1999/462/EC: Commission Decision of 24 June 1999 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of alanycarbe 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) 1715) (Text with EEA relevance)
Date: 1999-06-24
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical product, plant health product

15. 7. 1999

EN

Official Journal of the European Communities

L 180/49

COMMISSION DECISION

of 24 June 1999

recognising in principle the completeness of the dossier submitted for detailed examination in view
of the possible inclusion of alanycarbe 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) 1715)

(Text with EEA relevance)

(1999/462/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
1999/1/EC (2) and in particular Article 6(3) thereof,

(7) 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
the
the conditions laid down in Article 8(1) of
of
Directive, and in particular the condition to make a
detailed assessment of the active substances and the
plant protection products with regard to the require-
ments of the Directive;

(1) 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;

(8) Whereas such Decision does not prejudice that further
data or information may be requested from the applic-
ant where it would appear during the detailed exam-
ination that such information or data are required for a
Decision to be taken;

(2) Whereas the applicant has submitted a dossier for one
active substance to Member States’ authorities with a
view to obtain the inclusion of the active substances in
Annex I to the Directive;

(9) Whereas it is understood between the Member States
and the Commission that France will pursue the detailed
examination for the dossier for alanycarbe;

(3) Whereas a dossier for the active substance alanycarbe
was submitted by Otsuka Chemical Co. to the French
authorities on 24 July 1995;

(4) Whereas the said authorities indicated to the Commis-
sion the results of a first examination of the complete-
ness of the dossier with regard to the data and informa-
tion requirements provided for in Annex II and, for at
least one plant protection product containing the active
to the Directive;
substance concerned,
whereas subsequently, in accordance with the provisions
of Article 6(2),
the dossiers were submitted by the
applicant to the Commission and other Member States;

in Annex III

(5) Whereas the dossiers for alanycarbe were referred to the
Standing Committee on Plant Health on 18 February
1998;

the level of

(6) 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 and, for at least one plant protection product
containing the active substance concerned, in Annex III
to the Directive;

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 21, 28.1.1999, p. 21.

(10) Whereas France will report the conclusions of the exam-
ination accompanied by any recommendations on the
inclusion or non-inclusion and any conditions related
thereto to one 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;

(11) Whereas the measures provided for in this Decision are
the Standing

in accordance with the opinion of
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 180/50

EN

Official Journal of the European Communities

15. 7. 1999

1. The dossier submitted by Otsuka Chemical Co. to the Commission and the Member States with a view
to the inclusion of alanycarbe 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.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 24 June 1999.

For the Commission

Franz FISCHLER

Member of the Commission