HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 18/30
EN
Official Journal of the European Union
21.1.2011
DIRECTIVES
COMMISSION DIRECTIVE 2011/4/EU
of 20 January 2011
amending Council Directive 91/414/EEC to include cycloxydim as active substance and amending
Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
a regular and an accelerated procedure for the assessment
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
Austria,
which
had
Having regard to Council Directive 91/414/EEC of 15 July
been designated rapporteur Member State by Regulation
1991 concerning the placing of plant protection products on
(EC) No 451/2000. The time period for the accelerated
the market (
procedure was respected. The specification of the active

1 ), and in particular Article 6(1) thereof,
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
Whereas:
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
No 1490/2002 ( 3 ) lay down the detailed rules for the
implementation of the third stage of the programme of
(5) Austria
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
work referred to in Article 8(2) of Directive 91/414/EEC
communicated that report to the European Food Safety
and establish a list of active substances to be assessed,
Authority (hereinafter ‘the Authority’) and to the
with a view to their possible inclusion in Annex I to
Commission on 2 November 2009. The Authority
Directive 91/414/EEC. That list included cycloxydim.
communicated the additional report to the other
Member States and the applicant for comments and
forwarded the comments it had received to the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Commission. In accordance with Article 20(1) of Regu
1490/2002 the applicant withdrew its support of the
lation (EC) No 33/2008 and at the request of the
inclusion of that active substance in Annex I to
Commission, the Authority presented its conclusion on
Directive 91/414/EEC within 2 months from receipt of
cycloxydim to the Commission on 30 June 2010 ( 6 ). The
the draft assessment report. Consequently, Commission
draft assessment report, the additional report and the
Decision 2008/934/EC of 5 December 2008 concerning
conclusion of the Authority were reviewed by the
the non-inclusion of certain active substances in Annex I
Member States and the Commission within the
to Council Directive 91/414/EEC and the withdrawal of
Standing Committee on the Food Chain and Animal
authorisations for plant protection products containing
Health and finalised on 23 November 2010 in the
these substances (
format of the Commission review report for cycloxydim.

4 ) was adopted on the non-inclusion

of cycloxydim.
(6)
It has appeared from the various examinations made that
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
plant protection products containing cycloxydim may be
original notifier (hereinafter ‘the applicant’) submitted a
expected to satisfy, in general, the requirements laid
new application requesting the accelerated procedure to
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
be applied, as provided for in Articles 14 to 19 of
in particular with regard to the uses which have been
Commission Regulation (EC) No 33/2008 of
examined and detailed in the Commission review report.
17 January 2008 laying down detailed rules for the
It is therefore appropriate to include cycloxydim in
application of Council Directive 91/414/EEC as regards
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 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 cycloxydim.
( 3 ) OJ L 224, 21.8.2002, p. 23.
Summary: EFSA Journal 2010; 8(7):1669. [73 pp.]. doi:10.2903/
( 4 ) OJ L 333, 11.12.2008, p. 11.
j.efsa.2010.1669. Available online: www.efsa.europa.eu

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EN
21.1.2011 Official
Journal
of
the
European
Union L
18/31
Annex I, in order to ensure that in all Member States the
(11) It is therefore appropriate to amend Directive
authorisations of plant protection products containing
91/414/EEC accordingly.
this active substance can be granted in accordance with
the provisions of that Directive.
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
cycloxydim and the withdrawal of authorisations for
plant protection products containing that substance by
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
31 December 2011. It is necessary to delete the line
obtain further information on certain specific points.
concerning cycloxydim in the Annex to that Decision.
Article 6(1) of Directive 91/414/EEC provides that
inclusion of a substance in Annex I may be subject to
conditions. Therefore, it is appropriate to require that the
(13) It is therefore appropriate to amend Decision
applicant submit to the Commission, further information
2008/934/EC accordingly.
on methods for the analysis of residues of cycloxydim in
plant and animal products.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
HAS ADOPTED THIS DIRECTIVE:
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
Article 2
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
The line concerning cycloxydim in the Annex to Decision
containing cycloxydim to ensure that the requirements
2008/934/EC is deleted.
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
Article 3
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
Member States shall adopt and publish by 30 November 2011
accordance with the provisions of Directive 91/414/EEC.
at the latest the laws, regulations and administrative provisions
By derogation from the above deadline, a longer period
necessary to comply with this Directive. They shall forthwith
should be provided for the submission and assessment of
communicate to the Commission the text of those provisions
the complete Annex III dossier of each plant protection
and a correlation table between those provisions and this
product for each intended use in accordance with the
Directive.
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
I to Directive 91/414/EEC of active substances assessed
When Member States adopt those provisions, they shall contain
in the framework of Commission Regulation (EEC) No
a reference to this Directive or be accompanied by such a
3600/92 of 11 December 1992 laying down the detailed
reference on the occasion of their official publication. Member
rules for the implementation of the first stage of the
States shall determine how such reference is to be made.
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market (
Article 4

1 ) has
shown that difficulties can arise in interpreting the
1. Member States shall in accordance with Directive
duties of holders of existing authorisations in relation
91/414/EEC, where necessary, amend or withdraw existing
to access to data. In order to avoid further difficulties
authorisations for plant protection products containing
it therefore appears necessary to clarify the duties of
cycloxydim as an active substance by 30 November 2011.
the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that
By that date they shall in particular verify that the conditions in
Directive. However, this clarification does not impose any
Annex I to that Directive relating to cycloxydim are met, with
new obligations on Member States or holders of au-
the exception of those identified in part B of the entry
thorisations compared to the Directives which have
concerning that active substance, and that the holder of the
been adopted until now amending Annex I.
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
( 1 ) OJ L 366, 15.12.1992, p. 10.
the conditions of Article 13 of that Directive.

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L 18/32
EN
Official Journal of the European Union
21.1.2011
2. By
way
of
derogation
from
paragraph
1,
for
each
au-
withdraw the authorisation by 31 May 2015 or by the
thorised plant protection product containing cycloxydim as
date fixed for such an amendment or withdrawal in the
either the only active substance or as one of several active
respective Directive or Directives which added the relevant
substances all of which were listed in Annex I to Directive
substance or substances to Annex I to Directive
91/414/EEC by 31 May 2011 at the latest, Member States
91/414/EEC, whichever is the latest.
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
Article 5
III to that Directive and taking into account part B of the entry
This Directive shall enter into force on 1 June 2011.
in Annex I to that Directive concerning cycloxydim. On the
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
Article 6
(d) and (e) of Directive 91/414/EEC.
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing cycloxydim as the only
Done at Brussels, 20 January 2011.
active substance, where necessary, amend or withdraw the
authorisation by 31 May 2015 at the latest; or
For the Commission
(b) in the case of a product containing cycloxydim as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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21.1.2011 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
‘321 Cycloxydim
(5RS)-2-[(EZ)-1-
≥ 940 g/kg 1
June
2011 31
May
2021 PART
A

CAS No: 101205-02-1
(ethoxyimino)butyl]-3-
Only uses as herbicide may be authorised.
CIPAC No: 510
hydroxy-5-[(3RS)-thian-3-
yl]cyclohex-2-en-1-one
PART B
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on cycloxydim, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 23 November 2010 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the risk
to non-target plants.
icial
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of further
Jour
information concerning the methods for analysis of residues of cycloxydim in
nal
plant and animal products.
of
The Member States concerned shall ensure that the applicant submits such
the
methods of analysis to the Commission by 31 May 2013.’
European
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
18/33

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