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GUIDANCE DOCUMENT

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 November 2018

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2016-D-4484
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance document is intended to notify the public of FDA’s efforts to help U.S. manufacturers/processors (hereinafter referred to as “establishments”) that wish to export milk and milk products, seafood, infant formula, and formula for young children to China. 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, among other requirements, mandates that foreign competent authorities, including FDA, provide the Certification and Accreditation Administration of China (CNCA) with a “name list of overseas manufacturers of imported food applying for registration” with CNCA for commodities that CNCA has deemed to require registration. Milk and milk products, seafood, infant formula, and formula for young children are among the commodities for which registration of overseas manufacturers is required under AQSIQ Decree 145. China has recognized FDA as the competent food safety authority in the United States to establish and maintain the lists of U.S. establishments that intend to export U.S. milk and milk product, seafood, infant formula, and/or formula for young children to China, and the corresponding products for each establishment intended for export to China.

This guidance document revises a guidance document issued in June 2017 entitled “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.” It revises the procedures establishments should use to be included on FDA’s list of exporters to China for each type of product. This revised guidance document explains how establishments should apply to be included on FDA’s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2016-D-4484.

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