EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11141/2016 (POOL/E4/2016/11141/11141-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving peracetic acid as an existing active substance for use in biocidal products of 
product-types 11 and 12 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving peracetic acid as an existing active  substance for use in biocidal products of 
product-types 11 and 12 
(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 in cludes peracetic acid. 
(2) Peracetic acid has been evaluated for use in  products of product-t ype 11, preservatives 
for liquid-cooling and processing systems,  and of product-type 12, slimicides, as 
described 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 3 July 2015. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agency  were formulated on 14 June 2016 by the 
Biocidal Products Committee, having regard  to the conclusions of the evaluating 
competent authority. 
(5) According to those opinions, biocidal products of product-types 11 and 12 and 
containing peracetic acid may be expected to satisfy the criteria of  Article 19(1)(b) of 
Regulation (EU) No 528/2012, provided that certain spec ifications and conditions 
concerning their use are complied with. 
(6) It is therefore appropriate to approve peracetic acid for use in biocidal products of 
product-types 11 and 12, subj ect to compliance with ce rtain specifications and 
conditions. 
(7) Peracetic acid is in an aqueous solution containing acetic acid and hydrogen peroxide. 
Due to the presence of hydrogen peroxide, which can be used in the production of explosives precursors, author isations of biocidal products  containing peracetic acid 
                                                
 
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).  
EN 3   EN should be without prejudice  to Regulation (EU) No  98/2013 of the European 
Parliament and of the Council3.  
(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 
Peracetic acid is appr oved as an active substance for use in biocidal products of product-
types 11 and 12, subject to the specificatio ns and conditions se t 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  
                                                
 
3 Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the 
marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1).