme de produit intermédiaire en vrac;

o) dans le cas de l’importateur visé à l’alinéa n), selon le cas :

(i) le certificat d’un inspecteur canadien indiquant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur et de l’analyste satisfont aux exigences applicables des titres 2 à 4,

(ii) une autre preuve établissant que les bâtiments, l’équipement et les méthodes et pratiques du manufacturier, de l’emballeur-étiqueteur et de l’analyste satisfont aux exigences applicables des titres 2 à 4.

DORS/97-12, art. 5; DORS/2000-120, art. 2; DORS/2002-368, art. 4; DORS/2011-81, art. 2. Version précédente C.01A.006. (1) Toute demande de modification d’une licence d’établissement est présentée au ministre, en la forme établie par celui-ci, et contient les renseignements et documents visés à l’article C.01A.005 relativement à la modification demandée.

(2) Une licence d’établissement doit faire l’objet d’une modification lorsque le titulaire se propose :

a) d’ajouter une ou plusieurs activités ou une catégorie de drogues visées aux tableaux de l’article C.01A.008;

b) à l’égard d’une catégorie de drogues et d’une activité visées par la licence, d’autoriser des formes posologiques stériles;

c) d’ajouter un ou plusieurs bâtiments au Canada où il est autorisé de manufacturer, d’emballer-étiqueter, d’analyser conformément au titre 2 ou d’entreposer une drogue ou, pour un bâtiment existant, d’ajouter l’autorisation de manufacturer, d’emballer-étiqueter, d’analyser ou d’entreposer une catégorie de drogues ou des formes posologiques stériles de celle-ci;

d) dans le cas de tout importateur, en plus des éléments visés aux alinéas a) à c) :

(i) d’ajouter le nom d’un manufacturier, emballeur-étiqueteur ou analyste,

(ii) de modifier le nom ou l’adresse d’un manufacturier, emballeur-étiqueteur ou analyste indiqué dans la licence,

(iii) lorsque l’adresse des bâtiments où il est autorisé de manufacturer, d’emballer­ étiqueter ou d’analyser une drogue est indiquée sur la licence, d’ajouter un ou plusieurs bâtiments ou, pour un bâtiment existant, d’ajouter l’autorisation de manufacturer, d’emballer-étiqueter ou d’analyser une catégorie de drogues ou des formes posologiques stériles de celle-ci.

DORS/97-12, art. 5; DORS/2011-81, art. 3. Version précédente C.01A.007. (1) Sur réception de la demande de licence d’établissement ou de modification ou d’examen d’une telle licence, le ministre peut, en vue de prendre une décision, exiger des précisions quant aux renseignements contenus dans la demande.

(2) Au cours de l’examen d’une demande, le ministre peut exiger :

a) qu’une inspection soit effectuée aux heures normales de bureau de tout bâtiment visé aux alinéas C.01A.005g) et h);

b) que le demandeur, s’il s’agit du manufacturier, de l’emballeur-étiqueteur, de la personne qui effectue les analyses conformément au titre 2, du distributeur visé à l’alinéa C.01A.003b) ou de l’importateur, fournisse des échantillons de tout matériau servant à manufacturer, emballer-étiqueter ou analyser une drogue.

DORS/97-12, art. 5; DORS/2011-81, art. 4. Version précédente

Délivrance

C.01A.008. (1) Sous réserve de l’article C.01A.010, le ministre délivre ou modifie une licence d’établissement sur réception des renseignements et des matériaux visés aux articles C.01A.005 à C.01A.007.

(2) La licence indique à la fois :

a) chacune des activités autorisées et la catégorie de drogues pour chacune d’entre elles, selon les tableaux du présent article, en précisant pour chaque activité et catégorie de drogues, si des formes posologiques stériles sont autorisées;

b) l’adresse de chacun des bâtiments au Canada où il est autorisé de manufacturer, d’emballer-étiqueter, d’analyser conformément au titre 2 et d’entreposer une catégorie de drogues en précisant, pour chacun d’eux, l’activité et la catégorie de drogues, et si des formes posologiques stériles sont autorisées;

c) dans le cas de tout importateur, en plus des indications visées aux alinéas a) et b) :

(i) les nom et adresse de chaque manufacturier, emballeur-étiqueteur et analyste auprès de qui il est autorisé à obtenir la drogue pour l’importation,

(ii) l’adresse de chaque bâtiment où est autorisé la manufacture, l’emballage-étiquetage ou l’analyse de la drogue avec indication, pour chacun d’eux, des activités et de la catégorie de drogues autorisées et si des formes posologiques stériles sont autorisées.

d) [Abrogé, DORS/2002-368, art. 5]

(3) Le ministre peut indiquer dans la licence d’établissement toute période pendant laquelle les dossiers doivent être conservés sous le régime du titre 2 et qui, selon le profil de sûreté de la drogue ou des matériaux, est suffisante pour assurer la protection du consommateur.

(4) Le ministre peut, outre les exigences visées au paragraphe (2), assortir la licence d’établissement de conditions portant sur :

a) les analyses à effectuer à l’égard de la drogue et l’équipement à utiliser afin que la drogue puisse être utilisée sans danger;

b) tout autre élément nécessaire pour prévenir le risque pour la santé des consommateurs, notamment la façon dont la drogue est manufacturée, emballée-étiquetée ou analysée.

TABLEAU I

Article Activité 1. Manufacturer 2. Emballer-étiqueter 3. Analyser, y compris examiner, conformément au titre 2 4. Distribuer à titre de distributeur visé à l’alinéa C.01A.003a) 5. Distribuer à titre de distributeur visé à l’alinéa C.01A.003b) 6. Importer 7. Vendre en gros

TABLEAU II

Article Catégorie de drogues 1. Produit pharmaceutique 2. Vaccin 3. Sang entier et ses composants

Drogue visée à l’annexe D de la Loi, autre qu’un vaccin ou que le sang entier et4. ses composants 5. Drogue visée à l’annexe C de la Loi

Drogue visée à l’annexe F du présent règlement, drogue contrôlée au sens du 6. paragraphe G.01.001(1) de celui-ci, et stupéfiant au sens du Règlement sur les

stupéfiants

DORS/97-12, art. 5; DORS/2000-120, art. 3; DORS/2002-368, art. 5.

Examen annuel de la licence

C.01A.009. (1) Le titulaire d’une licence d’établissement qui n’est pas suspendue doit, avant le 1er avril de chaque année, présenter au ministre la demande d’examen de sa licence accompagnée des renseignements et documents visés à l’article C.01A.005.

(2) Le ministre fait un examen annuel de la licence en se fondant sur les renseignements et documents fournis par le titulaire et sur toute autre information utile qu’il a en sa possession.

DORS/97-12, art. 5; DORS/97-298, art. 1; DORS/2011-81, art. 5. Version précédente

Refus

C.01A.010. (1) Le ministre peut refuser de délivrer ou de modifier une licence d’établissement à l’égard de toute indication visée au paragraphe C.01A.008(2) dans les cas suivants :

a) le demandeur a fait une déclaration fausse ou trompeuse au sujet de sa demande de licence d’établissement;

b) sa licence d’établissement a été suspendue au même égard.

(2) Le ministre refuse de délivrer ou de modifier une licence d’établissement à l’égard de toute indication visée au paragraphe C.01A.008(2) s’il a des motifs raisonnables de croire que la délivrance ou la modification d’une telle licence constituerait un risque pour la santé des consommateurs.

(3) Lorsqu’il refuse de délivrer ou de modifier la licence d’établissement, le ministre :

a) en avise le demandeur par écrit, motifs à l’appui;

b) donne au demandeur la possibilité de se faire entendre.

DORS/97-12, art. 5.

Conditions

C.01A.011. (1) Le titulaire d’une licence d’établissement est tenu de se conformer :

a) aux conditions qui y sont énoncées;

b) aux exigences applicables des titres 2 à 4.

(2) [Abrogé, DORS/2000-120, art. 4]

DORS/97-12, art. 5; DORS/2000-120, art. 4.

C.01A.012. (1) Le ministre peut modifier les conditions d’une licence d’établissement s’il a des motifs raisonnables de croire que la modification est nécessaire pour prévenir des risques pour la santé des consommateurs.

(2) Le ministre donne au titulaire de la licence d’établissement un préavis d’au moins 15 jours indiquant les motifs de la modification et sa date d’entrée en vigueur.

DORS/97-12, art. 5.

Avis de modification

C.01A.013. Le titulaire d’une licence d’établissement doit aviser, par écrit, le ministre au plus tard le 15e jour suivant, selon le cas :

a) la modification des renseignements visés aux alinéas C.01A.005a), b), e), f), h) et i) ou aux sous-alinéas C.01A.005g)(i) ou (ii);

b) la survenance d’un fait susceptible d’avoir un effet sur la qualité, l’innocuité ou l’efficacité d’une drogue manufacturée, emballée-étiquetée, analysée conformément au titre 2 ou entreposée par lui qui entraîne le non-respect des exigences visées aux titres 2 à 4.

DORS/97-12, art. 5.

C.01A.014. (1) Il est interdit au titulaire d’une licence d’établissement d’exercer une activité visée par sa licence à l’égard d’une catégorie de drogues, si une modification visée au paragraphe (2) est apportée, sauf :

a) s’il a déposé auprès du ministre un avis contenant les renseignements nécessaires pour permettre à celui-ci d’évaluer l’innocuité de la drogue nouvelle compte tenu de la modification;

b) si le ministre lui a fait parvenir une lettre indiquant que les renseignements feront l’objet d’un examen, et qu’il ne lui a pas, dans les 90 jours suivant la date de cette lettre, fait parvenir un avis indiquant que la modification n’est pas acceptable.

(2) L’avis est exigé à l’égard des modifications suivantes susceptibles d’avoir pour effet que la drogue ne soit plus manufacturée, emballée-étiquetée, analysée ou entreposée conformément aux exigences applicables des titres 2 à 4 :

a) toute modification des plans et des devis du bâtiment où la drogue est manufacturée, emballée-étiquetée, analysée ou entreposée;

b) tout changement apporté à l’équipement servant à manufacturer, emballer-étiqueter ou analyser la drogue;

c) toute modification des méthodes ou pratiques;

d) dans le cas d’un importateur autre que celui d’une drogue qui, dans un pays participant, est manufacturée, emballée-étiquetée ou analysée dans un bâtiment reconnu,

tout changement visé à l’un des alinéas a) à c) ayant trait au manufacturier, à l’emballeur­ étiqueteur ou à l’analyste de la drogue importée.

DORS/97-12, art. 5; DORS/2000-120, art. 5; DORS/2002-368, art. 6.

C.01A.015. (1) L’importateur d’une drogue qui, dans un pays participant, est manufacturée, emballée-étiquetée ou analysée dans un bâtiment reconnu doit, sans délai, aviser le ministre si le manufacturier, l’emballeur-étiqueteur ou l’analyste indiqué dans la licence d’établissement de l’importateur n’est plus titulaire du permis, de la licence ou de toute autre autorisation valide délivré par l’autorité réglementaire qui reconnaissait le bâtiment.

(2) Sur réception de l’avis, le ministre modifie la licence d’établissement de l’importateur en radiant les nom et adresse du manufacturier, de l’emballeur-étiqueteur ou de l’analyste visé.

DORS/97-12, art. 5; DORS/2000-120, art. 6; DORS/2002-368, art. 7.

Suspension

C.01A.016. (1) Sous réserve du paragraphe (3), le ministre peut suspendre la licence d’établissement à l’égard de toute indication visée au paragraphe C.01A.008(2) lorsqu’il a des motifs raisonnables de croire que :

a) le titulaire de la licence d’établissement ne s’est pas conformé pas aux dispositions de la Loi ou du présent règlement;

b) il a fait une déclaration fausse ou trompeuse au sujet de sa demande de licence.

(2) Avant de suspendre une licence d’établissement, le ministre prend en compte les faits suivants :

a) les antécédents du titulaire pour ce qui est de la conformité aux dispositions de la Loi ou du présent règlement;

b) le risque que présenterait le maintien de la licence pour la santé des consommateurs.

(3) Sous réserve du paragraphe C.01A.017(1), le ministre ne peut suspendre la licence d’établissement que si, à la fois :

a) l’inspecteur a envoyé au titulaire un avis écrit précisant les motifs de la suspension, et, le cas échéant, les mesures correctives qui s’imposent ainsi que le délai accordé pour les prendre;

b) lorsque l’avis prévoit des mesures correctives, le titulaire ne les a pas prises dans le délai prévu;

c) le titulaire a eu la possibilité de se faire entendre à l’égard de la suspension.

DORS/97-12, art. 5.

C.01A.017. (1) Le ministre peut, lorsque cela est nécessaire pour prévenir des risques pour la santé des consommateurs, suspendre la licence d’établissement sans que le titulaire ait la possibilité de se faire entendre, en lui faisant parvenir un avis motivé.

(2) Le titulaire d’une licence d’établissement peut demander, par écrit, au ministre que la suspension soit revisée.

(3) Le ministre doit, dans les 45 jours suivant la date de réception de la demande, donner au titulaire la possibilité de se faire entendre.

DORS/97-12, art. 5.

C.01A.018. Le ministre peut mettre fin à la suspension d’une licence d’établissement.

DORS/97-12, art. 5.

Annulation

C.01A.018.1 Le ministre annule une licence dans les circonstances suivantes :

a) la licence a été suspendue pour plus de douze mois;

b) le titulaire a omis de présenter une demande d’examen annuel de sa licence conformément au paragraphe C.01A.009(1).

DORS/2011-81, art. 6.

Désignation

C.01A.019. (1) Pour l’application du présent titre et des titres 2 à 4, les autorités réglementaires mentionnées à la colonne 1 du tableau du présent article sont désignées à l’égard des activités visées à la colonne 3 pour les drogues ou catégories de drogues visées à la colonne 2.

(2) Le sang entier et des composants sont exclus des drogues ou catégories de drogues visées à la colonne 2 du tableau du présent article.

(3) La libération par lot des drogues visées à l’annexe D de la Loi est exclue de l’activité d’analyse visée à la colonne 3 du tableau du présent article.

TABLEAU

AUTORITÉS RÉGLEMENTAIRES DÉSIGNÉES

Colonne 1 Colonne 2 Colonne 3 Drogues ou catégories deArticle Autorités réglementaires Activitésdrogues

Swissmedic, Institut suisse des Produits pharmaceutiques Manufacture, 1. produits thérapeutiques, Berne, pour usage humain ou emballage-

Suisse vétérinaire étiquetage, analyse

Colonne 1 Colonne 2 Colonne 3

Article Autorités réglementaires Drogues ou catégories dedrogues Activités

Drogues visées aux annexes C ou D de la Loi

2.

Inspectorat régional des médicaments de la Suisse du Nord-Ouest (IRM-NO), Bâle, Suisse

Produits pharmaceutiques pour usage humain ou vétérinaire Drogues visées aux annexes C ou D de la Loi

Manufacture, emballage­ étiquetage, analyse

3.

Inspectorat régional des médicaments de la Suisse de l’Est et centrale (IRM-EC), Zurich, Suisse

Produits pharmaceutiques pour usage humain ou vétérinaire Drogues visées aux annexes C ou D de la Loi

Manufacture, emballage­ étiquetage, analyse

4.

Produits pharmaceutiques pour usage humain ou vétérinaire

Inspectorat régional des médicaments de la Suisse du Sud (IRM-S), Tessin, Suisse Drogues visées aux

annexes C ou D de la Loi

Manufacture, emballage­ étiquetage, analyse

5.

Inspectorat romand de la fabrication des agents thérapeutiques (IRFAT), Lausanne, Suisse

Produits pharmaceutiques pour usage humain ou vétérinaire Drogues visées aux annexes C ou D de la Loi

Manufacture, emballage­ étiquetage, analyse

DORS/97-12, art. 5; DORS/2000-120, art. 7; DORS/2002-368, art. 8.

Titre 2

Bonnes pratiques de fabrication C.02.001. [Abrogé, DORS/97-12, art. 5.1]

C.02.002. Dans le présent titre,

« drogue »[Abrogée, DORS/97-12, art. 6]

« gaz médical » désigne tout gaz ou mélange de gaz fabriqué ou vendu pour servir de drogue ou présenté comme pouvant servir de drogue; (medical gas)

« importateur »[Abrogée, DORS/97-12, art. 6]

« matériel de conditionnement »[Abrogée, DORS/89-174, art. 1]

« matériel d’emballage » comprend une étiquette; (packaging materian( �

« produire »[Abrogée, DORS/97-12, art. 6]

« service du contrôle de la qualité »[Abrogée, DORS/2010-95, art. 1]

« spécifications » s’entend de la description détaillée d’une drogue, de la matière première utilisée dans cette drogue ou du matériel d’emballage de la drogue, y compris :

a) la liste des propriétés et des qualités de la drogue, de la matière première ou du matériel d’emballage qui ont trait à la fabrication, à l’emballage et à l’emploi de la drogue, y compris l’identité, l’activité et la pureté de la drogue, de la matière première ou du matériel d’emballage,

b) une description détaillée des méthodes d’analyse et d’examen de la drogue, de la matière première ou du matériel d’emballage,

c) une indication des tolérances relatives aux propriétés et aux qualités de la drogue, de la matière première ou du matériel d’emballage. (specifications)

DORS/82-524, art. 3; DORS/85-754, art. 1; DORS/89-174, art. 1; DORS/97-12, art. 6; DORS/2010-95, art. 1. Version précédente C.02.002.1 Le présent titre ne s’applique pas aux activités visant à manufacturer, à emballer-étiqueter, à analyser, à entreposer ou à importer un agent antimicrobien.

DORS/2004-282, art. 3.

Vente

C.02.003. Il est interdit au distributeur visé à l’alinéa C.01A.003b) et à l’importateur de vendre une drogue qui n’a pas été manufacturée, emballée-étiquetée, analysée et entreposée conformément aux exigences du présent titre.

DORS/82-524, art. 3; DORS/97-12, art. 7; DORS/2000-120, art. 8; DORS/2010-95, art. 2(F). Version précédente

Locaux

C.02.004. Les locaux dans lesquels un lot ou un lot de fabrication d’une drogue est manufacturé, emballé-étiqueté ou entreposé sont conçus, construits et entretenus de manière :

a) à permettre l’exécution des opérations d’une façon propre, hygiénique et ordonnée;

b) à permettre le nettoyage efficace de toutes les surfaces qui s’y trouvent; et

c) à empêcher la contamination de la drogue et l’introduction de toute matière étrangère à la drogue.

DORS/82-524, art. 3; DORS/97-12, art. 8; DORS/2010-95, art. 3.

Version précédente

Équipement

C.02.005. L’équipement servant à manufacturer, emballer-étiqueter ou analyser un lot ou un lot de fabrication d’une drogue doit être conçu, fabriqué, entretenu, utilisé et disposé de façon :

a) à permettre le nettoyage efficace de toutes les surfaces qui s’y trouvent;

b) à empêcher la contamination de la drogue et l’introduction de toute matière étrangère à la drogue; et

c) à fonctionner selon son usage voulu.

DORS/82-524, art. 3; DORS/97-12, art. 9.

Personnel

C.02.006. Chaque lot ou lot de fabrication d’une drogue doit être manufacturé, emballé­ étiqueté, analysé et entreposé sous la surveillance d’un personnel qui, sur le plan des fonctions et responsabilités en cause, a reçu une formation technique, une formation théorique de même qu’un autre type de formation que le Directeur juge satisfaisantes dans l’intérêt de la santé du consommateur ou de l’acheteur.

DORS/82-524, art. 3; DORS/85-754, art. 2; DORS/97-12, art. 52.

Hygiène

C.02.007. (1) La personne qui manufacture ou emballe-étiquette une drogue doit avoir un programme d’hygiène, par écrit, qui est appliqué sous la surveillance d’un personnel compétent.

(2) Le programme d’hygiène visé au paragraphe (1) doit comprendre :

a) les méthodes de nettoyage des locaux où la drogue est manufacturée ou emballée­ étiquetée et de l’équipement servant à ces fins;

b) des instructions pour manufacturer et emballer-étiqueter les drogues dans des conditions hygiéniques et pour manutentionner le matériel utilisé à ces fins.

DORS/82-524, art. 3; DORS/97-12, art. 10 et 53.

C.02.008. (1) Le manufacturier et l’emballeur-étiqueteur d’une drogue doivent avoir, par écrit, les exigences minimales relatives à la santé ainsi qu’au comportement et aux vêtements du personnel afin que la drogue soit manufacturée et emballée-étiquetée dans des conditions hygiéniques.

(2) L’accès à une zone où est exposée une drogue à l’étape où elle est manufacturée ou emballée-étiquetée est interdite à la personne :

a) qui est atteinte ou porteuse d’une maladie transmissible, ou

b) qui présente une plaie ouverte sur une surface exposée de son corps.

DORS/82-524, art. 3; DORS/97-12, art. 11.

Analyse des matières premières

C.02.009. (1) Un lot ou un lot de fabrication d’une matière première doit être analysé en fonction des spécifications de cette matière première, avant d’être utilisé pour manufacturer une drogue.

(2) Un lot ou un lot de fabrication d’une matière première ne peut être utilisé pour manufacturer une drogue que s’il est conforme aux spécifications de cette matière première.

(3) Nonobstant le paragraphe (1), l’eau peut, avant la fin de l’analyse visée à ce paragraphe, être utilisée pour manufacturer une drogue.

(4) Si une propriété d’une matière première est susceptible de s’altérer au cours de l’entreposage, aucun lot ni lot de fabrication de cette matière ne peut être utilisé, après avoir été entreposé, pour manufacturer une drogue, à moins que la propriété n’ait été à nouveau analysée après un intervalle approprié et trouvée conforme aux spécifications établies à son égard.

(5) Si les spécifications visées aux paragraphes (1), (2) et (4) ne sont pas prescrites, elles doivent

a) être par écrit;

b) être jugées acceptables par le Directeur, qui tiendra compte des spécifications énoncées dans les publications visées à l’annexe B de la Loi; et

c) être approuvées par le responsable du service du contrôle de la qualité.

DORS/82-524, art. 3; DORS/97-12, art. 59.

C.02.010. (1) Les analyses visées à l’article C.02.009 doivent être effectuées sur un échantillon prélevé

a) après la réception de chaque lot ou chaque lot de fabrication de matières premières dans les locaux du manufacturier; ou

b) sous réserve du paragraphe (2), avant la réception de chaque lot ou chaque lot de fabrication de matières premières dans les locaux du manufacturier,

(i) si ce manufacturier :

(A) prouve, à la satisfaction du Directeur, que les matières premières qui lui ont été vendues par le vendeur du lot ou du lot de fabrication sont fabriquées d’une façon

constante selon les spécifications établies pour ces matières et qu’elles s’y conforment de manière constante, et

(B) effectue des analyses de vérification complètes à une fréquence satisfaisant le Directeur, et

(ii) si les matières premières n’ont pas été transportées ni entreposées dans des conditions pouvant modifier leur conformité aux spécifications établies à leur égard.

(2) Chaque lot ou chaque lot de fabrication de matières premières reçu dans les locaux du manufacturier, doit être soumis à une analyse d’identité.

DORS/82-524, art. 3; DORS/97-12, art. 12 et 60.

Contrôle de la fabrication

C.02.011. (1) Le manufacturier, l’emballeur-étiqueteur, le distributeur visé à l’alinéa C.01A.003b) et l’importateur doivent avoir, par écrit, les méthodes établies par un personnel compétent qui garantissent que la drogue est conforme à ses spécifications.

(2) Toute personne tenue d’avoir par écrit les méthodes visées au paragraphe (1) doit veiller à ce que chaque lot ou lot de fabrication soit manufacturé, emballé-étiqueté et analysé selon ces méthodes.

DORS/82-524, art. 3; DORS/97-12, art. 13.

C.02.012. (1) Le manufacturier, l’emballeur-étiqueteur, le distributeur visé à l’article C.01A.003, l’importateur et le grossiste doivent tenir :

a) un système de contrôle qui permet le retrait rapide et complet de tout lot ou tout lot de fabrication de la drogue se trouvant sur le marché;

b) un programme d’auto-inspection.

(2) Le manufacturier, l’emballeur-étiqueteur et, sous réserve des paragraphes (3) et (4), le distributeur visé à l’alinéa C.01A.003b) et l’importateur doivent tenir un système visant à garantir que tout lot ou tout lot de fabrication de la drogue manufacturé et emballé­ étiqueté ailleurs que dans leurs locaux l’est conformément aux exigences du présent titre.

(3) Le distributeur visé à l’alinéa C.01A.003b) d’une drogue manufacturée, emballée­ étiquetée et analysée au Canada par le titulaire d’une licence d’établissement autorisant ces activités à l’égard de cette drogue n’est pas tenu de satisfaire à l’exigence du paragraphe (2) pour cette drogue.

(4) Dans le cas d’une drogue qui, dans un pays participant, est manufacturée ou emballée­ étiquetée dans un bâtiment reconnu, le distributeur visé à l’alinéa C.01A.003b) ou l’importateur de cette drogue n’est pas tenu de se conformer à l’exigence du paragraphe (2) à l’égard de cette activité pour cette drogue si les conditions suivantes sont réunies :

a) l’adresse du bâtiment est indiquée dans sa licence d’établissement;

b) pour chaque lot ou lot de fabrication de la drogue qu’il a reçu, il conserve une copie du certificat de lot.

DORS/82-524, art. 3; DORS/97-12, art. 13; DORS/2000-120, art. 9; DORS/2002-368, art. 9.

Service du contrôle de la qualité

C.02.013. (1) Le manufacturier, l’emballeur-étiqueteur, le grossiste, le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue ont dans leurs locaux au Canada un service du contrôle de la qualité qui est sous la surveillance du personnel visé à l’article C.02.006.

(2) Sauf dans le cas d’un grossiste, le service du contrôle de la qualité est un service organisationnel distinct, qui relève de la direction et fonctionne indépendamment des autres services fonctionnels, y compris les services de fabrication, de traitement, d’emballage ou des ventes.

DORS/82-524, art. 3; DORS/89-174, art. 8(F); DORS/97-12, art. 55; DORS/2000-120, art. 10; DORS/2010-95, art. 4. Version précédente C.02.014. (1) Sauf dans le cas d’un grossiste, un lot ou un lot de fabrication d’une drogue ne peut être mis en vente sans l’approbation du responsable du service du contrôle de la qualité.

(2) Une drogue qui est retournée au manufacturier, à l’emballeur-étiqueteur, au grossiste, au distributeur visé à l’alinéa C.01A.003b) ou à l’importateur ne peut être remise en vente sans l’approbation du responsable du service du contrôle de la qualité.

(3) Un lot ou un lot de fabrication de matières premières ou de matériaux d’emballage­ étiquetage ne peut être utilisé pour manufacturer ou emballer-étiqueter une drogue sans l’approbation du responsable du service de contrôle de la qualité.

(4) Un lot ou un lot de fabrication d’une drogue ne peut être traité à nouveau sans l’approbation du responsable du service du contrôle de la qualité.

DORS/82-524, art. 3; DORS/89-174, art. 8(F); DORS/97-12, art. 14 et 55; DORS/2010­ 95, art. 5. Version précédente C.02.015. (1) Les méthodes et pratiques utilisées pour manufacturer, emballer-étiqueter, analyser, entreposer ou transporter une drogue qui peuvent avoir un effet sur sa qualité doivent être examinées et approuvées par le responsable du service de contrôle de la qualité avant d’être appliquées.

(2) Le responsable du service du contrôle de la qualité veille à ce que la plainte ou le renseignement reçu au sujet de la qualité d’une drogue — ou des défauts ou dangers

qu’elle comporte — fasse l’objet d’une enquête et à ce que les mesures correctives nécessaires soient prises, dans le cas où la plainte ou le renseignement concerne une activité sur laquelle le service exerce un contrôle de la qualité.

(2.1) Dans le cas contraire, il l’achemine au responsable du service du contrôle de la qualité qui exerce un contrôle de la qualité sur l’activité en cause.

(3) Le responsable du service du contrôle de la qualité doit s’assurer que les analyses et les examens exigés dans le présent titre sont effectués par un laboratoire compétent.

DORS/82-524, art. 3; DORS/97-12, art. 15; DORS/2010-95, art. 6. Version précédente

Analyse du matériel d'emballage

C.02.016. (1) Un lot ou un lot de fabrication de matériel d’emballage doit, avant d’être utilisé pour l’emballage d’une drogue, faire l’objet d’examens ou d’analyses en fonction des spécifications établies pour ce matériel.

(2) Un lot ou un lot de fabrication de matériel d’emballage ne peut être utilisé pour l’emballage d’une drogue que s’il est conforme aux spécifications établies pour ce matériel.

(3) Les spécifications visées aux paragraphes (1) et (2) doivent

a) être par écrit;

b) être jugées acceptables par le Directeur, qui tiendra compte des spécifications prévues dans les publications visées à l’annexe B de la Loi; et

c) être approuvées par le responsable du service du contrôle de la qualité.

DORS/82-524, art. 3; DORS/89-174, art. 8(F).

C.02.017. (1) Les examens ou les analyses visés à l’article C.02.016 doivent être effectués sur un échantillon prélevé

a) après la réception de chaque lot ou chaque lot de fabrication de matériel d’emballage dans les locaux de la personne qui emballe-étiquette une drogue; ou

b) sous réserve du paragraphe (2), avant la réception de chaque lot ou lot de fabrication de matériel d’emballage dans les locaux de la personne qui emballe une drogue :

(i) si cette personne

(A) prouve, à la satisfaction du Directeur, que le matériel d’emballage qui lui a été vendu par le vendeur du lot ou du lot de fabrication est fabriqué d’une façon constante selon les spécifications établies pour ce matériel et qu’il s’y conforme de manière constante, et

(B) effectue des examens ou des analyses de vérification complets à une fréquence satisfaisant le Directeur, et

(ii) si le matériel d’emballage n’a pas été transporté ni entreposé dans des conditions pouvant modifier sa conformité aux spécifications établies à son égard.

(2) Sur réception d’un lot ou d’un lot de fabrication de matériel d’emballage dans les locaux de la personne qui emballe-étiquette la drogue

a) le lot ou le lot de fabrication de matériel d’emballage doit être soumis à un examen ou à une analyse d’identité; et

b) les étiquettes doivent être examinées ou analysées pour assurer leur conformité aux spécifications établies à leur égard.

DORS/82-524, art. 3; DORS/89-174, art. 2(F) et 8(F); DORS/97-12, art. 56(F).

Analyse du produit fini

C.02.018. (1) Un lot ou un lot de fabrication d’une drogue doit, avant sa mise en vente, être analysé en fonction des spécifications établies pour cette drogue.

(2) Un lot ou un lot de fabrication d’une drogue ne peut être mis en vente que s’il est conforme aux spécifications établies pour cette drogue.

(3) Les spécifications visées aux paragraphes (1) et (2) doivent

a) être par écrit;

b) être approuvées par le responsable du service du contrôle de la qualité; et

c) être conformes à la Loi et au présent règlement.

DORS/82-524, art. 3.

C.02.019. (1) Dans le cas de l’emballeur-étiqueteur, du distributeur visé à l’alinéa C.01A.003b) et de l’importateur, les analyses visées à l’article C.02.018 doivent, sous réserve des paragraphes (3) et (4), être effectuées sur un échantillon prélevé :

a) après la réception au Canada de chaque lot ou chaque lot de fabrication de la drogue dans les locaux de l’emballeur-étiqueteur, du distributeur visé à l’alinéa C.01A.003b) ou de l’importateur de la drogue; ou

b) sous réserve du paragraphe (2), avant la réception de chaque lot ou chaque lot de fabrication de la drogue dans les locaux visés à l’alinéa a),

(i) si l’emballeur-étiqueteur, le distributeur visé à l’alinéa C.01A.003b) ou l’importateur

(A) prouve, à la satisfaction du Directeur, que la drogue qui lui a été vendue par le vendeur du lot ou du lot de fabrication a été fabriquée d’une façon constante selon les spécifications établies pour cette drogue et qu’elle s’y conforme de manière constante, et

(B) effectue des analyses de vérification complètes à une fréquence satisfaisant le Directeur, et

(ii) si la drogue n’a pas été transportée ni entreposée dans des conditions pouvant modifier sa conformité aux spécifications établies à son égard.

(2) Chaque lot ou lot de fabrication d’une drogue reçu au Canada dans les locaux de l’emballeur-étiqueteur, du distributeur visé à l’alinéa C.01A.003b) ou de l’importateur doit, lorsque la période de vie utile de cette drogue est de plus de 30 jours, être soumis à une analyse d’identité, celle-ci devant être confirmée par l’emballeur-étiqueteur après l’emballage-étiquetage.

(3) Le distributeur visé à l’alinéa C.01A.003b) d’une drogue manufacturée, emballée­ étiquetée et analysée au Canada par le titulaire d’une licence d’établissement autorisant ces activités à l’égard de cette drogue n’est pas tenu de satisfaire aux exigences prévues aux paragraphes (1) et (2) pour cette drogue.

(4) Dans le cas d’une drogue qui, dans un pays participant, est manufacturée, emballée­ étiquetée et analysée dans un bâtiment reconnu, le distributeur visé à l’alinéa C.01A.003b) ou l’importateur de cette drogue n’est pas tenu de se conformer aux exigences des paragraphes (1) et (2) pour cette drogue si les conditions suivantes sont réunies :

a) l’adresse du bâtiment est indiquée dans sa licence d’établissement;

b) pour chaque lot ou lot de fabrication de la drogue qu’il a reçu, il conserve une copie du certificat de lot.

DORS/82-524, art. 3; DORS/89-174, art. 8(F); DORS/97-12, art. 16 et 57; DORS/2000­ 120, art. 11; DORS/2002-368, art. 10.

Dossiers

C.02.020. (1) Le manufacturier, l’emballeur-étiqueteur, le distributeur visé à l’alinéa C.01A.003b) et l’importateur doivent conserver dans leurs locaux au Canada, pour chaque drogue vendue :

a) des documents-types de production;

b) une preuve attestant que chaque lot ou chaque lot de fabrication de la drogue a été manufacturé, emballé-étiqueté, analysé et entreposé conformément aux méthodes énoncées dans les documents-types de production;

c) une preuve attestant que les conditions dans lesquelles la drogue a été manufacturée, emballée-étiquetée, analysée et entreposée sont conformes aux exigences du présent titre;

d) une preuve attestant la durée pendant laquelle la drogue, placée dans le contenant dans lequel elle est vendue, demeurera conforme aux spécifications établies à son égard; et

e) une preuve satisfaisante des analyses visées à l’article C.02.018.

(2) Le distributeur visé à l’alinéa C.01A.003b) et l’importateur doivent fournir au Directeur, à sa demande, les résultats des analyses des matières premières et des

matériaux d’emballage-étiquetage effectuées pour chaque lot ou lot de fabrication d’une drogue vendue.

(3) Le manufacturier doit conserver dans ses locaux :

a) les spécifications écrites de ces matières; et

b) une preuve satisfaisante des analyses des matières premières visées à l’article C.02.009.

(4) La personne qui emballe une drogue doit conserver dans ses locaux :

a) les spécifications écrites du matériel d’emballage; et

b) une preuve satisfaisante des examens ou analyses visés à l’article C.02.016.

(5) Le manufacturier doit conserver dans ses locaux au Canada :

a) les plans et devis détaillés de chacun des bâtiments où la drogue est manufacturée, emballée-étiquetée ou analysée;

b) la description de la conception et de la construction de ces bâtiments.

(6) Le manufacturier, l’emballeur-étiqueteur et l’analyste doivent conserver dans leurs locaux au Canada des renseignements sur les employés qui supervisent les opérations visant à manufacturer, emballer-étiqueter ou analyser la drogue, notamment le titre, les responsabilités, les qualifications, l’expérience et la formation de ces personnes.

DORS/82-524, art. 3; DORS/89-174, art. 3(F) et 8(F); DORS/97-12, art. 17, 52 et 60.

C.02.021. (1) Sous réserve du paragraphe (2), les dossiers à tenir et les preuves à conserver aux termes du présent titre qui portent sur les opérations visant à manufacturer, emballer-étiqueter, analyser et entreposer une drogue doivent être conservés pendant au moins un an après la date limite d’utilisation indiquée sur l’étiquette de la drogue, sauf disposition contraire de la licence d’établissement de l’intéressé.

(2) Les dossiers et les preuves exigés par le présent titre au sujet de l’analyse des matières premières et des matériaux d’emballage-étiquetage doivent être conservés pendant au moins cinq ans après la dernière utilisation de ceux-ci au cours des opérations visant à manufacturer ou à emballer-étiqueter la drogue, sauf disposition contraire de la licence d’établissement de l’intéressé.

DORS/82-524, art. 3; DORS/89-174, art. 8(F); DORS/92-654, art. 6; DORS/97-12, art. 18.

C.02.022. Le distributeur visé à l’article C.01A.003, le grossiste et l’importateur d’une drogue doivent conserver les dossiers sur la vente de chaque lot ou lot de fabrication de la drogue qui leur permettent de retirer du marché le lot ou le lot de fabrication, pendant au moins un an après la date limite d’utilisation du lot ou du lot de fabrication, sauf disposition contraire de la licence d’établissement de l’intéressé.

DORS/82-524, art. 3; DORS/92-654, art. 7; DORS/97-12, art. 18.

C.02.023. (1) Sur réception d’une plainte ou d’un renseignement au sujet de la qualité d’une drogue — ou des défauts ou dangers qu’elle comporte — le manufacturier, l’emballeur-étiqueteur, le grossiste, le distributeur visé à l’alinéa C.01A.003b) ou l’importateur de la drogue, selon le cas :

a) s’il s’agit d’une plainte ou d’un renseignement visé au paragraphe C.02.015(2), ouvre un dossier sur la plainte ou le renseignement, les enquêtes menées à leur égard et, le cas échéant, les mesures correctives prises;

b) s’il s’agit d’une plainte ou d’un renseignement visé au paragraphe C.02.015(2.1), ouvre un dossier sur la plainte ou le renseignement et y note les nom et adresse du responsable du service du contrôle de la qualité à qui la plainte ou le renseignement a été acheminé et la date de l’acheminement.

(2) Le manufacturier, l’emballeur-étiqueteur, le grossiste, le distributeur visé à l’alinéa C.01A.003b) ou l’importateur de la drogue, selon le cas, conserve le dossier pendant au moins un an après la date limite d’utilisation du lot ou du lot de fabrication de la drogue, sauf disposition contraire de sa licence d’établissement.

DORS/82-524, art. 3; DORS/92-654, art. 7; DORS/97-12, art. 18; DORS/2010-95, art. 7. Version précédente C.02.024. (1) Le manufacturier, l’emballeur-étiqueteur, le distributeur visé à l’article C.01A.003, l’importateur et le grossiste doivent :

a) tenir des dossiers sur les résultats du programme d’auto-inspection exigé à l’article C.02.012 et les mesures prises relativement à ce programme; et

b) conserver ces dossiers pendant au moins trois ans.

(2) La personne qui manufacture ou emballe-étiquette une drogue doit

a) tenir des dossiers sur l’application du programme d’hygiène exigé à l’article C.02.007; et

b) conserver ces dossiers pendant au moins trois ans.

DORS/82-524, art. 3; DORS/97-12, art. 19 et 53.

Échantillons

C.02.025. (1) Le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue doivent conserver au Canada un échantillon de chaque lot ou lot de fabrication de la drogue emballée-étiquetée pendant au moins un an après la date limite d’utilisation indiquée sur l’étiquette de la drogue, sauf disposition contraire de la licence d’établissement de l’intéressé.

(2) Le manufacturier doit conserver un échantillon de chaque lot ou lot de fabrication des matières premières utilisées pour manufacturer une drogue pendant au moins deux ans après la dernière date d’utilisation de celles-ci, sauf disposition contraire de sa licence d’établissement.

DORS/82-524, art. 3; DORS/89-174, art. 4; DORS/92-654, art. 8; DORS/97-12, art. 20.

C.02.026. Les échantillons visés à l’article C.02.025 doivent être en quantité suffisante pour permettre de déterminer si la drogue ou les matières premières sont conformes à leurs spécifications respectives.

DORS/82-524, art. 3.

Stabilité

C.02.027. Le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue doivent déterminer la période durant laquelle la drogue, placée dans l’emballage dans lequel elle est vendue, demeurera conforme à ses spécifications.

DORS/82-524, art. 3; DORS/97-12, art. 58.

C.02.028. Le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue doivent surveiller, dans le cadre d’un programme permanent, la stabilité de la drogue dans l’emballage dans lequel elle est vendue.

DORS/82-524, art. 3; DORS/97-12, art. 58.

Produits stériles

C.02.029. Une drogue devant être stérile doit, outre les exigences énoncées dans le présent titre, être manufacturée et emballée-étiquetée :

a) dans des locaux distincts et clos;

b) sous la surveillance d’un personnel ayant reçu une formation en microbiologie; et

c) selon une méthode scientifiquement reconnue pour en assurer la stérilité.

DORS/82-524, art. 3; DORS/97-12, art. 21.

Gaz médicaux

C.02.030. Les articles C.02.025, C.02.027 et C.02.028 ne s’appliquent pas aux gaz médicaux.

DORS/85-754, art. 3.

Titre 3 Drogues de l'annexe C

C.03.001. Dans le présent titre,

« drogue » Toute drogue sous forme posologique visée à l’annexe C de la Loi ou toute drogue sous forme de produit intermédiaire en vrac pouvant être utilisée dans la préparation d’une drogue d’origine biologique visée à l’annexe C de la Loi. (drug)

« fabricant »[Abrogée, DORS/97-12, art. 22]

« générateur de radionucléide » désigne un dispositif contenant un élément mère radioactif et un élément de filiation,

a) absorbés sur une colonne échangeuse d’ions, ou

b) dissous dans un solvant approprié dans un appareil d’extraction liquide-liquide,

où l’élément de filiation est séparé de l’élément mère,

c) par élution sur la colonne échangeuse d’ions, ou

d) par extraction au solvant; (radionuclide generator)

« licence » ou « licence canadienne »[Abrogée, DORS/97-12, art. 22]

« maître-lot » désigne une certaine quantité d’une drogue, servant, par dilution ou mélange subséquents, à préparer un lot pour la vente. (master lot)

DORS/97-12, art. 22.

C.03.001.1 Nul distributeur visé à l’alinéa C.01A.003b) ou importateur ne peut vendre une drogue, sauf si elle a été manufacturée, emballée-étiquetée, analysée et entreposée conformément au présent titre.

DORS/97-12, art. 23.

C.03.002. à C.03.005. [Abrogés, DORS/97-12, art. 24]

C.03.006. [Abrogé, DORS/97-12, art. 67]

C.03.007. à C.03.011. [Abrogés, DORS/97-12, art. 26]

C.03.012. À la demande écrite du Directeur, le manufacturier, l’emballeur-étiqueteur, l’analyste, le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue doivent soumettre les protocoles des essais en même temps que des échantillons de tout lot ou maître-lot de drogue avant sa vente, et il est interdit de vendre tout lot dont le protocole ou l’échantillon ne satisfait pas aux exigences du présent règlement.

DORS/97-12, art. 27.

C.03.013. Il est interdit de manufacturer ou d’importer une drogue provenant d’un tissu animal, à moins que celui-ci ne provienne d’un animal sain et exempt de maladies contagieuses.

DORS/97-12, art. 27.

C.03.014. (1) L’article C.01.004 ne s’applique pas à une drogue.

(2) et (3) [Abrogés, DORS/97-12, art. 28]

DORS/79-236, art. 1; DORS/93-202, art. 15; DORS/97-12, art. 28.

C.03.015. L’emballage d’une drogue énumérée ou décrite à l’annexe F, sauf

a) une drogue vendue à un manufacturier de drogues,

b) une drogue fournie sur ordonnance,

c) un produit pharmaceutique radioactif défini à l’article C.03.201, ou

d) un constituant ou une trousse définis à l’article C.03.205,

doit porter le symbole Pr dans le quart supérieur gauche de l’espace principal des étiquettes intérieure et extérieure ou, dans le cas d’un récipient à dose unique, dans le quart supérieur gauche de l’étiquette extérieure.

DORS/80-543, art. 9; DORS/97-12, art. 61; DORS/2001-181, art. 4.

C.03.030. à C.03.045. [Abrogés, DORS/81-335, art. 2]

Produits pharmaceutiques radioactifs

C.03.201. Dans le présent règlement, « produit pharmaceutique radioactif » s’entend d’une drogue qui se caractérise par la désintégration spontanée du noyau instable accompagnée de l’émission de particules nucléaires ou de photons.

DORS/97-12, art. 29.

C.03.202. (1) L’emballage d’un produit pharmaceutique radioactif, sauf s’il s’agit d’un générateur de radionucléide, doit porter,

a) sur les étiquettes intérieure et extérieure,

(i) le nom propre de la drogue, immédiatement avant ou après la marque nominative, le cas échéant,

(ii) le nom du distributeur visé à l’alinéa C.01A.003b), et

(iii) le numéro de lot; et,

b) sur l’étiquette extérieure

(i) l’adresse du distributeur visé à l’alinéa C.01A.003b),

(ii) la norme à laquelle est censée répondre la drogue, s’il est fait mention de cette norme dans une publication mentionnée à l’annexe B de la Loi,

(iii) la mention de la forme pharmaceutique ou de la voie d’administration de la drogue,

(iv) la mention de l’emploi recommandé et de la radioactivité qu’il est recommandé d’administrer pour ledit emploi, ou une indication renvoyant au prospectus d’emballage où figurent les mêmes renseignements,

(v) le numéro de licence d’établissement du distributeur, précédé de la mention « Numéro de licence d’établissement » « Establishment Licence Number » ou d’une abréviation de cette mention,

(vi) le symbole de mise en garde contre les rayonnements prescrit par le Règlement sur le contrôle de l’énergie atomique et la mention « Attention — Produit radioactif » « Caution — Radioactive Material »,

(vii) les noms et les quantités de tout agent de conservation ou agent stabilisant que contient la drogue,

(viii) les noms et les quantités de tous les autres ingrédients non radioactifs de la drogue,

(ix) une déclaration de la teneur totale de la drogue en radioactivité, y compris celle de l’excédent de remplissage,

(x) une déclaration du volume total de la drogue, y compris l’excédent de remplissage, sauf si le contenu est entièrement sous forme gazeuse, sous forme de capsule ou sous forme lyophilisée,

(xi) une déclaration de la concentration de substance radioactive qui contient la drogue exprimée

(A) en unités de radioactivité par capsule, ou

(B) en unités de radioactivité par volume d’unité,

sauf si le contenu est entièrement sous forme gazeuse ou sous forme lyophilisée,

(xii) une déclaration de l’activité spécifique de la drogue, exprimée en unités de radioactivité par poids d’unité d’entraîneur présent ou, selon le cas, la mention « sans entraîneur » ou « carrier-free »,

(xiii) la mention de la période de référence à laquelle les valeurs de la radioactivité précisées aux sous-alinéas (ix), (xi) et (xii) du présent article peuvent s’appliquer (le nom du mois doit être écrit en toutes lettres ou abrégé en lettres),

(xiv) la mention de la vie utile recommandée ou la date après laquelle l’emploi de la drogue est déconseillé (le mois étant inscrit ou indiqué en abrégé), et

(xv) la mention des conditions de conservation particulières à respecter, avec indication de la température et de la lumière.

(2) [Abrogé, DORS/2001-203, art. 2]

(3) Le sous-alinéa (1)b)(viii) du présent article, ne s’applique pas lorsque les renseignements mentionnés dans ledit sous-alinéa figurent sur le prospectus d’emballage de la drogue.

(4) L’article C.01.005 ne s’applique pas aux produits pharmaceutiques radioactifs.

DORS/79-236, art. 2; DORS/93-202, art. 16; DORS/97-12, art. 54, 58 et 62; DORS/2001-203, art. 2.

C.03.203. (1) Un générateur de radionucléide doit porter sur son étiquette intérieure

a) le nom propre du générateur de radionucléide, immédiatement avant ou après la marque nominative, le cas échéant;

b) le nom et l’adresse du distributeur visé à l’alinéa C.01A.003b);

c) le numéro du lot;

d) la norme à laquelle le générateur de radionucléide semble se conformer si cette norme est mentionnée dans une publication visée à l’annexe B de la Loi;

e) le numéro de licence d’établissement du distributeur, précédé de la mention « Numéro de licence d’établissement » « Establishment Licence Number » ou d’une abréviation de cette mention;

f) le symbole de mise en garde contre les rayonnements exigé par le Règlement sur le contrôle de l’énergie atomique et la mention « Attention — Produit radioactif » « Caution — Radioactive Material »;

g) la mention de la totalité de la radioactivité mère contenue dans le générateur de radionucléide;

h) la mention de l’heure et la date de validité de la radioactivité visée à l’alinéa g) (le mois étant inscrit ou indiqué en abrégé);

i) la mention de la vie utile recommandée ou de la date après laquelle l’utilisation du générateur de radionucléide est déconseillée (le mois étant inscrit ou indiqué en abrégé);

j) la mention de la vie utile recommandée de la drogue après son extraction du générateur de radionucléide;

k) la mention des exigences particulières de température ou de blindage en entrepôt;

l) le mode d’emploi complet ou le renvoi à un document accompagnant l’emballage extérieur qui indique ces renseignements; et

m) une mise en garde contre le démontage du générateur de radionucléide.

(2) Les alinéas (1)i) et j) du présent article ne s’appliquent pas lorsque les renseignements qu’ils exigent apparaissent sur un document qui accompagne un générateur de radionucléide.

DORS/79-236, art. 3; DORS/93-202, art. 17; DORS/97-12, art. 54, 58 et 62.

C.03.204. (1) Il est interdit de vendre une drogue contenant, à un moment de sa vie utile, du technétium-99m si elle contient aussi une impureté radionucléique figurant dans la monographie sur l’injection de Sodium pertechnétate Tc-99m mentionnée dans la publication visée à l’article 7 de l’annexe B de la Loi, en une quantité plus grande que celle figurant dans cette monographie.

(2) Il est interdit de vendre un générateur de radionucléides dont il est possible d’extraire une drogue contenant, à un moment de sa vie utile, du technétium-99m, si cette drogue contient aussi une impureté radionucléique figurant dans la monographie sur l’injection de Sodium pertechnétate Tc-99m mentionnée dans la publication visée à l’article 7 de l’annexe B de la Loi, en une quantité plus grande que celle figurant dans cette monographie.

DORS/97-12, art. 30.

Drogues autres radionucléides, vendues pour être employées dans la préparation de produits pharmaceutiques radioactifs ou représentés comme pouvant servir à cette fin

C.03.205. Aux fins des articles C.03.206 à C.03.209, « constituants » désigne

a) une unité d’une drogue, autre qu’un radionucléide, emballés séparément dans une trousse pour être employée dans la préparation d’un produit pharmaceutique radioactif ou

b) un flacon vide ou autre article accessoire dans une trousse; (component)

« trousse » désigne un emballage destiné à la préparation de produits pharmaceutiques radioactifs,

a) qui contient des unités de drogues, autres que des radionucléides, conditionnées séparément, et

b) qui peut contenir des fioles vides ou autres articles accessoires. (kit)

DORS/79-236, art. 4.

C.03.206. Les articles C.01.005 et C.04.019 ne s’appliquent à aucun constituant ou trousse.

DORS/79-236, art. 4.

C.03.207. L’étiquette devant être apposée sur un constituant doit comprendre

a) son identification adéquate et une description adéquate de sa fonction;

b) le cas échéant, une liste quantitative de ses ingrédients ou un renvoi à l’étiquette de la trousse pour de tels renseignements;

c) le nom du distributeur visé à l’alinéa C.01A.003b);

d) le numéro de lot;

e) une déclaration des exigences spéciales d’entreposage quant à la température et la lumière;

f) la date après laquelle le constituant n’est pas recommandé pour usage, le mois étant inscrit au long ou indiqué en abrégé; et

g) le mode d’emploi approprié ou le renvoi à une prospectus de conditionnement accompagnant le produit.

DORS/79-236, art. 4; DORS/97-12, art. 58.

C.03.208. Chaque trousse doit être étiquetée pour montrer :

a) son nom propre;

b) la marque nominative de celle-ci, le cas échéant;

c) une liste de son contenu;

d) le nom et l’adresse de son distributeur visé à l’alinéa C.01A.003b);

e) le numéro de licence d’établissement du distributeur, précédé de la mention « Numéro de licence d’établissement » « Establishment Licence Number » ou d’une abréviation de cette mention;

f) son numéro de lot;

g) une déclaration des exigences spéciales d’entreposage quant à la température et la lumière;

h) la date après laquelle la trousse n’est pas recommandée pour usage, le mois étant inscrit au long ou indiqué en abrégé;

i) une liste quantitative des ingrédients d’un constituant lorsque l’étiquette de ce constituant renvoie à l’étiquette d’une trousse qui porte des renseignements concernant ses ingrédients;

j) une déclaration de la stérilité et de l’apyrogénicité des composants;

k) le mode d’emploi approprié pour la préparation de produits pharmaceutiques radioactifs ou le renvoi, pour ces renseignements, à un prospectus de conditionnement;

l) une déclaration de la vie utile du produit pharmaceutique radioactif préparé;

m) les conditions de conservation recommandées pour le produit pharmaceutique radioactif préparé;

n) l’usage recommandé pour le produit pharmaceutique radioactif préparé et la dose de radioactivité recommandée pour cet usage ou le renvoi, pour ces renseignements, à un prospectus de conditionnement;

o) la voie d’administration prévue pour le produit pharmaceutique radioactif préparé.

p) [Abrogé, DORS/2001-203, art. 3]

DORS/79-236, art. 4; DORS/93-202, art. 18; DORS/97-12, art. 58 et 62; DORS/2001­ 203, art. 3.

C.03.209. Chaque trousse doit contenir un prospectus de conditionnement qui doit indiquer,

a) le nom propre et la marque nominative, le cas échéant, de la trousse et une description de son usage;

b) une liste de son contenu;

c) le nom et l’adresse de son distributeur visé à l’alinéa C.01A.003b);

d) l’identification des sources de radionucléides qui peuvent être utilisées pour préparer le produit pharmaceutique radioactif;

e) le mode de préparation du produit pharmaceutique radioactif et les conditions de sa conservation une fois préparé;

f) une déclaration de la durée de la vie utile du produit pharmaceutique radioactif préparé;

g) une description des effets biologiques du produit pharmaceutique radioactif préparé;

h) les indications et contre-indications du produit pharmaceutique radioactif préparé;

i) les mises en garde et les précautions relatives aux constituants et au produit pharmaceutique radioactif préparé;

j) les effets nocifs, liés, le cas échéant, au produit pharmaceutique radioactif préparé;

k) lorsqu’il y a lieu, la pharmacologie et la toxicologie du produit pharmaceutique radioactif préparé ou une mention indiquant que ces renseignements sont disponibles sur demande;

l) la dosimétrie des rayonnements pour le produit pharmaceutique radioactif préparé;

m) une déclaration de l’usage recommandé pour le produit pharmaceutique radioactif recommandée pour cet usage;

n) une déclaration de la voie d’administration prévue pour le produit pharmaceutique radioactif préparé; et

o) une recommandation selon laquelle la pureté radiochimique et la teneur radioactive du produit pharmaceutique radioactif préparé doivent être vérifiées avant l’administration.

DORS/79-236, art. 4; DORS/93-202, art. 19; DORS/97-12, art. 58.

Titre 4 Drogues de l'annexe D

C.04.001. Dans le présent titre,

« date de fabrication » signifie

a) dans le cas d’un produit pour lequel il existe une norme d’activité, la date à laquelle il subit une épreuve satisfaisante d’activité,

b) dans le cas d’un produit animal pour lequel il n’existe pas de norme d’activité, la date de son extraction de l’animal, et

c) dans le cas d’un produit autre qu’un produit animal pour lequel il n’existe pas de norme d’activité, la date de cessation de la croissance; (date of manufacture)

« drogue » Toute drogue sous forme posologique visée à l’annexe D de la Loi ou toute drogue sous forme de produit intermédiaire en vrac pouvant être utilisée dans la préparation d’une drogue d’origine biologique visée à l’annexe D de la Loi. (drug)

« fabricant »[Abrogée, DORS/97-12, art. 31]

« licence » ou « licence canadienne »[Abrogée, DORS/97-12, art. 31]

DORS/97-12, art. 31.

C.04.001.1 Nul distributeur visé à l’alinéa C.01A.003b) ou importateur ne peut vendre une drogue, sauf si elle a été manufacturée, emballée-étiquetée, analysée et entreposée conformément au présent titre.

DORS/97-12, art. 32.

C.04.002. Le présent titre ne s’applique pas aux drogues sous forme posologique orale qui renferment des micro-organismes si elles sont recommandées uniquement pour reconstituer, normaliser ou stabiliser la flore intestinale.

DORS/97-12, art. 33.

C.04.003. La date de sortie d’une drogue doit être la date à laquelle le produit fini est retiré du frigorifique, mais ne doit en aucun cas dépasser

a) six mois après la date de fabrication, pour une drogue tenue constamment à une température ne dépassant pas 10 °C;

b) 12 mois après la date de fabrication, pour une drogue tenue constamment à une température ne dépassant pas 5 °C; ou

c) deux ans après la date de fabrication, pour une drogue tenue constamment à une température ne dépassant pas 0 °C.

C.04.004. à C.04.006. [Abrogés, DORS/97-12, art. 34]

C.04.007. [Abrogé, DORS/97-12, art. 67]

C.04.008. à C.04.012. [Abrogés, DORS/97-12, art. 36]

C.04.013. Le manufacturier et l’emballeur-étiqueteur doivent isoler toutes opérations faites avec des micro-organismes sporulés pathogènes et autres agents infectieux dont il est reconnu que la manipulation exige des précautions spéciales, et ils doivent prendre soin de l’outillage et exercer la surveillance nécessaire, de manière à exclure toute possibilité de contamination d’autres drogues.

DORS/97-12, art. 63.

C.04.014. Il est interdit d’utiliser tout procédé de laboratoire de nature diagnostique dans un établissement à moins qu’il ne soit complètement isolé des opérations visant à manufacturer, emballer-étiqueter ou analyser des drogues.

DORS/97-12, art. 37.

C.04.015. À la demande écrite du Directeur, le manufacturier, l’emballeur-étiqueteur, l’analyste, le distributeur visé à l’alinéa C.01A.003b) et l’importateur d’une drogue doivent soumettre les protocoles des essais en même temps que les échantillons de tout lot de la drogue avant sa vente, et il est interdit de vendre tout lot dont le protocole ou un échantillon ne satisfait pas aux exigences du présent règlement.

DORS/97-12, art. 37.

C.04.016. Tous les animaux qui servent à la préparation et à la conservation de certaines drogues doivent être :

a) sous la surveillance directe d’un personnel médical ou vétérinaire;

b) tenus en quarantaine par le manufacturier pendant au moins sept jours avant l’usage;

c) sains et exempts de maladie contagieuse.

DORS/97-12, art. 38.

C.04.017. Un manufacturier doit tenir des fiches des autopsies de tous les animaux qui meurent ou sont sacrifiés après avoir servi à la production d’une drogue.

DORS/97-12, art. 61.

C.04.018. Un manufacturier doit immédiatement isoler tout animal reconnu ou soupçonné d’être atteint de stomatite vésiculeuse, de fièvre aphteuse, d’encéphalomyélite, d’anémie infectieuse, de la morve, du charbon, du tétanos, ou de toute autre maladie contagieuse grave, et il doit en faire rapport au ministre.

DORS/97-12, art. 61.

C.04.019. Les dispositions de l’article C.01.004 ne s’appliquent pas à une drogue désignée dans le présent titre, mais tout emballage de ladite drogue doit porter

a) sur les étiquettes intérieure et extérieure,

(i) le nom propre de la drogue, immédiatement avant ou après la marque nominative, le cas échéant, en caractères d’une taille au moins égale à la moitié de celle des caractères de la marque nominative,

(ii) le nom du distributeur visé à l’alinéa C.01A.003b),

(iii) l’activité de la drogue, s’il y a lieu,

(iv) la dose recommandée de ladite drogue,

(v) le numéro du lot,

(vi) la date limite d’utilisation, sauf sur l’étiquette intérieure des récipients à dose unique, et

(vii) des directives appropriées d’emploi; et

b) sur l’étiquette extérieure

(i) l’adresse du distributeur visé à l’alinéa C.01A.003b),

(ii) dans le cas du sang entier et de ses composants, le numéro de licence d’établissement du distributeur visé à l’alinéa C.01A.003b), précédé de la mention « Numéro de licence d’établissement », « Establishment Licence Number » ou d’une abréviation de cette mention,

(iii) le nom propre ou, à défaut, le nom usuel de tout antiseptique incorporé à la drogue, ainsi que la quantité de celui-ci,

(iv) une mention portant que la drogue doit être conservée à une température d’au moins 2 °C et d’au plus 10 °C, à moins qu’il n’ait été prouvé au ministre qu’une telle mention n’est pas nécessaire,

(v) une déclaration du contenu net, en poids, en mesure, ou en nombre,

(vi) dans le cas d’une drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01, la mention suivante, inscrite en majuscules et de façon lisible :

« SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.

HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS. ».

DORS/78-424, art. 7; DORS/93-202, art. 21; DORS/97-12, art. 39, 54 et 58; DORS/2011-88, art. 6. Version précédente C.04.020. Sauf dans le cas des drogues suivantes, l’emballage d’une drogue visée à l’annexe F du présent règlement doit porter le symbole Pr dans le quart supérieur gauche de l’espace principal des étiquettes intérieure et extérieure ou, dans le cas d’un récipient à dose unique, dans le quart supérieur gauche de l’étiquette extérieure :

a) une drogue vendue au titulaire d’une licence d’établissement;

b) une drogue fournie sur ordonnance.

DORS/80-543, art. 10; DORS/97-12, art. 40; DORS/2001-181, art. 4.

Vaccins bactériens, produits analogues aux vaccins bactériens

C.04.050. Sous réserve des dispositions du présent titre, un vaccin bactérien doit être une suspension stérile de cultures tuées de bactéries, avec ou sans addition d’autre médication, mais ne doit pas comprendre un vaccin autogène.

C.04.051. Est interdite la vente d’un vaccin bactérien, à moins que la culture ayant servi à sa préparation n’ait été soumise à des essais d’identité et de pureté selon une méthode acceptable, que lesdits essais n’aient confirmé l’authenticité et la pureté de la souche, et qu’une fiche de la culture n’ait été conservée, portant une déclaration de son origine, de ses propriétés et de ses caractéristiques.

C.04.052. Est interdit à tout manufacturier d’employer, dans la production d’un vaccin bactérien, un substrat (milieu de culture) contenant de la viande de cheval ou du sérum de cheval.

DORS/97-12, art. 61.

C.04.053. Le manufacturier d’un vaccin bactérien préparé à partir d’une bactérie qui ne croît pas facilement dans les milieux de culture ordinaires, doit lui faire subir l’essai de stérilité sur des milieux spéciaux favorables à la croissance de ladite bactérie, et ledit vaccin doit être stérile.

DORS/97-12, art. 61.

C.04.054. Sous réserve des articles C.04.083, C.04.084 et C.04.090, les étiquettes intérieure et extérieure de tout récipient à doses multiples et l’étiquette extérieure de tout récipient à dose unique d’un vaccin bactérien doivent porter une déclaration

a) du nombre de bactéries par millilitre, ou du poids de substance bactérienne desséchée par millilitre,

b) du nombre de bactéries par millilitre, ou du poids de substance desséchée par millilitre, de chaque espèce ou type immunogène, si le vaccin contient plusieurs espèces ou types immunogènes de bactéries,

c) de la nature et de la quantité exactes de toute substance, autre qu’un simple diluant, combinée à un tel vaccin, et

d) de la dose recommandée,

et l’étiquette intérieure des récipients à dose unique doit porter la déclaration que le récipient ne contient qu’une seule dose.

C.04.055. La date limite d’utilisation d’un vaccin bactérien ne doit pas dépasser 18 mois après la date de fabrication ou la date de sortie.

Vaccin antityphoïdique

C.04.060. Les cultures de Salmonella typhosa employées à la préparation de vaccin antityphoïdique doivent être lisses, mobiles, de la forme Vi et avoir la structure antigénique IX, XII, Vi; d.-.

C.04.061. Est interdite la vente de tout lot de vaccin antityphoïdique, à moins que ledit lot n’ait subi un titrage satisfaisant de son activité d’après une méthode acceptable.

Vaccin anticoquelucheux

C.04.065. Le manufacturier ne peut employer pour la fabrication du vaccin anticoquelucheux que des souches de Bordetella pertussis qui satisfont aux exigences d’un essai d’antigénicité effectué d’après une méthode acceptable.

DORS/90-217, art. 1; DORS/97-12, art. 61.

C.04.066. Est interdite la vente de tout lot de vaccin anticoquelucheux, à moins que ledit lot n’ait subi un titrage satisfaisant de son activité d’après une méthode acceptable.

Vaccin B.C.G. (Bacille Calmette-Guérin)

C.04.070. Le vaccin B.C.G. doit être préparé à partir d’organismes B.C.G. vivants qui

a) ont été obtenus directement d’une source approuvée par le Directeur;

b) sont reconnus non pathogènes par une méthode acceptable; et

c) ont des antécédents de succès dans la production du vaccin B.C.G.

C.04.071. Est interdit à tout manufacturier d’employer à la fabrication de vaccin B.C.G. une personne qui

a) n’ait été et ne demeure exempte d’infection tuberculeuse sous toutes ses formes,

b) ne subisse tous les six mois un examen médical, lequel doit comprendre un examen aux rayons X de la poitrine, en vue de déceler la présence de tuberculose, ledit examen devant être fait par un praticien compétent qui doit signer un certificat établissant que ladite personne est exempte de tuberculose et devant être conservé dans les dossiers et être disponible en tout temps, et

c) n’habite avec une famille qui est, en tout temps, exempte de tuberculose active,

il est en outre interdit à un manufacturier d’employer une telle personne à tous autres travaux de laboratoire.

DORS/97-12, art. 61.

C.04.072. La préparation, la conservation et l’emballage-étiquetage du vaccin B.C.G. doivent être effectués sous la surveillance directe d’un bactériologiste d’expérience. De plus, ce bactériologiste doit :

a) avoir reçu une formation spécialisée d’au moins trois années en bactériologie et en immunologie;

b) s’être spécialisé dans le domaine de la bactériologie; et

c) posséder au moins un an d’expérience dans la fabrication du vaccin B.C.G.

DORS/97-12, art. 41.

C.04.073. Aucun manufacturier ne doit tolérer la présence, à quelque moment que ce soit, d’une culture qui n’est pas une culture de B.C.G. dans tout local où se fabrique du vaccin B.C.G.

DORS/97-12, art. 61.

C.04.074. Un emballeur-étiqueteur doit faire subir à chaque lot de vaccin B.C.G. une épreuve par une méthode acceptable, immédiatement après le remplissage du récipient définitif, en vue de déceler la présence de micro-organismes contaminants et le vaccin doit en être exempt.

DORS/97-12, art. 65.

C.04.075. Nonobstant l’article C.04.074, un vaccin B.C.G. liquide peut être mis en vente lorsqu’aucune croissance n’est apparue sur le milieu de culture d’épreuve après une incubation de 24 heures, mais s’il y a des signes de la présence de micro-organismes contaminants dans n’importe quel lot au cours de la période d’épreuve de 10 jours, l’emballeur-étiqueteur doit faire revenir immédiatement ledit lot.

DORS/97-12, art. 65.

C.04.076. Le manufacturier et l’emballeur-étiqueteur doivent déterminer le nombre d’organismes B.C.G. viables dans chaque lot de vaccin par une méthode acceptable et ils doivent en tenir registre.

DORS/97-12, art. 63.

C.04.077. Un manufacturier de vaccin B.C.G. doit conserver, à une température ne dépassant pas 5,0 °C et pendant au moins six mois,

a) la culture sur milieu glycériné de pomme de terre, qui a servi à faire les passages Sauton I et Sauton II, et

b) au moins six fioles du produit fini,

pour chaque lot dudit vaccin.

DORS/97-12, art. 61.

C.04.078. Le manufacturier et l’emballeur-étiqueteur de vaccin B.C.G. doivent conserver, sous une forme satisfaisante pour le ministre, des fiches cliniques continues de l’emploi du vaccin B.C.G. chez l’homme.

DORS/97-12, art. 63.

C.04.079. Un manufacturier de vaccin B.C.G. doit faire subir un examen pathologique à tous les animaux d’épreuve employés et signaler immédiatement au ministre tout indice de tuberculose active et évolutive chez lesdits animaux.

DORS/97-12, art. 61.

C.04.080. La date limite pour l’utilisation du vaccin B.C.G. ne doit pas dépasser

a) 10 jours après la récolte dans le cas du vaccin liquide;

b) 12 mois après la récolte dans le cas du vaccin desséché à froid (lyophilisation), conservé à 4 °C ou à une température plus élevée; ou

c) 20 mois après la récolte dans le cas du vaccin lyophilisé conservé à une température au-dessous de 4 °C.

C.04.081. Est interdite la vente de vaccin B.C.G. liquide qui n’est pas emballé dans des récipients scellés à la flamme.

C.04.082. Aucune étiquette intérieure n’est requise pour le vaccin B.C.G. liquide contenu dans des récipients à dose unique.

C.04.083. L’étiquette du vaccin B.C.G. liquide doit porter, plutôt que les déclarations prescrites aux alinéas C.04.054a) et b), une déclaration

a) du poids de bactéries par millilitre; et

b) de la voie d’administration du vaccin.

C.04.084. L’étiquette d’un vaccin B.C.G. desséché à froid (lyophilisation) doit porter, plutôt que les déclarations prescrites aux alinéas C.04.054a) et b), une déclaration

a) de la quantité de bactéries par ampoule ou par dose; et

b) de la voie d’administration du vaccin.

C.04.085. Les dispositions du sous-alinéa C.04.019b)(iv) ne s’appliquent pas au vaccin B.C.G. desséché à froid (lyophilisation).

Produits analogues aux vaccins bactériens

C.04.090. Un produit analogue à un vaccin bactérien doit être

a) un antigène bactérien autre qu’un vaccin bactérien, tel qu’un lysat, ou

b) un extrait préparé à partir d’une culture bactérienne,

et être conforme aux exigences du présent règlement relatif aux vaccins bactériens, sauf à celles des alinéas C.04.054a) et b).

C.04.091. La date limite d’utilisation d’un produit analogue à un vaccin bactérien ne doit pas dépasser 18 mois après la date de fabrication ou la date de sortie, mais dans le cas de la tuberculine desséchée et de la tuberculine contenant au moins 50 pour cent de glycérine, la date limite d’utilisation ne doit pas dépasser cinq ans après la date de fabrication ou la date de sortie, et dans le cas de toutes les autres tuberculines, elle ne doit pas dépasser 12 mois après la date de fabrication ou la date de sortie.

Virus vaccinaux et vaccins de rickettsies

C.04.100. Un virus vaccinal, un vaccin de rickettsies, doit être une suspension ou une préparation de virus ou de rickettsies vivants ou tués.

C.04.101. Il est interdit de vendre un virus ou un vaccin de rickettsies à moins que le manufacturier n’ait soumis à l’approbation du ministre les détails relatifs à la source des souches des virus ou des rickettsies utilisés, à leur mode de propagation, au procédé de préparation du vaccin et aux méthodes de détermination de la stérilité, de l’innocuité, de l’identité et de l’activité et autres analyses requises par le présent règlement.

DORS/95-411, art. 2; DORS/97-12, art. 42.

C.04.102. À la demande écrite du Directeur, le manufacturier et l’emballeur-étiqueteur doivent déposer pour chaque lot de virus vaccinal ou de vaccin de rickettsies prêt pour la vente des protocoles détaillés des essais de stérilité, de sécurité, d’identité, d’activité et de tout autre essai requis par le présent règlement.

DORS/97-12, art. 63.

Vaccin antivariolique

C.04.110. Le vaccin antivariolique est conforme aux exigences suivantes :

a) il est un virus vaccinal;

b) il est le virus vivant de la vaccine ou ses dérivés tirés de l’une des sources suivantes :

(i) pustules produites sur la peau de veaux sains par inoculation du virus,

(ii) membranes d’embryons de poussins expressément infectées,

(iii) culture de tissu adéquate infectée par le virus ou ses dérivés;

c) il est de forme liquide ou desséchée.

DORS/2006-2, art. 1.

C.04.111. Le manufacturier et l’emballeur-étiqueteur ne peuvent manufacturer et emballer-étiqueter le vaccin antivariolique que dans une unité distincte qui est isolée de tous les autres travaux de laboratoire, et dans laquelle ou au voisinage de laquelle aucune matière étrangère n’est tolérée ni entreposée.

DORS/97-12, art. 43.

C.04.112. Le manufacturier doit interdire au personnel préposé au soin des animaux à vaccin tout accès aux écuries et aux enclos à chevaux et tout contact avec les chevaux pendant la propagation du vaccin antivariolique.

