2006/927/EC: Commission Decision of 13 December 2006 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of flubendiamide in Annex I to Council Directive 91/414/EEC (notified under document number C(2006) 6457)   (Text with EEA relevance)
Date: 2006-12-13
Institutions: European Commission
Subjects: administrative formalities, exchange of information, marketing standard, pharmaceutical product, plant health product

L 354/54

EN

Official Journal of the European Union

14.12.2006

COMMISSION DECISION

of 13 December 2006

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of flubendiamide in Annex I to Council Directive 91/414/EEC

(notified under document number C(2006) 6457)

(Text with EEA relevance)

(2006/927/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 on the market (1),
and in particular Article 6(3) thereof,

Whereas:

(5)

(6)

data

in principle

satisfying
information
the
requirements provided for in Annex II and, for at least
one plant protection product containing the active
substance
in
concerned,
Annex III to Directive 91/414/EEC.

requirements

set out

and

the

This Decision should not prejudice the right of
the
Commission to request the applicant to submit further
data or information in order to clarify certain points in
the dossier.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

Directive 91/414/EEC provides for the development of a
Community list of active substances authorised for incor-
poration in plant protection products.

HAS ADOPTED THIS DECISION:

A dossier for the active substance flubendiamide was
submitted by Bayer CropScience AG to the authorities
of Greece on 30 March 2006 with an application to
obtain its inclusion in Annex I to Directive 91/414/EEC.

authorities of Greece have

also to satisfy the data
in Annex

indicated to the
The
Commission that, on preliminary examination,
the
dossier for the active substance concerned appears to
satisfy the data and information requirements set out in
Annex II to Directive 91/414/EEC. The dossier submitted
and information
appears
requirements
to Directive
III
91/414/EEC in respect of one plant protection product
containing the active substance concerned. In accordance
with Article 6(2) of Directive 91/414/EEC, the dossier
to the
was subsequently forwarded by the applicant
Commission and other Member
and was
referred to the Standing Committee on the Food Chain
and Animal Health.

set out

States,

By this Decision it should be formally confirmed at
is considered as
Community level

the dossier

that

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

2006/85/EC (OJ L 293, 24.10.2006, p. 3).

Article 1

Without prejudice to Article 6(4) of Directive 91/414/EEC, the
dossier concerning the active substance identified in the Annex
to this Decision, which was submitted to the Commission and
the Member States with a view to obtaining the inclusion of this
substance in Annex I to that Directive, satisfies in principle the
data and information requirements set out in Annex II to that
Directive.

The dossier also satisfies the data and information requirements
set out in Annex III to that Directive in respect of one plant
protection product containing the active substance, taking into
account the uses proposed.

Article 2

the dossier

concerned and shall

The rapporteur Member State shall pursue the detailed exam-
ination for
the
conclusions of its examinations accompanied by any recom-
mendations on the inclusion or non-inclusion of the active
substance concerned in Annex I of Directive 91/414/EEC and
any conditions related thereto to the European Commission as
soon as possible and at the latest within a period of one year
from the date of publication of this Decision in the Official
Journal of the European Union.

report

(1)

(2)

(3)

(4)

14.12.2006

EN

Official Journal of the European Union

L 354/55

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 13 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

ANNEX

ACTIVE SUBSTANCE CONCERNED BY THIS DECISION

No

1

Common Name,
CIPAC Identification Number

Applicant

Date of application

Rapporteur
Member State

Flubendiamide
CIPAC No. not yet allocated

Bayer CropScience AG

30 March 2006

EL