EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11152/2015 ANNEX (POOL/E3/2015/11152/11152-EN ANNEX.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving PHMB (1600; 1. 8) as an existing ac tive substance for use in biocidal products 
for product-type 4 
  
EN 2   EN ANNEX  
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 Date of 
approval Expiry 
date of 
approval Product 
type Specific conditions 
PHMB (1600; 
1.8) (polyhexamethylene biguanide 
hydrochloride 
with a mean 
number-average 
molecular weight (Mn) of 
1600 and a 
mean polydispersity 
(PDI) of 1.8) IUPAC Name:  
CoPoly(bisiminoimidocarbony
l, hexamethylene 
hydrochloride), (iminoimidocarbonyl, 
hexamethylene hydrochloride) 
 EC No: n.a. CAS No: 27083-27-8 and 
32289-58-0 956 g/kg 
(calculated dry 
weight 
specification). 
 
The active 
substance as 
manufactured is an 
aqueous solution of 
20% w/w of PHMB 
(1600; 1.8) 1st July 
2017 30 June 
2027 4 PHMB (1600; 1.8) is considered a candidate for substitution in 
accordance with Article 10(1 )(d) of Regulation (EU) 
No 528/2012. 
 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered 
by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For professional users, safe operational procedures 
and appropriate organisational measures shall be established. Products shall be used with appropriate 
personal protective equipment where exposure cannot 
be reduced to an acceptable level by other means. 
(2) In view of the risks identified for human health and 
the aquatic and soil compartments, products shall not 
be authorised for use as disinfectant of utensils by 
dipping, unless it can be demonstrated that risks can be reduced to an acceptable level 
(3) In view of the risks identified for human health and 
the aquatic compartment, products shall not be 
authorised for surface disinf ection by mopping, unless 
it can be demonstrated that risks can be reduced to an 
acceptable level. 
(4) In view of the risks identified for human health, 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance us ed for the evaluation made in a ccordance with Article 16(2) of 
Directive 98/8/EC. The active subs tance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the 
evaluated active substance.  
EN 3   EN labels, and where provided, safety data sheets of 
ready-to-use wipes shall indicate that the use is 
restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be 
reduced to an acceptable level by other means. 
(5) For products that may lead to residues in food or feed, 
the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation 
(EC) No 470/2009 of the European Parliament and of 
the Council
2 or Regulation (EC) No 396/2005 of the 
European Parliament and of the Council3 shall be 
verified, and any appropriate risk mitigation measures 
shall be taken to ensure th at the applicable MRLs are 
not exceeded. 
(6) Products shall not be incorporated in materials and 
articles intended to come into contact with food 
within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has 
established specific limits on the migration of PHMB 
(1600; 1.8) into food or it has been established pursuant to that Regulation that such limits are not 
necessary. 
 The placing on the market of tr eated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating PHMB (1600; 1.8) 
shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012. 
                                                                                                                                                                                                                                                    
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
EN 4   EN