Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act: SOR/2025-14

Canada Gazette, Part II, Volume 159, Number 4

Registration
SOR/2025-14 January 31, 2025

FOOD AND DRUGS ACT

The Minister of Health makes the annexed Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act under subsection 30.3(1)^{footnote a} of the Food and Drugs Act ^{footnote b}

Ottawa, January 31, 2025

Mark Holland
Minister of Health

Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act

Repeals

1 The following Marketing Authorizations are repealed:

(a) Marketing Authorization for Food Additives That May Be Used as Anticaking Agents ^{footnote 1};
(b) Marketing Authorization for Food Additives That May Be Used as Bleaching, Maturing or Dough Conditioning Agents ^{footnote 2};
(c) Marketing Authorization for Food Additives That May Be Used as Colouring Agents ^{footnote 3};
(d) Marketing Authorization for Food Additives That May Be Used as Emulsifying, Gelling, Stabilizing or Thickening Agents ^{footnote 4};
(e) Marketing Authorization for Food Additives That May Be Used as Food Enzymes ^{footnote 5};
(f) Marketing Authorization for Food Additives That May Be Used as Firming Agents ^{footnote 6};
(g) Marketing Authorization for Food Additives That May Be Used as Glazing or Polishing Agents ^{footnote 7};
(h) Marketing Authorization for Food Additives with Other Accepted Uses ^{footnote 8};
(i) Marketing Authorization for Food Additives That May Be Used as Sweeteners ^{footnote 9};
(j) Marketing Authorization for Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents ^{footnote 10};
(k) Marketing Authorization for Food Additives That May Be Used as Preservatives ^{footnote 11};
(l) Marketing Authorization for Food Additives That May Be Used as Sequestering Agents ^{footnote 12};
(m) Marketing Authorization for Food Additives That May Be Used as Starch-Modifying Agents ^{footnote 13};
(n) Marketing Authorization for Food Additives That May Be Used as Yeast Foods ^{footnote 14};
(o) Marketing Authorization for Food Additives That May Be Used as Carrier or Extraction Solvents ^{footnote 15}; and
(p) Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine ^{footnote 16}.

Coming into Force

2 This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) and the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food render 16 Marketing Authorizations (MAs) previously issued by the Minister of Health under section 30.3 of the Food and Drugs Act (the Act) redundant.

Background

Under section 30.3 of the Act, the Minister may issue marketing authorizations to exempt a food from the application of certain sections of the Act or any provision of the Food and Drug Regulations (the Regulations).

In October 2012, the Minister of Health issued 15 MAs as a measure to modernize the regulation of food additives. These MAs permitted certain uses of food additives that would otherwise be prohibited under the Regulations. Each of the 15 MAs correspond to a distinct category of food additives (e.g. preservatives, sweeteners) and incorporate by reference a list of food additives permitted for each category (e.g. List of Permitted Preservatives, List of Permitted Sweeteners). The 15 lists, known collectively as the Lists of Permitted Food Additives (the Lists), are Health Canada’s official up-to-date repository of substances that are permitted for use as food additives in or on foods sold in Canada. The MAs permit the food additive uses that are set out in the Lists, by exempting a food to which a listed food additive is added from the application of certain provisions of the Act and the Regulations, provided all applicable conditions are met. The Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food updated, consolidated and streamlined most provisions related to food additives under a revised Division 16 of Part B of the Regulations. These amendments include similar rules to those found in the 15 MAs, and incorporate by reference 15 revised versions of the Lists of Permitted Food Additives. These new regulatory amendments render the 15 MAs for food additives redundant.

Similarly, in December 2021, the Minister of Health issued an MA to allow cow’s milk, goat’s milk, and margarine to contain increased amounts of vitamin D, which the Regulations would have otherwise prohibited, by exempting these foods from the application of certain provisions of the Act and the Regulations, provided all applicable conditions were met. However, in June 2022, the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) ^{footnote 17} amended the Regulations, which now either require or permit the increased amounts of vitamin D previously set out in the MA. As a result, this MA is now also redundant.

Objective

The objective of this Order is to remove redundant legislative instruments by repealing 16 MAs. These changes are part of Health Canada’s broader objective to review, re-design, and modernize food regulations and to provide a more effective and adaptable regulatory environment for Canadians.

