Modernizing the food regulatory framework: updates to food compositional standards and food additives rules

On November 4, 2023, Health Canada and the Canadian Food Inspection Agency (CFIA) proposed amendments to the Food and Drug Regulations (FDR)¹ to modernize the food regulatory framework. In particular, the key proposed changes relate to the food compositional standards and food additive rules. The proposed amendments are intended to establish a more responsive and adaptable regulatory framework, rather than to introduce new regulatory requirements for food products. The proposed amendments are not yet law, and stakeholders can provide feedback on the proposed amendments until February 2, 2024.

What you need to know

• Creation of the Food Compositional Standards Document. The proposed amendments would repeal food compositional standards (which set out requirements such as permitted ingredients, quality parameters, manufacturing methods and prescribed common names) that are currently referenced in the FDR, and incorporate them by reference into the FDR through a new document entitled the Food Compositional Standards Document, which would allow administrative updates to the standards without legislative amendments.
• Consolidation of Food Additive Rules. The proposed amendments would consolidate duplicative food additive rules in the FDR and on the current 15 Lists of Permitted Food Additives made under marketing authorizations, into revised Lists of Permitted Food Additives that would be incorporated by reference directly into the FDR. The consolidation does not impact the permissibility of using food additives in currently marketed products.
• Modernizing the Regulatory Framework. The proposed amendments are not intended to impose new regulatory requirements or modify the substantive content, enforcement and application of the FDR. Rather, the intent of the changes is to modernize the regulatory framework through an update in format and administration that will enable timely updates to the FDR, as well as remove any unnecessary duplication of food additive rules to avoid confusion on proper interpretation, application and enforcement of such rules.

Changes introduced by the proposed amendments to the FDR

New Food Composition Standards Document

Food compositional standards establish requirements that must be met for foods imported for sale into Canada, or sold interprovincially, which may include requirements relating to product ingredients, manufacturing methods and prescribed common names. Health Canada and CFIA are proposing to modernize the FDR framework for food compositional standards by repealing food compositional standards set out in the FDR and introducing a new Food Compositional Standards Document setting out the food compositional standards of 19 specific food commodities², which would be incorporated by reference into the FDR. Changes to the Food Compositional Standards Document could be made via an administrative process, without regulatory amendment to the FDR, allowing for updates to the standards to be implemented more quickly.

The Food Compositional Standards Document will reflect the current FDR requirements related to the composition, strength, potency, purity, quality and other properties of standardized foods. Amendments to the FDR would clarify that substances such as food additives, vitamins and mineral nutrients could be required or permitted in a food for which a standard is set out in the Food Compositional Standards Document, if prescribed in the FDR. For example, the FDR will refer to the Lists of Permitted Additives and indicate that it is permissible for a standardized food to contain an additive in the amount and under the conditions as set forth within the Lists of Permitted Additives.

Some minor amendments to the Food Compositional Standards have been proposed for the purposes of clarifying the existing regulatory requirements, bringing consistency to the terminology used in various standards and aligning the English and French regulatory text; however, the proposed amendments are not intended to impose new regulatory requirements for currently marketed food products.

Consolidated Lists of Permitted Food Additives

The framework for permitted food additives has been revised over the years. Prior to October 2012, permitted food additives were specified in tables in Division 16, Part B of the FDR, requiring regulatory amendment for any modifications to these tables.

In 2012, tables of permitted food additives within Division 16, Part B of the FDR were replicated and published in 15 separate Lists of Permitted Additives which are incorporated by reference into 15 food additive marketing authorizations under the Food and Drugs Act. Since its publication in 2012, Health Canada has approved changes to the Lists of Permitted Additives, by authorizing new food additives or expanding the use of permitted food additives, without regulatory amendment to the FDR. While the Lists of Permitted Additives have been amended over time, the tables of permitted food additives within Division 16, Part B of the FDR remain unchanged since 2012, creating misalignment and rendering the tables obsolete.

The proposed amendments would consolidate all food additive regulations into a revised Lists of Permitted Food Additives that would be incorporated by reference directly into the FDR. The consolidation would eliminate duplicated references to food additives in Part B of the FDR, including those listed in the tables in Division 16, Part B of the FDR as well as those referenced in the food compositional standards, and would resolve the discrepancies between the tables in Division 16, Part B of the FDR and the Lists of Permitted Food Additives. Further, the revised Lists of Permitted Food Additives would be modified to have a consistent structure, and titles of certain Lists of Permitted Food Additives will be revised to reflect modern terminology.

Interim measure for the Food Compositional Standards Document and Lists of Permitted Food Additives

Health Canada is considering further updates to the Lists of Permitted Food Additives based on stakeholder input received during the consultation process and has administered some certain exceptions under the updated framework as an interim measure. Substances listed in the Lists of Permitted Food Additives would generally be excluded from the standards set out in the Food Compositional Standards Document, subject to certain exceptions. For example, the standards for flavouring preparations set out in Division 10, Part B of the FDR specify that flavouring preparations may contain certain additives like food colour, Class II preservative, Class IV preservative and emulsifying agents. These provisions for food additives will remain in the standards set out in the Food Compositional Standards Document for flavouring preparations as an interim measure until individual food additives in flavouring preparations are permitted by Health Canada through modification of the Lists of Permitted Food Additives. In doing so, Health Canada will review stakeholder submissions on the use of food additives in flavouring preparations and seek comments on proposed new list entries before finalization.

What’s next

Comments on the proposed amendments to the FDR may be made until February 2, 2024. Once the consultation closes, Health Canada will consider the feedback and publish the final regulations in the Canada Gazette, Part II. The proposed regulations will come into force on the date of publication in the Canada Gazette, Part II.