Biocidal products

Draft Commission Implementing Decision (EU) repealing Implementing Decision (EU) 2026/1089 postponing the expiry date of the approval of medetomidine for use in biocidal products of product-type 21 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; (3 page(s), in English)

This draft Commission Implementing Decision repeals the postponement of the expiry date of the approval of medetomidine for use in biocidal products of product type (PT) 21.

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. On 28 May 2024 the Agency adopted its opinion on medetomidine for PT21, having regard to the conclusions of the evaluating competent authority.

Given the opinion of Agency, medetomidine has endocrine disrupting properties that may cause adverse effects in humans in accordance with the criteria laid down in Commission Delegated Regulation (EU) 2017/2100. Medetomidine therefore meets the exclusion criterion set out in Article 5(1), point (d), of Regulation (EU) No 528/2012. Alternatives are available for its use in biocidal products of product-type 21. None of the derogation criteria under Article 5(2) of the BPR are considered met. Consequently, a draft Decision is being prepared to not renew the approval of medetomidine for PT 21. Further to that Decision, it is necessary to repeal the postponement of the expiry date of the approval of medetomidine for PT21. The present draft Decision therefore intends to repeal Decision (EU) 2026/1089 postponing the expiry date of the approval of medetomidine for PT21.