2006/584/EC: Commission Decision of 25 August 2006 allowing Member States to extend provisional authorisations granted for the new active substance beflubutamid (notified under document number C(2006) 3806)   (Text with EEA relevance)
Date: 2006-08-25
Institutions: European Commission
Subjects: EU control, market approval, marketing, pharmaceutical product, plant health product

29.8.2006

EN

Official Journal of the European Union

L 234/41

COMMISSION DECISION

of 25 August 2006

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

(notified under document number C(2006) 3806)

(Text with EEA relevance)

(2006/584/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

91/414/EEC, for the uses proposed by the applicant. The
rapporteur Member State submitted the draft assessment
report to the Commission on 3 August 2002.

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)

the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
in March 1998 Germany received an application from
UBE Europe GmbH for
the active
substance beflubutamid (former names: UBH 820, UR
91/414/EEC.
50601)
Commission Decision 2000/784/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.

to Directive

in principle,

in Annex

the data

I

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
provisional authorisations, for periods up to three years,
for plant protection products containing the active
concerned, while
substance
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 substance and the
plant protection product in the light of the requirements
laid down by that Directive.

complying with

(4)

(5)

(6)

Following submission of the draft assessment report by
it has been found to be
the rapporteur Member State,
necessary to request
information from the
further
applicant and to have the rapporteur Member State
its assessment.
information and submit
examine that
Therefore,
still
is
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
inclusion for beflu-
a decision on possible Annex I
butamid 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

HAS ADOPTED THIS DECISION:

(3)

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

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

last amended by
Commission Directive 2006/64/EC (OJ L 206, 27.7.2006, p. 107).

(2) OJ L 311, 12.12.2000, p. 47.

Article 1

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

L 234/42

EN

Official Journal of the European Union

29.8.2006

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 25 August 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission