Commission Implementing Regulation (EU) 2025/787 of 24 April 2025 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1,4-dimethylnaphthalene, amidosulfuron, bentazone, bixafen, clomazone, fenoxaprop-P, fludioxonil, fluoxastrobin, flutolanil, fluxapyroxad, gibberellic acid, gibberellins, halauxifen-methyl, mecoprop-P, paraffin oil, penthiopyrad, pirimiphos-methyl, propamocarb, propyzamide, prothioconazole, rimsulfuron, sedaxane and sulfoxaflor

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 17, first paragraph, thereof,

Whereas:

(1) Commission Implementing Regulation (EU) No 192/2014 (2) approved the active substance 1,4-dimethylnaphthalene until 30 June 2024.

(2) Commission Directive 2008/40/EC (3) included amidosulfuron as an active substance in Annex I to Council Directive 91/414/EEC (4) until 31 December 2018.

(3) Commission Directive 2000/68/EC (5) included bentazone as an active substance in Annex I to Directive 91/414/EEC until 31 July 2011 and Commission Implementing Regulation (EU) 2018/660 (6) renewed the approval of that active substance until 31 May 2025.

(4) Commission Implementing Regulation (EU) No 350/2013 (7) approved the active substance bixafen until 30 September 2023.

(5) Commission Directive 2007/76/EC (8) included clomazone and fludioxonil as active substances in Annex I to Directive 91/414/EEC until 31 October 2018.

(6) Commission Directive 2008/66/EC (9) included fenoxaprop-P as an active substance in Annex I to Directive 91/414/EEC until 31 December 2018.

(7) Commission Directive 2008/44/EC (10) included fluoxastrobin as an active substance in Annex I to Directive 91/414/EEC until 31 July 2018.

(8) Commission Directive 2008/108/EC (11) included flutolanil as an active substance in Annex I to Directive 91/414/EEC until 28 February 2019.

(9) Commission Implementing Regulation (EU) No 192/2014 (12) approved the active substance 1,4-dimethylnaphthalene until 30 June 2024.

(10) Commission Directive 2008/127/EC (13) included gibberellic acid and gibberellins as active substances in Annex I to Directive 91/414/EEC until 31 August 2019.

(11) Commission Implementing Regulation (EU) No 589/2012 (14) approved the active substance fluxapyroxad until 31 December 2022.

(12) Commission Implementing Regulation (EU) 2015/1165 (15) approved the active substance halauxifen-methyl until 5 August 2025.

(13) Commission Directive 2003/70/EC (16) included mecoprop-P as an active substance in Annex I to Directive 91/414/EEC until 31 May 2014.

(14) Council Directive 2009/117/EC (17) included paraffin oil as an active substance in Annex I to Directive 91/414/EEC until 31 December 2019.

(15) Commission Implementing Regulation (EU) No 1187/2013 (18) approved the active substance penthiopyrad until 30 April 2024.

(16) Commission Directive 2007/52/EC (19) included pirimiphos-methyl as an active substance in Annex I to Directive 91/414/EEC until 30 September 2017.

(17) Commission Directive 2007/25/EC (20) included propamocarb as an active substance in Annex I to Directive 91/414/EEC until 30 September 2017.

(18) Commission Directive 2003/39/EC (21) included propyzamide as an active substance in Annex I to Directive 91/414/EEC until 31 March 2014 and Commission Implementing Regulation (EU) 2018/755 (22) renewed the approval of that active substance until 30 June 2025.

(19) Commission Directive 2008/44/EC (23) included prothioconazole as an active substance in Annex I to Directive 91/414/EEC until 31 July 2018.

(20) Commission Directive 2006/39/EC (24) included rimsulfuron as an active substance in Annex I to Directive 91/414/EEC until 31 January 2017.

(21) Commission Implementing Regulation (EU) No 826/2013 (25) approved the active substance sedaxane until 31 January 2024.

(22) Commission Implementing Regulation (EU) 2015/1295 (26) approved the active substance sulfoxaflor until 18 August 2025.

(23) According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009.

(24) The active substances amidosulfuron, clomazone, fenoxaprop-P, fludioxonil, fluoxastrobin, flutolanil, gibberellic acid, gibberellins, mecoprop-P, paraffin oil, pirimiphos-methyl, propamocarb, prothioconazole and rimsulfuron were included in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (27). The active substances 1,4-dimethylnaphthalene, bentazone, bixafen, fluxapyroxad, halauxifen-methyl, penthiopyrad, sedaxane and sulfoxaflor were included in Part B, and the active substance propyzamide was included in Part E of the Annex to that Regulation.

(25) Commission Implementing Regulation (EU) 2020/2007 (28) extended the approval period of the active substance 1,4-dimethylnaphthalene until 30 June 2025, and the approval periods of the active substances bixafen, fluxapyroxad, penthiopyrad and sedaxane until 31 May 2025.

(26) Commission Implementing Regulation (EU) 2023/2592 (29) extended the approval periods of the active substances amidosulfuron, fenoxaprop-P and paraffin oil until 15 August 2025.

(27) Commission Implementing Regulation (EU) 2023/1757 (30) extended the approval periods of the active substances clomazone and fludioxonil until 15 June 2025.

(28) Commission Implementing Regulation (EU) 2023/918 (31) extended the approval periods of the active substances fluoxastrobin, pirimiphos-methyl and propamocarb until 15 June 2025, and the approval period of the active substance prothioconazole until 15 August 2025.

(29) Commission Implementing Regulation (EU) 2024/324 (32) extended the approval period of the active substance flutolanil until 15 June 2025, and the approval period of the active substance mecoprop-P until 15 May 2025.

(30) Commission Implementing Regulation (EU) 2023/1446 (33) extended the approval periods of the active substances gibberellic acid and gibberellins until 15 July 2025.

(31) Commission Implementing Regulation (EU) 2023/689 (34) extended the approval period of the active substance rimsulfuron until 15 August 2025.

(32) Applications and supplementary dossiers for the respective renewal of the approvals of each of those active substances were submitted in accordance with Commission Implementing Regulation (EU) 2020/1740 (35) three years before the extended expiry date of the active substances.

(33) On 13 September 2016, 1 July 2016, 21 July 2016, 22 March 2016, 27 August 2015, 1 December 2016, 6 October 2016, 2 September 2014, 1 February 2017, 23 March 2016, 28 April 2016, 15 September 2015 and 1 December 2015 respectively, the rapporteur Member States for the active substances amidosulfuron, clomazone, fenoxaprop-P, fludioxonil, fluoxastrobin, flutolanil, gibberellic acid, gibberellins, mecoprop-P, paraffin oil, pirimiphos-methyl, propamocarb, prothioconazole and rimsulfuron informed the co-rapporteur Member States, the Commission and the European Food Safety Authority (the ‘Authority’) that they had assessed the admissibility, and in particular the completeness and the timeliness, of each of the applications for renewal of the approvals of each of those active substances, and concluded that they were admissible.

(34) The supplementary dossiers for the renewal of the approval of the active substances 1,4-dimethylnaphthalene, halauxifen-methyl, propyzamide and sulfoxaflor were submitted via the central submission system on 24 June 2022, 28 July 2022, 27 June 2022 and 11 August 2022 respectively, and the rapporteur Member States are still in the process of assessing the admissibility of the applications for the renewal of the approval of each of those active substances. The applications for the renewal of the approval of the active substances bentazone, bixafen, fluxapyroxad, and sedaxane have been made public by the Authority pursuant to Article 10 of Implementing Regulation (EU) 2020/1740. For all those active substances, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) 2020/1740 has, therefore, not yet been finalised by the respective rapporteur Member States and additional time is needed to complete the remaining steps in each renewal procedure.

(35) For the active substance mecoprop-P, the Authority has communicated its conclusion to the applicant, the Member States and the Commission. However, for the purpose of efficiency, the Commission is awaiting the outcome of the Authority’s evaluation of the parallel application concerning the same substance submitted pursuant to Article 7 of Regulation (EC) No 1107/2009, in order to assess the variant mecoprop-p-2-ethylhexyl ester, before presenting a renewal report and a draft Regulation on the renewal of the approval of this active substance to the Standing Committee on Plants, Animals, Food and Feed.

(36) For the active substance penthiopyrad, the application for the renewal of the approval has been made public by the Authority. Pursuant to Article 12 of Implementing Regulation (EU) 2020/1740, the draft renewal assessment report received from the rapporteur Member State is under examination by the Authority, to conclude whether it contains all the relevant information in the agreed format, before circulating it to the applicant and to the other Member States. Therefore, the Authority needs additional time to conclude the risk assessment, including the organisation of a public consultation and, where appropriate, a consultation of experts. Additional time is also needed for the Commission to adopt the ensuing risk management decisions.

(37) For the active substances fluoxastrobin, pirimiphos-methyl, propamocarb and prothioconazole, for the purposes of assessment of the approval criteria set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, additional information was requested by the Authority pursuant Article 13(3a) of Commission Implementing Regulation (EU) No 844/2012 (36) and was submitted by the applicants within the deadline given. However, additional time is needed for the evaluation of this information by the Authority and for the issuance of the related conclusion by risk assessors, as well as for the Commission to adopt the ensuing risk management decisions.

(38) For the active substance rimsulfuron, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605 (37), was requested by the Authority in consultation with the Member States pursuant Article 14(1a) of Implementing Regulation (EU) No 844/2012. The deadline for the submission of the additional information has been set on 31 March 2026. Therefore, additional time is needed for the evaluation of the Authority and for the issuance of the related conclusion by risk assessors, as well as for the Commission to adopt the ensuing risk management decision.

(39) For the active substances amidosulfuron, clomazone, fenoxaprop-P, fludioxonil, flutolanil, gibberellic acid, gibberellins and paraffin oil, the Authority has communicated its conclusions to the applicant, the Member States and the Commission. The Commission has presented a renewal report and a draft Regulation on the renewal of the approvals of those active substances to the Standing Committee on Plants, Animals, Food and Feed. Additional time is needed for the delivery of the opinion of that Committee and for the Commission to adopt the ensuing risk management decisions.

(40) It is therefore likely for all of the active substances that no decision on the renewal of their approvals can be taken before the expiry of their respective approval periods, between 15 May and 18 August 2025. Furthermore, the reasons for the delays in those renewal procedures are beyond the control of the respective applicants. Therefore, the approval periods of those active substances should be extended to enable the completion of the assessments required and to finalise the respective procedures on the renewal of the approvals.

(41) For the active substances 1,4-dimethylnaphthalene, bentazone, bixafen, fluxapyroxad, halauxifen-methyl, mecoprop-P, penthiopyrad, propyzamide, sedaxane and sulfoxaflor, as the risk assessment has not yet been finalised by the respective rapporteur Member States and in light of the remaining steps to be completed in each renewal procedure, the duration of the extension of the approval periods should be set at 29 months.

(42) For the active substances fluoxastrobin, pirimiphos-methyl, propamocarb and prothioconazole, as the Authority needs additional time to reach a conclusion on the risk, and in light of the remaining steps to be completed in each renewal procedure, the extension of the approval period for each of these active substances should be set at 19 months and 2 weeks.

(43) For the active substance rimsulfuron, as the Authority needs additional time to reach a conclusion on the risk assessment because the submission by the applicant of the additional information requested and the assessment by the respective rapporteur Member State has not yet been finalised, and in light of the remaining steps to be completed in this renewal procedure, the duration of the extension of the approval period for this active substance should be set at 36 months.

(44) For the active substances amidosulfuron, clomazone, fenoxaprop-P, fludioxonil, flutolanil, gibberellic acid, gibberellins and paraffin oil, the delivery of an opinion of the Standing Committee on Plants, Animals, Food and Feed is pending. In light of the remaining steps to be completed in thoese renewal procedures, the duration of the extension of the approval periods should be set at 12 months for flutolanil, and at 15 months and 2 weeks for the active substances amidosulfuron, clomazone, fenoxaprop-P, fludioxonil, gibberellic acid, gibberellins and paraffin oil.

(45) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(46) 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.

(47) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 April 2025.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(2) Commission Implementing Regulation (EU) No 192/2014 of 27 February 2014 approving the active substance 1,4-dimethylnaphthalene, 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 (OJ L 59, 28.2.2014, p. 20, ELI: http://data.europa.eu/eli/reg_impl/2014/192/oj).

(3) Commission Directive 2008/40/EC of 28 March 2008 amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances (OJ L 87, 29.3.2008, p. 5, ELI: http://data.europa.eu/eli/dir/2008/40/oj).

(4) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).

(5) Commission Directive 2000/68/EC of 23 October 2000 including an active substance (bentazone) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 276, 28.10.2000, p. 41, ELI: http://data.europa.eu/eli/dir/2000/68/oj).

(6) Commission Implementing Regulation (EU) 2018/660 of 26 April 2018 renewing the approval of the active substance bentazone 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 (OJ L 110, 30.4.2018, p. 122, ELI: http://data.europa.eu/eli/reg_impl/2018/660/oj).