U.S. exports of bivalve molluscan shellfish products to the European Union (EU) are subject to EU listing requirements as a precondition for market access.
All shellfish intended for export to the EU must be harvested from shellfish growing areas that appear on the EU's List of U.S. Establishments Eligible to Export Live Bivalve Molluscs to the EU (EU shellfish export list). FDA will work with state shellfish authorities to ensure that all eligible growing areas are included on the EU shellfish export list.
All shellfish products intended for export to the EU must be harvested by U.S. establishments that appear on the EU shellfish export list. Any establishment that processes shellfish material for export to the EU must also be listed on the EU shellfish export list. U.S. establishments located in states that are listed in Annex I of Commission Implementing Regulation (EU) 2019/626 may apply for inclusion on the EU shellfish export list via 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.
Please note that the EU regulates food containing both products of plant origin and processed products of animal origin as "composite products" (Commission Delegated Regulation (EU) 2019/625). The EU listing requirements for establishments that produce composite products containing processed products of shellfish origin vary depending on how the shellfish material is processed.
- 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 be registered with FDA and must appear on the EU shellfish export list.
- 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 on the EU shellfish export list.
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 molluscs/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 molluscs, 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 these products to the EU should submit an ELM application for the EU seafood export list.
- The EU regulations define “bivalve molluscs” as “filter-feeding lamellibranch molluscs” (Regulation (EC) No 853/2004). U.S. establishments that intend to export oysters, clams, mussels, or scallops to the EU should submit an ELM application for the EU shellfish export list.