Canada’s Infant Formula Gets a Risk-Based Makeover

Canada is overhauling infant formula regulation with a three-tier risk classification system, balancing speed and safety. Starting in 2026, 70% of standard formulas (Tier 1) will only require post-market notification, provided they meet Canadian standards and are made in recognized jurisdictions (e.g., EU, U.S.).

25% of medical formulas (Tier 2) need pre-market approval but benefit from accelerated review based on foreign assessments. Only <5% of novel or high-risk products (Tier 3)—like those with new protein sources—face full clinical scrutiny.

This pragmatic approach ensures rapid access to safe products while reserving deep review for true unknowns. In infant nutrition, not all risks are created equal—and Canada’s new system finally reflects that.