2008/56/EC: Commission Decision of 16 January 2008 allowing Member States to extend provisional authorisations granted for the new active substances benthiavalicarb, proquinazid and silver thiosulphate (notified under document number C(2008) 9) (Text with EEA relevance)
Date: 2008-01-16
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health legislation, plant health product

L 14/26

EN

Official Journal of the European Union

17.1.2008

COMMISSION DECISION

of 16 January 2008

allowing Member States to extend provisional authorisations granted for the new active substances
benthiavalicarb, proquinazid and silver thiosulphate

(notified under document number C(2008) 9)

(Text with EEA relevance)

(2008/56/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

(4)

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:

(5)

(6)

(7)

(1)

(2)

(3)

In accordance with Article 6(2) of Directive 91/414/EEC,
in April 2002 Belgium received an application from
Kumiai Chemicals Industry Co. Ltd.,
for the inclusion
of the active substance benthiavalicarb in Annex I to
Directive
Decision
2003/35/EC (2)
dossier was
the
complete and could be considered as
in
satisfying,
the data and information requirements of
principle,
Annex II and Annex III to that Directive.

Commission
that

91/414/EEC.

confirmed

In January 2004 the United Kingdom received an appli-
cation from DuPont (UK) Ltd concerning proquinazid.
Commission Decision 2004/686/EC (3) confirmed that
the dossier was complete and could be considered as
and information
satisfying,
requirements of Annex II and Annex III to that Directive.

in principle,

the data

In January 2003 the Netherlands received an application
from Enhold B.V.
thiosulphate.
concerning
Commission Decision 2003/850/EC (4) confirmed that
the dossier was complete and could be considered as

silver

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

last amended by
Commission Directive 2007/76/EC (OJ L 337, 21.12.2007, p. 100).

(2) OJ L 11, 16.1.2003, p. 52.
(3) OJ L 313, 12.10.2004, p. 21.
(4) OJ L 322, 9.12.2003, p. 28.

satisfying,
and information
requirements of Annex II and Annex III to that Directive.

in principle,

the data

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 of up to
three years, for plant protection products containing the
active substances concerned, while complying with the
laid down in Article 8(1) of Directive
conditions
91/414/EEC and, in particular, the condition relating to
the detailed assessment of the active substances 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 applicants. The
rapporteur Member States submitted the draft assessment
reports to the Commission on 10 May 2004 (benthiava-
licarb), 9 June 2006 (proquinazid), 9 November 2005
(silver thiosulphate), respectively.

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

timeframe

provided

for

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 benthiava-
licarb, proquinazid and silver thiosulphate will have been
completed within 24 months.

the dossiers to continue.

is expected that

It

17.1.2008

EN

Official Journal of the European Union

L 14/27

(8)

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

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 16 January 2008.

Member States may extend provisional authorisations for plant
protection products containing benthiavalicarb, proquinazid or
silver thiosulphate for a period not exceeding 24 months from
the date of adoption of this Decision.

For the Commission

Markos KYPRIANOU
Member of the Commission