2004/212/EC: Commission Decision of 6 January 2004 on Community health conditions on imports of animals and fresh meat including minced meat from third countries and amending Decisions 79/542/EEC, 2000/572/EC and 2000/585/EC (notified under document number C(2003) 5248) (Text with EEA relevance)
Date: 2004-01-06
Institutions: European Commission
Subjects: fresh meat, health certificate, import, live animal, originating product, third country, veterinary legislation

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Official Journal of the European Union

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COMMISSION DECISION

of 6 January 2004

on Community health conditions on imports of animals and fresh meat including minced meat
from third countries and amending Decisions 79/542/EEC, 2000/572/EC and 2000/585/EC

(notified under document number C(2003) 5248)

(Text with EEA relevance)

(2004/212/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Regulation (EC) No 1398/2003 (8), and in particular Articles
6A(1)(e), 17(2) and (3), 18(1) and 19 thereof,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 72/462/EEC of 12
December 1972 on health and veterinary inspection problems
upon importation of bovine, ovine and caprine animals and
swine, fresh meat or meat products from third countries (1), as
last amended by Regulation (EC) No 807/2003 (2), and in
particular Articles 3(1), 6(3), 7 and 8, 11(2), 14(3)(c) and (d),
15, 16(1), 17(2)(b) and (d) and 22(2) thereof,

Having regard to Council Directive 92/118/EEC of 17
December 1992 laying down public health and animal health
requirements governing trade
into the
Community of products not subject to the said requirements
laid down in specific Community rules referred to in Annex A,
Chapter I, to Directive 89/662/EEC and, as regards pathogens,
to Directive 90/425/EEC (9), as last amended by Commission
Decision 2003/721/EC (10),
and in particular Article 10
thereof,

in and imports

Having regard to Council Directive 94/65/EEC of 14 December
1994 laying down the requirements for the production and
and meat
placing
preparations (11),
(EC) No
amended
806/2003, and in particular Articles 13 and 14 thereof,

the market
as

of minced meat

by Regulation

on

Having regard to Council Directive 91/496/EEC of 15 July
1991 laying down the principles governing the organisation of
veterinary checks on animals entering the Community from
89/662/EEC,
third
90/425/EEC and 90/675/EEC (3) as last amended by Directive
96/43/EC (4), and in particular Article 8B thereof,

amending Directives

countries

and

Having regard to Council Directive 92/45/EEC of 16 June 1992
on public health and animal health problems relating to the
killing of wild game and the placing on the market of
wild-game meat (5), as last amended by Regulation (EC) No
806/2003 (6), and in particular Article 16(2)(c) and (3) thereof,

Having regard to Council Directive 92/65/EEC of 13 July 1992
laying down animal health requirements governing trade in
and imports into the Community of animals, semen, ova and
embryos not subject to animal health requirements laid down
in specific Community rules referred to in Annex A(I)
to
Directive 90/425/EEC (7), as last amended by Commission

the
Having regard to Regulation (EC) No 999/2001 of
European Parliament and of
the Council of 22 May 2001
laying down rules for the prevention, control and eradication
of certain transmissible spongiform encephalopathies (12), as
last
(EC) No
2245/2003 (13), and in particular Articles 15(3), 16(7) and 23
thereof,

Commission

Regulation

amended

by

Having regard to Council Directive 2002/99/EC of 16
animal health rules
December 2002 laying down the
governing
distribution and
introduction of products of
animal origin for human
consumption (14), and in particular Articles 8 and 9(2) thereof,

the production, processing,

Whereas:

(1)

Community
conditions for

provisions

concerning
imports from third countries of

animal

health
live

(1) OJ L 302, 31.12.1972, p. 28.
(2) OJ L 122, 16.5.2003, p. 36.
(3) OJ L 268, 24.9.1991, p. 56.
(4) OJ L 162, 1.7.1996, p. 1.
(5) OJ L 268, 14.9.1992, p. 35.
(6) OJ L 122, 16.5.2003, p. 1.
(7) OJ L 268, 14.9.1992, p. 54.

(8) OJ L 198, 6.8.2003, p. 3.
(9) OJ L 62, 15.3.1993, p. 49.
(10) OJ L 260, 11.10.2003, p. 21.
(11) OJ L 368, 31.12.1994, p. 10.
(12) OJ L 147, 31.5.2001, p. 1.
(13) OJ L 333, 20.12.2003, p. 28.
(14) OJ L 18, 23.1.2003, p. 11.

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animals, their fresh meat and meat products require, in
general terms, (i) that these imports are only authorised
from a third country or part thereof which appears in a
list of authorised third countries, and (ii)
these
animals and products fulfil the health conditions to be
the exporting
certified by an official veterinarian of
country by means of a certificate.

that

(2) With a view to simplifying the legislative changes in
Community legislation that may occur whenever the
animal disease situation in a third country changes, it is
appropriate to group together under a single legal act
third
the import conditions,
countries and the models of certificates,
that are
applicable for the importation into the Community of
any kind of Artiodactyla and Proboscidea and fresh meat
from these animals and from equidae.

including the list of

Council Decision 79/542/EEC (15) draws up a list of
third countries from which the Member States authorise
imports of bovine animals, swine, equidae, sheep and
goats, fresh meat and meat products, according to the
provisions of Article 3 of Directive 72/462/EEC. This
Decision has historically been the main reference for
initiating Community procedures to allow exports from
third countries of a large variety of animals and their
derivatives; however, this has been superceded for fresh
including minced meat by Council Directive
meat
is appropriate to update
it
2002/99/EC. Therefore,
Decision 79/542/EEC as
the present
a basis
consolidation.

for

and

import

from third

Article 12 of Council Directive 90/426/EEC of 26 June
1990 on animal health conditions governing the
movement
countries of
equidae (16), establishes that imports of these animals
are only allowed from third countries or parts thereof
appearing in a list to be incorporated in the list of third
countries laid down according to the provisions of
Article
72/462/EEC. However,
Commission decisions adopted on the basis of Directive
for
90/426/EEC and concerning health conditions
imports of equidae provide for
the third
countries authorised to export
these animals to the
Community.

of Directive

lists of

3

(3)

(4)

(5)

live animals and amending Directives 72/462/EEC,
90/426/EEC, 92/65/EEC and 97/78/EC. In this context,
Article 12 of Directive 90/426/EEC will be amended in
order to establish therein the principles for drawing up
a specific list of third countries authorised to use the
required for
specific models of health certificates
this
exporting equidae to the Community. Moreover,
animals
foresees
Directive
imported
certain
into
non-commercial transactions.

specific provisions
Community

for
under

the

For the reasons above, and given the specificity of trade
in animals
imported under certain non-commercial
transactions, it is appropriate already to exclude equidae
and animals for shows, exhibitions, scientific (including
conservation or experimental) purposes and circuses
from the scope of Decision 79/542/EEC.

Regarding imports of meat products, on the basis of the
provisions of Directives 72/462/EEC, 77/99/EEC and
92/118/EEC, Commission Decisions 97/221/EC (18) and
97/222/EC (19) lay down, respectively, the animal health
conditions and model of veterinary certificate and the
list of third countries from which the Member States
authorise the importation of meat products obtained
these two
from a large variety of animals. Thus,
decisions
rules
concerning animal health conditions for importation
from third countries of meat products. Therefore,
in
order to avoid the duplication of lists of third countries
authorised for export of these products, it is appropriate
to exclude meat products from the scope of Decision
79/542/EEC.

harmonised

provide

already

the

Regarding those establishments where live animals are
regularly kept or bred, Directive 72/462/EEC provides
the definition of a ‘holding' for domestic bovine, ovine,
caprine and porcine animals and Directive 92/65/EEC
defines ‘approved body,
for other
kinds of animals. With a view to harmonising and
simplifying the terminology being used for the purpose
of this Decision, it is appropriate to consolidate under a
single definition all the establishments where any kind
of Artiodactyla and Proboscidea are regularly kept or bred.

institute or centre'

(6)

(7)

(8)

live animals pursuant

The rules governing animal health conditions for the
to Directive
importation of
72/462/EEC,
in particular the provisions of Article 3
referring to a list of third countries authorised for the
live animals, will be replaced by a
exportation of
Council directive (17)
laying down the animal health
rules for the importation into the Community of certain

(9)

Commission Decision 2000/572/EC (20)
lays down
animal and public health conditions and veterinary
certification for importation of minced meat and meat
preparations from third countries. Deep-frozen minced
meat can only be made from meat of domestic bovine,

(15) OJ L 146, 14.6.1979, p. 15.
(16) OJ L 224, 18.10.1990, p. 42.
(17) COM(2003) 570 final.

(18) OJ L 89, 4.4.1997, p. 32.
(19) OJ L 89, 4.4.1997, p. 39.
(20) OJ L 240, 23.9.2000, p. 19.

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animals. However, meat

ovine, caprine and porcine animals, and the same
concerns regarding animal diseases and animal health
apply in the same way as those for fresh meat from
such
preparations may
incorporate meat from other non-mammallian animals.
Therefore, Decision 2000/572/EC should be amended in
from
order to remove from its scope minced meat
domestic
be
can
incorporated in a more harmonised manner in Decision
79/542/EEC, while maintaining
conditions
applicable to the importation of meat preparations in a
separate decision.

cloven-hoofed

animals

that

the

therein.

For meat

Commission Decision 2000/585/EC (21)
lays down
animal and public health conditions and veterinary
certification for the importation of wild and farmed
game meat and rabbit meat from the third countries
listed
from farmed or wild
cloven-hoofed game and equidae the same concerns
regarding animal diseases and animal health apply as for
fresh meat from domestic bovines, swine, equidae, sheep
and goats. Therefore, Decision 2000/585/EC should be
to withdraw from its scope the
amended in order
import conditions for meat
from farmed and wild
cloven-hoofed game and from equidae that should be
incorporated in a more harmonised manner in Decision
79/542/EEC according to the requirements of Directive
2002/99/EC.

Commission Decision 84/390/EEC (22) has been adopted
on the basis of Directive 72/462/EEC and provides for
the conditions for approval of border inspection posts
on imports of live bovine animals and swine, and fresh
meat derived therefrom. Since the entry into force of
Council Directives 90/675/EEC (23) and 91/496/EEC, and
the
their
provisions of Decision 84/390/EEC are no longer
applicable and therefore should be repealed.

implementing

Commission

decisions,

(14)

(15)

for

for

the

and

States

animal

veterinary

certification

certification

third countries

establishes
veterinary

from which Member

the
conditions
importation of sheep and goats, and the lists of third
countries
authorise
such animals. Commission Decision
importation of
2002/199/EC (27)
health
the
and
conditions
importation of live bovine animals and swine, and the
list of
from which Member States
authorise such importations. Regarding cloven-hoofed
animals covered by Directive 92/65/EEC,
the health
conditions, the veterinary certification and the list of
third countries authorised to import these animals into
the Community have to be harmonised at Community
level. For all these animals the same concerns regarding
animal diseases and animal health apply. Therefore,
Decisions 93/198/EC, 97/232/EC and 2002/199/EC
should be repealed and their provisions incorporated in
a more harmonised manner in Decision 79/542/EEC.
Moreover, in order to preserve the health status of the
animals exported from a third country during their
transport to the Community, specific provisions should
be established.

records

93/52/EEC (28)

Commission Decision
the
compliance by certain Member States or regions with
the requirements relating to brucellosis (B. melitensis)
and accords them the status of a Member State or
region officially free of the diseases; this enables these
Member States to require additional guarantees which
should delivered by certification.

Commission
80/804/EEC (30),
82/414/EEC (33),
83/380/EEC (36),
86/63/EEC (39),
86/463/EEC (42),
90/445/EEC (45),
91/446/EEC (48),

Decisions
81/526/EEC (31),
82/426/EEC (34),
84/292/EEC (37),
86/72/EEC (40),
89/197/EEC (43),
91/73/EEC (46),
92/280/EEC (49),

80/801/EEC (29),
81/887/EEC (32),
83/84/EEC (35),
84/294/EEC (38),
86/117/EEC (41),
89/221/EEC (44),
91/445/EEC (47),
93/402/EC (50),

for

Commission Decision 91/189/EEC (24) establishes the
the standardisation of materials and
protocols
procedures
for veterinary diagnostic tests and the
conditions for the approval of markets in connection
with the import of domestic animals of the bovine and
porcine species from third countries. The provisions for
the approval of markets for trade in animals intended
for export to the European Community are no longer
applicable. Therefore that decision should be repealed
the
and its provisions
standardisation
for
veterinary tests incorporated in a more harmonised
manner in Decision 79/542/EEC.

regarding the protocols

for
procedures

of materials

and

Commission
and
97/232/EC (26) lay down, respectively, the animal health

93/198/EC (25)

Decisions

(21) OJ L 251, 6.10.2000, p. 1.
(22) OJ L 211, 8.8.1984, p. 20.
(23) OJ L 373, 31.12.1990, p. 1.
(24) OJ L 96, 17.4.1991, p. 1.
(25) OJ L 86, 6.4.1993, p. 34.
(26) OJ L 93, 8.4.1997, p. 43.

(27) OJ L 71, 13.3.2002, p. 1.
(28) OJ L 13, 21.1.1993, p. 14.
(29) OJ L 234, 5.9.1980, p. 41.
(30) OJ L 236, 9.9.1980, p. 25.
(31) OJ L 196, 18.7.1981, p. 19.
(32) OJ L 324, 12.11.1981, p. 25.
(33) OJ L 182, 26.6.1982, p. 27.
(34) OJ L 186, 30.6.1982, p. 54.
(35) OJ L 56, 3.3.1983, p. 26.
(36) OJ L 222, 13.8.1983, p. 27.
(37) OJ L 144, 30.5.1984, p. 10.
(38) OJ L 144, 30.5.1984, p. 17.
(39) OJ L 72, 15.3.1986, p. 36.
(40) OJ L 76, 21.3.1986, p. 47.
(41) OJ L 99, 15.4.1986, p. 26.
(42) OJ L 271, 23.9.1986, p. 23.
(43) OJ L 73, 17.3.1989, p. 53.
(44) OJ L 92, 5.4.1989, p. 16.
(45) OJ L 228, 22.8.1990, p. 28.
(46) OJ L 43, 16.2.1991, p. 45.
(47) OJ L 239, 28.8.1991, p. 17.
(48) OJ L 239, 28.8.1991, p. 18.
(49) OJ L 144, 26.5.1992, p. 21.
(50) OJ L 179, 22.7.1993, p. 11.

(10)

(11)

(12)

(13)

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98/371/EC (51), 98/625/EC (52), 1999/283/EC (53) and
2001/745/EC (54) provide the animal health conditions
and the veterinary certification for imports of
fresh
meat of domestic bovine, ovine, caprine, porcine or
equine animals from several third countries. Therefore,
these decisions should be repealed and their provisions
incorporated in a more harmonised manner in Decision
79/542/EEC.

(19) With a view to harmonising the layout of the veterinary
certificates to be issued and delivered by the official
veterinarian of the exporting country, and to facilitate
the possible use of electronic means of
transfer of
certificates,
the models of
veterinary certificates laid down in Decision 79/542/EEC
should be formatted accordingly, together with the notes
for producing these certificates in the exporting country.

appropriate

that

is

it

(16)

It

is prescribed in these principles that

The International Office of Epizootic Diseases and the
Codex Alimentarius have set up guidelines regarding the
principles of certification which veterinarians have to
follow.
the
certifying veterinarian only certifies matters that are
within their own knowledge at the time of signing the
certificate, or that have been separately attested by an
official of another
competent authority. Moreover,
Council Directive 96/93/EC (55) lays down standards of
certification which are necessary for valid certification
is appropriate to
and to prevent
applied by
ensure
third-country certifying officers provide guarantees
which are equivalent to those laid down in Directive
96/93/EC and that the models of veterinary certificate
laid down in Decision 79/542/EEC should exclusively
reflect facts which may be attested at the time of issuing
the certificate.

fraud. Therefore,

and principles

rules

that

the

it

(17) With a view to informing the certifying veterinarian, the
importers and the competent authorities in the Member
State where the certificates are presented, further details
should be established in the notes referring to the
period of validity of the certificate, the date of issue and
its coverage. For the same reasons, explanations on
certain definitions, on supplementary guarantees under
specific conditions and on the health requirements of
holdings, premises and animals should accompany each
model of certificate as appropriate.

(20) Annex A to Directive 72/462/EEC lays down the
specimen of public health certificate for imports from
third countries of fresh meat of domestic bovine, ovine,
caprine, porcine or equine animals intended for human
consumption. Regarding meat of farmed and wild game,
animal health and public health attestation
the
requirements,
including animal welfare, have been
incorporated in model certificates for each category of
meat by Commission Decision 2000/585/EC. New
Community measures are being adopted in the areas of
animal welfare and of public health that concern
imports of live animals and their fresh meat.

the

a more general

legislative procedure

transparency of Community requirements

(21) With a view to harmonising import conditions, ensuring
and
the
simplifying
for updating
Community legislation, it is appropriate to incorporate
into each model of the veterinary certificate laid down
in Decision 79/542/EEC the relevant requirements that
are necessary for exportation to the Community of each
category of animal or meat. However, other health
provisions of
adopted at
Community level still condition the ultimate acceptance
for
these
commodities. These provisions are laid down in Council
Directive 96/23/EC of 29 April 1996, on measures to
monitor substances and residues thereof in live animals
and
(EC)
No 178/2002 of the European Parliament and of the
Council of 28 January 2002, laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority and laying down
procedures in matters of food safety (57). They may also
in
result
Directives 91/496/EEC and 97/78/EC.

from safeguard measures as provided for

the Community

products (56)

importation

Regulation

animal

scope

into

and

of

(18)

bodies

the aegis of

dealing with

The United Nations has established guidelines for the
use of a common frame and the layout for drawing up
several
commercial documents. Under
facilitation
international
of
there are new
procedures in the international
and rules
principles
issuing
transactions.
intended
certificates
Regarding certification procedures,
the International
Office of Epizootic Diseases and the Codex Alimentarius
have
set up guidelines on the use of electronic
certification.

trade,
followed for

to be
for

international

(51) OJ L 170, 16.6.1998, p. 16.
(52) OJ L 299, 10.11.1998, p. 30.
(53) OJ L 110, 28.4.1999, p. 16.
(54) OJ L 278, 23.10.2001, p. 37.
(55) OJ L 13, 16.1.1997, p. 28.

(22)

their meat and other derivatives

Tariff and statistical nomenclatures worldwide classify
live animals,
in
different categories by allocating to them specific codes
and definitions. Declarations to the customs authorities
of these commodities by the importers have to take into
account these categories of animals and products. The
provisions of Directives 91/496/EEC and 97/78/EC on
veterinary checks at the Community frontiers require
close collaboration between the border inspection post
and the customs office where animals and products of
animal origin arrive from outside the Community.

(56) OJ L 125, 23.5.1996, p. 10.
(57) OJ L 31, 1.2.2002, p. 1.

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(23) With a view to harmonising and facilitating import
procedures at the Community frontiers, it is appropriate
that
is
import
accompanied by the appropriate veterinary certificate.

each consignment presented

for

(24)

In addition for Australia, as only fresh poultrymeat and
live poultry, in particular ratite meat and ratites, may be
imported under certain specific testing requirements due
to the use of Newcastle disease vaccines that do not
comply with Community legislation, the importation of
wild and farmed game meat should be suspended until
the situation can be further assesesed in these categories
of birds.

(25) Decision 79/542/EEC and Decision 2000/585/EC should

be amended accordingly.

(26)

(27)

Community provisions for the importation of certain
products of animal origin make references to the list of
third countries appearing in the Annex to Decision
79/542/EEC. Following the amendment of Decision
79/542/EEC, such references should be construed to be
to the list of third countries or parts thereof appearing
in Part 1 of Annex II
to Decision 79/542/EEC, as
amended by the present Decision.

In addition,

Based on Directive 72/462/EEC, Commission Decisions
89/18/EEC (58), 92/183/EEC (59) and 92/187/EEC (60)
were taken to harmonise the animal health conditions,
the veterinary certification and the rules governing the
importation from several third countries of raw material
for processing industries of fresh meat from domestic
bovine, ovine, caprine, porcine or equine animals not
intended for human consumption.
the
Commission decisions listed in recital 14, which should
be repealed by the present act, provide for the animal
health rules and certification for the importation of this
fresh meat when intended for the pet food processing
industry. Regulation (EC) No 1774/2002 of
the
European Parliament and of the Council (61) lays down
health
not
animal
including such raw
intended for human consumption,
material. The
be
reviewed and implemented by 1 May 2004, when
Regulation (EC) No 1774/2002 becomes fully applicable.
In the meantime, it is appropriate to maintain, until that
date, the animal health requirements and the model of
certificates of
these decisions which are required for
such products, by providing an appropriate transitional
period for the continuing acceptance of the old models
of certificates.

requirements

by-products

certification

concerning

rules

shall

(28)

in this Decision are in
The measures provided for
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Decision 79/542/EEC is amended as follows:

1. The title is replaced by the following:

‘Council Decision 79/542/EEC of 21 December 1976
drawing up a list of
third
countries, and laying down animal and public health and
veterinary certification conditions, for importation into the
Community of certain live animals and their fresh meat.'

third countries or parts of

2. Articles 1, 2 and 3 are replaced by the following:

‘Article 1

Subject matter and scope

This Decision establishes the sanitary conditions for the
importation into the Community of live animals excluding
equidae, and for the importation of fresh meat and meat
products of such animals, including equidae, but excluding
meat preparations.

to

not

shall

apply

imports

This Decision
of
non-domesticated animals for shows or exhibitions where
such animals are not regularly kept or bred, and those
non-domesticated animals forming part of circuses, or
or
intended
experimental purposes in a body, institute or centre that
has been approved in accordance with Annex C to
Directive 92/65/EEC.

conservation

including

scientific

for

animals

and fresh meat

Imports of
authorised in
accordance with this Decision shall remain subject to other
provisions that have been adopted, or may be adopted,
under European food law.

Article 2

Definitions

(58) OJ L 8, 11.1.1989, p. 17.
(59) OJ L 84, 31.3.1992, p. 37.
(60) OJ L 87, 2.4.1992, p. 20.
(61) OJ L 273, 10.10.2002, p. 1.

For the purposes of this Decision, the following definitions
shall apply:

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(a) “animals”: means

species
belonging to the taxa Proboscidea and Artiodactyla, and
their crossbreeds;

land mammals of

the

(b) “holding”: means a farm or other officially supervised
agricultural,
commercial undertaking,
including zoos, amusement parks and wildlife or
hunting reserves where animals are regularly kept or
bred;

industrial or

(c) “trimmed offal”: means offal from which the bones, the
cartilage, the trachea and main bronchi, the lymphatic
glands and adhering connective tissue, the fat and the
mucus have been completely removed; in the case of
meat
the whole
animals,
masseter muscles,
incised in accordance with point
41(a) of Chapter VIII of Annex I to Council Directive
64/433/EEC, are also considered as trimmed offal.

from domestic bovine

Article 3

Conditions for importation of live animals into the
Community

Imports into the Community of live animals shall only be
allowed if such animals comply with Articles 4, 5 and 6.

Article 4

Place of origin of live animals

The animals shall come from the territory of a third
country or a part thereof as listed in columns 1, 2 and 3
of the table set out in Part 1 of Annex I for which, in the
there is a specific model of
corresponding column 4,
veterinary certificate designated for these animals.

Article 5

Specific conditions

The animals shall meet the requirements set out in the
appropriate certificate established in accordance with the
corresponding model certificate drawn up under Part 2 of
Annex I,
the specific conditions
indicated in column 6 of the table set out in Part 1 of
Annex I, and, if so indicated in column 5 of the table, they
shall also meet any supplementary guarantees required in
that certificate.

taking into account

shall meet

If required by the Member State of destination, the animals
certification
concerned
the
requirements mentioned for
and
included in the certificate, based on the corresponding
model set out in Part 2.

that Member State

additional

Article 6

Transport of
Community

live animals for importation into the

1.
The animals shall not be loaded in a means of
transport carrying other animals that are not destined for
the Community or are of a lower health status.

2.
During the transport to the Community, the animals
shall not be unloaded in the territory of a third country or
part of a
approved for
third country that
importation into the Community of such animals.

is not

During the transport to the Community, the animals
3.
shall not be moved by road, railway or on foot through
the territory or part of the territory of a third country that
is not approved for importation into the Community of
such animals.

4.
The animals shall arrive at a border inspection post
of the Community within 10 days of the date of loading in
the exporting third country and be accompanied by a
veterinary certificate, drawn up in conformity with the
corresponding model, completed and signed by an official
veterinarian of the exporting third country.

In the case of transport by sea, the period of 10 days shall
be prolonged by the time of the sea journey. For that
purpose, a declaration by the master of the ship, drawn up
in accordance with the addendum of Part 3A of Annex I,
shall be attached in its original
form to the veterinary
certificate.

Article 7

Conditions to be applied following importation

Following
Directive 91/496/EEC,

the

importation and in accordance with

(i) animals intended for

immediate slaughter

shall be
conveyed without delay to the slaughterhouse of
destination where they shall be slaughtered within five
working days;

(ii) animals intended for breeding, production or fattening
purposes, and animals intended for zoos, amusement
shall be
parks and hunting or wildlife reserves,
conveyed without delay to the holding of destination
where they shall remain for a minimum period of 30
days before further movement outside the holding,
a
of
except
slaughterhouse.

dispatch

direct

case

the

to

in

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Article 8

hermetically sealed containers in a way as to achieve a
value of Fo ¯ 3.

Conditions for importation of
Community

fresh meat into the

Imports into the Community of fresh meat intended for
human consumption,
from the animals as defined in
Article 2 and from equidae, shall only be allowed if such
meat complies with Articles 9 to 11.

Article 9

Place of origin of fresh meat

The fresh meat shall come from the territory of a third
country or a part thereof as listed in columns 1, 2 and 3
of the table set out in Part 1 of Annex II for which, in the
there is a specific model of
corresponding column 4,
veterinary certificate designated for that meat.

the

For

2.
referred to in
categories of products
paragraph 1(b), the establishment of destination shall be an
establishment
specifically approved and registered for
processing those products by the Member State in which
the establishment is situated.

3.
In accordance with the procedures established by
Decision 2001/106/EC, Member States shall communicate
to each other and to the Commission:

(a)

the names and addresses of the establishments referred
to in paragraph 2 and of the local competent authority
responsible for the supervision of these establishments,
as well as

(b) the

categories

of

products

for which

these

establishments are approved and registered.

Article 10

Specific conditions

Article 13

Certification

certificate

corresponding

The fresh meat shall meet the requirements set out in the
appropriate
to the model
certificate drawn up under Part 2 of Annex II, taking into
account the specific conditions indicated in column 6 of
the table set out in Part 1 of Annex II, and, if so indicated
the
shall also meet
table,
in column 5 of
supplementary guarantees requested in that certificate.

the

it

in this Decision,

The veterinary certificates required for the importation of
into the Community, as
live animals and fresh meat
provided for
shall be drafted in
accordance with the notes set out in Part 2 of Annexes I
shall not preclude the use of
and II. However,
electronic
systems,
harmonised at Community level.'

this
certification

agreed

other

or

Article 11

3. Article 4 becomes Article 14.

Presentation of fresh meat at a Community border
inspection post

4. The Annex is replaced by Annex A to this Decision.

The fresh meat shall be presented at a Community border
inspection post accompanied by a veterinary certificate,
drawn up in conformity with the corresponding model,
completed and signed by an official veterinarian of the
exporting third country.

Article 2

Amendments to Decision 2000/572/EC

Article 12

Decision 2000/572/EC is amended as follows:

Conditions to be applied following importation

1. The title is replaced by:

Following importation,

the following categories of
1.
fresh meat
shall be conveyed without delay to the
processing establishment of destination, in accordance with
Directive 97/78/EC:

‘Commission Decision 2000/572/EC of 8 September 2000
laying down the animal and public health and veterinary
certification conditions for imports of meat preparations
into the Community from third countries'.

(a) unskinned carcases of wild cloven-hoofed game
further

consumption after

human

for

intended
processing;

(b) trimmed offal of domestic bovine animals intended for
human consumption as meat-based products after
core
by
further
a
to
sterilised in
temperature of

cooking
least 80 °C, or

heat-treatment

at

2. Article 1 is replaced by the following:

‘Article 1

This Decision lays down the animal and public health and
veterinary certification conditions for the importation of
meat preparations.'

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3. Article 2 is deleted.

4. Article 4(1) is deleted.

5. Article 6 is deleted.

6. Annex I is deleted.

Article 3

Amendments to Decision 2000/585/EC

Decision 2000/585/EC is amended as follows:

1. The title is replaced by the following:

‘Commission Decision 2000/585/EC of 7 September 2000
drawing up a list of third countries from which Member
States authorise imports of rabbit meat and certain wild
and farmed game meat, and laying down the animal and
public health and the veterinary certification conditions for
such imports'.

2. Article 2 is replaced by the following:

‘Article 2

Member States
following meat:

shall only authorise

imports of

the

— meat of wild game birds that do not contain offal,
in the case of unplucked and uneviscerated

except
game birds,

— meat of farmed game birds,

— meat of wild leporidae, defined as rabbits and hares,
in the case of

that do not contain offal, except
unskinned and uneviscerated leporidae,

— meat of farmed rabbits,

— meat of wild land mammals, other than ungulates and

leporidae, that do not contain offal.

Such meat shall come from third countries or parts of
third countries listed in Annex I, and it shall comply with
the conditions laid down in the veterinary certificate
established in accordance with the relevant model health
certificate set out in Annex III, as provided for in Annex II.

The specific requirements referred to in Annex II and set
out in Annex IV must be fulfilled by the exporting third
country and so certified by completing Section V of each
health certificate in accordance with the model set out in
Annex III.'

3. Annexes I and II are replaced by Annex B to this Decision.

4.

In Annex III, Models A, B, F, G and J are deleted.

5.

In Annex IV, paragraphs 1, 2, 5, and 7 are deleted.

Article 4

Repeals

83/84/EEC,

82/426/EEC,

Decisions 80/801/EEC, 80/804/EEC, 81/526/EEC, 81/887/EEC,
82/414/EEC,
83/380/EEC,
84/292/EEC, 84/294/EEC, 84/390/EEC, 86/63/EEC, 86/72/EEC,
89/197/EEC,
86/463/EEC,
89/221/EEC,
86/117/EEC,
91/189/EEC,
91/73/EEC,
91/445/EEC,
90/445/EEC
93/402/EEC,
93/198/EEC,
92/280/EEC,
91/446/EEC,
97/232/EC,
1999/283/EC,
98/625/EC,
98/371/EC,
2001/745/EC and 2002/199/EC are repealed.

Article 5

Transitional and final provisions

1.

This Decision shall apply from 1 May 2004.

2.
References made by Community legislation to the list of
third countries appearing in part 1 of the Annex to Decision
79/542/EEC, as laid down before the amendments introduced
by the present Decision, shall be construed as references to the
list of third countries appearing in Part 1 of Annex II to
Decision 79/542/EEC, as amended by the present Decision.

3.
Importation into the Community of live animals certified
before the date referred to in paragraph 1 and fresh meat from
animals slaughtered before the date referred to in paragraph 1,
in accordance with the models of veterinary certificates laid
down in the decisions referred to in Article 4, shall be
authorised for a period of 60 days following the application of
this Decision.

Article 6

This Decision is addressed to the Member States.

Done at Brussels, 6 January 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX A

‘ANNEX I (LIVE ANIMALS)

PART 1

List of third countries or parts thereof

Country

Code of
territory

Description of territory

1

2

3

BG — Bulgaria

BG-0

Whole country

BG-1

provinces

of Varna, Dobrich,

The
Choumen,
Targovitchte, Razgrad, Rousse, V.Tarnovo, Gabrovo, Pleven,
Lovetch, Plovdic, Smolian, Pasardjik, Sofia district, Sofia city,
Pernik, Kustendil, Blagoevgrad, Sliven, Starazagora, Vratza,
Montana and Vidin

Silistra,

Veterinary certificate

Model(s)

4

-

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y

SG

5

A

CA — Canada

CA-0

Whole country

POR-X

CA-1

Whole country except the Okanagan Valley region of British
Columbia, described as follows:

BOV-X,
OVI-X, OVI-Y

A

— from a point on the Canada/United States border 120°15¡

longitude, 49° latitude

— northerly to a point 119°35¡ longitude, 50°30¡ latitude

— north-easterly to a point 119° longitude, 50°45¡ latitude

— southerly to a point on the Canada/United States border

118°15¡ longitude, 49° latitude

Specific
conditions

6

VI

IVb
IX

CH — Switzerland

CH-0

Whole country

CL — Chile

CL-0

Whole country

CY — Cyprus

CY-0

Whole country

CZ — Czech Republic

CZ-0

Whole country

EE — Estonia

EE-0

Whole country

GL — Greenland

GL-0

Whole country

HR — Croatia

HR-0

Whole country

HU — Hungary

HU-0

Whole country

m:/3B2/SigmaLink_pdf/130180005en.3d***9.3.2004***11:3:50
Format: A4 596 x 842 pts Original: 595.276 x 841.89 pts *setpagedevice*

BOV-X, BOV-Y
OVI-X, OVI-Y
RUM

POR-X, POR-Y
SUI

OVI-X, RUM

POR-X, SUI

POR-X, POR-Y

B

B

B

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y
POR-X, POR-Y

BOV-X, BOV-Y, RUM,
OVI-Y

OVI-X, RUM

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y
POR-X, POR-Y

IVa
V

B

V

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1

2

3

IS — Iceland

IS-0

Whole country

LT — Lithuania

LT-0

Whole country

LV — Latvia

LV-0

Whole country

MT — Malta

MT-0

Whole country

NZ — New Zealand

NZ-0

Whole country

PL — Poland

PL-0

Whole country

PM — St Pierre
Miquelon

PM-0

Whole country

RO — Romania

RO-0

Whole country

SI — Slovenia

SI-0

Whole country

SK — Slovakia

SK-0

Whole country

Specific conditions (see footnotes in each certificate):

5

B

4

BOV-X, BOV-Y
RUM,
OVI-X, OVI-Y

POR-X, POR-Y

BOV-X, BOV-Y
OVI-Y, RUM

BOV-X, BOV-Y
OVI-Y, RUM

RUM, OVI-X, OVI-Y

BOV-X, BOV-Y, RUM,
POR-X, POR-Y
OVI-X, OVI-Y

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y

BOV-X, BOV-Y, RUM,
OVI-Y

BOV-X, BOV-Y, RUM,
OVI-X, OVI-Y

6

I

I

V

V

“I”:

territory where the presence of BSE in native cattle has been assessed as highly unlikely, for the purpose of exporting to the European
Community animals certified according to the models of certificate BOV-X and BOV-Y.

“II”:

territory recognised as having an official tuberculosis-free status for the purposes of exports to the European Community of animals certified
according to the model of certificate BOV-X.

“III”:

territory recognised as having an official brucellosis-free status for the purposes of exports to the European Community of animals certified
according to the model of certificate BOV-X.

“IVa”:

territory recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the European Community of
animals certified according to the model of certificate BOV-X.

“IVb”:

territory with approved holdings recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to the
European Community of animals certified according to the model of certificate BOV-X.

“V”:

territory recognised as having an official brucellosis-free status for the purposes of exports to the European Community of animals certified
according to the model of certificate OVI-X.

“VI”: Geographical constraints:

In the case of Bulgaria, code of territory BG-1, animals certified according to models of veterinary certificate BOV-X, BOV-Y, RUM, OVI-X and
OVI-Y can be imported only in those parts of the territory of a Member State appearing in Annex II to Decision 2001/138/EC of 9 February
2001, if that Member State so allows.

“VII”:

territory recognised as having an official tuberculosis-free status for the purposes of exports to the European Community of animals certified
according to the model of certificate RUM.

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“VIII”:

territory recognised as having an official brucellosis-free status for the purposes of exports to the European Community of animals certified
according to the model of certificate RUM.

“IX”:

territory recognised as having an official Aujeszky's disease-free status for the purposes of exports to the European Community of animals
certified according to the model of certificate POR-X.

PART 2

Models of veterinary certificates

Models:

“BOV-X”: Model of veterinary certificate for domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their cross-breeds) intended for

breeding and/or production after importation

“BOV-Y”: Model of veterinary certificate for domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their cross-breeds) intended for

immediate slaughter after importation

“OVI-X”: Model of veterinary certificate for domestic sheep (Ovis aries) and goats (Capra hircus) intended for breeding and/or production after

importation

“OVI-Y”: Model of veterinary certificate for domestic sheep (Ovis aries) and goats (Capra hircus) intended for immediate slaughter after importation

“POR-X”: Model of veterinary certificate for domestic porcine animals (Sus scrofa) intended for breeding and/or production after importation

“POR-Y”: Model of veterinary certificate for domestic porcine animals (Sus scrofa) intended for immediate slaughter after importation

“RUM”:

Model of veterinary certificate for non-domestic animals other than suidae

“SUI”:

Model of veterinary certificate for non-domestic suidae.

SG (supplementary guarantees):

“A”:

“B”:

guarantees regarding bluetongue and epizootic-haemorrhagic disease tests on animals certified according to the model of certificate BOV-X
(point 10.8a), OVI-X (point 10.6a) and RUM (point 10.7a)

guarantees regarding swine-vesicular disease and classical-swine-fever tests on animals certified according to the model of certificate POR-X
(point 10.4a) and SUI (point 10.4a)

“C”:

guarantees regarding brucellosis test on animals certified according to the model of certificate POR-X (point 10.4a) and SUI (point 10.4a)

Notes

(a) Veterinary certificates shall be produced by the exporting country, based on the models appearing in Part 2 of Annex I, according to the layout of the model that
corresponds to the animals concerned. They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country
and, as the case may be, those supplementary guarantees that are required for the exporting third country or part thereof.

If so requested by the EU Member State of destination, for the animals concerned the additional certification requirements shall be also incorporated in the original
form of the veterinary certificate.

(b) A separate and unique certificate must be provided for animals that are exported from a single territory appearing in columns 2 and 3 of Part 1 of Annex I which

are consigned to the same destination and transported in the same railway wagon, lorry, aircraft or ship.

(c) The original of each certificate shall consist of a single page, both sides, or, where more text is required, it shall be in such a form that all pages needed are part of an

integrated whole and indivisible.

(d)

(e)

It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU
Member State of destination. However, these Member States may allow another Community language instead of their own, accompanied, if necessary, by an official
translation.

If for reasons of identification of the items of the consignment (schedule in point 8.2 of the model of certificate), additional pages are attached to the certificate, these
pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying official veterinarian on
each of the pages.

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(f) When the certificate, including additional schedules referred to in (e), comprises more than one page, each page shall be numbered — (page number) of (total

number of pages) — at the bottom and shall bear the code number of the certificate that has been designated by the competent authority at the top.

(g) The original of the certificate must be completed and signed by an official veterinarian within 24 hours prior to loading of the consignment for exportation to the
Community. In doing so, the competent authorities of the exporting country shall ensure that principles of certification equivalent to those laid down in Council
Directive 96/93/EC are followed.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark.

(h) The original of the certificate must accompany the consignment until it reaches the EU border inspection post.

(i)

The certificate shall be valid for 10 days from the date of issuing.

In the case of transport by ship the time of validity is prolonged by the time of the trip in the ship. For this purpose, a declaration by the master of the ship, drawn
up in accordance with the addendum to Part 3 of Annex I to this Decision, shall be attached in its original form to the veterinary certificate.

(j) Animals shall not be transported together with other animals that either are not destined to the European Community or are of a lower health status.

(k) During their transport to the European Community, the animals shall not be unloaded in the territory of a country or part of a country that is not approved for

imports into the Community of these animals.

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PART 3

A — Addendum for transport of animals by sea

(To be completed and attached to the veterinary certificate when transport to the European Community frontier includes, even for part of the journey, transportation
by ship.)

Declaration by the master of the ship

I, the undersigned, master of ship (name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .),

declare that the animals referred to in the attached veterinary certificate No . . . . . . . . . . . . . . . . . . . . . have remained on board the ship

during the voyage from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(exporting country)

to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . in the European Community and that the ship did not call at

any place outside

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(exporting country)

en route to the European Community other than:

. . . . . . . . . . . . . . . . . . . . . . (ports of call en route). Moreover, during the journey, these

animals have not been in contact with other animals on board of a lower health status.

Done at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Port of arrival)

(Date of arrival)

(stamp)

(signature of master)

(name in capital letters and title)

B — Conditions for the authorisation of assembly centres

Approved assembly centres shall meet the following requirements:

I.

II.

III.

IV.

They shall be supervised by an official veterinarian.

They shall each be situated at the centre of an area 20 km in diameter in which, according to official findings, for at least 30 days prior to their
use as approved centres there has been no case of foot-and-mouth disease.

They shall, before each use as approved centres, be cleaned and disinfected with a disinfectant officially authorised in the exporting country as
effective in the control of the disease mentioned in condition II above.

They shall have, taking into account their animal capacity (a) a facility dedicated exclusively for this purpose; (b) appropriate facilities, easy to
clean and disinfect, for loading, unloading and adequate housing of a suitable standard for the animals, for watering and feeding them, and for
giving them any necessary treatment;
(d) appropriate equipment for cleaning and
disinfecting rooms and trucks; (e) an appropriate storage area for fodder, litter and manure; (f) appropriate systems for collecting and disposal of
waste water; (g) an office for the official veterinarian.

(c) appropriate facilities for inspection and isolation;

V. When operating, they shall have sufficient veterinarians to carry out all duties.

VI.

They shall only admit animals that are individually identified so as to guarantee traceability. To this end, when animals are admitted the owner
or person in charge of the centre shall ensure the animals are properly identified and accompanied by health documents or certificates for the
species and categories involved. Moreover, this person shall record on a register or a database and retain for at least three years the name of the
owner, the origin, date of entry and exit, number and identification of the animals or registration number of the herd of origin and their
destination and the registration number of the carrier and the registration number of the lorry delivering or collecting animals from the
premises.

VII. All animals passing through them shall fulfil the health conditions established for the importation of the relevant category of animal into the

European Community.

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VIII. Animals to be exported to the European Community which pass through an assembly centre must, within six days of arrival, be loaded and
dispatched directly to the frontier of the exporting country: (a) without coming into contact with cloven-hoofed animals other than animals
which fulfil the health conditions established for the importation of the relevant category of animal
(b)
segregated into consignments so that no consignment contains both animals for breeding or production and animals for immediate slaughter;
(c) in transport vehicles or containers which have first been cleaned and disinfected with a disinfectant officially authorised in the exporting
country as effective in the control of the disease mentioned in condition II above and which are so constructed that faeces, urine, litter or
fodder cannot flow or fall out during transportation.

into the European Community;

IX. Where the conditions for the export of animals to the Community require that a test be carried out within a specified period before loading,

that period includes any period of assembly, up to six days, after the arrival of the animals at the approved centres.

X.

The exporting country shall designate those approved centres which are approved for animals for breeding and production and those approved
centres which are approved for animals for slaughter and shall notify the Commission and the competent central authorities of the Member
States of the names and addresses of such premises and their regular updates.

XI.

The exporting country shall determine the procedure for official supervision of approved centres and shall ensure that such supervision is
carried out.

XII. They shall be regularly inspected in order to ascertain that the requirements for approval continue to be fulfilled. In case of failure and
suspension, the approval may only be restored when the competent authority is satisfied the full compliance of the centre with all the
provisions mentioned above.

C — Protocols for the standardisation of materials and testing procedures

Tu b e r c u l o s i s ( T B L )

The single intradermal tuberculin test using bovine tuberculin shall be carried out according to Annex B to Directive 64/432/EEC. In the case of
Suidae animals, the single intradermal tuberculin test using avian tuberculin shall be carried out according to Annex B to 64/432/EEC, except that the
site of injection shall be the loose skin at the base of the ear.

B r u c e l l o s i s ( B r u c e l l a a b o r t u s ) ( B R L )

The serum agglutination test, complement fixation test, buffered brucella antigen test and enzyme linked immuno-absorbent assays tests (ELISA) shall
be carried out according to Annex C to Directive 64/432/EEC.

Test shall be carried out according to Annex C to Directive 91/68/EEC.

B r u c e l l o s i s ( B r u c e l l a m e l i t e n s i s ) ( B R L )

E n z o o t i c B o v i n e L e u k o s i s ( E B L )

The agar gel immuno-diffusion test and the enzyme linked immuno-absorbent assay test (ELISA) shall be carried out according to paragraphs A and
C, chapter II of Annex D to Council Directive 64/432/EEC.

A. The blocking or competitive ELISA test shall be carried out according to the following protocol:

B l u e t o n g u e ( B T G )

The competitive ELISA using monoclonal antibody 3-17-A3 is capable of identifying antibodies to all known serotypes of bluetongue virus (BTV).

The principle of the test is the interruption of the reaction between BTV antigen and a group-specific monoclonal antibody (3-17-A3) by the
addition of test serum. Antibodies to BTV present in the test serum block the reactivity of the monoclonal antibody (Mab) and result in a
reduction in the expected colour development after the addition of enzyme labelled anti-mouse antibody and chromogen/substrate. Sera can be
tested at a single dilution of 1:5 (spot test — appendix 1) or may be titrated (serum titration — appendix 2) to give dilution end-point.
Inhibition values higher than 50 % may be regarded as positive.

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Material and reagents:

1. Appropriate ELISA microtitre plates.

2. Antigen: supplied as a cell extracted concentrate, prepared as described below, and stored at either –20 °C or –70 °C.

3.

Blocking buffer: phosphate buffered saline (PBS) containing 0,3 % BTV negative adult bovine serum, 0,1 % (v/v) Tween-20 (supplied as
polyoxyethylene sorbiton monolaurate syrup) in PBS.

4. Monoclonal antibody: 3-17-A3 (supplied as hybridoma tissue-culture supernatant) directed against the group-specific polypeptide VP7, stored

at -20 °C or freeze-dried and diluted 1/100 with blocking buffer before use.

5. Conjugate: rabbit anti-mouse globulin (adsorbed and eluted) conjugated to horseradish peroxidase and kept in the dark at 4 °C.

6. Chromogen and substrate: Orthophenylene diamine (OPD-chromogen) at a final concentration of 0,4 mg/ml

in sterile distilled water.
Hydrogen peroxide (30 % w/v-substrate) 0,05 % v/v added immediately before use (5µl H2O2 per 10 ml OPD). (Handle OPD with care —
wear rubber gloves — suspected mutagen).

7.

1 Molar sulphuric acid: 26,6 ml of acid added to 473,4 ml of distilled water. (Remember — always add acid to water, never water to acid.)

8. Orbital shaker.

9.

ELISA plate reader (the test may be read visually).

Test format

Cc: conjugate control (no serum/ no monoclonal antibody); C++: strong positive serum control; C+: weak positive serum control; C-: negative
serum control; Cm: monoclonal antibody control (no serum).

Appendix 1: Spot dilution (1:5) format (40 sera/plate)

Controls

Test sera

3

1

1

4

2

2

5

3

3

6

4

4

7

5

5

8

6

6

9

7

7

10

8

8

11

9

9

1

Cc

Cc

C++

C++

C+

C+

Cm

Cm

2

C-

C-

C++

C++

C+

C+

Cm

Cm

Appendix 2: Serum titration format (10 sera/plate)

Controls

Test sera

4

5

6

7

8

9

10

11

1

Cc

Cc

C++

C++

C+

C+

Cm

Cm

2

C-

C-

C++

C++

C+

C+

Cm

Cm

3

1:5

1:10

1:20

1:40

1:80

1:160

1:320

1:640

A

B

C

D

E

F

G

H

A

B

C

D

E

F

G

H

12

10

10

40

40

12

1:5

1:10

1:20

1:40

1:80

1:160

1:320

1:640

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Test protocol:

Conjugate control (Cc):

Wells 1A and 1B is a blank control consisting of BTV antigen and conjugate. This may be used to blank the
ELISA reader.

Mab control (Cm):

Columns 1 and 2, rows G and H are the monoclonal antibody control and contain BTV antigen, monoclonal
antibody and conjugate. These wells represent maximum colour. The mean of the optical density readings from
this control represents the 0 % inhibition value.

Positive control (C++, C–):

Columns 1 and 2, rows C-D-E-F. These wells contain BTV antigen, BTV strong and weak positive antiserum
respectively, Mab and conjugate.

Negative control (C-):

Wells 2A and 2B are the negative controls, which contain BTV antigen, BTV negative antiserum, Mab and
conjugate.

Test sera:

Procedure:

For large-scale serological surveys and rapid screening, sera could be tested at a single dilution of 1:5 (Appendix
1). Alternatively, 10 sera can be tested over a dilution range from 1:5 to 1:640 (Appendix 2). This will give
some indication of the titre of antibody in the test sera.

1. Dilute BTV antigen to pre-titrated concentration in PBS, sonicate briefly to disperse aggregated virus (if sonicator is not available, pipette

vigorously) and add 50 µl to all wells of the ELISA plate. Tap sides of plate to disperse antigen.

2.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash plates three times by flooding and emptying the wells with non-sterile PBS and
blot dry on absorbent paper.

3. Control wells: Add 100 µl of blocking buffer to Cc wells. Add 50 µl of positive and negative control sera, at a dilution of 1:5 (10 µl sera +

40 µl blocking buffer), to respective wells C–, C+ and C++. Add 50 µl blocking buffer to Mab control wells.

Spot titration method: Add a 1:5 dilution of each test serum in blocking buffer to duplicate wells of columns 3 to 12 (10 µl sera + 40 µl
blocking buffer),

or

Serum titration method: Prepare a two-fold dilution series of each test sample (1:5 to 1:640) in blocking buffer across eight wells of single
columns 3 to 12.

4.

Immediately after the addition of the test sera, dilute Mab 1:100 in blocking buffer and add 50 µl to all wells of the plate except for the
blank control.

5.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

6. Dilute rabbit anti-mouse concentrate to 1/5 000 in blocking buffer and add 50 µl to all wells of the plate.

7.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

8. Thaw the OPD and immediately before use add 5 µl of 30 % hydrogen peroxide to each 10 ml of OPD. Add 50 µl to all wells of the plate.
Allow colour to develop for approximately 10 minutes and stop the reaction with 1 M sulphuric acid (50 µl per well). Colour should
develop in the Mab control wells and in those wells containing sera with no antibody to BTV.

9.

Examine and record the plates either visually or using a spectrophotometric reader.

Analysis of results:

Using the software package print out the OD values, and the percentage inhibition (PI) for test and control sera based on the mean value
recorded in the antigen control wells. The date expressed as OD and PI values are used to determine whether the test has performed within
acceptable limits. The upper control limits (UCL) and lower control limits (LCL) for the Mab control (antigen plus Mab in the absence of test sera)
are between OD values 0,4 and 1,4. Any plate that fails to conform to the above criteria must be rejected.

If a computer software package is not available, print out the OD values using the ELISA printer. Calculate the mean OD value for the antigen
control wells, which is equivalent to the 100 % value. Determine the 50 % OD value and manually calculate the positivity and negativity of each
sample.

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Percentage inhibition (PI) value = 100 — (OD of each test control/Mean OD of Cm) × 100.

The duplicate negative control serum wells and the duplicate blank wells should record PI values between +25 % and –25 %, and between +95 %
and +105 %, respectively. Failure to be within these limits does not invalidate the plate but does suggest that background colour is developing.
The strong and weak positive control sera should record PI values between +81 % and +100 %, and between +51 % and +80 %, respectively.

The diagnostic threshold for test sera is 50 % (PI 50 % or OD 50 %). Samples recording PI values > 50 % are recorded negative. Samples that
record PI values above and below the threshold for the duplicate wells are considered doubtful; such samples may be retested in the spot test
and/or titration. Positive samples may also be titrated to provide an indication of the degree of positivity.

Visual reading: Positive and negative samples are easily discernible by eye; weakly positive or strong negative samples may be more difficult to
interpret by eye.

Preparation of BTV ELISA antigen:

1. Wash 40-60 roux of confluent BHK-21 cells three times with serum-free Eagle's medium and infect with bluetongue virus serotype 1 in

serum-free Eagle's medium.

2.

Incubate at 37 °C and examine daily for cytopathic effect (CPE).

3. When CPE are complete in 90 to 100 % of the cell sheet of each roux, harvest the virus by shaking any still-attached cells from the glass.

4. Centrifuge at 2 000 to 3 000 rpm to pellet the cells.

5. Discard the supernatant and re-suspend the cells in approximately 30 ml of PBS containing 1 % “Sarkosyl” and 2 ml phenylmethylsulphonyl
to form a gel and more lysis buffer may be added to reduce this effect.

fluoride (lysis buffer). This may cause the cells
(NB: phenylmethylsulphonyl fluoride is harmful — handle with extreme caution.)

6. Disrupt the cells for 60 seconds using an ultrasonic probe at an amplitude of 30 microns.

7. Centrifuge at 10 000 rpm for 10 minutes.

8.

Store the supernatant at +4 °C and resuspend the remaining cell pellet in 10 to 20 ml of lysis buffer.

9.

Sonicate and clarify, storing the supernatant at each stage, a total of three times.

10. Pool the supernatants and centrifuge at 24 000 rpm (100 000 g) for 120 minutes at +4 °C over a 5 ml cushion of 40 % sucrose (w/v in PBS)

using 30 ml Beckmann centrifuge tubes and an SW 28 rotor.

11. Discard the supernatant, drain the tubes thoroughly and re-suspend the pellet in PBS by sonication. Store the antigen in aliquots at –20 °C.

Titration of BTV ELISA antigen:

Bluetongue ELISA antigen is titrated by the indirect ELISA. Twofold dilutions of antigen are titrated against a constant dilution (1/100)
monoclonal antibody 3-17-A3. The protocol is as follows:

1. Titrate a 1:20 dilution of BTV antigen in PBS across the microtitre plate in a twofold dilution series (50 µl/well) using a multichannel pipette.

2.

Incubate for one hour at 37 °C on an orbital shaker.

3. Wash plates three times with PBS.

4. Add 50 µl of monoclonal antibody 3-17-A3 (diluted 1/100) to each well of the microtitre plate.

5.

Incubate for one hour at 37 °C on an orbital shaker.

6. Wash plates three times with PBS.

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7. Add 50 µl of rabbit anti-mouse globulin conjugated to horseradish peroxidase, diluted to a pretitrated optimal concentration, to each well of

the microtitre plate.

8.

Incubate for one hour at 37 °C on an orbital shaker.

9. Add substrate and chromogen as described previously. Stop the reaction after 10 minutes by the addition of 1 Molar sulphuric acid

(50 µl/well).

In the competitive assay, the monoclonal antibody must be in excess, therefore a dilution of antigen is chosen which falls on the titration curve
(not on the plateau region) which gives approximately 0,8 OD after 10 minutes.

B. The agar gel immuno-diffusion test shall be carried out according to the following protocol:

Antigen:

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of a reference strain of bluetongue virus. BHK
or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires 50 to 100-fold concentration
to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be inactivated by the addition of
0,3 % (v/v) beta-propiolactone.

Known positive control serum:

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the
international reference serum, freeze-dried and used as the known control serum in each test.

Test serum

Procedure:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum
depth of 3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern
consists of one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the
standard antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test
sera. The system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with
the control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the
line of the control serum. Petri dishes should be examined against a dark background and using indirect illumination.

The agar gel immuno-diffusion test shall be carried out according to the following protocol:

E p i z o o t i c h a e m o r r h a g i c d i s e a s e ( E H D )

Antigen:

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of the appropriate serotype(s) of epizootic
haemorrhagic disease virus. BHK or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires
50 to 100-fold concentration to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be
inactivated by the addition of 0,3 % (v/v) beta-propiolactone.

Known positive control serum:

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the
international reference serum, freeze-dried and used as the known control serum in each test.

