Commission Regulation (EC) No 21/2008 of 11 January 2008 amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests (Text with EEA relevance )

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (1), and in particular the first paragraph Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.

(2) Annex X, Chapter C, to Regulation (EC) No 999/2001 sets out a list of rapid tests approved for the monitoring of TSEs in bovine, ovine and caprine animals.

(3) Changes to rapid tests and to test protocols may only be made after prior notification to the Community Reference Laboratory (CRL) for TSEs and provided that the CRL finds that the changes do not alter the sensitivity, specificity or reliability of the tests. On 13 April 2007, the CRL approved changes made to the currently approved TSE rapid post-mortem test ‘Enfer TSE Kit version 2.0’, and therefore recommended that the amended version (Enfer TSE version 3) should also be listed in Annex X, Chapter C, to Regulation (EC) No 999/2001.

(4) Regulation (EC) No 999/2001 should therefore be amended accordingly.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annex X to Regulation (EC) No 999/2001 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 January 2008.

For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1428/2007 (OJ L 317, 5.12.2007, p. 61).