EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10373/2015 
(POOL/E3/2015/10373/10373-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving hydrogen peroxi de as an existing active substan ce 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 hydrogen peroxide as an existing ac tive 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 av ailable 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 Regul ation (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 incl udes hydrogen peroxide. 
(2) Hydrogen peroxide has been evaluated in ac cordance 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 biocidal products, product-type 3, veterina ry hygiene biocidal 
products, product-type 4, food and feed area  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 respectivel y 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, to the Commission on 
2 August 2013 in accordance with paragraphs  4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20074. 
(4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agency  were formulated on 2 February 2015 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
                                                 
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). 
4 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).  
EN 3   EN (5) According to those opinions, biocidal produc ts used for product-types 1, 2, 3, 4, 5 and 
6 and containing hydrogen peroxide may be ex pected to satisfy the requirements laid 
down in Article 5 of Directive 98/8/EC, provi ded that certain condi tions concerning its 
use are complied with.  
(6) It is therefore appropriate to approve hydr ogen peroxide for use in biocidal products 
for product-types 1, 2, 3, 4, 5 and 6 subject to compliance with ce rtain specifications 
and conditions.  
(7) For the use in product-type 4, the evalua tion did not address th e incorporation of 
biocidal products containing hydrogen peroxi de in materials and articles intended to 
come into contact directly or indirectly with food within the meaning of Regulation 
(EC) No 1935/2004 of the European Parliament and of the Council5. Such materials 
may require the establishment of specific limits  on the migration into  food, as referred 
to in Article 5(1)(e) of Regulation (EC)  No 1935/2004. The approval should therefore 
not cover such use unless the Commission ha s established such limits or it has been 
established pursuant to that Regulation that such limits are not necessary.  
(8) Regulation (EU) No 98/2013 on the marketing a nd use of explosive precursors applies 
to hydrogen peroxide6. 
(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 
Hydrogen peroxide is approved as an active substance for use in biocidal products for 
product-types 1, 2, 3, 4, 5 and 6, 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 . 
                                                 
5 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). 
6 Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15January 2013 on the 
marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1)  
EN 4   EN 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