98/512/EC: Commission Decision of 29 July 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of BAS 620H (tepraloxydim), S-metolachlor and SZX 0722 (iprovalicarb) 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) 2368) (Text with EEA relevance)
Date: 1998-07-29
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

15. 8. 98

EN

Official Journal of the European Communities

L 228/35

COMMISSION DECISION

of 29 July 1998

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of BAS 620H (tepraloxydim), S-
metolachlor and SZX 0722 (iprovalicarb) 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) 2368)

(Text with EEA relevance)

(98/512/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 98/47/EC (2) and in particular Article 6(3)
thereof,

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

the development

Whereas applicants have submitted dossiers for three
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 620H
(tepraloxydim) was submitted by BASF AG to the Spanish
authorities on 11 September 1997;

Whereas a dossier for the active substance S-metolachlor
was submitted by SA Novartis Agro NV to the Belgian
authorities on 1 August 1997;

Whereas a dossier for the active substance SZX 0722
(inprovalicarb) was submitted by Bayer AG to the Irish
authorities on 30 March 1998;

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
substance concerned,
in Annex III to the Directive;
whereas subsequently, in accordance with the provisions
of Article 6(2), the dossiers were submitted by the ap-
plicants to the Commission and other Member States;

Whereas the dossiers for BAS 620H (tepraloxydim), S-
metolachlor and SZX 0722 (iprovalicarb) were referred to

(1) OJ L 230, 19. 8. 1991, p. 1.
(2) OJ L 191, 7. 7. 1998, p. 50.

the Standing Committee on Plant Health on 21 April
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

Whereas such confirmation is necessary in order
to
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
containing this active substance in due respect of the
conditions laid down in Article 8(1) 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;

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 Spain will pursue the detailed
examination for the dossier for BAS 620H (tepraloxydim),
that Belgium will pursue the detailed examination for the
dossier for S-metolachlor and that Ireland will pursue the
detailed examination for the dossier for SZX 0722 (ipro-
valicarb);

the
Whereas Spain, Belgium and Ireland will report
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,
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;

L 228/36

EN

Official Journal of the European Communities

15. 8. 98

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 AG to the Commis-
sion and the Member States with a view to the in-
clusion of BAS 620H (tepraloxydim)
active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 21 April 1998.

as

2. The dossier submitted by SA Novartis Agro NV to the
Commission and the Member States with a view to the
inclusion of S-metolachlor as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 21 April 1998.

3. The dossier submitted by Bayer AG to the Commis-
sion and the Member States with a view to the in-
clusion of SZX 0722 (iprovalicarb) as active substance
in Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 21 April 1998.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 29 July 1998.

For the Commission

Franz FISCHLER

Member of the Commission