HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 45/12
EN
Official Journal of the European Union
15.2.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 145/2014
of 14 February 2014
approving the active substance thiencarbazone, 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,
submitted a draft assessment report on 17 December
2008. In accordance with Article 11(6) of Commission
Regulation (EU) No 188/2011 ( 4 ) additional information
Having regard to the Treaty on the Functioning of the European
was requested from the applicant on 7 July 2011. The
Union,
evaluation of the additional data by the United Kingdom
was submitted in the format of an updated draft
assessment report in April 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 ( 1 ), and in particular Article 13(2) and Article 78(2)
inafter ‘the Authority’). The Authority presented to the
thereof,
Commission its conclusion on the pesticide risk
assessment of the active substance thiencarbazone ( 5 )
on 17 June 2013. The draft assessment report and the
Whereas:
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Health and finalised on 13 December 2013 in the
1107/2009, Council Directive 91/414/EEC (
format of the Commission review report for thienc

2 ) is to apply,
with respect to the procedure and the conditions for
arbazone.
approval, to active substances for which a decision has
been adopted in accordance with Article 6(3) of that
Directive before 14 June 2011. For thiencarbazone the
conditions of Article 80(1)(a) of Regulation (EC) No
(5)
It has appeared from the various examinations made that
1107/2009 are fulfilled by Commission Decision
plant protection products containing thiencarbazone may
2008/566/EC (
be expected to satisfy, in general, the requirements laid

3 ).
down in Article 5(1)(a) and (b) and Article 5(3) of
Directive 91/414/EEC, in particular with regard to the
uses which were examined and detailed in the
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
Commission review report. It is therefore appropriate
the United Kingdom received on 13 April 2007 an appli
to approve thiencarbazone.
cation from Bayer CropScience AG for the inclusion of
the active substance thiencarbazone in Annex I to
Directive 91/414/EEC. Decision 2008/566/EC
confirmed that the dossier was ‘complete’ in the sense
(6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
that it could be considered as satisfying, in principle, the
1107/2009 in conjunction with Article 6 thereof and in
data and information requirements of Annexes II and III
the light of current scientific and technical knowledge, it
to Directive 91/414/EEC.
is, however, necessary to include certain conditions and
restrictions. It is, in particular, appropriate to require
further confirmatory information.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
(7) A
reasonable
period
should
be
allowed
to
elapse
before
applicant. The designated rapporteur Member State
approval in order to permit Member States and the
interested parties to prepare themselves to meet the
new requirements resulting from the approval.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
( 4 ) Commission Regulation (EU) No 188/2011 of 25 February 2011
19.8.1991, p. 1).
laying down detailed rules for the implementation of Council
( 3 ) Commission Decision 2008/566/EC of 1 July 2008 recognising in
Directive 91/414/EEC as regards the procedure for the assessment
principle the completeness of the dossier submitted for detailed
of active substances which were not on the market 2 years after the
examination in view of the possible inclusion of phosphane and
date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
thiencarbazone in Annex I to Council Directive 91/414/EEC (OJ
( 5 ) EFSA Journal 2013; 11(7):3270. Available online: www.efsa.
L 181, 10.7.2008, p. 52).
europa.eu

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EN
15.2.2014 Official
Journal
of
the
European
Union L
45/13
(8) Without
prejudice
to
the
obligations
provided
for
in
Article 2
Regulation (EC) No 1107/2009 as a consequence of
approval, taking into account the specific situation
Re-evaluation of plant protection products
created by the transition from Directive 91/414/EEC to
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Regulation (EC) No 1107/2009, the following should,
No 1107/2009, where necessary, amend or withdraw existing
however, apply. Member States should be allowed a
authorisations for plant protection products containing thienc
period of six months after approval to review authori
arbazone as an active substance by 31 December 2014.
sations of plant protection products containing thienc
arbazone. Member States should, as appropriate, vary,
replace or withdraw authorisations. By way of derogation
from that deadline, a longer period should be provided
for the submission and assessment of the complete
By that date they shall in particular verify that the conditions in
Annex III dossier, as set out in Directive 91/414/EEC,
Annex I to this Regulation are met, with the exception of those
of each plant protection product for each intended use
identified in the column on specific provisions of that Annex,
in accordance with the uniform principles.
and that the holder of the authorisation has, or has access to, a

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

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L 45/14
EN
Official Journal of the European Union
15.2.2014
Article 4
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 July 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 February 2014.
For the Commission
The President
José Manuel BARROSO

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15.2.2014 Off
ANNEX I
Common Name, Identification
Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Thiencarbazone
Methyl 4-[(4,5-dihydro-3-
≥ 950 g/kg 1
July
2014 30
June
2024
For the implementation of the uniform principles as referred to in Article 29(6)
methoxy-4-methyl-5-oxo-
of Regulation (EC) No 1107/2009, the conclusions of the review report on
EN
CAS No 317815-83-1
1H-1,2,4-triazol-1-
thiencarbazone, and in particular Appendices I and II thereof, as finalised in

yl)carbonylsulfamoyl]-5-
the Standing Committee on the Food Chain and Animal Health on
CIPAC No 797
methylthiophene-3-
13 December 2013 shall be taken into account.
carboxylate
In this overall assessment Member States shall pay particular attention to
(a) the risk to groundwater if the substance is applied under vulnerable
geographical or climatic conditions;
(b) the risk to aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
icial
The applicant shall submit confirmatory information as regards the potential of
Jour
thiencarbazone for long-range atmospheric transport and the related environ
mental impacts.
nal
of
That confirmatory information shall consist of the results of a monitoring
the
programme to assess the potential of thiencarbazone for long-range atmos
pheric transport and the related environmental impacts. The applicant shall
European
submit to the Commission, the Member States and the Authority this moni
toring programme by 30 June 2016 and the results in form of a monitoring
report by 30 June 2018.
Union
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
45/15

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L 45/16
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
‘71 Thiencarbazone
Methyl 4-[(4,5-dihydro-3-
≥ 950 g/kg 1
July
2014 30
June
2024 For the implementation of the uniform principles as referred to in

methoxy-4-methyl-5-oxo-
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
CAS No 317815-83-1
1H-1,2,4-triazol-1-
review report on thiencarbazone, and in particular Appendices I and II
yl)carbonylsulfamoyl]-5-
thereof, as finalised in the Standing Committee on the Food Chain and
CIPAC No 797
methylthiophene-3-
Animal Health on 13 December 2013 shall be taken into account.
carboxylate
In this overall assessment Member States shall pay particular attention to
(a) the risk to groundwater if the substance is applied under vulnerable
geographical or climatic conditions;
Off
(b) the risk to aquatic organisms.
icial
Conditions of use shall include risk mitigation measures, where appropriate.
Jour
The applicant shall submit confirmatory information as regards the
nal
potential of thiencarbazone for long-range atmospheric transport and the
of
related environmental impacts.
the
That confirmatory information shall consist of the results of a monitoring
European
programme to assess the potential of thiencarbazone for long-range atmos
pheric transport and the related environmental impacts. The applicant shall
submit to the Commission, the Member States and the Authority this
monitoring programme by 30 June 2016 and the results in form of a
Union
monitoring report by 30 June 2018.’
(*) Further details on identity and specification of active substance are provided in the review report.
15.2.2014

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