HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 108/34
EN
Official Journal of the European Union
28.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/57/EU
of 27 April 2011
amending Council Directive 91/414/EEC to include fluometuron as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
also complies with the remaining substantive
and procedural requirements of Article 15 of Regulation
Having regard to the Treaty on the Functioning of the European
(EC) No 33/2008.
Union,
(5)
Greece evaluated the additional data submitted by the
applicants and prepared an additional report. It
Having regard to Council Directive 91/414/EEC of 15 July
communicated that report to the European Food Safety
1991 concerning the placing of plant protection products on
Authority (hereinafter ‘the Authority’) and to the
the market ( 1 ), and in particular Article 6(1) thereof,
Commission on 27 January 2010. The Authority
communicated the additional report to the other
Whereas:
Member States and the applicant for comments and
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
lation (EC) No 33/2008 and at the request of the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Commission, the Authority presented its conclusion on
implementation of the second and third stages of the
fluometuron to the Commission on 14 December
programme of work referred to in Article 8(2) of
2010 (
Directive 91/414/EEC and establish a list of active

6 ). The draft assessment report, the additional
report and the conclusion of the Authority were
substances to be assessed, with a view to their possible
reviewed by the Member States and the Commission
inclusion in Annex I to Directive 91/414/EEC. That list
within the Standing Committee on the Food Chain and
included fluometuron.
Animal Health and finalised on 11 March 2011 in the
format of the Commission review report for
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
fluometuron.
1490/2002 the notifiers withdrew their support of the
inclusion of that active substance in Annex I to Directive
(6)
It has appeared from the various examinations made that
91/414/EEC within 2 months from receipt of the draft
plant protection products containing fluometuron may
assessment report. Consequently, Commission Decision
be expected to satisfy, in general, the requirements laid
2008/934/EC of 5 December 2008 concerning the
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
non-inclusion of certain active substances in Annex I
in particular with regard to the uses which have been
to Directive 91/414/EEC and the withdrawal of authori
examined and detailed in the Commission review report.
sations for plant protection products containing these
It is therefore appropriate to include fluometuron in
substances ( 4 ) was adopted on the non-inclusion of
Annex I, in order to ensure that in all Member States
fluometuron.
the authorisations of plant protection products
containing this active substance can be granted in
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
accordance with the provisions of that Directive.
original notifiers (hereinafter ‘the applicants’) submitted
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
a new application requesting the accelerated procedure
obtain further information on certain specific points.
to be applied, as provided for in Articles 14 to 19 of
Article 6(1) of Directive 91/414/EEC provides that
Commission Regulation (EC) No 33/2008 of 17 January
inclusion of a substance in Annex I may be subject to
2008 laying down detailed rules for the application of
conditions. Therefore, it is appropriate to require that the
Council Directive 91/414/EEC as regards a regular and an
applicants submit further information confirming the
accelerated procedure for the assessment of active
toxicological properties of the plant metabolite trifluor
substances which were part of the programme of work
oacetic acid and the analytical methods for the moni
referred to in Article 8(2) of that Directive but have not
toring of fluometuron in air and the soil metabolite
been included into its Annex I ( 5 ).
trifluoromethylaniline in soil and water. In case
fluometuron is classified under Regulation (EC) No
(4) The
application
was
submitted
to
Greece,
which
had
1272/2008 of the European Parliament and of the
been designated rapporteur Member State by Regulation
Council ( 7 ) as ‘suspected of causing cancer’, the Member
(EC) No 1490/2002. The time period for the accelerated
States concerned shall request the submission of further
procedure was respected. The specification of the active
information confirming the relevance for groundwater of
substance and the supported uses are the same as were
the soil metabolites desmethyl-fluometuron and trifluor
the subject of Decision 2008/934/EC. That application
omethylaniline.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance fluometuron.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2011;9(1):1958. [54 pp.] doi:10.2903/j.efsa.2011.
( 4 ) OJ L 333, 11.12.2008, p. 11.
1958. Available online: www.efsa.europa.eu/efsajournal.htm
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 7 ) OJ L 353, 31.12.2008, p. 1.

