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)
Date: 2008-07-15

num: Article 1
title: Amendments to Directive 64/432/EEC
paragraphs: Directive 64/432/EEC is hereby amended as follows:
1.
in Article 6, the first subparagraph of paragraph 2(a) shall be replaced by:
‘come from an officially tuberculosis-free bovine herd, and in the case of animals more than six weeks old, have reacted negatively to an intradermal tuberculin test carried out in accordance with the provisions of point 2.2 of Annex B either during the 30 days prior to leaving the herd of origin or in a place and under conditions to be defined in accordance with the procedure referred to in Article 17.’;
2.
the following Article shall be inserted:
num: ‘Article 6a
paragraphs: 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).’;
3.
in Article 11, paragraph 3 shall be replaced by the following:
‘3. The competent authority shall issue an approval number to each approved assembly centre. Approvals of assembly centres may be limited to a particular species or to animals for breeding and production or to animals for slaughter.
The competent authority shall draw up and keep up to date a list of approved assembly centres and their approval numbers and make it available to the other Member States and to the public.’;
4.
in Article 13, the following paragraphs shall be added:
‘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 make that list available to the other Member States and to the public.
6. Detailed rules for the uniform application of paragraph 5 may be adopted in accordance with the procedure referred to in Article 17(2).’;
5.
Article 16 shall be replaced by the following:
num: ‘Article 16
paragraphs: 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.’;
6.
Annex B shall be amended as follows:
(a)
point 4.1 shall be replaced by the following:
‘4.1. Tasks and responsibilities
The State institutes, national reference laboratories or official institutes designated in accordance with Article 6a shall be responsible for the official testing of tuberculins or reagents referred to in paragraphs 2 and 3 respectively in their respective Member States to ensure that each of these tuberculins or reagents is adequate in relation to the standards referred to in point 2.1 and paragraph 3 respectively.’;
(b)
point 4.2 shall be deleted;
7.
Annex C shall be amended as follows:
(a)
in point 4.1, the introductory sentence shall be replaced by the following:
‘National reference laboratories designated in accordance with Article 6a shall be responsible for:’;
(b)
point 4.2 shall be deleted;
8.
in Annex D, Chapter II.A, points 2 and 3 shall be replaced by the following:
‘2.
The State institutes, national reference laboratories or official institutes designated in accordance with Article 6a for coordinating standards and methods of diagnosis of the tests for enzootic bovine leucosis must be made responsible for calibrating the standard working antigen of the laboratory against the official EC standard serum (EI serum) provided by the National Veterinary Institute, Technical University of Denmark.
3.
The standard antigens used in the laboratory must be submitted at least once a year to the State institutes, national reference laboratories or official institutes designated in accordance with Article 6a, for testing against the official EC standard serum. Apart from such standardisation, the antigen in use may be calibrated in accordance with the method described in B.’.
num: Article 2
title: Amendments to Directive 77/504/EEC
paragraphs: The following Article shall be inserted in Directive 77/504/EEC:
num: ‘Article 4a
paragraphs: 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).’.
num: Article 3
title: Amendments to Directive 88/407/EEC
paragraphs: Directive 88/407/EEC is hereby amended as follows:
1.
in Article 5, paragraph 2 shall be replaced by the following:
‘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).’;
2.
Article 9 shall be replaced by the following:
num: ‘Article 9
paragraphs: 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).’;
3.
Article 12 shall be replaced by the following:
num: ‘Article 12
paragraphs: 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.’.
num: Article 4
title: Amendments to Directive 88/661/EEC
paragraphs: Directive 88/661/EEC is hereby amended as follows:
1.
the following Article shall be inserted:
num: ‘Article 4a
paragraphs: 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).’;
2.
the following Article shall be inserted:
num: ‘Article 7a
paragraphs: 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).’.
num: Article 5
title: Amendments to Directive 89/361/EEC
paragraphs: Article 5 of Directive 89/361/EEC shall be replaced by the following:
num: ‘Article 5
paragraphs: 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.’.
num: Article 6
title: Amendments to Directive 89/556/EEC
paragraphs: Directive 89/556/EEC is hereby amended as follows:
1.
in Article 5(2), the first subparagraph shall be replaced by the following:
‘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.’;
2.
