Export Requirements for the European Union

MADE IN BULGARIA

Home Producers Products made in Bulgaria Advertise with us Our partners Subdomain Offer

The free movement of goods is one of the freedoms of the single market of the European Union. Since January 1993, controls on the movement of goods within the internal market have been abolished and the European Union is now a single territory without internal frontiers.
The abolition of customs tariffs promotes intra-Community trade, which accounts for a large part of the total imports and exports of the Member States.
Articles 28 and 29 of the Treaty establishing the European Community prohibit import and export restrictions between all Member States. However, if there is a threat to public health or the environment, Member States may restrict the free movement of goods.

Section I: Eligible/Ineligible Products
Section II: Facility, Equipment, Procedures
Section III: Antemortem Inspection
Section IV: Pig Heart Incision
Section V: Bison and SRM Removal
Section VI: Trichinae
Section VII: Antimicrobial Treatments
Section VIII: Poultry Chilling
Section IX: Residue testing*
Section X: Non-hormone Treated Cattle Program
Section XI: Pork for the European Union (PFEU)
Section XII: Poultry Export Verification (PEV)
Section XIII: Source of Raw Material
Section XIV: Labeling
Section XV: Finland and Sweden
Section XVI: FSIS Oversight
Section XVII: Documentation - Required Certificates
Section XVIII: Other Requirements
Section XIX: Plant Approval Process
Section XX: List of Eligible Plants

Eligible/Ineligible Products
1. 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" since the product is considered farmed game, however, since EU considers bison as fresh meat, FSIS conducts plant review and signs export certification. For further information on FDA regulations covering farmed game, contact Dr. Amber McCoig at (240) 402-2131.
  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 now are considered meat products by the EU. Treatment of these products may include cleaning, salting or drying, and/or heating. 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) meat extracts; (2) rendered animal fat: fat derived from rendering meat, including bones, and intended for human consumption; (3) greaves: the protein-containing residue of rendering, after partial separation of fat and water; (4) gelatin (contact FDA - Dr. Amber McCoig at (240) 402-2131); and (5) meat powder, powdered rind, slated 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.
  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. Effective June 15, 2004, the importation of meat, poultry, offal, and giblets intended for pet food manufacture or pharmaceutical processing will be harmonized by the EU. Product certified on or after June 15, 2004, must comply with the additional denaturing (see Section II.R.), labeling and certification requirements identified in other sections of this document. Product produced and certified according to previous bilateral agreements with member countries must leave the U.S. by June 15, 2004 and can arrive in the EU as late as August 15, 2004. Exporters should work closely with their importers to assure the entry of products produced and certified according to member state requirements prior to June 15.
  13. Lamb and mutton are not currently eligible for export to the European Union. Parties interested in exporting lamb or mutton to the European Union should contact the FSIS Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.
2. Ships’ Stores: Products intended for ships’ stores are eligible from any federally inspected establishment. Product must be destined to an authorized bonded storage point. Obtain the appropriate EU transit certificate identified in Section XVII Documentation – Required Certificates, Transit Certificates.
3. Products intended for ships' stores destined to an EU registered cruise ship at a U.S. port are eligible from any federally inspected establishment. Obtain the appropriate EU transit certificate identified in Section XV Documentation - Required Certificates, Transit Certificates. FSIS Form 9060-5 may be certified and released for distribution before information is received to complete the EU transit certificate. The EU transit certificate is to be certified and released for distribution after the container and seal number have been provided by the shipping company. The name of the signing official for the EU transit/storage letterhead certificate should be the same as that on the FSIS 9060-5.
Facility, Equipment, and Procedural Requirements

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 6 months 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. Beef and pork raw material for pet food manufacture
  
  These products must be derived from animals/birds that passed antemortem and postmortem 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.
Antemortem Inspection

Antemortem 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. Antemortem 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.
Pig Heart Incision
1. For market hogs (animals up to 1 year old), the following number of swine hearts from inspected and passed carcasses at each approved slaughter establishment must be incised and their interior surfaces inspected by the IIC:
  1. Six (6) hearts per establishment per week (or a rate to yield 300 hearts/establishment/year) must be incised and their interior inspected. IICs should randomly select one time per week to conduct the inspection. During this time, 6 hearts should be randomly selected. Each of the hearts should be laid open for examination of the endocardium in all chambers and associated valves. Although the best location for conducting the inspection may vary from plant to plant, an appropriate location may be in the offal packing area near or at the heart washer exit.
  2. Gross pathological lesions, including lesions of endocarditis, should be described on the EU Pork Heart Weekly Data Sheet. Negative findings should also be recorded on a weekly basis. The Data Sheets should be maintained on file in the inspection office. Plant management should submit scanned copies of the Data Sheets to the Office of International Affairs, Export Programs Staff, Fax (202) 720-7990 or email scanned copies at importexport@fsis.usda.gov on a quarterly basis.
2. For sows and boars (animals over 1 year of age) from which meat or offal destined for the EU is produced, each heart must be incised and its interior surfaces inspected by FSIS personnel. Procedures have not been developed to conduct this inspection. Therefore, meat and offal from these animals cannot be exported to the EU at this time.
Bison and SRM Removal

The European Union applies the same SRM requirements to meat derived from bison as is applied to meat derived from cattle. 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 on or after November 1, 2009 must comply with this requirement.

Additional information about the EV program for bison and a list of EV approved establishments 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 ARCBranch@usda.gov. Inspection personnel should include their immediate supervisor on messages to AMS. The following information should be included in the message:
- Establishment name, address, and establishment number
- Product type, product code, and quantity of product
- Date of production, lot number, and shift
- Date and nature of observation
- Name of country product is intended for export
- Export certificate number (if applicable)
- Any other information to verify claim
- Name of inspection official
Trichinae
1. Pork meat shall be subjected to cold treatment according to 9 CFR 318.10, OR
2. Each pork carcass shall be tested for trichinae at the time of slaughter. Testing requires the following elements:
  1. The laboratory performing the tests must participate in the USDA, Agricultural Marketing Service (AMS) Trichinae Analyst and Laboratory Certification Program. For further information about this program, contact AMS:
    
    Isaac (Gene) Sterling (202) 720-5898
    Microbiologist, USDA, AMS, STD, TSB
    1400 Independence Avenue, SW
    Mail Stop 0272, Room 0604, South Building
    Washington, DC 20250-0272
  2. Each establishment must have a written program and procedures in place that assures that only product from carcasses that have tested negative for trichinae are certified for export as such. This program must include sampling procedures, testing procedures according to the AMS program, as well as non-comminglement procedures throughout slaughter, fabrication, processing, and packaging.
  3. The IIC will review the establishment's written control program to determine if it is adequate to maintain 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, the Office of International Affairs, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 should be notified through supervisory channels. Meat produced during this time should not be certified for export to the EU.
Antimicrobial Treatments
1. Antimicrobial treatments (for example, hyperchlorination, TSP, organic acids, etc) are not allowed for treatment of red meat or poultry carcasses, parts or viscera. Only the application of water or steam is permitted.

Poultry Chilling

Immersion chilling of carcasses must meet the following requirements:

Carcasses must move through the chiller against a counterflow of water.
Recirculation of chiller water is not allowed.
The temperature of the water in the chiller must not exceed 61° F at the carcass entry and 40° F at the carcass exit.

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.

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.

Alternative chilling systems to VII.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 the Office of International Affairs, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.

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.
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. Tanks or vats such as those specified in 9 CFR 381.66 (c) (4) (ii) should be used.
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.
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.

Residue Testing*

All samples collected under the EU Additional Residue Testing Program will be forwarded to Maxxam Analytics, Inc. in Canada for screening.

All slaughter establishments approved for export of meat and/or offal to the EU are required to participate in the EU Additional Residue Testing Program. The EU Additional Residue Testing Program is outlined in Table 1. (Table 1: EU Residue Sampling Frequency for Meat). This program was initiated in 1989 for all meat slaughter establishments approved for export of meat and/or offals to the EU.

The FSIS Office of International Affair (OIA), Export Programs Staff (EPS), coordinates the additional residue testing program for products destined to the EU. The only North American Laboratory qualified under this program is Maxxam Analytics, Inc., Mississauga, Ontario, Canada. Following is the Maxxam contact information: phone numbers (905) 817-5700 or 1-800-563-6266, email info@maxxamanalytics.com and website www.maxxamanalytics.com.
The cost of analysis is the responsibility of the establishment management. Questions concerning analytical costs may be addressed directly to the laboratories participating in the program.
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 Meat
Table 2: EU Residue Sampling Frequency for Poultry*
Each EU approved slaughter establishment must make arrangements with Maxxam Analytics Inc., Mississauga, Canada, phone (905) 817-5838, in order to perform analyses included in this testing program. Contact the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990, for assistance.
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. Below is a chart showing the Project Codes, Species, and Samples to be collected for each analysis.*

Project Code	Name	Analysis
EU_04_BO	EU_04_Wild Boar (Boar/Stag) - Kidney/Muscle Residues	Lead and Cadmium (Kidney,Muscle)
EU_07_BI	EU_07_Bison - Kidney Fat/Liver/Muscle Residues	MGA (Fat) Ractopamine and Zilpaterol, (Liver, Muscle)
EU_07_SH	EU_07_Steer or Heifer -- Kidney Fat/Liver/Muscle Residues	Zilpaterol (Liver, Muscle)
EU_07_SH	EU_07_Steer or Heifer -- Kidney Fat/Liver/Muscle Residues	MGA (Fat) Ractopamine and Zilpaterol (Liver, Muscle)
EU_09_BI	EU_09_Bison -- Urine Residues	Zeranol and Taleranol (Urine)
EU_09_SH	EU_09_Steer or Heifer -- Urine Residues	Zeranol and Taleranol(Urine)
EU_14_BI	EU_14_Bison -- Urine Residues	Trenbolone (Urine)
EU_14_SH	EU_14_Steer or Heifer -- Urine Residues	Trenbolone (Urine)
EU_15_MH	EU_15_Market Hogs - Muscle Residues	Ractopamine (Liver, Muscle)
EU_15_TU	EU_15_Turkey -- Muscle Residues	Ractopamine (Liver, Muscle)

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.
Any questions related to sample collection under the EU Additional Residue Testing Program should be directed to the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.

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, ARC Instruction 1013 Procedure. Contact FSIS Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990, if necessary, for a copy of these documents.
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. (Example of Producer Affidavit) 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 Office of International Affairs, Export Programs Staff. 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 (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.
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, the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 shall be notified through supervisory channels.
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 MGC Instruction 710, Pork to the European Union Program Contact the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 for a fax copy of these documents.
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, LSP for additional information regarding this program and to schedule the initial compliance review, which will be coordinated with the FSIS Export Coordination Staff, TSC. 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, the Office of International Affairs, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 shall be notified through supervisory channels.
Poultry Export Verification (PEV)

All poultry 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
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. (Example of Poultry Producer Affidavit. 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 (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
  
  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 (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.
  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, the Office of International Affairs, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, ImportExport@fsis.usda.gov should be notified through supervisory channels.
Source of Raw Material

Cutting and processing plants intending to prepare products for export to the EU must source the raw meat or poultry from EU approved slaughter establishments. The raw material must be eligible for export to the EU and bear the EU health mark. Adequate records supporting control of product transferred to separate processing facilities and cold storage warehouses must be maintained by plant management. Identification and segregation of the raw material must be acceptable to the IIC.

Raw material may be imported into the United States for the purpose of EU production provided it bears the EU Health Mark, as described above, and has accompanying documentation that identifies the establishment of origin and demonstrates its EU eligibility. The product must also be eligible for importation into the United States. Imported product must be handled exclusively in facilities approved for the European Union, including import and cold storage facilities.
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 the Office of International Affairs, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.
  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:
3. 1. Exporters must display the following information on labels attached to an individual piece or pieces of meat or to their packaging material:
    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: Establishment (FSIS slaughter establishment number).
    3. The phrase "Cut in the United States: Establishment (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 4 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".
    Note: Minced meat should indicate: "Prepared in the United States".
  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.
  1. 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
  2. Fresh meat cuts which have undergone a freezing process must bear an indication of the month and year in which is was frozen.
4. 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 from the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.
  
