2009/28/EC: Commission Decision of 13 January 2009 concerning the non-inclusion of flurprimidol 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) 8967) (Text with EEA relevance)
Date: 2009-01-13
Institutions: European Commission
Subjects: dangerous substance, environmental protection, health risk, marketing standard, pharmaceutical product, plant health product

15.1.2009

EN

Official Journal of the European Union

L 10/25

COMMISSION DECISION

of 13 January 2009

concerning the non-inclusion of flurprimidol 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) 8967)

(Text with EEA relevance)

(2009/28/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 flurprimidol.

For flurprimidol 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
reports and recommendations to
relevant assessment

(4)

(5)

(6)

the European Food Safety Authority (EFSA) in accordance
with Article 10(1) of Regulation (EC) No 1490/2002. For
flurprimidol the rapporteur Member State was Finland
and all relevant information was submitted on 20 April
2007.

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 31 July
2008 in the format of the EFSA conclusion regarding the
peer review of the pesticide risk assessment of the active
substance flurprimidol (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 26 September 2008 in the
format of the Commission review report for flurprimidol.

the AOEL

During the evaluation of this active substance, a number
of concerns have been identified. In particular, based on
the operator and worker
the available information,
exposure
operator
exceed
exposure level) in all evaluated scenarios and conditions
of use. Moreover, no data was available on the impurity
profile of batches used in toxicological studies. Conse­
quently,
it was not possible to conclude on the basis
of the information available that flurprimidol met the
criteria for inclusion in Annex I to Directive 91/414/EEC.

(acceptable

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 flurprimidol satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

(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) EFSA Scientific Report (2008) 151, Conclusion on the peer review of

flurprimidol, finalised 31 July 2008.

L 10/26

EN

Official Journal of the European Union

15.1.2009

(7)

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

HAS ADOPTED THIS DECISION:

(8)

(9)

(10)

(11)

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

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

This Decision does not prejudice the submission of an
application for flurprimidol 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
Commission Regulation (EC) No 33/2008 (1),
in view
of a possible inclusion in its Annex I.

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 1

Flurprimidol 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 flur­

primidol are withdrawn by 13 July 2009;

(b) no authorisations for plant protection products containing
flurprimidol 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 13 July
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 13 January 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

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