(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om endring av gjennomføringsforordning (EU) nr. 540/2011 med hensyn til forlengelsen av godkjenningsperiodene for de aktive stoffene metylester av 2,5-diklorbenzosyre, acekinocyl, eddiksyre, aluminiumfosfid, amidosulfuron, buprofezin, kalsiumkarbid, emamektin, eten, fettsyrer C7 til C20, fenoksaprop-P, flonikamid (IKI220), halosulfuronmetyl, jernsulfat, magnesiumfosfid, metamitron, appelsinolje, kinmerak, natriumsølv-tiosulfat, sulkotrion, tembotrion, Trichoderma asperellum-stammene ICC012, T25 og TV1, Trichoderma atroviride-stammen T-11, Trichoderma gamsii-stammen ICC080, Trichoderma harzianum-stammene T-22 og ITEM 908 og sinkfosfid
Plantevernmidler: forlengelse av godkjenningsperioden til flere aktive stoffer
(Draft) Commission Implementing Regulation (EU) .../... amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acequinocyl, acetic acid, aluminium phosphide, amidosulfuron, buprofezin, calcium carbide, emamectin, ethylene, fatty acids C7 to C20, fenoxaprop-P, flonicamid (IKI220), halosulfuron-methyl, iron sulphate, magnesium phosphide, metamitron, orange oil, quinmerac, sodium silver thiosulfate, sulcotrione, tembotrione, Trichoderma asperellum strains ICC012, T25 and TV1, Trichoderma atroviride strain T-11, Trichoderma gamsii strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, and zinc phosphide
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 30.9.2026
Bakgrunn
(fra kommisjons
(1) The active substances 2,5-dichlorobenzoic acid methylester, acequinocyl, acetic acid, aluminium phosphide, amidosulfuron, buprofezin, calcium carbide, emamectin, ethylene, fatty acids C7 to C20, fenoxaprop-P, flonicamid (IKI-220), halosulfuronmethyl, iron sulphate, magnesium phosphide, metamitron, orange oil, quinmerac, sodium silver thiosulfate, sulcotrione, tembotrione, Trichoderma asperellum strains ICC012, T25 and TV1, Trichoderma atroviride strain T-11, Trichoderma gamsii strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, and zinc phosphide were approved as active substances for use in plant protection products for a limited period of time and the applications for the renewal of their approvals are currently being evaluated pursuant to Article 14 of Regulation (EC) No 1107/2009.
(2) Commission Directive 2008/40/EC2 included amidosulfuron in Annex I to Council Directive 91/414/EEC3 as an active substance until 31 December 2018 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of amidosulfuron was extended seven times, most recently by Commission Implementing Regulation (EU) 2025/7874 until 30 November 2026.
(3) Commission Directive 2008/66/EC5 included fenoxaprop-P in Annex I to Council Directive 91/414/EEC as an active substance until 31 December 2018 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of fenoxaprop-P was extended nine times, most recently by Implementing Regulation (EU) 2025/787 until 30 November 2026.
(4) Commission Directive 2008/113/EC6 included Trichoderma asperellum strains ICC012, T25 and TV1, Trichoderma atroviride strain T-11, Trichoderma gamsii strain ICC080, and Trichoderma harzianum strains T-22 and ITEM 908 in Annex I to Council Directive 91/414/EEC as active substances until 30 April 2019 and they were subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approvals of all those active substances were extended six times, most recently by Commission Implementing Regulation (EU) 2025/997 until 30 November 2026.
(5) Commission Directive 2008/125/EC8 included 2,5-dichlorobenzoic acid methylester, aluminium phosphide, magnesium phosphide, metamitron and sulcotrione in Annex I to Council Directive 91/414/EEC as active substances until 31 August 2019 and they were subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approvals of 2,5-dichlorobenzoic acid methylester, aluminium phosphide, magnesium phosphide, metamitron and sulcotrione were extended three times, most recently by Commission Implementing Regulation (EU) 2023/14469 until 30 November 2026.
