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  7. Shellfish Exports to the European Union
  1. Food Export Lists

Shellfish Exports to the European Union


U.S. exports of shellfish products to the European Union (EU) are subject to EU listing and certification requirements as a precondition for market access. The EU maintains lists of establishments and growing areas from which live bivalve mollusks are approved for export to the EU. All shellfish exported to the EU must be harvested from growing areas and harvested by establishments that appear on these lists. Most shellfish products exported from the United States to the EU must also be accompanied by certificates issued by the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program.

Please review the sections below for more information on the EU import requirements for live bivalve mollusks (clams, mussels, oysters, and scallops), processed shellfish products, and composite products containing processed shellfish.

For more information on certificates, visit the  National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program.

Live Bivalve Mollusks

Live bivalve mollusks intended for export to the EU must be harvested from listed growing areas and harvested by listed establishments. FDA works with state shellfish authorities to ensure that all eligible U.S. growing areas are included on the EU's list. U.S. establishments that harvest live bivalve mollusks for export to the EU may apply to be included on the EU's list of U.S. establishments approved to export live bivalve mollusks by submitting an application in FDA's Export Listing Module (ELM). Please visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions. U.S. establishments that meet the following criteria are eligible to be included on this list:

  • Establishments must be located in states that are listed in Annex I of Commission Implementing Regulation (EU) 2019/626.
  • Establishments must be in good regulatory standing with their state shellfish authority and must appear on the Interstate Certified Shellfish Shippers List (ICSSL).
  • Establishments must be in good regulatory standing with FDA.

For more information, visit the EU Commission Implementing Regulation (EU) 2019/626 and the EU's list of U.S. establishments approved to export live bivalve mollusks.

Processed Shellfish Products

Any shellfish material used in processed shellfish products must be harvested from listed growing areas and harvested by listed establishments as described above.

Establishments that process shellfish material for export to the EU must be listed on the EU's lists of establishments approved to export fishery products. U.S. establishments that process shellfish for export to the EU may apply to be included on the EU's list of U.S. establishments approved to export fishery products by submitting an application in FDA's Export Listing Module (ELM). Please visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions.

Establishments that harvest live shellfish for export to the EU and process shellfish for export to the EU must be included on both the EU's list of U.S. establishments approved to export fishery products and the EU's list of U.S. establishments approved to export live bivalve mollusks.

For more information, visit the EU's list of U.S. establishments approved to export fishery products and the EU's list of U.S. establishments approved to export live bivalve mollusks.

Composite Products Containing Shellfish

The EU regulates food containing products of plant origin and processed products of animal origin as "composite products" (Commission Delegated Regulation (EU) 2019/625).

Any shellfish material used in composite products must be harvested from listed growing areas and harvested by listed establishments as described above. Any processed shellfish products used in composite products must be sourced from listed establishments as described above.

If the processing of the shellfish material is part of the production of the final composite product, the establishment that produces the composite product must appear on the EU's list of U.S. establishments approved to export fishery products. If the processing of the shellfish material occurs separately and is not part of the production of the final composite product, the establishment that produces the composite product must be registered with FDA, but it does not need to be listed.

For more information, visit the EU Commission Delegated Regulation (EU) 2019/625 and the EU's list of U.S. establishments approved to export fishery products.

Fishery Products vs. Live Bivalve Mollusks

The EU maintains separate listing and certificate requirements for products that it classifies and defines as fishery products versus those it classifies as live bivalve mollusks. U.S. establishments should review the EU regulatory definitions for these categories to determine how the EU classifies the products they intend to export and on which EU list(s) they must be included in order to export.

  • The EU regulations define “fishery products” as “all seawater or freshwater animals (except for live bivalve [mollusk], live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals” (Regulation (EC) No 853/2004). U.S. establishments that intend to export fishery products (including processed shellfish products) to the EU may submit an ELM application to request inclusion on the EU's list of U.S. establishments approved to export fishery products. For more information about this list, please visit Seafood Exports to the European Union and China.
  • The EU regulations define “bivalve [mollusk]” as “filter-feeding lamellibranch [mollusk]” (Regulation (EC) No 853/2004). U.S. establishments that intend to harvest live oysters, clams, mussels, or scallops for export to the EU may submit an ELM application to request inclusion on the EU's list of U.S. establishments approved to export live bivalve mollusks.

For more information, visit Regulation (EC) No 853/2004 and Regulation (EC) No 853/2004.

Processed vs. Unprocessed Products

The EU defines processing as “any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes” and processed products as "foodstuffs resulting from the processing of unprocessed products” (Regulation (EC) 852/2004). The EU defines unprocessed products as “foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed” (Regulation (EC) 852/2004).

For more information, visit Regulation (EC) 852/2004.

Additional Information on the EU Shellfish Export List:

 

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