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

• D.01.001.1 (1) The daily value of a vitamin or mineral nutrient set out in column 1 of Part 2 of the Table of Daily Values is, in respect of a food, the quantity

  • (a) set out in column 2, if the food is intended solely for infants six months of age or older but less than one year of age;

  • (b) set out in column 3, if the food is intended for infants six months of age or older but less than one year of age or for children one year of age or older but less than four years of age, and

  • (c) set out in column 4, in any other case.

• (2) Subsection (1) does not apply if the food is

  • (a) a human milk fortifier; or

  • (b) a human milk substitute intended solely for infants less than six months of age.

D.01.001.2 If both a nutrition symbol, as defined in subsection B.01.001(1), and a statement or claim referred to in any of sections D.01.004 to D.01.007 and D.02.002 to D.02.005 appear on the principal display panel of a prepackaged product,

• (a) the height of the upper case letters in the statement or claim must not exceed two times the height of the upper case letters, excluding any accents, in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”; and

• (b) the height of the tallest ascender of the lower case letters in the statement or claim must not exceed two times the height of the tallest ascender of the lower case letters in the nutrition symbol, other than in the words “Health Canada” and “Santé Canada”.

DIVISION 1Vitamins 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;

  • (m) biotin; and

  • (n) choline. (vitamine)

• (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.

• D.01.003 (1) For the purposes of these Regulations, the vitamin content of a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or 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, calculated on the basis of micrograms of retinol activity equivalents (RAE) and expressed in micrograms on the basis of the following relationships:

    • (i) 1 RAE = 1 microgram of retinol, and

    • (ii) 1 RAE = 12 micrograms of 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 niacin equivalents (NE) expressed in milligrams;

  • (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 folate, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated on the basis of micrograms of dietary folate equivalents (DFE) and expressed in micrograms on the basis of the following relationships:

    • (i) 1 DFE = 1 μg food folate, and

    • (ii) 1 DFE = 0.6 μg folic acid from food with added folic acid;

  • (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;

  • (m) in the case of biotin, in terms of the content of biotin, expressed in micrograms; and

  • (n) in the case of choline, in terms of the content of choline, 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.

• D.01.004 (1) It is prohibited, on the label of or in any advertisement for a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — to make a statement or claim concerning the vitamin content of the food unless

  • (a) the vitamin is set out in column 1 of Part 2 of the Table of Daily Values;

  • (b) the percentage of the daily value 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.

• (1.1) The condition set out in paragraph (1)(c) need not be met if the statement or claim described in subsection (1) is made on a label of or in any advertisement for 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 mineral oil, paraffin wax, petrolatum or any other protective coating.

• (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 or supplemented food facts table.

• (5) Paragraph (1)(c) does not apply to a declaration of the biotin content as required by subparagraph B.24.202(a)(vi).

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.

• 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.01.008.2(6), the vitamin is declared by its common name, and that common name is shown in parentheses immediately after the ingredient in respect of which it is a component, 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

  • (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).

• D.01.008 (1) Sections D.01.009, D.01.010 and D.01.011 do not apply to a human milk fortifier.

• (2) Sections D.01.009 and D.01.011 do not apply to a supplemented food.

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 that vitamin in an amount 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 any of the following vitamins have 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 that vitamin in an amount 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 that vitamin in an amount 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.