EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12666/2021 CIS 
(POOL/E4/2021/12666/12666 -EN 
CIS.docx)  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving didecyldimethyl 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 didecyldimethyl 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 of 22 May 2012 conc erning 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 e valuated for their possible approval for use in biocidal 
products. That list includes didecyldimethyl ammonium chloride  (DDAC) to be 
renamed  for the purposes of this Regulation  as didecyldimethyl ammonium chloride as 
a result of its evaluation . 
(2) Didecyldimethyl 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 
Parlia ment 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 Chemicals 
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 
didecyldimethyl ammonium chloride  may be expected to satisfy the requirements  laid 
                                                 
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 Opinion s on the application s for approval of the active substance 
didecyldimethylammonium chloride; Product -types: 3 and 4; ECHA/BPC/265 /2020  and 
ECHA/BPC/ 266/2020 , adopted on 6 October 2020 .  EN 2  EN down in Article 5 (1)(b), (c) and (d)  of Directive  98/8/EC, provided that certain 
specifications and conditions concerning their use are com plied with.  
(6) Taking into account the opinions of the Agency, it is appropriate to approve 
didecyldimethyl ammonium chloride  as an active substance  for use in biocidal 
products of product -types  3 and 4 subject to compliance with certain specifications 
and co nditions.  
(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  
Didecyldimethyl 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