Last updated on December 5, 2009
Below are a list of questions and answers on the referral of fishery products export health certification program from the U.S. Food and Drug Administration to NOAA Seafood Inspection Program. This document is intended to help the food industry and others comply with the guidance established by the June 15, 2009 Federal Register Notice issued by the FDA regarding changes to its EU export health certification program.
On January 15 2009, the Food and Drug Administration (FDA) published in the Federal Register notice that the FDA will no longer offer certification of fishery product exports to the European Union from the United States (Docket No. FDA-2004-D-0043, CFSAN 200843). The FDA completed a Certification Referral Program to the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) to include all fish and fishery products for export to EU or European Free Trade Association (EFTA) Member Countries.
Why did the FDA stop offering export certification to the EU for seafood?
The FDA has experienced significant increases in food safety responsibilities and declines in resources available for food safety. In order to carry out public health activities and regulatory oversight that are intended to protect the U.S. consuming public, FDA is focusing its resources to higher priority programs and determined that it could no longer justify the use of its limited food safety resources for issuance of EU Export Certificates, especially when another agency has resources available to issue certificates as part of its mission.
When did the change go into effect?
The effective date for the transition was June 17, 2009.
Is this a new program for the NOAA Seafood Inspection Program?
No. The NOAA Seafood Inspection Program has been recognized by the EU as a Competent Authority for issuance of export health certificates for many years. When FDA discontinued its export certification program for fishery products, NOAA remained. The number of certificates issued by NOAA increased when this change took effect.
What is the difference between an EU health certificate and EU IUU catch document? Why do I need both?
Certification for fish and fishery products is required by two separate EC directorates with distinct and separate responsibilities. The health certificate is required by the EU Directorate-General for Health and Consumer Protection and attests to the safety of fish and fishery products shipped to the EU. The IUU catch document is required by the EU Directorate-General for Maritime Affairs and Fisheries and attests that the items in the shipment were caught in compliance with the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.) and other applicable state and Federal conservation and management laws and regulations. Both are required under EU regulations.
What products require export health certification?
The EU requires a health certificate for all fish and fishery products, including molluscan shellfish. Fish and fishery products are all “Aquatic Animal Product” derived from species of the animal kingdom living in or in direct association with water, to include but not be limited to reptiles, finfish, crustaceans, mollusks and amphibians. The definition of ‘aquatic animal products’ may also include live aquatic animals destined for use as human food, stocking, relay, aquaculture, or reproduction.
Is health certification required for fishery products intended for animal feed or pet food?
Yes. All products derived from Aquatic Animals intended for use as animal feed, pet food and bait require certification.
Is health certification required for food transiting the EU for exportation to another country?
Yes. The product will require a bilingual health certificate for inspection at the Border Inspection Post of the EU Member State country where the product enters and transits. Health certificates many also be required for entry into non-EU countries to where the product is re-exported.
Are there exceptions or exemptions from health certification?
No. All fishery products entering into the EU require export health certification for entry and transit within the EU, including: Food items of small value or quantity; Food samples for research and development or for testing purposes; Food samples for test marketing or trade samples; and, Food intended for charity.
HOW TO REQUEST CERTIFICATION
How do I request for an EU health certificate from NOAA Seafood Inspection Program?
The NOAA Seafood Inspection Program launched a website through which current and new customers may request certificates for export to the European Union (EU). The Online Request System will streamline and simplify the process to request export certification services. To gain access to the new online system, customers must request access from the Seafood Inspection Program and log in using a username and password to place a new request. Questions about the program or technical difficulties should be directed to the Inspection Office nearest you.
Do I have to submit a request to both FDA and NOAA?
No. The FDA will refer all requests for export certification to NOAA Seafood Inspection Program. Shippers, processors, and packers wishing to export fish and fishery products to the EU and EFTA must apply to FDA for inclusion on the US-FDA and EU Export Certification Lists. Only establishments on the list will be granted a certificate from NOAA.
Are there other U.S. agencies certifying exports to the EU?
NOAA Seafood Inspection Program is now the only Competent Authority in the U.S. recognized by the EU to issue fishery product export certificates.
Who may submit requests to NOAA for health certification?
Anyone may request certificates for export of fishery products from the U.S. to the EU. Shippers, processors, and packers wishing to export fish and fishery products to the EU and EFTA must apply to FDA for inclusion on the US-FDA and EU Export Certification Lists. Only establishments on the list will be granted a certificate from NOAA.
May I request pre-issued signed health certificates?
