2008/599/EC: Commission Decision of 4 July 2008 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of Pseudomonas sp. strain DSMZ 13134 in Annex I to Council Directive 91/414/EEC (notified under document number C(2008) 3322) (Text with EEA relevance)
Date: 2008-07-04
Institutions: European Commission
Subjects: administrative formalities, exchange of information, marketing standard, pharmaceutical product, plant health control, plant health product

L 193/14

EN

Official Journal of the European Union

22.7.2008

COMMISSION DECISION

of 4 July 2008

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of Pseudomonas sp. strain DSMZ 13134 in Annex I to Council Directive
91/414/EEC

(notified under document number C(2008) 3322)

(Text with EEA relevance)

(2008/599/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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:

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

that
in principle

By this Decision it should be formally confirmed at
is 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

the dossier
data

in Annex III

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

(5)

(6)

A dossier for the active substance Pseudomonas sp. strain
Sourcon-Padena
submitted by
DSMZ 13134 was
GmbH&Co. KG to the authorities of
the Netherlands
on 28 August 2007 with an application to obtain its
inclusion in Annex I to Directive 91/414/EEC.

HAS ADOPTED THIS DECISION:

also to satisfy the data
in Annex

The authorities of the Netherlands have indicated to 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
and was
Commission and other Member
referred to the Standing Committee on the Food Chain
and Animal Health.

set out

States,

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

last amended by

Commission Directive 2008/69/EC (OJ L 172, 2.7.2008, p. 9).

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
that substance in Annex I to that Directive, satisfy 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.

(1)

(2)

(3)

22.7.2008

EN

Official Journal of the European Union

L 193/15

Article 2

The rapporteur Member State shall pursue the detailed examination for the dossier referred to in Article 1
and shall communicate to the Commission the conclusions of its examination accompanied by a recom­
mendation on the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance
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, 4 July 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

ANNEX

Active substance concerned by this Decision

Common Name, CIPAC Identification Number

Applicant

Date of application

Rapporteur Member
State

Pseudomonas sp. strain DSMZ 13134
CIPAC-No: Not relevant

Sourcon-Padena
GmbH&Co. KG

28 August 2007

NL