2010/150/: Commission Decision of 10 March 2010 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of fenpyrazamine in Annex I to Council Directive 91/414/EEC (notified under document C(2010) 1268) (Text with EEA relevance)
Date: 2010-03-10
Institutions: European Commission
Subjects: administrative formalities, chemical product, exchange of information, health risk, marketing standard, pharmaceutical product, plant health legislation, plant health product








L_2010061EN.01003501.xml










11.3.2010   


EN


Official Journal of the European Union


L 61/35








            COMMISSION DECISION
         
of 10 March 2010
         
recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of fenpyrazamine in Annex I to Council Directive 91/414/EEC
(notified under document C(2010) 1268)
(Text with EEA relevance)
(2010/150/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 Article 6(3) thereof,

Whereas:







(1)


Directive 91/414/EEC provides for the development of a European Union list of active substances authorised for incorporation in plant protection products.












(2)


The dossier for the active substance fenpyrazamine was submitted by Sumitomo Chemical to the authorities of Austria on 3 September 2009 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC.












(3)


The Austrian authorities 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 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 European Union 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)


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
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 Directive 91/414/EEC, 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 Directive 91/414/EEC in respect of one plant protection product containing the active substance, taking into account the uses proposed.


Article 2
The rapporteur Member State 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 any recommendations 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 by 31 May 2011 at the latest.


Article 3
This Decision is addressed to the Member States.




Done at Brussels, 10 March 2010.


For the Commission

John DALLI
            

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




Fenpyrazamine
CIPAC-No.: not attributed yet


Sumitomo Chemical


3.9.2009


AT