Commission Implementing Regulation (EU) 2025/1489

Contents

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^note, and in particular Article 17, first paragraph, thereof,Whereas:

(1)Commission Implementing Regulation (EU) No 200/2013^note approved the active substance ametoctradin until 31 July 2023.

(2)Commission Directive 2008/113/EC^note included Beauveria bassiana strains ATCC 74040 and GHA as an active substance in Annex I to Council Directive 91/414/EEC^note until 30 April 2019.

(3)Commission Directive 2011/6/EU^note included buprofezin as an active substance in Annex I to Directive 91/414/EEC until 31 January 2021.

(4)Commission Directive 2006/39/EC^note included clodinafop as an active substance in Annex I to Directive 91/414/EEC until 31 January 2017.

(5)Commission Directive 2009/37/EC^note included copper compounds as an active substance in Annex I to Directive 91/414/EEC until 30 November 2016 and Commission Implementing Regulation (EU) 2018/1981^note renewed the approval of the active substance as candidate for substitution until 31 December 2025.

(6)Commission Implementing Regulation (EU) No 22/2013^note approved the active substance cyflumetofen until 31 May 2023.

(7)Commission Directive 2005/53/EC^note included daminozide as an active substance in Annex I to Directive 91/414/EEC until 28 February 2016.

(8)Commission Implementing Regulation (EU) 2015/2084^note approved the active substance flupyradifurone until 9 December 2025.

(9)Commission Implementing Regulation (EU) No 368/2013^note approved the active substance Helicoverpa armigera nucleopolyhedrovirus until 31 May 2023.

(10)Commission Implementing Regulation (EU) 2015/2085^note approved the active substance mandestrobin until 9 December 2025.

(11)Commission Implementing Regulation (EU) No 188/2013^note approved the active substance mandipropamid until 31 July 2023.

(12)Commission Implementing Regulation (EU) No 359/2012^note approved the active substance metam until 30 June 2022.

(13)Commission Directive 2004/30/EC^note included pyraclostrobin as an active substance in Annex I to Directive 91/414/EEC until 31 May 2014.

(14)Commission Implementing Regulation (EU) 2015/2198^note approved the active substance rescalure until 18 December 2025.

(15)Commission Implementing Regulation (EU) No 367/2013^note approved the active substance Spodoptera littoralis nucleopolyhedrovirus until 31 May 2023.

(16)Commission Implementing Regulation (EU) No 917/2014^note approved the active substance Streptomyces lydicus strain WYEC 108 until 31 December 2024.

(17)Commission Implementing Regulation (EU) No 1238/2012^note approved the active substance Trichoderma asperellum strain T34 until 31 May 2023.

(18)Commission Implementing Regulation (EU) No 17/2013^note approved the active substance Trichoderma atroviride strain I-1237 until 31 May 2023.

(19)The active substances Beauveria bassiana strains ATCC 74040 and GHA, buprofezin, clodinafop, daminozide and pyraclostrobin were included in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011^note. The active substances ametoctradin, cyflumetofen, flupyradifurone, Helicoverpa armigera nucleopolyhedrovirus, mandestrobin, mandipropamid, metam, rescalure, Spodoptera littoralis nucleopolyhedrovirus, Streptomyces lydicus strain WYEC 108, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 were included in Part B, and the active substance copper compounds was included in Part E of the Annex to that Regulation.

(20)Commission Implementing Regulation (EU) 2020/2007^note extended the approval period of the active substance Streptomyces lydicus strain WYEC 108 until 31 December 2025.

(21)Commission Implementing Regulation (EU) 2023/689^note extended the approval period of the active substance Beauveria bassiana strains ATCC 74040 and GHA until 30 September 2025, and the approval period of the active substance clodinafop until 15 December 2025.

(22)Commission Implementing Regulation (EU) 2023/918^note extended the approval periods of the active substances cyflumetofen, Helicoverpa armigera nucleopolyhedrovirus, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 until 31 October 2025, the approval period of the active substance metam until 30 November 2025, and the approval periods of the active substances ametoctradin and mandipropamid until 31 December 2025.

(23)Commission Implementing Regulation (EU) 2023/1757^note extended the approval period of the active substance daminozide until 15 September 2025.

(24)Commission Implementing Regulation (EU) 2024/324^note extended the approval period of the active substance pyraclostrobin until 15 September 2025, and the approval period of the active substance buprofezin until 15 December 2025.

(25)Applications for the respective renewals of the approval of the active substances ametoctradin, buprofezin, cyflumetofen, daminozide, Helicoverpa armigera nucleopolyhedrovirus, mandipropamid, metam, pyraclostrobin, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012^note.

(26)On 20 September 2020, 2 December 2016, 23 July 2020, 10 July 2020, 15 April 2013, 22 July 2020, 13 October 2020, 18 July 2019, 7 March 2014, 22 July 2020, 24 September 2020 and 11 September 2020, the rapporteur Member States for the active substances ametoctradin, Beauveria bassiana strains ATCC 74040 and GHA, buprofezin, cyflumetofen, daminozide, Helicoverpa armigera nucleopolyhedrovirus, mandipropamid, metam, pyraclostrobin, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 informed the co-rapporteur Member States, the Commission and the European Food Safety Authority (the ‘Authority’) that they had assessed the admissibility of the applications pursuant to Article 3 of Implementing Regulation (EU) No 844/2012, and in particular the completeness and the timeliness, of each of the applications for renewal of the approval of each of those active substances and concluded that they were admissible. Those applications have been made public by the Authority pursuant to Article 5 of Implementing Regulation (EU) No 844/2012.

(27)The risk assessments pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 for ametoctradin and mandipropamid have not yet been finalised by the respective rapporteur Member States and additional time is required to complete the remaining steps in each renewal procedure.

(28)On 9 November 2023, 18 July 2024, 9 September 2021, 20 June 2017, 26 June 2023, 31 October 2018, 9 March 2020, 10 August 2021, 19 February 2018, 9 March 2022, 31 January 2024 and 2 September 2024, the rapporteur Member States for the active substances Beauveria bassiana strains ATCC 74040 and GHA, buprofezin, clodinafop, cyflumetofen, daminozide, Helicoverpa armigera nucleopolyhedrovirus, metam, pyraclostrobin, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 submitted the draft renewal assessment report to the Authority. The Authority, pursuant to Article 12 of Implementing Regulation (EU) No 844/2012, concluded that the reports for all those active substances contained all the relevant information in the agreed format, circulated them to the applicant and to the other Member States and made them available to the public for written comments.

(29)The evaluations for Spodoptera littoralis nucleopolyhedrovirus and Trichoderma atroviride strain I-1237 have not yet been completed by the Authority and additional time is needed for it to finalise its conclusions, as well as for the Commission to adopt the ensuing risk management decisions.

(30)For the active substances Beauveria bassiana strains ATCC 74040 and GHA, cyflumetofen, Helicoverpa armigera nucleopolyhedrovirus, metam and Trichoderma asperellum strain T34, additional information for the purposes of the assessment of the approval criteria was requested by the Authority pursuant to Article 13(3) of Implementing Regulation (EU) No 844/2012 and was submitted by the applicants within the deadline given. However, additional time is needed for the Authority to complete the evaluations and to finalise its conclusions, as well as for the Commission to adopt the ensuing risk management decisions.

(31)For the active substance clodinafop, 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 Regulation (EU) 2018/605, was requested by the Authority in consultation with the Member States pursuant to Article 14(1a) of Implementing Regulation (EU) No 844/2012. The additional information was submitted by the applicants within the deadline given. The revised draft renewal assessment report has been received from the rapporteur Member State and the public consultation on it has been finalised on 3 November 2024. However, additional time is needed for the Authority to complete the evaluation and to finalise its conclusion, as well as for the Commission to adopt the ensuing risk management decision.

(32)For the active substances buprofezin, daminozide, and pyraclostrobin, the Authority has adopted its conclusions on 1 April 2025, 18 December 2024, and 28 January 2025 respectively, and has communicated them to the applicants, the Member States and the Commission. The Commission has initiated discussions on the renewal of the approvals of those active substances in the Standing Committee on Plants, Animals, Food and Feed and has presented a renewal report and a draft regulation. Additional time is necessary for the delivery of the opinion of that Committee and for the Commission to adopt the ensuing risk management decisions.

(33)Applications for the respective renewal of the approvals of the active substances copper compounds, flupyradifurone, mandestrobin, rescalure and Streptomyces lydicus strain WYEC 108 were submitted in accordance with Commission Implementing Regulation (EU) 2020/1740^note.

(34)On 22 April 2024, 9 March 2023, 7 March 2023, and 15 December 2022, the rapporteur Member States for the active substances flupyradifurone, mandestrobin, rescalure and Streptomyces lydicus strain WYEC 108 informed the co-rapporteur Member States, the Commission and the Authority that they had assessed the admissibility pursuant to Article 8 of Implementing Regulation (EU) 2020/1740, and in particular the completeness and the timeliness, of each of the applications for renewal of the approval of each of those active substances and concluded that they were admissible. Those applications have been made public by the Authority pursuant to Article 10 of Implementing Regulation (EU) 2020/1740. The dossiers for the renewal of the approval of the active substance copper compounds were submitted in December 2022 and the rapporteur Member State is still in the process of assessing the admissibility of the application for renewal of the approval of that active substance pursuant to Article 8 of Implementing Regulation (EU) 2020/1740.

