Commission Directive 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance   (Text with EEA relevance)
Date: 2006-12-11
Institutions: European Commission
Subjects: derogation from EU law, marketing standard, pesticide, pharmaceutical product, plant health legislation, plant health product

12.12.2006

EN

Official Journal of the European Union

L 349/27

COMMISSION DIRECTIVE 2006/133/EC

of 11 December 2006

amending Council Directive 91/414/EEC to include flusilazole as 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 flusilazole.

For flusilazole the effects on human health and the envir-
onment 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), Ireland was designated
as Rapporteur Member State.
Ireland submitted the
relevant assessment report and recommendations to the
Commission on 30 April 1996 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).

(5)

(6)

As regards flusilazole two questions were submitted to
(the Scientific
the Scientific Committee on Plants
Committee). The first concerned the adequacy of
the
proposed NOEC (No Observed Effect Concentration) for
ensuring a sufficient protection from adverse effects on
reproduction and, more generally, the comparative sensi-
tivity of the early life stage test compared to the full fish
life cycle study. The second question related to the
potential
In
both cases,
the Scientific
Committee (4) have been taken into consideration in
formulating this Directive and the relevant review report.

impact on organic matter decomposition.

recommendations of

the

It has appeared from the various examinations made that
plant protection products containing flusilazole may 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
flusilazole is a
hazardous substance, its use should not be unrestricted.
In particular there are concerns about its intrinsic toxic
including potential endocrine disrupting prop-
effects,
erties. There is at present no scientific consensus on
the exact extent of the risk. Applying the precautionary
principle, and taking into account the 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.

the

proposed

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 Health,
the
inclusion period to seven years, so that Member States
would give priority to reviewing plant protection
products already on the market containing flusilazole.
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
flusilazole 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

restriction

implies

of

(4) Opinion of the Scientific Committee on Plants on specific questions
from the Commission concerning the evaluation of flusilazole in the
context of Council Directive 91/414/EEC (Opinion adopted by the
Scientific Committee on Plants on 18 July 2002).

L 349/28

EN

Official Journal of the European Union

12.12.2006

their

to be subject

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 flusilazole, it was considered
necessary to provide for a minimum harmonisation at
Community level of certain risk mitigation measures
that were to be applied by Member States when
granting authorisations.

of

laid

active

down

approval

procedures
the

by Directive
Under
the
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
acceptable
and consistent with the high level of
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 flusilazole.

several Member

reflect

States

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 6, 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

It may be expected that plant protection products
containing flusilazole 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 and providing that the
necessary risk mitigation measures are applied.

(7)

(8)

(9)

(10) Without prejudice to the conclusion that plant protection
products containing flusilazole 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 flusilazole have been
assessed in tests 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 to further refine the
assessment of potential endocrine disrupting properties.
Therefore it
flusilazole
should be subjected to such further testing as soon as
agreed OECD Test Guidelines exist and that such studies

is appropriate to require that

should be presented by the notifier. In addition, Member
States should require authorisation holders to provide
information on the use of flusilazole including any infor-
mation on incidences on operator health.

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

(12)

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

(13) 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

that

to ensure

six months after

containing flusilazole

in Annex I, Member States

replace or withdraw, as appropriate,

(14) 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
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 flusilazole, the period for Member States to
verify whether plant protection products containing flusi-
lazole, alone or in combination with other authorised
active substances, comply with the provisions of Annex
VI should not exceed 18 months.

12.12.2006

EN

Official Journal of the European Union

L 349/29

(15)

(16)

is

therefore
It
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,

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.

authorisations for plant protection products containing flusi-
lazole 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 flusilazole 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 flusilazole, Member States shall
re-evaluate the product in accordance with the uniform prin-
ciples 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 flusilazole. On the basis of
that evaluation,
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

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

Article 4

This Directive shall enter into force on 1 January 2007.

They shall apply those provisions from 1 July 2007.

Article 5

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.

This Directive is addressed to the Member States.

Done at Brussels, 11 December 2006.

Article 3

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing

States

shall

For the Commission

Markos KYPRIANOU
Member of the Commission

L 349/30

EN

Official Journal of the European Union

12.12.2006

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