Article 8 shall be replaced by the following:
num: ‘Article 8
paragraphs: 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).’;
3.
Article 11 shall be replaced by the following:
num: ‘Article 11
paragraphs: 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.’.
num: Article 7
title: Amendments to Directive 90/426/EEC
paragraphs: In Article 7 of Directive 90/426/EEC, paragraph 1 shall be replaced by the following:
‘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.’.
num: Article 8
title: Amendments to Directive 90/427/EEC
paragraphs: Article 5 of Directive 90/427/EEC shall be replaced by the following:
num: ‘Article 5
paragraphs: 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.’.
num: Article 9
title: Amendments to Directive 90/428/EEC
paragraphs: In Article 4 of Directive 90/428/EEC, paragraph 2 shall be replaced by the following:
‘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.’.
num: Article 10
title: Amendments to Directive 90/429/EEC
paragraphs: Directive 90/429/EEC is hereby amended as follows:
1.
in Article 5, paragraph 2 shall be replaced by the following:
‘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.’;
2.
Article 8 shall be replaced by the following:
num: ‘Article 8
paragraphs: 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).’;
3.
in Article 15, paragraph 2 shall be replaced by the following:
‘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.’.
num: Article 11
title: Amendments to Directive 90/539/EEC
paragraphs: Directive 90/539/EEC is hereby amended as follows:
1.
Article 4 shall be replaced by the following:
num: ‘Article 4
paragraphs: 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).’;
2.
the following Article shall be inserted:
num: ‘Article 6a
paragraphs: 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.
Annex I shall be amended as follows:
(i)
point 1 shall be deleted;
(ii)
point 2 shall be replaced by the following:
‘2.
The national reference laboratories for avian diseases designated in accordance with Article 4 shall be responsible in each Member State for coordinating the diagnostic methods provided for in this Directive. To this end:
(a)
they may supply approved laboratories with the reagents needed for diagnostic testing;
(b)
they shall monitor the quality of reagents used by the laboratories approved for the purpose of carrying out the diagnostic tests provided for in this Directive;
(c)
they shall organise periodic comparative tests.’.
num: Article 12
title: Amendments to Directive 91/68/EEC
paragraphs: Directive 91/68/EEC is hereby amended as follows:
1.
in Article 8a, paragraph 3 shall be replaced by the following:
‘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.’;
2.
in Article 8b, the following paragraph shall be added:
‘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).’.
num: Article 13
title: Amendments to Directive 91/496/EEC
paragraphs: In Article 10 of Directive 91/496/EEC, paragraph 4 shall be replaced by the following:
‘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.’.
num: Article 14
title: Amendments to Directive 92/35/EEC
paragraphs: Directive 92/35/EEC is hereby amended as follows:
1.
Article 14 shall be replaced by the following:
num: ‘Article 14
paragraphs: 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.’;
2.
in Annex I, Section A shall be deleted.
num: Article 15
title: Amendments to Directive 92/65/EEC
paragraphs: Directive 92/65/EEC is hereby amended as follows:
1.
Article 11 shall be replaced by the following:
num: ‘Article 11
paragraphs: 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.
in Article 13(2), point (d) shall be replaced by the following:
‘(d)
All approved bodies, institutes and centres shall be registered and issued with an approval number by the competent authority.
Each Member State shall draw up and keep up to date a list of approved bodies, institutes and centres 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 point may be adopted in accordance with the procedure referred to in Article 26.’;
3.
in Article 17, paragraph 2 and 3 shall be replaced by the following:
‘2. Only animals, semen, ova and embryos referred to in Article 1 which satisfy the following requirements may be imported into the Community:
(a)
they must come from a third country on a list to be drawn up in accordance with paragraph 3(a);
(b)
they must be accompanied by the health certificate corresponding to a specimen to be drawn up in accordance with the procedure referred to in Article 26, signed by the competent authority of the exporting country and certifying that,
(i)
the animals
—
meet the additional conditions or offer the equivalent guarantees referred to in paragraph 4, and
—
come from approved centres, bodies, institutes offering guarantees at least equivalent to those in Annex C;
(ii)
semen, ova and embryos come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those to be established in Annex D(I) in accordance with the procedure referred to in Article 26.
