Implementation plan for amendments to the Food and Drug Regulations (Supplemented Foods)

Introduction

On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations mostly in a new division for Supplemented Foods (Division 29) in the Canada Gazette Part II (CGII). This division represents a risk-based approach for regulating supplemented foods, which was previously under the Temporary Marketing Authorization (TMA) framework, to allow products with levels of certain permitted supplemental ingredients established as safe to access the Canadian food market.

Highlights of Division 29:

  • new labelling requirements of supplemental ingredients in supplemented foods (including a Supplemented Foods Facts table, cautionary statements with the presentation of Supplemented Foods Caution Identifier as required by specified conditions)
  • documents incorporated by reference and published as part of these amendments (such as the List of Permitted Supplemented Food Categories and the List of Permitted Supplemental Ingredients) may be modified based on a stakeholder request for change, new science or emerging health risk, following a Health Canada evaluation

The following is a summary of the Canadian Food Inspection Agency (CFIA) and Health Canada's multi-year implementation plan for these supplemented foods amendments.

Transition period

Prior to the publication of the new supplemented food regulations in CGII, supplemented foods could access the market if the manufacturers or distributors received a temporary market authorization letter issued by Health Canada. The regulatory amendments provide a 3.5 year transition period, ending on December 31, 2025. Products for which manufacturers or distributors receive Health Canada authorization after CGII publication will be provided the remaining transition period.

These regulations fall within the scope of the joint Health Canada and CFIA Food labelling coordination policy. This policy establishes compliance date options for food labelling requirements at a 2 year interval, beginning on January 1, 2026.

Transition timeline

Phase I (July 21, 2022 to December 31, 2025)

The coming into force of these amendments marks the beginning of Phase I. CFIA's efforts will be directed towards education and promoting compliance with the new requirements.

  • Key activities
    Tools and training

    Health Canada's guidance document to support the supplemented foods regulations is available at Guidance document: Supplemented Foods Regulations and the tolerance approach for supplemented foods is available by email request to supplementedfoods-alimentssupplementes@hc-sc.gc.ca. These documents will be available to CFIA staff to carry out inspection activities. Health Canada delivered a webinar to explain guidance for external stakeholders in the Fall of 2022. The CFIA developed and delivered an information session in September 2023 to staff on the new regulatory requirements that was paired with internal operational guidance documents.

    Enquiries

    Health Canada will respond to enquiries on the new requirements and their intent. These enquiries can be sent to supplementedfoods-alimentssupplementes@hc-sc.gc.ca. The CFIA will address enquiries related to compliance and enforcement. These can be submitted to a CFIA local office.

    Compliance and enforcement

    As per the Interim policy statement on rounding rules, Health Canada has determined that it would be appropriate to permit manufacturers to apply similar rounding rules used for the Nutrition Facts table for certain nutrients instead of the current supplemental ingredient rounding rules. The interim policy will apply until the Food and Drug Regulations are amended.

    For products without TMA or Health Canada authorization – Any new products, other than those for which an authorization has already been granted, coming onto the market the day after the regulations are published in CGII, will be required to immediately comply with the new regulations. Health Canada will conduct health risk assessments in support of the CFIA's compliance activities and provide guidance on the interpretation of these regulatory requirements.

    For products with a TMA prior to CGII – CFIA will take an educational approach towards compliance, informing industry of the new requirements and where to find more information.

Phase II (from January 1, 2026)

Phase II will begin after the end of the transition period, from January 1, 2026.

  • Key activities
    Tools and training

    Self-serve training and tools are available to CFIA staff so they can respond to enquiries and carry out inspection activities. The CFIA Industry Labelling Tool reflects the requirements for supplemented foods under the new regulations.

    Enquiries

    For all food labelling questions, including those related to the new requirements, the primary resource is the Industry Labelling Tool. Any additional questions related to food labelling regulatory requirements should be directed to AskCFIA while questions related to inspection tasks or on-going investigations and inspection decisions should be directed to a CFIA local office. Health Canada will continue to respond to enquiries on the intent of the new requirements.

    Health Canada will also continue to support questions related to the tolerance approach and rounding rules, until the regulations are amended. To request the most current information, e-mail supplementedfoods-alimentssupplementes@hc-sc.gc.ca with the subject line "Requesting Compliance of supplemental ingredients declared on labels of supplemented foods".

    Compliance and enforcement

    CFIA inspection activities will monitor compliance with the new labelling requirements. All labels are expected to comply with the new regulations, except the rounding rules for supplemental ingredients, which must follow Health Canada's interim policy until those specific regulations are amended. Health Canada will support the CFIA on incidence response related to supplemented foods.

Throughout both phases of the implementation plan, the CFIA may take action in cases of inaccurate, false or misleading labelling information and will address food safety issues related to the new Division 29 of the regulations on supplemented foods. Health Canada will conduct health risk assessments in support of CFIA's compliance activities and provide guidance on the interpretation of the regulatory amendments.

While TMA holders would no longer be required to submit documents to Health Canada, Safe Food for Canadians Regulations license holders will continue to be responsible for notifying the CFIA if an investigation establishes that their food presents a risk of injury to human health.

Related links

 
Date modified: