BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) No 193/2014 approved the active substance amisulbrom until 30 June 2024. Commission Implementing Regulation (EU) No 151/2014 approved the active substance S-abscisic acid until 30 June 2024. Commission Implementing Regulation (EU) No 145/20144 approved the active substance thiencarbazone until 30 June 2024. Commission Implementing Regulation (EU) No 144/2014 approved the active substance valifenalate until 30 June 2024.

(2) The active substances amisulbrom, s-abscisic acid, thiencarbazone and valifenalate are listed in Part B of the Annex of Commission Implementing Regulation (EU) No 540/2011. 

(3) Commission Implementing Regulation (EU) 2020/20077 extends the approval period of the active substances amisulbrom, s-abscisic acid, thiencarbazone and valifenalate until 30 September 2024. 

(4) Applications and supplementary dossiers for the renewal of the approvals of each of those active substances were submitted in accordance with Commission Implementing Regulation (EU) 2020/17408 three years before the extended expiry date of the active substances. On 3 May 2023, 11 April 2022, 28 June 2026 and 4 July 2022 the rapporteur Member States of amisulbrom, s-abscisic acid, thiencarbazone and valifenalate respectively informed the Commission that it had checked the admissibility, in particular the completeness and the timeliness, of each of these applications, and concluded that they were admissible. 

(5) For the active substances thiencarbazone and valifenalate, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) 2020/1740 has not yet been finalised by the respective rapporteur Member States . 

(6) For the active substances amisulbrom and s-abscisic acid, the European Food Safety Authority (the ‘Authority’) needs additional time to reach a conclusion requiring, where appropriate, a consultation of experts. Additional time is needed for the Commission to adopt the ensuing risk management decision. 

(7) It is therefore likely that no decision on the renewal of the approval of these active substances can be taken before the expiry of their respective approval periods on 30 September 2024, and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of those active substances should be extended in order to enable the completion of the assessments required and to finalise the respective procedures on renewal of approval.

(8) For the active substances thiencarbazone and valifenalate, as the risk assessment has not yet been finalised by the respective rapporteur Member States and in light of the time required to complete the remaining steps in each renewal procedure, the duration of the extension of the approval periods should be set at 29 months. 

(9) For the active substances amisulbrom and s-abscisic acid, as the Authority needs additional time to reach a conclusion on their risk assessment , the duration of the extension of the approval period for these active substances should be set at 23 months and 2 weeks. 

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

(11) In case the Commission adopts a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed, the Commission will set the expiry date at the date of entry into force of that Regulation or at the same date as it stood before the adoption of this Regulation, whichever date is later. In case the Commission adopts a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set the earliest possible application date, as appropriate under the circumstances. 

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