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WTO notification · TBT

CanadaProposed measure, may since have been adopted

Infant food – Canada

Official title

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

Canada notified this proposed TBT measure to the WTO on 2 December 2025. The comment period closed on 25 January 2025.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

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At a glance

Products

Infant formula for: healthy term infants; 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

Notifying member
Canada
Status
Proposed measure, may since have been adoptedNotified as a draft on 2 December 2025. Check WTO ePing or Canada for its current status.
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CAN/760
Keywords
Food standards

Key dates

Distributed by the WTO
Comment deadline
Closed on 25 January 2025
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 25 January 2025. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CAN/760; it can take them up with Canada.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

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.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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