EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12664/2021 ANNEX CIS 
(POOL/E4/2021/12664/12664 -EN 
ANNEX CIS.docx)  
[…](2021) XXX  draft  
ANNEX  
 
ANNEXES  
to the  
Commission Implementing Regulation (EU).../...  
approving alkyl (C 12-16) dimethylbenzyl ammonium chloride as an active substance for 
use in biocidal products of product -types 3 and 4    
EN 1  EN ANNEX  
Common Name  IUPAC Name  
Identification 
Numbers  Minimum degree of purity 
of the active substance1 Date of 
approval  Expiry 
date of 
approval  Product 
type Specific conditions  
Alkyl ( C12-16) 
dimethylbenzyl 
ammonium 
chloride  IUPAC name:  not 
applicable  
EC No: 270-325-2 
CAS No: 68424 -85-1 
 Minimum purity of the 
active substance evaluated: 
972 g/kg dry weight  1 
November 
2022  31 October 
2032  3 The authori sation of biocidal products is subject to the 
following conditions:  
(a) The product assessment shall pay particular 
attention to the exposures,  the risks and the efficacy 
linked to any uses covered by an application for 
authorisation, but not addr essed in the Union level 
risk assessment of the active substance.  
(b) In the light of the outcome of the risk assessment for 
the uses assessed, t he product assessment shall pay 
particular attention to:  
(1) professional  users ; 
(2) sediment following disinfection of vehicles 
used for animal transport and disinfection in 
hatcheries after fogging treatment;  
(3) soil following disinfection of vehicles used 
for animal transport, footwear disinfection  
and disinfection in hatcheries after fogging 
treatment . 
(c) For products that may lead t o residues in food or 
feed, the need to set new or to amend existing 
maximum residue levels (MRLs) in accordance with 
Regulation (EC) No 470/2009  of the European 
Parliament and of the Council2 or Regulation (EC) 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the  evaluated active substance . 
2 Regulation (EC) No 470/2009  of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin , repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/200 4 of the European Parliament and of the Council  (OJ L 152, 16.6.2009, p.11) .  
EN 2  EN No 396/2005  of the European Parliament and of the 
Council3 shall be verified, and any appropriate risk 
mitigation measures shall be taken to ensure that the 
applicable MRLs are not exceeded . 
4 The authorisation of biocidal products is subject to the 
following conditions:  
(a) The product assessment shall pay particular 
attention to the exposures, the risks and the efficacy 
linked to any uses covered by an application for 
authorisation, but not addressed in the Union level 
risk assessment of the active substance.  
(b) In the light of the outcome  of the risk assessment for 
the uses assessed, t he product assessment shall pay 
particular attention to:  
(1) professional  users ; 
(2) sediment and soil following disinfection in 
slaughterhouses and butcheries.  
(c) For products that may lead to residues in food or 
feed,  the need to set new or to amend existing 
MRLs in accordance with Regulation (EC) No 
470/2009 or Regulation (EC) No 396/2005 shall be 
verified, and any appropriate risk mitigation 
measures shall be taken to ensure that the applicable 
MRLs are not exceeded.  
(d) Alkyl (C 12-16) dimethylbenzyl ammonium chloride 
shall not be incorporated in materials and articles 
intended to come into contact with food falling 
within the scope of Regulation (EC) No 1935/2004  
of the European Parliament and of the Council4, 
                                                 
3 Regulation (E C) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in o r on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC  (OJ L 70, 16.3.2005, p. 1 ). 
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC  (OJ L 338, 13.11.2004, p.  4).  
EN 3  EN unless the  Commission has established specific 
limits on the migration of alkyl (C 12-16) 
dimethylbenzyl ammonium chloride into food or it 
has been established pursuant to that Regulation that 
such limits are not necessary.