EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2335/2022 
(POOL/E4/2022/2335/2335 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) as 
an active substance for use in biocidal products of product -type 1 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 Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) as 
an active  substance for use in biocidal products of product -type 1 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 89(1), third subparagraph, ther eof, 
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 (C 12-16) dimethylbenzyl ammonium chloride 
(ADBAC/BKC (C 12-C16)). 
(2) Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) has been 
evaluated  for use in biocidal products of product -type 1, human hygiene biocidal 
products , as described  in Annex V to Directive 98/8/EC  of the European Pa rliament 
and of the Council3, which correspond s to product -type 1, disinfectants : human 
hygiene, as described  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. After the submission of the assessment report, 
discussions took  place in technical meetings organised by the European Chemicals 
Agency (‘the Agency’).  
(4) It follows from Article 90(2) of Regulation (EU) No 528/2012 that substances for 
which the Member States’ evaluation has been completed by 1 September 2013 are to  
be as sessed in accordance with Directive 98/8/EC.  
(5) In accordance with Article 75(1) of Regulation (EU) No 528/2012, the Biocidal 
Products Committee prepares the opinion of the Agency regarding the applications for 
approval of active substances. In accordance wit h Article 7(2) of Delegated Regulation 
(EU) No 1062/2014, the Biocidal Products Committee ado pted the opinion of the 
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Delegated Regula tion (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 C ouncil  (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) . EN 2  EN Agency4 on 2 December 2021, having regard to the conclusions of the evaluating 
competent authority.  
(6) According to that opinion , bioc idal pro ducts of product -type 1 containing Alkyl (C 12-
16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) may be expected to 
satisfy the requirements laid down in Article 5 (1), points (b), (c) and (d) , of Directive 
98/8/EC,  provided that certain requirement s concerning their use are complied with.  
(7) Taking into account the opinion  of the Agency, it is appropriate to approve Alkyl (C 12-
16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) as an active 
substance  for use in biocidal products  of product -type 1 subject to compliance with 
certain conditions.  
(8) 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.  
(9) The measu res 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 (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) is approved as an 
active sub stance for use in biocidal products of product -type 1 subject to the 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  
  
 
                                                 
4 Bioc idal Products Committee Opinion on the a pplication  for approval of the active substance 
Alkyl(C12 -16) dimethylbenzyl ammonium chloride ; Product -type: 1; ECHA/BPC/ 309/2021, adopted 
on 2 December  2021. 