2006/806/EC: Commission Decision of 24 November 2006 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of orthosulfamuron in Annex I to Council Directive 91/414/EEC (notified under document number C(2006) 5539)   (Text with EEA relevance)
Date: 2006-11-24
Institutions: European Commission
Subjects: European Commission, Italy, exchange of information, marketing standard, pharmaceutical product, plant health product, testing

L 329/74

EN

Official Journal of the European Union

25.11.2006

COMMISSION DECISION

of 24 November 2006

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

(notified under document number C(2006) 5539)

(Text with EEA relevance)

(2006/806/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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 products 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.

A dossier for the active substance orthosulfamuron was
submitted by Isagro SpA to the authorities of Italy on 4
July 2005 with an application to obtain its inclusion in
Annex I to Directive 91/414/EEC.

The authorities of Italy 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 appears
also to satisfy the data and information requirements
set out in Annex III 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,
subsequently
forwarded by the applicant
to the Commission and
other Member States, and was referred to the Standing
Committee on the Food Chain and Animal Health.

the dossier was

that
in principle

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

the dossier
data

requirements

set out

the

(1)

(2)

(3)

(4)

(5)

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
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 this
substance in Annex I to that Directive, satisfies 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 dossier

concerned and shall

The rapporteur Member State shall pursue the detailed exam-
ination for
the
conclusions of its examinations accompanied by any recom-
mendations on the inclusion or non-inclusion of the active
substance concerned in Annex I of Directive 91/414/EEC and
any conditions related thereto to the European Commission 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.

report

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 24 November 2006.

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.

For the Commission

Markos KYPRIANOU
Member of the Commission

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

last amended by

Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

25.11.2006

EN

Official Journal of the European Union

L 329/75

ANNEX

Active substance concerned by this Decision

No

Common Name, CIPAC Identification Number

Applicant

Date of application

Rapporteur
Member State

1

Orthosulfamuron
CIPAC No not yet allocated

Isagro SpA

4 July 2005

IT