EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP42-Doc.4.1 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING RE GULATION (EU) No …/.. 
of XXX  
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in 
biocidal products fo r product-type 13 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in 
biocidal products for product-type 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 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 with a vi ew for their possible approval for use in 
biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012.  
(2) That list includes 2-me thylisothiazol-3(2H)-one. 
(3) 2-methylisothiazol-3(2H)-one has been eval uated in accordance Article 16(2) of 
Directive 98/8/EC of the European  Parliament and of the Council3 for use in biocidal 
products for product-type 13, metalworking-flui d preservatives, as defined in Annex V 
to that Directive, which correspond to product-type 13 as defined in Annex V to 
Regulation (EU) No 528/2012. 
(4) Slovenia was designated as evaluating competent authority and submitted the 
assessment reports, together with its reco mmendations, to the Commission on 11 April 
2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20074. 
(5) In accordance with Article 7(1)(b) of Commission Delegate d Regulation (EU) 
No 1062/2014,5 the opinion of the European Chemicals Agency was formulated on 2 
                                                 
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). 
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 
(OJ L 294, 10.10.2014, p. 1).   
EN 3   EN October 2014 by the Biocidal Product Committee, having regard to the conclusions of 
the evaluating competent authority.  
(6) According to that opinion, biocidal products used for product-type 13 and containing 
2-methylisothiazol-3(2H)-one may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of th e European Parliament and of the Council
6 
provided that certain specifications and conditions relating to its use are complied with.  
(7) It is therefore appropriate to approve 2-me thylisothiazol-3(2H)-one for use in biocidal 
products for product-type 13 subject to compliance with the specific conditions in the Annex.  
(8) 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.  
(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 
2-methylisothiazol-3(2H)-one is approved as an active substance for use in biocidal products 
for product-type 13, subject to the specifica tions 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 
  
                                                
 
6 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) .