EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11152/2015 (POOL/E3/2015/11152/11152-EN.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving PHMB (1600; 1.8)  as an existing ac tive substa nce for use in biocidal products 
for product-type 4 
(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-type 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 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 in accordance with Article 16(2) of Directive 
98/8/EC of the European Parliament and of the Council3 for use in product-type 4, 
food and feed area disinfectants, as define d in Annex V to that Directive, which 
corresponds to product-type 4 as defined in Annex V to Regulation (EU) No 528/2012. 
(3) France was designated as evaluating competent authority and submitted the 
assessment report, together with its reco mmendations, to the Commission on 10 April 
2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation 
(EC) No 1451/2007
4. 
(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 4 and containing 
PHMB (1600; 1.8) may be expected to sati sfy the requirements of 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 PH MB (1600; 1.8) for use in biocidal products 
for product-type 4 subject to compliance w ith certain specifications and conditions. 
(7) The opinion concludes 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 Council5. 
(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 practic e established under that Directive. 
(9) For the purposes of Article 23 of Re gulation (EU) No 528/2012 however, PHMB 
(1600; 1.8) meets the conditions of Article 10(1)(d) of that Regulation and should therefore be considered a candidate for substitution. 
(10) For the use in product-type 4, the evaluati on did not address the incorporation of 
biocidal products containing PHMB (1600; 1.8)  in materials and articles intended to 
come into contact directly or indirectly with food within the meaning of  Article 1(1) of 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council
6. Such 
materials may require the establishment of specific limits on the migration into food, 
as referred to in Article 5(1)(e) of Regulation (EC)  No 1935/2004. The approval 
should therefore not cover such use unless the Commission has established such limits 
or it has been established pursuant to that Regulation that such limits are not 
necessary. 
(11) 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. 
(12) 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. 
(13) 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-
type 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 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). 
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  Jean-Claude JUNCKER