2005/743/EC: Commission Decision of 19 October 2005 allowing Member States to extend provisional authorisations granted for the new active substances boscalid, indoxacarb, spinosad and Spodoptera exigua nuclear polyhedrosis virus (notified under document number C(2005) 4002)   (Text with EEA relevance)
Date: 2005-10-19
Institutions: European Commission
Subjects: market approval, marketing, marketing standard, pharmaceutical product, plant health product, product safety

22.10.2005

EN

Official Journal of the European Union

L 279/73

COMMISSION DECISION

of 19 October 2005

allowing Member States to extend provisional authorisations granted for the new active substances
boscalid, indoxacarb, spinosad and Spodoptera exigua nuclear polyhedrosis virus

(notified under document number C(2005) 4002)

(Text with EEA relevance)

(2005/743/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular
fourth subparagraph of
Article 8(1) thereof,

the

Whereas:

(1)

(2)

(3)

(4)

the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
in April 2001 Germany received an application from
the active substance
BASF AG for
to
boscalid (former name: nicobifen)
in Annex I
Decision
Directive
2002/268/EC (2)
dossier was
the
complete and could be considered as
in
satisfying,
principle,
the data and information requirements of
Annex II and Annex III to that Directive.

Commission
that

91/414/EEC.

confirmed

concerning

In October 1997 the Netherlands received an application
from DuPont de Nemours
indoxacarb
(former name: DPX-KN128). Commission Decision
98/398/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 that Directive.

Agrosciences

In July 1999 the Netherlands received an application
from Dow
spinosad.
Commission Decision 2000/210/EC (4) confirmed that
the dossier was complete and could be considered as
satisfying,
and information
requirements of Annex II and Annex III to that Directive.

in principle,

concerning

the data

In July 1996 the Netherlands received an application
from Biosys concerning Spodoptera exigua nuclear polyhe-
97/865/EC (5)
Commission Decision
drosis

virus.

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2005/34/EC (OJ L 125, 18.5.2005, p. 5).

(2) OJ L 92, 9.4.2002, p. 34.
(3) OJ L 176, 20.6.1998, p. 34.
(4) OJ L 64, 11.3.2000, p. 24.
(5) OJ L 351, 23.12.1997, p. 67.

(5)

(6)

(7)

(8)

confirmed that the dossier was complete and could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annex II and Annex III to that
Directive.

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 that 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
reports to the Commission on 22
draft assessment
2000
November
(indoxacarb), 5 March 2001 (spinosad)
and 19
November 1999 (Spodoptera exigua nuclear polyhedrosis
virus).

(boscalid),

February

2002

7

Following submission of the draft assessment reports by
the rapporteur Member States, it has been necessary to
request further information from the applicants and to
have the Rapporteur Member States examine that infor-
mation and submit
the
examination of the dossiers is still ongoing and it will
not be possible to complete the evaluation within the
timeframe provided for in Directive 91/414/EEC.

their assessments. Therefore,

As the evaluation so far has not identified any reason for
immediate concern, Member States should be given the
authorisations
possibility of prolonging provisional
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
Directive 91/414/EEC so as to enable the examination
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
within 24 months.

the dossiers to continue.

is expected that

It

L 279/74

EN

Official Journal of the European Union

22.10.2005

(9)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

Article 2

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Article 1

Done at Brussels, 19 October 2005.

Member States may extend provisional authorisations for plant
indoxacarb, spinosad
protection products containing boscalid,
or Spodoptera exigua nuclear polyhedrosis virus for a period
not exceeding 24 months from the date of adoption of this
Decision.

For the Commission

Markos KYPRIANOU
Member of the Commission