Commission Directive 2006/134/EC of 11 December 2006 amending Council Directive 91/414/EEC to include fenarimol 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

L 349/32

EN

Official Journal of the European Union

12.12.2006

COMMISSION DIRECTIVE 2006/134/EC

of 11 December 2006

amending Council Directive 91/414/EEC to include fenarimol 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 fenarimol.

For fenarimol 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), the United Kingdom
was designated as Rapporteur Member State. The
United Kingdom submitted the
relevant assessment
report and recommendations to the Commission on 30
April 1996 in accordance with Article 7(1)(c) of Regu-
lation (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).

adverse

for other

associated with

As regards fenarimol two questions were submitted to
(the Scientific
the Scientific Committee on Plants
Committee). The Scientific Committee was asked to
comment on the interpretation of the multi-generation
studies and to consider the aromatase inhibition effects
of fenarimol. In addition its opinion was sought on the
establishment of a reliable acceptable daily intake (ADI)
(AOEL) (4). The
and acceptable operator exposure level
Scientific Committee
effects of
the
concluded that
fenarimol on male fertility seen in rats had to be
considered relevant for human risk assessment although
man is less sensitive than rats to the effects of aromatase
inhibition. It also concluded that the effects of fenarimol
on parturition in rats could be considered as not relevant
for human risk assessment. It was further concluded that,
apart from male-mediated reduced fertility and effects
there was no
associated with delayed parturition,
reproductive
convincing evidence
effects
by
fenarimol. Finally, the Scientific Committee agreed that
the toxicological studies submitted permitted the estab-
lishment of a reliable ADI and AOEL. A second
opinion (5)
the
the
approach taken to calculate the Predicted Environmental
adequate. The
Concentrations
Committee proposed a combination of field dissipation
and laboratory degradation data to calculate an accu-
mulated soil PEC. This opinion has been examined by
the rapporteur Member State who considered never-
theless that this procedure was no more scientifically
justified than relying on field dissipation measurements
alone. Therefore it was decided to await the outcome of
the field dissipation studies that were ongoing. The
interim results from these studies are consistent with
the results of the model calculation and consequently
the issue was considered to be adequately addressed. It
is therefore concluded that in all cases, the recommen-
dations from the Scientific Committee have been taken
into consideration in formulating this Directive and the
relevant review report.

question whether

in soil was

aromatase

inhibition

addressed

(PEC)

(5)

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

(4) Opinion of the Scientific Committee on Plants regarding the possible
inclusion of
in Annex 1 to Directive 91/414/EEC
concerning the placing of plant protection products on the market
(SCP/FENARI/005 — Final)
(Opinion adopted by the Scientific
Committee on Plants on 18 May 1999).

fenarimol

(5) Opinion of the Scientific Committee on Plants on a specific question
from the Commission concerning the evaluation of Fenarimol in the
context of Council Directive 91/414/EEC (Opinion adopted by the
Scientific Committee on Plants on 8 November 2001).

12.12.2006

EN

Official Journal of the European Union

L 349/33

fenarimol

is a
mitigation measures are applied. As
hazardous substance, its use should not be unrestricted.
In particular there are concerns about its intrinsic toxic
effects,
including potential endocrine disrupting prop-
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.

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
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 fenarimol.
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
fenarimol 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
that other uses,
which were not or only partially covered by this
to a complete
assessment, had first
assessment, before
inclusion in Annex I of
Directive 91/414/EEC could be considered. Finally, due
to the hazardous nature of fenarimol, 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.

to be subject

implies

their

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
their
expressed by
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 fenarimol.

several Member

reflect

States

(6)

(7)

(8)

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

sought

sustainable

environment

it considered appropriate,

the
in
a
and
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.

(9)

It may be expected that plant protection products
containing fenarimol 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.

(10) Without prejudice to the conclusion that plant protection
products containing fenarimol 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 fenarimol 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
fenarimol
should be subjected to such further testing as soon as
agreed OECD Test Guidelines exist and that such studies
should be presented by the notifier. In addition, Member
States should require authorisation holders to provide
information on the use of fenarimol including any infor-
mation on incidences on operator health.

is appropriate to require that

(11) As with all substances included in Annex I to Directive
91/414/EEC, the status of fenarimol 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

L 349/34

EN

Official Journal of the European Union

12.12.2006

(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 fenarimol

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

(15)

(16)

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

and a correlation table between those provisions and this
Directive.

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

for

shall

plant

States

products

protection

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
fenarimol as an active substance by 30 June 2007. By that
the conditions in
date they shall
Annex I to that Directive relating to fenarimol are met, with
the exception 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.

those identified in part B of

in particular verify that

By derogation from paragraph 1, for each authorised plant
2.
protection product containing fenarimol, 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 fenarimol. 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 fenarimol, where necessary, amend or withdraw the
authorisation by 30 June 2008.

Article 4

HAS ADOPTED THIS DIRECTIVE:

This Directive shall enter into force on 1 January 2007.

Article 1

Article 5

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

This Directive is addressed to the Member States.

Article 2

Done at Brussels, 11 December 2006.

the

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

regulations

laws,

For the Commission

Markos KYPRIANOU
Member of the Commission

12.12.2006

EN

Official Journal of the European Union

L 349/35

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