Exemption Order in Respect of Foods for a Special Dietary Purpose (SOR/2025-248)

Conditions

Marginal note:Document

15 If any information shown on the label of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is information that would otherwise be required under the Regulations to be shown in both official languages but that information is shown in only one official language, the importer must prepare a document that sets out that same information in the other official language.

Marginal note:Notification of risk

16 The importer of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must notify the Minister immediately, in writing, of information in respect of any risk of injury to human health that they receive or become aware of in relation to the food.

Marginal note:Notification — foreign regulatory authority

17 If a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is no longer authorized by a foreign regulatory authority in a jurisdiction referred to in paragraph (a) of that section for sale within that jurisdiction, the importer must notify the Minister, in writing, immediately after becoming aware of that fact.

Marginal note:Document — copy to purchaser or consumer

18 Any person that sells a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must make a paper copy of the document referred to in section 15 available to the purchaser or consumer at the time of sale.

Marginal note:Sale of human milk fortifiers

19 A human milk fortifier to which the exemption under section 13 applies 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.

Coming into Force

Marginal note:Publication

20 This Order comes into force on the day on which it is published in the Canada Gazette, Part II.