2008/740/EC: Commission Decision of 12 September 2008 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of spinetoram in Annex I to Council Directive 91/414/EEC (notified under document number C(2008) 4965) (Text with EEA relevance)
Date: 2008-09-12
Institutions: European Commission
Subjects: administrative formalities, exchange of information, marketing standard, pharmaceutical product, plant health control, plant health product

18.9.2008

EN

Official Journal of the European Union

L 249/21

COMMISSION DECISION

of 12 September 2008

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

(notified under document number C(2008) 4965)

(Text with EEA relevance)

(2008/740/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)

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

the requirements set out

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

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:

for

A dossier
the active substance spinetoram was
submitted by Dow Agrosciences to the authorities of
the United Kingdom on 17 October 2007 with an appli­
cation to obtain its inclusion in Annex I to Directive
91/414/EEC.

also to satisfy the data
in Annex

The authorities of the United Kingdom 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
was subsequently forwarded by the applicant
to the
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
information
and
satisfying

that
in principle

the dossier
data

the

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

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.

Article 2

The rapporteur Member State shall pursue the detailed examina­
tion for the dossier referred to in Article 1 and shall commu­
nicate to the Commission the conclusions of its examination
accompanied by a recommendation 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.

(1)

(2)

(3)

(4)

L 249/22

EN

Official Journal of the European Union

18.9.2008

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 12 September 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

ANNEX

Active substance concerned by this Decision

Common Name,
CIPAC Identification Number

Spinetoram

CIPAC-No: 802

Applicant

Date of application

Rapporteur Member State

Dow Agrosciences

17 October 2007

UK