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Official Journal |
EN L series |
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2026/1421 |
1.7.2026 |
COMMISSION IMPLEMENTING REGULATION (EU) 2026/1421
of 30 June 2026
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, benzovindiflupyr, chlorotoluron, clethodim, cycloxydim, cymoxanil, dazomet, deltamethrin, diclofop, fenazaquin, fluopicolide, hymexazol, lambda-cyhalothrin, MCPA, MCPB, metaldehyde, metsulfuron-methyl, paclobutrazol and tebuconazole
(Text with EEA relevance)
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:
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(1) |
The active substances bensulfuron, benzovindiflupyr, chlorotoluron, clethodim, cycloxydim, cymoxanil, dazomet, deltamethrin, diclofop, fenazaquin, fluopicolide, hymexazol, lambda-cyhalothrin, MCPA, MCPB, metaldehyde, metsulfuron-methyl, paclobutrazol and tebuconazole 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. |
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(2) |
Commission Directive 2000/49/EC (2) included metsulfuron-methyl in Annex I to Council Directive 91/414/EEC (3) as an active substance until 30 June 2011. Commission Implementing Regulation (EU) 2016/139 (4) renewed the approval of that active substance as a candidate for substitution until 31 March 2023 and included it in Part E of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5). The approval of metsulfuron-methyl was extended twice, most recently by Commission Implementing Regulation (EU) 2024/324 (6) until 31 August 2026. |
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(3) |
Commission Directive 2000/80/EC (7) included lambda-cyhalothrin in Annex I to Directive 91/414/EEC as an active substance until 31 December 2011. Commission Implementing Regulation (EU) 2016/146 (8) renewed the approval of that active substance as a candidate for substitution until 31 March 2023 and included it in Part E of the Annex to Implementing Regulation (EU) No 540/2011. The approval of lambda-cyhalothrin was extended twice, most recently by Implementing Regulation (EU) 2024/324 until 31 August 2026. |
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(4) |
Commission Directive 2003/5/EC (9) included deltamethrin in Annex I to Directive 91/414/EEC as an active substance until 31 October 2013 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of deltamethrin was extended nine times, most recently by Commission Implementing Regulation (EU) 2023/1757 (10) until 15 August 2026. |
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(5) |
Commission Directive 2005/53/EC (11) included chlorotoluron in Annex I to Directive 91/414/EEC as an active substance until 28 February 2016 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of chlorotoluron was extended eight times, most recently by Implementing Regulation (EU) 2023/1757 until 15 August 2026. |
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(6) |
Commission Directive 2005/57/EC (12) included MCPA and MCPB in Annex I to Directive 91/414/EEC as active substances until 30 April 2016 and they were subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approvals of MCPA and MCPB were extended eight times, most recently by Implementing Regulation (EU) 2023/1757 until 15 August 2026. |
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(7) |
Commission Directive 2008/125/EC (13) included cymoxanil and tebuconazole in Annex I to 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 cymoxanil and tebuconazole were extended four and five times, respectively, most recently by Commission Implementing Regulation (EU) 2023/1446 (14) until 15 August 2026. |
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(8) |
Commission Directive 2009/11/EC (15) included bensulfuron in Annex I to Directive 91/414/EEC as an active substance until 31 October 2019 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of bensulfuron was extended three times, most recently by Implementing Regulation (EU) 2023/1757 until 15 August 2026. |
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(9) |
Commission Directive 2010/15/EU (16) included fluopicolide in Annex I to Directive 91/414/EEC as an active substance until 31 May 2020 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of fluopicolide was extended twice, most recently by Commission Implementing Regulation (EU) 2023/918 (17) until 31 August 2026. |
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(10) |
Commission Directive 2011/4/EU (18) included cycloxydim in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of cycloxydim was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(11) |
Commission Directive 2011/5/EU (19) included hymexazol in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of hymexazol was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(12) |
Commission Directive 2011/21/EU (20) included clethodim in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of clethodim was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(13) |
Commission Implementing Directive 2011/39/EU (21) included fenazaquin in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of fenazaquin was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(14) |
Commission Implementing Directive 2011/45/EU (22) included diclofop in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of diclofop was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(15) |
Commission Implementing Directive 2011/53/EU (23) included dazomet in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of dazomet was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(16) |
Commission Implementing Directive 2011/54/EU (24) included metaldehyde in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of metaldehyde was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(17) |
Commission Implementing Directive 2011/55/EU (25) included paclobutrazol in Annex I to Directive 91/414/EEC as an active substance until 31 May 2021 and it was subsequently included in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The approval of paclobutrazol was extended twice, most recently by Implementing Regulation (EU) 2023/918 until 31 August 2026. |
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(18) |
