2004/627/EC: Commission Decision of 31 August 2004 allowing Member States to extend provisional authorisations granted for the new active substances etoxazole and carvone (notified under document number C(2004) 3136)(Text with EEA relevance)
Date: 2004-08-31
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health product

2.9.2004

EN

Official Journal of the European Union

L 283/17

COMMISSION DECISION

of 31 August 2004

allowing Member States to extend provisional authorisations granted for the new active substances
etoxazole and carvone

(notified under document number C(2004) 3136)

(Text with EEA relevance)

(2004/627/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 the fourth subparagraph of Article
8(1) thereof,

Whereas:

(1)

(2)

active

In accordance with Article 6(2) of Directive 91/414/EEC,
in April 1998 Spain received an application from
Sumitomo Chemical Agro Europe SA for the inclusion
to Directive
of
the
1999/43/EC (2)
91/414/EEC.
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 Annex I

etoxazole

In March 1997 the Netherlands received an application
from Luxan BV concerning carvone (former name:
L 91105D). Commission Decision 1999/610/EC (3)
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.

(3)

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 2004/71 (OJ L 127, 29.4.2004, p. 104).

(2) OJ L 14, 19.1.1999, p. 30.
(3) OJ L 242, 14.9.1999, p. 29.

detail and to allow Member States the possibility of
granting provisional authorisations,
for periods up to
for plant protection products containing
three years,
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 substance 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 respective
applicants. The rapporteur Member States submitted the
reports to the Commission on 12
draft assessment
and 16 October 2000
October 2001 (etoxazole)
(carvone).

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

their assessments. Therefore,

As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
authorisations
possibility of prolonging provisional
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 each of the
active substances concerned will have been completed
within 24 months.

the dossiers to continue.

is expected that

It

(4)

(5)

(6)

L 283/18

EN

Official Journal of the European Union

2.9.2004

(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

Article 2

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Article 1

Done at Brussels, 31 August 2004.

Member States may extend provisional authorisations for plant
protection products containing etoxazole or carvone for a
period not exceeding 24 months from the date of adoption
of this Decision.

For the Commission

David BYRNE
Member of the Commission