EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10634/2020 ANNEX 
(POOL/EN/2020/10634/10634 -EN 
ANNEX.docx)  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Implementing Regulation (EU) .../...  
approving reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA) as an 
existing active substance for use in biocidal products of product -types 2, 3 and 4    
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  
Reaction mass 
of peracetic acid 
(PAA) and 
peroxyoctanoic 
acid (POOA)  IUPAC name:  
Reaction mass of 
peracetic acid (PAA) 
and peroxyoctanoic 
acid (POOA)  
EC No: 201-186-8 
and 450 -280-7 
CAS No: 79-21-0 and 
33734 -57-5 The minimum purity of the 
active substance is not relevant 
as the active substance is a 
double equilibrium using 
hydrogen peroxide, acetic acid 
and octanoic acid as starting 
materials. The specifications 
correspond to a range of 
concentration.  
Components  Specificat
ions 
range 
content 
(%w/w)  
Active 
substance  Peracetic 
acid 1,8 – 13,9 
Active 
substance  Peroxyoct
anoic acid  0,15 – 
2,42 
Relevant 
impurity  Hydrogn 
peroxyde  1,1 – 
25,45  
Relevant 
impurity  Acetic 
acid 5,74 - 51 
Relevant 
impurity  Octanoic 
acid 1,63 – 
9,03 
 1 April  
2022  31 March 
2032  2 The authorisations of biocidal products are 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 
assessment of the active substance.  
(b) In view of the risks identified for the uses assessed, 
the product assessment shall pay particular attention 
to professional users.  
3 The authorisations of biocidal products are 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 addresse d in the Union level 
assessment of the active substance.  
(b) In view of the risks identified for the uses assessed, 
the product assessment shall pay particular attention 
to professional users.  
4 The authorisations of biocidal products are 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 
                                                 
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 2  EN authorisation, but not addressed in the Union level 
assessment of the active subst ance.  
(b) Products containing reaction mass of peracetic acid 
and peroxyoctanoic acid 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  of the Europea n 
Parliament and of the Council2, unless the 
Commission has established specific limits on the 
migration of reaction mass of peracetic acid and 
peroxyoctanoic acid into food or it has established ] 
in accordance with  that Regulation that such limits 
are not  necessary . 
(c) In view of the risks identified for the uses assessed, 
the product assessment shall pay particular attention 
to professional users.  
 
                                                 
2 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles inten ded to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4 ).