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

Regulations are current to 2019-07-01 and last amended on 2019-06-17. Previous Versions

PART BFoods (continued)

DIVISION 25 (continued)

Human Milk Substitutes and Food Containing Human Milk Substitutes (continued)

 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.

  • SOR/78-637, s. 9(F)
  • SOR/83-933, s. 1

 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

  • (b) the number of Calories from

    • (i) fat, or

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

  • SOR/2003-11, s. 26
  • SOR/2016-305, s. 60
  •  (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.

  • SOR/83-933, s. 1
  • SOR/88-424, s. 2
  • SOR/90-174, s. 3
  • SOR/2018-69, ss. 12, 27
  •  (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 substitute or a new human milk substitute.

  • SOR/83-933, s. 1
  • SOR/90-174, s. 4
  •  (1) Subject to subsection (2), no person shall sell a food that is labelled or advertised for consumption by infants if the food contains a food additive.

  • (2) Subsection (1) does not apply to

    • (a) bakery products that are labelled or advertised for consumption by infants;

    • (b) the following foods that are labelled or advertised for consumption by infants and that contain ascorbic acid:

      • (i) fruit purées, and

      • (ii) cereals containing banana;

    • (c) infant cereal products that contain lecithin;

    • (d) foods that are labelled or advertised for consumption by infants and that contain citric acid;

    • (e) infant formula that contains the food additives set out in Tables IV and X to section B.16.100 for use in infant formula;

    • (f) infant formula that contains ingredients manufactured with food additives set out in Table V to section B.16.100;

    • (g) infant formula that contains concentrated or dried whey products manufactured with liquid whey to which sodium hexametaphosphate has been added;

    • (h) infant cereal products that contain amylase in accordance with Table V to section B.16.100;

    • (i) infant formula that contains ascorbyl palmitate or tocopherols; or

    • (j) infant formula that contains oils to which ascorbyl palmitate or tocopherols have been added.

    • SOR/83-933, s. 1
    • SOR/90-24, s. 4
    • SOR/91-149, s. 6
    • SOR/97-559, s. 1
    • SOR/2010-40, s. 3
    • SOR/2010-41, s. 8
    • SOR/2010-94, s. 6
    • SOR/2010-141, s. 3
    • SOR/2012-105, s. 2

    TABLE I

    Sodium Content in Infant Foods

    Column IColumn II
    FoodTotal Sodium in Grams per 100 Grams of Food
    1Junior Desserts blank line0.10
    2Junior Meat, Junior Meat Dinners, Junior Dinners, Junior Breakfasts blank line0.25
    3Junior Vegetables, Junior Soups blank line0.20
    4Strained Desserts blank line0.05
    5Strained Meats, Strained Meat Dinners, Strained Dinners, Strained Breakfasts blank line0.15
    6Strained Vegetables, Strained Soups blank line0.10
    • SOR/78-637, s. 10
    • SOR/83-933, s. 1

    TABLE II

    Item No.Column IColumn IIColumn III
    Vitamin or Mineral nutrientMinimum amount per 100 available kilocaloriesMaximum amount per 100 available kilocalories
    B.1Biotin2 mcg
    F.1Folic acid4 mcg
    N.1Niacin250 mcg
    P.1d-pantothenic acid300 mcg
    R.1Riboflavin60 mcg
    T.1Thiamine40 mcg
    T.2Alpha-tocopherol0.6 I.U.
    V.1Vitamin A250 I.U.500 I.U.
    V.2Vitamin B635 mcg
    V.3Vitamin B120.15 mcg
    V.4Vitamin C8 mg
    V.5Vitamin D40 I.U.80 I.U.
    V.6Vitamin K18 mcg
    C.1Calcium50 mg
    C.2Chloride55 mg150 mg
    C.3Copper60 mcg
    L.1Iodine5 mcg
    L.2Iron0.15 mg
    M.1Magnesium6 mg
    M.2Manganese5 mcg
    P.2Phosphorous25 mg
    P.3Potassium80 mg200 mg
    S.1Sodium20 mg60 mg
    Z.1Zinc0.5 mg
    • SOR/83-933, s. 1
    • SOR/98-458, s. 7(F)
 
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