2008/943/EC: Commission Decision of 12 December 2008 concerning the non-inclusion of bone oil 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) 8083) (Text with EEA relevance)
Date: 2008-12-12
Institutions: European Commission
Subjects: animal oil, health legislation, market approval, pharmaceutical product, plant health product

13.12.2008

EN

Official Journal of the European Union

L 335/97

COMMISSION DECISION

of 12 December 2008

concerning the non-inclusion of bone oil 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) 8083)

(Text with EEA relevance)

(2008/943/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

bone oil the rapporteur Member State was Belgium and
all relevant information was submitted in October 2006.

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
bone oil.

to Directive 91/414/EEC. That

list

For bone oil acid 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)

The Commission examined bone oil in accordance with
Article 24a of Regulation (EC) No 2229/2004. 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 26 September 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
there are clear
it was concluded that
Member States,
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) and acute reference dose (ARfD) and
such values are necessary to conduct the risk assessment.
In addition, the operator exposure is greater than 100 %
of the acceptable operator exposure level (AOEL) in all
modelled scenarios. 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

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

Bone oil 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 bone oil
are withdrawn within a fixed period of time and are not
renewed and that no new authorisations
such
products are granted.

for

L 335/98

EN

Official Journal of the European Union

13.12.2008

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

bone oil are withdrawn by 12 June 2009;

(b) no authorisations for plant protection products containing
bone oil 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 12 June
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 12 December 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
bone oil 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 bone oil remain available for 18 months
from the adoption of this Decision.

This Decision does not prejudice the submission of an
application for bone oil 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

Bone oil 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.