EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10372/2015 ANNEX 
(POOL/E3/2015/10372/10372-EN 
ANNEX.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving medetomidine as an active substance for use in bi ocidal products  for product-
type 21 
  
EN 2   EN ANNEX  
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 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: 
(1) For industrial or professional users, safe operational 
procedures and appropriate organisational measures shall be established.Products shal l be used with appropriate 
personal protective equipment where exposure cannot be 
reduced to an acceptable level by other means. 
(2) Persons making products containing medetomidine 
available on the market for non-professional users shall 
make sure that the products are supplied with appropriate 
gloves. Labels and, where provided, instructions for use shall indicate whether other pe rsonal protective equipment 
shall be used.  
(3) Labels and, where provided, instructions for use shall 
indicate that children shall be kept away until treated surfaces are dry. 
(4) Labels and, where provided, safety data sheets of products 
authorised shall indicate that application, maintenance and 
repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance us ed for the evaluation made in a ccordance with Article 8(1) of Regulation 
(EU) No 528/2012. The active substance in the product placed on the market can be of equal or di fferent purity if it has been p roven technically equivalent with the 
evaluated active substance.  
EN 3   EN soil covered with an impermeable material to prevent 
direct losses and minimize emissions to the environment, 
and that any losses or waste containing medetomidine shall be collected for reuse or disposal. 
(5) For products that may lead to re sidues in food or feed, the 
need to set new or to amend existing maximum residue 
levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the 
Council
2 or Regulation (EC) No 396/2005 of the 
European Parliament and of the Council3 shall be verified, 
and any appropriate risk mitigation measures shall be 
taken to ensure that the applicable MRLs are not 
exceeded. 
 
                                                                                                                                                                                                                                                    
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).