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1.11.2012 Official
Journal
of
the
European
Union L
305/27
COMMISSION IMPLEMENTING DECISION
of 30 October 2012
allowing Member States to extend provisional authorisations granted for the new active substances
ametoctradin (initially applied for under the development code BAS 650 F) and disodium
phosphonate
(notified under document C(2012) 7581)
(Text with EEA relevance)
(2012/677/EU)
THE EUROPEAN COMMISSION,
(4) Confirmation
of
the
completeness
of
the
dossiers
was
necessary in order to allow them to be examined in
detail and to allow Member States the possibility of
Having regard to the Treaty on the Functioning of the European
granting provisional authorisations, for periods of up to
Union,
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 (
to the detailed assessment of the active substances and

1 ), and in particular the fourth subparagraph of
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
(5) For
these
active
substances,
the
effects
on
human
health
concerning the placing of plant protection products on the
and the environment have been assessed, in accordance
market and repealing Council Directives 79/117/EEC and
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC ( 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 15 September 2009 (ame
toctradin) and on 27 August 2009 (disodium phos
phonate), respectively.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Directive 91/414/EEC shall continue to
apply to active substances for which a decision has
(6)
Following submission of the draft assessment reports by
been adopted in accordance with Article 6(3) of
the rapporteur Member States, it has been found to be
Directive 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 September 2008 the Netherlands received an appli
Therefore, the examination of the dossiers is still ongoing
cation from BASF SE for the inclusion of the active
and it will not be possible to complete the evaluation
substance ametoctradin (initially applied for under the
within the timeframe provided for in Directive
development code BAS 650 F) in Annex I to Directive
91/414/EEC.
91/414/EEC. Commission Decision 2009/535/EC
( 3 )
confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and
(7)
As the evaluation so far has not identified any reason for
information requirements of Annex II and Annex III to
immediate concern, Member States should be given the
that Directive.
possibility of prolonging provisional authorisations
granted for plant protection products containing the
active substances concerned for a period of 24 months
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in accordance with the provisions of Article 8 of
in May 2008 France received an application from ISK
Directive 91/414/EEC so as to enable the examination
Biosciences Europe SA for the inclusion of the active
of the dossiers to continue. It is expected that the
substance disodium phosphonate in Annex I to
evaluation and decision-making process with respect to
Directive 91/414/EEC. Commission Decision
a decision on a possible approval in accordance with
2008/953/EC ( 4 ) confirmed that the dossier was
Article 13(2) of Regulation (EC) No 1107/2009 for
complete and could be considered as satisfying, in prin
ametoctradin and disodium phosphonate will have been
ciple, the data and information requirements of Annex II
completed within 24 months.
and Annex III to that Directive.
( 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 179, 10.7.2009, p. 66.
accordance with the opinion of the Standing
( 4 ) OJ L 338, 17.12.2008, p. 62.
Committee on the Food Chain and Animal Health,

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L 305/28
EN
Official Journal of the European Union
1.11.2012
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 ametoctradin or disodium phos
Done at Brussels, 30 October 2012.
phonate for a period ending on 31 October 2014 at the latest.
For the Commission
Article 2
Maro EFOVI
This Decision shall expire on 31 October 2014.
Vice-President

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Document Outline

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