2002/133/EC: Commission Decision of 18 February 2002 making it possible for Member States to extend provisional authorisations granted for the new active substances carfentrazone-ethyl, cinidon-ethyl, cyhalofop-butyl, ethoxysulfuron, famoxadone, flazasulfuron, flufenacet, flumioxazine, flurtamone, fosthiazate, isoxaflutole, metalaxyl-M, prosulfuron, Pseudomonas chlororaphis, quinoxyfen, Spodoptera exigua nuclear polyhedrosis virus and sulfosulfuron (Text with EEA relevance) (notified under document number C(2002) 517)
Date: 2002-02-18
Institutions: European Commission
Subjects: European standard, marketing, pharmaceutical product, plant health product

19.2.2002

EN

Official Journal of the European Communities

L 47/41

COMMISSION DECISION

of 18 February 2002

making it possible for Member States to extend provisional authorisations granted for the new
active substances carfentrazone-ethyl, cinidon-ethyl, cyhalofop-butyl, ethoxysulfuron, famoxadone,
flazasulfuron, flufenacet, flumioxazine, flurtamone, fosthiazate, isoxaflutole, metalaxyl-M, prosul-
furon, Pseudomonas chlororaphis, quinoxyfen, Spodoptera exigua nuclear polyhedrosis virus and
sulfosulfuron

(notified under document number C(2002) 517)

(Text with EEA relevance)

(2002/133/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 2001/
87/EC (2), and in particular Article 8(1) fourth subparagraph
thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

In accordance with Article 6(2) of Council Directive
91/414/EEC France received on 14 February 1996 an
application from FMC Europe NV for the inclusion of
the active substance carfentrazone-ethyl in Annex I to
Directive 91/414/EEC. By Commission Decision 97/
362/EC (3)
the dossier was
it was confirmed that
i.e.
‘complete’
in
it could be considered as satisfying,
principle,
the data and information requirements of
Annex II and Annex III to the Directive.

The United Kingdom received a similar application on
28 April 1997 from BASF AG concerning cinidon-ethyl.
This application was declared complete by Commission
Decision 98/398/EC (4).

Italy received a similar application on 30 April 1997
from Dow AgroSciences concerning cyhalofop-butyl.
This application was declared complete by Commission
Decision 98/242/EC (5).

Italy received a similar application on 3 July 1996 from
AgrEvo (now Aventis Crop Sciences) concerning ethoxy-
sulfuron. This application was declared complete by
Commission Decision 97/591/EC (6).

France received a similar application on 2 October 1996
from Du Pont de Nemours concerning famoxadone.
This application was declared complete by Decision 97/
591/EC.

Spain received a similar application on 16 December
1996 from ISK Biosciences concerning flazasulfuron.

(7)

(8)

(9)

(10)

(11)

(12)

(13)

(14)

This application was declared complete by Commission
Decision 97/865/EC (7).

France received a similar application on 1 February
1996 from Bayer SA concerning flufenacet. This applica-
tion was declared complete by Decision 97/362/EC.

France received a similar application on 12 July 1996
from Sumitomo Chemicals Agro Europe SA concerning
flumioxazine. This application was declared complete by
Commission Decision 97/631/EC (8).

France received a similar application on 15 February
1994 from Rhone-Poulenc Agro France (now Aventis
Crop Sciences) concerning flurtamone. This application
was declared complete by Commission Decision 96/
341/EC (9).

The United Kingdom received a similar application on 5
March 1996 from ISK Biosciences concerning fosthia-
zate. This application was declared complete by Decision
97/362/EC.

The Netherlands received a similar application on 6
March 1996 from Rhone-Poulenc Agro France (now
Aventis Crop Sciences) concerning isoxaflutole. This
application was declared complete by Commission
Decision 96/524/EC (10).

Belgium received a similar application on 9 February
1996 from Novartis Crop Protection (now Syngenta)
concerning metalaxyl-M. This application was declared
complete by Decision 97/591/EC.

France received a similar application on 14 May 1995
(now Syngenta)
from Novartis Crop
concerning prosulfuron. This application was declared
complete by Commission Decision 97/137/EC (11).

Protection

Sweden received a similar application on 15 December
Lantmännen (now BioAgri)
1994 from Svenska
concerning Pseudomonas
chlororaphis. This application
was declared complete by Commission Decision 97/
248/EC (12) of 15 April 1997.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 10.10.2001, p. 17.
(3) OJ L 152, 11.6.1997, p. 31.
(4) OJ L 176, 20.6.1998, p. 34.
(5) OJ L 96, 28.3.1998, p. 45.
(6) OJ L 239, 30.8.1997, p. 48.

(7) OJ L 351, 23.12.1997, p. 67.
(8) OJ L 262, 24.9.1997, p. 7.
(9) OJ L 130, 31.5.1996, p. 20.
(10) OJ L 220, 30.8.1996, p. 27.
(11) OJ L 52, 22.2.1997, p. 20.
(12) OJ L 98, 15.4.1997, p. 15.

L 47/42

EN

Official Journal of the European Communities

19.2.2002

(15)

(16)

(17)

(18)

(19)

The United Kingdom received a similar application on 1
August 1995 from Dow Elanco Europe (now Dow Agro
Sciences) concerning quinoxyfen. This application was
declared
complete by Commission Decision 96/
457/EC (1).

The Netherlands received a similar application on 24
April 1997 from Biosys concerning Spodoptera exigua
nuclear polyhedrosis virus. This application was declared
complete by Commission Decision 97/865/EC (2).

Ireland received a similar application on 24 April 1997
from Monsanto concerning sulfosulfuron. This applica-
tion was declared complete also by Decision 97/865/EC.

Such confirmation of the completeness of the data and
information was necessary to permit a detailed exam-
ination 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
concerned, while
complying with the conditions laid down in Article 8(1)
of Directive 91/414/EEC 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.

substance

active

the

For these seventeen active substances, the effects on
human health and the environment have been assessed,
in accordance with the provisions of Article 6(2) and (4)
of Directive 91/414/EEC, for the uses proposed by the
respective applicant. The nominated rapporteur Member
States, submitted draft assessment reports concerning
the substances to the Commission on 14 May 1998
(carfentrazone-ethyl), 1 November 1998 (cinidon-ethyl),
30 November 1998 (cyhalofop-butyl), 20 May 1997
(ethoxysulfuron), 5 August 1998 (Famoxadone), 3
August 1999 (flazasulfuron), 6 January 1998 (flufe-
nacet), 20 January 1998 (flumioxazine); 21 May 1997
(flurtamone), 18 March 1998 (fosthiazate), 26 February
1997 (isoxaflutole), 27 July 1999 (metalaxyl-M), 18
January 1999 (prosulfuron), 7 April 1998 (Pseudomonas
chlororaphis), 11 October 1996 (quinoxyfen), 19
November 1999 (Spodoptera exigua nuclear polyhedrosis
virus) and 2 April 1998 (sulfosulfuron), respectively.

of the draft assessment reports by the respective rappor-
teur Member States.

(21) As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
possibility to prolong provisional authorisations granted
for plant protection products containing the concerned
active substances for a period of 24 months in accord-
ance with the provisions of Article 8 of Directive 91/
414/EEC so as to enable the examination of the dossiers
to continue. It is expected that within 24 months the
completion of
the evaluation and decision making
process with respect to a decision on possible Annex I
inclusion for each of the active substances concerned
will have been completed.

(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 carfentrazone-ethyl, cinidon-
ethyl, cyhalofop-butyl, ethoxysulfuron, famoxadone, flazasul-
furon, flufenacet, flumioxazine, flurtamone, fosthiazate, isoxa-
flutole, metalaxyl-M, prosulfuron, Pseudomonas
chlororaphis,
quinoxyfen, Spodoptera exigua nuclear polyhedrosis virus and
sulfosulfuron for a period not exceeding 24 months from the
date of adoption of this Decision.

Article 2

The present Decision is addressed to the Member States.

Done at Brussels, 18 February 2002.

(20)

It will not be possible to complete the evaluation of the
dossiers within the timeframe provided by the decisions
on completeness referred to above because the exam-
ination of the dossiers is still ongoing after submission

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 189, 30.7.1996, p. 112.
(2) OJ L 351, 23.12.1997, p. 67.