The FDA is asking establishments currently exporting certain food products to China to voluntarily submit information. We are making this request in response to new facility registration requirements from China. While China has not confirmed that collecting this information is a prerequisite for U.S. establishments to export to China, the FDA is making this request as a precaution against potential trade disruption. In April 2021, China’s General Administration of Customs (GACC) announced new registration requirements that affect all overseas food manufacturers, processors, and storage facilities of food products exported to China. These requirements are described in China’s Decree 248 and will be in effect on January 1, 2022.

Articles 7 and 8 of the Decree require the exporting countries’ competent authorities to recommend registration of establishments involved in the export to China of certain food categories:

1. Meat and meat products
2. Aquatic products
3. Dairy products
4. Bird nests and bird nest products
5. Casings
6. Bee products
7. Eggs and egg products
8. Edible oils and fats
9. Stuffed wheaten products
10. Edible grains
11. Milled grain industry products and malt
12. Fresh and dehydrated vegetables and dried beans
13. Condiments
14. Nuts and seeds
15. Dried fruits
16. Unroasted coffee beans and cocoa beans
17. Foods for special dietary purposes
18. Functional food

For products that do not fall within the 18 product categories listed in Article 7 and above, the GACC launched a system to facilitate self-registration as indicated in Article 9 of Decree 248. The USDA’s Foreign Agricultural Service (FAS) has published information on the self-registration process.

According to the GACC, it will continue to recognize existing registrations for establishments that export meat and meat products, aquatic products, dairy and infant formula products and bird nests and bird nest products. The FDA currently facilitates the registration of U.S. firms for seafood, dairy, and infant formula products by providing the GACC with documents that identify certified establishments and products that meet applicable U.S. requirements. U.S. firms that have applied in the FDA’s Export Listing Module (ELM) and are currently listed as certified by the GACC to export seafood, dairy, and infant formula products to China do not need to take any action at this time related to registration.

For all other categories of food, the U.S. government interprets the Decree to provide that these products are covered by the existing bilateral agreements with China, such as the Phase One Economic and Trade Agreement, and other bilateral facility registration arrangements. USTR has asked the GACC to confirm its understanding that U.S. establishments that export all other categories of products may self-register. To date the GACC has not confirmed this interpretation of Decree 248 and has failed to provide adequate further guidance for the United States. While the United States continues to engage with China at multiple levels to ensure minimal new requirements for the United States, the FDA is taking proactive steps to maintain current market access for FDA-regulated firms in the United States that export food to China.

For more details, please refer to 

https://www.fda.gov/food/cfsan-constituent-updates/fda-takes-steps-facilitate-export-food-under-chinas-new-facility-registration-requirements-decree

Article resource: FDA