2008/771/EC: Commission Decision of 30 September 2008 concerning the non-inclusion of buprofezin 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) 5109) (Text with EEA relevance)
Date: 2008-09-30
Institutions: European Commission
Subjects: insecticide, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 263/18

EN

Official Journal of the European Union

2.10.2008

COMMISSION DECISION

of 30 September 2008

concerning the non-inclusion of buprofezin 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) 5109)

(Text with EEA relevance)

(2008/771/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 of 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 buprofezin.

For buprofezin 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
buprofezin the rapporteur Member State was Finland and
all relevant information was submitted on 7 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 3 March
2008 in the format of the EFSA conclusion regarding the
peer review of the pesticide risk assessment of the active
substance buprofezin (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 20 May 2008 in the format of
the Commission review report for buprofezin.

to perform a

During the evaluation of this active substance, a number
of concerns have been identified. In particular it was not
possible
exposure
assessment as data are missing to determine an appro­
priate
it was not
possible to conclude on the basis of the information
available that buprofezin met the criteria for inclusion
in Annex I to Directive 91/414/EEC.

residue definition. Consequently,

consumer

reliable

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

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

for

plant

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buprofezin are withdrawn within a fixed period of time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

protection products

(5)

(6)

(7)

(8)

(4) EFSA Scientific Report (2008) 128, Conclusion regarding the peer
the active substance

the pesticide risk assessment of

review of
buprofezin, finalised 3 March 2008.

2.10.2008

EN

Official Journal of the European Union

L 263/19

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

This Decision does not prejudice the submission of an
application for buprofezin according to the provisions of
Article 6(2) of Directive 91/414/EEC, the detailed imple­
mentation 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

HAS ADOPTED THIS DECISION:

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

buprofezin are withdrawn by 30 March 2009;

(b) no authorisations for plant protection products containing
buprofezin 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.

Done at Brussels, 30 September 2008.

Article 1

Buprofezin shall not be included as 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.