HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 136/58
EN
Official Journal of the European Union
24.5.2011
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2011/60/EU
of 23 May 2011
amending Council Directive 91/414/EEC to include tebufenozide as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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
Germany,
which
had
been designated rapporteur Member State by Regulation
(EC) No 1490/2002. The time period for the accelerated
procedure was respected. The specification of the active
Having regard to Council Directive 91/414/EEC of 15 July
substance and the supported uses are the same as were
1991 concerning the placing of plant protection products on
the subject of Decision 2008/934/EC. That application
the market ( 1 ), and in particular Article 6(1) thereof,
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
(EC) No 33/2008.
Whereas:
(5) Germany
evaluated
the
additional
data
submitted
by
the
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
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 23 November 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 tebufenozide.
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
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
No
tebufenozide to the Commission on 19 October
1490/2002 the notifier withdrew its support of the
2010 (
inclusion of that active substance in Annex I to

6 ). The draft assessment report, the additional
report and the conclusion of the Authority were
Directive 91/414/EEC within 2 months from receipt of
reviewed by the Member States and the Commission
the draft assessment report. Consequently, Commission
within the Standing Committee on the Food Chain and
Decision 2008/934/EC of 5 December 2008 concerning
Animal Health and finalised on 11 March 2011 in the
the non-inclusion of certain active substances in Annex I
format of the Commission review report for
to Council Directive 91/414/EEC and the withdrawal of
tebufenozide.
authorisations for plant protection products containing
these substances ( 4 ) was adopted on the non-inclusion
of tebufenozide.
(6)
It has appeared from the various examinations made that
plant protection products containing tebufenozide may
be expected to satisfy, in general, the requirements laid
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
original notifier (hereinafter ‘the applicant’) submitted a
in particular with regard to the uses which have been
new application requesting the accelerated procedure to
examined and detailed in the Commission review report.
be applied, as provided for in Articles 14 to 19 of
It is therefore appropriate to include tebufenozide in
Commission Regulation (EC) No 33/2008 of
Annex I, in order to ensure that in all Member States
17 January 2008 laying down detailed rules for the
the authorisations of plant protection products
application of Council Directive 91/414/EEC as regards
containing this active substance can be granted in
a regular and an accelerated procedure for the assessment
accordance with the provisions of that Directive.
of active substances which were part of the programme
( 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 tebufenozide.
( 3 ) OJ L 224, 21.8.2002, p. 23.
Summary: EFSA Journal 2010; 8(12): 1871. [120 pp.].
( 4 ) OJ L 333, 11.12.2008, p. 11.
doi:10.2903/j.efsa.2010.1871. Available online: www.efsa.europa.eu

