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4.3.2011 Official
Journal
of
the
European
Union L
59/29
COMMISSION DIRECTIVE 2011/23/EU
of 3 March 2011
amending Council Directive 91/414/EEC to include triflumuron as active substance
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4)
Italy evaluated the new information and data submitted
by the applicant and prepared an additional report. It
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Having regard to the Treaty on the Functioning of the European
Commission on 5 March 2010.
Union,
(5) The
Authority
communicated
the
additional
report
to
the
Having regard to Council Directive 91/414/EEC of 15 July
other Member States and the applicant for comments
1991 concerning the placing of plant protection products on
and forwarded the comments it had received to the
the market ( 1 ), and in particular Article 6(1) thereof,
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the additional report was peer reviewed
Whereas:
by the Member States and the Authority. The Authority
then presented its conclusion on triflumuron to the
Commission on 9 December 2010
( 6 ). The draft
assessment report, the additional report and the
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
conclusion of the Authority were reviewed by the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Member States and the Commission within the
implementation of the third stage of the programme of
Standing Committee on the Food Chain and Animal
work referred to in Article 8(2) of Directive 91/414/EEC
Health and finalised on 28 January 2011 in the format
and establish a list of active substances to be assessed,
of the Commission review report for triflumuron.
with a view to their possible inclusion in Annex I to
Directive 91/414/EEC. That list included triflumuron.
By Commission Decision 2009/241/EC
( 4 ) it was
decided not to include triflumuron in Annex I to
(6) The
additional
report
by
the
rapporteur
Member
State
Directive 91/414/EEC.
and the new conclusion by the Authority concentrate
on the concerns that lead to the non-inclusion. Those
concerns were in particular that, based on the available
information, it had not been demonstrated that the
(2)
Pursuant to Article 6(2) of Directive 91/414/EEC the
consumer exposure was acceptable due to lack of data
original notifier (hereinafter ‘the applicant’) submitted a
in terms of nature and level of the relevant residues. In
new application requesting the accelerated procedure to
fact, it was not possible to perform an acute risk
be applied, as provided for in Articles 14 to 19 of
assessment for the metabolite M07 ( 7 ), because data
Commission Regulation (EC) No 33/2008 of
was not sufficient to allocate an acute reference dose
17 January 2008 laying down detailed rules for the
for this metabolite. Moreover, data was missing to
application of Council Directive 91/414/EEC as regards
determine an appropriate residue definition and to
a regular and an accelerated procedure for the assessment
estimate the level of residues in processed fruit
of active substances which were part of the programme
commodities.
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I ( 5 ).
(7) The
new
information
submitted
by
the
applicant
enabled
a consumer exposure assessment. The information
(3) The
application
was
submitted
to
Italy,
which
had
been
currently available indicates that the consumer exposure
designated rapporteur Member State by Regulation (EC)
is acceptable.
No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
substance and the supported uses are the same as those
that were the subject of Decision 2009/241/EC. That
(8) Consequently,
the
additional
data
and
information
application also complies with the remaining substantive
provided by the applicant permit to eliminate the
and procedural requirements of Article 15 of Regulation
specific concerns that led to the non-inclusion. No
(EC) No 33/2008.
other open scientific questions have arisen.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority: Conclusion on the peer review of the
( 2 ) OJ L 55, 29.2.2000, p. 25.
pesticide risk assessment of the active substance triflumuron; EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2011; 9(1):1941. [81 pp.]. doi:10.2903/j.efsa.2010.1941.
( 4 ) OJ L 71, 17.3.2009, p. 59.
Available online: www.efsa.europa.eu/efsajournal.htm.
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 7 ) 4-trifluoro-methoxyaniline

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L 59/30
EN
Official Journal of the European Union
4.3.2011
(9)
It has appeared from the various examinations made that
Article 2
plant protection products containing triflumuron may be
expected to satisfy, in general, the requirements laid
Member States shall bring into force the laws, regulations and
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
administrative provisions necessary to comply with this
in particular with regard to the uses which were
Directive by 30 September 2011 at the latest. They shall
examined and detailed in the Commission review
forthwith communicate to the Commission the text of those
report. It is therefore appropriate to include triflumuron
provisions and a correlation table between those provisions and
in Annex I, in order to ensure that in all Member States
this Directive.
the authorisations of plant protection products
containing this active substance may be granted in
accordance with the provisions of that Directive.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
(10) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
reference on the occasion of their official publication. Member
obtain confirmatory information on certain specific
States shall determine how such reference is to be made.
points. Article 6(1) of Directive 91/414/EEC provides
that the inclusion of a substance in Annex I may be
subject to conditions. Therefore, it is appropriate to
require that the applicant submit confirmatory
information as regards the long-term risk to birds, the
Article 3
risk to aquatic invertebrates and the risk to bee brood
development.
This Directive shall enter into force on 1 April 2011.
(11) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
Article 4
This Directive is addressed to the Member States.
(12) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Done at Brussels, 3 March 2011.
HAS ADOPTED THIS DIRECTIVE:
Article 1
For the Commission
Annex I to Directive 91/414/EEC is amended as set out in the
The President
Annex to this Directive.
José Manuel BARROSO

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4.3.2011 Off
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Entry
into
force Expiration
of
inclusion Specific
provisions
EN
‘328 Triflumuron
1-(2-chlorobenzoyl)-3-[4-
≥ 955 g/kg
1 April 2011 31
March
2021 PART
A

trifluoromethoxyphenyl]urea
CAS No: 64628-44-0
Impurities:
Only uses as insecticide may be authorised.
CIPAC No: 548
— N,N’-bis-[4-(trifluor
PART B
omethoxy)phenyl]urea: not
more than 1 g/kg,
For the implementation of the uniform principles of Annex VI
the conclusions of the review report on triflumuron, and in
— 4-trifluoro-methoxyaniline:
particular Appendices I and II thereof, as finalised in the
not more than 5 g/kg.
Standing Committee on the Food Chain and Animal Health
on 28 January 2011, shall be taken into account.
In this overall assessment, Member States shall pay particular
icial
attention to:
Jour
— the protection of the aquatic environment,
nal
— the protection of honeybees. Conditions of authorisation
shall include risk mitigation measures, where appropriate.
of
the
Conditions of authorisation shall include risk mitigation
European
measures, where appropriate.
The Member States concerned shall ensure that the applicant
submits to the Commission confirmatory information as
regards the long-term risk to birds, the risk to aquatic inver-
Union
tebrates and the risk to bee brood development.
The Member States concerned shall ensure that the applicant
submits such information to the Commission by 31 March
2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
59/31

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