Description

This Order repeals the following 16 MAs:

Marketing Authorization for Food Additives That May Be Used as Anticaking Agents ^{footnote 18}
Marketing Authorization for Food Additives That May Be Used as Bleaching, Maturing or Dough Conditioning Agents ^{footnote 19}
Marketing Authorization for Food Additives That May Be Used as Colouring Agents^{footnote 20}
Marketing Authorization for Food Additives That May Be Used as Emulsifying, Gelling, Stabilizing or Thickening Agents ^{footnote 21}
Marketing Authorization for Food Additives That May Be Used as Food Enzymes ^{footnote 22}
Marketing Authorization for Food Additives That May Be Used as Firming Agents ^{footnote 23}
Marketing Authorization for Food Additives That May Be Used as Glazing or Polishing Agents ^{footnote 24}
Marketing Authorization for Food Additives with Other Accepted Uses ^{footnote 25}
Marketing Authorization for Food Additives That May Be Used as Sweeteners ^{footnote 26}
Marketing Authorization for Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents ^{footnote 27}
Marketing Authorization for Food Additives That May Be Used as Preservatives ^{footnote 28}
Marketing Authorization for Food Additives That May Be Used as Sequestering Agents ^{footnote 29}
Marketing Authorization for Food Additives That May Be Used as Starch-Modifying Agents ^{footnote 30}
Marketing Authorization for Food Additives That May Be Used as Yeast Foods ^{footnote 31}
Marketing Authorization for Food Additives That May Be Used as Carrier or Extraction Solvents ^{footnote 32}
Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine ^{footnote 33}

This Order will come into force upon registration.

Regulatory development

Consultation

On October 20, 2022, Health Canada and the Canadian Food Inspection Agency held information sessions to provide stakeholders with an overview of the key elements of the proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, including the proposed repeal of the 15 food additive MAs. Approximately 300 representatives from the agri-food industry, academia, public health and patient groups as well as provincial and territorial governments attended these sessions. Overall, participants responded positively to the information provided and expressed their continued support for this initiative.

Notice of Intent

On January 29, 2024, Health Canada published on its website a notice of intent^{footnote 34} regarding the proposed repeal of the 16 MAs, with a 75-day comment period ending April 14, 2024. Three comments were received in response to the Notice of Intent. Two of the three comments received expressed support for the repeal of the 16 MAs; the other comment was out of scope of this regulatory proposal (indicated concerns relating to animal testing).

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, a detailed assessment of modern treaty implications was conducted on the proposal. The assessment did not identify any modern treaty implications or obligations.

Instrument choice

The Governor in Council does not have the authority under the Food and Drugs Act to repeal marketing authorizations issued by the Minister of Health under s. 30.3 of the Act. Therefore, in order to repeal the 16 MAs, the Minister must issue an Order under this same provision of the Act.

Regulatory analysis

Benefits and costs

As this Order repeals redundant MAs, the Department has not identified any resulting costs or benefits associated with the instrument.

Small business lens

The small business lens does not apply to this Order as it does not impose any changes in requirements.

One-for-one rule

The “One-for-One” Rule applies since 16 existing regulatory titles are being repealed to modernize certain food regulatory frameworks (which are considered “OUTs”). Health Canada has incorporated by reference the 15 MAs for Food Additives mentioned above into the Regulations. Health Canada has also amended the Regulations to either require or permit the increased amounts of vitamin D previously set out in the relevant MA listed above. Since the 16 MAs are redundant, this Order will not impose any incremental change in the administrative burden on businesses.

Regulatory cooperation and alignment

Regulatory cooperation and international obligations do not apply to this Order as it does not impose any new requirements.

Effects on the environment

A preliminary scan was completed according to the Cabinet Directive on Strategic Environmental and Economic Assessment (SEEA Directive) that did not identify any important environmental impacts of the proposed Order. Therefore, a strategic environmental analysis is not required.

Gender-based analysis plus

No disproportionate impacts on individuals or groups based on gender and other identity factors have been identified for this proposal.

Implementation, compliance and enforcement, and service standards