Council Directive 2009/143/EC of 26 November 2009 amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing
Council Directive 2009/143/ECof 26 November 2009amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testingTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission,Having regard to the Opinion of the European ParliamentOpinion of 20 October 2009 (not yet published in the Official Journal).,Whereas:(1)Under Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the CommunityOJ L 169, 10.7.2000, p. 1. the responsible official bodies in the Member States may only delegate the tasks provided for in that Directive, including laboratory testing, to a legal person which under its officially approved constitution is charged exclusively with specific public functions.(2)The laboratory tests which have to be carried out in the framework of Directive 2000/29/EC are of a highly technical nature and concern different scientific fields. Such tests require a wide range of different and expensive technical facilities and highly specialised laboratory staff capable of adapting to the rapid development of diagnostic methodology. The number of tests to be carried out has been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.(3)For these reasons it is appropriate to provide that the numerous and diverse laboratory tests required under Directive 2000/29/EC may, in addition to legal persons which are exclusively charged with specific public functions, be delegated to legal persons not fulfilling this requirement, such as universities, research institutes or private laboratories in any legal form recognised in the Member State in accordance with their national legislation, provided that they satisfy certain conditions.(4)It is appropriate that the responsible official bodies verify that the legal persons, to which the execution of the laboratory testing is delegated, can assure quality. They should for example be impartial, free of conflict of interest and able to ensure reliable results and protection of confidential information.(5)At the same time it is appropriate to allow legal persons carrying out delegated tasks in accordance with Directive 2000/29/EC to use their laboratories for testing activities which do not form part of their specific public functions.(6)The issue of an appropriate diagnostic infrastructure is one of the issues addressed in the ongoing evaluation of the plant health legislation. However, without prejudice to the outcome of the review, it is appropriate in the short term to modify the requirements on the delegation of laboratory testing to existing needs.(7)The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC should therefore be amended accordingly.(8)In accordance with point 34 of the Interinstitutional agreement on better law-makingOJ C 321, 31.12.2003, p. 1., Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public,HAS ADOPTED THIS DIRECTIVE: