EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/639/2023  
(POOL/E4/2023/639/639 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving reaction mass of N,N -didecyl -N-(2-hydroxyethyl) -N-methylammonium 
propionate and N,N -didecyl -N-(2-(2-hydroxyethoxy)ethyl) -N-methylammonium 
propionate and N,N -didecyl -N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl) -N-
methylammonium propionate as an active s ubstance for use in biocidal products of 
product -type 8 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 reaction mass of N,N -didecyl -N-(2-hydroxyethyl) -N-methylammonium 
propionate and N,N-didecyl -N-(2-(2-hydroxyethoxy)ethyl) -N-methylammonium 
propionate and N,N -didecyl -N-(2-(2-(2-hydroxyethoxy)ethoxy)ethyl) -N-
methylammonium propionate as an active substance for use in biocidal products of 
product -type 8 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 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 subparagraph, thereof,  
Whereas:  
(1) Didecylmethylpoly(oxyethyl)ammonium propionate was approved as an existing 
active substance for use in biocidal products of product -type 8  by Commission 
Implementing Regulation (EU) 2016/10932. 
(2) Didecylmethylpoly(oxyethyl)ammonium propionate is also included in the list of 
existing active substances of Annex II to  Commission Delegated Regulation (EU) 
No 1062/20143 for product -types 2, 4  and 10, referred to with its chemical name 
‘poly(oxy -1,2- ethanediyl),.alpha. -[2-(didecylmethylammonio)ethyl] - .omega. -
hydroxy -, propanoate (salt) ( ‘Bardap 26 ’). 
(3) On 22 November 2022, the Biocid al Products Committee of the European Chemical s 
Agency  (the ‘Agency’)  adopted the opinions  on the applications for approval of the 
active substance  for use in biocidal products of product -types  24 and 45, and submitted 
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Implementing Regulation (EU) No 2016/1093 of 6 July 2016 approving 
didecylmethylpoly(oxyethyl)ammonium propionate as an existing active substance for use in biocidal 
products of product -type 8  (OJ L 182, 7.7.2016, p. 1). 
3 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). 
4 Biocidal Products Committee Opinion on the application for approval of the active subs tance reaction 
mass of  N,N-didecyl -N-(2-hydroxyethyl) -N-methylammonium propionate and N,N -didecyl -N-(2-(2-
hydroxyethoxy)ethyl) -N-methylammonium propionate and N,N -didecyl -N-(2-(2-(2-
hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate ; product -type 2; E CHA/BPC/363/2022.  
5 Biocidal Products Committee Opinion on the application for approval of the active substance reaction 
mass of N,N -didecyl -N-(2-hydroxyethyl) -N-methylammonium propionate and N,N -didecyl -N-(2-(2-
hydroxyethoxy)ethyl) -N-methylammonium propio nate and N,N -didecyl -N-(2-(2-(2-
hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate ; product -type 4;  ECHA/BPC/364/2022.    
EN 2  EN them to the Commission  in accordance with Article 7(2) of Delegated Regulation (EU) 
No 1062/2014.  
(4) In those opinion s, the Agency  concluded that the substance composition and reference 
specification was consistent with the active substance assessed and approved under 
product -type 8, but that the name of the substance in the list of Annex II to Delegated 
Regulation (EU) No 1062/2014 and , consequently, in Implementing Regulation (EU) 
2016/1093 was not appropriate. Therefore, pursuant to Article 13 of Delegated 
Regulation (EU) No  1062/2014, the identity of the active substance 
didecylmethylpoly(oxyethyl)ammonium propionate was redefined to reaction mass of 
N,N-didecyl -N-(2-hydroxyethyl) -N-methylammonium propionate and N,N -didecyl -N-
(2-(2-hydroxyethoxy)ethyl) -N-methylammonium propi onate and N,N -didecyl -N-(2-
(2-(2-hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate  (‘DMPAP’) . 
(5) Consequently, the identity of the active substance also needs to be changed in  
Implementing Regulation (EU) 2016/1093. As a number of changes  related to the 
redefinition of the substance need  to be made in Implementing Regulation (EU) 
2016/1093 , in the interests of clarity, that Regulation should be replaced.  
(6) The measures provided for in this Regulation are in accordance with the opinion of th e 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Reaction mass of N,N -didecyl -N-(2-hydroxyethyl) -N-methylammonium propionate and N,N -
didecyl -N-(2-(2-hydroxyethoxy)ethyl) -N-methylammonium propionate and N,N -didecyl -N-
(2-(2-(2-hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate  is approved as an 
active substance for use in biocidal products of product -type 8, subject to the conditions set 
out in the Annex .  
Article 2  
Implementing Regulation (EU) 2016/1093 is repealed.  
Article 3 
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 Brusse ls, 
 For the Commission  
 The President  
 Ursula VON DER LEYEN