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EN
24.5.2011 Official
Journal
of
the
European
Union L
136/59
(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.
tebufenozide and the withdrawal of authorisations for
Article 6(1) of Directive 91/414/EEC provides that
plant 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 tebufenozide in the Annex to that Decision.
applicant submit confirmatory information as regards the
relevance of metabolites RH-6595
( 1 ), RH-2651
( 2 ),
M2 ( 3 ), the degradation of tebufenozide in soils of
(13) It is therefore appropriate to amend Decision
alkaline pH and the risk to Lepidoptera non-target
2008/934/EC accordingly.
insects.
(8) A
reasonable
period
should
be
allowed
to
elapse
before (14) The measures provided for in this Directive are in
an active substance is included in Annex I in order to
accordance with the opinion of the Standing
permit Member States and the interested parties to
Committee on the Food Chain and Animal Health,
prepare themselves to meet the new requirements
which will result from the inclusion.
HAS ADOPTED THIS DIRECTIVE:
(9) Without
prejudice
to
the
obligations
defined
by
Directive
91/414/EEC as a consequence of including an active
Article 1
substance in Annex I, Member States should be
allowed a period of 6 months after inclusion to review
Annex I to Directive 91/414/EEC is amended as set out in the
existing authorisations of plant protection products
Annex to this Directive.
containing tebufenozide 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 Annex I,
Article 2
are satisfied. Member States should vary, replace or
withdraw, as appropriate, existing authorisations, in
The line concerning tebufenozide in the Annex to Decision
accordance with the provisions of Directive 91/414/EEC.
2008/934/EC is deleted.
By derogation from the above deadline, a longer period
should be provided for the submission and assessment of
the complete Annex III dossier of each plant protection
Article 3
product for each intended use in accordance with the
uniform principles laid down in Directive 91/414/EEC.
Member States shall adopt and publish by 30 November 2011
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
(10) The
experience
gained
from
previous
inclusions
in
Annex
communicate to the Commission the text of those provisions
I to Directive 91/414/EEC of active substances assessed
and a correlation table between those provisions and this
in the framework of Commission Regulation (EEC) No
Directive.
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
They shall apply those provisions from 1 December 2011.
Council Directive 91/414/EEC concerning the placing
of plant protection products on the market ( 4 ) has
shown that difficulties can arise in interpreting the
When Member States adopt those provisions, they shall contain
duties of holders of existing authorisations in relation
a reference to this Directive or be accompanied by such a
to access to data. In order to avoid further difficulties
reference on the occasion of their official publication. Member
it therefore appears necessary to clarify the duties of
States shall determine how such reference is to be made.
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
Directive. However, this clarification does not impose any
Article 4
new obligations on Member States or holders of au
1. Member States shall in accordance with Directive
thorisations compared to the directives which have
91/414/EEC, where necessary, amend or withdraw existing
been adopted until now amending Annex I.
authorisations for plant protection products containing
tebufenozide as an active substance by 30 November 2011.
(11) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to tebufenozide are met, with
( 1 ) N'-[(4-acetylphenyl)carbonyl]-N-tert-butyl-3,5-dimethylbenzohy
the exception of those identified in part B of the entry
drazide.
concerning that active substance, and that the holder of the
( 2 ) 4-({2-tert-butyl-2-[(3,5-dimethylphenyl)carbonyl]hydrazinyl}carbonyl)
authorisation has, or has access to, a dossier satisfying the
benzoic acid.
( 3 ) Chemical name not yet identified.
requirements of Annex II to that Directive in accordance with
( 4 ) OJ L 366, 15.12.1992, p. 10.
the conditions of Article 13 of that Directive.

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L 136/60
EN
Official Journal of the European Union
24.5.2011
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 tebufenozide 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
in Annex I to that Directive concerning tebufenozide. On the
This Directive shall enter into force on 1 June 2011.
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 tebufenozide as the only
Done at Brussels, 23 May 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 tebufenozide as one of
The President
several active substances, where necessary, amend or
José Manuel BARROSO

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24.5.2011 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
‘355 Tebufenozide
N-tert-butyl-N′-(4-ethylbenzoyl)-
≥ 970 g/kg
1 June 2011 31
May
2021 PART
A

3,5-dimethylbenzohydrazide
CAS No: 112410-23-8
Relevant impurity
Only uses as insecticide may be authorised.
CIPAC No: 724
t-butyl hydrazine
PART B
< 0,001 g/kg
For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on tebufenozide, 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:
(1) pay particular attention to the safety of operators and
icial
workers after re-entry and ensure that conditions of auth
Jour
orisation prescribe appropriate protective equipment;
(2) pay particular attention to the protection of groundwater,
nal
when the active substance is applied in regions with
of
vulnerable soil and/or climatic conditions;
the
(3) pay particular attention to the protection of aquatic
European
organisms and ensure that conditions of use prescribe
adequate mitigation measures;
(4) pay particular attention to the risk to Lepidoptera non-
Union
target insects.
Conditions of authorisation shall include risk mitigation
measures, where appropriate.
The Member States concerned shall request the submission of
confirmatory information, as regards:
(1) the relevance of metabolites RH-6595, RH-2651, M2;
(2) the degradation of tebufenozide in anaerobic soils and soils
of alkaline pH.
The Member States concerned shall ensure that the applicant
submits to the Commission the information set out in points
(1) and (2) by 31 May 2013.’
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
136/61

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