U.S. FDA issues guidance for food exporters to China

The U.S. Food and Drug Administration (FDA) has issued an updated Guidance document for parties seeking to be added to the agency’s list of food exporters to China.

The FDA’s Guidance, “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,” was published in June 2017, and replaces the original version of the Guidance published in January 2014. In brief, the Guidance explains how establishments should apply to be included on the FDA’s list of exporters to China, how the FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how the FDA intents to update this information.

In the introduction to the updated Guidance, the FDA notes that the update is in response to Decree 145, issued by China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ). Decree 145 mandates that foreign competent authorities (including the FDA) provide Chinese authorities with a “name list of overseas manufacturers of imported food applying for registration” with the Certification and Accreditation Administration of China (CNCA) for certain, specified food products. Recognised by China as the “competent food safety authority” in the U.S., the FDA’s updated Guidance supports the agency’s efforts to collect and verify information as required by China food safety authorities.

Guidance documents issued by U.S. federal agencies do not have the force of law, but are intended to provide insight into an agency’s current thinking on a given subject. In that way, they can be useful in helping companies to meet applicable regulations and other requirements.