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FDA and the European Commission Finalize First Food Safety Equivalence Determinations Permitting Trade of Molluscan Shellfish

As previously reported on this blog, on March 8, 2018, the U.S. Food and Drug Administration (FDA) published a proposed determination that the European Union (EU) food safety control system for raw bivalve molluscan shellfish intended for export into the United States provides at least the same level of sanitary protection and is, therefore, equivalent to the United States’ system.  U.S. shellfish imports have not been allowed to enter the EU since 2010 and FDA has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the 1980s.

On September 24, 2020, FDA published a final determination that the adoption and implementation by Spain and the Netherlands of the EU’s system of food safety control measures for raw bivalve molluscan shellfish, along with their application of additional measures specifically adopted for export to the U.S., provides at least the same level of sanitary protection as comparable food safety measures in the U.S. and is therefore equivalent.  This final equivalence determination will permit the importation of raw shellfish harvested from certain production areas in Spain and the Netherlands from establishments that have been listed by FDA on the Interstate Certified Shellfish Shippers List (ICSSL).  Complementary action by the EC will permit the import of raw bivalve molluscan shellfish from Massachusetts and Washington.

While the scope of FDA’s equivalence determination was narrowed to encompass only Spain and the Netherlands, it provides a basis for making future determinations that may cover additional Member States that adopt and implement the same measures.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 272
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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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