Council Directive 2008/73/EC of 15 July 2008 simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC (Text with EEA relevance)

Member States shall designate State institutes, national reference laboratories or official institutes responsible for coordinating the standards and methods of diagnosis referred to in Annexes A to D. They shall maintain up-to-date lists thereof and make them available to the other Member States and to the public. The tasks and responsibilities of those State institutes, national reference laboratories and official institutes are set out in Annexes B and C and Chapter II of Annex D. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 17(2).’;

Annexes A and D (Chapter I) shall be amended by the Council, acting by a qualified majority on a Commission proposal, in particular with regard to their adaptation to technological and scientific developments. Annexes B, C, D (Chapter II), E and F shall be amended by the Commission in accordance with the procedure referred to in Article 17.’;

1 Member States shall draw up and keep up to date a list of bodies as referred to in Article 1(b), first indent, which are officially recognised for the purpose of maintaining or establishing herd books and make it available to the other Member States and to the public.

2 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 8(2).’.

‘2 All semen collection or storage centres shall be registered, each centre being given a veterinary registration number. Each Member State shall draw up and keep up to date a list of semen collection or storage centres and their veterinary registration numbers and make it available to the other Member States and to the public.

3 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 18(2).’;

1 Member States shall only authorise imports of semen dispatched from a semen collection or storage centre situated in one of the third countries appearing on the list referred to in Article 8 and for which the competent authority of the third country concerned is able to give the guarantees that the following conditions are met: (a) it meets the conditions: (i) for approval of semen collection centres or storage centres set out in Chapter I of Annex A; (ii) relating to the supervision of such centres set out in Chapter II thereof; (b) it has been officially approved by the competent authority of the third country for exports to the Community; (c) it is placed under the supervision of a centre veterinarian; (d) it is subject to inspections by an official veterinarian of the third country at least twice a year.

2 The list of semen collection or storages centres that the competent authority of the third country appearing on the list referred to in Article 8 has approved in accordance with the conditions set out in paragraph 1 of this Article and from which semen may be dispatched to the Community shall be communicated to the Commission. The approval of a semen collection or storage centre must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions set out in paragraph 1 and the Commission must be immediately informed thereof. The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country in accordance with this paragraph and shall make them available to the public for information purposes.

3 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 18(2).’;

The rules laid down in Directive 97/78/EC shall apply, in particular to the organisation of, and follow-up to the checks to be carried out by the Member States and the safeguard measures to be applied in accordance with the procedure referred to in Article 22 of that Directive.’.

Member States shall draw up and keep up to date a list of bodies as referred to in Article 1(c), first indent, and make it available to the other Member States and to the public. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 11(2).’;

Member States shall draw up and keep up to date a list of bodies as referred to in Article 1(d), first indent, and make it available to the other Member States and to the public. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 11(2).’.

Member States shall draw up and keep up to date a list of bodies as referred to in Article 2(b), first indent, which are officially approved for the purpose of maintaining or establishing flock books and which meet the criteria determined in accordance with the first indent of Article 4 and make it available to the other Member States and to the public. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 8.’.

‘2 The competent authority of each Member State concerned shall register embryo collection teams and give a veterinary registration number to each team. Each Member State shall draw up and keep up to date a list of embryo collection teams and their veterinary registration numbers and make it available to the other Member States and to the public.’;

1 Member States shall only authorise imports of embryos dispatched from an embryo collection or production team situated in one of the third countries appearing on the list referred to in Article 7 and for which the competent authority of the third country concerned is able to give the guarantees that the following conditions are met: (a) it meets the conditions: (i) for the approval of embryo collection and embryo production teams set out in Chapter I of Annex A; (ii) relating to the collection, processing, storage and transport of embryos by such teams set out in Chapter II of that Annex; (b) it has been officially approved by the competent authority of the third country for exports to the Community; (c) it is subject to inspections by an official veterinarian of the third country at least twice a year.

