BAKGRUNN (fra kommisjonsforordningen)

(1) According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009. Those substances are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 and active substances approved under Regulation (EC) No 1107/2009 are listed in Part B of that Annex, while active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution are listed in Part E of that Annex. 

(2) The active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, hexythiazox, isoxaben, lime sulphur, quinmerac, sintofen, tau-fluvalinate, tebufenozide and zinc phosphide are listed in Part A of the Annex to Implementing Regulation (EU) No 540/2011. The active substances orange oil, sodium silver thiosulfate and tembotrione are listed in Part B of that Annex and the active substance prosulfuron is listed in Part E of that Annex. 

(3) Commission Implementing Regulation (EU) 2020/2007 extended the approval period of the active substances orange oil, prosulfuron, quinmerac, sodium silver thiosulfate, tembotrione and zinc phosphide until 31 July 2024 and of the active substances 1- decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, hexythiazox, isoxaben, lime sulphur, sintofen, tau-fluvalinate and tebufenozide until 31 August 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 Regulations (EU) No 844/2012 and (EU) No 2020/1740, respectively. 

(5) For the active substances azadirachtin, bupirimate, dithianon, hexythiazox, isoxaben, lime sulphur, orange oil, quinmerac, sodium silver thiosulfate, tau-fluvalinate, tebufenozide, tembotrione and zinc phosphide, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) No 844/2012 has not yet been finalised by the respective rapporteur Member States. 

(6) For the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, dodine, fluometuron, prosulfuron and sintofen, the European Food Safety Authority (the ‘Authority’) needs additional time to reach a conclusion requiring, where appropriate, a consultation of experts. Further time is needed for the Commission to adopt the ensuing risk management decision. 

(7) Given that it is 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 31 July 2024 and 31 August 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 azadirachtin, bupirimate, dithianon, hexythiazox, isoxaben, lime sulphur, orange oil, quinmerac, sodium silver thiosulfate, tau-fluvalinate, tebufenozide, tembotrione and zinc phosphide, as the risk assessment has not yet been finalised by the 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 1-decanol, 6-benzyladenine, aluminium sulfate, dodine, fluometuron, prosulfuron and sintofen, 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,