EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/640/2023  
(POOL/E4/2023/640/640 -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 -types 2 and 4 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 -types 2 and 4 in accordance with Regulati on (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 Parliame nt 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) 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 didecylmethylpoly(oxyethyl)ammonium propionate . 
(2) Didecylmethylpoly(oxyethyl)ammonium propionate  has been evaluated for use in 
biocidal products of product -type 2, private area and public health area disinfectants 
and other biocidal products , and product -type 4, f ood and feed area disinfectants , as 
described  in Annex V to Directive 98/8/EC  of the Euro pean Parliament  and of the 
Council3, which correspond to product -type 2, disinfectants and algaecides not 
intended for direct application to humans or animals , and product -type 4, food and 
feed area  disinfectants , 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 s together with its conclusions to the 
Commission  on 27 July 2010. After the submission of the assessment report s, 
discu ssions took place in technical meetings organised by the Commission and, after 1 
September 2013, by the European Chemical s Agency (the ‘ Agency ’). 
(4) It follows  from Article 90(2) of Regulation (EU) 528/2012 that substances for which 
the Member States’ evaluat ion has been completed by 1 September 2013 are to  be 
assessed under the evaluation criteria of Directive 98/8/EC.  
                                                 
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 (5) During the examination of didecylmethylpoly(oxyethyl)ammonium propionate, the 
identity of this active substance has been redefined in accordance with Article 13 of 
Delegated Regulation (EU) No 1062/2014 to 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 (‘DMPAP’) .  
(6) In accordance with  Article 75(1) , second subparagraph,  point (a),  of Regulation (EU) 
No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency 
regarding the applications for approval of active substances.  In accordance with 
Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products 
Committee adopted th e opinion s of the Agency  ECHA/BPC/363/20224 and 
ECHA/BPC/36 4/20225 on 22 November  2022, having regard to the conclusions of the 
evaluating competent authority.  
(7) According to  those opinion s, biocidal products o f product -types 2 and 4  containing 
DMPAP  may be expected to satisfy the requirements corresponding to those laid down 
in Article 5 (1), points (b), (c) and (d) , of Directive 98/8/EC, provided that certain 
requirements  concerning their use are complied with.  
(8) Taking into account the opinion s of the Agency, it is appropriate to approve DMPAP  
as an active substance  for use in bi ocidal products of product -types 2 and 4  subject to 
compliance with certain conditions.  
(9) 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.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS RE GULATION:  
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 -types 2 and 4 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 . 
                                                 
4 Biocidal Pro ducts 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 propionate and N,N -didecyl -N-(2-(2-(2-
hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate ; Product -type 2; ECHA/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 propionate and N,N -didecyl -N-(2-(2-(2-
hydroxyethoxy)ethoxy)ethyl) -N-methylammonium propionate ; Product -type 4; ECHA/BPC/36 4/2022 .  
EN 3  EN 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