Commission Directive 2008/108/EC of 26 November 2008 amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances (Text with EEA relevance)
Date: 2008-11-26
Institutions: European Commission
Subjects: EU Member State, chemical product, marketing standard, microorganism, plant health control, plant health legislation, plant health product

L 317/6

EN

Official Journal of the European Union

27.11.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/108/EC

of 26 November 2008

amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole
and mepiquat as active substances

(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 Regulations (EC) No 451/2000 (2) and (EC)
No 1490/2002 (3) lay down the detailed rules for the
implementation of the third 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
Directive 91/414/EEC. That
flutolanil,
benfluralin, fluazinam, fuberidazole and mepiquat.

includes

list

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulations (EC) No
451/2000 and (EC) No 1490/2002 for a range of uses
proposed by the notifiers. 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

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 29.2.2000, p. 25.
(3) OJ L 224, 21.8.2002, p. 23.

accordance with Article 10(1) of Regulation (EC) No
1490/2002. For flutolanil the rapporteur Member State
was Finland and all relevant information was submitted
on 13 June 2005. For benfluralin the rapporteur Member
State was Belgium and all relevant
information was
fluazinam the
submitted on 16 February 2006. For
rapporteur Member State was Austria and all relevant
information was submitted on 3 January 2006. For
fuberidazole and mepiquat the rapporteur Member State
was the United Kingdom and all relevant information
was submitted on 5 April 2005.

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
flutolanil and
Commission on 3 March 2008 for
benfluralin, on 26 March 2008 for
fluazinam, on
14 November 2007 for fuberidazole and on 14 April
2008 for mepiquat in the format of the EFSA Scientific
Reports (4). These reports have been reviewed by the
the Commission within the
Member
Standing Committee on the Food Chain and Animal
Health and finalised on 20 May 2008 in the format of
the Commission review reports for flutolanil, benfluralin,
fluazinam, fuberidazole and mepiquat.

States

and

protection

It has appeared from the various examinations made that
plant
flutolanil,
benfluralin, fluazinam, fuberidazole and mepiquat may
be expected to satisfy, in general, the requirements laid
of Directive
down

in Article

containing

products

5(1)(a)

and

(b)

(3)

(4)

(4) EFSA Scientific Report (2008) 126. Conclusion regarding the peer
the active substance

the pesticide risk assessment of

the pesticide risk assessment of

review of
flutolanil (finalised 3 March 2008).
EFSA Scientific Report (2008) 127. Conclusion regarding the peer
review of
the active substance
benfluralin (finalised 3 March 2008).
EFSA Scientific Report (2008) 137. Conclusion regarding the peer
review of
the active substance
fluazinam (finalised 26 March 2008).
EFSA Scientific Report (2008) 118. Conclusion regarding the peer
review of the pesticide risk assessment of the active substance fuber­
idazole (finalised 14 November 2007).
EFSA Scientific Report (2008) 146. Conclusion regarding the peer
review of
the active substance
mepiquat (finalised on 14 April 2008).

the pesticide risk assessment of

the pesticide risk assessment of

27.11.2008

EN

Official Journal of the European Union

L 317/7

91/414/EEC, in particular with regard to the uses which
were examined and detailed in the Commission review
reports. It is therefore appropriate to include these active
substances in Annex I,
in order to ensure that in all
Member States the authorisations of plant protection
products containing these active substances can be
granted in accordance with the provisions of
that
Directive.

(5) Without prejudice to that conclusion, 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 it is appropriate to require that
benfluralin should be subject to further testing for confir­
mation of the risk assessment for consumers and for
aquatic organisms and that fluazinam should be subject
to further testing for confirmation of the risk assessment
for aquatic organisms and soil macro-organisms and such
studies should be presented by the notifiers.

(6)

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

to

six months after

in Annex I, Member States

(7) 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
fluazinam,
products containing flutolanil, benfluralin,
the
that
fuberidazole
ensure
and mepiquat
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, replace or withdraw, as appropriate, existing autho­
risations, in accordance with the provisions of Directive
91/414/EEC. By way of 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.

(8)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 (1) has shown that difficulties can arise in inter­
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further diffi­
culties it therefore appears necessary to clarify the duties
of the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that

(1) OJ L 366, 15.12.1992, p. 10.

Directive. However, this clarification does not impose any
new obligations on Member States or holders of autho­
risations compared to the Directives which have been
adopted until now amending Annex I.

(9)

(10)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

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

Member States shall adopt and publish by 31 August 2009 at
the latest the laws, regulations 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 September 2009.

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
containing
flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as
active substances by 31 August 2009.

protection

products

plant

for

By that date they shall in particular verify that the conditions in
to that Directive relating to flutolanil, benfluralin,
Annex I
fuberidazole and mepiquat are met, with the
fluazinam,
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 of that Directive.

L 317/8

EN

Official Journal of the European Union

27.11.2008

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product
containing flutolanil,
benfluralin, fluazinam, fuberidazole and mepiquat as either the
only active substance or as one of several active substances all
of which were listed in Annex I to Directive 91/414/EEC by
28 February 2009 at the latest, 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
fuberi­
Directive concerning flutolanil, benfluralin,
dazole and mepiquat
that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 4(1)(b),
(d) and (e) of
Directive 91/414/EEC.

respectively. On the basis of

fluazinam,

(c),

(b) in the case of a product containing flutolanil, benfluralin,
fluazinam,
fuberidazole and mepiquat as one of several
active substances, where necessary, amend or withdraw
the authorisation by 28 February 2013 or by the date
in the
fixed for
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

such an amendment or withdrawal

to Annex

substances

or

I

Article 4

This Directive shall enter into force on 1 March 2009.

Article 5

This Directive is addressed to the Member States.

Following that determination Member States shall:

Done at Brussels, 26 November 2008.

(a)

in the case of a product containing flutolanil, benfluralin,
fluazinam,
fuberidazole and mepiquat as the only active
substance, where necessary, amend or withdraw the autho­
risation by 28 February 2013 at the latest; or

For the Commission

Androulla VASSILIOU
Member of the Commission

27.11.2008

EN

Official Journal of the European Union

L 317/9

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27.11.2008

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