|
Export Requirements for the European Union
EU-94 (Jul 11, 2008)
Asterisks (*)
indicate the most recent revision to these requirements. To search, click on your
browser's "Edit" menu, then click on "Find (on this page)".
Enter "*" in the "Find What" field, then click "Find"
or "Find Next" until all asterisks have been identified. |
The EU member
countries are Austria, Belgium, Bulgaria, Denmark, Finland, France,
Germany, Greece, Italy, Ireland, Luxembourg, the Netherlands,
Portugal, Spain, 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.
Table of Contents
- Eligible/Ineligible Products
- 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.
- "Meat" means all parts of domestic bovine animals
(including bison), swine, sheep, goats, and solipeds
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 Bob Childers at (301) 436-1494.
- "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.
- "Poultry meat" means all parts fit for human
consumption from domestic birds of the following
species: domestic fowl, turkeys, guinea fowl, ducks and
geese.
- "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.
- "Offal" means fresh meat and fresh poultry meat
other than that of the carcass, even if it remains
naturally connected to the carcass.
- "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.
- "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.
- "Minced meat" means meat which has been minced into
fragments or passed through a spiral-screw mincer.
- "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 - Bob Childers at (301)
436-1494); and (5) meat powder, powdered rind, slated or
dried blood, salted or dried blood plasma.
- "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.
- "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.
- 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.
- 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.
- 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:
- 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.
- Animals whose meat is intended for export shall be
kept separate from animals whose meat is not eligible
for export.
- 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.
- 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.
- 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.
- Records of the origin of the animals from which the
meat was produced shall be retained for a period of 6
months after export.
- Accommodation for sick and suspect animals
- Wood shall not be used for pens for sick and suspect
animals.
- Sick and suspect animals shall not be allowed to
come into contact with animals intended for slaughter
for export to the EU.
- 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.
- 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.
- 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.
- 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.
- 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.
- Cattle
- Cattle under 30 months of age:
- Inspection by an FSIS veterinarian or;
- Antemortem inspection may be performed by an
official FSIS inspector with appropriate training,
knowledge, skills and abilities provided that:
- the animals originate from a premise where an
APHIS accredited veterinarian is present on an
ongoing basis, and
- a letter from the premise confirming such
presence must be on file at the plant.
- Cattle over 30 months of age must be inspected by an
FSIS veterinarian.
- Swine
- Swine under 1 year of age will be inspected by FSIS
in accordance with FSIS procedures.
- Swine over 1 year of age must be inspected by an
FSIS veterinarian.
- All animals demonstrating abnormal signs shall be
diagnosed and disposed of by an FSIS veterinarian.
- Pig Heart Incision
- 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:
- 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.
- 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 copies of the Data Sheets to
the Office of International Affairs, Import-Export
Programs Staff, Washington, DC, Phone (202) 720-0082,
Fax (202) 720-7990 on a quarterly basis.
- 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.
- Trichinae
- Pork meat and horsemeat shall be subjected to cold
treatment according to 9 CFR 318.10, OR
- Each pork or horse carcass shall be tested for
trichinae at the time of slaughter. Testing requires the
following elements:
- 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 Sterling (202) 720-5898 Chemist,
USDA, AMS, STD, TSB P.O. Box 96456, Room
3517-South 14th & Independence Avenue,
S.W. Washington, DC 20090-6456
- 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.
- 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, 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
- 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 IX.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, 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
- Poultry shall be chilled to an internal temperature
of 40° F in the shortest time possible after slaughter.
- 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.
- 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.
- 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
- 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 Red
Meat). This program was initiated in 1989 for all red
meat slaughter establishments approved for export of
meat and/or offals to the EU.
The FSIS Office of International Affair (OIA), Import
Export Program Staff (IEPS), 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 Red Meat Table 2:
Draft 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, Import-Export Programs Staff,
Washington, DC, Phone (202) 720-0082, Fax (202) 720-7990,
for assistance.
- Sample request forms (FSIS form 10,210-3) will be
preprinted and sent directly to the FSIS
Inspector-in-charge (IIC) at the EU approved slaughter
establishment periodically throughout the year. These
forms will designate the date samples are to be collected
(within 30 days of the specified date), tissue to be
collected, the code for the residue which will be
analyzed, and the laboratory designated to perform the
analysis.
- The IIC is responsible for collecting, securing and
freezing the samples. These samples will be sent 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, Import-Export
Programs Staff, Washington, DC, Phone (202) 720-0082, 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, Import-Export Programs Staff,
Washington, DC, Phone (202) 720-0082, Fax (202) 720-7990, if
necessary, for a copy of these documents.
- Beef and veal production
- 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.
- 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.
- All cattle must be slaughtered and processed in a
federally inspected establishment approved for
production of products destined for the EU.
- 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,
Import-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.
- 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.
- 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:
- 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.
- Product destined for the EU must be appropriately
identified and segregated throughout production
according to the establishment's written control
program.
- 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.
- 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.
- 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:
- Familiarity with the establishment's written control
program.
- 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.
- 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.
- 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.
- If repeated deficiencies occur, or a non-compliance
is not corrected in a reasonable time period, the Office
of International Affairs, Import-Export Programs Staff,
Washington, DC, Phone (202) 720-0082, 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, Import-Export Programs Staff, Washington, DC, Phone
(202) 720-0082, Fax (202) 720-7990 for a fax copy of these
documents.
- Pork production
- 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.
- 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 AffidavitThis affidavit can be
transmitted electronically or by facsimile, but must be
available when the shipment of hogs arrives at the
establishment.
- All hogs must be slaughtered and processed in a
federally inspected establishment approved for
production of products destined for the EU.
- 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.
- 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:
- 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.
- Product destined for the EU must be appropriately
identified and segregated throughout production
according to the establishment's written control
program.
- 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.
- 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:
- Familiarity with the establishment's written control
program.
- 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.
- 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.
- 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.
- 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, Fax (202) 720-7990 shall 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
- Health Marks
- 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:
- The oval mark must be 2.5 inches
(6.5cm) wide by 1.8 inches (4.5cm) high.
- within the oval:
- in the center - the establishment number.
- in the upper or lower part - the letters USA.
- 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.
- a sequential serial number that is unique to each
health mark label for that establishment.
- 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, Fax (202)
720-7990.
- 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.
- 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.
- Beef Labeling - Additional labeling information must
be present on beef arriving in the EU as of January 1,
2001. The labeling requirement applies to all beef
intended for human consumption, with the exception of
processed products and offal. The beef must be labeled in
one of two ways:
- Under "Option 1" exporters must display the
following information on cartons and vacuum bags:
- 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, 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.
- The phrase "Slaughtered in the United States:
Establishment (FSIS slaughter establishment number).
- The phrase "Cut in the United States:
Establishment (FSIS cutting establishment number).
- 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, e.g.,
"Origin: Canada". If the
animals were 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.)
Note: Minced meat should indicate:
"Prepared in the United States".
- Under "Option 2" exporters must display the
following information on cartons and vacuum bags:
- "Non EC and slaughtered in the United States".
- 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.
- Labeling of raw material for pet food manufacture and
pharmaceutical processing
- Carton labels of material intended for pet food
manufacture must indicate:
- the phrase "Raw Material Only for the Manufacture
of Pet Food"
- the name and address of the EU establishment of
destination
- Carton labels of material intended for
pharmaceutical processing must indicate:
- the phrase "Raw Material Only for the Manufacture
of Technical Products Including Pharmaceutical
Products"
- the name and address of the EU establishment of
destination
- Fresh meat cuts which have undergone a freezing
process must bear an indication of the month and year in
which is was frozen.
- 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, Import-Export Programs Staff,
Washington, DC, Phone (202) 720-0082, 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.
- 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 (01/08/2007), 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.
- 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.
- 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.
- 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.
- 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.
- Beef and Bison
- FSIS Form 9060-5 Export Certificate of Wholesomeness
- FSIS letterhead certificate, VETERINARY CERTIFICATE for fresh meat of domestic bovine, consigned
to the European Community, is available in
English,
French,
Italian,
German
and English/Romanian.
See Guidelines to complete.
The following SRM statement must be presented on a separate FSIS
letterhead certificate as an attachment in
response to FSIS bovine letterhead certificate section 9.4: at: "(5) (10) or [insert the relevant text
of European Parliament and Council Regulation No 999/2001 (as amended) for all meat from ruminants and
products containing meat from ruminants.
Note: The following tissues are designated as specified risk material according to Annex V of EC No. 999/2001
(as amended by Commission Regulation (EC) No 357/2008):
(a) as regards bovine animals:
(i) the skull excluding the mandible and including the brain and eyes, and
the spinal cord of animals aged over 12 months;
(ii)the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the
cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the
dorsal root ganglia of animals aged over 30 months; and
(iii) the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.
(b) as regards ovine and caprine animals:
(i) the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months
or which have a permanent incisor erupted through the gum, and
(ii) the spleen and ileum of animals of all ages.
Establishment operating procedures must include a process to assure that these SRM's, as defined by the EU,
have been removed from products intended for export to the EU.
Carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters
containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be
imported.
Although the injection of air during stunning is not permitted, captive bolt stunning alone is permitted.
- FSIS Form 9180-3 - Certificate of Authenticity for high quality beef and veal, if requested.
Product certified by FSIS Form 9180-3 must be either graded USDA Prime or Choice or be produced under an AMS
approved program which verified that production practices meet the definition of "High-Quality Beef"
(see reverse side of form). Further information about establishing a program can be obtained from AMS Meat
Grading and Certification Branch at (720) 497-2520.
Note: If live bison are imported from Canada for slaughter under EU production, see the labeling section and
the guideline for further information about completion of the certificate indicating origin of the animals.
- Pork
FSIS Form 9060-5, Export Certificate of
Wholesomeness
The FSIS Form - VETERINARY
CERTIFICATE for fresh meat of domestic swine consigned to
the European Community, is available to order in the
language choices below.
FSIS Form 9180-19 EN is in
English only FSIS Form 9180-19 EN/FR is in English and
French FSIS Form 9180-19 EN/DE is in English and
German FSIS Form 9180-19 EN/IT is in English and
Italian
Letterhead
Certificate for fresh pork meat in English and
Romanian.
Separate Letterhead Certificates for fresh pork meat in
English
and in
Spanish
(to be issued together).
See Guidelines
to complete.
- Horsemeat
FSIS Form 9060-10 Horsemeat Export
Certificate
The FSIS Form - VETERINARY CERTIFICATE
for fresh meat of domestic solipeds consiged to the
European Community, is available to order in the language
choices listed below.
FSIS Form 9180-17 EN is in
English only. FSIS Form 9180-17 FR is in English and
French. FSIS Form 9180-17 DE is in English and
German. FSIS Form 9180-17 IT is in English and
Italian
See Guidelines
to complete.
Note: Block 10.2 of
the FSIS Form 9180-17 series contains and/or statements.
If all horsemeat in the shipment was derived from horses
born and raised in the U.S. or horses which have been in
the U.S. for at least 3 months, then the first statement
is appropriate; strike through the second and/or
statement. If the horsemeat is derived from horses that
were imported from another country, such as Canada, into
the U.S. and have been in the U.S. less than three months,
then the second and/or statement in 10.2 is the
appropriate statement; strike through the first statement.
(Use CA-0 as the ISO code for Canada.) If the shipment
contains horsemeat from a mixture of these two categories,
then strike through the "or" of and/or, and leave both
statements.
- Fresh meat of wild boar
FSIS Form 9060-5 Export
certificate of Wholesomeness
The FSIS Form -
VETERINARY CERTIFICATE for fresh meat of wild suidae
consigned to the European Community, is available to order
in the language choices listed below.
FSIS Form
9180-20 EN is in in English only. FSIS Form 9180-20 FR
is in in English and French. FSIS Form 9180-20 DE is in
in English and German. FSIS Form 9180-20 IT is in in
English and Italian.
See Guidelines
to complete.
- 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).
- FSIS Form 9060-5 Export Certificate of Wholesomeness
for Meat Products
- 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.
- Animal casings
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. The ileum of the small
intestine of lamb is defined as SRM by the EU.
Depending upon the source of the casings, obtain one of
the following certificates:
- For U.S. origin casings processed only in the
U.S. - FSIS Form 9060-7, Animal Casings Export
Certificate for Countries Requiring Ante-Mortem,
Post-Mortem, and Fit for Human Food Statements, or
- For casings imported into the U.S. - FSIS Form
9060-18, Animal Casings Export Certificate for
Countries Requiring Ante-Mortem, Post-Mortem, and
Sound and Clean Statements. It is the U.S. exporter's
responsibility to provide documentation that the
casings originated from EU-approved casings
establishments in the exporting country.
- FSIS Form 9180-23 (10/18/2004), ANIMAL HEALTH
CERTIFICATE (for animal casing for importation into
the European Community)1, supercedes FSIS Form
9180-7, Animal Health Certificate for Animal Casings
Intended for Dispatch to the European Community
(EEC). FSIS Form 9180-23 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, FSIS
Form 9060-17 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.
- Raw Material for Pet Food Manufacture
Beef and
pork raw material from non-EU eligible animals must be
denatured according to EU requirements - see Section II,
D. For beef and pork raw material from EU eligible
animals (see Sections IX and X), 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/vs/ncie/iregs/products/vsavic.pdf.
See FSIS
Notice 17-05 for additional information.
The
FSIS Form - 9180-21 EN/FR/DE/PL, VETERINARY CERTIFICATE
for animal by-products for the manufacture of pet food
intended for dispatch to the European community is
available to order in the languages below:
FSIS
Form 9180-21 EN/FR/DE/PL is in English, French, German and
Polish.
See Guidelines
to complete.
These forms can be ordered via the
Field Service Center (FSC). FSIS Form 9180-21 EN/FR/DE/PL
supercedes previous letterhead FSIS Form 2630-9
(6/86).
- Raw Material for Pharmaceutical Processing*
- 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/vs/ncie/iregs/products/vsavic.pdf.
- 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.
This form supercedes FSIS Form 9180-22 which should no
longer be used.
