FDA Publishes Guidance for Registration of Certain Foods for Export to China

FDA has published a guidance document for the new registration procedure established in June through a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA). The MOU formally established a registration process for U.S. food manufacturers who export certain foods to China.

The newly published Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China further explains the information that exporting establishments should provide to FDA to register under this new arrangement. FDA will use the information received to establish and update a list of eligible exporters in a manner consistent with the MOU, and the agency will update the list of establishments and products four times per year.

As discussed in the June announcement, FDA took the action in response to China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145.

AQSIQ Decree 145 requires that CNCA receive certification of compliance with the relevant standards, laws, and regulations of China for the following products as of June 15, 2017: milk and milk products, seafood, infant formula, and/or formula for young children.  The MOU provides for a third-party certification process to ensure that manufacturers and products satisfy relevant food safety requirements of China, as specified in Decree 145. In accordance with the MOU, CNCA expects all eligible exporters to provide FDA with information concerning the third-party certification by a firm approved by China. Pursuant to the MOU, the FDA will also evaluate and provide CNCA with information about whether relevant U.S. establishments are in good standing with the FDA.

FDA understands that U.S. exporters want continued and uninterrupted access to the Chinese market, and the agency is working expeditiously to provide CNCA with the assurances it requires for FDA to establish and maintain a list of U.S. milk and milk product, seafood, infant formula, and formula for young children manufacturers/processors eligible for exporting to China.