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22.1.2013 Official
Journal
of
the
European
Union L
18/17
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 18 January 2013
allowing Member States to extend provisional authorisations granted for the new active substances
emamectin and maltodextrin
(notified under document C(2013) 51)
(Text with EEA relevance)
(2013/38/EU)
THE EUROPEAN COMMISSION,
(4) Confirmation
of
the
completeness
of
the
dossiers
was
necessary in order to allow them to be examined in
Having regard to the Treaty on the Functioning of the European
detail and to allow Member States the possibility of
Union,
granting provisional authorisations, for periods of up to
three years, for plant protection products containing the
active substances concerned, while complying with the
Having regard to Council Directive 91/414/EEC of 15 July
conditions laid down in Article 8(1) of Directive
1991 concerning the placing of plant protection products on
91/414/EEC and, in particular, the conditions relating
the market ( 1 ), and in particular the fourth subparagraph of
to the detailed assessment of the active substances and
Article 8(1) thereof,
the plant protection products in the light of the
requirements laid down by that Directive.
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
(5) For
these
active
substances,
the
effects
on
human
health
market and repealing Council Directives 79/117/EEC and
and the environment have been assessed, in accordance
91/414/EEC (
with the provisions of Article 6(2) and (4) of Directive

2 ), and in particular Article 80(1)(a) thereof,
91/414/EEC, for the uses proposed by the applicants. The
rapporteur Member States submitted the draft assessment
Whereas:
reports to the Commission on 6 March 2008 (ema
mectin) and on 10 December 2009 (maltodextrin),
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
respectively.
No 1107/2009, Directive 91/414/EEC shall continue to
apply to active substances for which a decision has been
adopted in accordance with Article 6(3) of Directive
(6)
Following submission of the draft assessment reports by
the rapporteur Member States, it has been found to be
91/414/EEC before 14 June 2011.
necessary to request further information from the
applicants and to have the rapporteur Member States
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
examine that information and submit their assessment.
in June 2006 the Netherlands received an application
Therefore, the examination of the dossiers is still ongoing
from Syngenta Ltd for the inclusion of the active
and it will not be possible to complete the evaluation
substance emamectin in Annex I to Directive
within the time-frame provided for in Directive
91/414/EEC. Commission Decision 2007/669/EC
( 3 )
91/414/EEC.
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
(7)
As the evaluation so far has not identified any reason for
that Directive.
immediate concern, Member States should be given the
possibility of prolonging provisional authorisations
granted for plant protection products containing the
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
active substances concerned for a period of 24 months
in July 2008 France received an application from
in accordance with the provisions of Article 8 of
Biological Crop Protection Ltd for the inclusion of the
Directive 91/414/EEC so as to enable the examination
active substance maltodextrin in Annex I to Directive
of the dossiers to continue. It is expected that the
91/414/EEC. Commission Decision 2008/20/EC
( 4 )
evaluation and decision-making process with respect to
confirmed that the dossier was complete and could be
a decision on a possible approval in accordance with
considered as satisfying, in principle, the data and
Article 13(2) of Regulation (EC) No 1107/2009 for
information requirements of Annex II and Annex III to
emamectin and maltodextrin will have been completed
that Directive.
within 24 months.
( 1 ) OJ L 230, 19.8.1991, p. 1.
(8) The
measures
provided
for
in
this
Decision
are
in
( 2 ) OJ L 309, 24.11.2009, p. 1.
( 3 ) OJ L 274, 18.10.2007, p. 15.
accordance with the opinion of the Standing
( 4 ) OJ L 1, 4.1.2008, p. 5.
Committee on the Food Chain and Animal Health,

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L 18/18
EN
Official Journal of the European Union
22.1.2013
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 emamectin or maltodextrin for a
Done at Brussels, 18 January 2013.
period ending on 31 January 2015 at the latest.
For the Commission
Article 2
Tonio BORG
This Decision shall expire on 31 January 2015.
Member of the Commission

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Document Outline

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