2008/819/EC: Commission Decision of 20 October 2008 concerning the non-inclusion of butralin 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) 6066) (Text with EEA relevance)
Date: 2008-10-20
Institutions: European Commission
Subjects: herbicide, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

29.10.2008

EN

Official Journal of the European Union

L 285/15

COMMISSION

COMMISSION DECISION

of 20 October 2008

concerning the non-inclusion of butralin 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) 6066)

(Text with EEA relevance)

(2008/819/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

with a view to their possible inclusion in Annex I to
Directive 91/414/EEC. That list includes butralin.

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)

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

(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.

(3)

(4)

(5)

For butralin the effects on human health and the en­
vironment 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
butralin the rapporteur Member State was France and all
relevant
information was submitted on 20 February
2006.

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

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
operators, 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

L 285/16

EN

Official Journal of the European Union

29.10.2008

(11)

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

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

Article 2

Member States shall ensure that:

(a) authorisations

for plant protection products containing

butralin are withdrawn by 20 April 2009;

(b) no authorisations for plant protection products containing
butralin 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 20 April
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 20 October 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(6)

(7)

(8)

(9)

(10)

to submit

to further support

its
The Commission invited the notifier
comments on the results of the examination of butralin
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
products
the
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC.

containing butralin satisfy in general

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

for

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

This Decision does not prejudice the submission of an
application for butralin 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.

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