1999/237/EC: Commission Decision of 18 March 1999 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of CGA 277 476 (oxasulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (notified under document number C(1999) 632) (Text with EEA relevance)
Date: 1999-03-18
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

31. 3. 1999

EN

Official Journal of the European Communities

L 87/15

COMMISSION DECISION

of 18 March 1999

recognising in principle the completeness of the dossier submitted for detailed
examination in view of the possible inclusion of CGA 277 476 (oxasulfuron) in
Annex I to Council Directive 91/414/EEC concerning the placing of plant-protec-
tion products on the market

(notified under document number C(1999) 632)

(Text with EEA relevance)

(1999/237/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 Direct-
ive') has provided for the development of a Community
list of active substances authorised for incorporation in
plant-protection products;

Whereas the applicant has submitted a dossier for one
active substance to Member States’ authorities in view of
obtaining the inclusion of the active substance in Annex I
to the Directive;

Whereas a dossier for the active substance CGA 277 476
(oxasulfuron) was submitted by Novartis Protezione Piante
SpA to the Italian authorities on 29 May 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
active
substance concerned,
in Annex III to the Directive;
whereas subsequently, in accordance with the provisions
of Article 6(2), the dossier was submitted by the applicant
to the Commission and other Member States;

containing the

Whereas the dossier for CGA 277 476 (oxasulfuron) was
referred to the Standing Committee on plant health on 1
December 1998;

the level of

Whereas Article 6(3) of the Directive requires it being
the Community that each
confirmed at
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

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

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
products containing this active substance in due respect
of
the
Directive, and in particular the condition to make a
detailed assessment of the active substance 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 Italy will pursue the detailed exam-
ination for the dossier for CGA 277 476 (oxasulfuron);

Whereas Italy will report the conclusions of its exam-
ination 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;

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 dossier satisfies 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:

L 87/16

EN

Official Journal of the European Communities

31. 3. 1999

the dossier submitted by Novartis Protezione Piante SpA to the Commission and the
Member States with a view to the inclusion of CGA 277 476 (oxasulfuron) as active
substance in Annex I to Directive 91/414/EEC and which was referred to the Standing
Committee on plant health on 1 December 1998.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 18 March 1999.

For the Commission

Franz FISCHLER

Member of the Commission