Commission Directive 2006/132/EC of 11 December 2006 amending Council Directive 91/414/EEC to include procymidone as active substance   (Text with EEA relevance)
Date: 2006-12-11
Institutions: European Commission
Subjects: market approval, pesticide, plant health control

L 349/22

EN

Official Journal of the European Union

12.12.2006

COMMISSION DIRECTIVE 2006/132/EC

of 11 December 2006

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

(Text with EEA relevance)

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 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 procymidone.

For procymidone 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
substances of plant
1994 laying down the active
protection products and designating the Rapporteur
Member State for the implementation of Commission
Regulation (EEC) No 3600/92 (3), France was designated
as Rapporteur Member State. France submitted the
relevant assessment report and recommendations to the
Commission on 15 January 2001 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.

(4)

It has appeared from the various examinations made that
plant protection products containing procymidone may

(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).

(5)

(6)

be expected to satisfy the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC, with
regard to the uses which were examined and detailed
in the Commission review report, provided that
adequate risk mitigation measures are applied. As procy-
midone is a hazardous substance, its use should not be
In particular there are concerns about its
unrestricted.
intrinsic
endocrine
including potential
disrupting properties. There is at present no scientific
consensus on the exact extent of the risk. Applying the
the
precautionary principle, and taking into account
current state of scientific knowledge,
risk mitigation
measures should be imposed in order to achieve the
high level of protection of human and animal health
and the environment chosen in the Community.

effects,

toxic

of

the

proposed

restriction

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

to be subject

implies

their

of

laid

active

down

approval

procedures
the

Under
the
by Directive
substances,
91/414/EEC,
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

several Member

reflect

States

12.12.2006

EN

Official Journal of the European Union

L 349/23

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 procymidone.

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
and
the
a
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

in Article

It may be expected that plant protection products
containing procymidone satisfy the requirements laid
down
of Directive
91/414/EEC, with regard to the uses which were
examined and detailed in the Commission review
report and providing that the necessary risk mitigation
measures are applied.

5(1)(a)

and

(b)

(7)

(8)

(9) Without prejudice to the conclusion that plant protection
products containing procymidone 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.
The potential endocrine-disrupting properties of procy-
midone have been assessed in test which follow the
best currently available practice. The Commission is
aware that the Organisation for Economic Cooperation
and Development (OECD) is developing test guidelines in
order
refine the assessment of potential
endocrine disrupting properties. Therefore it is appro-
priate to require that procymidone should be subjected
to such further testing as soon as agreed OECD test
guidelines
should be
exist
presented by the notifier.
In addition, Member States
should require authorisation holders to provide infor-
mation on the use of procymidone including any infor-
mation on incidences on operator health.

such studies

to further

and that

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

(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
the new requirements
prepare
which will result from the inclusion.

themselves

to meet

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
the
products containing procymidone to ensure that
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
vary,
existing
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
dossier of each plant protection product
for each
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC. Given the hazardous
properties of procymidone, the period for Member States
to verify whether plant protection products containing
procymidone, alone or
in combination with other
authorised active substances, comply with the provisions
of Annex VI should not exceed 18 months.

the

status of procymidone

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

(14)

(15)

(11)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

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
to the proposal
for implementing measures and it is
accordingly for the Commission to adopt these measures,

L 349/24

EN

Official Journal of the European Union

12.12.2006

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

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.

They shall apply those provisions from 1 July 2007.

Annex II to that Directive in accordance with the conditions of
Article 13.

By derogation from paragraph 1, for each authorised plant
2.
protection product containing procymidone, 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 procymidone. On the
basis of
the
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

they shall determine whether

that evaluation,

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

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 4

This Directive shall enter into force on 1 January 2007.

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 procy-
midone 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 procymidone 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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 11 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

12.12.2006

EN

Official Journal of the European Union

L 349/25

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12.12.2006

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