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

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.