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 product intended for commerce in the EU. Veterinary Certificate for egg products consigned to the European Community is available:

  For Certificates signed prior to June 14, 2022 in  English

  For Certificates signed on or after June 15, 2022 in English  

  
  Requests for certificates in other EU Member State languages should be directed to FSIS at 202-720-0082, , or at ImportExport@usda.gov.
  
  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 (EP)is available:

For Certificates signed prior to June 14, 2022 in English

For Certificates signed on or after June 15, 2022 in English  (TRANSIT) 

See Guidelines to complete.

Plant Eligibility

Plant management seeking EU approval should complete and submit FSIS Form 9080-3, Establishment Application for Export, to IEPDS (Fax (202) 720-7990 or importexport@usda.gov) through FSIS supervisory channels.

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 are eligible from any federally inspected establishment. 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. Exporters interested in exporting lamb or mutton to the European Union should contact FSIS at Phone (202) 720-0082 or importexport@usda.gov.
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.

Certain products such as, but not limited to, those on the following list do not have uniform requirements for import throughout the EU. Please see individual country pages in the export library for information on eligibility and requirements of non-harmonized products.

1. Product Samples not for sale
2. Test products not for entry into commerce
3. Products destined to trade shows

Requirements related to packaging material, wall/floor junctions, wooden pallets, separation of lavatories and work areas, dry storage of non-food material, waste water, separate storage of edible and inedible products, separate storage of packaged and unpackaged products, structural wood, use of suspended showers/sprays/hoses, sterilization of utensils/implements, stunning, batch condemnation, and casings facilities have been removed. Requirements related to employee medical certification and water testing have also been removed.

Establishments must continue to comply with the following requirements:

1. Non-comminglement
   
   Establishments that slaughter both animals whose meat is eligible for export to the EU and animals whose meat is not eligible for export to the EU shall comply with the following conditions.
   1. Animals whose meat is intended for export shall be kept separate from animals whose meat is not eligible for export.
   2. All slaughter, cutting, and packing areas of the establishment shall be cleaned and sanitized before animals whose meat is eligible for export are slaughtered and processed. Personnel shall don clean clothing and wash boots and hands before handling eligible meat.
   3. Meat intended for export shall not be handled, cut, or otherwise processed in the same room at the same time as meat not eligible for export.
   4. The packaging of meat intended for export shall be marked to distinguish it from meat not eligible for export. Meat must be stored in a manner that prevents cross contamination.
   5. Records of the origin of the animals from which the meat was produced shall be retained for a period of three years after export.
2. Accommodation for sick and suspect animals
   1. Wood shall not be used for pens for sick and suspect animals.
   2. Sick and suspect animals shall not be allowed to come into contact with animals intended for slaughter for export to the EU.
   3. Pens for sick and suspect animals shall be sited and constructed to preclude contact with animals intended for slaughter for export to the EU, and effluent from such pens shall not flow into adjoining pens or passageways.
3. Opening of stomachs and intestines
   
   There must be a separate room for emptying and cleaning stomachs and intestines, unless the processing is done by closed-circuit mechanical equipment which avoids contamination and eliminates odors.
4. Raw material for pet food manufacture
   
   These products must be derived from animals/birds that passed ante mortem and post mortem inspection at federally inspected establishments and comply with the following applicable EU marking requirements.
   1. Beef and pork raw material derived from non-EU eligible animals and intended for pet food manufacture in the EU must be marked with liquefied charcoal or activated carbon on each side of the frozen block in such a way that the marking covers at least 70% of the diagonal length and is at least 10 cm wide. If the product is marked prior to freezing, it should be marked by spraying with liquefied charcoal or by applying charcoal powder in such a way that the charcoal is clearly visible on the product.
   2. The marking requirement does not apply to beef and pork raw material for pet food manufacture derived from EU eligible animals. It also does not apply to poultry raw material for pet food manufacture or to raw material intended for pharmaceutical processing regardless of species.

1. Ante-mortem Inspection
   
   Ante-mortem inspection will be performed by FSIS in accordance with 9 CFR 309 and according to FSIS procedures.
   1. Cattle
      1. Cattle under 30 months of age:
         1. Inspection by an FSIS veterinarian or;
         2. Ante-mortem inspection may be performed by an official FSIS inspector with appropriate training, knowledge, skills and abilities provided that:
            1. the animals originate from a premise where an APHIS accredited veterinarian is present on an ongoing basis, and
            2. a letter from the premise confirming such presence must be on file at the plant.
      2. Cattle over 30 months of age must be inspected by an FSIS veterinarian.
   2. Swine
      1. Swine under 1 year of age will be inspected by FSIS in accordance with FSIS procedures.
      2. Swine over 1 year of age must be inspected by an FSIS veterinarian.
   3. All animals demonstrating abnormal signs shall be diagnosed and disposed of by an FSIS veterinarian.
2. Bison and SRM Removal
   
   Since U.S. BSE regulations do not apply to bison, meat and meat products derived from these species for export to the EU must be produced under an approved AMS EV program. Bison slaughtered for export to the EU must comply with this requirement Information about the EV program for bison and a list of EV approved suppliers can be obtained from AMS' Website.
   
