Commission Directive 2008/66/EC of 30 June 2008 amending Council Directive 91/414/EEC to include bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as active substances (Text with EEA relevance)
Date: 2008-06-30
Institutions: European Commission
Subjects: chemical product, herbicide, marketing standard, pesticide, plant health control, plant health legislation, plant health product

1.7.2008

EN

Official Journal of the European Union

L 171/9

DIRECTIVES

COMMISSION DIRECTIVE 2008/66/EC

of 30 June 2008

amending Council Directive 91/414/EEC to include bifenox, diflufenican, fenoxaprop-P, fenpropidin
and quinoclamine as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

rapporteur Member State was the United Kingdom and
all relevant
information was submitted on 1 August
2005. For fenoxaprop-P the rapporteur Member State
was Austria and all relevant information was submitted
on 2 May 2005. For fenpropidin and quinoclamine the
rapporteur Member State was Sweden and all relevant
information was
submitted on 24 June 2005 and
15 June 2005 respectively.

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,

(3)

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 list includes bifenox, diflu-
fenican, fenoxaprop-P, fenpropidin and quinoclamine.

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
accordance with Article 10(1) of Regulation (EC) No
1490/2002. For bifenox the rapporteur Member State
was
information was
For diflufenican the
submitted on 4 July 2005.

Belgium and

relevant

all

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

last amended by

Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regu-

lation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 14 November 2007 for quinoclamine,
on 29 November 2007 for bifenox and fenoxaprop-P
and on 17 December 2007 for diflufenican and
fenpropidin in the
the EFSA Scientific
format of
Reports (4). These reports have been reviewed by the
Member
the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 14 March 2008 in the format
of
the Commission review reports for bifenox, diflu-
fenican, fenoxaprop-P, fenpropidin and quinoclamine.

States

and

(4)

fenoxaprop-P,

It has appeared from the various examinations made that
plant protection products containing bifenox, diflu-
fenican,
fenpropidin and quinoclamine
may be expected to satisfy, in general, the requirements
laid down in Article 5(1)(a) and (b) of Directive
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

(4) EFSA Scientific Report (2007) 119, 1-84, Conclusion regarding the peer
the active substance bifenox

the pesticide risk assessment of

review of
(finalised 29 November 2007).
EFSA Scientific Report (2007) 122, 1-84, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance diflufenican
(finalised 17 December 2007).
EFSA Scientific Report (2007) 121, 1-76, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance fenoxaprop-P
(finalised 29 November 2007).
EFSA Scientific Report (2007) 124, 1-84, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance fenpropidin
(finalised 17 December, revision of 29 January 2008 with corrections of
miscalculations in the aquatic risk assessment).
EFSA Scientific Report (2007) 117, 1-70, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance quinoclamine
(finalised on 14 November 2007).

L 171/10

EN

Official Journal of the European Union

1.7.2008

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/EC provides
that
inclusion of a substance in Annex I may be subject to
conditions. Therefore it is appropriate to require that
bifenox should be subjected to further testing for confir-
mation of the risk assessment for consumers and the
and that
long-term risk to herbivorous mammals
fenpropidin should be subjected to further testing for
confirmation of the risk assessment for the long-term
risk to herbivorous and insectivorous birds 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
prepare
the new requirements
which will result from the inclusion.

themselves

to meet

to ensure

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
products containing bifenox, diflufenican, fenoxaprop-P,
the
fenpropidin and quinoclamine
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 auth-
orisations, 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.

that

(8)

inclusions

The experience gained from previous
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 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 an authorisation demon-
strates access to a dossier satisfying the requirements of
Annex II to that Directive. However, this clarification
does not
impose any new obligations on Member
States or holders of authorisations compared to the
directives which
now
amending Annex I.

adopted

been

until

have

(1) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 416/2008 (OJ L 125, 9.5.2008, p. 25).

(9)

(10)

is

therefore
It
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

the

laws,

regulations

Member States shall adopt and publish by 30 June 2009 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 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
containing
authorisations
bifenox, diflufenican,
fenpropidin and quino-
clamine as active substances by 30 June 2009.

fenoxaprop-P,

protection

products

plant

for

By that date they shall in particular verify that the conditions in
Annex I
to that Directive relating to bifenox, diflufenican,
fenoxaprop-P, fenpropidin and quinoclamine 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 of that Directive.

1.7.2008

EN

Official Journal of the European Union

L 171/11

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing bifenox, diflu-
fenican, fenoxaprop-P, fenpropidin and quinoclamine 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
31 December 2008 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
Directive
fenoxaprop-P,
fenpropidin and quinoclamine respectively. 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

diflufenican,

concerning

bifenox,

(b) in the case of a product containing bifenox, diflufenican,
fenpropidin and quinoclamine as one of
fenoxaprop-P,
several
amend or
substances, where necessary,
active
withdraw the authorisation by 31 December 2012 or by
the date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

This Directive shall enter into force on 1 January 2009.

Article 4

This Directive is addressed to the Member States.

Article 5

Following that determination Member States shall:

Done at Brussels, 30 June 2008.

(a)

in the case of a product containing bifenox, diflufenican,
fenoxaprop-P,
fenpropidin and quinoclamine as the only
active substance, where necessary, amend or withdraw the
authorisation by 31 December 2012 at the latest; or

For the Commission

Androulla VASSILIOU
Member of the Commission

L 171/12

EN

Official Journal of the European Union

1.7.2008

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