DIRECTIVES  
COMMISSION DIRECTIVE 2011/66/EU  
of 1 July 2011  
amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro- 
2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to 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 (  1 ), and in particular the 
second subparagraph of Article 16(2) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 1451/2007 of 
4 December 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 (  2 ) establishes a list of active substances to be 
assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Directive 98/8/EC. That list 
includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one.  
(2) Pursuant to Regulation (EC) No 1451/2007, 4,5- 
Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated 
in accordance with Article 11(2) of Directive 98/8/EC for 
use in product-type 8, wood preservatives, as defined in 
Annex V to that Directive.  
(3) Norway was designated as Rapporteur and submitted the 
competent authority report, together with a recommen ­
dation, to the Commission on 8 September 2008 in 
accordance with Article 14(4) and (6) of Regulation 
(EC) No 1451/2007.  
(4) The competent authority report was reviewed 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, within 
the Standing Committee on Biocidal Products on 
16 December 2010, in an assessment report.  
(5) It appears from the evaluations that biocidal products 
used as wood preservatives 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. It is therefore appropriate to include 
4,5-Dichloro-2-octyl-2H-isothiazol-3-one in Annex I to 
that Directive.  
(6) Not all potential uses have been evaluated at Union level. 
It is therefore appropriate that Member States assess 
those uses or exposure scenarios and those risks to 
human populations and to environmental compartments 
that have not been representatively addressed in the 
Union level risk assessment and, when granting 
product authorisations, ensure that appropriate 
measures are taken or specific conditions imposed in 
order to reduce the identified risks to acceptable levels.  
(7) In view of the risks identified for human health, it is 
appropriate to require that safe operational procedures 
are established for products authorised for industrial or 
professional use, and that those products are used with 
appropriate personal protective equipment unless it can 
be demonstrated in the application for product author ­
isation that risks to industrial or professional users can 
be reduced to an acceptable level by other means.  
(8) In view of the risks identified for the aquatic and 
terrestrial compartments, it is appropriate to require 
that freshly treated timber is stored after treatment 
under shelter or on impermeable hard standing, or 
both, and that any losses from the application of 
products used as wood preservatives and containing 
4,5-Dichloro-2-octyl-2H-isothiazol-3-one are collected 
for reuse or disposal.  
(9) Unacceptable risks for the environment were identified in 
various scenarios for in-service use of treated wood not 
covered and not in contact with the ground, which is 
either continually exposed to the weather or protected 
from the weather but subject to frequent wetting (use 
class 3 as defined by OECD (  3 )) and wood in contact 
with fresh water (use class 4b as defined by OECD (  4 )). 
It is therefore appropriate to require that products are 
not authorised for the treatment of wood intended for 
those uses, unless data is submitted demonstrating that 
the product will meet the requirements of both Article 5 
of and Annex VI to Directive 98/8/EC, if necessary by the 
application of appropriate risk mitigation measures.EN L 175/10 Official Journal of the European Union 2.7.2011  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.  ( 3 ) OECD series on emission scenario documents, Number 2, Emission 
Scenario Document for Wood Preservatives, Part 2, p. 64.  
( 4 ) Ibid.(10) It is important that the provisions of this Directive be 
applied simultaneously in all Member States in order to 
ensure equal treatment of biocidal products on the 
market containing the active substance 4,5-Dichloro-2- 
octyl-2H-isothiazol-3-one and also to facilitate the 
proper operation of the biocidal products market in 
general.  
(11) A reasonable period should be allowed to elapse before 
an active substance is included in Annex I to Directive 
98/8/EC in order to permit Member States and interested 
parties to prepare themselves to meet the new 
requirements entailed and to ensure that applicants 
who have prepared dossiers can benefit fully from the 
10-year period of data protection, which, in accordance 
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from 
the date of inclusion.  
(12) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.  
(13) Directive 98/8/EC should therefore be amended 
accordingly.  
(14) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on Biocidal Products,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex I to Directive 98/8/EC is amended in accordance with 
the Annex to this Directive.  Article 2  
Transposition  
1. Member States shall adopt and publish, by 30 June 2012 
at the latest, the laws, regulations and administrative provisions 
necessary to comply with this Directive.  
They shall apply those provisions from 1 July 2013.  
When Member States adopt those provisions, they shall contain 
a reference to this Directive or be accompanied by such a 
reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made.  
2. Member States shall communicate to the Commission the 
text of the main provisions of national law which they adopt in 
the field covered by this Directive.  
Article 3  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 1 July 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 2.7.2011 Official Journal of the European Union L 175/11ANNEX  
In Annex I to Directive 98/8/EC, the following entry is added:  
No Common Name  IUPAC Name 
Identification Numbers  Minimum purity 
of the active 
substance in the 
biocidal product 
as placed on the 
market  Date of 
inclusion  Deadline for compliance with 
Article 16(3) (except for products 
containing more than one active 
substance, for which the deadline to 
comply with Article 16(3) shall be the 
one set out in the last of the inclusion 
decisions relating to its active 
substances)  Expiry date of 
inclusion  Product type  Specific provisions (*)  
‘44 4,5-Dichloro- 
2-octyl-2H- 
isothiazol-3- 
one 4,5-Dichloro-2-octyl ­
isothiazol-3(2 H)-one 
EC No: 264-843-8 
CAS No: 64359-81-5  950 g/kg  1 July 2013  30 June 2015  30 June 2023  8  When assessing the application for authorisation of a product in 
accordance with Article 5 and Annex VI, Member States shall 
assess, when relevant for the particular product, those uses or 
exposure scenarios and those risks to human populations and to 
environmental compartments that have not been representatively 
addressed in the Union level risk assessment. 
Products shall not be authorised for treatment of wood that will be 
continually exposed to the weather, protected from the weather but 
subject to frequent wetting or in contact with fresh water, unless 
data have been submitted demonstrating that the product will meet 
the requirements of Article 5 and Annex VI, if necessary by the 
application of appropriate risk mitigation measures. 
Member States shall ensure that authorisations are subject to the 
following conditions: 
(1) for products authorised for industrial or professional use, safe 
operational procedures shall be established, and products shall 
be used with appropriate personal protective equipment unless 
it can be demonstrated in the application for product au ­
thorisation that risks to industrial or professional users can 
be reduced to an acceptable level by other means; 
(2) labels and, where provided, safety data sheets of products au ­
thorised shall indicate that freshly treated timber shall be stored 
after treatment under shelter or on impermeable hard standing 
under roof, or both, to prevent direct losses to soil or water, 
and that any losses from the application of the product shall be 
collected for reuse or disposal.’  
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN L 175/12 Official Journal of the European Union 2.7.2011