2001/315/EC: Commission Decision of 18 April 2001 making it possible for Member States to extend provisional authorisations granted for the new active substances flupyrsulfuron-methyl, carfentrazone-ethyl, famoxadone, prosulfuron, isoxaflutole, flurtamone, ethoxysulfuron, paecilomyces fumosoroseus, and cyclanilide (Text with EEA relevance) (notified under document number C(2001) 1090)
Date: 2001-04-18
Institutions: European Commission
Subjects: EU control, market approval, marketing, pharmaceutical product, plant health product

19.4.2001

EN

Official Journal of the European Communities

L 109/69

COMMISSION DECISION

of 18 April 2001

making it possible for Member States to extend provisional authorisations granted for the new
active substances flupyrsulfuron-methyl, carfentrazone-ethyl, famoxadone, prosulfuron, isoxaflu-
tole, flurtamone, ethoxysulfuron, paecilomyces fumosoroseus, and cyclanilide

(notified under document number C(2001) 1090)

(Text with EEA relevance)

(2001/315/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(10)

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 (2), and in particular Article 8(1) fourth subparagraph
thereof,

Whereas:

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.

The applicant Du Pont de Nemours submitted a dossier
for the new active substance flupyrsulfuron-methyl to
France on 26 October 1995.

The applicant FMC Europe NV submitted a dossier for
the new active substance carfentrazone-ethyl to France
on 14 February 1996.

The applicant Du Pont de Nemours submitted a dossier
for the new active substance famoxadone to France on 2
October 1996.

(11)

(12)

(13)

The applicant Novartis submitted a dossier for the new
active substance prosulfuron to France on 14 May 1995.

(14)

The applicant Rhone-Poulenc submitted a dossier for the
new active substance isoxaflutole to the Netherlands on
6 March 1996.

The applicant Rhone-Poulenc submitted a dossier for the
new active substance flurtamone to France on 15
February 1994.

(15)

The applicant AgrEvo submitted a dossier for the new
active substance ethoxysulfuron to Italy on 3 July 1996.

The applicant Thermo Trilogy Corporation submitted a
dossier for the new active substance paecilomyces fumosor-
oseus to Belgium on 18 May 1994.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 9.12.2000, p. 14.

The applicant Rhone-Poulenc Agrochimie SA submitted
a dossier for the new active substance cyclanilide to
Greece on 27 March 1996.

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/164/EC (3) that the dossier submitted for flupyrsul-
furon-methyl could be considered as satisfying, in prin-
ciple, 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
Directive,
the Commission confirmed in its Decision
97/362/EC (4) that the dossier submitted for carfentra-
zone-ethyl 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 (5) that the dossier submitted for famoxadone
could be considered as satisfying, in principle, the data
and information requirements of Annex II and for a
active
containing
plant
substance, of Annex III to the Directive.

protection

product

this

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/137/EC (6) that the dossier submitted for prosulfuron
could be considered as satisfying, in principle, the data
and information requirements of Annex II and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/524/EC (7) that the dossier submitted for isoxaflutole
could be considered as satisfying, in principle, the data
and information requirements of Annex II and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

(3) OJ L 64, 5.3.1997, p. 17.
(4) OJ L 152, 11.6.1997, p. 31.
(5) OJ L 239, 30.8.1997, p. 48.
(6) OJ L 52, 22.2.1997, p. 20.
(7) OJ L 220, 30.8.1996, p. 27.

L 109/70

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Official Journal of the European Communities

19.4.2001

(16)

(17)

(18)

(19)

(20)

(21)

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/341/EC (1) that the dossier submitted for flurtamone
could be considered as satisfying, in principle, the data
and information requirements of Annex II and for a
active
containing
plant
substance, of Annex III to the Directive.

protection

product

this

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/591/EC that the dossier submitted for ethoxysulfuron
could be considered as satisfying, in principle, the data
and information requirements of Annex II and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/164/EC of 17 February 1997 that
the dossier
submitted for paecilomyces fumosoroseus could be consid-
ered 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
Directive,
the Commission confirmed in its Decision
the dossier
97/137/EC of 3 February 1997 that
submitted for cyclanilide could be considered as satis-
fying,
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.

Such confirmation of data and information is necessary
to permit a detailed examination of the dossier and to
allow Member States the possibility to grant provisional
authorisations, for a period up to three years, for plant
protection products containing the active substance
concerned, while complying with the conditions laid
down in Articles 8(1) of the Directive and, in particular,
the condition relating to the detailed assessment of the
active substance and the plant protection product in the
light of the requirements laid down by the Directive.

For flupyrsulfuron-methyl 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. France
acting as nominated rapporteur Member State submitted
to the Commission on 2 December 1997 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.

(1) OJ L 130, 31.5.1996, p. 20.

(22)

(23)

(24)

(25)

(26)

For carfentrazone-ethyl, 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. France acting as
nominated rapporteur Member State submitted to the
Commission on 14 May 1998 the draft assessment
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.

submitted report

concerned. The

For famoxadone, 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. France acting as nomi-
nated rapporteur Member State
submitted to the
Commission on 5 August 1998 the draft assessment
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.

submitted report

concerned. The

For prosulfuron, 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. France acting as nomi-
submitted to the
nated rapporteur Member State
Commission on 18 January 1999 the draft assessment
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.

submitted report

concerned. The

For isoxaflutole, 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 Netherlands acting
as nominated rapporteur Member State submitted to the
Commission on 26 February 1997 the draft assessment
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.

submitted report

concerned. The

For flurtamone, 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. France acting as nomi-
submitted to the
nated rapporteur Member State
Commission on 21 May 1997 the draft assessment
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.

submitted report

concerned. The

19.4.2001

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Official Journal of the European Communities

L 109/71

(27)

(28)

(29)

(30)

For ethoxysulfuron, 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. Italy acting as nomi-
nated rapporteur Member State
submitted to the
Commission on 20 May 1997 the draft assessment
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.

submitted report

concerned. The

fumosoroseus,

the effects on human
For paecilomyces
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.
Belgium acting as nominated rapporteur Member State
submitted to the Commission on 9 December 1997 the
draft assessment report concerned. The submitted report
is being reviewed by the Member States and the
the Standing
Commission within the framework of
Committee on Plant Health and in Working Groups
thereof.

For cyclanilide, 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. Greece acting as nomi-
nated rapporteur Member State
submitted to the
Commission on 11 February 1998 the draft assessment
is being
report
reviewed by the Member States and the Commission
within the framework of the Standing Committee on
Plant Health and in Working Groups thereof.

submitted report

concerned. The

It will not be possible to complete the evaluation of the
dossiers within three years of the adoption of the deci-
sions on completeness referred to above because the
examination of the dossiers after submission of the draft
assessment reports by the respective rapporteur Member
States has taken longer than three years.

(31) Member States

should be given the possibility of
prolonging provisional authorisations of plant protec-
tion 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. It is expected that within 12
months the completion of the evaluation and decision
making process with respect to a decision on possible
Annex I
the active substances
concerned will have been completed.

inclusion for each of

(32)

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 flupyrsulfuron-methyl, carfen-
trazone-ethyl,
flurta-
mone, ethoxysulfuron, paecilomyces fumosoroseus, and cyclanilide
for a period not exceeding 12 months from the date of adop-
tion of this Decision.

famoxadone, prosulfuron,

isoxaflutole,

Article 2

The present Decision is addressed to the Member States.

Done at Brussels, 18 April 2001.

For the Commission

David BYRNE

Member of the Commission