A molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands has been finalized by The US Food and Drug Administration.

Anna Abram, deputy commissioner for policy, legislation and international affairs at FDA declared- “Today’s announcement is about an exemplary achievement that will restart the trade in shellfish between the US and the EU for the first time since 2010. These decisions represent vital strategic global engagement and several years of meticulous inspection by the FDA on behalf of national as well as international consumers. Today we’re assisting unlock economic opportunity by designing a path forward to new market access for US exporters.”

The equivalence determination concludes the proposed determination that the FDA issued in the Federal Register of 2018 and is an outcome of a multi-year, in-depth review of EU shellfish safety controls adopted in Spain and the Netherlands. Technical specialists on both sides of the Atlantic have done disparate equivalence assessments and each side suggested a finding of equivalence after auditing food safety control measures for molluscan shellfish and on-site reviews to validate the other’s systems. The FDA will identify other EU Member States appropriate in separate determinations in the future.

Frank Yiannas, FDA deputy commissioner for food policy and response informed- “Presently we’re making a larger selection of nutritious and non-hazardous seafood options available to the American customer from Europe. Americans can be sanguine regarding the equivalence determination that Spain and the Netherlands have executed safety controls that are equivalent to ours, thus making us able enough to allow Spain and the Netherlands to export raw molluscan shellfish to the US. The FDA is determined to keep consumers safe and ensure the safety of our food supply including the seafood, whether it is imported or is domestically harvested.”

In a different action, the European Commission has also agreed to a food safety equivalence determination that will allow raw and processed molluscan shellfish as well as mussels, clams, oysters and scallops, to be imported from the US, starting with shellfish from Massachusetts and Washington.

The FDA, an organization within the US Department of Health and Human Services, safeguards the public health by ensuring safety, efficiency, and security of human and veterinary drugs, vaccines and other biological tools for human utilization, and medical devices. The agency is also accountable for the safety and security of nation’s food supply, dietary supplements, products that give off electronic radiation, cosmetics, and for controlling tobacco products.




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