EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11865/2017 ANNEX 
(POOL/E4/2017/11865/11865 -EN 
ANNEX.doc)  
[…](2017) XXX  draft 
ANNEX 1  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving PHMB (1415; 4.7) as an active substance for use in biocidal products of 
product -types 2 and 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 (1 415; 
4.7) 
(polyhexamethy
lene biguanide 
hydrochloride 
with a mean 
number -average 
molecular 
weight (Mn) of 
1415 and a 
mean 
polydispersity 
(PDI) of 4.7)  IUPAC Name:  
CoPoly(bisiminoimidocarbony
l, hexamethylene 
hydrochloride),(iminoimidoca
rbonyl, hexamethylene 
hydrochloride)  
 
EC No: not available  
CAS No: 32289 -58-0 and 
1802181 -67-4 943g/kg (calculated 
dry weight 
specification).  
The active 
substance as 
manufactured is an 
aqueous solution of 
20% w/w of PHMB 
(1415; 4.7) 1st 
November  
2019 31 October 
2026  2 PHMB ( 1415; 4.7 ) is considered a candidate for substitution in 
accordance with point (d) of Article  10(1) Regulation (EU) 
No 528/2012.  
The authorisations of biocidal products are subject to the 
following conditions:  
1) 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 . 
2) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to:  
a) professional users;  
b) non-professional users;  
c) secondary exposure of the general public and 
toddlers;  
d) environment: surface water, sediment and soil.  
 
The placing on the market of treated 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 ( 1415; 4.7 ) 
shall ensure that the label of that treated arti cle provides the 
information listed in the second subparagraph of Article 58(3) 
of Regulation (EU) No 528/2012.  
4 PHMB (1415; 4.7) is considered a candidate for substitution in 
accordance with point (d) of Article  10(1) Regulation (EU) 
No 528/2012.  
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated . The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the evaluated active substance .  
EN 3  EN The authorisations of biocidal products are subject to the 
following conditions : 
1) 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 . 
2) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to:  
a) professional users;  
b) non-professional users;  
c) secondary exposure of the general  public;  
d) environment: surface water, sediment and soil.  
3) 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 
Council2 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 that the applicable MRLs are not exceeded.  
4) 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 (1415; 4.7) into 
food or it ha s been established pursuant to that Regulation 
that such limits are not necessary.  
 
The placing on the market of treated articles is subject to the 
following condition:  
                                                 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regula tion (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, 16.6.2009, 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 pesticides 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 The person responsible for the placing on the market of a 
treated article treated with  or incorporating PHMB ( 1415; 4.7 ) 
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.