EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12072/2015 ANNEX 
(POOL/E3/2015/12072/12072-EN ANNEX.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving peracetic acid as an existing active substance for use in biocidal products for 
product-types 1, 2, 3, 4, 5 and 6 
  
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 
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. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013. 
(2) For professional users, safe operational procedures 
and appropriate organisational measures shall be established.  
 Peracetic acid IUPAC Name:  
Peroxyethanoic acid  EC No: 201-186-8 CAS No: 79-21-0 995 g/kg 
 
Peracetic acid in an 
aqueous solution 
containing acetic 
acid and hydrogen 
peroxide. 1st 
October 
2017 30 
September 
2027 
2 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) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013. 
(2) For professional users, safe operational procedures 
and appropriate organisational measures shall be 
                                                 
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 established. Products shall be used with appropriate 
personal protective equipment where exposure cannot 
be reduced to an acceptable level by other means. 
(3) In view of the risks identified for the surface water, 
products for waste water disinfection shall not be 
authorised, unless it can be demonstrated that risks 
can be reduced to an acceptable level. 
 
3 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) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. 
(2) 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. 
 
4 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) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013. 
(2) For professional users, safe operational procedures  
EN 4   EN 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. 
(3) 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 
peracetic acid into food or it has been established pursuant to that Regulation that such limits are not 
necessary. 
 
5 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) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013. 
(2) 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. 
 
6 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  
EN 5   EN following conditions: 
(1) Due to the presence of hydrogen peroxide, 
authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013. 
(2) 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.