2004/400/EC: Commission Decision of 26 April 2004 allowing Member States to extend provisional authorisations granted for the new active substance profoxydim (Text with EEA relevance) (notified under document number C(2004) 1512)
Date: 2004-04-26
Institutions: European Commission
Subjects: market approval, plant health product

27.4.2004

EN

Official Journal of the European Union

L 123/107

COMMISSION

COMMISSION DECISION

of 26 April 2004

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

(notified under document number C(2004) 1512)

(Text with EEA relevance)

(2004/400/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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 the fourth subparagraph of
Article 8(1) thereof,

Whereas:

(1)

(2)

In accordance with Article 6(2) of Directive 91/414/EEC,
in March 1998 Spain received an application from BASF
AG for the inclusion of the active substance profoxydim
(former names: clefoxydim, BAS 625H) in Annex I to
1999/43/EC (2)
Directive
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 the
Directive.

91/414/EEC.

Decision

Confirmation of the completeness of the dossier was
necessary in order to allow it to be examined in detail
and to allow Member States the possibility of granting
provisional authorisations, for periods up to three years,
for plant protection products containing profoxydim,
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 substance and the plant protection product in the
light of the requirements laid down by that Directive.

(3)

For profoxydim, 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/

(1) OJ L 230, 19.08.1991, p. 1. Directive as last amended by Commis-

sion Directive 2004/30/EC (OJ L 77, 13.3.2004, p. 50).

(2) OJ L 14, 19.1.1999, p. 30.

(4)

(5)

EEC, for the uses proposed by the applicant. The rappor-
teur Member State submitted the draft assessment report
to the Commission on 28 March 2001.

The examination of the dossier is still ongoing after
submission of
reports by the
the draft assessment
rapporteur Member State and it will not be possible to
complete the evaluation within the timeframe foreseen
by Directive 91/414/EEC.

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 profox-
ydim 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 dossier to continue. It is
expected that
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

(6)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

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 Deci-
sion.

L 123/108

EN

Official Journal of the European Union

27.4.2004

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 26 April 2004.

For the Commission

David BYRNE

Member of the Commission