HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
3.3.2011 Official
Journal
of
the
European
Union L
58/49
COMMISSION DIRECTIVE 2011/21/EU
of 2 March 2011
amending Council Directive 91/414/EEC to include clethodim 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
the
Netherlands,
which
had been designated rapporteur Member State by Regu
lation (EC) No 1490/2002. The time period for the accel
Having regard to Council Directive 91/414/EEC of 15 July
erated procedure was respected. The specification of the
1991 concerning the placing of plant protection products on
active substance and the supported uses are the same as
the market ( 1 ), and in particular Article 6(1) thereof,
were the subject of Decision 2008/934/EC. That appli
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
Whereas:
(5) The
Netherlands
evaluated
the
additional
data
submitted
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
by the applicant and prepared an additional report. It
No 1490/2002 ( 3 ) lay down the detailed rules for the
communicated that report to the European Food Safety
implementation of the third stage of the programme of
Authority (hereinafter ‘the Authority’) and to the
work referred to in Article 8(2) of Directive 91/414/EEC
Commission on 1 December 2009. The Authority
and establish a list of active substances to be assessed,
communicated the additional report to the other
with a view to their possible inclusion in Annex I to
Member States and the applicant for comments and
Directive 91/414/EEC. That list included clethodim.
forwarded the comments it had received to the
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
clethodim to the Commission on 10 September 2010 ( 6 ).
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
The draft assessment report, the additional report and the
1490/2002 the notifier withdrew its support of the
conclusion of the Authority were reviewed by the
inclusion of that active substance in Annex I to
Member States and the Commission within the
Directive 91/414/EEC within 2 months from receipt of
Standing Committee on the Food Chain and Animal
the draft assessment report. Consequently, Commission
Health and finalised on 28 January 2011 in the format
Decision 2008/934/EC of 5 December 2008 concerning
of the Commission review report for clethodim.
the non-inclusion of certain active substances in Annex I
to Council Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products containing
these substances ( 4 ) was adopted on the non-inclusion
of clethodim.
(6)
It has appeared from the various examinations made that
plant protection products containing clethodim may be
expected to satisfy, in general, the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
in particular with regard to the uses which have been
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
examined and detailed in the Commission review report.
original notifier (hereinafter ‘the applicant’) submitted a
It is therefore appropriate to include clethodim in Annex
new application requesting the accelerated procedure to
I, in order to ensure that in all Member States the auth
be applied, as provided for in Articles 14 to 19 of
orisations of plant protection products containing this
Commission Regulation (EC) No 33/2008 of
active substance can be granted in accordance with the
17 January 2008 laying down detailed rules for the
provisions of that Directive.
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 clethodim. EFSA
( 3 ) OJ L 224, 21.8.2002, p. 23.
Journal 2010; 8(9):1771. [93 pp.]. doi:10.2903/j.efsa.2010.1771.
( 4 ) OJ L 333, 11.12.2008, p. 11.
Available online: www.efsa.europa.eu

---

L 58/50
EN
Official Journal of the European Union
3.3.2011
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to (12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
obtain further information on certain specific points.
clethodim and the withdrawal of authorisations for plant
Article 6(1) of Directive 91/414/EEC provides that
protection products containing that substance by
inclusion of a substance in Annex I may be subject to
31 December 2011. It is necessary to delete the line
conditions. Therefore, it is appropriate to require that the
concerning clethodim in the Annex to that Decision.
applicant submit further information to confirm the
results of the risk assessment, on the basis of most
recent scientific knowledge, as regards the soil and
(13) It is therefore appropriate to amend Decision
groundwater exposure assessments and the residue defi
2008/934/EC accordingly.
nition for risk assessment.
(14) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
(8) A
reasonable
period
should
be
allowed
to
elapse
before
an active substance is included in Annex I in order to
Committee on the Food Chain and Animal Health,
permit Member States and the interested parties to
prepare themselves to meet the new requirements
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:
Article 1
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
Annex I to Directive 91/414/EEC is amended as set out in the
substance in Annex I, Member States should be
Annex to this Directive.
allowed a period of 6 months after inclusion to review
existing authorisations of plant protection products
containing clethodim to ensure that the requirements
Article 2
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
The line concerning clethodim in the Annex to Decision
are satisfied. Member States should vary, replace or
2008/934/EC is deleted.
withdraw, as appropriate, existing authorisations, in
accordance with the provisions of Directive 91/414/EEC.
By derogation from the above deadline, a longer period
Article 3
should be provided for the submission and assessment of
the complete Annex III dossier of each plant protection
Member States shall adopt and publish by 30 November 2011
product for each intended use in accordance with the
at the latest the laws, regulations and administrative provisions
uniform principles laid down in Directive 91/414/EEC.
necessary to comply with this Directive. They shall forthwith

communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.
(10) The
experience
gained
from
previous
inclusions
in
Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
They shall apply those provisions from 1 December 2011.
3600/92 of 11 December 1992 laying down the detailed
rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of
When Member States adopt those provisions, they shall contain
Council Directive 91/414/EEC concerning the placing
a reference to this Directive or be accompanied by such a
of plant protection products on the market ( 1 ) has
reference on the occasion of their official publication. Member
shown that difficulties can arise in interpreting the
States shall determine how such reference is to be made.
duties of holders of existing authorisations in relation
to access to data. In order to avoid further difficulties
it therefore appears necessary to clarify the duties of
Article 4
the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
1. Member States shall in accordance with Directive
dossier satisfying the requirements of Annex II to that
91/414/EEC, where necessary, amend or withdraw existing
Directive. However, this clarification does not impose any
authorisations for plant protection products containing
new obligations on Member States or holders of auth
clethodim as an active substance by 30 November 2011.
orisations 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 clethodim are met, with the
exception of those identified in part B of the entry concerning
(11) It is therefore appropriate to amend Directive
that active substance, and that the holder of the authorisation
91/414/EEC accordingly.
has, or has access to, a dossier satisfying the requirements of
Annex II to that Directive in accordance with the conditions of
( 1 ) OJ L 366, 15.12.1992, p. 10.
Article 13 of that Directive.

---

EN
3.3.2011 Official
Journal
of
the
European
Union L
58/51
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
withdraw the authorisation by 31 May 2015 or by the
orised plant protection product containing clethodim as either
date fixed for such an amendment or withdrawal in the
the only active substance or as one of several active substances
respective Directive or Directives which added the relevant
all of which were listed in Annex I to Directive 91/414/EEC by
substance or substances to Annex I to Directive
31 May 2011 at the latest, Member States shall re-evaluate the
91/414/EEC, whichever is the latest.
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 III to that Directive and
Article 5
taking into account part B of the entry in Annex I to that
Directive concerning clethodim. On the basis of that evaluation,
This Directive shall enter into force on 1 June 2011.
they shall determine whether the product satisfies the conditions
set out in Article 4(1)(b), (c), (d) and (e) of Directive
91/414/EEC.
Article 6
This Directive is addressed to the Member States.
Following that determination Member States shall:
(a) in the case of a product containing clethodim as the only
Done at Brussels, 2 March 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 clethodim as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

---

L 58/52
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
‘336 Clethodim
(5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyl-
≥ 930 g/kg
1 June 2011 31
May
2021 PART
A

CAS No: 99129-21-2 oxyimino]propyl}-5-[(2RS)-2-
Impurities:
Only uses as herbicide on sugar beet may be authorised.
CIPAC No: 508
(ethylthio)propyl]-3-hydroxycyclohex-2-
toluene max. 4 g/kg
en-1-one
PART B
For the implementation of the uniform principles of Annex
VI the conclusions of the review report on clethodim, and
in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 28 January 2011, shall be taken into account.
Off
icial
In this overall assessment Member States shall pay particular
attention to the protection to aquatic organisms, birds and
Jour
mammals, and shall ensure that conditions of use include
the application of adequate risk mitigation measures.
nal
of
The Member States concerned shall request the submission
the
of confirmatory information, on the basis of most recent
scientific knowledge, as regards:
European
— the soil and groundwater exposure assessments,
— the residue definition for risk assessment.
Union
The Member States concerned shall ensure that the
applicant submits such confirmatory information to the
Commission by 31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
3.3.2011

---