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

• 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.

• 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.

• 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.

• 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    • (iii) [Repealed, SOR/2024-244, s. 138]

    • (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).

• 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.

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.

• 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.

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.

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) sugars,

  • (vi) fibre, or

  • (vii) cholesterol; or

• (b) the number of Calories from

  • (i) fat, or

  • (ii) saturated fatty acids and trans fatty acids.

• 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 Minister 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) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

• (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 Minister 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.

Additional Rules

• 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 fortifier, human milk substitute or new human milk substitute.

B.25.062 [Repealed, SOR/2024-244, s. 139]

	Column I	Column II
	Food	Total Sodium in Grams per 100 Grams of Food
1	Junior Desserts	0.10
2	Junior Meat, Junior Meat Dinners, Junior Dinners, Junior Breakfasts	0.25
3	Junior Vegetables, Junior Soups	0.20
4	Strained Desserts	0.05
5	Strained Meats, Strained Meat Dinners, Strained Dinners, Strained Breakfasts	0.15
6	Strained Vegetables, Strained Soups	0.10