COUNCIL DIRECTIVE 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 18 (1) thereof,
Having regard to the proposal from the Commission,
Whereas, by the judgment of the Court of Justice of the European Communities of 18 June 1996 (2), Council Directive 94/43/EC (3) of 27 July 1994, establishing Annex VI to Directive 91/414/EEC, was annulled;
Whereas Annex VI to Directive 91/414/EEC lays down uniform principles aiming to ensure that the Member States, in deciding on authorizations for plant protection products, apply the requirements of Article 4 (1) (b), (c), (d) and (e) of that Directive in an equivalent manner and at the high level of protection of human and animal health and the environment sought by the Directive;
Whereas it is therefore necessary to lay down detailed principles concerning the evaluation of information on plant protection products supplied by applicants and the decision to be made on authorization on the basis of the results of that evaluation;
Whereas such principles have to be laid down for each of the different requirements provided for in Article 4 (1) (b), (c), (d) and (e);
Whereas, initially, it is possible to lay down at this stage uniform principles for chemical plant protection products only; whereas therefore it remains for the uniform principles for products containing micro-organisms to be laid down in accordance with the same procedure as provided for in Article 18 (1) of Directive 91/414/EEC; whereas such approach is in line with Directive 91/414/EEC, and in particular Article 23 (2) thereof;
Whereas in particular for all plant protection products a high level of protection for all groundwater must be satisfied under the conditions of use which will be laid down in the authorization; whereas therefore it must be provided that plant protection products may only be authorized when it is adequately demonstrated that their use in accordance with the conditions to be laid down in the authorization will not lead to concentrations of the active substance or of relevant metabolites, degradation or reaction products in groundwater which exceed the lower of the limit values for groundwater referred to in this Directive; whereas this applies as well for plant protection products containing active substances, already on the market two years after notification of Directive 91/414/EEC, which means that for such products an authorization can be granted only where it is adequately demonstrated that, under the new conditions of use which will be laid down in the authorization, the expected concentrations resulting exclusively from the new use will not exceed the lower of the limit values referred to in this Directive;
Whereas the provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerned, and in particular Directives 75/440/EEC (4), 80/68/EEC (5) and 80/778/EEC (6);
Whereas a review of the abovementioned directives is in progress, and where necessary will have to be followed by an adaptation of this Directive;
Whereas a short implementation period is justified given that in the light of the decision of the Court of Justice of the European Communities of 18 June 1996 only those provisions concerning groundwater have been reviewed,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex VI to Directive 91/414/EEC is hereby established as set out in the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 October 1997.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 3
This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 22 September 1997.