U.S – The U.S Food and Drugs Administration (FDA) has called on establishments currently exporting certain food products to China to voluntarily submit information in response to new facility registration requirements from China.
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.
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. These requirements are described in China’s Decree 248 and will be effected as from January 1, 2022.
As the U.S competent authority for many of the product categories named in Article 7 of Decree 248, the FDA is collecting information in the Export Listing Module (ELM) from U.S. firms that may be needed to facilitate the registration process before the new requirements are enacted.
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 including meat and meat products, dairy products, edible oils and fats, milled grain industry products and malt, among others.
Beginning on December 6, 2021, U.S. establishments that currently produce or store FDA-regulated products for export to China that fall into the product categories 5-18, may submit an application via the FDA’s Export Listing Module (ELM), providing information for products they currently export to China.
This is to allow the FDA to facilitate registration of these establishments with China. The agency has availed step-by-step instructions for using the ELM on their website.
For products that do not fall within the 18 product categories listed in Article 7, 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.
Exempted from the new registration requirements are 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.
Other product categories
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.
The United States and China signed an historic and enforceable agreement on a Phase One trade deal on January 15, 2020. The agreement requires structural reforms and other changes to China’s economic and trade regime.
The Office of the United States Trade Representative (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.
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 the listed categories to China should submit, applications to the ELM by December 17, 2021. In addition to meeting U.S. requirements, firms exporting to China are responsible for meeting relevant China regulations and requirements.
The FDA does not intend to provide a declaration of conformity or other competent authority statement directly to U.S. establishments. However, in the event it is needed for registration for China, the FDA may provide an attestation directly to GACC for U.S. establishments and their products that comply with applicable U.S. requirements in order to facilitate registration.