EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10122/2017 (POOL/E4/2017/10122/10122-EN.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in 
biocidal products of product-type 11 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in 
biocidal products of product-type 11 
(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 includes 2-methylisothiaz ol-3(2H)-one. 
(2) 2-methylisothiazol-3(2H)-one has been ev aluated for use in products of product-
type 11, preservatives for liquid-cooling an d processing systems, as described in 
Annex V to Regulati on (EU) No 528/2012. 
(3) Slovenia was designated as evaluating competent authority and submitted the 
assessment report together with its recommendations on 7 April 2016. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agen cy was formulated on 15 December 2016 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(5) According to that opinion, biocidal products of product-t ype 11 containing 2-
methylisothiazol-3(2H)-one may be expected to  satisfy the criteria of Article 19(1)(b) 
of Regulation (EU) No 528/2012, provided that  certain specifications and conditions 
concerning their use are complied with. 
(6) It is therefore appropriate to approve 2-me thylisothiazol-3(2H)-one for use in biocidal 
products of product-type 11, subject to co mpliance with certai n specifications and 
conditions. 
(7) Since 2-methylisothiazol-3(2H)-one meets the criteria for classification as skin 
sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 
                                                 
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).  
EN 3   EN of the European Parliament and of the Council3, treated articles treated with or 
incorporating 2-methylisothiazol-3(2H)-one  should be appropriately labelled when 
placed on the market. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties 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 
of product-type 11, 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  Jean-Claude JUNCKER  
                                                 
3 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).