2000D0258 — EN — 28.01.2003 — 001.001 — 1
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►B COUNCILDECISION
of20March2000
designatingaspecificinstituteresponsibleforestablishingthecriteria necessaryforstandardising
theserological teststomonitortheeffectivenessofrabiesvaccines
(2000/258/EC)
(OJ L 79, 30.3.2000, p. 40)
Amended by:
Official Journal
No page date
►M1Commission Decision 2003/60/EC of 24 January 2003 L 23 30 28.1.2003
Corrected by:
►C1Corrigendum, OJ L 231, 13.9.2000, p. 18 (2000/258/EC)
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COUNCILDECISION
of20March2000
designating a specific institute responsible for establishing the
criteria necessary forstandardisingtheserological teststomonitor
theeffectivenessofrabiesvaccines
(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 toanimal health requirements laid down in specific Community rulesreferred 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 quar-
antine for the entry of certain domestic carnivores into theterritory of certain Member States free from rabies. That systemrequires checks on the effectiveness of the vaccination of thoseanimals by titration of antibodies.
(2)In order to guarantee an effective system of monitoring thelaboratories which will carry out these analyses, it is appropriate
to establisha system of Community approval of suchlabora-
tories.
(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 (FrenchFood 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 asprovided for in Article 28 of Council Decision 90/424/EEC of26 June 1990 on expenditure in the veterinary field(
2).
(6)The measures necessary for the implementation of this Decisionshould be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on the Commis-sion(
3),
HAS ADOPTED THIS DECISION:
Article 1
The laboratory of the Agence française de sécurité sanitaire des
aliments de Nancy (AFSSA, Nancy), the details of which are set outin Annex I, is hereby designated as the specific institute responsiblefor establishing the criteria necessary for standardising the serologicaltests to monitor the effectiveness of rabies vaccines.2000D0258 — EN — 28.01.2003 — 001.001 — 2
(1) OJ L 268, 14.9.1992, p. 54. Directive as last amended by Commission Deci-
sion 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.
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Article 2
The duties of the laboratory referred to in Article 1 are set out in
Annex II.
Article 3
The laboratory referred to in Article 1 shall send the Commission the
list of Community laboratories to be authorised to carry out serological
tests to monitor the effectiveness of rabies vaccines. These laboratories
shall be authorised in accordance with Article 5(2).
Article 4
The Annexes to this Decision shall be amended in accordance with the
procedure laid down in Article 5(2).
Article 5
1. The Commission shall be assisted by the Standing Veterinary
Committee, hereinafter referred to as the ‘Committee’, set up byArticle 1 of Decision 68/361/EEC(
1).
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply.
The period provided for in Article 5(6) of Decision 1999/468/EC shall
be three months.
3. The Committee shall adopt its rules of procedure.
Article 6
This Decision is addressed to the Member States.2000D0258 — EN — 28.01.2003 — 001.001 — 3
(1) OJ L 255, 18.10.1968, p. 23.
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ANNEX I
AFSSA, Nancy
Laboratoire d'études sur la rage et la pathologie des animaux sauvages
Domaine de Pixérécourt
BP 9
F-54220 Malzéville
Tel: (00-33) 383 29 89 50
Fax: (00-33) 383 29 89 59
E-mail: maubert@fitech.fr2000D0258 — EN — 28.01.2003 — 001.001 — 4
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ANNEX II
The specific institute responsible for establishing the criteria necessary for stan-
dardising the serological test to monitor the action of rabies vaccines shall:
— coordinate the establishment, improvement and standardisation of methods
of serological titration on carnivores vaccinated against rabies,
— appraise those laboratories for which Member States have submitted an
application for approval to perform the analyses refered to in the first indent;
the result of this appraisal must be sent to the Comission for the purposes of
suchapproval,
— provide any useful information on analysis methods and comparative trials
to these laboratories and organise training sessions and further training
courses for their staff,
— organise interlaboratory aptitude tests,
— collaborate with the laboratories responsible for carrying out these analyses
in third countries and communicate to the Commission the list of these
laboratories which have passed the inter-laboratory aptitude test (proficiency
test). These lists will be published on the following website:
http://forum.europa.eu.int/Public/irc/sanco/vets/information ,
— provide scientific and technical assistance to the Commission and to
Member States on these matters, in particular in cases of disagreement
between Member States on analysis results.2000D0258 — EN — 28.01.2003 — 001.001 — 5
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