EN    EN  
 EUROPEAN  
COMMISS IO N 
Brussels, XXX   
SANTE/11302/2017 
(POOL/E4/2017/11302/11302-EN.doc) 
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-methyl-1,2-benzisothiazol-3(2H)-one as an active substance for use in 
biocidal products of product-type 6 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving 2-methyl-1,2-benzisothiazol-3(2H)- one as an active substance for use in 
biocidal products of product-type 6 
(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) Poland received on 26 November 2009 an app lication, in accordan ce with Article 
11(1) of Directive 98/8/EC  of the European Parliament and of the Council
2, for the 
inclusion of the activ e substance 2-methyl-1,2-benzisot hiazol-3(2H)-one in Annex I to 
that Directive for use in products of product- type 6, in-can preser vatives, as described 
in Annex V to that Directive, which corre sponds to product-type 6 as described in 
Annex V to Regulati on (EU) No 528/2012. 
(2) Poland submitted the assessment report together with its recommendations on 
24 March 2016 in accordance  with Article 90(2) of Regulation (EU) No 528/2012. 
(3) The opinion of the European Chemicals Agency was formulated on 27 June 2017 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(4) According to that opinion, biocidal products  of product-type 6 containing 2-methyl-
1,2-benzisothiazol-3(2H)-one may be e xpected to satisfy the criteria of 
Article 19(1)(b) of Regulati on (EU) No 528/2012, provided th at certain specifications 
and conditions concerning their use are complied with. 
(5) It is therefore appropriate to approve 2-me thyl-1,2-benzisothiazol-3(2H)-one for use in 
biocidal products of product- type 6, subject to compliance with certain specifications 
and conditions. 
                                                 
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).  
EN 3   EN (6) Since 2-methyl-1,2-benzisothiazol-3(2H)-one me ets the criteria for classification as a 
skin sensitiser sub-category 1A (strong se nsitiser) as specifie d in point 3.4.2.2.1.2. of 
Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council3, treated articles treated with or in corporating 2-methyl-1,2-benzisothiazol-
3(2H)-one should be labelled approp riately 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-methyl-1,2-benzisothiazol-3(2H)- one is approved as an active substance for use in biocidal 
products of product-type 6, subjec t to the specifications and c onditions 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  
                                                 
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).