Commission Decision
of 1 February 2002
approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever
(notified under document number C(2002) 381)
(Text with EEA relevance)
(2002/106/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(1), and in particular Article 17(3) and Article 29(1) thereof,
Whereas:
(1) It is necessary to lay down at Community level diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation of classical swine fever.
(2) Annex IV to Directive 2001/89/EC lays down the functions and duties of the Community Reference Laboratory for classical swine fever in order to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing the disease; these functions and duties include the organisation of periodic comparative tests and the supplying of standard reagents at Community level.
(3) Classical swine fever virus is not considered to be a hazard for human health.
(4) Laboratory tests have been recently developed to ensure a quick diagnosis of classical swine fever.
(5) The experience gained in the control of classical swine fever in recent years has resulted in the identification of the most suitable sampling procedures and criteria for evaluation of the results of the laboratory tests for a proper diagnosis of this disease in different situations.
(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
1. Member States shall ensure that the confirmation of classical swine fever is based on:
(a) the detection of clinical signs and post-mortem lesions of disease;
(b) the detection of virus, antigen or genome in samples of pig tissues, organs, blood or excreta;
(c) the demonstration of a specific antibody response in blood samples,
in accordance with the procedures, sampling methods and criteria for evaluation of the results of laboratory tests laid down in the Manual annexed to this Decision.
2. However, the national diagnostic laboratories referred to in Annex III(1) to Directive 2001/89/EC may apply modifications to the laboratory tests referred to in the Manual annexed to this Decision, or use different tests, provided that an equal sensitivity and specificity can be demonstrated.
The sensitivity and specificity of these modified or different tests must be evaluated in the framework of the periodic comparative tests organised by the Community Reference Laboratory for classical swine fever.
Article 2
Annexes I and IV to Council Directive 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine fever(2), as last amended by the Act of Accession of Austria, Finland and Sweden, are hereby repealed.
Article 3
This Decision shall apply from 1 November 2002.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 1 February 2002.