DORS/97-12, art. 61.

C.04.113. Le manufacturier et l’emballeur-étiqueteur ne doivent délivrer le vaccin antivariolique que dans des récipients de verre stériles et scellés dans des conditions aseptiques.

DORS/97-12, art. 63.

C.04.114. Le manufacturier et l’emballeur-étiqueteur doivent faire subir une épreuve au vaccin antivariolique en vue d’établir l’absence

a) de tout micro-organisme anaérobie sporifère;

b) de tout staphylocoque à réaction positive de la coagulase;

c) de tout streptocoque hémolytique; et

d) de tout autre micro-organisme pathogène contagieux.

DORS/97-12, art. 63.

C.04.115. Le vaccin antivariolique, mis à l’épreuve suivant des méthodes acceptables,

a) doit être exempt de tout micro-organisme étranger, s’il s’agit d’un vaccin dont l’administration se fait par injection au pistolet; et

b) ne doit pas contenir, par millilitre, plus de 500 bactéries non pathogènes viables, s’il s’agit d’un vaccin dont l’administration se fait suivant la méthode de pression multiple ou par scarification.

C.04.116. Il doit être démontré que le vaccin antivariolique exerce une action préventive au moins égale à celle d’un vaccin qui remplit les conditions suivantes :

a) son action préventive contre la transmission de la variole entre humains est reconnue;

b) son activité est égale ou supérieure à 108 unités infectantes par millilitre, lorsqu’elle est déterminée à l’aide de membranes chorio-allantoïdes d’embryons de poussins.

DORS/2006-2, art. 2.

C.04.117. Il est interdit de vendre du vaccin antivariolique, à moins que :

a) dans le cas du vaccin sous forme liquide, ce vaccin n’ait été conservé à une température inférieure à -10 °C;

b) dans le cas du vaccin desséché, il n’ait été conservé à une température inférieure à 10 °C; et

c) l’étiquette extérieure ne porte une déclaration disant que le vaccin doit être conservé à une température non supérieure à 5 °C.

DORS/97-12, art. 44.

C.04.118. Nonobstant les dispositions de l’article C.04.003, la date de sortie du vaccin antivariolique ne doit pas dépasser

a) neuf mois depuis la date de fabrication, dans le cas du vaccin sous forme liquide;

b) 24 mois depuis la date de fabrication, dans le cas du vaccin sous forme desséchée.

C.04.119. À moins qu’une preuve n’établisse la stabilité du vaccin à la satisfaction du ministre, la date limite d’utilisation du vaccin antivariolique ne peut dépasser :

a) dans le cas du vaccin sous forme liquide, trois mois après la date de sortie;

b) dans le cas du vaccin sous forme desséchée, douze mois après la date de sortie.

DORS/2006-2, art. 3.

C.04.120. Aucune étiquette intérieure n’est requise pour le vaccin antivariolique contenu dans des récipients à dose unique ou dispensé dans des tubes capillaires.

C.04.121. Est interdite la vente de vaccin antivariolique additionné d’un antibiotique quelconque.

Vaccin antipoliomyélitique

C.04.122. Le vaccin antipoliomyélitique doit être une suspension aqueuse de virus tués de poliomyélite, types I, II et III.

C.04.123. Le vaccin antipoliomyélitique doit être préparé dans un milieu de culture tissulaire acceptable, à partir de souches de virus de poliomyélite qui se sont révélées capables de produire du vaccin d’activité acceptable.

C.04.124. Le vaccin antipoliomyélitique dans sa forme définitive, doit contenir au plus 0,35 milligramme par millilitre d’azote total, et au plus une partie par million de sérum animal.

C.04.125. Est interdite la vente de vaccin antipoliomyélitique à moins qu’il n’ait subi une épreuve d’après une méthode acceptable pour ce qui est de l’activité et de l’innocuité et, lorsqu’il a été ainsi éprouvé, il doit être stable et posséder une activité acceptable.

C.04.126. L’étiquette extérieure doit porter une déclaration de la présence de tout antibiotique dans le vaccin.

C.04.127. La date limite d’utilisation du vaccin antipoliomyélitique ne doit pas dépasser 12 mois après la date de la dernière épreuve satisfaisante d’activité à moins que des preuves, jugées satisfaisantes par le Directeur, ne soient présentées justifiant d’une période plus longue.

DORS/85-715, art. 6.

Vaccin buccal, de poliovirus vivant

C.04.128. Le Vaccin buccal de poliovirus vivant et le Vaccin buccal de poliovirus (nom de la souche) vivant, doivent être préparés avec des virus poliomyélitiques vivants des types I, II et III, lesquels

a) ont été obtenus directement d’une source acceptable par le Directeur;

b) démontrent une stabilité génétique établie par une méthode acceptable;

c) sont démontrés non pathogènes lorsqu’ils sont administrés par voie buccale chez les humains;

d) sont prouvés capables de proliférer dans le tube digestif humain, et de produire des anticorps neutralisants de leur type spécifique lorsqu’ils sont administrés par voie buccale; et

e) ont été employés avec succès pendant assez longtemps dans la production de vaccin buccal contre la poliomyélite à base de virus vivants.

C.04.129. Le vaccin buccal de poliovirus vivant doit être manufacturé, emballé-étiqueté et analysé dans des locaux isolés des bâtiments où d’autres produits sont manufacturés, emballés-étiquetés ou analysés et des bâtiments où des épreuves de contrôle comprenant l’usage d’une lignée de cellules ou d’une souche virale n’entrant pas dans ces opérations doivent être effectuées.

DORS/97-12, art. 45.

C.04.130. Il est interdit à tout manufacturier de permettre l’introduction de toute culture bactérienne ou virale autre que celles qui servent à la fabrication du vaccin buccal de poliovirus vivant, dans n’importe quel lieu qui sert à la fabrication du vaccin buccal de poliovirus vivant.

DORS/97-12, art. 61.

C.04.131. Nonobstant les articles C.04.129 et C.04.130, un manufacturier peut fabriquer d’autres drogues dans un lieu qui sert, de temps à autre, à la fabrication du vaccin buccal de poliovirus vivant, lorsque ce lieu ne sert pas à la fabrication dudit vaccin, pourvu que

a) les lieux soient nettoyés et désinfectés par des méthodes acceptables au Directeur, avant et après chaque fabrication de ce vaccin; et

b) le manufacturier ait reçu par écrit du Directeur, la permission d’effectuer cette fabrication d’autres drogues.

DORS/97-12, art. 61.

C.04.132. Le vaccin buccal de poliovirus doit être préparé uniquement

a) dans une culture de tissus,

b) dans un milieu, et

c) par des méthodes

jugés acceptables par le Directeur.

C.04.133. Est interdite à tout manufacturier la vente de vaccin buccal de poliovirus vivant, à moins que chaque lot n’ait été éprouvé pour la présence de micro-organismes étrangers et que le vaccin n’en soit exempt.

DORS/97-12, art. 61.

C.04.134. Un manufacturier de vaccin buccal de poliovirus vivant doit éprouver chaque lot de vaccin pour sa neurovirulence et ses traits génétiques marquants, par une méthode acceptable du Directeur, et ce vaccin doit remplir les conditions exigées par le Directeur.

DORS/97-12, art. 61.

C.04.135. Il est interdit à un manufacturier d’employer qui que ce soit dans la fabrication du vaccin buccal de poliovirus vivant, à moins que

a) chaque personne en cause ne soit exempte de maladie infectieuse;

b) chaque personne en cause n’ait été vaccinée avec succès contre la poliomyélite par le vaccin buccal de poliovirus vivant; et

c) des tests périodiques ne prouvent qu’elle n’est pas « porteuse de germes » du virus de la poliomyélite.

DORS/97-12, art. 61.

C.04.136. Un manufacturier de vaccin buccal de poliovirus vivant doit interdire l’entrée dans un immeuble où se fabrique ledit vaccin à quiconque

a) n’a pas directement affaire au procédé de fabrication; ou

b) a travaillé durant la journée avec des animaux d’expérience ou des agents infectieux.

DORS/97-12, art. 61.

Bactériophage

C.04.137. Un bactériophage doit être une préparation de virus douée d’une action lytique spécifique contre un ou des micro-organismes actuellement ou virtuellement pathogènes.

C.04.138. La date limite d’utilisation d’un bactériophage ne doit pas dépasser 12 mois après la date de fabrication ou la date de délivrance.

Toxines, anatoxines

Réactifs de Schick

C.04.140. Les réactifs de Schick pour le diagnostic de la réceptivité à la diphtérie doivent être

a) la toxine diphtérique pour la réaction de Schick;

b) le contrôle pour le Schick; et

c) la toxine diphtérique pour la réaction de Schick avec contrôle.

C.04.141. La toxine diphtérique pour la réaction de Schick doit être de la toxine diphtérique diluée, stérile et stabilisée par une méthode acceptable.

C.04.142. Le contrôle pour le Schick doit être une dilution convenable

a) d’anatoxine diphtérique; ou

b) de toxine diphtérique stérile chauffée à la température de 95 °C, pendant cinq minutes.

C.04.143. Dans le cas de vieille toxine contenant un antiseptique, la dose d’épreuve pour l’homme de la réaction de Schick doit être déterminée par

a) injection intradermique, à des cobayes, en mélange avec diverses proportions d’antitoxine diphtérique; une dose d’épreuve mélangée avec 1/750 ou plus d’une unité d’antitoxine ne doit produire de réaction locale, mais, mélangée avec 1/1 250 ou moins d’une unité d’antitoxine, elle doit produire une réaction locale nette du type connu sous le nom de « réaction de Schick positive »; et par

b) injection intradermique, à des cobayes, sans mélange avec l’antitoxine; 1/50 d’une dose d’épreuve ne doit pas, mais 1/25 doit, produire une réaction locale nette du type connu sous le nom de « réaction de Schick positive ».

C.04.144. Dans le cas de toxine fraîche ne contenant aucun antiseptique, la dose d’épreuve pour l’homme de la réaction de Schick doit être déterminée par

a) injection intradermique, à des cobayes, en mélange avec diverses proportions d’antitoxine diphtérique; une dose d’épreuve mélangée avec 1/750 ou plus d’une unité d’antitoxine ne doit pas produire de réaction locale, mais, mélangée avec 1/1 500 ou moins d’une unité d’antitoxine, elle doit produire une réaction locale nette du type connu sous le nom de « réaction de Schick positive »; et par

b) injection intradermique, à des cobayes, sans mélange avec l’antitoxine; 1/100 d’une dose d’épreuve ne doit pas, mais 1/50 doit, produire une réaction locale nette du type connu sous le nom de « réaction de Schick positive ».

C.04.145. La dose d’épreuve pour l’homme du contrôle pour le Schick, injectée par voie intradermique à des cobayes, doit donner une réaction de Schick négative.

C.04.146. Est interdite la vente de toxine diphtérique pour la réaction de Schick, à moins que les étiquettes intérieure et extérieure ne portent toutes deux la déclaration du nombre de doses humaines d’épreuve que contient l’emballage, ainsi que le nom de tout stabilisateur présent.

C.04.147. La date limite d’utilisation des réactifs de Schick pour le diagnostic de la réceptivité à la diphtérie ne doit pas dépasser 12 mois après la date de fabrication ou la date de sortie.

Anatoxine diphtérique

C.04.160. L’anatoxine diphtérique liquide doit être de la toxine diphtérique stérile, formulée et détoxifiée, et contenir au plus 0,02 pour cent de formaldéhyde libre.

C.04.161. L’anatoxine diphtérique précipitée par l’alun doit être préparée à partir d’anatoxine diphtérique et contenir au plus 15 milligrammes d’alun par dose humaine.

C.04.162. L’alun employé à la précipitation de l’anatoxine diphtérique précipitée par l’alun doit contenir au moins 99,5 pour cent d’alun potassique pur, Al K(SO4)2, 12H2O.

C.04.163. Dans la production de la toxine diphtérique, il est interdit au manufacturier d’employer des milieux de culture qui contiennent des protéines de cheval ou de la peptone de Witte, ou qui n’ont pas été débarrassés autant que possible de tous autres ingrédients allergéniques.

DORS/97-12, art. 61.

C.04.164. La toxine diphtérique qui sert à préparer l’anatoxine doit avoir une toxicité exprimée par une dose léthale (L+) d’au plus 0,20 millilitre ou par une dose léthale minimum (D.L.M.) d’au plus 0,0025 millilitre.

C.04.165. Avant le remplissage des récipients définitifs, le manufacturier doit soumettre le contenu de chaque récipient-vrac d’anatoxine diphtérique à une épreuve de toxicité d’après une méthode acceptable et ce contenu ne doit pas être toxique.

DORS/97-12, art. 61.

C.04.166. Est interdite la vente de tout lot d’anatoxine diphtérique, à moins que ledit lot n’ait subi un essai satisfaisant d’antigénicité d’après une méthode acceptable.

C.04.167. Un manufacturier doit introduire aseptiquement l’anatoxine diphtérique dans des récipients en verre limpide et, lorsqu’il n’y a pas addition d’un antiseptique, les récipients doivent être scellés à la flamme.

DORS/97-12, art. 61.

C.04.168. Est interdite la vente d’anatoxine diphtérique qui contient du phénol.

C.04.169. Est interdite la vente d’anatoxine diphtérique, à moins que les étiquettes intérieure et extérieure ne portent toutes deux la déclaration de la dose immunisante.

C.04.170. La date limite d’utilisation de l’anatoxine diphtérique ne doit pas dépasser deux ans après la date de fabrication ou la date de sortie.

Anatoxine tétanique

C.04.180. L’anatoxine tétanique liquide doit être de la toxine tétanique stérile, formulée et détoxifiée, et contenir au plus 0,02 pour cent de formaldéhyde libre.

C.04.181. L’anatoxine tétanique précipitée par l’alun doit être préparée à partir de l’anatoxine tétanique et contenir au plus 15 milligrammes d’alun par dose humaine.

C.04.182. L’alun employé à la préparation de l’anatoxine tétanique précipitée par l’alun doit contenir au moins 99,5 pour cent d’alun potassique pur, Al K(SO4)2, 12H2O.

C.04.183. Dans la production de la toxine tétanique, il est interdit au manufacturier d’employer des milieux de culture qui contiennent des protéines de cheval ou de la peptone de Witte, ou qui n’ont pas été débarrassés autant que possible de tous autres ingrédients allergéniques.

DORS/97-12, art. 61.

C.04.184. La toxine tétanique qui sert à préparer l’anatoxine tétanique doit avoir une toxicité exprimée par une dose léthale minimum (D.L.M.) d’au plus 0,0001 millilitre pour le cobaye.

C.04.185. Avant le remplissage des récipients définitifs, l’emballeur-étiqueteur doit soumettre le contenu de chaque récipient-vrac à une épreuve de toxicité d’après une méthode acceptable et ce contenu ne doit pas être toxique.

DORS/97-12, art. 65.

C.04.186. Est interdite la vente de tout lot d’anatoxine tétanique, à moins que ledit lot n’ait subi un essai satisfaisant d’antigénicité d’après une méthode acceptable.

C.04.187. Est interdite la vente d’anatoxine tétanique, à moins que les étiquettes intérieure et extérieure ne portent toutes deux la déclaration de la dose immunisante.

C.04.188. Un manufacturier doit introduire aseptiquement l’anatoxine tétanique dans des récipients en verre limpide et, lorsqu’il n’y a pas addition d’un antiseptique, les récipients doivent être scellés à la flamme.

DORS/97-12, art. 61.

C.04.189. Est interdite la vente d’anatoxine tétanique qui contient du phénol.

C.04.190. La date limite d’utilisation de l’anatoxine tétanique ne doit pas dépasser deux ans après la date de fabrication ou la date de sortie.

Antitoxines, antisérums

C.04.210. Une antitoxine ou un antisérum doit être le sérum, ou une fraction du sérum, séparé du sang d’animaux immunisés artificiellement contre les sous-produits ou les fractions antigéniques des cultures spécifiques de micro-organismes ou contre des venins spécifiques.

C.04.211. L’activité d’une antitoxine ou d’un antisérum doit être déterminée par une méthode acceptable et, lorsqu’il y a lieu, l’unité d’activité doit être l’unité internationale.

C.04.212. L’antitoxine diphtérique liquide doit posséder une activité d’au moins 500 unités internationales par millilitre.

C.04.213. L’antitoxine tétanique liquide doit posséder une activité d’au moins 400 unités internationales par millilitre.

C.04.214. Une antitoxine ou un antisérum liquide doit contenir au plus 20 pour cent de solides.

C.04.215. Une antitoxine desséchée doit être préparée à partir d’une antitoxine liquide et son activité, après reconstitution au volume original, ne doit pas être inférieure à celle qui est prescrite pour l’antitoxine liquide.

C.04.216. Une antitoxine desséchée, un antisérum desséché, doit contenir au plus un pour cent d’humidité, à l’épreuve par une méthode acceptable.

C.04.217. Chaque lot d’antitoxine ou d’antisérum doit subir l’épreuve de pyrogénéité par une méthode acceptable et il doit être exempt de pyrogènes; et, après remplissage des récipients définitifs, il doit subir l’épreuve d’identité et correspondre à son nom.

C.04.218. Est interdite la vente d’une antitoxine ou d’un antisérum, à moins que les étiquettes intérieure et extérieure ne portent toutes deux la déclaration de l’espèce d’animal utilisée, si elle est autre que le cheval, et du contenu net en millilitres ou du nombre d’unités du récipient.

C.04.219. En ce qui concerne les antitoxines, la date limite d’utilisation ne doit pas dépasser,

a) dans le cas d’antitoxines liquides soumises à des normes d’activité : cinq ans après la date de fabrication;

b) dans le cas d’antitoxines desséchées soumises à des normes d’activité : cinq ans après la date de fabrication;

c) dans le cas d’antitoxines liquides pour lesquelles il n’y a pas de normes d’activité : 12 mois après la date de fabrication; et

d) dans le cas d’antitoxines desséchées pour lesquelles il n’y a pas de normes d’activité : cinq ans après la date de fabrication.

C.04.220. En ce qui concerne les antisérums, la date limite d’utilisation ne doit pas dépasser,

a) dans le cas d’antisérums liquides soumis à des normes d’activité : trois ans après la date de fabrication;

b) dans le cas d’antisérums desséchés soumis à des normes d’activité : cinq ans après la date de fabrication;

c) dans le cas d’antisérums liquides pour lesquels il n’y a pas de normes d’activité : 12 mois après la date de fabrication; et

d) dans le cas d’antisérums desséchés pour lesquels il n’y a pas de normes d’activité : cinq ans après la date de fabrication.

Préparations de provenance humaine

C.04.230. Les préparations de provenance humaine doivent être du plasma sanguin ou du sérum sanguin mis en commun, ou des fractions de l’un ou de l’autre, séparés selon une méthode satisfaisante aux yeux du ministre.

C.04.231. Un manufacturier ne doit obtenir de sérum ou de plasma humains que de personnes certifiées en bonne santé par un praticien compétent.

DORS/97-12, art. 61.

C.04.232. Un manufacturier ne doit employer comme donneur de sang, de placenta ou de cordon, aucune personne ayant des antécédents de maladies transmissibles par la transfusion du sang, y compris la syphilis, l’hépatite infectieuse, ou le paludisme.

DORS/97-12, art. 61.

C.04.233. Le prélèvement du sang d’un donneur doit s’effectuer sous la surveillance d’un praticien compétent et dans une salle de saignée convenable sous la direction du manufacturier.

DORS/97-12, art. 61.

C.04.234. Un manufacturier ne doit se procurer les placentas et les cordons employés à la fabrication de préparations de provenance humaine que de femmes accouchées dans des hôpitaux publics; les donneuses desdits placentas et cordons doivent avoir été exemptes des toxémies de la grossesse et les placentas et les cordons ne doivent présenter aucun indice macroscopique de quelque état pathologique que ce soit.

DORS/97-12, art. 61.

C.04.235. (1) Sous réserve des paragraphes (2) et (3), le sérum humain desséché, le plasma humain desséché, ou les fractions desséchées de l’un ou de l’autre, doivent contenir au plus un pour cent d’humidité à l’épreuve par une méthode acceptable.

(2) L’immunoglobuline humaine Rho(D) desséchée doit contenir au plus trois pour cent d’humidité, à l’épreuve par une méthode acceptable.

(3) Le facteur antihémophilique (humain) desséché doit contenir au plus deux pour cent d’humidité à l’épreuve par une méthode acceptable.

DORS/81-334, art. 3.

C.04.236. Un manufacturier doit fournir avec les préparations de provenance humaine, livrées sous forme liquide ou reconstituées à partir de la substance desséchée, des instructions ou des moyens pour l’élimination des particules d’une grosseur telle qu’elles pourraient être dangereuses pour le receveur.

DORS/97-12, art. 61.

C.04.237. Un manufacturier de préparations de provenance humaine doit conserver des fiches complètes de tous les donneurs, y compris le certificat médical prescrit à l’article C.04.231.

DORS/97-12, art. 61.

C.04.238. Le manufacturier, l’emballeur-étiqueteur ou le distributeur visé à l’alinéa C.01A.003b) peut délivrer du sérum ou du plasma humains, ou des fractions de l’un ou de l’autre, pour usage prophylactique ou thérapeutique, sous les formes suivantes :

a) immun-sérum humain, qui doit être du sérum préparé à partir du sang d’individus rétablis de la maladie que le sérum est destiné à prévenir ou à traiter, ou d’individus spécifiquement immunisés contre cette même maladie;

b) immuno-globulines humaines ou autres fractions d’immun-sérum humain, qui doivent être préparées à partir d’immun-sérum ou d’immun-plasma humains;

c) sérum humain normal ou plasma humain normal, ou fractions de l’un ou de l’autre, qui doivent être préparés à partir du sang d’individus normaux; et

d) produits desséchés préparés à partir de n’importe quelle des préparations ci-dessus.

DORS/97-12, art. 46.

C.04.239. Est interdite la vente de toute préparation de provenance humaine, à moins que les étiquettes intérieure et extérieure ne portent toutes deux l’indication précise que la préparation est de provenance humaine.

C.04.240. La date limite d’utilisation des préparations de provenance humaine, délivrées sous la forme liquide ou la forme desséchée, ne doit pas dépasser cinq ans après la date de remplissage du récipient immédiat.

C.04.241. La date de fabrication des préparations de provenance humaine doit être la date de la saignée du donneur.

C.04.300. et C.04.301. [Abrogés, DORS/81-335, art. 3]

Plasma humain prélevé par plasmaphérèse

Interprétation

C.04.400. Les définitions qui suivent s’appliquent au présent article et aux articles C.04.401 à C.04.423.

« accident » Événement imprévu qui n’est pas imputable à une inobservation des procédures du manufacturier ou des règles de droit applicables et qui peut compromettre la sécurité du donneur ou l’innocuité, l’efficacité ou la qualité du plasma. (accident)

« donneur » Personne âgée d’au moins 17 ans qui a fourni son nom à un manufacturier en vue de participer à la plasmaphérèse avec celui-ci. (donor)

« effet indésirable grave » Réaction imprévue et indésirable du donneur relative à la plasmaphérèse ou à l’immunisation spécifique et qui entraîne chez lui l’une ou l’autre des conséquences suivantes :

a) son hospitalisation;

b) une incapacité persistante ou importante;

c) une intervention médicale ou chirurgicale visant à prévenir une incapacité persistante ou importante;

d) la mise en danger de sa vie;

e) sa mort. (serious adverse reaction)

« identificateur personnel » Série unique de lettres, de chiffres ou de symboles, ou toute combinaison de ceux-ci, attribuée à un donneur par le manufacturier. (personal identifier)

« identificateur unique » Série unique de lettres, de chiffres ou de symboles, ou toute combinaison de ceux-ci, attribuée par le manufacturier au plasma destiné au fractionnement ou aux globules rouges qui seront utilisés pour l’immunisation spécifique. (unique identifier)

« immunisation spécifique » L’administration d’un immunogène à un donneur visant à induire la production d’anticorps précis dans son sang en vue de la plasmaphérèse. (specific immunization)

« manquement » Inobservation des procédures du manufacturier ou des règles de droit applicables pouvant compromettre la sécurité du donneur ou l’innocuité, l’efficacité ou la qualité du plasma. (error)

« manufacturier » Titulaire d’une licence d’établissement délivrée aux termes du présent règlement et l’autorisant à manufacturer du plasma destiné au fractionnement. (fabricator)

« médecin » Personne habilitée à exercer la médecine en vertu des lois de la province où cette personne fournit les soins médicaux relatifs à la plasmaphérèse ou à l’immunisation spécifique. (physician)

« plasma destiné au fractionnement » Plasma humain prélevé par plasmaphérèse et destiné à la fabrication de drogues pour usage humain. (source plasma)

« plasmaphérèse » Procédé comportant les étapes suivantes :

a) est prélevé, du donneur, du sang duquel est séparé le plasma;

b) les globules rouges et autres éléments figurés du sang sont retournés au donneur. (plasmapheresis)

« séance de plasmaphérèse » Rencontre entre le manufacturier et le donneur tenue dans le but de procéder à la plasmaphérèse chez celui-ci. (plasmapheresis session)

« substitut » Personne qui, à la fois :

a) agit sous la surveillance et la direction générales d’un médecin;

b) est autorisée à fournir les services pouvant être effectués par le substitut aux termes des articles C.04.401 à C.04.423 en vertu des lois applicables de la province où elle fournit ces services. (physician substitute)

DORS/78-545, art. 1; DORS/85-1022, art. 1; DORS/2006-353, art. 1. Version précédente Interdictions

C.04.401. Il est interdit à toute personne :

a) de vendre du plasma destiné au fractionnement à moins que celui-ci n’ait été manufacturé, analysé, emballé-étiqueté et entreposé conformément aux articles C.04.402 à C.04.423;

b) de fabriquer du plasma destiné au fractionnement à partir de sang prélevé d’une personne jugée inadmissible à participer à la plasmaphérèse au titre des articles C.04.402 à C.04.423.

DORS/78-545, art. 1; DORS/85-1022, art. 2; DORS/2006-353, art. 1. Version précédente Responsabilité du manufacturier

C.04.402. (1) Le manufacturier veille à ce que toute personne qui lui fournit des services relatifs à la plasmaphérèse ou à l’immunisation spécifique soit qualifiée de par son éducation ainsi que de par sa formation ou son expérience à fournir ces services.

(2) Le manufacturier veille à ce que les locaux utilisés pour la sélection des donneurs, la plasmaphérèse ou l’immunisation spécifique soient conçus, construits et entretenus de manière à permettre la communication de renseignements médicaux en toute confidentialité.

DORS/78-545, art. 1; DORS/85-1022, art. 2; DORS/97-12, art. 47; DORS/2006-353, art. 1. Version précédente Consentement et évaluation préliminaire

C.04.403. (1) Le manufacturier ne peut procéder à la plasmaphérèse chez un donneur que si les conditions suivantes sont réunies :

a) le manufacturier informe le donneur de ce en quoi consiste la plasmaphérèse, notamment des risques que celle-ci présente pour la santé du donneur, dont ceux associés au fait d’y participer plus d’une fois toutes les huit semaines;

b) après avoir respecté l’alinéa a), il obtient de lui par écrit :

(i) la confirmation que les renseignements mentionnés à l’alinéa a) lui ont été communiqués,

(ii) un consentement éclairé à participer à la plasmaphérèse, donné conformément aux règles de droit régissant les consentements.

(2) Le manufacturier ne peut procéder à l’immunisation spécifique d’un donneur que si les conditions suivantes sont réunies :

a) un médecin choisit l’immunogène à être administré et informe le donneur :

(i) du nom et de la nature de l’immunogène choisi,

(ii) de la fréquence envisagée des injections et du nombre maximal d’injections que celui­ ci pourrait recevoir,

(iii) de ce en quoi consiste l’immunisation spécifique, notamment des risques que celle-ci présente pour sa santé, dont ceux associés au fait de recevoir l’immunogène choisi;

b) après avoir respecté l’alinéa a), il obtient de lui par écrit :

(i) la confirmation que les renseignements mentionnés à l’alinéa a) lui ont été communiqués,

(ii) un consentement éclairé à recevoir l’immunogène choisi, donné conformément aux règles de droit régissant les consentements.

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente C.04.404. (1) Le manufacturier ne peut procéder à la plasmaphérèse ou à l’immunisation spécifique que si un médecin ou son substitut décide si le donneur est admissible à participer à la plasmaphérèse plus d’une fois toutes les huit semaines d’après ses antécédents médicaux et un examen médical.

(2) Si le donneur est jugé admissible, le manufacturier consigne les renseignements suivants :

a) le fait que le donneur est admissible à participer à la plasmaphérèse plus d’une fois toutes les huit semaines;

b) les nom et identificateur personnel du donneur;

c) les nom et signature du médecin ayant pris la décision ou chargé de la surveillance du substitut qui l’a prise;

d) la date de la décision.

(3) Le manufacturier ne peut procéder à la plasmaphérèse ou à l’immunisation spécifique si la dernière décision visée à l’alinéa (1) à l’égard du donneur a été prise au-delà des délais suivants :

a) trente jours avant la date prévue pour sa première participation à la plasmaphérèse ou à l’immunisation spécifique;

b) un an avant toute autre date prévue pour sa participation à la plasmaphérèse ou à l’immunisation spécifique.

DORS/78-545, art. 1; DORS/85-1022, art. 3; DORS/2006-353, art. 1. Version précédente Immunisation spécifique

C.04.405. (1) Seul le médecin ou son substitut peut administrer un immunogène à un donneur en vue de l’immunisation spécifique.

(2) Le médecin surveille la réponse du donneur à l’immunogène pour décider si celui-ci peut continuer de recevoir l’immunisation spécifique.

(3) Le manufacturier s’abstient de procéder à l’immunisation spécifique du donneur qui ne peut continuer de la recevoir jusqu’à ce qu’un médecin décide que le donneur peut la recevoir de nouveau, soit avec le même immunogène, soit avec un autre.

DORS/78-545, art. 1; DORS/85-1022, art. 3; DORS/2006-353, art. 1. Version précédente Évaluation avant le prélèvement

C.04.406. (1) Au début de chaque séance de plasmaphérèse, le médecin ou son substitut décide si le donneur est admissible à participer à la plasmaphérèse.

(2) Si le donneur est jugé temporairement inadmissible eu égard aux critères énumérés au tableau 1 ou pour toute autre raison médicale justifiant une telle décision, le manufacturier annule la séance et informe le donneur des motifs pour lesquels il est jugé temporairement inadmissible et de la date à laquelle il pourra continuer à participer à la plasmaphérèse.

(3) Si le donneur est jugé inadmissible pour une durée indéterminée eu égard aux critères d’exclusion énumérés au tableau 2 ou pour toute autre raison médicale justifiant une telle décision, le manufacturier annule la séance de plasmaphérèse et informe le donneur des motifs pour lesquels il est jugé inadmissible à participer à la plasmaphérèse pour une durée indéterminée.

TABLEAU 1

Article Critères 1. Poids inférieur à 50 kg 2. Température anormale

Pression artérielle diastolique supérieure à 100 mmHg ou pression artérielle3. systolique supérieure à 180 mmHg Niveau d’hémoglobine inférieur à 125 g par litre de sang ou valeur hématocrite4. inférieure à 0,38 L par litre de sang

5. Niveau total de protéines inférieur à 60 g par litre de sang 6. Perte importante de sang 7. Don antérieur de plasma ou d’autres composants sanguins 8. Grossesse 9. Antécédents d’interventions médicales ou chirurgicales 10. Antécédents de convulsions nécessitant un traitement médical

Faculté à répondre aux questions compromise par la consommation d’alcool ou de11. drogue Transfusion antérieure de sang, d’un composant sanguin ou d’un dérivé sanguin

12. ou transplantation antérieure de cellules, de tissus ou d’organes autres que la dure­ mère

13. Infection de la peau à l’endroit où doit être pratiquée la phlébotomie 14. Signe ou symptôme d’infection

Risque d’une infection par le VIH, par le virus de l’hépatite B ou le virus de 15. l’hépatite C compte tenu, entre autres, d’antécédents d’acupuncture, de perçage

corporel, de tatouage, de piqûre accidentelle avec des aiguilles ou de relations

Article Critères sexuelles occasionnelles avec une personne présentant un risque d’être atteinte de l’une ou l’autre de ces infections Prise de médicaments, présente ou passée, présentant un risque pour les receveurs16. de produits fabriqués à partir de plasma destiné au fractionnement

17. Réception d’un vaccin à virus vivant atténué Morsure d’animal nécessitant une prophylaxie contre la rage ou pour laquelle la18. nécessité d’une prophylaxie post-exposition n’a pas été évaluée

TABLEAU 2

Article Critères d’exclusion 1. Fonction cardiovasculaire anormale ou cardiopathie grave ou chronique 2. Fonction respiratoire anormale ou maladie respiratoire grave ou chronique

Trouble de saignement présentant, pour le donneur, un risque associé à la3. plasmaphérèse Maladie grave ou état pathologique du foie, des reins, d’un autre organe, d’un4. système ou du sang Protéines plasmatiques anormales persistantes, y compris des gammopathies5. monoclonales ou polyclonales Prise de médicaments, présente ou passée, présentant un risque continu pour les6. receveurs de produits fabriqués à partir de plasma destiné au fractionnement

7. Antécédents d’évanouissements récurrents associés au don de sang ou de plasma Antécédents, signes ou symptômes d’abus de drogues injectables tels que traces8. de piqûres, cicatrices ou partage d’aiguilles pour l’injection de drogues

9. Antécédents, signes ou symptômes du SIDA ou d’une infection par le VIH 10. Risque d’une infection par le VIH compte tenu des pratiques sexuelles

Antécédents, signes ou symptômes d’une infection chronique ou persistante ou11. d’une maladie parasitaire transmissible par le sang 12. Antécédents, signes ou symptômes d’une hépatite autre que l’hépatite A

Cancer, autre qu’un cancer de la peau non-mélanocytique ou qu’un cancer13. cervical in situ Facteur de risque pour la maladie de Creutzfeldt-Jakob ou sa variante parce que le

14. donneur a, entre autres, reçu une transplantation de duremère ou subi un traitement avec une hormone pituitaire humaine

15. Résultat positif à un essai visant à dépister tout agent de maladie transmissible

DORS/78-545, art. 1; DORS/85-1022, art. 3; DORS/2006-353, art. 1. Version précédente Composition en protéines plasmatiques

C.04.407. (1) Avant de procéder à la plasmaphérèse, le manufacturier prélève un échantillon du sang du donneur afin d’en déterminer la composition en protéines

plasmatiques au moyen d’une électrophorèse des protéines sériques ou d’un essai équivalent.

(2) L’échantillon est prélevé dans les sept jours précédant la première séance de plasmaphérèse du donneur au cours de laquelle le manufacturier procède à la plasmaphérèse.

(3) S’il s’écoule vingt et un jours depuis le prélèvement de l’échantillon sans qu’un médecin n’examine les résultats de l’essai, le manufacturier ne peut procéder à la plasmaphérèse, et ce, jusqu’à ce qu’un médecin examine les résultats de l’essai.

(4) Si le médecin constate que la composition en protéines plasmatiques du sang du donneur ne se situe pas dans les limites normales, le manufacturier ne peut procéder à la plasmaphérèse, et ce, jusqu’à ce qu’un médecin constate le retour à la normale.

(5) Si aucun échantillon n’a été prélevé sur le donneur, comme l’exige le paragraphe (1), depuis plus de quatre mois, le manufacturier ne peut procéder à la plasmaphérèse, et ce, jusqu’à ce qu’un nouvel échantillon soit prélevé.

DORS/78-545, art. 1; DORS/85-1022, art. 3; DORS/2006-353, art. 1. Version précédente Examen permanent des dossiers

C.04.408. (1) Le médecin décide si le donneur est admissible à continuer à participer à la plasmaphérèse plus d’une fois toutes les huit semaines d’après les résultats des essais et les dossiers de prélèvement du donneur recueillis par le manufacturier dans les quatre mois précédents.

(2) La décision est prise au moins tous les quatre mois suivant la date à laquelle le donneur a été jugé admissible pour la première fois au titre de l’article C.04.404.

(3) Si le donneur est jugé inadmissible à participer à la plasmaphérèse pour une durée temporaire, le manufacturier informe le donneur des motifs de son inadmissibilité temporaire et de la date à laquelle il pourra continuer à participer à la plasmaphérèse.

(4) Le manufacturier ne peut plus procéder à la plasmaphérèse si le donneur est jugé inadmissible à y participer pour une durée indéterminée; le cas échéant, il en informe le donneur, motifs à l’appui.

(5) En cas de manquement au paragraphe (2), le manufacturier ne peut procéder à la plasmaphérèse tant que la décision n’a pas été prise.

DORS/78-545, art. 1; DORS/85-1022, art. 3; DORS/2006-353, art. 1. Version précédente Procédures de plasmaphérèse

C.04.409. Le manufacturier prend les mesures ci-après lors de la séance de plasmaphérèse :

a) il utilise des méthodes aseptiques et un système de prélèvement stérile homologué en vertu du Règlement sur les instruments médicaux;

b) il veille à ce que toute surface destinée à entrer en contact avec le sang ou le plasma soit apyrogène;

c) il veille à ce que la peau du donneur, à l’endroit où doit être pratiquée la phlébotomie, soit, à la fois :

(i) exempte de toute lésion, éruption cutanée ou autre source d’infection,

(ii) nettoyée et désinfectée;

d) il veille à ce que du personnel médical d’urgence puisse procurer des soins médicaux au donneur en moins de dix minutes après avoir été avisé par le manufacturier.

DORS/78-545, art. 1; DORS/85-1022, art. 4; DORS/2006-353, art. 1. Version précédente Quantité maximale et intervalle minimal

C.04.410. (1) Le manufacturier ne peut prélever du donneur une quantité de plasma qui, sans comprendre la solution anticoagulante, excède les quantités totales suivantes :

a) dans les cas où le poids du donneur est égal ou supérieur à 50 kg, mais inférieur à 68 kg :

(i) 625 mL ou 640 g par séance de plasmaphérèse,

(ii) 11,5 L pour l’ensemble des séances de plasmaphérèse au cours de la période précédente de six mois;

b) dans les cas où le poids du donneur est égal ou supérieur à 68 kg, mais inférieur à 80 kg :

(i) 750 mL ou 770 g par séance de plasmaphérèse,

(ii) 15,5 L pour l’ensemble des séances de plasmaphérèse au cours de la période précédente de six mois;

c) dans les cas où le poids du donneur est égal ou supérieur à 80 kg :

(i) 800 mL ou 820 g par séance de plasmaphérèse,

(ii) 18,5 L pour l’ensemble des séances de plasmaphérèse au cours de la période précédente de six mois.

(2) Le manufacturier se dote de procédures écrites exposant :

a) la période minimale d’attente qu’un donneur doit respecter entre chaque don de plasma et entre un don de plasma et un don de sang ou d’autres composants sanguins;

b) le nombre maximal de dons de plasma qu’un donneur peut faire au cours d’une période donnée.

DORS/78-545, art. 1; DORS/85-1022, art. 5; DORS/95-203, art. 1; DORS/2006-353, art. 1. Version précédente Solution anticoagulante

C.04.411. (1) Au cours de la plasmaphérèse, le manufacturier mélange une solution anticoagulante avec le sang prélevé du donneur.

(2) La solution anticoagulante doit porter une identification numérique de drogue valide attribuée aux termes du présent règlement qui indique que la solution convient à la plasmaphérèse.

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente Échantillons pour essais

C.04.412. (1) Au cours d’une séance de la plasmaphérèse, le manufacturier prélève un échantillon de sang ou de plasma de manière à ne pas contaminer l’échantillon ou le plasma destiné au fractionnement.

(2) Au moment de l’échantillonnage, le manufacturier étiquette clairement et de façon permanente le récipient contenant l’échantillon de sang ou de plasma avec l’identificateur unique assigné au plasma destiné au fractionnement.

(3) Le manufacturier veille à ce que la personne qui étiquette le récipient contenant l’échantillon soit la même qui étiquette le récipient contenant le plasma destiné au fractionnement au titre du paragraphe C.04.416(2).

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente C.04.413. (1) Le manufacturier soumet l’échantillon prélevé au titre de l’article C.04.412 à des essais visant à dépister les agents de maladie suivants :

a) le VIH, types 1 et 2;

b) le virus de l’hépatite B;

c) le virus de l’hépatite C;

d) la syphilis.

(2) Le manufacturier conserve tout plasma destiné au fractionnement prélevé lors de la séance de plasmaphérèse jusqu’à ce que tous les résultats des essais soient jugés négatifs ou non réactifs.

(3) Si le résultat d’un essai visant à dépister un agent de maladie énuméré au paragraphe (1) est positif ou réactif, le manufacturier prend les mesures suivantes :

a) il étiquette clairement et de façon permanente le récipient contenant le plasma destiné au fractionnement prélevé lors de la séance de plasmaphérèse avec les renseignements suivants :

(i) la mention « Précaution : Non destiné à la fabrication » ou « Caution : Not for Manufacturing Use »,

(ii) le signal de danger pour les matières infectieuses prévu à l’annexe II du Règlement sur les produits contrôlés;

b) il isole et élimine le plasma destiné au fractionnement.

(4) Si le résultat d’un essai visant à dépister l’agent de maladie pour la syphilis est positif ou réactif, le manufacturier ne peut procéder à la plasmaphérèse, et ce, jusqu’à ce qu’un essai subséquent démontre que le donneur n’est plus infecté par la syphilis et qu’un médecin décide que le donneur peut continuer à participer à la plasmaphérèse.

(5) Si le résultat d’un essai visant à dépister un agent de maladie énuméré au paragraphe (1), autre que la syphilis, est positif ou réactif, le manufacturier met fin à la plasmaphérèse du donneur et l’informe des motifs pour lesquels il est jugé inadmissible à participer à la plasmaphérèse pour une durée indéterminée.

DORS/78-545, art. 1; DORS/97-12, art. 48; DORS/2006-353, art. 1. Version précédente Agent de conservation et additif

C.04.414. Il est interdit d’ajouter un agent de conservation ou un additif au plasma destiné au fractionnement.

DORS/78-545, art. 1; DORS/85-1022, art. 6; DORS/2006-353, art. 1. Version précédente Récipients

C.04.415. Le manufacturier place le plasma destiné au fractionnement dans un récipient qui respecte les exigences suivantes :

a) il est homologué en vertu du Règlement sur les instruments médicaux et destiné au prélèvement et à l’entreposage de plasma;

b) il permet l’inspection visuelle, électronique ou automatisée du plasma;

c) il a été inspecté visuellement à la séance de plasmaphérèse et a été jugé intact;

d) il n’a pas servi à d’autres fins, dont celle d’avoir contenu du plasma destiné au fractionnement du même donneur.

DORS/78-545, art. 1; DORS/85-1022, art. 6; DORS/2006-353, art. 1. Version précédente Étiquetage

C.04.416. (1) Les articles C.01.004 et C.04.019 ne s’appliquent pas au plasma destiné au fractionnement.

(2) Le manufacturier étiquette clairement et de façon permanente le récipient utilisé pour contenir le plasma destiné au fractionnement avec les renseignements suivants :

a) l’identificateur unique attribué au plasma destiné au fractionnement contenu dans le récipient;

b) la mention « Plasma destiné au fractionnement » ou « Source Plasma »;

c) la mention « Précaution : À utiliser uniquement pour la fabrication » ou « Caution : For Manufacturing Use Only »;

d) la quantité de plasma destiné au fractionnement;

e) le nom et la quantité totale de la solution anticoagulante utilisée au cours de la plasmaphérèse;

f) la date limite d’utilisation du plasma destiné au fractionnement exprimée de façon claire et sans équivoque;

g) sous réserve du paragraphe C.04.413(3), une mention indiquant que le plasma destiné au fractionnement ne réagit pas aux agents de maladie pour le VIH, le virus de l’hépatite B et le virus de l’hépatite C;

h) si le plasma destiné au fractionnement est prélevé d’un donneur ayant reçu l’immunisation spécifique, une mention indiquant l’immunogène utilisé;

i) les nom, adresse et numéro de licence d’établissement du manufacturier;

j) une mention indiquant que le plasma destiné au fractionnement doit être conservé à une température de -20 °C ou moins.

(3) L’identificateur unique est ajouté sur l’étiquette du récipient au moment du prélèvement.

DORS/78-545, art. 1; DORS/85-1022, art. 7; DORS/2006-353, art. 1. Version précédente Entreposage

C.04.417. (1) S’agissant de l’entreposage du plasma destiné au fractionnement, y compris dans le cadre de son transport, le manufacturier est tenu aux obligations suivantes :

a) s’assurer que l’environnement soit conçu pour maintenir la température à -20 °C ou moins;

b) veiller à ce que la température ambiante soit constamment à -20 °C ou moins.

(2) Dans le cas où la température ambiante s’élève à plus de -20 °C, le manufacturier note les renseignements suivants :

a) une explication de la température élevée;

b) le plasma destiné au fractionnement touché;

c) la disposition finale du plasma destiné au fractionnement.

(3) Si la température ambiante s’élève entre -20 °C et +10 °C, le manufacturier étiquette clairement et de façon permanente le récipient contenant le plasma destiné au fractionnement avec la mention « Plasma destiné au fractionnement — recyclé » ou « Source Plasma — Salvaged ».

(4) Le paragraphe (3) ne s’applique pas dans les cas où la température ambiante s’élève entre -20 °C et -5 °C pour une seule période de moins de soixante-douze heures.

(5) Si la température ambiante s’élève à plus de +10 °C, le manufacturier élimine le plasma destiné au fractionnement.

(6) L’alinéa (1)b) et les paragraphes (2) à (5) ne s’appliquent pas à l’entreposage du plasma destiné au fractionnement dans le cadre de son transport, si celui-ci n’est pas effectué par le manufacturier.

DORS/78-545, art. 1; DORS/85-1022, art. 8; DORS/2006-353, art. 1. Version précédente C.04.418. (1) Le manufacturier inspecte chaque récipient contenant du plasma destiné au fractionnement pour vérifier son intégrité, l’intégrité de l’étiquette et la présence de signes de dégel du plasma destiné au fractionnement.

(2) Le manufacturier élimine le plasma destiné au fractionnement dans l’un ou l’autre des cas suivants :

a) le récipient est défectueux ou endommagé au point de ne plus fournir de protection contre les facteurs externes pouvant entraîner la détérioration ou la contamination du plasma destiné au fractionnement;

b) l’identificateur unique du plasma destiné au fractionnement manque ou est illisible;

c) un des renseignements visés aux alinéas C.04.416(2)b) à i) manque ou est illisible, à moins qu’il ne puisse être obtenu et extrait des dossiers du manufacturier;

d) le plasma destiné au fractionnement présente des signes de dégel.

DORS/78-545, art. 1; DORS/2006-353, art. 1.

Version précédente Documents

C.04.419. (1) Le manufacturier utilise et maintient un système de gestion de documents en vertu duquel :

a) il attribue un identificateur personnel à chaque donneur;

b) il place, au dossier du donneur, une photo servant à confirmer son identité ou y prévoit un autre moyen fiable d’identification;

c) il attribue un identificateur unique au plasma destiné au fractionnement à chaque séance de plasmaphérèse.

(2) Le système est organisé de manière à ce que le manufacturier puisse, à partir de l’identificateur personnel ou de l’identificateur unique, identifier le donneur et récupérer suffisamment de documents pour permettre la traçabilité et le retrait du plasma destiné au fractionnement.

(3) Le manufacturier conserve pour une période indéterminée les documents visés au paragraphe (2).

DORS/78-545, art. 1; DORS/85-1022, art. 9; DORS/2006-353, art. 1. Version précédente C.04.420. (1) Pour chaque donneur, le manufacturier conserve les documents suivants :

a) l’original ou une copie des confirmation et consentement visés aux alinéas C.04.403(1)b) et (2)b), le cas échéant;

b) l’original ou une copie des décisions, examens médicaux, résultats des essais, rapports et avis écrits visés aux articles C.04.401 à C.04.423;

c) pour chaque immunisation spécifique pratiquée chez le donneur par le manufacturier, un document indiquant :

(i) les date et lieu de l’immunisation,

(ii) le nom du médecin ou du substitut ayant administré l’immunogène,

(iii) le nom de l’immunogène administré, le nom de son fabricant, la quantité utilisée, sa date limite d’utilisation et, soit ses numéro de lot et identification numérique de drogue, soit son identificateur unique s’il s’agit de globules rouges;

d) pour chaque séance de plasmaphérèse avec le donneur, un document indiquant :

(i) les date et lieu de la séance,

(ii) le volume du plasma destiné au fractionnement prélevé,

(iii) l’identificateur unique du plasma destiné au fractionnement,

(iv) le volume de globules rouges prélevés qui ne lui a pas été retourné, notamment au cours de l’échantillonnage,

(v) le nom de la solution anticoagulante utilisée, le nom de son fabricant et ses numéro de lot et identification numérique de drogue,

(vi) le numéro de lot de tout récipient utilisé, le nom de son fabricant et sa date limite d’utilisation.

(2) Le manufacturier conserve un résumé de tout accident, manquement, effet indésirable grave et retrait de plasma destiné au fractionnement touchant le manufacturier.

(3) Le manufacturier conserve les données de température notées conformément au paragraphe C.04.417(2).

DORS/78-545, art. 1; DORS/85-1022, art. 10; DORS/97-12, art. 61; DORS/2006-353, art. 1. Version précédente Renseignements pour le ministre

C.04.421. (1) Le manufacturier avise le ministre de tout effet indésirable grave dans les délais suivants :

a) dans les vingt-quatre heures du moment où il en prend connaissance dans le cas d’un décès;

b) dans les quinze jours du moment où il en prend connaissance dans les autres cas.

(2) Le manufacturier fournit au ministre un rapport écrit concernant l’effet indésirable grave dans les vingt-quatre heures de l’avis donné conformément au paragraphe (1) si celui-ci a été donné verbalement.

(3) L’avis, s’il a été donné par écrit, ou le rapport écrit comprend la description de l’effet indésirable grave et de toute mesure corrective prise à la suite de sa survenance.

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente C.04.422. S’il retire du plasma destiné au fractionnement pour une raison qui a trait à la sécurité d’un produit, le manufacturier en avise le ministre par écrit en indiquant les motifs de retrait, le nombre d’unités touchées et le lieu d’où ces unités ont été retirées.

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente C.04.423. Afin de prévenir les risques pour la santé ou la sécurité des donneurs ou des receveurs de produits fabriqués à partir du plasma destiné au fractionnement, le manufacturier fournit au ministre, à la demande de celui-ci, une copie de tout document concernant la plasmaphérèse, l’immunisation spécifique ou le plasma destiné au fractionnement qu’il doit tenir en vertu des articles C.04.401 à C.04.422.

DORS/78-545, art. 1; DORS/2006-353, art. 1. Version précédente C.04.424. [Abrogé, DORS/2006-353, art. 1] Version précédente C.04.425. [Abrogé, DORS/2006-353, art. 1] Version précédente C.04.426. [Abrogé, DORS/2006-353, art. 1] Version précédente C.04.427. [Abrogé, DORS/97-12, art. 50]

C.04.428. [Abrogé, DORS/2006-353, art. 1] Version précédente

Préparations insuliniques

[DORS/82-769, art. 5]

C.04.550. (1) « Insuline » désigne le principe actif du pancréas, qui influe sur le métabolisme des hydrates de carbone dans l’organisme animal et qui est efficace dans le traitement du diabète sucré.

(2) L’étalon canadien d’insuline doit être l’étalon international d’insuline.

(3) Les préparations insuliniques décrites dans le présent règlement doivent renfermer de l’insuline à laquelle ne peuvent être ajoutés que les ingrédients prescrits dans le présent règlement.

(4) L’activité d’une préparation insulinique doit être exprimée en unités par centimètre cube et chaque unité par centimètre cube doit donner une unité internationale d’insuline par centimètre cube.

DORS/82-769, art. 4.

C.04.551. Il est interdit de vendre ou de fournir une préparation insulinique à moins de l’avoir continuellement emmagasinée à une température comprise entre 35 °F et 50 °F (2 °C et 10 °C).

DORS/82-769, art. 4.

C.04.552. Les cristaux d’insuline-zinc employés dans une préparation insulinique doivent renfermer, d’après une méthode acceptable,

a) au moins 21 unités internationales d’insuline par milligramme; et

b) sur la matière desséchée, au moins 0,30 pour cent et au plus 0,90 pour cent de zinc.

DORS/82-769, art. 4.

Injection insulinique ou insuline

C.04.553. Les préparations insuliniques appelées « Injection insulinique » ou « Insuline » doivent être une solution limpide, incolore ou presque incolore, stérile, exempte de turbidité et de matières insolubles, préparée avec de l’insuline ou des cristaux d’insuline­ zinc, doivent avoir un pH d’au moins 2,5 et d’au plus 3,5, ou d’au moins 7,0 et d’au plus 7,8 et doivent renfermer,

a) en poids par volume,

(i) au moins 0,1 pour cent et au plus 0,25 pour cent de phénol ou de crésol, et

(ii) au moins 1,4 pour cent et au plus 1,8 pour cent de glycérine; et

b) d’après une méthode acceptable, par 1 000 unités internationales d’insuline,

(i) au plus 7,0 milligrammes d’azote dans le cas de l’injection insulinique préparée avec des cristaux d’insuline-zinc et au plus 8,5 milligrammes d’azote dans le cas de l’injection insulinique autre que celle qui est faite avec des cristaux d’insuline-zinc,

(ii) au moins 0,10 milligramme et au plus 0,40 milligramme de zinc dans le cas de l’injection insulinique préparée avec des cristaux d’insuline-zinc et au plus 0,40 milligramme de zinc dans le cas de l’injection insulinique autre que celle faite avec des cristaux d’insuline-zinc, et

(iii) dans le cas de l’injection insulinique autre que celle qui est faite avec cristaux d’insuline-zinc, au plus 1,0 milligramme de cendres.

DORS/82-769, art. 4; DORS/85-715, art. 7.

C.04.554. Il est interdit de vendre de l’injection insulinique à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes;

b) que l’étiquette de la fiole n’indique que chaque centimètre cube a une activité égale à

(i) 40 unités internationales d’insuline,

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline; et

c) que chaque centimètre cube de ladite injection n’ait une activité réelle d’au moins 95 pour cent et n’excédant pas 105 pour cent de l’activité indiquée sur l’étiquette et déterminée par une méthode acceptable.

DORS/82-769, art. 4.

C.04.555. (1) Le manufacturier ne doit pas vendre d’injection insulinique à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc, ayant servi à la fabrication de l’injection insulinique,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc,

(iii) un rapport de la teneur en cendres, dans le cas de l’insuline, et

(iv) des rapports de dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du premier lot fini d’injection insulinique préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc, un rapport sur la quantité de chaque composant entrant dans ladite injection; et,

c) à l’égard du premier remplissage du premier lot fini d’injection insulinique préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport du dosage de la teneur en azote, en milligrammes par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc, en milligrammes par 1 000 unités internationales d’insuline,

(iii) un rapport sur la détermination du pH.

(iv) [Abrogé, DORS/95-203, art. 2]

DORS/82-769, art. 4; DORS/95-203, art. 2; DORS/97-12, art. 61.

C.04.556. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage d’injection insulinique ne doit pas dépasser deux ans après la date de retrait du lieu d’entreposage du manufacturier en vue de la distribution.

DORS/82-769, art. 4; DORS/97-12, art. 61.

Suspension d'insuline-zinc d'absorption rapide

C.04.557. La préparation insulinique appelée « Suspension d’insuline-zinc d’absorption rapide » doit être une suspension stérile, dans un milieu aqueux tamponné, d’insuline modifiée de telle façon par addition de zinc que le précipité en suspension soit une substance amorphe, doit avoir un pH d’au moins 7,0 et d’au plus 7,8 et doit renfermer,

a) en poids par volume,

(i) au moins 0,15 pour cent et au plus 0,17 pour cent d’acétate de sodium (NaC2H3O2,3H2O),

(ii) au moins 0,65 pour cent et au plus 0,75 pour cent de chlorure de sodium, et

(iii) au moins 0,09 pour cent et au plus 0,11 pour cent de p-hydroxybenzoate de méthyle; et

b) d’après une méthode acceptable, par 1 000 unités internationales d’insuline,

(i) au plus 7,0 milligrammes d’azote, et

(ii) au moins 1,2 milligrammes et au plus 2,5 milligrammes de zinc, dont au moins 20 pour cent et au plus 65 pour cent doivent être dans le liquide surnageant.

DORS/80-545, art. 1; DORS/82-769, art. 4; DORS/85-715, art. 8.

C.04.558. L’insuline servant à la préparation de la suspension d’insuline-zinc d’absorption rapide doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80, soit 100 unités internationales d’insuline par centimètre cube de suspension d’insuline-zinc d’absorption rapide, quand le précipité est répandu uniformément dans la suspension.

DORS/82-769, art. 4.

C.04.559. Le liquide surnageant obtenu de la suspension d’insuline-zinc d’absorption rapide doit renfermer au plus 1,0 unité internationale d’insuline par centimètre cube, quand l’activité de la préparation insulinique est de 40 unités par centimètre cube, et au plus 1,5 unités internationales d’insuline par centimètre cube, quand l’activité de ladite préparation est de 80 ou 100 unités par centimètre cube, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.560. Il est interdit de vendre une suspension d’insuline-zinc d’absorption rapide à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite suspension ne fournisse, quand le précipité est répandu uniformément dans la suspension,

(i) 40 unités internationales d’insuline, ou

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.561. (1) Le manufacturier ne doit pas vendre une suspension d’insuline-zinc d’absorption rapide à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc, ayant servi à la fabrication de la suspension d’insuline-zinc d’absorption rapide,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du premier lot fini de suspension d’insuline-zinc d’absorption rapide préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport sur la quantité de chaque composant entrant dans la préparation,

(ii) un rapport du dosage de la teneur en azote par 1 000 unités internationales d’insuline,

(iii) un rapport du dosage de la teneur en zinc par 1 000 unités internationales d’insuline,

(iv) un rapport de la teneur en insuline en unités internationales par centimètre cube du liquide surnageant après élimination du précipité en suspension,

(v) un rapport du dosage de la teneur en zinc du liquide surnageant, après élimination du précipité en suspension,

(vi) un rapport sur la détermination du pH, et

(vii) un rapport sur l’apparence au microscope du précipité en suspension; et,

c) à l’égard du premier remplissage du premier lot fini de suspension d’insuline-zinc d’absorption rapide préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline­ zinc,

(i) un rapport sur la détermination du pH,

(ii) un rapport sur l’examen du précipité au microscope,

(iii) un rapport sur son identification faite d’après une méthode acceptable.

(iv) [Abrogé, DORS/95-203, art. 3]

DORS/82-769, art. 4; DORS/95-203, art. 3; DORS/97-12, art. 61.

C.04.562. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage de suspension d’insuline-zinc d’absorption rapide ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Suspension d'insuline-zinc d'absorption moyenne

C.04.563. La préparation insulinique appelée « Suspension d’insuline-zinc d’absorption moyenne » doit être une suspension stérile, dans un milieu aqueux tamponné, d’insuline modifiée de telle façon par addition de zinc que le précipité en suspension soit un mélange de cristaux et de substance amorphe dans une proportion approximative de sept parties de cristaux pour trois parties de substance amorphe, doit avoir un pH d’au moins 7,0 et d’au plus 7,8 et doit renfermer,

a) en poids par volume,

(i) au moins 0,15 pour cent et au plus 0,17 pour cent d’acétate de sodium (NaC2H3O2,3H2O),

(ii) au moins 0,65 pour cent et au plus 0,75 pour cent de chlorure de sodium, et,

(iii) au moins 0,09 pour cent et au plus 0,11 pour cent de p-hydroxybenzoate de méthyle; et,

b) d’après une méthode acceptable, par 1 000 unités internationales d’insuline,

(i) au plus 7,0 milligrammes d’azote dont au moins 63 pour cent et au plus 73 pour cent doivent être dans le composant cristallin, et

(ii) au moins 1,2 milligrammes et au plus 2,5 milligrammes de zinc, dont au moins 20 pour cent et au plus 65 pour cent doivent être dans le liquide surnageant.

DORS/80-545, art. 2; DORS/82-769, art. 4; DORS/85-715, art. 9; DORS/88-323, art. 7.

C.04.564. L’insuline servant à la préparation de la suspension d’insuline-zinc d’absorption moyenne doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80, soit 100 unités internationales d’insuline par centimètre cube de la préparation, quand le précipité est répandu uniformément dans la suspension.

DORS/82-769, art. 4.

C.04.565. Le liquide limpide surnageant obtenu de la suspension d’insuline-zinc d’absorption moyenne doit renfermer au plus 1,0 unité internationale d’insuline par centimètre cube, quand l’activité de la préparation insulinique est de 40 unités par centimètre cube, et au plus 1,5 unités internationales d’insuline par centimètre cube, quand l’activité de ladite préparation est de 80 ou 100 unités par centimètre cube, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.566. Il est interdit de vendre une suspension d’insuline-zinc d’absorption moyenne à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite suspension ne fournisse, quand le précipité est répandu uniformément dans la suspension,

(i) 40 unités internationales d’insuline,

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.567. (1) Le manufacturier ne doit pas vendre une suspension d’insuline-zinc d’absorption moyenne à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc ayant servi à la fabrication d’une suspension insuline-zinc d’absorption moyenne,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du premier lot fini de suspension d’insuline-zinc d’absorption moyenne préparée avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport sur la quantité de chaque composant entrant dans la préparation,

(ii) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iv) un rapport de la teneur en insuline du liquide surnageant après élimination du précipité en suspension, exprimée en unités internationales par centimètre cube,

(v) un rapport sur la détermination de la proportion d’azote dans le composant cristallin du précipité en suspension,

(vi) un rapport du dosage de la teneur en zinc du liquide surnageant après élimination du précipité en suspension,

(vii) un rapport sur la détermination du pH, et

(viii) un rapport sur l’apparence au microscope du précipité en suspension; et,

c) à l’égard du premier remplissage du premier lot fini de suspension d’insuline-zinc d’absorption moyenne préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport sur la détermination du pH,

(ii) un rapport sur l’examen du précipité au microscope,

(iii) un rapport sur son identification faite d’après une méthode acceptable.

(iv) [Abrogé, DORS/95-203, art. 4]

DORS/82-769, art. 4; DORS/95-203, art. 4; DORS/97-12, art. 61.

C.04.568. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de la suspension d’insuline-zinc d’absorption moyenne ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Suspension d'insuline-zinc d'absorption prolongée

C.04.569. La préparation insulinique appelée « Suspension d’insuline-zinc d’absorption prolongée » doit être une suspension stérile, dans un milieu aqueux tamponné, d’insuline modifiée de telle façon par addition de zinc que le précipité en suspension consiste en cristaux et ne contienne au plus qu’une quantité infime de substance amorphe, doit avoir un pH d’au moins 7,0 et d’au plus 7,8 et doit renfermer,

a) en poids par volume,

(i) au moins 0,15 pour cent et au plus 0,17 pour cent d’acétate de sodium (NaC2H3O2,3H2O),

(ii) au moins 0,65 pour cent et au plus 0,75 pour cent de chlorure de sodium, et

(iii) au moins 0,09 pour cent et au plus 0,11 pour cent de p-hydroxybenzoate de méthyle; et,

b) d’après une méthode acceptable, pour 1 000 unités internationales d’insuline,

(i) au plus 7,0 milligrammes d’azote dont au moins 90 pour cent doivent être dans le composant cristallin, et

(ii) au moins 1,2 milligrammes et au plus 2,5 milligrammes de zinc, dont au moins 20 pour cent et au plus 65 pour cent doivent être dans le liquide surnageant.

DORS/80-545, art. 3; DORS/82-769, art. 4; DORS/85-715, art. 10.

C.04.570. L’insuline servant à la préparation de la suspension d’insuline-zinc d’absorption prolongée doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80, soit 100 unités internationales d’insuline par centimètre cube de la préparation, quand le précipité est répandu uniformément dans la suspension.

DORS/82-769, art. 4.

C.04.571. Le liquide limpide surnageant obtenu de la suspension d’insuline-zinc d’absorption prolongée doit renfermer au plus 1,0 unité internationale d’insuline par centimètre cube, quand l’activité de la préparation insulinique est de 40 unités par centimètre cube et au plus 1,5 unités internationales d’insuline par centimètre cube, quand l’activité de ladite préparation est de 80 ou 100 unités par centimètre cube, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.572. Il est interdit de vendre une suspension d’insuline-zinc d’absorption prolongée à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite suspension ne fournisse, quand le précipité est répandu uniformément dans la suspension,

(i) 40 unités internationales d’insuline,

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.573. (1) Le manufacturier ne doit pas vendre une suspension d’insuline-zinc d’absorption prolongée à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc ayant servi à la fabrication de la suspension d’insuline-zinc d’absorption prolongée,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du premier lot fini de suspension d’insuline-zinc d’absorption prolongée préparé avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport sur la quantité de chaque composant entrant dans la préparation,

(ii) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iv) un rapport de la teneur en insuline du liquide surnageant après élimination du précipité en suspension, exprimé en unités internationales par centimètre cube,

(v) un rapport sur la détermination de la proportion de l’azote dans le composant cristallin du précipité en suspension,

(vi) un rapport du dosage de la teneur en zinc du liquide surnageant après élimination du précipité en suspension,

(vii) un rapport sur la détermination du pH, et

(viii) un rapport sur l’apparence au microscope du précipité en suspension; et,

c) à l’égard du premier remplissage du premier lot fini de suspension d’insuline-zinc d’absorption prolongée préparée avec chaque maître-lot d’insuline ou de cristaux d’insuline-zinc,

(i) un rapport sur la détermination du pH,

(ii) un rapport sur l’examen du précipité au microscope,

(iii) un rapport sur son identification faite d’après une méthode acceptable.

(iv) [Abrogé, DORS/95-203, art. 5]

DORS/82-769, art. 4; DORS/95-203, art. 5; DORS/97-12, art. 61.

C.04.574. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage de suspension d’insuline-zinc d’absorption prolongée, ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Insuline-globine avec zinc

C.04.575. La préparation insulinique appelée insuline-globine avec zinc doit être une solution stérile d’insuline modifiée par addition de globine préparée avec du sang de boeuf, sous forme de chlorhydrate de globine, et de zinc; cette préparation doit être un liquide limpide, jaunâtre ou presque incolore, exempt de matière insoluble et suffisamment exempt de turbidité, avoir un pH d’au moins 3,4 et d’au plus 3,8 et doit renfermer,

a) en poids par volume, au moins 1,3 pour cent et au plus 1,7 pour cent de glycérine, et,

(i) soit au moins 0,15 pour cent et au plus 0,20 pour cent de crésol,

(ii) soit au moins 0,20 pour cent et au plus 0,26 pour cent de phénol; et,

b) d’après une méthode acceptable, pour 1 000 unités internationales d’insuline,

(i) au plus 15,0 milligrammes d’azote total,

(ii) au moins 36,0 milligrammes et au plus 40,0 milligrammes de globine, calculée à 6,0 fois la teneur en azote de globine, et

(iii) au moins 2,5 milligrammes et au plus 3,5 milligrammes de zinc.

DORS/82-769, art. 4.

C.04.576. Le chlorhydrate de globine servant à la préparation de l’insuline-globine avec zinc doit renfermer au moins 16,0 pour cent et au plus 17,5 pour cent d’azote, calculée sur la matière desséchée, exempte de cendres et d’acide chlorhydrique, et ne doit pas avoir une teneur en cendres de plus de 0,3 pour cent, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.577. L’insuline servant à la préparation de l’insuline-globine avec zinc doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80 unités internationales d’insuline par centimètre cube d’insuline-globine avec zinc.

DORS/82-769, art. 4.

C.04.578. (1) L’étalon canadien pour l’insuline-globine avec zinc doit être l’étalon adopté de temps à autre par le Directeur général pour ladite préparation.

(2) À la demande du titulaire de licence d’établissement, le Directeur général doit lui procurer un échantillon de l’étalon canadien et les directives nécessaires pour faire des essais comparatifs.

(3) L’essai de la réaction biologique de l’insuline-globine avec zinc doit être fait suivant une méthode acceptable et cette réaction biologique doit être comparable à la réaction biologique de l’échantillon et l’étalon canadien procuré par le Directeur général.

DORS/82-769, art. 4; DORS/97-12, art. 64.

C.04.579. Il est interdit de vendre de l’insuline-globine avec zinc à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite insuline-globine ne fournisse

(i) 40 unités internationales d’insuline, ou

(ii) 80 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.580. (1) Le manufacturier ne doit pas vendre de l’insuline-globine avec zinc à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc ayant servi à la fabrication de l’insuline-globine avec zinc,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, dans le cas des cristaux d’insuline-zinc, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du maître-lot de chlorhydrate de globine ayant servi à la préparation de l’insuline-globine avec zinc, des rapports de dosage de

(i) la teneur en azote exprimée en pourcentage et calculée sur la matière desséchée et exempte de cendres et d’acide chlorhydrique,

(ii) la teneur en chlorure exprimée en pourcentage et calculée comme chlorhydrate, et

(iii) la teneur en cendres, exprimée en pourcentage;

c) à l’égard des composants ayant servi à la préparation du mélange d’essai de l’insuline­ globine avec zinc, un rapport sur

(i) la quantité d’insuline, en grammes ou en unités internationales,

(ii) la quantité de zinc, en grammes ou en milligrammes, par 1 000 unités internationales d’insuline,

(iii) la quantité de chlorhydrate de globine, en grammes ou en milligrammes, par 1 000 unités internationales d’insuline, et

(iv) le volume de la préparation, en centimètres cubes ou en litres;

d) à l’égard du mélange d’essai de l’insuline-globine avec zinc,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) les protocoles de la réaction biologique montrant le retardement de l’effet insulinique, et

(iv) un rapport sur la détermination du pH;

e) à l’égard du premier lot fini d’insuline-globine avec zinc préparée avec chaque mélange d’essai de l’insuline-globine avec zinc, un rapport sur la quantité de chaque composant entrant dans la préparation; et,

f) à l’égard du premier remplissage du premier lot fini d’insuline-globine avec zinc préparée avec chaque mélange d’essai de l’insuline-globine avec zinc,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) un rapport sur la détermination du pH.

(iv) [Abrogé, DORS/95-203, art. 6]

DORS/82-769, art. 4: DORS/95-203, art. 6; DORS/97-12, art. 61.

C.04.581. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage d’insuline-globine avec zinc ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Insuline NPH ou insuline isophane

C.04.582. La préparation insulinique appelée « Insuline NPH ou insuline isophane » doit être une préparation stérile de cristaux en forme de bâtonnets renfermant de l’insuline, de la protamine et du zinc en suspension dans un milieu aqueux tamponné, doit avoir un pH d’au moins 7,0 et d’au plus 7,8 et doit renfermer,

a) en poids par volume, au moins 0,15 pour cent et au plus 0,25 pour cent de phosphate disodique anhydre et,

(i) soit au moins 1,4 pour cent et au plus 1,8 pour cent de glycérine, au moins 0,15 pour cent et au plus 0,17 pour cent de métacrésol et au moins 0,06 pour cent et au plus 0,07 pour cent de phénol,

(ii) soit au moins 0,40 pour cent et au plus 0,45 pour cent de chlorure de sodium, au moins 0,7 pour cent et au plus 0,9 pour cent de glycérine et au moins 0,18 pour cent et au plus 0,22 pour cent de métacrésol; et,

b) d’après une méthode acceptable, par 1 000 unités internationales d’insuline,

(i) au plus 8,5 milligrammes d’azote,

(ii) au moins 3,0 milligrammes et au plus 6,0 milligrammes de protamine, sous réserve que le rapport de la protamine à l’insuline ne doit pas être inférieur au rapport isophane et qu’il ne doit pas dépasser le rapport isophane de plus de 10 pour cent, et,

(iii) au moins 0,10 milligramme et au plus 0,40 milligramme de zinc, et

(iv) aucune activité protéasique importante pour la stabilité de l’insuline NPH.

DORS/82-769, art. 4; DORS/85-715, art. 11.

C.04.583. La protamine servant à la préparation de l’insuline NPH doit provenir du sperme ou des testicules arrivés à maturité de poissons appartenant à la famille Salmonidae, genre Oncorhynchus Suckley ou Salmo Linné.

DORS/82-769, art. 4.

C.04.584. « Rapport isophane » signifie le nombre minimum de milligrammes de protamine requis pour précipiter 100 unités internationales d’insuline et doit être déterminé par une méthode acceptable.

DORS/82-769, art. 4.

C.04.585. L’insuline servant à la préparation de l’insuline NPH doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80, soit 100 unités internationales d’insuline par centimètre cube de la préparation, quand le précipité est répandu uniformément dans la suspension.

DORS/82-769, art. 4.

