2007/415/EC: Commission Decision of 13 June 2007 concerning the non-inclusion of carbosulfan 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) 2463) (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 156/28

EN

Official Journal of the European Union

16.6.2007

COMMISSION DECISION

of 13 June 2007

concerning the non-inclusion of carbosulfan 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) 2463)

(Text with EEA relevance)

(2007/415/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
carbosulfan.

to Directive 91/414/EEC. That

list

(3)

For carbosulfan 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 2007/31/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.

(4)

(5)

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
carbosulfan the Rapporteur Member State was Belgium
and all relevant information was submitted on 11 August
2004.

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 carbosulfan (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 carbosulfan.

During the evaluation of this active substance, a number
of concerns have been identified. The use of carbosulfan
leads to the appearance of metabolites which have a
the
hazardous profile. This leads to concerns about
exposure of consumers and the possible risk of ground
water contamination. However, the data lodged by the
notifier within the legal deadlines did not allow these
concerns to be resolved. Furthermore, technical material
the active substance as sold in the market)
is,
(that
contains
least one
impurities, of which at
relevant
(N-nitrosodibutylamine)
is carcinogenic. This impurity is
found in the technical material at
levels which raise
concerns. The data lodged by the notifier within the
legal deadlines did not provide sufficient information to
resolve these concerns. As a result, the risk to operators
could not be assessed adequately. Finally, the data lodged
by the notifier within the legal deadlines did not
adequately address the risks to birds and mammals,
arthropods,
aquatic
earthworms, and non-target soil micro-organisms and
plants. Therefore, concerns remain as regards the risk
assessment for these species. Consequently,
it was not
possible to conclude on the basis of the information
available that carbosulfan met the criteria for inclusion
in Annex I to Directive 91/414/EEC.

organisms,

non-target

bees,

(4) EFSA Scientific Report (2006) 91, 1-84, Conclusion on the peer

review of carbosulfan.

16.6.2007

EN

Official Journal of the European Union

L 156/29

(6)

(7)

(8)

(9)

(10)

(11)

to submit

submitted its

its
The Commission invited the notifier
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 carbosulfan satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

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

Measures should be taken to ensure that authorisations
granted for plant protection products containing carbo-
sulfan 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
carbosulfan 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 carbosulfan 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

HAS ADOPTED THIS DECISION:

Article 1

Carbosulfan 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

carbosulfan are withdrawn by 13 December 2007;

(b) no authorisations for plant protection products containing
carbosulfan 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