Biocidal products

Draft Commission Implementing Decision (EU) not renewing the approval of medetomidine as an active substance 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; (6 page(s), in English)

This draft Commission Implementing Decision does not renew the approval of medetomidine as an active substance for use in biocidal products of product-type 21.

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[1]. 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.

It is therefore appropriate not to renew the approval of medetomidine as an active substance for use in biocidal products of product-type 21. The opinion of the European Chemicals Agency can be found on its website (Biocidal Products Committee opinions on active substance approval - ECHA (europa.eu)