(35)The risk assessments pursuant to Article 11 of Implementing Regulation (EU) 2020/1740 for active substances copper compounds, flupyradifurone, mandestrobin and Streptomyces lydicus strain WYEC 108 have not yet been finalised by the respective rapporteur Member States and additional time is required to complete the remaining steps in each renewal procedure.

(36)On 9 June 2025, the rapporteur Member State for the active substance rescalure submitted the draft renewal assessment report to the Authority. The Authority, pursuant to Article 12 of Implementing Regulation (EU) 2020/1740, is still in the process of examining whether the report containes all the relevant information in the agreed format.

(37)It is therefore likely for all of the active substances that no decision on the renewal of the approval can be taken before the expiry of their respective approval periods, between 15 September and 31 December 2025. Furthermore, the reasons for the delays in these 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.

(38)For the active substances ametoctradin, copper compounds, flupyradifurone, mandestrobin, mandipropamid and Streptomyces lydicus strain WYEC 108, the risk assessment has not been finalised yet by the rapporteur Member States. Taking into account the subsequent steps to be completed in each renewal procedure, the duration of the extension of the approval periods of these active substances should be set at 29 months for ametoctradin, and at 42 months for copper compounds, flupyradifurone, mandestrobin, mandipropamid and Streptomyces lydicus strain WYEC 108.

(39)For the active substances Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, cyflumetofen, Helicoverpa armigera nucleopolyhedrovirus, metam, rescalure, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237, the Authority needs additional time to reach a conclusion on the risk. Taking into account the subsequent steps to be completed in each renewal procedure, the duration of the extension of the approval periods of these active substances should be set at 19 and a half months for clodinafop, at 23 and a half months for Beauveria bassiana strains ATCC 74040 and GHA, cyflumetofen, Helicoverpa armigera nucleopolyhedrovirus, metam, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237, and at 29 months for rescalure.

(40)For the active substances buprofezin, daminozide and pyraclostrobin, as the delivery of an opinion of the Standing Committee on Plants, Animals, Food and Feed is pending, and in light of the remaining steps to be completed in these renewal procedures, the duration of the extension of the approval period should be set at 12 months.

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

(42)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, as appropriate under the circumstances, the earliest possible application date.

(43)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:

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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 third day following that of its publication in the Official Journal of the European Union.

1.Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)in the sixth column, expiration of approval, of row 81, Pyraclostrobin, the date is replaced by ‘15 September 2026’;

(2)in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by ‘15 September 2026’;

(3)in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘31 July 2027’;

(4)in the sixth column, expiration of approval, of row 197, Beauveria bassiana strains ATCC 74040 and GHA, the date is replaced by ‘15 September 2027’;

(5)in the sixth column, expiration of approval, of row 320, Buprofezin, the date is replaced by ‘15 December 2026’.

2.Part B of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)in the sixth column, expiration of approval, of row 22, Metam, the date is replaced by ‘15 November 2027’;

(2)in the sixth column, expiration of approval, of row 29, Trichoderma asperellum (strain T34), the date is replaced by ‘15 October 2027’;

(3)in the sixth column, expiration of approval, of row 31, Cyflumetofen, the date is replaced by ‘15 October 2027’;

(4)in the sixth column, expiration of approval, of row 32, Trichoderma atroviride strain I-1237, the date is replaced by ‘15 October 2027’;

(5)in the sixth column, expiration of approval, of row 33, Ametoctradin, the date is replaced by ‘31 May 2028’;

(6)in the sixth column, expiration of approval, of row 34, Mandipropamid, the date is replaced by ‘30 June 2029’;

(7)in the sixth column, expiration of approval, of row 38, Helicoverpa armigera nucleopolyhedrovirus, the date is replaced by ‘15 October 2027’;

(8)in the sixth column, expiration of approval, of row 42, Spodoptera littoralis nucleopolyhedrovirus, the date is replaced by ‘15 October 2027’;

(9)in the sixth column, expiration of approval, of row 79, Streptomyces lydicus strain WYEC 108, the date is replaced by ‘30 June 2029’;

(10)in the sixth column, expiration of approval, of row 91, Flupyradifurone, the date is replaced by ‘9 June 2029’;

(11)in the sixth column, expiration of approval, of row 92, Rescalure, the date is replaced by ‘18 May 2028’;

(12)in the sixth column, expiration of approval, of row 93, Mandestrobin, the date is replaced by ‘9 June 2029’.

3.In Part E of the Annex to Implementing Regulation (EU) No 540/2011, in the sixth column, expiration of approval, of row 10, Copper compounds, the date is replaced by ‘30 June 2029’.

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