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

B.25.021 It is prohibited, on the label of or in any advertisement for a human milk fortifier, to make any statement or claim relating to the content in the human milk fortifier 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.

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)

• 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 Minister 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 Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory.

B.25.047 Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes.

• 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 Minister 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 Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory.

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.

• 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) 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).

• 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.