2008/353/EC: Commission Decision of 29 April 2008 allowing Member States to extend provisional authorisations granted for the new active substances cyflufenamid, FEN 560 and flonicamid (notified under document number C(2008) 1644) (Text with EEA relevance)
Date: 2008-04-29
Institutions: European Commission
Subjects: market approval, marketing, pharmaceutical product, plant health legislation, plant health product

1.5.2008

EN

Official Journal of the European Union

L 117/45

COMMISSION DECISION

of 29 April 2008

allowing Member States to extend provisional authorisations granted for the new active substances
cyflufenamid, FEN 560 and flonicamid

(notified under document number C(2008) 1644)

(Text with EEA relevance)

(2008/353/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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
fourth subparagraph of
Article 8(1) thereof,

the

Whereas:

(1)

(2)

(3)

In accordance with Article 6(2) of Directive 91/414/EEC,
in January 2003 the United Kingdom received an appli-
cation from Nippon Soda Co. Ltd., for the inclusion of
the active substance cyflufenamid in Annex I to Directive
91/414/EEC. Commission Decision 2003/636/EC (2)
confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annex II and Annex III to that
Directive.

In June 2003 France received an application from Société
occitane de fabrications et de technologies concerning
2004/131/EC (3)
FEN 560. Commission Decision
confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annex II and Annex III to that
Directive.

In December 2003 France received an application from
IKI-
Enhold B.V. concerning flonicamid (former name:
220). Commission Decision 2004/686/EC (4) confirmed
that the dossier was complete and could be considered as
satisfying,
and information
requirements of Annex II and Annex III to that Directive.

in principle,

the data

(4)

Confirmation of the completeness of the dossiers was
necessary in order to allow them to be examined in

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

(2) OJ L 221, 4.9.2003, p. 42.
(3) OJ L 37, 10.2.2004, p. 34.
(4) OJ L 313, 12.10.2004, p. 21.

(5)

(6)

(7)

(8)

detail and to allow Member States the possibility of
granting provisional authorisations, for periods of up to
three years, for plant protection products containing the
active substances concerned, while complying with the
conditions
laid down in Article 8(1) of Directive
91/414/EEC and, in particular, the condition relating to
the detailed assessment of the active substances and the
plant protection product in the light of the requirements
laid down by that Directive.

For these active substances, the effects on human health
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
rapporteur Member States submitted the draft assessment
reports to the Commission on 30 January 2006 (cyflu-
fenamid), 18 February 2005 (FEN 560), 24 May 2005
(flonicamid), respectively.

Following submission of the draft assessment reports by
the rapporteur Member States, it has been found to be
information from the
further
necessary to request
applicants and to have the rapporteur Member States
examine that information and submit their assessment.
Therefore, the examination of the dossiers is still ongoing
and it will not be possible to complete the evaluation
within
in Directive
the
91/414/EEC.

timeframe

provided

for

As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
possibility of prolonging provisional
authorisations
granted for plant protection products containing the
active substances concerned for a period of 24 months
in accordance with the provisions of Article 8 of
Directive 91/414/EEC so as to enable the examination
of
the
evaluation and decision-making process with respect to
a decision on possible Annex I
inclusion for cyflu-
fenamid, FEN 560 and flonicamid will have been
completed within 24 months.

the dossiers to continue.

is expected that

It

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

L 117/46

EN

Official Journal of the European Union

1.5.2008

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant protection products containing cyflufenamid,
FEN 560 or flonicamid for a period not exceeding 24 months from the date of adoption of this Decision.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 29 April 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission