Should Infant Formula Approval Be Based on Risk Level?

Official title: Consultation: Proposed risk-based approach for the authorization of infant food for a special dietary purpose

Closed Regulations & Permits Agriculture & Food Health & Safety
Health Canada wants to change how it approves infant formula and medical foods for babies. Right now, all products go through the same review process. The proposal would create three tiers based on risk—lower-risk products could skip pre-market approval, while higher-risk ones would get full review.

Why This Matters

Have a baby or planning to? This affects what formula and specialized infant foods make it to store shelves. Parents of infants with special dietary needs—like premature babies needing human milk fortifiers—could see faster access to new products. But the trade-off is less government review upfront for some items.

What Could Change

Lower-risk infant foods could reach the market with just a notification to Health Canada—no pre-approval needed. Moderate-risk products would get expedited reviews. Only higher-risk products would face full pre-market authorization. These changes would eventually become formal regulations published in the Canada Gazette.

Key Issues

  • Should lower-risk infant foods be allowed on the market with just a post-market notification?
  • Is a three-tier system the right way to balance safety oversight with faster product access?
  • How should products be classified into risk tiers?

How to Participate

  1. Review the proposed risk-based approach document, including the 'Questions for stakeholders' in Section 6.0.
  2. Send your feedback by email to bns-bsn@hc-sc.gc.ca with your responses to the consultation questions.

Key Documents