  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.
5. 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 XIII.) 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. Export Notice 2005-2, April 1, 2005, provides information regarding the EU conformance verification review procedure, including documenting the review on the revised FSIS Form 9100-1 (03/25/2010), EU Conformance Verification Checklist for Meat and Poultry Establishments to be Used in Conjunction with the Export Requirements for the European Union. The new FSIS Form 9100-1 has been revised to reflect the requirements indicated in Section II above. In accordance with Export Notice 2005-2, 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 the Office of International Affairs, Export Programs Staff (EPS) at importexport@fsis.usda.gov, or by fax at (202) 720-7990. 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 the EPS.
6. Documentation - List of Required Certificates
  
  Advisory - Exporters should verify that the shipping date on any export certificate or accompanying shipping documents does not precede the FSIS signature date on the certificate. Failure to do so can result in the detention of the shipment at the Port of Entry into the European Union.
  1. Only meat and poultry and meat and poultry products slaughtered, processed, and stored at approved establishments that meet the requirements described herein may be certified for export to the EU. All certificates for EU except FSIS Form 9060-5 must have a preprinted blue seal. All EU documents must be signed by an FSIS Veterinarian in a color other than black.
  2. An important feature of all EU-specific export certificates is the requirement for the application of an Export Stamp identifying the Certificate Number indicated on FSIS Form 9060-5 Export Certificate of Wholesomeness. The signature block format has been changed to accommodate the export stamp. The Export Stamp must be applied in the area on the certificate provided for an "Official stamp." The Export Stamp must be applied in a color of ink other than black. The signature of the official signing the certificate must be in a color of ink other than black.
  3. Meat and poultry products transiting or being temporarily stored in an EU member state must have an appropriate transit certificate related to animal health. See “Transit Certificates” in the appropriate section below.
  4. Beef and Bison
    1. FSIS Form 9060-5 Export Certificate of Wholesomeness
    2. FSIS letterhead certificate, Veterinary Certificate for Fresh Meat of Domestic Bovines, Consigned to the European Community, is available in English, French, Italian, and German and Spanish.
      
      See Guidelines to complete.
      
      SRM certification is included in the certificate. Therefore, the separate SRM statement on FSIS letterhead is not necessary with the revised certificate.
    3. Certificate of Authenticity for high quality beef and veal, if product is shipped under the high quality beef quota.
      
      Effective immediately, one of the following certificates may be issued if the applicant provides a completed and signed AMS Statement of Verification (SOV) for High Quality Beef and has documentation that associates the SOV with the specified product:
      1. FSIS Form 9180-3, Certificate of Authenticity Beef and Veal if Statement A on the SOV is marked OR the beef is graded U.S. Choice or higher. When used for exports to the European Union, the phrase "Regulation (EC) No 810/2008" must be added to Box 5 of FSIS Form 9180-3 prior to being presented to the FSIS veterinarian for signature.
      2. FSIS Letterhead Certificate of Authenticity for Beef and Veal Regulation (EC) No 620/2009 if Statement B on the SOV is marked. The export stamp should be applied in Box 11 to the left of the signature, as well as to the second page of the certificate. Note: Details of the labeling requirement in Statement #4 of this certificate is provided in Section XIV. Labeling B. of these requirements.
      3. If both Statements A and B are checked, either certificate may be issued based upon request of the applicant.
      4. A Certificate of Authenticity may be issued after the FSIS 9060-5 and the EU veterinary certificate have been issued and after the product has left the U.S. if the applicant provides an SOV for the certified product. A replacement Certificate of Authenticity should only be issued if the original certificate is returned to the certifying official.
    4. Certificate of Authenticity for Bison
      
      FSIS Form 9180-3, Certificate of Authenticity, may be issued upon request of the applicant when producer affidavits are provided to FSIS personnel as part of the export certificate application. The affidavits must attest to the origin of the animals (U.S. or Canada) and that the animals meet the age and feeding requirement stated on the certificate. When used for exports to the European Union, the phrase “Regulation (EC) No 810/2008” must be added to Box 5 of FSIS Form 9180-3 prior to being presented to the FSIS veterinarian for signature.
  5. Pork
    1. FSIS Form 9060-5, Export Certificate of Wholesomeness
    2. Revised certification for fresh meat of domestic swine is required for certificates signed on or after January 1, 2009:
      
      FSIS letterhead certificate, Veterinary Certificate for Fresh Meat of Domestic Swine, Consigned to the European Community, is available in English, French, Italian, German, Romanian, and Spanish.
      
      See Guidelines to complete.
  6. Fresh Meat of Poultry
    1. FSIS Form 9060-5, Export Certificate of Wholesomeness
    2. FSIS letterhead certificate, Veterinary Certificate for Fresh Meat of Poultry, Consigned to the European Community, is available in English, Bulgarian, Danish, French, German, Greek, Hungarian, Italian, Netherlands, Polish, and Romanian. The English letterhead certificate should always be issued. Certificates in additional languages can be issued upon request of the exporter. The other language certificates are direct translations of the English certificate.
      
      See Guidelines to complete.
  7. Fresh meat of wild boar
    1. FSIS Form 9060-5 Export certificate of Wholesomeness.
    2. Revised certification for fresh meat of wild boar is required for certificates signed on or after January 1, 2009:
      
      FSIS letterhead certificate, Veterinary Certificate for Fresh Meat of Wild Suidae, Consigned to the European Community, is available in English, French, German, and Italian.
      
      See Guidelines to complete.
  8. Meat Preparations
    1. FSIS Form 9060-5 Export Certificate of Wholesomeness.
    2. FSIS letterhead certificate, Veterinary Certificate for Meat Preparations intended for Consignment to the European Community, is available in English, French, German, and Netherlands.
      
      See Guidelines to complete.
  9. Meat Products and treated stomachs, bladders and intestines (applies to meat products from bovines, swine, poultry, farmed game, domestic rabbits, and wild game).
    1. FSIS Form 9060-5 Export Certificate of Wholesomeness for Meat Products
    2. FSIS Letterhead Certificate for meat products and treated stomachs, bladders and intestines, "Veterinary Certificate for Meat Products and treated stomachs, bladders and intestines, imported into the European Community", in English. This letterhead certificate is also available in Spanish, French, Italian, German, Netherlands, Polish, Romanian and Bulgarian. If a foreign language version of this certificate is needed, it should be issued in conjunction with an English version. Use of the revised Letterhead Certificate, "Veterinary Certificate for Meat Products and Treated Stomachs, Bladders and Intestines Imported into the European Union" becomes mandatory for product being shipped as of May 1, 2008, and for entry into the European Union as of June 1, 2008.
      
      See Guidelines to complete.
      
      For meat products and treated stomachs, bladders and intestines that are destined for a non-EU country but that transit through or are stored in an EU country, see "Transit Certificates" section below.
  10. Animal casings
    
    Facilities, at which export certifications for casings to the EU are provided, are deemed to be processing facilities for purposes of export to the EU.
    
    Note: the EU defines all U.S. origin bovine intestines/casings as SRM and therefore they must originate from countries with negligible BSE risk. The following SRM statement must be presented on a separate FSIS letterhead certificate as an attachment to FSIS Form 9180-23 for bovine casings originating from negligible BSE risk countries. This letterhead certificate is also available in French, which can be issued in conjunction with the English version upon request of the exporter. The ileum of the small intestine of lamb is defined as SRM by the EU.
    
    Obtain one of the following certificates:
    1. Obtain FSIS Form 9060-7 (08/13/2008), Animal Casings Export Certificate for Countries Requiring Ante-Mortem, Post Mortem, and Fit for Human Food Statements or FSIS 9060-18 (08/13/2008), Animal Casings Export Certificate for Countries Requiring Ante-Mortem, Post-Mortem and Sound and Clean Statements as applicable. Refer to Directive 9000.2. It is the U.S. exporter's responsibility to provide documentation that the casings originated from EU-approved casings establishments in the exporting country.
    2. FSIS Form 9180-23 (10/18/2004), ANIMAL HEALTH CERTIFICATE (for animal casing for importation into the European Community)is a multi-language form containing text in English, Danish, French, German, Italian, Netherlands, Portuguese, Svenska, and Spanish. As the need arises, upon request, when other languages become available the form can be revised to include additional languages.
      
      An important feature of FSIS Form 9180-23 requires the application of an Export Stamp identifying the Serial Number indicated on FSIS Form 9060-7 or FSIS Form 9060-18, as appropriate. This is the same number used at the top right hand block of FSIS Form 9180-23 next to "No." The Export Stamp is applied below Section 9 (c), in the block provided for an "Official stamp." The Export Stamp must be applied to FSIS Form 9180-23 in a color of ink other than black. The signature of the official signing the certificate must be in a color of ink other than black.
      
      Animal casings not destined for an EU member state, that will be transiting or temporarily stored in an EU member state, must have an appropriate transit certificate related to animal health. See "Transit Certificates" in the appropriate section below.
  11. Raw Material for Pharmaceutical Processing
    1. Obtain FSIS Form 9060-5 only if the product bears the U.S. mark of inspection. Export certification of inedible products, other than technical animal fat (9 CFR 351) and certified pet food (9 CFR 355), is no longer provided by FSIS. Exporters should contact APHIS field offices to obtain information about certification of inedible products. A list of APHIS offices is available at: http://www.aphis.usda.gov/animal_health/area_offices/.
    2. Issue FSIS Letterhead Certificate for animal by-products to be used for technical purposes, in English. Use of the Letterhead Certificate, "Veterinary Certificate for Animal By-products to be Used for Technical Purposes" becomes mandatory for product being shipped as of July 1, 2008.
      
      See Guidelines to complete.
      
      Note: Effective December 1, 2011, this certification is obsolete and must not be used. Information about export certification for raw material for pharmaceutical processing will be posted as soon as it becomes available.
  12. Transit Certificates
    
    Meat, poultry or egg products destined for an non-European Union country, for ships’ stores, or for U.S. military use that is transiting through, is destined for a U.S. military base within, or is being temporarily stored in an EU member state must have the appropriate transit certificate related to animal health.
    
    The transit certificates attest only that the product complies with the animal health requirements of the EU. Currently, there are no animal health restrictions on U.S. meat, cooked poultry and egg products exported to the EU, however, see the pre-requisite flock health certification required below for raw poultry. Any changes to the animal health status will be included in these requirements.
    
    Transshipments of fresh meat or fresh poultry, meat or poultry products, meat or poultry preparations, egg products (on and after 4-26-2007), or animal casings through EU member countries, or shipments that will be temporarily stored in an EU member state, including ship stores and military shipments, must be accompanied by animal health certification. In addition to the certification/s required by the final destination country, the following EU transit certificates (as appropriate), must accompany shipments. For ships’ stores and military shipments, in addition to the appropriate transit certificate, the following statement must be included in the “Remarks” section of FSIS Form 9060-5: "Product consigned to ships’ stores" or "Product consigned to US military".
    1. FRESH MEAT TRANSIT/STORAGE
      1. Revised certification for fresh meat transit/storage is required for certificates signed on or after January 1, 2009:
        
        FSIS letterhead certificate, "Veterinary Certificate for Fresh Meat for Transit and/or Storage in the European Union", is available in English, French, German, Greek, Spanish, Netherlands, Lithuanian, and Polish.
        
        This transit certificate is related to animal health only and applies to fresh/frozen meat (red meats) that will transit through or be temporarily stored in a member state of the European Union.
        
        See Guidelines to complete.
    2. FRESH POULTRYMEAT TRANSIT/STORAGE
      1. Revised certification is required for product entering the EU on or after July 15, 2009.
        
        Veterinary Certificate for transit/storage of specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, ratites and wild game-bird, eggs and egg products is available in English, Bulgarian, French, German, Lithuanian, Romanian, Greek, Italian, Netherlands, Polish, and Spanish.
        
