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 [Repealed, SOR/94-289, s. 1]

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)

“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” 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; (fabricant) or (distributeur)

“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.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.

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

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

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

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

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

(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).

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.

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.

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

(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

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

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

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

(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

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

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.

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.

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)

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.”

(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.

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:

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

(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:

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).

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 [Repealed, SOR/93-243, s. 2]

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

(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.

(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

(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.