Order Fixing the Day on Which Certain Provisions of the Budget Implementation Act, 2024, No. 1 Come into Force (Food and Drugs Act): SI/2025-25

Canada Gazette, Part II, Volume 159, Number 7

Registration
SI/2025-25 March 26, 2025

BUDGET IMPLEMENTATION ACT, 2024, NO. 1

Order Fixing the Day on Which Certain Provisions of the Budget Implementation Act, 2024, No. 1 Come into Force (Food and Drugs Act)

P.C. 2025-0283 March 5, 2025

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, under section 333 of the Budget Implementation Act, 2024, No. 1, chapter 17 of the Statutes of Canada, 2024, fixes the day after the day on which this Order is published in the Canada Gazette, Part II, as the day on which subsection 325(2), section 330 and subsection 331(2) of that Act come into force.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council brings into force, the day after the Order is published, subsection 325(2), section 330, and subsection 331(2) of An Act to implement certain provisions of the budget tabled in Parliament on April 16, 2024, also known as the Budget Implementation Act, 2024, No. 1 (BIA 2024).

Subsection 325(2) repeals paragraph 30(1)(r) of the Food and Drugs Act (FDA) which sets out the Governor in Council’s authority to make regulations respecting marketing authorizations.

Section 330 repeals the heading before section 30.2 and sections 30.2 to 30.4 of the FDA. These provisions set out the authority for the Minister of Health to issue a marketing authorization that may be subject to conditions. As a result of the coming into force of this section, section 332 deems marketing authorizations issued under section 30.2 or 30.3 of the FDA to be made under subsection 30.05(1) of the FDA.

Subsection 331(2) amends subsection 30.5(1) of the FDA to remove references to marketing authorizations.

Objective

The objective of the proposal is to bring into force the section and subsections of BIA 2024 to repeal the authority for the Minister of Health to issue a marketing authorization, repeal certain references to marketing authorizations in the FDA and transition existing marketing authorizations to class exemption orders made under subsection 30.05(1) of the FDA. These amendments are necessary to ensure consistent statutory application as the new class exemption authorities under subsection 30.05(1) and marketing authorizations under sections 30.2 to 30.4 are similar legislative instruments.

Background

As the market for therapeutic products and food is becoming increasingly globalized, Health Canada and other regulators around the world frequently face challenges associated with disruptions to global markets and supply chains. While Canada’s regulations governing the sale of therapeutic products and food work well in most situations, issues can sometimes arise that require tailored regulatory approaches to ensure the safety and availability of the products that the people in Canada rely on.

Through BIA 2024, the Government made amendments to the FDA that enable precise regulatory solutions to emerging or ongoing issues.

These amendments included the introduction of a new authority under the FDA to enable the Minister of Heath to make a Ministerial Order to put in place targeted exemptions from the application of all or any of the provisions of Part I or section 37 of the FDA or specific regulatory requirements, for any class of foods, therapeutic products, persons or activities while adding conditions as appropriate to ensure that health and safety standards are met.

Implications

Existing marketing authorizations remain unchanged but are transitioned to a different authority under the FDA. The following marketing authorizations are deemed to be made under subsection 30.05(1) of the FDA:

• Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats;
• Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods;
• Marketing Authorization to Permit a Lower Calcium Threshold for Exemptions from the Requirement for Prepackaged Products to Carry a Nutrition Symbol in the Case of Cheese, Yogurt, Kefir and Buttermilk; and
• Marketing Authorization for Vitamin D in Yogurt and Kefir

Given that no changes are being proposed to the content or requirements of the existing marketing authorizations, there are no anticipated financial, social or environmental impacts.

Consultation

Health Canada has not directly consulted on these amendments. However, through the introduction of BIA 2024, the provisions of the legislation (including these amendments to the FDA) were subject to the parliamentary process and scrutiny by elected officials.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3001A
E-mail: lrm.consultations-mlr@hc-sc.gc.ca