FDA Explains Revised Submission Process for U.S. Animal Feed Additive, Premix, and Compound Feed Facilities Interested in Exporting to China

Update, October 18, 2022: Through the collaborative efforts of the United States Department of Agriculture – Agriculture Marketing Service (USDA-AMS), Food and Drug Administration’s Center for Veterinary Medicine (CVM) and American Feed Industry Association, the registering of non-animal-based additive, premix and compound feed manufacturing facilities for export to China to facilitate access to the Chinese feed additive, premix and compound feed market will now be managed by USDA-AMS Livestock and Poultry Program. Effective immediately, the CVM process is discontinued. For facilities that wish to register with China, please contact USDA-AMS. While USDA-AMS will manage this export program, CVM is still the U.S. federal regulatory authority for animal food.

June 7, 2021

The U.S.-China Economic and Trade Agreement signed by the United States and China on January 15, 2020, outlines procedures for U.S. facilities exporting animal feed additives, premixes, and compound feed to register with China to become eligible to export to China.

Consistent with Annex 12 of Chapter 3 of the Agreement, the U.S. Food and Drug Administration (FDA) will periodically submit to the General Administration of Customs of the People’s Republic of China (GACC) a list of U.S. facilities registered with FDA that are interested in exporting relevant products to China (GACC facility list). China has agreed that: “[e]ach time that the United States provides China with” such a list, “China shall, within 20 working days of receiving the information, register the facilities, publish the list on the GACC website, and allow imports of feed additives, premixes, [and] compound feed products, … from U.S. facilities appearing on the list on the GACC website.” (Annex 12, para. 2)

China maintains product registration and licensing requirements for feed additives, premix, and compound feeds that are separate from its GACC facility registration requirements. Completion of these product registration requirements is often a prerequisite for import into China, regardless of a facility’s GACC registration status. Manufacturers and exporters are responsible for ensuring that China’s Ministry of Agriculture and Rural Affairs (MARA) issues any product registration or product-registration waivers that are necessary for feed additives, premixes, and compound feed products produced at U.S. facilities to be imported into China. Although not required by Chapter 3, Annex 12, paragraph 2 of the Agreement, FDA requests that product registration and licensing for all products intended to be shipped to China should be completed before requesting to be placed on the GACC facility list. Your company should contact MARA if you have any questions about MARA’s product-registration requirements. Product registration materials may be found on MARA’s website.

FDA provided initial facility lists to China in March, May, and October 2020, utilizing the information outlined in a March 4, 2020 CVM Update. The lists submitted in 2020 will be retired and a new GACC facility list is being generated. The new GACC facility list will be sent to China in August 2021. FDA intends to provide updated facility lists to GACC on a quarterly basis moving forward.

If you would like to have your facility considered for inclusion on the new GACC facility list, email FDA at CVMChinaAnnex@fda.hhs.gov and include all the following information by Friday, July 16, 2021:

Email subject line: (Your Company’s Name): Facility Data for Export to China
Permission statement (such as): I, (Your Name, Company Name, Company Title), grant permission to FDA to share with the General Administration of Customs of the People’s Republic of China, the name and address of the registered animal food facilities I have designated below, to facilitate access to the Chinese feed additive, premix, and compound feed market.
Affirmation about registration of products: Products produced at the specified facility/facilities have official documentation from MARA.
- Please specify whether products from the facility have obtained:
  - MARA product registration
  - MARA waiver from product registration
  - Both (for facilities with multiple products)
Individual facility data: For each registered facility you wish to include on the list, provide the facility’s legal name, street address, city, state, zip code. (Note: Information provided to FDA will be verified against your facility’s data in FDA’s Unified Registration and Listing System (FURLS) Registration database before being included on the GACC facility list. If there are discrepancies between the facility data you provide and your FURLS data, FDA may contact you to correct/update your data in FURLS.)

After submitting your information for the GACC facility list by July 16, 2021, you will not need to submit a request to FDA again until after the end of the next food facility registration cycle, which ends December 31, 2022. Requests received after July 16 will be reserved for the next quarterly GACC facility list.

For information about the FDA’s food facility registration process, see FDA Registration of Food Facilities and Other Submissions.

Note: Companies interested in exporting pet food, non-ruminant derived feed ingredients, dried distillers’ grains, or dried distillers’ grains with solubles to China should consult USDA. If you are interested in exporting a pet food with no animal origin ingredients, please indicate that the product does not contain animal derived ingredients in your contact with USDA.

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.