Test serum

Procedure:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum depth of
3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern consists of
one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the standard
antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test sera. The
system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with the
control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the line of
the control serum. Petri dishes should be examined against a dark background and using indirect illumination.

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I n f e c t i o u s b o v i n e r h i n o t r a c h e i t i s ( I B R ) / i n f e c t i o u s p u s t u l a r v u l v o - v a g i n i t i s ( I P V )

A. The serum neutralisation test shall be carried out according to the following protocol:

Serum:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure:

The constant virus-varying serum neutralisation test on microtitre plates employs MDBK or other susceptible cells. The
Colorado, Oxford or any other reference strain of the virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted
serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated
for 24 hours at 37 °C in the microtitre plates before the MDBK cells are added. Cells are used at a concentration which
forms a complete monolayer after 24 hours.

Controls:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to six days
incubation at 37 °C. Serum titres are considered negative if there is no neutralisation at a dilution of 1/2 (undiluted
serum).

B. Any other test recognised in the frame of Commission Decision 93/42/EC concerning additional guarantees to infectious rhinotracheitis for

bovines destined for Member States or regions thereof free from the disease.

A. Collecting oesophageal/pharyngeal samples and testing shall be carried out according to the following protocol:

F o o t - a n d - m o u t h d i s e a s e ( F M D )

Reagents:

Prior to sampling, transport medium is prepared. Two ml volumes are dispensed in as many containers as there are
animals to be sampled. The containers used should withstand freezing over solid CO2 or liquid nitrogen. Samples are
obtained by the use of a specially-designed sputum collector or “probang”. To obtain a sample the probang cup is
passed through the mouth, over the dorsum of the tongue and down into the upper part of the oesophagus. Attempts
are made to scrape the surface epithelium of the upper oesophagus and pharynx by movements directed laterally and
dorsally. The probang is then withdrawn, preferably after the animal has swallowed. The cup should be full and contain
a mixture of mucus, saliva, oesophageal fluid and cellular debris. Care should be taken to ensure that each specimen
contains some visible cellular material. Very rough handling which causes bleeding should be avoided. Samples from
some animals may be heavily contaminated with ruminal contents. Such samples should be discarded and the mouth of
the animal flushed with water, or preferably physiological saline, before repeat sampling.

Treatment of samples:

Each sample collected in the probang cup is examined for quality and 2 ml added to an equal volume of transport
medium in a container which can withstand freezing. The containers are tightly closed, sealed, disinfected and labelled.
The samples are kept cool (+4 °C) and examined within three to four hours or placed over dry ice (–69 °C) or liquid
nitrogen and kept frozen until examined. Between animals the probang is disinfected and washed in three changes of
clean water.

Testing for FMD virus:

Samples are inoculated into cultures of primary bovine thyroid cell cultures using at least three tubes per sample. Other
susceptible cells e. g. primary bovine or porcine kidney cells can be used but it should be kept in mind that for some
strains of FMD virus they are less sensitive. The tubes are incubated at 37 °C on a roller apparatus and examined daily
for 48 hours for the presence of a cytopathic effect (CPE). If negative, cultures are blind passaged onto new cultures and
re-examined for 48 hours. The specificity of any CPE must be confirmed.

Recommended transport media:

1.

0,08M phosphate buffer pH 7,2 containing 0,01 % bovine serum albumin, 0,002 % phenol red and antibiotics.

2. Tissue culture medium (e.g. Eagle's MEM) containing 0,04M Hepes buffer, 0,01 % bovine serum albumin and antibiotics, pH 7,2.

3. Antibiotics (per ml final) should be added to the transport medium, e.g. penicillin 1 000 IU, neomycin sulphate 100 IU, polymyxin B

sulphate 50 IU, mycostatin 100 IU.

B. The virus neutralisation test shall be carried out according to the following protocol:

Reagents:

Stock FMDV antigen is prepared in cell cultures or on cattle tongues and stored at –70 °C or less or at –20 °C after the
addition of 50 % glycerol. This is the stock antigen. FMDV is stable under these conditions and titres vary little over a
period of months.

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Procedure:

The test is carried out in flat-bottomed tissue culture grade microtitre plates using susceptible cells such as IB-RS-2,
BHK-21 or calf kidney cells. Sera for the test are diluted 1/4 in serum-free cell culture medium with the addition of 100
IU/ml neomycin or other suitable antibiotics. Sera are inactivated at 56 °C for 30 minutes and 0,05 ml amounts are
used to prepare a twofold series on microtitre plates using 0,05 ml diluting loops. Pretitrated virus also diluted in
serum-free culture medium and containing 100 TCID50/0,05 ml is then added to each well. Following incubation at
37 °C for one hour to allow neutralisation to take place, 0,05 ml of suspension cells containing 0,5 to 1,0 × 106 cells
per 1 ml in cell culture medium containing serum free of FMD antibody is added to each well and the plates are sealed.
Plates are incubated at 37 °C. Monolayers are normally confluent within 24 hours. CPE is usually sufficiently advanced
at 48 hours for a microscopic reading of the test. At this time a final microscopic reading may be made or the plates
may be fixed and stained for macroscopic reading, for instance using 10 % formol-saline and 0,05 % methylene blue.

Controls:

Controls in each test include homologous antiserum of known titre, a cell control, a serum toxicity control a medium
control and a virus titration from which the actual amount of virus in the test is calculated.

Interpretation:

Wells with evidence of CPE are considered to be infected and neutralisation titres are expressed as the reciprocal of the
final dilution of serum present
the 50 % end point estimated according to the
Spearman-Karber method. (Karber, G., 1931, Archiv fuer Experimentelle Pathologie und Pharmokologie, 162, 480). Tests are
considered to be valid when the actual amount of virus used per well in the test is between 101,5 and 102,5 TCID50
and when the titre of the reference serum is within twofold of its expected titre, estimated from the mode of previous
titrations. When the controls are outside these limits the tests are repeated. An end point titre of 1/11 or less is taken
as negative.

in the serum/virus mixtures at

C. The detection and quantification of antibody by ELISA shall be carried out according to the following protocol:

Rabbit antisera to 146S antigen of seven types of foot-and-mouth disease virus (FMDV) used at a predetermined
optimum concentration in carbonate/bicarbonate buffer, pH 9,6. Antigens are prepared from selected strains of virus
grown on monolayers of BHK-21 cells. The unpurified supernatants are used and pretitrated according to the protocol
but without serum, to give a dilution which after the addition of an equal volume of PBST (phosphate buffered saline
containing 0,05 % Tween-20 and phenol red indicator) would give an optical density reading of between 1,2 and 1,5.
The viruses can be used inactivated. PBST is used as a diluent. Guinea-pig antisera are prepared by inoculating guinea
pigs with 146S antigen of each serotype. A predetermined optimum concentration is prepared in PBST containing 10 %
normal bovine serum and 5 % normal rabbit serum. Rabbit anti-guinea-pig immunoglobulin conjugated to horseradish
peroxidase is used at a predetermined optimum concentration in PBST containing 10 % normal bovine serum and 5 %
normal rabbit serum. Test sera are diluted in PBST.

Reagents:

Procedure:

1.

ELISA plates are coated with 50 µl of rabbit antiviral sera overnight in a humidity chamber at room temperature.

2.

Fifty microlitres of a duplicate, twofold series of each test serum starting at 1/4 are prepared in U-bottomed multiwell plates (carrier plates).
Fifty microlitres of a constant dose of antigen are added to each well and the mixtures are left overnight at 4 °C. The addition of the antigen
reduces the starting serum dilution to 1/8.

3. The ELISA plates are washed five times with PBST.

4.

Fifty microlitres of serum/antigen mixtures are then transferred from the carrier plates to the rabbit-serum-coated ELISA plates and incubated
at 37 °C for one hour on a rotary shaker.

5. After washing, 50 µl of guinea-pig antiserum to the antigen used in point 4 is added to each well. The plates are incubated at 37 °C for one

hour a rotary shaker.

6. The plates are washed and 50 µl of rabbit anti-guinea-pig immunoglobulin conjugated to horseradish peroxidase is added to each well. The

plates are incubated at 37 °C for one hour on a rotary shaker.

7.

The plates are washed and 50 µl of orthophenylene diamine containing 0,05 % H2O2 (30 %) w/v is added to each well.

8. The reaction is stopped after 15 minutes with 1,25M H2SO4.

The plates are read spectrophotometrically at 492 nm on an ELISA reader linked to a microcomputer.

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Controls:

Interpretation:

References:

For each antigen used 40 wells contain no serum but contain antigen diluted in PBST. A duplicated twofold dilution
series of homologous bovine reference antiserum. A duplicate twofold dilution series of negative bovine serum.

Antibody titres are expressed as the final dilution of tests serum giving 50 % of the mean OD value recorded in the
virus control wells where test serum is absent. Titres in excess of 1/40 are considered positive.

Hamblin C, Barnett ITR and Hedger RS (1986) “A new enzyme-linked immunosorbent assay (ELISA) for the detection
of antibodies against foot-and-mouth disease virus. I. Development and method of ELISA.” Journal of Immunological
Methods, 93, 115 to 121.11.

A. The serum neutralisation test shall be carried out according to the following protocol:

A u j e s z k y ' s d i s e a s e ( A J D )

Serum:

Procedure:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

The constant virus-varying serum neutralisation test on microtitre plates employs Vero or other sensitive cell systems.
Aujeszky's disease virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an
equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for two hours at 37 °C in the
microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete
monolayer after 24 hours.

Controls:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to seven days
incubation at 37 °C. Serum titres less than 1/2 (undiluted serum) are considered negative.

B. Any other test recognised in the frame of Commission Decision 2001/618/EC concerning additional guarantees to Aujeszky's disease for pigs

destined for certain parts of the territory of the Community.

The serum neutralisation test shall be carried out according to the following protocol:

T r a n s m i s s i b l e g a s t r o e n t e r i t i s ( T G E )

Serum:

Procedure:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

The constant virus-varying serum neutralisation test on microtitre plates employs A72 (dog tumour) cells or other sensitive
cell systems. TGE virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal
volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for 30 to 60 minutes at 37 °C in the
microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete
monolayer after 24 hours. Each cell receives 0,1 ml of cell suspension.

Controls:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to five days
incubation at 37 °C. Serum titres less than 1/2 (final dilution) are considered negative. If undiluted serum samples are toxic
to the tissue cultures, these sera may be diluted 1/2 before being used in the test. This will be equivalent to 1/4 final
dilution of serum. Serum titres of less than 1/4 (final dilution) are considered negative in these cases.

Tests for swine vesicular disease (SVD) shall be carried out according to Commission Decision 2000/428/EC.

S w i n e v e s i c u l a r d i s e a s e ( S V D )

Tests for classical swine fever (CSF) shall be carried out according to Commission Decision 2002/106/EC.

C l a s s i c a l s w i n e f e v e r ( C S F )

The performance of tests for CSF should follow the guidelines set out in the OIE Manual of Standards for Diagnostic Tests and Vaccines — Chapter
2.1.13.

The sensitivity and specificity of the serological test for CSF should be carried out by a national laboratory with a quality assurance scheme in place.
Tests employed must be shown to recognise a range of weak and strong positive reference sera and allow detection of antibody in early phase and
convalescence.

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ANNEX II (FRESH MEAT)

PART 1

List of third countries or parts thereof

Country

Code of
territory

Description of territory

1

2

3

AL — Albania

AL-0

Whole country

AR — Argentina

AR-0

Whole country

AR-1

The provinces of Buenos Aires, Catamarca, Chaco, Corrientes,
Entre Ríos, Formosa (except the territory of Ramon Lista), Jujuy,
La Pampa, La Rioja, Mendoza, Misiones, Neuquen, Rio Negro,
Salta (except the departments of General Jose de San Martin,
Rivadavia, Oran, Iruya, and Santa Victoria), San Juan, San Luis,
Santa Fe, Santiago del Estero, and Tucuman.

AR-2

La Pampa and Santiago del Estero

AR-3

Cordoba

AR-4

Chubut, Santa Cruz and Tierra del Fuego

AR-5

AR-6

Formosa (only the territory of Ramon Lista) and Salta (only the
department of Rivadavia)

Salta (only the departments of General
Oran, Iruya, and Santa Victoria)

Jose de San Martin,

AU — Australia

AU-0

Whole country

BA — Bosnia and

BA-0

Whole country

Herzegovina

BG — Bulgaria

BG-0

Whole country

BG-1

BG-2

provinces

of Varna, Dobrich,

The
Choumen,
Targovitchte, Razgrad, Rousse, V.Tarnovo, Gabrovo, Pleven,
Lovetch, Plovdic, Smolian, Pasardjik, Sofia district, Sofia city,
Pernik, Kustendil, Blagoevgrad, Vratza, Montana and Vidin

Silistra,

The provinces of Bourgas, Jambol, Sliven, Starazagora, Hasskovo
and Kardjali, excluding the 20 km wide corridor on the border
with Turkey

BH — Bahrain

BH-0

Whole country

BR — Brazil

BR-0

Whole country

Veterinary certificate

Model(s)

4

–

EQU

BOV

BOV

BOV

BOV, OVI

BOV

BOV

Specific
conditions

6

SG

5

A

1 and 2

A

A

A

A

1 and 2

1 and 2

1 and 2

1 and 2

BOV, OVI, POR, EQU,
RUF, RUW, SUF, SUW

–

EQU

BOV, OVI, RUW, RUF

–

EQU

BOV

A

1 and 2

States of Paraná, Minas Gerais (except regional delegations of
Oliveira, Passos, São Gonçalo de Sapucai, Setelagoas and
Bambuí), São Paulo, Espíritu Santo, Mato Grosso do Sul (except
for
the municipalities of Sete Quedas, Sonora, Aquidauana,
Bodoqueno, Bonito, Caracol, Coxim, Jardim, Ladario, Miranda,
Pedro Gomes, Porto Murtinho, Rio Negro, Rio Verde of Mato
Grosso and Corumbá), Santa Catarina, Goias and the regional
units of Cuiaba (except for the municipalities of San Antonio de
Leverger, Nossa Senhora do Livramento, Pocone and Barão de
Melgaço), Caceres (except for the municipality of Caceres), Lucas
for the municipality of
do Rio Verde, Rondonopolis (except
Itiquiora), Barra do Garça and Barra do Burges in Mato Grosso.

BR-1

BR-2

BR-3

State of Rio Grande do Sul

State of Mato Grosso do Sul, municipality of Sete Quedas

BOV

BOV

A

A

1 and 2

1 and 2

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11.3.2004

EN

Official Journal of the European Union

1

2

3

BW — Botswana

BW-0

Whole country

4

EQU, EQW

BW-1

The veterinary disease control zones 5, 6, 7, 8, 9 and 18

BOV, OVI, RUF, RUW

BW-2

The veterinary disease control zones 10, 11, 12, 13 and 14

BOV, OVI, RUF, RUW

L 73/61

6

1 and 2

1 and 2

5

F

F

BY — Belarus

BY-0

Whole country

BZ — Belize

BZ-0

Whole country

CA — Canada

CA-0

Whole country

CH — Switzerland

CH-0

Whole country

CL — Chile

CL-0

Whole country

CN — China (People's

CN-0

Whole country

Republic of)

CO — Colombia

CO-0

Whole country

CO-1

CO-2

CO-3

The zone included within the borderlines from the point where
the Murri River flows into the Atrato River, downstream along
the Atrato River to where it flows into the Atlantic Ocean from
to the Panamanian border following the Atlantic
this point
coastline to Cabo Tiburón; from this point to the Pacific Ocean
following the Columbian-Panamanian border; from this point to
the mouth of the Valle River along the Pacific coast and from
this point along a straight line to the point where the Murri
River flows into the Atrato River.

The municipalities of Arboletas, Necocli, San Pedro de Urah,
Turbo, Apartado, Chigorodo, Mutata, Daheiba, Uramita,
Murindo, Riosucio (right bank of the Atrato river) and Frontino.

The zone included within the borderlines from the mouth of the
Sinu River on the Atlantic Ocean, upstream along the Sinu River
to its head-Waters of Alto Paramillo, from this point to Puerto
Rey on the Atlantic Ocean, following the borderline between the
Department of Antiquia and Córdoba, and from this point to
the mouth of the Sinu River along the Atlantic coast.

CR — Costa Rica

CR-0

Whole country

CU — Cuba

CU-0

Whole country

CY — Cyprus

CY-0

Whole country

CZ — Czech Republic

CZ-0

Whole country

CZ-1

Whole country, except
Hodonin, Uherske, Hradiste, Zlin and Vsetin

the provinces of Kromeriz, Vyskov,

DZ — Algeria

DZ-0

Whole country

EE — Estonia

EE-0

Whole country

ET — Ethiopia

ET-0

Whole country

FK — Falkland Islands

FK-0

Whole country

GL — Greenland

GL-0

Whole country

–

BOV, EQU

BOV, OVI, POR, EQU,
SUF, SUW

RUF, RUW,

BOV, OVI, POR, EQU,
RUF, RUW, SUF, SUW

BOV, OVI, POR, EQU,
RUF, RUW

–

EQU

BOV

EQU

A

2

BOV

A

2

BOV, EQU

BOV, EQU

BOV, OVI, POR, EQU,
RUF, RUW, SUF, SUW

BOV, OVI, EQU, RUW,
RUF, POR, SUF

SUW

–

RUW, RUF

POR

–

D

BOV, OVI, EQU

BOV, OVI, EQU, RUF,
RUW

L 73/62

EN

Official Journal of the European Union

11.3.2004

1

2

3

4

5

6

GT — Guatemala

GT-0

Whole country

HK — Hong Kong

HK-0

Whole country

HN — Honduras

HN-0

Whole country

HR — Croatia

HR-0

Whole country

HU — Hungary

HU-0

Whole country

IL — Israel

IN — India

IL-0

Whole country

IN-0

Whole country

IS — Iceland

IS-0

Whole country

KE — Kenya

KE-0

Whole country

LT — Lithuania

LT-0

Whole country

LV — Latvia

LV-0

Whole country

MA — Morocco

MA-0

Whole country

MG — Madagascar

MG-0

Whole country

MK — Former Yugoslav
Republic of
Macedonia (*)

MK-0

Whole country

MT — Malta

MT-0

Whole country

MU — Mauritius

MU-0

Whole country

MX — Mexico

MX-0

Whole country

NA — Namibia

NA-0

Whole country

BOV, EQU

–

BOV, EQU

BOV, OVI, EQU, RUF,
RUW

BOV, POR, OVI, EQU,
RUW, RUF, SUF

SUW

C

–

–

BOV, OVI, EQU

–

BOV, OVI, EQU, RUW,
RUF

POR

D

RUW, RUF

EQU

–

OVI, EQU

BOV, POR, EQU

–

BOV, EQU

EQU, EQW

NA-1

South of the cordon fences which extend from Palgrave Point in
the west to Gam in the east

BOV, OVI, RUF, RUW

F

2

NC — New Caledonia

NC-0

Whole country

NI — Nicaragua

NI-0

Whole country

NZ — New Zealand

NZ-0

Whole country

PA — Panamá

PA-0

Whole country

PL — Poland

PL-0

Whole country

PY — Paraguay

PY-0

Whole country

PY-1

Chaco central and San Pedro areas

RO — Romania

RO-0

Whole country

BOV, RUF, RUW

–

In accordance with
Commission Decision
2003/56/EC

BOV, EQU

BOV, OVI, EQU, RUW,
RUF

POR

EQU

BOV

D

A & F

1 and 2

BOV, OVI, EQU, RUW,
RUF

11.3.2004

EN

Official Journal of the European Union

L 73/63

1

2

3

RU — Russian

Federation

RU-0

Whole country

RU-1

Region of Murmansk (Murmanskaya oblast)

SCG — Serbia and

SCG-0 Whole country

Montenegro

5

6

4

–

RUF

EQU

SCG-1 Whole country except the region of Kosovo and Metohija

BOV, OVI

SI — Slovenia

SI-0

Whole country

BOV, OVI, EQU, RUW,
RUF

SK — Slovakia

SK-0

Whole country

BOV, OVI, EQU, RUW,
RUF

BOV, OVI, EQU, RUW,
RUF, POR

D

SK-1

SK-2

The District Veterinary and Food Administrations (DVFA) of
Trnava (comprising Piešťany, Hlohovec and Trnava districts);
Levice (comprising Levice district); Nitra (comprising Nitra and
Zlaté Moravce districts); Topoľčany (comprising Topoľčany
district); Nové Mesto nad Váhom (comprising Nové Mesto nad
Váhom district); Trenčín (comprising Trenčín and Bánovce nad
Bebravou
and
Partizánske districts); Púchov (comprising Púchov and Ilava
districts); Žiar nad Hronom (comprising Žiar nad Hronom,
Žarnovica and Banská Štiavnica districts); Zvolen (comprising
Zvolen and Detva districts); Banská Bystrica (comprising Banská
Bystrica and Brezno districts).

(comprising

Prievidza

Prievidza

districts)

II.,

III.,

(comprising

The District Veterinary and Food Administrations (DVFA) of
Bratislava mesto (comprising Bratislava I.,
IV. and V.
districts); Senec
(comprising Senec, Pezinok and Malacky
districts); Dunajská Streda (comprising Dunajská Streda district);
Galanta (comprising Galanta district); Senica (comprising Senica
and Skalica districts); Nové Mesto nad Váhom (comprising
Myjava district); Púchov (comprising Považská Bystrica district);
Nové Zámky (comprising Nové Zámky district); Komárno
(comprising Komárno district); Šaľa (comprising Šaľa district);
Žilina (comprising Žilina and Bytča district); Dolný Kubín
(comprising Dolný Kubín, Tvrdošín and Námestovo districts);
Martin (comprising Martin and Turčianske Teplice districts);
Liptovský Mikuláš
and
Ružomberok districts); Lučenec (comprising Lučenec and Poltár
districts); Veľký Krtíš (comprising Veľký Krtíš district); Rimavská
Sobota (comprising Rimavská Sobota and Revúca districts);
Zvolen (comprising Krupina district);
Poprad (comprising
Poprad, Kežmarok and Levoča districts); Prešov (comprising
Prešov and Sabinov districts); Bardejov (comprising Bardejov
district); Vranov nad Topľou (comprising Vranov nad Topľou
district); Svidník (comprising Svidník and Stropkov districts);
Humenné
and Snina
(comprising Humenné, Medzilaborce
districts); Stará Ľubovňa (comprising Stará Ľubovňa district);
Košice—mesto (comprising Košice I., II., III. and IV. districts);
Košice—okolie (comprising Košice—okolie district); Michalovce
(comprising Michalovce
and Sobrance districts); Rožňava
(comprising Rožňava district); Spišská Nová Ves (comprising
Spišská Nová Ves and Gelnica districts) and Trebišov (comprising
Trebišov district).

