(1)

Commission Directive 2006/85/EC (2) included ethephon as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance ethephon, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 November 2024.

(4)

On 28 and 30 July 2014, applications for the renewal of the approval of the active substance ethephon were submitted to the Netherlands, the rapporteur Member State, and Poland, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicants submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 2 August 2017.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority forwarded the draft renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 18 January 2019, the Authority requested the applicants additionnal information on the endocrine disruptive properties of ethephon pursuant to Article 13(3a) of Implementing Regulation (EU) No 844/2012. The applicants submitted information as regards the criteria to identify endocrine disrupting properties set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605 (6).

(9)

In September 2022, the rapporteur Member State made an updated draft renewal assesment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and proposed renewing the approval of ethephon.

(10)

On 7 December 2022, the Authority communicated to the Commission its conclusion (7) which indicated that ethephon can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(11)

The Commission presented a draft renewal report and a draft Regulation regarding ethephon to the Standing Committee on Plants, Animals, Food and Feed on 24 May 2023 and on 11 July 2023, respectively.

(12)

The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which have been carefully examined and taken into consideration.

(13)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance ethephon that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(14)

The risk assessment for the renewal of the approval of the active substance ethephon is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing ethephon may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.

(15)

It is therefore appropriate to renew the approval of ethephon.

(16)

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

(17)

Commission Implementing Regulation (EU) 2023/918 (8) extended the approval period of ethephon to 15 November 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(18)

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