2001/231/EC: Commission Decision of 13 March 2001 making it possible for Member States to extend provisional authorisations granted for the new active substances IKI 1145; TO 1145 (fosthiazate), CGA 329351 (metalaxyl-m), MON 37500 (sulfosulfuron) and Spodoptera exigua nuclear polyhedrosis virus (Text with EEA relevance) (notified under document number C(2001) 698)
Date: 2001-03-13
Institutions: European Commission
Subjects: agro-industry, marketing standard, pharmaceutical product, plant health legislation, plant health product, toxic substance

23.3.2001

EN

Official Journal of the European Communities

L 84/55

COMMISSION DECISION

of 13 March 2001

making it possible for Member States to extend provisional authorisations granted for the new
active substances IKI 1145; TO 1145 (fosthiazate), CGA 329351 (metalaxyl-m), MON 37500 (sulfo-
sulfuron) and Spodoptera exigua nuclear polyhedrosis virus

(notified under document number C(2001) 698)

(Text with EEA relevance)

(2001/231/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 2000/
80/EC of 4 December 2000 (2), and in particular Article 8(1)
fourth subparagraph thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

Directive 91/414/EEC (hereinafter ‘the Directive’) has
provided for the development of a Community list of
active substances authorised for use in plant protection
products.

ISK Biosciences

submitted a dossier
The applicant
seeking the inclusion in this list for the new active
substance IKI 1145; TO 1145 (fosthiazate) to the United
Kingdom on 5 March 1996.

The applicant Novartis Crop protection Ag. submitted a
dossier seeking the inclusion in this list for the new
active substance CGA 329351 (metalaxyl-m) to Belgium
on 9 February 1996.

The applicant Monsanto submitted a dossier seeking the
inclusion in this list for the new active substance MON
37500 (sulfosulfuron) to Ireland on 24 April 1997.

The applicant Biosys submitted a dossier seeking the
inclusion in this list for the new active substance Spodop-
tera exigua nulcear polyhedrosis virus to the Netherlands
on 12 July 1996.

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/362/EC (3) that the dossier submitted for IKI 1145;
TO 1145 (fosthiazate) could be considered as satisfying,
in principle, the data and information requirements of
Annex II and for a plant protection product containing
this active substance, of Annex III to the Directive.

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/591/EC (4)
submitted for CGA

the dossier

that

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 9.12.2000, p. 14.
(3) OJ L 152, 11.6.1997, p. 31.
(4) OJ L 239, 30.8.1997, p. 48.

(8)

(9)

(10)

(11)

329351 (metalaxyl-m) could be considered as satisfying,
in principle, the data and information requirements of
Annex II and for a plant protection product containing
this active substance, of Annex III to the Directive.

that

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/865/EC (5)
submitted for MON
37500 (sulfosulfuron) could be considered as satisfying,
in principle, the data and information requirements of
Annex II and for a plant protection product containing
this active substance, of Annex III to the Directive.

the dossier

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/865/EC that
the dossier submitted for Spodoptera
exigua nuclear polyhedrosis virus could be considered as
satisfying, in principle, the data and information require-
ments of Annex II and for a plant protection product
containing this active substance, of Annex III to the
Directive.

protection

Such confirmation of data and information is necessry
to permit a detailed examination of the dossier and to
allow Member States the possibility of granting provi-
sional authorisations, for a period up to three years, for
plant
active
substances concerned, while complying with the condi-
tions laid down in Article 8(1) of the Directive and, in
particular, the condition relating to the detailed assess-
ment of the active substance and the plant protection
product in the light of the requirements laid down by
the Directive.

containing

products

the

For IKI 1145; TO 1145 (fosthiazate)
the effects on
human health and the environment are being assessed,
in accordance with the provisions of Article 6(2) and (4)
of the Directive, for the uses proposed by the applicant.
The United Kingdom acting as nominated rapporteur
Member State submitted to the Commission on 18
March 1998 the draft assessment report concerned. The
submitted report is being reviewed by the Member States
and the Commission within the framework of
the
Standing Committee on Plant Health and in working
groups thereof.

