COMMISSION DECISION of 20 March 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of cyhalofop-butyl, pyraflufen-ethyl and azafenidin in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (Text with EEA relevance) (98/242/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 97/73/EC (2), and in particular Article 6(3) thereof,
Whereas Directive 91/414/EEC (hereinafter 'the Directive`) has provided for the development of a Community list of active substances authorised for incorporation in plant-protection products;
Whereas applicants have submitted dossiers for three active substances to Member States' authorities in view of obtaining the inclusion of the active substances in Annex I to the Directive;
Whereas a dossier for the active substance cyhalofop-butyl was submitted by Dow Elanco Italia Srl to the Italian authorities on 30 April 1997;
Whereas a dossier for the active substance pyraflufen-ethyl was submitted by Nihon Nohyaku Co. Ltd to the Belgian authorities on 16 June 1997;
Whereas a dossier for the active substance azafenidin was submitted by du Pont de Nemours (France) SA to the Spanish authorities on 25 June 1997;
Whereas the said 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 applicants to the Commission and other Member States;
Whereas the dossiers for cyhalofop-butyl, pyraflufen-ethyl and azafenidin were referred to the Standing Committee on Plant Health on 16 December 1997;
Whereas Article 6(3) of the Directive requires it being confirmed at the level of the Community that each 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 Member States the possibility of granting provisional authorisation 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 substances and the plant protection products 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 Italy will pursue the detailed examination for the dossier for cyhalofop-butyl, that Belgium will pursue the detailed examination for the dossier for pyraflufen-ethyl and that Spain will pursue the detailed examination for the dossier for azafenidin;
Whereas Italy, Belgium and Spain will report the conclusions of their examinations 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 following dossiers satisfy 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, taking into account the uses proposed:
1. the dossier submitted by Dow Elanco Italia Srl to the Commission and the Member States with a view to the inclusion of cyhalofop-butyl as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 16 December 1997;
2. the dossier submitted by Nihon Nohyaku Co. Ltd to the Commission and the Member States with a view to the inclusion of pyraflufen-ethyl as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 16 December 1997;
3. the dossier submitted by Du Pont de Nemours (France) SA to the Commission and the Member States with a view to the inclusion of azafenidin as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 16 December 1997.
This Decision is addressed to the Member States.