2008/724/EC: Commission Decision of 8 September 2008 allowing Member States to extend provisional authorisations granted for the new active substances fluopicolide and pinoxaden (notified under document number C(2008) 4732) (Text with EEA relevance)
Date: 2008-09-08
Institutions: European Commission
Subjects: market approval, marketing, pharmaceutical product, plant health legislation, plant health product

13.9.2008

EN

Official Journal of the European Union

L 245/15

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 8 September 2008

allowing Member States to extend provisional authorisations granted for the new active substances
fluopicolide and pinoxaden

(notified under document number C(2008) 4732)

(Text with EEA relevance)

(2008/724/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

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

(3)

Whereas:

In March 2004 the United Kingdom received an appli­
cation from Syngenta
concerning pinoxaden.
Ltd
Commission Decision 2005/459/EC (3) confirmed that
the dossier was complete and could be considered as
and information
satisfying,
requirements of Annex II and Annex III to that Directive.

in principle,

the data

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
granting provisional authorisations, for periods of up to
three years, for plant protection products containing the
active substances concerned, while complying with the
laid down in Article 8(1) of Directive
conditions
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.

(1)

In accordance with Article 6(2) of Directive 91/414/EEC,
in May 2004 the United Kingdom received an appli­
cation from Bayer CropScience, for the inclusion of the
active substance fluopicolide in Annex I
to Directive
91/414/EEC. Commission Decision 2005/778/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.

(4)

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 State submitted the draft assessment
reports to the Commission on 12 December 2005 (fluo­
picolide) and on 30 November 2005 (pinoxaden).

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 293, 9.11.2005, p. 26.

(3) OJ L 160, 23.6.2005, p. 32.

L 245/16

EN

Official Journal of the European Union

13.9.2008

(5)

(6)

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

frame provided for

examination of

the dossiers

the

is

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 fluopicolide
and pinoxaden will have been completed within 24
months.

the dossiers to continue.

is expected that

It

(7)

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

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant
protection products containing fluopicolide or pinoxaden 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, 8 September 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission