(fra kommisjonsforordningen)

(1) Commission Directive 2011/6/EU included buprofezin 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 buprofezin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 March 2027. 

(4) An application for the renewal of the approval of the active substance buprofezin was submitted to Italy, the rapporteur Member State, and Austria, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/20125 within the time period provided for in that Article. 

(5) The applicant submitted the supplementary dossier 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 9 September 2021. In that draft renewal assessment report, based on the assessment of the data available at that time, the rapporteur Member State proposed to renew the approval of buprofezin. 

(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. 

(8) On 16 April 2025, the Authority communicated to the Commission its conclusion6 on whether buprofezin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(9) The Authority identified several concerns. In particular, it concluded that buprofezin meets the criteria to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and that it has not been demonstrated that the exposure of humans to that active substance in a plant protection product, under proposed realistic conditions of use, is negligible. In addition, the assessment of endocrine disrupting properties of buprofezin for non-target organisms other than mammals could not be conducted due to the lack of relevant data. 

(10) Furthermore, the assessment of the risks to consumers considering potential residues present in honey and in succeeding crops, the risks for bees and other non-target arthropods for the uses in non-permanent greenhouses and the risk for aquatic organisms could not be finalised due to the lack of appropriate data. 

(11) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 10 December 2025. 

(12) The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into due consideration. However, these comments did not eliminate the concerns regarding the active substance buprofezin. 

(13) Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing buprofezin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance buprofezin, in accordance with Article 20(1), point (b), of that Regulation. 

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

(15) Member States should be given sufficient time to withdraw authorisations for plant protection products containing buprofezin. 

(16) The concerns for human health, animal health and the environment identified during the risk assessment are serious but are not immediate within the meaning of Article 20(2), second subparagraph, of Regulation (EC) No 1107/2009. When withdrawing the authorisations of plant protection products containing buprofezin, Member States may therefore grant grace periods in accordance with Article 46 of Regulation (EC) No 1107/2009 that should expire within 12 months from the date of entry into force of this Regulation. 

(17) Commission Implementing Regulation (EU) 2026/XXX7 [Publications Office please insert here the number of the Implementing Regulation adopted under PLAN/2026/1408] extended the approval period of buprofezin to 15 March 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 non-renewal of the approval is taken ahead of the expiry date of that extended approval period, 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,