2007/615/EC: Commission Decision of 20 September 2007 concerning the non-inclusion of benfuracarb 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(2007) 4285) (Text with EEA relevance )
Date: 2007-09-20
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

21.9.2007

EN

Official Journal of the European Union

L 246/47

COMMISSION

COMMISSION DECISION

of 20 September 2007

concerning the non-inclusion of benfuracarb 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(2007) 4285)

(Text with EEA relevance)

(2007/615/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)

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 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 703/2001 (3)
lay down the detailed rules for the
implementation of the second 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
includes
benfuracarb.

to Directive 91/414/EEC. That

list

(3)

For benfuracarb the effects on human health and the
environment have been assessed in accordance with the

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.

provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 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
benfuracarb the Rapporteur Member State was Belgium
and all relevant information was submitted on 2 August
2004.

(4)

(5)

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 28 July
2006 in the format of the EFSA conclusion regarding the
peer review of the pesticide risk assessment of the active
substance benfuracarb. 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 16 March 2007 in the format
of the Commission review report for benfuracarb.

During the evaluation of this active substance, a number
of concerns have been identified. Benfuracarb is a
substance of which the main metabolite is carbofuran,
itself an active substance which has been reviewed under
Directive 91/414/EEC. The use of benfuracarb leads to
the presence of
the metabolite carbofuran which is
considerably more toxic than the parent compound
benfuracarb. For the carbofuran residues, resulting from
the use of benfuracarb,
the assessment has raised a
concern about the acute exposure of vulnerable groups
of consumers, in particular children. However, the EFSA
has stated that it is not possible to assess the risk for
consumers completely due to a lack of data in the dossier
presented by the notifier. Furthermore, the data lodged
within the legal deadlines were insufficient for the EFSA
to allow a full assessment of the risk of ground water
contamination from metabolites other than carbofuran.
Finally, based on the available data,
it has not been
the risk to birds and mammals,
demonstrated that

L 246/48

EN

Official Journal of the European Union

21.9.2007

(6)

(7)

(8)

(9)

ground

dwelling

organisms,
and

organisms,
aquatic
is
earthworms
other
acceptable. Consequently,
to
conclude on the basis of the information available that
benfuracarb met the criteria for inclusion in Annex I to
Directive 91/414/EEC.

non-target
organisms
it was not possible

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

(11)

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

Benfuracarb 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

benfuracarb are withdrawn by 20 March 2008;

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

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

for

plant

Measures should be taken to ensure that authorisations
granted
containing
benfuracarb 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
benfuracarb 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 benfuracarb remain available to farmers for
18 months from the adoption 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 20 March
2009 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 20 September 2007.

(10)

This Decision does not prejudice the submission of an
application for benfuracarb according to the provisions
of Article 6(2) of Directive 91/414/EEC in view of a
possible inclusion in its Annex I.

For the Commission

Markos KYPRIANOU
Member of the Commission