2001/626/EC: Commission Decision of 30 July 2001 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of Pethoxamide in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (Text with EEA relevance) (notified under document number C(2001) 2386)
Date: 2001-07-30
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product

L 217/14

EN

Official Journal of the European Communities

11.8.2001

COMMISSION

COMMISSION DECISION

of 30 July 2001

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of Pethoxamide in Annex I to Council Directive 91/414/EEC concerning
the placing of plant-protection products on the market

(notified under document number C(2001) 2386)

(Text with EEA relevance)

(2001/626/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant-protection products on
the market (1), as last amended by Commission Directive 2001/
49/EC (2), and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

91/414/EEC (hereinafter

Directive
‘the Directive’)
provides for the development of a Community list of
active substances authorised for incorporation in plant-
protection products.

A dossier for the active substance Pethoxamide (ASU
96 520 H, TKC-94 EC 60) was submitted by Stahler
Agrochemie GmbH & Co., KG, Tokuyama Europe
GmbH and Tomen France SA to the German authorities
on 16 October 2000 with a view to obtaining its inclu-
sion in Annex I to the Directive.

The German authorities have indicated to the Commis-
the dossier
sion that, on preliminary examination,
appears to satisfy the data and information requirements
of Annex II to the Directive. Further, they believe that
the dossier contains the data and information required
by Annex III to the Directive in respect of one plant-
protection product containing that active substance.
Subsequently,
in accordance with the provisions of
Article 6(2), the dossier was forwarded by the applicant
to the Commission and other Member States.

(4)

The dossier was referred to the Standing Committee on
Plant Health on 5 June 2001.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 176, 29.6.2001, p. 61.

Article 6(3) of the Directive requires formal confirma-
tion at Community level that each dossier is considered
as satisfying in principle the data and information
requirements provided for in Annex II and, for at least
one plant-protection product containing the active
substance concerned, the requirements of Annex III to
the Directive.

(6)

(7)

(8)

(9)

Such confirmation is necessary in order to permit the
detailed examination of the dossier as well as to allow
Member States the possibility of granting provisional
authorisation for plant-protection products containing
this active substance in accordance with Article 8(1) of
the Directive.

This Decision does not prejudice the right of
the
Commission to request the applicant to submit further
data or information to the rapporteur Member State in
order to clarify certain points in the dossier. The request
for the submission of further data necessary to clarify
the dossier shall not affect the time limit for the submis-
sion of the report referred to under recital 9.

The Member States of
the Commission agree that
Germany will pursue the detailed examination for the
dossier for Pethoxamide.

Germany will report the conclusions of their examina-
tions accompanied by any recommendation on inclusion
or non-inclusion and any conditions related thereto to
the Commission as soon as possible and at the latest
within a period of one year from the date of publication
of this Decision.

(10)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on Plant Health,

11.8.2001

EN

Official Journal of the European Communities

L 217/15

HAS ADOPTED THIS DECISION:

Article 1

The dossier submitted by Stahler Agrochemie GmbH & Co., KG, Tokuyama Europe GmbH and Tomen
France SA to the Commission and the Member States with a view to the inclusion of Pethoxamide as an
active substance in Annex I to Directive 91/414/EEC, which was referred to the Standing Committee on
Plant Health on 5 June 2001, satisfies in principle the data and information requirements provided for in
Annex II to the Directive. The dossier satisfies the data and information requirements set out in Annex III to
the Directive in respect of one plant-protection product containing Pethoxamide, taking into account the
uses proposed.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 30 July 2001.

For the Commission

David BYRNE

Member of the Commission