31.12.2008 EN Official Journal of the European Union L 352/38
COMMISSION DECISION
of 10 December 2008
amending Annex C to Council Directive 64/432/EEC and Decision 2004/226/EC as regards diagnostic tests for bovine brucellosis
(notified under document number C(2008) 7642)
(Text with EEA relevance)
(2008/984/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Article 6(2)(b) and the second subparagraph of Article 16 thereof,
Whereas:
(1) Annex C to Directive 64/432/EEC sets out the diagnostic methods for bovine brucellosis to be used for the control and eradication of that disease and for surveillance and monitoring, as well as for the establishment and maintenance of an officially brucellosis–free herd status and certification required for intra-Community trade in bovine animals.
(2) Commission Decision 2004/226/EC of 4 March 2004 approving tests for the detection of antibodies against bovine brucellosis within the framework of Council Directive 64/432/EEC (2) approves certain tests for bovine brucellosis that may be used as an alternative to the mandatory serum agglutination test (SAT) for certification of bovine animals in accordance with Article 6(2)(b) of Directive 64/432/EEC.
(3) The fluorescence polarisation assay (FPA) is a new diagnostic test that has been included as a prescribed test for international trade in Chapter 2.4.3 (bovine brucellosis) of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008 of the World Organisation for Animal Health (OIE).
(4) The Commission requested the European Food Safety Authority (EFSA) to provide a scientific opinion on the suitability of the FPA for inclusion in Annex C to Directive 64/432/EEC.
(5) In addition, the Commission asked EFSA to assess the suitability of the FPA and the tests listed in Article 1 of Decision 2004/226/EC for the purpose of certification of bovine animals for intra-Community trade.
(6) On 11 December 2006, the Panel on animal health and welfare adopted a scientific opinion on brucellosis diagnostic methods for bovines (3), in which it concluded that, except the SAT, the diagnostic tests for bovine brucellosis, included in Annex C to Directive 64/432/EEC are suitable to remain as standard tests for the purpose of certification of individual bovine animals for intra-Community trade.
(7) However, as the SAT is the pre-movement test for trade in cattle directly prescribed in Article 6(2)(b) of Directive 64/432/EEC, a technical specification must be available in Annex C to that Directive.
(8) In addition, the scientific opinion of 11 December 2006 concluded that the sensitivity and specificity of the FPA are comparable to those of tests included in Annex C to Directive 64/432/EEC and was also found to be suitable for inclusion in that Annex as a standard test for brucellosis diagnosis in such animals for intra-Community trade.
(9) The recently developed polymerase chain reaction methods as described in Section 1(d) of Chapter 2.4.3 of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008 of the OIE provide additional means of detection and identification of Brucella spp. and should therefore be included in Annex C to Directive 64/432/EEC.
(10) Annex C to Directive 64/432/EEC and Decision 2004/226/EC should therefore be amended accordingly.
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee of the Food Chain and Animal Health,
Annex C to Directive 64/432/EEC is replaced by the text in the Annex to this Decision.
Article 1 of Decision 2004/226/EC is replaced by the following:
‘Article 1
The complement fixation test, the buffered Brucella antigen test (rose Bengal test (RBT)), the ELISA tests and the fluorescence polarisation assay (FPA) carried out in accordance with Annex C to Directive 64/432/EEC are hereby approved for certification purposes.’
This Decision is addressed to the Member States.