2007/392/EC: Commission Decision of 21 May 2007 concerning the non-inclusion of oxydemeton-methyl 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) 2098)   (Text with EEA relevance)
Date: 2007-05-21
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

9.6.2007

EN

Official Journal of the European Union

L 148/7

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 21 May 2007

concerning the non-inclusion of oxydemeton-methyl 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) 2098)

(Text with EEA relevance)

(2007/392/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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 to
includes oxydemeton-
Directive 91/414/EEC. That
methyl.

list

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.

(2)

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3)
lay down the detailed rules for the

(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.

laid down in Regulations

For oxydemeton-methyl the effects on human health and
the environment have been assessed in accordance with
the provisions
(EC) No
451/2000 and (EC) No 703/2001 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 recommen-
dations to the European Food Safety Authority (EFSA) in
accordance with Article 8(1) of Regulation (EC) No
rapporteur
451/2000.
Member State was France and all relevant information
was submitted on 3 May 2004.

For oxydemeton-methyl

the

(4)

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
the active substance oxydemeton-methyl (4). This
of
report was reviewed by the Member States and the
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 oxydemeton-methyl.

(4) EFSA Scientific Report (2006) 86, 1-96, Conclusion regarding the peer

review of pesticide risk assessment of oxydemeton-methyl.

L 148/8

EN

Official Journal of the European Union

9.6.2007

(5)

(6)

(7)

(8)

(9)

is

exposure

During the evaluation of this active substance, a number
of concerns were identified. In particular based on the
available data it has not been demonstrated that
the
consumer
information
available indicates concerns for metabolites which are
at the same level of toxicity as the active substance,
and their presence at levels which might be of toxico-
logical concerns cannot be excluded. Moreover concerns
were identified with regard to operator, worker and
bystander exposure.

acceptable. The

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 oxydemeton-
methyl satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC.

(11)

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

Oxydemeton-methyl
substance in Annex I to Directive 91/414/EEC.

shall not be

included as

an active

Member States shall ensure that:

Article 2

(a) authorisations

for plant protection products containing
oxydemeton-methyl are withdrawn by 21 November 2007;

(b) no authorisations for plant protection products containing
oxydemeton-methyl are granted or renewed from the date
of publication of this Decision.

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

Article 3

for

Measures should be taken to ensure that authorisations
containing
granted
plant
oxydemeton-methyl
fixed
period of time and are not renewed and that no new
authorisations for such products are granted.

protection products
are withdrawn within a

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be
expire on 21
November 2008 at the latest.

as possible

and shall

short

as

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
oxydemeton-methyl, should be limited to 12 months in
order to allow existing stocks to be used in one further
growing season.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 21 May 2007.

(10)

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

For the Commission

Markos KYPRIANOU
Member of the Commission