COMMISSION DECISION of 17 November 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of KIF 3535 (mepanipyrim), imazamox (AC 299263), DE 570 (florasulam), fluazolat (JV 485), Coniothyrium minitans and benzoic acid in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (notified under document number C(1998) 3514) (Text with EEA relevance) (98/676/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 98/47/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 six 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 KIF 3535 (mepanipyrim) was submitted by Kumiai Chemical Industry Co. Ltd to the Italian authorities on 24 October 1997;
Whereas a dossier for the active substance imazamox (AC 299263) was submitted by Cyanamid Agro SA/NV to the French authorities on 2 December 1997;
Whereas a dossier for the active substance DE 570 (florasulam) was submitted by Dow Agro Sciences to the Belgian authorities on 2 February 1998;
Whereas a dossier for the active substance fluazolat (JV 485) was submitted by Twinagro Ltd to the United Kingdom authorities on 29 September 1997;
Whereas a dossier for the active substance Coniothyrium minitans was submitted by Prophyta GmbH to the German authorities on 10 September 1997;
Whereas a dossier for the active substance benzoic acid was submitted by Menno Chemie Vertriebsgesellschaft mbH to the German authorities on 25 May 1998;
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 dossiers were submitted by the applicant to the Commission and other Member States;
Whereas the dossiers for KIF 3535 (mepanipyrim), imazamox (AC 299263), DE 570 (florasulam), fluazolat (JV 485), Coniothyrium minitans and benzoic acid were referred to the Standing Committee on Plant Health on 7 July 1998;
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 KIF 3535 (mepanipyrim), that France will pursue the detailed examination for the dossier for imazamox (AC 299263), that Belgium will pursue the detailed examination for the dossier for DE 570 (florasulam), that the United Kingdom will pursue the detailed examination for the dossier for fluazolat (JV 485) and that Germany will pursue the detailed examination for the dossiers for Coniothyrium minitans and benzoic acid;
Whereas Italy, France, Belgium, the United Kingdom and Germany 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,
HAS ADOPTED THIS DECISION:
Article 1
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 Kumiai Chemical Industry Co. Ltd to the Commission and the Member States with a view to the inclusion of KIF 3535 (mepanipyrim) as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998;
2. the dossier submitted by Cyanamid Agro SA/NV to the Commission and the Member States with a view to the inclusion of imazamox (AC 299263) as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998;
3. the dossier submitted by Dow Agro Sciences to the Commission and the Member States with a view to the inclusion of DE 570 (florasulam) as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998;
4. the dossier submitted by Twinagro Ltd to the Commission and the Member States with a view to the inclusion of fluazolat (JV 485) as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998;
5. the dossier submitted by Prophyta GmbH to the Commission and the Member States with a view to the inclusion of Coniothyrium minitans as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998;
6. the dossier submitted by Menno Chemie Vertriebsgesellschaft mbH to the Commission and the Member States with a view to the inclusion of benzoic acid as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 7 July 1998.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 17 November 1998.