PURPOSE: to amend amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing.

LEGISLATIVE ACT: Council Directive 2009/143/EC amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing.

CONTENT: 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 also been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.

Accordingly, the Council adopted a directive authorising Member States to delegate laboratory tests on plants and plant products to legal persons such as universities, research institutes or private laboratories, provided that they satisfy certain conditions. They must be impartial, free of conflicts of interest as well as able to ensure reliable results and protect confidential information.

The laboratory testing may only be delegated if the responsible official body ensures throughout the time of the delegation that the legal person to which it delegates laboratory testing can assure impartiality, quality and protection of confidential information, and that no conflict of interest exists between the exercise of the tasks delegated to it and its other activities.

ENTRY INTO FORCE: 24/12/2009.

TRANSPOSITION: 01/01/2011.

The European Parliament adopted by 534 votes to 29, with 14 abstentions, a legislative resolution approving unamended, under the consultation procedure, the proposal for a Council directive amending Directive 2009/29/EC in relation to the delegation of laboratory analysis work.

The Committee on Agriculture and Rural Development adopted the report by Paolo De CASTRO (S-D, IT) approving unamended, under the consultation procedure, the proposal for a Council directive amending Directive 2009/29/EC in relation to the delegation of laboratory analysis work.

PURPOSE: to amend amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing

PROPOSED ACT: Council Directive.

BACKGROUND: 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 Community 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. Since then, the structure and tasks of the plant health authorities of the Member States have evolved. 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 also been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.

CONTENT: this proposal provides for certain amendments to Article 2(1)(g)(ii) of Directive 2000/29/EC in order to adapt the requirements on the delegation of laboratory testing to existing needs. The amendments include the following:

a provision to allow legal persons carrying out delegated tasks to diversify their activities with other laboratory testing activities than those referred to under that Directive; a provision allowing delegation of laboratory testing to legal persons which are not charged exclusively with public functions in the framework of that Directive; in both cases, provisions ensuring that the delegated tasks provided for under the Directive remain under the authority and supervision of the responsible official bodies in a Member State and that those responsible official bodies verify that the legal persons in question are impartial and free of conflict of interest as regards the execution of the delegated tasks.

IMPACT ASSESSMENT: a light scoping paper illustrating the issue has been produced in April 2008. Because of the limited impact of the proposed changes, no full impact assessment of the proposed changes was deemed necessary.

BUDGETARY IMPLICATIONS: this proposal for a Council Directive has no financial implications for the Community budget.

PURPOSE: to amend amending Directive 2000/29/EC as regards the delegation of the tasks of laboratory testing

PROPOSED ACT: Council Directive.

BACKGROUND: 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 Community 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. Since then, the structure and tasks of the plant health authorities of the Member States have evolved. 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 also been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.

CONTENT: this proposal provides for certain amendments to Article 2(1)(g)(ii) of Directive 2000/29/EC in order to adapt the requirements on the delegation of laboratory testing to existing needs. The amendments include the following:

a provision to allow legal persons carrying out delegated tasks to diversify their activities with other laboratory testing activities than those referred to under that Directive; a provision allowing delegation of laboratory testing to legal persons which are not charged exclusively with public functions in the framework of that Directive; in both cases, provisions ensuring that the delegated tasks provided for under the Directive remain under the authority and supervision of the responsible official bodies in a Member State and that those responsible official bodies verify that the legal persons in question are impartial and free of conflict of interest as regards the execution of the delegated tasks.

IMPACT ASSESSMENT: a light scoping paper illustrating the issue has been produced in April 2008. Because of the limited impact of the proposed changes, no full impact assessment of the proposed changes was deemed necessary.

BUDGETARY IMPLICATIONS: this proposal for a Council Directive has no financial implications for the Community budget.