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Implementation plan for amendments to the Food and Drug Regulations (Supplemented Foods)


On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations mostly in a new division for Supplemented Foods (Division 29) in the Canada Gazette Part II (CGII). This division represents a risk-based approach for regulating supplemented foods, which was previously under the Temporary Marketing Authorization (TMA) framework, to allow products with levels of certain permitted supplemental ingredients established as safe to access the Canadian food market.

Highlights of Division 29:

The following is a summary of the Canadian Food Inspection Agency (CFIA) and Health Canada's multi-year implementation plan for these supplemented foods amendments.

Transition period

Prior to the publication of the new supplemented food regulations in CGII, supplemented foods could access the market if the manufacturers or distributors received a temporary market authorization letter issued by Health Canada. The regulatory amendments provide a 3.5 year transition period, ending on December 31, 2025. Products for which manufacturers or distributors receive Health Canada authorization after CGII publication will be provided the remaining transition period.

These regulations fall within the scope of the joint Health Canada and CFIA Food labelling coordination policy. This policy establishes compliance date options for food labelling requirements at a 2 year interval, beginning on January 1, 2026.

Transition timeline

Phase I (July 21, 2022 to December 31, 2025)

The coming into force of these amendments marks the beginning of Phase I. CFIA's efforts will be directed towards education and promoting compliance with the new requirements.

Phase II (from January 1, 2026)

Phase II will begin after the end of the transition period, from January 1, 2026.

Throughout both phases of the implementation plan, the CFIA may take action in cases of inaccurate, false or misleading labelling information and will address food safety issues related to the new Division 29 of the regulations on supplemented foods. Health Canada will conduct health risk assessments in support of CFIA's compliance activities and provide guidance on the interpretation of the regulatory amendments.

While TMA holders would no longer be required to submit documents to Health Canada, Safe Food for Canadians Regulations license holders will continue to be responsible for notifying the CFIA if an investigation establishes that their food presents a risk of injury to human health.

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