2009/865/EC: Commission Decision of 30 November 2009 allowing Member States to extend provisional authorisations granted for the new active substances metaflumizone and gamma-cyhalothrin (notified under document C(2009) 9366) (Text with EEA relevance)
Date: 2009-11-30
Institutions: European Commission
Subjects: health risk, market approval, marketing, pharmaceutical product, plant health legislation, plant health product








L_2009314EN.01010001.xml










1.12.2009   


EN


Official Journal of the European Union


L 314/100








            COMMISSION DECISION
         
of 30 November 2009
         
allowing Member States to extend provisional authorisations granted for the new active substances metaflumizone and gamma-cyhalothrin
(notified under document C(2009) 9366)
(Text with EEA relevance)
(2009/865/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 2005 the United Kingdom received an application from BASF Agro S.A.S, France for the inclusion of the active substance metaflumizone in Annex I to Directive 91/414/EEC. Commission Decision 2006/517/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)


In August 2001 the United Kingdom received an application from Pytech Chemicals GmbH concerning gamma-cyhalothrin. Commission Decision 2004/686/EC (3) confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to Directive 91/414/EEC.












(3)


Confirmation of the completeness of the dossiers was necessary in order to allow them 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 substances 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.












(4)


For these active substances, 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 applicants. The rapporteur Member State submitted the respective draft assessment reports to the Commission on 15 April 2008 (metaflumizone) and on 25 January 2008 (gamma-cyhalothrin).












(5)


Following submission of the draft assessment reports by the rapporteur Member State, in each case it has been found to be necessary to request further information from the applicants and to have the rapporteur Member State examine that information and submit its assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluations before the expiry of the three-year period provided for in the first subparagraph of Article 8(1) of Directive 91/414/EEC.












(6)


As the evaluations so far have 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 dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on a possible Annex I inclusion for metaflumizone and gamma-cyhalothrin will have been completed within 24 months.












(7)


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 metaflumizone or gamma-cyhalothrin for a period not exceeding 24 months from the date of adoption of this Decision.


Article 2
This Decision is addressed to the Member States.




Done at Brussels, 30 November 2009.


For the Commission

Androulla VASSILIOU
            

Member of the Commission






(1)  
            OJ L 230, 19.8.1991, p. 1.

(2)  
            OJ L 201, 25.7.2006, p. 34.

(3)  
            OJ L 313, 12.10.2004, p. 21.