Commission Implementing Regulation (EU) 2016/177 (26) approved the active substance benzovindiflupyr as a candidate for substitution until 2 March 2023 and included it in Part E of the Annex to Implementing Regulation (EU) No 540/2011. The approval of benzovindiflupyr was extended twice, most recently by Implementing Regulation (EU) 2024/324 until 2 August 2026. |
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(19) |
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 inquired when the draft renewal assessment reports by the rapporteur Member States or the conclusions of the Authority could be expected to be finalised. |
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(20) |
On the basis of the information available at the moment of adoption of this Regulation, including that provided by the rapporteur Member States and the Authority, the Commission considers that the reasons for the delays in each of these renewal procedures are beyond the control of the applicants. |
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(21) |
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 at a particular moment in time, account should be taken of this degree of uncertainty. |
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(22) |
The applications for the renewal of the approval of the active substances bensulfuron, benzovindiflupyr, chlorotoluron, clethodim, cycloxydim, cymoxanil, dazomet, deltamethrin, diclofop, fenazaquin, fluopicolide, hymexazol, lambda-cyhalothrin, MCPA, MCPB, metaldehyde, metsulfuron-methyl, paclobutrazol and tebuconazole were submitted and are being evaluated in accordance with Commission Implementing Regulation (EU) No 844/2012 (27). |
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(23) |
The application for the renewal of the approval of the active substance bensulfuron was submitted on 27 October 2016 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 28 November 2017 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 30 August 2022, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 27 September and 26 November 2022. On 21 March 2023, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicant submitted that information on 21 April 2023 within the deadline given. On 28 August 2024, the Authority adopted its conclusion and communicated it to the applicant, the Member States and the Commission. The Commission has initiated discussions on the renewal of the approval of the active substance bensulfuron in the Standing Committee on Plants, Animals, Food and Feed by presenting the EFSA Conclusion. To facilitate the regulatory decision-making process and to clarify some of the remaining uncertainties, on 30 March 2026, the Commission submitted a request to the rapporteur Member State to re-evaluate some of the information available in the renewal dossier and to submit the updated renewal assessment report to the Commission, the Authority and the Member States by 10 June 2026. Subsequently, the Authority will be mandated to review the updated renewal assessment report and, if necessary, to update its Conclusion. As additional time will be necessary for the delivery of an opinion of the Standing Committee and for the Commission to adopt the ensuing risk management decision, the duration of the extension of the approval period should be set at 15 months, until 15 November 2027. |
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(24) |
The application for the renewal of the approval of the active substance benzovindiflupyr was submitted on 17 February 2020 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 31 July 2020 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. The rapporteur Member State has not finalised the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 and estimates that it will be able to submit the draft renewal assessment report to the Authority in the second quarter of 2026. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 2 January 2029. |
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(25) |
The application for the renewal of the approval of the active substance chlorotoluron was submitted on 26 February 2013 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 9 April 2013 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 6 June 2019, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 12 October and 11 December 2021. On 8 August 2022, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicant submitted that information on 8 September 2022 within the deadline given. On 17 June 2024, the Authority requested additional information for the purposes of assessment of the approval criteria concerning endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (28), pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012 to be submitted by the applicant by 18 December 2026 and the submission is pending. As the Authority estimates that it will need 120 days after receiving the revised draft renewal assessment report to complete the evaluation and to finalise its conclusion for chlorotoluron, and as the Commission will need time to adopt the ensuing risk management decisions, the duration of the extension of the approval period should be set at 22 months and 15 days, until 30 June 2028. |
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(26) |
The application for the renewal of the approval of the active substance clethodim was submitted on 25 May 2018 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 20 June 2018 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 28 March 2023, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 11 December 2023 and 9 February 2024. On 7 May 2024, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicant submitted that information on 7 June 2024 within the deadline given. The Authority expects to complete the evaluation and to finalise its conclusion for clethodim by 30 June 2026, and as the Commission will need time to adopt the ensuing risk management decisions, the duration of the extension of the approval period should be set at 15 months and 15 days, until 15 December 2027. |
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(27) |
The application for the renewal of the approval of the active substance cycloxydim was submitted on 24 May 2018 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 15 June 2018 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. The rapporteur Member State has not finalised the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 and estimates that it will submit the draft renewal assessment report to the Authority in June 2026. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(28) |
