2008/764/EC: Commission Decision of 30 September 2008 concerning the non-inclusion of dicofol 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(2008) 5105) (Text with EEA relevance)
Date: 2008-09-30
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, public health, withdrawal from the market

L 262/40

EN

Official Journal of the European Union

1.10.2008

COMMISSION DECISION

of 30 September 2008

concerning the non-inclusion of dicofol

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(2008) 5105)

(Text with EEA relevance)

(2008/764/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)

(3)

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 to 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 1490/2002 (3) lay down the detailed rules for the
implementation of the third 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 to
Directive 91/414/EEC. That list includes dicofol.

For dicofol the effects on human health and the environ­
ment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 1490/2002 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

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 29.2.2000, p. 25.
(3) OJ L 224, 21.8.2002, p. 23.

(4)

(5)

(6)

(7)

(8)

the rapporteur Member State was Spain and
on

information

submitted

was

dicofol
all
relevant
18 September 2006.

The Commission examined dicofol
in accordance with
Article 11a of Regulation (EC) No 1490/2002. A draft
review report for that substance was reviewed by the
Member
the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 20 May 2008 in the format of
the Commission review report.

States

and

During the examination of this active substance by the
Committee, taking into account comments received from
Member States,
there are clear
it was concluded that
indications that it may be expected that it has harmful
effects on human health and in particular on both
operators and workers, because the exposure is greater
than 100 % of the AOEL and data gaps in the consumer
risk assessment. Moreover, other concerns which were
identified by the rapporteur Member States
in its
assessment report are included in the review report for
the substance.

to submit

to further support

The Commission invited the notifier
its
comments on the results of the examination of dicofol
and on its intention or not
the
substance. The notifier submitted its 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 have
not demonstrated that it may be expected that, under
the proposed conditions of use, plant protection
the
products
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC.

containing dicofol

in general

satisfy

Dicofol 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 dicofol
are withdrawn within a fixed period of time and are not
renewed and that no new authorisations
such
products are granted.

for

1.10.2008

EN

Official Journal of the European Union

L 262/41

(9)

(10)

(11)

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
dicofol should be limited to 12 months in order to allow
existing stocks to be used in one further growing season,
which ensures that plant protection products containing
dicofol
from the
remain available
adoption of this Decision.

for 18 months

This Decision does not prejudice the submission of an
application for dicofol in accordance with Article 6(2) of
Directive 91/414/EEC and Commission Regulation (EC)
No 33/2008 of 17 January 2008 laying down detailed
rules for the application of Council Directive 91/414/EEC
as regards a regular and an accelerated procedure for the
assessment of active substances which were part of the
programme of work referred to in Article 8(2) of that
Directive but have not been included into its Annex I (1),
in view of a possible inclusion in its Annex I.

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

dicofol are withdrawn by 30 March 2009;

(b) no authorisations for plant protection products containing
dicofol are granted or renewed from the date of publication
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
on
possible
30 March 2010 at the latest.

expire

short

shall

and

be

as

as

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, 30 September 2008.

Article 1

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

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 15, 18.1.2008, p. 5.