2000/784/EC: Commission Decision of 4 December 2000 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of UBH 820;UR 50601 (beflubutamid) in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (notified under document number C(2000) 3648) (Text with EEA relevance)
Date: 2000-12-04
Institutions: European Commission
Subjects: application of EU law, marketing, pharmaceutical product, plant health product

12.12.2000

EN

Official Journal of the European Communities

L 311/47

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 4 December 2000

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of UBH 820;UR 50601 (beflubutamid) in Annex I to Council Directive
91/414/EEC concerning the placing of plant-protection products on the market

(notified under document number C(2000) 3648)

(Text with EEA relevance)

(2000/784/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

sions of Article 6(2), the dossier was forwarded by the
applicant to the Commission and other Member States.

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/
68/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 UBH 820;UR 50601
(beflubutamid) was submitted by UBE Europe GmbH to
the authorities of Germany on 27 June 2000 with a
view to obtaining its inclusion in Annex I
to the
Directive.

The authorities of Germany 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. Further, they
believe that the dossier contains the data and informa-
tion required by Annex III to the Directive in respect of
one plant protection product containing that active
substance. Subsequently, in accordance with the provi-

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 28.10.2000, p. 41.

(4)

(5)

(6)

(7)

The dossier was referred to the Standing Committee on
Plant Health on 18 October 2000.

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.

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.

(8)

The Member States and the Commission agree that
Germany will pursue the detailed examination for the
dossier for UBH 820;UR 50601 (beflubutamid).

L 311/48

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Official Journal of the European Communities

12.12.2000

(9)

Germany will report the conclusions of the examina-
tions 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 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,

HAS ADOPTED THIS DECISION:

Article 1

The dossier submitted by UBE Europe GmbH to the Commis-
sion and the Member States with a view to the inclusion of
UBH 820;UR 50601 (beflubutamid) as an active substance in
Annex I to Directive 91/414/EEC, which was referred to the

Standing Committee on Plant Health on 18 October 2000,
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 UBH 820;UR 50601 (beflubutamid), taking into
account the uses proposed.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 4 December 2000.

For the Commission

David BYRNE

Member of the Commission