2000/390/EC: Commission Decision of 7 June 2000 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of EXP60707B (acetamiprid) 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) 1562)
Date: 2000-06-07
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 145/36

EN

Official Journal of the European Communities

20.6.2000

COMMISSION DECISION

of 7 June 2000

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of EXP60707B (acetamiprid) 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) 1562)

(2000/390/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 1999/
80/EC (2), and in particular Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 91/414/EEC (hereinafter ‘the Directive’) has
provided for the development of a Community list of
active substances authorised for incorporation in plant
protection products.

Nisso Chemical Europe Gmbh submitted a dossier on
the active substance EXP60707B (acetamiprid) to the
Greek authorities on 22 October 1999.

The said authorities informed the Commission of the
results of an initial examination of the dossier to ensure
that it provides all the information laid down in Annex
least one plant-protection product
II and,
containing the active substance concerned, in Annex III
to the Directive. Subsequently,
in accordance with
Article 6(2), the applicant submitted the dossier to the
Commission and other Member States.

for at

The dossier for EXP60707B (acetamiprid) was referred
to the Standing Committee on Plant Health on 22
February 2000.

Article 6(3) of the Directive requires official confirma-
tion at Community level that each dossier fulfils the
requirements on information laid down in Annex II and,
for at least one plant protection product containing the
active substance concerned, in Annex III to the Directive.

Such confirmation is necessary to permit a detailed
examination of the dossier and to allow Member States
to grant provisional authorisation for plant-protection
products containing the active substance concerned
while complying with the conditions laid down in
Article 8(1) of the Directive and, in particular, the condi-
tion relating to the detailed assessment of the active
substance and the plant-protection product in the light
of the requirements laid down by the Directive.

(7)

Such decision does not prejudice that further data or
information may be requested from the applicant in
order to clarify certain points in the dossier. The request

by the rapporteur Member State for the submission of
further data necessary to clarify the dossier shall not
affect the time limit for the submission of the report
referred to under recital 9.

The Member States and the Commission agree that
the
Greece will carry out a detailed examination of
dossier EXP60707B (acetamiprid).

Greece will report the conclusions of its examination
accompanied by any recommendations on the inclusion
or non-inclusion and any conditions related thereto as
soon as possible and at the latest within a period of one
year from the date of publication of the 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 following dossier satisfies, in principle, the data and infor-
mation requirements provided for in Annex II and, for at least
one plant-protection product containing the active substance
concerned, in Annex III to the Directive, taking into account
the uses proposed:

the dossier submitted by Nisso Chemical Europe Gmbh to
the Commission and the Member States with a view to the
inclusion of EXP60707B (acetamiprid)
an active
substance in Annex I to Directive 91/414/EEC and which
was referred to the Standing Committee on Plant Health on
22 February 2000.

as

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 7 June 2000.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 210, 10.8.1999, p. 13.