   If FSIS inspection personnel become aware of concerns that an AMS approved EV establishment is not properly executing its EV program, AMS should be notified at QAD.AuditService@usda.gov. Inspection personnel should include their immediate supervisor on messages to AMS. The following information should be included in the message:
   1. Establishment name, address, and establishment number
   2. Product type, product code, and quantity of product
   3. Date of production, lot number, and shift
   4. Date and nature of observation
   5. Name of country product is intended for export
   6. Export certificate number (if applicable)
   7. Any other information to verify claim
   8. Name of inspection official
3. Trichinae
   1. Attestations
      The following attestations are present on letterhead certificates for meat, meat products, and meat preparations containing pig meat for entry into the EU:
      1. For those containing domesticated pig meat:
         "the meat fulfils the requirements of Regulation (EC) No 2015/1375 laying down specific rules on official controls for Trichinella in meat, and in particular: either [has been subjected to an examination by a digestion method with negative results] or [has been subjected to a freezing treatment in accordance with Annex II to Regulation (EC) No2015/1375]."
      2. For those containing wild boar meat:
         "the meat fulfils the requirements of Regulation (EC) No 2015/1375 laying down specific rules on official controls for Trichinella in meat, and in particular, has been subject to an examination by a digestion method with negative results."
   2. Verification activity
      The IIC will review the establishment's written control program to determine if it is adequate to maintain the required controls. FSIS inspection personnel will perform random checks of these procedures in operation as well as checks of the records maintained by plant management. If problems are observed in the program during the checks, IEPDS should be notified through supervisory channels. Meat produced during this time should not be certified for export to the EU.
   3. Required controls:
      1. The pork has tested negative for Trichinella spp. by a digestion method assay as described in FSIS Compliance Guideline for the Prevention and Control of Trichinella and Other Parasitic Hazards in Pork Products; or
      2. The raw pork or products were or are derived from raw pork that was subject to a freezing process validated by FSIS that guarantees the destruction of the parasite Trichinella spiralis, as described in FSIS Compliance Guideline for the Prevention and Control of Trichinella and Other Parasitic Hazards in Pork Products.
4. Antimicrobial Treatments
   
   With the exception of lactic acid solutions used on bovine or bison carcasses, antimicrobial treatments (for example, hyper chlorination, TSP, citric or ascorbic acids, etc.) are not allowed for treatment of red meat or poultry carcasses, parts or viscera. Only the application of water, recycled hot water or steam is permitted. Use of recycled hot water is only permitted when integrated into the facilities HACCP system and applied consistently with Commission Regulation (EU) 2015/1474.
   
   Note: The EU regulation which allows the use of recycled hot water to remove microbiological surface contamination from carcasses becomes effective September 18, 2015. Provided they meet all other export requirements for export to the EU, the entire carcass or half carcasses of domestic ungulates and farmed game treated with recycled hot water on or after September 18, 2015 can be certified for export by FSIS.
   1. Conditions of use of recycled hot water to remove microbiological surface contamination from whole or half carcasses of domestic ungulates and farmed game at the slaughterhouse.
      1. Recycled hot water must:
         1. Be obtained from heating ad recycling potable water in a closed and separated system;
         2. Be submitted to:
            1. A minimal heating temperature/time regime before its application on carcasses which must ensure compliance with microbiological parameters of the potable water; and
            2. A renewal regime at the appropriate frequency including, where necessary, skimming of gross particles, filtration and addition of potable water, which must ensure compliance with the chemical parameters of potable water
         3. Be only applied on entire carcasses or half carcasses of domestic ungulates and farmed game, under controlled and verified conditions;
         4. Not be applied to carcasses with visible fecal contamination;
         5. Not result in any irreversible physical modification of the meat;
         6. Be performed before the carcasses are placed in the chilling or refrigeration room;
            
            Note: The conditions in points (b) and (c) above must be integrated in the procedures based on the HACCP principles including at least the criteria set out in section 2:
      2. Minimum HACCP criteria and control parameters:
         1. Sampling of carcasses for the purpose of assess compliance within the meaning of Regulation (EC) No. 2073/2005 must be carried out before the application of recycled hot water on carcasses;
         2. The minimal heating temperature/time regime applied to recycled water before its application on carcasses must be continuously monitored by instrumental measurements, documented and recorded;
         3. The compliance of the recycled water applied on carcasses with the microbiological and chemical parameters set up for potable water must be verified periodically by testing of water, documented and recorded;
         4. The compliance of the recycled water applied on carcasses with indicator parameter of Clostridium perfringens set up for potable water must be verified by periodic monitoring, documented and recorded
      Note: The regulation which allows the use of lactic acid solutions on bovine and bison carcasses, half carcasses, or quarters to reduce microbiological surface contamination at the slaughterhouse destined for export to the EU becomes effective on February 25, 2013. Provided they meet all other export requirements for export to the EU, bovine and bison carcasses, half carcasses, or quarters treated with lactic acid solutions on or after February 25, 2013 can be certified for export by FSIS.
   2. Conditions of use of lactic acid to reduce microbiological surface contamination of bovine and bison carcasses, half carcasses or quarters at the slaughterhouse. The EU does not permit the use of lactic acid on cuts or trimmings.
      1. Lactic acid solutions must:
         1. only be applied on entire carcasses or half-carcasses or quarters of meat from domestic bovine animals (including Bison species) at the slaughterhouse.
         2. only be applied either by spraying or misting using from 2% to 5% lactic acid solution in potable water at temperatures of up to a maximum of 55°C.
         3. be applied under controlled and verifiable conditions integrated as part of the HACCP plan that include
            1. verification by periodic monitoring, documenting and recording the lactic acid concentration during treatment; and
            2. continuous monitoring by instrumental measurements, documenting and recording the temperature of the lactic acid solution during treatment.
         4. not be applied to carcasses with visible fecal contamination.
      2. The application of lactic acid solutions must not result in any irreversible physical modification of the meat.
      3. Establishments utilizing lactic acid within a HACCP-based management system must maintain documentation that validates the antimicrobial efficacy of the lactic acid treatments under their specific processing conditions and verify the lactic acid concentration, temperature of application and other factors affecting the efficacy of lactic acid as a decontaminating agent. The establishments must inform the EU facility receiving the treated carcasses, half-carcasses or quarters of such use. This information should be documented.
5. Poultry Chilling
   1. Immersion chilling of carcasses must meet the following requirements:
      1. Carcasses must move through the chiller against a counter flow of water.
      2. Recirculation of chiller water is not allowed.
      3. The temperature of the water in the chiller must not exceed 61° F at the carcass entry and 40° F at the carcass exit.
      4. The following amounts of water are required per bird:

         Bird Size	Inside/Outside washer	Chiller
         < 5.5 lb.	0.40 gal.	0.65 gal.
         5.5 to 11 lb.	0.65 gal.	1.00 gal.
         > 11 lb.	0.90 gal.	1.50 gal.

