EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11131/2015 
(POOL/E3/2015/11131/11131-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING  DECISION (EU) …/… 
of XXX  
not to approve PHMB (1600; 1.8) as an exis ting active substance for use in biocidal 
products for product-types 1, 6 and 9 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION (EU) …/… 
of XXX  
not to approve PHMB (1600; 1.8) as an existi ng active substance for use in biocidal 
products for product-types 1, 6 and 9 
(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 incl udes PHMB (1600; 1.8). 
(2) PHMB (1600; 1.8) has been evaluated fo r use in product-type 1, human hygiene, 
product-type 6, preservatives for products dur ing storage, and product-type 9, fibre, 
leather, rubber and polymerised materials preservatives, 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  recommendations, on 5 September 2013, 8 
October 2013 and 14 February 2014, respectively. 
(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 16 and 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 1, 6 and 9 and 
containing PHMB (1600; 1.8) may not be exp ected to satisfy the requirements laid 
down in Article 19(1)(b) of Regulation (EU) No 528/2012. For these product-types, 
the scenarios evaluated in the human health risk assessments and the environmental risk assessments identified  unacceptable risks. 
(6) It is therefore not appropriate to appr ove PHMB (1600; 1.8) for use in biocidal 
products for product-types 1, 6 and 9.  
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                
 
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 HAS ADOPTED THIS DECISION:  
Article 1 
PHMB (1600; 1.8) (EC No : n.a. , CAS No 27083- 27-8 and 32289-58-0) is not approved as an 
active substance for use in biocidal  products for product-types 1, 6 and 9. 
Article 2 
This Decision shall enter into force on the twen tieth day following that of its publication in 
the Official Journal of  the European Union . 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER