HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 117/20
EN
Official Journal of the European Union
27.4.2013
COMMISSION IMPLEMENTING DECISION
of 25 April 2013
allowing Member States to extend provisional authorisations granted for the new active substances
acequinocyl, aminopyralid, ascorbic acid, flubendiamide, gamma-cyhalothrin, ipconazole,
metaflumizone, orthosulfamuron, Pseudomonas sp. strain DSMZ 13134, pyridalil, pyroxsulam,
spiromesifen, thiencarbazone and topramezone
(notified under document C(2013) 2246)
(Text with EEA relevance)
(2013/205/EU)
THE EUROPEAN COMMISSION,
considered as satisfying, in principle, the data and
information requirements of Annex II and Annex III to
that Directive.
Having regard to the Treaty on the Functioning of the European
Union,
(4) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in September 2004 the Netherlands received an appli
Having regard to Council Directive 91/414/EEC of 15 July
cation from Citrex Nederland BV for the inclusion of
1991 concerning the placing of plant protection products on
the active substance ascorbic acid in Annex I to
the market ( 1 ), and in particular the fourth subparagraph of
Directive 91/414/EEC. Commission Decision
Article 8(1) thereof,
2005/751/EC ( 5 ) confirmed that the dossier was
complete and could be considered as satisfying, in prin
ciple, the data and information requirements of Annex II
Having regard to Regulation (EC) No 1107/2009 of the
and Annex III to that Directive.
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
(5) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
91/414/EEC ( 2 ), and in particular Article 80(1)(a) thereof,
in March 2006 Greece received an application from
Bayer CropScience AG for the inclusion of the active
substance flubendiamide in Annex I to Directive
Whereas:
91/414/EEC. Commission Decision 2006/927/EC
( 6 )
confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
information requirements of Annex II and Annex III to
1107/2009, Directive 91/414/EEC shall continue to
that Directive.
apply to active substances for which a decision has
been adopted in accordance with Article 6(3) of
Directive 91/414/EEC before 14 June 2011.
(6) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in August 2001 the United Kingdom received an appli
cation from Pytech Chemicals GmbH for the inclusion of
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
the active substance gamma-cyhalothrin in Annex I to
in March 2003 the Netherlands received an application
Directive 91/414/EEC. Commission Decision
from Agro-Kanesho for the inclusion of the active
2004/686/EC ( 7 ) confirmed that the dossier was
substance acequinocyl in Annex I to Directive
complete and could be considered as satisfying, in prin
91/414/EEC. Commission Decision 2003/636/EC
( 3 )
ciple, the data and information requirements of Annex II
confirmed that the dossier was complete and could be
and Annex III to that Directive.
considered as satisfying, in principle, the data and
information requirements of Annex II and Annex III to
that Directive.
(7) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in March 2007 the United Kingdom received an appli
cation from Kureha GmbH for the inclusion of the active
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
substance ipconazole in Annex I to Directive
in April 2004 the United Kingdom received an appli
91/414/EEC. Commission Decision 2008/20/EC
( 8 )
cation from Dow AgroSciences Ltd for the inclusion of
confirmed that the dossier was complete and could be
the active substance aminopyralid in Annex I to Directive
considered as satisfying, in principle, the data and
91/414/EEC. Commission Decision 2005/778/EC
( 4 )
information requirements of Annex II and Annex III to
confirmed that the dossier was complete and could be
that Directive.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 5 ) OJ L 282, 26.10.2005, p. 18.
( 2 ) OJ L 309, 24.11.2009, p. 1.
( 6 ) OJ L 354, 14.12.2006, p. 54.
( 3 ) OJ L 221, 4.9.2003, p. 42.
( 7 ) OJ L 313, 12.10.2004, p. 21.
( 4 ) OJ L 293, 9.11.2005, p. 26.
( 8 ) OJ L 1, 4.1.2008, p. 5.

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EN
27.4.2013 Official
Journal
of
the
European
Union L
117/21
(8) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
considered as satisfying, in principle, the data and
in November 2005 the United Kingdom received an
information requirements of Annex II and Annex III to
application from BASF SE for the inclusion of the
that Directive.
active substance metaflumizone in Annex I to Directive
91/414/EEC. Commission Decision 2006/517/EC
( 1 )
confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and
(14) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
information requirements of Annex II and Annex III to
in April 2007 the United Kingdom received an appli
that Directive.
cation from Bayer CropScience AG for the inclusion of

the active substance thiencarbazone in Annex I to
Directive 91/414/EEC. Commission Decision
2008/566/EC (
(9) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,

7 ) confirmed that the dossier was
in July 2005 Italy received an application from Isagro
complete and could be considered as satisfying, in prin
SpA for the inclusion of the active substance orthosul
ciple, the data and information requirements of Annex II
famuron in Annex I to Directive 91/414/EEC.
and Annex III to that Directive.
Commission Decision 2006/806/EC ( 2 ) confirmed that
the dossier was complete and could be considered as
satisfying, in principle, the data and information
(15) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
requirements of Annex II and Annex III to that Directive.
in May 2003 France received an application from BASF
SE for the inclusion of the active substance topramezone
in Annex I to Directive 91/414/EEC. Commission
(10) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
Decision 2003/850/EC ( 8 ) confirmed that the dossier
in August 2008 the Netherlands received an application
was complete and could be considered as satisfying, in
from Sourcon-Padena GmbH & Co KG for the inclusion
principle, the data and information requirements of
of the active substance Pseudomonas sp. strain DSMZ
Annex II and Annex III to that Directive.
13134 in Annex I to Directive 91/414/EEC. Commission
Decision 2008/599/EC ( 3 ) confirmed that the dossier was
complete and could be considered as satisfying, in prin
ciple, the data and information requirements of Annex II
(16) Confirmation
of
the
completeness
of
the
dossiers
was
necessary in order to allow them to be examined in
and Annex III to that Directive.
detail and to allow Member States the possibility of
granting provisional authorisations, for periods of up to
three years, for plant protection products containing the
(11) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
active substances concerned, while complying with the
in March 2006 the Netherlands received an application
conditions laid down in Article 8(1) of Directive
from Sumitomo Chemical Agro Europe SAS for the
91/414/EEC and, in particular, the conditions relating
inclusion of the active substance pyridalil in Annex I to
to the detailed assessment of the active substances and
Directive 91/414/EEC. Commission Decision
the plant protection products in the light of the
2007/669/EC ( 4 ) confirmed that the dossier was
requirements laid down by that Directive.
complete and could be considered as satisfying, in prin

ciple, the data and information requirements of Annex II
and Annex III to that Directive.
(17) For
these
active
substances,
the
effects
on
human
health
and the environment have been assessed, in accordance
(12) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
with the provisions of Article 6(2) and (4) of Directive
in February 2006 the United Kingdom received an appli
91/414/EEC, for the uses proposed by the applicants. The
cation from Dow AgroSciences GmbH for the inclusion
rapporteur Member States submitted the draft assessment
of the active substance pyroxsulam in Annex I to
reports to the Commission on 15 March 2005 (acequi
Directive 91/414/EEC. Commission Decision
nocyl), on 10 September 2007 (ascorbic acid), on
2007/277/EC ( 5 ) confirmed that the dossier was
22 August 2006 (aminopyralid), on 1 September 2008
complete and could be considered as satisfying, in prin
(flubendiamide), on 13 September 2012 (gamma-cyha
ciple, the data and information requirements of Annex II
lothrin), on 29 May 2008 (ipconazole), on 15 April
and Annex III to that Directive.
2008 (metaflumizone), on 19 July 2012 (orthosulfa
muron), on 3 November 2009 (Pseudomonas sp. strain
DSMZ 13134), on 13 January 2009 (pyridalil), on
(13) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
20 March 2008 (pyroxsulam), on 9 March 2004 (spi
in April 2002 the United Kingdom received an appli
romesifen), on 17 December 2008 (thiencarbazone) and
cation from Bayer CropScience AG for the inclusion of
on 26 July 2007 (topramezone).
the active substance spiromesifen in Annex I to Directive
91/414/EEC. Commission Decision 2003/105/EC
( 6 )
confirmed that the dossier was complete and could be
(18) Following submission of the draft assessment reports by
the rapporteur Member States, it has been found to be
( 1 ) OJ L 201, 25.7.2006, p. 34.
necessary to request further information from the
( 2 ) OJ L 329, 25.11.2006, p. 74.
applicants and to have the rapporteur Member States
( 3 ) OJ L 193, 22.7.2008, p. 14.
( 4 ) OJ L 274, 18.10.2007, p. 15.
( 5 ) OJ L 116, 4.5.2007, p. 59.
( 7 ) OJ L 181, 10.7.2008, p. 52.
( 6 ) OJ L 43, 18.2.2003, p. 45.
( 8 ) OJ L 322, 9.12.2003, p. 28.

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L 117/22
EN
Official Journal of the European Union
27.4.2013
examine that information and submit their assessment.
(20) The
measures provided for in this Decision are in
Therefore, the examination of the dossiers is still ongoing
accordance with the opinion of the Standing
and it will not be possible to complete the evaluation
Committee on the Food Chain and Animal Health,
within the timeframe provided for in Directive
91/414/EEC, read in conjunction with Commission
HAS ADOPTED THIS DECISION:
Implementing Decisions 2011/490/EU ( 1 ) (acequinocyl,
aminopyralid, flubendiamide, metaflumizone, pyroxsulam
Article 1
and thiencarbazone), 2011/252/EU ( 2 ) (ascorbic acid,
ipconazole, Pseudomonas sp. strain DSMZ 13134,
Member States may extend provisional authorisations for plant
spiromesifen and topramezone) and 2011/671/EU ( 3 )
protection products containing acequinocyl, aminopyralid,
(gamma-cyhalothrin).
ascorbic acid, flubendiamide, gamma-cyhalothrin, ipconazole,
metaflumizone, orthosulfamuron, Pseudomonas sp. DSMZ
13134, pyridalil, pyroxsulam, spiromesifen, thiencarbazone or
topramezone for a period ending on 30 April 2015 at the
(19) As the evaluation so far has not identified any reason for
latest.
immediate concern, Member States should be given the
possibility of prolonging provisional authorisations
Article 2
granted for plant protection products containing the
This Decision shall expire on 30 April 2015.
active substances concerned for a period of 24 months
in accordance with the provisions of Article 8 of
Directive 91/414/EEC so as to enable the examination
Article 3
of the dossiers to continue. It is expected that the
This Decision is addressed to the Member States.
evaluation and decision-making process with respect to
a decision on a possible approval in accordance with
Article 13(2) of Regulation (EC) No 1107/2009 for
acequinocyl, aminopyralid, ascorbic acid, flubendiamide,
Done at Brussels, 25 April 2013.
gamma-cyhalothrin, ipconazole, metaflumizone, ortho
sulfamuron, Pseudomonas sp. DSMZ 13134, pyridalil,
For the Commission
pyroxsulam, spiromesifen, thiencarbazone and
topramezone will have been completed within 24
Tonio BORG
months.
Member of the Commission
( 1 ) OJ L 201, 4.8.2011, p. 16.
( 2 ) OJ L 106, 27.4.2011, p. 11.
( 3 ) OJ L 267, 12.10.2011, p. 19.

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