U.S. flag An official website of the United States government
  1. Home
  2. Food
  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Food Imports & Exports
  5. Exporting Food Products from the United States
  6. Food Export Lists
  7. Shellfish Export Lists
  1. Food Export Lists

U.S. exports of shellfish products to the European Union (EU) and the United Kingdom (UK) are subject to listing and certification requirements as a precondition for market access. The EU and UK maintain lists of establishments and growing areas from which live bivalve mollusks are approved for export. All shellfish exported to the EU and UK 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 and UK 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 and UK 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 or the UK 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 and UK lists. U.S. establishments that harvest live bivalve mollusks for export to the EU or the UK may apply to be included on the EU and UK lists of U.S. establishments approved to export live bivalve mollusks by submitting an application in FDA's Export Listing Module (ELM). Please note that FDA does not have a separate application process for the UK lists; establishments that wish to export to the UK should apply for the relevant EU list in the 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.

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 or UK must be listed on the lists of establishments approved to export fishery products. U.S. establishments that process shellfish for export to the EU or UK may apply to be included on the lists of U.S. establishments approved to export fishery products by submitting an application in FDA's Export Listing Module (ELM). Please note that FDA does not have a separate application process for the UK lists; establishments that wish to export to the UK should apply for the relevant EU list in the 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 or UK and process shellfish for export to the EU and UK must be included on both the EU and UK lists of U.S. establishments approved to export fishery products and the EU and UK lists of U.S. establishments approved to export live bivalve mollusks.

Composite Products Containing Shellfish

The EU and the UK regulate 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 or UK lists 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.

Fishery Products vs. Live Bivalve Mollusks

he EU and the UK maintain 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 and UK regulatory definitions for these categories to determine how these destinations classify the products they intend to export and on which list(s) they must be included in order to export.

  • The EU and UK 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. Please note that FDA does not have a separate application process for the UK lists; establishments that wish to export to the UK should apply for the relevant EU list in the ELM For more information about this list, please visit Seafood Exports to the European Union and China.
  • The EU and UK 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 or UK 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 and the UK define 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 and the UK define 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 Shellfish Exports to the EU:

Additional Information on Shellfish Exports to the UK:

To view U.S. establishments eligible to export raw shellfish products you will need to filter by Country Name (United States), Sector (Food), and then Section (Section VII Live bivalve molluscs). To view U.S. establishments eligible to export fishery products filter by Country Name (United States), Sector (Food), and then Section (Section VIII Fishery products).

 

 

SUBSCRIBE

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top