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

May 21, 2024

Introduction

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.

Brominated vegetable oil (BVO) is a permitted food additive that may be used as a density adjusting agent in flavouring for use in beverages containing citrus or spruce oils. Health Canada completed an updated safety assessment of BVO taking into consideration new safety information that has recently become available. Based on the outcome of the updated assessment, Health Canada proposes to remove BVO from the List of permitted food additives with other accepted uses as described in the Notice of Proposal titled "Proposal to remove brominated vegetable oil from the List of permitted food additives with other accepted uses".

This supporting science document summarizes the safety considerations that informed Health Canada's proposal.

Safety Assessment

Previous laboratory studies had reported adverse effects on certain organs, for example the liver, heart or thyroid, of animals orally given BVO, but these effects were seen at much higher doses than humans would get from beverages that contain BVO as a food additive.

A recent, well-conducted study (Woodling et al., 2022) published by the United States Food and Drug Administration (US FDA) in collaboration with the National Institutes of Health (NIH) reported observations of adverse health effects in rats fed BVO in their diet at lower doses compared to doses given in previous animal studies.

Health Canada reviewed these recent study results as part of an updated safety assessment of BVO as a food additive. The updated assessment did not identify an immediate health concern with the currently-permitted use of BVO as a food additive. However, Health Canada could not establish an acceptable daily intake (ADI) for BVO as a food additive based on the available safety data, and given that adverse effects previously observed at higher doses have now been seen at lower doses, Health Canada concluded that BVO should not continue to be permitted for use as a food additive.

Other relevant information

Brominated vegetable oil is not permitted for use in Europe, the United Kingdom, and Australia and New Zealand, and there is no provision for its use as a food additive in the Codex Alimentarius General Standard for Food Additives (GSFA).

Brominated vegetable oil may be used in the United States (US) on an interim basis as a stabilizer for flavouring oils used in fruit-flavored beverages (except beverages having a standard that precludes such use) in an amount not to exceed 15 ppm in the finished beverage (21CFR180.30). However, the US Food and Drug Administration (US FDA) has proposed to amend their regulations to revoke the authorization for the use of BVO in food "because there is no longer a reasonable certainty of no harm from the continued use of BVO in food" (US FDA, 2023a).

Conclusion & Decision

Health Canada completed an updated safety assessment of BVO and concluded that BVO should not continue 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 as described in the Notice of Proposal titled "Proposal to remove brominated vegetable oil from the List of permitted food additives with other accepted uses".

References

[Canada, 2023]. List of Permitted Food Additives with Other Accepted Uses (Lists of Permitted Food Additives), Item No. B.3. (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/8-other-accepted-uses.html)

K.A. Woodling, P. Chitranshi, C.C. Jacob, L. Loukotková, L.S. Von Tungeln, G.R. Olso, R.E. Patton, S. Francke, S.R. Mog, R.P. Felton, F.A. Beland, Y. Zang, G. Gamboa da Costa, 2022. Toxicological evaluation of brominated vegetable oil in Sprague Dawley rats. Food and Chemical Toxicology, 165, 113137. (https://www.sciencedirect.com/science/article/pii/S0278691522003350)

[21CFR180.30] U.S. Code of Federal Regulations, Title 21, 180.30 Brominated vegetable oil (21CFR180.30). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-180/subpart-B/section-180.30

[US FDA, 2023a]. Federal Register, Revocation of Authorization for Use of Brominated Vegetable Oil in Food, A Proposed Rule by the Food and Drug Administration on 11/03/2023. (https://www.federalregister.gov/documents/2023/11/03/2023-24084/revocation-of-authorization-for-use-of-brominated-vegetable-oil-in-food)