Supplemented foods: Regulations and compliance

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• Regulations
• Compliance

Regulations

To help protect the health and safety of consumers while providing a clear and predictable regulatory environment for supplemented foods, Health Canada has published amendments to the:

• Food and Drug Regulations (FDR) and
• Cannabis Regulations

For more information, see the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) published in Canada Gazette, Part II on July 20, 2022.

As part of these amendments, 4 documents are incorporated by reference into the FDR. These documents outline specific compositional and labelling requirements for supplemented foods. They include:

• Directory of supplemented food caution identifier specifications
  • formatting specifications for the supplemented food caution identifier, including acceptable versions for use on prepackaged supplemented foods
• Directory of supplemented food facts table formats (SFFt)
  • listing of SFFt formats, including acceptable versions for use on prepackaged supplemented foods
• List of permitted supplemented food categories
  • list of all the food categories that are permitted to be supplemented
• List of permitted supplemental ingredients
  • list of all the supplemental ingredients that are permitted in supplemented foods, along with conditions of their use

The following 2 documents relate specifically to products eligible for the transition period:

• Lists of temporary marketing authorization letters
  • lists of foods that were issued a Temporary Marketing Authorization Letter as supplemented foods, and are eligible for a transition period to come into compliance with the Supplemented foods regulations
• Threshold levels for cautionary statements and other conditions of uses
  • technical requirements that a food needs to meet to be eligible for a notification authorizing the sale of the food after the coming into force of the Supplemented foods regulations, and therefore be eligible for the transition period

For more information, consult the transition to the supplemented foods regulatory framework.

Compliance

Health Canada is responsible for developing the Supplemented foods regulations. The Canadian Food Inspection Agency (CFIA) is responsible for enforcing them. Regulated parties have until December 31, 2025 to meet the new requirements published on July 20, 2022.

Health Canada and the CFIA have developed an implementation plan for the new regulations, including the transition period.

Health Canada and the CFIA share responsibility for answering questions about the new regulations:

• submit questions on the new requirements and their intent to Health Canada at supplementedfoods-alimentssupplementes@hc-sc.gc.ca.
• for questions on compliance and enforcement activities please refer to the implementation plan.

Guidance document: Supplemented foods regulations

Health Canada has developed a comprehensive guidance document to help food manufacturers and distributors interpret the Supplemented foods regulations. It provides Health Canada's interpretation of core elements of the requirements for supplemented foods.

For more information, please refer to the Guidance document for Supplemented foods regulations.

Templates for label designers

Under the FDR, all supplemented foods require a supplemented food facts table (SFFt).

Some supplemented foods may also require a list of cautionary statements and a supplemented food caution identifier.

This information must be in a specific format on the supplemented food label.

The Compendium of templates for supplemented food facts tables, supplemented food caution identifiers and lists of cautionary statements will help label designers and the food and packaging industries meet the format specifications.

The templates in the compendium are actual-size graphic illustrations for the various SFFt formats and supplemented food caution identifier formats permitted by the FDR.

For lists of cautionary statements, we've provided 2 examples in the compendium to show variations that meet the graphic specifications detailed in the FDR.

Related information

• About supplemented foods and their labels
• Guidance document for Supplemented foods regulations
• Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)