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9.2.2011 Official
Journal
of
the
European
Union L
34/41
DIRECTIVES
COMMISSION DIRECTIVE 2011/10/EU
of 8 February 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include bifenthrin as
an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(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
Having regard to the Treaty on the Functioning of the European
24 September 2010, in an assessment report.
Union,
Having regard to Directive 98/8/EC of the European Parliament
(5) It
appears
from
the
evaluations
that
biocidal
products
and of the Council of 16 February 1998 concerning the placing
used as wood preservatives and containing bifenthrin
of biocidal products on the market (
may be expected to satisfy the requirements laid down

1 ), and in particular the
second subparagraph of Article 16(2) thereof,
in Article 5 of Directive 98/8/EC. It is therefore appro
priate to include bifenthrin in Annex I to that Directive.
Whereas:
(6) Not
all
potential
uses
have
been
evaluated
at
the
Union
level. It is therefore appropriate that Member States assess
those uses or exposure scenarios and those risks to envi
ronmental compartments and populations that have not
(1) Commission
Regulation
(EC)
No
1451/2007 of
been representatively addressed in the Union level risk
4 December 2007 on the second phase of the 10-year
assessment and, when granting product authorisations,
work programme referred to in Article 16(2) of Directive
ensure that appropriate measures are taken or specific
98/8/EC of the European Parliament and of the Council
conditions imposed in order to reduce the identified
concerning the placing of biocidal products on the
risks to acceptable levels.
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 bifenthrin.
(7) Unacceptable
risks
were
identified
for
non-professional
users. It is therefore appropriate to require that product
authorisations are limited to industrial or professional
use, unless it is demonstrated in the application for
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
bifenthrin
has been evaluated in accordance with Article 11(2) of
product authorisation that risks to non-professional
Directive 98/8/EC for use in product type 8, wood
users can be reduced to acceptable levels in accordance
preservatives, as defined in Annex V to that Directive.
with Article 5 of, and Annex VI to, Directive 98/8/EC.


(3) France
was
designated
as
Rapporteur
Member
State
and (8) In view of the assumptions made during the risk
submitted the competent authority report, together with
assessment, it is appropriate to require that products
a recommendation, to the Commission on 3 January
authorised for industrial or professional use are used
2008 in accordance with Article 14(4) and (6) of Regu
with appropriate personal protective equipment, unless
lation (EC) No 1451/2007.
it can be demonstrated in the application for product
authorisation that risks to industrial or professional
( 1 ) OJ L 123, 24.4.1998, p. 1.
users can be reduced to an acceptable level by other
( 2 ) OJ L 325, 11.12.2007, p. 3.
means.

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L 34/42
EN
Official Journal of the European Union
9.2.2011
(9) In
view
of
the
risks
identified
for
the
soil
and
aquatic HAS ADOPTED THIS DIRECTIVE:
compartments, appropriate measures should be taken to
protect those compartments. It is therefore appropriate
to require that instructions are provided to indicate that
Article 1
freshly treated timber is stored after treatment under
shelter or on impermeable hardstanding, or both, and
Annex I to Directive 98/8/EC is amended in accordance with
that any losses from the application of products used
the Annex to this Directive.
as wood preservatives and containing bifenthrin are
collected for reuse or disposal. Furthermore, it is appro
priate to require that products are not authorised for the
Article 2
in situ treatment of wood outdoors, or for treatment of
wood that will be either continually exposed to the
Transposition
weather or protected from the weather but subject to
1. Member
States
shall
adopt
and
publish,
by
31
January
frequent wetting (use class 3 as defined by OECD ( 1 ),
2012 at the latest, the laws, regulations and administrative
unless data is submitted demonstrating that the product
provisions necessary to comply with this Directive.
will meet the requirements of Article 5 of, and Annex VI
to, Directive 98/8/EC, if necessary by the application of
appropriate risk mitigation measures.
They shall apply those provisions from 1 February 2013.
(10) It is important that the provisions of this Directive be
applied simultaneously in all Member States in order to
When Member States adopt those provisions, they shall contain
ensure equal treatment of biocidal products on the
a reference to this Directive or be accompanied by such a
market containing the active substance bifenthrin and
reference on the occasion of their official publication. Member
also to facilitate the proper operation of the biocidal
States shall determine how such reference is to be made.
products market in general.
2. Member
States
shall
communicate
to
the
Commission
the
(11) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
text of the main provisions of national law which they adopt in
98/8/EC in order to permit Member States and interested
the field covered by this Directive.
parties to prepare themselves to meet the new
requirements entailed and to ensure that applicants
who have prepared dossiers can benefit fully from the
Article 3
10-year period of data protection, which, in accordance
This Directive shall enter into force on the 20th day following
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
its publication in the Official Journal of the European Union.
the date of inclusion.
(12) After
inclusion,
Member States should
be allowed
a
Article 4
reasonable period to implement Article 16(3) of
This Directive is addressed to the Member States.
Directive 98/8/EC.
(13) Directive 98/8/EC should therefore be amended
Done at Brussels, 8 February 2011.
accordingly.
For the Commission
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
The President
Committee on Biocidal Products,
José Manuel BARROSO
( 1 ) OECD series on emission scenario documents, Number 2, Emission
Scenario Document for Wood Preservatives, part 2, p. 64.

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9.2.2011 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for compliance
with Article 16(3) (except
Minimum purity
for products containing
EN
of the active
more than one active
substance, for which the

No
Common
IUPAC name, identification substance in the
Expiry date of
name
numbers
biocidal product
Date of inclusion
deadline to comply with
inclusion
Product type Specific
provisions
(*)
as placed on the
Article 16(3) shall be the
market
one set out in the last of
the inclusion decisions
relating to its active
substances)
‘38 Bifenthrin IUPAC name: 2-methyl
911 g/kg 1
February
2013 31
January
2015 31
January
2023
8 When
assessing
the
application
for
authorisation
of
a
biphenyl-3-ylmethyl
product in accordance with Article 5 and Annex VI,
(1RS)-cis-3-[(Z)-2-chloro-
Member States shall assess, when relevant for the particular
3,3,3-trifluoroprop-1-
product, those uses or exposure scenarios and those risks to
icial
enyl]-2,2-dimethylcyclo
environmental compartments and populations that have not
Jour
propanecarboxylate
been representatively addressed in the Union level risk
assessment.
nal
EC No: n.a.
of
Member States shall ensure that authorisations are subject to
the
CAS No: 82657-04-3
the following conditions:
European
— Products shall be authorised only for industrial or profes
sional use, unless it is demonstrated in the application for
product authorisation that risks to non-professional users
Union
can be reduced to acceptable levels in accordance with
Article 5 and Annex VI.
— Products authorised for industrial or professional use
must be used with appropriate personal protective
equipment, unless it can be demonstrated in the appli
cation for product authorisation that risks to industrial or
professional users can be reduced to an acceptable level
by other means.
— Appropriate risk mitigation measures shall be taken to
protect the soil and aquatic compartments. In particular,
labels and, where provided, safety data sheets of products
authorised shall indicate that freshly treated timber shall
be stored after treatment under shelter or on imper
meable hardstanding, or both, to prevent direct losses
to soil or water, and that any losses from the application
L
34/43
of the product shall be collected for reuse or disposal.

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L 34/44
Deadline for compliance
with Article 16(3) (except
Minimum purity
for products containing
of the active
more than one active
substance, for which the
No
Common
IUPAC name, identification substance in the
Expiry date of
name
numbers
biocidal product
Date of inclusion
deadline to comply with
inclusion
Product type Specific
provisions
(*)
as placed on the
Article 16(3) shall be the
market
one set out in the last of
the inclusion decisions
EN
relating to its active

substances)
— Products shall not be authorised for the in situ treatment
of wood outdoors, or for treatment of wood that will be
either continually exposed to the weather or protected
from the weather but subject to frequent wetting,
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
Off
risk mitigation measures.’
icial
Jour
(*) 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
nal
of
the
European
Union
9.2.2011

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