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)
Grade B
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Address https://gelex.eu/eli/EU/decision/2008/953@2008-12-08/en
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, 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,
HAS ADOPTED THIS DECISION:
Article 1
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.
Article 2
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.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 8 December 2008. For the Commission Androulla Vassiliou Member of the Commission
ANNEX
ANNEX ACTIVE SUBSTANCES CONCERNED BY THIS DECISION
Common name, CIPAC identification number Applicant Date of application Rapporteur Member State Aureobasidium pullulans CIPAC-No: not applicable bio-ferm GmbH 17 April 2008 AT Disodium phosphonate CIPAC-No: 808 ISK Biosciences Europe SA 21 May 2008 FR
Versions
Cited by
- Commission Implementing Decision of 30 October 2012 allowing Member States to extend provisional authorisations granted for the new active substances ametoctradin (initially applied for under the development code BAS 650 F) and disodium phosphonate (notified under document C(2012) 7581) (Text with EEA relevance) (2012/677/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in May 2008 France received an application from ISK Biosciences Europe SA for the inclusion of the active substance disodium phosphonate in Annex I to Directive 91/414/EEC. Commission Decision 2008/953/EC 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.
- Commission Implementing Regulation (EU) No 832/2013 of 30 August 2013 approving the active substance disodium phosphonate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For disodium phosphonate the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/953/EC.
- Commission Implementing Regulation (EU) No 832/2013 of 30 August 2013 approving the active substance disodium phosphonate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC France received on 11 February 2008 an application from ISK BioSciences Europe N.V. for the inclusion of the active substance disodium phosphonate in Annex I to Directive 91/414/EEC. Decision 2008/953/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Regulation (EU) No 827/2013 of 29 August 2013 approving the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Aureobasidium pullulans (strains DSM 14940 and DSM 14941) the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/953/EC.
- Commission Implementing Regulation (EU) No 827/2013 of 29 August 2013 approving the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941), in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 17 April 2008 an application from bio-ferm Biotechnologische Entwicklung und Produktion GmbH for the inclusion of the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941) in Annex I to Directive 91/414/EEC. Decision 2008/953/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Decision of 16 August 2012 allowing Member States to extend provisional authorisations granted for the new active substance Aureobasidium pullulans (notified under document C(2012) 5709) (Text with EEA relevance) (2012/480/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in April 2008 Austria received an application from bio-ferm GmbH for the inclusion of the active substance Aureobasidium pullulans in Annex I to Directive 91/414/EEC. Commission Decision 2008/953/EC 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.