1999/392/EC: Commission Decision of 31 May 1999 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of ZA 1296 (mesotrione), Iodosulfuron-methyl-sodium (AEF 115008) Silthiopham (MON 65500) and Gliocladium catenulatum 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) 1400) (Text with EEA relevance)
Date: 1999-05-31
Institutions: European Commission
Subjects: dangerous substance, marketing, plant health control, plant health legislation, plant health product

L 148/44

EN

Official Journal of the European Communities

15. 6. 1999

COMMISSION DECISION

of 31 May 1999

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of ZA 1296 (mesotrione), Iodosul-
furon-methyl-sodium (AEF 115008) Silthiopham (MON 65500) and Gliocladium
catenulatum 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) 1400)

(Text with EEA relevance)

(1999/392/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC (1) of 15
July 1991 concerning the placing of plant-protection
products on the market as last amended by Commission
Directive 1999/1/EC (2) and in particular Article 6(3)
thereof,

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

(2) Whereas applicants have submitted dossiers for
four active substances to Member States’ authorities
in view of obtaining inclusion of
the active
substances in Annex I to the Directive;

(3) Whereas a dossier for the active substance ZA 1296
(mesotrione) was submitted by Zeneca Agrochemi-
cals to the United Kingdom authorities on 23 April
1998;

(4) Whereas a dossier for the active substance Iodosul-
furon-methyl-sodium (AEF 115008) was submitted
by Hoechst Schering Agrevo GmbH to the German
authorities on 14 December 1998;

(5) Whereas a dossier for the active substance Silth-
iopham (MON 65500) was submitted by Monsanto
Crop Protection to the Irish authorities on 14
December 1998;

(6) Whereas a dossier for the active substance Gliocla-
dium catenulatum was submitted by Kemira Agro
Oy to the Finish authorities on 19 May 1998;

(7) Whereas

the said authorities

indicated to the
Commission the results of a first examination of
the completeness of the dossier with regard to the

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

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 subse-
quently,
in accordance with the provisions of
Article 6(2), the dossiers were submitted by the
applicant to the Commission and other Member
States;

(8) Whereas the dossiers for ZA 1296 (mesotrione),
Iodosulfuron-methyl-sodium (AEF 115008), Silth-
iopham (MON 65500) and Gliocladium catenu-
latum were referred to the Standing Committee on
Plant Health on 11 February 1999;

(9) Whereas Article 6(3) of the Directive requires it
being confirmed at the level of 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;

(10) 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 conditions laid
down in Article 8(1) of the Directive, and in partic-
ular the condition to make a detailed assessment of
the active substances and the plant-protection
products with regard to the requirements of the
Directive;

(11) 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;

15. 6. 1999

EN

Official Journal of the European Communities

L 148/45

and the Commission that

for ZA 1296 (mesotrione),

is understood between the Member
(12) Whereas it
States
the United
Kingdom will pursue the detailed examination for
the dossier
that
Germany will pursue the detailed examination for
the dossier for Iodosulfuron-methyl-sodium (AEF
115008), that Ireland will pursue the detailed exam-
ination for
for Silthiopham (MON
65500), and that Finland will pursue the detailed
examination for the dossier for Gliocladium cate-
nulatum;

the dossier

(13) Whereas the United Kingdom, Germany, Ireland
and Finland will report the conclusions of their
examinations accompanied by any recommenda-
tions on the inclusion or non-inclusion and any
conditions related thereto to the Commission as
possible and at the latest within a perid of one year;
whereas on receipt of this report the detailed exam-
ination will be continued with the expertise from
all Member States within the framework of the
Standing Committee on Plant Health;

(14) Whereas

in this
the measures provided for
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 Zeneca Agrochemicals to the
Commission and the Member States with a view to the
inclusion of ZA 1296 (mesotrione) as an active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 11 February 1999.

2. The dossier submitted by Hoechst Schering Agrevo
GmbH to the Commission and the Member States
with a view to the inclusion of Iodosulfuron-methyl-
sodium (AEF 115008) as an active substance in Annex
I to Directive 91/414/EEC and which was referred to
the Standing Committee on Plant Health on 11
February 1999.

3. The dossier submitted by Monsanto Crop Protection to
the Commission and the Member States with a view to
the inclusion of Silthiopham (MON 65500) as an
active substance in Annex I to Directive 91/414/EEC
and which was referred to the Standing Committee on
Plant Health on 11 February 1999.

4. The dossier submitted by Kemira Agro Oy to the
Commission and the Member States with a view to the
inclusion of Gliocladium catenulatum as an active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 11 February 1999.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 31 May 1999.

For the Commission

Franz FISCHLER

Member of the Commission