2008/986/EC: Commission Decision of 15 December 2008 concerning the non-inclusion of antraquinone 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) 8133) (Text with EEA relevance)
Date: 2008-12-15
Institutions: European Commission
Subjects: animal health, health legislation, human nutrition, market approval, marketing standard, pharmaceutical product, plant health product

L 352/48

EN

Official Journal of the European Union

31.12.2008

COMMISSION DECISION

of 15 December 2008

concerning the non-inclusion of antraquinone 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) 8133)

(Text with EEA relevance)

(2008/986/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
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 1112/2002 (2) and (EC)
No 2229/2004 (3) lay down the detailed rules for the
implementation of the fourth 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
antraquinone.

to Directive 91/414/EEC. That

list

For antraquinone the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 1112/2002
and (EC) No 2229/2004 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 20 of Regulation (EC) No 2229/2004. For

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 168, 27.6.2002, p. 14.
(3) OJ L 379, 24.12.2004, p. 13.

(4)

(5)

(6)

(7)

(8)

antraquinone the rapporteur Member State was Belgium
and all relevant information was submitted in September
2006.

The Commission examined antraquinone in accordance
with Article 24a of Regulation (EC) No 2229/2004. 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 26 September 2008 in the
format of the Commission review report.

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 the crucial
missing data does not allow to set reliable acceptable
daily intake (ADI), acute reference dose (ARfD) and
(AOEL) and such
acceptable operator exposure level
values are necessary to conduct
the risk assessment.
Moreover, other concerns which were identified by the
rapporteur Member State in its assessment report are
included in the review report for the substance.

to submit

arguments put

The Commission invited the notifier
its
comments on the results of the examination of antra­
quinone 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,
antraquinone
plant protection products
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

requirements

forward by

containing

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

31.12.2008

EN

Official Journal of the European Union

L 352/49

(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
antraquinone 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
for 18
months from the adoption of this Decision.

antraquinone

available

remain

in

for

antraquinone

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

antraquinone are withdrawn by 15 June 2009;

(b) no authorisations for plant protection products containing
antraquinone 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 be as short as possible and shall expire on 15 June
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Done at Brussels, 15 December 2008.

Article 1

Antraquinone 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.