Modification to the List of permitted food additives with other accepted uses to remove brominated vegetable oil

• Notice of modification – Lists of Permitted Food Additives
• Reference number: M-FAA-24-08
• August 30, 2024

Background

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations. Permitted food additives and their conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs.

Brominated vegetable oil (BVO) is currently permitted for use as a density adjusting agent in "(Naming the flavour) Flavour for use in beverages containing citrus or spruce oils", as set out in Item B.3 of the List of Permitted Food Additives with Other Accepted Uses, at a maximum level of 15 ppm in beverages containing citrus or spruce oils, as consumed.

Issue

Health Canada recently completed an updated safety assessment of BVO based on new and previously reviewed information. Although Health Canada did not identify an immediate health concern with the current permitted use of BVO as a food additive, the outcome of the assessment does not support BVO continuing to be permitted for use as a food additive. As a result, Health Canada published the Notice of proposal titled Proposal to remove brominated vegetable oil from the List of permitted food additives with other accepted uses (Reference number: P-FAA-24-01). The Notice of Proposal was published on May 21, 2024, and was open to the public for comment for 70 days.

Rationale for action

Health Canada reviews the safety of permitted food additives when the Department receives a submission requesting an extension of use of an already-permitted food additive or when there is an emerging scientific development about the safety of an already-permitted food additive. The outcome of the updated safety assessment of BVO does not support BVO continuing to be permitted for use as a food additive, and Health Canada did not receive any new safety information during the comment period for the Proposal to remove brominated vegetable oil from the List of permitted food additives with other accepted uses. Therefore, Health Canada has modified the List of Permitted Food Additives with Other Accepted Uses by removing brominated vegetable oil as proposed.

Consultation

Summary of stakeholder comments and Health Canada's responses

Health Canada received 5 responses^{Footnote 1} to the Notice of Proposal published on May 21, 2024. Industry feedback supported Health Canada's proposal and confirmed that a one-year transition period is appropriate to allow impacted product to be reformulated and relabeled.

One industry respondent encouraged Health Canada to continue reviewing the safe use of permitted food additives but also expressed concern that not all food additives sold in Canada meet required food-grade specifications.

Health Canada and the Canadian Food Inspection Agency (CFIA) share federal regulation of food safety in Canada. Health Canada is responsible for setting specifications requirements for food additives and the CFIA is responsible for activities to monitor and enforce compliance with the requirements. Concerns that a food or food ingredient does not comply with Canadian requirements can be reported to the CFIA using the Report a food-related concern form.

One consumer respondent expressed concern about animal testing that is used to study the safety of food additives, such as BVO. Health Canada recognizes the global effort to reduce reliance on animal testing of substances that humans can be exposed to. However, non-animal methods have not yet been validated and widely accepted as being as predictive as animal methods for food safety assessments. As a result, Health Canada cannot rely solely on the results from these methods when evaluating the safety of food additives.

One industry respondent asked about when BVO would be removed from the food additive list and the transition period will begin. These questions are answered in the Implementation and enforcement section, below.

Modification to the List of Permitted Food Additives with Other Accepted Uses

Implementation and enforcement

This above modification came into force August 30, 2024, the day on which it is published in the List of Permitted Food Additives with Other Accepted Uses.

Health Canada is providing a one-year transition period, starting August 30, 2024, and ending August 30, 2025, to allow impacted products to be reformulated and relabeled, since the updated safety assessment did not find an immediate health concern with the current permitted use of BVO as a food additive. All requirements related to the current permitted use of BVO as a food additive continue to apply until the end of the transition period.

The CFIA is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

Health Canada's Food and Nutrition Directorate is committed to reviewing new scientific information on the safety in use of any permitted food additive. Anyone wishing to submit an inquiry or new scientific information on the use of a permitted food additive may do so by regular mail or email. If you wish to contact the Directorate by email about brominated vegetable oil, please use the words "Brominated vegetable oil M-FAA-24-08" in the subject line of your e-mail.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9

Email: bcs-bipc@hc-sc.gc.ca