2001/385/EC: Commission Decision of 4 May 2001 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of RH 2485 (methoxyfenozide) 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) 1179)
Date: 2001-05-04
Institutions: European Commission
Subjects: marketing, marketing standard, pharmaceutical product, plant health product, product safety

L 137/30

EN

Official Journal of the European Communities

19.5.2001

COMMISSION DECISION

of 4 May 2001

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of RH 2485 (methoxyfenozide) 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) 1179)

(Text with EEA relevance)

(2001/385/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

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 2000/
80/EC (2) and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

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 RH 2485 (methoxyfe-
nozide) was submitted by Rohm and Haas France SA to
the authorities of United Kingdom on 21 February 2000
with a view to obtaining its inclusion in Annex I to the
Directive.

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

The dossier was referred to the Standing Committee on
Plant Health on 2 February 2001.

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.

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.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 9.12.2000, p. 14.

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 at recital 9.

The Member States and the Commission agree that the
United Kingdom will pursue the detailed examination
for the dossier for RH 2485 (methoxyfenozide).

The United Kingdom will report the conclusions of their
examinations accompanied by any recommendations on
the 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 of the date
of publication of this Decision.

(8)

(9)

(10)

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

HAS ADOPTED THIS DECISION:

Article 1

The dossier submitted by Rhom and Haas France SA to the
Commission and the Member States with a view to the inclu-
sion of RH 2485 (methoxyfenozide) as an active substance in
Annex I to Directive 91/414/EEC, which was referred to the
Standing Committee on Plant Health on 2 February 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 RH 2485 (methoxyfenozide), taking into account
the uses proposed.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 4 May 2001.

For the Commission

David BYRNE

Member of the Commission