EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/2561/2022 ANNEX 
(POOL/E4/2022/2561/2561 -EN 
ANNEX.docx)  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
approving ozone generated from oxygen as an active substance for use in biocidal 
products of product -types 2, 4, 5 and 11 in accordance with Regulation (EU) No 
528/2012 of the European Parliament and of the C ouncil    
EN 1  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  
Ozone generated 
from oxygen  IUPAC name: Ozone  
EC No: not 
applicable  
CAS No: not 
applicable  For ozone generated from 
the precursor oxygen 
supplied in containers, the  
following  specifications 
apply:  
The purity of oxygen shall  
be at least 90% by volume 
fraction and the 
hydrocarbons content 
reported as methane 
equivalents (methane index) 
shall not exceed a volume 
fraction of 50 ppm. 
Depending on the 
production route of oxygen, 
oxygen may contain 
quantities of the following 
impurities: water, nitrogen, 
argon, carbon dioxide and 
other rare gases . 1 July 
2024 30 June  
2034  2 The authorisation of biocidal products is subject to the 
following conditions:  
(a) 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 ; 
 
(b) the product assessment shall pay particular attention to:  
(i) professional user s; 
(ii) non-professional users;  
(iii) the secondary exposure of the general public.  
 
4 The authorisation of biocidal products is subject to the 
following conditions:  
(a) 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 ; 
(b) the product assessment shall pay particular attention 
to: 
(i) professional users;  
(ii) the secondary  exposure of the gener al public ; 
(c) for products that may lead to residues in food or feed, 
it shall be assessed  whether new maximum residue 
levels (MRLs) need to be set or the existing MRLs 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance i n 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 2  EN need to be amended  in accordance with Regulation 
(EC) No 396/20052 or Regulation (EC) No 470/20093 
of the European Parliament and of the Council , and 
any appropriate risk mitigation measures shall be 
taken to ensure that the applicable MRLs are not 
exceeded.  
 
5 The authorisation of biocidal products is subject to the 
following conditions:  
(a) 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 ; 
(b) the product assessment shall pay particular attention 
to: 
(i) professional user s; 
(ii) the secondary exposure of the general public ; 
(c) for products that may lead to residues in food or feed, 
it shall be assessed whether new maximum residue 
levels (MRLs) need to be set or the existing MRLs 
need to be amended in accordance with Regulation 
(EC) No 396/2005 or Regulation (EC) No 470/2009  
of the European Parliament and of the Council , and 
any appropriate risk mitigation measures shall be 
taken to ensure that t he applicable MRLs are not 
exceeded.  
 
11 The authorisation of biocidal products is subject to the 
following conditions:  
                                                 
2 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (O J L 70, 16.3.2005, p. 1).  
3 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 
pharmacologic ally 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 Counc il (OJ L 152, 16.6.2009, p.  11).  
EN 3  EN (a) 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 ; 
(b) the product assessment shall pay particular attention 
to: 
(i) professional user s; 
(ii) surface water following direct discharge of 
treated cooling water.