Notice of Intent to Issue a Food Marketing Authorization Amending the Marketing Authorization for Food Additives with Other Generally Accepted Uses

September 9, 2016

Purpose

The purpose of this notice is to inform Canadians and other interested stakeholders of the Minister of Health’s intent to amend the Marketing Authorization for Food Additives with Other Generally Accepted Uses to allow for the addition of food additives for new purposes of use to the incorporated List of Permitted Food Additives with Other Generally Accepted Uses.

Background

This proposal is to further implement policy initiated through the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received royal assent on June 29, 2012. The amendments to the Food and Drugs Act included in Bill C-38 aimed to create greater efficiency in the federal regulation of substances in or on foods (e.g., food additives) and representations on or about foods (e.g., health claims on foods) by providing the Minister of Health with the authority to make Marketing Authorizations (a form of ministerial regulation) as well as a greater ability to incorporate documents by reference.

In October 2012, the then Minister of Health made use of the new authorities provided in Bill C-38 to modernize the regulatory framework for food additives by creating fifteen Marketing Authorizations (MA) that replicated the structure of the fifteen food additive tables in Part B, Division 16 of the Food and Drug Regulations. Each MA incorporates by reference corresponding lists of substances permitted for use as food additives. These lists, collectively referred to as the Lists of Permitted Food Additives, are administratively maintained by Health Canada’s Food Directorate following an established process that provides an opportunity for public comment.

The Marketing Authorization for Food Additives with Other Generally Accepted Uses and its incorporated list – the List of Permitted Food Additives with Other Generally Accepted Uses – set out food additives that have a purpose of use that cannot be classified in any of the fourteen other Marketing Authorizations (MA) for food additives. Paragraph 2(1)(a) of this MA presently limits the purposes of use that may appear on the incorporated list to those that were mentioned in column III of Table VIII, Part B, Division 16 of the Food and Drug Regulations on the day on which the MA and its incorporated list were made (October 25, 2012). Until paragraph 2(1)(a) is amended, Health Canada’s Food Directorate is unable to administratively amend the List of Permitted Food Additives with Other Generally Accepted Uses to permit food additives for new purposes of use that it has assessed as safe.

Proposed Amendment to the Marketing Authorization

Pursuant to section 30.2 of the Food and Drugs Act, it is the intention of the Minister of Health to amend the Marketing Authorization for Food Additives with Other Generally Accepted Uses, SOR/2012-209, as follows:

• Amend subsection 2(1) of the Marketing Authorization such that the purposes of use that may appear on the incorporated list would no longer be constrained to those that were mentioned in Table VIII of Part B, Division 16 of the Food and Drug Regulations on October 25, 2012 (i.e., those purposes of use that currently appear in Column 3 of the List of Permitted Food Additives with Other Generally Accepted Uses).
• Amend subsection 2(1) of the Marketing Authorization such that decisions to either A) permit the use an existing food additive^{Footnote 1} for a new purpose of use or B) to permit the use a new food additive for an existing purpose of use^{Footnote 2} can be enabled by the Food Directorate in the incorporated list through the established administrative process.
• Amend subsection 2(1) of the Marketing Authorization to require, exclusively in the case of a new food additive for a new purpose of use, that a new Schedule to the MA first be amended to list the new additive and purpose of use. This would require an amendment to the Marketing Authorization prior to the new food additive for the new purpose of use being administratively enabled in the incorporated list.

The proposed MA would be an enabling measure. It will come into force the date on which it is published in the Canada Gazette, Part II.

Rationale

Consideration was given to simply repealing the restriction in paragraph 2(1)(a) of the MA to provide the Food Directorate with the ability to administratively enable a food additive decision in the incorporated list. However, given the broad scope of this specific MA, it was determined that providing full discretion to the Food Directorate would not be appropriate, particularly in the unique scenario where the Directorate wishes to permit a new food additive for a new purpose of use. In such an instance, authorization from the Minister would first be obtained by means of a regulatory amendment to the MA. This proposed approach provides greater regulatory oversight and scrutiny, when dealing with a completely novel combination (within the Canadian context) of a new food additive for a new purpose of use while still allowing for a more efficient and timely regulatory process.

Public Comments

Interested persons may make representations, with respect to the Minister of Health’s intent to issue this Marketing Authorization, within 75 calendar days after the date of publication of this notice (by November 22, 2016). All such representations must cite the title, reference number and the date of publication of this notice, and be addressed to the contact identified below.

Contact

Marc-Aurele Gagnon
Office of Legislative and Regulatory Modernization
Health Canada
1600 Scott Street – Tower B
Ottawa, Ontario
K1A 0K9

Fax: (613) 941-7104
E-mail: lrm-mlr@hc-sc.gc.ca