HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 175/10
EN
Official Journal of the European Union
2.7.2011
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,
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.
Having regard to the Treaty on the Functioning of the European
Union,
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level.
Having regard to Directive 98/8/EC of the European Parliament
It is therefore appropriate that Member States assess
and of the Council of 16 February 1998 concerning the placing
those uses or exposure scenarios and those risks to
of biocidal products on the market ( 1 ), and in particular the
human populations and to environmental compartments
second subparagraph of Article 16(2) thereof,
that have not been representatively addressed in the
Union level risk assessment and, when granting
product authorisations, ensure that appropriate
Whereas:
measures are taken or specific conditions imposed in
order to reduce the identified risks to acceptable levels.
(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
(7) In
view
of
the
risks
identified
for
human
health,
it
is
98/8/EC of the European Parliament and of the Council
appropriate to require that safe operational procedures
concerning the placing of biocidal products on the
are established for products authorised for industrial or
market (
professional use, and that those products are used with

2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
appropriate personal protective equipment unless it can
Annex I, IA or IB to Directive 98/8/EC. That list
be demonstrated in the application for product author
includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one.
isation that risks to industrial or professional users can
be reduced to an acceptable level by other means.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
4,5-
Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated
(8) In
view
of
the
risks
identified
for
the
aquatic
and
in accordance with Article 11(2) of Directive 98/8/EC for
terrestrial compartments, it is appropriate to require
use in product-type 8, wood preservatives, as defined in
that freshly treated timber is stored after treatment
Annex V to that Directive.
under shelter or on impermeable hard standing, or
both, and that any losses from the application of
products used as wood preservatives and containing
(3) Norway
was
designated
as
Rapporteur
and
submitted
the
4,5-Dichloro-2-octyl-2H-isothiazol-3-one are collected
competent authority report, together with a recommen
for reuse or disposal.
dation, to the Commission on 8 September 2008 in
accordance with Article 14(4) and (6) of Regulation
(EC) No 1451/2007.
(9) Unacceptable
risks
for
the
environment
were
identified
in
various scenarios for in-service use of treated wood not
(4) The
competent
authority
report
was
reviewed
by
the
covered and not in contact with the ground, which is
Member States and the Commission. In accordance
either continually exposed to the weather or protected
with Article 15(4) of Regulation (EC) No 1451/2007,
from the weather but subject to frequent wetting (use
the findings of the review were incorporated, within
class 3 as defined by OECD ( 3 )) and wood in contact
the Standing Committee on Biocidal Products on
with fresh water (use class 4b as defined by OECD ( 4 )).
16 December 2010, in an assessment report.
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
(5) It
appears
from
the
evaluations
that
biocidal
products
the product will meet the requirements of both Article 5
used as wood preservatives and containing 4,5-
of and Annex VI to Directive 98/8/EC, if necessary by the
Dichloro-2-octyl-2H-isothiazol-3-one may be expected
application of appropriate risk mitigation measures.
to satisfy the requirements laid down in Article 5 of
( 3 ) OECD series on emission scenario documents, Number 2, Emission
( 1 ) OJ L 123, 24.4.1998, p. 1.
Scenario Document for Wood Preservatives, Part 2, p. 64.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 4 ) Ibid.

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EN
2.7.2011 Official
Journal
of
the
European
Union L
175/11
(10) It is important that the provisions of this Directive be
Article 2
applied simultaneously in all Member States in order to
ensure equal treatment of biocidal products on the
Transposition
market containing the active substance 4,5-Dichloro-2-
1. Member
States
shall
adopt
and
publish,
by
30
June
2012
octyl-2H-isothiazol-3-one and also to facilitate the
at the latest, the laws, regulations and administrative provisions
proper operation of the biocidal products market in
necessary to comply with this Directive.
general.
They shall apply those provisions from 1 July 2013.
(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
When Member States adopt those provisions, they shall contain
parties to prepare themselves to meet the new
a reference to this Directive or be accompanied by such a
requirements entailed and to ensure that applicants
reference on the occasion of their official publication. Member
who have prepared dossiers can benefit fully from the
States shall determine how such reference is to be made.
10-year period of data protection, which, in accordance
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
2. Member
States
shall
communicate
to
the
Commission
the
the date of inclusion.
text of the main provisions of national law which they adopt in
the field covered by this Directive.
(12) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
Article 3
Directive 98/8/EC.
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(13) Directive 98/8/EC should therefore be amended
accordingly.
Article 4
(14) The
measures provided for in this Directive are in
This Directive is addressed to the Member States.
accordance with the opinion of the Standing
Committee on Biocidal Products,
Done at Brussels, 1 July 2011.
HAS ADOPTED THIS DIRECTIVE:
Article 1
For the Commission
Annex I to Directive 98/8/EC is amended in accordance with
The President
the Annex to this Directive.
José Manuel BARROSO

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L 175/12
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance with
Minimum purity
Article 16(3) (except for products
of the active
containing more than one active
IUPAC Name
EN
No Common
Name
substance in the
Date of
substance, for which the deadline to
Expiry date of

Identification Numbers biocidal product
inclusion
comply with Article 16(3) shall be the
inclusion
Product type Specific
provisions
(*)
as placed on the
one set out in the last of the inclusion
market
decisions relating to its active
substances)
‘44 4,5-Dichloro- 4,5-Dichloro-2-octyl
950 g/kg 1
July
2013 30
June
2015 30
June
2023
8 When
assessing
the
application
for
authorisation
of
a
product
in
2-octyl-2H-
isothiazol-3(2H)-one
accordance with Article 5 and Annex VI, Member States shall
isothiazol-3-
assess, when relevant for the particular product, those uses or
one
EC No: 264-843-8
exposure scenarios and those risks to human populations and to
environmental compartments that have not been representatively
CAS No: 64359-81-5
addressed in the Union level risk assessment.
Off
icial
Products shall not be authorised for treatment of wood that will be
continually exposed to the weather, protected from the weather but
Jour
subject to frequent wetting or in contact with fresh water, unless
data have been submitted demonstrating that the product will meet
nal
the requirements of Article 5 and Annex VI, if necessary by the
of
application of appropriate risk mitigation measures.
the
Member States shall ensure that authorisations are subject to the
European
following conditions:
(1) for products authorised for industrial or professional use, safe
operational procedures shall be established, and products shall
Union
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 available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
2.7.2011

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