97/591/EC: Commission Decision of 29 July 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of mefenoxam (CGA 329 351), ethoxysulfuron, famoxadone and ampelomyces quisqualis in Annex I of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1997-07-29
Institutions: European Commission
Subjects: EU control, market approval, marketing, pharmaceutical product, plant health product













EUR-Lex - 31997D0591 - EN






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31997D0591

97/591/EC: Commission Decision of 29 July 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of mefenoxam (CGA 329 351), ethoxysulfuron, famoxadone and ampelomyces quisqualis 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 239 , 30/08/1997 P. 0048 - 0049 





COMMISSION DECISION of 29 July 1997 recognizing in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of mefenoxam (CGA 329 351), ethoxysulfuron, famoxadone and ampelomyces quisqualis in Annex I of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) (97/591/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 four 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 mefenoxam has been submitted by Novartis Crop Protection AG to the Belgian authorities on 9 February 1996;Whereas a dossier for the active substance ethoxysulfuron has been submitted by AgrEvo to the Italian authorities on 3 July 1996;Whereas a dossier for the active substance famoxadone has been submitted by DuPont de Nemours to the French authorities on 2 October 1996;Whereas a dossier for the active substance Ampelomyces quisqualis has been submitted by Ecogen to the French authorities on 12 April 1996;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 dossiers for mefenoxam, ethoxysulfuron and famoxadone were referred to the Standing Committee on Plant Health on 21 March 1997;Whereas the dossier for Ampelomyces quisqualis was referred to the Standing Committee on Plant Health on 6 February 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 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 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 Belgium will pursue the detailed examination for the dossier for mefenoxam, that Italy will pursue the detailed examination for the dossier for ethoxysulfuron and that France will pursue the detailed examination for the dossiers for famoxadone and Ampelomyces quisqualis;Whereas Belgium, Italy and France 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, taking into account the uses proposed:1. The dossier submitted by Novartis Crop Protection AG to the Commission and the Member States with a view to the inclusion of mefenoxam as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 21 March 1997.2. The dossier submitted by AgrEvo to the Commission and the Member States with a view to the inclusion of ethoxysulfuron as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 21 March 1997.3. The dossier submitted by DuPont de Nemours to the Commission and the Member States with a view to the inclusion of famoxadone as active substance in Annex I of Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 21 March 1997.4. The dossier submitted by Ecogen to the Commission and the Member States with a view to the inclusion of Ampelomyces quisqualis as active substance in Annex I of the Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 6 February 1997.Article 2 This Decision is addressed to the Member States.Done at Brussels, 29 July 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.