EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11658/2020 
(POOL/E4/2020/11658/11658 -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 -type 1  
(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 -type 1  
(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 Ma y 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 9( 1)(a)  thereof,   
Whereas:  
(1) On 31 July 2007, t he competent authority of Slovakia  (‘the evaluating competent 
authority ’) received an application, in  accordance with Article 11(1) of Directive 
98/8/EC of the European Parliament and of the Council2, for the inclusion of the active 
substance active chlorine released from hypochlorous acid  in Annex I to that Directive 
for use in biocidal products of produ ct-type 1, human hygiene , as defined in Annex V 
to that Directive, which correspond s to product -type 1 as defined in Annex V to 
Regulation (EU) No 528/2012.  
(2) On 19 November 2010 , the evaluating competent authority submitted the assessment 
report together w ith its conclusions to the Commission in accordance with Article 
11(2) of Directive  98/8/EC . 
(3) On 16 June 2020, t he Biocidal Products Committee adopted the opinion of the 
European Chemicals Agency3 (‘the Agency’ ), having regard to the conclusions of the 
evaluating competent authority.  
(4) According to that opinion, biocidal products of product -type 1 using  active chlorine 
released from hypochlorous acid  may be expected to satisfy the requirements laid 
down in Article 5 of Directive 98/8/EC , provided that cert ain specifications and 
conditions concerning their use are complied with.  
(5) Taking into account the opinion of the Agency, it is appropriate to approve active 
chlorine released from hypochlorous acid  as an active substance for use in biocidal 
products of pro duct-type 1 subject to compliance with certain specifications and 
conditions.  
(6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 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) . 
3 Biocidal Products Committee Opinion on the application for approval of the active substance active 
chlorine generated from sodium chloride by electrolysis , Product type:1 , ECHA /BPC/ 255 ado pted on 
16 June 2020.  EN 2  EN 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 -type 1 subject to the specifications and conditions set out in the 
Annex.  
Article  2 
This Regulation shall enter into force on the twe ntieth 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  