EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11466/2020 ANNEX 
(POOL/E4/2020/11466/11466 -EN 
ANNEX.docx  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
approving active chlorine generated from sodium chloride by electrolysis as an active 
substance for use in biocidal products of product types 2, 3, 4 and 5    
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  
Active chlorine 
generated from 
sodium chloride 
by electrolysis  IUPAC name:  not 
applicable  
EC No: not 
applicable  
CAS No: not 
applicable  
 
Precursor :  
IUPAC Name: 
Sodium Chloride  
EC No 231-598-3 
CAS No 7647 -14-5 The specification for active 
chlorine generated in situ is 
dependent on the precursor 
sodium chloride  which must 
comply with purity 
requirements of one of  the 
following standards : NF 
Brand, EN 973 A, EN 973 
B, EN 14805 Type 1, EN 
14805 Type 2, EN 16370 
Type 1, EN 16370 Type 2, 
EN 16401 Type 1, EN 
16401 Type 2, CODEX 
STAN 150 -1985 or 
European Pharmacopoeia 
9.0. 
 1 July 
2022  30 June 
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 risk assessment 
of the active substance.  
(b) the product assessment shall pay particular atte ntion 
to the protection of professional users for hard 
surface disinfection via mopping or wiping.   
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 addressed in the Union level risk assessment 
of the active substance.  
(b) 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 470/20092 or Regulation (EC) 
                                                 
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 . 
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 Regulation (EEC) No  2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2005  of the Europe an Parliament and of the Council  (OJ L 152, 16.6.2009, p.11) .  
EN 2  EN No 396/20053 shall be verified, and any appropriate 
risk mitigation measures shall be taken to ensure 
that the applicable MRLs are not exc eeded.  
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 authorisation, 
but not addressed in the Union level risk assessment 
of the active substance.  
(b) for products that may lead to residues in food or 
feed, the need to set new or to amend existing 
MRLs in accordance with Regulation (EC) No 
470/2009 or Regulation (EC) No 396/2005 shall be 
verified, and any appropriate risk mitigation 
measures shall be taken to ensure that the applicable 
MRLs are not exceeded.  
5 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 risk assessment 
of the active substance.  
(b) for products that may lead to residues in food or 
feed, the need to set new or to amend existing 
MRLs in accordance with Regulation (EC) No 
470/2009 or Regulation (EC) No 396/2005 shall be 
verified, and any appropriate risk mitigation 
measures shall be taken to ensure that the appli cable 
                                                 
3 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 amen ding Council Directive 91/414/EEC  (OJ L 70, 16.3.2005, p. 1 ).  
EN 3  EN MRLs are not exceeded.  
 