Pending the establishment of lists of third countries, approved establishments listed in point (b), animal health requirements and specimen health certificates as referred to in paragraphs (a) and (b), national rules shall continue to apply provided they are not more favourable than those laid down in Chapter II.
3. The following shall be established:
(a)
in accordance with the procedure referred to in Article 26, a list of third countries or parts of third countries able to provide Member States and the Commission with guarantees equivalent to those provided for in Chapter II in relation to animals, semen, ova and embryos;
(b)
in accordance with this point, a list of approved centres or teams as referred to in the first indent of paragraph 2 of Article 11 and the first indent of paragraph 3 of that article situated in one of the third countries appearing on the list referred to in point (a) of this paragraph and for which the competent authority is able to give the guarantees provided for in Article 11(2) and (3).
The list of approved centres and teams referred to in the first subparagraph and their veterinary registration numbers shall be communicated to the Commission.
The approval of centres or teams 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 11(2) and (3) 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 the second and third subparagraphs and shall make them available to the public for information purposes.
Detailed rules for the uniform application of this point may be adopted in accordance with the procedure referred to in Article 26;
(c)
in accordance with the procedure referred to in Article 26, the specific animal health requirements, in particular for the protection of the Community from certain exotic diseases, or guarantees equivalent to those provided for in this Directive.
The specific requirements and equivalent guarantees established for third countries may not be more favourable than those provided for in Chapter II.’;
4.
in Article 20, the first paragraph shall be replaced by the following:
‘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.’.
num: Article 16
title: Amendments to Directive 92/66/EEC
paragraphs: Directive 92/66/EEC is hereby amended as follows:
1.
Article 14 shall be amended as follows:
(a)
paragraph 2 shall be replaced by the following:
‘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.’;
(b)
in paragraph 3, the introductory phrase shall be replaced by the following:
‘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:’;
(c)
paragraph 4 shall be replaced by the following:
‘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).’;
2.
Annex IV shall be deleted.
num: Article 17
title: Amendments to Directive 92/119/EEC
paragraphs: Directive 92/119/EEC is hereby amended as follows:
1.
in Article 17, paragraph 5 shall be replaced by the following:
‘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.’;
2.
in Annex II, point 5 shall be deleted.
num: Article 18
title: Amendments to Directive 94/28/EC
paragraphs: Directive 94/28/EC is hereby amended as follows:
1.
Article 3 shall be amended as follows:
(a)
paragraph 1 shall be replaced by the following:
‘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.’;
(b)
in paragraph 2, point (a) shall be deleted;
(c)
paragraph 3 shall be deleted;
2.
in Article 10, the following paragraph shall be added:
‘Where any serious infringement to the provisions in Article 3(2)(b) so warrants, in particular in the light of findings in relation to on-the-spot checks referred to in the first paragraph of this Article, measures may be adopted to suspend the import of animals, semen, ova and embryos referred to in Article 1(1) in accordance with the procedure referred to in Article 12.’.
num: Article 19
title: Amendments to Directive 2000/75/EC
paragraphs: Directive 2000/75/EC is hereby amended as follows:
1.
Article 15 shall be replaced by the following:
num: ‘Article 15
paragraphs: 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.’;
2.
in Annex I, Section A shall be deleted.
num: Article 20
title: Amendments to Decision 2000/258/EC
paragraphs: Decision 2000/258/EC is hereby amended as follows:
1.
Article 3 shall be replaced by the following:
num: ‘Article 3
paragraphs: 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).’;
2.
the following Article shall be inserted:
num: ‘Article 5a
paragraphs: 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.’;
3.
Annexes I and II shall be replaced by the text in the Annex to this Directive.
num: Article 21
title: Amendments to Directive 2001/89/EC
paragraphs: 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.
num: Article 22
title: Amendments to Directive 2002/60/EC
paragraphs: 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.
num: Article 23
title: Amendments to Directive 2005/94/EC
paragraphs: In Article 51 of Directive 2005/94/EC, paragraph 2 shall be replaced by the following:
‘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).’.
num: Article 24
title: Transposition
paragraphs: 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.
num: Article 25
title: Entry into force
paragraphs: This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.