2007/387/EC: Commission Decision of 6 June 2007 concerning the non-inclusion of dichlorvos 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) 2338) (Text with EEA relevance)
Date: 2007-06-06
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 145/16

EN

Official Journal of the European Union

7.6.2007

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 6 June 2007

concerning the non-inclusion of dichlorvos 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) 2338)

(Text with EEA relevance)

(2007/387/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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:

For dichlorvos 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
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
dichlorvos the rapporteur Member State was Italy and all
relevant
submitted on 20 October
2003.

information was

(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
dichlorvos.

to Directive 91/414/EEC. That

list

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, 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.

(4)

(5)

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
of the active substance dichlorvos (4). This report was
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
for
the
dichlorvos.

the Commission review report

format of

During the evaluation of this active substance, a number
of concerns were identified. In particular, based on the
available toxicological data and taking into account the
uncertainties of
the genotoxic and carcinogenic prop-
erties of the substance also considering the overall poor
quality of the dossier, it has not been demonstrated that
the estimated operator, worker and bystander exposure,
is acceptable.

(4) EFSA Scientific Report (2006) 77, 1-43, Conclusion regarding the

peer review of pesticide risk assessment of dichlorvos.

7.6.2007

EN

Official Journal of the European Union

L 145/17

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

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

for

plant

Measures should be taken to ensure that authorisations
containing
granted
dichlorvos 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
dichlorvos, should be limited to twelve 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 dichlorvos 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 REGULATION:

Article 1

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

Member States shall ensure that:

Article 2

(a) authorisations

for plant protection products containing

dichlorvos are withdrawn by 6 December 2007;

(b) no authorisations for plant protection products containing
dichlorvos 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 6 December
2008 at the latest.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 6 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission