2008/748/EC: Commission Decision of 18 September 2008 concerning the non-inclusion of triflumizole in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2008) 5075) (Text with EEA relevance)
Date: 2008-09-18
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, public health, withdrawal from the market

20.9.2008

EN

Official Journal of the European Union

L 252/37

COMMISSION DECISION

of 18 September 2008

concerning the non-inclusion of triflumizole in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2008) 5075)

(Text with EEA relevance)

(2008/748/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(2) thereof,

the

Whereas:

(1)

(2)

(3)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
following the notification of
that Directive, authorise
the placing on the market of plant protection products
containing active substances not listed in Annex I to that
Directive that are already on the market two years after
the date of notification, while those substances are
gradually being examined within the framework of a
programme of work.

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 1490/2002 (3) lay down the detailed rules for the
implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC
and establish a list of active substances to be assessed
with a view to their possible inclusion in Annex I to
Directive 91/414/EEC. That list includes triflumizole.

For triflumizole the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 1490/2002 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
the
rapporteur Member States which have to submit

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 29.2.2000, p. 25.
(3) OJ L 224, 21.8.2002, p. 23.

(4)

(5)

(6)

(7)

(8)

relevant assessment reports and recommendations to the
European Food Safety Authority (EFSA)
in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
triflumizole the rapporteur Member State was the Neth­
erlands and all relevant information was submitted on
4 January 2006.

The Commission examined triflumizole in accordance
with Article 11a of Regulation (EC) No 1490/2002. A
draft review report for that substance was reviewed by
the Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 20 May 2008 in the format of
the Commission review report.

During the examination of this active substance by the
Committee, taking into account comments from Member
States, it was concluded that there are clear indications
that it may be expected that it has harmful effects on
human health and in particular the exposure of operator
and worker is greater than 100 % of the AOEL.

to submit

arguments put

The Commission invited the notifier
its
comments on the results of the examination of triflu­
mizole and on its intention or not to further support
the substance. The notifier
submitted its comments
which have been carefully examined. However, despite
the
the
the notifier,
and
identified could not be
concerns
eliminated,
the information
assessments made on the basis of
submitted have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing triflumizole satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

forwards by

Triflumizole should therefore not be included in Annex I
to Directive 91/414/EEC.

Measures should be taken to ensure that authorisations
granted for plant protection products containing triflu­
mizole are withdrawn within a fixed period of time and
are not renewed and that no new authorisations for such
products are granted.

L 252/38

EN

Official Journal of the European Union

20.9.2008

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

triflumizole are withdrawn by 18 March 2009;

(b) no authorisations for plant protection products containing
triflumizole are granted or renewed from the date of publi­
cation of this Decision.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be as short as possible and shall expire on 18 March
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 18 September 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(9)

(10)

(11)

Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
triflumizole should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season, which ensures that plant protection products
containing triflumizole remain available for 18 months
from the adoption of this Decision.

in

for

triflumizole

This Decision does not prejudice the submission of an
application
accordance with
Article 6(2) of Directive 91/414/EEC and Commission
Regulation (EC) No 33/2008 of 17 January 2008
application of
laying down detailed rules
Council Directive 91/414/EEC as regards a regular and
an accelerated procedure for the assessment of active
substances which were part of the programme of work
referred to in Article 8(2) of that Directive but have not
been included into its Annex I (1), in view of a possible
inclusion in its Annex I.

the

for

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

Triflumizole shall not be included as an active substance in
Annex I to Directive 91/414/EEC.

(1) OJ L 15, 18.1.2008, p. 5.