EC: Commission Decision of 22 December 2006 concerning the non-inclusion of phosalone 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(2006) 6897)   (Text with EEA relevance)
Date: 2006-12-22
Institutions: European Commission
Subjects: marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

28.12.2006

EN

Official Journal of the European Union

L 379/127

COMMISSION DECISION

of 22 December 2006

concerning the non-inclusion of phosalone 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(2006) 6897)

(Text with EEA relevance)

(2006/1010/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
following the notification of
that Directive, authorise
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
phosalone.

to Directive 91/414/EEC. That

list

For phosalone the effects on human health and the envi-
ronment 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

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

last amended by
Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).
(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.

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
phosalone the Rapporteur Member State was Austria and
all relevant information was submitted on 7 May 2004.

(4)

(5)

(6)

The assessment report has been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 13 January 2006 in the format of the
the
EFSA Conclusion regarding the peer
pesticide
substance
phosalone (4). This report has been reviewed by the
the Commission within the
Member
Standing Committee on the Food Chain and Animal
Health and finalised on 14 July 2006 in the format of
the Commission review report for phosalone.

assessment of

review of

States

active

and

risk

the

During the evaluation of this active substance, a number
of concerns have been identified. This was in particular
the case concerning the risk for vulnerable groups of
consumers, as estimated exposures to phosalone have
not been demonstrated to be acceptable. Moreover,
some of its metabolites and impurities need further toxi-
cological characterisation and additional concerns have
been identified concerning the risk for birds, mammals,
aquatic organisms, bees and non-target arthropods.

to submit

submitted its

The Commission invited the notifier
its
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 phosalone satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

(4) EFSA Scientific Report (2006) 60, 1-66, Conclusion regarding the

peer review of pesticide risk assessment of phosalone.

L 379/128

EN

Official Journal of the European Union

28.12.2006

(7)

(8)

(9)

(10)

(11)

(12)

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

HAS ADOPTED THIS DECISION:

Article 1

for

plant

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

protection products

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

Article 2

Member States shall ensure that:

Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant protection
products containing phosalone 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.

(a) authorisations

for plant protection products containing

phosalone are withdrawn by 22 June 2007;

(b) from 28 December 2006 no authorisations

for plant
protection products containing phosalone are granted or
renewed under the derogation provided for in Article 8(2)
of directive 91/414/EEC.

substance within the

This Decision does not prejudice
any action the
Commission may undertake at a later stage for this
active
framework of Council
Directive 79/117/EEC of 21 December 1978 prohibiting
the placing on the market and use of plant protection
products containing certain active substances (1).

This Decision does not prejudice the submission of an
application for phosalone according to the provisions of
Article 6(2) of Directive 91/414/EEC in view of a
possible inclusion in its Annex I.

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
22 June 2008.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 22 December 2006.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation
(EC) No 850/2004 of the European Parliament and of the Council
(OJ L 158, 30.4.2004, p. 7, corrected by OJ L 229, 29.6.2004, p. 5).