Extension of the approval period of some active substances

(1)

Pursuant to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC (2) are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex Commission Implementing Regulation (EU) No 540/2011 (3). Active substances approved under Regulation (EC) No 1107/2009 are listed in Part B of that Annex.

(2)

Commission Implementing Regulation (EU) 2022/708 (4) extends the approval period of the active substance flurochloridone until 31 May 2023. That Regulation also extends the approval period of the active substance metam until 30 June 2023 and of the active substances aclonifen, beflubutamid, benthiavalicarb, boscalid, captan, dimethomorph, ethephon, fluoxastrobin, folpet, formetanate, metazachlor, metribuzin, milbemectin, phenmedipham, pirimiphos-methyl, propamocarb, proquinazid, prothioconazole and S-metolachlor until 31 July 2023.

(3)

Commission Implementing Regulation (EU) 2018/1266 (5) extends the approval period of the active substances clethodim, cycloxydim, dazomet, diclofop, fenazaquin, hymexazol, indolylbutyric acid, metaldehyde and paclobutrazol until 31 May 2023.

(4)

Commission Implementing Regulation (EU) 2017/1527 (6) extends the approval period of the active substance fluopicolide until 31 May 2023.

(5)

Commission Implementing Regulation (EU) 2017/2069 (7) extends the approval period of the active substance metalaxyl until 30 June 2023, and of the active substance penoxsulam until 31 July 2023.

(6)

The approval of the active substance ametoctradin is set to expire on 31 July 2023 in accordance with Commission Implementing Regulation (EU) No 200/2013 (8).

(7)

The approval of the active substance cyflumetofen is set to expire on 31 May 2023 in accordance with Commission Implementing Regulation (EU) No 22/2013 (9).

(8)

The approval of the active substance Helicoverpa armigera nucleopolyhedrovirus is set to expire on 31 May 2023 in accordance with Commission Implementing Regulation (EU) No 368/2013 (10).

(9)

The approval of the active substance mandipropamid is set to expire on 31 July 2023 in accordance with Commission Implementing Regulation (EU) No 188/2013 (11).

(10)

The approval of the active substance Spodoptera littoralis nucleopolyhedrovirus is set to expire on 31 May 2023 in accordance with Commission Implementing Regulation (EU) No 367/2013 (12).

(11)

The approval of the active substance Trichoderma asperellum strain T34 is set to expire on 31 May 2023 in accordance with Commission Implementing Regulation (EU) No 1238/2012 (13).

(12)

The approval of the active substance Trichoderma atroviride strain I-1237 is set to expire on 31 May 2023 in accordance with Commission Implementing Regulation (EU) No 17/2013 (14).

(13)

Applications and supplementary dossiers for the renewal of the approval of those active substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (15), which continues to apply to these active substances pursuant to Article 17 of Commission Implementing Regulation (EU) 2020/1740 (16). They were declared admissible by the respective rapporteur Member States.

(14)

For the active substances aclonifen, ametoctradin, beflubutamid, clethodim, cycloxydim, cyflumetofen, dazomet, diclofop, fenazaquin, fluopicolide, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, mandipropamid, metalaxyl, metaldehyde, metam, metazachlor, paclobutrazol, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237, 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.

(15)

For the active substances boscalid, flurochloridone, indolylbutyric acid, penoxsulam, and proquinazid, the European Food Safety Authority (‘the Authority’) will need additional time, in accordance with Article 13 of Implementing Regulation (EU) No 844/2012, to adopt a conclusion and where appropriate to organise a consultation of experts. Furthermore, additional time is needed for the ensuing risk management decision in accordance with Article 14 of Implementing Regulation (EU) No 844/2012.

(16)

For the active substance prothioconazole, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 was requested by the Authority pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012, with a deadline of 15 April 2023. For the active substances dimethomorph, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, paclobutrazol, penoxsulam, phenmedipham, pirimiphos-methyl and propamocarb, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, was requested by the Authority pursuant to 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 its evaluation and for the related conclusion as well as for the ensuing risk management decision in accordance with Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

(17)

For the active substances benthiavalicarb and captan, the Authority has submitted its conclusion in accordance with Article 13 of Implementing Regulation (EU) No 844/2012. The Commission has initiated discussions on those active substances in the Standing Committee on Plants, Animals, Food and Feed pursuant to Article 14 of Implementing Regulation (EU) No 844/2012 and as regards captan, it has presented the renewal report and the draft Regulation renewing its approval. Pending the opinion of this Committee on that draft Regulation, additional time is needed for the ensuing risk management decision in accordance with Article 14 of Implementing Regulation (EU) No 844/2012.

(18)

For the active substance S-metolachlor, on 3 February 2023, the Authority has submitted to the Commission and Member States its conclusion in accordance with Article 13 of Implementing Regulation (EU) No 844/2012, excluding the assessment of the endocrine disrupting properties. However, additional time is needed for adopting a risk management decision in accordance with Article 14 of Implementing Regulation (EU) No 844/2012.

(19)

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 31 May 2023, 30 June 2023 and 31 July 2023. The reasons for the delay in the renewal procedures are also beyond the control of the respective applicants.

(20)

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 and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of the active substances should be extended in order to enable the completion of the assessments required and finalise the regulatory decision-making procedures on the respective applications for renewal of approval. Commission Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(21)

In case the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

(22)

Taking into account that the current approval of clethodim, cycloxydim, cyflumetofen, dazomet, diclofop, fenazaquin, fluopicolide, flurochloridone, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, indolylbutyric acid, metaldehyde, paclobutrazol, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 expires on 31 May 2023, this Regulation should enter into force as soon as possible.

(23)

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