·        Infant formula for:

o   healthy term infants

o   infants with medical conditions such as:

§  Pre-term infant formulas

§  Metabolic infant formulas

§  Amino acid-based infant formulas

§  Extensively hydrolyzed protein infant formulas

§  Infant formulas with no added carbohydrates

§  Infant formulas intended for infants with failure to thrive

·        Fortified medical foods for infants including:

o   human milk fortifiers

o   fortified modulars

semi-solid foods/mixes for ages 6 months and up for the dietary management of medical conditions

Proposed risk-based approach for the authorization of infant food for a special dietary purpose, (25 pages in English and 27 pages in French)

Health Canada is moving forward with efforts to modernize its regulations for foods for a special dietary use and infant foods. As part of this process, on November 26, 2025, the Department launched a 60-day pre-consultation about a proposed risk-based approach to authorizing infant formula and fortified medical foods for infants.

This consultation is a follow up to two previous pre-consultations on:

·        Regulatory Modernization of Foods for Special Dietary Use and Infant Foods: Divisions 24 and 25 of the Food and Drug Regulations, held from November 28, 2023, to February 26, 2024.

·        Compositional requirements for infant foods and foods currently regulated as foods for special dietary use from October 23, 2024, to January 22, 2025.

The proposed approach would introduce a three-tiered authorization framework, scaling regulatory oversight according to 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 comprehensive review for higher-risk products

To make its reviews more efficient, Health Canada would also leverage information and decisions from comparable foreign regulatory authorities.

The consultation will close to new input on January 25, 2026.