        Plant management must present a monthly certification from an APHIS accredited veterinarian when making application for the fresh poultry meat transit/storage certificate. The veterinarian must have Category II accreditation in the State where the flock is located to sign the flock health certificate. To determine if a veterinarian is accredited in a particular State, the contact information for location of offices in each State is available at APHIS' Web site. The certificate must be dated within the previous 30 days of the date of slaughter. This certificate is for U.S. use only and should not be sent with the transit certificate.
        
        See Guidelines to complete.
    3. MEAT PRODUCTS AND TREATED STOMACHS, BLADDERS AND INTESTINES TRANSIT/STORAGE - FSIS Letterhead Certificate, "Veterinary Certificate for meat products and Treated Stomachs, Bladders and Intestines, for transit/storage in the European Union" in English. This transit certificate for meat products and treated stomachs, bladders and intestines applies to meat products from bovines, swine, sheep, goats, horsemeat, poultry, farmed game, domestic rabbits, and wild game. This letterhead certificate is also available in Spanish, French, Italian, Netherlands, Polish and German, Romanian, and Bulgarian. If a foreign language version of this certificate is needed, it is to be issued in conjunction with an English version. Use of the revised Letterhead Certificate, "Veterinary Certificate for Meat Products and Treated Stomachs, Bladders and Intestines for transit/storage in the European Union" becomes mandatory for product being shipped as of May 1, 2008, and for entry into the European Union as of June 1, 2008.
      
      See guidelines to complete.
    4. ANIMAL CASING TRANSIT/STORAGE - FSIS Form 9180-24 EN/FR/DE/IT/ES/HU, VETERINARY CERTIFICATE for animal casing for [transit][storage] in the European Community, is available to order. This form contains the following languages: English, French, German, Italian, Spanish and Hungarian. This transit certificate applies to animal casings that will transit through or be temporarily stored in a member state of the European Union. See guidelines to complete.
    5. MEAT PREPARATION TRANSIT/STORAGE
      
      Effective immediately, revised certification is required for meat preparations shipments transiting or being stored in the EU.
      
      Veterinary Certificate for Meat Preparations for Transit/Storage is available in English, Spanish, Italian, French, German, and Netherlands.
      
      See Guidelines to complete.
    6. EGG PRODUCTS TRANSIT/STORAGE
      1. Revised certification is required for product entering the EU on or after July 15, 2009.
        
