April 14, 2021

Purpose

The purpose of this notice is to inform Canadians, regulated parties and other stakeholders of the Minister of Health's intent to amend 2 Marketing Authorizations for Food Additives so that Health Canada can authorize safe uses of food additives in human milk fortifiers (HMFs) and other infant foods.

Background

In Canada, food additives are regulated by both the Food and Drug Regulations (FDR) and Marketing Authorizations (MAs) issued by the Minister of Health. Approved food additives and their permitted conditions of use are set out in the 15 Lists of Permitted Food Additives that are incorporated by reference in the corresponding 15 MAs and published on the Canada.ca website. Each List and its corresponding MA is for one or more specific functional class or classes of food additive, with the exception of one List and its corresponding MA that addresses various purposes of use.

Before new food additive uses are added to the Lists they are reviewed by Health Canada for safety. Health Canada notifies the public about all changes to the Lists. In the case of new food additives, the Department publishes a proposal to permit the use of the new food additive and provides 75 days for comments on the proposal or for the submission of new safety information about the food additive before permitting its use.

The MAs legally authorize the food additives uses that are set out in the Lists by exempting a food from the application of certain prohibitions in the Food and Drugs Act and FDR when certain conditions are met. One of these provisions in the FDR is subsection B.25.062(1), which prohibits the sale of infant foods that contain food additives. Given this prohibition, in order for Health Canada to be able to modify the applicable Lists to permit new, safe uses of food additives in HMFs or other infant foods, it is necessary to amend the MAs that incorporate by reference these Lists to exempt HMFs and other infant foods from the application of subsection B.25.062(1) of the FDR under specified conditions.

None of the proposed MA amendments, as described below, impose new restrictions. Therefore, they would come into force on the day on which they are published in the Canada Gazette, Part II.

Proposed Amendments to the Marketing Authorizations for Food Additives

Pursuant to section 30.3 of the Food and Drugs Act, the Minister of Health intends to amend 2 MAs for food additives as described below to include a new or revised exemption from subsection B.25.062(1) of the FDR.

The Marketing Authorization for Food Additives That May Be Used as Preservatives will be amended by adding an exemption from the application of the prohibition set out in subsection B.25.062(1) of the FDR. The exemption will apply with respect to the use or presence of a food additive in an infant food as set out in the List that is incorporated by reference in the corresponding MA.

The Marketing Authorization for Food Additives That May Be Used as Food Enzymes already contains an exemption^{Footnote 1} from subsection B.25.062(1). However, in order for the same exemptions to apply to this MA as the above MA, additional minor amendments are required.

Rationale

The Minister of Health published Health Canada's regulatory framework to permit the sale of HMFs in Canada in the Canada Gazette, Part II in April 2021. Food additives are used in some HMF products to perform certain technological functions. As part of the proposed regulatory changes, the Minister intends to amend two of the food additive MAs so that Health Canada will be able to permit new, safe uses of food additives in HMFs and other infant foods by adding them to the food additive Lists using the same administrative process that is followed for authorizing safe uses of food additives in other foods.

Public Comments

Comment on the Minister of Health's proposal to modify the two food additive MAs as described in this Notice of Intent can be provided during the next 30 calendar days ending May 14, 2021. The proposal may be revised prior to the final regulatory amendments to the MAs being published in the Canada Gazette, Part II. Comments can be submitted by email or in paper format to Health Canada's Bureau of Chemical Safety at the coordinates below. Please cite the title and the date of publication of this Notice of Intent in the subject line of your correspondence.

Contact Information:

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