European Union – USDA Food Safety and Inspection Service
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The EU member countries are Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, the Netherlands, Portugal, Spain (including areas in the Outermost Regions, such as the Canary Islands), Sweden, the United Kingdom, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovak Republic, and Slovenia.*
Finland and Sweden have additional requirements. See Section XIV for more information.
At this time, Croatia will accept export certificates in English.
IMPORTANT: Please see section below for areas under EU restrictions. From these areas U.S. fresh poultry meat is not eligible for export or transit through the EU. Processed poultry products continue to be eligible provided the product has undergone the appropriate heat treatment.
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:
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.
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.
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.
Antemortem inspection will be performed by FSIS in accordance with 9 CFR 309 and according to FSIS procedures.
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 QAD.AuditService@ams.usda.gov. Inspection personnel should include their immediate supervisor on messages to AMS. The following information should be included in the message:
With the exception of lactic acid solutions used on bovine or bison carcasses, antimicrobial treatments (for example, hyperchlorination, 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.
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.
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 (855) 444-9904, Fax (202) 720-7990 or importexport@fsis.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.
All samples collected under the EU Additional Residue Testing Program will be forwarded to an AMS approved laboratory for screening.
The FSIS coordinates the additional residue testing program for products destined to the EU. However, AMS has set up the Laboratory Approval Program for export where they provide information on approved laboratories which conduct the required residue testing.The Official Listing of USDAApproved Laboratories Export Laboratory Approval Program is available on the AMS Website.
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. FDA will be responsible for the analytical cost for samples with the _Den suffixin 2016. Contact Andrew Yeung at (240) 402-1541 with questions.The FDA laboratory address is as follows: FDA/ Denver Laboratory Sample Custodian, 6th & Kipling St., DFC,BLDG 20, Entrance W-10, Denver, CO 80225. 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.
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 at Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990 or importexport@fsis.usda.gov, if necessary, for a copy of these documents.
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.
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:
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:
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 FSIS at Phone (202) 720-0082 or (855) 444-9904, Fax (202) 720-7990, or importexport@fsis.usda.gov for a copy of these documents.
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:
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:
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
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:
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:
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.
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 or (855) 444-9904, Fax (202) 720-7990).
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.
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 FSIS 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.
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.
The exporter should check with their importer whether letterhead certificate for each product type, in one shipment, should have a unique number in Box I.2, which is the number serial number of the corresponding 9060-5, Meat and Poultry Export Certificate of Wholesomeness.
Note: Many of the EU Model Health Certificates below contain material that is pre-marked through. While that material must remain marked through, there may be additional statements, words, species, etc. that must be marked through prior to certification. Applicable statements shall be kept as appropriate and statements which are not relevant, should be marked through (single line through non-applicable text), initialed and stamped by the certifying FSIS veterinarian. Only the additional marked through material should be initialed and stamped by the FSIS veterinarian.
Note: All of the EU certificates listed below require the gross and net weights in kilograms in box I.20.
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.
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.
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:
Note: Bison is not eligible for the high quality beef quota B and only the reference to Regulation (EC) No 593/2013 (quota A) can be added to FSIS Form 9180-3 as described below. FSIS PHVs should not certify bison under the high quality beef quota, B, (EC) No 481/2012.
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 593/2013" must be added to Box 5 of FSIS Form 9180-3 prior to being presented to the FSIS veterinarian for signature.
See Guidelines to complete.
See Guidelines to complete.
See Guidelines to complete.
See Guidelines to complete.
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.
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. These facilities must be present on the list of EU-approved casings establishments in the United States. See Section XX, Plants Eligible for Export, to access the list. Casings do not have to originate from animals slaughtered at establishments approved by 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 separateFSIS 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:
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, which 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.
Meat, poultry or egg products destined for a 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".
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.
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. If the consignment consists of poultry enter U.S., enter US and US-1. If the consignment consists of egg products, enter US and US-0. If from another country, enter appropriate code.
See guidelines to complete
If the consignment consists of poultry enter U.S., enter US and US-1. If the consignment consists of egg products, enter US and US-0. If the consignment consists of heat treated poultry and poultry products from a restricted state, enter US and US-2. If from another country, enter appropriate code.
Please see new guidelines to complete I.28.
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.
Certification is required for composite products transiting or being stored in the EU. Composite product is defined by the EU as "a foodstuff intended for human consumption that contains both processed products of animal origin and products of plant origin and includes those where the processing of primary product is an integral part of the production of the final product".
Composite products regulated by FSIS, including products containing processed egg components sourced from an FSIS inspected plant or eligible foreign country, can be certified for transit through the EU. Note that all FSIS inspected and passed egg products (or legally imported egg products) have been pasteurized to comply with the time and temperature requirements described in this certificate.
If the dairy products trigger the need for the certification statements marked through on the Veterinary Certificate for Composite Products for Transit/Storage, the exporter is to contact the Import/Export Program Development Staff at importexport@fsis.usda.gov or call (202) 720-0082.
Veterinary Certificate for Composite Product for Transit/Storage is available in English, Bulgarian, Estonian, French, German, Greek, Italian, Latvian, Lithuanian, Netherlands, Polish, Romanian, and Spanish.
See guidelines to complete.
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.
Note: The letterhead transit certificate for fresh poultry meat and egg products is the same certificate. See Guidelines to complete.
The APHIS monthly certificate is no longer required for egg products transiting the EU.
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:
The European Union official website where EU lists are published is available at https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_en.htm. Scroll to "United States" and click on the list of interest.
Originally posted here:
European Union - USDA Food Safety and Inspection Service