European Union (EU) and European Free Trade Association (EFTA) Export Certificates for Fishery/Aquaculture Products and Live/Raw Molluscan Shellfish

ATTENTION ALL SHIPPERS

The following changes became effective on November 1, 2007.

1) Live molluscan shellfish

Previously, shipments of live molluscan shellfish for retail/human consumption to the EU were subject to the certification and public health attestation as defined in Commission Decision 96/333/EC of 3 May 1996. However, as of November 1, 2007 shipments of live molluscan shellfish must be accompanied by new public health certificates, which include the public health and animal health attestations required by EC Regulation 1664/2006 (OJ L 320; 18 Nov. 2006, available in PDF and other languages.)

It is our understanding that only the public health attestation section of the certificate needs to be completed for product intended for retail/human consumption. The animal health section of the certificate is only applicable for product intended for grow out in the EU and may be crossed out on certificates for retail only products.

For any shipments intended for grow out that need the animal health section of the certificate completed, please contact the National Marine Fisheries Service's (NMFS), Seafood Inspection Program at (301) 713-2355.

The EU has also requested a listing of all shellfish production areas and associated codes. The information provided on the certificate must match the information on the list or the exporter risks refusal of his product by the EU. The FDA has provided the following list for this purpose and will maintain the list through coordination with the state shellfish control authorities.

• EU Live Molluscan Shellfish Growing Area List (Areas/Zones) by State

2) Aquacultured finfish

Shipments of aquacultured finfish to the EU intended for retail/human consumption will continue to use the existing certificate issued in accordance with 96/199/EC, providing they comply with current packaging and labeling requirements, as outlined in 853/2004/EC.

However, as of November 1, 2007, shipments of aquacultured finfish intended for other than retail/human consumption must be accompanied by the public health certificates, and animal health attestations required by EC Regulation 664/2006 (OJ L 320; 18 Nov. 2006, available in PDF and other languages.)

For any shipments of aquacultured finfish that need an animal health attestation, please contact the NMFS Seafood Inspection Program at (301) 713-2355.

In the past the EU has accepted and used the Food and Drug Administrations (FDA) list of approved seafood establishments for acceptance of U.S. seafood shipments. However, due to a change in EU legislation, the EU began maintaining their own Official List of approved establishments. This has resulted in two separate (and different) lists for fish and fishery products:

• FDA list of approved establishments
• Official EU list (available in PDF*) updated 04/29/2008

In addition, live molluscan shellfish are not considered fish and fishery products by EU definition and are handled under bilateral agreement with the EU member states. Therefore, a separate list was needed for EU acceptance of live /raw molluscan shellfish. The EU member states have been provided the following list for this purpose:

• Interstate Certified Shellfish Shippers List

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.