EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10121/2017 (POOL/E4/2017/10121/10121-EN.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-octyl-isot hiazol-3(2H)-one as an active substance for use in biocidal 
products of product-type 8 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-octyl-isothiazol-3(2H)-one as an active substance for use in biocidal 
products of product-type 8 
(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 Article 90(2) thereof, 
Whereas: (1) The United Kingdom received on 27 April 2010 an application, in accordance with 
Article 11(1) of Directive 98/8/EC of th e European Parliament and of the Council
2, for 
the inclusion of the active substance 2-octy l-isothiazol-3(2H)-one in Annex I to that 
Directive for use in products of product-type  8, wood preservatives, as described in 
Annex V to that Directive, which corresponds  to product-type 8 as  described in Annex 
V to Regulation (EU) No 528/2012. 
(2) The United Kingdom submitted the assessment report together with its 
recommendations on 4 February 2016 in accordance  with Article 90(2) of Regulation 
(EU) No 528/2012. 
(3) The opinion of the European Chemicals Agency was formulated on 15 December 
2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. 
(4) According to that opinion, bi ocidal products of product-t ype 8 and containing 2-octyl-
isothiazol-3(2H)-one may be ex pected to satisfy the criteria of Article 19(1)(b) of 
Regulation (EU) No 528/2012, provided that certain spec ifications and conditions 
concerning their use are complied with. 
(5) It is therefore appropriate to approve 2-oc tyl-isothiazol-3(2H)-one for use in biocidal 
products of product-type 8, subject to co mpliance with certain specifications and 
conditions. 
(6) Since 2-octyl-isothiazol-3(2H)-one meets th e criteria for cla ssification as skin 
sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 
of the European Parliament and of the Council
3, treated articles treated with or 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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). 
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).  
EN 3   EN incorporating 2-octyl-isothi azol-3(2H)-one should be appropriately labelled when 
placed on the market. 
(7) 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. 
(8) 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-octyl-isothiazol-3(2H)-one is a pproved as an active substance fo r use in biocidal  products of 
product-type 8, subject to th e specifications and conditi ons 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  Jean-Claude JUNCKER