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

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.