Three applications for the renewal of the approval of the active substance cymoxanil were submitted on 26 August 2016 (two applications) and 30 August 2016, respectively, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 3 October 2016 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 28 February 2020, the rapporteur Member State submitted the draft renewal assessment report to the Authority. On 6 April 2021, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicants submitted that information on 4-5 May 2021 within the deadline given. On 14 December 2021, the Authority requested additional information for the purposes of assessment of the approval criteria concerning endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012 and the applicants submitted that information on 12 June 2024 within the deadline given. On 10 September 2024, the rapporteur Member State submitted the revised draft renewal assessment report to the Authority, which conducted a public consultation on it between 20 December 2024 and 18 February 2025. The Authority expects to complete the evaluation and to finalise its conclusion for cymoxanil by 31 May 2026, and as the Commission will need time to adopt the ensuing risk management decisions, the duration of the extension of the approval period should be set at 15 months and 15 days, until 30 November 2027. |
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(29) |
The application for the renewal of the approval of the active substance dazomet was submitted on 28 May 2018 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 5 November 2020 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. The rapporteur Member State has not finalised the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 and estimates that it will be able to submit the draft renewal assessment report to the Authority in June 2027. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 39 months, until 30 November 2029. |
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(30) |
Five applications for the renewal of the approval of the active substance deltamethrin were submitted on 18 October 2013, 24 October 2013, 26 October 2013 and 28 October 2013 (two applications), respectively, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 25 November 2013 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 19 February 2018, the rapporteur Member State submitted the draft renewal assessment report to the Authority. On 21 December 2018, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicant submitted that information on 19-21 January 2019 within the deadline given. On 28 August 2023, the Authority requested additional information for the purposes of assessment of the approval criteria concerning endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012 and the applicant submitted that information on 4 March 2026 within the deadline given. As the Authority estimates that it will need 120 days after receiving the revised draft renewal assessment report to complete the evaluation and to finalise its conclusion for deltamethrin, and as the Commission will need time to adopt the ensuing risk management decisions, the duration of the extension of the approval period should be set at 22 months and 15 days, until 30 June 2028. |
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(31) |
Two applications for the renewal of the approval of the active substance diclofop were submitted, both on 21 May 2018, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 17 July 2018 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 6 May 2025, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which requested revisions to be made in the report. The submission of the revised draft renewal assessment report by the rapporteur Member State to the Authority is pending. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(32) |
The application for the renewal of the approval of the active substance fenazaquin was submitted on 30 May 2018 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 13 July 2018 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 19 September 2024, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 14 July and 13 September 2025. The rapporteur Member State estimates that it will be able to submit the completed reporting table of the collated comments from the public consultation to the Authority by the end of May 2026. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 23 months and 15 days, until 15 August 2028. |
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(33) |
The application for the renewal of the approval of the active substance fluopicolide was submitted on 24 May 2017 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 15 June 2017 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 27 May 2025, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which requested revisions to be made. On 22 April 2026, the rapporteur Member State submitted the revised draft renewal assessment report to the Authority. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(34) |
The application for the renewal of the approval of the active substance hymexazol was submitted on 23 May 2018 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 21 June 2018 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 29 April 2026, the rapporteur Member State submitted the draft renewal assessment report to the Authority. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(35) |
The application for the renewal of the approval of the active substance lambda-cyhalothrin was submitted on 31 March 2020 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 29 April 2020 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 31 July 2025, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which on 24 November 2025 requested revisions to be made in the report. The submission of the revised draft renewal assessment report by the rapporteur Member State is pending. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(36) |
