2007/389/EC: Commission Decision of 6 June 2007 concerning the non-inclusion of malathion 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) 2337) (Text with EEA relevance)
Date: 2007-06-06
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

8.6.2007

EN

Official Journal of the European Union

L 146/19

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 6 June 2007

concerning the non-inclusion of malathion 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) 2337)

(Text with EEA relevance)

(2007/389/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

(3)

Whereas:

(1)

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.

(4)

(2)

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

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).
(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.

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
malathion.

to Directive 91/414/EEC. That

list

For malathion 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 703/2001 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 8(1) of Regulation (EC) No 451/2000. For
malathion the rapporteur Member State was Finland and
all relevant information was submitted on 2 February
2004.

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 13
January 2006 in the format of
the EFSA conclusion
regarding the peer review of the pesticide risk assessment
the active substance malathion (4). This report has
of
been reviewed
the
the Member
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on 29
September 2006 in the format of
the Commission
review report for malathion.

States

and

by

(4) EFSA Scientific Report (2006) 63, 1-87, Conclusion on the peer

review of malathion.

L 146/20

EN

Official Journal of the European Union

8.6.2007

(5)

(6)

(7)

(8)

(9)

the

excluded,

and bystanders

During the evaluation of this active substance, a number
of concerns have been identified. Due to the presence of
varying levels in the technical material of isomalathion,
which is an impurity that contributes significantly to the
toxicity profile of malathion and the genotoxicity of
risk to operators,
which cannot be
workers
concluded.
Moreover, based on the available information it has not
been demonstrated that
the estimated exposure of
consumers resulting from the acute and chronic intake
of edible crops is acceptable, due to the insufficient infor-
mation on the effects of certain toxicologically relevant
metabolites. Consequently,
to
conclude on the basis of the information available that
malathion met the criteria for inclusion in Annex I to
Directive 91/414/EEC.

it was not possible

could not be

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 put
forwards 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 malathion satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC.

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

for

plant

Measures should be taken to ensure that authorisations
granted
containing
malathion are withdrawn within a fixed period of time
and are not renewed and that no new authorisations for
such products are granted.

protection products

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
malathion should be limited to 12 months in order to
allow existing stocks to be used in one further growing
season.

(10)

(11)

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

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

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

Member States shall ensure that:

Article 2

(a) authorisations

for plant protection products containing

malathion are withdrawn by 6 December 2007;

(b) no authorisations for plant protection products containing
malathion are granted or renewed from the date of publi-
cation 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 6 December
2008 at the latest.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 6 June 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission