2000/767/EC: Commission Decision of 5 December 2000 making it possible to extend provisional authorisations granted for the new active substances FOE 5043 (flufenacet - earlier name fluthiamide) and flumioxazine (notified under document number C(2000) 3658) (Text with EEA relevance)
Date: 2000-12-05
Institutions: European Commission
Subjects: marketing standard, pharmaceutical product, plant health legislation, plant health product, toxic substance

L 306/34

EN

Official Journal of the European Communities

7.12.2000

COMMISSION

COMMISSION DECISION

of 5 December 2000

making it possible to extend provisional authorisations granted for the new active substances FOE
5043 (flufenacet — earlier name fluthiamide) and flumioxazine

(notified under document number C(2000) 3658)

(Text with EEA relevance)

(2000/767/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 2000/
68/EC (2), and in particular Article 8(1) fourth subparagraph
thereof,

(6)

Whereas:

(1)

(2)

(3)

(4)

(5)

Directive 91/414/EEC (hereinafter ‘the Directive’) has
provided for the development of a Community list of
active substances authorised for use in plant protection
products.

The applicant Bayer SA submitted a dossier for the new
active substance FOE 5043 (flufenacet)
(previously
known as fluthiamide) to France on 1 February 1996.

(7)

The applicant Cyanamid submitted a dossier for the new
active substance flumioxazine to France on 2 May 1994.

In accordance with the provisions of Article 6(3) of the
the Commission confirmed in its Decision
Directive,
97/362/EC (3) that the dossier submitted for FOE 5043
(flufenacet) could be considered as satisfying,
in prin-
ciple, the data and information requirements of Annex II
and for a plant protection product containing this active
substance, of Annex III to the Directive.

In accordance with the provisions of Article 6(3) of the
Directive,
the Commission confirmed in its Decision
97/631/EC (4) that the dossier submitted for flumioxa-
zine could be considered as satisfying, in principle, the

(8)

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 28.10.2000, p. 41.
(3) OJ L 152, 11.6.1997, p. 31.
(4) OJ L 262, 24.9.1997, p. 7.

data and information requirements of Annex II and for a
plant
active
containing
substance, of Annex III to the Directive.

protection

product

this

Such confirmation of data and information is necessary
to permit a detailed examination of the dossier and to
allow Member States the possibility to grant provisional
authorisations, for a period up to three years, for plant-
protection products containing the active substance
concerned, while complying with the conditions laid
down in Article 8(1) of the Directive 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 FOE 5043 (flufenacet) the effects on human health
and the environment are being assessed, in accordance
with the provisions of Article 6(2) and (4) of
the
Directive, for the uses proposed by the applicant. France
acting as nominated rapporteur Member State submitted
to the Commission on 6 January 1998 the draft assess-
ment report concerned. The submitted report is being
reviewed by the Member States and the Commission
within the framework of the Standing Committee on
Plant Health and in working groups thereof.

For flumioxazine, the effects on human health and the
environment are being assessed, in accordance with the
provisions of Article 6(2) and (4) of the Directive, for the
uses proposed by the applicant. France acting as nomi-
submitted to the
nated rapporteur Member State
Commission on 20 January 1998 the draft assessment
report
is being
reviewed by the Member States and the Commission
within the framework of the Standing Committee on
Plant Health and in working groups thereof.

submitted report

concerned. The

7.12.2000

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Official Journal of the European Communities

L 306/35

(9)

(10)

(11)

It will not be possible to complete the evaluation of the
dossiers within three years of the adoption of the deci-
sions on completeness referred to above because the
examination of the dossiers after submission of the draft
assessment reports by the rapporteur Member State,
France, have been subject to longer time periods than
the Community average for new active substance evalu-
ation.
The evaluation processes for both applications have
been examined according to a set of assessment criteria.
From this analysis it would appear that the longer time
periods for the Community evaluation have been due to
factors essentially not due to the two applicants referred
to above.
To enable the assessment of the FOE 5043 (flufenacet)
and flumioxazine to continue, and to permit plant-
protection products containing these active substances
to continue to be made provisionally available for use in
agriculture, Member States should therefore be permitted
to prolong authorisations of plant protection products
containing these active substances granted under Article
8(1) of the Directive.

(12) An extension of 12 months is proposed in both cases, as
this should be sufficient to allow the completion of the
evaluation and decision making process with respect to
a decision on possible Annex I inclusion.
Such provisions to extend the possible time limits for
provisional authorisations should be seen as a temporary
measure. The Commission has already taken steps to
improve the efficiency of the evaluation system with a

(13)

view to complete the evaluation of a new active
substance within a period of three years from the date of
publication of the completeness.

(14)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on Plant Health,

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations already
granted for plant-protection products containing FOE 5043
(flufenacet) and flumioxazine for a period not exceeding 12
months from the date of adoption of this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 5 December 2000.

For the Commission

David BYRNE

Member of the Commission