2009/464/EC: Commission Decision of 15 June 2009 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of fluopyram in Annex I to Council Directive 91/414/EEC (notified under document number C(2009) 4437) (Text with EEA relevance)
Date: 2009-06-15
Institutions: European Commission
Subjects: administrative formalities, exchange of information, marketing standard, pharmaceutical product, plant health control, plant health product








L_2009151EN.01003701.xml










16.6.2009   


EN


Official Journal of the European Union


L 151/37








            COMMISSION DECISION
         
of 15 June 2009
         
recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of fluopyram in Annex I to Council Directive 91/414/EEC
(notified under document number C(2009) 4437)
(Text with EEA relevance)
(2009/464/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 Article 6(3) thereof,

Whereas:







(1)


Directive 91/414/EEC 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 fluopyram was submitted by Bayer CropScience AG to the authorities of Germany on 30 June 2008 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC.












(3)


The authorities of Germany have indicated to the Commission that, on preliminary examination, the dossier for the active substance concerned appears to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossier submitted appears also to satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substance concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossier was subsequently forwarded by the respective applicant to the Commission and other Member States, and was referred to the Standing Committee on the Food Chain and Animal Health.












(4)


By this Decision it should be formally confirmed at Community level that the dossier is considered as satisfying in principle the data and information requirements set out in Annex II and, for at least one plant protection product containing the active substance concerned, the requirements set out in Annex III to Directive 91/414/EEC.












(5)


This Decision should not prejudice the right of the Commission to request the applicant to submit further data or information in order to clarify certain points in the dossier.












(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
Without prejudice to Article 6(4) of Directive 91/414/EEC, the dossier concerning the active substance identified in the Annex to this Decision, which was submitted to the Commission and the Member States with a view to obtaining the inclusion of that substance in Annex I to that Directive, satisfies in principle the data and information requirements set out in Annex II to that Directive.
The dossier also satisfies the data and information requirements set out in Annex III to that Directive in respect of one plant protection product containing the active substance, taking into account the uses proposed.


Article 2
The rapporteur Member States shall pursue the detailed examination for the dossier referred to in Article 1 and shall communicate to the Commission the conclusions of its examination accompanied by a recommendation on the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance referred to in Article 1 and any conditions for that inclusion as soon as possible and at the latest within a period of one year from the date of publication of this Decision in the Official Journal of the European Union.


Article 3
This Decision is addressed to the Member States.




Done at Brussels, 15 June 2009.


For the Commission

Androulla VASSILIOU
            

Member of the Commission






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




ANNEX

ACTIVE SUBSTANCE CONCERNED BY THIS DECISION









Common Name, CIPAC Identification Number


Applicant


Date of application


Rapporteur Member State




Fluopyram
CIPAC-No: 807


Bayer CropScience AG


30 June 2008


DE