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"B 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)
(OJ L 79, 30.3.2000, p. 40)
Corrected by:
"C1 Corrigendum, OJ L 231, 13.9.2000, p. 18 (2000/258)2000D0258 — EN — 30.03.2000 — 000.001 — 1
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 inAnnex 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 ofantibodies.
(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 conditionsrequired 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 onexpenditure 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:
Article 1
The laboratory of the Agence française de sécurité sanitaire des aliments de
Nancy (AFSSA, Nancy), the details of which are set out in Annex I, is herebydesignated as the specific institute responsible for establishing the criteria
necessary for standardising the serological tests to monitor the effectiveness
of rabies vaccines.
Article 2
The duties of the laboratory referred to in Article 1 are set out in Annex II.!B
(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. 23.2000D0258 — EN — 30.03.2000 — 000.001 — 2
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 by Article 1 of Decision68/361/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.!B
(1) OJ L 255, 18.10.1968, p. 23.2000D0258 — EN — 30.03.2000 — 000.001 — 3
ANNEX I
AFSSA, Nancy
Laboratoire d’études sur la rage et la pathologie des animaux sauvages
Domaine de Pixérécourt
BP 9F-54220 Malzéville
Tel: (00-33) 383 29 89 50
Fax: (00-33) 383 29 89 59
E-mail: maubert@fitech.fr!
B2000D0258 — EN — 30.03.2000 — 000.001 — 4
ANNEX II
The specific institute responsible for establishing the criteria necessary for standardis-
ing 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 thisappraisal must be sent to the Comission for the purposes of such approval,
— provide any useful information on analysis methods and comparative trials to these
laboratories and organise training sessions and further training courses for theirstaff,
— organise interlaboratory aptitude tests,— collaborate with the laboratories responsible for carrying out these analyses in third
countries and propose to the Commission, a procedure for approving thoselaboratories,
— 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.!
B
!C1
!B2000D0258 — EN — 30.03.2000 — 000.001 — 5