2007/428/EC: Commission Decision of 18 June 2007 concerning the non-inclusion of cadusafos 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) 2511) (Text with EEA relevance)
Date: 2007-06-18
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 160/26

EN

Official Journal of the European Union

21.6.2007

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 18 June 2007

concerning the non-inclusion of cadusafos 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) 2511)

(Text with EEA relevance)

(2007/428/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

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:

(3)

(4)

(1)

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.

(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).

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
cadusafos.

to Directive 91/414/EEC. That

list

For cadusafos the effects on human health and the envir-
onment 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
cadusafos the rapporteur Member State was Greece and
all relevant information was submitted on 1 June 2004.

The assessment report was peer reviewed by the Member
States and the EFSA and presented to the Commission
on 24 April 2006 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
the active substance cadusafos (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 24 November 2006 in
the
for
cadusafos.

the Commission review report

format of

(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) EFSA Scientific Report (2006) 68, 1-70, Conclusion regarding the peer

review of pesticide risk assessment of cadusafos.

21.6.2007

EN

Official Journal of the European Union

L 160/27

(5)

(6)

(7)

(8)

(9)

During the evaluation of this active substance, a number
of concerns were identified. Based on the available infor-
mation, it has not been demonstrated that the estimated
exposure of consumers resulting from the acute and
chronic intake assessment is acceptable, due to insuf-
ficient information on the residue level. Moreover the
risk to groundwater could not be assessed, due to a
lack of data. Therefore it was not possible to conclude,
on the basis of the information available, that cadusafos
met the criteria for inclusion in Annex I to Directive
91/414/EEC.

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

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

for

plant

Measures should be taken to ensure that authorisations
granted
containing
cadusafos 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 Member States for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
cadusafos, should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season.

Article 6(2) of Directive 91/414/EEC in view of a
possible inclusion in its Annex I.

(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

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

Member States shall ensure that:

Article 2

(a) Authorisations for plant protection products containing

cadusafos are withdrawn by 18 December 2007;

(b) no authorisations for plant protection products containing
cadusafos are granted or renewed under the derogation
provided for in Article 8(2) of Directive 91/414/EEC.

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 not later than
18 December 2008 at the latest.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 18 June 2007.

(10)

This Decision does not prejudice the submission of an
application for cadusafos according to the provisions of

For the Commission

Markos KYPRIANOU
Member of the Commission