2007/333/EC: Commission Decision of 8 May 2007 allowing Member States to extend provisional authorisations granted for the new active substances benalaxyl-M, fluoxastrobin, prothioconazole, spirodiclofen, spiromesifen and sulfuryl fluoride (notified under document number C(2007) 1929) (Text with EEA relevance )
Date: 2007-05-08
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health legislation, plant health product

15.5.2007

EN

Official Journal of the European Union

L 125/27

COMMISSION DECISION

of 8 May 2007

allowing Member States to extend provisional authorisations granted for the new active substances
benalaxyl-M, fluoxastrobin, prothioconazole, spirodiclofen, spiromesifen and sulfuryl fluoride

(notified under document number C(2007) 1929)

(Text with EEA relevance)

(2007/333/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)

for

the

inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
in February 2002 Portugal received an application from
Isagro,
substance
active
benalaxyl-M in Annex I
to Directive 91/414/EEC.
Commission Decision 2003/35/EC (2) 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

the

In March 2002 the United Kingdom received an appli-
cation from Bayer CropScience concerning fluoxastrobin.
the dossier was
Decision 2003/35/EC confirmed that
complete and could be considered as
in
satisfying,
the data and information requirements of
principle,
Annex II and Annex III to that Directive.

In March 2002 the United Kingdom received an appli-
cation from Bayer CropScience concerning prothioco-
nazole. Decision 2003/35/EC confirmed
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

that

(4)

In August 2001 the Netherlands received an application
from Bayer AG concerning spirodiclofen. Commission

(5)

(6)

(7)

(8)

Decision 2002/593/EC (3) confirmed that the dossier was
complete and could be considered as
in
the data and information requirements of
principle,
Annex II and Annex III to that Directive.

satisfying,

from Bayer AG concerning

In April 2002 the United Kingdom received an appli-
cation
spiromesifen.
Commission Decision 2003/105/EC (4) 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 July 2002 the United Kingdom received an application
from Dow AgroSciences Ltd concerning sulfuryl fluoride.
Commission Decision 2003/305/EC (5), which used the
name sulphuryl fluoride in the English version, 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,

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
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 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 applicant. The
rapporteur Member States submitted the draft assessment
reports
to the Commission on 4 December 2003
(benalaxyl-M), 14 October 2003 (fluoxastrobin), 20
October 2004 (prothioconazole), 18 May 2004 (spirodi-
and on 9
clofen), 16 April 2004 (spiromesifen)
November 2004 (sulfuryl fluoride), respectively.

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).

(2) OJ L 11, 16.1.2003, p. 52.

(3) OJ L 192, 20.7.2002, p. 60.
(4) OJ L 43, 18.2.2003, p. 45.
(5) OJ L 112, 6.5.2003, p. 10.

L 125/28

EN

Official Journal of the European Union

15.5.2007

(9)

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

(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
Directive 91/414/EEC so as to enable the examination
the
of
evaluation and decision-making process with respect to
a decision on possible Annex I inclusion for benalaxyl-M,
fluoxastrobin,
spiro-
mesifen and sulfuryl fluoride will have been completed
within 24 months.

the dossiers to continue.

is expected that

prothioconazole,

spirodiclofen,

It

(11)

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

Member States may extend provisional authorisations for plant
fluoxastrobin,
protection products
prothioconazole,
sulfuryl
or
fluoride for a period not exceeding 24 months from the date
of adoption of this Decision.

containing benalaxyl-M,
spiromesifen

spirodiclofen,

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 8 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission