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12.10.2011 Official
Journal
of
the
European
Union L
267/19
COMMISSION IMPLEMENTING DECISION
of 11 October 2011
allowing Member States to extend provisional authorisations granted for the new active substances
benalaxyl-M, gamma-cyhalothrin and valifenalate
(notified under document C(2011) 7092)
(Text with EEA relevance)
(2011/671/EU)
THE EUROPEAN COMMISSION,
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 the Treaty on the Functioning of the European
Union,
(4) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
Having regard to Council Directive 91/414/EEC of 15 July
in September 2005 Hungary received an application
1991 concerning the placing of plant protection products on
from ISAGRO SpA for the inclusion of the active
the market (
substance valifenalate, previously referred to as

1 ), and in particular the fourth subparagraph of
Article 8(1) thereof,
valiphenal, in Annex I to Directive 91/414/EEC.
Commission Decision 2006/586/EC ( 5 ) confirmed that
the dossier was complete and could be considered as
satisfying, in principle, the data and information
Having regard to Regulation (EC) No 1107/2009 of the
requirements of Annex II and Annex III to that Directive.
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 2 ), and in particular Article 80(1)(a) thereof,
(5) Confirmation
of
the
completeness
of
the
dossiers
was
necessary in order to allow them to be examined in
Whereas:
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
active substances concerned, while complying with the
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
conditions laid down in Article 8(1) of Directive
No 1107/2009, Directive 91/414/EEC shall continue to
91/414/EEC and, in particular, the conditions relating
apply to active substances for which a decision has been
to the detailed assessment of the active substances and
adopted in accordance with Article 6(3) of Directive
the plant protection products in the light of the
91/414/EEC before 14 June 2011.
requirements laid down by that Directive.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in February 2002 Portugal received an application from
(6) For
these
active
substances,
the
effects
on
human
health
ISAGRO IT for the inclusion of the active substance
and the environment have been assessed, in accordance
benalaxyl-M in Annex I to Directive 91/414/EEC.
with the provisions of Article 6(2) and (4) of Directive
Commission Decision 2003/35/EC ( 3 ) confirmed that
91/414/EEC, for the uses proposed by the applicants. The
the dossier was complete and could be considered as
rapporteur Member States submitted the respective draft
satisfying, in principle, the data and information
assessment reports to the Commission on 21 November
requirements of Annex II and Annex III to that Directive.
2003 (benalaxyl-M), on 25 January 2008 (gamma-cyha
lothrin) and on 19 February 2008 (valifenalate).
(3) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
in August 2001 the United Kingdom received an appli
cation from Pytech Chemicals GmbH for the inclusion of
the active substance gamma-cyhalothrin in Annex I to
(7)
Following submission of the draft assessment reports by
Directive 91/414/EEC. Commission Decision
the rapporteur Member States, it has been found to be
2004/686/EC (
necessary to request further information from the

4 ) confirmed that the dossier was
applicants and to have the rapporteur Member States
examine that information and submit their assessment.
( 1 ) OJ L 230, 19.8.1991, p. 1.
Therefore, the examination of the dossiers is still ongoing
( 2 ) OJ L 309, 24.11.2009, p. 1.
( 3 ) OJ L 11, 16.1.2003, p. 52.
( 4 ) OJ L 313, 12.10.2004, p. 21.
( 5 ) OJ L 236, 31.8.2006, p. 31.

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L 267/20
EN
Official Journal of the European Union
12.10.2011
and it will not be possible to complete the evaluation
HAS ADOPTED THIS DECISION:
within the time-frame provided for in Directive
91/414/EEC, read in conjunction with Commission
Article 1
Decisions 2009/579/EC
( 1 ) (benalaxyl-M) and Member States may extend provisional authorisations for plant
2009/865/EC ( 2 ) (gamma-cyhalothrin).
protection products containing benalaxyl-M, gamma-cyhalothrin
or valifenalate for a period ending on 31 October 2013 at the
(8)
As the evaluation so far has not identified any reason for
latest.
immediate concern, Member States should be given the
possibility of prolonging provisional authorisations
Article 2
granted for plant protection products containing the
This Decision shall expire on 31 October 2013.
active substances concerned for a period of 24 months
in accordance with the provisions of Article 8 of
Article 3
Directive 91/414/EEC so as to enable the examination
of the dossiers to continue. It is expected that the
This Decision is addressed to the Member States.
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
Done at Brussels, 11 October 2011.
benalaxyl-M, gamma-cyhalothrin and valifenalate will
have been completed within 24 months.
For the Commission
(9) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
John DALLI
Committee on the Food Chain and Animal Health,
Member of the Commission
( 1 ) OJ L 198, 30.7.2009, p. 80.
( 2 ) OJ L 314, 1.12.2009, p. 100.

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