Notice of Modification to the List of Permitted Colouring Agents to Extend the Use of Allura Red to Fruit Flavoured Beer

Notice of Modification – Lists of Permitted Food Additives
Reference Number: NOM/ADM-0211
December 12, 2023

Background

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (Regulations). Approved food additives and their permitted 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. A petitioner can request that Health Canada approve a new additive, or a new source or a new condition of use for an already permitted food additive, by filing a food additive submission with the Department's Food Directorate. Health Canada uses this premarket authorization process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada.

Issue

Health Canada's Food Directorate received a food additive submission seeking authorization for the use of allura red as a colouring agent in fruit flavoured beer. The requested maximum level of use is 10 p.p.m. The function of this food additive is to give a hint of colour indicative of the fruit flavour added to the product. At the time of the petitioner's submission, allura red was already permitted for use in unstandardized foods, including unstandardized alcoholic beverages, at a level of 300 p.p.m. but was not permitted for use in standardized beer^{Footnote 1}.

Rationale for action

Health Canada's Food Directorate completed a premarket safety assessment of allura red for use as a colouring agent in fruit flavoured beer. The Directorate considered allergenicity, chemistry, microbiology, nutrition, and toxicology in the assessment. The results of the assessment support the safety of allura red for its requested use. Therefore, Health Canada has modified the List of Permitted Colouring Agents to extend the use of allura red to fruit flavoured beer by adding the entry shown below to the list (in bold font in this Notice to illustrate the change).

Other Relevant Information

Food additives such as allura red are required to meet food-grade specifications set out in Part B of the Regulations, where such specifications exist, or those set out in the most recent edition of the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications where there are no specifications in Part B. The Food Chemicals Codex is a compendium of standards for purity and identity for food ingredients, including food additives, published by the United States Pharmacopeial Convention. Specifications in the Combined Compendium of Food Additive Specifications are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the United Nations.

The Canadian Food Inspection Agency (CFIA), Beer Canada and the Canadian Craft Brewers Association were consulted on the requested use of allura red in fruit flavoured beer. No objections were raised by these organizations. One member of one of the industry associations expressed the view that if the addition of allura red to fruit flavoured beer is permitted, then the exemption for beer from the requirement to carry an ingredient^{Footnote 2} list should be repealed because of reported concerns regarding sensitivities to synthetic colouring agents, but did not provide new safety data supporting this concern.

The Food Directorate nevertheless considered this comment. Since reports of adults, which is the main subpopulation that should be consuming fruit flavoured beer, having an allergic or intolerance reaction to allura red in food are very rare in the scientific literature, the Food Directorate concluded there is insufficient safety evidence to warrant what would be a significant labelling change for the industry.

Implementation and Enforcement

The above modification came into force December 12, 2023, the day it was published in the List of Permitted Colouring Agents.

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

Health Canada's Food 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 in writing, by regular mail or electronically. If you wish to contact the Food Directorate electronically about allura red, please use the words "allura red (NOM-0211)" in the subject line of your e-mail.

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2202C
Ottawa, Ontario K1A 0K9
E-mail: bcs-bipc@hc-sc.gc.ca