EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12664/2021 CIS 
(POOL/E4/2021/12664/12664 -EN 
CIS.docx)  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving alkyl (C 12-16) dimethylbenzyl ammonium chloride as an active substance for 
use in biocidal products of product -types 3 and 4  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving alkyl (C 12-16) dimethylbenzyl ammonium chloride as an active substance for 
use in biocidal products of product -types 3 and 4  
(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 o f 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 alkyl  (C12-16) dimethylbenzyl ammonium chloride  
(ADBAC/BKC (C 12-C16)) to be renamed for the purposes of this Regulation as alkyl 
(C12-16) dimethylbenzyl ammonium chloride as a result  of its evaluation .  
(2) Alkyl (C12-16) dimethylbenzyl ammonium chloride has been evaluated for use in 
biocidal products of product -type 3, veterinary hygiene biocidal products  and product -
type 4, food and feed area 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 3 and  4 as defined in Annex V to Regulation (EU) No 528/2012 . 
(3) Italy was designated as the rapporteur Member State and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
Commission on 10 September 2012 . 
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
Biocidal Products Committee adopted the opinions of the European Chemical Agency4 
(‘the Agency’)  on 6 October 2020, having regard to the conclusions of the evaluating 
competent authority.  
(5) According to those opinions, bioc idal products of product -types 3 and 4  containing 
alkyl (C12-16) dimethylbenzyl ammonium chloride may be expected to satisfy the 
                                                 
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 528/2012 of the European Parliament a nd of the Counc il (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 Opinions on the applications for approval of the active substance 
alkyl(C 12-16) dimethylbenzyl ammonium chloride ; Product types: 3 and 4; ECHA/BPC/267 /2020  and 
ECHA/BPC/ 268/2020 , adopted on 6 October 2020 . EN 2  EN requirements laid down in Article 5 (1)(b), (c) and (d)  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 alkyl 
(C12 -16) dimethylbenzyl ammonium chloride as an active substance  for use in 
biocidal products of product -types 3 and 4, subject to compliance with certain 
specifications 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 Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Alkyl  (C12-16) dimethylbenzyl ammonium chloride is approved as an active substance for use 
in biocidal products of product -types 3 and  4 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