EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10373/2015 ANNEX 
(POOL/E3/2015/10373/10373-EN 
ANNEX.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving hydrogen peroxi de as an existing active substan ce 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) Authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013 on the 
marketing and use of explosive precursors. 
(2) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. Hydrogen peroxide IUPAC Name:  
Hydrogen peroxide 
 EC No: 231-765-0 CAS No: 7722-84-1 The active 
substance as 
manufactured is an 
aqueous solution of 
350-<700 g/kg (35-
<70 %, by weight) 
solution of 
hydrogen peroxide. 
 
The theoretical 
(calculated) dry 
weight 
specification: 
minimum purity of 
hydrogen peroxide 
is 995 g/kg (99.5% 
by wt). 1 
February 
2017 31 January 
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) The authorisations of biocidal products are subject to the 
following conditions:Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 
on the marketing and use of explosive precursors. 
(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. 
                                                 
1 The purity indicated in this column was the minimum degree of pu rity of the active substance used for the evaluation made in a ccordance with Article 16(2) of Directive 
98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven tec hnically equivalent with the evaluated active 
substance.  
EN 3   EN 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) The authorisations of biocidal products are subject to the 
following conditions:Authorisations of biocidal products 
shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors. 
(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) Authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013 on the 
marketing and use of explosive precursors. 
(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. 
(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)  
EN 4   EN 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 hydrogen peroxide 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) Authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013 on the 
marketing and use of explosive precursors. 
(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 
                                                 
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 Union level risk assessment of the active substance. 
The authorisations of biocidal  products are subject to the 
following conditions: 
(1) Authorisations of biocidal products shall be without 
prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors. 
(2) For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used w ith appropriate personal 
protective equipment where exposure cannot be reduced 
to an acceptable level by other means.