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            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:

            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.

            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.

            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.

            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

            Flowchart - implementation timeline summary. Description follows.

            Image description for implementation timeline summary

            December 14, 2016 to December 14, 2021

            • Transition period
            • New or old labels valid
            • CFIA focus on education and compliance promotion

            December 15, 2021 to December 14, 2022

            • Transition period has ended
            • Former regulations are no longer in effect
            • New labelling requirements apply
            • CFIA will continue to focus on education and compliance promotion

            December 15, 2022 to December 14, 2023

            • Regulated parties must comply with new labelling requirements or have a detailed plan to be compliant by (or before) December 14, 2023

            After December 14 , 2023

            • Regulated parties must comply with new labelling requirements

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