2003/370/EC: Commission Decision of 21 May 2003 allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid-P (Text with EEA relevance) (notified under document number C(2003) 1583)
Date: 2003-05-21
Institutions: European Commission
Subjects: Belgium, Germany, Netherlands, Spain, application of EU law, chemical product

L 127/58

EN

Official Journal of the European Union

23.5.2003

COMMISSION DECISION

of 21 May 2003

allowing Member States to extend provisional authorisations granted for the new active
indoxacarb, S-metolachlor, Spodoptera exigua nuclear
substances iodosulfuron-methyl-sodium,

polyhedrosis virus, tepraloxydim and dimethenamid-P

(notified under document number C(2003) 1583)

(Text with EEA relevance)

(2003/370/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

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

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

In accordance with Article 6(2) of Directive 91/414/EEC,
in December 1998 Germany received an application
from AgrEvo GmbH (now Bayer CropScience) for the
inclusion of the active substance iodosulfuron-methyl-
sodium in Annex I to Directive 91/414/EEC. Commis-
sion Decision 1999/392/EC (3)
the
dossier was complete and could be considered as satis-
fying,
in principle, the data and information require-
ments of Annex II and Annex III to the Directive.

confirmed that

The authorities of the Netherlands received a similar
application in October 1997 from Du Pont de Nemours
concerning
indoxacarb. This dossier was declared
complete by Commission Decision 98/398/EC (4).

Belgium received a similar application in August 1997
from Novartis NV (now Syngenta) concerning S-metol-
achlor. This dossier was declared complete by Commis-
sion Decision 98/512/EC (5).

The Netherlands received a similar application in July
1996 from Biosys concerning Spodoptera exigua nuclear
polyhedrosis virus. This dossier was declared complete
by Commission Decision 97/865/EC (6).

Spain received a similar application in September 1997
from BASF AG concerning tepraloxydim. This dossier
was declared complete by Decision 98/512/EC.

Germany received a similar application in April 1999
from BASF AG concerning dimethenamid-P. This dossier
was declared complete by Commission Decision 1999/
555/EC (7).

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 101, 23.4.2003, p. 3.
(3) OJ L 148, 15.6.1999, p. 44.
(4) OJ L 176, 20.6.1998, p. 34.
(5) OJ L 228, 15.8.1998, p. 35.
(6) OJ L 351, 23.12.1997, p. 67.
(7) OJ L 210, 10.8.1999, p. 22.

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.

(8)

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 30 May
2000 (iodosulfuron-methyl-sodium), 7 February 2000
(indoxacarb), 3 May 1999 (S-metolachlor), 9 November
1999 (Spodoptera exigua NPV), 21 January 2001 (tepra-
loxydim) and 26 September 2000 (dimethenamid-P).

(9)

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 Directive 91/414/EEC.

(10) 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.

23.5.2003

EN

Official Journal of the European Union

L 127/59

(11)

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

Article 2

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant
protection products containing iodosulfuron-methyl-sodium,
indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhe-
drosis virus, tepraloxydim and dimethenamid-P for a period not
exceeding 24 months from the date of adoption of
this
Decision.

Done at Brussels, 21 May 2003.

For the Commission

David BYRNE

Member of the Commission