News from the Canadian Food Inspection Agency

Following consultation and stakeholder input on Directive 99-06: Policy on the Issuance of Phytosanitary Certificates for Export and for Re-export, the directive was updated and revised to include procedural changes for the application and issuance of phytosanitary certificates using the My CFIA online service portal.

The updates provide clarifications for the issuance date on the phytosanitary certificate including the potential addition of an inspection date in the Additional Declaration field, and, general administrative improvements.

The revised directive is available at the following link:

D- 99-06: Policy on the Issuance of Phytosanitary Certificates for Export and for Re-export

Please contact cfia.ippc.acia@inspection.gc.ca if you have further questions.

News from AAFC’s Market Access Secretariat

This is a follow up to our message dated December 21, 2022, regarding India’s requirement of registration of foreign food manufacturing facilities.

On April 4, 2024, the Food Safety and Standards Authority of India (FSSAI) issued an Order indicating that imports from foreign food manufacturing facilities of specific categories (see below) that are not yet registered will be allowed into India until August 31, 2024.

After August 31, 2024, the FSSAI authorities will commence enforcement activities, and consequently, imported products from unregistered foreign manufacturing facilities will not be permitted into India.

The following hyperlinks include instructions on how to add, update or remove establishments on India’s registration list of manufacturers food, administered by the FSSAI.

• Egg and egg products
• Fish and seafood
• Food supplements (Nutraceuticals)
• Infant food
• Meat and poultry

If you are interested in being registered in FSSAI’s list of foreign manufacturing facilities, we encourage you to contact your local CFIA office to initiate the process.

December 22, 2022 – Please note that on October 10, 2022, the Food Safety and Standards Authority of India (FSSAI) issued an order regarding registration of foreign food manufacturing facilities that export specified food products to India. The order will be effective from February 1st, 2023. India subsequently notified this measure to the WTO in notification G/TBT/N/IND/237, below.

This order provides for the mandatory registration of foreign food manufacturing facilities under the following food categories :

• milk and milk products;
• meat and meat products, including poultry, fish and their products;
• egg powder;
• infant food; and
• nutraceuticals

Based on this order, Competent Authorities of exporting countries are required to register with FSSAI manufacturers intending to export the above-noted products to India using the format outlined in the order.

Should you have comments regarding this notification, please send them to the Market Access Secretariat at aafc.mas-sam.aac@agr.gc.ca by January 6, 2023.

April 12, 2024 – The US Food and Drug Administration (FDA) will reopen the comment period for 60 days for the draft guidance “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE,” announced in the Federal Register on February 12, 2024. The Federal Register Notice is forthcoming. We are taking this action in response to a request from stakeholders for additional time to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-5303.

February 9, 2024 – The US Food and Drug Administration (FDA) issued draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.

The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE.

This guidance addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE.

The intent of this draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation.

To Submit Comments

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register. Submit electronic comments to www.regulations.gov to docket number FDA-2023-D-5303. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2023-D-5303.

Additional Information:

Federal Register Notice for the Draft Guidance

Seafood Guidance Documents & Regulatory Information

More on Seafood from FDA

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).

NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future NDIN. The intent of the guidance, once finalized, will be to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files.

The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

To Submit Comments:

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit electronic comments to www.regulations.gov to docket number FDA-2024-D-0706. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2024-D-0706.

Additional Information:

Federal Register Notice for the Draft Guidance

New Dietary Ingredient (NDI) Notification Process

Information for Industry on Dietary Supplements

The Canadian Food Inspection Agency (CFIA) adjusts its service fees annually based on the Consumer Price Index in accordance with the Service Fees Act. This requirement ensures that the CFIA’s service fees keep pace with the costs of providing services.

The next annual adjustment will result in an increase of the service fees by 6.8% as of March 31, 2024.

This fee increase reflects the percentage change over 12 months in the April All-items CPI for Canada, published by Statistics Canada, for the previous fiscal year.

More information on Adjusting service fees for inflation is available on the CFIA’s website.