 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/2561/2022  
(POOL/E4/2022/2561/2561 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regar d 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 Article 9(1), point (a), thereof,  
Whereas:  
(1) On 5 June 2015 and 22 August 2016 , the European Chemicals Agency (‘the Agency’) 
received  application s, in accordance with Article 7(1) of Regulation (EU) No 
528/2012 , for the approval of ozone generated from oxygen as an active substance for 
use in bioci dal products of product -type 2, disinfectants and algaecides not intended 
for direct application to humans or animals , product -type 4 , food and feed area , 
product -type 5 , drinking water , and product -type 11 , preservatives for liquid -cooling 
and processing systems , as described  in Annex V to Regulation (EU) No 528/2012 . 
These applications were evaluated  by the competent authority of Germany (‘the 
evaluating competent authority of Germany’) and the competent authority of the 
Netherlands (‘the evaluating compe tent authority of the Netherlands’).  
(2) On 9 September 2020 , the evaluating competent authority of Germany submitted the 
assessment report  on the applications together with the conclusions of its evaluation to 
the Agency . The Agency  discussed the assessment report and the conclusions in 
technical meetings . 
(3) On 28 October 2021 , the evaluating competent authority of the Netherlands submitted 
the assessment report  on the applications together with the conclusions  of its 
evaluation  to the Agency . The Agency  discus sed the assessment report and the 
conclusions in technical meetings . 
(4) In accordance with Article 75(1) , second subparagraph, point (a),  of Regulation (EU) 
No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency 
regarding the applicat ions for approval of active substances. I n accordance with 
Article 8(4) of Regulation (EU) No 528/2012 , the Biocidal Products Committee 
adopted the opinion s of the Agency  on 1 December 20212, having regard to the 
conclusions of the evaluating competent authority  of Germany , and on  26 September  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Biocidal Products Committee Opinions on the application for approval of the active substance ozone 
generated from oxygen ; Product types: 2, 4, 5 and 11 ; ECHA/BPC/303/2021 , ECHA/BPC/304/2021 , 
ECHA/BPC/305 /2021 and ECHA/BPC/306 /2021 ; adopted on 1 December 2021.   
EN 2  EN 20223, having regard to the conclusions of the evaluating competent authority  of the 
Netherlands . 
(5) In the opinion s the Agency concludes that  biocidal products of product -types 2, 4, 5 
and 11 using  ozone  generated fr om oxygen may be expected to satisfy the criteria laid 
down in  Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that 
certain conditions concerning their use are complied with.  
(6) Taking into account the opinion s of the Agency, it is appropri ate to approve ozone 
generated from oxygen as an active substance for use in bi ocidal products of product -
types 2, 4, 5 and 11  subject to compliance with certain 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 Regulation are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOP TED THIS REGULATION:  
Article 1  
Ozone generated from oxygen is approved as an active substance for use in bi ocidal products 
of product -types 2, 4, 5 and 11 subject to the conditions  set out in the Annex.  
Article 2 
This Regulation shall enter into force on t he 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 VO N DER LEYEN  
  
 
                                                 
3 Biocidal Products Committee Opinions on the application for approval of the active substance ozone 
generated from oxygen ; Product types: 2, 4, 5 and 11 ; ECHA/BPC/3 50/2022 , ECHA/BPC/35 1/2022 , 
ECHA/BPC/35 2/2022  and ECHA/BPC/35 3/2022 ; adopted on 26 September 2022 .  