(fra kommisjonsforordningen)

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

(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. 

(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 corapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/20125 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. 

(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 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, 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 nondietary 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 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, mecopropP 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 reentering the treated fields because this was considered by the Authority to be a worstcase 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. 

(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 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,