EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10372/2015 
(POOL/E3/2015/10372/10372-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving medetomidine as an active substance for use in bi ocidal products  for product-
type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving medetomidine as an active substan ce for use in biocidal products for product-
type 21 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making av ailable on the market and use of biocidal 
products
1, and in particular Article 90(2) thereof, 
Whereas: (1) The United Kingdom received on 27 April 2009 an application, in accordance with 
Article 11(1) of Directive 98/8/EC  of the European Parliament and of the Council
2, for 
the inclusion of the active substance medetomidine in it s Annex I for use in product-
type 21, antifouling products, as defined in Annex V to that Directive , which 
corresponds to product-type 21 as defined in Annex V to Regulation (EU) No 528/2012 .  
(2) Medetomidine was not on the market on 14 May 2000 as an active substance of a 
biocidal product.  
(3) The United Kingdom submitted an assessment report, together with its 
recommendations, to the European Chemicals Agency on 12 March 2014 in 
accordance with Article 8(1) of Regulation (EU) No 528/2012. 
(4) The opinion of the European Chemicals Agency was formulated on 3 February 2015 
by the Biocidal Product Committee,  having regard to the conclusions of the evaluating 
competent authority.  
(5) According to that opinion, biocidal products used for product-type 21 and containing 
medetomidine may be expected to satisfy the re quirements laid down in Article 
19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions concerning 
its use are complied with.  
(6) It is therefore appropriate to approve medetomidine for use in biocidal products for 
product-type 21 subject to compliance with  certain specifications and conditions.  
                                                
 
1 OJ L 167, 27.6.2012, p. 1. 
2 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1) .  
EN 3   EN (7) The opinion concludes that the characteristics of medetomidine  render it very 
persistent (vP) and toxic (T) in accordance w ith the criteria laid down in Annex XIII to 
Regulation (EC) No 1907/2006 of the Euro pean Parliament and of the Council3. In 
addition, the opinion conclude s that the active substanc e contains a significant 
proportion of non-active isomers or impurities. 
(8) Medetomidine meets the conditions set out in  points (d) and (f) of  Article 10(1) of 
Regulation (EU) No 528/2012 and should ther efore be considered a candidate for 
substitution. 
(9) Pursuant to Article 10(4) of that Regulation, the approval of an activ e substance that is 
considered as a candidate for substitution shou ld be for a period not exceeding 7 years.  
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Medetomidine is approved as an active substan ce for use in biocidal pr oducts for product-type 
21, subject to the specifications a nd conditions set out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER 
                                                
 
3 Regulation (EC) No 1907/2006 of  the European Parliament and of  the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).