(5) OJ L 351, 23.12.1997, p. 67.

L 84/56

EN

Official Journal of the European Communities

23.3.2001

(12)

(13)

(14)

(15)

for

For CGA 329351 (metalaxyl-m), the effects on human
health and the environment are being asessed, in accord-
ance with the provisons of Article 6(2) and (4) of the
Directive,
the uses proposed by the applicant.
Belgium acting as nominated rapporteur Member State
submitted to the Commission on 27 July 1999 the draft
assessment report concerned. The submitted report is
being reviewed by the Member States and the Commis-
sion within the framework of the Standing Committee
on Plant Health and in working groups thereof.

For MON 37500 (sulfosulfuron), the effects on human
health and the environment are being assessed,
in
accordance with the provisons of article 6(2) and (4) of
the Directive, for the uses proposed by the applicant.
Ireland acting as nominated rapporteur Member State
submtited to the Commission on 2 April 1998 the draft
assessment report concerned. the submitted report is
being reviewed by the Member States and the Commis-
sion within the framework of the Standing Committee
on Plant Health and in working groups thereof.

For Spodoptera exigua nuclear polyhedrosis virus,
the
effects on human health and the environment are being
in accordance with the provisions of Article
assessed,
6(2) and (4) of the Directive, for the uses proposed by
the applicant. The Netherlands acting as nominated
rapporteur Member State submitted to the Commission
on 19 November 1999 the draft assessment report
concerned. The submitted reports is being reviewed by
the Member States and the Commission within the
framework of the Standing Committee on Plant Health
and in working groups thereof.

It has not been possible to complete the evaluation of
these dossiers within three years of the adoption of the
decisions on completeness referred to. In the case of
fosthiazate there has been a lengthy and in-depth exam-
ination of questions relating to operator exposure and
fate in the environment. In the case of metalaxyl-m the
issue of fate in the environment has been the subject of
much discussion. For sulfosulfuron there has been an
in-depth examination of an issue relating to mammalian
toxicology. For Spodoptera exigua nuclear polyhedrosis
virus, the risk assessments for human health and the
environment have been the subject of lengthy exam-
ination and discussions.

(17)

(18)

(19)

Belgium granted the first provisional authorisation for
CGA 329351 (metalaxyl-m) on 20 January 1998 which
will expire on 20 January 2001.

Ireland granted the first provisional authorisation for
MON 37500 (sulfosulfuron) on 16 February 1998
which will expire on 16 February 2001.

The Netherlands granted the first provisional author-
isation for Spodoptera exigua nuclear polyhedrosis virus
on 1 December 1997 which will expire on 1 December
2000.

(20) Member States

should be given the possibility to
prolong provisional authorisations of plant protection
products containing these active substances for a period
of 12 months in accordance with the provisions of
Article 8 of the Directive so as to enable examination of
the dossiers to continue.

(21)

Provisional authorisations may only be maintained if the
Member State concerned has established that the active
substance can still satisfy the safety requirements of
Article 5(1) of the Directive and that the plant protec-
tion product may be expected to satisfy the require-
ments of Article 4(1) points (b) to (f).

(22)

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

Member States may extend provisional authorisations for plant
protection products containing IKI 1145; TO 1145 (fosthia-
zate), CGA 329351 (metalaxyl-m), MON 37500 (sulfosulfuron)
and Spodoptera exigua nuclear polyhedrosis virus for a period
not exceeding 12 months from the date of adoption of this
Decision.

The present Decision is addressed to the Member States.

Article 2

Done at Brussels, 13 March 2001.

(16)

The United Kingdom granted the first provisional
authorisation for IKI 1145; TO 1145 (fosthiazate) on 25
February 1998 which will expire on 25 February 2001.

For the Commission

David BYRNE

Member of the Commission