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27.4.2011 Official
Journal
of
the
European
Union L
106/11
COMMISSION IMPLEMENTING DECISION
of 26 April 2011
allowing Member States to extend provisional authorisations granted for the new active substances
ascorbic acid, ipconazole, spiromesifen, topramezone, and Pseudomonas sp. strain DSMZ 13134
(notified under document C(2011) 2668)
(Text with EEA relevance)
(2011/252/EU)
THE EUROPEAN COMMISSION,
(5) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in August 2008 the Netherlands received an application
Having regard to the Treaty on the Functioning of the European
from Sourcon-Padena GmbH & Co KG for the inclusion
Union,
of the active substance Pseudomonas sp. strain DSMZ
13134 in Annex I to Directive 91/414/EEC. Commission
Having regard to Council Directive 91/414/EEC of 15 July
Decision 2008/599/EC ( 6 ) confirmed that the dossier was
1991 concerning the placing of plant protection products on
complete and could be considered as satisfying, in
the market ( 1 ), and in particular the fourth subparagraph of
principle, the data and information requirements of
Article 8(1) thereof,
Annex II and Annex III to that Directive.
Whereas:
(6) Confirmation
of
the
completeness
of
the
dossiers
was
necessary in order to allow them to be examined in
(1) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
detail and to allow Member States the possibility of
in September 2004 the Netherlands received an appli
granting provisional authorisations, for periods of up to
cation from Citrex Nederland BV for the inclusion of
3 years, for plant protection products containing the
the active substance ascorbic acid in Annex I to
active substances concerned, while complying with the
Directive 91/414/EEC. Commission Decision
conditions laid down in Article 8(1) of Directive
2005/751/EC ( 2 ) confirmed that the dossier was
91/414/EEC and, in particular, the condition relating to
complete and could be considered as satisfying, in
the detailed assessment of the active substances and the
principle, the data and information requirements of
plant protection products in the light of the requirements
Annex II and Annex III to that Directive.
laid down by that Directive.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC, (7) For
these
active
substances,
the
effects
on
human
health
in March 2007 the United Kingdom received an appli
and the environment have been assessed, in accordance
cation from Kureha GmbH for the inclusion of the active
with the provisions of Article 6(2) and (4) of Directive
substance ipconazole in Annex I to Directive
91/414/EEC, for the uses proposed by the applicants. The
91/414/EEC. Commission Decision 2008/20/EC
( 3 )
rapporteur Member States submitted the respective draft
confirmed that the dossier was complete and could be
assessment reports to the Commission on 10 September
considered as satisfying, in principle, the data and
2007 (ascorbic acid), on 29 May 2008 (ipconazole), on
information requirements of Annex II and Annex III to
9 March 2004 (spiromesifen), on 26 July 2007
that Directive.
(topramezone) and on 3 November 2009 (Pseudomonas
sp. strain DSMZ 13134).
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in April 2002 the United Kingdom received an appli
(8)
Following submission of the draft assessment reports by
cation from Bayer CropScience AG for the inclusion of
the rapporteur Member States, it has been found to be
the active substance spiromesifen in Annex I to Directive
necessary to request further information from the
91/414/EEC. Commission Decision 2003/105/EC
( 4 )
applicants and to have the rapporteur Member States
confirmed that the dossier was complete and could be
examine that information and submit their assessment.
considered as satisfying, in principle, the data and
Therefore, the examination of the dossiers is still ongoing
information requirements of Annex II and Annex III to
and it will not be possible to complete the evaluation
that Directive.
within the timeframe provided for in Directive
91/414/EEC, read in conjunction with Commission
(4) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
Decisions 2009/579/EC
( 7 ) (ascorbic acid) and
in May 2003 France received an application from BASF
2009/311/EC ( 8 ) (topramezone).
SE for the inclusion of the active substance topramezone
in Annex I to Directive 91/414/EEC. Commission
(9)
As the evaluation so far has not identified any reason for
Decision 2003/850/EC (
immediate concern, Member States should be given the

5 ) confirmed that the dossier
was complete and could be considered as satisfying, in
possibility of prolonging provisional authorisations
principle, the data and information requirements of
granted for plant protection products containing the
Annex II and Annex III to that Directive.
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
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 282, 26.10.2005, p. 18.
( 3 ) OJ L 1, 4.1.2008, p. 5.
( 6 ) OJ L 193, 22.7.2008, p. 14.
( 4 ) OJ L 43, 18.2.2003, p. 45.
( 7 ) OJ L 198, 30.7.2009, p. 80.
( 5 ) OJ L 322, 9.12.2003, p. 28.
( 8 ) OJ L 91, 3.4.2009, p. 25.

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L 106/12
EN
Official Journal of the European Union
27.4.2011
of the dossiers to continue. It is expected that the
spiromesifen, topramezone, or Pseudomonas sp. strain DSMZ
evaluation and decision-making process with respect to
13134 for a period ending on 30 April 2012 at the latest.
a decision on a possible inclusion in Annex I to that
Directive for ascorbic acid, ipconazole, spiromesifen,
topramezone, and Pseudomonas sp. strain DSMZ 13134
Article 2
will have been completed within 24 months.
This Decision shall expire on 30 April 2012.
(10) The
measures provided for in this Decision are in
Article 3
accordance with the opinion of the Standing
This Decision is addressed to the Member States.
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Done at Brussels, 26 April 2011.
Article 1
For the Commission
Member States may extend provisional authorisations for plant
John DALLI
protection products containing ascorbic acid, ipconazole,
Member of the Commission

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