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14.4.2011 Official
Journal
of
the
European
Union L
100/47
COMMISSION IMPLEMENTING DIRECTIVE 2011/45/EU
of 13 April 2011
amending Council Directive 91/414/EEC to include diclofop 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
1991 concerning the placing of plant protection products on
(5)
France evaluated the additional data submitted by the
the market (
applicant and prepared an additional report. It

1 ), and in particular Article 6(1) thereof,
communicated that report to the European Food Safety
Authority (hereinafter the Authority) and to the
Whereas:
Commission on 11 August 2009. The Authority
communicated the additional report to the other
Member States and the applicant for comments and
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
forwarded the comments it had received to the
No 1490/2002 ( 3 ) lay down the detailed rules for the
Commission. In accordance with Article 20(1) of Regu
implementation of the third stage of the programme of
lation (EC) No 33/2008 and at the request of the
work referred to in Article 8(2) of Directive 91/414/EEC
Commission, the Authority presented its conclusion on
and establish a list of active substances to be assessed,
diclofop (considered variant diclofop-methyl) to the
with a view to their possible inclusion in Annex I to
Commission on 1 September 2010
( 6 ). The draft
Directive 91/414/EEC. That list included diclofop.
assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
Standing Committee on the Food Chain and Animal
1490/2002 the notifier withdrew its support of the
Health and finalised on 11 March 2011 in the format
inclusion of that active substance in Annex I to
of the Commission review report for diclofop.
Directive 91/414/EEC within 2 months from receipt of
the draft assessment report. Consequently, Commission
Decision 2008/934/EC of 5 December 2008 concerning
(6)
It has appeared from the various examinations made that
the non-inclusion of certain active substances in Annex I
plant protection products containing diclofop may be
to Council Directive 91/414/EEC and the withdrawal of
expected to satisfy, in general, the requirements laid
authorisations for plant protection products containing
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
these substances ( 4 ) was adopted on the non-inclusion
in particular with regard to the uses which have been
of diclofop.
examined and detailed in the Commission review report.
It is therefore appropriate to include diclofop in Annex I,
in order to ensure that in all Member States the au-
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter the applicant) submitted a
thorisations of plant protection products containing
new application requesting the accelerated procedure to
this active substance can be granted in accordance with
be applied, as provided for in Articles 14 to 19 of
the provisions of that Directive.
Commission Regulation (EC) No 33/2008 of
17 January 2008 laying down detailed rules for the
application of Council Directive 91/414/EEC as regards
(7) Without
prejudice
to
that
conclusion,
it
is
appropriate
to
a regular and an accelerated procedure for the assessment
obtain further information on certain specific points.
of active substances which were part of the programme
Article 6(1) of Directive 91/414/EC provides that
of work referred to in Article 8(2) of that Directive but
inclusion of a substance in Annex I may be subject to
have not been included into its Annex I (
conditions. Therefore, it is appropriate to require that the

5 ).
applicant submit further information confirming the
results of the risk assessment on the basis of most
(4) The
application
was
submitted
to
France,
which
had
been
recent scientific knowledge as regards a metabolism
designated rapporteur Member State by Regulation (EC)
study on cereals. Moreover, it is appropriate to require
No 1490/2002. The time period for the accelerated
the submission of confirmatory information on the
procedure was respected. The specification of the active
possible environmental impact of the preferential degra
dation/conversion of the isomers.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance diclofop. EFSA
( 4 ) OJ L 333, 11.12.2008, p. 11.
Journal 2010; 8(10):1718. [74 pp.]. doi:10.2903/j.efsa.2010.1718
( 5 ) OJ L 15, 18.1.2008, p. 5.
Available online: www.efsa.europa.eu

