EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12072/2015 
(POOL/E3/2015/12072/12072-EN.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving peracetic acid as an existing active substance for use in biocidal products for 
product-types 1, 2, 3, 4, 5 and 6 
(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 for 
product-types 1, 2, 3, 4, 5 and 6 
(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 in acco rdance with Article 16(2) of Directive 
98/8/EC of the European Parliament and of the Council3 for use in product-type 1, 
human hygiene biocidal products, product-type  2, private area and public health area 
disinfectants and other biocid al products, product-type 3, veterinary hygiene biocidal 
products, product-type 4, food and feed ar ea disinfectants, produc t-type 5, drinking 
water disinfectants, and product-type 6, in-can  preservatives, as defined in Annex V to 
that Directive, which correspond respectiv ely to product-types 1, 2, 3, 4, 5 and 6 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(1)(b) of Delegated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agen cy were formulated on 30 September 2015 
by the Biocidal Product Committee,  having regard to the conclusions of the evaluating 
competent authority. 
(5) According to those opinions, biocidal products used for pr oduct-types 1, 2, 3, 4, 5 and 
6 and containing peracetic acid may be e xpected to satisfy the requirements of 
Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions 
concerning its use are complied 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 (6) It is therefore appropriate to approve per acetic acid for use in biocidal products for 
product-types 1, 2, 3, 4, 5 and 6 subject to compliance with  certain specifications and 
conditions. 
(7) For the use in product-type 4, the evaluati on did not address the incorporation of 
biocidal products containing peracetic acid in  materials and articles intended to come 
into contact directly or indi rectly with food within the meaning of Article 1(1) of 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council4. Such 
materials may require the establishment of specific limits on the migration into food, 
as referred to in Article 5(1)(e) of that  Regulation. The approva l should therefore not 
cover such use unless the Commission has established such limits or it has been established pursuant to that Regulati on that such limits are not necessary. 
(8) 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 explosive precursors, Regulation (EU) No 98/ 2013 of the European Parliament and of 
the Council
5 should continue to appl y to hydrogen peroxide.  
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements. 
(10) 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 approved as an active subs tance for use in biocidal products for product-
types 1, 2, 3, 4, 5 and 6, subject to the specifi cations 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). 
5 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).