97/631/EC: Commission Decision of 12 September 1997 recognizing in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of flumioxazine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1997-09-12
Institutions: European Commission
Subjects: marketing, pharmaceutical legislation, pharmaceutical product, plant health product













EUR-Lex - 31997D0631 - EN






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31997D0631

97/631/EC: Commission Decision of 12 September 1997 recognizing in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of flumioxazine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)  


Official Journal L 262 , 24/09/1997 P. 0007 - 0008 





COMMISSION DECISION of 12 September 1997 recognizing in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of flumioxazine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) (97/631/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 the applicant has submitted a dossier for the active substance 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 flumioxazine was submitted by Cyanamid to the French authorities on 2 May 1994;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 applicant to the Commission and other Member States;Whereas the dossier for flumioxazine was referred to the Standing Committee on Plant Health on 12 July 1996;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 at Annex II and, for at least one plant protection product containing the active substance concerned, at 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 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 France will pursue the detailed examination for the dossier for flumioxazine;Whereas France will 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,HAS ADOPTED THIS DECISION:Article 1 The following dossier is considered as satisfying in principle the data and information requirements provided for at Annex II and, for a plant protection product containing the active substance concerned, at Annex III to the Directive, taking into account the uses proposed.The dossier submitted by Cyanamid to the Commission and the Member States with a view to the inclusion of flumioxazine as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 12 July 1996.Article 2 This Decision is addressed to the Member States.Done at Brussels, 12 September 1997.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19. 8. 1991, p. 1.(2) OJ L 277, 30. 10. 1996, p. 25.