17.12.2008 EN Official Journal of the European Union L 338/62
COMMISSION DECISION
of 8 December 2008
recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Aureobasidium pullulans and disodium phosphonate in Annex I to Council Directive 91/414/EEC
(notified under document number C(2008) 7709)
(Text with EEA relevance)
(2008/953/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 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 Aureobasidium pullulans was submitted by bio-ferm GmbH to the authorities of Austria on 17 April 2008 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC. For disodium phosphonate a dossier was submitted by ISK Biosciences Europe S.A. to the authorities of France on 21 May 2008 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC.
(3) The authorities of Austria and France have indicated to the Commission that, on preliminary examination, the dossiers for the active substances concerned appear to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossiers submitted appear 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 dossiers were subsequently forwarded by the respective applicants to the Commission and other Member States, and were 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 dossiers are 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,
Without prejudice to Article 6(4) of Directive 91/414/EEC, the dossiers concerning the active substances identified in the Annex to this Decision, which were submitted to the Commission and the Member States with a view to obtaining the inclusion of these substances in Annex I to that Directive, satisfy in principle the data and information requirements set out in Annex II to that Directive.
The dossiers also satisfy 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.
The rapporteur Member States shall pursue the detailed examination for the dossiers referred to in Article 1 and shall communicate to the Commission the conclusions of their examinations accompanied by a recommendation on the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substances 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.
This Decision is addressed to the Member States.