Liptovský Mikuláš

L 73/64

EN

Official Journal of the European Union

11.3.2004

1

SV — El Salvador

SZ — Swaziland

2

SV-0

SZ-0

SZ-1

3

Whole country

Whole country

Area west of the “red line” fences which extends northwards
from the river Usutu to the frontier with South Africa west of
Nkalashane, but
foot-and-mouth
the
surveillance and vaccination control areas gazetted as a statutory
instrument under legal notice No 51 of 2001

veterinary

excluding

TH — Thailand

TH-0

Whole country

TN — Tunisia

TN-0

Whole country

TR — Turkey

TR-0

Whole country

TR-1

The provinces of Amasya, Ankara, Aydin, Balikesir, Bursa,
Cankiri, Corum, Denizli,
Izmir, Kastamonu, Kutahya, Manisa,
Usak, Yozgat and Kirikkale

UA — Ukraine

UA-0

Whole country

US — United States

US-0

Whole country

UY — Uruguay

UY-0

Whole country

ZA — South Africa

ZA-0

Whole country

ZA-1

The whole country except:

— the part of the foot-and-mouth disease control area situated
in the veterinary regions of Mpumalanga and Northern
in the district of Ingwavuma of the veterinary
provinces,
region of Natal and in the border area with Botswana east
of longitude 28°, and

— the

district

of Camperdown,

in

the

province

of

KwaZuluNatal

4

–

EQU, EQW

BOV, RUF, RUW

5

F

6

2

–

–

–

EQU

–

BOV, OVI, POR, EQU,
SUF, SUW, RUF, RUW

EQU

BOV

OVI

EQU, EQW

BOV, OVI,
RUF, RUW

A

B

F

1

1 and 2

2

ZW — Zimbabwe

ZW-0 Whole country

–

(*) Former Yugoslav Republic of Macedonia; provisional code that does not affect the definitive denomination of the country to be attributed after the conclusion of the

negotiations currently taking place in the United Nations.

— No certificate laid down and fresh meat imports are not authorised.

Specific conditions referred to in column 6

“1”: Geographic and timing restrictions

Code of Territory

Veterinary certificate

AR-1

AR-2

AR-3

Model

BOV

BOV

BOV

SG

A

A

A

Time period/dates for which importation into the Community is authorised or not authorised in
relation to dates of slaughter/killing of animals from which the meat was obtained

Before and including 31 January 2002

Not authorised

After and including 1 February 2002

Authorised

Before and including 8 March 2002

Not authorised

After and including 9 March 2002

Authorised

Before and including 26 March 2002

None

After and including 27 March 2002

Authorised

11.3.2004

EN

Official Journal of the European Union

L 73/65

Code of Territory

Veterinary certificate

AR-4

AR-5

AR-6

BR-2

BR-3

BW-1

BW-2

PY-1

Model

BOV, OVI,
RUM, RUF

BOV

BOV

BOV

BOV

BOV, OVI,
RUM, RUF

BOV, OVI,
RUM, RUF

BOV

SG

–

A

A

A

A

A

A

A

Time period/dates for which importation into the Community is authorised or not authorised in
relation to dates of slaughter/killing of animals from which the meat was obtained

Before and including 28 February 2002

Not authorised

After and including 1 March 2002

Authorised

Before and including 10 July 2003

Authorised

After and including 11 July 2003

Not authorised

Before and including 4 September 2003

Authorised

After and including 5 September 2003

Not authorised

Before and including 30 November 2001

Not authorised

After and including 1 December 2001

Authorised

Before and including 31 October 2002

Authorised

After and including 1 November 2002

Not authorised

Before and including 7 July 2002

Not authorised

After and including 8 July 2002 to
23 December 2002

Authorised

After and including 24 December 2002
to
6 June 2003

Not authorised

After and including 7 June 2003

Authorised

Before and including 6 March 2002

Not authorised

After and including 7 March 2002

Authorised

Before and including 31 August 2002

Not authorised

After and including 1 September 2002 to
19 February 2003

Authorised

After and including 20 February 2003

Not authorised

UY-0

BOV, OVI

A

Before and including 31 October 2001

Not authorised

After and including 1 November 2001

Authorised

“2”: Category restrictions

No offal authorised (except bovine diaphragm and masseter muscles).

PART 2

Models of veterinary certificates

Model(s):

“BOV”: Model of veterinary certificate for fresh meat of domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their cross-breeds)

“POR”: Model of veterinary certificate for fresh meat of domestic porcine animals (Sus scrofa)

“OVI”: Model of veterinary certificate for fresh meat of domestic sheep (Ovis aries) and goats (Capra hircus)

“EQU”: Model of veterinary certificate for fresh meat of domestic equine animals (Equus caballus, Equus asinus and their cross-breeds)

L 73/66

EN

Official Journal of the European Union

11.3.2004

“RUF”: Model of veterinary certificate for fresh meat of farmed non-domestic animals other than suidae and solipeds

“RUW”: Model of veterinary certificate for fresh meat of wild non-domestic animals other than suidae and solipeds

“SUF”: Model of veterinary certificate for fresh meat of farmed non-domestic suidae

“SUW”: Model of veterinary certificate for fresh meat of wild non-domestic suidae

“EQW”: Model of veterinary certificate for fresh meat of wild non-domestic solipeds

SG (Supplementary guarantees):

guarantees regarding the maturation, pH measurement and deboning of fresh meat, excluding offal, certified according to the models of
certificates BOV (point 10.6), OVI (point 10.6), RUF (point 10.7) and RUW (point 10.4)

guarantees regarding matured trimmed offal as described in the model of certificate BOV (point 10.6)

guarantees regarding laboratory test for classical swine fever in the carcases from which fresh meat certified according to the model of
certificate SUW (point 10.3 a) was obtained

guarantees regarding swill feed on holding(s) of animals from which fresh meat certified according to models of certificate POR (point 10.3
(d)) was obtained

guarantees regarding tuberculosis test in the animals from where fresh meat certified according to the model of certificate BOV (point 10.4
(d)) was obtained

guarantees regarding the maturation and deboning of fresh meat, excluding offal, certified according to the models of certificates BOV (point
10.6), OVI (point 10.6), RUF (point 10.7) and RUW (point 10.4)

“A”:

“B”:

“C”:

“D”:

“E”:

“F”:

Notes

(a) Veterinary certificates shall be produced by the exporting country, based on the models appearing in Part 2 of Annex II, according to the layout
of the model that corresponds to the meats concerned. They shall contain, in the numbered order that appears in the model, the attestations that
are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country or
part thereof.

(b) A separate and unique certificate must be provided for meat that is exported from a single territory appearing in columns 2 and 3 of Part 1 of

Annex II which is consigned to the same destination and transported in the same railway wagon, lorry, aircraft or ship.

(c) The original of each certificate shall consist of a single page, both sides, or, where more text is required, it shall be in such a form that all pages

needed are part of an integrated whole and indivisible.

(d)

(e)

It shall be drawn up in at least one of the official languages of the EU Member State in which the inspection at the border post shall be carried
out and of the EU Member State of destination. However, these Member States may allow other languages, if necessary, accompanied by an
official translation.

If for reasons of identification of the items of the consignment (schedule in point 8.3 of the model of certificate), additional pages are attached to
the certificate, these pages shall also be considered as forming part of the original of the certificate by the application of the signature and stamp
of the certifying official veterinarian, in each of the pages.

(f) When the certificate, including additional schedules referred to in (e), comprises more than one page, each page shall be numbered — (page
number) of (total number of pages) — at the bottom and shall bear the code number of the certificate that has been designated by the
competent authority at the top.

(g) The original of the certificate must be completed and signed by an official veterinarian. In doing so, the competent authorities of the exporting

country shall ensure that the principles of certification equivalent to those laid down in Council Directive 96/93/EC are followed.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or
watermarked.

(h) The original of the certificate must accompany the consignment at the EU border inspection post.

11.3.2004

EN

Official Journal of the European Union

L 73/93

ANNEX B

‘ANNEX I

Description of territories of third countries authorised to export to the Community

Country

Code of territory

Version

Description of the territory

Brazil

BR-1

—

Any country
appearing in the first
column of Annex II

ISO code as
indicated in the first
column of Annex II

(1) OJ L 378, 31.12.1994, p. 11.

As described in Annex I to Commission Decision
94/984/EC (1) (as last amended)

The whole country

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L 73/94

EN

Official Journal of the European Union

11.3.2004

Animal and public health conditions appearing in the model of veterinary certificate to be requested

ANNEX II

Country

Code of
territory

Wild

Farmed

Wild

Domestic rabbit

Game birds

Leporidae
(rabbit and hare)

Wild land mammals
other than leporidae
and ungulates

MC (1)

SC (2)

MC (1)

SC (2)

MC (1)

SC (2)

MC (1)

SC (2)

BM (1)

BB (2)

AR

AU

BG

BR

CA

CH

CL

CY

CZ

EE

GL

HR

HU

IL

LT

LV

NZ

PL

RO

RU

SI

Argentina

Australia

Bulgaria

Brazil

Canada

Switzerland

Chile

Cyprus

Czech
Republic

Estonia

Greenland

Croatia

Hungary

Israel

Lithuania

Latvia

AR

AU

BG

BR

BR-1

CA

CH

CL

CY

CZ

EE

GR

HR

HU

IL

LT

LV

New Zealand

NZ

Poland

Romania

Russia

Slovenia

PL

RO

RU

SI

D

—

D

—

D

D

D

D

D

D

—

D

D

D

D

D

—

D

D

D

—

D

8

8

8

8

8

8

8

I

—

I

—

I

I

I

I

I

I

—

—

I

I

I

I

—

I

I

I

—

I

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

C

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

H

—

E

—

—

—

E

—

—

—

—

E

E

—

—

—

E

E

E

—

E

E

—

11.3.2004

EN

Official Journal of the European Union

L 73/95

Country

Code of
territory

Wild

Farmed

Wild

Domestic rabbit

Game birds

Leporidae
(rabbit and hare)

Wild land mammals
other than leporidae
and ungulates

MC (1)

SC (2)

MC (1)

SC (2)

MC (1)

SC (2)

MC (1)

SC (2)

BM (1)

BB (2)

SK

TH

TN

US

Slovak
Republic

Thailand

Tunisia

United States

SK

TH

TN

US

Any other third country appearing
in the list drawn up in Part 1 of
Annex II to Decision 79/542/EEC, as
last amended.

D

D

D

D

—

8

8

8

I

I

I

I

—

C

C

C

C

C

H

H

H

H

H

—

—

—

—

—

(1) MC: model of certificate to be completed. The letters (C, H, E) appearing in the table refer to the model of certificate, as described in Annex III to this Decision, to

(2)

SC:

be used for each category of meat. A dash “—” indicates that imports of the meat are not authorised.
specific conditions. The numbers appearing in the table refer to the specific conditions to be provided by the exporting country, as described in Annex IV to
this Decision. They must be inserted by the exporting country in Section V of the relevant model of certificate set down in Annex III to this Decision.'