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EN
28.4.2011 Official
Journal
of
the
European
Union L
108/35
(8) A
reasonable
period
should
be
allowed
to
elapse
before HAS ADOPTED THIS DIRECTIVE:
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements
Article 1
which will result from the inclusion.
Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
Article 2
substance in Annex I, Member States should be
The line concerning fluometuron in the Annex to Decision
allowed a period of 6 months after inclusion to review
2008/934/EC is deleted.
existing authorisations of plant protection products
containing fluometuron to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Article 3
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should vary, replace or
Member States shall adopt and publish by 30 November 2011
withdraw, as appropriate, existing authorisations, in
at the latest the laws, regulations and administrative provisions
accordance with the provisions of Directive 91/414/EEC.
necessary to comply with this Directive. They shall forthwith
By derogation from the above deadline, a longer period
communicate to the Commission the text of those provisions
should be provided for the submission and assessment of
and a correlation table between those provisions and this
the complete Annex III dossier of each plant protection
Directive.
product for each intended use in accordance with the
uniform principles laid down in Directive 91/414/EEC.
They shall apply those provisions from 1 December 2011.
(10) The
experience
gained
from
previous
inclusions
in
Annex
When Member States adopt those provisions, they shall contain
I to Directive 91/414/EEC of active substances assessed
a reference to this Directive or be accompanied by such a
in the framework of Commission Regulation (EEC) No
reference on the occasion of their official publication. Member
3600/92 of 11 December 1992 laying down the detailed
States shall determine how such reference is to be made.
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
Article 4
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market ( 1 ) has
1. Member States shall in accordance with Directive
shown that difficulties can arise in interpreting the
91/414/EEC, where necessary, amend or withdraw existing
duties of holders of existing authorisations in relation
authorisations for plant protection products containing
to access to data. In order to avoid further difficulties
fluometuron as an active substance by 30 November 2011.
it therefore appears necessary to clarify the duties of
the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
By that date they shall in particular verify that the conditions in
dossier satisfying the requirements of Annex II to that
Annex I to that Directive relating to fluometuron are met, with
Directive. However, this clarification does not impose any
the exception of those identified in Part B of the entry
new obligations on Member States or holders of au-
concerning that active substance, and that the holder of the
thorisations compared to the directives which have
authorisation has, or has access to, a dossier satisfying the
been adopted until now amending Annex I.
requirements of Annex II to that Directive in accordance with

the conditions of Article 13 of that Directive.
(11) It is therefore appropriate to amend Directive
2. By way of derogation from paragraph 1, for each au-
91/414/EEC accordingly.
thorised plant protection product containing fluometuron as
either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
91/414/EEC by 31 May 2011 at the latest, Member States
fluometuron and the withdrawal of authorisations for
shall re-evaluate the product in accordance with the uniform
plant protection products containing that substance by
principles provided for in Annex VI to Directive 91/414/EEC,
31 December 2011. It is necessary to delete the line
on the basis of a dossier satisfying the requirements of Annex
concerning fluometuron in the Annex to that Decision.
III to that Directive and taking into account Part B of the entry
in Annex I to that Directive concerning fluometuron. On the
basis of that evaluation, they shall determine whether the
(13) It is therefore appropriate to amend Decision
product satisfies the conditions set out in Article 4(1)(b), (c),
2008/934/EC accordingly.
(d) and (e) of Directive 91/414/EEC.
(14) The
measures provided for in this Directive are in
Following that determination Member States shall:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) in the case of a product containing fluometuron as the only
active substance, where necessary, amend or withdraw the
( 1 ) OJ L 366, 15.12.1992, p. 10.
authorisation by 31 May 2015 at the latest; or

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L 108/36
EN
Official Journal of the European Union
28.4.2011
(b) in the case of a product containing fluometuron as one of several active substances, where necessary,
amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or
withdrawal in the respective Directive or Directives which added the relevant substance or substances to
Annex I to Directive 91/414/EEC, whichever is the latest.
Article 5
This Directive shall enter into force on 1 June 2011.
Article 6
This Directive is addressed to the Member States.
Done at Brussels, 27 April 2011.
For the Commission
The President
José Manuel BARROSO

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28.4.2011 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
‘343 Fluometuron
1,1-dimethyl-3-(α,α,α
≥ 940 g/kg 1
June
2011 31
May
2021 PART
A

-trifluoro-m-tolyl)urea
CAS No: 2164-17-2
Only uses as herbicide on cotton may be authorised.
CIPAC No: 159
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of
the review report on fluometuron, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on
11 March 2011 shall be taken into account.
In this overall assessment Member States shall:
(a) pay particular attention to the protection of the operators and workers and
ensure that conditions of use include the application of adequate personal
icial
protective equipment;
Jour
(b) pay particular attention to the protection of the groundwater where the active
substance is applied in regions with vulnerable soil and/or climatic conditions;
nal
they shall ensure that conditions of authorisation include risk mitigation
of
measures and the obligation to carry out monitoring programmes to verify
the
potential leaching of fluometuron and soil metabolites desmethyl-fluometuron
European
and trifluoromethylaniline in vulnerable areas, where appropriate;
(c) pay particular attention to the risk to non-target soil macro-organisms others
than earthworms and non-target plants, and ensure that conditions of au-
thorisation include risk mitigation measures, where appropriate.
Union
The Member States concerned shall ensure that the applicants submit to the
Commission confirmatory information as regards:
(a) the toxicological properties of the plant metabolite trifluoroacetic acid;
(b) the analytical methods for the monitoring of fluometuron in air;
(c) the analytical methods for the monitoring of the soil metabolite trifluo-
romethylaniline in soil and water;
(d) the relevance for ground water of the soil metabolites desmethyl-fluometuron
and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No
1272/2008 as “suspected of causing cancer”.
The Member States concerned shall ensure that the applicants submit to the
Commission the information set out in points (a), (b) and (c) by 31 March 2013
and the information set out in point (d) within 6 months from the notification of
the decision classifying fluometuron.’
L
(1 ) Further details on identity and specification of active substance are provided in the review report.
108/37

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