EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1818 
(POOL/E4/2023/1818/1818 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) 
as an existing active substance for use in biocidal products of product -type 2 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  existing active substance for use in biocidal products of product -type 2 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 Fun ctioning 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 su bparagraph, 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 (C 12-16) dimethylbenzyl ammonium chloride 
(ADBAC/BKC (C 12-C16)) for product -type 2  (CAS No: 68424 -85-1). 
(2) Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) has been 
evaluated  for use in biocidal products of product -type 2, private area and public health 
area di sinfectants and other biocidal products , as described  in Annex V to Directive 
98/8/EC  of the European Parliament and of the Council3, which correspond s to 
product -type 2, disinfectants and algaecides not intended for direct application to 
humans or animals , 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) , first subparagraph,  of Regulation (EU) No 528/2012 that 
substances for which th e Member States’ evaluation has been completed by 1 
September 2013 are to  be assessed in accordance with Directive 98/8/EC.  
                                                 
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 Council  (OJ L 294, 10.10.2014, 
p. 1). 
3 Directive 98/8/EC of the Euro pean 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 (5) 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 applications for approval of active substances. In accordance with 
Article 7( 2) of Delegated Regulation (EU) No 1062/2014  read in conjunction with 
Article 75(1) and (4) of Regulation (EU) No 528/2012 , the Biocidal Products 
Committee ado pted the opinion of the Agency on 2 December  20214, having regard to 
the conclusions of the evalu ating competent authority.  In its opinion , the Agency 
concluded that  Alkyl (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC 
(C12-C16)) may be approved as an active substance , but three members of the Biocidal 
Products Committee provided minority opinio ns expressing concern for a possible risk 
for the soil compartment.  
(6) The Commission initiated a further consultation of Member States on the matter in the 
Standing Committee on Biocidal Products , where it was decided that further 
discussion was needed at te chnical level regarding the risk for the soil compartment. 
Subsequently, a request for an opinion  was submitted to the Agency  in accordance 
with Article 75(1) , point (g), of Regulation (EU) No 528/2012 . The Biocidal Products 
Committee ado pted a revised opinion of the Agency on 7 June 20235, concluding  that 
the risk for the soil compartment  is acceptable.  According to that opinion of the 
Agency , the biocidal products of product -type 2 containing Alkyl (C 12-16) 
dimethylbenzyl ammonium chlori de (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 2 subject to compliance with 
certain conditions.  
(8) A reasonable period shou ld 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 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 (C 12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12-C16)) is approved as 
an active substance for use in biocidal products of product -type 2, subject to the conditions set 
out in the Annex.  
                                                 
4 Bioc idal Products Committee Opinion on the application  for approval of the active substance Alkyl(C 12-
16) dimeth ylbenzyl ammonium chloride ; Product -type: 2; ECHA/BPC/ 310/2021, adopted on 2 
December  2021. 
5 Bioc idal Products Committee Opinion on the application  for approval of the active substance Alkyl(C 12-
16) dimethylbenzyl ammonium chloride ; Product -type: 2; ECHA/BPC/ 387/2023, adopted on 7 June 
2023.  
EN 3  EN 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