Commission Directive 2006/131/EC of 11 December 2006 amending Council Directive 91/414/EEC to include methamidophos as an active substance   (Text with EEA relevance)
Date: 2006-12-11
Institutions: European Commission
Subjects: derogation from EU law, insecticide, marketing standard, pharmaceutical product, plant health legislation, plant health product

12.12.2006

EN

Official Journal of the European Union

L 349/17

COMMISSION DIRECTIVE 2006/131/EC

of 11 December 2006

amending Council Directive 91/414/EEC to include methamidophos as an active substance

(Text with EEA relevance)

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 Article 6(1) thereof,

Whereas:

(1)

(2)

Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive
91/414/EEC concerning the placing of plant protection
products on the market (2), establishes 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 methamidophos.

For methamidophos the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulation (EEC) No 3600/92
for a range of uses proposed by the notifier. By
Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active
substances of plant
protection products and designating the Rapporteur
Member State for the implementation of Commission
Regulation (EEC) No 3600/92 (3),
Italy was designated
as Rapporteur Member State.
Italy submitted on 30
July 1999 the relevant assessment report and recommen-
dations to the Commission in accordance with Article
7(1)(c) of Regulation (EEC) No 3600/92.

(3)

The assessment report has been reviewed by the Member
States
Standing
and the Commission within the
Committee on the Food Chain and Animal Health.

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

last amended by

Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).
(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu-

lation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

the

the

first

dermal

question

estimated

to the insecticide methamidophos.
on

The review of methamidophos revealed a number of
open questions which were addressed by the Scientific
Panel on Plant health, Plant protection products and their
Residues (PPR) of the European Food Safety Authority
(EFSA). The Scientific Panel was asked to define a value
for the degree of dermal adsorption scientifically based
on the different results of the studies submitted by the
notifier to be used in the assessment of human risk
arising from the dermal route of exposure. Moreover,
the Scientific Panel was asked to review the estimates
of avoidance, time spent foraging in treated areas and
proportion of contaminated diet obtained in treated
areas, and advise on their implications for estimates of
short and long term exposure of birds and
acute,
In its
mammals
opinion
PPR Panel
concluded (4) that, on the basis of the available data the
best
diluted
preparation is considered to be about 5 %. On the
second question,
concentrated its
assessment on two species considered by the notifier
and Rapporteur Member State, yellow wagtail and
wood mouse, as they make substantial use of the crops
supported
Panel
disagreed (5) with the values proposed by the notifier
the
and the Rapporteur Member State as
proportion of contaminated diet set for yellow wagtails
and the estimates used in dietary composition for yellow
wagtails and wood mouse. The PPR Panel noted that
these values would underestimate acute exposure of indi-
vidual animals. The PPR Panel developed an alternative
approach for assessing the potential role of avoidance.
The mechanisms involved are complex but it appears
possible that both yellow wagtail and wood mouse
feed quickly enough for mortality to occur in
might
field conditions. The PPR Panel
identified several
options for laboratory or field studies, which could be
considered to assess these risks with more certainty.

for methamidophos.

adsorption of

PPR Panel

regards

PPR

The

the

the

(5)

Articles 5(4) and 6(1) of Directive 91/414/EEC provide
that inclusion of a substance in Annex I may be subject
to restrictions and conditions. In this case, restrictions on
the inclusion period and on the authorised crops are
deemed necessary. The original measures presented to
the Standing Committee on the Food Chain and Animal

(4) Opinion of the Scientific Panel on Plant Health, Plant Protection
Products and their Residues on a request from the Commission
related to the evaluation of methamidophos in toxicology in the
context of Council Directive 91/414/EEC (The EFSA Journal (2004),
95, 1 to 15). Adopted on 14 September 2004.

(5) Opinion of the Scientific Panel on Plant Health, Plant Protection
Products and their Residues on a request from the Commission
related to the evaluation of methamidophos in ecotoxicology in
the context of Council Directive 91/414/EEC (The EFSA Journal
(2004), 144, 1 to 50). Adopted on 14 December 2004.

L 349/18

EN

Official Journal of the European Union

12.12.2006

Health, proposed the restriction of the inclusion period
to seven years, so that Member States would give priority
to reviewing plant protection products already on the
market containing methamidophos.
In order to avoid
discrepancies in the high level of protection sought, the
inclusion in Annex I
to Directive 91/414/EEC was
intended to be limited to the uses of methamidophos
that have been actually assessed within the Community
evaluation and for which the proposed uses were
considered to comply with the conditions of Directive
91/414/EEC. This implies that other uses, which were
not or only partially covered by this assessment, had
to be subject
first
to a complete assessment, before
their
inclusion in Annex I of Directive 91/414/EEC
could be considered. Finally, due to the hazardous
it was considered necessary
nature of methamidophos,
to
at
Community level of certain risk mitigation measures
that were to be applied by Member States when
granting authorisations.

a minimum harmonisation

provide

for

of

laid

active

down

approval

procedures
the

by Directive
Under
the
91/414/EEC,
substances,
including the definition of risk management measures,
is decided by the Commission. Member States bear the
responsibility for the implementation, application and
control of the measures intended to mitigate the risks
generated by plant protection products. Concerns
expressed by
their
that additional restrictions are necessary to
judgment
reduce the risk to a level
that can be considered
and consistent with the high level of
acceptable
is sought within the Community. At
protection that
present, it is a question of risk management to set the
adequate level of safety and protection for the continued
production, commercialisation and use of methami-
dophos.

several Member

reflect

States

with regard to the uses which were examined and
detailed
and
providing that
the necessary risk mitigation measures
are applied.

the Commission

review report

in

(9) Without prejudice to the conclusion that plant protection
products containing methamidophos may be expected to
satisfy the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC, it is appropriate to obtain
further information on certain specific points. Article
6(1) of Directive 91/414/EEC provides that inclusion of
a substance in Annex I may be subject to conditions.
Therefore,
is appropriate to require that methami-
dophos should be subjected to further testing for confir-
mation of the risk assessment for birds and mammals
should be presented by the
and that
notifiers.
should require
authorisation holders to provide information on the
use of methamidophos including any information on
incidences on operator health.

such studies
In addition, Member States

it

(10) As with all substances included in Annex I to Directive
the status of methamidophos could be
91/414/EEC,
reviewed under Article 5(5) of
that Directive in the
light of any new data becoming available. Equally, the
this substance in Annex I
fact
expires on a particular date does not prevent
the
inclusion being renewed according to the procedures
laid down in the Directive.

the inclusion of

that

(11)

sustainable

As a consequence of
the Commission re-
the above,
examined its position. In order to correctly reflect the
high level of protection of human and animal health
the
a
and
in
Community,
in addition to
the principles set out in Recital 5, to further reduce the
period of inclusion to 18 months instead of seven years.
This further reduces any risk by ensuring a priority re-
assessment of this substance.

it considered appropriate,

environment

sought

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Regulation (EEC) No 3600/92 has
shown that difficulties can arise in interpreting the duties
of holders of existing authorisations in relation to access
to data. In order to avoid further difficulties it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
to a dossier
an authorisation demonstrates
to that
satisfying
Directive. However,
impose
any new obligations on Member States or holders of
authorisations compared to the directives which have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

(6)

(7)

(8)

It may be expected that plant protection products
containing methamidophos satisfy the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,

(12) A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare
the new requirements
which will result from the inclusion.

themselves

to meet

12.12.2006

EN

Official Journal of the European Union

L 349/19

six months after

in Annex I, Member States

replace or withdraw, as appropriate,

(13) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant protection
review existing
products containing methamidophos to ensure that the
requirements laid down by Directive 91/414/EEC,
in
particular in its Article 13 and the relevant conditions
set out in Annex I, are satisfied. Member States should
existing
vary,
authorisations.
in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
for each
dossier of each plant protection product
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC. Given the hazardous
properties of methamidophos, the period for Member
States to verify whether the plant protection products,
which contain methamidophos
the only active
as
substance or
in combination with other authorised
active substances, comply with the provisions of Annex
VI should not exceed 18 months.

(14)

(15)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

submitted to the Council

The measures provided for in this Directive are not in
accordance with the opinion delivered by the Standing
Committee on the Food Chain and Animal Health. The
Commission therefore
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, the Council had
neither adopted the proposed implementing act nor
indicated its opposition to the proposal for implementing
measures and it is accordingly for the Commission to
adopt these measures,

They shall apply those provisions from 1 July 2007.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing metha-
midophos as an active substance by 30 June 2007.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to methamidophos are met,
with the exception of those identified in part B of the entry
concerning that active substance, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13.

2.
By derogation from paragraph 1, for each authorised plant
protection product containing methamidophos, Member States
shall re-evaluate the product in accordance with the uniform
principles provided for in Annex VI to Directive 91/414/EEC,
on the basis of a dossier satisfying the requirements of Annex
III to that Directive and taking into account part B of the entry
in Annex I to that Directive concerning methamidophos. On
the basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c), (d)
and (e) of Directive 91/414/EEC.

Following that determination Member States shall for products
containing methamidophos, where
or
withdraw the authorisation by 30 June 2008.

necessary

amend

HAS ADOPTED THIS DIRECTIVE:

Article 1

Article 4

This Directive shall enter into force on 1 January 2007.

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 5

This Directive is addressed to the Member States.

Article 2

the

laws,

regulations

Member States shall adopt and publish by 30 June 2007 at the
latest
and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

Done at Brussels, 11 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 349/20

EN

Official Journal of the European Union

12.12.2006

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