Commission Decision
of 30 July 2001
recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of Pethoxamide in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market
(notified under document number C(2001) 2386)
(Text with EEA relevance)
(2001/626/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 2001/49/EC(2), and in particular Article 6(3) thereof,
Whereas:
(1) Directive 91/414/EEC (hereinafter "the Directive") provides for the development of a Community list of active substances authorised for incorporation in plant-protection products.
(2) A dossier for the active substance Pethoxamide (ASU 96 520 H, TKC-94 EC 60) was submitted by Stahler Agrochemie GmbH & Co., KG, Tokuyama Europe GmbH and Tomen France SA to the German authorities on 16 October 2000 with a view to obtaining its inclusion in Annex I to the Directive.
(3) The German authorities have indicated to the Commission that, on preliminary examination, the dossier appears to satisfy the data and information requirements of Annex II to the Directive. Further, they believe that the dossier contains the data and information required by Annex III to the Directive in respect of one plant-protection product containing that active substance. Subsequently, in accordance with the provisions of Article 6(2), the dossier was forwarded by the applicant to the Commission and other Member States.
(4) The dossier was referred to the Standing Committee on Plant Health on 5 June 2001.
(5) Article 6(3) of the Directive requires formal confirmation at Community level that each dossier is 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, the requirements of Annex III to the Directive.
(6) Such confirmation is necessary in order to permit the detailed examination of the dossier as well as to allow Member States the possibility of granting provisional authorisation for plant-protection products containing this active substance in accordance with Article 8(1) of the Directive.
(7) This Decision does not prejudice the right of the Commission to request the applicant to submit further data or information to the rapporteur Member State in order to clarify certain points in the dossier. The request for the submission of further data necessary to clarify the dossier shall not affect the time limit for the submission of the report referred to under recital 9.
(8) The Member States of the Commission agree that Germany will pursue the detailed examination for the dossier for Pethoxamide.
(9) Germany will report the conclusions of their examinations accompanied by any recommendation on 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 from the date of publication of this Decision.
(10) 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 dossier submitted by Stahler Agrochemie GmbH & Co., KG, Tokuyama Europe GmbH and Tomen France SA to the Commission and the Member States with a view to the inclusion of Pethoxamide as an active substance in Annex I to Directive 91/414/EEC, which was referred to the Standing Committee on Plant Health on 5 June 2001, satisfies in principle the data and information requirements provided for in Annex II to the Directive. The dossier satisfies the data and information requirements set out in Annex III to the Directive in respect of one plant-protection product containing Pethoxamide, taking into account the uses proposed.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 30 July 2001.