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7.7.2012 Official
Journal
of
the
European
Union L
177/25
DIRECTIVES
COMMISSION DIRECTIVE 2012/20/EU
of 6 July 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron
as an active substance for product-type 8 in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
may be expected to satisfy the requirements laid down in
Article 5 of Directive 98/8/EC. Therefore, and notwith
standing the fact that flufenoxuron has not been
Having regard to the Treaty on the Functioning of the European
approved in certain other areas for which the use
Union,
specific risk assessments gave a different result ( 3 ), it is
appropriate to include flufenoxuron for use in product-
type 8 in Annex I to that Directive.
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,
(6) In
view
of
its
characteristics,
which
render
it
persistent,
liable to bioaccumulate and toxic (PBT), as well as very
Whereas:
persistent and very liable to bioaccumulate (vPvB), in
accordance with the criteria laid down in Annex XIII to
Regulation (EC) No 1907/2006 of the European
(1) Commission
Regulation
(EC)
No
1451/2007 of
Parliament and of the Council of 18 December 2006
4 December 2007 on the second phase of the 10-year
concerning the Registration, Evaluation, Authorisation
work programme referred to in Article 16(2) of Directive
and Restriction of Chemicals (REACH), establishing a
98/8/EC of the European Parliament and of the Council
European Chemicals Agency, amending Directive
concerning the placing of biocidal products on the
1999/45/EC and repealing Council Regulation (EEC) No
market ( 2 ) establishes a list of active substances to be
793/93 and Commission Regulation (EC) No 1488/94 as
assessed, with a view to their possible inclusion in
well as Council Directive 76/769/EEC and Commission
Annex I, IA or IB to Directive 98/8/EC. That list
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
includes flufenoxuron.
2000/21/EC ( 4 ), flufenoxuron should be included in
Annex I for three years only and should be made
subject to a comparative risk assessment in accordance
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
flufen
with the second subparagraph of Article 10(5)(i) of
oxuron has been evaluated in accordance with
Directive 98/8/EC before its inclusion in Annex I is
Article 11(2) of Directive 98/8/EC for use in product-
renewed.
type 8, wood preservatives, as defined in Annex V to
that Directive.
(7) The
Union
level
risk
assessment
of
flufenoxuron
used
in
(3) France
was
designated
as
rapporteur
Member
State
and
submitted the competent authority report, together with
wood preservatives only addressed treatment of wood
a recommendation, to the Commission on 17 March 2009
intended to be used indoors (use classes 1 and 2 as
in accordance with Article 14(4) and (6) of Regulation
defined by OECD ( 5 )) or outdoors not covered and not
(EC) No 1451/2007.
in contact with the ground and continually exposed to

the weather, protected from the weather but subject to
frequent wetting or in contact with fresh water (use class
(4) The
competent
authority
report
was
reviewed
by
the
Member States and the Commission. In accordance
( 3 ) Commission Implementing Regulation (EU) No 942/2011 of
with Article 15(4) of Regulation (EC) No 1451/2007,
22 September 2011 concerning the non-approval of the active
the findings of the review were incorporated, within
substance flufenoxuron, in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council
the Standing Committee on Biocidal Products on
concerning the placing of plant protection products on the
22 September 2011, in an assessment report.
market, and amending Commission Decision 2008/934/EC (OJ L 246,
23.9.2011, p. 13); Commission Decision 2012/77/EU of 9 February
2012 concerning the non-inclusion of flufenoxuron for product type
(5) It
appears
from
the
evaluations
that
biocidal
products
18 in Annex I, IA or IB to Directive 98/8/EC of the European
used as wood preservatives and containing flufenoxuron
Parliament and of the Council concerning the placing of biocidal
products on the market (OJ L 38, 11.2.2012, p. 47).
( 4 ) OJ L 396, 30.12.2006, p. 1.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 5 ) 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 177/26
EN
Official Journal of the European Union
7.7.2012
3 as defined by OECD ( 6 )), which will not be used in
provided for in this Directive, and the Commission
animal housing or come into contact with food or
therefore submitted to the Council a proposal relating
feed. Unacceptable risks for the environment were
to the measures and forwarded it to the European
identified for the in situ treatment of wood outdoors,
Parliament. The Council did not act within the two-
as well as in various scenarios for outdoor use of
month period provided for by Article 5a of Council
treated wood. In view of the characteristics of flufen
Decision 1999/468/EC of 28 June 1999 laying down
oxuron, it is appropriate to authorise only those uses
the procedures for the exercise of implementing powers
and exposure scenarios that have been representatively
conferred on the Commission ( 7 ), and the Commission
addressed in the Union level risk assessment, and for
therefore submitted the proposal to the European
which no unacceptable risk was found.
Parliament without delay. The European Parliament did
not oppose the measure within four months from the
(8) In
view
of
the
risks
identified
for
human
health
for
abovementioned forwarding,
industrial and professional use it is appropriate to
require that safe operational procedures be established
HAS ADOPTED THIS DIRECTIVE:
for products authorised for such use, and that those
products be used with appropriate personal protective
Article 1
equipment unless it can be demonstrated in the appli
cation for product authorisation that risks to industrial or
Annex I to Directive 98/8/EC is amended in accordance with
professional users can be reduced to an acceptable level
the Annex to this Directive.
by other means.
Article 2
(9) In view of the risks identified for the aquatic and
terrestrial compartments, it is appropriate to require
Transposition
that appropriate risk mitigation measures be taken to
1. Member
States
shall
adopt
and
publish,
by
31
January
2013
protect those compartments, in particular that freshly
at the latest, the laws, regulations and administrative provisions
treated timber be stored after treatment under shelter
necessary to comply with this Directive.
or on impermeable hard standing, or both, and that
any losses from the application of products used as
wood preservatives and containing flufenoxuron be
They shall apply those provisions from 1 February 2014.
collected for reuse or disposal.
When Member States adopt those provisions, they shall contain
(10) The
provisions
of
this
Directive
should
be
applied
at
the
a reference to this Directive or be accompanied by such a
same time in all Member States in order to ensure equal
reference on the occasion of their official publication. Member
treatment on the Union market of biocidal products of
States shall determine how such reference is to be made.
product-type 8 containing the active substance flufen
oxuron and also to facilitate the proper operation of
2. Member
States
shall
communicate
to
the
Commission
the
the biocidal products market in general.
text of the main provisions of national law which they adopt in
the field covered by this Directive.
(11) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I to Directive
Article 3
98/8/EC in order to permit Member States and interested
parties to prepare themselves to meet the new
This Directive shall enter into force on the twentieth day
requirements entailed and to ensure that applicants
following that of its publication in the Official Journal of the
who have prepared dossiers can benefit fully from the
European Union.
10-year period of data protection, which, in accordance
with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from
Article 4
the date of inclusion.
This Directive is addressed to the Member States.
(12) After
inclusion,
Member States should
be allowed
a
reasonable period to implement Article 16(3) of
Directive 98/8/EC.
Done at Brussels, 6 July 2012.
(13) Directive
98/8/EC
should
therefore
be
amended
accord
ingly.
For the Commission
(14) The
Committee
established
by
Article
28(1)
of
Directive
The President
98/8/EC has not delivered an opinion on the measures
José Manuel BARROSO
( 6 ) Ibid.
( 7 ) OJ L 184, 17.7.1999, p. 23.

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7.7.2012 Off
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
Deadline for
compliance with
Article 16(3) (except
EN
Minimum purity
for products containing

of the active
more than one active
No Common
Name
IUPAC Name
substance in the
substance, for which
Identification Numbers
biocidal product
Date of inclusion
the deadline to comply Expiry date of inclusion Product
type
Specific provisions (*)
as placed on the
with Article 16(3) shall
market
be the one set out in
the last of the inclusion
decisions relating to its
active substances)
‘57 flufenoxuron 1-[4-(2-chloro-alpha,alpha,
960 g/kg 1
February
2014 31
January
2016 31
January
2017
8 Flufenoxuron
shall
be
subject
to
a
comparative
risk
alpha-trifluoro-para-tolyloxy)-2-
assessment in accordance with the second
fluorophenyl]-3-(2,6-
subparagraph of Article 10(5)(i) of Directive
icial
difluorobenzoyl)urea
98/8/EC before its inclusion in this Annex is renewed.
Jour
EC No: 417-680-3
nal
CAS No: 101463-69-8
The Union level risk assessment addressed treatment
of
of wood which will not be used in animal housing or
the
come into contact with food or feed. Products shall
European
not be authorised for uses or exposure scenarios that
have not been representatively addressed in the Union
level risk assessment.
Union
Member States shall ensure that authorisations are
subject to the following conditions:
(1) Products shall only be used for treatment of wood
intended for indoor use.
(2) For products authorised for industrial or profes
sional 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
L
product authorisation that risks to industrial or
177/27
professional users can be reduced to an acceptable
level by other means.

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L 177/28
Deadline for
compliance with
Article 16(3) (except
Minimum purity
for products containing
of the active
more than one active
No Common
Name
IUPAC Name
substance in the
substance, for which
Identification Numbers
biocidal product
Date of inclusion
the deadline to comply Expiry date of inclusion Product
type
Specific provisions (*)
as placed on the
with Article 16(3) shall
market
be the one set out in
EN
the last of the inclusion

decisions relating to its
active substances)
(3) Appropriate risk mitigation measures shall be
taken to protect the soil and aquatic compart
ments. In particular, labels and, where provided,
safety data sheets of authorised products shall
indicate that freshly treated timber shall be
stored after treatment under shelter or on imper
meable hard standing, or both, to prevent direct
Off
losses to soil or water, and that any losses from
icial
the application of the product shall be collected
for reuse or disposal.’
Jour
nal
(*) 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
of
the
European
Union
7.7.2012

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Document Outline

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