Commission Implementing Regulation (EU) 2026/2025 of 10 September 2026 renewing the approval of the active substance mecoprop-P as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

Official Journal EN of the European Union L series 2026/2025 11.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2025 of 10 September 2026 renewing the approval of the active substance mecoprop-P as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (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 20(1) in conjunction with Article 24(1) thereof,

Whereas:

(1) Commission Directive 2003/70/EC(2) included mecoprop-P as an active substance in Annex I to Council Directive 91/414/EEC(3).

(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation

(EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation

(EU) No 540/2011(4).

(3) The approval of the active substance mecoprop-P, as set out in Part A of the Annex to Implementing Regulation

(EU) No 540/2011, expires on 15 October 2027.

(4) An application for the renewal of the approval of the active substance mecoprop-P was submitted to the United Kingdom, the rapporteur Member State, and Ireland, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012(5) and within the time period provided for in that Article.

(5) The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 1 April 2016. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of mecoprop-P, as a candidate for substitution due to its high persistence in fresh water and toxicity for fresh water organisms.

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

(2) Commission Directive 2003/70/EC of 17 July 2003 amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as active substances (OJ L 184, 23.7.2003, p. 9, ELI: http://data.europa.eu/eli/dir/2003/70/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) 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).

(5) 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).

ELI: http://data.europa.eu/eli/reg_impl/2026/2025/oj 1/6EN OJ L, 11.9.2026

(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8) On 18 May 2017, the Authority communicated to the Commission its conclusion(6)on whether mecoprop-P can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9) In its conclusion, the Authority identified two critical areas of concern. The first concern related to the exposure of workers when re-entering the treated fields. The second concern concerned a high long-term risk to wild mammals.

Furthermore, the Authority noted that mecoprop-P is unlikely to be an endocrine disruptor in humans, but that a conclusion in fish and birds could not be drawn.

(10) The Commission presented a draft renewal report for mecoprop-P to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017.

(11) Since it was not possible for the risk managers to conclude whether mecoprop-P is an endocrine disruptor in accordance with the scientific criteria for the determination of endocrine disrupting properties set out in points

3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation

(EU) 2018/605(7), the Commission asked the Authority on 4 December 2018 to re-assess the existing information, to request additional information from the applicant if needed and to update its conclusion on the endocrine disrupting potential of mecoprop-P pursuant to Article 13(3a), first subparagraph, of Implementing Regulation

(EU) No 844/2012. The Authority was also asked to review the risk assessment as regards non-dietary exposure to cover realistic agricultural practices.

(12) Following the departure of the United Kingdom from the Union, the ongoing application for renewal of approval of mecoprop-P was reallocated to Ireland as rapporteur Member State. Ireland therefore updated the draft renewal assessment report upon request of the Authority.

(13) On 16 May 2022, the rapporteur Member State made the updated draft renewal assessment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and the non-dietary exposure. The rapporteur Member State concluded that the criteria for endocrine disrupting properties are not met and found the non-dietary exposure assessment to be acceptable. The rapporteur Member State therefore proposed renewing the approval of mecoprop-P as a candidate for substitution.

(14) On 29 September 2023, the Authority communicated to the Commission its updated conclusion(8)indicating that plant protection products containing mecoprop-P can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that, based on the scientific evidence, mecoprop-P does not meet the criteria for endocrine disruption. Furthermore, the Authority no longer identified a critical area of concern for the exposure of workers when re-entering the treated fields because this was considered by the Authority to be a worst-case scenario, not matching realistic agricultural practices. On the basis of a new study submitted by the applicant, the Authority also no longer identified a high long-term risk to wild mammals.

However, a critical area of concern was identified regarding the exposure of children entering treated areas. The Commission considers that this concern can be addressed by adjusting the application rate for the representative uses on winter and spring cereals so that the exposure of children to vapour and spray drift does not exceed the agreed acceptable toxicological reference value.

(6) Conclusion on pesticides peer review of the pesticide risk assessment of the active substance mecoprop-P; EFSA Journal, 2017;15(5):4832, 23 pp., https://doi.org/10.2903/j.efsa.2017.4832.

(7) 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).

(8) Updated conclusion on pesticides peer review of the pesticide risk assessment of the active substance mecoprop-P; EFSA Journal, 2023:21(10), 26 pp., https://doi.org/10.2903/j.efsa.2023.8344.

2/6 ELI: http://data.europa.eu/eli/reg_impl/2026/2025/ojEN OJ L, 11.9.2026

(15) The Commission presented the updated renewal report on 2 October 2025 and a draft of this Regulation on 29 June 2026 to the Standing Committee on Plants, Animals, Food and Feed.

(16) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the updated renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

(17) It has been established with respect to one or more representative uses of at least one plant protection product containing mecoprop-P that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of mecoprop-P.

(18) Although the risk assessment for the renewal of the approval of the active substance mecoprop-P is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing mecoprop-P may be authorised. It is therefore appropriate not to maintain the restriction to use as a herbicide.

(19) The Commission, however, considers that mecoprop-P is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Based on the endpoints listed in Appendix A of the updated EFSA Conclusion of 2023, mecoprop-P is considered a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water is higher than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L.

Mecoprop-P therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation

(EC) No 1107/2009.

(20) It is therefore appropriate to renew the approval of mecoprop-P as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009.

(21) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge as well as the outcome of the risk assessment, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate that the Member States pay particular attention to the nature and magnitude of residues of mecoprop-P in food of plant and animal origin to evaluate the dietary exposure of consumers, to the protection of children residing close to the fields where mecoprop-P is used, to the protection of operators and workers, in particular during mixing and loading and while inspecting treated crops, and to the protection of non-target terrestrial plants and birds.

(22) In addition, to increase confidence in the decision to renew the approval, because the risk assessment for birds could not be finalised, the applicant should submit to the Commission, the Member States and the Authority the full report of the Avian Reproduction Test performed according to OECD Test Guideline 206, as confirmatory information.

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

(24) Commission Implementing Regulation (EU) 2025/787(9) extended the approval period of mecoprop-P until 15 October 2027 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on the renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.

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

(9) 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 (OJ L, 2025/787, 25.4.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/787/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/2025/oj 3/6EN OJ L, 11.9.2026

HAS ADOPTED THIS REGULATION:

Article 1 Renewal of the approval of the active substance The approval of the active substance mecoprop-P, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011 The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 October 2026.

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

Done at Brussels, 10 September 2026.

For the Commission The President Ursula VON DER LEYEN 4/6 ELI: http://data.europa.eu/eli/reg_impl/2026/2025/ojANNEX I Common Name, Expiration of IUPAC Name Purity(1) Date of approval Specific provisions Identification Numbers approval Mecoprop-P (2R)-2-(4-chloro-2- ≥ 890 g/kg 1 October 2026 30 September For the implementation of the uniform principles as

CAS No: 16484-77-8 methylphenoxy) 2033 referred to in Article 29(6) of Regulation 4-chloro-2-methylphenol propanoic acid (EC) No 1107/2009, the conclusions of the renewal report

CIPAC No: 475 (PCOC) < 5 g/kg on mecoprop-P of 30 June 2026 and any subsequent updates, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay

particular attention to: — the nature and magnitude of residues in food of plant and animal origin to evaluate the dietary exposure of consumers; — the protection of resident children; — the protection of operators and workers in particular during mixing and loading and while inspecting treated crops;

— the protection of non-target terrestrial plants and birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit the full report of the Avian Reproduction Test performed according to OECD Test Guideline 206 as confirmatory information by 1 April

2027.

(1) Further details on the identity and specification of the active substance are provided in the renewal report.

ELI:

http://data.europa.eu/eli/reg_impl/2026/2025/oj 5/6 OJ L,

11.9.2026 ENANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1) in Part A, entry 57 on mecoprop-P is deleted;

(2) in Part E, the following entry is added:

Common Name, Expiration of No IUPAC Name Purity(1) Date of approval Specific provisions Identification Numbers approval ‘17 Mecoprop-P (2R)-2-(4-chloro- ≥ 890 g/kg 1 October 2026 30 September For the implementation of the uniform principles as

CAS No: 16484-77-8 2-methylphenoxy) 2033 referred to in Article 29(6) of Regulation 4-chloro-2- propanoic acid (EC) No 1107/2009, the conclusions of the renewal

CIPAC No: 475 methylphenol report on mecoprop-P of 30 June 2026 and any

(PCOC) < 5 g/kg subsequent updates, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay

particular attention to: — the nature and magnitude of residues in food of plant and animal origin to evaluate the dietary exposure of consumers; — the protection of resident children; — the protection of operators and workers in particular during mixing and loading and while inspecting treated crops;

— the protection of non-target terrestrial plants and birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit the full report of the Avian Reproduction Test performed according to OECD Test Guideline 206 as confirmatory information by 1 April

2027.’

(1) Further details on the identity and specification of the active substance are provided in the renewal report.

6/6

ELI:

http://data.europa.eu/eli/reg_impl/2026/2025/oj EN OJ L,

11.9.2026