2008/770/EC: Commission Decision of 30 September 2008 concerning the non-inclusion of tricyclazole 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) 5108) (Text with EEA relevance)
Date: 2008-09-30
Institutions: European Commission
Subjects: marketing restriction, pesticide, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 263/16

EN

Official Journal of the European Union

2.10.2008

COMMISSION DECISION

of 30 September 2008

concerning the non-inclusion of tricyclazole 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) 5108)

(Text with EEA relevance)

(2008/770/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

tricyclazole the rapporteur Member State was France and
all relevant information was submitted on 26 June 2006.

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 tricyclazole.

For tricyclazole 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
rapporteur Member States which have to submit
the
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

(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)

The Commission examined tricyclazole 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 received from
Member States,
there are clear
it was concluded that
indications that it may be expected that it has harmful
effects on human health and in particular the crucial
missing data does not allow to set reliable ADI, ARfD
and AOEL and such values are necessary to conduct the
risk assessment. Moreover, other concerns which were
identified by the rapporteur Member States
in its
assessment report are included in the review report for
the substance.

to submit

arguments put

The Commission invited the notifier
its
comments on the results of the examination of tricy­
clazole 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 tricyclazole satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

forwards by

Tricyclazole 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 tricy­
clazole are withdrawn within a fixed period of
time
and are not renewed and that no new authorisations
for such products are granted.

2.10.2008

EN

Official Journal of the European Union

L 263/17

(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
tricyclazole 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 tricyclazole remain available for 18 months
from the adoption of this Decision.

in

for

tricyclazole

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
laying down detailed rules
application of
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

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

tricyclazole are withdrawn by 30 March 2009;

(b) no authorisations for plant protection products containing
tricyclazole 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 30 March
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Done at Brussels, 30 September 2008.

Article 1

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

For the Commission

Androulla VASSILIOU
Member of the Commission

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