2009/241/EC: Commission Decision of 16 March 2009 concerning the non-inclusion of triflumuron 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(2009) 1681) (Text with EEA relevance)
Date: 2009-03-16
Institutions: European Commission
Subjects: dangerous substance, market approval, marketing restriction, pharmaceutical product, plant health legislation, plant health product

17.3.2009

EN

Official Journal of the European Union

L 71/59

COMMISSION DECISION

of 16 March 2009

concerning the non-inclusion of triflumuron 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(2009) 1681)

(Text with EEA relevance)

(2009/241/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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
that Directive, authorise
following the notification of
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 triflumuron.

For triflumuron 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 10(1) of Regulation (EC) No 1490/2002. For
triflumuron the rapporteur Member State was Italy and
all relevant information was submitted on 15 July 2005.

(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.

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on
the EFSA
30 September 2008 in the
conclusion regarding the peer review of
the pesticide
risk assessment of the active substance triflumuron (4).
This report has been reviewed by the Member States
and the Commission within the Standing Committee
on the Food Chain and Animal Health and finalised on
2 December 2008 in the format of the Commission
review report for triflumuron.

format of

During the evaluation of this active substance, a number
of concerns have been identified. In particular, based on
the available information, it has not been demonstrated
that the consumer exposure is acceptable due to lack of
data in terms of nature and level of the relevant residues.
In fact,
it was not possible to perform an acute risk
assessment for the metabolite M07, because data was
to allocate an acute reference dose for
not sufficient
this metabolite. Moreover,
to
determine an appropriate residue definition and to
estimate
in processed fruit
the
a high risk to aquatic
commodities.
organisms has been identified. Consequently, it was not
possible to conclude on the basis of the information
available that triflumuron met the criteria for inclusion
in Annex I to Directive 91/414/EEC.

level of
In addition,

data were missing

residues

to submit

submitted its

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

(5)

(6)

(7)

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

(4) EFSA Scientific Report (2008) 194, Conclusion on the peer review

of triflumuron, finalised 30 September 2008.

L 71/60

EN

Official Journal of the European Union

17.3.2009

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

triflumuron are withdrawn by 16 September 2009;

(b) no authorisations for plant protection products containing
triflumuron 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,
on
possible
shall
16 September 2010 at the latest.

expire

short

shall

and

be

as

as

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 16 March 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

(8)

(9)

(10)

(11)

for

plant

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

protection products

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
triflumuron 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 triflumuron remain available to farmers for
18 months from the adoption of this Decision.

Regulation

This Decision does not prejudice the submission of an
application for triflumuron according to the provisions
of Article 6(2) of Directive 91/414/EEC, the detailed im­
plementation rules of which have been laid down in
of
Commission
17 January 2008 laying down detailed rules for the
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.

(EC) No

33/2008

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

in this Decision are in
Standing
the

opinion

the

of

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