COMMISSION IMPLEMENTING REGULATION (EU) 2015/1731
of 28 September 2015
approving medetomidine as an active substance for use in biocidal products for product-type 21
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Common name |
IUPAC name Identification Numbers |
Minimum degree of purity of the active substance(1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||||
Medetomidine |
IUPAC name: (RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole EC No: not available CAS No: 86347-14-0 |
99,5 % w/w. Medetomidine is manufactured as a racemic mixture of R and S enantiomers: dexmedetomidine and levomedetomidine. |
1 January 2016 |
31 December 2022 |
21 |
Medetomidine is considered a candidate for substitution in accordance with Article 10(1)(d) and (f) of Regulation (EU) No 528/2012. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. The authorisations of biocidal products are subject to the following conditions:
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating medetomidine shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of the Regulation (EU) No 528/2012. |