2 The list of embryo collection or production teams that the competent authority of the third country appearing on the list referred to in Article 7 has approved in accordance with the conditions set out in paragraph 1 of this Article and from which embryos may be dispatched to the Community shall be communicated to the Commission. The approval of an embryo collection or production team must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions set out in paragraph 1 and the Commission must be immediately informed thereof. The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country concerned in accordance with this paragraph and shall make them available to the public for information purposes.

3 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 18(2).’;

The rules laid down in Directive 97/78/EC shall apply, in particular to the organisation of, and follow-up to the checks to be carried out by the Member States and the safeguard measures to be applied in accordance with the procedure referred to in Article 22 of that Directive.’.

‘1 The equidae must be transported, as soon as possible, from the holding of origin either directly or via an approved market or marshalling centre as defined as “assembly centre” in Article 2(2)(o) of Directive 64/432/EEC to the place of destination in vehicles or containers which have been regularly cleansed and disinfected with a disinfectant at intervals to be fixed by the Member State of dispatch. The vehicles must be designed in such a way that equidae droppings, litter or fodder cannot escape from the vehicle during transportation. Transportation must be effected in such a way that the health and well-being of the equidae can be protected effectively.’.

Member States shall draw up and keep up to date the list of bodies maintaining or establishing studbooks as referred to in Article 2(c), first indent, which are approved or recognised on the basis of the criteria determined in accordance with Article 4(2)(a) and make it available to the other Member States and to the public. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 10.’.

‘2 However, the obligations referred to in Article 3 shall not affect the organisation of: (a) competitions reserved for equidae registered in a specific stud book for the purpose of permitting the improvement of the breed; (b) regional competitions with a view to selecting equidae; (c) historic or traditional events. Member States intending to avail themselves of these possibilities shall make this intention and the justifications thereof available to the other Member States and to the public beforehand; for each competition or type of competition Member States shall be authorised to reserve, through the bodies officially approved or recognised for that purpose, a certain percentage of the prize money or profits referred to in paragraph 1(c) for the safeguard, development and improvement of breeding. The percentage may not exceed 20 % from 1993. The criteria for the distribution of these funds in the Member State concerned shall be made available to the other Member States and to the public.’.

‘2 All semen collection centres shall be registered, each centre being given a veterinary registration number. Each Member State shall draw up and keep up to date a list of semen collection centres and their veterinary registration numbers and make it available to the other Member States and to the public.’;

1 Member States shall only authorise imports of semen dispatched from a semen collection centre situated in one of the third countries appearing on the list referred to in Article 7 and for which the competent authority of the third country concerned is able to give the guarantees that the following conditions are met: (a) it meets the conditions: (i) for the approval of semen collection centres set out in Chapter I of Annex A; (ii) relating to the supervision of such centres set out in Chapter II thereof; (b) it has been officially approved by the competent authority of the third country for exports to the Community; (c) it is placed under the supervision of a centre veterinarian; (d) it is subject to inspections by an official veterinarian of the third country concerned at least twice a year.

2 The list of semen collection centres that the competent authority of the third country appearing on the list referred to in Article 7 has approved in accordance with the conditions set out in paragraph 1 of this Article and from which semen may be dispatched to the Community shall be communicated to the Commission. The approval of a semen collection centre must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions set out in paragraph 1 and the Commission must be immediately informed thereof. The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country concerned in accordance with this paragraph and shall make them available to the public for information purposes.

