Instructions for completing EU Health Certificates
for Fish and Fishery Products

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Completing the EU Non-Molluscan Health Certificate

The completed form (not including the sections to be completed by FDA, i.e., the reference number, the "official signature," and the official seal) should be delivered to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate.  The following provides guidance for completing various sections of the EU Certificate:

Reference Number - FDA will assign and enter a certificate number.

Country of Dispatch - Enter "United States of America."

Competent Authority - Enter "United States Food and Drug Administration," and the district name and address.

Description of fishery/aquaculture product - Enter an appropriate description of the product(s) being shipped, i.e., "Frozen, Dressed Head-off Coho Salmon."  Cross out either "fishery" or "aquaculture," whichever does not apply.

Species (scientific name) - Enter the scientific name of the species being shipped, e.g., "Oncorhynchus kisutch" for Coho salmon.  The FDA Seafood List is a listing of common and species fish names.

 Presentation of Product and Type of Treatment - Enter "frozen," "canned," "dried," "smoked," "preserved," or other description as appropriate.

Code Number (where available) - Enter lot number if available. If none, leave blank.

Type of Packaging - Enter a description of the packaging, e.g., "Fiberboard Master Cartons with Plastic Liners."

Number of Packages - Enter the exact number of packages in the shipment.

Net Weight - Enter the total net weight of the shipment.

Requisite Storage and Transport Temperature - Enter the manufacturer's recommendation for shipping temperature, e.g., "45° F or 6° C."  General storage terms, such as "ambient," "refrigerated" "iced," or "frozen" are acceptable.

Name(s) and Official Approval/Registration number(s) of establishment(s), factory vessel(s), or Cold Store(s) Approved or Freezer Vessel(s) Registered by the Competent Authority to the EC - For Value-Added Processors:  Enter the name of the last Value-Added Processor, city, state, and CFN or FEI number.  If the processor is a vessel, enter the vessel name.  If the shipment includes product from more than one establishment, the names and CFN or FEI numbers of all the establishments should be entered.

Example:

If the product has been value added by several different establishments, the EU Certificate should identify the last establishment that processed the product.  For example, if salmon were eviscerated and frozen at establishment "A," portioned at establishment "B," and breaded and placed in the final package at establishment "C," then the EU Certificate should identify establishment "C" as the processor.

For establishments acting solely as dispatchers:  Enter the names, city, state, and CFN or FEI numbers of the last value added processor of the product being shipped.

For Other Than Value-Added Processors:  Enter the name, city, state, and CFN or FEI numbers of the Other Than Value-Added Processor shipping the product.  You should supply FDA with the names, cities, states, and CFN or FEI numbers of the Value-Added Processors of the product being shipped.

The Products are Dispatched: From - Enter the place the product left the country, e.g., Los Angeles, CA , USA.    

The Products are Dispatched: To - Enter the port of debarkation, e.g., "Le Havre, France," or if it is an air shipment, "Charles De Gaulle International Airport, Paris, France." 

By the Following Means of Transport - Enter the means of transport, e.g., "Air freight Northwest Airlines Flight 666."  (Note:  Flight information is optional but advisable, as there many need to be additional confirmation of this by some EU countries.)

Name and Address of Dispatcher - Enter the establishment name and address of the company or person that is making the shipment, e.g., "East West Seafood, P.O. Box 123 Nahcotta, WA, USA" 

Name and Address of Consignee at Place of Destination - Enter the name and address of the final destination, e.g., "Pierre's Seafood, 508 Rue Lafayette, Paris, France."

Done at - Enter the place the certificate will be signed (not prepared), e.g., "Boston, MA, USA." 

On - Enter the actual date of the voyage or flight.

Signature of Official Inspector - FDA official signs here in non-black ink.

Name in capitals, capacity and qualifications - FDA should enter in non-black ink the signatory's name, capacity, and qualifications, as appropriate in capitals.

Official Seal - FDA will apply the official seal (or stamp) to the circle as indicated. 

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Completing EU Molluscan Shellfish Health Certificates

The completed form should be delivered to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate. Complete these EU Certificates as follows:

I.1. Consignor - Enter the name, address, zip code, and telephone number of the company or person sending the shipment to be delivered (the owner of the product).

I.2. Certificate reference number - FDA will assign and enter a certificate number.

I.3. Central Competent Authority - Enter the name of the competent authority issuing the certificate, e.g., - "United States Food and Drug Administration"

I.4. Local Competent Authority - Enter the name and address of the State Shellfish Control Authority, e.g. "Commonwealth of Massachusetts, Dept. of Public Health, Div. of Food and Drug, 305 South Street, Jamaica Plain, MA 02130".
Note: Addresses for the State Shellfish Control Authority can be found in the Interstate Certified Shellfish Shippers List.

I.5. Consignee - Enter the name, address, postal code, and telephone number of the company or person that is to whom the shipment is to be delivered (the buyer of the product).

I.7. Country of origin - Enter the ISO name and the ISO code for the country of origin, e.g. - "United States" and "US" respectively.
Note: ISO country names and codes can be found at the International Organization for Standardization web site.

I.8. Region of origin - Enter the Name and Code (Approval Number) of the production area.
Note: Production area name and code can be found on the US FDA-EU Live Molluscan Shellfish Growing Area List.

I.9. Country of destination - Enter the ISO name and the ISO code for the country of destination.
Note: ISO country names and codes can be found at the International Organization for Standardization web site.

I.11. Place of origin - Enter the name, address, and approval number (CFN or FEI) [followed by a slash (/) and the Interstate Certified Shellfish Shippers List number] of last Certified Shellfish Shipper that handled (dispatched/shipped) the molluscan shellfish for each species. 
Note: Names, addresses (City and State), and Interstate Certified Shellfish Shippers List numbers of firms can be found on the Interstate Certified Shellfish Shippers List. CFN or FEI Numbers of firms can be found on the US FDA-EU Export Certificate Lists.

I.13. Place of loading - Enter the port of embarkation, e.g., "Seattle, WA USA" or if it is an air shipment, e.g., "Seattle-Tacoma International Airport, Seattle, WA USA."

1.14. Date of departure - Enter the actual date of the voyage or flight.

I.15. Means of transport - Check the appropriate box for the means of transport.

I.16. Entry BIP in EU - Enter the port of debarkation, e.g., "Le Havre, France," or if it is an air shipment, e.g.,"Charles De Gaulle International Airport, Paris, France."  
Note: Approved Border Inspection Posts can be found in the most recent amendment to the 2001/881/EC: Commission Decision of 7 December 2001 drawing up a list of border inspection posts agreed for veterinary checks on animals and animal products from third countries.

I.19. Commodity Code (HS code) - No Entry required. This has already been filled in with the appropriate code, i.e., "03 07."

I.18. Description of commodity - Enter a general description of the commodity or commodities, e.g., "Live oysters and live mussels."

I.20. Quantity - Enter the total net weight, in kilograms (kg) of the products in the shipment.

I.22. Number of packages - Enter the exact number of packages in the shipment.

I.23. Identification of container/Seal number - Enter the container number(s) and/or the seal number(s), if applicable.
Note: Enter "Not Applicable" if not applicable.

I.24. Type of packaging - Enter the type of packaging, e.g., "cardboard boxes" or "mesh bags."
Note: Enter "Various," if necessary.

I.25. Commodities certified for - Check the box for "Human Consumption."

I.27. For import or admission into EU - Check the box for "For import or admission into the EU.

I.28. Identification of the commodities

II.a. Certificate reference number - FDA will assign and enter a certificate number.

II.b. For EU Use Only - This space is to be left Blank.

Printing Certificate:  Print both Pages (back-to-back) on a Legal size sheet of paper.

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FOR FDA CERTIFYING OFFICER ONLY:

I.2. Certificate reference number - Enter a unique certificate number (in non-black ink).
Note: A Stamp (in non-black ink) may be used.

II.a. Certificate reference number – Enter the same certificate number (in non-black ink) entered in I.2.
Note: A Stamp (in non-black ink) may be used.

- Animal health attestation - Mark (draw a diagonal line in non-black ink) through the entire Animal health attestation (from upper-right to bottom-left) in paragraph (II.2.) on page 2.

- Official Inspector):

Name - Enter the Name of the certifying officer in CAPITAL LETTERS (If hand written use non-black ink).
Note: A Name Stamp (in non-black ink) may be used.

Date- Enter the Date of the shipment (If hand written use non-black ink).  Alternatively: The Month and Year may be Entered if Batching.
Note: A Date Stamp (in non-black ink) may be used.

Qualification and title - Enter qualification and title information (If hand written use non-black ink).
Note: A Qualification and Title Stamp (in non-black ink) may be used.

Signature of official inspector - Sign (in non-black ink).

Stamp - Apply Stamp (Embossed Seal).

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Guidance for Industry: Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association January 2008

European Union (EU) and European Free Trade Association (EFTA) Export Certificates for Fishery/Aquaculture Products and Live/Raw Molluscan Shellfish February 26, 2001; Updated January 2008