Supplemented foods: Regulations and compliance

Consult the guidance document developed to help industry interpret the supplemented foods regulations.

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Supplemented foods regulations

The supplemented foods regulations:

Health Canada has published amendments to the:

As part of these amendments, 4 documents are incorporated by reference into the FDR. These documents outline requirements related to foods that can be supplemented, supplemental ingredients and their conditions of use, and labelling. They include:

Transition to the supplemented foods regulatory framework

Before the supplemented foods regulations were published in Canada Gazette, Part II, Health Canada issued temporary marketing authorization letters (TMAL) for supplemented foods before they could be sold. The supplemented foods regulations allow new products that comply with all applicable requirements to be sold without seeking an authorization.

The regulations are in force, but supplemented foods that are eligible for the transition period have until December 31, 2025 to comply with the regulations, including having updated labels.

Products eligible for the transition include:

Any new supplemented food entering the market, other than those mentioned as eligible for the transition period, must immediately comply with the regulations.

There are 2 documents that relate specifically to supplemented foods that were eligible for the transition period:

Supplemented food categories

Specific food categories are permitted to be supplemented. Some examples of permitted categories include:

Foods that aren’t eligible as supplemented foods include:

They aren’t eligible as supplemented foods because:

The list of permitted supplemented food categories is incorporated by reference into the FDR. The guidance document provides additional information on the types of permitted food categories and the process to add a new food category to the list or modify an existing one.

Supplemental ingredients

Some ingredients are permitted to be added as supplemental ingredients to supplemented foods. Some examples of permitted supplemental ingredients include:

Some nutrients aren’t currently allowed to be supplemented into foods. For example, iron and folic acid aren’t allowed as supplemental ingredients because cautionary labelling isn’t likely to be enough to reduce the risk associated with overconsumption of these nutrients.

The list of permitted supplemental ingredients is incorporated by reference into the FDR. The guidance document provides additional information on the types of permitted supplemental ingredients and the process to add a new ingredient to the list or modify an existing one.

Compliance

Health Canada developed the supplemented foods regulations. The Canadian Food Inspection Agency (CFIA) enforces them.

Health Canada and the CFIA share responsibility for answering questions about the regulations. You can:

Templates for designers to meet labelling requirements

Canada has federal regulations and requirements for food labels. Companies producing, importing and selling food products must make sure their labels meet these requirements. The Food and Drug Regulations (FDR) require a supplemented food facts table on all supplemented foods. A supplemented food caution identifier and list of cautionary statements may also need to appear on some supplemented foods. To know whether your supplemented food requires a supplemented food caution identifier and list of cautionary statements, please refer to the guidance document for supplemented foods regulations.

The compendium of templates will help label designers and the food and packaging industries meet the format specifications.

The compendium includes:

File formats available

The compendium of templates was created using Adobe InDesign CC 2020. It’s available in 2 formats:

To obtain these files, please email the Submission Management and Information Unit (SMIU) at smiu-ugdi@hc-sc.gc.ca with the subject line: Requesting labelling compendium for supplemented foods.

Technical documents

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