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L 100/48
EN
Official Journal of the European Union
14.4.2011
(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
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
allowed a period of 6 months after inclusion to review
The line concerning diclofop-methyl in the Annex to Decision
existing authorisations of plant protection products
2008/934/EC is deleted.
containing diclofop to ensure that the requirements laid
down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in
Article 3
Annex I, are satisfied. Member States should vary,
Member States shall adopt and publish by 30 November 2011
replace or withdraw, as appropriate, existing authori
at the latest the laws, regulations and administrative provisions
sations, in accordance with the provisions of Directive
necessary to comply with this Directive. They shall forthwith
91/414/EEC. By derogation from the above deadline, a
communicate to the Commission the text of those provisions
longer period should be provided for the submission and
and a correlation table between those provisions and this
assessment of the complete Annex III dossier of each
Directive.
plant protection 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
Council Directive 91/414/EEC concerning the placing
Article 4
of plant protection products on the market ( 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
diclofop as an active substance by 30 November 2011. By
the Member States, especially the duty to verify that
that date they shall in particular verify that the conditions in
the holder of an authorisation demonstrates access to a
Annex I to that Directive relating to diclofop are met, with the
dossier satisfying the requirements of Annex II to that
exception of those identified in Part B of the entry concerning
Directive. However, this clarification does not impose any
that active substance, and that the holder of the authorisation
new obligations on Member States or holders of au-
has, or has access to, a dossier satisfying the requirements of
thorisations compared to the directives which have
Annex II to that Directive in accordance with the conditions of
been adopted until now amending Annex I.
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 diclofop as either
the only active substance or as one of several active substances
all of which were listed in Annex I to Directive 91/414/EEC by
(12) Decision
2008/934/EC
provides
for
the
non-inclusion
of
31 May 2011 at the latest, Member States shall re-evaluate the
diclofop-methyl and the withdrawal of authorisations for
product in accordance with the uniform principles provided for
plant protection products containing that substance by
in Annex VI to Directive 91/414/EEC, on the basis of a dossier
31 December 2011. It is necessary to delete the line
satisfying the requirements of Annex III to that Directive and
concerning diclofop-methyl in the Annex to that
taking into account Part B of the entry in Annex I to that
Decision.
Directive concerning diclofop. On the basis of that evaluation,
they shall determine whether the product satisfies the conditions
set out in Article 4(1)(b), (c), (d) and (e) of Directive
(13) It is therefore appropriate to amend Decision
91/414/EEC.
2008/934/EC accordingly.
Following that determination Member States shall:
(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,
(a) in the case of a product containing diclofop 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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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/49
(b) in the case of a product containing diclofop 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, 13 April 2011.
For the Commission
The President
José Manuel BARROSO

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L 100/50
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:
No
Common name,
identification numbers
IUPAC name Purity
(1 ) Entry
into
force
Expiration of
inclusion
Specific provisions
EN
‘348 Diclofop
Diclofop
≥ 980 g/kg (expressed as 1 June 2011 31
May
2021 PART
A

diclofop-methyl)
CAS No 40843-25-2 (parent) (RS)-2-[4-(2,4-dichlorophenoxy)
Only uses as herbicide may be authorised.
phenoxy]propionic acid
CAS No 257-141-8
PART B
Diclofop-methyl
(diclofop-methyl)
For the implementation of the uniform principles of Annex
methyl (RS)-2-[4-(2,4-dichlorophenoxy)
VI, the conclusions of the review report on diclofop, and in
CIPAC No 358 (parent)
phenoxy]propionate
particular Appendices I and II thereof, as finalised in the
CIPAC No 358.201
Standing Committee on the Food Chain and Animal Health
on 11 March 2011 shall be taken into account.
(diclofop-methyl)
In this overall assessment Member States shall:
Off
— pay particular attention to the operators and workers
icial
safety and include as a condition for authorisation the
Jour
application of adequate personal protective equipment,
nal
— pay particular attention to the risk to aquatic organisms
and non-target plants and require risk mitigation measures
of
to be applied.
the
The Member States concerned shall request the submission of
European
confirmatory information as regards:
(a) a metabolism study on cereals;
(b) an update of the risk assessment concerning the possible
Union
environmental impact of the preferential degrada
tion/conversion of the isomers.
The Member States concerned shall ensure that the applicant
submits to the Commission the information set out in point
(a) by 31 May 2013 and the information set out in point (b)
at latest 2 years after the adoption of a specific guidance
document on evaluation of isomers mixtures.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
14.4.2011

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