2008/754/EC: Commission Decision of 18 September 2008 concerning the non-inclusion of dichlobenil 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) 5077) (Text with EEA relevance)
Date: 2008-09-18
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, public health, withdrawal from the market

L 258/70

EN

Official Journal of the European Union

26.9.2008

COMMISSION DECISION

of 18 September 2008

concerning the non-inclusion of dichlobenil 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) 5077)

(Text with EEA relevance)

(2008/754/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

erlands and all relevant information was submitted on
7 May 2007.

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 dichlobenil.

For dichlobenil
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 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
dichlobenil the rapporteur Member State was the Neth­

(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 Commission examined dichlobenil
in accordance
with Article 11a of Regulation (EC) No 1490/2002. A
draft review report for that substance was reviewed by
the Member States and 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.

During the examination of this active substance by the
Committee, taking into account comments from Member
States, it was concluded that there are clear indications
that it may be expected that it has harmful effects on
human health and in particular consumer exposure from
drinking water, because the exposure is greater than
the ADI of a relevant metabolite and the
100 % of
leaching to groundwater
in all
modeled
relevant metabolite.
for
Moreover, other concerns which were identified by the
rapporteur Member State in its assessment report are
included in the review report for the substance.

above 0,1 μg/l

scenarios

is
this

the

have

been

results of

to submit

intention or not

substance. The notifier

its
The Commission invited the notifier
examination of
comments on the
to further
dichlobenil and on its
submitted its
support
the
examined.
comments which
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
the proposed conditions of use, plant
that, under
satisfy in
protection products containing dichlobenil
general
the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

carefully

Dichlobenil 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
dichlobenil are withdrawn within a fixed period of time
and are not renewed and that no new authorisations for
such products are granted.

protection products

26.9.2008

EN

Official Journal of the European Union

L 258/71

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

in

for

dichlobenil

This Decision does not prejudice the submission of an
application
accordance with
Article 6(2) of Directive 91/414/EEC and Commission
Regulation (EC) No 33/2008 of 17 January 2008
application of
laying down detailed rules
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.

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

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

dichlobenil are withdrawn by 18 March 2009;

(b) no authorisations for plant protection products containing
dichlobenil 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.

HAS ADOPTED THIS DECISION:

Done at Brussels, 18 September 2008.

Article 1

Dichlobenil 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.