On October 16, 2020, Health Canada issued a G/TBT/N/CAN/621 notification, which will amend the Food and Drug Regulations (FDR) to establish a regulatory framework for the sale of human milk fortifiers (HM) in Canada. The main contents include:

1. HMF is a food designed to be added to human milk to increase its nutritional value to meet the special needs of infants with physical conditions due to diseases, illnesses or abnormal physical conditions. It is a prepackaged instant food. At present, there are no regulations specifically for these products in the FDR, so the FDR needs to be amended to allow HMF to add vitamins, mineral nutrients and amino acids, and include relevant provisions to protect the health and safety of vulnerable people using HMF;

2. Formulate pre-market submission requirements for HMFs that have newly entered the market and HMFs that undergo major changes; formulate a list of types of vitamins, minerals, nutrients and amino acids allowed to be added to HMF; formulate labeling requirements; list sales conditions;

3. To ensure that certain vulnerable groups of infants in Canada continue to obtain safe and adequately maintained HMFs so that they can be used outside hospitals under medical supervision, clear regulatory requirements have been formulated and provided for manufacturers and importers who sell these products in Canada. Provide greater transparency.

These regulations have been published in the second part of the Canadian Gazette and become effective on the date of publication; HMF currently sold in Canada will have a one-year transition period after the new regulations take effect to comply with the new regulations.

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