2008/953/EC: Commission Decision of 8 December 2008 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Aureobasidium pullulans and disodium phosphonate in Annex I to Council Directive 91/414/EEC (notified under document number C(2008) 7709) (Text with EEA relevance)
Date: 2008-12-08
Institutions: European Commission
Subjects: administrative formalities, exchange of information, marketing standard, pharmaceutical product, plant health control, plant health product

L 338/62

EN

Official Journal of the European Union

17.12.2008

COMMISSION DECISION

of 8 December 2008

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

(notified under document number C(2008) 7709)

(Text with EEA relevance)

(2008/953/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

referred to the Standing Committee on the Food Chain
and Animal Health.

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)

(3)

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

A dossier for the active substance Aureobasidium pullulans
was submitted by bio-ferm GmbH to the authorities of
Austria on 17 April 2008 with an application to obtain
its inclusion in Annex I to Directive 91/414/EEC. For
disodium phosphonate a dossier was submitted by ISK
Biosciences Europe S.A. to the authorities of France on
21 May 2008 with an application to obtain its inclusion
in Annex I to Directive 91/414/EEC.

II

to Directive 91/414/EEC. The

The authorities of Austria and France have indicated to
the Commission that, on preliminary examination, the
dossiers for the active substances concerned appear to
satisfy the data and information requirements set out in
dossiers
Annex
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
were subsequently forwarded by the respective applicants
to the Commission and other Member States, and were

in Annex

set out

III

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

(4)

(5)

(6)

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

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

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 these 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.

17.12.2008

EN

Official Journal of the European Union

L 338/63

Article 2

The rapporteur Member States shall pursue the detailed examination for the dossiers referred to in Article 1
and shall communicate to the Commission the conclusions of their examinations 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 that inclusion 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, 8 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

Common name,
CIPAC identification number

Aureobasidium pullulans
CIPAC-No: not applicable

Disodium phosphonate
CIPAC-No: 808

Applicant

Date of application

Rapporteur Member State

bio-ferm GmbH

17 April 2008

ISK Biosciences Europe SA

21 May 2008

AT

FR