98/676/EC: Commission Decision of 17 November 1998 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of KIF 3535 (mepanipyrim), imazamox (AC 299263), DE 570 (florasulam), fluazolat (JV 485), Coniothyrium minitans and benzoic acid 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) 3514) (Text with EEA relevance)
Date: 1998-11-17
Institutions: European Commission
Subjects: dangerous substance, health control, marketing standard, pharmaceutical product, plant health product, quality label

26. 11. 98

EN

Official Journal of the European Communities

L 317/47

COMMISSION DECISION

of 17 November 1998

recognising in principle the completeness of the dossiers submitted for detailed
examination in view of the possible inclusion of KIF 3535 (mepanipyrim),
imazamox (AC 299263), DE 570 (florasulam), fluazolat (JV 485), Coniothyrium
minitans and benzoic acid 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) 3514)

(Text with EEA relevance)

(98/676/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 applicants have submitted dossiers for six active
substances
in view of
to Member States’ authorities
obtaining the inclusion of the active substances in Annex
I to the Directive;

Whereas a dossier for the active substance KIF 3535
(mepanipyrim) was
submitted by Kumiai Chemical
Industry Co. Ltd to the Italian authorities on 24 October
1997;

Whereas a dossier for the active substance imazamox (AC
299263) was submitted by Cyanamid Agro SA/NV to the
French authorities on 2 December 1997;

Whereas a dossier for the active substance DE 570 (flora-
sulam) was submitted by Dow Agro Sciences to the
Belgian authorities on 2 February 1998;

Whereas a dossier for the active substance fluazolat (JV
485) was submitted by Twinagro Ltd to the United
Kingdom authorities on 29 September 1997;

Whereas a dossier for the active substance Coniothyrium
minitans was submitted by Prophyta GmbH to the
German authorities on 10 September 1997;

Whereas a dossier for the active substance benzoic acid
was submitted by Menno Chemie Vertriebsgesellschaft
mbH to the German authorities on 25 May 1998;

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

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
substance concerned,
in Annex III to the Directive;
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;

the dossiers

Whereas
for KIF 3535 (mepanipyrim),
imazamox (AC 299263), DE 570 (florasulam), fluazolat (JV
485), Coniothyrium minitans and benzoic acid were
referred to the Standing Committee on Plant Health on 7
July 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
least one plant protection product
II
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 conditions laid down in Article 8(1) of the Direct-
ive, and in particular the condition to make a detailed
assessment of the active substances and the plant protec-
tion products with regard to the requirements of the
Directive;

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 KIF 3535 (mepanipyrim), that
France will pursue the detailed examination for
the
dossier for imazamox (AC 299263), that Belgium will
pursue the detailed examination for the dossier for DE

L 317/48

EN

Official Journal of the European Communities

26. 11. 98

570 (florasulam), that the United Kingdom will pursue
the detailed examination for the dossier for fluazolat (JV
485) and that Germany will pursue the detailed exam-
ination for the dossiers for Coniothyrium minitans and
benzoic acid;

Whereas Italy, France, Belgium, the United Kingdom and
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 Kumiai Chemical Industry
Co. Ltd to the Commission and the Member States
with a view to the inclusion of KIF 3535 (mepani-
pyrim) as active substance in Annex I to Directive
91/414/EEC and which was referred to the Standing
Committee on Plant Health on 7 July 1998;

2. the dossier submitted by Cyanamid Agro SA/NV to
the Commission and the Member States with a view to
imazamox (AC 299263) as active
the inclusion of
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 7 July 1998;

3. the dossier submitted by Dow Agro Sciences to the
Commission and the Member States with a view to the
inclusion of DE 570 (florasulam) as active substance in
Annex I to Directive 91/414/EEC and which was
referred to the Standing Committee on Plant Health
on 7 July 1998;

4. the dossier submitted by Twinagro Ltd to the Commis-
sion and the Member States with a view to the inclu-
sion of fluazolat (JV 485) as active substance in Annex
I to Directive 91/414/EEC and which was referred to
the Standing Committee on Plant Health on 7 July
1998;

5. the dossier submitted by Prophyta GmbH to the
Commission and the Member States with a view to the
inclusion of Coniothyrium minitans
active
substance in Annex I to Directive 91/414/EEC and
which was referred to the Standing Committee on
Plant Health on 7 July 1998;

as

6. the dossier submitted by Menno Chemie Vertriebsge-
sellschaft mbH to the Commission and the Member
States with a view to the inclusion of benzoic acid as
active substance in Annex I to Directive 91/414/EEC
and which was referred to the Standing Committee on
Plant Health on 7 July 1998.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 17 November 1998.

For the Commission

Franz FISCHLER

Member of the Commission