3 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 18(2).’;

Each Member State shall designate a national reference laboratory to be responsible for coordinating the diagnostic methods provided for in this Directive and their use by the approved laboratories located in its territory. Each Member State shall make the details of its national reference laboratory, and any subsequent changes, available to the other Member States and to the public. Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 32(2).’;

Each Member State shall draw up and keep up to date a list of establishments approved in accordance with point 1(a) of Article 6 and their distinguishing numbers, and shall make it available to the other Member States and to the public. Detailed rules for the uniform application of this article may be adopted in accordance with the procedure referred to in Article 32.’;

‘3 The competent authority shall issue an approval number to each approved assembly centre. Approvals may be limited to one or more species covered by this Directive or to animals for breeding or fattening, or to animals for slaughter. The competent authority shall draw up and keep up to date a list of approved assembly centres and their unique approval numbers and make it available to the other Member States and to the public.’;

‘5 Member States shall draw up and keep up to date a list of approved dealers and registered premises used by dealers in connection with their business and their approval numbers and shall make it available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 15(2).’.

‘4 (a) The procedure laid down in Article 22 must be followed for the approval and subsequent updating of the list of quarantine centres referred to in the first indent of paragraph 1. The Commission shall publish the list of these quarantine centres and any subsequent updates in the Official Journal of the European Union. (b) Quarantine centres referred to in the second indent of paragraph 1 and the first indent of paragraph 2 that fulfil the conditions laid down in Annex B shall be approved by the Member States, each centre being given an approval number. Each Member State shall draw up and keep up to date a list of approved quarantine centres and their approval numbers and make it available to the other Member States and to the public. Quarantine centres shall be subject to the inspection provided for in Article 19. Detailed rules for the uniform application of this subparagraph may be adopted in accordance with the procedure referred to in Article 22.’.

1 Member States shall designate a national laboratory to carry out the laboratory examinations provided for in this Directive, and shall make the details of that laboratory, and any subsequent changes, available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 19.

2 The functions and duties of the national laboratories designated in accordance with paragraph 1 are set out in Annex I.

3 The national laboratories designated in accordance with paragraph 1 shall liaise with the Community reference laboratory referred to in Article 15.’;

1 The Member States shall ensure that, without prejudice to the decisions to be taken in implementation of Articles 21 and 23, only semen, ova and embryos meeting the conditions laid down in paragraphs 2, 3, 4 and 5 are the subject of trade.

2 Semen of the ovine, caprine and equine species must, without prejudice to any criteria to be complied with for the entry of equids in stud books for certain specific breeds: have been collected, processed and stored with a view to artificial insemination in a centre approved from the health point of view in accordance with Annex D(I), or, in the case of ovine and caprine animals by way of derogation from the above, in a holding satisfying the requirements of Directive 91/68/EEC, have been collected from animals meeting the conditions laid down in Annex D(II), have been collected, processed, preserved, stored and transported in accordance with Annex D(III), have been accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26.

3 Ova and embryos of the ovine, caprine, equine and porcine species must: have been removed from donor females meeting the conditions laid down in Annex D(IV) by a collection team or have been produced by a production team approved by the competent authority of the Member State and satisfying the conditions to be established in Annex D(I) in accordance with the procedure referred to in Article 26, have been collected, processed and preserved in an appropriate laboratory, stored and transported in accordance with Annex D(III), be accompanied during transport to another Member State by a health certificate corresponding to a specimen to be determined in accordance with the procedure referred to in Article 26. Semen used for the insemination of donor females must comply with the provisions of paragraph 2 in the case of sheep, goats and equids and with the provisions of Directive 90/429/EEC for swine. Any additional guarantees may be determined in accordance with the procedure referred to in Article 26.

4 The approved centres referred to in the first indent of paragraph 2 and the approved teams referred to in the first indent of paragraph 3 shall be registered by the competent authority of the Member State concerned, each centre and team being given a veterinary registration number. Each Member State shall draw up and keep up to date a list of those approved centres and teams and their veterinary registration numbers and shall make it available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 26.

5 The animal health requirements and the specimen health certificates applicable to semen, ova and embryos of species not mentioned in paragraphs 2 and 3 shall be established in accordance with the procedure referred to in Article 26. Pending the establishment of animal health requirements and specimen health certificates for trade in such semen, ova and embryos, national rules shall continue to apply.’;

‘2 The national laboratories referred to in paragraph 1 shall be responsible for coordinating standards and methods of diagnosis, use of reagents and testing of vaccines.’;

‘3 The national laboratories referred to in paragraph 1 shall be responsible for coordinating the standards and diagnostic methods laid down in each Newcastle-disease diagnostic laboratory within the Member State. To this end:’;

‘4 The national laboratories referred to in paragraph 1 shall liaise with the Community reference laboratory referred to in Article 15.

