Commission Decision
of 25 August 2006
allowing Member States to extend provisional authorisations granted for the new active substance beflubutamid
(notified under document number C(2006) 3806)
(Text with EEA relevance)
(2006/584/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), and in particular the fourth subparagraph of Article 8(1) thereof,
Whereas:
(1) In accordance with Article 6(2) of Directive 91/414/EEC, in March 1998 Germany received an application from UBE Europe GmbH for the inclusion of the active substance beflubutamid (former names: UBH 820, UR 50601) in Annex I to Directive 91/414/EEC. Commission Decision 2000/784/EC(2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.
(2) Confirmation of the completeness of the dossier was necessary in order to allow it to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods up to three years, for plant protection products containing the active substance concerned, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the condition relating to the detailed assessment of the active substance and the plant protection product in the light of the requirements laid down by that Directive.
(3) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The rapporteur Member State submitted the draft assessment report to the Commission on 3 August 2002.
(4) Following submission of the draft assessment report by the rapporteur Member State, it has been found to be necessary to request further information from the applicant and to have the rapporteur Member State examine that information and submit its assessment. Therefore, the examination of the dossier is still ongoing and it will not be possible to complete the evaluation within the timeframe provided for in Directive 91/414/EEC.
(5) As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing the active substance concerned for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossier to continue. It is expected that the evaluation and decision-making process with respect to a decision on possible Annex I inclusion for beflubutamid will have been completed within 24 months.
(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/64/EC (OJ L 206, 27.7.2006, p. 107).