(fra kommisjonsforordningen)

(1) On 2 July 2018, the Netherlands received an application from FMC International Switzerland Sarl (‘the applicant’) pursuant to Article 7(1) of Regulation (EC) No 1107/2009 for the approval of the active substance bixlozone. 

(2) On 28 August 2018, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application in accordance with Article 9(3) of Regulation (EC) No 1107/2009. 

(3) On 31 August 2021, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether bixlozone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. In its draft assessment report, the rapporteur Member State proposed that bixlozone can be approved as an active substance. 

(4) The Authority circulated the draft assessment report to the applicant and the other Member States. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report on 31 October 2023. 

(5) On 2 October 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance bixlozone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. 

(6) The Commission presented a review report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 2 October 2025 and 10 December 2025, respectively. 

(7) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report. The applicant submitted its comments, which were taken into due consideration. 

(8) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. 

(9) It is therefore appropriate to approve bixlozone. 

(10) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions. It is, in particular appropriate to set a maximum level for one impurity (TBAB) in the active substance as manufactured. In addition, in order to confirm the acceptability of the proposed reference specification, confirmatory information is required on the technical specification of the active substance as commercially manufactured, on the relevance of one of the impurities and on the compliance of the toxicity batches with the confirmed technical specification. Furthermore, in order to confirm the conclusion that there are no concerns expected from exposure through the diet, it is appropriate to require further confirmatory information on the natural occurrence, toxicity and relevance of several metabolites of bixlozone and the effect of water treatment processes on the nature of residues present in surface water and groundwater, when abstracted for drinking water. 

(11) In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly. 

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