Eligible/Ineligible Products

• Eligible Products:
  1. Egg products that are regulated by FSIS
• Ineligible Products:
  
  Egg products that have not undergone one of the treatments listed under the second (a) of II.2.3. on the EP certificate, coming from the zones listed below, as illustrated in the hyperlinked map in the "zone" column, produced on or after indicated "date of start of ineligibility" are not eligible to export to or transit via the European Union. If a facility is located in multiple zones, the earliest date of ineligibility must be used. Within the zone, egg products processed before the indicated date are eligible.

• Egg Products Intended for Commerce to the European Union


• Flock Certificate:
  Plant management must present an Egg Product flock certificate, signed by the accredited veterinarian responsible for animal health at the farm where the eggs for breaking originate, when making application for the Egg Products export certificate. The veterinarian must have Category II accreditation in the State where the flock is located to sign the flock health certificate. If you need assistance locating a private veterinarian with the appropriate accreditation, please utilize the Accredited Veterinarians Search Tool. Applicants may look up the FDA Establishment Identifier (FEI) number for the establishments (farm/shell egg producer) in the FEI Search Portal.
  NOTE: This flock certificate is for U.S. use only and should not be sent to the EU.
• Labeling Requirements and Identification Marking:
  In addition to the general requirements for identification, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured. The label should include a "Best Before Date of DD/MM/YYYY under Storage Temperature of xx C, with the understanding that shelf life and storage conditions are determined by specifications of _________ (name of establishment)."
• Sampling:
  1. The sampling requirements for unpasteurized and finished product laboratory analyses to be completed for each production lot for certification purposes are:
     1. Organic acid (3 OH-butyric acid and lactic acid)- To provide an adequate amount of product for these analyses, collect a separate sample of unpasteurized product. If the production run involves the processing of liquid unpasteurized egg which is representative of the shell egg broken, an 8-ounce sample is adequate. However, if different storage tanks represent different shell eggs broken or bulk liquid received, an 8-ounce composite from all storage tanks shall be submitted. Unpasteurized albumen intended for drying must be sampled prior to adding culture or adjustment of the pH with a food grade acid(s). The sample must be specifically identified with applicable information for analysis for organic acids. Freeze the sample for shipment. Complete a separate certificate, Form PY-200, to accompany the sample to the laboratory in a separate shipping container. If laboratory results show no detection of organic acids, the results will be recorded as negative. When results are positive, the laboratory will indicate the type and amount of organic acid present.
        
        To be eligible for certification the amount of each organic acid cannot exceed that listed below:
        
        Lactic acid - 1,000 mg/kg
        OH-butyric acid - 10 mg/kg
        
        Example of instruction to the laboratory technician: Test for organic acids (3 OH-butyric acid and lactic acid.)
     2. Enterobacteriaceae - Identify in the instructions to the laboratory technician, five samples for individual analysis for enterobacteriaceae. Results for each sample will be reported on the certificate. A lot is not eligible for certification if any result for enterobacteriaceae is reported as more than 100 colony forming units per gram or ml or if more than 2 samples are greater than 10 colony forming units per gram or ml. Example of the instructions to the laboratory technician: Analyze (five samples) sample individually for enterobacteriaceae.
     3. Extraneous material (egg shell, egg membrane, and other particles) - Collect and identify a separate sample of finished product for analysis for extraneous material. Submit an 8-ounce sample for both pasteurized liquid/frozen or dried product. To be eligible for certification, results cannot exceed 100 mg/kg in finished product. Example of the instructions to the laboratory technician: Analyze for extraneous material.

  To prevent confusion at the laboratory, it is essential that all samples be legibly identified (sample number, code date, name of plant, and the type of analysis to be performed - e.g., microbiological, organic acids, extraneous material). Additionally, the instructions to the laboratory technician must be specific to assure that the necessary analyses are completed.
  
  All samples for this certification must be sent to:
  
  USDA,AMS, Science and Technology National Science Laboratory
  801 Summit Crossing Place, Suite B
  Gastonia, NC 28054
  Telephone: (704) 867-3873

  Documentation - Required Certificates

  Upon receipt of results of laboratory analyses, determine that the lot of product tested is eligible (does not exceed the criteria stated above) for certification, and review of the Flock Certificate to ensure compliance with Animal Health attestations. Each shipment consigned to a destination within the European Union must be accompanied by FSIS Form 9060-5EP, Egg Products Export Certificate of Wholesomeness, the FSIS Letterhead Certificate, and a copy of the PY-200 that identifies lab results.

  Additional Certification requirements for all shipments

  1. The English letterhead certificate should be issued for all shipments and certificates in other languages may be issued upon request of the exporter.
  2. Apply an export stamp (as shown in 9 CFR 381.104) to each page of the letterhead certificate in a color other than black. The export stamp will show the corresponding FSIS Form 9060-5EP certificate number. Each page of the export certificate must be signed by an FSIS Veterinarian. Applicable statements shall be kept as appropriate and statements which are not relevant, should be marked through (single line through non-applicable text), initialed, dated, and stamped with the Export mark of inspection by the certifying FSIS veterinarian.
     
     NOTE: All attestations that have been pre-marked through on the versions below, and any attestations that are marked through by the signing official, need to be initialed, dated, and stamped by the FSIS veterinarian.
  3. Exporters must ensure that the egg product establishment number on the certificates and the containers is identified exactly as shown in the plants eligible to export to the EU.
  4. Exporters must ensure that the shipping date on any original export certificate or accompanying shipping documents does not precede the FSIS signature date on the certificate. Failure to do so will result in the rejection of the shipment at the Port of Entry into the European Union. If the consignment has departed, FSIS will not sign the certificate. On replacement certificates, the date of departure may precede the signature date as the shipment may have departed prior to issuing the replacement certificate.
  5. EU requires that the export stamp be applied on the containers.
  6. For all Replacement certificates please add the following statement on the last page of the letterhead certificate:
     
     "This certificate no________to the EU is issued on (today's date) is in lieu of certificate no . ___________ dated_____________."
  If multiple certificates are consolidated into one Replacement certificate, then please list each certificate number and the date.
  
  The following letterhead certificate is required for egg products intended for commerce in the EU: ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF EGG PRODUCTS INTENDED FOR HUMAN CONSUMPTION (EP) in English
  
  Requests for certificates in other EU Member State languages should be submitted through askFSIS.
  
  See guidelines to complete the letterhead certificate.

Egg products for transit through or temporary storage in the European Union

Flock Certificate:

Plant management must present an Egg Product flock certificate, signed by the accredited veterinarian responsible for animal health at the farm where the eggs for breaking originate, when making application for the Egg Products export certificate. The veterinarian must have Category II accreditation in the State where the flock is located to sign the flock health certificate. If you need assistance locating a private veterinarian with the appropriate accreditation, please utilize the Accredited Veterinarians Search Tool. Applicants may look up the FDA Establishment Identifier (FEI) number for the establishments (farm/shell egg producer) in the FEI Search Portal.

NOTE: This flock certificate is for U.S. use only and should not be sent to the EU.

Shipments of U.S. egg products transiting through or being temporarily stored in a European Union member country (including ships' stores) must be accompanied by the:

FSIS Letterhead Certificate, ANIMAL HEALTH CERTIFICATE FOR THE TRANSIT THROUGH THE UNION TO A THIRD COUNTRY EITHER BY IMMEDIATE TRANSIT OR AFTER STORAGE IN THE UNION OF EGG PRODUCTS INTENDED FOR HUMAN CONSUMPTION (TRANSIT EP) in English

See Guidelines to complete.

Plant Eligibility

Plant management seeking EU approval should complete and submit FSIS Form 9080-3, Establishment Application for Export, through PHIS.

NOTE: Establishments that are not using PHIS must submit a fully completed (not including FSIS signatures) 9080-3 Form to the FSIS Proxy for entry into PHIS. Information on sending completed 9080-3 Forms to the FSIS Proxy is available on the FSIS Export Library - Requirements by Country page or by clicking here.

The European Union official website where US approved establishments for export to the EU is available at Establishment Lists - TRACES NT (europa.eu).

The products defined below are eligible for export to the European Union provided that the production systems used to produce them and all pertinent EU requirements are met.

