EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12666/2021 ANNEX CIS 
(POOL/E4/2021/12666/12666 -EN 
ANNEX CIS.docx)  
[…](2021) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Implementing Regulation (EU) .../...  
approving didecyldimethyl 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  
Didecyldimethyl 
ammonium 
chloride  IUPAC name: N,N-
Didecyl -N,N-
dimethylammonium 
chloride  
EC No: 230-525-2 
CAS No: 7173 -51-5 
 
 Minimum purity of the 
active substance evaluated: 
908 g/kg dry weight  
 1 
November 
2022  31 October   
2032  3 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 n ot addressed in the Unio n 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 of 
vehicles used for animal transport and 
disinfection in hatcheries after fogging 
treatment . 
(c) For products that may lead to residues in food or 
feed, the need to set new or to amend existing 
maximum residues levels (MRLs) in accordance 
with Re gulation (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 o f 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 ame nding 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 396/2 005 of the European Parliament and of the 
Council3 shall be verified, and any appropriate risk 
mitigation measur es shall be taken to ensure that the 
applica ble 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 a ddressed in the Unio n level 
risk assessment of the active substance.  
(b) In the light of the outcome of the risk assessment for 
the used assessed, t he product assessment shall pay 
particular attention to:  
(1) professional us ers; 
(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 tha t the applicable 
MRLs are not exceeded.  
(d) Didecyldimethyl 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, unless the 
                                                 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (O J 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 Commission has established specific limits on t he 
migration of didecyldimethyl ammonium chloride 
into food or it has been established pursuant to that 
Regulation that such limits are not necessary.  
 