EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10084/2015 
(POOL/E3/2015/10084/10084-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 5-Chloro-2-(4-chlorophenoxy)-phenol as an existing active substance for use 
in biocidal products for product-types 1, 2 and 4 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 5-Chloro-2-(4-chlorophenoxy)-phenol as an existing active substance for use 
in biocidal products for product-types 1, 2 and 4 
(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 5- Chloro-2-(4-chlorophenoxy)-phenol. 
(2) 5-Chloro-2-(4-chlorophenoxy)-phenol 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 1, human hygiene bioc idal products, product- type 2, private area 
and public health area disinf ectants and other biocidal products, and product-type 4, 
food and feed area disinfectants, as define d in Annex V to that Directive, which 
correspond respectively to product-types 1, 2 and 4, as defined in Annex V to 
Regulation (EU) No 528/2012. 
(3) Austria was designated as evaluating competent authority and submitted the 
assessment reports, together with its recommendations, to the Commission on 13 
February 2013 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 
opinions of the European Chemicals Agency were formulated on 4 December 2014 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
(5) According to those opinions, biocidal produc ts used for product-types 1, 2 and 4 and 
containing 5-Chloro-2-(4-chlorophenoxy)-phe nol may be expected to satisfy the 
                                                 
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 requirements laid down in Article 5 of Directive 98/8/EC, pr ovided that certain 
conditions concerning its use are complied with.  
(6) It is therefore appropriate to approve 5- Chloro-2-(4-chlorophenoxy)-phenol for use in 
biocidal products for product-types 1, 2 an d 4 subject to compliance with certain 
specifications and conditions.  
(7) The opinions conclude that 5-Chloro-2 -(4-chlorophenoxy)-phenol meets the criteria 
for being very bioaccumulative (vB) and toxic (T) according to Annex XIII to Regulation (EC) No 1907/2006
5.  
(8) Since, pursuant to Article 90(2) of Re gulation (EU) No 528/2012, substances for 
which the Member States' evaluation has been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, the period of approval should be 
10 years in accordance with  the practice established under Directive 98/8/EC.  
(9) For the purposes of Articl e 23 of Regulation (EU) No 528/2012 however, 5-Chloro-2-
(4-chlorophenoxy)-phenol meets the conditions of Article 10(1)(d) of that Regulation 
and should therefore be consider ed a candidate for substitution. 
(10) For the use in product-type 4, the evalua tion did not address th e incorporation of 
biocidal products containing 5-Chloro-2 -(4-chlorophenoxy)-phenol  in materials and 
articles intended to come into contact dire ctly or indirectly with food within the 
meaning of Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council
6. Such materials may require the establishment of specific limits on the 
migration into food, as referre d to in Article 5( 1)(e) of Regulation (EC) No 1935/2004. 
The approval should therefore not c over such use unless the Commission has 
established such limits or it has been establ ished pursuant to that Regulation that such 
limits are not necessary.  
(11) 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.  
(12) 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 
5-Chloro-2-(4-chlorophenoxy)-pheno l is approved as an active s ubstance for use in biocidal 
products for product-types 1, 2 and 4, subject to the specifications and conditions set out in 
the Annex. 
                                                 
5 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 Chemical s 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). 
6 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact  with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).  
EN 4   EN 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