2008/832/EC: Commission Decision of 3 November 2008 concerning the non-inclusion of bromuconazole 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) 6290) (Text with EEA relevance)
Date: 2008-11-03
Institutions: European Commission
Subjects: herbicide, marketing restriction, pesticide, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

4.11.2008

EN

Official Journal of the European Union

L 295/53

COMMISSION DECISION

of 3 November 2008

concerning the non-inclusion of bromuconazole 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) 6290)

(Text with EEA relevance)

(2008/832/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 bromuconazole.

For bromuconazole 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
the
rapporteur Member States which have to submit
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 10(1) of Regulation (EC) No 1490/2002. For
bromuconazole
State was
Belgium and all relevant information was submitted on
14 November 2005.

rapporteur Member

the

(5)

(6)

(7)

(8)

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on
26 March 2008 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
of the active substance bromuconazole (4). This report
has been reviewed by the Member States and the
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
11 July 2008 in the format of the Commission review
report for bromuconazole.

contamination of

During the evaluation of this active substance, a number
of concerns have been identified. In particular, based on
the available information,
it was not possible to assess
and
the potential
groundwater. Moreover, with regard to ecotoxicology,
there are concerns due to the high risk to aquatic
organisms. Consequently,
to
conclude on the basis of the information available that
bromuconazole met the criteria for inclusion in Annex I
to Directive 91/414/EEC.

it was not possible

surface water

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 put
forward by the notifier, the concerns identified could not
be eliminated, and assessments made on the basis of the
information submitted and evaluated during the EFSA
expert meetings have not demonstrated that it may be
expected that, under the proposed conditions of use,
plant protection products containing bromuconazole
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

requirements

Bromuconazole 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 bromu­
conazole are withdrawn within a fixed period of time
and are not renewed and that no new authorisations
for such products are granted.

(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.

(4) EFSA Scientific Report (2008) 136, Conclusion regarding the peer
the active substance

the pesticide risk assessment of

review of
bromuconazole, finalised 26 March 2008.

L 295/54

EN

Official Journal of the European Union

4.11.2008

(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
bromuconazole should be limited to twelve months in
order to allow existing stocks to be used in one further
growing season, which ensures that plant protection
products containing bromuconazole remain available to
farmers
this
Decision.

from the adoption of

for 18 months

for

bromuconazole

This Decision does not prejudice the submission of an
application
the
provisions of Article 6(2) of Directive 91/414/EEC, the
detailed implementation rules of which have been laid
down in Commission Regulation (EC) No 33/2008 (1),
in view of a possible inclusion in its Annex I.

according

to

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

bromuconazole are withdrawn by 3 May 2009;

(b) no authorisations for plant protection products containing
bromuconazole 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 3 May 2010
at the latest.

Article 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Done at Brussels, 3 November 2008.

Article 1

Bromuconazole shall not be included as 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.