2007/416/EC: Commission Decision of 13 June 2007 concerning the non-inclusion of carbofuran 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) 2467) (Text with EEA relevance)
Date: 2007-06-13
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 156/30

EN

Official Journal of the European Union

16.6.2007

COMMISSION DECISION

of 13 June 2007

concerning the non-inclusion of carbofuran 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) 2467)

(Text with EEA relevance)

(2007/416/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:

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
carbofuran.

to Directive 91/414/EEC. That

list

(1)

(2)

(3)

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
carbofuran the Rapporteur Member State was Belgium
and
on
all
2 August 2004.

information was

submitted

relevant

(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 carbofuran (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 24 November 2006 in the
format of the Commission review report for carbofuran.

During the evaluation of this active substance, a number
of concerns have been identified. The risk assessment for
ground water contamination could not be concluded, in
particular because the data supplied by the notifier within
the legal deadlines did not provide sufficient information
about a number of metabolites which have a hazardous
profile. Also the consumer risk assessment, which raised
a concern about the acute exposure of vulnerable groups
in particular children, could not be
of consumers,
finalised due to the lack of
information as regards
certain relevant residues. Furthermore, the data supplied
by the notifier within the legal deadlines was insufficient
to allow the EFSA to assess the ecotoxicological effects of
the active substance. As a result, concerns remain as
for birds and mammals,
regards the risk assessment
aquatic
arthropods,
bees,
organisms,
and soil non-target organisms. Conse-
earthworms,
it was not possible to conclude on the basis
quently,
of
the
the information available that carbofuran met
criteria for inclusion in Annex I to Directive 91/414/EEC.

non-target

For carbofuran 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 703/2001 for a range of uses proposed by
the notifier. Moreover, those regulations designate the
Rapporteur Member States which have to submit the

(6)

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

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).
(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.

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
comments which have been
notifier
carefully examined. However, despite the arguments put
forwards by the notifier, the concerns identified could

submitted its

to submit

(4) EFSA Scientific Report (2006) 90, 1-88. Conclusion on the peer review of

carbofuran.

16.6.2007

EN

Official Journal of the European Union

L 156/31

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

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

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

Member States shall ensure that:

for

plant

Measures should be taken to ensure that authorisations
granted
containing
carbofuran 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
carbofuran should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season.

This decision does not prejudice the submission of an
application for carbofuran according to the provisions of
Article 6(2) of Directive 91/414/EEC 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

(a) authorisations

for plant protection products containing

carbofuran are withdrawn by 13 December 2007;

(b) no authorisations for plant protection products containing
carbofuran 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 December
2008 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 13 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(7)

(8)

(9)

(10)

(11)