(1)

Medetomidine was approved as an active substance for use in biocidal products of product-type 21 by Commission Implementing Regulation (EU) 2015/1731 (2) until 31 December 2022 subject to the conditions set out in the Annex to that Regulation.

(2)

On 27 June 2021, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of medetomidine for use in biocidal products of product-type 21 (‘the application’).

(3)

On 10 December 2021, the evaluating competent authority of Norway informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(4)

The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(5)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(6)

Commission Implementing Decision (EU) 2022/1495 (3) postponed the expiry date of the approval of medetomidine for use in biocidal products of product-type 21 to 30 June 2025, in order to allow sufficient time for the examination of the application.

(7)

On 18 August 2023, the evaluating competent authority submitted the renewal assessment report and the conclusions of its evaluation to the Agency.

(8)

In accordance with Article 14(3) of Regulation (EU) No 528/2012, on 28 May 2024, the Agency adopted the opinion (4) formulated by its Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority and submitted it to the Commission.

(9)

According to the opinion of the Agency, medetomidine is considered as having endocrine-disrupting properties that may cause adverse effects in humans, and therefore meets the exclusion criterion set out in Article 5(1), point (d), of Regulation (EU) No 528/2012.

(10)

Pursuant to Article 5(2), first subparagraph, of Regulation (EU) No 528/2012, active substances meeting an exclusion criterion may only be approved if they meet the conditions laid down in Article 4(1), and at least one of the conditions set out in Article 5(2), first subparagraph, of that Regulation.

(11)

Between 6 September 2024 and 6 November 2024, the Commission, with the support of the Agency, carried out a third parties consultation in order to contribute to gathering information as to whether the conditions set out in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 were satisfied for medetomidine.

(12)

Commission Implementing Decision (EU) 2025/953 (5) postponed the expiry date of the approval of medetomidine for use in biocidal products of product-type 21 to 30 June 2026, in order to allow sufficient time for the Commission to complete the examination of the application.

(13)

The opinion of the Agency and the contributions to the third parties consultation are still subject to discussion with Member State representatives in the Standing Committee on Biocidal Products. Considering the time still needed to complete this discussion, it will not be possible to adopt a decision on the application for renewal of approval of medetomidine before the current expiry of approval.

(14)

Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time needed to complete the examination of the application. Taking into account the time needed for the Commission to complete the discussion in the Standing Committee on Biocidal Products and to decide whether to renew the approval of medetomidine for use in biocidal products of product-type 21, the expiry date should be postponed to 31 December 2026.

(15)

After the further postponement of the expiry date of the approval, medetomidine remains approved for use in biocidal products of product-type 21 subject to the conditions set out in the Annex to Implementing Regulation (EU) 2015/1731,