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Frequently Asked Questions: FDA Submission Process for U.S. Companies Interested in Exporting Animal Feed Additives, Premixes, or Compound Feed 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.

How often does FDA intend to provide the General Administration of Customs of the People’s Republic of China (GACC) facility list to China?

Beginning in August 2021, FDA intends to provide the GACC facility list to China quarterly. In 2021, updated GACC facility lists will be provided in August and December.

Does an animal food facility have to complete the FDA Food Facility Registration process in order to be included in the GACC facility list?

Yes.

How often does an animal food facility have to request to be included on the GACC facility list?

Facilities will only need to request to be placed on the GACC facility list once during the FDA biennial food facility registration cycle.

The current FDA food facility registration cycle runs through the end of 2022. Food facility registration with FDA must be renewed between October 1 and December 31 of even numbered years. A facility must resubmit its request for inclusion on the GACC facility list following the end of each FDA food facility renewal period (e.g., January of odd numbered years). 

A facility that wants to be included on FDA’s next list to GACC must be registered with FDA and will need to submit the requested information to [email protected] before July 16, 2021.  Inclusion on that list will be good until the end of the next food facility registration cycle, which ends December 31, 2022. 

Companies with multiple animal food facilities may submit a request to FDA for more than one facility to be included on the GACC facility list. 

Where can I find information on FDA’s food facility registration process?

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

Do I need to resubmit information to FDA to be included on the new GACC facility list if I already provided information in 2020?

Yes.

Can I use a facility name or a corporate address for inclusion on the GACC facility list that is different from the facility name or facility address that is listed in my FDA food facility registration?

No. The data submitted for an animal food facility (facility name, street address, city, state, and zip code) should match the data in your FDA food facility registration. FDA will verify the data you provide for the GACC facility list against data that we maintain in our FURLS database. To be placed on the GACC facility list, the data you submit must match what is in your FDA food facility registration.

Where do I send my request to FDA to be placed on the GACC facility list?

The information should be sent via email to [email protected]

Do I have to register my animal feed additive, premix, or compound feed product with China’s Ministry of Agriculture and Rural Affairs (MARA) as a prerequisite for import into China?

China maintains product registration and licensing requirements for animal 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 MARA issues any product registrations or product-registration waivers that are necessary for animal feed additives, premixes, and compound feed products produced at U.S. facilities to be imported into China. 

Do I have to complete the MARA process before requesting placement on the GACC facility list?

Although not required by Chapter 3, Annex 12, paragraph 2 of the U.S. -China Economic and Trade Agreement, completing the MARA process is a prerequisite for importing an animal feed additive, premix, or compound feed product into China. Therefore, FDA is asking that facilities complete the MARA process before requesting placement on the GACC facility list. To be placed on the GACC facility list, the facility should have at least one product that has either a MARA product registration or a product-registration waiver.

Do I need to send any MARA documentation to FDA when requesting to be placed on the GACC facility list?

No. FDA is asking only for confirmation that you have obtained the appropriate MARA documentation and requesting that you indicate which type of MARA documentation (product registration or product-registration waiver) has been issued for products from the facility/facilities you are requesting to be added to the GACC facility list.

What parts of the U.S.-China Economic and Trade Agreement are specific to animal feed additive, premix, and compound-feed product registration with MARA?

See Chapter 3, Annex 12, paragraph 4.

Where can I find additional information on product registration with MARA?

Product registration materials may be found on MARA’s website

Can a U.S. government agency, such as FDA or USDA, help me with the MARA registration process?

No. Currently, there are no U.S. government agencies that can assist with this process. Your company must contact MARA if you have questions about their registration process.  Product registration materials may be found on MARA’s website.

Can I request that FDA add my manufacturing facility that produces dried distillers' grains (DDG) or dried distillers’ grains with solubles (DDGS) to the GACC facility list?

No, the facility list that FDA sends to GACC will contain only those facilities that manufacture animal feed additives, premixes, and/or compound feed. Manufacturers of DDG and DDGS need to utilize a different process, which is managed primarily by USDA. Companies interested in exporting DDG or DDGS to China should contact USDA’s Export Verification Program at [email protected]

Can I request that FDA add my manufacturing facility that produces pet food or non-ruminant derived feed/feed ingredients/fats to the GACC facility list?

No, the facility list that FDA sends to GACC will contain only those facilities that manufacture animal feed additives, premixes, and/or compound feed. Manufacturers of pet food and non-ruminant derived feed ingredients should visit the APHIS International Regulations (IRegs) for Animal Product Exports website for China and review the information provided. You also may contact your local VS Field Office for more information.

If you are exporting a pet food with no animal origin ingredients, please indicate that the product does not contain animal derived ingredients when you contact USDA. The U.S. government is working with China to determine the process for registering these facilities.

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