EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11468/2020 
(POOL/E4/2020/11468/11468 -EN.docx  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving active chlorine released from hypochlorous acid as an active substance for 
use in biocidal products of product -types 2, 3, 4 and 5  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving active chlorine released from hypochlorous acid as an active substance for 
use in biocidal products of product -types 2, 3, 4 and 5  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 may 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagraph of Article 89(1) thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approval for use in biocidal 
products. That list includes active chlorine released from hypochlorous acid . 
(2) Active chlorine released from hypochlorous acid  has been evaluated  for use in biocidal 
products o f product -type 2, private area and public health area disinfectants and other 
biocidal products , product -type 3, veterinary hygiene biocidal products , product -type 
4, food and feed area disinfectants , and product -type 5 , drinking water disinfectants  as 
defined in Annex V to Directive  98/8/EC  of the European Parliament and of the 
Council3, which correspond respectively to product -types 2, 3, 4 and 5  as defined in 
Annex V to Regulation (EU) No 528/2012 . 
(3) Slovakia  was designated as the rapporteur Member State and its evaluating competent 
authority submitted the assessment report s together  with its conclusions to the 
Commission on 19 November 2010 . 
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/ 2014, the 
Biocidal Products Committee adopted the opinions of the European Chemicals 
Agency4 (‘the Agency’ ) on 16 June 2020 , having regard to the conclusions of the 
evaluating competent authority.  
(5) According to those opinions, biocidal products of product -types 2, 3 , 4 and 5 using 
active chlorine released from hypochlorous acid by electrolysis  may be expected to 
                                                 
1 OJ L 167, 27.6.2012, p.  1  
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 582/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014,  
p. 1) 
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1)  
4 Biocidal Products Committee Opinion on the application for approval of the active substance active 
chlorine generated from sodium chloride by electrolysis , Product type: 1, 2, 3, 4 and 5 , ECHA 
/BPC/ 255, 256, 257, 258, 259 adopted on 16 June 2020  EN 2  EN satisfy the requirements laid down in Article 5 of Directive 98/8/EC , provided that 
certain specifications and conditions concerning their use are complied with.  
(6) Taking into account the opinions of the Agency, it is appropriate to approve active 
chlorine released from hypochlorous acid for use in biocidal products of product -types 
2, 3, 4 and 5  subject to compliance with certain specification s and conditions.  
(7) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet the new requirements.  
(8) The measures provided for in this Regula tion are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Active chlorine released from hypochlorous acid  is approved as an active substance for use in 
biocidal products of product -types  2, 3, 4 and 5  subject to the specifications and conditions set 
out in the Annex.  
Article  2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be  binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN