Enzymes and Preservatives Allowed in Infant Foods

Summary#

The federal government issued the Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act (Food Enzymes and Preservatives) to let Health Canada more easily approve the safe use of certain food enzymes and preservatives in infant foods, including human milk fortifiers (HMFs). The change took effect on the day it was published in the Canada Gazette, Part II (August 4, 2021).

What it does#

• Adds a definition of infant food (the same meaning as in section B.25.001 of the Food and Drug Regulations) to two marketing authorizations.
• Amends the Marketing Authorization for Food Additives That May Be Used as Food Enzymes to:
  • Allow infant foods to be exempted from certain prohibitions so enzymes listed by Health Canada can be used in those foods, within specified maximum use levels and conditions.
  • Remove an older definition of “infant formula” and replace narrow infant-formula rules with broader infant-food provisions.
  • Note: the public Lists of permitted enzymes are not changed by this amendment. Manufacturers must still submit safety information and have uses added to the Lists before the enzymes can be used.
• Amends the Marketing Authorization for Food Additives That May Be Used as Preservatives to:
  • Allow infant foods to be exempted from the same kinds of prohibitions so listed preservatives can be used in those foods, within specified maximum levels and conditions.
  • Note: the public Lists of permitted preservatives are not changed by this amendment. Manufacturers must submit safety information and have uses added to the Lists before the preservatives can be used.
• Confirms these MA changes come into force on publication (August 4, 2021) and do not replace Health Canada’s existing safety review process.

Who's affected#

• Manufacturers of human milk fortifiers (HMFs) and other infant food makers who may want to use certain food enzymes or preservatives.
• Health Canada, which will evaluate and add any new, safe uses to its Lists after pre-market safety reviews.
• The Canadian Food Inspection Agency, which enforces food rules (the amendments do not create extra enforcement work according to the government).
• Parents and caregivers of infants who may see new infant food products in the future; the amendments are aimed at enabling safe, innovative products for vulnerable infants (for example, premature or medically small infants).

Why it matters#

• It lets Health Canada use its routine, faster administrative process to permit new, safe uses of enzymes and preservatives in infant foods once those uses pass safety review. That can speed up bringing new HMFs or other infant foods to market.
• The change does not lower safety standards. Any new use still needs a pre-market safety evaluation before it can appear on the public Lists and be sold.
• The amendments themselves do not immediately allow any new additives in infant foods — they simply remove legal hurdles so Health Canada can approve such uses through its normal list-update process.