        Veterinary Certificate for transit/storage of specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, ratites and wild game-bird, eggs and egg products is available in English, Bulgarian, French, German, Lithuanian, Romanian, Greek, Italian, Netherlands, Polish, and Spanish.
      2. Note: The letterhead transit certificate for fresh poultry meat and egg products is the same certificate.
        The APHIS monthly certificate is no longer required for egg products transiting the EU.
    7. All transit certificates must be stamped with the export stamp as described in Section B. above. FSIS Letterhead certificates must always be stamped with the "Export Stamp" and signed at the bottom of each page in ink a color other than black.
    8. Requests for transit certificates for products other than fresh/frozen meat and poultry; meat products, and, requests for certificates in various languages should be directed to the Office of International Affairs at (202) 720-0082 or (855) 444-9904.
7. Other Requirements
  1. Product for personal consumption - Products for personal consumption must meet all export requirements found in this document, i.e. be certified from an eligible plant (see EU plants lists) and be accompanied by all required certificates issued by an FSIS veterinarian. Hand carried or mailed items will not be allowed unless they meet these requirements. EU member countries are listed at the beginning of this document).
  2. European Union requires treatment of all packing material made of conifer materials as a preventive measure against pinewood parasites. This includes wood pallets. USDA, APHIS has established a marking procedure for treated pallets. More information is available at APHIS' Website.
  3. European Union Pork Tariff Rate Quota And Certificate Of Origin. A new, supplementary tariff rate quota (TRQ) and Certificate of Origin has been set by the European Union (EU) specifically for U.S. pork loins and hams. For more detail, see information provided by the U.S. Meat Export Federation at the following link: http://usmef.org/TradeLibrary/Europe.asp#Pork_TRQ. This information is for the use of U.S. exporters. It should not be considered by FSIS personnel in determining the eligibility of product for FSIS export certification. FSIS does not issue and is not involved in the issuance of the Certificate of Origin.
8. Plant Approval Process
  1. Under Council Decision 98/258/EC (the Veterinary Equivalence Agreement):
    1. The Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990, will provide technical assistance regarding the provisions of the agreement to plant management and FSIS personnel. In addition, U.S. Meat Export Federation (303-623-6328) and U.S.A. Poultry and Egg Export Council (770-413-0006) may provide technical assistance to plant management interested in EU approval.
    2. Plant management seeking EU approval should complete and submit FSIS 9080-3, Establishment Application for Export, to the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 through FSIS supervisory channels. The Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 may perform on-site visits to confirm that an establishment complies with the conditions of the Agreement as outlined in the Library of Export Requirements for the European Union. FSIS Form 9100-1 (03/25/2010), EU Conformance Verification Checklist for Meat and Poultry Establishments to be Used in Conjunction with the Export Requirements for the European Union, will be completed prior to FSIS OIA submitting a request to the EU for approval.
    3. Plants that comply with the conditions stated herein will be submitted to the EU for approval. FSIS will certify to the EU that U.S. meat and poultry establishments comply with the appropriate conditions as outlined above. The EU will approve and list the plants in a timely manner. Plants may begin producing for export to the EU under the conditions of the new agreement on the date of EU listing.
    4. Farmed Game plants are reviewed by FSIS and determined to meet EU requirements for export. Farmed game plants are recommended to EU through FDA, as the "competent authority." Application and review matters are conducted by FSIS, Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990. For further information on FDA regulations covering farmed game, contact Esther Z. Lazar at (301) 436-1485.
    5. The EU has the right to audit approved plants to confirm that they comply with the conditions of the agreement.
  2. Partial approvals - Applies to red meat only
    
    Establishment management seeking approval of only the part of their plant that processes product for EU export can request partial plant approval for certain products under the following conditions:
    1. The establishment shall develop a Quality Assurance (QA) program which addresses the mode of operation, the identification of product, and the segregation of the product from receiving to shipping. Establishments which want to apply for partial approval must meet the facility requirements in the approved areas to ensure physical and/or time separation of approved and non-approved products.
    2. The QA program shall include an establishment monitoring schedule and a log to document both monitoring actions and corrective actions.
    3. The QA program shall be acceptable to the IIC and be available and acceptable to the EU auditor.
    4. The IIC shall monitor the establishment's application of the QA program and document such monitoring and ensure correction of deficiencies.
    5. The establishment must be able to demonstrate the program during an audit. All relevant documentation must be available.
  3. Animal casings establishments operating under FSIS voluntary inspection should submit FSIS Form 9080-3 to the Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 through FSIS supervisory channels. In addition to meeting FSIS requirements, these plants must comply with additional EU requirements indicated in Section II.Q. Casing plants are recommended to the EU through FDA, as the competent authority. Application and review matters are conducted by FSIS Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.
9. Plants Eligible for Export
  1. Lists of eligible plants for the various product categories are available through the Export Library. Plants must meet all EU requirements in addition to being listed on the appropriate list. Cold storage approval is not species specific. Establishments with cold storage approval are eligible to store product of any species.
    
    Contact the FSIS Office of International Affairs, Export Programs Staff, Washington, DC, Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990.
    
    The European Union official website where EU lists are published is available at http://ec.europa.eu/food/food/biosafety/establishments/third_country/index_en.htm.. Scroll to "United States" and click on the list of interest.
  2. Products intended for pharmaceutical manufacture can originate from any federally inspected establishment.
  3. Beef and bison originating from Est. 889A, J.F. O'Neill Packing Co., Omaha, NE that were produced prior to July 28, 2011, and on or after October 11, 2011, are eligible for export to the European Union. Beef and bison originating from this establishment that were produced on or after July 28, 2011, and prior to October 11, 2011, are ineligible for export to the European Union.
EU-141 (Mar 6, 2012)