EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11130/2015 ANNEX (POOL/E3/2015/11130/11130-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-types 2, 3, 11 
  
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 
2024 2 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 industrial or professiona l users, safe operational 
procedures and appropriate organisational measures shall be established. Products shall be used with 
appropriate personal pr otective 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 environment, products sh all not be authorised for 
the treatment of swimming pools, 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 environment, products sh all not be authorised for 
disinfection of medical equipment by dipping, unless 
it can be demonstrated that risks can be reduced to an 
acceptable level. 
                                                 
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 (4) In view of the risks identified for human health, 
ready-to-use wipes shall not be authorised for non-
professionals, unless it can be demonstrated that risks can be reduced to an acceptable level. 
(5) In view of the risks identified for human health, 
labels, and where provided, safety data sheets of 
ready-to-use wipes shall indicate that the use is restricted to areas not accessible to general public, 
unless it can be demonstrated that risks can be 
reduced to an acceptable level by other means. 
 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. 
3 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, 
products shall not be authorised for disinfection of  
EN 4   EN equipment by dipping, unless it can be demonstrated 
that risks can be reduced to an acceptable level. In 
addition, in case products are authorised, in view of the risks identified for the environment, labels, and 
where provided, safety data sheets shall indicate that 
no release to sewage treatment plants shall be allowed, unless it can be de monstrated that risks can 
be reduced to an acceptable level by other means. 
(3) In view of the risks identified for human health, 
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. 
(4) 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. 
 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) 
                                                 
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 5   EN of Regulation (EU) No 528/2012. 
 
11 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 industrial or professiona l users, safe operational 
procedures and appropriate organisational measures shall be established. Products shall be used with 
appropriate personal pr otective equipment where 
exposure cannot be reduced to an acceptable level by 
other means. 
(2) In view of the risks identified for human health, labels 
and, where provided, safety  data sheets shall indicate 
that loading of product into the cooling system shall be automated, that the pump shall be rinsed before 
cleaning and that appropriate personal protective 
equipment shall be worn during the cleaning phase, unless it can be demonstrated that risks can be 
reduced to an acceptable level by other means. 
(3) In view of the risks identified for water, sediments 
and soil, labels and, where provided, safety data sheets shall indicate that disposal of  preserved liquids 
following drainage of the cl osed recirculating system 
shall be handled as hazardous waste, unless it can be 
demonstrated at product authorisation that risks to the 
environment can be reduced to an acceptable level by other means. 
  
EN 6   EN 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.