C.04.586. Le liquide limpide surnageant obtenu de l’insuline NPH doit renfermer au plus 0,4 unité internationale d’insuline par centimètre cube, quand l’activité de la préparation insulinique est de 40 unités par centimètre cube, au plus 0,6 unité internationale d’insuline par centimètre cube, quand l’activité de ladite préparation est de 80 unités par centimètre cube, et au plus 0,7 unité internationale d’insuline par centimètre cube, quand l’activité de ladite préparation est de 100 unités par centimètre cube, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.587. Il est interdit de vendre de l’insuline NPH à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite insuline ne fournisse

(i) 40 unités internationales d’insuline,

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.588. (1) Le manufacturier ne doit pas vendre de l’insuline NPH à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot de cristaux d’insuline-zinc ayant servi à la fabrication de l’insuline NPH,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par milligramme,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard du maître-lot de protamine, une déclaration du rapport isophane pour l’insuline ayant servi à la préparation de l’insuline NPH;

c) à l’égard du mélange d’essai d’insuline NPH,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) un rapport de la teneur en insuline exprimée en unités internationales par centimètre cube du liquide surnageant après élimination du précipité en suspension,

(iv) un rapport sur la détermination du pH, et

(v) un rapport sur l’examen du précipité au microscope;

d) à l’égard du premier lot fini d’insuline NPH préparée avec chaque mélange d’essai d’insuline NPH, un rapport sur la quantité de chaque composant entrant dans la préparation; et,

e) à l’égard du premier remplissage du premier lot fini d’insuline NPH préparée avec chaque mélange d’essai d’insuline NPH,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) un rapport sur la détermination du pH,

(iv) un rapport sur l’examen du précipité au microscope,

(v) un rapport sur l’identification faite d’après une méthode acceptable.

(vi) [Abrogé, DORS/95-203, art. 7]

DORS/82-769, art. 4; DORS/95-203, art. 7; DORS/97-12, art. 61.

C.04.589. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de l’insuline NPH ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Insuline-zinc-protamine

C.04.590. La préparation insulinique appelée Insuline-zinc-protamine doit être une suspension blanche et stérile répandue dans un milieu aqueux tamponné et renfermant de l’insuline modifiée par addition de protamine et de zinc, doit avoir un pH d’au moins 7,1 et d’au plus 7,4 et doit renfermer,

a) en poids par volume,

(i) au moins 0,15 pour cent et au plus 0,25 pour cent de phosphate disodique anhydre,

(ii) au moins 1,4 pour cent et au plus 1,8 pour cent de glycérine, et,

(iii) soit au moins 0,18 pour cent et au plus 0,22 pour cent de crésol, soit au moins 0,22 pour cent et au plus 0,28 pour cent de phénol; et,

b) d’après une méthode acceptable, par 1 000 unités internationales d’insuline,

(i) au plus 12,5 milligrammes d’azote total,

(ii) au moins 10,0 milligrammes et au plus 15,0 milligrammes de protamine, et

(iii) au moins 1,7 milligramme et au plus 2,5 milligrammes de zinc.

DORS/82-769, art. 4.

C.04.591. La protamine servant à la préparation de l’insuline-zinc-protamine doit provenir du sperme ou des testicules arrivés à maturité de poissons appartenant à la famille Salmonidae, genre Oncorhynchus Suckley, ou Salmo Linné.

DORS/82-769, art. 4.

C.04.592. L’insuline servant à la préparation de l’insuline-zinc-protamine doit provenir d’un ou de plusieurs maîtres-lots et doit être en quantité suffisante pour fournir soit 40, soit 80, soit 100 unités internationales d’insuline par centimètre cube de la préparation, quand le précipité est répandu uniformément dans la suspension.

DORS/82-769, art. 4.

C.04.593. (1) L’étalon canadien pour l’insuline-zinc-protamine doit être l’étalon adopté de temps à autre par le Directeur général pour ladite préparation.

(2) À la demande du titulaire de licence d’établissement, le Directeur général doit lui procurer un échantillon de l’étalon canadien et les directives nécessaires pour faire des essais comparatifs.

(3) L’essai de la réaction biologique de l’insuline-zinc-protamine doit être faite suivant une méthode acceptable et cette réaction biologique doit être comparable à la réaction biologique de l’étalon canadien procuré par le Directeur général.

DORS/82-769, art. 4; DORS/97-12, art. 64.

C.04.594. Il est interdit de vendre de l’insuline-zinc-protamine à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite insuline ne fournisse

(i) 40 unités internationales d’insuline,

(ii) 80 unités internationales d’insuline, ou

(iii) 100 unités internationales d’insuline.

DORS/82-769, art. 4.

C.04.595. (1) Le manufacturier ne doit pas vendre de l’insuline-zinc-protamine à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot d’insuline ou de cristaux d’insuline-zinc ayant servi à la fabrication de l’insuline-zinc-protamine,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube, dans le cas de l’insuline, et en unités internationales par milligramme, dans le cas des cristaux d’insuline-zinc,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, et dans le cas des cristaux d’insuline-zinc, et

(iii) des rapports de dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline;

b) à l’égard de composants ayant servi à la préparation du mélange d’essai de l’insuline­ zinc-protamine, un rapport sur

(i) la quantité d’insuline, en grammes ou en unités internationales,

(ii) la quantité de zinc, en grammes ou en milligrammes par 1 000 unités internationales d’insuline,

(iii) la quantité de protamine, en grammes ou en milligrammes par 1 000 unités internationales d’insuline, et

(iv) le volume de la préparation, en centimètres cubes ou en litres;

c) à l’égard du mélange d’essai de l’insuline-zinc-protamine,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales d’insuline,

(iii) les protocoles de la réaction biologique montrant le retardement de l’effet insulinique, et

(iv) un rapport sur la détermination du pH;

d) à l’égard du premier lot fini d’insuline-zinc-protamine préparée avec chaque mélange d’essai d’insuline-zinc-protamine, un rapport sur la quantité de chaque composant entrant dans la préparation; et,

e) à l’égard du premier remplissage du premier lot fini d’insuline-zinc-protamine préparée avec chaque mélange d’essai de l’insuline-zinc-protamine,

(i) un rapport du dosage de la teneur en azote exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales,

(ii) un rapport du dosage de la teneur en zinc exprimée en milligrammes par centimètre cube ou par 1 000 unités internationales,

(iii) un rapport sur la détermination du pH.

(iv) [Abrogé, DORS/95-203, art. 8]

DORS/82-769, art. 4; DORS/95-203, art. 8; DORS/97-12, art. 61.

C.04.596. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage d’insuline-zinc-protamine ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/82-769, art. 4.

Insuline sulfurisée

C.04.597. La préparation insulinique appelée insuline sulfurisée doit être une préparation isotonique limpide ou légèrement trouble, incolore ou presque incolore, stérile, faite avec des cristaux d’insuline-zinc chimiquement modifiés par l’action de l’acide sulfurique, doit avoir un pH d’au moins 6,0 et d’au plus 7,0 et doit renfermer,

a) en poids par volume,

(i) au moins 0,6 pour cent et au plus 1,0 pour cent de chlorure de sodium, et

(ii) au moins 0,2 pour cent et au plus 0,3 pour cent de phénol; et,

b) d’après une méthode acceptable,

(i) au plus 200 milligrammes de protéine par 1 000 unités internationales d’insuline, et

(ii) au moins 5,5 et au plus 6,5 groupements sulfurés par molécule d’insuline.

DORS/82-769, art. 4.

C.04.598. « Rapport de neutralisation » signifie la quantité de sérum antiglobine de boeuf requise pour neutraliser une unité d’insuline sulfurisée divisée par la quantité requise pour neutraliser une unité d’insuline de boeuf et doit être déterminé par une méthode acceptable.

DORS/82-769, art. 4.

C.04.599. Le rapport de neutralisation de l’insuline sulfurisée doit être au moins de 4 à 1.

DORS/82-769, art. 4.

C.04.600. Il est interdit de vendre de l’insuline sulfurisée à moins

a) qu’elle ne soit offerte dans une fiole d’une capacité approximative de 10 centimètres cubes, laquelle doit présenter un excédent de volume permettant d’en retirer 10 centimètres cubes; et

b) que chaque centimètre cube de ladite insuline ne fournisse 100 unités internationales d’insuline, d’après une méthode acceptable.

DORS/82-769, art. 4.

C.04.601. (1) Le manufacturier ne doit pas vendre de l’insuline sulfurisée à moins qu’il

a) n’ait procuré au Directeur général, en conformité du paragraphe (2), une présentation relative à ladite préparation, sous une forme et dans une teneur qui soient à la satisfaction du Directeur général;

b) n’ait fourni au Directeur général les renseignements supplémentaires que celui-ci pourrait lui avoir demandés; et

c) n’ait reçu du Directeur un avis portant que les renseignements contenus dans la présentation sont conformes aux exigences du présent article.

(2) Une présentation soumise en exécution du paragraphe (1) doit contenir au moins,

a) à l’égard de chaque maître-lot de cristaux d’insuline-zinc ayant servi à la fabrication de l’insuline sulfurisée,

(i) les protocoles du titrage de l’activité exprimée en unités internationales par milligramme,

(ii) un rapport de la teneur en humidité, exprimée en pourcentage et déterminée par dessiccation à poids constant à 100 °C, et

(iii) des rapports du dosage de la teneur en azote en milligrammes et de la teneur en zinc en milligrammes par 1 000 unités internationales d’insuline; et,

b) à l’égard de chaque lot d’insuline sulfurisée préparée avec chaque maître-lot de cristaux d’insuline-zinc,

(i) un rapport sur la quantité de chaque composant,

(ii) un rapport sur la teneur en protéines exprimée en milligrammes par 1 000 unités internationales d’insuline,

(iii) un rapport sur la détermination du rapport de neutralisation,

(iv) un rapport sur la détermination du nombre de groupements sulfurés par molécule d’insuline,

(v) les protocoles du titrage de l’activité exprimée en unités internationales par centimètre cube,

(vi) un rapport sur la détermination du pH.

(vii) [Abrogé, DORS/95-203, art. 9]

DORS/82-769, art. 4; DORS/95-203, art. 9; DORS/97-12, art. 61.

C.04.602. La date limite d’utilisation imprimée sur les étiquettes intérieure et extérieure de chaque emballage d’insuline-sulfurisée ne doit pas dépasser deux ans après la date du remplissage du contenant immédiat.

DORS/80-545, art. 4; DORS/82-769, art. 4.

Étiquetage des préparations insuliniques

[DORS/82-769, art. 8]

C.04.650. L’emballeur-étiqueteur d’injection insulinique ne peut mettre sur l’étiquette de cette préparation insulinique « Insuline faite avec des cristaux d’insuline-zinc » que si elle a été préparée avec des cristaux d’insuline-zinc.

DORS/82-769, art. 7; DORS/97-12, art. 65.

C.04.651. L’emballeur-étiqueteur d’une préparation insulinique doit faire imprimer les renseignements requis par le présent règlement à la fois sur les étiquettes intérieure et extérieure de chaque emballage de cette préparation insulinique, de la façon indiquée au tableau du présent article.

TABLEAU

Colonne I Colonne II Colonne III Activité dePoste Nécessités d’impression pour

o Préparation insulinique lan l’étiquettepréparation

a) 40 unités a) caractères noirs sur fond jaunepar cc Injection insulinique non b) 80 unités b) caractères noirs sur fond vert1. étiquetée de la façon indiquée au par cc poste 2 100

c) unités par c) caractères noirs sur fond blanc cc

2. a) 40 unitéspar cc Injection insulinique dont l’étiquette porte : « Insuline faite a) caractères rouges sur fond gris

avec des cristaux d’insuline . . . b) 80 unités b) caractères verts sur fond gris

Colonne I Colonne II Colonne III

Poste no Préparation insulinique

zinc »

Activité de la préparation

par cc

c) 100 unités par cc

Nécessités d’impression pour l’étiquette

c) caractères noirs sur fond blanc

caractères rouges sur fond a) 40 unités a) lavande ainsi qu’une marque ou

Suspension d’insuline-zinc par cc un symbole distinctifs d’absorption rapide, suspension caractères verts sur fond lavanded’insuline-zinc d’absorption b) 80 unités3. b) ainsi qu’une marque ou unmoyenne et suspension par cc symbole distinctifsd’insuline-zinc d’absorption prolongée 100

c) unités par c) caractères noirs sur fond blanc cc

caractères rouges sur fond brun, sauf que l’expression « 40 unités

a) 40 unités a) par centimètre cube » peut êtrepar cc imprimée en caractères blancs sur fond rouge4. Insuline-globine avec zinc caractères verts sur fond brun, sauf que l’expression « 80 unités

b) 80 unités b) par centimètre cube » peut êtrepar cc imprimée en caractères blancs sur fond vert

a) 40 unités a) caractères rouges sur fond bleupar cc

b) 80 unités b) caractères verts sur fond bleu5. Insuline NPH par cc 100

c) unités par c) caractères noirs sur fond blanc cc

a) 40 unités a) caractères rouges sur fond blancpar cc

b) 80 unités b) caractères verts sur fond blanc6. Insuline-zinc-protamine par cc 100

c) unités par c) caractères noirs sur fond blanc cc 100 caractères noirs sur fond blanc7. Insuline sulfurisée unités par ainsi que l’avertissement « Mise

Colonne I Colonne II Colonne III

Poste no Préparation insulinique

Activité de la préparation

Nécessités d’impression pour l’étiquette

cc en garde . . . Non destiné à l’usage courant . . . Voir le feuillet de l’emballage »

DORS/82-769, art. 7; DORS/97-12, art. 65.

C.04.652. L’emballeur-étiqueteur d’une préparation insulinique doit faire imprimer sur l’étiquette extérieure de chaque emballage de ladite préparation des directives demandant de garder celle-ci au réfrigérateur à une température comprise entre 35 ° et 50 °F (2 ° et 10 °C) et d’éviter de l’exposer à être congelée.

DORS/82-769, art. 7; DORS/97-12, art. 65.

C.04.653. L’emballeur-étiqueteur d’une préparation insulinique qui consiste en un précipité en suspension dans un milieu aqueux tamponné doit faire imprimer sur l’étiquette intérieure de chaque emballage de ladite préparation l’avertissement « Agiter avec soin ».

DORS/82-769, art. 7; DORS/97-12, art. 65.

C.04.654. L’emballeur-étiqueteur d’une préparation insulinique peut, au lieu de faire imprimer les directives appropriées d’emploi sur les étiquettes intérieure et extérieure de ladite préparation, comme l’exige le sous-alinéa C.04.019a)(vii), les faire imprimer dans un prospectus explicatif rédigé en conformité avec l’article C.04.655, auquel cas, il doit

a) inclure un exemplaire du prospectus dans l’emballage contenant la préparation; et

b) mentionner sur l’étiquette extérieure de l’emballage qu’une telle circulaire y est incluse.

DORS/82-769, art. 7 et 9; DORS/97-12, art. 65.

C.04.655. Le prospectus explicatif visé à l’article C.04.654 doit contenir au moins les renseignements suivants :

a) un avertissement disant que

(i) le traitement du diabète sucré exige la surveillance et l’examen du médecin,

(ii) que les préparations insuliniques doivent être employées uniquement de la façon prescrite par le médecin à chaque malade, à la lumière des quantités de sucre trouvées dans le sang et l’urine, et

(iii) que les directives du médecin au sujet du régime alimentaire, de la posologie, du repos et de l’exercice doivent être suivies minutieusement;

b) une description de la méthode à suivre pour retirer la préparation insulinique de la fiole, y compris le mode de stérilisation de la seringue et de l’aiguille, du bouchon de la fiole et du point d’injection;

c) un avertissement expliquant que les injections doivent être sous-cutanées, et non pas intraveineuses ni intramusculaires, et une mise en garde contre des injections successives au même endroit;

d) un avertissement disant que les doses sont spécifiées en termes d’unités d’activité par centimètre cube et que le volume de chaque dose dépend de l’activité en unités par centimètre cube déclarée sur l’étiquette de la préparation insulinique et que, pour ces raisons, il importe que le malade comprenne bien la graduation des seringues;

e) une brève explication de l’hypoglycémie ainsi que des mesures d’urgence que peuvent prendre les malades et ceux qui les soignent en cas de réactions hypoglycémiques;

f) un avertissement sur l’apparition possible de réactions indésirables par suite de maladie ou d’infection, de l’omission d’un repas et d’un manque de la préparation insulinique;

g) un avertissement de n’employer aucune autre sorte de préparation insulinique que celle qui a été prescrite par le médecin;

h) un avertissement de ne pas commencer à se servir d’un emballage après la date limite d’utilisation imprimée sur l’emballage;

i) un avertissement recommandant d’employer le contenu d’une façon aussi continue que possible et de jeter toute fiole entamée qui n’a pas servi depuis plusieurs semaines;

j) un avertissement signalant l’importance de consulter régulièrement un médecin et de suivre fidèlement ses directives;

k) dans le cas de préparations insuliniques consistant en une solution limpide, incolore ou presque incolore, exempte de turbidité et matière insoluble, un avertissement disant que, si le contenu d’une fiole devient brouillé ou trouble, il faut cesser d’utiliser cette fiole;

l) dans le cas de préparations insuliniques consistant en un précipité en suspension dans un milieu aqueux tamponné, un avertissement expliquant qu’il est nécessaire d’agiter la fiole avec soin avant d’en retirer une dose et signalant que, si le contenu prend une apparence grumeleuse ou granulée ou s’il s’est formé un dépôt de particules sur la paroi du contenant, il faut cesser d’utiliser cette fiole;

m) des directives demandant de garder la préparation insulinique au réfrigérateur à une température comprise entre 35 ° et 50 °F (2 ° et 10 °C) et de ne pas l’exposer à être congelée; et,

n) dans le cas de l’insuline sulfurisée, un avertissement expliquant que cette préparation insulinique n’est pas destinée à l’usage courant mais est une insuline chimiquement modifiée qui peut être plus efficace que les préparations insuliniques usuelles chez certains diabétiques résistant ou allergiques à l’insuline.

DORS/82-769, art. 7 et 10.

C.04.656. (1) Nonobstant l’article C.04.554, un titulaire de licence d’établissement peut vendre de l’injection insulinique faite avec des cristaux d’insuline-zinc et offerte dans des fioles d’une capacité approximative de 20 centimètres cubes, dont chacune

a) contient un excédent de volume permettant d’en retirer 20 centimètres cubes, et

b) fournit 500 unités internationales d’insuline par centimètre cube,

si

c) nonobstant l’article C.04.651, les étiquettes intérieure et extérieure sont toutes deux imprimées en caractères noirs sur fond blanc et portent en surcharge d’étroites bandes diagonales brunes et blanches, en nombre d’au moins cinq et d’au plus 20 au pouce;

d) les étiquettes intérieure et extérieure portent toutes deux la mention « Avertissement — Activité élevée — Ne pas employer aux fins ordinaires »; et

e) chaque emballage contient un prospectus explicatif conforme aux exigences de l’article C.04.655 et portant de plus :

(i) au début du prospectus, l’avertissement :

« Mise en garde — Cette préparation insulinique contient 500 unités internationales d’insuline par centimètre cube. Mettre un soin extrême à mesurer les doses, car une dose excessive donnée par inadvertance peut provoquer un état de choc irréversible. L’employer autrement que sous la surveillance constante d’un médecin peut avoir de graves conséquences. À moins que cette préparation ne soit spécifiquement prescrite, les malades ne devraient jamais l’employer à la place de quelque autre préparation insulinique. »,

(ii) un avertissement de ne pas administrer par voie intraveineuse de l’insuline faite avec des cristaux d’insuline-zinc à 500 unités internationales par centimètre cube, et

(iii) un exposé des renseignements nécessaires au médecin pour l’administration sûre et efficace de ladite drogue dans le traitement par choc insulinique et dans le traitement des diabétiques offrant une grande résistance à l’insuline (besoin quotidien de plus de 200 unités internationales d’insuline).

(2) [Abrogé, DORS/95-203, art. 10]

DORS/82-769, art. 7 et 11; DORS/95-203, art. 10; DORS/97-12, art. 64.

Extraits hypophysaires (lobe antérieur)

[DORS/82-769, art. 14]

C.04.675. L’extrait hypophysaire (lobe antérieur) doit comprendre tous les produits naturels préparés à partir du lobe antérieur de la glande hypophysaire d’animaux, et

possédant des propriétés physiologiques associées aux hormones du lobe antérieur de la glande hypophysaire, et leurs noms propres doivent être

a) Hormone adrénocorticotrope, Corticotrophine,

b) Hormone thyrotrope, Thyrotrophine,

c) Hormone pituitaire de la croissance, Somatotrophine,

d) Hormone lactogène, Prolactine,

e) Hormone gonadotrope, Gonadotrophine, suivi de qualificatifs pour indiquer l’activité gonadotrope que possède l’extrait,

et, s’il s’agit d’extrait hypophysaire (lobe antérieur) non purifié,

f) Extrait hypophysaire (lobe antérieur) suivi de qualificatifs qui indiquent les propriétés physiologiques attribuées audit extrait.

DORS/82-769, art. 13.

C.04.676. Les étalons de l’extrait hypophysaire (lobe antérieur) doivent être

a) l’étalon international;

b) dans le cas où il n’y a pas d’étalon international, l’étalon canadien qui doit être établi et conservé par le Directeur, lequel peut, sur demande, en fournir des portions pour fins d’essais comparatifs; et

c) dans le cas où il n’y a pas d’étalon international ni d’étalon canadien, un étalon provisoire qui doit consister en une quantité appropriée du produit, soumise par le distributeur visé à l’alinéa C.01A.003b) au Directeur, en vue du contrôle de l’uniformité du produit.

DORS/82-769, art. 13; DORS/97-12, art. 58.

C.04.677. Les étiquettes intérieure et extérieure de l’extrait hypophysaire (lobe antérieur) doivent toutes deux porter une déclaration de l’activité en fonction de l’étalon d’extrait hypophysaire (lobe antérieur) prévu à l’article C.04.676, déterminée par une méthode acceptable; toutefois, lorsqu’il n’y a pas d’étalon pour un extrait hypophysaire de lobe antérieur, le distributeur visé à l’alinéa C.01A.003b) doit adjoindre à tout emballage d’extrait hypophysaire de lobe antérieur une déclaration acceptable de l’unité d’activité et de la méthode de dosage employées.

DORS/82-769, art. 13; DORS/97-12, art. 58; DORS/97-543, art. 6.

C.04.678. Il est interdit à tout titulaire de licence d’établissement de vendre des hormones corticotrophiques pour injection sous-cutanée ou intramusculaire, à moins que la préparation n’ait été mise à l’épreuve par une méthode acceptable comportant une injection sous-cutanée et, si la préparation est recommandée pour usage intraveineux, à moins que l’étiquette n’indique la dose précise pour cet usage.

DORS/82-769, art. 13; DORS/97-12, art. 64.

C.04.679. Est interdite la vente, comme telle, d’hormone adrénocorticotrope, d’hormone thyrotrope, d’hormone pituitaire de la croissance, d’hormone lactogène, ou d’hormone gonadotrope, qui ne sont pas suffisamment exemptes d’extrait hypophysaire (lobe antérieur) autre que celui d’après lequel l’hormone a été nommée.

DORS/82-769, art. 13.

C.04.680. L’étiquette extérieure d’un mélange de deux ou plusieurs des hormones adrénocorticotrope, thyrotrope, pituitaire de la croissance, lactogène ou gonadotrope, ou d’un mélange de l’une ou plusieurs de ces hormones avec de l’extrait hypophysaire (lobe antérieur), doit porter une mention du nom propre et de la quantité de chaque composant du mélange.

DORS/82-769, art. 13; DORS/93-202, art. 22.

C.04.681. L’étiquette extérieure d’un extrait hypophysaire (lobe antérieur) ou d’un mélange d’extraits hypophysaires (lobe antérieur) doit porter une déclaration

a) donnant le nom de l’espèce d’animal dont proviennent les glandes ayant servi à la préparation de l’extrait hypophysaire (lobe antérieur);

b) avertissant que le produit doit être conservé à la température du réfrigérateur; et

c) sauf dans le cas des hormones gonadotropes, de n’employer ce produit que sur l’avis ou l’ordonnance d’un médecin.

DORS/82-769, art. 13.

C.04.682. Les étiquettes intérieure et extérieure d’une hormone adrénocorticotrope doivent toutes deux porter une déclaration de la voie d’administration, en plus d’être conformes aux dispositions des alinéas C.04.681a) et b).

DORS/82-769, art. 13 et 15.

C.04.683. La date limite d’utilisation d’un extrait hypophysaire (lobe antérieur) ou d’un mélange d’extraits hypophysaires (lobe antérieur) ne doit pas dépasser deux ans après la date d’épreuve satisfaisante de son activité.

DORS/82-769, art. 13.

Titre 5

Drogues destinées aux essais cliniques sur des sujets humains Définitions

C.05.001. Les définitions qui suivent s’appliquent au présent titre.

« bonnes pratiques cliniques » Pratiques cliniques généralement reconnues visant à assurer la protection des droits, la sûreté et le bien-être des sujets d’essai clinique et d’autres personnes ainsi que les bonnes pratiques cliniques visées à l’article C.05.010. (good clinical practices)

« brochure du chercheur » Document dans lequel figurent les données précliniques et cliniques d’une drogue visées à l’alinéa C.05.005e). (investigator’s brochure)

« chercheur qualifié » La personne qui est responsable auprès du promoteur de la conduite de l’essai clinique à un lieu d’essai clinique, qui est habilitée à dispenser des soins de santé en vertu des lois de la province où ce lieu d’essai clinique est situé et qui est :

a) dans le cas d’un essai clinique portant sur une drogue destinée à être utilisée exclusivement en médecine dentaire, un médecin ou un dentiste, membre en règle d’une association médicale ou dentaire professionnelle;

b) dans tout autre cas, un médecin, membre en règle d’une association médicale professionnelle. (qualified investigator)

« comité d’éthique de la recherche » Organisme, qui n’est pas lié au promoteur, ayant les caractéristiques suivantes :

a) son principal mandat est d’approuver la tenue de projets de recherche biomédicale sur des sujets humains et d’en contrôler périodiquement le déroulement afin d’assurer la protection des droits des sujets, ainsi que leur sûreté et leur bien-être;

b) il est composé d’au moins cinq membres, la majorité de ses membres sont des citoyens canadiens ou des résidents permanents au sens de la Loi sur l’immigration et la protection des réfugiés et il compte parmi ses membres des hommes et des femmes, dont au moins :

(i) deux membres possèdent de l’expertise et de l’expérience principalement dans un domaine scientifique ainsi qu’une vaste expérience des méthodes et champs de recherche à approuver, l’un d’entre eux provenant d’une discipline des soins de la santé ou, dans le cas d’un essai clinique portant sur une drogue destinée à être utilisée exclusivement en médecine dentaire, d’une discipline des soins de la santé ou des soins dentaires,

(ii) un membre possède des connaissances de l’éthique,

(iii) un membre possède des connaissances de la législation canadienne applicable à la recherche biomédicale à approuver,

(iv) un membre possède de l’expertise et de l’expérience principalement dans un domaine non scientifique,

(v) un membre, qui n’est pas lié au promoteur ni au lieu d’essai clinique proposé, est un individu de la collectivité ou un représentant d’un organisme intéressé aux champs de recherche à approuver. (research ethics board)

« drogue » Drogue pour usage humain destinée à faire l’objet d’un essai clinique. (drug)

« essai clinique » Recherche sur des sujets humains dont l’objet est soit de découvrir ou de vérifier les effets cliniques, pharmacologiques ou pharmacodynamiques d’une drogue pour usage humain, soit de déceler les incidents thérapeutiques liés à cette drogue, soit d’en étudier l’absorption, la distribution, le métabolisme et l’élimination ou soit d’en établir l’innocuité ou l’efficacité. (clinical trial)

« importer » Importer une drogue au Canada pour la vendre dans le cadre d’un essai clinique. (import)

« incident thérapeutique » Événement indésirable affectant la santé d’un sujet d’essai clinique à qui une drogue a été administrée — qui peut ou non être causé par l’administration de la drogue, — y compris toute réaction indésirable à une drogue. (adverse event)

« promoteur » Personne physique ou morale, établissement ou organisme qui mène un essai clinique. (sponsor)

« protocole » Document qui expose les objectifs, le plan de travail, la méthodologie, les considérations statistiques et l’organisation d’un essai clinique. (protocol)

« réaction indésirable à une drogue » Réaction nocive et non intentionnelle à une drogue qui est provoquée par l’administration de toute dose de celle-ci. (adverse drug reaction)

« réaction indésirable grave à une drogue » Réaction indésirable à une drogue qui nécessite ou prolonge l’hospitalisation, entraîne une malformation congénitale ou une invalidité ou incapacité persistante ou importante, met la vie en danger ou entraîne la mort. (serious adverse drug reaction)

« réaction indésirable grave et imprévue à une drogue » Réaction indésirable grave à une drogue dont la nature, la sévérité ou la fréquence ne sont pas mentionnées dans les renseignements sur les risques qui figurent dans la brochure du chercheur ou sur l’étiquette de la drogue. (serious unexpected adverse drug reaction)

DORS/2001-203, art. 4; 2001, ch. 27, art. 273.

Champ d'application

C.05.002. (1) Sous réserve du paragraphe (2), le présent titre s’applique à la vente et à l’importation d’une drogue destinée à un essai clinique sur des sujets humains.

(2) À l’exception de l’alinéa C.05.003a), des paragraphes C.05.006(2) et (3), des alinéas C.05.010a) à i), de l’article C.05.011, des paragraphes C.05.012(1) et (2), des alinéas C.05.012(3)a) à d) et f) à h), du paragraphe C.05.012(4) et des articles C.05.013, C.05.016 et C.05.017, le présent titre ne s’applique ni à la vente ni à l’importation d’une drogue destinée à un essai clinique autorisées en vertu du paragraphe C.05.006(2).

DORS/2001-203, art. 4.

Interdiction

C.05.003. Malgré les articles C.01.014, C.08.002, C.08.002.02 et C.08.003, il est interdit à quiconque de vendre ou d’importer une drogue destinée à un essai clinique à moins que les conditions ci-après ne soient réunies :

a) il y est autorisé sous le régime du présent titre;

b) il se conforme au présent titre et aux articles C.01.015, C.01.036, C.01.037 à C.01.040, C.01.040.2, C.01.064 à C.01.067, C.01.070, C.01.131, C.01.133 à C.01.136 et C.01.435;

c) si la drogue doit être importée, il a un représentant au Canada qui est responsable de la vente de la drogue.

DORS/2001-203, art. 4; DORS/2011-88, art. 7. Version précédente

Disposition générale

C.05.004. Malgré le présent règlement, le promoteur peut présenter une demande conformément au présent titre pour la vente ou l’importation d’une drogue destinée à un essai clinique qui contient une substance dont la vente est interdite par le présent règlement, s’il établit, sur la foi d’informations scientifiques, que l’inclusion de cette substance dans la drogue peut avoir un effet thérapeutique bénéfique pour tout être humain.

DORS/2001-203, art. 4.

Demande d'autorisation

C.05.005. La demande d’autorisation pour la vente ou l’importation d’une drogue destinée à un essai clinique sous le régime du présent titre est présentée au ministre par le promoteur, est signée et datée par le directeur médical ou scientifique du promoteur au Canada et par le premier dirigeant du promoteur et contient les renseignements et documents suivants :

a) un exemplaire du protocole de l’essai clinique;

b) un exemplaire de la déclaration, qui figurera dans chaque formule de consentement éclairé, exposant les risques ainsi que les bénéfices prévus pour la santé des sujets d’essai clinique résultant de leur participation à l’essai clinique;

c) une attestation relative à l’essai clinique, signée et datée par le directeur médical ou scientifique du promoteur au Canada et par le premier dirigeant du promoteur, contenant :

(i) le titre du protocole et le numéro de l’essai clinique,

(ii) la marque nominative, le nom chimique ou le code de la drogue,

(iii) les catégories thérapeutique et pharmacologique de la drogue,

(iv) les ingrédients médicinaux de la drogue,

(v) les ingrédients non médicinaux de la drogue,

(vi) la forme posologique de la drogue,

(vii) le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique du promoteur,

(viii) si la drogue doit être importée, le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique du représentant du promoteur au Canada qui est responsable de la vente de la drogue,

(ix) pour chaque lieu d’essai clinique, le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique du chercheur qualifié, si ces renseignements sont connus au moment de la présentation de la demande,

(x) pour chaque lieu d’essai clinique, le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique du comité d’éthique de la recherche qui a approuvé le protocole visé à l’alinéa a) et une formule de consentement éclairé contenant la déclaration visée à l’alinéa b), si ces renseignements sont connus au moment de la présentation de la demande,

(xi) une déclaration précisant :

(A) que l’essai clinique sera mené conformément aux bonnes pratiques cliniques et au présent règlement,

(B) que les renseignements contenus dans la demande d’autorisation ou auxquels celle-ci renvoie sont exacts, complets et ne sont ni faux ni trompeurs;

d) si un comité d’éthique de la recherche a refusé auparavant d’approuver le protocole de l’essai clinique visé à l’alinéa a), le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique de ce comité, ainsi que la date et les motifs du refus, si ces renseignements sont connus au moment de la présentation de la demande;

e) la brochure du chercheur qui contient les renseignements suivants :

(i) les propriétés physiques, chimiques et pharmaceutiques de la drogue,

(ii) les aspects pharmacologiques de la drogue, y compris ses métabolites observés chez les espèces animales testées,

(iii) le comportement pharmacocinétique de la drogue et le métabolisme de celle-ci, y compris la façon dont elle est transformée biologiquement chez les espèces animales testées,

(iv) le cas échéant, les effets toxicologiques de la drogue observés chez les espèces animales testées lors d’études à dose unique, d’études à dose répétée ou d’études spéciales,

(v) le cas échéant, les résultats des études de carcinogénicité chez les espèces animales testées à l’égard de la drogue,

(vi) le cas échéant, les résultats des études cliniques sur le comportement pharmacocinétique de la drogue,

(vii) le cas échéant, lorsque des essais cliniques ont déjà été menés sur des sujets humains, les renseignements suivants obtenus lors de ces essais : l’innocuité de la drogue, son comportement pharmacodynamique, son efficacité et ses doses-réponses,

(viii) si la drogue est un produit pharmaceutique radioactif au sens de l’article C.03.201, les renseignements sur le mode de préparation du produit ainsi que sur la dosimétrie des rayonnements pour le produit préparé et les conditions de sa conservation une fois préparé;

f) si la drogue contient un excipient d’origine humaine, y compris toute utilisation dans un placebo :

(i) la mention, le cas échéant, que l’excipient a fait l’objet d’une identification numérique en vertu du paragraphe C.01.014.2(1) ou, s’agissant d’une drogue nouvelle, d’un avis de conformité en vertu du paragraphe C.08.004(1),

(ii) dans tout autre cas, les renseignements justifiant l’identité, la pureté, la puissance, la stabilité et l’innocuité de l’excipient;

g) s’il s’agit d’une drogue à l’égard de laquelle aucune identification numérique n’a été attribuée en vertu du paragraphe C.01.014.2(1) ou s’il s’agit d’une drogue nouvelle à l’égard de laquelle aucun avis de conformité n’a été délivré en application des articles C.08.004 ou C.08.004.01, les renseignements sur la chimie et la fabrication de la drogue, y compris le lieu de fabrication;

h) la date projetée du début de l’essai clinique à chaque lieu d’essai clinique, si ce renseignement est connu au moment de la présentation de la demande.

DORS/2001-203, art. 4; DORS/2011-88, art. 8. Version précédente

Autorisation

C.05.006. (1) Sous réserve du paragraphe (3), le promoteur peut vendre ou importer une drogue destinée à un essai clinique, autre qu’une drogue visée au paragraphe (2), si les conditions suivantes sont réunies :

a) il a présenté au ministre une demande conformément à l’article C.05.005;

b) le ministre ne lui a pas envoyé, dans les trente jours suivant la date de réception de la demande, un avis lui indiquant qu’il ne peut vendre ou importer la drogue pour l’un des motifs suivants :

(i) les renseignements et documents à l’égard de la demande, selon le cas :

(A) n’ont pas été fournis conformément au présent règlement,

(B) ne sont pas suffisants pour permettre au ministre d’évaluer l’innocuité et les risques de la drogue ou la sûreté et les risques de l’essai clinique,

(ii) le ministre a des motifs raisonnables de croire, d’après l’examen de la demande ou des renseignements fournis en vertu de l’article C.05.009, ou d’après l’évaluation de tout autre renseignement, que l’une des conditions suivantes existe :

(A) l’utilisation de la drogue destinée à l’essai clinique met en danger la santé des sujets d’essai clinique ou celle d’autres personnes,

(B) l’essai clinique va à l’encontre de l’intérêt des sujets d’essai clinique,

(C) les objectifs de l’essai clinique ne seront pas atteints;

c) pour chaque lieu d’essai clinique, le promoteur a obtenu l’approbation du comité d’éthique de la recherche à l’égard du protocole visé à l’alinéa C.05.005a) et à l’égard d’une formule de consentement éclairé contenant la déclaration visée à l’alinéa C.05.005b);

d) avant la vente ou l’importation de la drogue à un lieu d’essai clinique, le promoteur a fourni au ministre les renseignements visés aux sous-alinéas C.05.005c)(ix) et (x) et aux alinéas C.05.005d) et h) qui n’ont pas été fournis à l’égard de ce lieu au moment de la présentation de la demande.

(2) Sous réserve du paragraphe (3), le promoteur peut vendre ou importer une drogue destinée à un essai clinique lorsque :

a) s’agissant d’une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré en vertu du paragraphe C.08.004(1), l’essai clinique porte sur les fins ou le mode d’emploi pour lesquels l’avis de conformité a été délivré;

b) s’agissant d’une drogue, autre qu’une drogue nouvelle, à l’égard de laquelle une identification numérique a été attribuée en vertu du paragraphe C.01.014.2(1), l’essai clinique porte sur l’usage ou les fins pour lesquels l’identification numérique a été attribuée.

(3) Le promoteur ne peut vendre ou importer la drogue destinée à un essai clinique :

a) durant la période de la suspension ordonnée en vertu des articles C.05.016 ou C.05.017;

b) après l’annulation ordonnée en vertu des articles C.05.016 ou C.05.017.

DORS/2001-203, art. 4.

Notification

C.05.007. Lorsque la vente ou l’importation d’une drogue est autorisée sous le régime du présent titre, le promoteur peut apporter un ou plusieurs des changements suivants s’il en avise le ministre par écrit dans les quinze jours suivant la date du changement :

a) tout changement apporté aux renseignements sur la chimie et la fabrication de la drogue qui n’a aucune incidence sur la qualité ou l’innocuité de celle-ci, autre qu’un changement pour lequel une modification est exigée par l’article C.05.008;

b) tout changement apporté au protocole qui ne modifie pas le risque pour la santé des sujets d’essai clinique, autre qu’un changement pour lequel une modification est exigée par l’article C.05.008.

DORS/2001-203, art. 4.

Modification

C.05.008. (1) Sous réserve des paragraphes (4) et (5), lorsque la vente ou l’importation d’une drogue est autorisée sous le régime du présent titre et que le promoteur envisage d’apporter l’une des modifications visées au paragraphe (2), il peut vendre ou importer la drogue destinée à un essai clinique selon l’autorisation modifiée, si les conditions suivantes sont réunies :

a) il a présenté au ministre une demande de modification conformément au paragraphe (3);

b) le ministre ne lui a pas envoyé, dans les trente jours suivant la date de réception de la demande de modification, un avis lui indiquant qu’il ne peut vendre ou importer la drogue conformément à la modification pour l’un des motifs suivants :

(i) les renseignements et documents à l’égard de la demande de modification, selon le cas :

(A) n’ont pas été fournis conformément au présent règlement,

(B) ne sont pas suffisants pour permettre au ministre d’évaluer l’innocuité et les risques de la drogue ou la sûreté et les risques de l’essai clinique,

(ii) le ministre a des motifs raisonnables de croire, d’après l’examen de la demande de modification ou des renseignements fournis en vertu de l’article C.05.009, ou d’après l’évaluation de tout autre renseignement, que l’une des conditions suivantes existe :

(A) l’utilisation de la drogue destinée à l’essai clinique met en danger la santé des sujets d’essai clinique ou celle d’autres personnes,

(B) l’essai clinique va à l’encontre de l’intérêt des sujets d’essai clinique,

(C) les objectifs de l’essai clinique ne seront pas atteints;

c) avant la vente ou l’importation de la drogue, le promoteur a fourni au ministre les renseignements et documents suivants :

(i) pour chaque lieu d’essai clinique, le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique du comité d’éthique de la recherche qui a approuvé tout protocole modifié présenté conformément à l’alinéa (3)a) ou toute déclaration modifiée présentée conformément à l’alinéa (3)c),

(ii) si un comité d’éthique de la recherche a refusé auparavant d’approuver toute modification au protocole, le nom, l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique de ce comité, ainsi que la date et les motifs du refus;

d) avant la vente ou l’importation de la drogue, le promoteur tient des registres sur les renseignements suivants :

(i) les renseignements visés à l’alinéa C.05.005h),

(ii) les renseignements visés au sous-alinéa C.05.005c)(ix), s’ils ont changé depuis leur présentation;

e) avant la vente ou l’importation de la drogue conformément à l’autorisation modifiée, le promoteur cesse de vendre ou d’importer la drogue conformément à l’autorisation existante;

f) le promoteur mène l’essai clinique en conformité avec l’autorisation modifiée.

(2) Pour l’application du paragraphe (1), les modifications visées sont les suivantes :

a) une modification du protocole qui a une incidence sur la sélection, le suivi ou le renvoi des sujets d’essai clinique;

b) une modification du protocole qui a une incidence sur l’évaluation de l’efficacité clinique de la drogue;

c) une modification du protocole qui modifie le risque pour la santé des sujets d’essai clinique;

d) une modification du protocole qui a une incidence sur l’évaluation de l’innocuité de la drogue;

e) une modification du protocole qui prolonge la durée de l’essai clinique;

f) une modification des renseignements sur la chimie et la fabrication de la drogue qui peut avoir une incidence sur l’innocuité ou la qualité de celle-ci.

(3) La demande de modification visée au paragraphe (1) doit contenir, en plus d’un renvoi à la demande présentée en vertu de l’article C.05.005, les documents et renseignements suivants :

a) s’il s’agit d’une modification visée à l’un des alinéas (2)a) à e), un exemplaire du protocole modifié sur lequel les modifications sont indiquées, un exemplaire du protocole présenté conformément à l’alinéa C.05.005a) et les justifications des modifications;

b) s’il s’agit d’une modification visée à l’alinéa (2)e), un exemplaire de la brochure du chercheur modifiée ou un supplément à celle-ci indiquant les nouveaux renseignements, y compris les études toxicologiques à l’appui et les données sur la sûreté de l’essai clinique;

c) s’il s’agit d’une modification visée à l’un des alinéas (2)a) à f), et qu’en raison de cette modification, il est nécessaire de modifier la déclaration visée à l’alinéa C.05.005b), un exemplaire de la déclaration modifiée sur laquelle les modifications sont indiquées;

d) s’il s’agit d’une modification visée à l’alinéa (2)f), une copie des renseignements modifiés sur la chimie et la fabrication de la drogue indiquant les modifications ainsi que les justifications de celles-ci.

(4) Si l’une des modifications visées au paragraphe (2) est requise sur-le-champ parce que l’utilisation de la drogue destinée à un essai clinique ou l’essai clinique met en danger la santé des sujets d’essai clinique ou d’autres personnes, le promoteur peut immédiatement apporter cette modification; il doit alors fournir au ministre les renseignements exigés au paragraphe (3) dans les quinze jours suivant la date de la modification.

(5) Le promoteur ne peut vendre ou importer la drogue destinée à un essai clinique :

a) durant la période de la suspension ordonnée en vertu des articles C.05.016 ou C.05.017;

b) après l’annulation ordonnée en vertu des articles C.05.016 ou C.05.017.

DORS/2001-203, art. 4.

Renseignements complémentaires et échantillons

C.05.009. Lorsque les renseignements et documents contenus dans la demande visée à l’article C.05.005 ou dans la demande de modification visée à l’article C.05.008 ne sont pas suffisants pour permettre au ministre de déterminer si l’un des motifs visés aux alinéas C.05.006(1)b) ou C.05.008(1)b) existe, le ministre peut exiger que le promoteur lui fournisse, dans les deux jours suivant la réception de la demande, les renseignements complémentaires concernant la drogue ou l’essai clinique ou les échantillons de la drogue qui lui sont nécessaires pour faire cette détermination.

DORS/2001-203, art. 4.

Obligations du promoteur

Bonnes pratiques cliniques

C.05.010. Le promoteur doit veiller à ce que tout essai clinique soit mené conformément aux bonnes pratiques cliniques et, en particulier, veiller à ce que :

a) l’essai clinique soit fondé sur le plan scientifique et clairement décrit dans un protocole;

b) l’essai clinique soit mené et la drogue utilisée en conformité avec le protocole de l’essai clinique et le présent titre;

c) des systèmes et des procédures visant à assurer la qualité de tous les aspects de l’essai clinique soient mis en oeuvre;

d) pour chaque lieu d’essai clinique, l’approbation d’un comité d’éthique de la recherche soit obtenue avant le début de l’essai clinique à ce lieu;

e) à chaque lieu d’essai clinique, il y ait au plus un chercheur qualifié;

f) à chaque lieu d’essai clinique, les soins de santé et les décisions médicales dans le cadre de l’essai clinique relèvent du chercheur qualifié de ce lieu;

g) chaque individu collaborant à la conduite de l’essai clinique soit qualifié, par ses études, sa formation et son expérience, pour accomplir les tâches qui lui sont confiées;

h) le consentement éclairé — donné conformément aux règles de droit régissant les consentements — soit obtenu par écrit de chaque personne avant qu’elle participe à l’essai clinique mais seulement après qu’elle a été informée de ce qui suit :

(i) des risques et bénéfices prévus pour sa santé résultant de sa participation à l’essai clinique,

(ii) de tout autre aspect de l’essai clinique nécessaire à la prise de sa décision de participer à l’essai clinique;

i) les exigences relatives aux renseignements et registres prévues à l’article C.05.012 soient respectées;

j) la drogue soit manufacturée, manutentionnée et entreposée conformément aux bonnes pratiques de fabrication visées aux titres 2 à 4, à l’exception des articles C.02.019, C.02.025 et C.02.026.

DORS/2001-203, art. 4.

Étiquetage

C.05.011. Malgré les autres dispositions du présent règlement relatives à l’étiquetage, le promoteur doit veiller à ce que la drogue porte une étiquette sur laquelle figurent, dans les deux langues officielles, les renseignements suivants :

a) une mention indiquant que la drogue est de nature expérimentale et ne doit être utilisée que par un chercheur qualifié;

b) le nom, le numéro ou la marque d’identification de la drogue;

c) la date limite d’utilisation de la drogue;

d) les conditions d’entreposage recommandées de la drogue;

e) le numéro de lot de la drogue;

f) les nom et adresse du promoteur;

g) le code ou l’identification du protocole;

h) si la drogue est un produit pharmaceutique radioactif au sens de l’article C.03.201, les renseignements exigés par le sous-alinéa C.03.202(1)b)(vi).

DORS/2001-203, art. 4.

Registres

C.05.012. (1) Le promoteur doit consigner dans des registres, traiter et conserver les renseignements relatifs à un essai clinique de façon à permettre la présentation de rapports complets et exacts sur ceux-ci ainsi que leur interprétation et leur vérification.

(2) Le promoteur doit tenir des registres complets et précis afin de démontrer que l’essai clinique est mené conformément aux bonnes pratiques cliniques et au présent règlement.

(3) Le promoteur doit tenir des registres complets et précis sur l’utilisation d’une drogue dans un essai clinique, y compris les renseignements et documents suivants :

a) un exemplaire de toutes les versions de la brochure du chercheur concernant la drogue;

b) un registre sur toutes les modifications apportées à la brochure du chercheur et les motifs de celles-ci, ainsi que les documents les justifiant;

c) un registre sur tous les incidents thérapeutiques liés à la drogue, survenus au Canada ou à l’étranger, ainsi que les indications de la drogue et sa forme posologique au moment où l’incident thérapeutique est survenu;

d) un registre sur l’inscription des sujets d’essai clinique dans lequel sont consignés les renseignements permettant d’identifier et de contacter ceux-ci si la vente de la drogue peut présenter un risque pour leur santé ou celle d’autres personnes;

e) un registre sur l’expédition, la réception, l’aliénation, le retour et la destruction de la drogue;

f) pour chaque lieu d’essai clinique, un engagement signé et daté par le chercheur qualifié, avant son entrée en fonction dans le cadre de l’essai clinique, portant :

(i) qu’il conduira l’essai clinique d’une manière conforme aux bonnes pratiques cliniques,

(ii) qu’en cas de cessation de l’essai clinique par le promoteur en totalité ou à un lieu d’essai clinique, il informera immédiatement les sujets d’essai clinique et le comité d’éthique de la recherche de la cessation et des motifs de celle-ci et les avisera par écrit des risques possibles pour la santé des sujets d’essai clinique ou celle d’autres personnes, le cas échéant;

g) pour chaque lieu d’essai clinique, un exemplaire de la formule de consentement éclairé et du protocole, ainsi que les modifications qui y ont été apportées, que le comité d’éthique de la recherche pour ce lieu a approuvés;

h) pour chaque lieu d’essai clinique, une attestation signée et datée par le comité d’éthique de la recherche pour ce lieu portant qu’il a examiné et approuvé le protocole et la formule de consentement éclairé et qu’il exerce ses activités d’une manière conforme aux bonnes pratiques cliniques.

(4) Le promoteur doit tenir les registres visés au présent titre durant vingt-cinq ans.

DORS/2001-203, art. 4.

Présentation de renseignements et d'échantillons

C.05.013. (1) Le ministre doit exiger que le promoteur lui fournisse, dans les deux jours suivant la réception de la demande, des renseignements concernant la drogue ou l’essai clinique ou des échantillons de la drogue, s’il a des motifs raisonnables de croire que l’une des situations suivantes existe :

a) l’utilisation de la drogue destinée à l’essai clinique met en danger la santé des sujets d’essai clinique ou celle d’autres personnes;

b) l’essai clinique va à l’encontre de l’intérêt des sujets d’essai clinique;

c) les objectifs de l’essai clinique ne seront pas atteints;

d) un chercheur qualifié ne respecte pas l’engagement visé à l’alinéa C.05.012(3)f);

e) les renseignements fournis concernant la drogue ou l’essai clinique sont faux ou trompeurs.

(2) Le ministre peut exiger que le promoteur lui fournisse tout registre ou renseignement visé à l’article C.05.012 ou des échantillons de la drogue, dans les sept jours suivant la réception de la demande, afin d’évaluer l’innocuité de la drogue ou la santé des sujets d’essai clinique ou celle d’autres personnes.

DORS/2001-203, art. 4.

Rapport sur les réactions indésirables graves et imprévues à la drogue

C.05.014. (1) Le promoteur doit, au cours d’un essai clinique, informer le ministre de toute réaction indésirable grave et imprévue à la drogue, survenue au Canada ou à l’étranger, selon le cas :

a) dans les quinze jours suivant le moment où il en a eu connaissance, lorsque cette réaction n’entraîne pas la mort ni ne met en danger la vie;

b) dans les sept jours suivant le moment où il en a eu connaissance, lorsque cette réaction entraîne la mort ou met en danger la vie.

(2) Dans les huit jours suivant la communication de l’information au ministre conformément à l’alinéa (1)b), le promoteur lui remet un rapport exhaustif à ce sujet, y compris une analyse de l’importance et des répercussions des constatations.

(3) Les articles C.01.016 et C.01.017 ne s’appliquent pas aux drogues destinées à un essai clinique.

DORS/2001-203, art. 4.

Cessation d'un essai clinique

C.05.015. (1) En cas de cessation de l’essai clinique par le promoteur en totalité ou à un lieu d’essai clinique, celui-ci doit :

a) en aviser le ministre dans les quinze jours suivant la date de cessation;

b) faire connaître au ministre les motifs de la cessation et les répercussions sur ses autres essais cliniques qui sont prévus ou en cours au Canada relativement à la drogue;

c) informer tous les chercheurs qualifiés, le plus tôt possible, de la cessation et des motifs de cette mesure et les aviser par écrit des risques possibles pour la santé des sujets d’essai clinique ou celle d’autres personnes, le cas échéant;

d) à tout lieu d’essai clinique en cause, cesser la vente ou l’importation de la drogue à partir de la date de cessation et prendre des mesures raisonnables pour assurer la récupération de toute quantité inutilisée de la drogue vendue.

(2) En cas de cessation de l’essai clinique par le promoteur en totalité ou à un lieu d’essai clinique, celui-ci peut recommencer à vendre ou à importer la drogue destinée à un essai clinique en totalité ou à un lieu d’essai clinique, s’il fournit au ministre les renseignements visés aux sous-alinéas C.05.005c)(ix) et (x) et aux alinéas C.05.005d) et h) à l’égard de chaque lieu d’essai clinique où la vente ou l’importation recommencera.

DORS/2001-203, art. 4.

Suspension et annulation

C.05.016. (1) Sous réserve du paragraphe (2), le ministre doit suspendre l’autorisation de vendre ou d’importer une drogue destinée à un essai clinique, en totalité ou à l’égard d’un lieu d’essai clinique, s’il a des motifs raisonnables de croire, que l’une des situations suivantes existe :

a) le promoteur a contrevenu au présent règlement ou à toute disposition de la Loi relative à la drogue;

b) les renseignements fournis à l’égard de la drogue ou de l’essai clinique sont faux ou trompeurs;

c) le promoteur ne s’est pas conformé aux bonnes pratiques cliniques;

d) le promoteur a omis :

(i) soit de fournir les renseignements ou les échantillons de la drogue tel qu’exigés en vertu des articles C.05.009 et C.05.013,

(ii) soit d’informer le ministre ou de lui remettre un rapport conformément à l’article C.05.014.

(2) Sous réserve de l’article C.05.017, le ministre ne peut suspendre l’autorisation visée au paragraphe (1) que si les conditions suivantes sont réunies :

a) il a envoyé au promoteur un avis écrit de son intention de suspendre l’autorisation, indiquant si l’autorisation est suspendue en totalité ou à l’égard d’un lieu d’essai clinique, ainsi que les motifs de la suspension projetée;

b) le promoteur n’a pas, dans les trente jours suivant la réception de l’avis visé à l’alinéa a), fourni au ministre les renseignements ou documents démontrant que l’autorisation ne devrait pas être suspendue pour l’un des motifs suivants :

(i) la situation donnant lieu à la suspension projetée n’a pas existé,

(ii) la situation donnant lieu à la suspension projetée a été corrigée;

c) le ministre a donné au promoteur la possibilité de se faire entendre conformément à l’alinéa b).

(3) Le ministre suspend l’autorisation en envoyant au promoteur un avis écrit de la suspension de l’autorisation indiquant si l’autorisation est suspendue en totalité ou à l’égard d’un lieu d’essai clinique, la date de prise d’effet de la suspension ainsi que les motifs de celle-ci.

(4) Si le ministre a suspendu une autorisation, il doit :

a) soit rétablir l’autorisation en totalité ou à l’égard d’un lieu d’essai clinique, selon le cas, si dans les trente jours suivant la date de prise d’effet de la suspension, le promoteur lui a fourni les renseignements ou documents démontrant que la situation ayant donné lieu à la suspension a été corrigée;

b) soit annuler l’autorisation en totalité ou à l’égard d’un lieu d’essai clinique, selon le cas, si dans les trente jours suivant la date de prise d’effet de la suspension, le promoteur ne lui a pas fourni les renseignements ou documents visés à l’alinéa a).

DORS/2001-203, art. 4.

C.05.017. (1) Le ministre doit suspendre l’autorisation de vendre ou d’importer une drogue destinée à un essai clinique, en totalité ou à l’égard d’un lieu d’essai clinique, avant d’avoir donné au promoteur la possibilité de se faire entendre, s’il a des motifs raisonnables de croire que cela est nécessaire pour prévenir que ne soit causé un préjudice à la santé des sujets d’essai clinique ou celle d’autres personnes.

(2) Le ministre suspend l’autorisation en envoyant au promoteur un avis écrit de la suspension de l’autorisation indiquant si l’autorisation est suspendue en totalité ou à

l’égard d’un lieu d’essai clinique, la date de prise d’effet de la suspension ainsi que les motifs de celle-ci.

(3) Si le ministre a suspendu une autorisation, il doit :

a) soit rétablir l’autorisation en totalité ou à l’égard d’un lieu d’essai clinique, selon le cas, si dans les soixante jours suivant la date de prise d’effet de la suspension, le promoteur lui a fourni les renseignements ou documents démontrant que la situation ayant donné lieu à la suspension n’a pas existé ou a été corrigée;

b) soit annuler l’autorisation en totalité ou à l’égard d’un lieu d’essai clinique, selon le cas, si dans les soixante jours suivant la date de prise d’effet de la suspension, le promoteur ne lui a pas fourni les renseignements ou documents visés à l’alinéa a).

DORS/2001-203, art. 4.

Titre 6 NORMES CANADIENNES DES DROGUES

1. Oestrogènes conjugués

2. Oestrogènes conjugués pour injection

3. Oestrogènes conjugués (comprimés d')

4. Digitoxine

5. Digitoxine (comprimés de)

6. Digoxine

7. Digoxine (élixir de)

8. Digoxine (injection de)

9. Digoxine (comprimés de)

10. Oestrogènes estérifiés

11. Oestrogènes estérifiés (comprimés d')

12. Gélatine

13. Thyroïde

DORS/80-544, art. 11.

Dispositions générales

C.06.001. Dans le présent titre,

a) la solubilité et la densité doivent être déterminées à 25 °C;

b) les essais d’identité, la détermination quantitative de l’arsenic, du plomb, du cuivre, du zinc, du fluor et de l’anhydride sulfureux, et les essais limites doivent être faits par des méthodes acceptables; et

c) la détermination des constantes physiques et chimiques doit être faite par des méthodes acceptables.

Oestrogènes conjugués

C.06.002. [N]. Les oestrogènes conjugués doivent être la drogue décrite dans la Pharmacopeia of the United States of America, XVIII (1970), sauf que

a) la solution A diluée, les solutions A et B, ainsi que le réactif de l’équiline qui y sont décrits sont préparés selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981; et que

b) l’épreuve d’identité qui y est décrite est effectuée selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981.

DORS/82-429, art. 5.

Oestrogènes conjugués pour injection

C.06.003. [N]. Les oestrogènes conjugués pour injection doivent être la drogue décrite dans la Pharmacopeia of the United States of America, XVIII (1970), sauf que

a) la solution A diluée, les solutions A et B, ainsi que le réactif de l’équiline qui y sont décrits sont préparés selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981; et que

b) l’épreuve d’identité qui y est décrite est effectuée selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981.

DORS/82-429, art. 6.

Comprimés d'oestrogènes conjugués

C.06.004. [N]. Les comprimés d’oestrogènes conjugués doivent être la drogue décrite dans la Pharmacopeia of the United States of America, XVIII (1970), sauf que

a) la solution A diluée, les solutions A et B, ainsi que le réactif de l’équiline qui y sont décrits sont préparés selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981; et que

b) l’épreuve d’identité qui y est décrite est effectuée selon la méthode officielle DO-29, Oestrogènes conjugués, du 15 octobre 1981.

DORS/82-429, art. 7.

C.06.100. et C.06.101. [Abrogés, DORS/80-544, art. 12]

Digitoxine

C.06.120. [N]. La digitoxine doit être la drogue digitoxin décrite dans la Pharmacopeia of the United States of America.

Comprimés de digitoxine

C.06.121. [N]. Les comprimés de digitoxine doivent être la drogue digitoxin tablets décrite dans la Pharmacopeia of the United States of America.

Digoxine

C.06.130. [N]. La digoxine doit être la drogue digoxin décrite dans la Pharmacopeia of the United States of America.

Élixir de digoxine

C.06.131. [N]. L’élixir de digoxine doit être la drogue digoxin elixir décrite dans la Pharmacopeia of the United States of America.

Injection de digoxine

C.06.132. [N]. L’injection de digoxine doit être la drogue digoxin injection décrite dans la Pharmacopeia of the United States of America.

Comprimés de digoxine

C.06.133. [N]. Les comprimés de digoxine doivent être la drogue digoxin tablets décrite dans la Pharmacopeia of the United States of America.

C.06.140. à C.06.142. [Abrogés, DORS/80-544, art. 12]

C.06.150. à C.06.153. [Abrogés, DORS/80-544, art. 12]

C.06.154. à C.06.156. [Abrogés, DORS/80-544, art. 12]

C.06.157. à C.06.160. [Abrogés, DORS/80-544, art. 12]

Oestrogènes estérifiés

C.06.161. [N]. Les oestrogènes estérifiés doivent être la drogue esterified estrogens décrite dans la Pharmacopeia of the United States of America.

Comprimés d'oestrogènes estérifiés

C.06.162. [N]. Les comprimés d’oestrogènes estérifiés doivent être la drogue esterified estrogens tablets décrite dans la Pharmacopeia of the United States of America.

Gélatine

C.06.170. La gélatine doit être la drogue gélatine décrite dans la Pharmacopeia of the United States ou la British Pharmacopeia.

C.06.180. à C.06.183. [Abrogés, DORS/80-544, art. 12]

C.06.230. à C.06.233. [Abrogés, DORS/80-544, art. 12]

C.06.240. à C.06.242. [Abrogés, DORS/80-544, art. 12]

Thyroïde

C.06.250. La thyroïde doit être le produit des glandes thyroïdes nettoyées, desséchées et pulvérisées d’animaux domestiques comestibles, contenir au moins 0,17 pour cent et au plus 0,23 pour cent d’iode, sans aucune addition d’iode sous forme organique ou minérale, et

a) posséder les caractères suivants :

description, —

(i) généraux, — la thyroïde se présente sous forme d’une poudre amorphe de couleur crème; elle a une légère odeur et une faible saveur de viande, et

(ii) microscopiques, — convenablement montée sur une lame et examinée au microscope, la thyroïde présente de nombreux fragments colloïdaux hyalius, lisses ou striés, de formes angulaires ou irrégulières, incolores ou jaune pâle dans l’eau, bruns dans la solution de Mallory, et roses dans la solution d’éosine; dans certains de ces fragments se trouvent des granules, des vacuoles minuscules, des corps cristalloïdes et des cellules; de nombreux fragments irréguliers d’épithélium folliculaire qui se colorent en brun par la solution de Mallory; les cellules individuelles sont plus ou moins polygonales, à angles arrondis ou irrégulièrement cubiques, et contenant souvent des noyaux bien marqués qui se colorent en bleu foncé tandis que le cytoplasme se colore en pourpre dans la solution d’hématoxyline de Delafield; des segments de capillaires chatoyants, minces, d’un profil ondulé serré; de nombreux segments minces de neuraxones; de nombreux agrégats de parcelles de substance intercellulaire et des fibres minces de tissu conjonctif, droites pour la plupart, qui se colorent en bleu ou en bleu verdâtre par un mélange de solution de Mallory et de solution d’acide phosphotungstique, les faisceaux de fibres paraissant souvent rougeâtres dans la solution de Mallory; quelques fragments chatoyants de vaisseaux sanguins dont les extrémités, vues dans un montage à l’eau, apparaissent crénelées ou dentées; et

b) satisfaire aux essais de pureté suivants :

(i) iode inorganique, — ajouter à un gramme de thyroïde 10 millilitres d’une solution aqueuse saturée de sulfate de zinc, agiter, laisser reposer cinq minutes, et passer dans un filtre de verre poreux; ajouter à cinq millilitres du filtrat 0,5 millilitre de colle d’amidon, plus quatre gouttes d’une solution aqueuse de 10 grammes par 100 millilitres de nitrite de sodium et quatre gouttes d’acide sulfurique dilué, et agiter à chaque addition : il ne doit pas se produire de couleur bleue, et

(ii) humidité, — la thyroïde perd au plus six pour cent d’humidité, à la dessiccation.

C.06.251. La thyroïde doit être

a) dosée par la méthode officielle DO-26, Thyroïde, du 15 octobre 1981; et

b) conservée au frais dans des récipients hermétiquement bouchés.

DORS/82-429, art. 8.

C.06.252. [Abrogé, DORS/80-544, art. 12]

C.06.260. à C.06.264. [Abrogés, DORS/80-544, art. 12]

C.06.270. à C.06.280. [Abrogés, DORS/80-544, art. 12]

Titre 7

Vente de drogues aux fins de mise en oeuvre de la décision du Conseil général Définitions

C.07.001. Les définitions qui suivent s’appliquent au présent titre.

« commissaire aux brevets » Le commissaire aux brevets nommé en vertu du paragraphe 4(1) de la Loi sur les brevets. (Commissioner of Patents)

« décision du Conseil général » S’entend au sens du paragraphe 30(6) de la Loi. (General Council Decision)

DORS/2005-141, art. 1.

Champ d’application

C.07.002. Le présent titre s’applique à la vente de drogues aux fins de mise en oeuvre de la décision du Conseil général.

DORS/2005-141, art. 1.

Demande d’autorisation

C.07.003. La demande d’autorisation pour la vente d’une drogue sous le régime du présent titre est présentée au ministre par le fabricant et comporte les renseignements et documents suivants :

a) une déclaration du fabricant portant qu’il a l’intention de présenter une demande au commissaire aux brevets aux termes de l’article 21.04 de la Loi sur les brevets;

b) dans le cas d’une drogue nouvelle, le numéro et la date de dépôt de la présentation de drogue nouvelle ou de la présentation abrégée de drogue nouvelle déposées respectivement aux termes des articles C.08.002 et C.08.002.1, ainsi que de tout supplément à l’une ou l’autre présentation déposé aux termes de l’article C.08.003;

c) dans le cas d’une drogue autre qu’une drogue nouvelle :

(i) soit le numéro et la date de dépôt de la demande d’identification numérique présentée à l’égard de la drogue aux termes de l’article C.01.014.1,

(ii) soit l’identification numérique attribuée à la drogue, le cas échéant, aux termes de l’article C.01.014.2;

d) dans le cas où la drogue se présente sous une forme posologique solide, la méthode suivie pour marquer la drogue conformément à l’alinéa C.07.008a) ainsi qu’une preuve établissant que cette méthode n’a aucune incidence sur son innocuité ou son efficacité;

e) dans le cas où la drogue se présente sous une forme posologique non solide, la méthode suivie pour marquer le récipient immédiat conformément à l’alinéa C.07.008a);

f) un échantillon de l’étiquette de la drogue, laquelle doit comporter les renseignements prévus à l’alinéa C.07.008c).

DORS/2005-141, art. 1.

Autorisation

C.07.004. Le ministre avise le fabricant et le commissaire aux brevets, pour l’application de l’alinéa 21.04(3)b) de la Loi sur les brevets, que la drogue en cause satisfait aux exigences de la Loi et du présent règlement si les conditions suivantes sont réunies :

a) le fabricant a présenté au ministre une demande conforme à l’article C.07.003 et il a fourni à ce dernier un exemplaire de la demande qu’il a présentée au commissaire aux brevets aux termes de l’article 21.04 de la Loi sur les brevets;

b) dans le cas d’une drogue nouvelle, le ministre conclut que la présentation de drogue nouvelle, la présentation abrégée de drogue nouvelle ou tout supplément à l’une ou l’autre présentation est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1;

c) dans le cas d’une drogue autre qu’une drogue nouvelle, une identification numérique a été attribuée à la drogue aux termes de l’article C.01.014.2;

d) le ministre est convaincu que le fabricant et la drogue satisfont aux exigences de la Loi et du présent règlement.

DORS/2005-141, art. 1.

C.07.005. Malgré les articles C.01.014, C.08.002 et C.08.003, le fabricant peut vendre une drogue sous le régime du présent titre si les conditions suivantes sont réunies :

a) le ministre a avisé le commissaire aux brevets, pour l’application de l’alinéa 21.04(3)b) de la Loi sur les brevets, que la drogue satisfait aux exigences de la Loi et du présent règlement;

b) le fabricant a reçu l’autorisation prévue à l’article 21.04 de la Loi sur les brevets.

DORS/2005-141, art. 1.

C.07.006. Les articles C.01.005 et C.01.014.1 à C.01.014.4 ne s’appliquent pas aux drogues nouvelles vendues sous le régime du présent titre.

DORS/2005-141, art. 1.

Avis au commissaire aux brevets

C.07.007. Le ministre avise le fabricant et le commissaire aux brevets, pour l’application de l’alinéa 21.13b) de la Loi sur les brevets, s’il est d’avis que la drogue dont la vente est autorisée sous le régime du présent titre ne satisfait plus aux exigences de la Loi et du présent règlement.

DORS/2005-141, art. 1.

Marquage et étiquetage

C.07.008. Il est interdit de vendre une drogue sous le régime du présent titre à moins que :

a) la drogue elle-même ne porte de façon permanente la marque « XCL », dans le cas où elle se présente sous une forme posologique solide, ou son récipient immédiat ne porte de façon permanente la marque « XCL », dans le cas où elle se présente sous une forme posologique non solide;

b) la drogue elle-même ne soit d’une couleur nettement différente de la couleur de la version de la drogue vendue au Canada, dans le cas où elle se présente sous une forme posologique solide;

c) l’étiquette de la drogue ne porte de façon permanente la marque « XCL », le numéro de suivi d’exportation attribué par le ministre aux termes de l’article C.07.009 et la mention « POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA. » ou « FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA. ».

DORS/2005-141, art. 1.

C.07.009. Le ministre attribue un numéro de suivi d’exportation à la drogue à l’égard de laquelle il a avisé le commissaire aux brevets en application de l’article C.07.004.

DORS/2005-141, art. 1.

Registre

C.07.010 Le fabricant est tenu, à l’égard de la drogue dont la vente est autorisée sous le régime du présent titre :

a) d’établir et de tenir, de façon à en permettre la vérification, un registre concernant les renseignements visés à l’article C.08.007;

b) de fournir au ministre les rapports visés à l’article C.08.008.

DORS/2005-141, art. 1.

Avis au ministre

C.07.011. Le fabricant est tenu d’aviser le ministre par écrit au moins quinze jours avant de commencer à fabriquer le premier lot de la drogue dont la vente est autorisée sous le régime du présent titre et au moins quinze jours avant l’exportation de tout lot subséquent de celle-ci.

DORS/2005-141, art. 1.

Titre 8 Drogues nouvelles

C.08.001. Pour l’application de la Loi et du présent titre, « drogue nouvelle » désigne :

a) une drogue qui est constituée d’une substance ou renferme une substance, sous forme d’ingrédient actif ou inerte, de véhicule, d’enrobage, d’excipient, de solvant ou de tout autre constituant, laquelle substance n’a pas été vendue comme drogue au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de ladite substance employée comme drogue;

b) une drogue qui entre dans une association de deux drogues ou plus, avec ou sans autre ingrédient, qui n’a pas été vendue dans cette association particulière, ou dans les proportions de ladite association pour ces drogues particulières, pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de cette association ou de ces proportions employées comme drogue; ou

c) une drogue pour laquelle le fabricant prescrit, recommande, propose ou déclare un usage comme drogue ou un mode d’emploi comme drogue, y compris la posologie, la voie d’administration et la durée d’action, et qui n’a pas été vendue pour cet usage ou selon ce mode d’emploi au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de cet usage ou de ce mode d’emploi pour ladite drogue.

DORS/95-172, art. 2.

C.08.001.1. Les définitions qui suivent s’appliquent au présent titre.

« équivalent pharmaceutique » S’entend d’une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d’ingrédients médicinaux identiques, sous

des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux. (pharmaceutical equivalent)

« produit de référence canadien » Selon le cas :

a) une drogue à l’égard de laquelle un avis de conformité a été délivré en application des articles C.08.004 ou C.08.004.01 et qui est commercialisée au Canada par son innovateur;

b) une drogue jugée acceptable par le ministre et qui peut être utilisée pour la détermination de la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, lorsqu’une drogue pour laquelle un avis de conformité a été délivré en application des articles C.08.004 ou C.08.004.01 ne peut être utilisée à cette fin parce qu’elle n’est plus commercialisée au Canada;

c) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, par comparaison à une drogue visée à l’alinéa a). (Canadian reference product)

« spécifications » S’entend de la description détaillée d’une drogue nouvelle et de ses ingrédients, notamment :

a) la liste des propriétés et des qualités des ingrédients qui ont trait à la fabrication et à l’emploi de la drogue nouvelle, y compris leur identité, leur activité et leur pureté;

b) la description détaillée des méthodes d’analyse et d’examen des ingrédients;

c) la liste des tolérances relatives aux propriétés et aux qualités des ingrédients. (specifications)

DORS/95-411, art. 3; DORS/2011-88, art. 9. Version précédente C.08.002. (1) Il est interdit de vendre ou d’annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies :

a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel que celui-ci juge acceptable;

b) le ministre a délivré au fabricant de la drogue nouvelle, en application des articles C.08.004 ou C.08.004.01, un avis de conformité relativement à la présentation;

c) l’avis de conformité relatif à la présentation n’a pas été suspendu aux termes de l’article C.08.006;

d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons des étiquettes — y compris toute notice jointe à l’emballage, tout dépliant et toute fiche sur le produit — destinées à être utilisées pour la drogue nouvelle, ainsi qu’une déclaration indiquant la date à laquelle il est prévu de commencer à utiliser ces étiquettes.

(2) La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle, notamment :

a) une description de la drogue nouvelle et une mention de son nom propre ou, à défaut, de son nom usuel;

b) une mention de la marque nominative de la drogue nouvelle ou du nom ou code d’identification projeté pour celle-ci;

c) la liste quantitative des ingrédients de la drogue nouvelle et les spécifications relatives à chaque ingrédient;

d) la description des installations et de l’équipement à utiliser pour la fabrication, la préparation et l’emballage de la drogue nouvelle;

e) des précisions sur la méthode de fabrication et les mécanismes de contrôle à appliquer pour la fabrication, la préparation et l’emballage de la drogue nouvelle;

f) le détail des épreuves qui doivent être effectuées pour contrôler l’activité, la pureté, la stabilité et l’innocuité de la drogue nouvelle;

g) les rapports détaillés des épreuves effectuées en vue d’établir l’innocuité de la drogue nouvelle, aux fins et selon le mode d’emploi recommandés;

h) des preuves substantielles de l’efficacité clinique de la drogue nouvelle aux fins et selon le mode d’emploi recommandés;

i) la déclaration des noms et titres professionnels de tous les chercheurs à qui la drogue nouvelle a été vendue;

j) une esquisse de chacune des étiquettes qui doivent être employées relativement à la drogue nouvelle;

k) la déclaration de toutes les recommandations qui doivent être faites dans la réclame pour la drogue nouvelle, au sujet

(i) de la voie d’administration recommandée pour la drogue nouvelle,

(ii) de la posologie proposée pour la drogue nouvelle,

(iii) des propriétés attribuées à la drogue nouvelle,

(iv) des contre-indications et les effets secondaires de la drogue nouvelle;

l) la description de la forme posologique proposée pour la vente de la drogue nouvelle;

m) les éléments de preuve établissant que les lots d’essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d’une manière représentative de la production destinée au commerce;

n) dans le cas d’une drogue nouvelle destinée à être administrée à des animaux producteurs de denrées alimentaires, le délai d’attente applicable.

(3) Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce que celui-ci estime nécessaire pour évaluer l’innocuité et l’efficacité de la drogue dans le cadre de la présentation de drogue nouvelle, les renseignements et le matériel suivants :

a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente;

b) des échantillons des ingrédients de la drogue nouvelle;

c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente;

d) tout renseignement ou matériel supplémentaire se rapportant à l’innocuité et à l’efficacité de la drogue nouvelle.

DORS/85-143, art. 1; DORS/93-202, art. 24; DORS/95-411, art. 4; DORS/2011-88, art. 10. Version précédente C.08.002.01 (1) Le fabricant d’une drogue nouvelle peut déposer à l’égard de celle-ci une présentation de drogue nouvelle pour usage exceptionnel si les conditions ci-après sont réunies :

a) la drogue nouvelle est destinée à être utilisée :

(i) en cas d’urgence, lorsqu’une personne a été exposée à une substance chimique, biologique, radiologique ou nucléaire et qu’il y a lieu d’agir pour traiter, atténuer ou prévenir une maladie, un désordre ou un état physique anormal graves — mettant notamment la vie en danger —, ou leurs symptômes, qui résultent — ou résulteraient vraisemblablement — d’une telle exposition,

(ii) en tant que mesure préventive chez toute personne qui pourrait être exposée à une substance chimique, biologique, radiologique ou nucléaire qui risque d’entraîner une incapacité permanente ou la mort;

b) il est impossible de remplir les exigences prévues aux alinéas C.08.002(2)g) et h) pour les raisons suivantes :

(i) l’exposition de volontaires humains à la substance visée à l’alinéa a) risque d’entraîner une incapacité permanente ou la mort,

(ii) les circonstances de l’exposition à la substance ne se produisent que de façon sporadique et à intervalles peu fréquents.

(2) Sous réserve des paragraphes (3) et (5), la présentation de drogue nouvelle pour usage exceptionnel doit contenir :

a) une attestation, signée et datée par le premier dirigeant au Canada du fabricant qui dépose la présentation et par son directeur médical ou scientifique, portant que les conditions prévues aux alinéas (1)a) et b) sont remplies, accompagnée de suffisamment de renseignements à l’appui pour permettre au ministre de conclure que ces conditions sont remplies;

b) suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de cette drogue nouvelle, notamment :

(i) les renseignements et le matériel visés aux alinéas C.08.002(2)a) à f) et i) à m),

(ii) des renseignements concernant le processus pathophysiologique de la toxicité de la substance chimique, biologique, radiologique ou nucléaire et décrivant la capacité de la drogue nouvelle de traiter, d’atténuer ou de prévenir ce processus,

(iii) des rapports détaillés d’études in vitro effectuées relativement à la toxicité et à l’activité de la drogue nouvelle, aux fins recommandées,

(iv) des rapports détaillés d’études, effectuées sur une espèce animale dont les réactions devraient permettre de prédire celles chez l’être humain, établissant l’innocuité de la drogue nouvelle et fournissant des preuves substantielles de ses effets lorsqu’elle est utilisée aux fins et selon le mode d’emploi recommandés,

(v) des renseignements confirmant que le résultat d’études sur les animaux est clairement relié aux avantages recherchés chez l’être humain,

(vi) des renseignements indiquant une connaissance suffisante de la pharmacocinétique et de la pharmacodynamie de la drogue nouvelle chez l’animal et l’être humain pour en tirer des conclusions permettant de déterminer une dose thérapeutique chez l’être humain,

(vii) des renseignements concernant l’innocuité de la drogue nouvelle chez l’être humain, notamment des rapports détaillés de tout essai clinique établissant l’innocuité de la drogue nouvelle,

(viii) tout renseignement concernant l’efficacité de la drogue nouvelle chez l’être humain aux fins et selon le mode d’emploi recommandés,

(ix) un plan visant à surveiller et à établir l’innocuité et l’efficacité de la drogue nouvelle aux fins et selon le mode d’emploi recommandés, qui contient les procédures de collecte et d’analyse des données,

(x) tout rapport d’évaluation disponible concernant la drogue nouvelle, préparé par toute autorité réglementaire dans tout pays autre que le Canada.

(3) Il n’est pas nécessaire de fournir les rapports visés au sous-alinéa (2)b)(iii) ou les renseignements visés au sous-alinéa (2)b)(vi) si la présentation de drogue nouvelle pour usage exceptionnel contient une explication scientifique détaillée de la raison pour laquelle ils ne sont pas disponibles.

(4) Tout renseignement ou matériel nécessaire pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle doit être ajouté, à la demande du ministre, à la présentation de drogue nouvelle pour usage exceptionnel, notamment :

a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle ainsi que ceux des fabricants de la drogue nouvelle sous la forme posologique proposée pour la vente;

b) des échantillons des ingrédients de la drogue nouvelle;

c) des échantillons de la drogue nouvelle sous la forme posologique proposée pour la vente;

d) tout renseignement qui n’a pas été fourni au titre du paragraphe (3).

(5) Si la présentation de drogue nouvelle pour usage exceptionnel vise une fin nouvelle d’une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004, il n’est pas nécessaire de fournir les renseignements et le matériel visés au sous-alinéa (2)b)(i) à moins qu’ils ne diffèrent de ceux fournis à l’origine.

DORS/2011-88, art. 11.

C.08.002.02 Malgré les articles C.08.002 et C.08.003, il est interdit au fabricant et à l’importateur de vendre une drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01, sauf :

a) au gouvernement du Canada ou à celui d’une province, à l’usage d’un de ses ministères ou organismes, sur réception d’une commande écrite signée par le ministre en cause ou le responsable de l’organisme, ou leur représentant dûment autorisé;

b) à une administration municipale ou un de ses organismes, sur réception d’une commande écrite signée par un cadre supérieur de l’administration ou de l’organisme, ou son représentant dûment autorisé.

DORS/2011-88, art. 11.

C.08.002.1. (1) Le fabricant d’une drogue nouvelle peut déposer à l’égard de celle-ci une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel si, par comparaison à un produit de référence canadien :

a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;

b) elle est bioéquivalente au produit de référence canadien d’après les caractéristiques pharmaceutiques et, si le ministre l’estime nécessaire, d’après les caractéristiques en matière de biodisponibilité;

c) la voie d’administration de la drogue nouvelle est identique à celle du produit de référence canadien;

d) les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi celles qui s’appliquent au produit de référence canadien.

(2) La présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle, notamment :

a) les renseignements et le matériel visés :

(i) aux alinéas C.08.002(2)a) à f) et j) à l), dans le cas d’une présentation abrégée de drogue nouvelle,

(ii) aux alinéas C.08.002(2)a) à f) et j) à l) et aux sous-alinéas C.08.002.01(2)b)(ix) et (x), dans le cas d’une présentation abrégée de drogue nouvelle pour usage exceptionnel;

b) les renseignements permettant d’identifier le produit de référence canadien utilisé pour les études comparatives menées dans le cadre de la présentation;

c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle :

(i) d’une part, est un équivalent pharmaceutique du produit de référence canadien,

(ii) d’autre part, si le ministre l’estime nécessaire d’après les caractéristiques pharmaceutiques et, le cas échéant, d’après les caractéristiques en matière de biodisponibilité de celle-ci, est bioéquivalente au produit de référence canadien selon les résultats des études en matière de biodisponibilité, des études pharmacodynamiques ou des études cliniques;

d) les éléments de preuve établissant que les lots d’essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d’une manière représentative de la production destinée au commerce;

e) dans le cas d’une drogue destinée à être administrée à des animaux producteurs de denrées alimentaires, les renseignements permettant de confirmer que le délai d’attente est identique à celui du produit de référence canadien.

(3) Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce que celui-ci estime nécessaire pour évaluer l’innocuité et l’efficacité de la drogue dans le cadre de la présentation abrégée de drogue nouvelle ou de la présentation abrégée de drogue nouvelle pour usage exceptionnel, les renseignements et le matériel suivants :

a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente;

b) des échantillons des ingrédients de la drogue nouvelle;

c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente;

d) tout renseignement ou matériel supplémentaire se rapportant à l’innocuité et à l’efficacité de la drogue nouvelle.

(4) Pour l’application du présent article, dans le cas d’une présentation abrégée de drogue nouvelle, la drogue nouvelle pour usage exceptionnel à l’égard de laquelle un avis de conformité a été délivré en application de l’article C.08.004.01 n’est pas un produit de référence canadien.

DORS/95-411, art. 5; DORS/2011-88, art. 12. Version précédente C.08.003. (1) Malgré l’article C.08.002, il est interdit de vendre une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré à son fabricant et n’a pas été suspendu aux termes de l’article C.08.006, lorsqu’un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle, la présentation de drogue nouvelle pour usage exceptionnel, la présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel, à moins que les conditions ci-après ne soient réunies :

a) le fabricant de la drogue nouvelle a déposé auprès du ministre un supplément à la présentation;

b) le ministre a délivré au fabricant un avis de conformité relativement au supplément;

c) l’avis de conformité relatif au supplément n’a pas été suspendu aux termes de l’article C.08.006;

d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons de toute étiquette — y compris une notice jointe à l’emballage, un dépliant et une fiche sur le produit — destinée à être utilisée pour la drogue nouvelle, dans le cas où la modification d’un des éléments visés au paragraphe (2) nécessite un changement dans l’étiquette.

(2) Pour l’application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :

a) sa description;

b) sa marque nominative ou le nom ou code sous lequel il est proposé de l’identifier;

c) les spécifications de ses ingrédients;

d) les installations et l’équipement à utiliser pour sa fabrication, sa préparation et son emballage;

e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage;

f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité;

g) les étiquettes à utiliser pour la drogue nouvelle;

h) les observations faites relativement :

(i) à la voie d’administration recommandée pour la drogue nouvelle,

(ii) à sa posologie,

(iii) aux propriétés qui lui sont attribuées,

(iv) à ses contre-indications et à ses effets secondaires,

(v) au délai d’attente applicable à celle-ci;

i) sa forme posologique proposée pour la vente.

(3) Le supplément à toute présentation visée au paragraphe (1) contient, à l’égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle relativement à ces éléments.

(4) S’il porte sur un élément visé au sous-alinéa (2)h)(iii), le supplément à une présentation de drogue nouvelle pour usage exceptionnel ou à une présentation abrégée de drogue nouvelle pour usage exceptionnel contient l’attestation et les renseignements à l’appui prévus à l’alinéa C.08.002.01(2)a).

DORS/85-143, art. 2; DORS/93-202, art. 25; DORS/95-411, art. 6; DORS/2011-88, art. 13. Version précédente C.08.003.1 Le ministre peut, dans le cadre de son examen d’une présentation de drogue nouvelle, d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, examiner les renseignements ou le matériel que lui présente toute personne, en vertu du titre 5 ou des articles C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1, pour déterminer l’innocuité et l’efficacité de la drogue nouvelle visée par la présentation ou le supplément.

DORS/95-411, art. 6; DORS/2001-203, art. 5; DORS/2011-88, art. 14. Version précédente

C.08.004. (1) Sous réserve de l’article C.08.004.1, après avoir terminé l’examen d’une présentation de drogue nouvelle, d’une présentation abrégée de drogue nouvelle ou d’un supplément à l’une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, en informe le fabricant.

(2) Lorsqu’une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l’une de ces présentations n’est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, le fabricant qui l’a déposé peut le modifier en déposant des renseignements ou du matériel supplémentaires.

(3) Sous réserve de l’article C.08.004.1, après avoir terminé l’examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, à une présentation abrégée de drogue nouvelle ou à un supplément à l’une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, en informe le fabricant.

(4) L’avis de conformité délivré à l’égard d’une drogue nouvelle d’après les renseignements et le matériel contenus dans la présentation déposée conformément à l’article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue la déclaration d’équivalence de cette drogue.

DORS/84-267, art. 1 à 3; DORS/85-143, art. 3; DORS/86-1009, art. 1; DORS/86-1101, art. 1; DORS/88-42, art. 1; DORS/88-257, art. 1; DORS/95-411, art. 6.

C.08.004.01 (1) Sous réserve de l’article C.08.004.1, après avoir terminé l’examen d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, en informe le fabricant.

(2) Lorsqu’une présentation de drogue nouvelle pour usage exceptionnel ou une présentation abrégée de drogue nouvelle pour usage exceptionnel ou un supplément à l’une de ces présentations n’est pas conforme aux articles C.08.002.01, C.08.002.1 ou

C.08.003, selon le cas, ou à l’article C.08.005.1, le fabricant qui l’a déposé peut le modifier en déposant des renseignements ou du matériel supplémentaires.

(3) Sous réserve de l’article C.08.004.1, après avoir terminé l’examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle pour usage exceptionnel, à une présentation abrégée de drogue nouvelle pour usage exceptionnel ou à un supplément à l’une de ces présentations, le ministre :

a) si la présentation ou le supplément est conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, et à l’article C.08.005.1, délivre un avis de conformité;

b) si la présentation ou le supplément n’est pas conforme aux articles C.08.002.01, C.08.002.1 ou C.08.003, selon le cas, ou à l’article C.08.005.1, en informe le fabricant.

(4) L’avis de conformité délivré à l’égard d’une drogue nouvelle pour usage exceptionnel d’après les renseignements et le matériel contenus dans la présentation déposée aux termes de l’article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue la déclaration d’équivalence de cette drogue.

DORS/2011-88, art. 15.

C.08.004.1 (1) Les définitions qui suivent s’appliquent au présent article.

« drogue innovante » S’entend de toute drogue qui contient un ingrédient médicinal non déjà approuvé dans une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe. (innovative drug)

« population pédiatrique » S’entend de chacun des groupes suivants : les bébés prématurés nés avant la 37e semaine de gestation, les bébés menés à terme et âgés de 0 à 27 jours, tous les enfants âgés de 28 jours à deux ans, ceux âgés de deux ans et un jour à 11 ans et ceux âgés de 11 ans et un jour à 18 ans. (pediatric populations)

« présentation abrégée de drogue nouvelle » S’entend également d’une présentation abrégée de drogue nouvelle pour usage exceptionnel. (abbreviated new drug submission)

« présentation de drogue nouvelle » S’entend également d’une présentation de drogue nouvelle pour usage exceptionnel. (new drug submission)

(2) Le présent article s’applique à la mise en œuvre de l’article 1711 de l’Accord de libre­ échange nord-américain, au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord de libre-échange nord-américain, et du paragraphe 3 de l’article 39 de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce figurant à l’annexe 1C de l’Accord sur l’Organisation mondiale du commerce, au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord sur l’Organisation mondiale du commerce.

(3) Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et la drogue innovante :

a) le fabricant ne peut déposer pour cette drogue nouvelle de présentation de drogue nouvelle, de présentation abrégée de drogue nouvelle ou de supplément à l’une de ces présentations avant l’expiration d’un délai de six ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante;

b) le ministre ne peut approuver une telle présentation ou un tel supplément et ne peut délivrer d’avis de conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante.

(4) Le délai prévu à l’alinéa (3)b) est porté à huit ans et six mois si, à la fois :

a) l’innovateur fournit au ministre la description et les résultats des essais cliniques concernant l’utilisation de la drogue innovante dans les populations pédiatriques concernées dans sa première présentation de drogue nouvelle à l’égard de la drogue innovante ou dans tout supplément à une telle présentation déposé au cours des cinq années suivant la délivrance du premier avis de conformité à l’égard de cette drogue innovante;

b) le ministre conclut, avant l’expiration du délai de six ans qui suit la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante, que les essais cliniques ont été conçus et menés en vue d’élargir les connaissances sur l’utilisation de cette drogue dans les populations pédiatriques visées et que ces connaissances se traduiraient par des avantages pour la santé des membres de celles-ci.

(5) Le paragraphe (3) ne s’applique pas si la drogue innovante n’est pas commercialisée au Canada.

(6) L’alinéa (3)a) ne s’applique pas au fabricant ultérieur dans le cas où l’innovateur consent à ce qu’il dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l’une de ces présentations avant l’expiration du délai de six ans prévu à cet alinéa.

(7) L’alinéa (3)a) ne s’applique pas au fabricant ultérieur s’il dépose une demande d’autorisation pour vendre cette drogue nouvelle aux termes de l’article C.07.003.

(8) L’alinéa (3)b) ne s’applique pas au fabricant ultérieur dans le cas où l’innovateur consent à ce que lui soit délivré un avis de conformité avant l’expiration du délai de huit ans prévu à cet alinéa ou de huit ans et six mois prévu au paragraphe (4).

(9) Le ministre tient un registre des drogues innovantes, lequel contient les renseignements relatifs à l’application des paragraphes (3) et (4).

DORS/95-411, art. 6; DORS/2006-241, art. 1; DORS/2011-88, art. 16. Version précédente C.08.005. (1) Sous réserve du paragraphe (1.1) et par dérogation aux articles C.08.002 et C.08.003, le fabricant d’une drogue nouvelle peut vendre celle-ci à un chercheur qualifié

à la seule fin d’effectuer un essai clinique pour obtenir des preuves sur l’innocuité, la posologie et l’efficacité de la drogue nouvelle, si les conditions suivantes sont réunies :

a) le fabricant a, avant la vente, déposé auprès du ministre, conformément à l’article C.08.005.1, une présentation préclinique contenant des renseignements et du matériel se rapportant à ce qui suit :

(i) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci,

(ii) la structure chimique ou tout autre détail spécifique qui permet de déterminer la composition de la drogue nouvelle,

(iii) la provenance de la drogue nouvelle,

(iv) un protocole détaillé de l’essai clinique,

(v) les résultats des recherches effectuées pour motiver l’usage clinique de la drogue nouvelle,

(vi) les contre-indications et les précautions connues relativement à la drogue nouvelle, ainsi que le traitement recommandé en cas d’absorption de dose excessive,

(vii) tous les ingrédients de la drogue nouvelle, déclarés sous forme quantitative,

(viii) l’usine, les méthodes, l’outillage et les contrôles utilisés pour la fabrication, le conditionnement et l’empaquetage de la drogue nouvelle,

(ix) les essais effectués en vue de contrôler l’activité, la pureté et l’innocuité de la drogue nouvelle,

(x) les noms et les titres et compétences de tous les chercheurs auxquels la drogue doit être vendue, ainsi que les noms de tous les établissements où l’essai clinique doit avoir lieu;

b) dans les 60 jours suivant la date de réception de la présentation préclinique, le Directeur n’a pas fait parvenir au fabricant, par courrier recommandé, un avis indiquant que la présentation de drogue nouvelle n’est pas satisfaisante;

c) toutes les étiquettes intérieures et extérieures utilisées relativement à la vente de la drogue nouvelle portent les mentions suivantes :

(i) « Drogue de recherche » ou « Investigational Drug »,

(ii) « Réservé uniquement à l’usage de chercheurs compétents » ou « To Be Used By Qualified Investigators Only »;

d) le fabricant, avant la vente, vérifie que tout chercheur compétent à qui il est censé vendre la drogue nouvelle :

(i) dispose des installations voulues pour l’essai clinique qu’il doit effectuer,

(ii) a reçu les renseignements et la documentation visés aux sous-alinéas a)(i) à (vi);

e) tout chercheur compétent à qui la drogue nouvelle doit être vendue a convenu par écrit avec le fabricant qu’il :

(i) n’utilisera pas la drogue nouvelle ou ne permettra pas son utilisation à d’autres fins que l’essai clinique,

(ii) ne permettra pas l’usage de la drogue nouvelle par une personne autre que lui-même, sauf sous sa direction,

(iii) signalera immédiatement au fabricant, ainsi qu’au Directeur si celui-ci le lui demande, tout ce qui touche les réactions indésirables importantes qui auront été observées pendant l’essai clinique,

(iv) rendra compte au fabricant, sur demande de celui-ci, de toutes les quantités de drogue nouvelle qu’il aura reçues.

(1.1) Le présent article ne s’applique qu’aux drogues nouvelles pour usage vétérinaire.

(2) Nonobstant le paragraphe (1) ci-dessus, il est interdit à tout fabricant de vendre une drogue nouvelle à un chercheur compétent, à moins que, au sujet de toutes les ventes préalables de cette drogue nouvelle à n’importe quel chercheur compétent, le fabricant n’ait

a) tenu des registres exacts de la distribution de cette drogue nouvelle et des résultats des épreuves cliniques, et présenté lesdits registres à l’inspection, à la demande du Directeur; et

b) rapporté immédiatement au Directeur tous les renseignements obtenus par lui-même au sujet de réactions fâcheuses importantes.

(3) Le ministre peut aviser le fabricant d’une drogue nouvelle que la vente de cette drogue nouvelle aux chercheurs compétents est interdite si, de l’avis du ministre, cette mesure est dans l’intérêt de la santé publique.

(4) Nonobstant le paragraphe (1) ci-dessus, il est interdit à un fabricant de vendre une drogue nouvelle à un chercheur compétent si le ministre a avisé ce fabricant que la vente de ladite drogue est interdite.

(5) L’alinéa (1)c) ne s’applique pas aux produits pharmaceutiques radioactifs définis à l’article C.03.201, ni aux constituants ni aux trousses définis à l’article C.03.205.

DORS/79-236, art. 5; DORS/85-143, art. 4; DORS/87-511, art. 1; DORS/93-202, art. 26; DORS/95-411, art. 7; DORS/2001-203, art. 6.

C.08.005.1. (1) Le fabricant qui dépose une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle, une présentation abrégée de drogue nouvelle pour usage exceptionnel, un supplément à l’une de ces présentations ou une présentation pour l’essai clinique

d’une drogue nouvelle pour usage vétérinaire doit, en plus des renseignements et du matériel exigés aux articles C.08.002, C.08.002.01, C.08.002.1, C.08.003 et C.08.005, y inclure :

a) une copie des rapports d’observations cliniques relatifs à chaque sujet ayant participé à une étude comprise dans la présentation ou le supplément si celui-ci soit est mort, soit a subi une réaction indésirable grave ou une réaction indésirable imprévue, ou si l’étude, dans la mesure où elle a trait au sujet, n’a pas été complétée;

b) un résumé de section pour chaque étude sur l’homme, sur l’animal et in vitro comprise dans la présentation ou le supplément;

c) une synthèse globale de chaque étude sur l’homme, sur l’animal et in vitro qui est comprise dans la présentation ou le supplément ou à laquelle il est fait renvoi;

d) une attestation concernant les renseignements et le matériel que contient la présentation ou le supplément, ainsi que les renseignements ou le matériel supplémentaires déposés, le cas échéant, aux fins de la modification de la présentation ou du supplément.

(2) Le résumé de section visé à l’alinéa (1)b) doit comprendre :

a) un résumé de chaque étude comprise dans la présentation ou le supplément;

b) un sommaire des renseignements ou du matériel supplémentaires déposés, le cas échéant, aux fins de la modification de la présentation ou du supplément;

c) lorsque le fabricant dispose des données brutes d’une étude :

(i) un sommaire de ces données,

(ii) les renvois aux parties pertinentes du résumé de section,

(iii) la description des conditions dans lesquelles se sont déroulées les expériences desquelles les données ont été obtenues,

(iv) les détails du mode de traitement des données,

(v) les résultats et les conclusions de l’étude.

(3) La synthèse globale visée à l’alinéa (1)c) doit comprendre un sommaire des méthodes utilisées, des résultats obtenus et des conclusions émises pour les études qui sont comprises dans la présentation ou le supplément ou auxquelles il est fait renvoi, et doit indiquer les renvois aux parties pertinentes des résumés de sections.

(4) L’attestation visée à l’alinéa (1)d) doit :

a) attester que les renseignements et le matériel compris dans la présentation ou le supplément et tout renseignement ou matériel supplémentaire déposé aux fins de la modification de la présentation ou du supplément sont exacts et complets, et que les résumés de sections et la synthèse globale représentent fidèlement les renseignements et

le matériel qui sont compris dans la présentation ou le supplément ou auxquels il est fait renvoi;

b) être datée et signée à la fois par :

(i) le premier dirigeant au Canada du fabricant qui dépose la présentation ou le supplément,

(ii) le directeur médical ou scientifique du fabricant.

(5) Il est interdit de signer une attestation si un résumé de section, la synthèse globale ou tout renseignement ou matériel compris dans la présentation ou le supplément, ou tout renseignement ou matériel supplémentaire déposé aux fins de la modification de cette présentation ou de ce supplément :

a) soit est faux ou trompeur;

b) soit comporte des omissions qui peuvent avoir une incidence sur son exactitude et son intégralité.

(6) Le fabricant qui a déposé une présentation de drogue nouvelle, une présentation de drogue nouvelle pour usage exceptionnel, une présentation abrégée de drogue nouvelle, une présentation abrégée de drogue nouvelle pour usage exceptionnel, un supplément à l’une de ces présentations ou une présentation pour l’essai clinique d’une drogue nouvelle pour usage vétérinaire sans y inclure les fiches d’observations cliniques ou les données brutes y ayant trait doit conserver ces fiches ou ces données et les soumettre au ministre, s’il en fait la demande par écrit, dans les trente jours suivant la réception de celle-ci.

DORS/85-143, art. 5; DORS/92-543, art. 1; DORS/94-689, art. 2(F); DORS/95-411, art. 8; DORS/2001-203, art. 7; DORS/2011-88, art. 17. Version précédente C.08.006. (1) Pour l’application du présent article, les éléments de preuve ou les nouveaux renseignements obtenus par le ministre comprennent les renseignements et le matériel que lui présente toute personne en vertu du titre 5 ou des articles C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1.

(2) Le ministre peut suspendre, pour une période déterminée ou indéterminée, un avis de conformité délivré à l’égard d’une présentation de drogue nouvelle, d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, en envoyant au fabricant qui a déposé la présentation ou le supplément une notification déclarant cette mesure nécessaire, s’il estime :

a) que la drogue n’est pas sans danger aux fins spécifiées dans la présentation ou le supplément, en s’appuyant sur des éléments de preuve obtenus :

(i) soit d’essais cliniques ou autres expériences qui ne sont pas signalés dans la présentation ou le supplément ou qui ne lui étaient accessibles au moment de la délivrance de l’avis de conformité,

(ii) soit d’analyses par de nouvelles méthodes ou par des méthodes qui ne pouvaient vraisemblablement s’appliquer au moment de la délivrance de l’avis de conformité;

b) que, d’après de nouveaux renseignements obtenus après la délivrance de l’avis de conformité, il n’y a pas assez de preuves substantielles que la drogue aura l’effet qui lui est attribué, dans les conditions d’usage prescrites, recommandées ou proposées par le fabricant;

c) que la présentation ou le supplément renfermait une fausse déclaration touchant un fait substantiel;

d) que le fabricant n’a pas établi un système pour tenir les registres exigés, ou qu’il a manqué, à plusieurs reprises, ou délibérément, de tenir lesdits registres;

e) que, d’après des renseignements nouveaux obtenus après la délivrance de l’avis de conformité, les méthodes, l’outillage, l’usine ou les contrôles employés pour la fabrication, le conditionnement ou l’empaquetage de la drogue, ne suffisent pas à assurer ou à conserver l’identité, la force, la qualité ou la pureté de la drogue nouvelle;

f) que, d’après des renseignements nouveaux obtenus après la délivrance de l’avis de conformité, l’étiquette de la drogue est fausse, trompeuse ou incomplète sous quelque rapport que ce soit, et que le fabricant n’a pas rectifié ce défaut après que le Directeur l’en a informé par écrit, en spécifiant l’aspect particulier de l’étiquette qui est faux, trompeur ou incomplet; ou

g) dans le cas d’une drogue nouvelle pour usage exceptionnel, que le fabricant n’a pas suivi le plan visé au sous-alinéa C.08.002.01(2)b)(ix).

DORS/95-411, art. 9; DORS/2001-203, art. 8; DORS/2011-88, art. 18. Version précédente C.08.007. (1) Lorsqu’un fabricant a reçu un avis de conformité à l’égard d’une présentation de drogue nouvelle, d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, il doit établir et tenir, de façon à en permettre la vérification, des registres concernant ce qui suit :

a) les expériences animales et les épreuves cliniques, les études, recherches et tests, effectués par le fabricant ou qui lui sont rapportés par toute autre personne, au sujet de cette drogue nouvelle;

b) les rapports publiés dans la documentation scientifique, ou la bibliographie scientifique dont il dispose, au sujet de cette drogue nouvelle;

c) les expériences, recherches, études et tests, au sujet des propriétés physiques ou chimiques, ou de toute autre propriété de cette drogue nouvelle;

d) toute substitution d’une autre substance pour cette drogue nouvelle, et tout mélange d’une autre substance avec cette drogue nouvelle;

e) toute erreur dans l’étiquetage de cette drogue nouvelle, ou dans l’usage des étiquettes destinées à cette drogue nouvelle;

f) toute modification ou détérioration importante de nature physique ou chimique, tout changement au point de vue bactériologique, et toute autre modification ou détérioration, dans n’importe quel lot de cette drogue nouvelle;

g) toute occasion où un ou plusieurs lots distribués de cette drogue nouvelle n’étaient pas conformes aux spécifications établies dans la présentation ou le supplément;

h) tout cas inhabituel où la drogue nouvelle ne produit pas l’effet prévu.

i) [Abrogé, DORS/95-521, art. 3]

(2) Le fabricant ou l’importateur qui vend une drogue nouvelle pour usage exceptionnel conformément à l’article C.08.002.02 doit conserver la commande écrite durant une période minimale de quinze ans à partir de l’exécution de la commande.

DORS/95-411, art. 10; DORS/95-521, art. 3; DORS/2011-88, art. 19. Version précédente C.08.008. Il est interdit au fabricant de vendre une drogue nouvelle à moins que, à l’égard de ses ventes antérieures de cette drogue, il n’ait fourni au ministre :

a) sur demande, des rapports de tous les dossiers relatifs aux renseignements visés aux alinéas C.08.007a) à c);

b) dès leur réception, des rapports de tous les dossiers relatifs aux renseignements visés aux alinéas C.08.007d) à f);

c) dans les 15 jours suivant la réception par lui des renseignements visés aux alinéas C.08.007g) et h), un rapport sur les renseignements reçus.

DORS/95-411, art. 11; DORS/95-521, art. 4.

C.08.008.1 Lorsqu’un fabricant a reçu un avis de conformité à l’égard d’une présentation de drogue nouvelle pour usage exceptionnel, d’une présentation abrégée de drogue nouvelle pour usage exceptionnel ou d’un supplément à l’une de ces présentations, il doit :

a) suivre le plan visé au sous-alinéa C.08.002.01(2)b)(ix);

b) fournir au ministre, avant le 1er octobre de chaque année et lorsque celui-ci lui en fait la demande afin d’évaluer l’innocuité et l’efficacité de la drogue visée par l’avis de

conformité, un rapport sur son utilisation, y compris une analyse critique des renseignements à jour disponibles concernant son innocuité et son efficacité.

DORS/2011-88, art. 20.

C.08.009. (1) Lorsque le ministre a décidé

a) de notifier le fabricant d’une drogue nouvelle pour usage vétérinaire que la vente de cette drogue aux chercheurs qualifiés est interdite, ou

b) de suspendre l’avis de conformité délivré en application des articles C.08.004 ou C.08.004.01,

le fabricant peut s’il n’est pas satisfait de cette décision, demander au ministre de lui fournir les raisons de ladite décision.

(2) Lorsque ledit fabricant a reçu les raisons de la décison du ministre par application du paragraphe (1), il peut demander au ministre de déférer cette décision à un Comité des drogues nouvelles et, sur ce, il doit fournir au ministre une déclaration des motifs de son insatisfaction, ainsi que tout renseignement et tout matériel à l’appui de ses motifs.

(3) Lorsque le ministre a été prié de déférer une décision à un Comité des drogues nouvelles par application du paragraphe (2), il doit nommer un membre au Comité des drogues nouvelles, le fabricant insatisfait doit nommer un membre au Comité des drogues nouvelles, et les deux membres ainsi nommés doivent, ensemble, nommer au Comité des drogues nouvelles, un troisième membre qui sera président du Comité, ou si ces deux membres ne peuvent le faire dans un délai raisonnable, le ministre doit nommer au Comité des drogues nouvelles, un troisième membre qui sera président du Comité.

(4) Aucune personne qui est employée à temps complet par le ministère, ou employée à temps complet par le fabricant non satisfait, ne sera nommée membre d’un Comité des drogues nouvelles.

(4.1) Chaque membre nommé à un Comité des drogues nouvelles est tenu de signer l’engagement de ne pas communiquer ni utiliser les renseignements, matériel, données, preuves et observations considérés en vertu du paragraphe (6).

(5) Le ministre doit payer des honoraires et des frais raisonnables au membre du Comité des drogues nouvelles nommé par le ministre, et le fabricant non satisfait doit payer des honoraires et des frais raisonnables au membre qu’il aura lui-même nommé au comité des drogues nouvelles, et le ministre et le fabricant insatisfait paieront, à parts égales, des honoraires et des frais raisonnables au président de ce comité.

(6) Le Comité des drogues nouvelles formé en application du paragraphe (3) doit peser les motifs de la décision du ministre, les motifs de l’insatisfaction du fabricant et tout renseignement ou matériel à l’appui de la décision du ministre ou de l’insatisfaction du fabricant et peut prendre en considération d’autres preuves, matériel, renseignements ou observations.

(7) Le Comité des drogues nouvelles formé par application du paragraphe (3), doit faire rapport au ministre de ses constatations et de ses recommandations.

(7.1) Les membres d’un Comité des drogues nouvelles ne peuvent divulguer ni utiliser les renseignements, matériel, données, preuves et observations considérés en vertu du paragraphe (6).

(8) Lorsque le ministre a reçu les constatations et recommandations du Comité des drogues nouvelles, il peut revenir sur la décision qui fait l’objet de ces constatations et recommandations.

DORS/95-411, art. 12; DORS/2001-203, art. 9; DORS/2011-88, art. 21. Version précédente

Vente d'une drogue nouvelle pour un traitement d'urgence

C.08.010. (1) Le Directeur général peut fournir une lettre d’autorisation permettant la vente d’une certaine quantité d’une drogue nouvelle d’usage humaine ou vétérinaire à un praticien nommé dans la lettre d’autorisation pour le traitement d’urgence d’un malade traité par ledit praticien, si

a) le praticien a fourni au Directeur général des renseignements concernant

(i) l’état pathologique urgent pour laquel la drogue est requise,

(ii) les données que possède le praticien à propos de l’usage, de l’innocuité et de l’efficacité de ladite drogue,

(iii) le nom de tous les établissements où la drogue doit être utilisée, et

(iv) les autres renseignements que le Directeur général pourrait lui demander; et

b) le praticien a consenti à

(i) faire part au fabricant de la drogue nouvelle et au Directeur général des résultats de l’usage de la drogue au cours de l’urgence, y compris les renseignements se rapportant à toute réaction défavorable qu’il aura observée, et

(ii) rendre compte au Directeur général, sur demande, de toutes les quantités de la drogue qu’il aura reçues.

(2) Le Directeur général doit, dans toute lettre d’autorisation fournie conformément au paragraphe (1), spécifier

a) le nom du praticien auquel la drogue nouvelle peut être vendue;

b) l’état pathologique urgent pour lequel la drogue nouvelle peut être vendue; et

c) la quantité de la drogue nouvelle qui peut être vendue audit praticien pour ledit cas urgent.

C.08.011. (1) Nonobstant l’article C.08.002, un fabricant peut vendre à un praticien mentionné dans une lettre d’autorisation fournie conformément à l’article C.08.010, une quantité de la drogue nouvelle nommée dans ladite lettre qui n’excède pas la quantité spécifiée dans la lettre.

(2) La vente d’une drogue nouvelle faite en conformité du paragraphe (1) n’est pas soumise aux dispositions de la Loi et du présent règlement.

Vente d'aliments médicamentés

C.08.012. (1) Nonobstant toute autre disposition du présent titre, il est permis de vendre, aux termes d’une ordonnance écrite d’un vétérinaire, un aliment médicamenté si

a) quant à la drogue ou aux drogues utilisées comme substances médicatrices dans l’aliment médicamenté :

(i) soit le Directeur leur a attribué une identification numérique conformément à l’article C.01.014.2,

(ii) soit leur vente est permise aux termes des articles C.08.005, C.08.011 ou C.08.013;

b) l’aliment médicamenté est destiné au traitement d’animaux directement soumis aux soins du vétérinaire ayant signé l’ordonnance;

c) l’aliment médicamenté n’est prévu qu’à des fins thérapeutiques; et

d) l’ordonnance écrite renferme les renseignements suivants :

(i) le nom et l’adresse de la personne désignée dans l’ordonnance comme celle pour qui l’aliment médicamenté est préparé,

(ii) l’espèce, le type de production et l’âge ou le poids des animaux qui seront traités avec l’aliment médicamenté,

(iii) le genre et la quantité d’aliment médicamenté à préparer,

(iv) le nom propre ou, à défaut, le nom usuel de la drogue ou de chacune des drogues, selon le cas, à être utilisées comme substances médicamenteuses dans la préparation de l’aliment médicamenté, ainsi que la posologie de ces substances,

(v) toute instruction spéciale pour la préparation, et

(vi) les instructions d’étiquetage, y compris

(A) les instructions d’alimentation,

(B) une mise en garde concernant la période de retrait à observer après l’utilisation de l’aliment médicamenté, et

(C) le cas échéant, les précautions à prendre à l’égard de la santé de l’animal ou de la manipulation ou de l’entreposage de l’aliment médicamenté.

(2) Aux fins du présent article, le terme « aliment médicamenté » a le sens que lui donne le Règlement sur les aliments du bétail.

DORS/80-741, art. 1; DORS/92-130, art. 1; DORS/93-202, art. 27.

Études expérimentales

Conditions de vente

C.08.013. (1) Nonobstant toute autre disposition du présent titre, il est permis de vendre à un expert en études expérimentales, une quantité spécifiée par le Directeur, de drogues nouvelles d’application vétérinaire destinées à l’exécution d’une étude expérimentale chez l’animal si,

a) l’expert en études expérimentales a reçu un certificat d’études expérimentales selon le paragraphe C.08.015(1) et si le certificat n’a pas été suspendu ou annulé selon l’article C.08.018; et

b) la drogue est étiquetée conformément au paragraphe C.08.016(1).

(2) Aux fins des articles C.08.013 à C.08.018,

« certificat d’études expérimentales » désigne un certificat délivré selon le paragraphe C.08.015(1);

« expert en études expérimentales » désigne la personne visée dans un certificat d’études expérimentales;

« étude expérimentale » désigne un test limité effectué par un expert en études expérimentales sur des animaux auxquels on a administré une drogue nouvelle.

DORS/81-333, art. 1.

Certificat d'études expérimentales

C.08.014. (1) Afin d’obtenir un certificat d’études expérimentales, un requérant doit présenter au Directeur, par écrit, les renseignements et pièces suivants :

a) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci;

b) les objectifs et le protocole du projet d’étude expérimentale de la drogue nouvelle;

c) l’espèce, le nombre et le type de production des animaux auxquels la nouvelle drogue doit être administrée;

d) le nom et l’adresse du fabricant de la drogue nouvelle;

e) l’adresse de l’établissement où l’étude expérimentale doit être effectuée;

f) une description des installations devant servir à l’étude expérimentale;

g) le nom, l’adresse et les qualifications de l’expert en études expérimentales proposé;

h) la structure chimique, si elle est connue, et les caractéristiques pertinentes de la composition de la drogue nouvelle;

i) la quantité de drogue nouvelle que l’on se propose d’utiliser au cours de l’étude expérimentale;

j) les résultats de toutes les études toxicologiques ou pharmacologiques qui ont été conduites avec la drogue nouvelle;

k) l’engagement écrit mentionné au paragraphe (2); et

l) tous autres renseignements et pièces que le Directeur exige.

(2) Lorsque des animaux de boucherie doivent servir d’une manière quelconque dans une étude expérimentale, le requérant mentionné au paragraphe (1) doit, afin d’obtenir un certificat d’études expérimentales, obtenir un engagement écrit du propriétaire desdits animaux, ou d’une personne autorisée par lui, de ne pas vendre ces animaux ou tout produit en dérivant, sans obtenir au préalable une autorisation de l’expert en études expérimentales.

(3) Le Directeur peut demander au fabricant d’une drogue nouvelle qu’il lui fournisse des échantillons de ladite drogue, ou de l’un quelconque de ses ingrédients, sous une forme et d’une manière satisfaisantes, et tout autre renseignement que le Directeur demande. Si le Directeur ne reçoit pas les échantillons et les renseignements voulus, il peut refuser de délivrer le certificat d’études expérimentales demandé.

DORS/81-333, art. 1; DORS/93-202, art. 28.

C.08.015. (1) Lorsque, à la réception des renseignements et pièces fournis selon l’article C.08.014, le Directeur est convaincu que :

a) le requérant a les qualifications voulues pour les fins de l’étude expérimentale envisagée,

b) les installations destinées à servir à l’étude expérimentale envisagée sont appropriées, et

c) l’étude expérimentale peut être effectuée sans risque indu et prévisible pour l’homme ou l’animal,

le Directeur doit délivrer le certificat d’études expérimentales pour la conduite de l’étude expérimentale envisagée et doit y préciser la quantité de la drogue nouvelle qui peut être vendue à l’expert en études expérimentales.

(2) Lorsque, à la réception des renseignements et pièces fournis aux termes de l’article C.08.014, le Directeur n’est pas convaincu que l’on a satisfait aux exigences des alinéas (1)a), b) et c), il doit refuser de délivrer un certificat d’études expérimentales.

DORS/81-333, art. 1.

Étiquetage

C.08.016. (1) L’étiquette d’une drogue nouvelle, vendue selon l’article C.08.013, doit porter :

a) la marque nominative de la drogue nouvelle ou le nom ou code d’identification projeté pour celle-ci;

b) une mise en garde indiquant que ladite drogue ne doit être utilisée que pour les études expérimentales effectuées sur les animaux;

c) le numéro de lot;

d) le nom et l’adresse du fabricant; et

e) le nom de la personne à qui la drogue à été fournie.

(2) Les articles C.01.004, C.01.005 et C.01.014 ne s’appliquent pas à une drogue qui est vendue selon l’article C.08.013 et étiquetée conformément au paragraphe (1).

DORS/81-333, art. 1; DORS/88-378, art. 2; DORS/93-202, art. 29.

Conditions applicables aux études expérimentales

C.08.017. Un expert en études expérimentales doit

a) utiliser la drogue nouvelle conformément au protocole de l’étude expérimentale;

b) signaler immédiatement au Directeur toute réaction indésirable grave liée à l’utilisation de la drogue nouvelle;

c) communiquer rapidement au Directeur, sur demande, les résultats de l’étude expérimentale;

d) retourner au fabricant, sur demande, toute quantité de la drogue nouvelle non utilisée dans l’étude expérimentale;

e) conserver tous les dossiers de l’étude expérimentale pendant au moins deux ans suivant la fin de l’étude, et, sur demande, les mettre à la disposition du Directeur;

f) signaler rapidement au Directeur tout cas où l’on a disposé, contrairement aux termes de l’engagement mentionné au paragraphe C.08.014(2), d’animaux servant d’une manière quelconque dans une étude expérimentale, ou de leurs produits; et

g) rendre compte au Directeur, sur demande, de toutes les quantités de la drogue nouvelle qu’il aura reçues.

DORS/81-333, art. 1; DORS/2001-203, art. 10.

Suspension ou annulation du certificat d'études expérimentales

C.08.018. (1) Lorsque le Directeur est d’avis qu’il est nécessaire de sauvegarder la santé de l’animal ou la santé publique, ou d’assurer la sécurité publique, il peut suspendre un certificat d’études expérimentales pour une période définie ou indéfinie, ou encore l’annuler.

(2) Sans restreindre la portée générale du paragraphe (1), le Directeur peut suspendre ou annuler un certificat d’études expérimentales si

a) les renseignements et pièces fournis selon l’article C.08.014 comportent une fausse déclaration ou une omission concernant les propriétés de la drogue nouvelle, qui sont connues du fabricant ou de l’expert en études expérimentales, ou qui auraient raisonnablement dû l’être;

b) l’étiquetage de la drogue nouvelle est, à n’importe quel moment, faux, mensonger, trompeur ou incomplet;

c) l’expert en études expérimentales n’a pas les qualifications voulues;

d) il existe des preuves que l’expert en études expérimentales n’a pas satisfait aux conditions mentionnées à l’article C.08.017; ou

e) une activité du fabricant, relative à la drogue nouvelle, a entraîné la condamnation dudit fabricant pour infraction à l’article C.08.002.

DORS/81-333, art. 1.

Titre 9 Médicaments vendus sans ordonnance

C.09.001. Le présent titre ne s’applique pas

a) à une drogue qui doit être vendue sur ordonnance aux termes du présent règlement ou du Règlement sur les stupéfiants; ni

b) à une drogue destinée exclusivement aux animaux.

DORS/84-145, art. 4.

Analgésiques

Dispositions générales

C.09.010. Après le 30 juin 1986, il est interdit à un fabricant ou à un importateur de vendre un produit analgésique renfermant une combinaison

a) d’un sel ou dérivé de l’acide salicylique et d’un autre sel ou dérivé de l’acide salicylique ou du salicylamide; ou

b) de l’acétaminophène et d’un sel ou dérivé de l’acide salicylique ou du salicylamide.

DORS/84-145, art. 4.

C.09.011. Après le 30 juin 1986, l’étiquette d’une drogue renfermant de l’acétaminophène, de l’acide salicylique ou l’un de ses sels ou dérivés et destinée à l’usage interne doit porter une mise en garde indiquant :

a) qu’un médecin doit être consulté si l’état pathologique sous-jacent persiste pendant plus de cinq jours; et

b) qu’il est dangereux de dépasser la dose maximum recommandée sans l’autorisation d’un médecin.

DORS/84-145, art. 4; DORS/86-589, art. 1.

C.09.012. Après le 30 juin 1986, l’étiquette d’une drogue renfermant de l’acide salicylique ou l’un de ses sels ou dérivés et destinée à l’usage interne doit porter un avertissement indiquant qu’il ne faut pas utiliser la drogue pendant les trois derniers mois de la grossesse et au cours de l’allaitement sans avoir consulté un médecin.

DORS/84-145, art. 4.

Acétaminophène

C.09.020. (1) La dose normale d’acétaminophène est, pour les adultes, de 325 mg.

(2) La dose normale pour enfants d’acétaminophène est de 80 mg ou 160 mg en unités posologiques.

DORS/84-145, art. 4; DORS/90-587, art. 4.

C.09.021. (1) Dans le présent titre, le terme « produit d’acétaminophène » désigne une drogue renfermant

a) de l’acétaminophène comme seul ingrédient médicinal; ou

b) de l’acétaminophène combiné avec de la caféine.

(2) Il est interdit à un fabricant ou à un importateur de vendre un produit d’acétaminophène qui n’est pas conforme aux exigences du présent titre.

(3) [Abrogé, DORS/90-587, art. 5]

DORS/84-145, art. 4; DORS/90-587, art. 5.

C.09.022. (1) Sous réserve des paragraphes (2) à (4), un produit d’acétaminophène vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale doit renfermer une seule dose normale, pour adultes, d’acétaminophène, dans chaque forme posologique individuelle.

(2) Un produit d’acétaminophène vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale peut renfermer

500 mg d’acétaminophène dans chaque forme posologique individuelle, s’il porte une étiquette indiquant qu’il ne s’agit pas d’un produit à dose normale.

(3) Un produit d’acétaminophène vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale peut renfermer 325 mg d’acétaminophène à libération immédiate et 325 mg d’acétaminophène à libération subséquente, s’il porte une étiquette indiquant qu’il ne s’agit pas d’un produit à dose normale.

(4) Un produit d’acétaminophène vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale et qui est spécialement recommandé pour les enfants doit renfermer une dose normale, pour enfants, d’acétaminophène, dans chaque forme posologique individuelle.

(5) Un produit d’acétaminophène de forme liquide qui est destiné à être administré en gouttes et qui est spécialement recommandé pour les enfants doit renfermer une dose normale, pour enfants, d’acétaminophène, dans chaque millilitre.

(6) L’emballage d’un produit visé au paragraphe (5) doit être accompagné d’un instrument de mesure capable de contenir exactement 0,5 mL du produit.

(7) Un produit d’acétaminophène de forme liquide qui n’est pas destiné à être administré en gouttes et qui est spécialement recommandé pour les enfants doit renfermer une dose normale, pour enfants, d’acétaminophène, dans chaque cuillerée à thé.

(8) Un produit d’acétaminophène de forme liquide doit renfermer une dose normale, pour adultes, d’acétaminophène, dans chaque cuillerée à thé.

DORS/84-145, art. 4; DORS/85-966, art. 4; DORS/86-954, art. 1; DORS/99-441, art. 1.

Salicylates

C.09.030. (1) La dose normale d’un salicylate est, pour les adultes,

a) de 325 mg, dans le cas de l’acide acétylsalicylique, du salicylate de sodium et du salicylate de magnésium; et

b) de 435 mg, dans le cas du salicylate de choline.

(2) La dose normale d’un salicylate est, pour les enfants,

a) de 80 mg, dans le cas de l’acide acétylsalicylique, du salicylate de sodium et du salicylate de magnésium; et

b) de 110 mg, dans le cas du salicylate de choline.

DORS/84-145, art. 4.

C.09.031. (1) Dans le présent titre, « produit de salicylate » désigne une drogue renfermant

a) un sel ou un dérivé de l’acide salicylique comme seul ingrédient médicinal;

b) un sel ou un dérivé de l’acide salicylique combiné avec de la caféine;

c) un sel ou un dérivé de l’acide salicylique combiné avec un ou plusieurs agents de tamponnage ou antiacides; ou

d) un sel ou un dérivé de l’acide salicylique combiné avec de la caféine et un ou plusieurs agents de tamponnage ou antiacides.

(2) Après le 30 juin 1986, il est interdit à un fabricant ou à un importateur de vendre un produit de salicylate qui n’est pas conforme aux exigences du présent titre.

(3) Jusqu’au 30 juin 1986, il est interdit à un fabricant ou à un importateur de vendre un produit de salicylate en doses autres que celles prévues dans le présent titre, à moins que ledit produit ne fût légalement disponible au Canada le 1er février 1984.

DORS/84-145, art. 4; DORS/85-966, art. 5(A).

C.09.032. (1) Sous réserve des paragraphes (2) et (3) et de l’article C.09.035, un produit de salicylate vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale doit renfermer une seule dose normale pour adultes d’un salicylate, dans chaque forme posologique individuelle.

(2) Un produit de salicylate vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale peut renfermer

a) 500 mg d’acide acétylsalicylique, de salicylate de sodium, ou de salicylate de magnésium, ou

b) 670 mg de salicylate de choline

dans chaque forme posologique individuelle, s’il porte une étiquette indiquant qu’il [ne] s’agit pas d’un produit à dose normale.

(3) Un produit de salicylate vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale, peut renfermer dans chaque forme posologique individuelle

a) deux doses normales, pour adultes, d’un salicylate, s’il porte une étiquette indiquant que chaque forme posologique individuelle renferme deux doses normales pour adultes; ou

b) trois doses normales, pour adultes, d’un salicylate, s’il porte une étiquette indiquant que chaque forme posologique individuelle renferme trois doses normales pour adultes.

DORS/84-145, art. 4; DORS/85-966, art. 6.

C.09.033. (1) Sous réserve du paragraphe (2), un produit de salicylate de forme liquide doit renfermer une dose normale, pour adultes, d’un salicylate, dans chaque cuillerée à thé.

(2) Un produit de salicylate de forme liquide peut renfermer dans chaque cuillerée à thé

a) deux doses normales, pour adultes, d’un salicylate, s’il porte une étiquette indiquant que chaque cuillerée à thé renferme deux doses normales pour adultes; ou

b) trois doses normales, pour adultes, d’un salicylate, s’il porte une étiquette indiquant que chaque cuillerée à thé renferme trois doses normales pour adultes.

DORS/84-145, art. 4.

C.09.034. Un produit de salicylate dit tamponné doit être capable de neutraliser au moins 1,9 milliéquivalents d’acide par dose normale, pour adultes, d’un salicylate.

DORS/84-145, art. 4.

C.09.035. Un produit de salicylate vendu sous forme de comprimé ou de capsule ou sous une autre forme posologique solide destinée à l’administration orale et qui est spécialement recommandé pour les enfants doit renfermer une seule dose normale, pour enfants, d’un salicylate, dans chaque forme posologique individuelle.

DORS/84-145, art. 4.

Titre 10

[Abrogé, DORS/98-423, art. 9]

PARTIE D VITAMINES, MINÉRAUX ET ACIDES AMINÉS D.01.001. (1) Dans la présente partie,

« apport nutritionnel recommandé pondéré » Quantité d’une vitamine ou d’un minéral nutritif indiquée au tableau II du titre 1 et au tableau II du titre 2. (weighted recommended nutrient intake)

« apport quotidien recommandé » Quantité d’une vitamine ou d’un minéral nutritif indiquée :

a) à la colonne II du tableau I du titre 1 et à la colonne II du tableau I du titre 2, dans le cas des aliments destinés aux personnes âgées d’au moins deux ans;

b) à la colonne III du tableau I du titre 1 et à la colonne III du tableau I du titre 2, dans le cas des aliments destinés aux nourrissons et aux enfants âgés de moins de deux ans. (recommended daily intake).

« faire de la publicité » signifie faire de la publicité auprès du grand public; (advertise)

« marque nominative » Dans le cas d’une drogue, le nom en français ou en anglais, avec ou sans le nom d’un fabricant, d’une personne morale, d’une société de personnes ou d’un particulier :

a) qui lui a été attribué par le fabricant;

b) sous lequel elle est vendue ou fait l’objet de publicité;

c) qui sert à l’identifier. (brand name)

« nom usuel » Dans le cas d’un sel ou d’un dérivé d’une vitamine, le nom en français ou en anglais sous lequel il est :

a) généralement connu;

b) désigné dans des revues scientifiques ou techniques. (common name)

« produit préemballé » désigne un aliment contenu dans un emballage qui est celui dans lequel l’aliment est normalement vendu, utilisé ou acheté; (prepackaged product)

« ration quotidienne normale », lorsqu’il s’agit d’une substance alimentaire dont le nom figure à l’un des articles de l’annexe K à la colonne I, signifie la quantité de cette substance alimentaire précisée à la colonne II en regard de cet article; (reasonable daily intake)

« témoignage », lorsqu’il s’agit d’un aliment ou d’une drogue présentée comme contenant une vitamine, un minéral nutritif ou un minéral, signifie n’importe quelle présentation orale, écrite ou en images, dramatisée ou non, quant à l’effet que produit, a produit ou peut produire l’addition, au régime alimentaire d’une personne, de cette vitamine, de ce minéral nutritif ou de ce minéral, selon le cas. (testimonial)

(2) Pour l’application de la présente partie, toute portion déterminée d’un aliment est :

a) fondée sur l’aliment tel qu’il est vendu;

b) exprimée, selon le cas :

(i) en grammes, dans l’un ou l’autre des cas suivants :

(A) la quantité nette de l’aliment est mentionnée en poids ou en unités sur l’étiquette,

(B) l’aliment figure à la colonne 1 des articles 78, 149 ou 150 de l’annexe M,

(ii) en millilitres, dans le cas où la quantité nette de l’aliment, autre qu’un aliment visé à la division (i)(B), est mentionnée en volume sur l’étiquette.

(3) La quantité nette de l’aliment dans l’emballage est une portion déterminée dans les cas suivants :

a) la quantité de l’aliment peut être raisonnablement consommée par une personne en une seule fois;

b) la quantité de référence, au sens de l’article B.01.001, de l’aliment est inférieure à 100 g ou 100 mL et l’emballage contient moins de 200 % de cette quantité;

c) la quantité de référence, au sens de l’article B.01.001, de l’aliment est d’au moins 100 g ou 100 mL et l’emballage contient au plus 150 % de cette quantité.

DORS/88-559, art. 31; DORS/93-202, art. 31; DORS/96-259, art. 3; DORS/2003-11, art. 27.

Titre 1

Vitamines dans les aliments D.01.002. (1) Dans le présent titre, « vitamine » désigne l’une des vitamines suivantes :

a) vitamine A;

b) vitamine D;

c) vitamine E;

d) vitamine K;

e) vitamine C;

f) thiamine ou vitamine B1;

g) riboflavine ou vitamine B2;

h) niacine;

i) vitamine B6;

j) folacine ou folate;

k) vitamine B12;

l) acide pantothénique ou pantothénate;

m) biotine. (vitamin)

(2) Pour l’application du présent titre, il est interdit d’utiliser des désignations autres que celles prévues au paragraphe (1) pour la déclaration de la teneur en vitamines d’un aliment.

(3) Le présent titre ne s’applique qu’aux aliments présentés comme contenant une vitamine destinée à être utilisée dans l’alimentation humaine.

DORS/88-559, art. 32; DORS/2003-11, art. 28.

D.01.003. (1) Pour l’application du présent règlement, la teneur en vitamines d’un aliment, autre qu’une préparation pour régime liquide, un succédané du lait humain ou un aliment présenté comme contenant un succédané du lait humain, doit être déterminée :

a) dans le cas de la vitamine A, en fonction de la teneur en rétinol et ses dérivés et en bêta-carotène, exprimée en équivalents de rétinol (ER) selon les équivalences suivantes :

(i) 1 ER = 1 microgramme de rétinol,

(ii) 1 ER = 6 microgrammes de bêta-carotène;

b) dans le cas de la vitamine D, en fonction de la teneur en cholécalciférol et en ergocalciférol, exprimée en microgrammes;

c) dans le cas de la vitamine E, en fonction de la teneur en d-alpha-tocophérol et en dl­ alpha-tocophérol et leurs dérivés, exprimée en milligrammes selon les équivalences suivantes :

(i) 1 milligramme de d-alpha-tocophérol = 1 milligramme de vitamine E,

(ii) 1 milligramme de dl-alpha-tocophérol = 0,74 milligramme de vitamine E;

d) dans le cas de la vitamine K, en fonction de la teneur en phylloquinone et en ménaquinones, exprimée en microgrammes;

e) dans le cas de la vitamine C, en fonction de la teneur en acide L-ascorbique et en acide L-déhydroascorbique et leurs dérivés, calculée en milligrammes d’équivalents d’acide L­ ascorbique et exprimée en milligrammes;

f) dans le cas de la thiamine ou vitamine B1 et ses dérivés, en fonction de la teneur en thiamine, exprimée en milligrammes;

g) dans le cas de la riboflavine ou vitamine B2 et ses dérivés, en fonction de la teneur en riboflavine, exprimée en milligrammes;

h) dans le cas de la niacine, en fonction de la teneur en niacine et ses dérivés, calculée en milligrammes d’acide nicotinique, plus la teneur en tryptophane, calculée en milligrammes et divisée par 60, le total étant exprimé en équivalents de niacine (EN);

i) dans le cas de la vitamine B6, en fonction de la teneur en pyridoxine, en pyridoxal et en pyridoxamine et leurs dérivés, calculée en milligrammes d’équivalents de pyridoxine et exprimée en milligrammes;

j) dans le cas de la folacine, en fonction de la teneur en acide folique (acide ptéroylmonoglutamique) et ses composés apparentés présentant l’activité biologique de l’acide folique, calculée en microgrammes d’équivalents d’acide folique et exprimée en microgrammes;

k) dans le cas de la vitamine B12, en fonction de la teneur en cyanocobalamine et ses composés apparentés présentant l’activité biologique de la cyanocobalamine, calculée en microgrammes d’équivalents de cyanocobalamine et exprimée en microgrammes;

l) dans le cas de l’acide pantothénique ou pantothénate, en fonction de la teneur en acide d-pantothénique, exprimée en milligrammes;

m) dans le cas de la biotine, en fonction de la teneur en biotine exprimée en milligrammes.

(2) Pour l’application de l’alinéa (1)h), la teneur en tryptophane peut être calculée comme étant équivalente à :

a) 1,1 pour cent des protéines, lorsque celles-ci proviennent d’un aliment contenant des protéines de plus d’une source ou d’une source autre que le lait, la viande, la volaille, le poisson ou les oeufs;

b) 1,3 pour cent des protéines, lorsque celles-ci proviennent du lait, de la viande, de la volaille ou du poisson;

c) 1,5 pour cent des protéines, lorsque celles-ci proviennent des oeufs.

DORS/88-559, art. 32; DORS/90-830, art. 7.

D.01.004. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, autre qu’une préparation pour régime liquide, un succédané de lait humain ou un aliment présenté comme contenant un succédané de lait humain, toute mention ou allégation relative à sa teneur en une vitamine, à moins que les conditions suivantes soient réunies :

a) il s’agit d’une vitamine figurant à la colonne I du tableau I du présent titre;

b) le pourcentage de l’apport quotidien recommandé pour cette vitamine, par portion déterminée, est de 5 % ou plus;

c) la teneur en cette vitamine est indiquée, sur l’étiquette ou dans l’annonce, en pourcentage de la valeur quotidienne, par portion déterminée.

(2) Si la mention ou l’allégation visée au paragraphe (1) est faite dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, le pourcentage de la valeur quotidienne, par portion déterminée, répond aux critères suivants :

a) dans le cas d’une annonce autre qu’une annonce radiophonique ou télévisée :

(i) d’une part, il précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence,

(ii) d’autre part, il figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence;

b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, il précède ou suit immédiatement la mention ou l’allégation;

c) dans le cas d’une annonce télévisée, il est communiqué :

(i) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci,

(ii) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(3) Le pourcentage de la valeur quotidienne, par portion déterminée, qui est communiqué en mode visuel dans une annonce télévisée conformément au sous-alinéa (2)c)(ii), à la fois :

a) paraît en même temps et pendant au moins la même durée que la mention ou l’allégation;

b) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

c) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

(4) L’alinéa (1)b) ne s’applique pas à l’indication de la teneur en une vitamine dans tout tableau de la valeur nutritive.

(5) L’alinéa (1)c) ne s’applique pas à l’indication de la teneur en biotine exigée par le sous-alinéa B.24.202a)(v).

DORS/84-300, art. 57(A); DORS/88-559, art. 32; DORS/90-830, art. 8; DORS/96-259, art. 9; DORS/2003-11, art. 29.

D.01.005. [Abrogé, DORS/2003-11, art. 29]

D.01.006. Est interdite sur l’étiquette ou dans les annonces d’un aliment toute allégation concernant l’action ou les effets d’une vitamine que contient l’aliment, sauf celle indiquant que la vitamine :

a) contribue au maintien de la santé;

b) est généralement reconnue comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé et à la croissance et au développement normaux.

DORS/88-559, art. 32.

D.01.007. (1) Si un constituant d’un ingrédient d’un produit préemballé mentionné au tableau du paragraphe B.01.009(1) est une vitamine, est interdite, sur l’étiquette ou dans l’annonce de ce produit préemballé, toute mention ou allégation selon laquelle la vitamine est un constituant de cet ingrédient, à moins que les conditions suivantes soient réunies :

a) malgré le paragraphe B.01.008(6), la vitamine est désignée par son nom usuel juste après l’indication de l’ingrédient de manière à indiquer qu’elle est un constituant de cet ingrédient;

b) tous les constituants de l’ingrédient sont indiqués.

(2) L’alinéa (1)b) ne s’applique pas à la farine utilisée comme ingrédient dans la fabrication de tout produit préemballé visé au paragraphe (1).

DORS/84-300, art. 59(A); DORS/88-559, art. 32; DORS/2003-11, art. 30.

D.01.008. [Abrogé, DORS/88-559, art. 32]

D.01.009. Sous réserve de l’article D.01.010, il est interdit de vendre un aliment auquel l’une des vitamines suivantes a été ajoutée, à moins qu’une ration quotidienne normale de cet aliment n’apporte à une personne qui la consomme,

a) dans le cas de la vitamine A, au moins 1 600 unités internationales;

b) dans le cas de la thiamine, au moins 0,6 milligramme;

c) dans le cas de la riboflavine, au moins un milligramme;

d) dans le cas de la niacine ou de la niacinamide, au moins six milligrammes;

e) dans le cas de l’acide ascorbique, au moins 20 milligrammes; et

f) dans le cas de la vitamine D, au moins 300 unités internationales.

D.01.010. Lorsqu’un aliment auquel a été ajoutée une vitamine est présenté comme étant destiné exclusivement à l’alimentation des enfants de moins de deux ans, il est interdit de vendre un tel aliment à moins qu’une ration quotidienne normale de cet aliment n’apporte à un enfant de moins de deux ans qui la consomme,

a) dans le cas de la vitamine A, au moins 1 000 unités internationales;

b) dans le cas de la thiamine, au moins 0,4 milligramme;

c) dans le cas de la riboflavine, au moins 0,6 milligramme;

d) dans le cas de la niacine ou de la niacinamide, au moins quatre milligrammes;

e) dans le cas de la pyridoxine, au moins 0,6 milligramme;

f) dans le cas de l’acide ascorbique, au moins 20 milligrammes;

g) dans le cas de la vitamine D, au moins 300 unités internationales; et

h) dans le cas de la vitamine E, au moins cinq unités internationales.

D.01.011. Il est interdit de vendre un aliment auquel une des vitamines suivantes a été ajoutée si une ration quotidienne normale de cet aliment apporte à une personne qui la consomme,

a) dans le cas de la vitamine A, plus de 2 500 unités internationales;

b) dans le cas de la thiamine, plus de deux milligrammes;

c) dans le cas de la riboflavine, plus de trois milligrammes;

d) dans le cas de la niacine ou de la niacinamide, plus de 20 milligrammes;

e) dans le cas de la pyridoxine, plus de 1,5 milligramme;

f) dans le cas de l’acide ascorbique, plus de 60 milligrammes;

g) dans le cas de la vitamine D, plus de 400 unités internationales; et

h) dans le cas de la vitamine E, plus de 15 unités internationales.

D.01.012. Il est interdit, dans la publicité faite au sujet d’un aliment présenté comme contenant une vitamine ou sur l’étiquette d’un tel aliment,

a) de donner quelque garantie que ce soit quant à l’effet que peut produire, qu’a produit ou que produira l’addition de la vitamine au régime d’une personne; ou

b) de mentionner, reproduire ou citer un témoignage quelconque.

D.01.013. [Abrogé, DORS/2003-11, art. 31]

TABLEAU I

APPORT QUOTIDIEN RECOMMANDÉ

Colonne I Colonne II Colonne III Apport pour bébés et

Unité* Apport pour personnesArticle Vitamine enfants de moins deâgées d’au moins 2 ans 2 ans 1. Vitamine A (ER) 1000 400 2. Vitamine D (µg) 5 10 3. Vitamine E (mg) 10 3 4. Vitamine C (mg) 60 20

Thiamine ou5. (mg) 1,3 0,45vitamine B1 Riboflavine ou6. (mg) 1,6 0,55vitamine B2

7. Niacine (EN) 23 8 8. Vitamine B6 (mg) 1,8 0,7 9. Folacine ou folate (µg) 220 65

Colonne I Colonne II Colonne III Apport pour bébés et

Unité* Apport pour personnesArticle Vitamine enfants de moins deâgées d’au moins 2 ans 2 ans 10. Vitamine B12 (µg) 2 0,3

Acide pantothénique11. (mg) 7 2ou pantothénate 12. Vitamine K (µg) 80 30 13. Biotine (µg) 30 8 * ER = équivalent de rétinol

mg = milligramme µg = microgramme EN = équivalent de niacine

DORS/88-559, art. 33; DORS/96-259, art. 4; DORS/2003-11, art. 32 et 33.

TABLEAU II

APPORT NUTRITIONNEL RECOMMANDÉ PONDÉRÉ

Colonne I Colonne II Colonne III Article Vitamine Unités Quantité 1. Biotine microgrammes 90 2. Folacine microgrammes 195 3. Niacine équivalents de niacine 16 4. Acide pantothénique milligrammes 5,0 5. Riboflavine milligrammes 1,2 6. Thiamine milligrammes 1,0 7. Vitamine A équivalents de rétinol 870 8. Vitamine B6 milligrammes 1,0 9. Vitamine B12 microgrammes 1,0 10. Vitamine C milligrammes 34 11. Vitamine D microgrammes 3,0 12. Vitamine E milligrammes 7,0

DORS/96-259, art. 5.

Titre 2

Minéraux nutritifs dans les aliments

D.02.001. (1) Dans le présent titre, « minéral nutritif » désigne l’un des éléments chimiques suivants, soit seul, soit en combinaison avec un ou plusieurs autres éléments chimiques :

a) sodium;

b) potassium;

c) calcium;

d) phosphore;

e) magnésium;

f) fer;

g) zinc;

h) iode;

i) chlore;

j) cuivre;

k) fluor;

l) manganèse;

m) chrome;

n) sélénium;

o) cobalt;

p) molybdène;

q) étain;

r) vanadium;

s) silicium;

t) nickel. (mineral nutrient)

(2) Le présent titre ne s’applique qu’aux aliments présentés comme contenant un minéral nutritif destiné à être utilisé dans l’alimentation humaine.

DORS/88-559, art. 34; DORS/90-830, art. 9(F).

D.02.002. (1) Est interdite, sur l’étiquette ou dans l’annonce d’un aliment, autre que du sel de table ou d’usage domestique général contenant de l’iodure ajouté, de l’eau ou de la glace préemballées, une préparation pour régime liquide, un succédané de lait humain ou un aliment présenté comme contenant un succédané de lait humain, toute mention ou

allégation relative à sa teneur en un minéral nutritif, à moins que les conditions suivantes soient réunies :

a) il s’agit d’un minéral nutritif figurant à la colonne I du tableau I du présent titre;

b) le pourcentage de l’apport quotidien recommandé pour ce minéral nutritif, par portion déterminée, est de 5 % ou plus;

c) la teneur en ce minéral nutritif est indiquée, sur l’étiquette ou dans l’annonce, en pourcentage de la valeur quotidienne, par portion déterminée.

(2) Si la mention ou l’allégation visée au paragraphe (1) est faite dans l’annonce d’un aliment qui n’est pas un produit préemballé ou dans l’annonce d’un produit préemballé faite par une personne autre que le fabricant du produit ou une personne agissant sous ses ordres, le pourcentage de la valeur quotidienne, par portion déterminée, répond aux critères suivants :

a) dans le cas d’une annonce autre qu’une annonce radiophonique ou télévisée :

(i) d’une part, il précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence,

(ii) d’autre part, il figure en caractères d’une taille au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence;

b) dans le cas d’une annonce radiophonique ou de la composante audio d’une annonce télévisée, il précède ou suit immédiatement la mention ou l’allégation;

c) dans le cas d’une annonce télévisée, il est communiqué :

(i) en mode audio, si la mention ou l’allégation fait partie uniquement de la composante audio de l’annonce ou, à la fois, des composantes audio et visuelle de celle-ci,

(ii) en mode audio ou en mode visuel, si la mention ou l’allégation fait partie uniquement de la composante visuelle de l’annonce.

(3) Le pourcentage de la valeur quotidienne, par portion déterminée, qui est communiqué en mode visuel dans une annonce télévisée conformément au sous-alinéa (2)c)(ii), à la fois :

a) paraît en même temps et pendant au moins la même durée que la mention ou l’allégation;

b) précède ou suit, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé, la mention ou allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, celle qui est la plus en évidence;

c) figure en caractères d’une taille qui est au moins égale et aussi bien en vue que ceux de la mention ou de l’allégation ne paraissant qu’une seule fois ou, si la mention ou l’allégation est répétée, que ceux de celle qui est la plus en évidence.

(4) Le paragraphe (1) ne s’applique pas aux mentions et allégations relatives à la teneur en sodium ou en potassium.

(5) Les alinéas (1)a) et c) ne s’appliquent pas à l’indication de la teneur totale en ion fluorure exigée par les articles B.12.002 et B.12.008.

(6) L’alinéa (1)b) ne s’applique pas à l’indication de la teneur en un minéral nutritif dans tout tableau de la valeur nutritive.

(7) L’alinéa (1)c) ne s’applique pas à l’indication de la teneur en chrome, en cuivre, en manganèse, en molybdène et en sélénium exigée par le sous-alinéa B.24.202a)(v).

DORS/84-300, art. 60(A); DORS/88-559, art. 34; DORS/90-830, art. 10; DORS/96-259, art. 9; DORS/2003-11, art. 34.

D.02.003. [Abrogé, DORS/2003-11, art. 34]

D.02.004. Est interdite sur l’étiquette ou dans les annonces d’un aliment toute allégation concernant l’action ou les effets d’un minéral nutritif que contient l’aliment, sauf celle indiquant que le minéral nutritif :

a) contribue au maintien de la santé;

b) est généralement reconnu comme aidant à entretenir les fonctions de l’organisme nécessaires au maintien de la santé et à la croissance et au développement normaux.

DORS/84-300, art. 61(A); DORS/88-559, art. 34.

D.02.005. (1) Si un constituant d’un ingrédient de tout produit préemballé mentionné au tableau du paragraphe B.01.009(1) est un minéral nutritif, est interdite, sur l’étiquette ou dans l’annonce de ce produit préemballé, toute mention ou allégation à l’égard du minéral nutritif comme constituant de cet ingrédient, à moins que les conditions suivantes soient réunies :

a) malgré le paragraphe B.01.008(6), le minéral nutritif est désigné par son nom usuel juste après l’indication de l’ingrédient de manière à indiquer qu’il est un constituant de cet ingrédient;

b) tous les constituants de l’ingrédient sont indiqués.

(2) L’alinéa (1)b) ne s’applique pas à la farine utilisée comme ingrédient dans la fabrication d’un produit préemballé visé au paragraphe (1).

DORS/88-559, art. 34; DORS/2003-11, art. 35.

D.02.006. [Abrogé, DORS/2003-11, art. 35]

TABLEAU I

APPORT QUOTIDIEN RECOMMANDÉ

Colonne I Colonne II Colonne III

Article Minéral Unité* Apport pour personnes âgées Apport pour bébés et enfantsnutritif d’au moins 2 ans de moins de 2 ans 1. Calcium (mg) 1 100 500 2. Phosphore (mg) 1 100 500 3. Magnésium (mg) 250 55 4. Fer (mg) 14 7 5. Zinc (mg) 9 4 6. Iode (µg) 160 55 7. Sélénium (µg) 50 15 8. Cuivre (mg) 2 0,5 9. Manganèse (mg) 2 1,2 10. Chrome (µg) 120 12 11. Molybdène (µg) 75 15 12. Chlorure (mg) 400 1 000 * mg = milligramme

µg = microgramme

DORS/88-559, art. 34; DORS/96-259, art. 6; DORS/2003-11, art. 36.

TABLEAU II

APPORT NUTRITIONNEL RECOMMANDÉ PONDÉRÉ

Colonne I Colonne II Colonne III Article Minéral nutritif Unités Quantité 1. Calcium milligrammes 780 2. Iode microgrammes 155 3. Fer milligrammes 10 4. Phosphore milligrammes 885 5. Magnésium milligrammes 210 6. Zinc milligrammes 10

DORS/96-259, art. 7.

D.02.007. [Abrogé, DORS/88-599, art. 34]

D.02.008. Il est interdit, dans la publicité faite au sujet d’un aliment présenté comme contenant un minéral nutritif ou sur l’étiquette d’un tel aliment,

a) de donner quelque garantie que ce soit quant à l’effet que peut produire, qu’a produit ou que produira l’addition de ce minéral nutritif au régime d’une personne; ou

b) de mentionner, reproduire ou citer un témoignage quelconque.

D.02.009. Il est interdit de vendre un aliment auquel un des minéraux nutritifs suivants a été ajouté à moins qu’une ration quotidienne normale de cet aliment n’apporte à une personne qui la consomme,

a) dans le cas du calcium, au moins 300 milligrammes;

b) dans le cas du phosphore, au moins 300 milligrammes;

c) dans le cas du fer, au moins quatre milligrammes; et

d) dans le cas de l’iode, au moins 0,10 milligramme.

D.02.010. (1) Il est interdit de vendre de la poudre de fer élémentaire pour usage dans les aliments en tant que source du minéral nutritif fer, à moins,

a) sous réserve de l’alinéa b), que cette poudre ne soit conforme aux spécifications

(i) du carbonyle de fer,

(ii) du fer sous forme électrolytique, ou

(iii) du fer sous forme réduite

précisées dans le Food Chemicals Codex, troisième édition, 1981, publié par le National Academy of Sciences des États-Unis; et

b) dans le cas du fer sous forme réduite, que 100 pour cent, en poids, des particules de poudre ne parviennent à passer par un tamis de 100 mailles et qu’au moins 95 pour cent, en poids, des particules de poudre ne parviennent à passer par un tamis de 325 mailles.

(2) Il est interdit de vendre un aliment auquel a été ajoutée une poudre de fer élémentaire en tant que source du minéral nutritif fer, à moins que cette poudre ne soit conforme aux exigences des alinéas (1)a) et b).

DORS/84-303, art. 1.

D.02.011. Il est interdit à toute personne de vendre un aliment auquel a été ajouté du pyrophosphate de sodium et de fer en tant que source du minéral nutritif fer, à moins

a) que la biodisponibilité du fer dans l’aliment ne soit au moins égale à 50 pour cent de la biodisponibilité du sulfate ferreux, déterminée selon la méthode officielle FO-42, Détermination de la biodisponibilité du fer, 15 décembre 1982; et

b) que cette personne ne possède une preuve documentaire établissant que la biodisponibilité du fer dans l’aliment a été déterminée selon la méthode visée à l’alinéa a), et ne fournisse cette preuve au Directeur s’il en fait la demande.

DORS/84-303, art. 1.

Titre 3

Addition de vitamines, de minéraux nutritifs ou d'acides aminés aux aliments D.03.001. (1) Dans le présent titre, les expressions « vitamine » et « minéral nutritif » ont le même sens que dans les titres 1 et 2 respectivement.

(2) Le présent titre ne s’applique qu’aux aliments présentés comme contenant une vitamine, un minéral nutritif ou un acide aminé destiné à être utilisé dans l’alimentation humaine.

DORS/88-559, art. 35.

D.03.002. (1) Sous réserve de l’article D.03.003, il est interdit de vendre un aliment auquel une vitamine, un minéral nutritif ou un acide aminé a été ajouté, à moins que cet aliment ne figure à la colonne I du tableau du présent article et à moins que la vitamine, le minéral nutritif ou l’acide aminé, selon le cas, ne figure dans la colonne II dudit tableau en regard du nom de l’aliment.

(2) Sauf mention du contraire, le lait ou les produits ou dérivés du lait visés à la colonne I du tableau du présent article proviennent de la vache, genre Bos.

TABLEAU

Colonne I Aliment

1. Céréales à déjeuner

Nectars de fruits, boissons aux légumes, 2. bases et mélanges pour boissons aux

légumes et mélanges de jus de légumes

2.1 Boissons à arôme de fruit qui répondentaux exigences de l’article B.11.150 Bases, concentrés et mélanges pour préparer les boissons à arôme de fruit qui répondent aux exigences de l’article B.11.151

3. Produits céréaliers pour bébés

Margarine et autres succédanés similaires4. du beurre 5. Pâtes alimentaires

Colonne II Vitamine, minéral nutritif ou acide aminé Thiamine, niacine vitamine B6, acide folique, acide pantothénique, magnésium, fer et zinc

Vitamine C

Vitamines C, acide folique, thiamine, fer, potassium

Vitamine C, acide folique, thiamine, fer, potassium

Thiamine, riboflavine, niacine ou niacinamide, calcium, phosphore, fer, iode

Vitamine A, vitamine D, alphatocophérol

Thiamine, riboflavine, niacine ou

2.2

Colonne I Aliment

Préparations pour nourrissons et6. préparations pour régime liquide

Aliments présentés comme étant conçus 6.1 pour régimes à très faible teneur en

énergie

Mélanges et bases aromatisés qu’il est7. recommandé d’ajouter au lait

Simili-produits de viande, simili-produits de volaille, allongeurs de produits de8. viande et allongeurs de produits de volaille

Substituts de repas et suppléments9. nutritifs

Colonne II Vitamine, minéral nutritif ou acide aminé niacinamide, acide folique, acide pantothénique, vitamine B6, fer, magnésium Acides aminés — acide aspartique, acide glutamique, alanine, arginine, cystine, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, méthionine, phénylalanine, proline, sérine, taurine, thréonine, tryptophane, tyrosine, valine; Minéraux — calcium, chlorure, chrome, cuivre, iode, fer, magnésium, manganèse, molybdène, phosphore, potassium, sélénium, sodium, zinc; Vitamines — acide folique, acide d­ pantothénique, alpha-tocophérol, biotine, niacine, riboflavine, thiamine, vitamine A, vitamine B6, vitamine B12, vitamine C, vitamine D, vitamine K. Vitamines — acide d-pantothénique, acide folique, alpha-tocophérol, biotine, niacine, riboflavine, thiamine, vitamine A, vitamine B6, vitamine B12, vitamine C, vitamine D, vitamine K Minéraux — calcium, chlorure, chrome, cuivre, fer, iode, magnésium, manganèse, molybdène, phosphore, potassium, sélénium, sodium, zinc Vitamine A, thiamine, niacine ou niacinamide, vitamine C, fer Thiamine, riboflavine, niacine, pyridoxine, acide d-pantothénique, acide folique, vitamine B12, fer, magnésium, potassium, zinc, cuivre, histidine, isoleucine, leucine, lysine, méthionine, phénylalanine, thréonine, tryptophane, valine. Vitamines — acide folique, acide d­ pantothénique, alpha-tocophérol, biotine, niacine, riboflavine, thiamine, vitamine A, vitamine B6, vitamine B12, vitamine C, vitamine D Minéraux — calcium, chlorure, chrome, cuivre, fer, iode, magnésium, manganèse,

9.1

Colonne I Aliment

Déjeuner tout prêt, déjeuner instantané et autres aliments semblables de remplacement quelle qu’en soit la description

10. Lait condensé, lait, poudre de lait, laitstérilisé, lait (indication de l’arôme) Lait écrémé additionné de solides du lait, lait partiellement écrémé additionné de solides du lait, lait écrémé (indication de l’arôme), lait partiellement écrémé (indication de l’arôme), lait écrémé à

11. (indication de l’arôme) additionné de solides de lait, lait partiellement écrémé à (indication de l’arôme) additionné de solides du lait, lait écrémé, lait partiellement écrémé, poudre de lait écrémé

12. Lait évaporé Lait écrémé évaporé, lait écrémé concentré, lait partiellement écrémé13. évaporé, lait partiellement écrémé concentré Jus de pomme, jus de pomme reconstitué, jus de raisin, jus de raisin reconstitué, jus d’ananas, jus d’ananas

14. reconstitué, jus de pomme et de (nom du fruit) visé à l’article B.11.132, jus de fruit concentré sauf le jus d’orange concentré congelé

15. Farine, farine blanche, farine enrichie oufarine blanche enrichie

16. [Abrogé, DORS/94-689, art. 2] 17. Sel de table, succédanés du sel de table 18. Pommes de terre déshydratées

19. Produits imitant l’oeuf entier

Colonne II Vitamine, minéral nutritif ou acide aminé molybdène, phosphore, potassium, sélénium, sodium, zinc

fer, niacine ou niacinamide, riboflavine, thiamine, vitamine A, vitamine C

Vitamine D

Vitamine A, vitamine D

Vitamine C, vitamine D

Vitamine A, vitamine C, vitamine D

Vitamine C

Thiamine, riboflavine, niacine, vitamine B6, acide folique, acide d­ pantothénique, calcium, fer, magnésium

Iode Vitamine C Vitamine A, thiamine, riboflavine, niacine ou niacinamide, vitamine B6, acide d­ pantothénique, acide folique, vitamine B12, alphatocophérol, calcium, fer, zinc,

Colonne I Aliment

20. [Abrogé, DORS/90-830, art. 11] 21. Lait de chèvre, lait de chèvre en poudre

Lait de chèvre partiellement écrémé, lait de chèvre écrémé, lait de chèvre22. partiellement écrémé en poudre, lait de chèvre écrémé en poudre

23. Lait de chèvre concentré

24. Lait de chèvre concentré partiellementécrémé, lait de chèvre concentré écrémé

25. Riz précuit, au sens du paragrapheB.13.010.1(1)

26. Eau minérale, eau de source, eau encontenants scellés, glace pré-emballée Oeuf entier liquide, poudre d’oeuf entier, oeuf entier congelé, jaune d’oeuf liquide, poudre de jaune d’oeuf, jaune d’oeuf congelé, blanc d’oeuf liquide (albumen liquide), poudre de blanc d’oeuf (poudre d’albumen), blanc d’oeuf congelé

27. (albumen congelé), mélange liquide d’oeufs entiers, mélange de poudre d’oeufs entiers, mélange congelé d’oeufs entiers, mélange liquide de jaunes d’oeufs, mélange de poudre de jaunes d’oeufs, mélange congelé de jaunes d’oeufs

Colonne II Vitamine, minéral nutritif ou acide aminé potassium

vitamine D

vitamines A et D

vitamines C, D, acide folique

vitamines A, C, D, acide folique

Thiamine, niacine, vitamine B6, acide folique, acide pantothénique, fer

Fluor

Vitamine A, vitamine D, vitamine E, thiamine, riboflavine, niacine, vitamine B6, folacine, vitamine B12, acide pantothénique, calcium, phosphore, magnésium, potassium, fer, zinc

DORS/78-64, art. 8; DORS/78-403, art. 29; DORS/78-478, art. 3; DORS/78-637, art. 11(A); DORS/78-698, art. 10; DORS/79-6, art. 1; DORS/81-60, art. 14; DORS/83-858, art. 2; DORS/84-300, art. 62; DORS/85-623, art. 4; DORS/86-320, art. 2; DORS/87-640, art. 10; DORS/88-559, art. 36; DORS/89-145, art. 3; DORS/89-198, art. 18; DORS/90­ 830, art. 11; DORS/94-35, art. 5; DORS/94-689, art. 2; DORS/95-474, art. 6; DORS/96­ 259, art. 8; DORS/2010-143, art. 39(A). Version précédente D.03.003. L’article D.03.002 ne s’applique pas à un aliment qui répond aux exigences suivantes :

a) l’aliment est :

(i) soit un aliment sans gluten visé à l’alinéa B.24.003(1)g),

(ii) soit présenté comme étant destiné à un usage diététique spécial visé aux alinéas B.24.003(1)h) ou i);

b) il n’y a pas de normes applicables dans ce règlement pour l’aliment;

c) l’aliment n’est pas annoncé.

DORS/78-64, art. 9; DORS/84-334, art. 2; DORS/90-830, art. 12; DORS/95-444, art. 3.

Titre 4

[Abrogé, DORS/2003-196, art. 105]

Titre 5

Minéraux dans les drogues D.05.001. à D.05.007. [Abrogés, DORS/2003-196, art. 106]

D.05.008. (1) Sous réserve du paragraphe (2), il est interdit de vendre une drogue contenant du fluor si la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion par une personne de plus d’un milligramme d’ion fluor.

(2) Le paragraphe (1) ne s’applique pas à une drogue vendue sur ordonnance.

DORS/81-196, art. 2.

D.05.009. Lorsqu’une drogue contient du fluor, les étiquettes intérieure et extérieure de la drogue doivent porter une mise en garde précisant que, si la drogue est utilisée dans une région où l’eau potable naturelle a une teneur en fluor supérieure à 0,7 partie d’ion fluor par million de parties d’eau ou est fluorurée par des moyens artificiels, il peut s’ensuivre une tacheture de l’émail des dents chez l’usager de la drogue.

D.05.010. [Abrogé, DORS/2003-196, art. 107]

PARTIE E ÉDULCORANTS À LA SACCHARINE ET AU CYCLAMATÉ E.01.001. (1) Aux fins de cette partie,

« édulcorant au cyclamate » désigne l’acide cyclohexylsulfamique ou l’un de ses sels, ainsi qu’une substance en contenant, vendus comme édulcorants; (cyclamate sweetener)

« édulcorant à la saccharine » désigne

a) la saccharine ou l’un de ses sels, ou

b) une substance en contenant,

vendus comme édulcorants. (saccharin sweetener)

(2) La partie B ne s’applique pas aux édulcorants au cyclamate ou à la saccharine.

DORS/78-422, art. 4.

Vente E.01.002. Il est interdit

a) de vendre un édulcorant au cyclamate ou à la saccharine si ce dernier n’est pas étiqueté de la manière prescrite dans la présente partie; ou

b) de vendre au public, à compter du 15 juin 1978, sauf dans une pharmacie, un édulcorant à la saccharine.

DORS/78-422, art. 4.

Publicité E.01.003. Dans la publicité destinée au public relativement aux édulcorants au cyclamate ou à la saccharine, seuls le nom, le prix et la quantité de l’édulcorant peuvent être annoncés.

DORS/78-422, art. 4.

Étiquetage E.01.004. (1) Tout édulcorant au cyclamate qui n’est pas en même temps un édulcorant à la saccharine doit porter, sur l’étiquette, une mise en garde précisant que cet édulcorant ne doit être utilisé que sur avis d’un médecin.

(2) À compter du 1er juin 1979, les édulcorants à la saccharine doivent porter sur leur étiquette une déclaration indiquant que l’utilisation continue de la saccharine peut être néfaste pour la santé et que ce produit ne doit pas être utilisé, sauf sur avis du médecin, par les femmes enceintes.

DORS/78-422, art. 4.

E.01.005. À compter du 1er juin 1979, les édulcorants au cyclamate ou à la saccharine doivent porter sur leur étiquette leur valeur énergétique exprimée en calories par cuillerée à thé, comprimé, goutte ou autre, selon le mode d’emploi, et en grammes par 100 grammes ou 100 millilitres, ainsi que la liste de tous leurs ingrédients et, le cas échéant, les quantités présentes d’acide cyclohexylsulfamique, de saccharine ou de leurs sels et de glucides.

DORS/78-422, art. 4.

PARTIE G DROGUES CONTRÔLÉES Titre 1 Dispositions générales

G.01.001. (1) Dans la présente partie,

« autorité compétente » Organisme public d’un pays étranger qui est habilité, aux termes des lois du pays, à consentir à l’importation ou à l’exportation de drogues contrôlées. (competent authority)

« commande écrite »[Abrogée, DORS/85-550, art. 1]

« commande verbale » désigne une commande donnée de vive voix; (verbal order)

« distributeur autorisé » Le titulaire d’une licence délivrée en vertu de l’article G.02.003.2. (licensed dealer)

« drogue contrôlée » Toute drogue visée à l’annexe de la présente partie, y compris une préparation. (controlled drug)

« hôpital »

a) Établissement qui fait l’objet d’un permis délivré par la province ou qui a été approuvé ou désigné par elle, en conformité avec ses lois, en vue d’assurer des soins ou des traitements aux personnes ou aux animaux atteints d’une maladie ou d’une affection;

b) établissement qui assure des soins de santé et qui appartient au gouvernement du Canada ou d’une province ou est exploité par lui; (hospital)

« implant agricole » Produit qui est présenté sous une forme qui permet la libération lente d’un principe actif dans un délai donné et qui est destiné à être inséré sous la peau d’un animal producteur de denrées alimentaires aux fins de l’accroissement du gain pondéral et de l’indice de consommation. (agricultural implant)

« licence »[Abrogée, DORS/2004-238, art. 1]

« nécessaire d’essai » désigne un nécessaire

a) contenant des réactifs, des substances-tampons ou les deux,

b) employé au cours d’une opération chimique ou analystique effectuée à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques, et

c) dont le contenu n’est pas destiné à être administré à des humains; (test kit)

« nom propre » désigne, à l’égard d’une drogue contrôlée, le nom en anglais ou en français

a) attribué à la drogue dans l’article C.01.002,

b) figurant en caractères gras pour cette drogue dans les règlements et lorsque la drogue est distribuée sous une forme autre que celle qui est décrite à la partie C, le nom de la forme sous laquelle ladite drogue est distribuée, ou

c) attribué dans l’une des publications mentionnées à l’annexe B de la Loi sur les aliments et drogues, dans le cas de drogues non visées aux alinéas a) ou b) de la présente définition. (proper name)

« nom usuel » désigne, à l’égard d’une drogue contrôlée, le nom en anglais ou en français sous lequel ladite drogue contrôlée est généralement connue; (common name)

« obligation internationale » Toute obligation relative à une drogue contrôlée prévue par une convention, un traité ou un autre instrument multilatéral ou bilatéral que le Canada a ratifié ou auquel il adhère. (international obligation)

« ordonnance » désigne une directive donnée par un praticien qu’une quantité déclarée d’une drogue contrôlée spécifiée soit dispensée à la personne nommée dans ladite ordonnance; (prescription)

« permis » désigne une autorisation délivrée en vertu de l’article G.02.008; (permit)

« personne qualifiée responsable » La personne physique qui, possédant les qualifications énoncées au paragraphe G.02.001.2(2), est responsable de la supervision des opérations effectuées par le distributeur autorisé en vertu de sa licence, à l’installation qui y est spécifiée. (qualified person in charge)

« pharmacien »

a) désigne une personne inscrite et autorisée par les lois d’une province

(i) à exercer la profession de pharmacien, et

(ii) à exploiter ou diriger une pharmacie ou une officine, et qui exploite ou dirige une pharmacie ou une officine et exerce la profession de pharmacien en vertu desdites lois dans cette province, et

b) s’entend en outre, pour l’application des articles G.01.002, G.01.003, G.03.002 à G.03.008, G.03.014, G.03.015 et G.03.017 et des paragraphes G.05.003(3) et (4), d’une personne inscrite et autorisée en vertu des lois d’une province à exercer la pharmacie et qui exerce la pharmacie dans cette province. (pharmacist)

« praticien »[Abrogée, DORS/97-228, art. 7]

« préparation » désigne une drogue qui renferme une drogue contrôlée et un ou plusieurs ingrédients actifs de nature médicinale, en dose thérapeutique reconnue, autre qu’une drogue contrôlée; (preparation)

« usage parentéral », relativement à une drogue contrôlée, signifie l’administration au moyen d’une seringue ou d’une aiguille hypodermique ou autre instrument à travers ou dans la peau ou une muqueuse. (parenteral use)

(2) Les définitions qui suivent s’appliquent à la présente partie et à la partie J.

« Directive en matière de sécurité » La Directive sur les exigences en matière de sécurité physique pour les substances désignées (Exigences en matière de sécurité physique pour les substances désignées entreposées chez les distributeurs autorisés), publiée par le ministère, avec ses modifications successives. (Security Directive)

« emballage » S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (package)

« étiquette » S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (label)

« infraction désignée en matière criminelle » L’une ou l’autre des infractions suivantes :

a) infraction relative au financement du terrorisme visée à l’un des articles 83.02 à 83.04 du Code criminel;

b) infraction de fraude visée à l’un des articles 380 à 382 du Code criminel;

c) infraction de recyclage des produits de la criminalité visée à l’article 462.31 du Code criminel;

d) infraction relative à une organisation criminelle visée à l’un des articles 467.11 à 467.13 du Code criminel;

e) le complot ou la tentative de commettre une infraction visée à l’un des alinéas a) à d), la complicité après le fait à son égard ou le fait de conseiller de la commettre. (designated criminal offence)

« infraction désignée en matière de drogue » S’entend de l’une des infractions suivantes :

a) toute infraction prévue aux articles 39, 44.2, 44.3, 48, 50.2 ou 50.3 de la Loi sur les aliments et drogues, dans leur version antérieure au 14 mai 1997;

b) toute infraction prévue aux articles 4, 5, 6, 19.1 ou 19.2 de la Loi sur les stupéfiants, dans leur version antérieure au 14 mai 1997;

c) toute infraction prévue à la partie I de la Loi, à l’exception du paragraphe 4(1);

d) le complot ou la tentative de commettre une infraction visée aux alinéas a) à c), la complicité après le fait à son égard ou le fait de conseiller de la commettre. (designated drug offence)

« Loi » La Loi réglementant certaines drogues et autres substances. (Act)

« ministère » S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (Department)

« publicité » ou « annonce » S’entend au sens de l’article 2 de la Loi sur les aliments et drogues. (advertisement)

(3) Sauf indication contraire, les définitions figurant au paragraphe 2(1) de la Loi réglementant certaines drogues et autres substances s’appliquent à la présente partie et à la partie J.

DORS/78-220, art. 1; DORS/85-550, art. 1; DORS/86-91, art. 1; DORS/90-261, art. 1(F); DORS/92-386, art. 1; DORS/97-228, art. 7; DORS/97-515, art. 2; DORS/2003-135, art. 2; DORS/2004-238, art. 1.

G.01.002. (1) Toute personne est autorisée à avoir en sa possession une drogue contrôlée mentionnée à l’un des articles 1 à 3, 8 à 10, 12 à 14, 16 et 17 de la partie I de l’annexe de la présente partie si elle l’a obtenue en vertu du présent règlement ou lors de l’exercice d’une activité se rapportant à l’application ou à l’exécution d’une loi ou d’un règlement, ou si elle l’a obtenue d’une personne bénéficiant d’une exemption accordée aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à l’application du paragraphe 5(1) de cette loi à cette drogue contrôlée, et que, selon le cas :

a) elle a besoin de cette drogue pour son entreprise ou sa profession, étant :

(i) soit un distributeur autorisé,

(ii) soit un pharmacien,

(iii) soit un praticien inscrit et autorisé à exercer dans la province où elle détient cette drogue;

b) elle est un praticien inscrit et autorisé à exercer dans une province autre que celle où elle détient cette drogue et la possession de celle-ci est restreinte aux seules fins d’urgences médicales;

c) elle est un employé d’un hôpital ou un praticien exerçant dans un hôpital;

d) elle a obtenu cette drogue pour son propre usage d’un praticien ou en vertu d’une ordonnance qui n’a pas été délivrée ou obtenue en violation du présent règlement;

e) elle est un praticien en médecine qui a reçu cette drogue contrôlée en vertu des paragraphes G.06.001(3) ou (4) et qui l’a en sa possession à l’une des fins énoncées au paragraphe G.06.001(5);

f) elle est un représentant d’un praticien en médecine qui a reçu cette drogue contrôlée en vertu du paragraphe G.06.001(3) et qui l’a en sa possession à la seule fin de se conformer au paragraphe G.06.001(4);

g) elle est employée à titre d’inspecteur, de membre de la Gendarmerie royale du Canada, d’agent de police, d’agent de la paix ou de membre du personnel technique ou scientifique de tout service du gouvernement du Canada, d’une province ou d’une université, et elle a cette drogue en sa possession dans le cadre de ses fonctions;

h) elle est une personne non visée aux alinéas e) ou f), elle bénéficie d’une exemption accordée aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession de cette drogue contrôlée et elle en a la possession aux fins énoncées dans l’exemption;

i) elle est une personne visée à l’alinéa G.06.001(5)b).

(2) Une personne est autorisée à avoir une drogue contrôlée mentionnée au paragraphe (1) en sa possession lorsqu’elle agit comme agent de toute personne visée à l’un des alinéas (1)a) à e), h) et i).

(3) Une personne est autorisée à avoir une drogue contrôlée mentionnée au paragraphe (1) en sa possession lorsque :

a) d’une part, elle agit comme agent de toute personne dont elle a des motifs raisonnables de croire que celle-ci est une personne visée à l’alinéa (1)g);

b) d’autre part, la possession de la drogue a pour but d’aider cette dernière dans l’application ou l’exécution d’une loi ou d’un règlement.

DORS/97-515, art. 3; DORS/99-125, art. 1; DORS/2003-34, art. 1; DORS/2003-413, art. 1.

G.01.002.1. L’article C.01.004 ne s’applique pas à un nécessaire d’essai contenant une drogue contrôlée, et portant un numéro d’enregistrement émis selon l’article G.06.002.3 et non annulé selon l’article G.06.002.4.

DORS/80-543, art. 11.

G.01.003. L’article C.01.004 ne s’applique pas à une drogue contrôlée fournie par un pharmacien d’après une ordonnance, mais l’étiquette de l’emballage de la drogue contrôlée doit porter :

a) le nom et l’adresse de la pharmacie ou du pharmacien;

b) la date et le numéro de l’ordonnance;

c) le nom de la personne à qui la drogue contrôlée est destinée;

d) le nom du praticien;

e) le mode d’emploi; et

f) tout autre renseignement que l’ordonnance exige sur cette étiquette.

DORS/80-543, art. 11; DORS/2004-238, art. 2(F).

G.01.004. La Loi réglementant certaines drogues et autres substances et la présente partie ne s’appliquent pas aux drogues contrôlées contenues dans des implants agricoles et mentionnées à la partie III de l’annexe de la présente partie. Le présent article n’a toutefois pas pour effet d’exempter ces drogues de l’application de la partie C.

DORS/92-386, art. 2; DORS/97-228, art. 8.

G.01.005. [Abrogé, DORS/80-543, art. 12]

G.01.006. Sauf de la manière prévue par la présente partie, est interdite la vente d’une drogue contrôlée ou d’une préparation qui n’est pas conforme à toutes les dispositions des parties C et D qui s’y appliquent.

G.01.007. Est interdite

a) l’annonce d’une drogue contrôlée auprès du grand public; ou

b) la publication de toute annonce écrite au sujet d’une drogue contrôlée à moins que

l’annonce ne porte le symbole de couleur et de dimensions claires et bien visibles au quart supérieur gauche de la première page de l’annonce.

G.01.008. [Abrogé, DORS/80-543, art. 12]

Manière prescrite de présenter un avis de demande d'une ordonnance de restitution

G.01.010. (1) Pour l’application du paragraphe 24(1) de la Loi réglementant certaines drogues et autres substances, le préavis de demande d’ordonnance de restitution doit être donné par écrit, sous pli recommandé, au procureur général.

(2) L’avis mentionné au paragraphe (1) doit être mis à la poste au moins 15 jours entiers avant la date à laquelle la demande d’ordonnance de restitution doit être présentée au magistrat et doit préciser

a) le nom du magistrat à qui la demande sera présentée;

b) l’heure et le lieu d’instruction de la demande;

c) la drogue contrôlée ou toute autre chose qui fait l’objet de la demande; et

d) la preuve que le demandeur projette de présenter pour établir qu’il a le droit de posséder la drogue contrôlée ou l’autre chose dont il est question dans l’alinéa c).

DORS/97-228, art. 9.

Titre 2

Licences et distributeurs autorisés

G.02.001. Sous réserve des autres dispositions de la présente partie, il est interdit à toute personne autre que le distributeur autorisé, de produire, de fabriquer, d’assembler, d’importer, d’exporter, de vendre, de fournir, de transporter, d’expédier ou de livrer une drogue contrôlée.

DORS/2004-238, art. 3.

G.02.001.1. Sont admissibles à la licence de distributeur autorisé :

a) la personne physique qui réside habituellement au Canada;

b) la personne morale qui a son siège social au Canada ou qui y exploite une succursale;

c) le titulaire d’un poste qui comporte la responsabilité de drogues contrôlées pour le compte d’un ministère du gouvernement fédéral ou d’un gouvernement provincial, d’un service de police, d’un hôpital ou d’une université au Canada.

DORS/2004-238, art. 3.

G.02.001.2. (1) Le distributeur autorisé :

a) désigne une seule personne qualifiée responsable — il peut lui-même exercer cette fonction s’il est une personne physique — qui doit travailler à l’installation visée par la licence et qui est à la fois chargée de superviser les opérations relatives aux drogues contrôlées visées par la licence et d’assurer la conformité de ces opérations avec le présent règlement au nom du distributeur autorisé;

b) peut désigner une personne qualifiée responsable suppléante qui doit travailler à l’installation visée par la licence et qui est autorisée à remplacer la personne qualifiée responsable lorsque celle-ci est absente.

(2) La personne qualifiée responsable et, le cas échéant, la personne qualifiée responsable suppléante doivent se conformer aux exigences suivantes :

a) bien connaître les dispositions de la Loi et de ses règlements qui s’appliquent à la licence du distributeur autorisé qui les a désignées et posséder des connaissances et une expérience de la chimie et de la pharmacologie pour pouvoir bien s’acquitter de leurs fonctions;

b) être des pharmaciens ou des praticiens agréés par l’autorité provinciale attributive de licences en matière d’activités professionnelles ou être titulaire d’un diplôme dans une discipline scientifique connexe — notamment la pharmacie, la médecine, la dentisterie, la médecine vétérinaire, la pharmacologie, la chimie organique ou le génie chimique — décerné par une université canadienne ou, s’il s’agit d’une université étrangère, reconnu par une université ou une association professionnelle canadiennes;

c) ne pas avoir, au cours des dix dernières années, été reconnues coupables en tant qu’adulte :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii).

DORS/2004-238, art. 3; DORS/2010-222, art. 1(A) et 34. Version précédente G.02.002. Il est interdit à tout distributeur autorisé d’importer ou d’exporter une drogue contrôlée sans un permis à cette fin.

G.02.002.1 Un distributeur autorisé est autorisé à avoir une drogue contrôlée en sa possession, en vue de son exportation, s’il l’a obtenue conformément au présent règlement.

DORS/97-515, art. 4.

G.02.003. (1) Quiconque souhaite obtenir une licence de distributeur autorisé présente au ministre une demande dans laquelle il inscrit les renseignements suivants :

a) si la licence est demandée :

(i) pour une personne physique, le nom de celle-ci,

(ii) pour une personne morale, sa dénomination sociale et tout autre nom enregistré dans une province sous lequel elle entend s’identifier ou poursuivre les opérations prévues dans la licence,

(iii) pour le titulaire d’un poste, le nom du demandeur et le titre du poste;

b) l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique de l’installation visée par la licence de même que, si elle diffère de l’adresse de l’installation, son adresse postale;

c) les nom, date de naissance et sexe du responsable de l’installation;

d) s’agissant de la personne qualifiée responsable proposée et, le cas échéant, de la personne qualifiée responsable suppléante proposée :

(i) leurs nom, date de naissance et sexe,

(ii) les diplômes d’études, la formation et l’expérience de travail qui se rapportent à leurs fonctions,

(iii) leurs heures de travail à l’installation,

(iv) leur titre à l’installation,

(v) les nom et titre de leur supérieur immédiat à l’installation,

(vi) dans le cas d’un pharmacien ou d’un praticien, le nom de la province où a été délivré le permis d’exercice, la licence ou le certificat professionnel valide qu’il détient, ainsi que le numéro de ce permis, de cette licence ou de ce certificat;

e) les nom et sexe des personnes physiques autorisées à commander des drogues contrôlées pour son compte;

f) dans le cas où la demande vise un produit ou un composé qui contient une drogue contrôlée mais n’est pas un nécessaire d’essai et qui serait fabriqué ou assemblé par lui ou pour son compte :

(i) la marque nominative de chaque produit ou composé, le cas échéant,

(ii) la drogue contrôlée que contient chaque produit ou composé,

(iii) la concentration de la drogue contrôlée dans chaque unité du produit ou du composé,

(iv) la quantité ou les formats d’emballage de chaque produit ou composé,

(v) dans le cas où le produit ou composé est fabriqué ou assemblé, sur commande spéciale, par un autre distributeur autorisé ou pour son compte, les nom, adresse et numéro de licence de cet autre distributeur;

g) les opérations visées à l’article G.02.001 pour lesquelles la licence est demandée et qui seraient effectuées à l’installation à laquelle s’appliquerait la licence;

h) dans le cas où il demande la licence pour produire une drogue contrôlée, à l’exclusion des produits ou composés contenant une drogue contrôlée :

(i) le nom de la drogue contrôlée à produire,

(ii) la quantité qu’il entend produire en vertu de la licence et la période prévue pour sa production,

(iii) s’il s’agit d’une drogue contrôlée produite sur commande spéciale pour le compte d’un autre distributeur autorisé, les nom, adresse et numéro de licence de ce dernier;

i) la description détaillée des mesures établies conformément à la Directive en matière de sécurité qui sont appliquées à l’installation;

j) la description détaillée de la méthode prévue pour la consignation des transactions des drogues contrôlées;

k) dans le cas d’une opération visée à l’article G.02.001 qui n’est pas une opération à laquelle s’appliquent les alinéas f) et h), la drogue contrôlée à l’égard de laquelle cette opération sera effectuée et le but de l’opération.

(2) La demande de licence de distributeur autorisé doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation visée par la demande;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) La demande de licence de distributeur autorisé doit être accompagnée de ce qui suit :

a) une déclaration signée du responsable de l’installation visée par la demande, une autre de la personne qualifiée responsable proposée et une autre, le cas échéant, de la personne qualifiée responsable suppléante proposée, chaque déclaration attestant que le signataire n’a pas, au cours des dix dernières années, été reconnu coupable en tant qu’adulte :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

b) un document émanant d’un service de police canadien pour chacune des personnes mentionnées à l’alinéa a), attestant qu’elle a ou n’a pas, au cours des dix dernières années, été reconnue coupable en tant qu’adulte d’une infraction désignée en matière de drogue ou d’une infraction désignée en matière criminelle;

c) dans le cas où l’une des personnes visées à l’alinéa a) a eu, au cours des dix dernières années, sa résidence habituelle dans un pays autre que le Canada, un document émanant d’un service de police de ce pays attestant qu’elle a ou n’a pas, au cours des dix dernières années, été reconnue coupable dans ce pays en tant qu’adulte d’une infraction qui, si elle avait été commise au Canada, aurait été une infraction désignée en matière de drogue ou une infraction désignée en matière criminelle;

d) une déclaration, signée et datée par le responsable de l’installation visée par la demande, attestant que la personne qualifiée responsable proposée et, le cas échéant, la personne qualifiée responsable suppléante proposée, ont les connaissances et l’expérience exigées par l’alinéa G.02.001.2(2)a);

e) dans le cas où la personne qualifiée responsable proposée ou, le cas échéant, la personne qualifiée responsable suppléante proposée n’est pas un pharmacien ou un praticien agréé par l’autorité provinciale attributive de licences en matière d’activités professionnelles, une copie du diplôme visé à l’alinéa G.02.001.2(2)b) et une copie du relevé de notes relatif à ce diplôme;

f) dans le cas où le nom du demandeur figure sur l’étiquette d’un produit ou d’un composé contenant une drogue contrôlée, une copie de l’étiquette intérieure, au sens de l’article A.01.010, de chaque produit ou composé auquel s’appliquerait la licence;

g) dans le cas où le demandeur est une personne morale, à la fois :

(i) une copie de son certificat de constitution ou de tout autre acte constitutif,

(ii) une copie de tout document déposé auprès de la province où se trouve l’installation à laquelle s’appliquerait la licence, qui indique sa dénomination sociale ou tout autre nom enregistré dans la province sous lequel le demandeur entend s’identifier ou poursuivre les opérations prévues dans la licence.

(4) La méthode prévue aux termes de l’alinéa (1)j) doit permettre :

a) d’une part, la consignation des transactions de drogues contrôlées conformément à l’article G.02.014;

b) d’autre part, la vérification par le ministre des opérations du distributeur autorisé relativement aux drogues contrôlées.

(5) Les documents visés aux alinéas (3)b) et c) n’ont pas à être fournis si les personnes mentionnées à ces alinéas consentent par écrit :

a) à ce qu’une recherche soit effectuée pour vérifier si elles ont eu, au cours des dix dernières années, un casier judiciaire, en tant qu’adulte, relativement aux infractions visées à ces alinéas;

b) à fournir les renseignements nécessaires à la vérification du casier judiciaire et à se soumettre à toute opération d’identification nécessaire pour obtenir la vérification;

c) à payer le prix exigé pour la vérification aux termes du Règlement sur le prix à payer pour la vérification de casiers judiciaires à des fins civiles (Gendarmerie royale du Canada).

DORS/2004-238, art. 4; DORS/2010-222, art. 2. Version précédente G.02.003.1. Sur réception d’une demande présentée en vertu de la présente partie, le ministre peut exiger tout renseignement supplémentaire au sujet des renseignements contenus dans la demande dont il a besoin pour traiter celle-ci.

DORS/2004-238, art. 4.

G.02.003.2. Sous réserve de l’article G.02.003.3, le ministre délivre au demandeur, après examen des renseignements et des documents exigés aux articles G.02.003 et G.02.003.1, une licence de distributeur autorisé qui contient les renseignements suivants :

a) le numéro de la licence;

b) le nom du titulaire, qu’il s’agisse de son propre nom ou du titre du poste dont il est titulaire, ou, s’il s’agit d’une personne morale, sa dénomination sociale;

c) la liste des opérations autorisées;

d) l’adresse de l’installation où le distributeur peut se livrer aux opérations autorisées;

e) le nom de la drogue contrôlée à l’égard de laquelle les opérations sont autorisées;

f) le niveau de sécurité applicable à l’installation, établi conformément à la Directive en matière de sécurité;

g) la date de prise d’effet de la licence;

h) la date d’expiration de la licence, laquelle ne peut suivre de plus de trois ans la date de prise d’effet de celle-ci;

i) le cas échéant, les conditions que le titulaire doit remplir :

(i) pour que soit respectée une obligation internationale,

(ii) pour assurer le niveau de sécurité visé à l’alinéa f),

(iii) pour réduire tout risque d’atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue contrôlée vers un marché ou un usage illicite;

j) dans le cas du producteur d’une drogue contrôlée, la quantité de celle-ci qui peut être produite en vertu de la licence et la période de production autorisée;

k) dans le cas du fabricant ou de l’assembleur d’un produit ou d’un composé qui contient une drogue contrôlée mais n’est pas un nécessaire d’essai, une liste figurant en annexe qui indique, pour chaque type de produit ou de composé qui peut être fabriqué ou assemblé en vertu de la licence :

(i) le numéro de licence,

(ii) la marque nominative de chaque produit ou composé, le cas échéant,

(iii) le nom de la drogue contrôlée que contient chaque produit ou composé,

(iv) la concentration de la drogue contrôlée dans chaque unité du produit ou du composé,

(v) la quantité ou les formats d’emballage de chaque produit ou composé.

DORS/2004-238, art. 4; DORS/2010-222, art. 3 et 35(F). Version précédente G.02.003.3. (1) Le ministre refuse de délivrer la licence de distributeur autorisé, de la modifier ou de la renouveler dans les cas suivants :

a) le demandeur n’est pas admissible aux termes de l’article G.02.001.1;

b) le demandeur n’a pas fourni à l’inspecteur qui lui en a fait la demande l’occasion de procéder à une inspection aux termes de l’article G.02.015;

c) le demandeur a fourni des renseignements faux ou trompeurs dans sa demande ou des documents faux ou falsifiés à l’appui de celle-ci;

d) l’une des opérations pour lesquelles la licence est demandée entraînerait le non-respect d’une obligation internationale;

e) les renseignements reçus d’une autorité compétente ou des Nations Unies laissent raisonnablement croire que le demandeur a participé au détournement d’une drogue contrôlée vers un marché ou un usage illicite ou qu’il s’est livré à des opérations qui ont entraîné le non-respect d’une obligation internationale;

f) le demandeur n’a pas mis en oeuvre les mesures prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle il demande la licence;

g) le demandeur contrevient ou a contrevenu au cours des dix dernières années :

(i) soit à une disposition de la Loi ou des règlements pris ou maintenus en vigueur sous le régime de celle-ci,

(ii) soit à une condition d’une autre licence de distributeur autorisé ou d’un permis d’importation ou d’exportation qui lui a été délivré en vertu d’un règlement pris ou maintenu en vigueur sous le régime de la Loi;

h) la délivrance, la modification ou le renouvellement de la licence risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue contrôlée vers un marché ou un usage illicite;

i) le responsable de l’installation, la personne qualifiée responsable proposée ou, le cas échéant, la personne qualifiée responsable suppléante proposée a, au cours des dix dernières années, été reconnu coupable en tant qu’adulte, selon le cas :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

j) la méthode prévue aux termes de l’alinéa G.02.003(1)j) ne permet pas la consignation des transactions des drogues contrôlées conformément à l’article G.02.014 ou la vérification par le ministre, en temps opportun, des opérations du demandeur relatives aux drogues contrôlées;

k) les renseignements supplémentaires exigés en vertu de l’article G.02.003.1 n’ont pas été fournis ou sont insuffisants pour que la demande puisse être traitée.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicite, le ministre ne peut, dans les cas visés aux alinéas (1)c) ou g), refuser de délivrer, de modifier ou de renouveler la licence si le demandeur :

a) d’une part, n’a pas d’antécédents quant à la contravention de la Loi et des règlements pris ou maintenus en vigueur en vertu de celle-ci;

b) d’autre part, a pris les mesures correctives nécessaires pour assurer le respect de la Loi et du présent règlement, ou a signé un engagement à cet effet.

DORS/2004-238, art. 4; DORS/2010-222, art. 4 et 35(F). Version précédente G.02.003.4. (1) Le distributeur autorisé qui souhaite obtenir le renouvellement de sa licence présente au ministre une demande :

a) dans laquelle il inscrit les renseignements visés aux alinéas G.02.003(1)a) à k);

b) à laquelle il joint les documents suivants :

(i) les documents visés aux alinéas G.02.003(3)a) et d) et, sous réserve du paragraphe G.02.003(5), le document visé à l’alinéa G.02.003(3)b),

(ii) le cas échéant, le document visé à l’alinéa G.02.003(3)e), s’il n’a pas déjà été fourni relativement à la licence à renouveler,

(iii) l’original de la licence à renouveler.

(2) La demande de renouvellement doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation à laquelle s’appliquerait la licence;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) Sous réserve de l’article G.02.003.3, après examen des renseignements et des documents exigés aux paragraphes (1) et (2) et à l’article G.02.003.1, le ministre renouvelle la licence de distributeur autorisé qui contient les renseignements prévus aux alinéas G.02.003.2a) à k).

DORS/2004-238, art. 4.

G.02.003.5. (1) Le distributeur autorisé qui souhaite faire modifier sa licence présente les documents suivants au ministre :

a) une demande écrite expliquant la modification souhaitée, à laquelle sont joints ceux des documents visés à l’article G.02.003 qui sont pertinents à l’égard de la demande de modification;

b) l’original de la licence en cause.

(2) La demande de modification de la licence doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation à laquelle s’appliquerait la licence;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) Sous réserve de l’article G.02.003.3, après examen de la demande et des documents à l’appui, le ministre modifie la licence en conséquence et peut l’assortir de conditions supplémentaires que le titulaire doit remplir à l’une ou l’autre des fins suivantes :

a) pour que soit respectée une obligation internationale;

b) pour assurer le niveau de sécurité applicable visé à l’alinéa G.02.003.2f) ou tout autre niveau qui s’impose par suite de la modification;

c) pour réduire tout risque d’atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue contrôlée vers un marché ou un usage illicite.

DORS/2004-238, art. 4; DORS/2010-222, art. 5(F) et 35(F). Version précédente G.02.003.6. (1) Le distributeur autorisé doit satisfaire aux exigences suivantes :

a) obtenir l’approbation du ministre avant de procéder :

(i) à une modification touchant la sécurité à l’installation mentionnée dans sa licence,

(ii) à la désignation d’autres personnes physiques qui remplacent les suivantes ou, le cas échéant, s’ajoutent à elles :

(A) le responsable de l’installation à laquelle s’applique la licence,

(B) la personne qualifiée responsable à l’installation à laquelle s’applique la licence et le cas échéant, la personne qualifiée responsable suppléante,

(C) les personnes physiques autorisées à commander une drogue contrôlée au nom du distributeur autorisé;

b) aviser le ministre, dans les dix jours, qu’une personne visée à l’une des divisions a)(ii)(A) ou (C) a cessé d’exercer les fonctions mentionnées dans l’un des documents suivants :

(i) la demande de licence présentée aux termes de l’article G.02.003,

(ii) la demande de renouvellement de la licence présentée aux termes de l’article G.02.003.4,

(iii) la demande d’approbation présentée pour l’application de l’alinéa a);

c) aviser le ministre, au plus tard le jour ouvrable suivant, qu’une personne visée à la division a)(ii)(B) a cessé d’exercer les fonctions mentionnées dans l’un des documents suivants :

(i) la demande de licence présentée aux termes de l’article G.02.003,

(ii) la demande de renouvellement de la licence présentée aux termes de l’article G.02.003.4,

(iii) la demande d’approbation présentée pour l’application de l’alinéa a).

(2) En plus de la demande d’approbation visée au sous-alinéa (1)a)(ii), le distributeur autorisé doit, relativement à toute nomination, fournir ce qui suit au ministre :

a) dans le cas du remplacement du responsable de l’installation à laquelle s’applique la licence :

(i) les renseignements visés à l’alinéa G.02.003(1)c),

(ii) les déclarations visées à l’alinéa G.02.003(3)a) et, sous réserve du paragraphe G.02.003(5), les documents visés aux alinéas G.02.003(3)b) et c);

b) dans le cas du remplacement de la personne qualifiée responsable à l’installation à laquelle s’applique la licence, ou dans celui du remplacement ou de l’adjonction d’une personne qualifiée responsable suppléante à cette installation :

(i) les renseignements visés à l’alinéa G.02.003(1)d),

(ii) les documents visés aux alinéas G.02.003(3)a), d) et e) et, sous réserve du paragraphe G.02.003(5), les documents visés aux alinéas G.02.003(3)b) et c);

c) dans le cas du remplacement ou de l’adjonction d’une personne physique autorisée à commander une drogue contrôlée en son nom, le nom et le sexe de celle-ci.

DORS/2004-238, art. 4.

G.02.003.7. Le ministre révoque la licence de distributeur autorisé si le titulaire en fait la demande ou l’informe de la perte ou du vol de celle-ci.

DORS/2004-238, art. 4.

G.02.003.8. (1) Sous réserve du paragraphe (2), le ministre révoque la licence de distributeur autorisé conformément à l’article G.02.003.91 dans les cas suivants :

a) la licence a été délivrée d’après des renseignements faux ou trompeurs fournis dans la demande ou des documents faux ou falsifiés à l’appui de celle-ci;

b) le titulaire a contrevenu à la Loi ou à ses règlements ou aux conditions de sa licence ou d’un permis d’importation ou d’exportation délivré en vertu de la présente partie;

c) le titulaire n’est plus admissible aux termes de l’article G.02.001.1;

d) il a été découvert que le responsable de l’installation à laquelle s’applique la licence, la personne qualifiée responsable à cette installation ou, le cas échéant, la personne qualifiée responsable suppléante a, au cours des dix dernières années, été reconnu coupable en tant qu’adulte, selon le cas :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

e) les renseignements reçus d’une autorité compétente ou des Nations Unies laissent raisonnablement croire que le titulaire a participé au détournement d’une drogue contrôlée vers un marché ou un usage illicite.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicite, le ministre ne peut, dans les cas visés aux alinéas (1)a) ou b), révoquer la licence de distributeur autorisé si :

a) d’une part, le distributeur autorisé n’a pas d’antécédents quant à la contravention de la Loi et des règlements pris ou maintenus en vigueur sous le régime de celle-ci;

b) d’autre part, il a pris les mesures correctives nécessaires pour assurer le respect de la Loi et du présent règlement, ou a signé un engagement à cet effet.

DORS/2004-238, art. 4; DORS/2010-222, art. 6 et 35(F). Version précédente G.02.003.9. Le ministre suspend sans préavis la licence de distributeur autorisé s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicite.

DORS/2004-238, art. 4; DORS/2010-222, art. 35(F). Version précédente G.02.003.91. (1) Lorsqu’il envisage de refuser de délivrer, de modifier ou de renouveler une licence de distributeur autorisé, aux termes de la présente partie, ou qu’il envisage de la révoquer, le ministre donne au demandeur ou au titulaire :

a) un avis à cet effet et un exposé écrit des motifs du refus ou de la révocation envisagés;

b) la possibilité de se faire entendre à l’égard du refus ou de la révocation envisagés.

(2) La décision du ministre de suspendre la licence de distributeur autorisé aux termes de la présente partie prend effet aussitôt qu’il en avise l’intéressé et lui fournit un exposé écrit des motifs de la suspension.

(3) La personne qui reçoit un avis de suspension aux termes du paragraphe (2) peut, dans les dix jours qui en suivent la réception, présenter au ministre les motifs pour lesquels la suspension de sa licence de distributeur autorisé n’est pas fondée.

DORS/2004-238, art. 4.

G.02.004. Le distributeur autorisé ne peut fabriquer, produire, assembler, vendre, fournir, transporter, expédier ou livrer que les drogues contrôlées mentionnées sur sa licence, à la condition d’en respecter les modalités.

DORS/2004-238, art. 4.

G.02.005. à G.02.007. [Abrogés, DORS/2004-238, art. 4]

G.02.008. Le ministre peut, sur demande à cet effet, délivrer à tout distributeur autorisé un permis d’importer ou d’exporter une drogue contrôlée.

G.02.009. La demande de permis doit être rédigée dans la forme approuvée par le ministre.

G.02.010. Toute licence ou tout permis délivré en vertu de la présente partie est soumis à la condition que le distributeur autorisé observe les dispositions de ladite partie.

G.02.011. Le ministre révoque le permis si le titulaire en fait la demande ou l’informe de la perte ou du vol de celui-ci.

DORS/2004-238, art. 5; DORS/2010-222, art. 7. Version précédente G.02.011.1. (1) Sous réserve du paragraphe (2), le ministre révoque le permis, en prenant les mêmes mesures que celles prévues au paragraphe G.02.003.91(1), dans les cas suivants :

a) l’un des cas prévus aux alinéas G.02.003.8(1)a) à e) s’applique à l’égard de la licence de distributeur autorisé qui vise la drogue contrôlée à importer ou exporter;

b) le permis d’importation ou d’exportation, selon le cas, a été délivré sur la foi de renseignements faux ou trompeurs fournis dans la demande ou de documents faux ou falsifiés à l’appui de celle-ci.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue contrôlée vers un marché ou un usage illicite, le ministre ne peut, dans les cas visés aux alinéas G.02.003.8(1)a) ou b) ou G.02.011.1(1)b), révoquer le permis si son titulaire remplit les conditions prévues aux alinéas G.02.003.8(2)a) et b).

(3) Si le titulaire ne se conforme pas à la décision du ministre de suspendre son permis aux termes de l’article G.02.011.2 ou ne corrige pas la situation ayant donné lieu à la suspension, le ministre peut révoquer le permis.

DORS/2010-222, art. 7.

G.02.011.2. (1) Le ministre suspend le permis sans préavis dans les cas suivants :

a) la licence de distributeur autorisé qui vise la drogue contrôlée à importer ou à exporter est expirée ou a été suspendue ou révoquée;

b) il a des motifs raisonnables de croire que la protection de la sécurité ou de la santé publiques l’exige;

c) il a des motifs raisonnables de croire que le maintien de la licence présenterait un risque de détournement de la drogue contrôlée vers un marché ou un usage illicite;

d) l’importation ou l’exportation contrevient aux règles de droit du pays d’exportation ou d’importation, selon le cas, ou de tout pays de transit ou de transbordement.

(2) La décision du ministre de suspendre un permis prend effet aussitôt qu’il en avise l’intéressé et lui fournit un exposé écrit des motifs.

(3) La personne dont le permis est suspendu aux termes du paragraphe (1) peut, dans les dix jours suivant la réception de l’avis de suspension, présenter au ministre les raisons pour lesquelles la suspension ne serait pas fondée.

DORS/2010-222, art. 7.

G.02.012. La licence de distributeur autorisé est valide jusqu’à celle des dates suivantes qui est antérieure à l’autre :

a) la date d’expiration indiquée dans la licence;

b) la date de la révocation ou de la suspension de la licence au titre des articles G.02.003.7, G.02.003.8 ou G.02.003.9.

DORS/2004-238, art. 5.

G.02.013. Un permis délivré en vertu de l’article G.02.008 ne s’applique qu’à l’importation ou l’exportation particulière pour laquelle ledit permis a été délivré.

G.02.014. (1) Le distributeur autorisé doit, au lieu indiqué dans sa licence, tenir un registre permanent des drogues contrôlées indiquant pour les deux dernières années

a) le nom et la quantité de toute drogue contrôlée qu’il a reçue, les nom et adresse de la personne qui la lui a vendue ou fournie et la date à laquelle il l’a reçue;

b) le nom, la quantité et la forme de toute drogue contrôlée qu’il vend ou fournit, les nom et adresse de la personne à qui elle est vendue ou fournie et la date de cette vente ou fourniture;

c) le nom et la quantité de toute drogue contrôlée employée dans la fabrication ou l’assemblage d’un produit ou d’un composé qui contient cette drogue, le nom et la quantité du produit ou du composé fabriqué ou assemblé et la date à laquelle ce produit ou ce composé a été stocké;

c.1) le nom et la quantité de toute drogue contrôlée produite et la date à laquelle elle a été stockée;

d) le nom et la quantité de toute drogue contrôlée en stock à la fin de chaque mois.

(2) Les renseignements visés au paragraphe (1) sont conservés :

a) de manière à en permettre la vérification;

b) sous réserve du paragraphe (3), dans un cahier, un registre ou un dossier semblable réservé exclusivement aux drogues contrôlées;

c) pendant au moins deux ans dans l’établissement mentionné sur la licence du distributeur autorisé.

(3) Les renseignements visés aux ainéas (1)a), b) et d) peuvent, dans le cas d’une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie, être conservés sous une forme autre que celle précisée à l’alinéa (2)b).

DORS/78-427, art. 1; DORS/97-228, art. 10; DORS/2004-238, art. 6; DORS/2010-222, art. 8(A). Version précédente G.02.015. (1) Le ministre peut, à l’égard du demandeur ou du distributeur autorisé, exiger, à tout moment raisonnable :

a) l’inspection de l’installation utilisée ou envisagée pour la fabrication, la production, l’assemblage ou l’entreposage d’une drogue contrôlée;

b) l’examen, lors de l’inspection, des procédés utilisés pour ces opérations et des conditions dans lesquelles elles se déroulent.

(2) [Abrogé, DORS/2010-222, art. 9]

DORS/78-427, art. 2; DORS/2004-238, art. 7; DORS/2010-222, art. 9. Version précédente G.02.016. Tout distributeur autorisé doit

a) fournir tels renseignements relatifs à toute transaction dudit distributeur, en matière de n’importe quelle drogue contrôlée, dans la forme et au moment que peut fixer le ministre;

b) présenter à un inspecteur tout cahier, registre ou document dont la tenue est exigée par la présente partie;

c) permettre à un inspecteur de prendre copie, ou de noter des extraits desdits cahiers, registres ou documents; et

d) permettre à un inspecteur de vérifier tous les stocks de drogues contrôlées gardés sur les lieux décrits dans la licence du distributeur autorisé.

G.02.017. [Abrogé, DORS/78-427, art. 3]

G.02.018. Tout distributeur autorisé doit avertir le ministre sans délai de tout changement relatif

a) [Abrogé, DORS/2010-222, art. 10]

b) à l’installation où la drogue contrôlée est fabriquée, produite, assemblée ou entreposée;

c) aux procédés ou conditions de fabrication, de production, d’assemblage ou d’entreposage.

DORS/2004-238, art. 8; DORS/2010-222, art. 10. Version précédente G.02.019. Tout distributeur autorisé doit

a) assurer à toute drogue contrôlée en sa possession telle protection contre la perte ou contre le vol que peut exiger le ministre;

b) signaler au ministre le vol ou la perte de toute drogue contrôlée au plus tard 10 jours après l’avoir constaté; et

c) emballer solidement une drogue contrôlée dans son récipient immédiat et le sceller de telle manière que le récipient ne puisse être ouvert sans briser le sceau.

DORS/88-482, art. 2(F).

G.02.020. Il est interdit à un distributeur autorisé d’importer une drogue contrôlée au Canada, ou d’exporter ladite drogue à l’étranger, ailleurs qu’à l’endroit spécifié dans son permis.

G.02.021. Un distributeur autorisé doit emballer solidement, dans un empaquetage scellé de telle manière qu’il soit impossible de l’ouvrir sans briser le sceau, toute drogue contrôlée destinée à l’exportation en pays étranger.

G.02.022. Un distributeur autorisé, lorsqu’il prend livraison d’une drogue contrôlée qu’il a importée ou en faisant la livraison d’une drogue contrôlée,

a) doit prendre les mesures nécessaires pour assurer que la drogue contrôlée sera en sécurité durant le transport; et

b) doit employer tel moyen de transport qui assurera qu’un registre exact est gardé de la drogue et des signatures de toutes les personnes qui ont eu la drogue en charge jusqu’à sa livraison au consignataire.

G.02.023. Par dérogation à l’article G.02.022, une préparation peut être livrée par un voiturier public.

G.02.024. Il est interdit au distributeur autorisé de vendre ou de fournir une drogue contrôlée à des personnes autres que les suivantes :

a) un distributeur autorisé;

b) un pharmacien;

c) un praticien;

d) un employé d’un hôpital ou un praticien exerçant dans un hôpital;

e) [Abrogé, DORS/2010-222, art. 11]

f) une personne qui bénéficie d’une exemption accordée aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession d’une drogue contrôlée.

DORS/78-220, art. 3; DORS/85-550, art. 2; DORS/99-125, art. 2; DORS/2004-238, art. 9; DORS/2010-222, art. 11. Version précédente G.02.024.1. Sous réserve de l’article G.02.024.2 et nonobstant les articles G.02.024 et G.02.025, il est interdit à tout distributeur autorisé de

a) vendre ou fournir une drogue contrôlée, autre qu’une préparation, à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2;

b) vendre ou fournir une préparation à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2;

c) vendre ou fournir une drogue contrôlée, autre qu’une préparation, à un praticien nommé dans un avis communiqué par le ministre selon l’article G.04.004.2;

d) vendre ou fournir une préparation à un praticien nommé dans un avis communiqué par le ministre selon l’article G.04.004.2.

DORS/2003-135, art. 7 et 8; DORS/2004-238, art. 10.

G.02.024.2. L’article G.02.024.1 ne s’applique pas au distributeur autorisé auquel le ministre a donné un avis de rétractation de l’avis :

a) selon l’article G.03.017.3, à l’égard de tout pharmacien nommé dans un avis donné par le ministre selon l’article G.03.017.2;

b) selon l’article G.04.004.3, à l’égard de tout praticien nommé dans un avis donné par le ministre selon l’article G.04.004.2.

DORS/2003-135, art. 3.

G.02.025. (1) Sous réserve du présent article, le distributeur autorisé peut, conformément aux modalités de sa licence, vendre ou fournir une drogue contrôlée à une personne visée à l’article G.02.024, si les conditions suivantes sont réunies :

a) [Abrogé, DORS/2010-222, art. 12]

b) le distributeur autorisé a reçu, au lieu indiqué dans la licence, une commande sous l’une des formes suivantes, précisant le nom de la drogue et la quantité devant être fournie :

(i) une commande écrite,

(ii) une commande envoyée par ordinateur à partir d’un périphérique d’entrée à distance,

(iii) une commande verbale, dans le cas d’une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie.

(2) Le distributeur autorisé qui reçoit une commande écrite visée au sous-alinéa (1)b)(i) et en a vérifié la signature peut vendre ou fournir une drogue contrôlée à une personne visée à l’article G.02.024 si la commande est signée et datée par l’une des personnes suivantes :

a) dans les cas où la drogue contrôlée doit être vendue ou fournie à une personne visée aux alinéas G.02.024a), b), c) ou f), par cette personne;

b) dans les cas où la drogue contrôlée doit être fournie à un employé d’un hôpital ou à un praticien exerçant dans un hôpital, par le pharmacien responsable de l’officine de l’hôpital ou par un praticien autorisé par la personne à qui est confiée la charge de l’hôpital à signer la commande.

(3) Le distributeur autorisé peut vendre ou fournir une drogue contrôlée par suite d’une commande reçue par ordinateur à partir d’un périphérique d’entrée à distance, si le programme informatique et le périphérique d’entrée à distance satisfont aux exigences visées aux paragraphes (5) et (6).

(3.1) Le distributeur autorisé qui reçoit une commande envoyée par ordinateur à partir d’un périphérique d’entrée à distance, telle que visée au sous-alinéa (1)b)(ii), peut fournir une drogue contrôlée à un employé d’un hôpital ou à un praticien exerçant dans un hôpital, si cette commande a été faite par le pharmacien responsable de l’officine de l’hôpital ou par un praticien autorisé par le responsable de l’hôpital à faire une telle commande.

(3.2) Le distributeur autorisé qui reçoit une commande verbale mentionnée au sous-alinéa (1)b)(iii) peut fournir une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie à un employé d’un hôpital ou à un praticien exerçant dans un hôpital, si cette commande a été faite par le pharmacien responsable de l’officine de l’hôpital ou par le praticien autorisé par le responsable de l’hôpital à faire une telle commande.

(4) Le distributeur autorisé qui reçoit la commande verbale visée au sous-alinéa (1)b)(iii) et qui vend ou fournit une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie à une personne visée à l’un des alinéas G.02.024b) à d) consigne immédiatement les renseignements suivants :

a) le nom de la personne à laquelle il a vendu ou fourni la drogue contrôlée;

b) lorsque la drogue a été fournie à un employé d’un hôpital ou à un praticien exerçant dans un hôpital, le nom du pharmacien responsable de l’officine de l’hôpital ou du praticien autorisé par la personne à qui est confiée la charge de l’hôpital à signer la commande;

c) la date de réception de la commande.

(5) Aux fins de cet article, un périphérique d’entrée à distance doit être un appareil de transmission électronique des commandes de médicaments, autre qu’un dispositif de transmission de la voix, qui

a) comporte un code d’identification unique pouvant être associé au périphérique et au pharmacien ou praticien en possession de ce périphérique;

b) est en la possession et sous la surveillance de ce pharmacien ou praticien; et

c) est conçu de telle façon que le code d’identification unique pour le périphérique d’entrée à distance soit partie intégrante de l’ensemble des circuits et ne puisse être modifié qu’en démontant le dispositif.

(6) Aux fins de cet article, un programme informatique doit pouvoir

a) identifier le périphérique d’entrée à distance et le nom et l’adresse du pharmacien ou praticien en possession de ce périphérique;

b) identifier le pharmacien ou praticien faisant la commande au moyen du code d’identification unique propre au pharmacien ou praticien;

c) traiter séparément et identifier les drogues contrôlées en séparant les commandes pour ces drogues;

d) déceler les commandes inhabituelles, qui de ce fait, nécessitent l’intervention manuelle du distributeur autorisé; et

e) exiger l’intervention manuelle du distributeur autorisé si un ou plus d’un procédé de contrôle fait défaut.

(7) Le distributeur autorisé qui reçoit d’un pharmacien ou d’un praticien une commande envoyée par ordinateur à partir d’un périphérique d’entrée à distance, telle que visée au sous-alinéa (1)b)(ii), ou une commande verbale visée au sous-alinéa (1)b)(iii) doit, dans les cinq jours ouvrables suivant l’exécution de la commande obtenir et conserver un reçu portant :

a) la signature du pharmacien ou praticien qui a reçu la drogue contrôlée;

b) la date de la réception; et

c) le nom ainsi que la quantité de la drogue contrôlée.

(8) Si, dans le délai prévu au paragraphe (7), le distributeur autorisé n’obtient pas le reçu requis du pharmacien ou du praticien à qui il a vendu ou fourni la drogue contrôlée, il

doit refuser, jusqu’à ce qu’il obtienne le reçu, d’honorer l’une ou l’autre des commandes suivantes faite par le pharmacien ou le praticien :

a) la commande visée au sous-alinéa (1)b)(ii) envoyée par ordinateur au moyen d’un périphérique d’entrée à distance;

b) la commande verbale visée au sous-alinéa (1)b)(iii).

DORS/78-220, art. 4; DORS/78-427, art. 4; DORS/85-550, art. 3; DORS/88-482, art. 3(F); DORS/90-261, art. 2(F); DORS/97-228, art. 11; DORS/2004-238, art. 11; DORS/2010-222, art. 12. Version précédente G.02.026. Il est interdit au distributeur autorisé de vendre ou de fournir une drogue contrôlée plus d’une fois à la suite d’une commande à moins :

a) que, dans la commande de la drogue, il soit indiqué que la quantité de la drogue doit être vendue ou fournie :

(i) en portions spécifiées,

(ii) en livraisons distinctes, ne dépassant pas quatre livraisons, et

(iii) à des intervalles spécifiés; ou

b) que le distributeur autorisé ne dispose pas temporairement de toute la quantité de la drogue demandée au moment où il reçoit la commande, auquel cas il peut vendre ou fournir la quantité de la drogue qu’il a en main et livrer le reliquat par la suite, conformément à la commande.

DORS/2004-238, art. 12; DORS/2010-222, art. 13(F). Version précédente G.02.027. [Abrogé, DORS/80-543, art. 12]

Titre 3

Pharmacien G.03.001. (1) Sur réception d’une drogue contrôlée provenant d’un distributeur autorisé ou d’un autre pharmacien, le pharmacien consigne le nom et la quantité de la drogue contrôlée reçue, les nom et adresse de celui qui la lui a vendue ou fournie et la date de réception.

(2) Les renseignements visés au paragraphe (1) doivent être conservés

a) de manière à en permettre la vérification; et

b) sous réserve du paragraphe (3), dans un cahier, un registre ou un autre dossier semblable réservé exclusivement aux drogues contrôlées.

(3) Les renseignements visés au paragraphe (1) peuvent, dans le cas d’une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie, être conservés sous une forme autre que celle précisée à l’alinéa (2)b).

DORS/78-427, art. 5; DORS/85-550, art. 4; DORS/86-91, art. 2(F); DORS/90-261, art. 3(F); DORS/97-228, art. 12; DORS/2004-238, art. 13; DORS/2010-222, art. 14(A). Version précédente G.03.002. Il est interdit à tout pharmacien, sous réserve des autres dispositions de la présente partie, de vendre ou de fournir une drogue contrôlée à qui que ce soit, à moins d’avoir reçu au préalable une ordonnance à cet effet et d’avoir pris à son égard les mesures suivantes :

a) si l’ordonnance est écrite, s’assurer qu’elle est signée et datée par le praticien dont elle émane et vérifier lui-même toute signature qu’il ne connaît pas;

b) si l’ordonnance est verbale, prendre les précautions raisonnables pour s’assurer que la personne la prescrivant est bien un praticien.

DORS/2004-238, art. 14.

G.03.002.1. Sous réserve de l’article G.03.002.2 et nonobstant les articles G.03.002, G.03.003 et G.03.005, il est interdit à un pharmacien de

a) vendre ou fournir une drogue contrôlée, autre qu’une préparation, à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2;

b) vendre ou fournir une préparation à un pharmacien nommé dans un avis communiqué par le ministre selon l’article G.03.017.2;

c) délivrer, vendre ou fournir une drogue contrôlée, autre qu’une préparation, à un praticien, ou en vertu d’une ordonnance ou commande faite par un praticien nommé dans un avis communiqué par le ministre selon l’article G.04.004.2;

d) délivrer, vendre ou fournir une préparation à un praticien, ou en vertu d’une ordonnance ou commande faite par un praticien nommé dans un avis communiqué par le ministre selon l’article G.04.004.2.

DORS/2003-135, art. 7 et 8; DORS/2004-238, art. 15.

