COMMISSION DECISION of 29 July 1996 recognizing in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of spiroxamine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) (96/522/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
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), as last amended by Commission Directive 96/12/EC (2), and in particular Article 6 (3) thereof,
Whereas Directive 91/414/EEC has provided for the development of a Community list of authorized pesticide active substances;
Whereas Bayer AG introduced on 13 October 1995 a dossier to the German authorities in view of obtaining the inclusion of the active substance spiroxamine in Annex I to the Directive; whereas the German authorities indicated to the Commission the results of a first examination of the completeness of the dossier with regard to the data and information requirements provided for in Annex II and, for at least one plant protection product containing the active substance concerned, in Annex III to the Directive; whereas subsequently, in accordance with the provisions of Article 6 (2), the dossier was submitted by the applicant to the Commission and the other Member States;
Whereas the Commission referred the dossier to the Standing Committee on Plant Health in the meeting of the working group 'legislation` thereof on 22 April 1996, during which the Member States confirmed the receipt of the dossier;
Whereas Article 6 (3) of the Directive requires it being confirmed at the level of the Community that the dossier is to be considered as satisfying, in principle, the data and information requirements provided for in Annex II and, for at least one plant protection product containing the active substance concerned, in Annex III to the Directive;
Whereas such confirmation is necessary in order to pursue the detailed examination of the dossier as well as in order to open to the Member States the possibility of granting provisional authorization for plant protection products containing this active substance in due respect of the conditions laid down in Article 8 (1) of the Directive, and in particular the condition to make a detailed assessment of the active substance and the plant protection product with regard to the requirements of the Directive;
Whereas such decision does not prejudice that further data or information may be requested from the applicant where it would appear during the detailed examination that such information or data are required for a decision to be taken;
Whereas it is understood between the Member States and the Commission that Germany will pursue the detailed examination of the dossier and report the conclusions of its examination accompanied by any recommendations on the inclusion or non-inclusion and any conditions related thereto to the Commission as soon as possible and at the latest within a period of one year; whereas on receipt of this report the detailed examination will be continued with the expertise from all Member States within the framework of the Standing Committee on Plant Health;
Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plant Health,
The dossier submitted by Bayer AG to the Commission and the Member States with a view to the inclusion of spiroxamine as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 22 April 1996, is considered as satisfying in principle the date and information requirements provided for in Annex II and, for a plant protection product containing the active substance concerned, in Annex III to the Directive.
This Decision is addressed to the Member States.