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CFSAN/Office of Food Safety
April 2009
The EU's first implementation of new procedures requiring their formal "acceptance" of establishments on the FDA list has resulted in a substantial time lag between FDA's acceptance and recognition of an establishment into the program/FDA listing, and appearance of the establishment on the Official EU list. In response to this situation, the EU has informed FDA that they will provide member countries with the most up to date FDA list, but it will be up to each individual member state to decide if they will accept a shipment from an establishment not on the Official EU list. In these cases U.S. shippers will ship at their own risk.
FDA has continued and will continue to provide the EU with quarterly updates. However, even after resolution of the above situation, EU procedures indicate that there will be at least a 30 working day lag time between FDA's submission of updates and publication of the EU's Official list. In all cases shippers should check the Official EU list to verify an establishment is on that list prior to making a shipment. If a firm does not appear on the EU's Official list but does appear on the FDA's list, shipments may be made but will risk rejection, as noted above.
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The following lists are provided for use by European Union (EU) Member States for determining whether individual shipments of molluscan shellfish have been obtained in conditions at least equivalent to those governing the production and placing on the market of Community products, in conformance with Commission Regulation (EC) No 1666/2006 (and Commission Regulations (EC) No 853/2004 and (EC) No 854/2004).
US FDA-EU Export Certificate List (April 2009):
List of molluscan shellfish production areas (May 2008):
List of molluscan shellfish establishments:
These establishments are subject to the oversight of the National Shellfish Sanitation program (NSSP). The United States Food and Drug Administration (FDA) has the necessary powers to suspend the activities of the listed establishments from exporting to the European Union (EU) in the case of non compliance with the requirements stated above.