November 14, 2018

November 14, 2018

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November 13, 2018

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November 12, 2018

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Expanded FDA Electronic System Now Includes All Exports Lists

  • The U.S. Food and Drug Authority (FDA) announced the launch of an electronic portal, Export Listing Module (ELM), for receiving and processing requests from FDA- regulated establishments that want to be included on export lists for FDA-regulated food products. By way of background, some foreign authorities require FDA to provide publicly available lists of exporters eligible to ship certain food products to their country. For example, China requires a certification for compliance with relevant standards, laws, and regulations of China for imported milk and milk products, seafood, infant formula, and formula for young children. (See our June 30, 2018 blog for more details.)

  • Currently, FDA has export lists of companies that meet importing country requirements for dairy, infant formula, collagen, gelatin, and seafood products. The expanded ELM will include all exports lists and, therefore, improve efficiency. FDA stated that it will use the information collected through the ELM to review firms’ information and to provide updates to foreign regulatory agencies.

  • On July 9, 2018, FDA began receiving, updating, and processing new requests on current listing information using the ELM for firms exporting seafood and infant formula to China, as well as establishments exporting collagen and gelatin products to the European Union. FDA strongly recommends that companies currently listed for these products submit a new request via the ELM. However, companies that previously submitted requests for inclusion on the dairy exports lists via the previous Dairy Listing Module (DLM) will be able to access these requests via the ELM.

  • Firms exporting milk and milk products, seafood, infant formula, and formula for young children to China may have them removed from China’s lists by the Certification and Accreditation Administration of the People’s Republic of China (CNCA) if they do not provide information through the ELM by June 15, 2019. Therefore, these firms should not delay transitioning to the new ELM.

© 2018 Keller and Heckman LLP

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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