(Utkast) Kommisjonens gjennomføringsforordning om forlenget godkjenning av det aktive stoffet 2,4-DB, i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om markedsføring av plantevernmidler, og om endring av vedlegget til gjennomføringsforordning (EU) nr. 540/2011
(Draft) Commission Implementing Regulation renewing the approval of the active substance 2,4-DB 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
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 28.7.2017
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2003/31/EC included 2,4-DB as an active substance in Annex I to Council Directive 91/414/EEC .
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 .
(3) The approval of the active substance 2,4-DB, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, expires on 31 October 2017.
(4) An application for the renewal of the approval of 2,4-DB was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
(5) The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.
(6) The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 3 June 2015.
(7) The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.
(8) On 13 May 2016, the Authority communicated to the Commission its conclusion on whether 2,4-DB can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for 2,4-DB to the Standing Committee on Plants, Animals, Food and Feed on 18 May 2017.
(9) The applicant was given the opportunity to submit comments on the draft renewal report.
(10) It has been established with respect to one or more representative uses of at least one plant protection product containing 2,4-DB that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of 2,4-DB.
(11) The risk assessment for the renewal of the approval of 2,4-DB is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing 2,4-DB may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide.
(12) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(13) Commission Implementing Regulation (EU) 2016/950 extended the approval period of 2,4-DB to 31 October 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
(14) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
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