Commission Directive 2008/107/EC of 25 November 2008 amending Council Directive 91/414/EEC to include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances (Text with EEA relevance)
Date: 2008-11-25
Institutions: European Commission
Subjects: exchange of information, marketing standard, pharmaceutical product, plant health control, plant health legislation, plant health product

L 316/4

EN

Official Journal of the European Union

26.11.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/107/EC

of 25 November 2008

amending Council Directive 91/414/EEC to include abamectin, epoxiconazole,

fenpropimorph,

fenpyroximate and tralkoxydim 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 list includes abamectin, epox­
iconazole,
and tralk­
oxydim.

fenpropimorph,

fenpyroximate

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 abamectin the
rapporteur Member
State was the Netherlands and all relevant information
was submitted on 27 October 2005. For epoxiconazole,
rapporteur
fenpropimorph
Member State was Germany and all relevant information

fenpyroximate

and

the

(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.

was submitted on 28 April 2005, 17 March 2005 and
25 October 2005 respectively. For
tralkoxydim the
rapporteur Member State was the United Kingdom and
all relevant information was submitted on 6 September
2005.

(3)

(4)

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 29 May 2008 for abamectin, on
26 March 2008 for epoxiconazole and tralkoxydim, on
14 April 2008 for fenpropimorph, on 5 May 2008 for
the EFSA Scientific
fenpyroximate in the 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 11 July 2008 in the format of
abamectin,
review reports
the
epoxiconazole,
and
tralkoxydim.

for
fenpyroximate

fenpropimorph,

Commission

States

and

It has appeared from the various examinations made that
plant protection products containing abamectin, epoxico­
nazole, fenpropimorph, fenpyroximate and tralkoxydim
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
all Member States the authorisations of plant protection
products containing these active substances can be
granted in accordance with the provisions of
that
Directive.

(4) EFSA Scientific Report (2008) 148. Conclusion regarding the peer
the active substance

the pesticide risk assessment of

review of
abamectin (finalised 29 May 2008).
EFSA Scientific Report (2008) 138. Conclusion regarding the peer
review of the pesticide risk assessment of the active substance epox­
iconazole (finalised 26 March 2008).
EFSA Scientific Report (2008) 144. Conclusion regarding the peer
review of
the active substance
fenpropimorph (finalised 14 April 2008).
EFSA Scientific Report (2008) 143, Conclusion regarding the peer
review of
the active substance
fenpyroximate (finalised 5 May 2008).
EFSA Scientific Report (2008), Conclusion regarding the peer review
of the pesticide risk assessment of the active substance tralkoxydim
(finalised 26 March 2008).

the pesticide risk assessment of

the pesticide risk assessment of

26.11.2008

EN

Official Journal of the European Union

L 316/5

further

information is

(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
it is appropriate to require that
conditions. Therefore,
abamectin should be subjected to further studies on the
required to
specification and further
confirm the risk to birds and mammals,
to aquatic
organisms, and to groundwater with respect to the meta­
bolite U8. Epoxiconazole should be subjected to further
testing of its potential endocrine disrupting properties
and to a monitoring programme to assess the long-
range atmospheric transport and related environmental
risks;
information is required as regards the
residues of its metabolites in primary crops, rotational
crops and products of animal origin as well as infor­
mation to address the long-term risk to herbivorous
birds
be
subjected to further testing to confirm the mobility in
soil of metabolite BF-421-7. Fenpyroximate should be
subjected to further testing for confirmation of the risk
to aquatic organisms from metabolites containing the
benzyl moiety and the risk of biomagnification in
aquatic food chains. Tralkoxydim should be subjected
to further testing for confirmation of the long-term risk
to herbivorous mammals. All
the above mentioned
studies and information should be presented by the
notifiers within the deadlines set
this
Directive.

and mammals.

in Annex I of

Fenpropimorph

should

(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

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 abamectin, epoxiconazole,
fenpro­
pimorph, fenpyroximate and tralkoxydim to ensure that
the 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 authoris­
ations,
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.

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
Directive. However, this clarification does not impose any
new obligations on Member States or holders of author­
isations 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 October 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 November 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
abamectin, epoxiconazole, fenpropimorph, fenpyroximate and
tralkoxydim as active substances by 31 October 2009.

protection

products

plant

for

(8)

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

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

L 316/6

EN

Official Journal of the European Union

26.11.2008

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to abamectin, epoxiconazole,
fenpropimorph, fenpyroximate and tralkoxydim 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 of that Directive.

those identified in part B of

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing abamectin,
epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim
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 30 April 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 Directive concerning abamectin, epoxico­
nazole, fenpropimorph, fenpyroximate and tralkoxydim respect­
they shall determine
ively. On the basis of that evaluation,
in
satisfies
whether
Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

the product

conditions

set out

the

the only active substance, where necessary, amend or
withdraw the authorisation by 30 April 2013 at
the
latest; or

(b) in the case of a product containing abamectin, epoxico­
nazole, fenpropimorph, fenpyroximate and tralkoxydim as
one of several active substances, where necessary, amend or
withdraw the authorisation by 30 April 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 May 2009.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 25 November 2008.

Following that determination Member States shall:

(a)

in the case of a product containing abamectin, epoxico­
nazole, fenpropimorph, fenpyroximate and tralkoxydim as

For the Commission

Androulla VASSILIOU
Member of the Commission

L 316/7

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2

26.11.2008

EN

Official Journal of the European Union

L 316/11

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