Two applications for the renewal of the approval of the active substance MCPA were submitted on 21 and 24 April 2013, respectively, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 29 May 2013 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 24 March 2022, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 24 May and 23 July 2022. On 16 January 2023, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicants submitted that information in February 2023 within the deadline given. The submission of the revised draft renewal assessment report by the rapporteur Member State following the experts’ meetings held in November-December 2025 is pending. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 23 months and 15 days, until 31 July 2028. |
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(37) |
The application for the renewal of the approval of the active substance MCPB was submitted on 27 March 2013 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 5 August 2013 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. On 17 March 2022, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which conducted a public consultation on it between 5 May and 4 July 2022. On 16 January 2023, the Authority requested additional information for the purposes of the renewal assessment pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and the applicants submitted that information in February 2023 within the deadline given. The submission of the revised draft renewal assessment report by the rapporteur Member State following the experts’ meetings held in November-December 2025 is pending. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 23 months and 15 days, until 31 July 2028. |
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(38) |
Three applications for the renewal of the approval of the active substance metaldehyde were submitted, all on 29 May 2018, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 5 September 2018 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 4 July 2024, the rapporteur Member State submitted the draft renewal assessment report to the Authority. The rapporteur Member State and the Authority estimate that the public consultation on the draft renewal assessment report will start in May 2026. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 25 months and 15 days, until 15 October 2028. |
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(39) |
The application for the renewal of the approval of the active substance metsulfuron-methyl was submitted on 25 March 2020 and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 16 October 2023 that it had assessed the admissibility of the application pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular its completeness and timeliness, and concluded that it was admissible. The application has been made public by the Authority. The rapporteur Member State has not finalised the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 and estimates that it will be able to submit the draft renewal assessment report to the Authority in February 2027. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 35 months, until 31 July 2029. |
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(40) |
Two applications for the renewal of the approval of the active substance paclobutrazol were submitted, both on 29 May 2018, and the rapporteur Member State informed the co-rapporteur Member State, the Commission and the Authority on 26 June 2018 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 21 May 2025, the rapporteur Member State submitted the draft renewal assessment report to the Authority, which requested revisions to be made in the report. On 12 February 2026, the rapporteur Member State submitted the revised draft renewal assessment report to the Authority. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 29 months, until 31 January 2029. |
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(41) |
Two applications for the renewal of the approval of the active substance tebuconazole were submitted on 24 and 29 August 2016, respectively, and the rapporteur Member State informed the Commission and the Authority on 27 September 2016 that it had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular their completeness and timeliness, and concluded that they were admissible. The applications have been made public by the Authority. On 8 April 2019, the original rapporteur Member State submitted the draft renewal assessment report to the Authority. On 3 April 2020, the newly appointed rapporteur requested additional information for the purposes of assessment of the approval criteria concerning endocrine disrupting properties set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, that was submitted by the applicants in May 2020 within the deadline given. On 19 November 2021, the rapporteur Member State re-submitted the revised draft renewal assessment report to the Authority. The Authority conducted a public consultation on it between 27 February and 28 April 2025. The submission of the completed reporting table of the collated comments from the public consultation by the rapporteur Member State is pending. As additional time is necessary to complete the remaining steps in the renewal procedure, the duration of the extension of the approval period should be set at 23 months and 15 days, until 31 July 2028. |
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(42) |
For the active substances benzovindiflupyr, cycloxydim, dazomet, diclofop, fenazaquin, fluopicolide, hymexazol, lambda-cyhalothrin, MCPA, MCPB, metaldehyde, metsulfuron-methyl, paclobutrazol and tebuconazole, the Authority, in consultation with the Member States, may still request additional information from the applicants pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012. The extension periods proposed for these active substances do not include any additional time that might be necessary to provide and evaluate that information. |
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(43) |
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(44) |
In case the Commission adopts a Regulation providing that the approval of an active substance listed in the Annex to this Regulation is not renewed, the Commission should set the expiry date for the approval of this active substance 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 should set, as appropriate under the circumstances, the earliest possible application date. |
|
(45) |
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, 30 June 2026.
