2007/417/EC: Commission Decision of 13 June 2007 concerning the non-inclusion of diuron 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(2007) 2468) (Text with EEA relevance)
Date: 2007-06-13
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 156/32

EN

Official Journal of the European Union

16.6.2007

COMMISSION DECISION

of 13 June 2007

concerning the non-inclusion of diuron 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(2007) 2468)

(Text with EEA relevance)

(2007/417/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 of 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 703/2001 (3)
lay down the detailed rules for the
implementation of the second 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
diuron.

to Directive 91/414/EEC. That

list

For diuron the effects on human health and the envir-
onment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 for a range of uses proposed by
the notifiers. 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

(4)

(5)

(6)

with Article 8(1) of Regulation (EC) No 451/2000. For
diuron the rapporteur Member State was Denmark and
all relevant information was submitted on 19 September
2003.

The assessment report has been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 14 January 2005 in the format of the
the
EFSA Conclusion regarding the peer
pesticide
substance
diuron (4). This
report has been reviewed by the
Member
the Commission within the
and
States
Standing Committee on the Food Chain and Animal
Health and finalised on 24 November 2006 in the
format of the Commission review report for diuron.

assessment of

review of

active

risk

the

During the evaluation of this active substance, a number
of concerns have been identified. The assessment of the
data provided by the notifier indicated that even with
protective equipment, operators would be exposed to
quantities of the substance which exceed the Acceptable
Operator Exposure Level (AOEL). It was not possible to
reach a conclusion on the possible risk of groundwater
contamination because of the lack of data on the degra-
dation pattern of certain metabolites and the overly opti-
mistic assumption made by the notifier that application
rates may be considered significantly lower in practise.
Similarly, based on the available data,
it has not been
demonstrated that the exposure for birds and mammals
is acceptable.

to submit

submitted its

its
The Commission invited the notifier
comments on the results of the peer review and on its
intention or not to further support the substance. The
notifier
comments which have been
carefully examined. However, despite the arguments
advanced, the above concerns remained unsolved, and
the information
assessments made on the basis of
the EFSA expert
submitted and evaluated during
meetings have not demonstrated that
it may be
expected that, under the proposed conditions of use,
plant protection products containing diuron satisfy in
general
the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.

(7)

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

(4) EFSA Scientific Report (2005) 25, 1-58. Conclusion on the peer

review of diuron.

16.6.2007

EN

Official Journal of the European Union

L 156/33

(8)

(9)

(10)

Measures should be taken to ensure that existing author-
isations for plant protection products containing diuron
are withdrawn within a prescribed period and are not
renewed and that no new authorisations
such
products are granted.

for

Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing diuron allowed by Member States,
should be limited to a period no longer than 12 months
to allow existing stocks to be used in no more than one
further growing season.

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

(a) Authorisations for plant protection products containing

diuron are withdrawn by 13 December 2007;

(b) from 16 June 2007 no authorisations for plant protection
products containing diuron are granted or renewed under
the derogation provided for in Article 8(2) of Directive
91/414/EEC.

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 not later than
13 December 2008.

Article 4

This Decision is addressed to the Member States.

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

Done at Brussels, 13 June 2007.

Article 2

Member States shall ensure that:

For the Commission

Markos KYPRIANOU
Member of the Commission