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

Infant Foods

B.25.002 No person shall sell or advertise for sale an infant food that is set out in Column I of an item of Table I to this Division and contains more than the amount of sodium set out in Column II of that item.

• B.25.003 (1) Subject to subsection (2), no person shall sell infant food that contains

  • (a) strained fruit,

  • (b) fruit juice,

  • (c) fruit drink, or

  • (d) cereal,

  if sodium chloride has been added to that food.

• (2) Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d).

Human Milk Fortifiers

B.25.010 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.

B.25.011 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.

• B.25.012 (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.

B.25.013 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.

• B.25.014 (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.

• B.25.015 (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.

• B.25.016 (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.

B.25.017 A manufacturer named in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 referred to in section B.25.013 is not entitled to submit an application referred to in paragraph B.25.015(1)(a) in respect of a human milk fortifier set out in the List unless the Minister has

• (a) notified them under paragraph B.25.012(1)(a) or (3)(a) that the sale or advertisement for sale of the human milk fortifier is authorized; or

• (b) notified them 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.

• B.25.018 (1) If the manufacturer of a human milk fortifier is requested in writing by the Minister to submit evidence with respect to the human milk fortifier within a time limit specified by the Minister, the manufacturer shall make no further sales of the human milk fortifier — and shall not advertise it for sale — after the expiry of the time limit unless they have submitted the requested evidence.

• (2) The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

• (3) If the Minister determines that the evidence submitted by the manufacturer is insufficient, the Minister shall notify the manufacturer accordingly in writing.

• (4) If the manufacturer is notified that the evidence with respect to the human milk fortifier is insufficient, the manufacturer shall make no further sales of the human milk fortifier – and shall not advertise it for sale — unless they submit additional evidence and are notified in writing by the Minister that the additional evidence is sufficient.

• (5) In this section, evidence with respect to the human milk fortifier means

  • (a) 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; and

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

• B.25.019 (1) Even if the Minister has notified the manufacturer of a human milk fortifier that the sale or advertisement for sale of the human milk fortifier is authorized, it may only be sold in the following situations:

  • (a) it is sold by the manufacturer to

    • (i) a hospital, or

    • (ii) an individual, if

      • (A) the individual has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province, and

      • (B) the manufacturer has received a written request from a hospital that specifies the product name and quantity of the human milk fortifier that needs to be provided to the individual; or

  • (b) it is sold by a hospital to an individual who has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province.

• (2) The following definitions apply in this section.

  dietitian

  dietitian means a person who is registered and entitled under the laws of a province to practise as a dietitian and who is practising as a dietitian under those laws in that province. (diététiste)

  hospital

  hospital has the same meaning as in section B.24.001. (hôpital)

  nurse practitioner

  nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien)

  physician

  physician has the same meaning as in section B.24.001. (médecin)

• B.25.020 (1) The following information is required to be displayed on the outer label of a human milk fortifier:

  • (a) a statement of the quantity, expressed in grams, of protein, fat, available carbohydrate and, where present, fibre in a quantity of human milk fortifier specified in the directions for use;

  • (b) a statement of the energy value, expressed in Calories, in a quantity of human milk fortifier specified in the directions for use;

  • (c) a statement of the quantity, expressed in milligrams, micrograms or International Units, of all vitamins, mineral nutrients and amino acids set out in item 6, Column II, of the table to section D.03.002 that are present in a quantity of human milk fortifier specified in the directions for use;

  • (d) a statement of the quantity, expressed in grams, milligrams, micrograms or International Units, of any other nutritive substance that is present in a quantity of human milk fortifier specified in the directions for use;

  • (e) directions for the storage of the human milk fortifier before and after the package has been opened;

  • (f) the directions for use for the human milk fortifier, including directions for the preparation, use and storage of the mixture of human milk fortifier and human milk;

  • (g) a statement indicating that the human milk fortifier is to be used only under medical supervision;

  • (h) the expiration date of the human milk fortifier; and

  • (i) the lot number of the human milk fortifier.

• (2) If the human milk fortifier does not have an outer label,

  • (a) the information referred to in subsection (1) is required to be displayed on the inner label, except as otherwise provided in paragraph (b); and

  • (b) the information referred to in paragraphs (1)(e) and (f) may, despite section A.01.016, be displayed on a leaflet that is affixed or attached to the container that is in direct contact with the human milk fortifier.

• (3) If the human milk fortifier has an outer label, the information referred to in paragraphs (1)(h) and (i) is also required to be displayed on the inner label.