EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10094/2016 
(POOL/E4/2016/10094/10094-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Amines, N-C10–C16-alkyltrime thylenedi-, reaction products with 
chloroacetic acid as an existing active subs tance for use in biocidal products of product-
types 2, 3 and 4 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Amines, N-C10–C16-alkyltrime thylenedi-, reaction products with 
chloroacetic acid as an existing active subs tance for use in biocidal products of product-
types 2, 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 concerning the making avai lable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes Amines, N-C10–C16-alkyltrimethylenedi-, reaction 
products with chloroacetic acid. 
(2) Amines, N-C10–C16-alkyltrimethylenedi-, r eaction products with chloroacetic acid 
has been evaluated in accordance with Ar ticle 16(2) of Direct ive 98/8/EC of the 
European Parliament and of the Council3 for use in products of product-type 2, private 
area and public health area disinfectant s and other biocidal products, of product-
type 3, veterinary hygiene bioc idal products, and of product- type 4, food and feed area 
disinfectants, as described in Annex V to that Directive, which correspond 
respectively to product-types 2, 3 and 4 as described in Annex V to Regulation (EU) 
No 528/2012. 
(3) Ireland was designated as evaluating competent authority and submitted the 
assessment reports together with its recommendations on 30 August 2013. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agen cy were formulated on 15 April 2015 for 
use in products of product-type 3 and on 8 December 2015 for use in products of product-types 2 and 4 by the Biocidal Pr oducts Committee, having regard to the 
conclusions of the evaluating competent authority. 
(5) According to those opinions, biocidal products of product-types 2, 3 and 4 and 
containing Amines, N-C10–C16-alkyltrim ethylenedi-, reaction products with 
                                                
 
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 substan ces 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 3   EN chloroacetic acid may be expected to sa tisfy the requirements of Article 5 of 
Directive 98/8/EC, provided that certain sp ecifications and conditi ons concerning their 
use are complied with. 
(6) It is therefore appropriate to approve  Amines, N-C10–C16-alkyltrimethylenedi-, 
reaction products with chlo roacetic acid for use in bi ocidal products of product-
types 2, 3 and 4, subject to compliance w ith certain specifications and conditions. 
(7) For use in products of product-type 4, the ev aluation did not address the incorporation 
of biocidal products containing Amines , N-C10–C16-alkyltrimethylenedi-, reaction 
products with chloroacetic acid in materials and articles intended to come into contact 
directly or indirec tly with food referred to in Ar ticle 1(1) of Regulation (EC) 
No 1935/2004 of the European Parliament and of the Council4. The approval should 
therefore not cover such use, unless the Co mmission has established specific limits on 
the migration into food, as referred to in Article 5(1)(e) of th at Regulation, or has 
established that such limits are not necessary. 
(8) 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 th e new requirements. 
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Amines, N-C10–C16-alkyltrimethylenedi-, reac tion products with chloroacetic acid is 
approved as an active substanc e for use in biocidal product s of product-types 2, 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  Jean-Claude JUNCKER  
                                                
 
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).