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

Regulations are current to 2022-07-25 and last amended on 2022-07-21. 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

    • (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.

  • 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

Additional Rules

[
  • SOR/2021-57, s. 14
]
  •  (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.

  •  (1) Subject to subsection (2), it is prohibited to sell an infant food 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
    • SOR/2021-57, s. 16

    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)

DIVISION 26Food Irradiation

Interpretation

[
  • SOR/2017-16, s. 2(F)
]

 In this Division, irradiation means treatment with ionizing radiation.

  • SOR/89-175, s. 3
  • SOR/2017-16, s. 3

Application

 This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures.

  • SOR/89-175, s. 3

General

  •  (1) Subject to subsection (2), no person shall sell a food that has been irradiated.

  • (2) A food that is set out in column 1 of the table to this Division that has been irradiated may be sold if both of the following requirements are met:

    • (a) the ionizing radiation is of a type and from a source set out in column 2 for the purpose of irradiation set out in column 3; and

    • (b) the ionizing radiation that is absorbed by the food is either within the range set out in columns 4 and 5 or, if there is no minimum absorbed dose set out in column 4, is not more than the maximum absorbed dose set out in column 5.

  • SOR/89-175, s. 3
  • SOR/2017-16, s. 4

Records

  •  (1) A manufacturer who sells a food that has been irradiated shall keep on their premises, for at least two years after the date of the irradiation, a record that contains all of the following information:

    • (a) the name of the food that was irradiated and the quantity and lot numbers of the food;

    • (b) the purpose of the irradiation;

    • (c) the date of the irradiation;

    • (d) the dose of ionizing radiation that was absorbed by the food;

    • (e) the type and source of the ionizing radiation;

    • (f) a statement that indicates whether the food was previously irradiated and, if it was previously irradiated, the information referred to in paragraphs (a) to (e) in respect of that previous irradiation.

  • (2) A person who imports a food for sale in Canada that has been irradiated shall keep on their premises, for at least two years after the date of importation, a record of the information required by subsection (1).

  • SOR/89-175, s. 3
  • SOR/2017-16, s. 5

Changes to the Table

 A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Minister containing the following information:

  • (a) the purpose and details of the proposed irradiation — including the type and source of the ionizing radiation — and the proposed number of treatments and the minimum and maximum absorbed doses of the ionizing radiation;

  • (b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;

  • (c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;

  • (d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;

  • (e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;

  • (f) where the Minister so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;

  • (g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;

  • (h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and

  • (i) such other data as the Minister may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food.

TABLE

ItemColumn 1Column 2Column 3Column 4Column 5
FoodType and Source of Ionizing RadiationPurpose of IrradiationMinimum Absorbed Dose (kGy)Maximum Absorbed Dose (kGy)
1Potatoes (Solanum tuberosum L.)Gamma radiation from cobalt-60To inhibit sprouting during storage0.15
2Onions (Allium cepa)Gamma radiation from cobalt-60To inhibit sprouting during storage0.15
3Wheat, flour, whole wheat flour (Triticum spp.)Gamma radiation from cobalt-60To control insect infestation in stored food0.75
4Whole or ground spices and dehydrated seasoning preparations
  • (1) Gamma radiation from cobalt-60

  • (1) To reduce microbial load

  • (1) 10.0 (total overall average dose)

  • (2) Gamma radiation from cesium-137

  • (2) To reduce microbial load

  • (2) 10.0 (total overall average dose)

  • (3) Electrons from machine sources operated at or below 3 MeV

  • (3) To reduce microbial load

  • (3) 10.0 (total overall average dose)

5Fresh raw ground beef
  • (1) Gamma radiation from cobalt-60

  • (1) To reduce microbial load, including pathogens

  • (1) 1.0

  • (1) 4.5

  • (2) Gamma radiation from cesium-137

  • (2) To reduce microbial load, including pathogens

  • (2) 1.0

  • (2) 4.5

  • (3) Electrons from machine sources operated at or below 10 MeV

  • (3) To reduce microbial load, including pathogens

  • (3) 1.0

  • (3) 4.5

  • (4) X-rays from machine sources operated at or below one of the following:

  • (a) 7.5 MeV when the target material is tantalum or gold;

  • (a) To reduce microbial load, including pathogens;

  • (a) 1.0

  • (a) 4.5

  • (b) 5 MeV in any other case.

  • (b) To reduce microbial load, including pathogens.

  • (b) 1.0

  • (b) 4.5

6Frozen raw ground beef
  • (1) Gamma radiation from cobalt-60

  • (1) To reduce microbial load, including pathogens

  • (1) 1.5

  • (1) 7.0

  • (2) Gamma radiation from cesium-137

  • (2) To reduce microbial load, including pathogens

  • (2) 1.5

  • (2) 7.0

  • (3) Electrons from machine sources operated at or below 10 MeV

  • (3) To reduce microbial load, including pathogens

  • (3) 1.5

  • (3) 7.0

  • (4) X-rays from machine sources operated at or below one of the following:

  • (a) 7.5 MeV when the target material is tantalum or gold;

  • (a) To reduce microbial load, including pathogens;

  • (a) 1.5

  • (a) 7.0

  • (b) 5 MeV in any other case.

  • (b) To reduce microbial load, including pathogens.

  • (b) 1.5

  • (b) 7.0

  • SOR/89-175, s. 3
  • SOR/98-458, s. 7(F)
  • SOR/2017-16, ss. 6, 7
  • SOR/2018-69, s. 27
 
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