EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11135/2015 CIS 
(POOL/E3/2015/11135/11135-EN 
CIS.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving C(M)IT/MIT ( 3:1) as an existing active substan ce for use in biocidal products 
for product-types 2, 4, 6, 11, 12 and 13 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving C(M)IT/MIT (3:1) as an existing ac tive substance for use in biocidal products 
for product-types 2, 4, 6, 11, 12 and 13 
(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 includ es C(M)IT/MIT (3:1). 
(2) C(M)IT/MIT (3:1) 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 2, 
private area and public health  area disinfectants and othe r biocidal products, product-
type 4, food and feed area disinfectants, pr oduct-type 6, in-can preservatives, product-
type 11, preservatives for liquid-cooling and processing systems, product-type 12, 
slimicides, and product-type 13, metalworki ng-fluid preservative s, as defined in 
Annex V to that Directive, which corres pond respectively to pr oduct-types 2, 4, 6, 11, 
12 and 13 as defined in Annex V to Regulation (EU) No 528/2012. 
(3) France was designated as evaluating competent authority and submitted the 
assessment reports, together with its recommendations, to the Commission on 
19 October 2011, 27 November 2012 and 22 April 2013 in accordance with paragraphs 4 and 6 of Article 14 of  Commission Regula tion (EC) No 1451/2007
4. 
(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 5 February 2015, 14 
April 2015 and 17 June 2015 by the Biocidal Pr oduct 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 products used for product-types 2, 4, 6, 11, 12 
and 13 and containing C(M)IT/MIT (3:1) 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. 
(6) It is therefore appropriate to  approve C(M)IT/MIT (3:1) fo r use in biocidal products 
for product-types 2, 4, 6, 11, 12 and 13 s ubject 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 C(M)IT/MIT (3:1) in materials 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 Eur opean Parliament and of the Council
5. 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) Since C(M)IT/MIT (3:1) meets the criteria fo r classification as skin  sensitiser category 
1 as defined in Annex I to Regulation (E C) No 1272/2008 of the European Parliament 
and of the Council
6, treated articles treated with or incorporating C(M)IT/MIT (3:1) 
should be appropriately labelled when placed on the market. 
(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 
C(M)IT/MIT (3:1) is approved as  an active substance for use in  biocidal products for product-
types 2, 4, 6, 11, 12 and 13, subject to the specif ications and conditions set out in the Annex. 
                                                 
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 (EC) No 1272/2008 of the European Parliament and of the Council 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).  
EN 4   EN 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