(Utkast) Kommisjonens gjennomføringsforordning (EU) .../.... om endring av gjennomføringsforordning (EU) nr. 540/2011 med hensyn til forlengelse av godkjenningsperiodene for de aktive stoffene acekinocyl, aluminiumsilikat, emamectin, fettsyrene C7 til C20, pendimetalin, planteoljer/rapsolje og triklopyr
Plantevernmidler: forlenget godkjenning av acekinocyl, aluminiumsilikat, emamectin, fettsyrene C7 til C20, pendimetalin, planteoljer/rapsolje og triklopyr
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 18.7.2024
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BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Directive 2006/74/EC approved the active substance triclopyr until 31 May 2017. Commission Directive 2008/127/EC approved the active substances aluminium silicate, fatty acids and plant oils / rape seed oil until 31 August 2019.
(2) According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009.
(3) Commission Implementing Regulation (EU) No 828/2013 approved the active substance emamectin until 30 April 2024. Commission Implementing Regulation (EU) No 496/2014 approved the active substance acequinocyl, until 31 August 2024. Commission Implementing Regulation (EU) 2017/1114 renewed the approval of the active substance pendimethalin until 31 August 2024.
(4) The approvals of the active substances aluminium silicate, fatty acids, plant oils / rape seed oil and triclopyr, respectively, are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 . The approvals of the active substances acequinocyl and emamectin, respectively, are listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011. The approval of the active substance pendimethalin is listed in Part E of the Annex of Commission Implementing Regulation (EU) No 540/2011.
(5) Commission Implementing Regulation (EU) 2020/2007 extends the respective approval periods of the active substances acequinocyl, emamectin and pendimethalin until 30 November 2024 .
(6) Commission Implementing Regulation (EU) 2023/1446 extends the respective approval periods of the active substances aluminium silicate, fatty acids, plant oils / rape seed oil until 15 December 2024.
(7) Commission Implementing Regulation (EU) 2023/689 extends the approval period of the active substance triclopyr until 15 December 2024.
(8) Applications and supplementary dossiers for the renewal of the approvals of each of these active substances were submitted, in accordance with Commission Implementing Regulation (EU) 2020/1740, three years before the extended expiry date of the active substances. On 23 May 2023, 6 December 2016, 29 February 2016, 23 August 2022, 4 June 2018, 9 December 2015, 1 February 2022, 29 September 2016 and 4 September 2014 respectively, the rapporteur Member States for acequinocyl, aluminium silicate, emamectin, fatty acids C7 to C20, pendimethalin, plant oils / rape seed oil and triclopyr, respectively informed the co-rapporteur Member State, the Commission and the European Food Safety Authority (the ‘Authority’) that they had assessed the admissibility, in particular the completeness and the timeliness, of each of these applications, and concluded that they were admissible.
(9) With regard to the renewal of the approvals of the active substances acequinocyl, emamectin, fatty acids C7 to C20 and pendimethalin, respectively, the Authority needs additional time to conclude the risk assessment carried out for these substances, including, where appropriate, a public consultation and a consultation of experts. Additional time is necessary for the Commission to adopt the ensuing risk management decision.
(10) For the active substances aluminium silicate, plant oils / rape seed oil and triclopyr, the Authority has submitted its conclusion to the applicant, the Member States and the Commission. The Commission has presented a renewal report and a draft Regulation on the renewal of these active substances’ approvals to the Standing Committee on Plants, Animals, Food and Feed.
(11) Given that it is therefore likely that no decision on the renewal of the approval of those active substances can be taken before the expiry of their respective approval periods on 15 November 2024, 30 November 2024 and 15 December 2024, and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of those active substances should be extended in order to enable the completion of the assessments required and to finalise the respective procedures on renewal of approval.
(12) As the Authority needs additional time to reach a conclusion on the risk assessment of the active substances acequinocyl, emamectin and fatty acids C7 to C20, the duration of the extension of the approval period for these active substances should be set at twenty three months and two weeks. For the active substance pendimethalin, two additional months are necessary to finalise the public consultation pursuant to Article 12 of Commission Implementing Regulation (EU) 2020/1740, therefore the extension of the approval period for this active substance should be set at twenty five months and two weeks.
(13) As for the active substances aluminium silicate, plant oils / rape seed oil and triclopyr, the delivery of an opinion of the Standing Committee on Plants, Animals, Food and Feed is pending, and in light of the time required to accomplish each renewal procedure, the duration of the extension of the approval periods for those active substances should be set at fifteen months and two weeks and Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(14) In case the Commission adopts a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed, the Commission will set the expiry date at the date of entry into force of that Regulation or at the same date as it stood before the adoption of this Regulation, whichever date is later. In case the Commission adopts a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set the earliest possible application date, as appropriate under the circumstances.
(15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,