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 Directive 2000/49/EC of 26 July 2000 including an active substance (metsulfuron-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 197, 3.8.2000, p. 32, ELI: http://data.europa.eu/eli/dir/2000/49/oj).
(3) 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).
(4) Commission Implementing Regulation (EU) 2016/139 of 2 February 2016 renewing the approval of the active substance metsulfuron-methyl, 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 Implementing Regulation (EU) No 540/2011 (OJ L 27, 3.2.2016, p. 7, ELI: http://data.europa.eu/eli/reg_impl/2016/139/oj).
(5) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).
(6) Commission Implementing Regulation (EU) 2024/324 of 19 January 2024 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benzovindiflupyr, bromuconazole, buprofezin, cyflufenamid, fluazinam, fluopyram, flutolanil, lambda-cyhalothrin, mecoprop-P, mepiquat, metsulfuron-methyl, phosphane and pyraclostrobin (OJ L, 2024/324, 22.1.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/324/oj).
(7) Commission Directive 2000/80/EC of 4 December 2000 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market, so as to consolidate that Annex and include a further active substance (lambda-cyhalothrin) (OJ L 309, 9.12.2000, p. 14, ELI: http://data.europa.eu/eli/dir/2000/80/oj).
(8) Commission Implementing Regulation (EU) 2016/146 of 4 February 2016 renewing the approval of the active substance lambda-cyhalothrin, 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 Implementing Regulation (EU) No 540/2011 (OJ L 30, 5.2.2016, p. 7, ELI: http://data.europa.eu/eli/reg_impl/2016/146/oj).
(9) Commission Directive 2003/5/EC of 10 January 2003 amending Council Directive 91/414/EEC to include deltamethrin as active substance (OJ L 8, 14.1.2003, p. 7, ELI: http://data.europa.eu/eli/dir/2003/5/oj).
(10) Commission Implementing Regulation (EU) 2023/1757 of 11 September 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bensulfuron, chlormequat, chlorotoluron, clomazone, daminozide, deltamethrin, eugenol, fludioxonil, flufenacet, flumetralin, fosthiazate, geraniol, MCPA, MCPB, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulfuryl fluoride, tebufenpyrad, thymol, and tritosulfuron (OJ L 224, 12.9.2023, p. 28, ELI: http://data.europa.eu/eli/reg_impl/2023/1757/oj).
(11) Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ L 241, 17.9.2005, p. 51, ELI: http://data.europa.eu/eli/dir/2005/53/oj).
(12) Commission Directive 2005/57/EC of 21 September 2005 amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances (OJ L 246, 22.9.2005, p. 14, ELI: http://data.europa.eu/eli/dir/2005/57/oj).
(13) Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (OJ L 344, 20.12.2008, p. 78, ELI: http://data.europa.eu/eli/dir/2008/125/oj).
(14) Commission Implementing Regulation (EU) 2023/1446 of 12 July 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, calcium carbide, cymoxanil, dodemorph, ethylene, extract from tea tree, fat distillation residues, fatty acids C7-C20, flonicamid (IKI-220), gibberellic acid, gibberellins, halosulfuron-methyl, hydrolysed proteins, iron sulphate, magnesium phosphide, maltodextrin, metamitron, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, pyrethrins, sulcotrione, tebuconazole and urea (OJ L 178, 13.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/1446/oj).
(15) Commission Directive 2009/11/EC of 18 February 2009 amending Council Directive 91/414/EEC to include bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad as active substances (OJ L 48, 19.2.2009, p. 5, ELI: http://data.europa.eu/eli/dir/2009/11/oj).
(16) Commission Directive 2010/15/EU of 8 March 2010 amending Council Directive 91/414/EEC to include fluopicolide as active substance (OJ L 58, 9.3.2010, p. 5, ELI: http://data.europa.eu/eli/dir/2010/15/oj).
(17) Commission Implementing Regulation (EU) 2023/918 of 4 May 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aclonifen, ametoctradin, beflubutamid, benthiavalicarb, boscalid, captan, clethodim, cycloxydim, cyflumetofen, dazomet, diclofop, dimethomorph, ethephon, fenazaquin, fluopicolide, fluoxastrobin, flurochloridone, folpet, formetanate, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, indolylbutyric acid, mandipropamid, metalaxyl, metaldehyde, metam, metazachlor, metribuzin, milbemectin, paclobutrazol, penoxsulam, phenmedipham, pirimiphos-methyl, propamocarb, proquinazid, prothioconazole, S-metolachlor, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 (OJ L 119, 5.5.2023, p. 160, ELI: http://data.europa.eu/eli/reg_impl/2023/918/oj).
(18) Commission Directive 2011/4/EU of 20 January 2011 amending Council Directive 91/414/EEC to include cycloxydim as active substance and amending Decision 2008/934/EC (OJ L 18, 21.1.2011, p. 30, ELI: http://data.europa.eu/eli/dir/2011/4/oj).
(19) Commission Directive 2011/5/EU of 20 January 2011 amending Council Directive 91/414/EEC to include hymexazol as active substance and amending Decision 2008/934/EC (OJ L 18, 21.1.2011, p. 34, ELI: http://data.europa.eu/eli/dir/2011/5/oj).
(20) Commission Directive 2011/21/EU of 2 March 2011 amending Council Directive 91/414/EEC to include clethodim as active substance and amending Decision 2008/934/EC, (OJ L 58, 3.3.2011, p. 49, ELI: http://data.europa.eu/eli/dir/2011/21/oj).
(21) Commission Implementing Directive 2011/39/EU of 11 April 2011 amending Council Directive 91/414/EEC to include fenazaquin as active substance and amending Commission Decision 2008/934/EC (OJ L 97, 12.4.2011, p. 30, ELI: http://data.europa.eu/eli/dir_impl/2011/39/oj).
(22) Commission Implementing Directive 2011/45/EU of 13 April 2011 amending Council Directive 91/414/EEC to include diclofop as active substance and amending Commission Decision 2008/934/EC (OJ L 100, 14.4.2011, p. 47, ELI: http://data.europa.eu/eli/dir_impl/2011/45/oj).
(23) Commission Implementing Directive 2011/53/EU of 20 April 2011 amending Council Directive 91/414/EEC to include dazomet as active substance and amending Commission Decision 2008/934/EC (OJ L 105, 21.4.2011, p. 24, ELI: http://data.europa.eu/eli/dir_impl/2011/53/oj).
(24) Commission Implementing Directive 2011/54/EU of 20 April 2011 amending Council Directive 91/414/EEC to include metaldehyde as active substance and amending Commission Decision 2008/934/EC (OJ L 105, 21.4.2011, p. 28, ELI: http://data.europa.eu/eli/dir_impl/2011/54/oj).
(25) Commission Implementing Directive 2011/55/EU of 26 April 2011 amending Council Directive 91/414/EEC to include paclobutrazol as active substance and amending Commission Decision 2008/934/EC (OJ L 106, 27.4.2011, p. 5, ELI: http://data.europa.eu/eli/dir_impl/2011/55/oj).
(26) Commission Implementing Regulation (EU) 2016/177 of 10 February 2016 approving the active substance benzovindiflupyr, 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 Implementing Regulation (EU) No 540/2011 (OJ L 35, 11.2.2016, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2016/177/oj).
(27) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26, ELI: http://data.europa.eu/eli/reg_impl/2012/844/oj).
(28) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33, ELI: http://data.europa.eu/eli/reg/2018/605/oj).
ANNEX
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
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Part A is amended as follows:
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Part E is amended as follows:
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ELI: http://data.europa.eu/eli/reg_impl/2026/1421/oj
ISSN 1977-0677 (electronic edition)