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9.2.2011 Official
Journal
of
the
European
Union L
34/49
COMMISSION DIRECTIVE 2011/12/EU
of 8 February 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include fenoxycarb
as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
environmental compartments and populations that have
not been representatively addressed in the Union level
risk assessment and, when granting product author-
Having regard to the Treaty on the Functioning of the European
isations, ensure that appropriate measures are taken or
Union,
specific conditions imposed in order to reduce the
identified risks to acceptable levels.
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 (
(7) In view of the assumptions made during the risk

1 ), and in particular the
second subparagraph of Article 16(2) thereof,
assessment, it is appropriate to require that freshly
treated timber is stored after treatment under shelter or
on impermeable hardstanding, or both, and that any
Whereas:
losses from the application of products used as wood
preservatives and containing fenoxycarb are collected
for reuse or disposal.
(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
(8) In
view
of
the
risks
identified
for
the
aquatic
98/8/EC of the European Parliament and of the Council
compartment, appropriate measures should be taken to
concerning the placing of biocidal products on the
protect those compartments. Unacceptable risks were
market ( 2 ) establishes a list of active substances to be
identified during the in-service use of treated wood not
assessed, with a view to their possible inclusion in
covered and not in contact with the ground, which is
Annex I, IA or IB to Directive 98/8/EC. That list
either continually exposed to the weather or protected
includes fenoxycarb.
from the weather but subject to frequent wetting (use
class 3 as defined by OECD ( 3 )) in the specific scenario
bridge over pond. It is therefore appropriate to require
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
fenoxycarb
that products are not authorised for the treatment of
has been evaluated in accordance with Article 11(2) of
wood intended for outdoor constructions near or
Directive 98/8/EC for use in product type 8, wood
above water, unless data is submitted demonstrating
preservatives, as defined in Annex V to that Directive.
that the product will meet the requirements of
Article 5 of, and Annex VI to Directive 98/8/EC, if
(3) Germany
was
designated
as
Rapporteur
Member
State
necessary by the application of appropriate risk
and submitted the competent authority report, together
mitigation measures.
with a recommendation, to the Commission on
12 September 2008 in accordance with Article 14(4)
and (6) of Regulation (EC) No 1451/2007.
(9)
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
(4) The
competent
authority
report
was
reviewed
by
the
market containing the active substance fenoxycarb and
Member States and the Commission. In accordance
also to facilitate the proper operation of the biocidal
with Article 15(4) of Regulation (EC) No 1451/2007,
products market in general.
the findings of the review were incorporated, within
the Standing Committee on Biocidal Products on
24 September 2010, in an assessment report.
(10) 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 the
(5) It
appears
from
the
evaluations
that
biocidal
products
interested parties to prepare themselves to meet the
used as wood preservatives and containing fenoxycarb
new requirements entailed and to ensure that applicants
may be expected to satisfy the requirements laid down
who have prepared dossiers can benefit fully from the
in Article 5 of Directive 98/8/EC. It is therefore
10-year period of data protection, which, in accordance
appropriate to include fenoxycarb in Annex I to that
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
Directive.
the date of inclusion.
(6) Not
all
potential
uses
have
been
evaluated
at
Union
level. (11) After
inclusion,
Member States should
be allowed
a
It is therefore appropriate that Member States assess
reasonable period to implement Article 16(3) of
those uses or exposure scenarios and those risks to the
Directive 98/8/EC.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 3 ) OECD series on emission scenario documents, Number 2, Emission
( 2 ) OJ L 325, 11.12.2007, p. 3.
Scenario Document for Wood Preservatives, part 2, p. 64.

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L 34/50
EN
Official Journal of the European Union
9.2.2011
(12) Directive 98/8/EC should therefore be amended
When Member States adopt those provisions, they shall contain
accordingly.
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.
(13) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on Biocidal Products,
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.
HAS ADOPTED THIS DIRECTIVE:
Article 3
Article 1
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Annex I to Directive 98/8/EC is amended in accordance with
the Annex to this Directive.
Article 4
This Directive is addressed to the Member States.
Article 2
Transposition
1. Member
States
shall
adopt
and
publish,
by
31
January Done at Brussels, 8 February 2011.
2012 at the latest, the laws, regulations and administrative
provisions necessary to comply with this Directive.
For the Commission
The President
They shall apply those provisions from 1 February 2013.
José Manuel BARROSO

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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 for
Minimum purity of the
products containing more
EN
than one active substance, for

No Common
name
IUPAC name
active substance in the
Expiry date of
Product
Identification numbers
biocidal product as
Date of inclusion
which the deadline to comply
inclusion
type
Specific provisions (*)
placed on the market
with Article 16(3) shall be the
one set out in the last of the
inclusion decisions relating to
its active substances)
‘40 Fenoxycarb IUPAC
name:
Ethyl
[2-(4- 960 g/kg 1
February
2013 31
January
2015 31
January
2023
8 When
assessing
the
application
for
authorisation
phenoxyphenoxy)
of a product in accordance with Article 5 and
ethyl]carbamate
Annex VI, Member States shall assess, when
relevant for the particular product, those uses
EC No: 276-696-7
or exposure scenarios and those risks to en-
CAS No: 72490-01-8
vironmental compartments and populations
icial
that have not been representatively addressed
in the Union level risk assessment.
Jour
Member States shall ensure that authorisations
nal
are subject to the following conditions:
of
— Appropriate risk mitigation measures shall
the
be taken to protect the soil and aquatic
European
compartments. In particular, labels and,
where provided, safety data sheets of
products authorised shall indicate that
freshly treated timber shall be stored after
Union
treatment under shelter or on impermeable
hardstanding 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.
— Products shall not be authorised for
treatment of wood that will be used in
outdoor constructions near or above
water, unless data is submitted demon
strating that the product will meet the
requirements of Article 5 and Annex VI, if
necessary by the application of appropriate
risk mitigation measures.’
(*) 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
L
34/51

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