G.03.002.2. L’article G.03.002.1 ne s’applique pas au pharmacien auquel le ministre a donné un avis de rétractation de l’avis :

a) selon l’article G.03.017.3, à l’égard de tout pharmacien nommé dans un avis donné par le ministre selon l’article G.03.017.2;

b) selon l’article G.04.004.3, à l’égard de tout praticien nommé dans un avis donné par le ministre selon l’article G.04.004.2.

DORS/2003-135, art. 4.

G.03.003. Le pharmacien peut vendre ou fournir une drogue contrôlée à un praticien pour l’usage de sa pratique professionnelle dans l’une des circonstances suivantes :

a) sur réception d’une commande écrite, signée et datée par le praticien, pourvu qu’il vérifie la signature du praticien si elle lui est inconnue;

b) sur réception d’une commande verbale, précisant le nom et la quantité de la drogue, s’il prend les moyens raisonnables pour s’assurer que la personne qui fait la commande est un praticien.

DORS/85-550, art. 5; DORS/2004-238, art. 16.

G.03.004. Tout pharmacien doit, à l’égard des drogues contrôlées vendues ou fournies à un praticien en vertu de l’article G.03.003, tenir un registre spécial des ordonnances, où seront consignés la date de l’ordonnance, les nom et adresse du praticien et la nature et la quantité de la drogue contrôlée vendue ou fournie.

DORS/2004-238, art. 17.

G.03.005. Un pharmacien peut fournir une drogue contrôlée à un employé d’un hôpital ou à un praticien exerçant dans un hôpital, sur réception d’une commande écrite datée et signée par le pharmacien responsable de l’officine de l’hôpital ou par un praticien autorisé par le responsable de l’hôpital à signer la commande, si le pharmacien reconnaît la signature du pharmacien ou du praticien ou, dans le cas contraire, qu’il l’a vérifiée.

DORS/85-550, art. 6; DORS/2004-238, art. 18(A).

G.03.006. Il est interdit à un pharmacien de remplir de nouveau une ordonnance pour une drogue contrôlée, à moins

a) que le praticien, au moment où il l’a prescrite, n’ait indiqué, par écrit dans le cas d’une drogue contrôlée mentionnée à la partie I de l’annexe de la présente partie, et par écrit ou verbalement dans le cas d’une drogue contrôlée mentionnée aux parties II ou III de cette annexe, que cette ordonnance est renouvelable pour un certain nombre de fois à des dates ou des intervalles précis;

b) que le pharmacien ne consigne au registre chaque renouvellement d’une ordonnance.

DORS/78-427, art. 6; DORS/97-228, art. 13.

G.03.007 Le pharmacien qui, conformément à une commande ou à une ordonnance, fournit une drogue contrôlée mentionnée à la partie I de l’annexe de la présente partie, autre qu’une préparation, doit consigner immédiatement dans un cahier, un registre ou un dossier semblable tenu à cette fin :

a) le nom et l’adresse de la personne nommée dans cette commande ou ordonnance;

b) le nom, les initiales et l’adresse du praticien qui a prescrit la commande ou l’ordonnance;

c) son nom ou ses initiales;

d) le nom, la quantité et la forme de cette drogue contrôlée;

e) la date de vente ou de fourniture de cette drogue;

f) le numéro assigné à cette commande ou ordonnance.

DORS/78-427, art. 7; DORS/81-359, art. 1(F); DORS/97-228, art. 14; DORS/2004-238, art. 19.

G.03.008. Le pharmacien doit, avant de fournir une drogue contrôlée en exécution d’une commande verbale ou d’une ordonnance verbale, consigner dans un registre les détails suivants :

a) le nom et l’adresse de la personne nommée dans l’ordonnance;

b) le nom, la quantité et la forme de ladite drogue contrôlée;

c) le mode d’emploi indiqué dans ladite ordonnance;

d) le nom, les initiales et l’adresse du praticien qui a émis l’ordonnance;

e) le nom ou les initiales du pharmacien qui fournit ladite drogue contrôlée;

f) la date à laquelle la drogue contrôlée est vendue ou fournie;

g) le numéro assigné à l’ordonnance.

DORS/85-550, art. 7; DORS/2004-238, art. 20.

G.03.009. Tout pharmacien doit tenir un registre spécial des ordonnances où il doit consigner, par ordre chronologique et numérique, toutes les commandes par écrit et les ordonnances écrites, pour toutes les drogues contrôlées qu’il fournit, et le rapport écrit de toutes les drogues contrôlées fournies en vertu d’une ordonnance ou d’une commande données verbalement.

G.03.010. Tout pharmacien doit conserver en sa possession durant au moins deux ans, tous les dossiers et registres dont la tenue est exigée par la présente partie.

G.03.011. Tout pharmacien doit

a) fournir tout renseignement relatif aux transactions dudit pharmacien à l’égard de toute drogue contrôlée, dans la manière et au moment que peut fixer le ministre;

b) présenter à un inspecteur, sur demande, son registre spécial des ordonnances, ainsi que tout autre cahier, registre ou document qu’il est obligé de tenir;

c) permettre à l’inspecteur de prendre copie ou de noter des extraits de tous lesdits cahiers, registres, dossiers ou documents; et

d) permettre à l’inspecteur de vérifier tous les stocks de drogues contrôlées dans son établissement.

G.03.012. Le pharmacien doit prendre toutes les mesures raisonnables qui sont nécessaires pour protéger contre la perte et le vol les drogues contrôlées qui se trouvent dans son établissement ou dont il a la garde.

DORS/85-550, art. 8.

G.03.013. Tout pharmacien doit signaler au ministre toute perte ou tout vol d’une drogue contrôlée, 10 jours au plus après en avoir fait la découverte.

G.03.014. Le pharmacien peut, lorsqu’il reçoit une commande écrite pour une drogue contrôlée, signée et datée

a) par le distributeur autorisé qui lui a vendu ou fourni la drogue, lui retourner cette drogue;

b) par un autre pharmacien, lui vendre ou lui fournir la quantité de drogue demandée pour une urgence;

c) par un directeur régional du ministère, vendre ou fournir à ce dernier ou conformément à sa commande la quantité de drogue demandée dont le directeur a besoin dans l’exercice de ses fonctions;

d) par une personne qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à cette drogue, lui vendre ou lui fournir la quantité de drogue demandée.

DORS/81-359, art. 2; DORS/85-550, art. 9; DORS/99-125, art. 3; DORS/2004-238, art. 21.

G.03.015. Le pharmacien, immédiatement après avoir reçu, vendu ou fourni une drogue contrôlée conformément aux alinéas G.03.014b) ou c) ou au paragraphe G.05.003(4), consigne les détails de la transaction dans un cahier, un registre ou tout autre dossier approprié.

DORS/85-550, art. 10; DORS/2004-238, art. 22.

G.03.016. Un pharmacien doit, immédiatement après avoir retiré, transporté ou transféré une drogue contrôlée de son établissement d’affaires à tout autre établissement d’affaires exploité par lui-même, avertir le ministre en précisant les détails.

G.03.017. Le ministre communique par écrit à l’autorité provinciale attributive de licences en matière d’activités professionnelles ayant la responsabilité d’inscrire la personne ou d’autoriser cette dernière à exercer sa profession des renseignements factuels sur tout pharmacien obtenus sous le régime de la Loi ou du présent règlement :

a) soit dans la province où le pharmacien est inscrit ou habilité à exercer, dans l’un ou l’autre des cas suivants :

(i) l’autorité soumet une demande écrite qui précise le nom et l’adresse du pharmacien, la nature des renseignements requis et une déclaration que les renseignements sont requis dans le but d’aider l’autorité à mener une enquête licite,

(ii) le ministre a des motifs raisonnables de croire que le pharmacien a :

(A) soit enfreint une règle de conduite établie par l’autorité,

(B) soit été reconnu coupable par un tribunal d’une infraction désignée en matière de drogue ou d’une contravention à la présente partie,

(C) soit commis un acte qui contrevient à une disposition de la présente partie;

b) soit dans une province où le pharmacien n’est pas inscrit ou habilité à exercer, si l’autorité soumet au ministre les éléments suivants :

(i) une demande écrite de renseignements qui précise :

(A) le nom et l’adresse du pharmacien,

(B) la nature des renseignements requis,

(ii) une documentation qui montre que le pharmacien a demandé à cette autorité l’autorisation d’exercer dans cette province.

DORS/86-881, art. 1; DORS/97-228, art. 15; DORS/2003-135, art. 5; DORS/2010-222, art. 15. Version précédente G.03.017.1. Tout pharmacien peut demander par écrit au ministre d’envoyer aux personnes et aux autorités visées au paragraphe G.03.017.2(3) un avis, émis conformément à l’article G.03.017.2, les informant que ne doivent pas lui être vendu ou fourni toute drogue contrôlée autre qu’une préparation, toute préparation, ou les deux.

DORS/2003-135, art. 5.

G.03.017.2. (1) Dans les circonstances exposées au paragraphe (2), le ministre donne un avis aux personnes et aux autorités visées au paragraphe (3) les informant que les distributeurs autorisés et les pharmaciens qui exercent dans les pharmacies avisées ne doivent pas vendre ou fournir au pharmacien nommé dans l’avis toute drogue contrôlée autre qu’une préparation, toute préparation, ou les deux.

(2) L’avis est donné si le pharmacien qui y est nommé se trouve dans l’une des circonstances suivantes :

a) il a demandé au ministre de donner l’avis conformément à l’article G.03.017.1;

b) il a enfreint une règle de conduite établie par l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il exerce et cette autorité a demandé par écrit au ministre de donner l’avis;

c) il a été reconnu coupable par le tribunal d’une infraction désignée en matière de drogue ou d’une contravention à la présente partie.

(3) L’avis doit être donné aux personnes ou organismes suivants :

a) tous les distributeurs autorisés;

b) toutes les pharmacies de la province où le pharmacien nommé dans l’avis est inscrit et exerce;

c) l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le pharmacien est inscrit ou habilité à exercer;

d) toute autorité provinciale attributive de licences en matière d’activités professionnelles d’une autre province qui en a fait la demande au ministre.

(4) Sous réserve du paragraphe (5), le ministre peut donner l’avis prévu au paragraphe (1) aux personnes et organismes mentionnés au paragraphe (3) s’il a des motifs raisonnables de croire que le pharmacien nommé dans l’avis a posé l’un des actes suivants :

a) il a enfreint l’un des articles G.03.001 à G.03.016;

b) à plus d’une reprise, il s’est administré une drogue contrôlée autre qu’une préparation d’une façon non conforme aux pratiques pharmaceutiques reconnues;

c) à plus d’une reprise, il s’est administré une préparation d’une façon non conforme aux pratiques pharmaceutiques reconnues;

d) à plus d’une reprise, il a fourni ou administré une drogue contrôlée autre qu’une préparation à son époux ou conjoint de fait, son père ou sa mère ou son enfant, y compris un enfant adopté de fait, d’une façon non conforme aux pratiques pharmaceutiques reconnues;

e) à plus d’une reprise, il a fourni ou administré une préparation à son époux ou conjoint de fait, son père ou sa mère ou son enfant, y compris un enfant adopté de fait, d’une façon non conforme aux pratiques pharmaceutiques reconnues;

f) il est dans l’impossibilité de rendre compte de la quantité de drogue contrôlée dont il était responsable aux termes de la présente partie.

(5) Dans les circonstances décrites au paragraphe (4), le ministre donne l’avis mentionné au paragraphe (1) aux conditions suivantes :

a) il a consulté l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le pharmacien en cause est inscrit ou habilité à exercer;

b) il a donné au pharmacien l’occasion de présenter les raisons pour lesquelles l’avis ne devrait pas être donné et il les a prises en considération;

c) il a pris en considération les éléments suivants :

(i) les antécédents du pharmacien quant au respect de la Loi et des règlements pris ou maintenus en vigueur en vertu de celle-ci,

(ii) la question de savoir si les actions du pharmacien risqueraient ou non de porter atteinte à la santé ou à la sécurité publiques, notamment en raison du risque de détournement de la drogue contrôlée vers un marché ou un usage illicite.

DORS/2003-135, art. 5; DORS/2010-222, art. 16 et 35(F). Version précédente G.03.017.3. Le ministre envoie aux distributeurs autorisés, pharmacies et autorités provinciales attributives de licences en matière d’activités professionnelles ayant reçu un avis conformément au paragraphe G.03.017.2(1) un avis de rétractation de cet avis dans les cas suivants :

a) dans le cas visé à l’alinéa G.03.017.2(2)a), si les conditions prévues aux sous-alinéas b)(i) et (ii) du présent article ont été remplies et il s’est écoulé un an depuis que l’avis a été envoyé par le ministre;

b) dans les cas visés aux alinéas G.03.017.2(2)b) et c) et (4)a) à f), si le pharmacien nommé dans l’avis, à la fois :

(i) lui a demandé par écrit la rétractation de l’avis en cause,

(ii) lui a remis une lettre de l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il est inscrit ou habilité à exercer, dans laquelle l’autorité accepte la rétractation de l’avis.

DORS/2003-135, art. 5; DORS/2010-222, art. 17. Version précédente G.03.017.4. et G.03.017.5. [Abrogés, DORS/2003-135, art. 5]

Titre 4

Praticiens G.04.001. (1) Dans le présent article,

« administrer » s’entend notamment du fait de prescrire, de vendre ou de fournir; (administer)

« drogue désignée » signifie l’une des drogues contrôlées suivantes :

a) amphétamine et ses sels,

b) benzphétamine et ses sels,

c) méthamphétamine et ses sels,

d) phenmétrazine et ses sels, ou

e) phendimétrazine et ses sels. (designated drug)

(2) Sous réserve des paragraphes (3) et (4) et d’une exemption dont il bénéficie aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à l’administration de la drogue contrôlée qui est nommée dans l’exemption, il est interdit à tout praticien d’administrer une drogue contrôlée à une personne ou à un animal.

(3) Un praticien peut administrer, à une personne ou à un animal, une drogue contrôlée, autre qu’une drogue désignée, si

a) ladite personne ou ledit animal sont des sujets qu’il traite à titre professionnel; et si

b) l’état de ladite personne ou dudit animal traités commande l’emploi de ladite drogue contrôlée.

(4) Un praticien peut administrer une drogue désignée à un animal ou à une personne qu’il traite à titre professionnel, lorsque la drogue désignée est destinée au traitement de l’un des états suivants :

a) chez l’homme,

(i) narcolepsie,

(ii) troubles hypercinétiques chez l’enfant,

(iii) arriération mentale (dysfonction cérébrale minimale),

(iv) épilepsie,

(v) syndrome parkinsonien, ou

(vi) hypotension liée à l’anesthésie; et

b) chez les animaux, dépression des centres cardiaques et respiratoires.

DORS/99-125, art. 4; DORS/2004-238, art. 23.

G.04.002. (1) Tout praticien qui vend ou fournit à une personne une drogue contrôlée qu’elle s’administrera à elle-même ou qu’elle administrera à un animal, qu’il la facture ou non, consigne le nom et la quantité de la drogue contrôlée vendue ou fournie, les nom et adresse de la personne à laquelle elle l’a été et la date de la transaction, s’il s’agit d’une quantité :

a) supérieure à trois fois la dose quotidienne maximum recommandée par le fabricant, le producteur ou l’assembleur de cette drogue contrôlée;

b) supérieure à trois fois la dose thérapeutique quotidienne maximum généralement admise pour cette drogue contrôlée, si le fabricant, le producteur ou l’assembleur n’a pas spécifié de dose quotidienne maximum.

(2) Tout praticien qui est requis, par le présent article, de tenir un registre doit garder le registre en un endroit et le tenir sous une forme et d’une manière qui permettent à un inspecteur de l’examiner et d’y trouver des renseignements avec facilité.

DORS/88-482, art. 4(F); DORS/2004-238, art. 24.

G.04.002A. Tout praticien doit

a) fournir au ministre, sur demande, tout renseignement concernant

(i) l’usage que ce praticien fait des drogues contrôlées qu’il reçoit — y compris les cas où il les administre, les vend ou les fournit à une personne,

(ii) les ordonnances de drogues contrôlées que délivre ce praticien,

selon que peut l’exiger le ministre;

b) présenter à un inspecteur, sur demande, tout registre que ce praticien est requis de tenir en vertu du présent règlement;

c) permettre à un inspecteur de prendre copie de ces registres ou de noter des extraits desdits registres;

d) permettre à un inspecteur de vérifier tous les stocks de drogues contrôlées dans les locaux de ce praticien;

e) conserver en sa possession durant au moins deux ans tout registre qu’il est requis de tenir en vertu du présent règlement;

f) prendre les mesures appropriées pour protéger les drogues contrôlées qu’il a en sa possession contre la perte ou le vol; et

g) signaler au ministre tout vol ou perte d’une drogue contrôlée au plus tard 10 jours après avoir constaté un tel vol ou une telle perte.

DORS/2004-238, art. 25.

G.04.003. [Abrogé, DORS/2010-222, art. 18] Version précédente G.04.004. Le ministre communique par écrit à l’autorité provinciale attributive de licences en matière d’activités professionnelles ayant la responsabilité d’inscrire la personne ou d’autoriser cette dernière à exercer sa profession des renseignements factuels sur tout praticien obtenus sous le régime de la Loi ou du présent règlement :

a) soit dans la province où le praticien est inscrit ou habilité à exercer, dans l’un ou l’autre des cas suivants :

(i) l’autorité soumet une demande écrite qui précise le nom et l’adresse du praticien, la nature des renseignements requis et une déclaration que les renseignements sont requis dans le but d’aider l’autorité à mener une enquête licite,

(ii) le ministre a des motifs raisonnables de croire que le praticien a :

(A) soit enfreint une règle de conduite établie par l’autorité,

(B) soit été reconnu coupable par un tribunal d’une infraction désignée en matière de drogue ou d’une contravention à la présente partie,

(C) soit commis un acte qui contrevient à une disposition de la présente partie;

b) soit dans une province où le praticien n’est pas inscrit ou habilité à exercer si l’autorité soumet au ministre les éléments suivants :

(i) une demande écrite de renseignements qui précise :

(A) le nom et l’adresse du praticien,

(B) la nature des renseignements requis,

(ii) une documentation qui montre que le praticien a demandé à cette autorité l’autorisation d’exercer dans cette province.

DORS/86-881, art. 2; DORS/97-228, art. 17; DORS/2003-135, art. 6; DORS/2010-222, art. 19. Version précédente G.04.004.1. Tout praticien peut demander par écrit au ministre d’envoyer aux pharmacies et aux distributeurs autorisés un avis, émis conformément à l’article G.04.004.2, les informant de tout ou partie des exigences suivantes :

a) aucune drogue contrôlée, autre qu’une préparation, ne doit lui être vendue ou fournie par un destinataire de cet avis;

b) aucune préparation ne doit lui être vendue ou fournie par un destinataire de cet avis;

c) aucune de ses ordonnances ou commandes de drogue contrôlée, autre qu’une préparation, ne doit être remplie par des pharmaciens exerçant dans les pharmacies ayant reçu l’avis;

d) aucune de ses ordonnances ou commandes de préparation ne doit être remplie par des pharmaciens exerçant dans les pharmacies ayant reçu l’avis.

DORS/2003-135, art. 6.

G.04.004.2. (1) Dans les circonstances décrites au paragraphe (2), le ministre donne un avis aux personnes et aux autorités visées au paragraphe (3) les informant, selon le cas, que :

a) les distributeurs autorisés et les pharmaciens qui exercent dans les pharmacies avisées ne doivent pas vendre ou fournir au praticien nommé dans l’avis toute drogue contrôlée autre qu’une préparation, toute préparation, ou les deux;

b) les pharmaciens qui exercent dans les pharmacies avisées ne doivent pas remplir une ordonnance ou une commande, du praticien nommé dans l’avis, de drogue contrôlée autre qu’une préparation, de préparation, ou des deux.

(2) L’avis est donné si le praticien nommé dans l’avis se trouve dans l’une des circonstances suivantes :

a) il a demandé au ministre de donner l’avis conformément à l’article G.04.004.1;

b) il a enfreint une règle de conduite établie par l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il exerce et cette autorité a demandé par écrit au ministre de donner l’avis;

c) il a été reconnu coupable par le tribunal d’une infraction désignée en matière de drogue ou d’une contravention à la présente partie.

(3) L’avis doit être donné aux personnes ou organismes suivants :

a) tous les distributeurs autorisés;

b) toutes les pharmacies de la province où le praticien nommé dans l’avis est inscrit et exerce;

c) l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le praticien est inscrit ou habilité à exercer;

d) toute autorité provinciale attributive de licences en matière d’activités professionnelles d’une autre province qui en a fait la demande au ministre;

e) les pharmacies d’une province adjacente par lesquelles une ordonnance ou une commande du praticien nommé dans l’avis pourrait être remplie.

(4) Sous réserve du paragraphe (5), le ministre peut donner l’avis prévu au paragraphe (1) aux personnes et organismes mentionnés au paragraphe (3) s’il a des motifs raisonnables de croire que le praticien nommé dans l’avis a posé l’un des actes suivants :

a) il a enfreint l’un des articles G.04.001 à G.04.002A;

b) à plus d’une reprise, il s’est administré une drogue contrôlée, autre qu’une préparation, obtenue sur ordonnance ou commande écrite par lui ou, à défaut d’une ordonnance ou commande, d’une façon non conforme aux pratiques médicales, dentaires ou vétérinaires reconnues;

c) à plus d’une reprise, il s’est administré une préparation obtenue sur ordonnance ou commande écrite par lui ou, à défaut d’une ordonnance ou commande, d’une façon non conforme aux pratiques médicales, dentaires ou vétérinaires reconnues;

d) à plus d’une reprise, il a prescrit, fourni ou administré une drogue contrôlée autre qu’une préparation à son époux ou conjoint de fait, son père ou sa mère ou son enfant, y compris un enfant adopté de fait, d’une façon non conforme aux pratiques médicales, dentaires ou vétérinaires reconnues;

e) à plus d’une reprise, il a prescrit, fourni ou administré une préparation à son époux ou conjoint de fait, son père ou sa mère ou son enfant, y compris un enfant adopté de fait, d’une façon non conforme aux pratiques médicales, dentaires ou vétérinaires reconnues;

f) il est dans l’impossibilité de rendre compte de la quantité de drogue contrôlée dont il était responsable en vertu de la présente partie.

(5) Dans les circonstances décrites au paragraphe (4), le ministre donne l’avis mentionné au paragraphe (1) aux conditions suivantes :

a) il a consulté l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où le praticien en cause est inscrit ou habilité à exercer;

b) il a donné au praticien l’occasion de présenter les raisons pour lesquelles l’avis ne devrait pas être donné et il les a prises en considération;

c) il a pris en considération les éléments suivants :

(i) les antécédents du praticien quant au respect de la Loi et des règlements pris ou maintenus en vigueur en vertu de celle-ci,

(ii) la question de savoir si les actions du praticien risqueraient ou non de porter atteinte à la santé ou à la sécurité publiques, notamment en raison du risque de détournement de la drogue contrôlée vers un marché ou un usage illicite.

DORS/2003-135, art. 6; DORS/2010-222, art. 20 et 35(F). Version précédente G.04.004.3. Le ministre envoie aux distributeurs autorisés, pharmacies et autorités provinciales attributives de licences en matière d’activités professionnelles ayant reçu un avis conformément au paragraphe G.04.004.2(1) un avis de rétractation de cet avis dans les cas suivants :

a) dans le cas visé à l’alinéa G.04.004.2(2)a), si les conditions prévues aux sous-alinéas b)(i) et (ii) du présent article ont été remplies et il s’est écoulé un an depuis que l’avis a été envoyé par le ministre;

b) dans les cas visés aux alinéas G.04.004.2(2)b) et c) et (4)a) à f), si le praticien nommé dans l’avis, à la fois :

(i) lui a demandé par écrit la rétractation de l’avis en cause,

(ii) lui a remis une lettre de l’autorité provinciale attributive de licences en matière d’activités professionnelles de la province où il est inscrit ou habilité à exercer, dans laquelle l’autorité accepte la rétractation de l’avis.

DORS/88-482, art. 5(F); DORS/2003-135, art. 6; DORS/2010-222, art. 21. Version précédente G.04.004.4. et G.04.004.5. [Abrogés, DORS/2003-135, art. 6]

Titre 5

Hôpitaux G.05.001. (1) Le responsable d’un hôpital doit tenir ou faire tenir un registre indiquant les renseignements suivants :

a) le nom et la quantité de toute drogue contrôlée reçue, au nom de l’hôpital, par un employé de cet hôpital ou un praticien exerçant dans cet hôpital;

b) le nom et l’adresse du fournisseur, ainsi que la date de réception;

c) le nom et la quantité de toute drogue contrôlée employée dans la fabrication ou l’assemblage d’un produit ou d’un composé qui contient cette drogue, le nom et la quantité du produit ou du composé fabriqué ou assemblé et la date à laquelle ce produit ou ce composé a été stocké;

c.1) le nom et la quantité de toute drogue contrôlée produite et la date à laquelle elle a été stockée;

d) le nom du malade pour qui cette drogue a été prescrite;

e) le nom du praticien qui la commande ou la prescrit; et

f) la date à laquelle une drogue contrôlée est commandée ou prescrite, ainsi que la forme et la quantité concernées.

(2) Sous réserve des paragraphes (3) et (4), le registre visé au paragraphe (1) doit :

a) être tenu de façon à en permettre la vérification;

b) se présenter sous forme de cahier, de livre ou d’un autre document semblable réservé aux drogues contrôlées;

c) être conservé pendant au moins deux ans.

(3) Dans le cas d’une préparation, un registre autre que celui décrit à l’alinéa (2)b) peut être utilisé pour l’inscription des renseignements visés aux alinéas (1)d) à f).

(4) Les renseignements visés au paragraphe (1) peuvent, dans le cas d’une drogue contrôlée mentionnée aux parties II ou III de l’annexe de la présente partie, être conservés sous une forme autre que celle précisée à l’alinéa (2)b).

DORS/78-427, art. 8; DORS/85-550, art. 11; DORS/88-482, art. 6; DORS/97-228, art. 18; DORS/2004-238, art. 27.

G.05.002. Toute personne à qui est confiée la charge d’un hôpital doit

a) fournir tout renseignement relatif à l’emploi des drogues contrôlées dans ledit hôpital, dans la forme et au moment que peut fixer le ministre;

b) présenter à un inspecteur tous les cahiers, dossiers, registres ou documents que le présent règlement exige de tenir;

c) permettre à un inspecteur de prendre copie ou de noter des extraits desdits cahiers, registres ou documents; et

d) permettre à un inspecteur de vérifier tous les stocks de drogues contrôlées dans ledit hôpital.

G.05.003. (1) Il est interdit à la personne à qui est confiée la charge d’un hôpital de permettre qu’une drogue contrôlée soit vendue, fournie ou administrée si ce n’est en conformité avec le présent article.

(2) La personne à qui est confiée la charge d’un hôpital peut permettre qu’une drogue contrôlée soit administrée à la personne ou à l’animal qui reçoit un traitement comme patient hospitalisé ou externe de cet hôpital, ou soit vendue ou fournie à cette personne ou au responsable de l’animal, sur réception d’une ordonnance ou d’une commande écrite, signée et datée par un praticien.

(3) Sous réserve du paragraphe (6), la personne à qui est confiée la charge d’un hôpital peut permettre qu’une drogue contrôlée soit fournie pour une urgence à un employé d’un autre hôpital ou à un praticien exerçant dans un autre hôpital, sur réception d’une commande écrite, signée et datée par le pharmacien de l’autre hôpital ou par le praticien autorisé par la personne à qui est confiée la charge de l’autre hôpital à signer une telle commande.

(4) Sous réserve du paragraphe (6), la personne à qui est confiée la charge d’un hôpital peut permettre qu’une drogue contrôlée soit vendue ou fournie à un pharmacien pour une urgence, sur réception d’une commande écrite, signée et datée par ce pharmacien.

(5) Le responsable d’un hôpital peut permettre qu’une drogue contrôlée soit fournie, à des fins de recherches, à un employé d’un laboratoire de recherche de cet hôpital.

(6) Il est interdit à la personne à qui est confiée la charge d’un hôpital de permettre que soit vendue ou fournie la drogue contrôlée visée aux paragraphes (3) et (4) à moins que la personne qui la vend ou la fournit reconnaisse ou sinon vérifie la signature du pharmacien de l’autre hôpital ou du praticien autorisé par la personne à qui est confiée la charge de l’autre hôpital à signer une commande.

DORS/85-550, art. 12; DORS/88-482, art. 7; DORS/2004-238, art. 28; DORS/2010-222, art. 22(F). Version précédente

G.05.004. Le responsable d’un hôpital doit prendre toutes les mesures nécessaires pour empêcher, dans son établissement, la perte ou le vol de drogues contrôlées et doit signaler au ministre toute perte ou tout vol dans les 10 jours en suivant la découverte.

DORS/78-427, art. 9.

Titre 6 Autorités et peines

G.06.001. (1) et (2) [Abrogés, DORS/99-125, art. 5]

(3) Malgré toute disposition du présent règlement, une personne peut, aux fins d’identification ou d’analyse, fournir ou livrer une drogue contrôlée qu’elle a en sa possession :

a) à un praticien en médecine; ou

b) à un représentant d’un praticien en médecine qui bénécifie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession d’une telle drogue contrôlée.

(4) Lorsque le représentant d’un praticien en médecine a reçu une drogue contrôlée, aux termes du paragraphe (3), il la fournit ou la livre sans délai :

a) au praticien dont il est le représentant; ou

b) au ministre ou à son représentant.

(5) Le praticien en médecine qui a reçu une drogue contrôlée aux termes du paragraphe (3) ou (4) la fournit ou la livre sans délai :

a) à des fins d’identification ou d’analyse, à une personne qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement la possession d’une telle drogue à ces fins; ou

b) au ministre ou à son représentant.

DORS/99-125, art. 5; DORS/2004-238, art. 29.

G.06.002. Toute personne qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession ou à l’administration d’une drogue contrôlée doit :

a) inscrire, dans un registre, les renseignements suivants qui doivent être conservés pendant deux ans à compter de la date de leur inscription :

(i) de la sorte et de la quantité de toute drogue contrôlée qu’elle a achetée ou reçue, ainsi que de la date de ladite acquisition ou réception,

(ii) du nom et de l’adresse de la personne de qui ladite drogue contrôlée a été reçue, et

(iii) des détails de l’usage fait de ladite drogue contrôlée; et

b) fournir, à l’égard desdites drogues contrôlées, tout renseignement que peut exiger le ministre, et donner accès aux registres dont la tenue est exigée par la présente partie.

DORS/85-550, art. 13; DORS/88-482, art. 8(F); DORS/99-125, art. 6.

Nécessaires d'essai contenant des drogues contrôlées

G.06.002.1. Toute personne peut vendre, posséder ou autrement manipuler un nécessaire d’essai contenant une drogue contrôlée si

a) un numéro d’enregistrement a été émis pour le nécessaire, selon l’article G.06.002.3;

b) le nécessaire d’essai porte, sur sa surface extérieure,

(i) le nom du fabricant, du producteur ou de l’assembleur,

(ii) le nom commercial ou la marque de commerce, et

(iii) le numéro d’enregistrement émis selon l’article G.06.002.3;

c) le nécessaire d’essai est vendu, acquis ou autrement manipulé, à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques; et

d) le numéro d’enregistrement n’a pas été annulé selon l’article G.06.002.4.

DORS/2004-238, art. 30.

G.06.002.2. Le fabricant d’un nécessaire d’essai contenant une drogue contrôlée peut demander un numéro d’enregistrement en présentant au Directeur une demande contenant

a) les détails de la présentation et de la composition du nécessaire d’essai;

b) une description détaillée de la drogue contrôlée et des autres substances, s’il en est, que contient le nécessaire d’essai, y compris la composition qualitative et quantitative de chacun des composants;

c) une description de l’usage auquel on destine le nécessaire d’essai; et

d) tout autre renseignement et document susceptibles d’être demandés par le ministre afin qu’il puisse déterminer s’il peut émettre un numéro d’enregistrement pour le nécessaire d’essai.

G.06.002.3. Lorsque, sur une demande selon l’article G.06.002.2, le ministre est convaincu que le nécessaire d’essai ne sera utilisé qu’à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques, et qu’il

a) contient une drogue contrôlée et une ou plusieurs substances adultérantes ou dénaturantes, mélangées de telle manière et en quantités, proportions ou concentrations telles que la préparation ou le mélange ne présente que très peu ou aucun potentiel d’abus, ou

b) contient des quantités ou concentrations de drogues contrôlées si infimes qu’elles ne présentent aucun potentiel d’abus significatif,

le ministre peut émettre un numéro d’enregistrement pour ce nécessaire, qu’il fera précéder des lettres « TK ».

DORS/81-21, art. 1 et 2; DORS/86-91, art. 3(F).

G.06.002.4. Le ministre peut annuler le numéro d’enregistrement d’un nécessaire d’essai si celui-ci est retiré du marché par le fabricant ou si, de l’avis du ministre,

a) il convient de l’annuler dans l’intérêt de la santé publique; ou

b) le nécessaire d’essai est utilisé ou est susceptible de l’être, à des fins autres que médicales, expérimentales, industrielles, éducatives ou scientifiques.

G.06.003. Toute personne qui enfreint une disposition de la présente partie est coupable d’une infraction et passible, sur déclaration sommaire de culpabilité, d’une amende d’au plus 500 $, ou d’un emprisonnement d’au plus six mois, ou à la fois de l’amende et de l’emprisonnement.

Titre 7 Dispositions générales

G.07.001. (1) Dans le présent article,

« membre » désigne toute personne inscrite, licenciée ou certifiée au tableau d’un organisme de nursing; (member)

« organisme de nursing » désigne tout organisme de réglementation professionnelle autorisé, par les lois d’une province, à inscrire, licencier ou certifier une personne, lui donnant ainsi le droit d’exercer la profession de nursing. (nursing statutory body)

(2) Le ministre peut communiquer à un organisme de nursing tout renseignement concernant un de ses membres obtenu sous le régime de la Loi réglementant certaines drogues et autres substances, de la Loi sur les aliments et drogues ou du présent règlement.

DORS/82-120, art. 1; DORS/97-228, art. 19.

G.07.002 Lorsque, en vertu du Règlement sur l’exécution policière de la Loi réglementant certaines drogues et autres substances, un membre d’un corps policier ou une personne qui agit sous l’autorité et la supervision d’un membre d’un corps policier est, à l’égard d’une activité, soustrait à l’application du paragraphe 4(2) ou des articles 5, 6, ou 7 de la Loi réglementant certaines drogues et autres substances, ce membre ou cette personne est, à l’égard de cette activité, soustrait à l’application de la présente partie.

DORS/97-228, art. 20.

ANNEXE

(articles G.01.001 et G.01.004, paragraphe G.02.014(3), sous-alinéa G.02.025(1)b)(iii), paragraphes G.02.025(3.2) et (4) et G.03.001(3), alinéa G.03.006a), article G.03.007 et paragraphe G.05.001(4))

PARTIE I Les amphétamines, leurs sels, dérivés, isomères et analogues, ainsi que les sels de leurs dérivés, isomères et analogues, sauf ceux mentionnés à l'article 1 de l'annexe de la partie J. Sont compris :

1. (1) amphétamine (α-méthylbenzèneéthanamine) (2) méthamphétamine (N,α-diméthylbenzèneéthanamine) (3) benzphétamine (N-benzyl N,α-diméthylbenzèneéthanamine) Méthylphénidate (ester méthylique de l'acide α-phénylpipéridine-2 acétique) et ses2. sels

3. Méthaqualone (méthyl-2 (méthyl-2 phényl)-3(3H)-quinazolinone-4) et ses sels 4. Phendimétrazine (d-diméthyl-3,4 phényl-2 morpholine) et ses sels 5. Phenmétrazine (méthyl-3 phényl-2 morpholine) et ses sels 6. Pentobarbital (acide éthyl-5 (méthyl-1 butyl)-5 barbiturique) 7. Sécobarbital (acide allyl-5 (méthyl-1 butyl)-5 barbiturique) 8. Acide hydroxy-4 butanoïque et ses sels 9. Aminorex (dihydro-4,5 phényl-5 oxazolamine-2) et ses sels

10. Fénétylline (d,l-dihydro-3,7 diméthyl-1,3 [[(méthyl-1 phényl-2 éthyl)amino]-2 éthyl]­7 1H-purinedione-2,6) et ses sels 11. Glutéthimide (éthyl-2 phényl-2 glutarimide) 12. Léfétamine ((-)-N,N-diméthyl-α-phénylbenzèneéthanamine) et ses sels 13. Mécloqualone (méthyl-2(chloro-2 phényl)-3 (3H)-quinazolinone-4) et ses sels 14. Mésocarbe ((α-méthylphénéthyl)-3 N-(phénylcarbamoyl)sydnone imine) et ses sels 15. Pémoline (amino-2 phényl-5 oxazolinone-4) et ses sels

16. Zipéprol ((méthoxy-2 phényl-2 éthyl)-4 α-(méthoxyphénylméthyl)-1­pipérazineéthanol) et ses sels

17. Amineptine [(dihydro-10,11 5H-dibenzo[a,d]cycloheptenyl-5)amino]-7 heptanoïqueet ses sels

PARTIE II 1. Barbituriques, ainsi que leurs sels et dérivés, sauf ceux mentionnés aux articles 6 et 7de la partie I de la présente annexe. Sont compris :

(1) allobarbital (acide diallyl-5,5 barbiturique) (2) alphénal (acide allyl-5 phényl-5 barbiturique) (3) amobarbital (acide éthyl-5 (méthyl-3 butyl)-5 barbiturique)

(4) aprobarbital (acide allyl-5 isopropyl-5 barbiturique) (5) barbital (acide diéthyl-5,5 barbiturique) (6) acide barbiturique ((1H,3H,5H)-pyrimidinetrione-2,4,6) (7) butabarbital (acide sec-butyl-5 éthyl-5 barbiturique) (8) butalbital (acide allyl-5 isobutyl-5 barbiturique) (9) butallylonal (acide (bromo-2 allyl)-5 sec-butyl-5 barbiturique) (10) butéthal (acide butyl-5 éthyl-5 barbiturique) (11) cyclobarbital (acide (cyclohexène-1 yl-1)-5 éthyl-5 barbiturique) (12) cyclopal (acide allyl-5 (cyclopentène-2 yl-1)-5 barbiturique) (13) heptabarbital (acide (cycloheptène-1 yl-1)-5 éthyl-5 barbiturique) (14) hexéthal (acide éthyl-5 hexyl-5 barbiturique) (15) hexobarbital (acide (cyclohexène-1 yl-1)-5 diméthyl-1,5 barbiturique) (16) méphobarbital (acide éthyl-5 méthyl-1 phényl-5 barbiturique) (17) méthabarbital (acide diéthyl-5,5 méthyl-1 barbiturique) (18) méthylphénobarbital (acide éthyl-5 méthyl-1 phényl-5 barbiturique) (19) propallylonal (acide (bromo-2 allyl)-5 isopropyl-5 barbiturique) (20) phénobarbital (acide éthyl-5 phényl-5 barbiturique) (21) probarbital (acide éthyl-5 isopropyl-5 barbiturique) (22) acide phénylméthylbarbiturique (acide méthyl-5 phényl-5 barbiturique) (23) sigmodal (acide (bromo-2 allyl)-5 (méthyl-1 butyl)-5 barbiturique) (24) talbutal (acide allyl-5 sec-butyl-5 barbiturique) (25) vinbarbital (acide éthyl-5 (méthyl-1 butényl-1)-5 barbiturique) (26) vinylbital (acide (méthyl-1 butyl)-5 vinyl-5 barbiturique)

2. Thiobarbituriques, ainsi que leurs sels et dérivés, notamment : (1) thialbarbital (acide allyl-5 (cyclohexène-2 yl-1)-5 thio-2 barbiturique) (2) thiamylal (acide allyl-5 (méthyl-1 butyl)-5 thio-2 barbiturique) (3) acide thiobarbiturique (acide thio-2 barbiturique) (4) thiopental (acide éthyl-5 (méthyl-1 butyl)-5 thio-2 barbiturique)

3. Chlorphentermine ((p-chlorophényl)-1 méthyl-2 amino-2 propane) et ses sels 4. Diéthylpropion ((diéthylamino)-2 propiophenone) et ses sels 5. Phentermine (α,α-diméthylbenzèneéthanamine) et ses sels 6. Butorphanol (1-N-cyclobutylméthyl dihydroxy-3,14 morphinane) et ses sels 7. Nalbuphine (N-cyclobutylméthyl époxy-4,5 morphinanetriol-3,6,14) et ses sels 8. Pyrovalérone (méthyl-4'(pyrrolidinyl-1)-2 valérophénone) et ses sels

PARTIE III 1. Stéroïdes anabolisants et leurs dérivés, notamment :

(1) androisoxazole (hydroxy-17ß méthyl-17α androstano[3,2-c]isoxazole)

(2) androstanolone (hydroxy-17ß 5α-androstanone-3) (3) androstènediol (androstène-5 diol-3ß,17ß) (4) bolandiol (estrène-4 diol-3ß,17ß) (5) bolastérone (hydroxy-17ß diméthyl-7α,17 androstène-4 one-3) (6) bolazine (hydroxy-17ß méthyl-2α 5α-androstanone-3 azine) (7) boldénone (hydroxy-17ß androstadiène-1,4 one-3) (8) bolénol (nor-19 17α-prégnène-5 ol-17) (9) calustérone (hydroxy-17ß diméthyl-7ß,17 androstène-4 one-3) (10) clostébol (chloro-4 hydroxy-17ß androstène-4 one-3) (11) drostanolone (hydroxy-17ß méthyl-2α 5α-androstanone-3) (12) énestébol (dihydroxy-4,17ß méthyl-17 androstadiène-1,4 one-3) (13) épitiostanol (épithio-2α,3α 5α-androstanol-17ß) (14) éthylestrénol (nor-19 17α-prégnène-4 ol-17) (15) hydroxy-4 nor-19 testostérone (16) fluoxymestérone (fluoro-9 dihydroxy-11ß,17ß méthyl-17 androstène-4 one-3)

(17) formébolone (dihydroxy-11α,17ß méthyl-17 oxo-3 androstadiène-1,4carboxaldéhyde-2) (18) furazabol (méthyl-17 5α-androstano[2,3-c]furazanol-17ß) (19) mébolazine (hydroxy-17ß diméthyl-2α,17 5α-androstanone-3 azine) (20) mésabolone ([(méthoxy-1 cyclohexyl) oxy]-17ß 5α-androstène-1 one-3) (21) mestérolone (hydroxy-17ß méthyl-1α 5α-androstanone-3) (22) métandiénone (hydroxy-17ß méthyl-17 androstadiène-1,4 one-3) (23) méténolone (hydroxy-17ß méthyl-1 5α-androstène-1 one-3) (24) méthandriol (méthyl-17α androstène-5 diol-3ß,17ß) (25) méthyltestostérone (hydroxy-17ß méthyl-17 androstène-4 one-3) (26) métribolone (hydroxy-17ß méthyl-17 estratriène-4,9,11 one-3) (27) mibolérone (hydroxy-17ß diméthyl-7α,17 estrène-4 one-3) (28) nandrolone (hydroxy-17ß estrène-4 one-3) (29) norbolétone (éthyl-13 hydroxy-17ß dinor-18,19 prégnène-4 one-3) (30) norclostébol (chloro-4 hydroxy-17ß estrène-4 one-3) (31) noréthandrolone (éthyl-17α hydroxy-17ß estrène-4 one-3) (32) oxabolone (dihydroxy-4,17ß estrène-4 one-3) (33) oxandrolone (hydroxy-17ß méthyl-17 oxa-2 5α-androstanone-3) (34) oxymestérone (dihydroxy-4,17ß méthyl-17 androstène-4 one-3)

(35) oxymétholone (hydroxy-17ß (hydroxyméthylène)-2 méthyl-17 5α-androstanone­3) (36) prastérone (hydroxy-3ß androstène-5 one-17) (37) quinbolone ((cyclopentènyl-1 oxy-1)-17ß androstadiène-1,4 one-3)

(38) stanozolol (hydroxy-17ß méthyl-17 5α-androstano[3,2-c]pyrazole) (39) stenbolone (hydroxy-17ß méthyl-2 5α-androstène-1 one-3) (40) testostérone (hydroxy-17ß androstène-4 one-3) (41) tibolone (hydroxy-17 méthyl-7α nor-19 17α-prégnène-5(10) yne-20 one-3) (42) tiomestérone (bis(acétylthio)-1α,7α hydroxy-17ß méthyl-17 androstène-4 one-3) (43) trenbolone (hydroxy-17ßestratriène-4,9,11 one-3)

2. Zéranol (trihydroxy-7,14,16 méthyl-3 décahydro-3,4,5,6,- 7,8,9,10,11,12 1H-benzoxa­2 cyclotétradécinone-1)

DORS/78-427, art. 10; DORS/79-753, art. 1; DORS/81-84, art. 1; DORS/85-550, art. 14(F); DORS/86-678, art. 1; DORS/89-381, art. 1; DORS/92-386, art. 3; DORS/97-228, art. 21; DORS/99-425, art. 1; DORS/2003-34, art. 2 et 3; DORS/2003-413, art. 2.

PARTIE J DROGUES D'USAGE RESTREINT Titre 1 Dispositions générales

J.01.001. Dans la présente partie,

« autorité compétente » Organisme public d’un pays étranger qui est habilité, aux termes des lois du pays, à consentir à l’importation ou à l’exportation de drogues d’usage restreint. (competent authority)

« chercheur compétent » signifie, en ce qui concerne les drogues d’usage restreint, une personne qui

a) est employée par un établissement ou est en contact avec celui-ci, ou

b) se livre à des recherches sur cette drogue dans un établissement,

et que le ministre a autorisée, en vertu de l’article J.01.018, à utiliser et à posséder cette drogue; (qualified investigator)

« distributeur autorisé » Le titulaire d’une licence délivrée en vertu de l’article J.01.007.2. (licensed dealer)

« drogue d’usage restreint » Toute drogue mentionnée à l’annexe de la présente partie. (restricted drug)

« établissement » indique un établissement se livrant à la recherche sur les drogues et comprend les hôpitaux autorisés par les provinces, les universités, les ministères ou

organismes du gouvernement du Canada ou des provinces ou une partie quelconque de ceux-ci; (institution)

« licence »[Abrogée, DORS/2004-238, art. 31]

« nécessaire d’essai » désigne un nécessaire

a) contenant des réactifs, des substances-tampons ou les deux,

b) employé au cours d’une opération chimique ou analytique effectuée à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques, et

c) dont le contenu n’est pas destiné à être administré à des humains; (test kit)

« obligation internationale » Toute obligation relative à une drogue d’usage restreint prévue par une convention, un traité ou un autre instrument multilatéral ou bilatéral que le Canada a ratifié ou auquel il adhère. (international obligation)

« permis » signifie un permis délivré en vertu de l’article J.01.005; (permit)

« personne qualifiée responsable » La personne physique qui, possédant les qualifications énoncées au paragraphe J.01.003.2(2), est responsable de la supervision des opérations effectuées par le distributeur autorisé en vertu de sa licence, à l’installation qui y est spécifiée. (qualified person in charge)

« praticien » signifie une personne qui, en vertu des lois d’une province, a le droit d’exercer la médecine et est inscrite à cette fin. (practitioner)

DORS/97-228, art. 22; DORS/2004-238, art. 31.

Possession

J.01.002. (1) Les personnes suivantes peuvent avoir en leur possession des drogues d’usage restreint :

a) un distributeur autorisé;

b) un chercheur compétent s’il se sert de la drogue à des fins de recherches dans un établissement ou en rapport avec un établissement;

c) un analyste, un inspecteur, un membre de la Gendarmerie royale du Canada, un agent de police, un agent de la paix, un membre du personnel du ministère de la Santé ou un officier de justice, si la possession a quelque rapport avec l’emploi;

d) une personne qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à une telle drogue.

(2) Une personne est autorisée à avoir une drogue d’usage restreint en sa possession lorsqu’elle agit comme agent de toute personne visée aux alinéas (1)a), b) ou d).

(2.1) Une personne est autorisée à avoir une drogue d’usage restreint en sa possession lorsque :

a) d’une part, elle agit comme agent de toute personne dont elle a des motifs raisonnables de croire que celle-ci est une personne visée à l’alinéa (1)c);

b) d’autre part, la possession de cette drogue a pour but d’aider cette dernière dans l’application ou l’exécution d’une loi ou d’un règlement.

DORS/97-228, art. 23; DORS/99-125, art. 7; DORS/2010-222, art. 23. Version précédente

Licences, permis et distributeurs autorisés

J.01.003. Sous réserve des autres dispositions de la présente partie, il est interdit à toute personne autre qu’un distributeur autorisé, de produire, de fabriquer, d’assembler, d’importer, d’exporter, de vendre, de fournir, de transporter, d’expédier ou de livrer une drogue d’usage restreint.

DORS/2004-238, art. 32.

J.01.003.1. Sont admissibles à la licence de distributeur autorisé :

a) la personne physique qui réside habituellement au Canada;

b) la personne morale qui a son siège social au Canada ou qui y exploite une succursale;

c) le titulaire d’un poste qui comporte la responsabilité de drogues d’usage restreint pour le compte d’un ministère du gouvernement fédéral ou d’un gouvernement provincial, d’un service de police, d’un hôpital ou d’une université au Canada.

DORS/2004-238, art. 32.

J.01.003.2. (1) Le distributeur autorisé :

a) désigne une seule personne qualifiée responsable — il peut lui-même exercer cette fonction s’il est une personne physique — qui doit travailler à l’installation visée par la licence et qui est chargée de superviser les opérations relatives aux drogues d’usage restreint visées par la licence et d’assurer la conformité de ces opérations avec le présent règlement au nom du distributeur autorisé;

b) peut désigner une personne qualifiée responsable suppléante qui doit travailler à l’installation visée par la licence et qui est autorisée à remplacer la personne qualifiée responsable lorsque celle-ci est absente.

(2) La personne qualifiée responsable et, le cas échéant, la personne qualifiée responsable suppléante doivent se conformer aux exigences suivantes :

a) bien connaître les dispositions de la Loi et de ses règlements qui s’appliquent à la licence du distributeur autorisé qui les a désignées et posséder des connaissances et une

expérience de la chimie et de la pharmacologie pour pouvoir bien s’acquitter de leurs fonctions;

b) être des pharmaciens ou des praticiens agréés par l’autorité provinciale attributive de licences en matière d’activités professionnelles ou être titulaire d’un diplôme dans une discipline scientifique connexe — notamment la pharmacie, la médecine, la dentisterie, la médecine vétérinaire, la pharmacologie, la chimie organique ou le génie chimique — décerné par une université canadienne ou, s’il s’agit d’une université étrangère, reconnu par une université ou une association professionnelle canadiennes;

c) ne pas avoir, au cours des dix dernières années, été reconnues coupables en tant qu’adulte :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii).

DORS/2004-238, art. 32; DORS/2010-222, art. 24(A) et 34. Version précédente J.01.004. Aucun distributeur autorisé ne peut importer ou exporter une drogue d’usage restreint sans permis.

J.01.004.1 Un distributeur autorisé est autorisé à avoir une drogue d’usage restreint en sa possession, en vue de son exportation, s’il l’a obtenue conformément au présent règlement.

DORS/97-515, art. 5.

J.01.005. Le ministre peut, s’il a reçu une demande à cet effet, après les enquêtes qu’il estime nécessaires, et sous réserve des modalités qu’il juge convenables, délivrer à un distributeur autorisé un permis pour l’importation ou l’exportation d’une drogue d’usage restreint.

J.01.006. Les demandes de permis doivent être présentées sous une forme approuvée par le ministre.

J.01.007. (1) Quiconque souhaite obtenir une licence de distributeur autorisé présente au ministre une demande dans laquelle il inscrit les renseignements suivants :

a) si la licence est demandée :

(i) pour une personne physique, le nom de celle-ci,

(ii) pour une personne morale, sa dénomination sociale et tout autre nom enregistré dans une province sous lequel elle entend s’identifier ou poursuivre les opérations prévues dans la licence,

(iii) pour le titulaire d’un poste, le nom du demandeur et le titre du poste;

b) l’adresse, le numéro de téléphone et, le cas échéant, le numéro de télécopieur et l’adresse électronique de l’installation visée par la licence de même que, si elle diffère de l’adresse de l’installation, son adresse postale;

c) les nom, date de naissance et sexe du responsable de l’installation;

d) s’agissant de la personne qualifiée responsable proposée et, le cas échéant, de la personne qualifiée responsable suppléante proposée :

(i) leurs nom, date de naissance et sexe,

(ii) les diplômes d’études, la formation et l’expérience de travail qui se rapportent à leurs fonctions,

(iii) leurs heures de travail à l’installation,

(iv) leur titre à l’installation,

(v) les nom et titre de leur supérieur immédiat à l’installation,

(vi) dans le cas d’un pharmacien ou d’un praticien, le nom de la province où a été délivré le permis d’exercice, la licence ou le certificat professionnel valide qu’il détient, ainsi que le numéro de ce permis, de cette licence ou de ce certificat;

e) les nom et sexe des personnes physiques autorisées à commander des drogues d’usage restreint pour son compte;

f) les opérations visées à l’article J.01.003 pour lesquelles la licence est demandée et qui seraient effectuées à l’installation à laquelle s’appliquerait la licence;

g) dans le cas où la demande vise un produit ou un composé qui contient une drogue d’usage restreint mais n’est pas un nécessaire d’essai et qui serait fabriqué ou assemblé par lui ou pour son compte :

(i) le nom, le numéro ou la marque d’identification de chaque produit ou composé, le cas échéant,

(ii) la drogue d’usage restreint que contient chaque produit ou composé,

(iii) la concentration de la drogue d’usage restreint dans chaque unité du produit ou du composé,

(iv) la quantité ou les formats d’emballage de chaque produit ou composé,

(v) dans le cas où le produit ou composé est fabriqué ou assemblé, sur commande spéciale, par un autre distributeur autorisé ou pour son compte, les nom, adresse et numéro de licence de cet autre distributeur;

h) dans le cas où il demande la licence pour produire une drogue d’usage restreint, à l’exclusion des produits ou composés contenant une drogue d’usage restreint :

(i) le nom de la drogue d’usage restreint à produire,

(ii) la quantité qu’il entend produire en vertu de la licence et la période prévue pour sa production,

(iii) s’il s’agit d’une drogue d’usage restreint produite sur commande spéciale pour le compte d’un autre distributeur autorisé, les nom, adresse et numéro de licence de ce dernier;

i) la description détaillée des mesures établies conformément à la Directive en matière de sécurité qui sont appliquées à l’installation;

j) la description détaillée de la méthode prévue pour la consignation des transactions relatives aux drogues d’usage restreint;

k) dans le cas où la licence est demandée relativement à une opération visée à l’article J.01.003 qui n’est pas une opération à laquelle s’appliquent les alinéas g) et h), la drogue d’usage restreint à l’égard de laquelle cette opération sera effectuée et le but de l’opération.

(2) La demande de licence de distributeur autorisé doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation visée par la demande;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) La demande de licence de distributeur autorisé doit être accompagnée de ce qui suit :

a) une déclaration signée du responsable de l’installation visée par la demande, une autre de la personne qualifiée responsable proposée et une autre, le cas échéant, de la personne qualifiée responsable suppléante proposée, chaque déclaration attestant que le signataire n’a pas, au cours des dix dernières années, été reconnu coupable en tant qu’adulte :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

b) un document émanant d’un service de police canadien pour chacune des personnes mentionnées à l’alinéa a), attestant qu’elle a ou n’a pas, au cours des dix dernières

années, été reconnue coupable en tant qu’adulte d’une infraction désignée en matière de drogue ou d’une infraction désignée en matière criminelle;

c) dans le cas où l’une des personnes visées à l’alinéa a) a eu, au cours des dix dernières années, sa résidence habituelle dans un pays autre que le Canada, un document émanant d’un service de police de ce pays attestant qu’elle a ou n’a pas, au cours des dix dernières années, été reconnue coupable dans ce pays en tant qu’adulte d’une infraction qui, commise au Canada, aurait été une infraction désignée en matière de drogue ou une infraction désignée en matière criminelle;

d) une déclaration, signée et datée par le responsable de l’installation visée par la demande, attestant que la personne qualifiée responsable proposée et, le cas échéant, la personne qualifiée responsable suppléante proposée, ont les connaissances et l’expérience exigées par l’alinéa J.01.003.2(2)a);

e) dans le cas où la personne qualifiée responsable proposée ou, le cas échéant, la personne qualifiée responsable suppléante proposée n’est pas un pharmacien ou un praticien agréé par l’autorité provinciale attributive de licences en matière d’activités professionnelles, une copie du diplôme visé à l’alinéa J.01.003.2(2)b) et une copie du relevé de notes relatif à ce diplôme;

f) dans le cas où le nom du demandeur figure sur l’étiquette d’un produit ou d’un composé contenant une drogue d’usage restreint, une copie de l’étiquette intérieure, au sens de l’article A.01.010, de chaque produit ou composé auquel s’appliquerait la licence;

g) dans le cas où le demandeur est une personne morale, à la fois :

(i) une copie de son certificat de constitution ou de tout autre acte constitutif,

(ii) une copie de tout document déposé auprès de la province où se trouve l’installation à laquelle s’appliquerait la licence, qui indique sa dénomination sociale ou tout autre nom enregistré dans la province sous lequel le demandeur entend s’identifier ou poursuivre les opérations prévues dans la licence.

(4) La méthode prévue aux termes de l’alinéa (1)j) doit permettre :

a) d’une part, la consignation des transactions de drogues d’usage restreint conformément à l’article J.01.021;

b) d’autre part, la vérification par le ministre des opérations du distributeur autorisé relativement aux drogues d’usage restreint.

(5) Les documents visés aux alinéas (3)b) et c) n’ont pas à être fournis si les personnes mentionnées à ces alinéas consentent par écrit :

a) à ce qu’une recherche soit effectuée pour vérifier si elles ont eu, au cours des dix dernières années, un casier judiciaire, en tant qu’adulte, relativement aux infractions visées à ces alinéas;

b) à fournir les renseignements nécessaires à la vérification du casier judiciaire et à se soumettre à toute opération d’identification visant à en obtenir la vérification;

c) à payer le prix exigé pour la vérification aux termes du Règlement sur le prix à payer pour la vérification de casiers judiciaires à des fins civiles (Gendarmerie royale du Canada).

DORS/2004-238, art. 33; DORS/2010-222, art. 25. Version précédente J.01.007.1. Sur réception d’une demande présentée en vertu de la présente partie, le ministre peut exiger tout renseignement supplémentaire au sujet des renseignements contenus dans la demande dont il a besoin pour traiter celle-ci.

DORS/2004-238, art. 33.

J.01.007.2. Sous réserve de l’article J.01.007.3, le ministre délivre au demandeur, après examen des renseignements et des documents exigés aux articles J.01.007 et J.01.007.1, une licence de distributeur autorisé qui contient les renseignements suivants :

a) le numéro de la licence;

b) le nom du titulaire, qu’il s’agisse de son propre nom ou du titre du poste dont il est titulaire, ou, s’il s’agit d’une personne morale, sa dénomination sociale;

c) la liste des opérations autorisées;

d) l’adresse de l’installation où le distributeur peut se livrer aux opérations autorisées;

e) le nom de la drogue d’usage restreint à l’égard de laquelle les opérations sont autorisées;

f) le niveau de sécurité applicable à l’installation, établi conformément à la Directive en matière de sécurité;

g) la date de prise d’effet de la licence;

h) la date d’expiration de la licence, laquelle ne peut suivre de plus de trois ans la date de prise d’effet de celle-ci;

i) le cas échéant, les conditions que le titulaire doit remplir :

(i) pour que soit respectée une obligation internationale,

(ii) pour assurer le niveau de sécurité visé à l’alinéa f),

(iii) pour réduire tout risque d’atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue d’usage restreint vers un marché ou un usage illicite;

j) dans le cas du producteur d’une drogue d’usage restreint, la quantité de celle-ci qui peut être produite en vertu de la licence et la période de production autorisée;

k) dans le cas du fabricant ou de l’assembleur d’un produit ou d’un composé qui contient une drogue d’usage restreint mais n’est pas un nécessaire d’essai, une liste figurant en annexe qui indique, pour chaque type de produit ou de composé qui peut être fabriqué ou assemblé en vertu de la licence :

(i) le numéro de la licence,

(ii) le nom, numéro ou marque d’identification, le cas échéant, de chaque produit ou composé,

(iii) le nom de la drogue d’usage restreint que contient chaque produit ou composé,

(iv) la concentration de la drogue d’usage restreint dans chaque unité du produit ou du composé,

(v) la quantité ou les formats d’emballage de chaque produit ou composé.

DORS/2004-238, art. 33; DORS/2010-222, art. 26 et 35(F). Version précédente J.01.007.3. (1) Le ministre refuse de délivrer la licence de distributeur autorisé, de la modifier ou de la renouveler dans les cas suivants :

a) le demandeur n’est pas admissible aux termes de l’article J.01.003.1;

b) le demandeur n’a pas fourni à l’inspecteur qui lui en a fait la demande l’occasion de procéder à une inspection aux termes de l’article J.01.025;

c) le demandeur a fourni des renseignements faux ou trompeurs dans sa demande ou des documents faux ou falsifiés à l’appui de celle-ci;

d) l’une des opérations pour lesquelles la licence est demandée entraînerait le non-respect d’une obligation internationale;

e) les renseignements reçus d’une autorité compétente ou des Nations Unies laissent raisonnablement croire que le demandeur a participé au détournement d’une drogue d’usage restreint vers un marché ou un usage illicite ou qu’il s’est livré à des opérations qui ont entraîné le non-respect d’une obligation internationale;

f) le demandeur n’a pas mis en oeuvre les mesures prévues dans la Directive en matière de sécurité à l’égard d’une opération pour laquelle il demande la licence;

g) le demandeur contrevient ou a contrevenu au cours des dix dernières années :

(i) soit à une disposition de la Loi ou des règlements pris ou maintenus en vigueur sous le régime de celle-ci,

(ii) soit à une condition d’une autre licence de distributeur autorisé ou d’un permis d’importation ou d’exportation qui lui a été délivré en vertu d’un règlement pris ou maintenu en vigueur sous le régime de la Loi;

h) la délivrance, la modification ou le renouvellement de la licence risquerait vraisemblablement de porter atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue d’usage restreint vers un marché ou un usage illicite;

i) le responsable de l’installation, la personne qualifiée responsable proposée ou, le cas échéant, la personne qualifiée responsable suppléante proposée a, au cours des dix dernières années, été reconnu coupable en tant qu’adulte, selon le cas :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, si elle avait été commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

j) la méthode prévue aux termes de l’alinéa J.01.007(1)j) ne permet pas la consignation des transactions des drogues d’usage restreint conformément à l’article J.01.023 ou la vérification par le ministre, en temps opportun, des opérations du demandeur relatives aux drogues d’usage restreint;

k) les renseignements supplémentaires exigés en vertu de l’article J.01.007.1 n’ont pas été fournis ou sont insuffisants pour que la demande puisse être traitée.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicite, le ministre ne peut dans les cas visés aux alinéas (1)c) ou g), refuser de délivrer, de modifier ou de renouveler la licence si le demandeur :

a) d’une part, n’a pas d’antécédents quant à la contravention de la Loi et des règlements pris ou maintenus en vigueur en vertu de celle-ci;

b) d’autre part, a pris les mesures correctives nécessaires pour assurer le respect de la Loi et du présent règlement, ou a signé un engagement à cet effet.

DORS/2004-238, art. 33; DORS/2010-222, art. 27 et 35(F). Version précédente J.01.007.4. (1) Le distributeur autorisé qui souhaite obtenir le renouvellement de sa licence doit présenter au ministre une demande :

a) dans laquelle il inscrit les renseignements visés aux alinéas J.01.007(1)a) à k);

b) à laquelle il joint les documents suivants :

(i) les documents visés aux alinéas J.01.007(3)a) et d) et, sous réserve du paragraphe J.01.007(5), le document visé à l’alinéa J.01.007(3)b),

(ii) le cas échéant, le document visé à l’alinéa J.01.007(3)e), s’il n’a pas déjà été fourni relativement à la licence à renouveler,

(iii) l’original de la licence à renouveler.

(2) La demande de renouvellement doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation à laquelle s’appliquerait la licence;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) Sous réserve de l’article J.01.007.3, après examen des renseignements et des documents exigés aux paragraphes (1) et (2) et à l’article J.01.007.1, le ministre renouvelle la licence de distributeur autorisé qui contient les renseignements prévus aux alinéas J.01.007.2a) à k).

DORS/2004-238, art. 33.

J.01.007.5. (1) Le distributeur autorisé qui souhaite faire modifier sa licence doit présenter les documents suivants au ministre :

a) une demande écrite expliquant la modification souhaitée, à laquelle sont joints ceux des documents visés à l’article J.01.007 qui sont pertinents à l’égard de la demande de modification;

b) l’original de la licence en cause.

(2) La demande de modification de la licence doit satisfaire aux exigences suivantes :

a) être signée par le responsable de l’installation à laquelle s’appliquerait la licence;

b) être accompagnée d’une attestation signée par celui-ci portant :

(i) d’une part, qu’à sa connaissance tous les renseignements et documents fournis à l’appui de la demande sont exacts et complets,

(ii) d’autre part, qu’il est habilité à lier le demandeur.

(3) Sous réserve de l’article J.01.007.3, après examen de la demande et des documents à l’appui, le ministre modifie la licence en conséquence et peut l’assortir de conditions supplémentaires que le titulaire doit remplir à l’une ou l’autre des fins suivantes :

a) pour que soit respectée une obligation internationale;

b) pour assurer le niveau de sécurité applicable visé à l’alinéa J.01.007.2f) ou tout autre niveau qui s’impose par suite de la modification;

c) pour réduire tout risque d’atteinte à la sécurité ou à la santé publiques, notamment en raison du risque de détournement de la drogue d’usage restreint vers un marché ou un usage illicite.

DORS/2004-238, art. 33; DORS/2010-222, art. 28(F) et 35(F). Version précédente J.01.007.6. (1) Le distributeur autorisé doit satisfaire aux exigences suivantes :

a) obtenir l’approbation du ministre avant de procéder :

(i) à une modification touchant la sécurité à l’installation mentionnée dans sa licence,

(ii) à la désignation d’autres personnes physiques qui remplacent les suivantes ou, le cas échéant, s’ajoutent à elles :

(A) le responsable de l’installation à laquelle s’applique la licence,

(B) la personne qualifiée responsable à l’installation à laquelle s’applique la licence et, le cas échéant, la personne qualifiée responsable suppléante,

(C) les personnes physiques autorisées à commander une drogue d’usage restreint au nom du distributeur autorisé;

b) aviser le ministre, dans les dix jours, qu’une personne visée à l’une des divisions a)(ii)(A) ou (C) a cessé d’exercer les fonctions mentionnées dans l’un des documents suivants :

(i) la demande de licence présentée aux termes de l’article J.01.007,

(ii) la demande de renouvellement de la licence présentée aux termes de l’article J.01.007.4,

(iii) la demande d’approbation présentée pour l’application de l’alinéa a);

c) aviser le ministre, au plus tard le jour ouvrable suivant, qu’une personne visée à la division a)(ii)(B) a cessé d’exercer les fonctions mentionnées dans l’un des documents suivants :

(i) la demande de licence présentée aux termes de l’article J.01.007,

(ii) la demande de renouvellement de la licence présentée aux termes de l’article J.01.007.4,

(iii) la demande d’approbation présentée aux termes de l’alinéa a).

(2) En plus de la demande d’approbation visée au sous-alinéa (1)a)(ii), le distributeur autorisé doit, relativement à toute nomination, fournir ce qui suit au ministre :

a) dans le cas du remplacement du responsable de l’installation à laquelle s’applique la licence :

(i) les renseignements visés à l’alinéa J.01.007(1)c),

(ii) les déclarations visées à l’alinéa J.01.007(3)a) et, sous réserve du paragraphe J.01.007(5), les documents visés aux alinéas J.01.007(3)b) et c);

b) dans le cas du remplacement de la personne qualifiée responsable à l’installation à laquelle s’applique la licence, ou dans celui du remplacement ou de l’adjonction d’une personne qualifiée responsable suppléante à cette installation :

(i) les renseignements visés à l’alinéa J.01.007(1)d),

(ii) les documents visés aux alinéas J.01.007(3)a), d) et e) et, sous réserve du paragraphe J.01.007(5), les documents visés aux alinéas J.01.007(3)b) et c);

c) dans le cas du remplacement ou de l’adjonction d’une personne physique autorisée à commander une drogue d’usage restreint en son nom, le nom et le sexe de celle-ci.

DORS/2004-238, art. 33.

J.01.007.7. Le ministre révoque la licence de distributeur autorisé si le titulaire en fait la demande ou l’informe de la perte ou du vol de celle-ci.

DORS/2004-238, art. 33.

J.01.007.8. (1) Sous réserve du paragraphe (2), le ministre révoque la licence de distributeur autorisé conformément à l’article J.01.007.91 dans les cas suivants :

a) la licence a été délivrée d’après des renseignements faux ou trompeurs fournis dans la demande ou des documents faux ou falsifiés à l’appui de celle-ci;

b) le titulaire a contrevenu à la Loi ou à ses règlements ou aux conditions de sa licence ou d’un permis d’importation ou d’exportation délivré en vertu de la présente partie;

c) le titulaire n’est plus admissible aux termes de l’article J.01.003.1;

d) il a été découvert que le responsable de l’installation à laquelle s’applique la licence, la personne qualifiée responsable à cette installation ou, le cas échéant, la personne qualifiée responsable suppléante a, au cours des dix dernières années, été reconnu coupable en tant qu’adulte, selon le cas :

(i) d’une infraction désignée en matière de drogue,

(ii) d’une infraction désignée en matière criminelle,

(iii) d’une infraction commise à l’étranger qui, commise au Canada, aurait constitué une infraction visée au sous-alinéa (i) ou (ii);

e) les renseignements reçus d’une autorité compétente ou des Nations Unies laissent raisonnablement croire que le titulaire a participé au détournement d’une drogue d’usage restreint vers un marché ou un usage illicite.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publique, y compris en vue de prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicite, le ministre ne peut, dans les cas visés aux alinéas (1)a) ou b), révoquer la licence de distributeur autorisé si :

a) d’une part, le distributeur autorisé n’a pas d’antécédents quant à la contravention de la Loi et des règlements pris ou maintenus en vigueur sous le régime de celle-ci;

b) d’autre part, il a pris les mesures correctives nécessaires pour assurer le respect de la Loi et du présent règlement, ou a signé un engagement à cet effet.

DORS/2004-238, art. 33; DORS/2010-222, art. 29 et 35(F). Version précédente J.01.007.9. Le ministre suspend sans préavis la licence de distributeur autorisé s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicite.

DORS/2004-238, art. 33; DORS/2010-222, art. 35(F). Version précédente J.01.007.91. (1) Lorsqu’il envisage de refuser de délivrer, de modifier ou de renouveler une licence de distributeur autorisé, aux termes de la présente partie, ou qu’il envisage de la révoquer, le ministre donne au demandeur ou au titulaire :

a) un avis à cet effet et un exposé écrit des motifs du refus ou de la révocation envisagés;

b) la possibilité de se faire entendre à l’égard du refus ou de la révocation envisagés.

(2) La décision du ministre de suspendre la licence de distributeur autorisé aux termes de la présente partie prend effet aussitôt qu’il en avise l’intéressé et lui fournit un exposé écrit des motifs de la suspension.

(3) La personne qui reçoit un avis de suspension aux termes du paragraphe (2) peut, dans les dix jours qui en suivent la réception, présenter au ministre les motifs pour lesquels la suspension de sa licence de distributeur autorisé n’est pas fondée.

DORS/2004-238, art. 33.

J.01.008. [Abrogé, DORS/2004-238, art. 33]

J.01.009. Le ministre peut imposer à un distributeur autorisé toutes les restrictions et conditions qu’il juge nécessaires pour le contrôle d’une drogue d’usage restreint.

J.01.010. Un distributeur autorisé peut, à tout moment, demander au ministre de modifier sa licence pour lui permettre de devenir distributeur autorisé pour une drogue d’usage restreint autre qu’une drogue d’usage restreint mentionnée sur sa licence ou de changer les modalités de sa licence.

J.01.011. Le distributeur autorisé ne peut fabriquer, produire, assembler, vendre, fournir, transporter, expédier ou livrer que les drogues d’usage restreint mentionnées sur sa licence, à la condition d’en respecter les modalités.

DORS/2004-238, art. 34.

J.01.012. Le ministre révoque le permis si le titulaire en fait la demande ou l’informe de la perte ou du vol de celui-ci.

DORS/2004-238, art. 34; DORS/2010-222, art. 30. Version précédente J.01.012.1. (1) Sous réserve du paragraphe (2), le ministre révoque le permis, en prenant les mêmes mesures que celles prévues au paragraphe J.01.007.91(1), dans les cas suivants :

a) l’un des cas visés aux alinéas J.01.007.8(1)a) à e) existe relativement à la licence de distributeur autorisé qui vise la drogue d’usage restreint à importer ou à exporter;

b) le permis d’importation ou d’exportation, selon le cas, a été délivré sur la foi de renseignements faux ou trompeurs fournis dans la demande ou de documents faux ou falsifiés à l’appui de celle-ci.

(2) Sauf s’il est nécessaire de le faire en vue de protéger la sécurité ou la santé publiques, y compris en vue de prévenir le détournement d’une drogue d’usage restreint vers un marché ou un usage illicite, le ministre ne peut, dans les cas visés aux alinéas J.01.007.8(1)a) ou b) ou J.01.012.1(1)b), révoquer le permis si son titulaire remplit les conditions prévues aux alinéas J.01.007.8(2)a) et b).

(3) Dans le cas où le titulaire ne se conforme pas à la décision du ministre de suspendre son permis aux termes de l’article J.01.012.2 ou ne corrige pas la situation ayant donné lieu à la suspension, le ministre peut révoquer le permis.

DORS/2010-222, art. 30.

J.01.012.2. (1) Le ministre suspend le permis sans préavis dans les cas suivants :

a) la licence de distributeur autorisé qui vise la drogue d’usage restreint à importer ou à exporter est expirée ou a été suspendue ou révoquée;

b) il a des motifs raisonnables de croire que la protection de la sécurité ou de la santé publiques l’exige;

c) il a des motifs raisonnables de croire que le maintien du permis présenterait un risque de détournement de la drogue d’usage restreint vers un marché ou un usage illicite;

d) l’importation ou l’exportation contreviendrait aux règles de droit du pays d’exportation ou d’importation, selon le cas, ou de tout pays de transit ou de transbordement.

(2) La décision du ministre de suspendre un permis prend effet aussitôt qu’il en avise l’intéressé et lui fournit un exposé écrit des motifs.

(3) La personne dont le permis est suspendu aux termes du paragraphe (1) peut, dans les dix jours suivant la réception de l’avis de suspension, présenter au ministre les raisons pour lesquelles la suspension ne serait pas fondée.

DORS/2010-222, art. 30.

J.01.013. La licence de distributeur autorisé est valide jusqu’à celle des dates suivantes qui est antérieure à l’autre :

a) la date d’expiration indiquée dans la licence;

b) la date de la révocation ou de la suspension de la licence au titre des articles J.01.007.7, J.01.007.8 ou J.01.007.9.

DORS/2004-238, art. 34.

J.01.014. Un permis n’est valable que pour l’importation ou l’exportation d’une drogue pour laquelle il a été spécifiquement délivré.

Vente des drogues d'usage restreint

J.01.015. Un établissement peut, sous une forme approuvée par le ministre, faire à un distributeur autorisé ou au ministre, une demande d’achat d’une drogue d’usage restreint

a) pour l’utilisation clinique dans l’établissement par des chercheurs compétents dans le but de déterminer les dangers et l’efficacité de la drogue; ou

b) pour des recherches de laboratoire, dans l’établissement, par des chercheurs compétents.

J.01.016. Lorsqu’un distributeur autorisé reçoit une demande en vertu de l’article J.01.015, il doit, avant de vendre la drogue d’usage restreint à l’établissement qui en a fait la demande,

a) fournir au ministre une copie de la demande; et

b) obtenir l’autorisation écrite du ministre de vendre ladite drogue d’usage restreint.

J.01.017. Une demande présentée conformément à l’article J.01.015 doit contenir

a) le nom et l’adresse de l’établissement qui demande à acheter la drogue;

b) les noms et qualifications des chercheurs qui seront en possession de la drogue et l’utiliseront;

c) les détails de l’utilisation prévue de la drogue;

d) la quantité de drogue requise;

e) la forme posologique de la drogue requise par l’établissement; et

f) le nom et l’adresse du distributeur autorisé à qui la drogue sera achetée.

J.01.018. Lorsque le ministre reçoit d’un établissement une demande ou une copie d’une demande faite en vertu de l’article J.01.005, il peut, sous réserve des qualités et des limites qu’il estime appropriées, autoriser

a) la vente, à l’établissement, par un distributeur licencié, de la drogue à usage restreint demandée, en la quantité et selon le dosage qu’il estime approprié; et

b) des chercheurs compétents à faire un usage clinique de la drogue à usage restreint, dans l’établissement ou pour fins de recherches en laboratoire dans l’établissement et à détenir cette drogue en vue d’un tel usage ou de telles recherches.

J.01.019. Un établissement n’utilisera une drogue d’usage restreint que dans le but et de la façon indiqués dans la demande présentée pour ladite drogue restreinte conformément à l’article J.01.015.

J.01.020. Lorsqu’un distributeur a été autorisé en vertu de l’article J.01.018 à vendre une drogue d’usage restreint, il peut, nonobstant l’article C.08.002, vendre ladite drogue, sous réserve des qualifications et des restrictions éventuelles imposées par le ministre.

Registres et inspection

J.01.021. Tout établissement doit tenir des registres, qu’il doit garder pour une période de deux ans après leur établissement, indiquant

a) la quantité de chacune des drogues d’usage restreint reçues par l’établissement;

b) les détails d’emploi des drogues d’usage restreint par l’établissement;

c) les noms et qualifications de toutes les personnes utilisant les drogues d’usage restreint dans l’établissement; et

d) toutes les données cliniques concernant l’utilisation des drogues d’usage restreint reçues par l’établissement.

DORS/85-550, art. 15.

J.01.022. Tout établissement doit mettre à la disposition du ministre, sur sa demande, les registres mentionnés à l’article J.01.021, et doit permettre toute inspection de l’établissement, en ce qui concerne les drogues d’usage restreint, que le ministre pourra exiger.

J.01.023. Tout distributeur autorisé doit tenir un registre contenant

a) le nom, la quantité et la forme de toute drogue d’usage restreint qu’il a reçue, les nom et adresse de la personne qui la lui a vendue ou fournie et la date à laquelle il l’a reçue;

b) le nom, la quantité et la forme de toute drogue d’usage restreint qu’il vend ou fournit, les nom et adresse de la personne à qui elle est vendue ou fournie et la date de sa vente ou de sa fourniture;

c) le nom et la quantité de toute drogue d’usage restreint employée dans la fabrication ou l’assemblage d’un produit ou d’un composé qui contient cette drogue, le nom et la quantité du produit ou du composé fabriqué ou assemblé et la date à laquelle ce produit ou ce composé a été stocké;

d) le nom et la quantité de toute drogue d’usage restreint produite et la date à laquelle elle a été stockée;

e) le nom, la quantité et la forme de toute drogue d’usage restreint en stock.

DORS/2004-238, art. 35; DORS/2010-222, art. 31(F). Version précédente J.01.024. Tout distributeur autorisé ou toute personne ayant été un distributeur autorisé doit conserver le registre mentionné à l’article J.01.023, dans les locaux décrits sur la licence qui lui a été délivrée, ou dans tout autre endroit ayant pu être approuvé par le ministre, pendant au moins deux ans et il doit conserver ce registre sous une forme facilitant sa vérification à n’importe quel moment.

J.01.025. (1) Le ministre peut, à l’égard du demandeur ou du distributeur autorisé, exiger, à tout moment raisonnable :

a) l’inspection de l’installation utilisée ou envisagée pour la fabrication, la production, l’assemblage ou l’entreposage d’une drogue d’usage restreint;

b) l’examen, lors de l’inspection, des procédés utilisés pour ces opérations et des conditions dans lesquelles elles se déroulent.

(2) [Abrogé, DORS/2010-222, art. 32]

DORS/2004-238, art. 36; DORS/2010-222, art. 32. Version précédente J.01.026. Toute personne qui vend ou fournit une drogue d’usage restreint doit :

a) fournir au ministre des renseignements, sous la forme qu’il peut exiger, concernant l’utilisation de ladite drogue par une personne quelconque;

b) montrer à un inspecteur tout livre, registre ou document qu’elle doit tenir en vertu de la présente partie;

c) permettre à un inspecteur de faire des copies ou de prendre des extraits de tout livre, registre ou document; et

d) permettre à un inspecteur de vérifier tous les stocks de drogues d’usage restreint conservés dans les locaux décrits sur la licence.

DORS/2004-238, art. 37.

J.01.027. Tout distributeur autorisé doit avertir le ministre, dès qu’un changement se produit

a) [Abrogé, DORS/2010-222, art. 33]

b) dans l’installation où est fabriquée, produite, assemblée ou entreposée une drogue d’usage restreint;

c) dans le procédé et les conditions de fabrication, de production, d’assemblage ou d’entreposage de la drogue d’usage restreint.

DORS/2004-238, art. 38; DORS/2010-222, art. 33. Version précédente J.01.028. Toute personne qui est en possession d’une drogue d’usage restreint et tout établissement auquel le ministre a autorisé la vente d’une drogue d’usage restreint doivent

a) prendre toute disposition, contre la perte ou le vol de ladite drogue d’usage restreint, que le ministre peut exiger; et

b) avertir le ministre et les autorités locales responsables de l’application des lois dès qu’il y a perte ou vol d’une drogue d’usage restreint.

J.01.029. Lorsqu’un distributeur autorisé livre une drogue d’usage restreint, il doit

a) prendre les mesures nécessaires pour assurer la protection de la drogue pendant le transport; et

b) utiliser les méthodes de transport garantissant la tenue d’un registre exact du cheminement de la drogue et portant les signatures des personnes en charge de la drogue jusqu’au moment de la livraison au destinataire.

Emballage et étiquetage

J.01.030. Toute drogue d’usage restreint vendue à un établissement doit être soigneusement emballée par le distributeur autorisé qui vend la drogue, d’une manière telle que l’emballage ne puisse être ouvert sans que le sceau ne se brise.

J.01.031. Les dispositions de l’article C.01.004 ne s’appliquent pas à une drogue d’usage restreint.

J.01.032. Tout emballage contenant une drogue d’usage restreint doit être étiqueté de sorte que les étiquettes intérieure et extérieure indiquent

a) le nom propre, s’il n’y a pas de nom propre, le nom commun de la drogue;

b) le contenu net de l’emballage;

c) la force unitaire de la drogue si elle est en unités;

d) le numéro du lot de la drogue;

e) les mots « Drogues d’usage restreint »; et

f) les nom et adresse du fabricant, producteur ou assembleur de la drogue.

DORS/2004-238, art. 39.

J.01.032.1. L’article J.01.032 ne s’applique pas à un nécessaire d’essai contenant une drogue d’usage restreint, et portant un numéro d’enregistrement émis selon l’article J.01.033.3 et non annulé selon l’article J.01.033.4.

J.01.033. (1) et (2) [Abrogés, DORS/99-125, art. 8]

(3) Malgré toute disposition du présent règlement, une personne peut, aux fins d’identification ou d’analyse, fournir ou livrer une drogue d’usage restreint qu’elle a en sa possession :

a) à un praticien; ou

b) à un représentant d’un praticien qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession d’une telle drogue à ces fins.

(4) Lorsque le représentant d’un praticien a reçu une drogue d’usage restreint, aux termes du paragraphe (3), il doit, sans délai, la fournir ou la livrer :

a) au praticien dont il est le représentant; ou

b) au ministre ou à son représentant.

(5) Le praticien qui a reçu une drogue d’usage restreint aux termes du paragraphe (3) ou (4) doit, sans délai, la fournir ou la livrer :

a) aux fins d’identification ou d’analyse, à une personne qui bénéficie d’une exemption aux termes de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à la possession d’une telle drogue à ces fins; ou

b) au ministre.

(6) Les articles J.01.021 et J.01.022 s’appliquent, compte tenu des modifications nécessaires, à toute personne qui a reçu une drogue d’usage restreint aux termes du présent article, à l’exception d’une personne à laquelle une telle drogue a été administrée aux termes d’une exemption accordée en vertu de l’article 56 de la Loi réglementant certaines drogues et autres substances relativement à l’administration de cette drogue.

DORS/99-125, art. 8; DORS/2004-238, art. 40.

Nécessaires d'essai contenant des drogues d'usage restreint

J.01.033.1. Toute personne peut vendre, posséder ou autrement manipuler un nécessaire d’essai contenant une drogue d’usage restreint si

a) un numéro d’enregistrement a été émis pour le nécessaire, selon l’article J.01.033.3;

b) le nécessaire d’essai porte, sur sa surface extérieure,

(i) le nom du fabricant, du producteur ou de l’assembleur,

(ii) le nom commercial ou la marque de commerce, et

(iii) le numéro d’enregistrement émis selon l’article J.01.033.3;

c) le nécessaire d’essai est vendu, acquis ou autrement manipulé, à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques; et

d) le numéro d’enregistrement n’a pas été annulé selon l’article J.01.033.4.

DORS/2004-238, art. 41.

J.01.033.2. Le fabricant d’un nécessaire d’essai contenant une drogue d’usage restreint peut demander un numéro d’enregistrement en présentant au Directeur une demande contenant

a) les détails de la présentation et de la composition du nécessaire d’essai;

b) une description détaillée de la drogue d’usage restreint et des autres substances, s’il en est, que contient le nécessaire d’essai, y compris la composition qualitative et quantitative de chacun des composants;

c) une description de l’usage auquel on destine le nécessaire d’essai; et

d) tout autre renseignement et document susceptibles d’être demandés par le ministre afin qu’il puisse déterminer s’il peut émettre un numéro d’enregistrement pour le nécessaire d’essai.

J.01.033.3. Lorsque, sur une demande selon l’article J.01.033.2, le ministre est convaincu que le nécessaire d’essai ne sera utilisé qu’à des fins médicales, expérimentales, industrielles, éducatives ou scientifiques et qu’il

a) contient une drogue d’usage restreint et une ou plusieurs substances adultérantes ou dénaturantes, mélangées de telle manière et en quantités, proportions ou concentrations telles que la préparation ou le mélange ne présente que très peu ou aucun potentiel d’abus, ou

b) contient des quantités ou concentrations de drogues d’usage restreint si infimes qu’elles ne présentent aucun potentiel d’abus significatif,

le ministre peut émettre un numéro d’enregistrement pour ce nécessaire, qu’il fera précéder des lettres « TK ».

DORS/81-21, art. 3 et 4; DORS/86-91, art. 4(F).

J.01.033.4. Le ministre peut annuler le numéro d’enregistrement d’un nécessaire d’essai si celui-ci est retiré du marché par le fabricant ou si, de l’avis du ministre,

a) il convient de l’annuler dans l’intérêt de la santé publique; ou

b) le nécessaire d’essai est utilisé ou est susceptible de l’être, à des fins autres que médicales, expérimentales, industrielles, éducatives ou scientifiques.

Manière prescrite de présenter un avis de demande d'une ordonnance de restitution

J.01.035. (1) Pour l’application du paragraphe 24(1) de la Loi réglementant certaines drogues et autres substances, le préavis de demande d’ordonnance de restitution doit être donné par écrit, sous pli recommandé, au procureur général.

(2) L’avis mentionné au paragraphe (1) doit être mis à la poste au moins 15 jours entiers avant la date à laquelle la demande doit être présentée au magistrat et doit préciser

a) le nom du magistrat à qui la demande sera présentée;

b) l’heure et le lieu d’instruction de la demande;

c) la drogue d’usage restreint ou toute autre chose qui fait l’objet de la demande;

d) la preuve que le demandeur projette de présenter pour établir qu’il a le droit de posséder la drogue d’usage restreint ou l’autre chose visés à l’alinéa c).

DORS/97-228, art. 24.

J.01.036 Lorsque, en vertu du Règlement sur l’exécution policière de la Loi réglementant certaines drogues et autres substances, un membre d’un corps policier ou une personne qui agit sous l’autorité et la supervision d’un membre d’un corps policier est, à l’égard d’une activité, soustrait à l’application du paragraphe 4(2) ou des articles 5, 6, ou 7 de la Loi réglementant certaines drogues et autres substances, ce membre ou cette personne est, à l’égard de cette activité, soustrait à l’application de la présente partie.

DORS/97-228, art. 25.

ANNEXE

(article J.01.001)

1. Les amphétamines suivants, leurs sels, dérivés, isomères et analogues, ainsi que lessels de leurs dérivés, isomères et analogues : (1) N-éthylamphétamine (N-éthyl α-méthylbenzèneéthanamine)

méthyl-4 diméthoxy-2,5 amphétamine (STP) (diméthoxy-2,5 4,α­(2) diméthylbenzèneéthanamine) méthylènedioxy-3,4 amphétamine (MDA) (α-méthyl benzodioxole-1,3(3) éthanamine-5)

(4) diméthoxy-2,5 amphétamine (diméthoxy-2,5α-méthylbenzèneéthanamine) (5) méthoxy-4 amphétamine (méthoxy-4 α-méthylbenzèneéthanamine) (6) triméthoxy-2,4,5 amphétamine (triméthoxy-2,4,5 α-méthylbenzèneéthanamine)

N-méthyl méthylènedioxy-3,4 amphétamine (N,α-diméthyl benzodioxole-1,3(7) éthanamine-5) éthoxy-4 diméthoxy-2,5 amphétamine (éthoxy-4 diméthoxy-2,5 α­(8) méthylbenzèneéthanamine) méthoxy-5 méthylènedioxy-3,4 amphétamine (N,α-diméthyl benzodioxole-1,3(9) éthanamine-5)

(10) N,N-diméthyl méthylènedioxy-3,4 amphétamine (N,N, α-triméthylbenzodioxole-1,3 éthanamine-5)

(11) N-éthyl méthylènedioxy-3,4 amphétamine (N-éthyl α-méthyl benzodioxole-1,3éthanamine-5)

(12) éthyl-4 diméthoxy-2,5 amphétamine (DOET) (éthyl-4 diméthoxy-2,5α­méthylbenzèneéthanamine)

(13) bromo-4 diméthoxy-2,5 amphétamine (bromo-4 diméthoxy-2,5 α­méthylbenzèneéthanamine)

(14) chloro-4 diméthoxy-2,5 amphétamine (chloro-4 diméthoxy-2,5 α­méthylbenzèneéthanamine) (15) éthoxy-4 amphétamine (éthoxy-4 α-méthylbenzèneéthanamine)

(16) N-propyl méthylènedioxy-3,4 amphétamine (α-méthyl N-propyl benzodioxole­1,3 éthanamine)

(17) N-hydroxy méthylènedioxy-3,4 amphétamine (N-[α-méthyl (méthylènedioxy)­3,4 phénéthyl]hydroxylamine) (18) triméthoxy-3,4,5 amphétamine (triméthoxy-3,4,5 α-méthylbenzèneéthanamine)

2. Diéthylamide de l'acide lysergique (LSD) (N,N-diéthyl-lysergamide) et ses sels 3. N,N-Diéthyltryptamine (DET) ((diéthylamino-2 éthyl)-3 indole) et ses sels 4. N,N-Diméthyltryptamine (DMT) ((diméthylamino-2 éthyl)-3 indole) et ses sels

N-Méthyl pipéridyl-3 benzilate (LBJ) ([(hydroxy-diphénylacétyl)oxy]-3 méthyl-15. pipéridine) et ses sels 6. Harmaline (dihydro-4,9 méthoxy-7 méthyl-1 3H-pyrido(3,4-ß) indole) et ses sels 7. Harmalol (dihydro-4,9 hydroxy-7 méthyl-1 3H-pyrido(3,4-b) indole) et ses sels 8. Psilocine ((diméthylamino-2 éthyl)-3 hydroxy-4 indole) et ses sels 9. Psilocybine ((diméthylamino-2 éthyl)-3 phosphoryloxy-4 indole) et ses sels 10. N-(Phényl-1 cyclohexyl) éthylamine (PCE) et ses sels 11. [(Thiényl-2)-1 cyclohexyl]-1 pipéridine (TCP) et ses sels 12. Phényl-1 N-propylcyclohexanamine et ses sels

13. Mescaline (triméthoxy-3,4,5 benzèneéthanamine) et ses sels, sauf le peyote(lophophora) 14. Méthyl-4 aminorex (dihydro-4,5 méthyl-4 phényl-5 oxazolamine-2) et ses sels 15. Méthylamino-2 phényl-1 propanone-1 et ses sels 16. [Cyclohexyl (phénylméthyl)-1] pipéridine-1 et ses sels 17. [Cyclohexyl (méthyl-4 phényl)-1] pipéridine-1 et ses sels

18. Étryptamine ((amino-2 butyl)-3 indole) et ses sels 19. Rolicyclidine ((phényl-1 cyclohexyl)-1 pyrrolidine) et ses sels

DORS/97-228, art. 25; DORS/2003-34, art. 4 et 5.

ANNEXE F

(Articles C.01.001, C.01.041 à C.01.047, C.01.601 et C.10.005)

PARTIE I Abacavir et ses sels

Abacavir and its salts

Abatacept

Abatacept

Abciximab

Abciximab

Acamprosate et ses sels

Acamprosate and its salts

Acarbose et ses dérivés

Acarbose and its derivatives

Acébutolol et ses sels

Acebutolol and its salts

Acétazolamide

Acetazolamide

Acétohexamide

Acetohexamide

Acétylcarbromal

Acetylcarbromal

Acétylcholine (chlorure d’)

Acetylcholine Chloride

Acide azélaïque

Azelaic acid

Acide folinique et ses sels

Leucovorin and its salts

Acide folique présenté en unités posologiques orales contenant chacune plus de 1,0 mg d’acide folique ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion, par une personne, de plus de 1,0 mg d’acide folique

Folic acid in oral dosage form containing more than 1.0 mg of folic acid per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1.0 mg of folic acid

Acide ibandronique et ses sels

Ibandronic acid and its salts

Acide lactique, s’il est recommandé pour usage parentéral comme agent sclérosant

Lactic acid, when recommended for parenteral use as a tissue sclerosing agent

Acide nicotinique vendu sous l’une des forme suivantes :

a) en forme posologique à libération modifiée fournissant, par unité posologique ou par dose quotidienne, 500 mg ou plus d’acide nicotinique administré par voie orale;

b) en forme posologique à libération immédiate fournissant, par unité posologique ou par dose quotidienne, plus de 500 mg d’acide nicotinique administré par voie orale

Nicotinic acid when sold in

(a) a modified-release oral dosage form that provides 500 mg or more per dosage unit or per daily dose; or

(b) an immediate-release oral dosage form that provides more than 500 mg per dosage unit or per daily dose

Acide risédronique et ses sels

Risedronic acid and its salts

Acide zolédronique et ses sels et dérivés

Zoledronic acid and its salts and derivatives

Acitrétine, ses sels et dérivés

Acitretin and its salts and derivatives

Aconiazide et ses sels

Aconiazide and its salts

Acyclovir et ses sels

Acyclovir and its salts

Adalimumab

Adalimumab

Adapalène, ses sels et dérivés

Adapalene and its salts and derivatives

Adéfovir, ses sels et dérivés

Adefovir and its salts and derivatives

Adénosine et ses sels, s’il est vendu ou recommandé pour administration par injection intraveineuse

Adenosine and its salts, when sold or recommended for administration by intravenous injection

Agalsidase alfa

Agalsidase alfa

Alatrofloxacine et ses sels et dérivés

Alatrofloxacin and its salts and derivatives

Aldésleukine

Aldesleukin

Aléfacept

Alefacept

Alemtuzumab

Alemtuzumab

Alendronique (acide) et ses sels

Alendronic acid and its salts

Alfacalcidol

Alfacalcidol

Alfaxalone

Alphaxalone

Alfuzosine et ses sels

Alfuzosin and its salts

Alglucosidase alfa

Alglucosidase alfa

Aliskirène et ses sels

Aliskiren and its salts

Alkyle (nitrites d’)

Alkyl nitrites

Allopurinol

Allopurinol

Allylisopropylacétylurée

Allylisopropylacetylurea

Almotriptan et ses sels

Almotriptan and its salts

Alpha-chloralose

Alpha-chloralose

Alphadolone et ses sels

Alphadolone and its salts

Altéplase, ses sels et dérivés

Alteplase and its salts and derivatives

Altrénogest

Altrenogest

Altrétamine

Altretamine

Amantadine et ses sels

Amantadine and its salts

Ambénonium (chlorure d’)

Ambenonium Chloride

Ambrisentan

Ambrisentan

Amifostine et ses sels

Amifostine and its salts

Amikacine, ses sels et dérivés

Amikacin and its salts and derivatives

Amiloride et ses sels

Amiloride and its salts

Aminocaproïque (acide)

Aminocaproic acid

Aminoglutéhimide

Aminoglutethimide

Aminolévulinique (acide), ses sels et dérivés

Aminolevulinic acid and its salts and derivatives

Aminophylline

Aminophylline

Aminoptérine et ses sels

Aminopterin and its salts

Amino-4-ptéroyl aspartique (acide) et ses sels

4-Amino-pteroyl aspartic acid and its salts

Amino-5-salicylique (acide)

5-Aminosalicylic acid

Amino-4 salicylique (acide) et ses sels

4-Aminosalicylic Acid and its salts

Amiodarone et ses sels

Amiodarone and its salts

Amitraz

Amitraz

Amitriptyline et ses sels

Amitriptyline and its salts

Amlexanox, ses sels et dérivés

Amlexanox and its salts and derivatives

Amlodipine et ses sels

Amlodipine and its salts

Amoxapine

Amoxapine

Amoxicilline, ses sels et dérivés

Amoxicillin and its salts and derivatives

Amphotéricine B, ses sels et dérivés

Amphotericin B and its salts and derivatives

Ampicilline, ses sels et dérivés

Ampicillin and its salts and derivatives

Amprénavir et ses sels et dérivés

Amprenavir and its salts and derivatives

Amrinone et ses sels

Amrinone and its salts

Amsacrine et ses sels

Amsacrine and its salts

Anagrélide et ses sels

Anagrelide and its salts

Anakinra, ses sels et dérivés

Anakinra and its salts and derivatives

Anastrozole

Anastrozole

Ancestim

Ancestim

Anidulafungine

Anidulafungin

Apiol (huile d’)

Apiol, oil of

Apraclonidine et ses sels

Apraclonidine and its salts

Aprépitant et ses dérivés

Aprepitant and its derivatives

Aprotinine

Aprotinin

Argatroban, ses sels et dérivés

Argatroban and its salts and derivatives

L-Asparaginase

L-Asparaginase

Astémizole et ses sels

Astemizole and its salts

Atazanavir et ses sels

Atazanavir and its salts

Aténolol et ses sels

Atenolol and its salts

Atipamézole et ses sels

Atipamezole and its salts

Atomoxétine et ses sels

Atomoxetine and its salts

Atorvastatine et ses sels

Atorvastatin and its salts

Atovaquone

Atovaquone

Atracurium (bésilate d’)

Atracurium besilate

Atropine et ses sels dans les préparations pour usage ophtalmique ou parentéral seulement

Atropine and its salts in ophthalmic or parenteral preparations only

Auranofine

Auranofin

Aurothioglucose

Aurothioglucose

Aurothiomalate de sodium

Sodium aurothiomalate

Azacyclonol et ses sels

Azacyclonol and its salts

Azaribine

Azaribine

Azatadine et ses sels

Azatidine and its salts

Azathioprine et ses sels

Azathioprine and its salts

Azlocilline, ses sels et dérivés

Azlocillin and its salts and derivatives

Aztréonam et ses sels

Aztreonam and its salts

Baclofène et ses sels

Baclofen and its salts

Bambutérol et ses sels

Bambuterol and its salts

Basiliximab

Basiliximab

Bécaplermine

Becaplermin

Bémégride

Bemegride

Benactyzine et ses sels

Benactyzine and its salts

Bénazépril, ses sels et dérivés

Benazepril and its salts and derivatives

Bendazac et ses sels

Bendazac and its salts

Benoxaprofène et ses sels

Benoxaprofen and its salts

Bensérazide et ses sels

Benserazide and its salts

Benzathine pénicilline, ses sels et dérivés

Benzathine penicillin, and its salts and derivatives

Benzatropine et ses sels

Benztropine and its salts

Benzoyle (peroxyde de) lorsqu’il constitue plus de cinq pour cent d’un mélange ou qu’il est vendu en association avec un autre ingrédient médicinal

Benzoyl peroxide in concentrations greater than 5 per cent or when sold in combination with another medicinal ingredient

Benzydamine et ses sels

Benzydamine and its salts

Béractant

Beractant

Bétahistine et ses sels

Betahistine and its salts

Bétaïne et ses sels s’ils sont vendus ou recommandés pour le traitement de l’homocystinurie

Betaine and its salts when sold or recommended for the treatment of homocystinuria

Betaxolol et ses sels

Betaxolol and its salts

Béthanéchol (chlorure de)

Bethanechol chloride

Béthanidine et ses sels

Bethanidine and its salts

Bévacizumab

Bevacizumab

Bezafibrate, ses sels et dérivés

Bezafibrate, and its salts and derivatives

Bicalutamide

Bicalutamide

Bimatoprost et ses dérivés

Bimatoprost and its derivatives

Bipéridène et ses sels

Biperiden and its salts

Bishydroxycoumarine, ses sels et dérivés

Bishydroxycoumarin and its salts and derivatives

Bisoprolol et ses sels

Bisoprolol and its salts

Bitoltérol et ses sels

Bitolterol and its salts

Bivalirudine

Bivalirudin

Bléomycine

Bleomycin

Bortézomib

Bortezomib

Bosentan et ses sels et dérivés

Bosentan and its salts and derivatives

Brétylium (tosylate de)

Bretylium tosylate

Brimonidine et ses sels

Brimonidine and its salts

Bromal

Bromal

Bromal (hydrate de)

Bromal hydrate

Brométone

Brometone

Bromhydrate de glutamate de magnésium

Magnesium glutamate hydrobromide

Bromisoval

Bromisoval

Bromocriptine et ses sels

Bromocriptine and its salts

Bromoforme

Bromoform

Bromolactobionate de calcium

Calcium bromolactobionate

Bromure d’ammonium

Ammonium bromide

Bromure de calcium

Calcium bromide

Bromure de potassium

Potassium bromide

Bromure de sodium

Sodium bromide

Bromure de strontium

Strontium bromide

Bumétanide, ses sels et dérivés

Bumetanide and its salts and derivatives

Bupropione et ses sels

Bupropion and its salts

Buséréline et ses sels

Buserelin and its salts

Buspirone et ses sels

Buspirone and its salts

Busulfan

Busulfan

Butapérazine et ses sels

Butaperazine and its salts

Butoconazole et ses sels

Butoconazole and its salts

Butylchloral (hydrate de)

Butyl chloral hydrate

Cabergoline et ses sels

Cabergoline and its salts

Calcipotriol

Calcipotriol

Calcitonine

Calcitonin

Calcitriol

Calcitriol

Calcium (carbimide de)

Calcium carbimide

Candésartan et ses sels et dérivés

Candesartan and its salts and derivatives

Candicidine, ses sels et dérivés

Candicidin and its salts and derivatives

Capécitabine et ses sels et dérivés

Capecitabine and its salts and derivatives

Capréomycine, ses sels et dérivés

Capreomycin and its salts and derivatives

Captodiamine et ses sels

Captodiamine and its salts

Captopril et ses sels

Captopril and its salts

Carbachol

Carbachol

Carbamazépine

Carbamazepine

Carbénicilline, ses sels et dérivés

Carbenicillin and its salts and derivatives

Carbenoxolone et ses sels

Carbenoxolone and its salts

Carbétocine et ses sels

Carbetocin and its salts

Carbidopa et ses sels

Carbidopa and its salts

Carbimazole

Carbimazole

Carbocistéine

Carbocisteine

Carbomycine, ses sels et dérivés

Carbomycin and its salts and derivatives

Carboplatine

Carboplatin

Carbromal

Carbromal

Carisoprodol

Carisoprodol

Carmustine

Carmustine

Carphénazine et ses sels

Carphenazine and its salts

Carprofène, ses sels et dérivés

Carprofen and its salts and derivatives

Carvédilol et ses sels

Carvedilol and its salts

Caspofungine et ses sels et dérivés

Caspofungin and its salts and derivatives

Cefdinir et ses sels et dérivés

Cefdinir and its salts and derivatives

Céfépime, ses sels et dérivés

Cefepime and its salts and derivatives

Céfonicide et ses sels

Cefonicide and its salts

Céfopérazone, ses sels et dérivés

Cefoperazone and its salts and derivatives

Cefprozil, ses sels et dérivés

Cefprozil and its salts and derivatives

Ceftibutène, ses sels et dérivés

Ceftibuten and its salts and derivatives

Célécoxib et ses sels

Celecoxib and its salts

Céphalosporine C, ses sels et dérivés

Cephalosporin C and its salts and derivatives

Cérivastatine et ses sels

Cerivastatin and its salts

Cétirizine et ses sels lorsque vendue en concentration supérieure à 8,5 mg de cétirizine par unité posologique

Cetirizine and its salts when sold in concentrations greater than 8.5 mg cetirizine per unit dose

Cétrorélix et ses sels

Cetrorelix and its salts

Cétuximab

Cetuximab

Chloral

Chloral

Chloral (hydrate de)

Chloral hydrate

Chloralformamide

Chloralformamide

Chloralimide

Chloralimide

Chlorambucil, ses sels et dérivés

Chlorambucil and its salts and derivatives

Chloramphénicol, ses sels et dérivés

Chloramphenicol and its salts and derivatives

Chlorcyclizine et ses sels (sauf dans les préparations pour usage externe seulement)

Chlorcyclizine and its salts (except in preparations for external use only)

Chlorisondamine et ses sels

Chlorisondamine and its salts

Chlormézanone

Chlormezanone

Chloroquine et ses sels

Chloroquine and its salts

Chlorpropamide

Chlorpropamide

Chlorprothixène et ses sels

Chlorprothixene and its salts

Choline (salicylate de) s’il est vendu en association avec le salicylate de magnésium

Choline salicylate, when sold in combination with magnesium salicylate

Choline (théophyllinate de)

Choline theophyllinate

Choriogonadotropine alfa

Choriogonadotropin alfa

Ciclopirox et ses sels

Ciclopirox and its salts

Cilastatine et ses sels

Cilastatin and its salts

Cilazapril, ses sels et dérivés

Cilazapril and its salts and derivatives

Cimétidine et ses sels, sauf s’ils sont vendus en une concentration de 200 mg ou moins par unité posologique orale pour le traitement des brûlures d’estomac

Cimetidine and its salts, except when sold in concentrations of 200 mg or less per oral dosage unit and indicated for the treatment of heartburn

Cinacalcet et ses sels

Cinacalcet and its salts

Cinchophène et ses sels

Cinchophene and its salts

Cinoxacine

Cinoxacin

Ciprofloxacine et ses sels

Ciprofloxacin and its salts

Cisapride et ses sels

Cisapride and its salts

Cisatracurium (bésilate de)

Cisatracurium besilate

Cisplatine

Cisplatin

Citalopram et ses sels

Citalopram and its salts

Cladribine et ses sels

Cladribine and its salts

Clenbutérol et ses sels

Clenbuterol and its salts

Clindamycine et ses sels et dérivés

Clindamycin and its salts and derivatives

Clodronique (acide) et ses sels

Clodronic acid and its salts

Clofibrate

Clofibrate

Clomiphène et ses sels

Clomiphene and its salts

Clomipramine et ses sels

Clomipramine and its salts

Clonidine et ses sels

Clonidine and its salts

Clopidogrel et ses sels

Clopidogrel and its salts

Cloprosténol, ses sels et dérivés

Cloprostenol and its salts and derivatives

Clorazépique (acide) et ses sels

Clorazepic acid and its salts

Clotrimazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Clotrimazole and its salts (except in preparations for topical and vaginal use)

Cloxacilline, ses sels et dérivés

Cloxacillin and its salts and derivatives

Clozapine et ses sels

Clozapine and its salts

Colchicine

Colchicine

Colestipol et ses sels

Colestipol and its salts

Colfoscéril et ses dérivés

Colfosceril and its derivatives

Colistine, ses sels et dérivés

Colistin and its salts and derivatives

Cromoglicique (acide) et ses sels (sauf le cromoglicate de sodium dans les solutions pour usage ophtalmique ou nasal en concentration de 2 % ou moins)

Cromoglicic acid and its salts (except sodium cromoglicate in solutions for ophthalmic or nasal use in concentrations of 2 % or less)

Cyclobenzaprine et ses sels

Cyclobenzaprine and its salts

Cyclopentolate et ses sels dans les préparations pour usage parentéral ou ophtalmique, sauf lorsqu’ils sont vendus pour usage diagnostique à un optométriste agréé dans une province du Canada

Cyclopentolate and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada

Cyclophosphamide

Cyclophosphamide

Cyclosérine

Cycloserine

Cyclosporine

Cyclosporine

Cyprotérone (acétate de)

Cyproterone acetate

Cytarabine et ses sels

Cytarabine and its salts

Dabigatran et ses sels et dérivés

Dabigatran and its salts and derivatives

Dacarbazine

Dacarbazine

Daclizumab

Daclizumab

Dactinomycine

Dactinomycin

Dalfopristine et ses sels

Dalfopristin and its salts

Daltéparine et ses sels

Dalteparin and its salts

Danaparoïde, ses sels et dérivés

Danaparoid and its salts and derivatives

Danazol

Danazol

Danofloxacine et ses sels

Danofloxacin and its salts

Dantrolène et ses sels

Dantrolene and its salts

Dapiprazole et ses sels

Dapiprazole and its salts

Daptomycine

Daptomycin

Darifénacine et ses sels

Darifenacin and its salts

Darunavir

Darunavir

Dasatinib

Dasatinib

Daunorubicine et ses sels

Daunorubicin and its salts

Déanol, ses sels et dérivés

Deanol, and its salts and derivatives

Debrisoquine et ses sels

Debrisoquin and its salts

Déférasirox

Deferasirox

Déféroxamine et ses sels

Deferoxamine and its salts

Délavirdine et ses sels

Delavirdine and its salts

Déracoxib

Deracoxib

Déserpidine, ses alcaloïdes et sels

Deserpidine and its alkaloids and salts

Desflurane

Desflurane

Désipramine et ses sels

Desipramine and its salts

Desmopressin et ses sels

Desmopressin and its salts

Détomidine et ses sels

Detomidine and its salts

Dexfenfluramine et ses sels

Dexfenfluramine and its salts

Dexrazoxane et ses sels

Dexrazoxane and its salts

Diazoxide et ses sels

Diazoxide and its salts

Dichloroacétique (acide)

Dichloroacetic Acid

Diclofénac et ses sels sauf s’ils sont vendus comme ingrédient médicinal unique en une concentration maximale de 1 % dans les préparations pour usage topique sur la peau

Diclofenac and its salts, except when sold as a single medicinal ingredient in a concentration equivalent to 1% or less diclofenac in preparations for topical use on the skin

Dicloxacilline, ses sels et dérivés

Dicloxacillin and its salts and derivatives

Didanosine, ses sels et dérivés

Didanosine and its salts and derivatives

Diéthylbromacétamide

Diethylbromacetamide

Diéthylcarbamazine et ses sels

Diethylcarbamazine and its salts

Diéthylstilbestrol, ses sels et dérivés

Diethylstilbestrol and its salts and derivatives

Difloxanine et ses sels et dérivés

Difloxanin and its salts and derivatives

Diflunisal et ses sels

Diflunisal and its salts

Digitalis lanata et ses glycosides

Digitalis lanata and its glycosides

Digitalis purpurea et ses glycosides

Digitalis purpurea and its glycosides

Digoxine [Fragments d’anticorps spécifiques de la digoxine Fab (ovins)]

Digoxin immune Fab (ovine)

Dihydrotachystérol

Dihydrotachysterol

Diiodohydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)

Diiodohydroxyquin (except in preparations for topical use on the skin)

Diltiazem et ses sels

Diltiazem and its salts

Dimercaprol

Dimercaprol

Diméthylsulfoxyde

Dimethyl sulfoxide

Dinitro-2,4-phénol, ses sels et dérivés

2,4-Dinitrophenol and its salts and derivatives

Dinoprostone, ses sels et dérivés

Dinoprostone and its salts and derivatives

Diphénidol et ses sels

Diphenidol and its salts

Diphénylhydantoine (phénytoïne) et ses sels

Diphenylhydantoin (phenytoin) and its salts

Dipivefrine et ses sels

Dipivefrin and its salts

Diprophylline et ses sels

Diprophylline and its salts

Dipyridamole

Dipyridamole

Disopyramide et ses sels

Disopyramide and its salts

Disulfirame

Disulfiram

Dobutamine et ses sels

Dobutamine and its salts

Docétaxel et ses dérivés

Docetaxel and its derivatives

Dolasétron et ses sels

Dolasetron and its salts

Dompéridone

Domperidone

Donépézil et ses sels

Donepezil and its salts

Dopamine et ses sels

Dopamine and its salts

Dornase alfa

Dornase alfa

Dorzolamide et ses sels

Dorzolamide and its salts

Doxacurium (chlorure de)

Doxacurium chloride

Doxapram

Doxapram

Doxazosine et ses sels

Doxazosin and its salts

Doxépine et ses sels

Doxepin and its salts

Doxercalciférol et ses dérivés

Doxercalciferol and its derivatives

Doxorubicine et ses sels

Doxorubicin and its salts

Doxycycline, ses sels et dérivés, lorsque vendus pour administration intramusculaire aux oiseaux en cage

Doxycycline and its salts and derivatives, when sold for intramuscular administration in caged birds

Doxylamine et ses sels lorsque vendus ou recommandés contre les nausées ou vomissements de la grossesse

Doxylamine and its salts, when sold or recommended for use in the nausea or vomiting of pregnancy

Dropéridol et ses sels

Droperidol and its salts

Drotrécogine

Drotrecogin

Duloxétine et ses sels

Duloxetine and its salts

Dutastéride

Dutasteride

Éconazole et ses sels

Econazole and its salts

Écothiophate et ses sels

Ecothiophate and its salts

Ectylurée et ses sels

Ectylurea and its salts

Éculizumab

Eculizumab

Édrophonium (chlorure d’)

Edrophonium chloride

Éfalizumab

Efalizumab

Éfavirenz

Efavirenz

Éflornithine, ses sels et dérivés

Eflornithine and its salts and derivatives

Élétriptan et ses sels

Eletriptan and its salts

Embutramide

Embutramide

Émédastine et ses sels

Emedastine and its salts

Emtricitabine

Emtricitabine

Émylcamate

Emylcamate

Énalaprilate, ses sels et dérivés

Enalaprilat and its salts and derivatives

Enflurane

Enflurane

Enfuvirtide

Enfuvirtide

Énoxaparine et ses sels

Enoxaparin and its salts

Enrofloxacine

Enrofloxacin

Entacapone

Entacapone

Entécavir

Entecavir

Épirubicine et ses sels

Epirubicine and its salts

Époprosténol et ses sels

Epoprostenol and its salts

Éprosartan et ses sels et dérivés

Eprosartan and its salts and derivatives

Epsiprantel

Epsiprantel

Eptifibatide et ses sels

Eptifibatide and its salts

Erlotinib et ses sels

Erlotinib and its salts

Ertapénem et ses sels

Ertapenem and its salts

Érythropoiétine

Erythropoietin

Escitalopram et ses sels

Escitalopram and its salts

Esmolol et ses sels

Esmolol and its salts

Ésoméprazole et ses sels

Esomeprazole and its salts

Estramustine et ses sels

Estramustine and its salts

Étacrynique (acide)

Ethacrynic acid

Étanercept

Etanercept

Éthambutol et ses sels

Ethambutol and its salts

Éthionamide et ses sels

Ethionamide and its salts

Éthomoxane et ses sels

Ethomoxane and its salts

Éthotoine et ses sels

Ethotoin and its salts

Éthyle (trichloramate d’)

Ethyl trichloramate

Étidronique (acide) et ses sels

Etidronic acid and its salts

Étodolac, ses sels et dérivés

Etodolac and its salts and derivatives

Étoposide et ses dérivés

Etoposide and its derivatives

Étravirine et ses sels

Etravirine and its salts

Étrétinate

Etretinate

Étymémazine et ses sels

Etymemazine and its salts

Exémestane

Exemestane

Ézétimibe

Ezetimibe

Famciclovir et ses sels

Famciclovir and its salts

Famotidine et ses sels, sauf s’ils sont vendus en une concentration de 20 mg ou moins par unité posologique orale et indiqués pour le traitement des brûlures d’estomac

Famotidine and its salts, except when sold in concentrations of 20 mg or less per oral dosage unit and indicated for the treatment of heartburn

Félodipine et ses sels

Felodipine and its salts

Fenfluramine et ses sels

Fenfluramine and its salts

Fénofibrate

Fenofibrate

Fénoprofène et ses sels

Fenoprofen and its salts

Fénotérol et ses sels

Fenoterol and its salts

Filgrastime

Filgrastim

Finastéride

Finasteride

Flavoxate et ses sels

Flavoxate and its salts

Flécaïnide et ses sels

Flecainide and its salts

Fléroxacine, ses sels et dérivés

Fleroxacin and its salts and derivatives

Floctafénine

Floctafenine

Florfénicol et ses dérivés

Florfenicol and its derivatives

Fluconazole, sauf s’il est vendu en une concentration de 150 mg par unité posologique orale pour le traitement des candidoses vaginales

Fluconazole, except when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis

Flucytosine

Flucytosine

Fludarabine, ses sels et dérivés

Fludarabine and its salts and derivatives

Flunarizine et ses sels

Flunarizine and its salts

Flunixine, ses sels et dérivés

Flunixin and its salts and derivatives

Fluorouracile et ses dérivés

Fluorouracil and its derivatives

Fluoxétine et ses sels

Fluoxetine and its salts

Flupentixol, ses sels et dérivés

Flupentixol and its salts and derivatives

Fluphénazine et ses sels

Fluphenazine and its salts

Fluprosténol, ses sels et dérivés

Fluprostenol and its salts and derivatives

Flurbiprofène et ses sels

Flurbiprofen and its salts

Fluspirilène

Fluspirilene

Flutamide

Flutamide

Fluvastatine, ses sels et dérivés

Fluvastatin and its salts and derivatives

Fluvoxamine et ses sels

Fluvoxamine and its salts

Folliculo-stimulante (hormone)

Follicle stimulating hormone

Fomépizole et ses sels

Fomepizole and its salts

Fondaparinux sodique

Fondaparinux sodium

Formestane et ses dérivés

Formestane and its derivatives

Formotérol et ses sels

Formoterol and its salts

Foscarnet sodique

Foscarnet sodium

Fosfomycine et ses sels

Fosfomycin and its salts

Fosinopril et ses sels

Fosinopril and its salts

Fosphénytoïne et ses sels

Fosphenytoin and its salts

Frovatriptan et ses sels

Frovatriptan and its salts

Fulvestrant

Fulvestrant

Fusidique (acide) et ses sels

Fusidic acid and its salts

Gabapentin, ses sels et dérivés

Gabapentin and its salts and derivatives

Galantamine et ses sels et dérivés

Galantamine and its salts and derivatives

Gallamine (triéthiodure de)

Gallamine triethiodide

Gallium et ses sels

Gallium and its salts

Ganciclovir et ses sels

Ganciclovir and its salts

Ganirélix, ses sels et dérivés

Ganirelix and its salts and derivatives

Gatifloxacine, ses sels et dérivés

Gatifloxacin and its salts and derivatives

Géfitinib

Gefitinib

Gemcitabine et ses sels

Gemcitabine and its salts

Gemfibrozil et ses sels

Gemfibrozil and its salts

Gémifloxacine et ses sels

Gemifloxacin and its salts

Gentamicine, ses sels et dérivés

Gentamicin and its salts and derivatives

Glatiramère et ses sels

Glatiramer and its salts

Gliclazide

Gliclazide

Glimépiride

Glimepiride

Glipizide

Glipizide

Glyburide, ses sels et dérivés

Glyburide and its salts and derivatives

Glycosaminoglycan polysulfaté

Polysulfated glycosaminoglycan

Golimumab

Golimumab

Gonadoréline et ses sels

Gonadorelin and its salts

Gonadotropine chorionique (humain)

Gonadotropin, chorionic (human)

Gonadotropines sériques (humains)

Gonadotropins, serum (human)

Goséréline et ses sels

Goserelin and its salts

Granisetron et ses sels

Granisetron and its salts

Grépafloxacine et ses sels et dérivés

Grepafloxacin and its salts and derivatives

Guanéthidine et ses sels

Guanethidine and its salts

Halofantrine et ses sels

Halofantrine and its salts

Halopéridol

Haloperidol

Halothane

Halothane

Hétacilline, ses sels et dérivés

Hetacillin and its salts and derivatives

Hetastarch et ses dérivés

Hetastarch and its derivatives

Hexachlorophène et ses sels

Hexachlorophene and its salts

Hexacyclonate sodique

Hexacyclonate sodium

Hexaméthonium et ses sels

Hexamethonium and its salts

Histréline et ses sels

Histrelin and its salts

Hyaluronique (acide) et ses sels, s’il est vendu ou recommandé pour administration par injection intra-articulaire aux chevaux

Hyaluronic acid and its salts, when sold or recommended for administration by intra­ articular injection to horses

Hydralazine et ses sels

Hydralazine and its salts

Hydroxychloroquine et ses sels

Hydroxychloroquine and its salts

Hydroxy-4 coumarine et ses dérivés, s’ils sont vendus ou recommandés comme anticoagulants

4-Hydroxycoumarin and its derivatives when sold or recommended as anticoagulants

Hydroxyurée

Hydroxyurea

Hydroxyzine, ses sels et dérivés

Hydroxyzine and its salts and derivatives

Ibutilide et ses sels et dérivés

Ibutilide and its salts and derivatives

Ibuprofène et ses sels, sauf s’ils sont vendus pour administration par voie orale en une concentration de 400 mg ou moins par unité posologique

Ibuprofen and its salts except when sold for oral administration in a concentration of 400 mg or less per dosage unit

Idarubicine et ses sels

Idarubicin and its salts

Idoxuridine

Idoxuridine

Ifosfamide

Ifosfamide

Imatinib et ses sels

Imatinib and its salts

Imiglucérase

Imiglucerase

Imipénem, ses sels et dérivés

Imipenem and its salts and derivatives

Imipramine et ses sels

Imipramine and its salts

Imiquimod et ses sels

Imiquimod and its salts

Indapamide et ses sels

Indapamide and its salts

Indinavir et ses sels

Indinavir and its salts

Indométhacine

Indomethacin

Infliximab

Infliximab

Inosiplex

Inosiplex

Insuline humaine inhalée

Inhaled human insulin

Interféron

Interferon

Iodochlorhydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)

Iodochlorohydroxyquin (except in preparations for topical use on the skin)

Ipratropium et ses sels

Ipratropium and its salts

Iproniazide et ses sels

Iproniazid and its salts

Irbésartan et ses sels

Irbesartan and its salts

Irinotécan et ses sels

Irinotecan and its salts

Isocarboxazide et ses sels

Isocarboxazid and its salts

Isoflurane

Isoflurane

Isoniazide

Isoniazid

Isoprotérénol (Isoprénaline) et ses sels

Isoproterenol (Isoprenaline) and its salts

Isotrétinoïne et ses sels

Isotretinoin and its salts

Isoxsuprine et ses sels

Isoxsuprine and its salts

Isradipine et ses sels

Isradipine and its salts

Itraconazole et ses sels

Itraconazole and its salts

Ivermectine et ses dérivés, destinés à l’usage humain ou à l’usage vétérinaire, s’ils sont vendus pour injection intramusculaire aux chevaux ou pour administration par voie orale aux chiens et aux chats

Ivermectin and its derivatives, for human use or for veterinary use when sold for intramuscular injection into horses or for oral administration to dogs and cats

Kétansérine et ses sels

Ketanserin and its salts

Kétoconazole et ses sels (excepté pour les préparations pour usage topique sous la forme d’un shampooing)

Ketoconazole and its salts (except in preparations for topical use as a shampoo)

Kétoprofène et ses sels

Ketoprofene and its salts

Kétorolac et ses sels

Ketorolac and its salts

Kétotifène et ses sels

Ketotifen and its salts

Labétalol et ses sels

Labetalol and its salts

Lamivudine et ses sels

Lamivudine and its salts

Lamotrigue et ses sels

Lamotrigine and its salts

Lanréotide et ses sels

Lanreotide and its salts

Lansoprazole et ses sels

Lansoprazole and its salts

Lapatinib et ses sels

Lapatinib and its salts

Laronidase

Laronidase

Latanoprost

Latanoprost

Léflunomide et ses sels

Leflunomide and its salts

Lénalidomide

Lenalidomide

Létrozole

Letrozole

Leuproréline et ses sels

Leuprolide and its salts

Lévétiracétam

Levetiracetam

Levobunolol et ses sels

Levobunolol and its salts

Lévocabastine, ses sels et dérivés

Levocabastine and its salts and derivatives

Lévocarnitine et ses sels et dérivés

Levocarnitine and its salts and derivatives

Lévodopa et ses sels

Levodopa and its salts

Linézolide et ses sels

Linezolid and its salts

Lisinopril, ses sels et dérivés

Lisinopril and its salts and derivatives

Lithium et ses sels

Lithium and its salts

Lodoxamide, ses sels et dérivés

Lodoxamide and its salts and derivatives

Loméfloxacine et ses sels

Lomefloxacin and its salts

Lomustine

Lomustine

Lopinavir

Lopinavir

Loracarbef, ses sels et dérivés

Loracarbef and its salts and derivatives

Losartan et ses sels

Losartan an its salts

Losoxantrone et ses sels

Losoxantrone and its salts

Lovastatine

Lovastatin

Loxapine et ses sels

Loxapine and its salts

Lumiracoxib

Lumiracoxib

Lutropine alfa

Lutropine alfa

Maprotiline et ses sels

Maprotiline and its salts

Maraviroc

Maraviroc

Marbofloxacine et ses sels et dérivés

Marbofloxacin and its salts and derivatives

Mécamylamine et ses sels

Mecamylamine and its salts

Méchloréthamine et ses sels

Mechlorethamine and its salts

Mécillinam, ses sels et dérivés

Mecillinam and its salts and derivatives

Méclofénamique (acide) et ses sels

Meclofenamic acid and its salts

Médétomidine et ses sels

Medetomidine and its salts

Méfénamique (acide) et ses sels

Mefenamic acid and its salts

Méfloquine, ses sels et dérivés

Mefloquine and its salts and derivatives

Mégestrol et ses sels

Megestrol and its salts

Mélarsomine et ses sels, s’ils sont vendus pour le traitement du ver du coeur chez le chien

Melarsomine and its salts, when sold for the treatment of heartworm in dogs

Méloxicam et ses sels et dérivés

Meloxicam and its salts and derivatives

Melphalan

Melphalan

Mémantine et ses sels

Memantine and its salts

Ménotropines (humains)

Menotropins (human)

Mépacrine et ses sels

Mepacrine and its salts

Mépazine et ses sels

Mepazine and its salts

Méphenoxalone

Mephenoxalone

Méphentermine et ses sels

Mephentermine and its salts

Mercaptopurine

Mercaptopurine

Méropénem, ses sels et dérivés

Meropenem and its salts and derivatives

Mésiletine et ses sels

Mexiletine and its salts

Mesna

Mesna

Mésoridazine et ses sels

Mesoridazine and its salts

Métaldéhyde

Metaldehyde

Metformine, ses sels et dérivés

Metformin and its salts and derivatives

Méthacholine (chlorure de)

Methacholine chloride

Méthazolamide et ses sels

Methazolamide and its salts

Méthicilline, ses sels et dérivés

Methicillin and its salts and derivatives

Méthimazole

Methimazole

Méthisazone

Methisazone

Méthoïne (méphénytoine) et ses sels

Methoin (Mephenytoin) and its salts

Méthotrexate et ses sels

Methotrexate and its salts

Méthotriméprazine et ses sels

Methotrimeprazine and its salts

Méthoxamine et ses sels

Methoxamine and its salts

Méthoxsalène

Methoxsalen

Méthoxy polyéthylèneglycol-époétine bêta

Methoxy polyethylene glycol-epoetin beta

Méthyldopa et ses sels

Methyldopa and its salts

Méthylparafynol

Methylparafynol

Méthysergide, ses sels et dérivés

Methysergide and its salts and derivatives

Métoclopramide

Metoclopramide

Métolazone et ses sels

Metolazone and its salts

Métomidate et ses sels

Metomidate and its salts

Métopimazine et ses sels

Metopimazine and its salts

Métoprolol et ses sels

Metoprolol and its salts

Métronïdazole

Metronidazole

Métyrapone et ses sels

Metyrapone and its salts

Mézlocilline, ses sels et dérivés

Mezlocillin and its salts and derivatives

Micafungine et ses sels

Micafungin and its salts

Miconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Miconazole and its salts (except in preparations for topical and vaginal use)

Midodrine et ses sels

Midodrine and its salts

Miglustat

Miglustat

Milbémycine et ses dérivés

Milbemycin and its derivatives

Milrinone et ses sels

Milrinone and its salts

Minoxidil (sauf dans les solutions pour usage topique où sa concentration est de 2 % ou moins)

Minoxidil (except in solutions for topical use in concentrations of 2% or less)

Mirtazapine et ses sels

Mirtazapine and its salts

Mitomycine et ses sels

Mitomycin and its salts

Mitotane (o,p′-DDD)

Mitotane (o,p′-DDD)

Mitoxantrone et ses sels

Mitoxantrone and its salts

Mivacurium (chlorure de)

Mivacurium chloride

Modafinil et ses sels

Modafinil and its salts

Molgramostim

Molgramostim

Montélukast et ses sels

Montelukast and its salts

Moxidectine et ses dérivés, s’ils sont vendus pour la prévention du ver du coeur chez le chien

Moxidectin and its derivatives, when sold for the prevention of heartworm in dogs

Moxifloxacine, ses sels et dérivés

Moxifloxacin and its salts and derivatives

Muromonab-CD3

Muromonab-CD3

Mycophénolique (acide) et ses sels et dérivés

Mycophenolic acid and its salts and derivatives

Nabumétone

Nabumetone

Nadolol et ses sels

Nadolol and its salts

Nadroparine et ses sels

Nadroparin and its salts

Nafaréline, ses sels et dérivés

Nafarelin and its salts and derivatives

Nafcilline, ses sels et dérivés

Nafcillin and its salts and derivatives

Nalidixique (acide)

Nalidixic acid

Nalméfène et ses sels

Nalmefene and its salts

Naloxone et ses sels

Naloxone and its salts

Naltrexone, ses sels et ses dérivés

Naltrexone and its salts and derivatives

Naproxène et ses sels, sauf lorsque vendu pour administration par voie orale en dose quotidienne de 440 mg

Naproxen and its salts, except when sold for oral use with a daily dosage of 440 mg

Naratriptan et ses sels

Naratriptan and its salts

Natalizumab

Natalizumab

Natéglinide et ses sels et dérivés

Nateglinide and its salts and derivatives

Nédocromil et ses sels

Nedocromil and its salts

Néfazodone et ses sels

Nefazodone and its salts

Nélarabine

Nelarabine

Nelfinavir et ses sels

Nelfinavir and its salts

Néocinchophène et ses sels

Neocinchophen and its salts

Néostigmine (les sels de)

Neostigmine salts

Népafénac

Nepafenac

Nétilmicine, ses sels et dérivés

Netilmicin and its salts and derivatives

Névirapine et ses sels

Nevirapine and its salts

Nialamide et ses sels

Nialamide and its salts

Nicardipine et ses sels

Nicardipine and its salts

Nicotine et ses sels, destinés à l’usage humain, sauf :

a) dans les substances naturelles;

b) sous forme de gomme à mâcher contenant 4 mg ou moins de nicotine par unité posologique;

c) sous forme de timbre cutané ayant un taux de libération de 22 mg ou moins de nicotine par jour;

d) sous une forme destinée à être administrée par voie orale au moyen d’un inhalateur libérant 4 mg ou moins de nicotine par unité posologique;

e) sous forme de pastille contenant 4 mg ou moins de nicotine par unité posologique

Nicotine and its salts, for human use, except

(a) in natural substances;

(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit;

(c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day;

(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit; or

(e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit.

Nifédipine

Nifedipine

Nilotinib et ses sels

Nilotinib and its salts

Nilutamide

Nilutamide

Nimodipine et ses sels

Nimodipine and its salts

Nitroscanate

Nitroscanate

Nizatidine et ses sels (sauf lorsque vendue sous une forme posologique orale contenant au plus l’équivalent de 75 mg de nizatidine)

Nizatidine and its salts (except when sold in an oral dosage form containing not more than the equivalent of 75 mg of nizatidine)

Nomifensine et ses sels

Nomifensine and its salts

Norfloxacine

Norfloxacin

Nortriptyline et ses sels

Nortriptyline and its salts

Nylidrine et ses sels

Nylidrin and its salts

Octatropine (méthylbromure d’)

Octatropine methylbromide

Octréotide

Octreotide

Ofloxacine et ses sels

Ofloxacin and its salts

Olanzapine et ses sels

Olanzapine and its salts

Olmésartan, ses sels et dérivés

Olmesartan and its salts and derivatives

Olopatadine et ses sels

Olopatadine and its salts

Olsalazine et ses sels

Olsalazine and its salts

Omalizumab

Omalizumab

Oméprazole et ses sels

Omeprazole and its salts

Ondansétron et ses sels

Ondansetron and its salts

Or et ses sels

Gold and its salts

Orbifloxacine, ses sels et dérivés

Orbifloxacin and its salts and derivatives

Orciprénaline (Métaprotérénol) et ses sels

Orciprenaline (Metaproterenol) and its salts

Orlistat

Orlistat

Ormétoprime et ses sels

Ormetoprim and its salts

Ornidazole

Ornidazole

Oséltamivir et ses sels

Oseltamivir and its salts

Oxacilline, ses sels et dérivés

Oxacillin and its salts and derivatives

Oxaliplatine

Oxaliplatin

Oxanamide

Oxanamide

Oxaprozine, ses sels et dérivés

Oxaprozin and its salts and derivatives

Oxcarbazépine

Oxcarbazepine

Oxolinique (acide) et ses sels

Oxolinic acid and its salts

Oxprénolol et ses sels

Oxprenolol and its salts

Oxybutynine et ses sels

Oxybutynin and its salts

Oxyde nitrique

Nitric oxide

Oxyphenbutazone et ses sels

Oxyphenbutazone and its salts

Oxytocine

Oxytocin

Paclitaxel et ses dérivés

Paclitaxel and its derivatives

Palifermine

Palifermin

Palipéridone, ses sels et ses dérivés

Paliperidone and its salts and derivatives

Palivizumab

Palivizumab

Pamidronique (acide) et ses sels

Pamidronic acid and its salts

Pancuronium et ses sels

Pancuronium and its salts

Panitumumab

Panitumumab

Pantoprazole et ses sels

Pantoprazole and its salts

Paraldéhyde

Paraldehyde

Paraméthadione

Paramethadione

Pargyline et ses sels

Pargyline and its salts

Paricalcitol

Paricalcitol

Paroxétine et ses sels

Paroxetine and its salts

Pegaptanib et ses sels

Pegaptanib and its salts

Pegfilgrastim

Pegfilgrastim

Pegvisomant

Pegvisomant

Pémétrexed et ses sels

Pemetrexed and its salts

Penciclovir et ses sels

Penciclovir and its salts

Pénicillamine

Penicillamine

Pentamidine et ses sels

Pentamidine and its salts

Pentolinium (tartrate de)

Pentolinium tartrate

Pentosane polysulfate et ses sels

Pentosan polysulfate and its salts

Pentostatine et ses sels

Pentostatin and its salts

Pentoxifylline et ses sels

Pentoxifylline and its salts

Perflutrène

Perflutren

Pergolide et ses sels

Pergolide and its salts

Péricyazine et ses sels

Pericyazine and its salts

Périndopril et ses sels

Perindopril and its salts

Perphénazine et ses sels

Perphenazine and its salts

Phacétopérane et ses sels

Phacetoperane and its salts

Phénacémide

Phenacemide

Phénacétine

Phenacetin

Phénaglycodol

Phenaglycodol

Phénazopyridine et ses sels

Phenazopyridine and its salts

Phénelzine et ses sels

Phenelzine and its salts

Phenformine et ses sels

Phenformin and its salts

Phéniprazine et ses sels

Pheniprazine and its salts

Phentoxate et ses sels

Phenthoxate and its salts

Phentolamine et ses sels

Phentolamine and its salts

Phénylbutazone et ses sels

Phenylbutazone and its salts

Phényléphrine et ses sels dans les préparations pour usage ophtalmique ou parentéral lorsqu’il constitue plus de 2,5 % d’un mélange

Phenylephrine and its salts in preparations for ophthalmic or parenteral use in concentrations greater than 2.5%

Phénylindanédione et ses dérivés

Phenylindanedione and its derivatives

Phénylpropanolamine, ses sels et dérivés, destinés à l’usage vétérinaire

Phenylpropanolamine and its salts and derivatives, for veterinary use

Pilocarpine et ses sels

Pilocarpine and its salts

Pimécrolimus

Pimecrolimus

Pimobendan

Pimobendan

Pimozide

Pimozide

Pinavérium (bromure de)

Pinaverium bromide

Pindolol et ses sels

Pindolol and its salts

Pioglitazone et ses sels

Pioglitazone and its salts

Pipécuronium (bromure de)

Pipecuronium bromide

Pipéracétazine et ses sels

Piperacetazine and its salts

Pipérilate et ses sels

Piperilate and its salts

Pipotiazine et ses sels

Pipotiazine and its salts

Pipobroman

Pipobroman

Pirbutérol et ses sels

Pirbuterol and its salts

Pirenzépine et ses sels

Pirenzepine and its salts

Pirlimycine et ses sels

Pirlimycin and its salts

Piroxicam et ses sels

Piroxicam and its salts

Pizotyline et ses sels

Pizotyline and its salts

Podophyllum, ses extraits et principes actifs suivants lorsque vendus ou recommandés pour usage topique :

a) podophyllotoxine

b) podophyllum (résine de)

Podophyllum and the following extracts and active principles, when sold or recommended for topical use:

(a) podophyllotoxin

(b) podophyllum resin

Ponazuril

Ponazuril

Poractant alfa

Poractant alfa

Porfimère et ses sels

Porfimer and its salts

Posaconazole

Posaconazole

Potassium (gluconate de), lorsqu’il est vendu ou recommandé pour administration aux chats

Potassium gluconate, when sold or recommended for administration to cats

Potassium (para-aminobenzoate de) (sauf dans les préparations pour usage topique sur la peau)

Potassium para-aminobenzoate (except in preparations for topical use on the skin)

Pralidoxime et ses sels

Pralidoxime and its salts

Pramipexole et ses sels

Pramipexole and its salts

Pravastatine et ses sels

Pravastatin and its salts

Praziquantel, sauf s’il est vendu pour le traitement du ver solitaire Anoplocephala perfoliata chez les chevaux

Praziquantel, except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses

Prazosine et ses sels

Prazosin and its salts

Prégabaline, ses sels et ses dérivés

Pregabalin and its salts and derivatives

Prénylamine et ses sels

Prenylamine and its salts

Primaquine et ses sels

Primaquine and its salts

Probénécide et ses sels

Probenecid and its salts

Probucol

Probucol

Procainamide et ses sels

Procainamide and its salts

Procarbazine et ses sels

Procarbazine and its salts

Procatérol et ses sels

Procaterol and its salts

Prochlorpérazine et ses sels

Prochlorperazine and its salts

Procyclidine et ses sels

Procyclidine and its salts

Prodilidine et ses sels

Prodilidine and its salts

Profénamine et ses sels

Profenamine and its salts

Proguanil et ses sels

Proguanil and its salts

Propafénone et ses sels

Propafenone and its salts

Propofol

Propofol

Propranolol et ses sels

Propranolol and its salts

Prostaglandines, leurs sels et dérivés

Prostaglandins and their salts and derivatives

Prothipendyl (chlorhydrate de)

Prothipendyl hydrochloride

Protireline

Protirelin

Protriptyline et ses sels

Protriptyline and its salts

Pyrazinamide

Pyrazinamide

Pyridostigmine (bromure de)

Pyridostigmine bromide

Pyriméthamine et ses sels

Pyrimethamine and its salts

Quétiapine et ses sels

Quetiapine and its salts

Quinagolide et ses sels

Quinagolide and its salts

Quinapril, ses sels et dérivés

Quinapril and its salts and derivatives

Quinupristine et ses sels

Quinupristin and its salts

Rabéprazole et ses sels

Rabeprazole and its salts

Raloxifène et ses sels

Raloxifene and its salts

Raltégravir et ses sels

Raltegravir and its salts

Raltitrexed, ses sels et dérivés

Raltitrexed and its salts and derivatives

Ramipril, ses sels et dérivés

Ramipril and its salts and derivatives

Ranibizumab

Ranibizumab

Ranitidine et ses sels, sauf s’ils sont vendus en une concentration de 150 mg ou moins par unité posologique orale et indiqués pour le traitement des brûlures d’estomac

Ranitidine and its salts, except when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn

Rasagiline et ses sels

Rasagiline and its salts

Rasburicase

Rasburicase

Raubasine et ses sels

Raubasine and its salts

Rauwolfia

Rauwolfia

Rémoxipride et ses sels

Remoxipride and its salts

Répaglinide et ses sels et dérivés

Repaglinide and its salts and derivatives

Rescinnamine et ses sels

Rescinnamine and its salts

Résocortol et ses dérivés

Resocortol and its derivatives

Rétapamuline

Retapamulin

Réviparine et ses sels

Reviparin and its salts

Ribavirine

Ribavirin

Rifabutine et ses sels

Rifabutin and its salts

Rifampine, ses sels et dérivés

Rifampin and its salts and derivatives

Riluzole et ses sels

Riluzole and its salts

Rispéridone et ses sels

Risperidone and its salts

Ritodrine et ses sels

Ritodrine and its salts

Ritonavir

Ritonavir

Rituximab

Rituximab

Rivaroxaban

Rivaroxaban

Rivastigmine et ses sels

Rivastigmine and its salts

Rizatriptan et ses sels

Rizatriptan and its salts

Rocuronium (bromure de)

Rocuronium bromide

Rofécoxib

Rofecoxib

Romifidine et ses sels

Romifidine and its salts

Romiplostim

Romiplostim

Ropinirole et ses sels

Ropinirole and its salts

Rosiglitazone et ses sels

Rosiglitazone and its salts

Rosoxacine et ses sels

Rosoxacin and its salts

Rosuvastatine et ses sels

Rosuvastatin and its salts

Salbutamol et ses sels

Salbutamol and its salts

Salmetérol et ses sels

Salmeterol and its salts

Salsalate, ses sels et dérivés

Salsalate and its salts and derivatives

Saquinavir, ses sels et dérivés

Saquinavir and its salts and derivatives

Saralasine et ses sels

Saralasin and its salts

Sargramostim

Sargramostim

Sélégiline et ses sels

Selegiline and its salts

Sels de lanthane vendus pour le traitement de l’hyperphosphatémie

Lanthanum salts, when sold for the treatment of hyperphosphatemia

Sermoréline et ses sels

Sermorelin and its salts

Sertraline et ses sels

Sertraline and its salts

Sérum antithymocytes

Anti-thymocyte globulin

Sévélamer et ses sels

Sevelamer and its salts

Sibutramine et ses sels

Sibutramine and its salts

Sildénafil et ses sels

Sildenafil and its salts

Simvastatine

Simvastatin

Sirolimus et ses dérivés

Sirolimus and its derivatives

Sitagliptine et ses sels

Sitagliptin and its salts

Sitaxentan et ses sels

Sitaxentan and its salts

Sodium (nitroprussiate de) et ses sels

Sodium nitroprusside and its salts

Solifénacine et ses sels

Solifenacin and its salts

Somatostatine

Somatostatin

Somatrem

Somatrem

Somatropine

Somatropin

Sorafénib et ses sels

Sorafenib and its salts

Sotalol et ses sels

Sotalol and its salts

Spironolactone

Spironolactone

Stavudine

Stavudine

Streptozocine

Streptozocin

Succinimide, ses sels et dérivés (sauf les produits utilisés pour décontaminer l’eau)

Succinimide and its salts and derivatives (except those compounds used for decontaminating water)

Sucralfate

Sucralfate

Sulconazole et ses sels

Sulconazole and its salts

Sulfinpyrazone et ses sels

Sulfinpyrazone and its salts

Sulfonate de polystyrène de sodium

Sodium polystyrene sulfonate

Sulindac et ses sels

Sulindac and its salts

Sulphones et leurs dérivés

Sulphones and their derivatives

Sumatriptan et ses sels

Sumatriptan and its salts

Sunitinib et ses sels

Sunitinib and its salts

Suprofène et ses sels

Suprofen and its salts

Suxaméthonium (chlorure de)

