2008/564/EC: Commission Decision of 30 June 2008 allowing Member States to extend provisional authorisations granted for the new active substance profoxydim (notified under document number C(2008) 3080) (Text with EEA relevance)
Date: 2008-06-30
Institutions: European Commission
Subjects: market approval, pesticide, pharmaceutical product, plant health legislation, plant health product

10.7.2008

EN

Official Journal of the European Union

L 181/47

COMMISSION

COMMISSION DECISION

of 30 June 2008

allowing Member States to extend provisional authorisations granted for the new active substance
profoxydim

(notified under document number C(2008) 3080)

(Text with EEA relevance)

(2008/564/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

plant protection product in the light of the requirements
laid down by that Directive.

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)

for the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
in March 1998 the Spain received an application from
BASF AG,
the active substance
profoxydim in Annex I
to Directive 91/414/EEC.
Commission Decision 1999/43/EC (2) 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

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
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

(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 14, 19.1.1999, p. 30.

(3)

(4)

(5)

(6)

For this active substance, 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
report to the Commission on 28 March 2001.

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

timeframe provided for

examination of

the dossier

the

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 substance 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 profoxydim
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 181/48

EN

Official Journal of the European Union

10.7.2008

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant protection products containing profoxydim
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, 30 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission