On October 23, 2017, the FDA released a new guide to help farmers and food manufacturers determine when they need to comply with provisions of the Food Safety Modernization Act (FSMA). On the same page, the agency also released a visual breakdown of key FSMA dates between 2015 and 2024.

Of particular interest for the majority of Canadian exporters are the compliance dates for U.S. importers under the Foreign Supplier Verification Program for Food Importers (FSVP). If applicable, we encourage Canadian exporters to identify the upcoming compliance date and to contact their U.S. importer ahead of time to ensure they are ready for these new requirements.

Guidance

On October 19, 2017, the FDA issued guidance documents intended for facilities that may be subject to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule. The guidance is intended for domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act because they manufacture, process, pack, or hold animal food for consumption in the U.S.

The first guidance document contains information to help these facilities determine whether they need to comply with the current good manufacturing practice requirements for animal food established under in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (Title 21 of the Code of Federal Regulations (21 CFR) part 507).

The second draft guidance document is intended to help establishments and facilities subject to 21 CFR part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) or 21 CFR part 507 to determine whether they are "solely engaged" in certain activities. Establishments and facilities "solely engaged" in certain activities are exempt from some or all of the requirements in parts 117 or 507.

On November 3, 2017, the FDA released guidance for persons who participate in "co-manufacturing" agreements in Supply-Chain Program Requirements. Under the FSVP, the FDA established that an importer that is a receiving facility is deemed to be in compliance with most of the requirements of the FSVP regulation for a food it imports, as long as the importer is in compliance with the supply-chain program requirements of part 117 or part 507 for that food. When an importer that is a receiving facility is in compliance with the supply-chain program requirements, the only requirement of the FSVP regulation that applies is the requirement for identification of the importer at entry. We encourage Canadian companies who co-manufacture products in the U.S. to review this new guidance.

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LABELING AND REGULATIONS

FOOD LABELING AND REGULATIONS

FOOD LABELING MODERNIZATION

In December 2016, Health Canada published amendments to the food labelling regulations in Canada Gazette Part II.

Thus, as of December 14, 2021, prepackaged food products being manufactured or imported, and foods prepackaged in store and sold by retailers, must comply with the new labelling requirements.

The Export Group offers a series of four publications to assist you in this major change. We encourage you to adapt this plan to your business reality.

LABELLING : Health Canada’s new requirements