EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10120/2017 
(POOL/E4/2017/10120/10120-EN.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving peracetic acid generated from tetraacetylethylenediamine and sodium 
percarbonate as an existing active substance 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 peracetic acid generated from  tetraacetylethylenediamine and sodium 
percarbonate as an existing active substance 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 peracetic acid ge nerated from tetraacetylethylenediamine 
and sodium percarbonate. 
(2) Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate has 
been evaluated in accordance with Article 16 (2) of Directive 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 disinfectants and other bi ocidal products, product-type 3, veterinary 
hygiene biocidal products, and product-type 4, food and feed area disinfectants, as 
defined in Annex V to that  Directive, which correspond respectively to product-types 
2, 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012. 
(3) Finland was designated as evaluating competent authority and submitted the 
assessment reports together with its  recommendations on 16 January 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 13 December 2016 
by the Biocidal Products Committee, havi ng regard to the conclusions of the 
evaluating competent authority. 
(5) According to those opinions, biocidal produc ts of product-types 2, 3 and 4 based on 
peracetic acid generated fr om tetraacetylethylenediamine and sodium percarbonate 
may be expected to satisfy the requireme nts of Article 5 of Directive 98/8/EC, 
                                                 
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 provided that certain specifi cations and conditions con cerning its use are complied 
with. 
(6) It is therefore appropriate to a pprove peracetic acid generated from 
tetraacetylethylenediamine and sodium percarbonate for use in biocidal products of product-types 2, 3 and 4, subject to compli ance with certain sp ecifications and 
conditions. 
(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 th e new requirements. 
(8) 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 
Peracetic acid generated from tetraacetylet hylenediamine and sodium percarbonate is 
approved as an active substance for use in biocidal products 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