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

Regulations are current to 2021-10-07 and last amended on 2021-09-16. Previous Versions

PART BFoods (continued)

DIVISION 25 (continued)

Human Milk Fortifiers

 Subject to section B.25.013, it is prohibited to sell or advertise for sale a human milk fortifier unless the Minister has notified the manufacturer under paragraph B.25.012(1)(a) or (3)(a) that those activities are authorized.

 An application to sell or advertise for sale a human milk fortifier shall be submitted by the manufacturer and signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information:

  • (a) the brand name and product name under which the human milk fortifier will be sold or advertised for sale;

  • (b) the manufacturer’s name and address;

  • (c) the name and address of each establishment in which the human milk fortifier is manufactured;

  • (d) a list of all of the human milk fortifier’s ingredients, stated quantitatively;

  • (e) the scientific rationale for the formulation of the human milk fortifier;

  • (f) the specifications for nutrient, microbiological and physical quality for the human milk fortifier and its ingredients;

  • (g) details of the quality control procedures respecting the testing of the human milk fortifier and its ingredients;

  • (h) details of the human milk fortifier’s manufacturing process and the quality control procedures used throughout the process;

  • (i) the results of the tests carried out to determine the expiration date of the human milk fortifier;

  • (j) the evidence that establishes that the human milk fortifier is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

  • (k) a description of the type of packaging to be used for the human milk fortifier;

  • (l) directions for use for the human milk fortifier;

  • (m) the written text of all labels, including package inserts, to be used in connection with the human milk fortifier; and

  • (n) the name and title of the individual who signed the application and the date of signature.

  •  (1) After having conducted an assessment of the information submitted under section B.25.011 and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application

    • (a) is authorized if

      • (i) the application meets the requirements set out in section B.25.011, and

      • (ii) the information is sufficient to establish the safety of the human milk fortifier; or

    • (b) is not authorized, in any other case.

  • (2) If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

  • (3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier

    • (a) is authorized, if the conditions set out in paragraph (1)(a) are satisfied; or

    • (b) is not authorized, in any other case.

  • (4) Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive.

 The prohibition set out in section B.25.010 does not apply in respect of a human milk fortifier that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website if, on or before April 30, 2022,

  • (a) the manufacturer of the human milk fortifier submits to the Minister

    • (i) an attestation signed and dated by the manufacturer, or by an individual authorized to sign on their behalf, confirming that the human milk fortifier has not undergone a major change since the date set out in the List in connection with the human milk fortifier, and

    • (ii) the written text of all labels, including package inserts, that will be required to be used in connection with the human milk fortifier after the second anniversary of the day on which section B.25.020 comes into force; and

  • (b) the Minister notifies the manufacturer under subsection B.25.014(1) or paragraph B.25.014(3)(a) that they are authorized to continue to sell or advertise for sale the human milk fortifier.

  •  (1) The Minister shall notify the manufacturer in writing that they are authorized to continue to sell or advertise for sale the human milk fortifier if

    • (a) the manufacturer has submitted the information referred to in paragraph B.25.013(a) in sufficient time for the Minister to assess the information before April 30, 2022; and

    • (b) the written text of the labels submitted under subparagraph B.25.013(a)(ii) satisfies the relevant requirements of these Regulations.

  • (2) If the information that is submitted is insufficient to satisfy the conditions set out in subsection (1), the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

  • (3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that

    • (a) they are authorized to continue to sell or advertise for sale the human milk fortifier, if the conditions set out in subsection (1) are satisfied; or

    • (b) they are not authorized to continue to sell or advertise for sale the human milk fortifier, in any other case.

  •  (1) It is prohibited to sell or advertise for sale a human milk fortifier that has undergone a major change unless

    • (a) the manufacturer of the human milk fortifier submits to the Minister an application in accordance with subsection (2) that reflects the major change; and

    • (b) the Minister notifies the manufacturer under paragraph B.25.016(1)(a) or (3)(a) that the sale or advertisement for sale of the human milk fortifier is authorized.

  • (2) The application shall be signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information:

    • (a) the brand name and product name under which the human milk fortifier will be sold or advertised for sale;

    • (b) the manufacturer’s name and address;

    • (c) a description of, and the rationale for, the major change;

    • (d) the evidence that establishes that the human milk fortifier is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

    • (e) the evidence that establishes that the major change has had no adverse effect on the human milk fortifier;

    • (f) the written text of all labels, including package inserts, to be used in connection with the human milk fortifier; and

    • (g) the name and title of the individual who signed the application and the date of signature.

  •  (1) After having conducted an assessment of the information submitted under subsection B.25.015(2) and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application

    • (a) is authorized if

      • (i) the application meets the requirements set out in subsection B.25.015(2), and

      • (ii) the information is sufficient to establish the safety of the human milk fortifier; or

    • (b) is not authorized, in any other case.

  • (2) If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

  • (3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier

    • (a) is authorized, if the conditions set out in paragraph (1)(a) are satisfied; or

    • (b) is not authorized, in any other case.

  • (4) Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive.

 
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