No. All NOAA Seafood Inspection Program health certificates are completed, signed, stamped and issued as they are requested. Customers may request multiple certificates at one time for products that will be exported in distinct shipments using the Online Request System.
Is EU certification available in languages other than English?
Yes. The NOAA Seafood Inspection Program offers certification on bilingual certificates for each EU Member State.
PRODUCT INSPECTION AND HEALTH CERTIFICATION
Will product be physically inspected prior to shipment?
The NOAA Seafood Inspection Program will conduct random sampling for EU Export Certificate inspections. Based on product evaluation, each request will fall into risk assessment categories, and then will be randomly chosen for physical product inspection. NOAA will inspect product in all contract facilities during quarterly audits. All products from non-contracted facilities must be available if chosen at random for physical inspection. The processor or exporter will incur no additional costs when products are chosen at random.
How will the health certificates be prepared?
The NOAA Seafood Inspection Program launched a website through which current and new customers may request certificates for export to the European Union (EU). The Online Request System will streamline and simplify the process to request export certification services. After a new request is submitted, the Inspection Branch nearest you will prepare, validate, sign, stamp and deliver the certificate.
How long does it take to create health certificates after the request is filed?
EU Regulations require products to be certified prior to departure from the exporting country. The NOAA Seafood Inspection Program has a long history of issuing export certificates and will provide export certification in a timely manner that will not inhibit commerce. Requests should be submitted with reasonable lead time to allow for product inspection, loading and the creation and distribution of paperwork.
How can the health certificates be delivered?
Export health certificates are delivered via FedEx Overnight or may be picked up in person at the Inspection Office nearest you.
What happens to food that is exported without adequate health certification?
Fishery product shipments will be held or refused admission for lack of certification at the EU Border Inspection Posts. Health certification must be issued prior to departure of the product from the U.S.
Are seal or container numbers mandatory on the EU export health certificate?
No, EU Regulations do not require seal or container numbers to be included on the health certificate. However, some Member States are requesting this information and it may be added to the certificate upon request and under certain circumstances.
How can I be sure of the correct HS code when preparing an export health certificate?
The Harmonized System (HS) is a multipurpose international product nomenclature developed by the World Customs Organization (WCO). A list of HS codes can be found on WCO's website or click below.
Fish and crustaceans, molluscs and other aquatic invertebrates
Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates
Can I request health certificates electronically? Can the health certificate be delivered electronically?
Both EU health certificates and EU IUU catch documents may be requested from the NOAA Seafood Inspection Program electronically using the Online Request System. At this time, there is no electronic system for health certification; health certificates may only be provided on paper with physical stamps and signatures. Catch documents required by the EU to prevent, deter, and to prevent, deter and eliminate Illegal, Unreported, and Unregulated (IUU) fishing are issued by NOAA Seafood Inspection Program electronically.
COSTS AND PAYMENTS
How does it cost to get an EU export health certificate?
Current NOAA Seafood Inspection Program approved establishments with in-plant inspectors and other contracted services such as lot inspection, will incur no additional charges for health certificates beyond current contract rates. Costs will be absorbed in the daily contract services. All services provided above and beyond contract hours will be billed additional time at hourly rates. NOAA Seafood Inspection Program approved establishments with HACCP QMP and IQA contracts will be charged at the flat rate of $79 per certificate. Requestors without a current contract will be billed at the flat rate of $99 per certificate.
Why is there a charge for these certificates?
The NOAA Seafood Inspection Program is a fee for service program that is required to recuperate all costs associated with the program and its services.
Is there an additional charge for random product inspections?
There are no additional costs associated with the requests that are selected for random sampling. These inspection costs are included in the fees charged for the overall EU certificate program.
Must I prepay or can I establish an account for billing?
All non-contract services must be pre-paid through the website Pay.gov.
The Pay.gov website will notify the Seafood Inspection Program when a payment is made.
WHERE TO GET ADDITIONAL INFORMATION
The U.S. Food and Drug Administration Guidance for Industry regarding the Referral Program from FDA to NOAA for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/ucm113218.htm
U.S. Department of Commerce/NOAA Fisheries • 1315 East West Highway • Silver Spring, MD 20910 • Phone (301) 427-8300 • Toll Free (800) 422-2750
- NOAA Inspection Manual
- Inspection & Analytical Services Fees
- Consumer Tips
- Certificate Validation
- "An informed society that has confidence in the seafood that they purchase, sell and consume today and in the future."
- To ensure the safety and quality as well as enhance the marketability and sustainability of seafood products for the benefit of the American consumer by providing science based inspection services to the seafood industry.