EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11133/2015 CIS 
(POOL/E3/2015/11133/11133-EN 
CIS.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING DECISION (EU) …/… 
of XXX  
not approving cybutryne as an existing active  substance for use in biocidal products for 
product-type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION (EU) …/… 
of XXX  
not approving cybutryne as an existing active  substance 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 the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Regul ation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes cybutryne. 
(2) Cybutryne has been evaluated in accordance with Article 16(2) of  Directive 98/8/EC 
of the European Parliament and of the Council3 for use in product-type 21, antifouling 
products, as defined in Annex V to that Directive, whic h corresponds to product-type 
21, as defined in Annex V to Regulation (EU) No 528/2012. 
(3) The Netherlands was designated as evalua ting competent authority and submitted the 
assessment report, together with its reco mmendations, to the Commission on 7 April 
2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20074. 
(4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agency was formulated on 17 June 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 
cybutryne may not be expected to satisfy the requirements laid down in Article 5 of 
Directive 98/8/EC. The scenarios evaluate d in the environmental risk assessment 
identified unacceptable risks. 
                                                
 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, 
p. 1). 
3 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). 
4 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).  
EN 3   EN (6) It is therefore not appropriate to approve cybutryne for use in biocidal products for 
product-type 21.  
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DECISION:  
Article 1 
Cybutryne (EC No 248-872-3, CAS No 28159-98-0) is not approved as an active substance 
for use in biocidal products for product-type 21. 
Article 2 
This Decision shall enter into force on the twen tieth day following that of its publication in 
the Official Journal of  the European Union . 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER