COMMISSION DIRECTIVE 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic 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 (2) thereof,
Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;
Whereas it is necessary to indicate to applicants in Annexes II and III, as precisely as possible, the details of the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossiers;
Whereas greater precision can be given at the present time to the general introductionary provisions to Annexes II and III and to the data requirements concerning efficacy testing provided for in Section 6 of Parts A and B of Annex III;
Whereas the introductions to the Annexes II and III currently refer to the application of the principles of good laboratory practice (GLP) for any data requirements; whereas, however, the application of such principles is not considered to be appropriate for efficacy testing and for the testing of certain physico-chemical properties or other information which are not related to data on the properties and/or safety with respect to human or animal health or the environment;
Whereas moreover it is necessary to provide for a temporary exemption of the application of these principles for certain data requirements to permit the laboratories concerned to adapt themselves to the requirements of GLP;
Whereas the specific European and Mediterranean Plant Protection Organization (EPPO) guidelines constitute for the time being the best available basis for setting the minimum requirements to be applied in all Member States with regard to the guidelines used for efficacy testing, whereas it appears necessary however to proceed urgently to a detailed examination of these guidelines and to provide for higher standards in Directive 91/414/EEC in cases where certain guidelines would appear inadequate for efficacy testing;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 91/414/EEC is amended as follows:
1. the section headed 'Introduction' in Annex II is replaced by Annex I hereto;
2. the section headed 'Introduction' in Annex III is replaced by Annex II hereto,
3. Section 6 headed 'Efficacy data' in both Parts A and B of Annex III is replaced by Annex III hereto.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within twelve months following notification thereof. They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States.
Done at Brussels, 27 July 1993.