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

B.24.304 The label of a food represented for use in a very low energy diet shall carry the following information:

• (a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel;

• (f) directions for use of the food, including

  • (i) a statement of the rationale for the use of the food,

  • (ii) criteria to be used for the selection of the persons to whom the food may be prescribed,

  • (iii) instructions for consultation with and evaluation of the patient and patient follow-up, and

  • (iv) a statement concerning adequate precautions and contra-indications;

• (g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and

• (h) the expiration date of the food.

• B.24.305 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell the food or advertise the food for sale.

• (2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information:

  • (a) the name under which the food is to be sold or advertised for sale;

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

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

  • (d) a list of the ingredients of the food, stated quantitatively;

  • (e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food;

  • (f) details of quality control procedures respecting the testing of the ingredients and of the food;

  • (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 food;

  • (i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is 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 food; 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 food represented for use in a very low energy diet, if the Minister, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).

• B.24.306 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, 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 food that has undergone the major change.

• (2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information:

  • (a) the name under which the food is to be sold or advertised for sale;

  • (b) the name and 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 food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;

  • (e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;

  • (f) the written text of all labels, including package inserts, to be used in connection with the food; 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 food represented for use in a very low energy diet that has undergone a major change, if the Minister, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).

DIVISION 25

Interpretation

B.25.001 In this Division,

expiration date

expiration date means, in respect of a human milk fortifier or human milk substitute, the date

• (a) after which the manufacturer does not recommend that it be consumed, and

• (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)

human milk fortifier

human milk fortifier means a food that

• (a) includes at least one added vitamin, mineral nutrient or amino acid, and

• (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; (fortifiant pour lait humain)

human milk substitute

human milk substitute means any food that is labelled or advertised

• (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or

• (b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)

infant

infant[Repealed, SOR/2024-244, s. 137]

infant food

infant food[Repealed, SOR/2024-244, s. 137]

junior (naming a food)

junior (naming a food) means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; ((nom d’un aliment) pour enfants en bas âge)

major change

major change means, in respect of a human milk fortifier or human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk fortifier or human milk substitute where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk fortifier or human milk substitute; (changement majeur)

new human milk substitute

new human milk substitute means a human milk substitute that is

• (a) manufactured for the first time,

• (b) sold in Canada for the first time, or

• (c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)

strained (naming a food)

strained (naming a food) means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. ((nom d’un aliment) en purée ou tamisé)

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.