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

• 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.

B.25.021 It is prohibited, on the label of or in any advertisement for a human milk fortifier, to make any statement or claim relating to the content in the human milk fortifier 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.

Human Milk Substitutes and Food Containing Human Milk Substitutes

B.25.045 The common name of a human milk substitute or a new human milk substitute shall be infant formula. (préparation pour nourrissons)

• B.25.046 (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the new human milk substitute.

• (2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information:

  • (a) the name under which it will be sold or advertised for sale;

  • (b) the name and the address of the principal place of business of the manufacturer;

  • (c) the names and addresses of each establishment in which it is manufactured;

  • (d) a list of all of its ingredients, stated quantitatively;

  • (e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute;

  • (f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute;

  • (g) details of the manufacturing process and quality control procedures used throughout the process;

  • (h) the results of tests carried out to determine the expiration date of the new human milk substitute;

  • (i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

  • (j) a description of the type of packaging to be used;

  • (k) directions for use;

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

  • (m) the name and title of the person who signed the notification and the date of signature.

• (3) Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory.

B.25.047 Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes.

• B.25.048 (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the human milk substitute.

• (2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information:

  • (a) the name under which it will be sold or advertised for sale;

  • (b) the name and the address of the principal place of business of the manufacturer;

  • (c) a description of the major change;

  • (d) the evidence relied on to establish 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;

  • (e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute;

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

  • (g) the name and title of the person who signed the notification and the date of signature.

• (3) Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory.

B.25.050 [Repealed, SOR/90-174, s. 2]

• B.25.051 (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes.

• (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 the nutritional requirements set out in this Division for human milk substitutes.