EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.4.7 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving 4,5-Dichloro-2-octyl-2H-isothiazol-3 -one as an existing active substance for 
use in biocidal products for product-type 21 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-o ne as an existing active substance for 
use in biocidal products for product-type 21 
(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 Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes 4,5-
Dichloro-2-octyl-2H-isothiazol-3-one. 
(2) 4,5-Dichloro-2-octyl-2H-isothiazol-3-one ha s been evaluated in accordance with 
Article 11(2) of Directive 98/8/EC for use in product-type 21, an tifouling products, as 
defined in Annex V to that Directive, which corresponds to  product-type 21 as defined 
in Annex V to Regulation (EU) No 528/2012. 
(3) Norway was designated as Rapporteur Me mber State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 21 December 
2010 in accordance with Article 14(4) a nd (6) of Regulati on (EC) No 1451/2007. 
(4) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated in  an assessment report reviewed within the 
Standing Committee on Biocidal Products on [date SCB].  
(5) According to that assessment report, bioc idal products used for product-type 21 and 
containing 4,5-Dichloro-2-octyl-2H-isothiazol- 3-one may be expected to satisfy the 
requirements laid down in Article 5 of Directive 98/8/EC, provided that certain 
specifications and conditions rela ting to its use are satisfied. 
(6) It is therefore appropriate to approve 4,5-Dichloro-2-octyl -2H-isothiazol-3-one for use 
in biocidal products for product-type 21 subj ect to compliance with  such specifications 
and conditions. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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). 
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) . EN 3   EN (7) Since the evaluation did not a ddress nanomaterials, the appr oval should not cover such 
materials pursuant to Article 4( 4) of Regulation (EU) No 528/2012. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested pa rtiesto take the preparatory measures 
necessary to meet the ne w requirements laid down.  
(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 
4,5-Dichloro-2-octyl-2H-isothiazol- 3-one shall be approved as an active substance for use in 
biocidal products for product-type 21, subject to  the specifications and conditions 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  José Manuel BARROSO 
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
4,5-
Dichloro-2-octyl-2H-
isothiazol-
3-one IUPAC Name :  
4,5-Dichloro-2-octylisothiazol-3(2H)-one  EC n° : 264-843-8 CAS n° : 64359-81-5 950 g/kg 1 January 
2016 31 
December 
2025
 21 The product assessment shall pay particular 
attention to the exposures, the risks and the efficacy linked to any uses covered by an 
application for authorisation, but not 
addressed in the Union level risk 
assessment of the active substance. 
Authorisations are subject to the following 
conditions: 
(1) For industrial or professional 
users, safe operational procedures and appropriate 
organizational measures shall be 
established. Where exposure cannot be reduced to an 
acceptable level by other means, 
products shall be used with appropriate personal protective 
equipment. 
(2) Products authorised for non-
professional users shall be sold 
with the appropriate protective 
gloves. Labels and, where 
                                                 
4 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 of Regulation (EU) 
No 528/2012. The active substance in the product placed on the market  can be of equal or different  purity if it has been proven  technically equivalent with the evaluated 
active substance. 
5 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm .  
EN 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
provided, instructions for use 
shall indicate whether other personal protective equipments 
shall be used.  
(3) Labels and, where provided, 
safety data sheets of products 
authorised shall indicate that 
application, maintenance and 
repair activities shall be 
conducted within a contained area and on impermeable hard 
standing with bunding to prevent 
direct losses and minimize emissions to the environment, 
and that any losses or waste 
containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one shall be 
collected for reuse or disposal. 
(4) For products that may lead to 
residues in food or feed, the 
need to set new or to amend 
existing maximum residue levels (MRLs) in accordance with 
Regulation (EC) No 470/2009 of 
the European Parliament and of 
                                                                                                                                                                                                                                                    
6 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
7 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
EN 6   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
the Council6 or Regulation (EC) 
No 396/2005 of the European Parliament and of the Council
7 
shall be verified, and any 
appropriate risk mitigation measures shall be taken to 
ensure that the applicable MRLs 
are not exceeded.