      5. Water consumption during carcass washing and immersion chilling, temperature of the water at the entrance and exit points of the chiller, and the number of carcasses in each weight range must be measured and recorded.
   2. Alternative chilling systems to V.A.1-5. may be used if they demonstrate a decreased microbial load for: aerobic plate counts; enterobacteriaceae; and E. coli before and after chilling. FSIS will validate and assess the data before the establishment is proposed for listing for export to the EU. This validation and assessment shall be carried out without the use of antimicrobial treatment, throughout a full day's production.
      
      During the course of the day, plant management should select 30 or more carcasses prior to entry into the chiller and the same number of carcasses at the exit of the chiller. Samples should be taken randomly throughout a day's production. Whole bird rinses should be used for sample collection. Analysis of samples should be done using an AOAC International approved method. Plant management should submit a report of the assessment and results to FSIS at Phone (202) 720-0082 or importexport@usda.gov.
      
      This assessment shall be carried out each time any changes are made to a plant's chilling system. Records shall be kept of the validation and assessments and shall be available to the EU.
   3. Poultry temperature requirements
      1. Poultry shall be chilled to an internal temperature of 40° F in the shortest time possible after slaughter.
         1. In the case of small birds (up to 6 pounds), the internal temperature of 40° F shall be achieved by the end of the immersion chilling process.
         2. Where crushed ice is used to chill large birds (over 6 pounds) after immersion chilling, such use must not result in cross contamination of the product. The use of boxes with leak holes for this purpose is not acceptable.
      2. When further processing (cutting) occurs after poultry has been chilled to 40° F, the internal temperature may exceed 40°F for a maximum of one hour, but may not exceed 50° F.
   4. Crushed ice
      1. The use of crushed ice must not result in cross contamination of the product. When crushed ice is used for further transport or storage, stacking of boxes with leak-holes or other practices which could result in cross contamination shall be prohibited.
6. Residue Testing 
   
   EU Additional Residue Testing Program 
   
   All samples collected under the EU Additional Residue Testing Program will be forwarded to an AMS approved laboratory for screening.

   1. All slaughter establishments approved for export of poultry, beef (including bison), pork meat and/or offal to the EU are required to participate in the EU Additional Residue Testing Program. The cost of analysis is the responsibility of the establishment management.

      The FSIS coordinates the additional residue testing program for products destined to the EU. However, AMS administers the Export Laboratory Approval Program where they provide information on approved laboratories, which conduct the required residue testing. The Official Listing of USDA-Approved Laboratories Export Laboratory Approval Program is available on the AMS Website.

   2. Bison -The cost of analysis is the responsibility of the establishment management, including analytical costs for test samples of Bison imported for slaughter. Questions concerning analytical costs can be addressed directly to the laboratories participating in the program. Test samples for U.S. born and raised Bison, covered under FDA’s residue monitoring program, must be sent to Bureau Veritas 4606 Canada Way Burnaby, BC Canada V5G 1K5. Phone 604 734 7276.  

   3. The species, target compounds, and numbers of samples to be collected are listed in the table below. The targeted number of samples for each species is based on the total number of head slaughtered by all EU approved establishments of the species from the previous year. The number of samples to be collected at each establishment will be predicated by the number and the volume of EU destined product slaughtered.
      
      Table 1: EU Residue Sampling Frequency for Pork, Steers/Heifers, Wild Boars and Turkey
      Table 2: EU Residue Frequency for Bison.  This plan is designed by FDA. The sample forms, supplies and collection of the samples are the same as described in Section IX with the exception that a portion of samples (project code with a suffix of “_DEN”) will be forwarded to a FDA laboratory for analysis instead of one of the AMS approved laboratories. Only U.S. born and raised Bison are eligible for the “_Den” testing. The FDA laboratory address is as follows:  FDA/ Denver Laboratory – Sample Custodian, 6th & Kipling St., DFC, BLDG 20, Entrance W-10, Denver, CO 80225. Contact FDA at FDA-CFSAN-International-Engagement@fda.hhs.gov with questions on this process.
      
      Note: If the establishment is slaughtering imported Bison on the day IPP have scheduled the __Den” residue sampling task, IPP are to reschedule the sample for a day when a sample from U.S. born and raised Bison can be collected and submitted for analysis.
       

   4. Each EU approved slaughter establishment must make arrangements with one of the AMS approved laboratories in order to perform analyses included in this testing program. The analytes and methods are listed in Table 3: EU Analytes and Methods. Contact FSIS, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990, for assistance.

      Project Code	Project Name	Analysis
      EU_01_BI	EU_01_Bison - Urine Residues	Stilbenes/Resorcyclic Acid Lactones
      EU_02_BI_DEN	EU_02_Bison - Muscle/Liver/Kidney Residues	Multi-Residue Method
      EU_04_BO	EU_04_Wild Boar - Kidney/Muscle Residues	Lead/Cadmium
      EU_07_BI	EU_07 Bison - Kidney Fat	MGA
      EU_07_SH	EU_07_Steer/Heifer - Kidney Fat/Liver/Muscle Residues	MGA/Ractopamine/Zilpaterol
      EU_09_SH	EU_09_Steer/Heifer - Urine Residues	Zeranol/Taleranol
      EU_12_BI	EU_12_Bison - Muscle Residues	Nitrofurans
      EU_14_BI	EU_14_Bison - Urine Residues	Trenbolone
      EU_14_SH	EU_14_Steer/Heifer - Urine Residues	Trenbolone
      EU_15_MH	EU_15_Market Hogs - Muscle Residues	Ractopamine
      EU_15_TU	EU_15_Turkey - Muscle Residues	Ractopamine

   5. Sampling tasks will be assigned to EU approved slaughter establishments periodically throughout the year via laboratory sample tasks in the Public Health Information System (PHIS). The FSIS Inspector-In-Charge (IIC) assigned to the establishment will receive an Alert notifying them of the sample, and the sampling task will be visible on the Task List of the Task Calendar in PHIS. The EU sampling task will be scheduled in the Task Calendar. The sampling task will designate the date that samples are to be collected, the tissue to be collected, the code for the residue which will be analyzed, and the laboratory designated to perform the analysis. IIC will print the sample request form and send it along with the sample to the designated laboratory. Above is a chart showing the Project Codes, Species, and Samples to be collected for each analysis.
      
      Note: Samples with the “_Den” suffix are not to be mailed on Friday.

   6. Meat and Poultry -The IIC is responsible for collecting, securing and freezing the samples. Samples must be taken from EU-eligible animals only. Please collect 200 ml of urine and 200 gm of muscle, kidney or fat. These samples will be sent frozen to the designated lab via overnight express mail in containers provided by the slaughter establishment, at the expense of the slaughter establishment. Sample selection and shipment of the samples cannot be delegated to plant management. When samples are sent out of the United States for analyses, plant management must use a company that will deliver perishable products in a timely fashion and must provide International airbills. To avoid unnecessary delays, include all appropriate documents for entry into the country where the samples are destined.

   EU Animal Casings Additional Residue Testing Program
   
   All samples collected under the EU Animal Casings Additional Residue Testing Program will be forwarded to an AMS approved laboratory for screening, unless otherwise noted.

   1. All establishments approved for export of beef, pork, or ovine casings to the EU and are actively exporting to the EU are required to participate in the EU Animal Casing Additional Residue Testing Program. 

      The FSIS coordinates the additional residue testing program for casings destined to the EU. However, AMS administers the Export Laboratory Approval Program where they provide information on approved laboratories which conduct the required residue testing. The Official Listing of USDA Approved Laboratories Export Laboratory Approval Program is available on the AMS Website.

   2. The cost of analysis is the responsibility of the establishment management, including mailing costs for test samples of Casings. Questions concerning analytical costs may be addressed directly to the laboratories participating in the program. Test samples for Casings, must be sent to Eurofins Central Analytical Laboratory in New Orleans, LA, phone (504) 297-3400.

   3. EU Residue Frequency for Casings.
      The targeted compounds of the samples to be collected are listed in the table below. This plan is designed by FDA and based on testing frequencies required by the EU. The targeted number of samples is based on the total volume of casings exported to the EU from all eligible U.S. casings establishments during the previous year. The number of samples to be collected at each establishment eligible to export to the EU will be calculated by the ratio of volume of EU destined product from that establishment.

      Project Code	Project Name	Analysis	Species
      	Nitromidazoles and the 5-hydroxy-metabolites
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Dimetridazole	Bovine Porcine Ovine
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Dimetridazole-OH
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Metronidazole
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Metronidazole-OH
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Ipronidazole
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Ipronidazole-OH
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Ronidazole
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Nitrofuran metabolites
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Furazolidone: amino-oxazolidinone (AOZ)	Bovine Porcine Ovine
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Furaltadone: 3-amino-5-morpholinomethyl-2-oxazolidinone (AMOZ)
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Nitrofurazone: semicarbazide (SEM)
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Nitrofurantoin: aminohydantoin (AHD)
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Other
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Chloramphenicol	Bovine Porcine Ovine
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Chloramphenicol
      EU_17_CS	EU_17_Bovine Porcine Ovine Casing Residues	Chloramphenicol

      1. Sampling tasks will be assigned to EU approved Casing processing establishments periodically throughout the year via laboratory sample tasks in the Public Health Information System (PHIS). The FSIS Inspector-In-Charge (IIC) assigned to the establishment will receive an Alert notifying them of the sample, and the sampling task will be visible on the Task List of the Task Calendar in PHIS. The EU sampling task will be scheduled in the Task Calendar. The sampling task will designate the date that samples are to be collected, the tissue to be collected, the code for the residue which will be analyzed, and the laboratory designated to perform the analysis. IIC will print the sample request form and send it along with the sample to the designated laboratory. Above is a chart showing the Project Codes, Species, and Samples to be collected for each analysis.

      2. The IIC is responsible for collecting and securing the samples per instructions. Samples must be collected from casings eligible for export to the EU after processing. These samples will be sent to: Eurofins Central Analytical Laboratories, 2219 Lakeshore Drive, Suite 500, New Orleans, LA 70122, via overnight express mail in containers provided by the processing establishment, at the expense of the establishment. Sample selection and shipment of the samples cannot be delegated to plant management

      3. Any questions related to sample collection under the EU Animal Casings Additional Residue Testing Program should be directed to FSIS at Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990).

7. Non-Hormone Treated Cattle (NHTC) Program: Beef and Veal (An NHTC program is not required for bison.)
   
   All bovine meat exported to the European Union must originate from animals that have never been treated with hormonal growth promotants. In order for FSIS to provide export certification for this product, there must be assurances that there are effective controls in all phases of production, from birth to slaughter, and subsequent processing and final packaging activities. FSIS has developed guidelines for the industry, which provide the system requirements and components of the program (Program for Certifying Non-hormone Treated Beef to the European Union).
   
