2001/6/EC: Commission Decision of 12 December 2000 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of QRD 133 WP (Bacillus subtilis strain QST 713) 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(2000) 3747)
Date: 2000-12-12
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

5.1.2001

EN

Official Journal of the European Communities

L 2/25

COMMISSION DECISION

of 12 December 2000

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of QRD 133 WP (Bacillus subtilis strain QST 713) 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) 3747)

(Text with EEA relevance)

(2001/6/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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:

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 QRD 133 WP (Bacillus
subtilis strain QST 713) was submitted by AgraQuest to
the authorities of Germany on 19 April 2000 with a
to the
view to obtaining its inclusion in Annex I
Directive.

The authorities of Germany have indicated to the
the
Commission that, on preliminary examination,
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-
sions of Article 6(2), the dossier was forwarded by the
applicant to the Commission and other Member States.

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 point 9.

The Member States and the Commission agree that
Germany will pursue the detailed examination for the
dossier for QRD 133 WP (Bacillus subtilis strain QST
713)

Germany will report the conclusions of its 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 from the date of publication
of this Decision.

(7)

(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:

The dossier was referred to the Standing Committee on
Plant Health on 1 September 2000.

Article 1

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.

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

The dossier submitted by AgraQuest to the Commission and
the Member States with a view to the inclusion of QRD 133
WP (Bacillus subtilis strain QST 713) as an active substance in
Annex I to Directive 91/414/EEC, which was referred to the
Standing Committee on Plant Health on 1 September 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 QRD 133 WP (Bacillus subtilis strain QST 713),
taking into account the uses proposed.

(1)

(2)

(3)

(4)

(5)

L 2/26

EN

Official Journal of the European Communities

5.1.2001

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 12 December 2000.

For the Commission

Franz FISCHLER

Member of the Commission