BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) No 827/2013 approved the active substance Aureobasidium pullulans (strains DSM 14940 and DSM 14941) until 31 January 2024. 

(2) Commission Implementing Regulation (EU) No 1316/2014 approved the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747 until 31 March 2025. 

(3) Commission Implementing Regulation (EU) No 1175/2013 approved the active substance benalaxyl-M until 30 April 2024.

(4) Commission Directive 2006/64/CE included cyprodinil and fosetyl as active substances in Annex I to Council Directive 91/414/EEC until 30 April 2017. 

(5) Commission Directive 2006/74/EC included dichlorprop-P and pyrimethanil as active substances until 31 May 2017. 

(6) Commission Directive 2007/5/EC included formetanate as an active substance until 30 September 2017. 

(7) Commission Implementing Regulation (EU) No 356/2013 approved the active substance halosulfuron-methyl until 30 September 2023. 

(8) Commission Directive 2003/23/EC included imazamox as an active substance until 30 June 2013. 

(9) Commission Directive 2005/58/EC included milbemectin as active substance until 30 November 2015. 

(10) Commission Directive 2004/58/EC included phenmedipham as an active substance until 28 February 2015. 

(11) Commission Directive 2006/39/EC included pirimicarb and triticonazole as active substances until 31 January 2017. 

(12) Commission Implementing Regulation (EU) No 829/2013 approved the active substance Pseudomonas sp. strain DSMZ 13134 until 31 January 2024. 

(13) Commission Implementing Regulation (EU) No 833/2013 approved the active substance pyriofenone until 31 January 2024. 

(14) Commission Implementing Regulation (EU) No 1176/2013 approved the active substance pyroxsulam until 30 April 2024. 

(15) Commission Directive 2007/6/EC included spinosad as an active substance until 31 January 2017. 

(16) Commission Directive 2009/70/EC included sulphur as an active substance until 31 December 2019. 

(17) Commission Directive 2008/113/EC included several micro-organisms such as Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11 and Trichoderma gamsii (formerly T. viride) strain ICC080 as active substances until 30 April 2019. 

(18) Commission Directive 2003/81/EC included ziram as active substance until 31 July 2014. 

(19) The active substances cyprodinil, dichlorprop-P, formetanate, fosetyl, milbemectin, phenmedipham, pirimicarb, pyrimethanil, spinosad, sulphur, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, triticonazole and ziram were included in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011. The active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, halosulfuron-methyl, Pseudomonas sp. strain DSMZ 13134, pyriofenone and pyroxsulam were included in Part B, and the active substance imazamox was included in Part E of the Annex to that Regulation. 

(20) Commission Implementing Regulation (EU) 2020/2007 extended the approval periods of the active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Pseudomonas sp. strain DSMZ 13134, pyriofenone and imazamox until 31 January 2025, and the approval periods of the active substances benalaxyl-M and pyroxsulam until 30 April 2025. 

(21) Commission Implementing Regulation (EU) 2023/689 extended the approval periods of the active substances cyprodinil, dichlorprop-P, fosetyl, pirimicarb, pyrimethanil, spinosad, triticonazole and ziram until 15 March 2025, and the approval periods of the active substances Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, and Trichoderma gamsii (formerly T. viride) strain ICC080, until 15 April 2025. 

(22) Commission Implementing Regulation (EU) 2023/918 extended the approval periods of the active substances formetanate, milbemectin and phenmedipham until 15 February 2025.

(23) Commission Implementing Regulation (EU) 2023/1446 extended the approval period of the active substance halosulfuron-methyl until 31 March 2025. 

(24) Commission Implementing Regulation (EU) 2023/2592 extended the approval period of the active substance sulphur until 15 April 2025. 

(25) Applications and supplementary dossiers for the respective renewal of the approvals of each of those active substances were submitted in accordance with Commission Implementing Regulation (EU) 2020/1740. 

(26) On 1 October 2014, 27 November 2015, 6 April 2016, 16 December 2015, 10 December 2020, 17 June 2015, 15 May 2015, 1 February 2016, 10 December 2015, 26 November 2015, 21 February 2017, 31 May 2016, 30 November 2015 and 31 October 2014, the rapporteur Member States for the active substances cyprodinil, dichlorprop-P, formetanate, fosetyl, halosulfuron-methyl, milbemectin, phenmedipham, pirimicarb, pyrimethanil, spinosad, sulphur, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, triticonazole and ziram informed the co-rapporteur Member States, the Commission and the European Food Safety Authority (the ‘Authority’) that they had assessed the admissibility, and in particular the completeness and the timeliness, of each of the applications for renewal of the approvals of each of those active substances , and concluded that they were admissible. 

(27) The supplementary dossiers for the renewal of the approval of the active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, imazamox, Pseudomonas sp. strain DSMZ 13134, pyriofenone and pyroxsulam were submitted via the central submission system on 28 January 2022, 31 March 2022, 27 April 2022, 31 January 2022, 28 January 2022, 27 January 2022 and 30 April 2022 respectively, and the rapporteur Member States are still in the process of assessing the admissibility of the applications for the renewal of the approval of each of those active substances. As a consequence, the risk assessment pursuant to Article 11 of Implementing Regulation (EU) 2020/1740 has not yet been finalised by the respective rapporteur Member States and additional time is required to complete the remaining steps in each renewal procedure. The applications for the renewal of the approval of the active substances Bacillus amyloliquefaciens subsp. plantarum D747, imazamox, pyriofenone and pyroxsulam have been made public by the Authority pursuant to Article 10 of Implementing Regulation (EU) 2020/1740. 

(28) For the active substances Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, and Trichoderma gamsii (formerly T. viride) strain ICC080, the Authority needs additional time to conclude the risk assessment carried out for the substances, including, where appropriate, to organise a public consultation and a consultation of experts. Additional time is also necessary for the Commission to adopt the ensuing risk management decisions. 

(29) For the active substances fosetyl, phenmedipham and spinosad, for the purposes of assessment of the approval criteria set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, and in accordance with Article 14(1a) of Implementing Regulation (EU) No 844/2012, the Authority needs additional time to issue the conclusion related to those approval criteria. Additional time is also necessary for the Commission to adopt the ensuing risk management decisions. 

(30) For the active substances cyprodinil, formetanate, halosulfuron-methyl, pirimicarb, triticonazole and ziram, additional information for the purposes of assessment of the approval criteria set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Regulation (EU) 2018/605, was requested by the Authority pursuant Article 13(3a) of Implementing Regulation (EU) No 844/2012 and was submitted by the applicants within the deadline given. However, additional time is needed for the evaluation of the Authority and for the issuance of the related conclusion by risk assessors, as well as for the Commission to adopt the ensuing risk management decisions. 

(31) For the active substance dichlorprop-P, the Authority has communicated its conclusion to the applicant, the Member States and the Commission. However, for the purpose of efficiency, the Commission is awaiting the outcome of the Authority’s evaluation of the parallel application concerning the same substance submitted pursuant to Article 7 of Regulation (EC) No 1107/2009 before presenting a renewal report and a draft Regulation on the renewal of the approval of this active substance to the Standing Committee on Plants, Animals, Food and Feed. 

(32) For the active substances milbemectin, pyrimethanil and sulphur, the Authority has communicated its conclusions to the applicant, the Member States and the Commission. The Commission has presented a renewal report and a draft Regulation on the renewal of the approvals of those active substances to the Standing Committee on Plants, Animals, Food and Feed. Additional time is necessary for the delivery of the opinion of that Committee and for the Commission to adopt the ensuing risk management decisions. 

(33) It is therefore likely that no decision on the renewal of the approvals of all the active substances covered by this Regulation can be taken before the expiry of their respective approval periods, between 31 January and 30 April 2025. Furthermore, the reasons for the delays in these renewal procedures are beyond the control of the respective applicants. Therefore, 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 the renewal of the approvals. 

(34) For the active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, imazamox, Pseudomonas sp. strain DSMZ 13134, pyriofenone and pyroxsulam, as the risk assessment has not yet been finalised by the respective rapporteur Member States and in light of the remaining steps to be completed in each renewal procedure, the duration of the extension of the approval periods should be set at 29 months. 

(35) For the active substances cyprodinil, formetanate, fosetyl, halosulfuron – methyl, phenmedipham, pirimicarb, spinosad, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11 and Trichoderma gamsii (formerly T. viride) strain ICC080, as the Authority needs additional time to reach a conclusion on the risk , and in light of the remaining steps to be completed in each renewal procedure, the extension of the approval period for each of these active substances should be set at 19 months and 2 weeks. 

(36) For the active substances triticonazole and ziram, the Authority needs additional time to reach a conclusion on the risk assessment because the assessment of the additional information submitted by the applicants has not yet been finalised by the respective rapporteur Member States. In light of the remaining steps to be completed in these renewal procedures, the duration of the extension of the approval period for these active substances should be set at 22 months and 2 weeks. 

(37) For the active substances dichlorprop-P, milbemectin, pyrimethanil and sulphur, as the delivery of an opinion of the Standing Committee on Plants, Animals, Food and Feed is pending, and in light of the remaining steps to be completed in these renewal procedures, the duration of the extension of the approval period should be set at 19 months and 2 weeks for dichlorprop-P, pending the outcome of the Authority’s evaluation of the parallel application amending the conditions of approval, and at 15 months and 2 weeks for the other active substances. 

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

(39) 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, as appropriate under the circumstances, the earliest possible application date. 

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