CFSAN Constituent Update

FDA Expands Electronic System to Include All Export Lists July 9, 2018

The U.S. Food and Drug Administration has launched the Export Listing Module (ELM), an electronic portal for receiving and processing requests from FDA-regulated establishments that seek to be included on all export lists for FDA-regulated food products. For certain exported food products, some foreign food safety authorities require FDA to provide publicly available lists of exporters eligible to ship products to that country. This expanded module improves the FDA’s ability to efficiently process establishments’ requests to be added to the lists, monitor listed establishments, and generate updates for foreign regulatory agencies.

The FDA has established and currently maintains export lists in response to importing country requirements for dairy, infant formula, collagen, gelatin, and seafood products. Foreign authorities that require these lists use FDA-provided information to identify and publish their own lists of approved firms. The FDA Unified Registration and Listing Systems(FURLS) is an expansion of the Dairy Listing Module (DLM), which was launched in July 2016 to manage dairy export lists. The expanded ELM allows all types of establishments to request inclusion on export lists, update listing information, and renew requests for inclusion on export lists as necessary. The FDA will use the information collected through the ELM to review firms’ information and provide updates to foreign authorities on a regular basis.

Beginning July 9, 2018, the FDA will receive and process new requests and updates to current listing information using the ELM for establishments exporting seafood and infant formula to China and establishments exporting collagen and gelatin products to the European Union. To ensure a successful transition to the electronic system, establishments that are currently listed for these products are strongly encouraged to submit a new request via the ELM. Establishments that previously submitted requests for inclusion on the dairy exports lists via the DLM will have continued access to these requests via the ELM.

The ELM will also allow establishments that wish to export milk, milk products, seafood, infant formula, and formula for young children to China to upload additional information requested by the Certification and Accreditation Administration of the People’s Republic of China (CNCA), regarding third-party certification of compliance with the relevant standards, law, and regulations of China. (For additional information, see 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: Guidance for Industry.) All currently listed establishments that wish to remain on the applicable export lists should provide such information through the ELM by June 15, 2019—if such information is not uploaded into the ELM by that time, we understand that CNCA intends to remove firms that have not provided such information from its lists. Establishments that wish to be added to an applicable list will be able to submit the third-party certification when they submit a new request for these lists in the ELM.

Establishments needing additional information may email CFSANExportCertification@fda.hhs.gov or call 240-402-2307.