98/242/EC: Commission Decision of 20 March 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of cyhalofop-butyl, pyraflufen-ethyl and azafenidin in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (Text with EEA relevance)
Date: 1998-03-20
Institutions: European Commission
Subjects: dangerous substance, exchange of information, marketing, plant health legislation, plant health product

28. 3. 98

EN

Official Journal of the European Communities

L 96/45

COMMISSION

COMMISSION DECISION

of 20 March 1998

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of cyhalofop-butyl, pyraflufen-ethyl
and azafenidin in Annex I to Council Directive 91/414/EEC concerning the
placing of plant-protection products on the market

(Text with EEA relevance)

(98/242/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;

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 cyhalofop-butyl
was submitted by Dow Elanco Italia Srl to the Italian
authorities on 30 April 1997;

Whereas a dossier for the active substance pyraflufen-
ethyl was submitted by Nihon Nohyaku Co. Ltd to the
Belgian authorities on 16 June 1997;

Whereas a dossier for the active substance azafenidin was
submitted by du Pont de Nemours (France) SA to the
Spanish authorities on 25 June 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 cyhalofop-butyl, pyraflufen-ethyl
and azafenidin were referred to the Standing Committee
on Plant Health on 16 December 1997;

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
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 Italy will pursue the detailed exam-
ination for the dossier for cyhalofop-butyl, that Belgium
will pursue the detailed examination for the dossier for
pyraflufen-ethyl and that Spain will pursue the detailed
examination for the dossier for azafenidin;

L 96/46

EN

Official Journal of the European Communities

28. 3. 98

Whereas Italy, Belgium and Spain will report the conclu-
sions of their examinations accompanied by any recom-
mendations 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,

2. the dossier submitted by Nihon Nohyaku Co. Ltd to
the Commission and the Member States with a view to
the inclusion of pyraflufen-ethyl as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 16 December 1997;

3. the dossier

submitted by Du Pont de Nemours
(France) SA to the Commission and the Member States
with a view to the inclusion of azafenidin as active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 16 December 1997.

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 Dow Elanco Italia Srl to the
Commission and the Member States with a view to the
inclusion of cyhalofop-butyl as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 16 December 1997;

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 20 March 1998.

For the Commission

Franz FISCHLER

Member of the Commission