,"Health Canada has initiated a major regulatory modernization effort for infant formula and fortified medical foods, launching a 60-day public consultation on a proposed risk-based authorization framework for these products. The consultation opened on 26 November 2025 and will accept stakeholder input until 25 January 2026.
The notification outlines Health Canada’s plan to overhaul regulatory pathways for foods for special dietary use, including products for healthy infants, pre-term infants, and infants with metabolic or medical conditions. The proposal covers a wide range of items, including infant formulas, amino-acid based formulas, extensively hydrolyzed formulas, formulas with no added carbohydrates, fortified human-milk fortifiers, fortified modulars, and semi-solid medical foods for infants six months and older.
This initiative builds on two earlier consultations:
• Modernization of regulations for foods for special dietary use and infant foods (Nov 2023–Feb 2024)
• Compositional requirements for infant and special-dietary-use foods (Oct 2024–Jan 2025)
Health Canada proposes a three-tiered authorization system, with regulatory oversight calibrated to the level of product risk:
• 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
As part of the modernization effort, Health Canada plans to leverage assessments and decisions from comparable foreign regulatory authorities to streamline evaluations and reduce duplication. The goal is to improve product access, diversify the infant-nutrition market, reduce administrative burden, and help safeguard against future supply shortages, while upholding Canada’s strict safety standards.
Stakeholder feedback gathered during this consultation phase will inform the drafting of new regulations, which will later be published in the Canada Gazette, Part I, for formal public comment."