2007/404/EC: Commission Decision of 12 June 2007 allowing Member States to extend provisional authorisations granted for the new active substance novaluron (notified under document number C(2007) 2454)   (Text with EEA relevance)
Date: 2007-06-12
Institutions: European Commission
Subjects: market approval, marketing, pharmaceutical product, plant health legislation, plant health product

13.6.2007

EN

Official Journal of the European Union

L 151/45

COMMISSION DECISION

of 12 June 2007

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

(notified under document number C(2007) 2454)

(Text with EEA relevance)

(2007/404/EC)

applicant and to have the rapporteur Member State
its assessment.
examine that
information and submit
still
is
Therefore,
ongoing and it will not be possible to complete the
evaluation within the
in
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 novaluron
will have been completed within 24 months.

is expected that

to continue.

the dossier

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

(5)

(6)

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 12 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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)

(4)

In accordance with Article 6(2) of Directive 91/414/EEC,
in March 2001 the United Kingdom received an appli-
cation from Makhteshim Agan Ltd. for the inclusion of
the active substance novaluron in Annex I to Directive
91/414/EEC. Commission Decision 2001/861/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.

Confirmation of
the dossier was
the completeness of
necessary in order to allow it to be examined in detail
and to allow Member States the possibility of granting
for periods of up to three
provisional authorisations,
years,
for plant protection products containing the
active substance 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 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 applicant. The
rapporteur Member State submitted the draft assessment
report to the Commission on 19 September 2005.

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

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

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

(2) OJ L 321, 6.12.2001, p. 34.