2008/744/EC: Commission Decision of 18 September 2008 concerning the non-inclusion of dicloran 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) 5086) (Text with EEA relevance)
Date: 2008-09-18
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical product, plant health legislation, plant health product, public health, withdrawal from the market

19.9.2008

EN

Official Journal of the European Union

L 251/43

COMMISSION DECISION

of 18 September 2008

concerning the non-inclusion of dicloran 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) 5086)

(Text with EEA relevance)

(2008/744/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 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 dicloran.

For dicloran 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 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
dicloran the rapporteur Member State was Spain and all
relevant information was submitted on 22 July 2005.

(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.

The Commission examined dicloran 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

(5)

(6)

it was

it may be expected that

During the examination of this active substance by the
Committee,
taking into account
concluded,
comments received from Member States, that there are
clear indications that
it has
harmful effects on human health and in particular on
workers, because the exposure is greater than 100 % of
the AOEL. Moreover, other concerns which were iden­
tified by the rapporteur Member States in its assessment
report are
the
substance.

included in the

review report

for

the

to submit

arguments put

its
The Commission invited the notifier
comments on the
examination of
results of
dicloran and on its intention or not to further support
the substance. The notifier
submitted its comments
which have been carefully examined. However, despite
the
the
the notifier,
eliminated,
concerns
and
identified could not be
the information
assessments made on the basis of
submitted have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing dicloran satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC.

forwards by

(7)

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

(8)

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

for

L 251/44

EN

Official Journal of the European Union

19.9.2008

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

dicloran are withdrawn by 18 March 2009;

(b) no authorisations for plant protection products containing
dicloran 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 18 March
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 18 September 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(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
dicloran 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 dicloran remain available for 18 months
from the adoption of this Decision.

This Decision does not prejudice the submission of an
application for dicloran 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
substances
assessment of
which were part of the programme of work referred to
that Directive but have not been
in Article 8(2) of
included into its Annex I (1),
in view of a possible
inclusion in its Annex I.

active

the

for

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

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

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