COMMISSION DECISION
of 5 November 2010
allowing Member States to extend provisional authorisations granted for the new active substance spirotetramat
(notified under document C(2010) 7437)
(Text with EEA relevance)
(2010/671/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
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 October 2006 Austria received an application from Bayer CropScience AG for the inclusion of the active substance spirotetramat in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/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 of 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 substances and the plant protection products 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 its respective draft assessment report to the Commission on 29 April 2008.
(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 time-frame 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 a possible inclusion in Annex I to that Directive for spirotetramat 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:
Article 1
Member States may extend provisional authorisations for plant protection products containing spirotetramat for a period ending on 31 December 2012 at the latest.
Article 2
This Decision shall expire on 31 December 2012.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 5 November 2010.