2007/669/EC: Commission Decision of 15 October 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Adoxophyes orana granulovirus , amisulbrom, emamectin, pyridalil and Spodoptera littoralis nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC (notified under document number C(2007) 4647) (Text with EEA relevance)
Date: 2007-10-15
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health legislation, plant health product, toxic substance

18.10.2007

EN

Official Journal of the European Union

L 274/15

COMMISSION

COMMISSION DECISION

of 15 October 2007

recognising in principle the completeness of the dossiers submitted for detailed examination in
view of the possible inclusion of Adoxophyes orana granulovirus, amisulbrom, emamectin, pyridalil
and Spodoptera littoralis nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC

(notified under document number C(2007) 4647)

(Text with EEA relevance)

(2007/669/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.

A dossier for the active substance Adoxophyes orana gran-
ulovirus was submitted by Andermatt Biocontrol GmbH
to the authorities of Germany on 29 November 2004
with an application to obtain its inclusion in Annex I to
Directive 91/414/EEC. For amisulbrom a dossier was
submitted by Nissan Chemical Europe S.A.R.L. to the
authorities of the United Kingdom on 24 March 2006
with an application to obtain its inclusion in Annex I to
Directive 91/414/EEC. For emamectin a dossier was
the
submitted by Syngenta Ltd.
Netherlands on 23 June 2006 with an application to
obtain
to Directive
91/414/EEC. For pyridalil a dossier was submitted by
Sumitomo Chemical Agro Europe SAS to the authorities
of the Netherlands on 28 March 2006 with an appli-
cation to obtain its inclusion in Annex I to Directive

to the authorities of

in Annex

inclusion

its

I

(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).

(3)

(4)

(5)

(6)

91/414/EEC. For Spodoptera littoralis nucleopolyhedrovirus a
dossier was submitted by Andermatt Biocontrol GmbH
to the authorities of Estonia on 2 January 2007 with an
application to obtain its inclusion in Annex I to Directive
91/414/EEC.

II

and

have

Estonia

indicated

The authorities of Germany, the United Kingdom, the
the
Netherlands
to
Commission that, on preliminary examination,
the
dossiers for the active substances concerned appear to
satisfy the data and information requirements set out in
to Directive 91/414/EEC. The 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
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

set out

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 274/16

EN

Official Journal of the European Union

18.10.2007

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 States shall pursue the detailed exam-
ination for the dossiers referred to in Article 1 and shall

communicate to the Commission the conclusions of their 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, 15 October 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

ANNEX

ACTIVE SUBSTANCE CONCERNED BY THIS DECISION

Common Name, CIPAC Identification
Number

Adoxophyes orana granulovirus
CIPAC-No.: Not applicable

Amisulbrom
CIPAC-No.: 789

Emamectin
CIPAC-No.: 791

Pyridalil
CIPAC-No.: 792

littoralis

Spodoptera
drovirus
CIPAC-No.: Not applicable

nucleopolyhe-

Applicant

Date of application

Rapporteur Member State

Andermatt Biocontrol GmbH

29 November 2004

Nissan Chemical Europe S.A.R.L. 24 March 2006

Syngenta Ltd.

23 June 2006

Sumitomo Chemical Agro Europe
SAS

28 March 2006

Andermatt Biocontrol GmbH

2 January 2007

DE

UK

NL

NL

EE