98/398/EC: Commission Decision of 2 June 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of BAS 615H, KBR 2738 (fenhexamid), oxadiargyl and DPX-KN128 (indoxacarb) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (notified under document number C(1998) 1447) (Text with EEA relevance)
Date: 1998-06-02
Institutions: European Commission
Subjects: health legislation, market approval, pharmaceutical legislation, pharmaceutical product, plant health product

L 176/34

EN

Official Journal of the European Communities

20. 6. 98

COMMISSION DECISION

of 2 June 1998

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of BAS 615H, KBR 2738 (fenhex-
amid), oxadiargyl and DPX-KN128 (indoxacarb) in Annex I to Council Directive
91/414/EEC concerning the placing of plant protection products on the market

(notified under document number C(1998) 1447)

(Text with EEA relevance)

(98/398/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 Commis-
sion Directive 97/73/EC (2), and in particular Article 6(3)
thereof,

Whereas Directive 91/414/EEC (hereinafter ‘the Direct-
ive') has provided for the development of a Community
list of active substances authorised for incorporation in
plant protection products;

four
Whereas applicants have submitted dossiers for
active substances to Member States’ authorities in view of
obtaining the inclusion of the active substances in Annex
I to the Directive;

Whereas a dossier for the active substance BAS 615H was
submitted by BASF plc to the United Kingdom author-
ities on 28 April 1997;

Whereas a dossier for the active substance KBR 2738
(fenhexamid) was submitted by Bayer plc to the United
Kingdom authorities on 8 May 1997;

Whereas a dossier for the active substance oxadiargyl was
submitted by Rh(cid:147)ne Poulenc Agro SpA to the Italian
authorities on 16 June 1997;

Whereas a dossier for the active substance DPX-KN128
(indoxacarb) was submitted by Du Pont de Nemours
France SA to the Dutch authorities on 6 October 1997;

Whereas the said authorities indicated to the Commission
the results of a first examination of the completeness of
the dossier with regard to the data and information
requirements provided for in Annex II and, for at least
one plant protection product containing the active
in Annex III to the Directive;
substance concerned,

(1) OJ L 230, 19. 8. 1991, p. 1.
(2) OJ L 353, 24. 12. 1997, p. 26.

whereas subsequently, in accordance with the provisions
of Article 6(2), the dossier was submitted by the applicants
to the Commission and other Member States;

Whereas the dossiers for BAS 615H, KBR 2738 (fenhex-
amid), oxadiargyl and DPX-KN128 (indoxacarb) were
referred to the Standing Committee on Plant Health on
18 February 1998;

the level of

Whereas Article 6(3) of the Directive requires it being
confirmed at
the Community that each
dossier is to be considered as satisfying in principle the
data and information requirements provided for in Annex
II
least one plant protection product
containing the active substance concerned, in Annex III
to the Directive;

and,

for

at

to
Whereas such confirmation is necessary in order
pursue the detailed examination of the dossier as well as
in order to open to Member States the possibility of
granting provisional authorisation for plant protection
products containing this active substance in due respect
of
the
Directive, and in particular the condition to make a
detailed assessment of the active substances and the plant
protection products with regard to the requirements of
the Directive;

laid down in Article 8(1) of

the conditions

Whereas such Decision does not prejudice that further
data or information may be requested from the applicant
where it would appear during the detailed examination
that such information or data are required for a Decision
to be taken;

Whereas it is understood between the Member States and
the Commission that the United Kingdom will pursue
the detailed examinations for the dossiers for BAS 615H
and KBR 2738 (fenhexamid), that Italy will pursue the
detailed examination for the dossier for oxadiargyl and
that the Netherlands will pursue the detailed examination
for the dossier for DPX-KN128 (indoxacarb);

20. 6. 98

EN

Official Journal of the European Communities

L 176/35

Whereas the United Kingdom, Italy and the Netherlands
will report the conclusions of their examinations accom-
panied 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; whereas on receipt of this report the
detailed examination will be continued with the expertise
from all Member States within the framework of the
Standing Committee on Plant Health;

Whereas 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 dossiers satisfy 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, in Annex III to the Directive,
taking into account the uses proposed.

1. The dossier submitted by BASF plc to the Commis-
sion and the Member States with a view to the inclu-
sion of BAS 615H as active substance in Annex I to
Directive 91/414/EEC and which was referred to the
Standing Committee on Plant Health on 18 February
1998.

2. The dossier submitted by Bayer plc to the Commission
and the Member States with a view to the inclusion of
KBR 2738 (fenhexamid) as active substance in Annex I
to Directive 91/414/EEC and which was referred to the
Standing Committee on Plant Health on 18 February
1998.

3. The dossier submitted by Rh(cid:147)ne Poulenc Agro SpA to
the Commission and the Member States with a view to
the inclusion of oxadiargyl as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 18 February 1998.

4. The dossier submitted by Du Pont de Nemours France
SA to the Commission and the Member States with a
view to the inclusion of DPX-KN128 (indoxacarb) as
active substance in Annex I to Directive 91/414/EEC
and which was referred to the Standing Committee on
Plant Health on 18 February 1998.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 2 June 1998.

For the Commission

Franz FISCHLER

Member of the Commission