EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP42-Doc.2.1 […](2014) XXX  draft 
  
COMMISSION IMPLEMENTING RE GULATION (EU) No …/.. 
of XXX  
approving glutaraldehyde as an active substance for use in biocidal products for 
product-types 2, 3, 4, 6, 11 and 12 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving glutaraldehyde as an existing active  substance for use in biocidal products for 
product-types 2, 3, 4, 6, 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 their possible approval for use in biocidal products. 
(2) That list includes glutaraldehyde. 
(3) Glutaraldehyde has been evaluated in acco rdance with Article 16(2) of Directive 
98/8/EC of the European Parliament and of the Council
3 for use in product-type 2, 
private area and public health  area disinfectants and othe r biocidal products, product-
type 3, veterinary hygiene biocidal pr oducts, product-type 4, food and feed area 
disinfectants, product-type 6, in-can preservatives, produc t-type 11, preservatives for 
liquid-cooling and processing systems, and pr oduct-type 12, slimicides, as defined in 
Annex V to that Directive, which corres pond respectively to product-types 2, 3, 4, 6, 
11 and 12 as defined in Annex V to Regulation (EU) No 528/2012. 
(4) Finland was designated as evaluating competent authority and submitted the 
assessment reports, together with its recommendations, to the Commission on 30 March 2011 and 31 January 2013 in accordance with paragraphs 4 and 6 of 
Article 14 of Commission Regulation (EC) No 1451/2007.
4 
                                                 
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 substances 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 December 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) In accordance with Article 7(1)(b) of Commission Delegated Regulation (EU) 
No 1062/2014,5 the opinions of the European Chemicals Agency were formulated on 
1 October 2014 by the Biocidal Product Comm ittee, having regard to the conclusions 
of the evaluating competent authority. 
(6) According to those opinions, biocidal produc ts used for product-types 2, 3, 4, 6, 11 
and 12 and containing glutaral dehyde may be expected to satisfy the requirements of 
Article 5 of Directive 98/8/EC, provided that certain conditions concerning its use 
are complied with. 
(7) It is therefore appropriate to approve glut araldehyde for use in biocidal products for 
product-types 2, 3, 4, 6, 11 and 12 subject to compliance with the specific conditions 
in the Annex. 
(8) The opinions conclude that glutaraldehyde m eets the criteria for classification as a 
respiratory sensitiser as defined in poi nt 3.4.1.2 of Annex I to Regulation (EC) 
No 1272/2008 of the European Parliament and of the Council6. 
(9) Since, pursuant to Article 90(2) of Re gulation (EU) No 528/2012, substances for 
which the Member States' evaluation ha s not been completed by 1 September 2013 
should be approved in accordance with Directive 98/8/EC, the period of approval for such substances should be 10 years, in accordance with the practice established under that Directive. 
(10) For the purposes of Article 23 of Regulation (EU) No 528/2012 however, 
glutaraldehyde meets the condi tions of Article 10 (1)(b) of that Regul ation and should 
therefore be considered a candidate for substitution. 
(11) For the use in product-type 4, the evaluati on did not address the incorporation of 
biocidal products containi ng glutaraldehyde in material s and articles intended to 
come into contact directly or  indirectly with food within the meaning of Article 1(1) 
of Regulation (EC) No 1935/2004 of the Eu ropean Parliament and of the Council
7. 
Such materials may require the establishmen t 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 has established such limits or it has been established pursuant to that Regulation that such limits are not necessary. 
(12) 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. 
(13) The measures provided for in this Regulat ion are in accordance with the opinion of 
the Standing Committee on Biocidal Products, 
(14) HAS ADOPTED THIS REGULATION: 
                                                
 
5 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the 
systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council Text with EEA relevance  
6 Regulation (EC) No 1272/2008 of the European Par liament and of the Counc il of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, 
p. 1). 
7 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).  
EN 4   EN Article 1 
Glutaraldehyde is approved as an active subs tance for use in biocidal products for product-
types 2, 3, 4, 6, 11 and 12, subject to the specif ications 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