2008/20/EC: Commission Decision of 20 December 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of ipconazole and maltodextrin in Annex I to Council Directive 91/414/EEC (notified under document number C(2007) 6479) (Text with EEA relevance)
Date: 2007-12-20
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health legislation, plant health product, toxic substance

4.1.2008

EN

Official Journal of the European Union

L 1/5

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 20 December 2007

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of ipconazole and maltodextrin in Annex I to Council Directive
91/414/EEC

(notified under document number C(2007) 6479)

(Text with EEA relevance)

(2008/20/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:

(1)

(2)

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

for

A dossier
the active substance Ipconazole was
submitted by Kureha GmbH to the authorities of the
United Kingdom on 30 March 2007 with an application
to obtain its
to Directive
inclusion in Annex I
91/414/EEC. For maltodextrin a dossier was submitted
by Biological Crop Protection Ltd. to the authorities of
the United Kingdom on 2 July 2007 with an application
to obtain its
to Directive
inclusion in Annex I
91/414/EEC.

(3)

The authorities of the United Kingdom have indicated to
the Commission that, on preliminary examination, the

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

last amended by

Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

(4)

(5)

(6)

II

set out

dossiers for the active substances concerned appear to
satisfy the data and information requirements set out in
Annex
to Directive 91/414/EEC. The dossiers
submitted appear also to satisfy the data and information
requirements
to Directive
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 dossiers
to the
were subsequently forwarded by the applicant
Commission and other Member States,
and were
referred to the Standing Committee on the Food Chain
and Animal Health.

in Annex

III

that

in principle

By this Decision it should be formally confirmed at
the dossiers are considered as
Community level
satisfying
information
and
the
requirements set out in Annex II and, for at least one
plant protection product containing the active substance
concerned,
to
Directive 91/414/EEC.

the requirements set out

in Annex III

data

the
This Decision should not prejudice the right of
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

L 1/6

EN

Official Journal of the European Union

4.1.2008

HAS ADOPTED THIS DECISION:

Article 1

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

The dossiers also satisfy 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 rapporteur Member State shall pursue the detailed exam-
ination for the dossiers referred to in Article 1 and shall

communicate to the Commission the conclusions of its exam-
ination accompanied by a recommendation on the inclusion or
non-inclusion in Annex I to Directive 91/414/EEC of the active
substances referred to in Article 1 and any conditions for those
inclusions 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.

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 20 December 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

ANNEX

ACTIVE SUBSTANCE CONCERNED BY THIS DECISION

Common Name,
CIPAC Identification Number

Applicant

Date of application

Rapporteur
Member State

Ipconazole
CIPAC-No: 798

Maltodextrin
CIPAC-No: 801

Kureha GmbH

30 March 2007

United Kingdom

Biological Crop Protection Ltd

2 July 2007

United Kingdom