EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11130/2015 (POOL/E3/2015/11130/11130-EN.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving PHMB (1600; 1.8) as an existing ac tive substance for use in biocidal products 
for product-types 2, 3, 11 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving PHMB (1600; 1.8) as an existing ac tive substance for use in biocidal products 
for product-types 2, 3, 11 
(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 incl udes PHMB (1600; 1.8). 
(2) PHMB (1600; 1.8) has been evaluated for use in product-type 2, disinfectants and 
algaecides not intended for direct applica tion to humans or animals, product-type 3, 
veterinary hygiene, and product-type 11, preservatives for liquid-cooling and 
processing systems, as defined in Annex V to Regulation (EU) No 528/2012. 
(3) France was designated as evaluating competent authority and submitted the 
assessment reports, together with its r ecommendations, on 8 October 2013 and 14 
November 2013. 
(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 17 June 2015 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 2, 3, and 11 and 
containing PHMB (1600; 1.8) may be expected  to satisfy the requirements of 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 PH MB (1600; 1.8) for use in biocidal products 
for product-types 2, 3, and 11 subject to comp liance with certain specifications and 
conditions. 
                                                
 
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).  
EN 3   EN (7) The opinions conclude that the characteris tics of PHMB (1600; 1.8) 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 Eur opean Parliament and of the Council3. 
(8) PHMB (1600; 1.8) meets the conditions set out in point (d) 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) Since PHMB (1600; 1.8) meets the criteria fo r being very persistent (vP) according to 
Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or 
incorporating PHMB (1600; 1.8) should be appropriately labelled when placed on the 
market. 
(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 
PHMB (1600; 1.8) is approved as an active subs tance for use in biocidal products for product-
types 2, 3, and 11, subject to the specificat ions 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  
                                                
 
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).