EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1197/2022 
(POOL/E4/2022/1197/1197 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving chloramin B as an active substance for use in biocidal products of 
product -types 2, 3, 4 and 5 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 DECISION (EU) …/…  
of XXX  
not approving chloramin B as an active substance for use in biocidal products of 
product -types 2, 3, 4 and 5 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 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 Article 9(1), point (b), thereof,  
Whereas:  
(1) Pursuant to Article 11(1) of Directive 9 8/8/EC of the Europea n Parliament and of the 
Council2, applications for approval of chloramin B for use in biocidal products of 
product -types 2, 3, 4 and 5 (private area and public health area disinfectants and other 
biocidal products, veterinary hygiene b iocidal products, food and feed area 
disinfectants, drinking water disinfectants) as described in Annex V of that Directive, 
corresponding to product -types 2, 3, 4 and 5 (disinfectants and algaecides not intended 
for direct application to humans or animals , veterinary hygiene, food and feed area, 
drinking water) as described in Annex V to Regulation (EU) No 528/2012, were 
submitted to the competent authority of the Czech Republic on 25 October 2008.  
(2) Pursuant to Article 90(2), first subparagraph, of Regulati on (EU) No 528/2012, 
applications submitted for the purposes of Directive 98/8/EC for which the Member 
States’ evaluation in accordance with Article 11(2) of Directive 98/8/EC has not been 
completed by 1 September 2013 are to be evaluated by the competent authorities in 
accordance with the provisions of that Regulation.  
(3) On 25 October 2021, during the evaluation of the active substance by the evaluating 
competent authority, the applicant withdrew its applications and no longer requests the 
approval of chlora min B as an active substance for use in biocidal products of product -
types 2, 3, 4 and 5.  
(4) Chloramin B is not included for product -types 2, 3, 4 and 5  in Annex II to 
Commission Delegat ed Regulation (EU) No 1062/20143, which lists the active 
substance/produc t-type combinations included in the work programme for the 
examination of existing biocidal active substances contained in 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 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 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 
1).  
EN 2  EN Biocidal products of product -types 2, 3, 4 and 5 containing chloramin B are therefore 
not covered by the transitio nal provisions laid down in Article 89(2) of Regulation 
(EU) No 528/2012 and may therefore not be made available or used on the Union 
market.  
(5) However, in accordance with the transitional provision set out in Article 94(1), point 
(a), of Regulation (EU) No  528/2012, a treated article treated with or intentionally 
incorporating one or more biocidal products containing only active substances that are 
under examination for the relevant product -type in the work programme referred to in 
Article 89(1) of that Reg ulation on 1 September 2016 or for which an application for 
approval for the relevant product -type is submitted by that date, or containing only a 
combination of such substances and active substances included in the list drawn up in 
accordance with Article  9(2) of that Regulation for the relevant product -type and use 
or included in Annex I, may be placed on the market until the date falling 180 days 
after a decision not to approve one of the active substances for the relevant use, when 
such decision is adop ted after 1 September 2016.  
(6) As the applicant has withdrawn the application s for approval of ch loramin B for use in 
biocidal products of product -types 2, 3, 4 and 5, there are no biocidal product s to be 
evaluated. Consequently, the competent authority did n ot finalise the assessment 
report s and the European Chemicals Agency did not prepare any opinion. Finally, as 
there are no biocidal product s of product -types 2, 3, 4 and 5 containing chloramin B 
that may be expected to meet the criteria laid down in Article 19(1), point (b), of 
Regulation (EU) No 528/2012, the conditions laid down in Article 4(1) of that 
Regulation are not met. Considering als o the need to ensure that treated articles treated 
with or intentionally incorporating chloramin B for product -types 2, 3, 4 and 5 are no 
longer placed on the Union market, it is appropriate not to approve chloramin B for 
use in biocidal products of produc t-types 2, 3, 4 and 5.  
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS DECISION:  
Article 1  
Chloramin B (EC No: 204 -847-9; CAS No: 127-52-6) is not approved as a n active substance 
for use in biocidal products of product -types 2, 3, 4  and 5. 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN