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18.8.2012 Official
Journal
of
the
European
Union L
222/13
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 16 August 2012
allowing Member States to extend provisional authorisations granted for the new active substance
Aureobasidium pullulans
(notified under document C(2012) 5709)
(Text with EEA relevance)
(2012/480/EU)
THE EUROPEAN COMMISSION,
provisional authorisations, for periods of up to three
years, for plant protection products containing the
active substance concerned, while complying with the
Having regard to the Treaty on the Functioning of the European
conditions laid down in Article 8(1) of Directive
Union,
91/414/EEC and, in particular, the conditions relating
to the detailed assessment of the active substance and
the plant protection products in the light of the
Having regard to Council Directive 91/414/EEC of 15 July
requirements laid down by that Directive.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular the fourth subparagraph of
Article 8(1) thereof,
(4) For
this
active
substance,
the
effects
on
human
health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
Having regard to Regulation (EC) No 1107/2009 of the
91/414/EEC, for the uses proposed by the applicant. The
European Parliament and of the Council of 21 October 2009
rapporteur Member State submitted the draft assessment
concerning the placing of plant protection products on the
report to the Commission on 16 December 2009.
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 2 ), and in particular Article 80(1)(a) thereof,
(5) Following
submission
of
the
draft
assessment
report
by
the rapporteur Member State, it has been found to be
Whereas:
necessary to request further information from the
applicant and to have the rapporteur Member State
examine that information and submit its assessment.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
Therefore, the examination of the dossier is still
1107/2009, Directive 91/414/EEC shall continue to
ongoing and it will not be possible to complete the
apply to active substances for which a decision has
evaluation within the timeframe provided for in
been adopted in accordance with Article 6(3) of
Directive 91/414/EEC.
Directive 91/414/EEC before 14 June 2011.
(6)
As the evaluation so far has not identified any reason for
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in April 2008 Austria received an application from bio-
immediate concern, Member States should be given the
ferm GmbH for the inclusion of the active substance
possibility of prolonging provisional authorisations
Aureobasidium pullulans in Annex I to Directive
granted for plant protection products containing the
91/414/EEC. Commission Decision 2008/953/EC
(
active substance concerned for a period of 24 months

3 )
confirmed that the dossier was complete and could be
in accordance with the provisions of Article 8 of
considered as satisfying, in principle, the data and
Directive 91/414/EEC so as to enable the examination
information requirements of Annex II and Annex III to
of the dossier to continue. It is expected that the
that Directive.
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
Aureobasidium pullulans will have been completed within
(3)
Confirmation of the completeness of the dossier was
24 months.
necessary in order to allow it to be examined in detail
and to allow Member States the possibility of granting
(7) The
measures
provided
for
in
this
Decision
are
in
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 309, 24.11.2009, p. 1.
accordance with the opinion of the Standing
( 3 ) OJ L 338, 17.12.2008, p. 62.
Committee on the Food Chain and Animal Health,

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L 222/14
EN
Official Journal of the European Union
18.8.2012
HAS ADOPTED THIS DECISION:
Article 3
This Decision is addressed to the Member States.
Article 1
Member States may extend provisional authorisations for plant
protection products containing Aureobasidium pullulans for a
Done at Brussels, 16 August 2012.
period ending on 31 August 2014 at the latest.
For the Commission
Article 2
John DALLI
This Decision shall expire on 31 August 2014.
Member of the Commission

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Document Outline

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