   Each phase of the production of these animals will maintain a written control program that describes the procedures for maintaining identity of and segregating non-hormone treated cattle, as well as the controls that are in place to prevent the administration of restricted compounds to the animals. The documented system will be audited by the Agricultural Marketing Service (AMS), or by an AMS-accredited independent third party. AMS has developed instructions providing the general policies and procedures for providing service under the NHTC Program 1013 Procedure Instructions.
   1. Beef and veal production
      1. Each phase of the production of these cattle, from birth through delivery at the slaughter establishment, must receive third party verification prior to FSIS certifying NHTC to the EU.
      2. A copy of a signed producer affidavit certifying that the animals have never been treated with hormonal growth promotants must accompany each lot of cattle presented to the slaughter establishment. This affidavit can be transmitted electronically or by facsimile, but must be available when the shipment of cattle arrives at the establishment.
         1. All cattle must be slaughtered and processed in a federally inspected establishment approved for production of products destined for the EU.
         2. Each establishment must have a written program and procedures in place that will assure the production and shipment of product derived from animals that have never been administered hormonal growth promotants. AMS (or an AMS accredited independent third party) will review the program documentation for receiving cattle into the beef slaughter operations to ensure adequacy and continuity of animal identification procedures from the producer to the slaughter facility. Contact AMS, ARC Branch for additional information regarding this program and to schedule the initial compliance review, which will be coordinated with the FSIS in-plant inspection personnel will ensure adequacy of the controls through the slaughter and processing establishment and will maintain operational oversight in the establishment.
   2. Dairy/breeding cow product production
      Pending further discussion with the EU, cow meat and cow offal will not be eligible for export to the EU unless it is produced according to the NHTC program guidelines referenced above.
   3. In-process Controls
      Each establishment involved in the production of NHTC beef must maintain documentation in accordance with an approved written control program and follow procedures that will assure the production and shipment of product derived from non-hormone treated cattle. Mandatory in-plant controls include:
      1. Plant management must maintain documents to record the number of animals presented for slaughter and the number of animals slaughtered under EU mode of production.
      2. Product destined for the EU must be appropriately identified and segregated throughout production according to the establishment's written control program.
      3. Slaughter establishments must perform 100% palpation of the ears for hormone implants of all cattle or veal to be slaughtered under the NHTC program. This is to be done with the oversight of the FSIS/IIC.
      4. Slaughter establishments must issue an affidavit confirming the non-hormone treated status of meat shipped to cutting plants without an EU Health Mark applied in a tamper evident fashion. Adequate records supporting control of product transferred to separate processing facilities and cold storage warehouses must be maintained by plant management.
   4. FSIS Inspector-in-Charge Responsibilities (IIC Procedures)
      The IIC will verify that the establishment's written control program is adequate to maintain product and identification controls throughout the slaughter, fabrication, processing, packaging process, to the point that the EU Health Mark is applied in a tamper evident fashion. FSIS inspection personnel will perform random checks of these procedures in operation throughout the EU production, as well as checks of the records maintained by plant management. In addition, FSIS will check company records, when necessary, to verify proper transfer for subsequent storage prior to certification of the product to the EU. Compliance oversight by FSIS includes:
      1. Familiarity with the establishment's written control program.
      2. Verification that the NHTC lot comes from an AMS approved premise. The affidavit will be reviewed to confirm that it complies with the parameters outlined in the establishment's written control program, including animal identification and authorized affidavit signer controls. The affidavit can be transmitted electronically or by facsimile but must be available for the verification check at the time the shipment of cattle arrives at the slaughter establishment. Cattle arriving at the slaughter establishment without adequate identification or certification (producer affidavit) will not be permitted to be slaughtered for the EU until the deficiency is corrected according to the company's control procedures.
      3. Performing additional random procedures to determine compliance with the program. Procedures will include all aspects from receiving through shipping and may include observation, review of records, or both. All records from an entire lot of product will be reviewed on a periodic basis. Reviewed records will be signed and dated.
      4. If there is noncompliance with EU requirements or with the establishment's control program, the IIC will notify management and request correction of the deficiency. If a deficiency is not corrected, the IIC will withhold the EU health mark label (or brand). The labels (or brand) will be returned to the IIC and secured until correction is made. The IIC will document the noncompliance.
      5. If repeated deficiencies occur, or a non-compliance is not corrected in a reasonable time period, FSIS, Phone (202) 720-0082 shall be notified through supervisory channels.
8. Pork for the European Union (PFEU) Program
   
