EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10086/2016 
(POOL/E4/2016/10086/10086-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-bromo-2-(bromomethyl)pentanedi nitrile (DBDCB) as an existing active 
substance for use in biocidal products of product-type 6 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-bromo-2-(bromomethyl)pentanedi nitrile (DBDCB) as an existing active 
substance for use in biocidal products of product-type 6 
(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 avai lable 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 Re gulation (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 2-bromo-2 -(bromomethyl)pentanedinitrile (DBDCB). 
(2) DBDCB has been evaluated in accordance with  Article 16(2) of Di rective 98/8/EC of 
the European Parliament and of the Council3 for use in product-type 6, in-can 
preservatives, as described in Annex V to that Directive, which corresponds to 
product-type 6 as described in A nnex V to Regulation (EU) No 528/2012. 
(3) The Czech Republic was designated as eval uating competent authority and submitted 
the assessment reports t ogether with its recommendations on 21 January 2009. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agen cy was formulated on 10 December 2015 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(5) According to that opinion, biocidal produc ts of product-type 6 and containing DBDCB 
may be expected to satisfy the requireme nts of Article 5 of Directive 98/8/EC, 
provided that certain specifications and conditions concerning their use are complied 
with. 
(6) It is therefore appr opriate to approve DBDCB for use in biocidal products of product-
type 6, subject to compliance with cer tain specifications and conditions. 
(7) Since DBDCB meets the criteria for classifi cation as skin sensitiser category 1 as 
defined in Annex I to Regul ation (EC) No 1272/2008 of the European Parliament and 
                                                 
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).  
EN 3   EN of the Council4, treated articles treated with or incorporating DBDCB should be 
labelled appropriately when placed on the market. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet th e new requirements. 
(9) 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 
2-bromo-2-(bromomethyl)pentane dinitrile (DBDCB) is approved as an active substance for 
use in biocidal products of produc t-type 6, subject to the specif ications and 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  
                                                
 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, 
p. 1).