5 Member States shall maintain up-to-date lists of the national laboratories or institutes referred to in paragraph 1 and make them available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 25(2).’;

‘5 Member States shall maintain up-to-date lists of the national laboratories referred to in paragraph 1 and make them available to the other Member States and to the public.’;

‘1 A list of bodies in respect of the species and/or races concerned that the competent authority of the third country has approved for the purpose of this Directive shall be communicated to the Commission. The approval of a body must be immediately suspended or withdrawn by the competent authority of the third country where it no longer complies with the conditions referred to in Article 3(2)(b) and the Commission must be immediately informed thereof. The Commission shall provide the Member States with any new and updated lists that it receives from the competent authority of the third country concerned in accordance with the second subparagraph and shall make them available to the public for information purposes.’;

1 Member States shall designate a national laboratory responsible for carrying out the laboratory tests provided for by this Directive, and shall make the details of that laboratory, and any subsequent changes, available to the other Member States and to the public. Detailed rules for the uniform application of this paragraph may be adopted in accordance with the procedure referred to in Article 20(2).

2 The tasks of the national laboratories designated in accordance with paragraph 1 are listed in Annex I.

3 The national laboratories designated in accordance with paragraph 1 of this Article shall liaise with the Community reference laboratory referred to in Article 16.’;

1 On the basis of a favourable result of the appraisal of an applicant laboratory in a Member State, documented by AFSSA, Nancy, the competent authority of the Member State may authorise the applicant laboratory to carry out the serological tests to monitor the effectiveness of rabies vaccines. Member States shall draw up and keep up to date a list of those laboratories that they have authorised and shall make it available to the other Member States and to the public.

2 On the basis of a favourable result of the appraisal of an applicant laboratory in a third country documented by AFSSA, Nancy, and following an application for approval from the competent authority of the third country of origin of the applicant laboratory, such laboratory shall be authorised in accordance with the procedure referred to in Article 5(2) to carry out serological tests to monitor the effectiveness of rabies vaccines.

3 Detailed rules for the uniform application of this Article may be adopted in accordance with the procedure referred to in Article 5(2).’;

Applications for approval of laboratories submitted by the Member States prior to 1 January 2010, in accordance with Article 3 and Annex II, shall continue to be governed by this Decision, in its version before 3 September 2008.’;

Directive 2001/89/EC is hereby amended as follows: 1. in Article 17(1), point (b) shall be replaced by the following: ‘(b) a national laboratory is responsible for coordinating standards and methods of diagnosis in each Member State in accordance with the provisions of Annex III. Member States shall make the details of their national laboratory, and any subsequent changes, available to the other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 26(2).’; 2. Annex III shall be amended as follows: (a) the title shall be replaced by the following: ‘Duties of national laboratories for classical swine fever’; (b) point 1 shall be deleted.

Directive 2002/60/EC is hereby amended as follows: 1. in Article 18(1), point (b) shall be replaced by the following: ‘(b) a national laboratory is responsible for coordinating standards and diagnostic methods in each Member State in accordance with Annex IV. Member States shall make the details of their national laboratory, and any subsequent changes, available to the other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 23(2).’; 2. Annex IV shall be amended as follows: (a) the title shall be replaced by the following: ‘Duties of national laboratories for African swine fever’; (b) point 1 shall be deleted.

‘2 Member States shall designate a national reference laboratory and shall make the details thereof, and any subsequent changes, available to the other Member State and to the public in a manner that may be specified in accordance with the procedure referred to in Article 64(2).’.

1 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2 Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by the Directive.

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.