HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 201/16
EN
Official Journal of the European Union
4.8.2011
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 2 August 2011
allowing Member States to extend provisional authorisations granted for the new active substances
acequinocyl, Adoxophyes orana granulovirus, aminopyralid, flubendiamide, mandipropamid,
metaflumizone, phosphane, pyroxsulam and thiencarbazone
(notified under document C(2011) 5321)
(Text with EEA relevance)
(2011/490/EU)
THE EUROPEAN COMMISSION,
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in November 2004 Germany received an application
from Andermatt Biocontrol GmbH for the inclusion of
the active substance Adoxophyes orana granulovirus in
Having regard to the Treaty on the Functioning of the European
Annex I to Directive 91/414/EEC. Commission
Union,
Decision 2007/669/EC ( 4 ) confirmed that the dossier
was complete and could be considered as satisfying, in
principle, the data and information requirements of
Annex II and Annex III to that Directive.
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular the fourth subparagraph of
Article 8(1) thereof,
(4) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in April 2004 the United Kingdom received an appli
cation from Dow AgroSciences Ltd for the inclusion of
the active substance aminopyralid in Annex I to Directive
Having regard to Regulation (EC) No 1107/2009 of the
91/414/EEC. Commission Decision 2005/778/EC
( 5 )
European Parliament and of the Council of 21 October 2009
confirmed that the dossier was complete and could be
concerning the placing of plant protection products on the
considered as satisfying, in principle, the data and
market and repealing Council Directives 79/117/EEC and
information requirements of Annex II and Annex III to
91/414/EEC ( 2 ), and in particular Article 80(1)(a) thereof,
that Directive.
Whereas:
(5) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in March 2006 Greece received an application from
Bayer CropScience AG for the inclusion of the active
substance flubendiamide in Annex I to Directive
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
91/414/EEC. Commission Decision 2006/927/EC
( 6 )
No 1107/2009, Directive 91/414/EEC shall continue to
confirmed that the dossier was complete and could be
apply to active substances for which a decision has been
considered as satisfying, in principle, the data and
adopted in accordance with Article 6(3) of Directive
information requirements of Annex II and Annex III to
91/414/EEC before 14 June 2011.
that Directive.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC, (6) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in March 2003 the Netherlands received an application
in December 2005 Austria received an application from
from Agro-Kanesho for the inclusion of the active
Syngenta Ltd for the inclusion of the active substance
substance acequinocyl in Annex I to Directive
mandipropamid in Annex I to Directive 91/414/EEC.
91/414/EEC. Commission Decision 2003/636/EC
( 3 )
Commission Decision 2006/589/EC ( 7 ) confirmed that
confirmed that the dossier was complete and could be
the dossier was complete and could be considered as
considered as satisfying, in principle, the data and
satisfying, in principle, the data and information
information requirements of Annex II and Annex III to
requirements of Annex II and Annex III to that Directive.
that Directive.
( 4 ) OJ L 274, 18.10.2007, p. 15.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 5 ) OJ L 293, 9.11.2005, p. 26.
( 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 240, 2.9.2006, p. 9.

---

EN
4.8.2011 Official
Journal
of
the
European
Union L
201/17
(7) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
assessment reports to the Commission on 15 March
in November 2005 the United Kingdom received an
2005 (acequinocyl), on 13 August 2008 (Adoxophyes
application from BASF SE for the inclusion of the
orana granulovirus), on 22 August 2006 (aminopyralid),
active substance metaflumizone in Annex I to Directive
on 1 September 2008 (flubendiamide), on 30 November
91/414/EEC. Commission Decision 2006/517/EC
( 1 )
2006 (mandipropamid), on 15 April 2008 (meta
confirmed that the dossier was complete and could be
flumizone), on 24 February 2010 (phosphane), on
considered as satisfying, in principle, the data and
20 March 2008 (pyroxsulam) and on 17 December
information requirements of Annex II and Annex III to
2008 (thiencarbazone).
that Directive.
(13) Following submission of the draft assessment reports by
(8) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
the rapporteur Member States, it has been found to be
in October 2007 Germany received an application from
necessary to request further information from the
S&A GmbH for the inclusion of the active substance
applicants and to have the rapporteur Member States
phosphane in Annex I to Directive 91/414/EEC.
examine that information and submit their assessment.
Commission Decision 2008/566/EC ( 2 ) confirmed that
Therefore, the examination of the dossiers is still ongoing
the dossier was complete and could be considered as
and it will not be possible to complete the evaluation
satisfying, in principle, the data and information
within the time-frame provided for in Directive
requirements of Annex II and Annex III to that Directive.
91/414/EEC, read in conjunction with Commission
Decisions 2009/579/EC ( 4 ) (acequinocyl, aminopyralid
and mandipropamid) and 2009/865/EC
( 5 ) (meta
(9) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
flumizone).
in February 2006 the United Kingdom received an appli
cation from Dow AgroSciences GmbH for the inclusion
of the active substance pyroxsulam in Annex I to
Directive 91/414/EEC. Commission Decision (14) As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
2007/277/EC ( 3 ) confirmed that the dossier was
possibility of prolonging provisional authorisations
complete and could be considered as satisfying, in
granted for plant protection products containing the
principle, the data and information requirements of
active substances concerned for a period of 24 months
Annex II and Annex III to that Directive.
in accordance with the provisions of Article 8 of
Directive 91/414/EEC so as to enable the examination
of the dossiers to continue. It is expected that the
(10) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
evaluation and decision-making process with respect to
in April 2007 the United Kingdom received an appli
a decision on a possible approval in accordance with
cation from Bayer CropScience AG for the inclusion of
Article 13(2) of Regulation (EC) No 1107/2009 for
the active substance thiencarbazone in Annex I to
acequinocyl, Adoxophyes orana granulovirus, amin
Directive 91/414/EEC. Decision 2008/566/EC
opyralid, flubendiamide, mandipropamid, metaflumizone,
confirmed that the dossier was complete and could be
phosphane, pyroxsulam and thiencarbazone will have
considered as satisfying, in principle, the data and
been completed within 24 months.
information requirements of Annex II and Annex III to
that Directive.
(15) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
(11) Confirmation
of
the
completeness
of
the
dossiers
was
Committee on the Food Chain and Animal Health,
necessary in order to allow them to be examined in
detail and to allow Member States the possibility of
granting provisional authorisations, for periods of up to
3 years, for plant protection products containing the
HAS ADOPTED THIS DECISION:
active substances concerned, while complying with the
conditions laid down in Article 8(1) of Directive
91/414/EEC and, in particular, the conditions relating
Article 1
to the detailed assessment of the active substances and
the plant protection products in the light of the
Member States may extend provisional authorisations for plant
requirements laid down by that Directive.
protection products containing acequinocyl, Adoxophyes orana
granulovirus, aminopyralid, flubendiamide, mandipropamid,
metaflumizone, phosphane, pyroxsulam and thiencarbazone
(12) For
these
active
substances,
the
effects
on
human
health
for a period ending on 31 July 2013 at the latest.
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 applicants. The
Article 2
rapporteur Member States submitted the respective draft
This Decision shall expire on 31 July 2013.
( 1 ) OJ L 201, 25.7.2006, p. 34.
( 2 ) OJ L 181, 10.7.2008, p. 52.
( 4 ) OJ L 198, 30.7.2009, p. 80.
( 3 ) OJ L 116, 4.5.2007, p. 59.
( 5 ) OJ L 314, 1.12.2009, p. 100.

---

L 201/18
EN
Official Journal of the European Union
4.8.2011
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 2 August 2011.
For the Commission
John DALLI
Member of the Commission

---