EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10274/2022 
(POOL/E4/2022/10274/10274 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving didecyldimethylammonium chloride  as an active substance for use in biocidal 
products of product -types 1 and 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 didecyldimethylammonium chloride  as an active substance for use in biocidal 
products of product -types 1 and 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 Functioning of the European Union , 
Having r egard 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 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 evaluated for their possible approval for use in biocidal 
products.  That list includes didecyldimethylammonium chloride.  
(2) Didecyldimethylammonium chloride  has been evaluated for use in bi ocidal products 
of product -type 1 (human hygiene biocidal products)  and product -type 2 (private area 
and public health area disinfectants and other biocidal products ), as defined in Annex 
V to Directive 98/8/EC  of the European Parliament  and of the Council3, which 
correspond respectively to product -types 1 and 2 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 201 2. After the submission of the assessment report, 
discussions took plac e in technical meetings organised by the Commission and, after 1 
September 2013, by the European Chemicals Agency (‘the Agency’).  
(4) It follows  from Article 90(2) of Regulation (EU) 528/2012 that substances for which 
the Member States’ evaluation has been com pleted by 1 September 2013 are to be 
evaluated in accordance with the provisions of 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 applica tions for 
approval of active substances. In accordance with Article 7(2) of Delegated Regulation 
(EU) No 1062/2014, the Biocidal Products Committee adopted the opinions 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 Council  (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  those opinions  biocidal products o f product -types 1 and 2 containing
 didecyldimethylammonium chloride  may be expected to satisfy the requirements laid 
down in Article 5 (1), points (b), (c) and (d) , read in conjunction with Article 10(1) of 
Directive 98/8/EC, provided that certain requirements concerning their use are 
complied with.  
(7) Taking into account the opinions of the Agency, it is appropriate to approve 
didecyldimethylammonium chloride  as an acti ve substance  for use in bi ocidal products 
of product -types 1 and 2 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 prepa ratory 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  
Didecyldimethylammonium chloride  is approved as an active substance for use in biocidal 
products of product -types 1 and 2 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 Biocidal Pro ducts Committee Opinion s on the application s for approval of the active substance 
didecyldimethylammonium chloride ; Product -types: 1 and 2; ECHA/BPC/ 311/2021 and 
ECHA/BPC/ 312/2021, adopted on 2 December  2021.