   All pork exported to the EU must originate from animals that have never been treated with hormonal growth promotants. In order for FSIS to provide export certification for this product, there must be assurances that there are effective controls in all phases of production in growing the animal, as well as at the slaughter establishment. FSIS has developed guidelines for the industry, which provide the system requirements and components of the program (Program for Certifying Pork Intended for Export to the EU). Though each phase of production (or ownership stage) will have to demonstrate that their system controls are adequate, emphasis will be placed on the controls at the finishing unit to ensure ractopamine hydrochloride (ractopamine) is not fed. The documented system will be audited by AMS (or by an AMS-accredited independent third party). AMS has developed instructions providing general policies and procedures for providing services under the PFEU Program for QAD Procedure 1014.
   1. Pork production
      1. Pork production systems finishing hogs for the production of meat intended for export to the EU must receive third party verification through delivery to the slaughter establishment.
      2. Each lot of hogs presented to the slaughter establishment must be accompanied by a signed producer affidavit certifying that the animals have never been fed ractopamine. (Example of Pork Producer Affidavit). This affidavit can be transmitted electronically or by facsimile but must be available when the shipment of hogs arrives at the establishment.
      3. All hogs must be slaughtered and processed in a federally inspected establishment approved for production of products destined for the EU.
      4. Each establishment must have a written program and procedures in place that will assure the production and shipment of product derived from animals that have never been administered hormonal growth promotants. AMS (or an AMS accredited independent third party) will review the program documentation for receiving hogs into the pork slaughter operations to ensure adequacy and continuity of animal identification procedures from the producer to the slaughter facility. Contact AMS, LP for additional information regarding this program and to schedule the initial compliance review, which will be coordinated with the FSIS OPPD IEPDS. FSIS in-plant inspection personnel will ensure adequacy of the controls through the slaughter and processing establishment and will maintain operational oversight in the establishment.
   2. In-process Controls
      Each establishment involved in the production of pork must maintain documentation in accordance with an approved written control program and follow procedures that will assure the production and shipment of product derived from hogs that have not been fed ractopamine. Mandatory in-plant controls include:
      1. Plant management must maintain documents to record the number of animals presented for slaughter and the number of animals slaughtered under EU mode of production.
      2. Product destined for the EU must be appropriately identified and segregated throughout production according to the establishment's written control program.
      3. Slaughter establishments must issue an affidavit confirming the eligibility of the pork for export to the EU, if carcasses are transferred to a separate cutting plant without an EU Health Mark applied in a tamper evident fashion (Example of Transfer Affidavit). Adequate records supporting control of product transferred to separate processing facilities and cold storage warehouses must be maintained by plant management.
   3. FSIS Inspector-in-Charge Responsibilities (Pork IIC Procedures)
      The IIC will verify that the establishment's written control program to determine if it is adequate to maintain product and identification controls throughout the slaughter, fabrication, processing, packaging process, to the point that the EU Health Mark is applied in a tamper evident fashion. FSIS inspection personnel will perform random checks of these procedures in operation throughout the EU production, as well as checks of the records maintained by plant management. In addition, FSIS will check company records, when necessary, to verify proper transfer for subsequent storage prior to certification of the product to the EU. Compliance oversight by FSIS includes:
      1. Familiarity with the establishment's written control program.
      2. Verification that the PFEU lot comes from an AMS approved premise. The affidavit will be reviewed to confirm that it complies with the parameters outlined in the establishment's written control program, including lot identification and authorized affidavit signer controls. The affidavit can be transmitted electronically or by facsimile but must be available for the verification check at the time the shipment of hogs arrives at the slaughter establishment. Hogs arriving at the slaughter establishment without adequate identification or certification (producer affidavit) will not be permitted to be slaughtered for the EU until the deficiency is corrected according to the company's control procedures.
      3. Performing additional random procedures to determine compliance with the program. Procedures will include all aspects from receiving through shipping and may include observation, review of records, or both. All records from an entire lot of product will be reviewed on a periodic basis. Reviewed records will be signed and dated.
      4. If there is noncompliance with EU requirements or with the establishment's control program, the IIC will notify management and request correction of the deficiency. If a deficiency is not corrected, the IIC will withhold the EU health mark label (or brand). The labels (or brand) will be returned to the IIC and secured until correction is made. The IIC will document the noncompliance.
      5. If repeated deficiencies occur, or a non-compliance is not corrected in a reasonable time period, FSIS OPPD IEPDS shall be notified through supervisory channels at Phone (202) 720-0082 or importexport@usda.gov.
9. Poultry Export Verification (PEV)
   
   All poultry (including turkey) exported to the EU must originate from birds that were produced under an approved AMS Poultry Export Verification (PEV) program. In the case of turkeys, the PEV program must include controls at the finishing unit to ensure ractopamine hydrochloride (ractopamine) is not fed. In order for FSIS to provide export certification for this product, there must be assurances that there are effective controls in all phases of production in growing the birds, as well as at the slaughter establishment. AMS has developed instructions providing general policies and procedures for providing services under the PEV Program. This information is available on AMS' website for QAD 1063 Procedures.
   1. Poultry Production
      1. Poultry for the production of meat intended for export to the EU must receive verification through the AMS PEV program.
      2. Each lot of birds presented to the slaughter establishment must be accompanied by a signed producer affidavit certifying that the birds comply with PEV requirements. This affidavit can be transmitted electronically or by facsimile but must be available when the shipment of birds arrives at the establishment.
      3. All birds must be slaughtered and processed in a federally inspected establishment approved for production of products destined for the EU.
      4. Each establishment must have a written program and procedures in place that will assure the production and shipment of product derived from birds that have been produced according to the PEV program. AMS will review the program documentation for receiving birds into the poultry slaughter operation to ensure adequacy and continuity of bird identification procedures from the producer to the slaughter facility. FSIS in-plant inspection personnel will ensure adequacy of the controls through the slaughter and processing establishment and will maintain operational oversight in the establishment.
   2. In-process Controls
      Each establishment involved in the production of poultry must maintain documentation in accordance with an approved written control program and follow procedures that will assure the production and shipment of product derived from birds that have been produced under the AMS PEV program. Mandatory in-plant controls include:
      1. Plant management must maintain documents to record the number of birds presented for slaughter and the number of birds slaughtered under EU mode of production.
      2. Product destined for the EU must be appropriately identified and segregated throughout production according to the establishment's written control program.
      3. Slaughter establishments must issue an affidavit confirming the eligibility of the poultry for export to the EU, if poultry is transferred to a separate further processing plant without an EU Health Mark applied in a tamper evident fashion Adequate records supporting control of product transferred to separate processing facilities and cold storage warehouses must be maintained by plant management.
      4. FSIS Inspector-in-Charge Responsibilities
         The IIC will verify that the establishment's written control program to determine if it is adequate to maintain product and identification controls throughout the slaughter, processing, packaging process, to the point that the EU Health Mark is applied in a tamper evident fashion. FSIS inspection personnel will perform random checks of these procedures in operation throughout the EU production, as well as checks of the records maintained by plant management. In addition, FSIS will check company records, when necessary, to verify proper transfer for subsequent storage prior to certification of the product to the EU. Compliance oversight by FSIS includes:
         1. Familiarity with the establishment's written control program.
         2. Verification that the live birds come with a PEV affidavit. The affidavit will be reviewed to confirm that it complies with the parameters outlined in the establishment's written control program, including lot identification and authorized affidavit signer controls. The affidavit can be transmitted electronically or by facsimile but must be available for the verification check at the time the shipment of birds arrives at the slaughter establishment. Birds arriving at the slaughter establishment without adequate identification or certification (PEV affidavit) will not be permitted to be slaughtered for the EU until the deficiency is corrected according to the company's control procedures.
         3. Performing additional random procedures to determine compliance with the program. Procedures will include all aspects from receiving through shipping and may include observation, review of records, or both. All records from an entire lot of product will be reviewed on a periodic basis.
         4. If there is noncompliance with EU requirements or with the establishment's control program, the IIC will notify management and request correction of the deficiency. If a deficiency is not corrected, the IIC will withhold the EU health mark label. The labels will be returned to the IIC and secured until correction is made. The IIC will document the noncompliance.
         5. If repeated deficiencies occur, or a non-compliance is not corrected in a reasonable time period, FSIS OPPD IEPDS should be notified through supervisory channels, at Phone (202) 720-0082, or importexport@usda.gov.
10. MEAT PRODUCTS INCLUDING STOMACH, BLADDERS, AND INTESTINES (EXCLUDING CASINGS)
    
