32004D0212

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,

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

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 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 Council Directive 92/118/EEC of 17 December 1992 laying down public health and animal health requirements governing trade in and imports 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,

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

Having regard to Regulation (EC) No 999/2001 of the 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 amended by Commission Regulation (EC) No 2245/2003(13), and in particular Articles 15(3), 16(7) and 23 thereof,

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

Whereas:

(1) Community provisions concerning animal health conditions for imports from third countries of live 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) that these animals and products fulfil the health conditions to be certified by an official veterinarian of the exporting country by means of a certificate.

(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 the import conditions, including the list of third 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.

(3) 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 meat including minced meat by Council Directive 2002/99/EC. Therefore, it is appropriate to update Decision 79/542/EEC as a basis for the present consolidation.

(4) Article 12 of Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third 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 3 of Directive 72/462/EEC. However, Commission decisions adopted on the basis of Directive 90/426/EEC and concerning health conditions for imports of equidae provide for lists of the third countries authorised to export these animals to the Community.

(5) The rules governing animal health conditions for the importation of live animals pursuant to Directive 72/462/EEC, in particular the provisions of Article 3 referring to a list of third countries authorised for the exportation of live animals, will be replaced by a Council directive(17) laying down the animal health rules for the importation into the Community of certain 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 specific models of health certificates required for exporting equidae to the Community. Moreover, this Directive foresees specific provisions for animals imported into the Community under certain non-commercial transactions.

(6) 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.

(7) 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 from a large variety of animals. Thus, these two decisions already provide the harmonised 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.

(8) 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, institute or centre" 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.

(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, 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 animals. However, meat preparations may incorporate meat from other non-mammallian animals. Therefore, Decision 2000/572/EC should be amended in order to remove from its scope minced meat from domestic cloven-hoofed animals that can be incorporated in a more harmonised manner in Decision 79/542/EEC, while maintaining the conditions applicable to the importation of meat preparations in a separate decision.

(10) 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 therein. For meat 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 amended in order to withdraw from its scope the 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.

(11) 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 their implementing Commission decisions, the provisions of Decision 84/390/EEC are no longer applicable and therefore should be repealed.

(12) Commission Decision 91/189/EEC(24) establishes the protocols for the standardisation of materials and 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 and its provisions regarding the protocols for the standardisation of materials and procedures for veterinary tests incorporated in a more harmonised manner in Decision 79/542/EEC.

(13) Commission Decisions 93/198/EC(25) and 97/232/EC(26) lay down, respectively, the animal health conditions and veterinary certification for the importation of sheep and goats, and the lists of third countries from which Member States authorise importation of such animals. Commission Decision 2002/199/EC(27) establishes the animal health conditions and veterinary certification for the importation of live bovine animals and swine, and the list of third countries 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.

(14) Commission Decision 93/52/EEC(28) records 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.

(15) Commission Decisions 80/801/EEC(29), 80/804/EEC(30), 81/526/EEC(31), 81/887/EEC(32), 82/414/EEC(33), 82/426/EEC(34), 83/84/EEC(35), 83/380/EEC(36), 84/292/EEC(37), 84/294/EEC(38), 86/63/EEC(39), 86/72/EEC(40), 86/117/EEC(41), 86/463/EEC(42), 89/197/EEC(43), 89/221/EEC(44), 90/445/EEC(45), 91/73/EEC(46), 91/445/EEC(47), 91/446/EEC(48), 92/280/EEC(49), 93/402/EC(50), 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.

(16) The International Office of Epizootic Diseases and the Codex Alimentarius have set up guidelines regarding the principles of certification which veterinarians have to follow. It is prescribed in these principles that 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 and to prevent fraud. Therefore, it is appropriate to ensure that the rules and principles applied by 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.

(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.

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

(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, it is appropriate that 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.

(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, the animal health and public health attestation 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.

(21) With a view to harmonising import conditions, ensuring the transparency of Community requirements and simplifying the legislative procedure 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 a more general scope adopted at Community level still condition the ultimate acceptance for importation into the Community of 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 animal products(56) and Regulation (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 result from safeguard measures as provided for in Directives 91/496/EEC and 97/78/EC.

(22) Tariff and statistical nomenclatures worldwide classify live animals, their meat and other derivatives 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.

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

(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) 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.

(27) 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. In addition, 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 rules concerning animal by-products not intended for human consumption, including such raw material. The certification requirements shall 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.

(28) The measures provided for in this Decision are in 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 or parts 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."

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.

This Decision shall not apply to imports 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 intended for scientific including conservation or experimental purposes in a body, institute or centre that has been approved in accordance with Annex C to Directive 92/65/EEC.

Imports of animals and fresh meat 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

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

(a) 'animals': means land mammals of the species belonging to the taxa Proboscidea and Artiodactyla, and their crossbreeds;

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

(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 from domestic bovine animals, the whole 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.

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 corresponding column 4, there is a specific model of 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, taking into account 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.

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

Article 6

Transport of live animals for importation into the Community

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 third country that is not approved for importation into the Community of such animals.

3. During the transport to the Community, the animals 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 the importation and in accordance with Directive 91/496/EEC,

(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 parks and hunting or wildlife reserves, shall be 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, except in the case of direct dispatch to a slaughterhouse.

Article 8

Conditions for importation of fresh meat into the Community

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 corresponding column 4, there is a specific model of veterinary certificate designated for that meat.

Article 10

Specific conditions

The fresh meat shall meet the requirements set out in the appropriate certificate corresponding 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 in column 5 of the table, it shall also meet the supplementary guarantees requested in that certificate.

Article 11

Presentation of fresh meat at a Community border inspection post

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 12

Conditions to be applied following importation

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

(a) unskinned carcases of wild cloven-hoofed game intended for human consumption after further processing;

(b) trimmed offal of domestic bovine animals intended for human consumption as meat-based products after further heat-treatment by cooking to a core temperature of at least 80 °C, or sterilised in hermetically sealed containers in a way as to achieve a value of Fo >= 3.

2. For the categories of products referred to in 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 13

Certification

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

3. Article 4 becomes Article 14.

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

Article 2

Amendments to Decision 2000/572/EC

Decision 2000/572/EC is amended as follows:

1. The title is replaced by:

"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".

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."

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 shall only authorise imports of the following meat:

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

- meat of farmed game birds,

- meat of wild leporidae, defined as rabbits and hares, that do not contain offal, except in the case of 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

Decisions 80/801/EEC, 80/804/EEC, 81/526/EEC, 81/887/EEC, 82/414/EEC, 82/426/EEC, 83/84/EEC, 83/380/EEC, 84/292/EEC, 84/294/EEC, 84/390/EEC, 86/63/EEC, 86/72/EEC, 86/117/EEC, 86/463/EEC, 89/197/EEC, 89/221/EEC, 90/445/EEC 91/73/EEC, 91/189/EEC, 91/445/EEC, 91/446/EEC, 92/280/EEC, 93/198/EEC, 93/402/EEC, 97/232/EC, 98/371/EC, 98/625/EC, 1999/283/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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(17) COM(2003) 570 final.

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(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.

(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.

(56) OJ L 125, 23.5.1996, p. 10.

(57) OJ L 31, 1.2.2002, p. 1.

(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.

ANNEX A

"ANNEX I (LIVE ANIMALS)

PART 1

List of third countries or parts thereof

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Specific conditions (see footnotes in each certificate):

"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.

"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": 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)

"B": 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) 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.

(e) 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.

(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.)

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B - Conditions for the authorisation of assembly centres

Approved assembly centres shall meet the following requirements:

I. They shall be supervised by an official veterinarian.

II. 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.

III. 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.

IV. 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; (c) appropriate facilities for inspection and isolation; (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.

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.

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 into the European Community; (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.

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

Tuberculosis (TBL)

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.

Brucellosis (Brucella abortus) (BRL)

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.

Brucellosis (Brucella melitensis) (BRL)

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

Enzootic Bovine Leukosis (EBL)

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.

Bluetongue (BTG)

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

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.

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)

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

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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: 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.

Procedure:

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 1/5000 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.

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 2000 to 3000 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 fluoride (lysis buffer). This may cause the cells to form a gel and more lysis buffer may be added to reduce this effect. (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 10000 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 24000 rpm (100000 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.

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.

Epizootic haemorrhagic disease (EHD)

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 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.

Infectious bovine rhinotracheitis (IBR)/infectious pustular vulvo-vaginitis (IPV)

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.

Foot-and-mouth disease (FMD)

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

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 1000 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.

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 in the serum/virus mixtures at 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.

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

Reagents: 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.

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.

Controls: 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.

Interpretation: 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.

References: 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.

Aujeszky's disease (AJD)

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 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.

Transmissible gastroenteritis (TGE)

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 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.

Swine vesicular disease (SVD)

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

Classical swine fever (CSF)

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

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.

ANNEX II (FRESH MEAT)

PART 1

List of third countries or parts thereof

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Specific conditions referred to in column 6

"1": Geographic and timing restrictions

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"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)

"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):

"A": 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)

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

"C": 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

"D": 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

"E": 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

"F": 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)

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) 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.

(e) 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.

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ANNEX B

"ANNEX I

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

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ANNEX II

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

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