(fra kommisjonsforordningen)

(1) Commission Directive 2008/127/EC included pelargonic acid 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 pelargonic acid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 1 December 2026. 

(4) An application for the renewal of the approval of the active substance pelargonic acid was submitted to Greece, the rapporteur Member State, and to Austria, 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 applicants submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The rapporteur Member State considered the application admissible. 

(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 5 May 2020. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of pelargonic acid. 

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

(8) The Authority communicated to the Commission its conclusion on 29 July 2021 and its updated conclusion7 on 16 April 2025, according to which, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing pelargonic acid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified risks with respect to groundwater, aquatic organisms, non-target arthropods including bees and soil organisms for some but not all representative uses evaluated, but no critical area of concern. 

(9) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 13 October 2022 and 25 January 2023, respectively. 

(10) The Commission invited the applicants to submit their 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 renewal report. The applicants submitted their comments, which have been carefully examined and taken into consideration. 

(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pelargonic acid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(12) Although the risk assessment for the renewal of the approval of the active substance pelargonic acid is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing pelargonic acid may be authorised. 

(13) It is therefore appropriate to renew the approval of pelargonic acid. 

(14) 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 and the outcome of the risk assessment, it is necessary to require that Member States, when authorising plant protection products containing pelargonic acid, pay particular attention to the protection of groundwater, aquatic organisms, non-target arthropods including bees and soil organisms, including by imposing mitigation measures if appropriate, taking into account the local agroecological conditions and the modalities of use of the plant protection products. 

(15) Pelargonic acid has been listed in the Annex to Implementing Regulation (EU) No 540/2011 in the same entry as several other fatty acids. Following the renewal of the approval of pelargonic acid, this entry should be modified to remove pelargonic acid, which should be listed under a specific entry. 

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

(17) Commission Implementing Regulation (EU) 2024/2221 extended the expiry date of pelargonic acid to 1 December 2026 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 renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. 

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