HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 314/6
EN
Official Journal of the European Union
23.11.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1192/2013
of 22 November 2013
approving the active substance tembotrione, in accordance with Regulation (EC) No 1107/2009 of
the European Parliament and of the Council concerning the placing of plant protection products on
the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
2007. In accordance with Article 11(6) of Commission
Regulation (EU) No 188/2011 ( 4 ) additional information
was requested from the applicant on 14 May 2012. The
Having regard to the Treaty on the Functioning of the European
evaluation of the additional data by Austria was
Union,
submitted in the format of an updated draft assessment
report in September 2012.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(4) The
draft
assessment
report
was
reviewed
by
the
Member
market and repealing Council Directives 79/117/EEC and
States and the European Food Safety Authority (here
91/414/EEC (
inafter ‘the Authority’). The Authority presented to the

1 ), and in particular Articles 13(2) and 78(2)
thereof,
Commission its conclusion on the pesticide risk
assessment of the active substance tembotrione ( 5 ) on
6 March 2013. The draft assessment report and the
conclusion of the Authority were reviewed by the
Whereas:
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 3 October 2013 in the format
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
of the Commission review report for tembotrione.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
(5)
It has appeared from the various examinations made that
Directive before 14 June 2011. For tembotrione the
plant protection products containing tembotrione may
conditions of Article 80(1)(a) of Regulation (EC) No
be expected to satisfy, in general, the requirements laid
1107/2009 are fulfilled by Commission Decision
down in Article 5(1)(a) and (b) and Article 5(3) of
2006/586/EC ( 3 ).
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
Commission review report. It is therefore appropriate
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
to approve tembotrione.
Austria received on 25 November 2005 an application
from Bayer CropScience AG for the inclusion of the
active substance tembotrione in Annex I to Directive
91/414/EEC. Decision 2006/586/EC confirmed that the
(6) A
reasonable
period
should
be
allowed
to
elapse
before
dossier was ‘complete’ in the sense that it could be
approval in order to permit Member States and the
considered as satisfying, in principle, the data and
interested parties to prepare themselves to meet the
information requirements of Annexes II and III to
new requirements resulting from the approval.
Directive 91/414/EEC.
(3) For
that
active
substance,
the
effects
on
human
and (7) Without
prejudice
to
the
obligations
provided
for
in
animal health and the environment have been assessed,
Regulation (EC) No 1107/2009 as a consequence of
in accordance with the provisions of Article 6(2) and (4)
approval, taking into account the specific situation
of Directive 91/414/EEC, for the uses proposed by the
created by the transition from Directive 91/414/EEC to
applicant. The designated rapporteur Member State
Regulation (EC) No 1107/2009, the following should,
submitted a draft assessment report on 7 February
however, apply. Member States should be allowed a
period of six months after approval to review authori
sations of plant protection products containing tembo
( 1 ) OJ L 309, 24.11.2009, p. 1.
trione. Member States should, as appropriate, vary,
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
( 3 ) Commission Decision 2006/586/EC of 25 August 2006 recognising
laying down detailed rules for the implementation of Council
in principle the completeness of the dossiers submitted for detailed
Directive 91/414/EEC as regards the procedure for the assessment
examination in view of the possible inclusion of chromafenozide,
of active substances which were not on the market 2 years after the
halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ
( 5 ) EFSA Journal 2013; 11(3):3131. Available online: www.efsa.europa.
L 236, 31.8.2006, p. 31).
eu

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EN
23.11.2013 Official
Journal
of
the
European
Union
L
314/7
replace or withdraw authorisations. By way of derogation
By that date they shall in particular verify that the conditions in
from that deadline, a longer period should be provided
Annex I to this Regulation are met, with the exception of those
for the submission and assessment of the complete
identified in the column on specific provisions of that Annex,
Annex III dossier, as set out in Directive 91/414/EEC,
and that the holder of the authorisation has, or has access to, a
of each plant protection product for each intended use
dossier satisfying the requirements of Annex II to Directive
in accordance with the uniform principles.
91/414/EEC in accordance with the conditions of Article 13(1)
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
(8) The
experience
gained
from
inclusions
in
Annex
I
to
Directive 91/414/EEC of active substances assessed in
the framework of Commission Regulation (EEC) No
2. By way of derogation from paragraph 1, for each auth
3600/92 ( 1 ) has shown that difficulties can arise in inter
orised plant protection product containing tembotrione as
preting the duties of holders of existing authorisations in
either the only active substance or as one of several active
relation to access to data. In order to avoid further
substances, all of which were listed in the Annex to Imple
difficulties it therefore appears necessary to clarify the
menting Regulation (EU) No 540/2011 by 30 April 2014 at
duties of the Member States, especially the duty to
the latest, Member States shall re-evaluate the product in
verify that the holder of an authorisation demonstrates
accordance with the uniform principles, as referred to in
access to a dossier satisfying the requirements of Annex
Article 29(6) of Regulation (EC) No 1107/2009, on the basis
II to that Directive. However, this clarification does not
of a dossier satisfying the requirements of Annex III to Directive
impose any new obligations on Member States or holders
91/414/EEC and taking into account the column on specific
of authorisations compared to the Directives which have
provisions of Annex I to this Regulation. On the basis of that
been adopted until now amending Annex I to that
evaluation, they shall determine whether the product satisfies
Directive or the Regulations approving active substances.
the conditions set out in Article 29(1) of Regulation (EC) No
1107/2009.
(9) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
1107/2009, the Annex to Commission Implementing
Following that determination Member States shall:
Regulation (EU) No 540/2011 ( 2 ) should be amended
accordingly.
(a) in the case of a product containing tembotrione as the only
active substance, where necessary, amend or withdraw the
(10) The
measures
provided
for
in
this
Regulation
are
in
authorisation by 31 October 2015 at the latest; or
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(b) in the case of a product containing tembotrione as one of
several active substances, where necessary, amend or
HAS ADOPTED THIS REGULATION:
withdraw the authorisation by 31 October 2015 or by
the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant
Article 1
substance or substances to Annex I to Directive 91/414/EEC
or approved that substance or those substances, whichever
Approval of active substance
is the latest.
The active substance tembotrione, as specified in Annex I, is
approved subject to the conditions laid down in that Annex.
Article 3
Amendments to Implementing Regulation (EU) No
Article 2
540/2011
Re-evaluation of plant protection products
The Annex to Implementing Regulation (EU) No 540/2011 is
amended in accordance with Annex II to this Regulation.
1. Member
States
shall
in
accordance
with
Regulation
(EC)
No 1107/2009, where necessary, amend or withdraw existing
authorisations for plant protection products containing tembo
trione as an active substance by 31 October 2014.
Article 4
Entry into force and date of application
( 1 ) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
This Regulation shall enter into force on the twentieth day
stage of the programme of work referred to in Article 8(2) of
following that of its publication in the Official Journal of the
Council Directive 91/414/EEC concerning the placing of plant
European Union.
protection products on the market (OJ L 366, 15.12.1992, p. 10).
( 2 ) Commission Implementing Regulation (EU) No 540/2011 of
25 May 2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards the list of
approved active substances (OJ L 153, 11.6.2011, p. 1).
It shall apply from 1 May 2014.

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L 314/8
EN
Official Journal of the European Union
23.11.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 November 2013.
For the Commission
The President
José Manuel BARROSO

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23.11.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Tembotrione
2-{2-chloro-4-mesyl-3-
≥ 945 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred to in
[(2,2,2-trifluoro
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
EN
CAS No 335104-84-2
ethoxy)methyl]ben
The following relevant
review report on tembotrione, and in particular Appendices I and II

impurities must not
CIPAC No 790
zoyl}cyclohexane-1,3-
thereof, as finalised in the Standing Committee on the Food Chain and
dione
exceed a certain
Animal Health on 3 October 2013, shall be taken into account.
threshold in the
technical material:
In this overall assessment Member States shall pay particular attention to:
Toluene: ≤ 10 g/kg
(a) the protection of operators and workers;
HCN: ≤ 1 g/kg
(b) the risk to aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
(1 ) Further details on identity and specification of active substance are provided in the review report.
icial
Jour
nal
of
the
European
Union
L
314/9

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L 314/10
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
EN
‘59 Tembotrione
2-{2-chloro-4-mesyl-3-
≥ 945 g/kg
1 May 2014 30
April
2024
For the implementation of the uniform principles as referred

[(2,2,2-trifluoro
to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 335104-84-2
ethoxy)methyl]ben
The following relevant
conclusions of the review report on tembotrione, and in
impurities must not exceed
CIPAC No 790
zoyl}cyclohexane-1,3-dione
particular Appendices I and II thereof, as finalised in the
a certain threshold in the
Standing Committee on the Food Chain and Animal Health
technical material:
on 3 October 2013, shall be taken into account.
Toluene: ≤ 10 g/kg
In this overall assessment Member States shall pay particular
HCN: ≤ 1 g/kg
attention to:
(a) the protection of operators and workers;
Off
(b) the risk to aquatic organisms.
icial
Conditions of use shall include risk mitigation measures,
where appropriate.’
Jour
nal
(*) Further details on identity and specification of active substance are provided in the review report.
of
the
European
Union
23.11.2013

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