1. "Meat" means all parts of domestic bovine animals (including bison) and swine, which are suitable for human consumption. Note: For bison, FDA is the "competent authority" however, since EU considers bison as fresh meat, FSIS conducts plant review and signs export certification.
2. "Fresh meat" means meat, including meat vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any treatment other than cold treatment to ensure preservation.
3. "Poultry meat" means all parts fit for human consumption from domestic birds of the following species: domestic fowl, turkeys, guinea fowl, ducks and geese.
4. "Fresh poultry meat" means poultry meat, including meat which is vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any preservation process other than chilling or freezing.
5. "Offal" means fresh meat and fresh poultry meat other than that of the carcass, even if it remains naturally connected to the carcass.
6. "Meat preparations" means meat (from carcasses, offal, poultry meat, minced meat, wild game, or rabbit) which have had foodstuffs, seasonings or additives added to them; or which have undergone a treatment insufficient to modify the internal cellular structure of the meat and, thus, does not cause the characteristics of the fresh meat to disappear.
7. "Meat products and treated stomachs, bladders and intestines" means products prepared from or with meat, including poultry meat, which has undergone treatment such that the cut surface shows that the product no longer has the characteristics of fresh meat. Treated stomachs, bladders and intestines are considered meat products by the EU. Treatment of these products may include cleaning, salting or drying, and/or heating. Meat extracts and meat powders for human consumption, including concentrated or dried poultry, beef, and pork stock, are considered meat products by the EU and must comply with all meat products requirements. The following are not meat products: meat which has undergone only cold treatment and products such as minced meat, meat in pieces of less than 100 grams, and meat preparations.
8. "Minced meat" means meat which has been minced into fragments or passed through a spiral-screw mincer.
9. "Other products of animal origin" are (1) rendered animal fat: fat derived from rendering meat, including bones, and intended for human consumption; (2) greaves: the protein-containing residue of rendering, after partial separation of fat and water; (3) gelatin (contact FDA - Dr. Jeff Hamer at jeffrey.hamer@fda.hhs.gov ; and (4) powdered rind, salted or dried blood, salted or dried blood plasma.
10. "Farmed game" means land mammals or birds which are not considered as domestic and are not referred to in the definitions of meat or poultry meat, but which are farmed as domestic animals. For further information on FDA regulations covering farmed game, contact Dr. Jeff Hamer at jeffrey.hamer@fda.hhs.gov
11. "Wild game" means wild land mammals which are hunted (including wild mammals living within an enclosed area under conditions of freedom similar to those enjoyed by wild game) and wild birds which are not covered by the EU farmed game meat directive.
12. Meat, poultry, offal, and giblets intended for pet food manufacture or pharmaceutical processing must comply with the additional denaturing, labeling and certification requirements identified in other sections of this document.
13. Ships' Stores
    1. Ships' Stores: Products intended for ships’ stores in the EU must be sourced from slaughter establishments on the EU Eligible Establishment List - TRACES NT (europa.eu) OR registered on the "Official Listing for Eligible Suppliers for the USDA Export Verification Program for Products Transiting the EU”. Product must be destined to an authorized bonded storage point. 
14. Military Shipments
    1. See Military Tab subsection.
15. Fish of the order Siluriformes
    1. Until further notice, the National Oceanic and Atmospheric Administration (NOAA) is the competent authority for issuance of certificates for fish of the order Siluriformes to the EU. Please see the NOAA guidelines for EU export certification of fish. Refer to the Military tab for shipments of fish of the order Siluriformes destined for Military use.
16. Composite products:
    1. Food containing both products of plant origin and processed products of animal origin regardless of the percentage of animal product used as an ingredient.

1. Lamb and mutton are currently not eligible for export to the European Union.
2. Eligibility of equine products, including horsemeat, has not been determined at this time. Information will be provided as it becomes available. Until eligibility information is provided, export certification cannot be issued for equine products intended for export to the European Union.
3. Poultry meat and poultry meat products produced prior to the ineligibility dates indicated below are eligible for export, however, they must enter the European Union within 90 days of the ineligibility date in order to be allowed entry. Exporters are advised to check with their importers to confirm eligibility of poultry meat and poultry product prior to shipping product from before the ineligibility date.
   1. Poultry meat and poultry meat products from the 10 km zones below, produced on or after the indicated date are not eligible to export to or transit via the European Union. If a facility is located in multiple zones, the earliest date of ineligibility must be used. Within the 10 km zones, poultry slaughtered and processed before the indicated date are eligible, unless otherwise noted in one of the restricted zones below.