Kommisjonens gjennomføringsforordning (EU) 2015/2105 av 20. november 2015 om forlenget godkjenning av det aktive stoffet imazamox som erstatningskandidat, 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 imazamox, as a candidate for substitution, 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 2003/23/EC included imazamox 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 imazamox, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2018.
(4) An application for the renewal of the approval of imazamox 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 (‘the Authority’) and the Commission on 13 April 2015.
(7) The Authority communicated the renewal assessment report to the applicant and to the other 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 15 March 2016 the Authority communicated to the Commission its conclusion on whether imazamox 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 imazamox to the Standing Committee on Plants, Animals, Food and Feed on 11 July 2016.
(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 imazamox 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 imazamox.
(11) The risk assessment for the renewal of the approval of imazamox is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing imazamox may be authorised. It is therefore appropriate to remove the restriction to use only as a herbicide.
(12) The Commission, however, considers that imazamox is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Imazamox is a persistent and toxic substance in accordance with points 184.108.40.206 and 220.127.116.11 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water and sediment is higher than 120 days and the long term no-observed effect concentration for aquatic plants is 0.0045 mg/L. Imazamox therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.
(13) It is therefore appropriate to renew the approval of imazamox as a candidate for substitution.
(14) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
(15) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(16) Commission Implementing Regulation (EU) 2017/841 extended the approval period of imazamox to 31 July 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation should apply from 1 November 2017.
(17) 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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