EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11867/2017 
(POOL/E3/2017/11867/11867 -EN.doc)  
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal 
products of product -types 1, 5 and 6  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal 
products of product -types 1, 5 and 6  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to R egulation (EU) No 528/2012 of the European Parliament and of the 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 89(1) thereof , 
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approv al for use in biocidal 
products. That list includes PHMB ( 1415; 4.7 ) (EC No: n.a., CAS No: 32289 -58-0 and 
1802181 -67-4). 
(2) PHMB ( 1415; 4.7 ) has been evaluated for use in  products of product -type 1, human 
hygiene , 5, drinking water , and 6, p reservatives for products during storage , as 
describ ed in Annex V to Regulation (EU) No  528/2012.  
(3) France  was designated as evaluating competent authority and submitt ed the 
assessment reports together with its recommendations on 13 December 2016.  
(4) In accordance with Article 7 (2) of Delegated  Regulation (EU) No  1062/2014 , the 
opinion s of the European Chemicals Agency w ere formulated on 4 October 2017  by 
the Biocidal Prod ucts Committee , having regard to the conclusions of the evaluating 
competent authority.  
(5) According to those opinions,  biocidal products used for product -types 1, 5 and 6 
containing PHMB ( 1415; 4.7 ) may not be expected to satisfy the requirements laid 
down in Article 19(1)(b)  of Regulation (EU) No 528/2012 . For those product -types, 
the scenarios evaluated in the human health and environmental risk assessment s 
identified unacceptable risk s. 
(6) It is therefore not appropriate to approve PHMB ( 1415; 4.7 ) for use in biocidal 
products of product -types 1, 5 and 6 .  
(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 Regula tion (EU) No 1062 /2014 of 4 August 2014  on the work programme for 
the systematic examination of all existing active substances 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 2  EN HAS ADOPTED THIS DECISION:  
Article 1  
PHMB ( 1415; 4.7 ) (EC No: n.a., CAS No: 32289 -58-0 and 1802181 -67-4) is not  approved as 
an active substance for use in bio cidal products of product -types 1, 5 and 6.  
Article 2 
This Decision shall enter into force on the twentieth  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