2003/896/EC: Commission Decision of 19 December 2003 allowing Member States to extend provisional authorisations granted for the new active substances thiacloprid, thiametoxam, quinoxyfen, flazasulfuron, Spodoptera exigua nuclear polyhedrosis virus, spinosad, Giocladium catenulatum, Pseudomonas chlororaphis and indoxacarb (Text with EEA relevance) (notified under document number C(2003) 4851)
Date: 2003-12-19
Institutions: European Commission
Subjects: market approval, marketing standard, pharmaceutical product, plant health product

L 333/94

EN

Official Journal of the European Union

20.12.2003

COMMISSION DECISION

of 19 December 2003

allowing Member States to extend provisional authorisations granted for the new active
substances thiacloprid, thiametoxam, quinoxyfen, flazasulfuron, Spodoptera exigua nuclear polyhe-
drosis virus, spinosad, Giocladium catenulatum, Pseudomonas chlororaphis and indoxacarb

(notified under document number C(2003) 4851)

(Text with EEA relevance)

(2003/896/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 2003/
84/EC (2) and in particular the fourth subparagraph of Article
8(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Article 6(2) of Directive 91/414/EEC,
in September 1998 the United Kingdom received an
application from Bayer AG (now Bayer CropScience) for
the inclusion of the active thiacloprid in Annex I to
Directive 91/414/EEC. Commission Decision 2000/181/
EC (3) confirmed that the dossier was complete and could
be considered as satisfying,
in principle, the data and
information requirements of Annex II and Annex III to
the Directive.

The authorities of Spain received a similar application in
March 1999 from Novartis Crop Protection AG (now
Bayer CropScience)
thiametoxam. This
concerning
dossier was declared complete by Commission Decision
2000/181/EC.

The authorities of the United Kingdom received a similar
application in August 1995 from Dow Elanco Europe
(now Dow AgroSciences) concerning quinoxyfen. This
dossier was declared complete by Commission Decision
96/457/EC (4).

The authorities of Spain received a similar application in
December 1996 from ISK Biosciences Europe SA
concerning flazasulfuron. This dossier was declared
complete by Comission Decision 97/865/EC (5).

The authorities of the Netherlands received a similar
application in July 1996 from Biosys concerning Spodop-
tera exigua nuclear polyhedrosis virus. This dossier was
declared complete by Decision 97/865/EC.

(6)

(7)

(8)

(9)

(10)

(11)

The authorities of the Netherlands received a similar
application in July 1999 from Dow AgroSciences
concerning spinosad. This dossier was declared complete
by Decision Commission 2000/210/EC (6).

The authorities of Finland received a similar application
in May 1998 from Kemira Agro Oy concerning Gliocla-
dium catenulatum. This dossier was declared complete by
Commission Decision 1999/392/EC (7).

The authorities of Sweden received a similar application
in December 1994 from Bio Agri AB concerning Pseudo-
monas chlororaphis. This dossier was declared complete
by Commission Decision 97/248/EC (8).

The authorities of the Netherlands received a similar
application in October 1997 from Du Pont de Nemours
France SA concerning indoxacarb. This dossier was
declared complete by Commission Decision 98/398/
EC (9).

Confirmation of the completeness of the dossiers was
necessary in order to allow them to be examined in
detail and to allow Member States the possibility of
granting provisional authorisations, for periods up to
three years, for plant protection products containing the
active substances 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.

For these 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
applicants. The rapporteur Member States submitted the
draft assessment reports to the Commission on 29
November 2000 (thiacloprid), 20 January 2002 (thiame-
toxam), 11 October 1996 (quinoxyfen), 1 August 1999
(flazasulfuron), 19 November 1999 (Spodoptera exigua
nuclear polyhedrosis virus ), 1 February 2001 (spinosad),
16 May 2001 (Gliocladium catenulatum), 7 April 1998
and 7 February 2000
(Pseudomonas
(indoxacarb).

chlororaphis)

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 247, 30.9.2003, p. 20.
(3) OJ L 57, 2.3.2000, p. 35.
(4) OJ L 189, 30.7.1996, p. 112.
(5) OJ L 351, 23.12.1997, p. 67.

(6) OJ L 64, 11.3.2000, p. 24.
(7) OJ L 148, 15.6.1999, p. 44.
(8) OJ L 98, 15.4.1997, p. 15.
(9) OJ L 176, 20.6.1998, p. 34.

20.12.2003

EN

Official Journal of the European Union

L 333/95

(12)

The examination of the dossiers is still ongoing after
submission of the draft assessment reports by the respec-
tive rapporteur Member States and it will not be possible
to complete the evaluation within the timeframe fore-
seen by Council Directive 91/414/EEC.

(13) As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
possibility of prolonging provisional
authorisations
granted for plant protection products containing the
active substances concerned for a period of 24 months
in accordance with the provisions of Article 8 of Direc-
tive 91/414/EEC so as to enable the examination of the
dossiers to continue. It is expected that 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 within
24 months.

(14)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

containing

Member States may extend provisional authorisations for plant
thiametoxam,
protection products
flazasulfuron, Spodoptera exigua nuclear polyhe-
quinoxyfen,
drosis virus,
spinosad, Giocladium catenulatum, Pseudomonas
chlororaphis or indoxacarb for a period not exceeding 24
months from the date of adoption of this Decision.

thiacloprid,

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 19 December 2003.

For the Commission

David BYRNE

Member of the Commission