ECHA Launches Consultation on Medetomidine

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for medetomidine in accordance with Articles 10 and 5 of Regulation (EU) No 528/2012 (the Biocidal Products Regulation, BPR). The Biocidal Products Committee (BPC) has determined that medetomidine does not meet the renewal criteria for product type 21 set out in Article 5(1)(d) of the BPR. As a result, the approval for medetomidine will not be renewed unless it meets one of the exceptions specified in Article 5(2). 

Overview of Medetomidine 

Medetomidine is a synthetic compound used as an anaesthetic and analgesic in veterinary medicine and as a sedative in human medicine. It consists of two stereoisomers, of which dexmedetomidine exhibits significant biocidal activity as an antifouling agent. Dexmedetomidine selectively activates α2 adrenoceptors, reducing norepinephrine release and decreasing central nervous system excitation, which contributes to its sedative effects and potential toxicity. In antifouling applications, medetomidine binds to octopamine receptors on marine larvae, increasing their motility and preventing settling.  

Safety Assessment 

The BPC has concluded that medetomidine is not mutagenic, carcinogenic, or a reproductive toxicant. However, it does exhibit endocrine-disrupting properties that  affect and related biological pathways. Although there are no standardized methods for assessing these effects, medetomidine is categorized as an endocrine disruptor under EU regulations. Traditional exposure assessment revealed no significant risks, except for young children who may come into contact with freshly treated surfaces. However, a definitive conclusion regarding the overall risk to human health remains elusive. 

Substitution 

Medetomidine has been determined to meet the exclusion criteria specified in Article 5(1)(d) of the BPR, making it eligible for substitution under Article 10. This classification is due to its identification as a persistent, bio-accumulative, and toxic (PBT) substance containing a significant amount of non-active isomers. The assessment was carried out in accordance with guidelines established during recent meetings of Member State Competent Authorities, focusing on the relevant exclusion and substitution criteria in the BPR. 

Consultation Deadline 

The consultation for medetomidine will close on November 6, 2024.