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9.3.2011 Official
Journal
of
the
European
Union L
62/27
COMMISSION DIRECTIVE 2011/34/EU
of 8 March 2011
amending Council Directive 91/414/EEC to include flurochloridone as active substance and
amending Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substance and the supported uses are the same as were
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
Having regard to the Treaty on the Functioning of the European
procedural requirements of Article 15 of Regulation
Union,
(EC) No 33/2008.
Having regard to Council Directive 91/414/EEC of 15 July
(5) Spain
evaluated
the
additional
data
submitted
by
the
1991 concerning the placing of plant protection products on
applicant and prepared an additional report. It
the market ( 1 ), and in particular Article 6(1) thereof,
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 3 November 2009. The Authority
Whereas:
communicated the additional report to the other
Member States and the applicant for comments and
forwarded the comments it had received to the
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
Commission. In accordance with Article 20(1) of Regu
No 1490/2002 ( 3 ) lay down the detailed rules for the
lation (EC) No 33/2008 and at the request of the
implementation of the third stage of the programme of
Commission, the Authority presented its conclusion on
work referred to in Article 8(2) of Directive 91/414/EEC
flurochloridone to the Commission on 14 October
and establish a list of active substances to be assessed,
2010 (
with a view to their possible inclusion in Annex I to

6 ). The draft assessment report, the additional
report and the conclusion of the Authority were
Directive 91/414/EEC. That list included flurochloridone.
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Animal Health and finalised on 4 February 2011 in the
1490/2002 the notifier withdrew its support of the
format of the Commission review report for fluro
inclusion of that active substance in Annex I to
chloridone.
Directive 91/414/EEC within 2 months from receipt of
the draft assessment report. Consequently, Commission
(6)
It has appeared from the various examinations made that
Decision 2008/934/EC of 5 December 2008 concerning
plant protection products containing flurochloridone
the non-inclusion of certain active substances in Annex I
may be expected to satisfy, in general, the requirements
to Council Directive 91/414/EEC and the withdrawal of
laid down in Article 5(1)(a) and (b) of Directive
authorisations for plant protection products containing
91/414/EEC, in particular with regard to the uses
these substances ( 4 ) was adopted on the non-inclusion
which have been examined and detailed in the
of flurochloridone.
Commission review report. It is therefore appropriate
to include flurochloridone in Annex I, in order to
ensure that in all Member States the authorisations of
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
plant protection products containing this active
original notifier (hereinafter the applicant) submitted a
substance can be granted in accordance with the
new application requesting the accelerated procedure to
provisions of that Directive.
be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
application of Council Directive 91/414/EEC as regards
obtain further information on certain specific points.
a regular and an accelerated procedure for the assessment
Article 6(1) of Directive 91/414/EEC provides that
of active substances which were part of the programme
inclusion of a substance in Annex I may be subject to
of work referred to in Article 8(2) of that Directive but
conditions. Therefore, it is appropriate to require that the
have not been included into its Annex I ( 5 ).
applicant submit further information confirming: the
relevance of impurities other than toluene, the
compliance of ecotoxicological test material with the
(4) The
application
was
submitted
to
Spain,
which
had
been
technical specifications, the relevance of the groundwater
designated rapporteur Member State by Regulation (EC)
metabolite R42819
( 7 ) and the potential endocrine
No 1490/2002. The time period for the accelerated
disrupting properties of flurochloridone.
procedure was respected. The specification of the active
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 1 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance flurochloridone.
( 2 ) OJ L 55, 29.2.2000, p. 25.
EFSA Journal 2010;8(12):1869. [66 pp.]. doi:10.2903/j.efsa.
( 3 ) OJ L 224, 21.8.2002, p. 23.
2010.1869. Available online: www.efsa.europa.eu/efsajournal.htm
( 4 ) OJ L 333, 11.12.2008, p. 11.
( 7 ) R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]
( 5 ) OJ L 15, 18.1.2008, p. 5.
pyrrolidin-2-one.

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L 62/28
EN
Official Journal of the European Union
9.3.2011
(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
which will result from the inclusion.
Article 1

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
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
Article 2
existing authorisations of plant protection products
containing flurochloridone to ensure that the
The line concerning flurochloridone in the Annex to Decision
requirements laid down by Directive 91/414/EEC, in
2008/934/EC is deleted.
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
vary, replace or withdraw, as appropriate, existing au
Article 3
thorisations, in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
Member States shall adopt and publish by 30 November 2011
deadline, a longer period should be provided for the
at the latest the laws, regulations and administrative provisions
submission and assessment of the complete Annex III
necessary to comply with this Directive. They shall forthwith
dossier of each plant protection product for each
communicate to the Commission the text of those provisions
intended use in accordance with the uniform principles
and a correlation table between those provisions and this
laid down in Directive 91/414/EEC.
Directive.
(10) The
experience
gained
from
previous
inclusions
in
Annex
They shall apply those provisions from 1 December 2011.
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC)
No 3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage
When Member States adopt those provisions, they shall contain
of the programme of work referred to in Article 8(2) of
a reference to this Directive or be accompanied by such a
Council Directive 91/414/EEC concerning the placing of
reference on the occasion of their official publication. Member
plant protection products on the market ( 1 ) has shown
States shall determine how such reference is to be made.
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
Article 4
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
1. Member States shall in accordance with Directive
an authorisation demonstrates access to a dossier
91/414/EEC, where necessary, amend or withdraw existing
satisfying the requirements of Annex II to that Directive.
authorisations for plant protection products containing fluro
However, this clarification does not impose any new
chloridone as an active substance by 30 November 2011.
obligations on Member States or holders of authori
sations compared to the directives which have been
adopted until now amending Annex I.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to flurochloridone are met,
(11) It is therefore appropriate to amend Directive
with the exception of those identified in part B of the entry
91/414/EEC accordingly.
concerning that active substance, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
the conditions of Article 13 of that Directive.
flurochloridone and the withdrawal of authorisations for
plant protection products containing that substance by
31 December 2011. It is necessary to delete the line
concerning flurochloridone in the Annex to that
2. By way of derogation from paragraph 1, for each au
Decision.
thorised plant protection product containing flurochloridone
as either the only active substance or as one of several active
substances all of which were listed in Annex I to Directive
(13) It is therefore appropriate to amend Decision
91/414/EEC by 31 May 2011 at the latest, Member States
2008/934/EC accordingly.
shall re-evaluate the product in accordance with the uniform
principles provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of Annex
(14) The
measures provided for in this Directive are in
III to that Directive and taking into account part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning flurochloridone. On the
Committee on the Food Chain and Animal Health,
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1) (b), (c),
( 1 ) OJ L 366, 15.12.1992, p. 10.
(d) and (e) of Directive 91/414/EEC.

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EN
9.3.2011 Official
Journal
of
the
European
Union L
62/29
Following that determination Member States shall:
Article 5
This Directive shall enter into force on 1 June 2011.
(a) in the case of a product containing flurochloridone as the
only active substance, where necessary, amend or withdraw
Article 6
the authorisation by 31 May 2015 at the latest; or
This Directive is addressed to the Member States.
(b) in the case of a product containing flurochloridone as one
of several active substances, where necessary, amend or
Done at Brussels, 8 March 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
For the Commission
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
The President
91/414/EEC, whichever is the latest.
José Manuel BARROSO

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L 62/30
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:
No
Common Name,
Expiration of
Identification Numbers
IUPAC Name Purity
(*)
Entry into
force
inclusion
Specific provisions
EN
‘342 Flurochloridone
(3RS,4RS;3RS,4SR)-3-chloro-4-chloro
≥ 940 g/kg.
1 June
31 May
PART A

CAS No: 61213-25-0 methyl-1-
Relevant impurities:
2011
2021
Only uses as herbicide may be authorised.
CIPAC No: 430
(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone
Toluene: max 8 g/kg
PART B
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on flurochloridone, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health on 4 February 2011 shall be taken into account.
Off
In this overall assessment Member States shall pay particular attention to:
icial
1. the risk for non-target plants and aquatic organisms;
Jour
2. the protection of the groundwater, when the active substance is applied in
nal
regions with vulnerable soil and/or climatic conditions.
of
the
Conditions of authorisation shall include risk mitigation measures, where
appropriate.
European
The Member States concerned shall ensure that the applicant submits to the
Commission further confirmatory information as regards:
Union
1. the relevance of impurities other than toluene;
2. the compliance of ecotoxicological test material with the technical specifi
cations;
3. the relevance of the groundwater metabolite R42819 (R42819: (4RS)-4-
(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one);
4. the potential endocrine disrupting properties of flurochloridone.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1) and (2) by 1 December
2011, the information set out in point (3) by 31 May 2013 and the
information set out in point (4) within 2 years after the adoption of the
OECD test guidelines on endocrine disruption.’
(*) Further details on identity and specification of active substance are provided in the review report.
9.3.2011

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