(6) Commission Directive 2008/127/EC10 included acetic acid, calcium carbide, ethylene, fatty acids C7 to C20 and iron sulphate in Annex I to Council Directive 91/414/EEC as active substances until 31 August 2019 and they were subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approvals of acetic acid, calcium carbide and ethylene were extended three times, of iron sulphate five times and of fatty acids C7 to C20 six times, most recently by Implementing Regulation (EU) 2023/1446 for acetic acid, calcium carbide ethylene and iron sulphate until 30 November 2026, and by Commission Implementing Regulation (EU) 2024/222111 for fatty acids C7 to C20 until 1 December 2026.
(7) Commission Directive 2010/29/EU12 included flonicamid (IKI-220) in Annex I to Council Directive 91/414/EEC as an active substance until 31 August 2020 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of flonicamid (IKI-220) was extended two times, most recently by Implementing Regulation (EU) 2023/1446 until 30 November 2026.
(8) Commission Directive 2010/85/EU13 included zinc phosphide in Annex I to Council Directive 91/414/EEC as an active substance until 30 April 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of zinc phosphide was extended three times, most recently by Commission Implementing Regulation (EU) 2024/120614 until 31 December 2026.
(9) Commission Directive 2010/89/EU15 included quinmerac in Annex I to Council Directive 91/414/EEC as an active substance until 30 April 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of quinmerac was extended three times, most recently by Implementing Regulation (EU) 2024/1206 until 31 December 2026.
(10) Commission Directive 2011/6/EU16 included buprofezin in Annex I to Council Directive 91/414/EEC as an active substance until 31 January 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of buprofezin was extended four times, most recently by Implementing Regulation (EU) 2025/148917 until 15 December 2026.
(11) Commission Implementing Regulation (EU) No 356/201318 approved the active substance halosulfuron-methyl until 30 September 2023 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of halosulfuron-methyl was extended two times, most recently by Implementing Regulation (EU) 2025/99 until 15 November 2026. (12) Commission Implementing Regulation (EU) No 828/201319 approved the active substance emamectin until 30 April 2024 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of emamectin was extended two times, most recently by Implementing Regulation (EU) 2024/2221 until 15 November 2026.
(13) Commission Implementing Regulation (EU) No 1165/201320 approved the active substance orange oil until 30 April 2024 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of orange oil was extended two times, most recently by Implementing Regulation (EU) 2024/1206 until 31 December 2026.
(14) Commission Implementing Regulation (EU) No 1192/201321 approved the active substance tembotrione until 30 April 2024 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of tembotrione was extended two times, most recently by Implementing Regulation (EU) 2024/1206 until 31 December 2026.
(15) Commission Implementing Regulation (EU) No 1195/201322 approved the active substance sodium silver thiosulfate until 30 April 2024 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of sodium silver thiosulfate was extended two times, most recently by Implementing Regulation (EU) 2024/1206 until 31 December 2026.
(16) Commission Implementing Regulation (EU) No 496/201423 approved the active substance acequinocyl until 30 April 2024 and included it in Part B of the Annex to Implementing Regulation (EU) No 540/2011. The approval of acequinocyl was extended two times, most recently by Implementing Regulation (EU) 2024/2221 until 15 November 2026.
(17) As the approvals of these active substances are likely to expire before decisions have been taken on their renewal as part of the ongoing renewal procedures, the Commission inquired with the rapporteur Member States concerned and the European Food Safety Authority (‘the Authority’) on the reasons for the delays in the renewal procedures of these active substances. The Commission also asked when the draft renewal assessment reports by the rapporteur Member States or the conclusions of the Authority were expected to be finalised.
(18) The information available, including that provided by the rapporteur Member States and the Authority, shows that the reasons for the delays in each of these renewal procedures are beyond the control of the applicants.
(19) Therefore, taking into account the temporary and exceptional nature of the mechanism for the extension of approvals, the approval periods of those active substances should be extended for the period assessed as necessary, in each specific case and on the basis of the information available at the moment of adoption of this Regulation, to finalise the respective procedures on the renewal of the approvals. Given that the case-by-case assessment of the time needed to complete each renewal procedure is based on estimates, account should be taken of this degree of uncertainty.
(20) - (52) utelatt her.