1999/43/EC: Commission Decision of 22 December 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of CGA 279 202 (trifloxystrobin), clefoxydim (BAS 625H), etoxazol and ferric phosphate 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) 4355) (Text with EEA relevance)
Date: 1998-12-22
Institutions: European Commission
Subjects: EU Member State, EU control, market approval, marketing, pharmaceutical product, plant health product

L 14/30

EN

Official Journal of the European Communities

19. 1. 1999

COMMISSION DECISION

of 22 December 1998

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of CGA 279 202 (trifloxystrobin),
clefoxydim (BAS 625H), etoxazol and ferric phosphate 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) 4355)

(Text with EEA relevance)

(1999/43/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 Direc-
tive') 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 CGA 279 202
(trifloxystrobin) was submitted by Novaritis Crop Protec-
tion UK Ltd to the United Kingdom authorities on 28
January 1998;

Whereas a dossier for the active substance clefoxydim
(BAS 625H) was submitted by BASF AG to the Spanish
authorities on 2 April 1998;

Whereas a dossier for the active substance etoxazol was
submitted by Sumitomo Chemical Agro Europe SA to the
French authorities on 21 April 1998;

Whereas a dossier for the active substance ferric phos-
phate was submitted by W. Neudorff GmbH to the
German authorities on 27 August 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 date 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 191, 7. 7. 1998, p. 50.

whereas subsequently, in accordance with the provisions
of Article 6(2), the dossiers were submitted by the appli-
cant to the Commission and other Member States;

Whereas the dossiers for CGA 279 202 (trifloxystrobin),
clefoxydim (BAS 625H), etoxazol and ferric phosphate
were referred to the Standing Committee on Plant Health
on 15 October 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
the
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 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 examination for the dossier for CGA 279 202
(trifloxystrobin), that Spain will pursue the detailed exam-
ination for the dossier for clefoxydim (BAS 625H), that
France will pursue the detailed examination for
the
dossier for etoxazol, and that Germany will pursue the
detailed examination for the dossier for ferric phosphate;

19. 1. 1999

EN

Official Journal of the European Communities

L 14/31

the United Kingdom, Spain, France and
Whereas
Germany will report the conclusions of their examina-
tions 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 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 Novaritis Crop Protection
UK Ltd to the Commission and the Member States
with a view to the inclusion of CGA 279 202 (trifloxy-
strobin) as active substance in Annex I to Directive
91/414/EEC and which was referred to the Standing
Committee on Plant Health on 15 October 1998.

2. The dossier submitted by BASF AG to the Commis-
sion and the Member States with a view to the inclu-
sion of clefoxydim (BAS 625H) as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 15 October 1998.

3. The dossier submitted by Sumitomo Chemical Agro
Europe SA to the Commission and the Member States
with a view to the inclusion of etoxazol as active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 15 October 1998.

4. The dossier submitted by W. Neudorff GmbH KG to
the Commission and the Member States with a view to
the inclusion of ferric phosphate as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 15 October 1998.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 22 December 1998.

For the Commission

Franz FISCHLER

Member of the Commission