EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10086/2015 
(POOL/E3/2015/10086/10086-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving IPBC as an existing active substa nce for use in biocidal products for product-
type 13 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving IPBC as an existing active substa nce for use in biocidal products for product-
type 13 
(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 IPBC. 
(2) IPBC has been evaluated in accordance with Ar ticle 16(2) of Directive 98/8/EC of the 
European Parliament and of the Council3 for use in product-type 13, metalworking-
fluid preservatives, as define d in Annex V to that Dire ctive, which correspond to 
product-type 7, as defined in Anne x V to Regulation (EU) No 528/2012. 
(3) Denmark was designated as evaluating competent authority and submitted the 
assessment report, together with its recommendations, to the Commission on 3 
December 2013 in accordance with paragra phs 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 Agen cy was formulated on 3 December 2014 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 13 and containing 
IPBC may be expected to satisfy the re quirements laid dow n in Article 5 of 
Directive 98/8/EC provided that certain conditions concerning its use are complied 
with.  
                                                 
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 appropriate to approve IPBC for use in biocidal products for product-
type 13 subject to compliance with ce rtain specifications and conditions.  
(7) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements.  
(8) 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 
IPBC is approved as an active substance for use in biocidal produc ts for product-type 13, 
subject to the specifications 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