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

Notice of Proposal – Lists of permitted food additives
Reference Number: P-FAA-24-01
May 21, 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 and published on the Canada.ca website.

As set out in Item B.3 of the List of permitted food additives with other accepted uses, 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", 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.

A summary of the Department's safety assessment can be found here:

Summary of Health Canada's updated safety assessment of brominated vegetable oil as food additive

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. Consequently, Health Canada proposes to remove BVO from the List of permitted food additives with other accepted uses.

Proposed Modification to the List of permitted food additives with other accepted uses
Item No. Additive Permitted in or Upon Purpose of Use Maximum Level of Use and Other Conditions
B.3 Brominated vegetable oil Removed, YYYY-MM-DD, (See M-FAA-24-XX)

Implementation and Enforcement

The proposed modification will come into effect the day on which it is published in the List of permitted food additives with other accepted uses.

Since the proposed modification stems from an emerging scientific development regarding the safety of BVO and its delisting from the List of permitted food additives with other accepted uses, the proposal is exempt from the application of the joint Health Canada-CFIA Food Labelling Coordination policy.

However, Health Canada considers it appropriate to provide a one-year transition period to allow impacted beverages 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 will continue to apply until the end of the transition period.

The modification to the list and the transition period will be announced by a Notice of Modification that will be published on the Government of Canada's website.

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

Contact Information

If you wish to submit comments related to this proposal, please contact:

Food Incorporation by Reference Unit
Bureau of Policy, Intergovernmental and International Affairs,
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2204C
Ottawa, Ontario K1A 0K9
E-mail: food.ibr-ipr.aliments@hc-sc.gc.ca

If communicating by e-mail, please use the words "brominated vegetable oil P-FAA-24-01" in the subject line of your e-mail. Health Canada is able to consider information received by July 30, 2024, 70 days from the date of this posting.

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