FDA Guidance on EU Export Certificates for Seafood
Questions and Answers
(November 2004)

Introduction

Since 1993, the European Union (EU) has required that an EU Export Certificate accompany all shipments of fish and fishery products that are shipped to the EU.  For fish and fishery products generally, the certificates that FDA signs essentially attest that the products have been produced in accordance with a Hazard Analysis Critical Control Point (HACCP)-based safety system that is at least equivalent to the EU system of control.  The FDA HACCP regulations have been deemed by the European Commission to be equivalent, in principle, to the EU system of control.  In 1996, the EU also began requiring a different certificate specifically for shipments of live molluscan shellfish (e.g., oysters, clams, mussels).  These certificates are based partly on equivalence to, and partly on consistency with, EU requirements.

In 1993, to ensure the smooth flow of trade in fish and fishery products to the EU, FDA began issuing certificates for shipments of fish and fishery products to the EU.  The FDA also issues certificates for shipments of fish and fishery products to EU Accession Partnership Countries and EFTA Members.  A certificate is issued if it is determined that the establishment⁽¹⁾ is in regulatory good standing with FDA.  The Seafood Inspection Program of the National Oceanic and Atmospheric Administration (NOAA SIP) of the U.S. Department of Commerce also issues EU Export Certificates as one service that it offers U.S. seafood processors and other entities in its voluntary, fee-for-service seafood inspection program. 

1. What is FDA issuing today?

   FDA is issuing two draft guidance documents relating to certification of seafood for export to the EU. The first draft guidance is a draft protocol for industry and FDA for purposes of overall clarification and to ensure uniformity in the procedures used to issue these certificates. The draft guidance provides considerable detail on the circumstances under which a firm is eligible to receive a certificate, e.g., when products are produced in the U.S. or value is somehow added in the U.S., and when a firm is not eligible, e.g., when a product is transshipped through the U.S. with no value added.

   The second draft guidance proposes a Referral Program for a 24-month period to test the viability and effectiveness of referring requests for EU certification for live and fresh products to NOAA SIP. During this period, EU Export Certificates for all shipments of live and perishable fish and fishery products destined for the EU, EU Accession Partnership Countries, and EFTA Members would be issued by the NOAA SIP under the authority of the Agricultural Marketing Act.

2. What has prompted FDA to issue the draft guidance for the referral program?

   The demand for EU Export Certificates by the U.S. seafood industry has risen dramatically in recent years and has caused significant resource allocation problems for FDA. The diversion of agency resources to such discretionary activities, which do not contribute to U.S. public health protection, diminishes the agency’s ability to carry out public health activities and regulatory oversight that are intended to protect the U.S. consuming public. The increased demand, in combination with limited FDA resources, creates a particular problem for live and perishable fish and fishery products whose value depends on prompt exportation.

3. Does FDA still have a role in issuing EU Certificates?

   Yes, FDA will continue to issue EU certificates for frozen, canned and preserved products that are not time sensitive. In addition, the basis for issuing EU Export Certificates under the Referral Program would be, as it is now, whether the establishment or establishments in question are in regulatory good standing with FDA, which will be determined by FDA. FDA intends to continue to serve as the lead competent authority in the U.S. for fish and fishery products. FDA will also maintain an updated database on the current regulatory status of U.S. entities that have applied to receive EU Export Certificates.

4. What costs are involved in the referral program?

   Please refer to The National Oceanic and Atmospheric Administration website for costs (available in PDF).

5. What products are affected by the referral program?

   Live and fresh fish and fishery products e.g. live lobster and crab, fresh salmon, fresh monkfish fillets are included in the referral program.

6. What products are not affected by the referral program?

   Products that are preserved, such as frozen, canned, dried, vacuum packed, etc. are not affected by the referral program.

7. Who can I contact if I have live and fresh fish and fishery product shipments?

   You may contact the National Oceanic and Atmospheric Administration's website or for more information visit FDA's website on food export certificates.

⁽¹⁾ "Establishment" refers to any structure, or structures under one ownership at one general physical location, or, in the case of a mobile establishment, traveling to multiple locations that manufactures/processes, packs, or holds food.  Transport vehicles are not establishments if they hold food only in the usual course of business as carriers. An establishment may consist of one or more contiguous structures, and a single building may house more than one distinct establishment if the establishments are under separate ownership. 

Draft Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association November 22, 2004

Draft Guidance for Industry: Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association November 22, 2004