    Establishments treating stomachs, bladders and intestines must ensure compliance with the following requirements:
    1. Animal intestines, bladders and stomachs may be exported to the EU only if:
       1. They derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;
       2. They are salted, heated or dried; and
       3. After the treatment referred to in (b), effective measures are taken to prevent re-contamination.
    2. Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored/chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3°C.
11. MEAT PRODUCTS INCLUDING RENDERED ANIMAL FATS AND GREAVES
    
    Establishments processing rendered animal fats and greaves must ensure compliance with the following requirements:
    1. Raw materials must:
       1. Be derived from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;
       2. consist of adipose tissues or bones, which are reasonably free from blood and impurities;
       3. comes from an EU approved establishment; and
       4. be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within 12 hours after the day on which they were obtained.
    2. During rendering the use of solvents is prohibited.
    3. When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality.
    4. Rendered animal fat, depending on type, must meet the following standards:

       	Ruminants			Porcine animals			Other animal fat
       	Edible tallow		Tallow for refining	Edible fat		Lard and other fat for refining	Edible	For refining
       	Premier jus (1)	Other		Lard (2)	Other
       FFA (m/m% oleic acid) maximum	0.75	1.25	3.0	0.75	1.25	2.0	1.25	3.0
       Peroxide maximum	4 meq/kg	4 meq/kg	6 meq/kg	4 meq/kg	4 meq/kg	6 meq/kg	4 meq/kg	10 meq/kg
       Total insoluble impurities	Maximum 0.15%			Maximum 0.5%
       Odour, taste, colour	Normal
       Rendered animal fat obtained by low-temperature rendering of fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms. Rendered animal fat obtained from the adipose tissues of porcine animals.