- 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, poultry and egg
products exported to the EU. 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".
- FRESH MEAT TRANSIT/STORAGE - FSIS Form 9180-26
EN-PL, VETERINARY CERTIFICATE For Fresh Meat for Transit
and/or Storage in the European Community, is available
to order. This form contains the following languages:
English French, German, 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.
FSIS Form 9180-26 EN-PL can be
ordered via the field Service Center (FSC). This
form supercedes previous letterhead FSIS form 2630-9
(6/86).
- FRESH POULTRYMEAT TRANSIT/STORAGE - Obtain FSIS
letterhead transit certificate, "Transit/storage of
meat, minced meat and mechanically separated meat of
poultry, ratites and wild game-birds, and egg products".
FSIS Form 9180-25 EN-PL, VETERINARY CERTIFICATE for
Fresh Poultrymeat for Transit and/or Storage in the
European Community, will not be accepted in the EU after
04/25/2007 and will become obsolete (should not be
signed) after that date.
This letterhead is
available in English,
French,
German,
Spanish,
Italian,
Netherlands,
Lithuanian,
Greek,
and Polish
translations. For shipments to Romania or Bulgaria, use
the English
version. Exporters should work closely with importers to
obtain any necessary translations. See guidelines
to complete.
- 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.
- 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.
- MEAT PREPARATION TRANSIT/STORAGE - This transit
certificate applies to meat and to poultry
preparations. See guidelines
to complete.
FSIS Form 9180-29 EN/ES/IT/FR/DE/NL
(03/10/2006) Veterinary Certificate for meat
preparations for transit/storage in the European
Community”. This
form contains the following languages: English, Spanish,
Italian, French, German, and Netherlands.
- EGG PRODUCTS TRANSIT/STORAGE – Obtain letterhead
transit certificate, "Transit/storage of meat, minced
meat and mechanically separated meat of poultry, ratites
and wild game-birds, and egg products". Shipments of egg
products transiting through or being stored in an EU
country arriving in the EU on and after April 26, 2007,
must be accompanied by this certificate. This letterhead
is available in English,
French,
German,
Spanish,
Italian,
Netherlands,
Lithuanian,
Greek,
and Polish
translations. For shipments to Romania or Bulgaria, use
the English
version. For Romania and Bulgaria, exporters should work
closely with importers to obtain any necessary
translations. Note that the new letterhead certificate
requires an export stamp in ink a color other than
black. See guidelines
to complete.
Note: The
letterhead transit certificate for fresh poultry meat
and egg products is the same certificate.
- 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.
- 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.
- Other Requirements
- 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).
- 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 the
following web site: http://www.aphis.usda.gov/ppq/wpm.
- 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.
- Plant Approval Process
- Under Council Decision 98/258/EC (the Veterinary
Equivalence Agreement):
- The Office of International Affairs, Import-Export
Programs Staff, Washington, DC, Phone (202) 720-0082,
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.
- Plant management seeking EU approval should complete
and submit FSIS 9080-3, Establishment Application for
Export, to the Office of International Affairs,
Import-Export Programs Staff, Washington, DC, Phone
(202) 720-0082, Fax (202) 720-7990 through FSIS
supervisory channels. The Office of International
Affairs, Import-Export Programs Staff, Washington, DC,
Phone (202) 720-0082, 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 (04/06/2005), 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.
- 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.
- 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, Import-Export Programs Staff, Washington, DC,
Phone (202) 720-0082 , Fax (202) 720-7990. For
further information on FDA regulations covering farmed
game, contact Marilyn Balmer at (301) 436-1492.
- The EU has the right to audit approved plants to
confirm that they comply with the conditions of the
agreement.
- 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:
- 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.
- The QA program shall include an establishment
monitoring schedule and a log to document both
monitoring actions and corrective actions.
- The QA program shall be acceptable to the IIC and be
available and acceptable to the EU auditor.
- The IIC shall monitor the establishment's
application of the QA program and document such
monitoring and ensure correction of deficiencies.
- The establishment must be able to demonstrate the
program during an audit. All relevant documentation must
be available.
- Animal casings establishments operating under FSIS
voluntary inspection should submit FSIS Form 9080-3 to the
Office of International Affairs, Import-Export Programs
Staff, Washington, DC, Phone (202) 720-0082, 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,
Import-Export Programs Staff, Washington, DC, Phone (202)
720-0082, Fax (202) 720-7990.
- Lists of Eligible
Plants
- 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.
Contact the FSIS
Office of International Affairs, Import-Export Programs
Staff, Washington, DC, Phone (202) 720-0082, Fax (202)
720-7990.
The European Union official website were
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.
- Products intended for pet food or pharmaceutical
manufacture can originate from any federally inspected
establishment.
EU-94 (Jul 11, 2008)
|
|
|
|