2007/355/EC: Commission Decision of 21 May 2007 concerning the non-inclusion of carbaryl 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) 2093) (Text with EEA relevance)
Date: 2007-05-21
Institutions: European Commission
Subjects: dangerous substance, marketing, pesticide, pharmaceutical product, plant health control, plant health legislation, plant health product, withdrawal from the market

L 133/40

EN

Official Journal of the European Union

25.5.2007

COMMISSION DECISION

of 21 May 2007

concerning the non-inclusion of carbaryl 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) 2093)

(Text with EEA relevance)

(2007/355/EC)

(4)

(5)

(6)

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
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 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
carbaryl.

to Directive 91/414/EEC. That

list

For carbaryl the effects on human health and the envi-
ronment 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
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
carbaryl the rapporteur Member State was Spain and all
relevant information was submitted on 29 April 2004.

The assessment report was peer reviewed by the Member
States and the EFSA and presented to the Commission
on 12 May 2006 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
the active substance carbaryl (4). This report was
of
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and finalised on 29 September 2006 in
the format of the Commission review report for carbaryl.

is

exposure

acceptable. The

During the evaluation of this active substance, a number
of concerns were identified. In particular based on the
available data it has not been demonstrated that
the
information
consumer
available indicates concerns for metabolites which are
at the same level of
toxicity as the active substance,
and their presence at levels which might be of toxico-
logical concerns can not be excluded. Moreover there are
the
concerns on potential carcinogenic properties of
active substance. There is also a high long-term risk for
insectivorous birds and a high acute risk to herbivorous
mammals, a high acute and long-term risk to aquatic
organisms and a high risk for beneficial arthropods.

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
advanced, the above concerns remained unsolved, and
the information
assessments made on the basis of
the EFSA expert
submitted and evaluated during
meetings have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing carbaryl 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. Directive as

last amended by
Commission Directive 2007/25/EC (OJ L 106, 24.04.2007, p. 34).
(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.

(7)

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

(4) EFSA Scientific Report (2006) 80, 1-71, Conclusion regarding the

peer review of pesticide risk assessment of carbaryl.

25.5.2007

EN

Official Journal of the European Union

L 133/41

(8)

(9)

(10)

(11)

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

for

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
carbaryl, should be limited to twelve months in order to
allow existing stocks to be used in one further growing
season.

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

carbaryl are withdrawn by 21 November 2007;

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

Article 3

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

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 21 November
2008 at the latest.

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 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Done at Brussels, 21 May 2007.

Article 1

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

For the Commission

Markos KYPRIANOU
Member of the Commission