2007/628/EC: Commission Decision of 19 September 2007 concerning the non-inclusion of methomyl 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) 4258) (Text with EEA relevance)
Date: 2007-09-19
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 255/40

EN

Official Journal of the European Union

29.9.2007

COMMISSION

COMMISSION DECISION

of 19 September 2007

concerning the non-inclusion of methomyl 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) 4258)

(Text with EEA relevance)

(2007/628/EC)

THE COMMISSION OF THE EUROPEAN UNION,

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
includes
Annex I
methomyl.

to Directive 91/414/EEC. That

list

For methomyl 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 notifier. Moreover, those Regulations designate the

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

last amended by

Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).
(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.

(4)

(5)

(6)

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
methomyl the rapporteur Member State was the United
Kingdom and all relevant information was submitted on
3 May 2004.

The assessment report was peer reviewed by the Member
States and the EFSA and presented to the Commission
on 23 June 2006 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
of the active substance methomyl (4). This report was
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health.

information,

the operator

During the evaluation of this active substance, a number
of concerns were identified. In particular, based on the
available
exposure would
exceed the AOEL (acceptable operator exposure level)
and it has not been demonstrated that the worker and
bystander exposure is acceptable. Moreover, with regard
to ecotoxicology, there are concerns due to a high risk
for birds and 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 methomyl satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

(4) EFSA Scientific Report (2006) 83, 1-73, Conclusion regarding the peer

review of pesticide risk assessment of methomyl.

29.9.2007

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Official Journal of the European Union

L 255/41

(7)

(8)

(9)

(10)

(11)

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

HAS ADOPTED THIS DECISION:

for

plant

Measures should be taken to ensure that authorisations
containing
granted
methomyl 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
methomyl, 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 methomyl remain available to farmers for
18 months from the adoption of this Decision.

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

The Standing Committee on the Food Chain and Animal
Health did not deliver an opinion within the time-limit
laid down by its Chairman and the Commission therefore
submitted to the Council a proposal relating to these
measures. On the expiry of the period laid down in the
second subparagraph of Article 19(2) of Directive
91/414/EEC,
adopted the
the Council had neither
proposed implementing act nor indicated its opposition
for implementing measures and it is
to the proposal
accordingly for the Commission to adopt these measures,

Article 1

Methomyl 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

methomyl are withdrawn by 19 March 2008;

(b) no authorisations for plant protection products containing
methomyl 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 19 March 2009.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 19 September 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission