Modification to the List of permitted sweeteners to extend the use of sucralose

Notice of Modification - Lists of Permitted Food Additives
Reference Number: M-FAA-24-07
July 11, 2024

Background

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (FDR). Authorized 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. A petitioner can request that Health Canada authorize 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 and Nutrition 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 and Nutrition Directorate received a food additive submission seeking authorization for the use of sucralose as a sweetener in a ready-to-serve liquid protein modular supplement intended for use by adults. The requested maximum level of use is 0.08% in the ready-to-serve protein modular supplement, which is a level the petitioner indicated improves the taste of the product. The product is intended to be used under medical supervision.

At the time of the petitioner's submission, sucralose was already permitted for use as a sweetener in a variety of beverages and solid foods.

Rationale for action

Health Canada's Food and Nutrition Directorate completed a premarket safety assessment of the petitioner's requested use of sucralose. The Directorate considered allergenicity, chemistry, nutrition and toxicology in the assessment. The requested maximum level of use of 0.08% in the product as consumed is well within the range of permitted levels for sucralose in other foods. The results of the assessment supports the safety of sucralose for its requested use. Therefore, Health Canada has modified the List of Permitted Sweeteners to extend the use of sucralose by adding subitem S.2(20) to the list, as shown in the table below (in bold font in this notice to illustrate the addition).

Modification to the List of Permitted Sweeteners

Item No.	Column 1 Additive	Column 2 Permitted in or Upon	Column 3 Maximum Level of Use and Other Conditions
S.2	Sucralose	(20) Liquid protein preparations represented for use under medical supervision and by individuals 18 years of age or older	(20) 0.08%

Other relevant information

Food additives such as sucralose are required to meet food-grade specifications set out in Part B of the FDR, 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.

Implementation and enforcement

The above modification came into force July 11, 2024, the day it was published in the List of Permitted Sweeteners.

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 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 in writing, by regular mail or e-mail. If you wish to contact the Food and Nutrition Directorate by e-mail about sucralose, please use the words "sucralose (M-FAA-24-07)" 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