Food and Drug Regulations

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).