2008/743/EC: Commission Decision of 18 September 2008 concerning the non-inclusion of diniconazole-M 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) 5068) (Text with EEA relevance)
Date: 2008-09-18
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical product, plant health legislation, plant health product, public health, withdrawal from the market

19.9.2008

EN

Official Journal of the European Union

L 251/41

COMMISSION DECISION

of 18 September 2008

concerning the non-inclusion of diniconazole-M 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) 5068)

(Text with EEA relevance)

(2008/743/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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

For diniconazole-M 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
diniconazole-M the rapporteur Member State was France
and all relevant information was submitted on 31 May
2007.

(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.

(5)

(6)

The Commission examined diniconazole-M 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 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 on operators,
because the exposure is greater than 100 % of the AOEL.
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

its
The Commission invited the notifier
comments on the results of the examination of dinico­
nazole-M 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,
plant protection products containing diniconazole-M
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

forwards by

requirements

(7)

Diniconazole-M should therefore not be included in
Annex I to Directive 91/414/EEC.

(8)

Measures should be taken to ensure that authorisations
granted for plant protection products containing dinico­
nazole-M are withdrawn within a fixed period of time
and are not renewed and that no new authorisations for
such products are granted.

L 251/42

EN

Official Journal of the European Union

19.9.2008

Article 2

Member States shall ensure that:

(a) authorisations for plant protection products containing dini­

conazole-M are withdrawn by 18 March 2009;

(b) no authorisations for plant protection products containing
diniconazole-M 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 18 March
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 18 September 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
diniconazole-M 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 diniconazole-M remain available
for 18 months from the adoption of this Decision.

This Decision does not prejudice the submission of an
application for diniconazole-M in 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

HAS ADOPTED THIS DECISION:

Article 1

Diniconazole-M 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.