97/164/EC: Commission Decision of 17 February 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of flupyrsulfuron-methyl, azimsulfuron and paecilomyces fumosoroseus in Annex I of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1997-02-17
Institutions: European Commission
Subjects: EU control, committee (EU), market approval, marketing, pharmaceutical product, plant health product













EUR-Lex - 31997D0164 - EN






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31997D0164

97/164/EC: Commission Decision of 17 February 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of flupyrsulfuron-methyl, azimsulfuron and paecilomyces fumosoroseus in Annex I of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)  


Official Journal L 064 , 05/03/1997 P. 0017 - 0018 





COMMISSION DECISION of 17 February 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of flupyrsulfuron-methyl, azimsulfuron and paecilomyces fumosoroseus in Annex I of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) (97/164/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 96/68/EC (2), and in particular Article 6 (3) thereof,Whereas Council Directive 91/414/EEC has provided for the development of a Community list of active substances authorized 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 of the Directive;Whereas a dossier for the active substance flupyrsulfuron-methyl (DPX-KE459) has been submitted by Du Pont de Nemours France to the French authorities on 26 October 1995;Whereas a dossier for the active substance azimsulfuron has been submitted by Du Pont de Nemours Italiana SpA to the Italian authorities on 4 March 1996;Whereas a dossier for the active substance Paecilomyces fumosoroseus has been submitted by Thermo Trilogy Corporation to the Belgian authorities on 18 May 1994;Whereas the said authorities indicated to the Commission the results of a first examination of the completeness of the dossiers 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 of Directive; whereas subsequently, in accordance with the provisions of Article 6 (2), the dossiers were submitted by the applicants to the Commission and other Member States;Whereas the dossier for flupyrsulfuron-methyl was referred to the Standing Committee on Plant Health on 16 August 1996;Whereas the dossier for azimsulfuron was referred to the Standing Committee on Plant Health on 11 October 1996;Whereas the dossier for Paecilomyces fumosoroseus was referred to the Standing Committee on Plant Health on 24 November 1995;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 of 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 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 substances and the plant protection products with regard of 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 France will pursue the detailed examination for the dossier for flupyrsulfuron-methyl, that Italy will pursue the detailed examination for the dossier for azimsulfuron and that Belgium will pursue the detailed examination for the dossier for Paecilomyces fumosoroseus;Whereas France, Italy and Belgium 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 these reports 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,HAS ADOPTED THIS DECISION:Article 1 The following dossiers are considered as satisfying in principle the data and information requirements provided for in Annex II and, for a plant protection product containing the active substance concerned, in Annex III of the Directive:1. the dossier submitted by Du Pont de Nemours France to the Commission and the Member States with a view to the inclusion of flupyrsulfuron-methyl as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 16 August 1996;2. the dossier submitted by Du Pont de Nemours Italiana SpA to the Commission and the Member States with a view to the inclusion of azimsulfuron as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 11 October 1996;3. the dossier submitted by Thermo Trilogy Corporation to the Commission and the Member States with a view to the inclusion of paecilomyces fumosoroseus as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 24 November 1995.Article 2 This Decision is addressed to the Member States.Done at Brussels, 17 February 1997.For the CommissionFranz FISCHLERMember of the Commission(1) OJ No L 230, 19. 8. 1991, p. 1.(2) OJ No L 277, 30. 10. 1996, p. 25.