Suxamethonium chloride

Tacrolimus et ses dérivés

Tacrolimus and its derivatives

Tadalafil et ses sels

Tadelafil and its salts

Tamoxifène et ses sels

Tamoxifen and its salts

Tamsulosine et ses sels

Tamsulosin and its salts

Tazarotène

Tazarotene

Tazobactam, ses sels et dérivés

Tazobactam and its salts and derivatives

Teflubenzuron

Teflubenzuron

Tégafur et ses sels

Tegafur and its salts

Tégasérod et ses sels

Tegaserod and its salts

Telbivudine

Telbivudine

Télithromycine et ses sels et dérivés

Telithromycin and its salts and derivatives

Telmisartan et ses sels et dérivés

Telmisartan and its salts and derivatives

Témozolomide et ses sels

Temozolomide and its salts

Ténectéplase et ses sels et dérivés

Tenecteplase and its salts and derivatives

Téniposide

Teniposide

Ténofovir et ses sels et dérivés

Tenofovir and its salts and derivatives

Ténoxicam et ses sels

Tenoxicam and its salts

Térazosine et ses sels

Terazosin and its salts

Terbinafine et ses sels

Terbinafine and its salts

Terbutaline et ses sels

Terbutaline and its salts

Terconazole et ses sels

Terconazole and its salts

Terfénadine et ses sels

Terfenadine and its salts

Tériparatide et ses sels

Teriparatide and its salts

Terlipressine et ses sels

Terlipressin and its salts

Tétrabénazine et ses sels

Tetrabenazine and its salts

Thalidomide

Thalidomide

Théobromine et ses sels

Theobromine and its salts

Théophylline et ses sels

Theophylline and its salts

Thiéthylpérazine et ses sels

Thiethylperazine and its salts

Thiocarlide

Thiocarlide

Thioguanine

Thioguanine

Thiopropazate et ses sels

Thiopropazate and its salts

Thiopropérazine et ses sels

Thioproperazine and its salts

Thioridazine et ses sels

Thioridazine and its salts

Thiotépa

Thiotepa

Thiothixène et ses sels

Thiothixene and its salts

Thiouracile et ses dérivés

Thiouracil and its derivatives

Thyrotropine alfa

Thyrotropin alfa

Thyroxine et ses sels

Thyroxin and its salts

Tiaprofénique (acide) et ses sels

Tiaprofenic acid and its salts

Ticarcilline, ses sels et dérivés

Ticarcillin and its salts and derivatives

Ticlopidine et ses sels

Ticlopidine and its salts

Tigécycline

Tigecycline

Tilmicosine, sauf dans les préparations pour usage vétérinaire destinées à être administrées par voie orale

Tilmicosin, except in preparations for veterinary use to be administered orally

Tiludronique (acide) et ses sels

Tiludronic acid and its salts

Timolol et ses sels

Timolol and its salts

Tinidazole

Tinidazole

Tinzaparine et ses sels

Tinzaparin and its salts

Tioconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)

Tioconazole and its salts (except in preparations for topical and vaginal use)

Tiotropium (bromure de)

Tiotropium bromide

Tipranavir et ses sels

Tipranavir and its salts

Tirofiban et ses sels et dérivés

Tirofiban and its salts and derivatives

Tizanidine et ses sels

Tizanidine and its salts

Tobramycine, ses sels et dérivés

Tobramycin and its salts and derivatives

Tocaïnide et ses sels

Tocainide and its salts

Tolazamide

Tolazamide

Tolazoline et ses sels

Tolazoline and its salts

Tolbutamide

Tolbutamide

Tolcapone

Tolcapone

Tolfénamique (acide), ses sels et dérivés

Tolfenamic acid and its salts and derivatives

Tolmétine et ses sels

Tolmetin and its salts

Toltérodine et ses sels

Tolterodine and its salts

Topiramate

Topiramate

Topotécane et ses sels

Topotecan and its salts

Torasémide et ses sels

Torasemide and its salts

Torémifène et ses sels

Toremifene and its salts

Toxine botulinique, type A

Botulinum toxin Type A

Toxine botulinique, type B

Botulinum Toxin Type B

Trandolaprilat et ses sels et dérivés

Trandolaprilat and its salts and derivatives

Tranexamique (acide)

Tranexamic acid

Tranylcypromine

Tranylcypromine

Trastuzumab

Trastuzumab

Trazodone et ses sels

Trazodone and its salts

Tréosulfan

Treosulfan

Tréprostinil et ses sels

Treprostinil and its salts

Trétamine

Tretamine

Trétinoïne (acide de vitamine A)

Tretinoin (Vitamin A acid)

Trétinoïne, ses sels et dérivés

Tretinoin and its salts and derivatives

Triamtérène et ses sels

Triamterene and its salts

Tricaïne et ses sels

Tricaine and its salts

Trifluopérazine et ses sels

Trifluoperazine and its salts

Triflupromazine et ses sels

Triflupromazine and its salts

Trifluridine

Trifluridine

Trihexyphénidyle et ses sels

Trihexyphenidyl and its salts

Triiodothyropropionique (acide)

Triiodothyropropionic acid

Trilostane

Trilostane

Trimébutine et ses sels

Trimebutine and its salts

Triméthadione

Trimethadione

Trimétaphan (camsilate de)

Trimethaphan camsylate

Triméthoprime et ses sels

Trimethoprim and its salts

Trimétrexate et ses sels

Trimetrexate and its salts

Trimipramine et ses sels

Trimipramine and its salts

Trioxysalène

Trioxsalen

Troglitazone

Troglitazone

Tropicamide et ses sels dans les préparations pour usage ophtalmique ou parentéral, sauf lorsque vendu pour usage diagnostique à un optométriste enregistré dans une province du Canada

Tropicamide and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada

Trospium (chlorure de)

Trospium chloride

Trovafloxacine et ses sels et dérivés

Trovafloxacin and its salts and derivatives

L-Tryptophane, s’il est vendu comme seul ingrédient

L-Tryptophan, when sold as a single ingredient

Tubocurarine (chlorure de)

Tubocurarine chloride

Tybamate

Tybamate

Tylosine, ses sels et dérivés, lorsque vendu pour le traitement de la colite chronique chez le chien

Tylosin and its salts and derivatives, when sold for the treatment of chronic colitis in dogs

Unoprostone, ses sels et dérivés

Unoprostone and its salts and derivatives

Uracile et ses sels

Uracil and its salts

Uracile (moutarde à l’) et ses sels

Uracil mustard and its salts

Ursodéoxycholique (acide) et ses sels

Ursodeoxycholic acid and its salts

Ustekinumab

Ustekinumab

Vaccin thérapeutique contre le mélanome

Melanoma therapeutic vaccine

Valaciclovir et ses sels

Valaciclovir and its salts

Valdécoxib et ses sels

Valdecoxib and its salts

Valganciclovir, ses sels et dérivés

Valganciclovir and its salts and derivatives

Valproïque (acide) et ses sels

Valproic acid and its salts

Valrubicine et ses dérivés

Valrubicin and its derivatives

Valsartan et ses sels et dérivés

Valsartan and its salts and derivatives

Vancomycine, ses sels et dérivés

Vancomycin and its salts and derivatives

Vardénafil et ses sels

Vardenafil and its salts

Varénicline et ses sels

Varenicline and its salts

Vasopressine et ses sels

Vasopressin and its salts

Vecuronium (bromure de)

Vecuronium bromide

Védaprofène et ses sels et dérivés

Vedaprofen and its salts and derivatives

Venlafaxine et ses sels

Venlafaxine and its salts

Vérapamil et ses sels

Verapamil and its salts

Vertéporfine et ses sels et dérivés

Verteporfin and its salts and derivatives

Vidarabine

Vidarabine

Vigabatrine, ses sels et dérivés

Vigabatrin and its salts and derivatives

Vinblastine et ses sels

Vinblastine and its salts

Vincristine et ses sels

Vincristine and its salts

Vindésine et ses sels

Vindesine and its salts

Vinorelbine et ses sels

Vinorelbine and its salts

Viomycine, ses sels et dérivés

Viomycin and its salts and derivatives

Vitamine A présentée en unités posologiques orales contenant chacune plus de 10 000 unités internationales de vitamine A ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion, par une personne, de plus de 10 000 unités internationales de vitamine A

Vitamin A in oral dosage form containing more than 10,000 International Units of Vitamin A per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 10,000 International Units of Vitamin A

Vitamine B12 avec concentré de facteur intrinsèque

Vitamin B12 with Intrinsic Factor Concentrate

Vitamine D présentée en unités posologiques orales contenant chacune plus de 1 000 unités internationales de vitamine D ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion, par une personne, de plus de 1 000 unités internationales de vitamine D

Vitamin D in oral dosage form containing more than 1,000 International Units of Vitamin D per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1,000 International Units of Vitamin D

Voriconazole

Voriconazole

Vorinostat

Vorinostat

Xantinol (nicotinate de)

Xanthinol nicotinate

Xylazine et ses sels

Xylazine and its salts

Yohimbine et ses sels

Yohimbine and its salts

Zafirlukast et ses sels

Zafirlukast and its salts

Zalcitabine et ses sels

Zalcitabine and its salts

Zanamivir et ses sels et dérivés

Zanamivir and its salts and derivatives

Zidovudine

Zidovudine

Ziprasidone et ses sels

Ziprasidone and its salts

Zomépirac et ses sels

Zomepirac and its salts

Zopiclone et ses sels

Zopiclone and its salts

Zuclopenthixol, ses sels et dérivés

Zuclopenthixol and its salts and derivatives

PARTIE II Acépromazine et ses sels

Acepromazine and its salts

Acétanilide

Acetanilide

Acide folique

Folic acid

Aminopyrine et ses dérivés

Aminopyrine and its derivatives

Amprolium et ses sels

Amprolium and its salts

Antipyrine (sauf dans les préparations pour usage topique)

Antipyrine (except preparations for topical use)

Apramycine et ses sels

Apramycin and its salts

Azithromycine, ses sels et dérivés

Azithromycin and its salts and derivatives

Calcium (sels de) vendus pour le traitement de l’hyperphosphatémie

Calcium salts when sold for the treatment of hyperphosphatemia

Centella asiatica (extrait de) et ses principes actifs

Centella asiatica extract and active principles thereof

Chlorhexidine et ses sels, dans les préparations pour usage oral topique

Chlorhexidine and its salts, when used as a topical oral preparation

Chlorothiazide, ses sels et dérivés

Chlorothiazide and its salts and derivatives

Chlorpromazine et ses sels

Chlorpromazine and its salts

Clarithromycine, ses sels et dérivés

Clarithromycin and its salts and derivatives

Colestyramine (résine de)

Cholestyramine resin

Cyclizine

Cyclizine

Dihydrostreptomycine, ses sels et dérivés

Dihydrostreptomycin and its salts and derivatives

Dirithromycine

Dirithromycin

Ergot (alcaloïdes d’) et leurs sels

Ergot alkaloids and their salts

Érythromycine, ses sels et dérivés

Erythromycin and its salts and derivatives

Fer, ses dérivés pour usage parentéral seulement

Iron derivatives for parenteral use only

Framycétine, ses sels et dérivés

Framycetin and its salts and derivatives

Furaltadone et ses sels

Furaltadone and its salts

Furazolidone et ses sels

Furazolidone and its salts

Furosémide

Furosemide

Griséofulvine, ses sels et dérivés

Griseofulvin and its salts and derivatives

Hormones corticosurrénales, leurs sels et dérivés sauf les suivants :

a) l’hydrocortisone et l’acétate d’hydrocortisone vendus en tant qu’ingrédient médicinal unique dont la concentration permet un apport en hydrocortisone de 0,5 % dans les préparations pour usage topique sur la peau;

b) le butyrate de clobétasone vendu sous forme de crème contenant 0,05 % de butyrate de clobétasone pour usage topique sur la peau

Adrenocortical hormones and their salts and derivatives, except

(a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 0.5% hydrocortisone in preparations for topical use on the skin; and

(b) clobetasone butyrate, when sold in a concentration of 0.05% clobetasone butyrate in cream preparations for topical use on the skin

Hormones sexuelles, sauf :

Sex hormones, except the following:

Androisoxazole

Androisoxazole

Androstanolone

Androstanolone

Androstènediol et ses dérivés

Androstenediol and its derivatives

Bolandiol et ses dérivés

Bolandiol and its derivatives

Bolastérone

Bolasterone

Bolazine

Bolazine

Boldénone et ses dérivés

Boldenone and its derivatives

Bolénol

Bolenol

Calustérone

Calusterone

Clostébol et ses dérivés

Clostebol and its derivatives

Cyprotérone et ses dérivés

Cyproterone and its derivatives

Diéthylstilbestrol et ses dérivés

Diethylstilbestrol and its derivatives

Drostanolone et ses dérivés

Drostanolone and its derivatives

Énestébol

Enestebol

Épitiostanol

Epitiostanol

Éthylestrénol

Ethylestrenol

Fluoxymestérone

Fluoxymesterone

Formébolone

Formebolone

Furazabol

Furazabol

Hydroxy-4 nor-19 testostérone et ses dérivés

4-Hydroxy-19-nortestosterone and its derivatives

Lévonorgestrel, s’il est vendu en une concentration de 0,75 mg par unité posologique orale

Levonorgestrel, when sold in concentrations of 0,75 mg per oral dosage unit

Mébolazine

Mebolazine

Mégestrol et ses dérivés

Megestrol and its derivatives

Mésabolone

Mesabolone

Mestérolone

Mesterolone

Métandiénone

Metandienone

Méténolone et ses dérivés

Metenolone and its derivatives

Méthandriol

Methandriol

Méthyltestostérone et ses dérivés

Methyltestosterone and its derivatives

Métribolone

Metribolone

Mibolérone

Mibolerone

Nandrolone et ses dérivés

Nandrolone and its derivatives

Norbolétone

Norboletone

Norclostébol et ses dérivés

Norclostebol and its derivatives

Noréthandrolone

Norethandrolone

Oxabolone et ses dérivés

Oxabolone and its derivatives

Oxandrolone

Oxandrolone

Oxymestérone

Oxymesterone

Oxymétholone

Oxymetholone

Prastérone

Prasterone

Quinbolone

Quinbolone

Stanozolol

Stanozolol

Stenbolone et ses dérivés

Stenbolone and its derivatives

Testostérone et ses dérivés

Testosterone and its derivatives

Tibolone

Tibolone

Tiomestérone

Tiomesterone

Trenbolone et ses dérivés

Trenbolone and its derivatives

Zéranol

Zeranol

Kanamycine, ses sels et dérivés

Kanamycin and its salts and derivatives

Lévamisole et ses sels

Levamisole and its salts

Lincomycine, ses sels et dérivés

Lincomycin and its salts and derivatives

Liothyronine et ses sels

Liothyronine and its salts

Mébendazole

Mebendazole

Méclizine et ses sels s’ils sont vendus en une concentration supérieure à 25 mg par unité posologique

Meclizine and its salts when sold in concentrations greater than 25 mg per dosage unit

Néomycine, ses sels et dérivés

Neomycin and its salts and derivatives

Nicarbazin

Nicarbazin

Nitrofurantoine et ses sels

Nitrofurantoin and its salts

Novobiocine, ses sels et dérivés

Novobiocin and its salts and derivatives

Nystatine (sauf dans les préparations pour usage topique sur la peau), ses sels et dérivés

Nystatin (except preparations for topical use on the skin) and its salts and derivatives

Oléandomycine, ses sels et dérivés

Oleandomycin and its salts and derivatives

Pénicilline, ses sels et dérivés, (sauf amoxicilline, ampicilline, azlocilline, benzathine pénicilline, carbénicilline, cloxacilline, dicloxacilline, hétacilline, mécillinam, méthicilline, mezlocilline, nafcilline, oxacilline et ticarcilline, leurs sels et dérivés)

Penicillin and its salts and derivatives (except amoxicillin, ampicillin, azlocillin, benzathine penicillin, carbenicillin, cloxacillin, dicloxacillin, hetacillin, mecillinam, methicillin, mezlocillin, nafcillin, oxacillin and ticarcillin and their salts and derivatives)

Physostigmine (salicylate de), (sauf dans les préparations pour usage oral et topique seulement)

Physostigmine salicylate (except preparations for oral or topical use only)

Polymyxine B, ses sels et dérivés (sauf pour usage topique ou local dans la cavité buccale ou dans les voies nasales)

Polymyxin B and its salts and derivatives (except for topical use or for local action in the oral cavity or nasal passages) and its salts and derivatives

Primidone

Primidone

Promazine et ses sels

Promazine and its salts

Réserpine et ses sels

Reserpine and its salts

Ronidazole, ses sels et dérivés

Ronidazole and its salts and derivatives

Sodium (fluorure de) (sous forme posologique solide orale contenant plus d’un milligramme d’ion fluor)

Sodium fluoride (in solid oral dosage forms containing more than one milligram of fluoride ion)

Spectinomycine, ses sels et dérivés

Spectinomycin and its salts and derivatives

Spiramycine, ses sels et dérivés

Spiramycin and its salts and derivatives

Streptomycine, ses sels et dérivés

Streptomycin and its salts and derivatives

Sulfamides, leurs sels et dérivés

Sulphonamides and their salts and derivatives

Tétracycline (sauf doxycycline si elle est vendue pour administration intramusculaire aux oiseaux en cage) et ses sels et dérivés

Tetracycline (except doxycycline when sold for intramuscular administration in caged birds) and its salts and derivatives

Thiabendazole

Thiabendazole

Thyroïde

Thyroid

Tioconazole et ses sels

Tioconazole and its salts

Triméprazine et ses sels

Trimeprazine and its salts

Tylosine, ses sels et dérivés (sauf lorsque vendu pour le traitement de la colite chronique chez le chien)

Tylosin and its salts and derivatives (except when sold for the treatment of chronic colitis in dogs)

Veratrum album, ses alcaloïdes et leurs sels

Veratrum album and its alkaloids and their salts

Veratrum viride, ses alcaloïdes et leurs sels

Veratrum viride and its alkaloids and their salts

Virginiamycine, ses sels et dérivés

Virginiamycin and its salts and derivatives

Vitamine A

Vitamin A

Vitamine D

Vitamin D

Vitamine K, sauf la vitamine K1 et la vitamine K2 vendues :

a) soit pour un usage externe destiné aux humains;

b) soit sous une forme posologique orale destinée aux humains si la dose quotidienne maximale recommandée est de 0,120 mg ou moins

Vitamin K, except Vitamin K1 and Vitamin K2 sold

a) for external use in humans; or

b) in oral dosage form for use in humans if the maximum recommended daily dose is 0.120 mg or less

DORS/78-423, art. 5; DORS/78-427, art. 11; DORS/79-754, art. 1; DORS/80-279, art. 1; DORS/81-334, art. 6; DORS/81-358, art. 2; DORS/82-1072, art. 1; DORS/85-551, art. 2; DORS/86-91, art. 5; DORS/86-955, art. 1; DORS/87-332, art. 1; DORS/87-447, art. 1; DORS/87-496, art. 1 à 18; DORS/87-669, art. 1 et 2; DORS/88-351, art. 1 à 11; DORS/88-511, art. 1 à 11; DORS/89-195, art. 1; DORS/89-454, art. 1 à 4; DORS/89-504, art. 1 à 4; DORS/89-572, art. 1 à 45; DORS/90-119, art. 1 à 10; DORS/90-173, art. 2(F); DORS/90-443, art. 1(F) à 4(F), 5 et 6(F) à 15(F); DORS/90-585, art. 1 à 5; DORS/91­ 197, art. 1 et 2(F); DORS/91-521, art. 1 à 15; DORS/92-95, art. 1 à 9; DORS/92-386, art. 4 à 8; DORS/92-591, art. 2; DORS/92-647, art. 1 à 15; DORS/92-724, art. 1; DORS/93­ 110, art. 1 à 3, 4(A), 5(A) et 6 à 11; DORS/93-243, art. 2; DORS/93-435, art. 1 à 38; DORS/94-166, art. 1 à 17, 18(A) et 19 à 30; DORS/94-286, art. 1 et 2; DORS/94-458, art. 1 à 13; DORS/94-462, art. 1; DORS/94-557, art. 1 à 9; DORS/94-461, art. 1; DORS/95-59, art. 1; DORS/95-172, art. 2; DORS/95-201, art. 1; DORS/95-546, art. 1; DORS/96-253, art. 1 et 2; DORS/96-306, art. 1; DORS/97-140, art. 1; DORS/97-407, art. 1; DORS/97-410, art. 1 et 2; DORS/97-414, art. 1; DORS/97-543, art. 8 et 9; DORS/97­ 544, art. 1; DORS/97-567, art. 1; DORS/98-291, art. 1 à 7; DORS/98-292, art. 1; DORS/98-293, art. 1; DORS/98-294, art. 1; DORS/99-370, art. 1, 2(F), 3 et 4(F); DORS/99-373, art. 1; DORS/99-374, art. 1(F) et 2; DORS/99-412, art. 1; DORS/2000­ 119, art. 1; DORS/2000-124, art. 1; DORS/2000-197, art. 1 et 2; DORS/2000-219, art. 2; DORS/2000-403, art. 1 et 2; DORS/2001-95, art. 1; DORS/2001-531, art. 1; DORS/2002-53, art. 1; DORS/2002-418, art. 1; DORS/2003-34, art. 6 à 8; DORS/2003­ 36, art. 1; DORS/2003-80, art. 1 et 2; DORS/2003-248, art. 1; DORS/2003-327, art. 1; DORS/2004-108, art. 1 à 6; DORS/2005-105, art. 1; DORS/2005-167, art. 1; DORS/2005-270, art. 1; DORS/2005-307, art. 1; DORS/2006-143, art. 1; DORS/2006­ 144, art. 1 et 2; DORS/2006-211, art. 1; DORS/2006-212, art. 1; DORS/2006-213, art. 1; DORS/2006-214, art. 1; DORS/2006-215, art. 1; DORS/2006-251, art. 1; DORS/2007­ 36, art. 1; DORS/2007-37, art. 1; DORS/2007-38, art. 1; DORS/2007-39, art. 1; DORS/2007-40, art. 1; DORS/2007-41, art. 1; DORS/2007-42, art. 1 et 2; DORS/2007­ 83, art. 1; DORS/2007-224, art. 1; DORS/2007-234, art. 1; DORS/2008-35, art. 1; DORS/2008-100, art. 1; DORS/2008-101, art. 1 et 2; DORS/2008-108, art. 1; DORS/2008-204, art. 1; DORS/2008-205, art. 1; DORS/2008-206, art. 1; DORS/2008­ 207, art. 1; DORS/2008-260, art. 1; DORS/2009-116, art. 1; DORS/2009-117, art. 1; DORS/2009-118, art. 1; DORS/2009-119, art.1; DORS/2009-120, art. 1; DORS/2009­

279, art. 1 et 2; DORS/2009-305, art. 1; DORS/2010-114, art. 1; DORS/2011-58, art. 1; DORS/2011-93, art. 1. Version précédente ANNEXE K

RATION QUOTIDIENNE NORMALE DE DIVERSES SUBSTANCES ALIMENTAIRES

Colonne I Colonne II Poste

o Nom et description R.Q.N.n 1. Pâtes alimentaires, sèches ....... 3,0 oz 85 g

Bacon (de flanc), simili-produit de viande qui rappelle le2. 1,0 oz 28 gbacon de flanc (cuit) ....... Base et mélanges aromatisés, pour boissons, pour ajouter 16,0 oz3. 454 mlau lait (prêts à servir) ....... liq

4. Pain, 5 tranches ....... 5,3 oz 150 g 5. Beurre ....... 2,0 oz 57 g

30,0 oz6. Lait de beurre ....... 852 mlliq 7. Céréales, à déjeuner ou pour nourrissons ....... 1,0 oz 28 g 8. Céréales, soufflées ....... 0,5 oz 14 g 9. Fromage (autre que le fromage cottage) ....... 2,0 oz 57 g 10. Fromage cottage ....... 3,5 oz 100 g

15,0 oz11. Lait condensé ....... 426 mlliq 12. Crème à fouetter ....... 2,0 oz 57 g 13. Oeuf, jaune d’oeuf substitué ....... 3,5 oz 100 g

30,0 oz 852 mlLait évaporé, lait écrémé évaporé, lait partiellement liq14. écrémé évaporé ....... (reconstitué à son volume original)

15. Poisson, coquillages ....... 3,5 oz 100 g 16. Fruits secs ....... 2,0 oz 57 g 17. Fruits (sauf bananes, citrons, limes, melons d’eau) ....... 3,5 oz 100 g 18. Fruits, bananes ....... 5,3 oz 150 g 19. Fruits, citrons ....... 1,8 oz 50 g 20. Fruits, limes ....... 1,8 oz 50 g 21. Fruits, melons d’eau ....... 7,0 oz 200 g 22. Boissons aux fruits, nectars de fruits (prêts à servir) ....... 4,0 oz liq 114 ml 23. Bases, mélanges et concentrés pour boissons aux fruits 4,0 oz liq 114 ml

Colonne I Colonne II Poste

o Nom et description R.Q.N.n (prêts à servir) .......

24. Jus de fruit (sauf jus de citron et jus de lime) ....... 4,0 oz liq 114 ml 25. Jus de fruit, citron ....... 1,0 oz liq 28 ml 26. Jus de fruit, lime ....... 1,0 oz liq 28 ml 27. Crème glacée, lait glacé ....... 3,5 oz 100 g

Selon le mode d’emploi28. Préparations pour nourrissons (prêtes à servir) ....... inscrit sur l’étiquette Selon le mode d’emploi29. Déjeuner instantané, déjeuner prêt à servir ....... inscrit sur l’étiquette

30. Margarine ....... 2,0 oz 57 g 31. Produits de viande ....... 3,5 oz 100 g 32. Allongeurs de produits de viande ....... 3,5 oz 100 g 33. Produits de viande avec allongeur ....... 3,5 oz 100 g

30,0 oz34. Lait entier ....... 852 mlliq 30,0 oz35. Lait en poudre (reconstitué et prêt à servir) ....... 852 mlliq 30,0 oz36. Lait (nom de l’arôme) ....... 852 mlliq

37. Mélasse ....... 1,5 oz 43 g 38. Noix ....... 1,0 oz 28 g 39. Beurre d’arachide ....... 1,0 oz 28 g 40. Produits de volaille ....... 3,5 oz 100 g 41. Produits de volaille avec allongeur ....... 3,5 oz 100 g 42. Allongeurs de produits de volaille ....... 3,5 oz 100 g

Simili-produits de viande, sauf les simili-produits de43. 3,5 oz 100 gviande qui rappellent le bacon de flanc ....... 44. Simili-produits de volaille ....... 3,5 oz 100 g

30,0 oz45. Lait écrémé, lait partiellement écrémé ....... 852 mlliq Lait écrémé (nom de l’arôme), lait partiellement écrémé 30,0 oz46. 852 ml(nom de l’arôme) ....... liq Lait écrémé en poudre, lait partiellement écrémé en 30,0 oz47. 852 mlpoudre (reconstitués et prêts à servir) ....... liq Lait écrémé additionné d’extrait sec du lait, lait 30,0 oz48. 852 mlpartiellement écrémé additionné d’extrait sec du lait ....... liq

49. Lait écrémé additionné d’extrait sec du lait (nom de 30,0 oz 852 ml

__________

Colonne I Colonne II Poste

o Nom et description R.Q.N.n l’arôme), lait partiellement écrémé additionné d’extrait liq sec du lait (nom de l’arôme) .......

50. Soupe (prête à servir) ....... 7,0 oz liq 200 ml 30,0 oz51. Lait stérilisé ....... 852 mlliq

52. Jus de légumes ....... 4,0 oz liq 114 ml 53. Boissons aux légumes ....... 4,0 oz liq 114 ml

Concentrés, mélanges et bases pour boissons aux54. 4,0 oz liq 114 mllégumes (prêts à servir) ....... Légumes (autres que fèves au four et pommes de terre55. 3,5 oz 100 gcuites) .......

56. Légumes, fèves au four ....... 8,5 oz 250 g 57. Légumes, pommes de terre cuites ....... 7,0 oz 200 g 58. Levure ....... 0,5 oz 14 g 59. Yogourt, nature ....... 5,0 oz 150 g

DORS/78-64, art. 10; DORS/84-300, art. 63(A).

APPENDICES I ET II [Abrogés, DORS/81-935, art. 2] APPENDICE III FORMULES Certificat d’exportation (En vertu de la Loi des aliments et drogues*—S.R.C. de 1970, ch. F-27)

L’exportateur soussigné certifie par les présentes que (description de l’article)

emballé et étiqueté comme suit : __________ et portant distinctement imprimé le mot « Exportation »,

1. n’est pas fabriqué pour la consommation au Canada,

2. n’est pas vendu pour la consommation au Canada, et

__________

3. que le paquet et son contenu ne contreviennent à aucune disposition connue de la loi de

au(x)quel(s) ils sont destinés.

(nom du ou des pays)

Fait à le 19 .

Canada : En ce qui a trait à un certificat d’exportation délivré en vertu de la Loi des aliments et drogues,

Province

EN FOI Je, __________ DE QUOI : de de __________

dans de __________

déclare solennellement :

1. que je suis l’« exportateur » délivrant le présent certificat et que je suis au courant des renseignements que j’ai ai [sic] déclarés

ou

que je suis de __________

l’« exportateur » délivrant le présent certificat et que je suis au courant des renseignements que j’y ai déclarés (si l’exportateur est une société commerciale, indiquer que le déclarant est l’agent de l’« exportateur »),

2. que les renseignements donnés dans ledit certificat sont véridiques,

3. que tous les renseignements pertinents y sont consignés et qu’aucun renseignement utile n’a été omis sciemment.

Et je fais la présente déclaration solennelle la croyant vraie et sachant qu’elle a la même valeur que si elle était faite sous serment et en vertu de la Loi sur la preuve au Canada.

Déclaration faite en ma présence à __________

le 19 .

Commissaire à l’assermentation

*Voir l’article 32 de la Loi des aliments et drogues et l’appendice III du Règlement sur les aliments et drogues

DORS/80-318, art. 2.

ANNEXE L

(articles B.01.402, B.01.403, B.01.450 et B.01.454 à B.01.465)

MODÈLES DE TABLEAU DE LA VALEUR NUTRITIVE

CES GRAPHIQUES NE SONT PAS EXPOSÉS, VOIR ERR., VOL. 137, No 5

DORS/2003-11, art. 37; err., Vol. 137, no 5.

ANNEXE M

(articles B.01.001, B.01.002A et D.01.001)

QUANTITÉS DE RÉFÉRENCE

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

Produits de boulangerie 1. Pain, à l’exception des petits pains sucrés à cuisson rapide 50 g

Bagels, biscuits pour le thé, galettes écossaises, petits pains 2. mollets, petits pains au lait, croissants, tortillas, bâtonnets de 55 g

pain mollets, bretzels mollets et pain de maïs 3. Carrés au chocolat 40 g

Gâteau lourd : 10 g ou plus par cube de 2,5 cm, tel que gâteau au fromage, renversé aux ananas, gâteau contenant, à l’état fini,4. 125 gau moins 35 % en poids de fruits, de noix ou de légumes ou toute combinaison de ceux-ci Gâteau mi-léger : 4 g ou plus par cube de 2,5 cm mais moins5. de 10 g par cube de 2,5 cm, tel que gâteau avec ou sans glaçage 80 g

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

ou garniture, gâteau contenant, à l’état fini, moins de 35 % en poids de fruits, de noix ou de légumes ou toute combinaison de ceux-ci, léger avec glaçage, à la bostonnaise, petits gâteaux, éclairs et choux à la crème Gâteau léger : moins de 4 g par cube de 2,5 cm tel que gâteau6. 55 gdes anges, chiffon ou éponge sans glaçage ni garniture Brioches, beignes, pâtisseries danoises, petits pains au lait7. 55 gsucrés, petits pains sucrés à cuisson rapide et muffins

8. Biscuits avec ou sans enrobage ou garniture et biscuits Graham 30 g 9. Craquelins, bâtonnets de pain sec et biscottes Melba 20 g 10. Pain sec, matzo et biscottes 30 g 11. Feuilletés avec ou sans garniture ou glaçage 55 g 12. Tartelettes à griller 55 g 13. Cornets à crème glacée 5 g 14. Croûtons 7 g 15. Pain doré, crêpes et gaufres 75 g

Tablettes et barres à base de céréales avec garniture ou16. 40 genrobées en tout ou en partie 17. Tablettes et barres à base de céréales sans garniture ni enrobage 30 g 18. Galettes de riz ou de maïs 15 g 19. Tartes, tartelettes, pavés, chaussons et autres pâtisseries 110 g

1/6 d’une croûte de 20 cm ou 1/820. Croûte de tarte d’une croûte de 23 cm

21. Croûte de pizza 55 g 22. Coquilles à taco croustillantes 30 g

Boissons Boissons gazéifiées et non gazéifiées, thé glacé et panachés de23. 355 mLvin

24. Boissons pour sportif et eau 500 mL Café : ordinaire, instantané et fin, notamment expresso, café au25. 175 mLlait, aromatisé et sucré

26. Thé et tisane : a) ordinaire et instantané (chaud) 175 mL b) aromatisé et sucré préparé à partir d’un mélange 250 mL

27. Cacao et chocolat chaud 175 mL

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

Céréales et autres produits céréaliers 40 g sèchesCéréales à déjeuner chaudes, telles que gruau d’avoine ou28. 250 mL une foiscrème de blé préparées

Céréales à déjeuner prêtes à consommer, soufflées et non29. 15 genrobées (moins de 20 g par 250 mL) Céréales à déjeuner prêtes à consommer, soufflées et enrobées, en flocons, extrudées, sans fruits ni noix (20 g à 42 g par30. 30 g250 mL) et céréales à teneur très élevée en fibres (avec 28 g ou plus de fibres par 100 g) Céréales à déjeuner prêtes à consommer, avec fruits et noix, de

31. type granola (43 g ou plus par 250 mL) et céréales de type 55 g biscuit

32. Son et germe de blé 15 g 33. Farines, y compris farine de maïs 30 g

45 g secs34. Grains, tels que riz ou orge 140 g cuits 85 g sèches35. Pâtes alimentaires, sans sauce 215 g cuites

Pâtes alimentaires, sèches et prêtes à consommer, telles que36. 25 gnouilles frites (chow mein) en conserve Fécules, telles que fécule de maïs, fécule de pomme de terre,37. 10 gtapioca ou amidon de blé

38. Farce 100 g Produits laitiers et succédanés Fromage, y compris fromage à la crème et fromage à tartiner,39. 30 gsauf les variétés énumérées à un autre article

40. Fromage cottage 125 g Fromage utilisé comme ingrédient, tel que fromage blanc41. 55 gpressé ou ricotta

42. Fromage à pâte dure râpé, tel que parmesan ou romano 15 g 43. Quark, fromage frais et desserts laitiers frais 100 g

Crème et succédané de crème sauf ceux énumérés à un autre44. 15 mLarticle 45. Crème et succédané de crème, en poudre 2 g 46. Crème et succédané de crème, fouettés ou en aérosol 15 g 47. Lait de poule 125 mL

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

48. Lait, évaporé ou condensé 15 mL Boissons végétales, lait, lait de beurre et boissons lactées, telles49. 250 mLque lait chocolaté Laits frappés et succédanés de lait frappé, tels que préparation50. 250 mLpour lait frappé

51. Crème sure 30 mL 52. Yogourt 175 g

Desserts 53. Crème glacée, lait glacé, yogourt glacé et sorbet 125 mL

Desserts laitiers glacés, tels que gâteaux, barres, sandwiches ou54. 125 mLcornets Autres desserts glacés, tels que glaces et sucettes glacées

55. aromatisées et sucrées, jus de fruits congelés en barres ou en 75 mL coupes

56. Coupe glacée 250 mL 57. Crème pâtissière, gélatine et crème-dessert (pouding) 125 mL

Nappages et garnitures à desserts Nappages à desserts, telles que beurre d’érable et crème de58. 30 gguimauve

59. Glaces et glaçages à gâteau 35 g 60. Garnitures pour tartes 75 mL

Oeufs et succédanés d’oeufs Préparations aux oeufs, telles que foo young aux oeufs, oeufs61. 110 gbrouillés ou omelette

62. Oeufs 50 g 63. Succédanés d’oeufs 50 g

Matières grasses 64. Beurre, margarine, graisse végétale et saindoux 10 g 65. Huile végétale 10 mL 66. Succédané de beurre en poudre 2 g 67. Vinaigrettes 30 mL

Mayonnaise, sauce à salade de type mayonnaise et tartinade à68. 15 mLsandwich 69. Huile en pulvérisateur 0,5 g

Animaux marins et animaux d’eau douce 70. Anchois en conserve, pâte d’anchois et caviar 15 g2

71. Animaux marins et animaux d’eau douce en sauce, tels que 140 g cuits

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

poisson en sauce à la crème ou crevettes dans une sauce au homard Animaux marins et animaux d’eau douce sans sauce, tels que 125 g crus poisson ou fruits de mer nature ou frits et croquettes de poisson72. ou de fruits de mer, enrobés ou non de chapelure ou de pâte à 100 g cuits frire

73. Animaux marins et animaux d’eau douce en conserve 55 g2

Animaux marins et animaux d’eau douce fumés, marinés ou à74. 55 g2tartiner Fruits et jus de fruits

140 gFruits frais, en conserve ou congelés, sauf ceux énumérés à un75. 150 mL enautre article 2conserve 76. Fruits, confits ou marinés 30 g2

77. Fruits secs, tels que raisins, dattes ou figues 40 g 78. Fruits pour garnir ou aromatiser, tels que cerises au marasquin 4 g2

79. Achards (relish) de fruits 60 mL 80. Avocat utilisé comme ingrédient 30 g 81. Canneberges, citron et limette utilisés comme ingrédients 55 g 82. Melon d’eau, cantaloup, melon de miel et autres melons 150 g

Jus, nectars et boissons aux fruits représentés comme83. 250 mLsuccédanés des jus de fruits Jus utilisés comme ingrédients, tels que jus de citron ou de84. 5 mLlimette Légumineuses

85. Caillé de soya(tofu) et tempeh 85 g2

100 g secsHaricots, pois et lentilles, tels que haricots blancs, haricots86. 250 mL cuits ourouges, haricots romains, fèves de soya ou pois chiches 2en conserve Viande, volaille, leurs produits et succédanés3

54 g non cuites87. Couennes de porc et bacon 15 g cuites 30 g non cuites88. Languettes de boeuf, de porc et de poulet à déjeuner 15 g cuites

Viande et volaille séchées, tels que jerky, boeuf séché ou 89. jambon de Parme, saucissons dont l’activité de l’eau est égale 30 g

ou inférieure à 0,90, tels que salami, saucisson de Thuringe sec

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

ou cervelas sec Viandes à sandwich, telles que saucisson de Bologne, boudin, roulé de viande barattée, saucisse de foie, mortadelle, pain de

90. jambon et fromage ou tête fromagée; pâté; tartinade à sandwich; terrine; garnitures à taco; garnitures pour pâtés à la viande et cretons Saucisses, telles que saucisses en chapelet, saucisse viennoise, saucisse fumée, saucisse à déjeuner, saucisse de Francfort, saucisse de porc, saucisse bratwurst, saucisse kolbassa,91. saucisson polonais, saucisson d’été, saucisson fumé, saucisse fumée campagnarde, pepperoni, knackwurst, saucisson de Thuringe ou cervelas Morceaux de viande et de volaille sans sauce ou prêts à cuire,

92. enrobés ou non de chapelure ou de pâte à frire, y compris morceaux de viande marinés, attendris et injectés Galettes de viande, escalopettes, chopettes, steakettes,

93. boulettes, chair à saucisse et viande hachée, enrobées ou non de chapelure ou de pâte à frire Produits de salaison, tels que jambon salé, jambon salé à sec, bacon de dos, bacon de dos salé à sec, capicollo salé à sec,

94. boeuf salé, pastrami, jambon campagnard, épaule de porc picnic salé, salaison de viande et de volaille, boeuf fumé ou viandes marinées

95. Viande et volaille en conserve Viande et volaille en sauce, telles que viande en sauce96. barbecue ou dinde en sauce, à l’exclusion des plats composés Divers

97. Poudre à pâte, bicarbonate de soude et pectine Décorations pour pâtisseries, telles que sucre de couleur ou98. perles pour biscuits

99. Chapelure et préparations pour pâte à frire 100. Vin de cuisine 101. Cacao en poudre

Préparations pour cocktail non alcoolisées, telles que102. préparations pour pina colada ou daïquiri 103. Gomme à mâcher

Garnitures pour salade et pommes de terre, telles que garnitures 104. croquantes ou croustillantes pour salade ou succédanés de

miettes de bacon

75 g non cuites

55 g cuites

75 g non cuites

55 g cuites

125 g crus

100 g cuits

100 g crues

60 g cuites

85 g crus

55 g cuits

55 g2

140 g

0,6 g

4 g

30 g 30 mL 5 g

250 mL

3 g

7 g

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

105. Sel, succédanés de sel et sel épicé, tel que sel d’ail 1 g 106. Épices et fines herbes 0,5 g

Plats composés Mets mesurables à la tasse, tels que mets en cocotte, hachis, macaroni au fromage avec ou sans viande, pâté à la viande et aux légumes, spaghetti avec sauce, sauté, viande ou volaille en cocotte, haricots au four ou haricots frits, haricots et saucisses107. 250 mLfumées, chili à la viande, haricots au chili, émincé de boeuf à la crème, raviolis au boeuf ou au poulet en sauce, boeuf Stroganoff, timbales de volaille, ragoût américain, goulache, ragoût ou poutine Mets non mesurables à la tasse, tels que burritos, pâtés 140 g sans sauce impériaux (egg rolls), enchiladas, pizza, roulés de type pizza, ou jus de viande friands, mets en croûte, cigares au chou, quiche, sandwiches, emballages de craquelins et de viande ou volaille, gyros,108. hamburgers, saucisses de Francfort avec pain, calzones, tacos, 195 g avec sauce cachettes à la viande, lasagne, poulet cordon bleu, légumes ou jus de viande farcis à la viande ou à la volaille, brochettes, empanadas, fajitas, souvlakis, pâté à la viande ou tourtière

109. Hors-d’oeuvre 50 g Noix et graines Noix et graines qui ne sont pas utilisées comme grignotines :110. 30 g écaléesentières, hachées, tranchées, effilées ou moulues Beurres, pâtes et crèmes de noix et de graines, sauf beurre111. 30 gd’arachide

112. Beurre d’arachide 15 g 113. Farines, telles que farine de noix de coco 15 g

Pommes de terre, patates douces et ignames 85 g frites

Pommes de terre frites ou rissolées et pelures ou galettes de congelées114. pommes de terre 70 g une fois préparées

115. En purée, glacées, farcies ou en sauce 140 g 110 g fraîches ou congelées 125 g emballées116. Nature, fraîches, en conserve ou congelées sous vide 160 g en

2conserve

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

Salades Salades, telles que salades aux oeufs, au poisson, aux fruits de

117. mer, aux haricots, aux fruits, aux légumes, à la viande, au 100 g jambon ou à la volaille, sauf celles énumérées à un autre article

118. Salade en gelée 120 g 119. Salade de pâtes alimentaires ou de pommes de terre 140 g

Sauces, trempettes, sauces au jus de viande et condiments Sauces pour trempettes, telles que sauce barbecue, sauce

120. hollandaise, sauce tartare, sauce à la moutarde et sauce aigre- 30 mL douce Trempettes, telles que trempettes à base de légumineuses ou de121. 30 gproduits laitiers Sauces pour plats principaux utilisées en grande quantité, telles122. 125 mLque sauce à spaghetti Sauces pour plats principaux utilisées en petite quantité, telles que sauce à pizza, sauce pesto et autres sauces utilisées comme123. 60 mLgarniture, telles que la sauce blanche, sauce au fromage, salsa, sauce à cocktail ou sauce au jus de viande Condiments utilisés en grande quantité, tels que ketchup, sauce124. 15 mLpour bifteck, sauce soya, vinaigre, sauce teriyaki ou marinades Condiments utilisés en petite quantité, tels que raifort, sauce125. 5 mLpiquante, moutarde ou sauce Worcestershire Grignotines Croustilles, bretzels, maïs éclaté, grignotines extrudées,

126. grignotines mélangées à base de céréales et grignotines à base 50 g de fruits, telles que croustilles de fruits

127. Noix et graines à grignoter 50 g écalées 128. Bâtonnets à la viande ou à la volaille 20 g

Soupes 129. Toutes les sortes 250 mL

Sucres et sucreries Friandises, y compris tablettes de chocolat et autres produits à130. 40 gbase de chocolat, sauf ceux énumérés à un autre article

131. Bonbons durs, sauf ceux énumérés à un autre article 15 g 132. Confiseries à cuire, telles que brisures de chocolat 15 g 133. Menthes 2 g

Bonbons durs, en rouleaux ou miniaturisés en emballage134. 5 gdistributeur

Colonne 1 Colonne 2 Quantité deArticle Aliment référence1

135. Sucre à glacer Tartinades, sauf celles énumérées à un autre article, miel et136. mélasse Confitures, gelées, marmelades, beurres de fruits et tartinades137. de fruits

138. Guimauves 139. Sucres, sauf ceux énumérés à un autre article

140. Succédané de sucre

Sirops, y compris sirop de chocolat, sirop d’érable et sirop de141. maïs

Légumes

Légumes sans sauce, y compris le maïs en crème et les tomates 142. étuvées, à l’exception des légumes sans sauce énumérés à un

autre article

143. Légumes en sauce

Légumes utilisés principalement comme garnitures ou 144. aromatisants, frais, en conserve ou congelés, mais non

déshydratés, tels que persil ou ail 145. Piment rouge et oignon vert 146. Algues marines 147. Laitue et graines germées 148. Jus et boisson de légumes 149. Olives 150. Marinades 151. Achards (relish) 152. Pâtes de légumes, telles que pâte de tomate

30 g

20 g

15 mL

30 g 4 g quantité équivalant en pouvoir édulcorant à 4 g de sucre 30 mL utilisés comme ingrédients 60 mL autres usages

85 g frais ou congelés, 125 mL en

2conserve 110 g frais ou congelés 125 mL en conserve

4 g

30 g 15 g 65 g 250 mL 15 g2

30 g2

15 mL 30 mL

153. Sauce ou purée de légumes, telle que sauce ou purée de tomate 60 mL

1Sauf indication contraire, la quantité de référence se rattache aux aliments prêts à servir ou presque prêts à servir. Si elle n’est pas mentionnée séparément, la quantité de référence pour les produits à préparer, tels que les mélanges secs, concentrés, pâte, pâte à frire et pâtes alimentaires fraîches ou congelées, est la quantité requise pour obtenir la quantité de référence du produit une fois préparé. 2Est exclu tout liquide dans lequel l’aliment solide est emballé ou mis en conserve, à moins qu’il soit habituellement consommé avec l’aliment. 3Les succédanés de viande et de volaille comprennent les produits de viande et de volaille avec allongeur et les simili-produits de viande et de volaille.

DORS/2003-11, art. 37; DORS/2010-94, art. 7(F). Version précédente

DISPOSITIONS CONNEXES

 — DORS/97-12

66. L'emballage des drogues étiquetées conformément à la partie C du Règlement sur les aliments et drogues, dans sa version au 31 décembre 1996, est, jusqu'au 1er janvier 1999, soustrait à l'application des exigences d'étiquetage du présent règlement.

 — DORS/98-423

10. Pour l'application des articles 11 à 13, « Directeur » s'entend au sens de l'article A.01.010 du Règlement sur les aliments et drogues.

 — DORS/98-423

11. Malgré les articles 1 et 7 à 9, ainsi que l'article C.01.001A, les alinéas C.01.015(2)b) et C.01.062(5)b), le titre 10 de la partie C ainsi que l'annexe et le tableau de ce titre du Règlement sur les aliments et drogues, dans leur version antérieure à l'entrée en vigueur du présent règlement, continuent de s'appliquer jusqu'au 1er octobre 1998 — à l'exception de leurs exigences relatives aux renseignements qui ne figurent pas dans leur version modifiée par le présent règlement — aux drogues qui font l'objet d'un certificat d'inscription numéroté mais auxquelles une identification numérique n'a pas été attribuée aux termes de l'article C.01.014.2 du Règlement sur les aliments et drogues édicté par l'article 4 du présent règlement, ou aux termes de l'article 12 du présent règlement.

 — DORS/98-423

12. (1) Malgré les autres dispositions du présent règlement et sous réserve du paragraphe (3), jusqu'au 1er octobre 1998, le Directeur, lorsque les conditions du paragraphe (2) sont remplies, fournit au fabricant ou à l'importateur visé à l'alinéa (2)c) :

a) dans le cas où les renseignements visés à l'article C.01.014.3 du Règlement sur les aliments et drogues édicté par l'article 5 du présent règlement n'ont pas été présentés à l'égard de la drogue, le document prévu au paragraphe C.01.014.2(1) du Règlement sur les aliments et drogues édicté par l'article 4 du présent règlement;

b) dans les autres cas :

(i) soit l'identification numérique attribuée à la drogue, précédée de l'abréviation « DIN »,

(ii) soit, si la drogue a deux marques nominatives ou plus, les identifications numériques attribuées à celle-ci par le Directeur, dont chacune correspond à une marque nominative et est précédée de l'abréviation « DIN ».

(2) Les conditions visées au paragraphe (1) sont les suivantes :

a) un certificat d'inscription numéroté a été délivré à l'égard de la drogue conformément au paragraphe C.10.004(1) du Règlement sur les aliments et drogues, dans sa version antérieure à l'entrée en vigueur du présent règlement;

b) le certificat d'inscription numéroté n'a pas été annulé selon l'article C.10.008 du Règlement sur les aliments et drogues, dans sa version antérieure à l'entrée en vigueur du présent règlement;

c) le fabricant ou l'importateur de la drogue a fourni au Directeur, avant le 1er septembre 1998 :

(i) le nom de la drogue à laquelle une identification numérique est destinée,

(ii) les renseignements visés au paragraphe C.01.014.1(2) du Règlement sur les aliments et drogues.

(3) Si une drogue fait l'objet de plus d'un certificat d'inscription numéroté en raison uniquement d'une différence de couleur, d'aromatisant ou de parfum, une seule identification numérique lui est attribuée.

 — DORS/98-423

13. Malgré l'article 4 du présent règlement et sous réserve de l'article C.10.005 du Règlement sur les aliments et drogues dans sa version antérieure à l'entrée en vigueur du présent règlement, le Directeur peut, jusqu'au 30 septembre 1998, délivrer un certificat d'inscription numéroté à l'égard d'une drogue, au fabricant :

a) d'une part, qui précise qu'il souhaite qu'un certificat d'inscription numéroté à l'égard de cette drogue lui soit délivré;

b) d'autre part, dont la demande a été acceptée pour étude, par le Directeur, avant l'entrée en vigueur du présent règlement.

 — DORS/98-423

14. Malgré l'article 2, le fabricant peut, jusqu'au 30 septembre 2000, apposer sur une drogue la même étiquette que celle-ci portait le 30 septembre 1998.

 — DORS/2001-203

11. Toute demande concernant la vente d'une drogue pour usage humain destinée à un essai clinique qui est reçue conformément au titre 8 du Règlement sur les aliments et drogues avant le 1er septembre 2001 est assujettie à ce règlement, y compris les procédures établies sous son régime, dans sa version en vigueur au moment de la réception de la demande.

 — DORS/2003-11

38. (1) Les définitions qui suivent s'appliquent au présent article.

« fabricant » S'entend au sens de l'article A.01.010 du Règlement sur les aliments et drogues. (manufacturer)

« produit préemballé » S'entend au sens de l'article B.01.001 du Règlement sur les aliments et drogues. (prepackaged product)

« règlement antérieur » » Le Règlement sur les aliments et drogues dans sa version antérieure à l'entrée en vigueur du présent règlement. (former Regulations)

(2) Malgré les articles 1 à 37 et sous réserve du paragraphe (3), le règlement antérieur continue de s'appliquer au produit préemballé qui est étiqueté conformément à ce règlement, jusqu'à l'expiration d'une période de trois ans suivant l'entrée en vigueur du présent règlement, sauf si l'étiquette du produit ou encore l'annonce faite par le fabricant du produit ou sous ses ordres comporte :

a) soit une mention ou allégation figurant à la colonne 4 des articles 15 ou 16 ou de l'un des articles 22 à 26 du tableau suivant l'article B.01.513 du Règlement sur les aliments et drogues, édicté par l'article 20 du présent règlement;

b) soit une mention ou allégation figurant à la colonne 1 du tableau suivant l'article B.01.603 du Règlement sur les aliments et drogues, édicté par l'article 20 du présent règlement;

c) soit les expressions « valeur nutritive », « valeurs nutritives » ou « nutrition facts ».

(3) La mention de « trois ans » au paragraphe (2) vaut mention de « cinq ans » pour l'application de ce paragraphe à l'égard du produit préemballé vendu par un fabricant dont le revenu brut tiré des ventes d'aliments au Canada est inférieur à 1 000 000 $ pour la période de douze mois précédant l'entrée en vigueur du présent règlement.

 — DORS/2006-241

2. L’article C.08.004.1 du Règlement sur les aliments et drogues, dans sa version antérieure à l’entrée en vigueur du présent règlement, s’applique à l’égard de la drogue pour laquelle un avis de conformité a été délivré avant le 17 juin 2006.

 — DORS/2007-302, art. 12

12. Les articles 1 à 6 et 11 ne s’appliquent pas dans le cas de fromages qui sont produits avant la date d’entrée en vigueur du présent règlement.

MODIFICATIONS NON EN VIGUEUR

 — DORS/2010-105, art. 1

1. Le paragraphe C.01.001(1) du Règlement sur les aliments et drogues1 est modifié par adjonction, selon l’ordre alphabétique, de ce qui suit : 1C.R.C., ch. 870

« encre pharmaceutique » Ingrédient non médicinal ou mélange d’ingrédients non médicinaux utilisé pour imprimer des marques ou des symboles sur la drogue. (pharmaceutical ink)

« ingrédient non médicinal » Substance, autre qu’une drogue pharmacologiquement active, ajoutée à la drogue au cours de la fabrication et présente dans le produit fini. (non-medicinal ingredient)

« parfum » Ingrédient non médicinal ou mélange d’ingrédients non médicinaux ajouté à la drogue pour produire ou masquer une odeur. (fragrance)

« saveur » Ingrédient non médicinal ou mélange d’ingrédients non médicinaux ajouté à la drogue pour produire ou masquer une saveur, à l’exclusion de ceux qui lui confèrent uniquement un goût sucré. (flavour)

 — DORS/2010-105, art. 2

2. (1) L’article C.01.004 du même règlement est modifié par adjonction, après le paragraphe (1), de ce qui suit :

(1.1) En outre, lorsque la drogue est pour usage humain, la liste de ses ingrédients non médicinaux figure sur l’étiquette extérieure de la drogue ou, si l’étiquette est trop petite, elle est placée sur une étiquette mobile, un ruban ou une carte attaché à l’emballage.

(1.2) Les ingrédients non médicinaux figurent sur la liste par ordre alphabétique ou par ordre décroissant de leurs proportions respectives dans la drogue et un libellé qui les distingue clairement des ingrédients médicinaux précède cette liste.

(1.3) Dans le cas d’une encre pharmaceutique, d’un parfum ou d’une saveur, les mentions « encre pharmaceutique/pharmaceutical ink », « parfum/fragrance » ou « saveur/flavour » peuvent figurer sur la liste, pour en indiquer l’ajout, au lieu que chacun des ingrédients ou mélange d’ingrédients soit énuméré.

(1.4) Si la composition de la drogue varie de lot en lot, l’étiquette extérieure indique la présence possible de tout substitut à un ingrédient non médicinal en le faisant précéder du symbole « +/– » ou « ± » ou bien des termes « ou/or » ou « peut contenir/may contain ».

(1.5) Les paragraphes (1.1) à (1.4) ne s’appliquent pas à une drogue :

a) qui ne peut être vendue que sur ordonnance;

b) qui peut être vendue sans ordonnance mais qui doit être administrée uniquement sous la surveillance d’un praticien;

c) qui est présentée comme étant destinée exclusivement à la désinfection de surfaces dures non poreuses;

d) pour usage vétérinaire.

(2) Le passage du paragraphe C.01.004(2) du même règlement précédant l’alinéa a) est remplacé par ce qui suit :

(2) Outre les exigences du paragraphe (1) et, s’il y a lieu, des paragraphes (1.1) à (1.4), les renseignements ci-après figurent sur l’étiquette extérieure d’une drogue :

 — DORS/2011-28, art. 1

1. L’alinéa B.01.008(5)a) du Règlement sur les aliments et drogues1 est remplacé par ce qui suit : 1C.R.C., ch. 870

a) immédiatement après l’ingrédient dont ils sont des constituants de manière à indiquer qu’ils en sont des constituants; cependant, dans le cas où, en application de l’alinéa B.01.010.1(8)a), une source d’allergène alimentaire ou de gluten doit figurer immédiatement à la suite de l’ingrédient, ils doivent plutôt figurer immédiatement après cette source; et

 — DORS/2011-28, art. 2

2. (1) L’article 30 du tableau du paragraphe B.01.009(1) de la version anglaise du même règlement est remplacé par ce qui suit :

Item Ingredient 30. hydrolyzed plant protein

(2) L’alinéa B.01.009(3)c) du même règlement est remplacé par ce qui suit :

c) protéine végétale hydrolysée;

(3) Le paragraphe B.01.009(5) du même règlement est abrogé.

 — DORS/2011-28, art. 3

3. (1) L’article 8 du tableau de l’alinéa B.01.010(3)a) du même règlement est remplacé par ce qui suit :

Colonne I Colonne II

Article Ingrédient ou Nom usuelconstituant protéine végétale l’expression « protéine hydrolysée de » suivie du8. hydrolysée nom de la plante

(2) Le tableau de l’alinéa B.01.010(3)a) du même règlement est modifié par adjonction, après l’article 19, de ce qui suit :

Colonne I Colonne II

Article Ingrédient ou Nom usuelconstituant l’expression « amidon de » suivie du nom de la20. amidon plante l’expression « amidon de » suivie du nom de la21. amidon modifié plante, lui-même suivi du terme « modifié » l’expression « lécithine de » suivie du nom de la22. lécithine source de lécithine

23. crustacé le nom du crustacé 24. mollusque le nom du mollusque

(3) L’article 21 du tableau de l’alinéa B.01.010(3)b) du même règlement est remplacé par ce qui suit :

Colonne I Colonne II Article Ingrédient ou constituant Nom usuel

un ou plusieurs des additifs alimentaires suivants : acide agents desulfureux, anhydride sulfureux, bisulfite de potassium,21. sulfitage oubisulfite de sodium, dithionite de sodium, métabisulfite de sulfitespotassium, métabisulfite de sodium et sulfite de sodium

 — DORS/2011-28, art. 4

4. Le même règlement est modifié par adjonction, après l’article B.01.010, de ce qui suit :

B.01.010.1 (1) Les définitions qui suivent s’appliquent au présent article et à l’article B.01.010.3.

« allergène alimentaire » Toute protéine provenant d’un des aliments ci-après, ou toute protéine modifiée –– y compris toute fraction protéique — qui est dérivée d’un tel aliment :

a) amandes, noix du Brésil, noix de cajou, noisettes, noix de macadamia, pacanes, pignons, pistaches ou noix;

b) arachides;

c) graines de sésame;

d) blé ou triticale;

e) oeufs;

f) lait;

g) soja;

h) crustacés;

i) mollusques;

j) poissons;

k) graines de moutarde. (food allergen)

« gluten »

a) Toute protéine de gluten provenant des grains d’une des céréales ci-après ou des grains d’une lignée hybride issue d’au moins une de ces céréales :

(i) orge,

(ii) avoine,

(iii) seigle,

(iv) triticale,

(v) blé;

b) toute protéine de gluten modifiée — y compris toute fraction protéique de gluten — qui est dérivée des grains d’une des céréales mentionnées à l’alinéa a) ou des grains d’une lignée hybride qui est visée à cet alinéa. (gluten)

(2) Dans le cas où un allergène alimentaire ou du gluten est présent dans un produit préemballé, la source de l’allergène alimentaire ou de gluten, selon le cas, figure sur l’étiquette du produit :

a) soit dans la liste des ingrédients;

b) soit sous la mention « Contient », auquel cas les exigences du paragraphe B.01.010.3(1) doivent être respectées.

(3) Le paragraphe (2) ne s’applique pas à l’allergène alimentaire ou au gluten présent dans un produit préemballé par suite de contamination croisée.

(4) Le paragraphe (2) ne s’applique pas à l’allergène alimentaire ou au gluten présent dans un produit préemballé visé à l’un des alinéas B.01.008(2)a) à e), sauf si l’étiquette d’un tel produit porte une liste des ingrédients.

(5) Le paragraphe (2) ne s’applique pas à l’allergène alimentaire ou au gluten présent dans un produit préemballé pour lequel une norme a été prescrite selon les articles B.02.130 ou B.02.131, sauf si l’étiquette d’un tel produit porte une liste des ingrédients.

(6) La source de l’allergène alimentaire devant figurer en application du paragraphe (2) est indiquée :

a) s’agissant d’un allergène alimentaire provenant d’un aliment mentionné à l’un des alinéas a), b) et e) de la définition de « allergène alimentaire », au paragraphe (1), ou dérivé d’un tel aliment, par le nom de l’aliment tel qu’il est indiqué à l’alinéa applicable, écrit au singulier ou au pluriel;

b) s’agissant d’un allergène alimentaire provenant de l’aliment mentionné à l’alinéa c) de la même définition ou dérivé d’un tel aliment, par le nom « sésame », « graine de sésame » ou « graines de sésame »;

c) s’agissant d’un allergène alimentaire provenant d’un aliment mentionné à l’un des alinéas d) et f) de la même définition ou dérivé d’un tel aliment, par le nom de l’aliment tel qu’il est indiqué à l’alinéa applicable;

d) s’agissant d’un allergène alimentaire provenant de l’aliment mentionné à l’alinéa g) de la même définition ou dérivé d’un tel aliment, par le nom « soja » ou « soya »;

e) s’agissant d’un allergène alimentaire provenant d’un aliment mentionné à l’un des alinéas h) à j) de la même définition ou dérivé d’un tel aliment, par le nom usuel de l’aliment qui est visé à celui des articles 6, 23 ou 24 du tableau de l’alinéa B.01.010(3)a), dans la colonne II, qui est applicable;

f) s’agissant d’un allergène alimentaire provenant de l’aliment mentionné à l’alinéa k) de la même définition ou dérivé d’un tel aliment, par le nom « moutarde », « graine de moutarde » ou « graines de moutarde ».

(7) La source de gluten devant figurer en application du paragraphe (2) est indiquée :

a) s’agissant du gluten provenant de grains d’une céréale mentionnée à l’un des sous-alinéas a)(i) à (v) de la définition de « gluten », au paragraphe (1), ou dérivé de tels grains, par le nom de la céréale tel qu’il est indiqué au sous-alinéa applicable;

b) s’agissant du gluten provenant de grains d’une lignée hybride issue d’une ou de plusieurs céréales mentionnées aux sous-alinéas a)(i) à (v) de la même définition,

ou dérivé de tels grains, par le nom de la ou des céréales tel qu’il est indiqué aux sous-alinéas applicables.

(8) Pour l’application de l’alinéa (2)a), la source de l’allergène alimentaire ou de gluten figure dans la liste des ingrédients entre parenthèses :

a) immédiatement à la suite de l’ingrédient qui figure dans la liste des ingrédients si l’allergène alimentaire ou le gluten :

(i) est cet ingrédient,

(ii) est présent dans cet ingrédient mais n’en est pas un constituant ni n’est présent dans un de ses constituants,

(iii) est un constituant de cet ingrédient, ou est présent dans un tel constituant, et le constituant ne figure pas dans la liste des ingrédients;

b) immédiatement à la suite du constituant qui figure dans la liste des ingrédients si l’allergène alimentaire ou le gluten est ce constituant ou s’il est présent dans celui-ci.

(9) Malgré le paragraphe (2), la source de l’allergène alimentaire ou de gluten figure sur l’étiquette du produit sous la mention « Contient » si l’allergène alimentaire ou le gluten est, selon le cas :

a) un ingrédient qui ne figure pas dans la liste des ingrédients, ou est présent dans un tel ingrédient mais n’en n’est pas un constituant ni n’est présent dans un de ses constituants;

b) un constituant ou est présent dans un constituant et ni le constituant ni l’ingrédient dans lequel il est présent ne figurent dans la liste des ingrédients.

(10) Malgré le paragraphe (8), la source de l’allergène alimentaire ou du gluten n’a pas à figurer entre parenthèses immédiatement à la suite de l’ingrédient ou du constituant, selon le cas, si elle figure à l’un ou l’autre des endroits suivants :

a) dans la liste des ingrédients :

(i) soit comme partie du nom usuel de l’ingrédient ou du constituant,

(ii) soit entre parenthèses, immédiatement à la suite d’un autre ingrédient ou constituant, conformément au paragraphe (8);

b) sous la mention « Contient ».

(11) Il est entendu que le paragraphe (8) est sans effet sur la façon dont les ingrédients ou constituants peuvent être indiqués dans la liste des ingrédients en vertu de l’alinéa B.01.010(3)b).

B.01.010.2 (1) Au présent article et à l’article B.01.010.3, « sulfites » s’entend d’un ou de plusieurs additifs alimentaires qui figurent exclusivement dans la

colonne I de l’article 21 du tableau de l’alinéa B.01.010(3)b), et qui sont présents dans un produit préemballé.

(2) Il est entendu que la définition de « sulfites » au paragraphe (1) ne vise que les sulfites dont la présence dans le produit préemballé est le résultat de leur ajout à celui-ci.

(3) Si des sulfites sont présents dans un produit préemballé en une quantité totale égale ou supérieure à 10 parties par million et qu’aucun n’a à être indiqué dans la liste des ingrédients en application des articles B.01.008 ou B.01.009, ils figurent sur l’étiquette du produit :

a) soit dans la liste des ingrédients;

b) soit sous la mention « Contient », auquel cas les exigences du paragraphe B.01.010.3(1) doivent être respectées.

(4) Le paragraphe (3) ne s’applique pas aux sulfites présents dans les produits préemballés visés aux alinéas B.01.008(2)a) à e), sauf si l’étiquette de ces produits porte une liste des ingrédients.

(5) Le paragraphe (3) ne s’applique pas aux sulfites présents dans un produit préemballé pour lequel une norme a été prescrite selon les articles B.02.130 ou B.02.131, sauf si l’étiquette de ce produit porte une liste des ingrédients.

(6) Les sulfites devant figurer sur l’étiquette du produit en application du paragraphe (3) sont indiqués :

a) s’ils figurent dans la liste des ingrédients :

(i) soit par l’un des noms usuels « agents de sulfitage » ou « sulfites »,

(ii) soit, individuellement, par celui des noms mentionnés à la colonne I de l’article 21 du tableau de l’alinéa B.01.010(3)b) qui s’applique, sauf lorsqu’il s’agit d’un des noms « dithionite de sodium », « anhydride sulfureux » ou « acide sulfureux » auquel cas ce nom doit être suivi, entre parenthèses, par l’un des noms usuels « agents de sulfitage » ou « sulfites »;

b) s’ils figurent sous la mention « Contient », par l’un des noms usuels « agents de sulfitage » ou « sulfites ».

(7) Les sulfites figurant dans la liste des ingrédients en application de l’alinéa (6)a) sont indiqués :

a) s’ils sont des constituants d’un ingrédient figurant dans la liste des ingrédients, soit entre parenthèses immédiatement à la suite de l’ingrédient, soit à la fin de la liste des ingrédients auquel cas ils peuvent figurer dans n’importe quel ordre avec les autres ingrédients indiqués à la fin de la liste aux termes du paragraphe B.01.008(4);

b) dans tous les autres cas, à la fin de la liste des ingrédients où ils peuvent figurer dans n’importe quel ordre avec les autres ingrédients indiqués à la fin de la liste des ingrédients aux termes du paragraphe B.01.008(4).

(8) Si des sulfites sont présents dans un produit préemballé en une quantité totale égale ou supérieure à 10 parties par million et qu’un ou plusieurs d’entre eux, d’une part, doivent figurer dans la liste des ingrédients en application des articles B.01.008 ou B.01.009 et, d’autre part, y sont désignés individuellement par celui des noms « dithionite de sodium », « anhydride sulfureux » ou « acide sulfureux » qui s’applique, ce nom doit être suivi, entre parenthèses, de l’un des noms usuels « agents de sulfitage » ou « sulfites ».

(9) Si la quantité totale de sulfites présents dans le produit préemballé est égale ou supérieure à 10 parties par million, les sulfites qui doivent figurer dans la liste des ingrédients en application des articles B.01.008 ou B.01.009 peuvent en plus figurer sur l’étiquette du produit sous la mention « Contient », auquel cas les exigences du paragraphe B.01.010.3(1) doivent être respectées.

(10) Malgré le sous-alinéa (6)a)(ii) et le paragraphe (8), si des sulfites sont désignés individuellement dans la liste des ingrédients par l’un des noms « dithionite de sodium », « anhydride sulfureux » ou « acide sulfureux », ce nom n’a pas à être suivi, entre parenthèses, de l’un des noms usuels « agents de sulfitage » ou « sulfites » si, selon le cas :

a) dans la liste des ingrédients :

(i) la mention « sulfite » figure dans le nom usuel d’un autre sulfite,

(ii) l’un des noms usuels « agents de sulfitage » ou « sulfites » figure entre parenthèses à la suite d’un autre sulfite;

b) sous la mention « Contient », l’un des noms usuels « agents de sulfitage » ou « sulfites » figure sur l’étiquette du produit.

B.01.010.3 (1) Si la mention « Contient » figure sur l’étiquette d’un produit préemballé en application de l’un ou de plusieurs des paragraphes B.01.010.1(2), B.01.010.1(9), B.01.010.2(3) ou B.01.010.2(9), les exigences ci-après doivent être respectées :

a) la mention suit la liste des ingrédients du produit, le cas échéant, sans qu’aucun texte imprimé ou écrit ni aucun signe graphique ne soit intercalé;

b) tous les renseignements ci-après figurent sous cette mention, que l’un ou plusieurs d’entre eux figurent ou non dans la liste des ingrédients du produit :

(i) la source de chacun des allergènes alimentaires présents dans le produit,

(ii) chacune des sources de gluten présent dans le produit,

(iii) l’un des noms usuels « agents de sulfitage » ou « sulfites », si la quantité totale de sulfites présents dans le produit est égale ou supérieure à 10 parties par million.

(2) Malgré l’alinéa (1)b), les renseignements ci-après n’ont à figurer qu’une seule fois sous la mention applicable :

a) une même source d’allergène alimentaire;

b) une même source de gluten;

c) l’un des noms usuels « agents de sulfitage » ou « sulfites ».

 — DORS/2011-28, art. 5

5. L’article B.13.011 du même règlement est remplacé par ce qui suit :

B.13.011. [N]. L’amidon de maïs ou la fécule de maïs doit être l’amidon extrait du maïs et doit contenir au moins 84 % d’amidon.

 — DORS/2011-28, art. 6

6. L’article B.24.018 du même règlement est remplacé par ce qui suit :

B.24.018. Il est interdit d’étiqueter, d’emballer ou de vendre un aliment qui contient une protéine de gluten ou une protéine de gluten modifiée, y compris toute fraction protéique de gluten, visée à la définition de « gluten » au paragraphe B.01.010.1(1), ou d’en faire la publicité, de manière qui puisse donner l’impression qu’il est sans gluten.

 — DORS/2011-28, art. 7

7. L’alinéa D.01.007(1)a) du même règlement est remplacé par ce qui suit :

a) malgré le paragraphe B.01.008(6), la vitamine est désignée par son nom usuel lequel figure juste après l’ingrédient de manière à indiquer que la vitamine est un constituant de cet ingrédient; cependant, dans le cas où, en application de l’alinéa B.01.010.1(8)a), une source d’allergène alimentaire ou de gluten doit figurer immédiatement à la suite de l’ingrédient, le nom usuel de la vitamine doit plutôt figurer immédiatement après cette source.

 — DORS/2011-28, art. 8

8. L’alinéa D.02.005(1)a) du même règlement est remplacé par ce qui suit :

a) malgré le paragraphe B.01.008(6), le minéral nutritif est désigné par son nom usuel lequel figure juste après l’ingrédient de manière à indiquer que le minéral nutritif est un constituant de cet ingrédient; cependant, dans le cas où, en application de l’alinéa B.01.010.1(8)a), une source d’allergène alimentaire ou de gluten doit figurer immédiatement à la suite de l’ingrédient, le nom usuel du minéral nutritif doit plutôt figurer immédiatement après cette source.


التشريعات يحلّ محل (1 نصوص) يحلّ محل (1 نصوص) يحلّ محله (1 نصوص) يحلّ محله (1 نصوص)
لا توجد بيانات متاحة.

ويبو لِكس رقم CA122