On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing 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.
Overview of China’s Decree 248
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. 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:
- Meat and meat products
- Aquatic products
- Dairy products
- Bird nests and bird nest products
- Bee products
- Eggs and egg products
- Edible oils and fats
- Stuffed wheaten products
- Edible grains
- Milled grain industry products and malt
- Fresh and dehydrated vegetables and dried beans
- Nuts and seeds
- Dried fruits
- Unroasted coffee beans and cocoa beans
- Foods for special dietary purposes
- Functional food
The new requirements go into effect on January 1, 2022.
However, to ensure that the FDA has the relevant establishment information before the end of the year, any U.S. establishment currently exporting food products in categories 5-18 to China should submit applications to the FDA’s Export Listing Module (ELM) by December 17, 2021.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.