Council Decision

of 20 March 2000

designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines

(2000/258/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

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(1) to Directive 90/425/EEC(1), and in particular Article 10(6) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1) Directive 92/65/EEC provides for an alternative system to quarantine for the entry of certain domestic carnivores into the territory of certain Member States free from rabies. That system requires checks on the effectiveness of the vaccination of those animals by titration of antibodies.

(2) In order to guarantee an effective system of monitoring the laboratories which will carry out these analyses, it is appropriate to establish a system of Community approval of such laboratories.

(3) The approval of those laboratories should be coordinated by a Community reference laboratory for those matters.

(4) The Agence française de sécurité sanitaire des aliments de Nancy (French Food Safety Agency, Nancy) laboratory meets the conditions required for designation as Community reference laboratory for those matters.

(5) That reference laboratory may receive Community aid as provided for in Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(2).

(6) The measures necessary for the implementation of this Decision should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(3),

HAS ADOPTED THIS DECISION:

[F1 Article 1 U.K.

The laboratory at Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB is designated as the institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines within the United Kingdom in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, as amended from time to time.]

Textual Amendments

F1 Art. 1 substituted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(2); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K.

The duties of the laboratory referred to in Article 1 are set out in Annex II.

[F2 Article 3 U.K.

1. On the basis of a favourable result of the appraisal of an applicant laboratory in a [F3 part of Great Britain, any relevant competent authority] may authorise the applicant laboratory to carry out the serological tests to monitor the effectiveness of rabies vaccines.

[F4 The Secretary of State, with the consent of the Welsh Ministers and the Scottish Ministers must draw up, keep up to date and publish a list of those laboratories that have been so authorised.]

2. On the basis of a favourable result of the appraisal of an applicant laboratory in a third country F5 ..., 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 F6 ... to carry out serological tests to monitor the effectiveness of rabies vaccines.

2A. [F7 In this Article and in Annex 2—

(a) “the relevant competent authorities” means—

(i) in relation to England, the Secretary of State;

(ii) in relation to Scotland, the Scottish Ministers;

(iii) in relation to Wales, the Welsh Ministers;

(b) “third country” means any country other than the United Kingdom.]

F8 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F2 Substituted by 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).

F3 Words in Art. 3(1) substituted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(a) (as amended by S.I. 2020/1388, regs. 1(2)(a), 25(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 3(1) substituted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(b) (as amended by S.I. 2020/1388, regs. 1(2)(a), 25(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 3(2) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 3(2) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 3(2A) inserted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(d) (as amended by S.I. 2020/1388, regs. 1(2)(a), 25(2)(c)) ; 2020 c. 1, Sch. 5 para. 1(1)

F8 Art. 3(3) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(3)(e); 2020 c. 1, Sch. 5 para. 1(1)

F9 Article 4 U.K.

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Textual Amendments

F9 Art. 4 omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(4); 2020 c. 1, Sch. 5 para. 1(1)

F10 Article 5 U.K.

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Textual Amendments

F10 Art. 5 omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(4); 2020 c. 1, Sch. 5 para. 1(1)

F11 Article 5a U.K.

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Textual Amendments

F11 Deleted by Council Decision of 5 May 2009 correcting Directive 2008/73/EC simplifying procedures of listing and publishing information in the veterinary and zootechnical fields (2009/436/EC).

F12 Article 6 U.K.

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Textual Amendments

F12 Art. 6 omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(4); 2020 c. 1, Sch. 5 para. 1(1)

F13 ANNEX I U.K.

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Textual Amendments

F13 Annex 1 omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(5); 2020 c. 1, Sch. 5 para. 1(1)

[F2 ANNEX II U.K.

[F14 The institute mentioned in Article 1] shall:

Textual Amendments

F14 Words in Annex 2 substituted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

• coordinate the establishment, improvement and standardisation of methods of serological titration on carnivores vaccinated against rabies [F15 in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, as amended from time to time],

• F16 ...

• appraise those laboratories in third countries which have submitted an application to perform the serological titrations referred to in the first indent; the result of this appraisal must be sent to the applicant laboratory F17 ... where the result is favourable for the purpose of approval,

• provide any useful information on analysis methods and comparative trials to those laboratories and organise training sessions and further training courses for their staff,

• organise inter-laboratory aptitude tests (proficiency tests),

• provide scientific and technical assistance to the [F18 relevant competent authorities] on the matters referred to in this Annex, in particular in cases of disagreement on results of serological titrations.]

Textual Amendments

F15 Words in Annex 2 inserted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Annex 2 omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(6)(c); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Annex 2 inserted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(6)(d); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Annex 2 substituted (31.12.2020) by The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 5(6)(e); 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 268, 14.9.1992, p. 54. Directive as last amended by Commission Decision 95/176/EC (OJ L 117, 24.5.1995, p. 23).

(2)

OJ L 224, 18.8.1990, p. 19. Decision at last amended by Regulation (EC) No 1258/1999 (OJ L 160, 26.6.1999, p. 103).

(3)

OJ L 184, 17.7.1999, p. 23.