Implementation plan for amendments to the Food and Drug Regulations related to nutrition labelling, list of ingredients and food colours

Introduction

Health Canada published amendments to nutrition labelling, list of ingredients and food colour requirements of the Food and Drug Regulations (regulations) in Canada Gazette Part II on December 14, 2016. The key changes relate to:

• new requirements regarding the legibility of the list of ingredients
• grouping of sugars in the list of ingredients
• various changes to information contained in the Nutrition Facts table (NFt)
• new requirements for how food colours are declared
• removal of the requirement for certification of synthetic colours
• incorporation by reference of daily values, templates for the NFt formats, reference amounts, serving sizes and most food colour specifications

These regulatory amendments provide a 5 year transition period for regulated parties to meet the new labelling requirements, ending on December 14, 2021. Amendments dealing with food colour specifications and removal of the synthetic colour certification requirement came into effect immediately at the time of publication of the amendments.

For the first year following the transition period, the Canadian Food Inspection Agency (CFIA) will focus its efforts on education and compliance promotion (until December 14, 2022). After that date, the CFIA will verify compliance and apply enforcement discretion in cases of non-compliance when regulated parties have a detailed plan that shows how they intend to comply at the earliest possible time, and no later than December 14, 2023.

On January 19, 2022, Health Canada published a marketing authorization (MA) in Canada Gazette Part II to permit increased vitamin D levels in cow's milk, goat's milk and margarine. The MA allows manufacturers to voluntarily increase vitamin D in these products to specified levels. This allows milks to maintain the "excellent source of vitamin D" claim when using the increased daily values for vitamins and mineral nutrients in the new Nutrition Facts tables.

This document provides a summary of the CFIA and Health Canada's multi-year implementation plan during this transition period.

Overview

Regulated parties may apply either the former regulations or the new regulations over the 5 year transition period. Health Canada and the CFIA have developed a phased implementation plan for this transition period.

The key activities for each phase are summarized below.

Phase I (December 14, 2016 – May 10, 2018)

The publication of these amendments in Canada Gazette Part II marked the beginning of Phase I.

• Key activities

  • Tools and training - The CFIA updated its web guidance and tools to reflect the requirements under the new regulations, while maintaining guidance and tools that reflect the requirements under the former regulations. During the transition period, 2 sets of guidance and tools will therefore be available on the CFIA website. In March 2017, Health Canada, in collaboration with the CFIA, delivered technical webinars for external stakeholders and updated its web guidance. The CFIA developed and delivered an information session to staff.
  • Enquiries - Health Canada responded to enquiries on the new requirements and their intent. CFIA addressed enquiries related to compliance and enforcement.
  • Compliance and enforcement - CFIA inspection activities focused on the availability (presence on the label) and accuracy of mandatory information (such as values declared in the NFt, validity of claims and ingredients declaration, including allergens), regardless of the former or new labelling requirements being followed by the manufacturer. Health Canada conducted health risk assessments in support of CFIA's compliance activities and provided guidance on the interpretation of these regulatory amendments.

Phase II (May 11, 2018 – December 14, 2021)

Phase II began mid May 2018, when the role of responding to enquiries on the new requirements transitioned from Health Canada to the CFIA, and continues until the end of the transition period (December 14, 2021). CFIA's efforts will be directed towards education and promoting compliance with the new requirements.

• 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.
  • Enquiries - For all food labelling questions, including those related to the new requirements, the primary resource is the Industry Labelling Tool. Any additional questions should be directed to a CFIA local office.
  • Compliance and enforcement - CFIA inspection activities focus on the availability and accuracy of mandatory information, regardless of the former or new labelling requirements being followed by the manufacturer. Health Canada conducts health risk assessments in support of CFIA's compliance activities and continues to provide guidance on the interpretation of these regulatory amendments.

Phase III (December 15, 2021 – December 14, 2022)

Phase III marks the end of the transition period. The former regulations cease to be in effect as of December 15, 2021. During this phase, CFIA will continue to focus on education and promoting compliance with the new requirements.

• Key activities

  • Tools and training - CFIA guidance and tools available on the CFIA website will solely reflect the requirements under the new regulations.
  • Enquiries - For all food labelling questions, including those related to the new requirements, the primary resource will be the Industry Labelling Tool. Any additional questions will be directed to a CFIA local office.
  • Compliance and enforcement - At the end of the transition period, information presented in accordance with the former requirements will no longer be compliant. For the first year following the end of the transition period (until December 14, 2022), CFIA's efforts will continue to be directed towards education and promoting compliance with the new requirements at all levels of trade.

Compliance and enforcement after December 14, 2022

CFIA inspection activities will monitor compliance with the new labelling requirements for prepackaged products imported, manufactured in Canada or packaged at retail after December 14, 2022. However, the CFIA will apply enforcement discretion in cases where regulated parties have a detailed plan showing how they intend to meet the new requirements at the earliest possible time, and no later than December 14, 2023.

A "detailed plan" could be similar to a corrective action plan that regulated parties provide in response to a report of noncompliance, however, has a compliance date no later than December 14, 2023. Refer to the example of a corrective action(s) record for guidance on an acceptable plan.

Regulated parties must comply with the new labelling provisions after the compliance date of December 14, 2022 or any other date established in their detailed plan. Products imported, manufactured in Canada or packaged at retail before that date can remain in the warehouse and continue to be sold on store shelves.

Throughout all phases of the implementation plan (including the 2 years after the end of the transition period) the CFIA may take action in cases of inaccurate, false or misleading labelling information. In addition, Health Canada will conduct health risk assessments in support of CFIA's compliance activities and continue to provide guidance on the interpretation of these regulatory amendments.

Implementation timeline summary

Related links

• Food labelling changes
• Amendments to the Food and Drug Regulations related to nutrition labelling, list of ingredients and food colours
• Marketing Authorization for Vitamin D in Milk, Goat's Milk and Margarine