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12-6-2021
FDA Takes Steps to Facilitate the Export of Food under China’s New Facility Registration Requirements – Decree 248
Constituent Update
December 6, 2021
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:
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.
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 go into effect on January 1, 2022.
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 listed above may submit an application via theFDA’s Export Listing Module (ELM), providing information for products they currently export to China to allow the FDA to facilitate registration of these establishments with China. Step-by-step instructions for using the ELM are available on the FDA’s website.
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 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.
Please note that the FDA does not intend to provide a declaration of conformity or other competent authority statement directly to U.S. establishments. 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.
For more details on China’s requirements, additional information on the U.S. competent authority for certain products that are under the FDA’s authority or the USDA’s Food Safety and Inspection Service’s authority, or both and for step-by-step instructions on how to apply to the ELM, visit Food Export Library and Online Applications for Export Lists.
For more information, contact the Export Certification Team at CFSANExportCertification@fda.hhs.gov.
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