    5. Greaves intended for human consumption must be stored in accordance with the following temperature requirements.
       1. When greaves are rendered at a temperature of not more than 70°C, they must be stored:
          1. at a temperature of not more than 7°C for a period not exceeding 24 hours; or
          2. at a temperature of not more than -18°C.
       2. When greaves are rendered at a temperature of more than 70°C and have a moisture content of 10% (m/m) or more, they must be stored:
          1. at a temperature of not more than 7°C for a period not exceeding 48 hours or a time/temperature ratio giving an equivalent guarantee; or
          2. at a temperature of not more than -18°C.
       3. When greaves are rendered at a temperature of more than 70°C and have a moisture content of less than 10% (m/m), there are no specific requirements.
12. Source of Raw Material
    1. Cutting and processing plants intending to prepare products for export to the EU must source meat or poultry ingredients from EU approved slaughter establishments. The raw material must be eligible for export to the EU and bear the EU health mark. Raw meat and poultry material may be imported into the United States and used for EU production provided it is eligible for export to the EU and bears the EU health mark. The product must also be eligible for importation into the United States.
    2. Meat and poultry materials used to produce products exported to the EU must be handled exclusively in facilities approved for the EU, including official import establishments and cold storage facilities. The establishment must have a control plan to ensure that the product is appropriately identified and segregated throughout production, was sourced from an EU approved facility, meets all EU requirements, and has been handled exclusively in EU approved facilities. Establishment records must include a transfer affidavit for domestically slaughtered product as stated in the PFEU, NHTC, and PEV program requirements above. The control plan and implementation of the plan will be verified by the IIC.
    3. If there is noncompliance with EU requirements or with the establishment's control plan, the IIC will notify management and request correction of the deficiency. If a deficiency is not corrected, the IIC will withhold the EU health mark label (or brand) and refuse export certification services for the product. The labels (or brand) will be returned to the IIC and secured until correction is made. The IIC will document the noncompliance.
    4. If repeated deficiencies occur, or a non-compliance is not corrected in a reasonable time, the IIC will notify FSIS OPPD IEPDS through supervisory channels at Phone (202) 720-0082 or, Email importexport@usda.gov.
13. Labeling
    1. Health Marks
       1. Health mark labels must be applied to each carton of product in such a manner that the health mark label is destroyed when the package is opened. The health mark label must bear the following information:
          1. The oval mark must be 2.5 inches (6.5cm) wide by 1.8 inches (4.5cm) high.
          2. within the oval:
             1. in the center - the establishment number.
             2. in the upper or lower part - the letters USA.
             3. the letters must be at least 0.3 in (0.8 cm) high and the numbers should be at least 0.4 in (1 cm) high.
          3. a sequential serial number that is unique to each health mark label for that establishment.
       2. Health Mark for Wild Game
          The health mark for wild game must be pentagonal shaped rather than oval. The pentagonal mark should be similar in size and bear the same information as the oval mark as indicated above. For information concerning the marking of small wild game, contact FSIS at Phone (202) 720-0082
       3. The health mark labels and brands must be kept under security by the IIC in a manner analogous to USDA brands. The IIC is responsible for maintaining an inventory of the health mark labels. Health mark labels should be given to plant management only while eligible products are being identified and marked and only for the length of time necessary to complete the task.
       4. Meat carcasses must be stamped with ink or hot branded using a stamp or brand with the specifications described in A.1. and A.2. Those carcasses weighing more than 143 pounds (65 kg) must be stamped in at least the following places: external surface of the thighs, loins, back, brisket, and shoulder. Other carcasses must be marked in at least four places: on the shoulders and on the external surface of the thighs. Carcass stamping is not required if the carcasses are slaughtered, cut and packaged within the same establishment. Plant management must assure, to the satisfaction of the IIC, that proper identification of eligible carcasses is maintained throughout the establishment.
    2. Beef Labeling - Additional labeling information must be present on fresh, chilled, or frozen beef arriving in the EU as of January 1, 2002. The labeling requirement applies to all beef intended for human consumption, with the exception of processed products and offal other than thin skirt and thick skirt. The beef must be labeled as follows:
       1. Exporters must display the following information on labels attached to an individual piece or pieces of meat or to their packaging material:
          Note: Minced meat should indicate: "Prepared in the United States".
          1. A reference number that links the meat with the individual animal from which it originates. In the case of meat derived from a group of animals with a homogeneous background, which enables the accuracy of the information to be checked, the reference number can link the meat with the group of animals rather than an individual animal. For the purposes of this labeling requirement, the size of a group of animals is limited to one day's production. There is no specific requirement for the format of the reference number as long as it provides linkage to the animal or group of animals and the origin premises.
          2. The phrase "Slaughtered in the United States: (FSIS slaughter establishment number).
          3. The phrase "Cutting in the United States: (FSIS cutting establishment number).
          4. The phrase "Origin: United States" if the animals were born, raised and slaughtered in the United States. In the case of imported animals, the countries of birth and of feeding must be indicated. If the animals were raised in a country other than the United States for less than 30 days, an indication of the other country is not required. (EU implementation of point 3 is January 1, 2002, rather than January 1, 2001.) In the case of bison coming from Canada and slaughtered in the United States, the required labeling would be as follows: "Born and raised: Canada/Slaughtering: USA Est. - No xxx,/Cutting: USA Est - No xxx/Reference-No".
       2. When the origin of the meat is unknown, exporters must display the following information on cartons and vacuum bags:
          1. "Origin: Non-EC and slaughtered in the United States".
       3. The labeling is mandatory to the retail level in the EU, or to the point of preparation in the case of product used for HRI purposes.
       4. It is not permitted to mention "non-hormone treated cattle", "NHTC" or any other reference to the non-use of hormones in the production of the beef on the labels for terminology of U.S. beef in the EU marketplace.
    3. Labeling of raw material for pet food manufacture and pharmaceutical processing
       1. Carton labels of material intended for pet food manufacture must indicate:
          1. the phrase "Raw Material Only for the Manufacture of Pet Food"
          2. the name and address of the EU establishment of destination
       2. Carton labels of material intended for pharmaceutical processing must indicate:
          1. the phrase "Raw Material Only for the Manufacture of Technical Products Including Pharmaceutical Products"
          2. the name and address of the EU establishment of destination
    4. Fresh meat cuts which have undergone a freezing process must bear an indication of the month and year in which it was frozen.
    5. Export stamping
       When exported product transits the EU for US military use, the USDA export stamp may be applied to a securely enclosed pallet or pallets within the consignment (e.g., shrink-wrapped or other effective means) and not applied to each outside container within the pallet. Exporters who elect to use this option for the application of the export stamp are to be aware that any product marked in this way is not eligible to return to U.S. commerce unless the entire shipment is returned intact bearing the marks applied at the time of export that connect the product to an FSIS-issued U.S. export certificate.
14. Finland and Sweden
    
    Finland and Sweden require additional microbiological testing of fresh veal, beef, pork, and poultry meat for salmonella prior to export certification. The sampling methods and number of samples to be taken varies with the class of product and the size of the consignment. Specific information regarding sampling methods, number of samples to be taken, and the testing methodology is available.
    
    The additional testing is not required if the fresh veal, beef, pork or poultry meat is destined for the manufacture of meat products in Sweden or Finland.
15. Compliance Oversight by FSIS
    
    Production modes - Plants must be in an EU production mode whenever producing for EU export. It is not necessary that establishments be in an EU mode when producing for non-EU markets. However, all establishments must provide an EU mode control program to the IIC to assure that all EU requirements are met before beginning EU production. The plant must be in the EU mode during prescreening by FSIS and during any EU review. The key role in assuring compliance with the requirements for export to the EU is with the IIC. If an approved plant is not in compliance with the EU requirements, the IIC should withhold the use of the EU health mark label (See Section XIV Labeling.) and notify plant management of the non-compliance through a memorandum of interview (MOI). The EU health mark label should be returned to the secured location until the deficiency has been corrected. Product not bearing the EU health mark label was not produced according to the requirements for export to the EU and is not eligible for export certification to an EU member state.
    
    An EU approved plant will be reviewed periodically to assure that the EU listed plant continues to comply with standards for export of product to the EU. The review will be documented on the revised FSIS Form 9100-1. EU Conformance Verification Checklist for Meat and Poultry Establishments to be used in Conjunction with the Export Requirements for the European Union. The Checklist should be completed a minimum of once per year and for plants that produce product for export to the EU on a routine basis, the review should be conducted each calendar quarter that product is produced. The FSIS inspector in charge (IIC) at the establishment should submit a scanned copy of the Checklist to FSIS at internationalcoordination@usda.gov. Any change in the status of the establishment, such as alteration of name or discontinuation of operation in the EU mode should also be submitted to FSIS.