COMMISSION DECISION
of 23 February 2000
recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of thiacloprid, forchlorfenuron, thiamethoxam in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market
(notified under document number C(2000) 474)
(Text with EEA relevance)
(2000/181/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 1999/80/EC(2), and in particular Article 6(3) thereof,
Whereas:
(1) Directive 91/414/EEC (hereinafter referred to as "the Directive") has provided for the development of a Community list of active substances authorised for incorporation in plant protection products.
(2) Applicants have submitted dossiers for four active substances to Member States' authorities with a view to obtaining the inclusion of the active substances in Annex I to the Directive.
(3) A dossier for the active substance thiacloprid was submitted by Bayer plc to the authorities of the United Kingdom on 11 September 1998.
(4) A dossier for the active substance forchlorfenuron was submitted by SKW Trostberg AG to the Spanish authorities on 7 December 1998.
(5) A dossier for the active substance thiamethoxam was submitted by Novartis Crop Protection AG to the Spanish authorities on 17 March 1999.
(6) 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. Subsequently, in accordance with the provisions of Article 6(2), the dossiers were submitted by the applicant to the Commission and other Member States.
(7) The dossiers for thiacloprid, forchlorfenuron, thiamethoxam were referred to the Standing Committee on Plant Health on 20 July 1999.
(8) Article 6(3) of the Directive requires it be confirmed at Community level 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.
(9) 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.
(10) 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.
(11) It is understood between the Member States and the Commission that the United Kingdom will pursue the detailed examination for the dossier for thiacloprid, that Spain will pursue the detailed examination for the dossiers forchlorfenuron and thiamethoxam.
(12) The United Kingdom 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. On receipt of this evaluation report the detailed examination will be continued with the expertise of all Member States within the framework of the Standing Committee on Plant Health.
(13) 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 Bayer plc to the Commission and the Member States with a view to the inclusion of thiacloprid as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 20 July 1999.
2. The dossier submitted by SKW Trostberg AG to the Commission and the Member States with a view to the inclusion of forchlorfenuron as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 20 July 1999.
3. The dossier submitted by Novartis Crop Protection AG to the Commission and the Member States with a view to the inclusion of thiamethoxam as active substance in Annex I to Directive 91/414/EEC and which was referred to the Standing Committee on Plant Health on 20 July 1999.
This Decision is addressed to the Member States.