June 15, 2017
The U.S. Food and Drug Administration has signed a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA), formally establishing a registration process for U.S. food manufacturers who export certain foods to China. The FDA is taking this 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 the 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.
This MOU formalizes a new registration procedure. The details about how the agency intends to implement this process and what information exporting establishments should provide to the FDA to register under this new procedure will be provided in a forthcoming FDA Guidance for Industry. The FDA will use the information it receives to establish and update a list of eligible exporters in a manner consistent with the MOU. The FDA intends to update the list of establishments and products four times per year.
The 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 the 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.