Food and Drug Regulations (C.R.C., c. 870)

DIVISION 15Contaminants

• B.15.001 (1) A food referred to in column 2 of Part 1 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food.

• (2) A food referred to in column 2 of Part 2 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food in an amount that exceeds the maximum level set out in column 3.

• (3) If a substance referred to, by name or class, in column 1 in Part 2 the List of Contaminants and Other Adulterating Substances in Foods is present in or on the corresponding food referred to in column 2, the food is, in respect of the presence of the substance, exempt from the application of paragraph 4(1)(a) of the Act if the amount of the substance does not exceed the maximum level set out in column 3.

• (4) Subsections (1) to (3) do not apply to a substance that is present in or on a food as

  • (a) a food additive;

  • (a.1) a supplemental ingredient;

  • (b) a pest control product as defined in subsection 2(1) of the Pest Control Products Act or its components or derivatives; or

  • (c) a veterinary drug or its metabolites.

• 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]

B.15.003 [Repealed, SOR/2016-74, s. 8]

DIVISION 16Food Additives

Interpretation

B.16.001 The following definitions apply in this Division.

dye

dye, in relation to a synthetic colour, means the principal dye and associated subsidiary and isomeric dyes contained in the synthetic colour. (pigment)

synthetic colour

synthetic colour means any organic food colour, other than caramel, that is produced by chemical synthesis and that has no counterpart in nature. (colorant synthétique)

Adulteration

B.16.002 A food is adulterated if a food additive is present in or on, or has been added to, the food.

Exemptions

B.16.003 Subject to sections B.16.005 and B.16.006, if a food additive set out in column 1 of the Lists of Permitted Food Additives is added to a corresponding food set out in column 3, that food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that the food additive is in or on it, or has been added to it, if

• (a) the food additive is obtained from any corresponding source set out in column 2;

• (b) the food additive is used for any corresponding purpose of use set out in column 4;

• (c) the amount of the food additive does not exceed

  • (i) any corresponding maximum level of use and any corresponding maximum level of residue set out in column 5, and

  • (ii) the amount that is required to accomplish the purpose for which it is added, in the case where the words “Good Manufacturing Practice” appear in column 5 for that food additive in the food; and

• (d) any other corresponding condition set out in column 5 is met.

B.16.004 If a food additive set out in column 1 of the Lists of Permitted Food Additives is combined with other ingredients to manufacture a pre-mix — other than a pre-mix set out in column 3 — the pre-mix is not adulterated for the purposes of paragraph 4(1)(d) of the Act by reason only that the food additive is in or on it if

• (a) the pre-mix is intended solely for use as an ingredient in the manufacture of another food intended for sale to a consumer at the retail level or as an ingredient in the preparation of another food by a commercial or industrial enterprise or an institution;

• (b) the pre-mix is not intended for sale to a consumer at the retail level;

• (c) the food additive is obtained from any corresponding source set out in column 2; and

• (d) the food additive is intended for any corresponding purpose of use set out in column 4 in relation to a corresponding food set out in column 3.

B.16.005 If a food that, under section B.16.003, does not contain a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — is used as an ingredient in another food, that other food also does not contain a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act and is not adulterated for the purposes of paragraph 4(1)(d) of the Act by reason only that the food additive referred to in section B.16.003 is present in or on that other food, or has been added to the ingredient.

• B.16.006 (1) Subject to subsections (2) to (4), sections B.16.003 and B.16.005 do not apply to an infant food.

• (2) Sections B.16.003 and B.16.005 apply to an infant food if

  • (a) it is a bakery product; or

  • (b) the food additive in or on the food is citric acid.

• (3) Section B.16.003 applies to an infant food if

  • (a) the word “infant” is mentioned in column 3 of the Lists of Permitted Food Additives in relation to a food set out in that column; or

  • (b) it is a human milk fortifier set out in column 3 of the Lists of Permitted Food Additives.

