Consultation: Proposed risk-based approach for the authorization of infant food for a special dietary purpose
Current status: Closed
Opened on November 26, 2025 and will close to new input on January 25, 2026.
Health Canada was seeking comments on its proposed risk-based approach for the authorization of infant food for a special dietary purpose. These foods are regulated under Division 25 of the Food and Drug Regulations and include infant formula and medical foods for infants (e.g., human milk fortifiers).
Who was the focus of this consultation
We were seeking input from all interested stakeholders, including:
- health professionals and associated organizations
- industry stakeholders and associated organizations
- non-governmental organizations
- academics and researchers
- all levels of government
- parents and caregivers of infants consuming these products
Key questions for discussion
We were seeking your input on the proposed risk-based framework for the authorization of infant food for a special dietary purpose which would align regulatory oversight to product risk, by setting out the following three tiers for product authorization:
- Tier 1: Post-market notification for lower risk products
- Tier 2: Pre-market authorization with expedited review for moderate-risk products
- Tier 3: Pre-market authorization with full review for higher-risk products
The input gathered through this process will help inform the development of draft regulations which are anticipated to be published in the Canada Gazette, Part I for comment.
Contact us
Bureau of Nutritional Sciences, Food and Nutrition Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Mail stop 2203E
Ottawa, ON K1A 0K9
Email: bns-bsn@hc-sc.gc.ca