• (4) Section B.16.005 applies to an infant food if

  • (a) it contains, as an ingredient, a food set out in column 3 of the Lists of Permitted Food Additives to which a corresponding food additive set out in column 1 has been added, and the use of that ingredient in that infant food is mentioned in column 3; or

  • (b) it is an infant formula that contains, as an ingredient, a food set out in column 3 of the List of Permitted Food Enzymes that contains a corresponding food additive set out in column 1.

• B.16.007 (1) Sections B.16.003, B.16.005 and B.16.006 apply to the foods referred to in those sections if the other requirements of these Regulations that apply with respect to the food additive referred to in those sections are met.

• (2) Section B.16.004 applies to the pre-mix referred to in that section if the other requirements of these Regulations that apply with respect to the food additive referred to in that section are met.

Prohibitions

B.16.008 No person shall sell any fresh fruit or vegetable, except grapes, to which sulphurous acid or any of its salts has been added and that is intended to be consumed raw.

B.16.009 No person shall sell a substance as a food additive unless the substance is set out in column 1 of the Lists of Permitted Food Additives.

B.16.010 No person shall sell vanilla extract or vanilla flavour for which a standard is set out in Volume 9 of the Food Compositional Standards Document to which a food colour has been added.

Specifications

• B.16.011 (1) A food additive set out in column 1 of the Table of Food Additive Specifications must meet the specifications set out in column 2 for that food additive.

• (2) If a food additive is not listed in the Table of Food Additive Specifications, but specifications are set out for the food additive in one of the following publications, the food additive must meet the specifications set out for it in that publication:

  • (a) the Food Chemicals Codex, published by the United States Pharmacopeial Convention, including its supplements, as amended from time to time; or

  • (b) the Combined Compendium of Food Additive Specifications, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by the Food and Agriculture Organization of the United Nations on its website, as amended from time to time.

• (3) For greater certainty, the specifications referred to in subsection (1) may incorporate portions of the publications referred to in paragraphs (2)(a) and (b).

• (4) In this section, Table of Food Additive Specifications means the Table of Food Additive Specifications, published by the Government of Canada on its website, as amended from time to time.

B.16.012 If a food additive is a water soluble synthetic colour, its lake must be the calcium or aluminum salt of the synthetic colour adsorbed or precipitated on alumina.

Labelling and Packaging

B.16.013 A quantitative statement of the amount of each food additive present or directions for use that, if followed, will produce a food that does not contain these food additives in excess of the maximum levels of use or maximum levels of residue prescribed by these Regulations must be shown, grouped together with the list of ingredients, in respect of any substance or mixture of substances for use as a food additive.

B.16.014 A quantitative statement of the amount of each food additive referred to in section B.16.004 and directions for use that, if followed, will produce a corresponding food set out in column 3 of the Lists of Permitted Food Additives that does not contain these food additives in excess of the maximum levels of use or maximum levels of residue prescribed by these Regulations must be shown, grouped together with the list of ingredients, in respect of a pre-mix referred to in that section.

B.16.015 No person shall sell for household use in or on a food, a food colour preparation containing one or more synthetic colours unless

• (a) the words “Food Colour Preparation” appear on the principal display panel;

• (b) in the case of a liquid food colour preparation, the container has a capacity of 60 mL or less and permits dropwise discharge only; and

• (c) the food colour preparation contains less than 3% dye.

• B.16.016 (1) The label of a food that contains aspartame must carry a statement warning individuals with phenylketonuria that the food contains phenylalanine or a statement to the effect that aspartame contains phenylalanine.

• (2) The statement must

  • (a) be shown in bold type;

  • (b) appear, in respect of each linguistic version, immediately after the list of ingredients appearing in the same language, either on the same line as the last ingredient in the list or on the following line, without any intervening printed, written or graphic material; and

  • (c) appear on the same continuous surface as the list of ingredients and be shown in the same manner as that list is shown in accordance with subsection B.01.008.2(2).