Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance)
Date: 2008-12-19
Institutions: European Commission
Subjects: chemical product, environmental impact, health risk, human nutrition, market approval, marketing standard, plant health control, plant health product

L 344/78

EN

Official Journal of the European Union

20.12.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/125/EC

of 19 December 2008

amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide,
magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron,
sulcotrione, tebuconazole and triadimenol 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
includes aluminium
phosphide, calcium phosphide, magnesium phosphide,
cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methyl-
ester, metamitron, sulcotrione,
tebuconazole and tria­
dimenol.

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
accordance with Article 10(1) of Regulation (EC) No
1490/2002.
calcium
phosphide, magnesium phosphide, 2,5-dichlorobenzoic
acid methylester
rapporteur
Member State was Germany and all relevant information
aluminium
was
phosphide, calcium phosphide, magnesium phosphide

submitted on 19 June 2007 for

aluminium phosphide,

sulcotrione

and

For

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.

relevant

acid methylester

rapporteur Member State was

and 2,5-dichlorobenzoic
and on
9 August 2006 for sulcotrione. For metamitron, and
triadimenol
the
the
United Kingdom and all
information was
submitted on 22 August 2007 and 29 May 2006 re­
spectively. For cymoxanil, the rapporteur Member State
was Austria and all relevant information was submitted
on 15 June 2007. For dodemorph,
the rapporteur
Member State was the Netherlands and all relevant infor­
mation was submitted on 9 February 2007. For tebuco­
nazole the rapporteur Member State was Denmark and
all relevant information was submitted on 5 March 2007.

(3)

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 29 September 2008 for aluminium
phosphide,
calcium phosphide and metamitron, on
30 September 2008 for magnesium phosphide, on
17 September 2008 for cymoxanil and dodemorph, on
26 September 2008 for 2,5-dichlorobenzoic acid methyl-
ester, on 31 July 2008 for
and on
25 September 2008 for tebuconazole and triadimenol
in the format of the EFSA Scientific Reports (4). These
reports have been reviewed by the Member States and

sulcotrione

(4) EFSA Scientific Report (2008) 182, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance aluminium phosphide
(finalised 29 September 2008).
EFSA Scientific Report (2008) 183, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance calcium phosphide
(finalised 29 September 2008).
EFSA Scientific Report (2008) 190, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance magnesium phosphide
(finalised 30 September 2008).
EFSA Scientific Report (2008) 167, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance cymoxanil (finalised
17 September 2008).
EFSA Scientific Report (2008) 170, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance dodemorph (finalised
17 September 2008).
EFSA Scientific Report (2008) 180, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance 2,5-dichlorobenzoic
acid methylester (finalised 26 September 2008).
EFSA Scientific Report (2008) 185, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance metamitron (finalised
29 September 2008).
EFSA Scientific Report (2008) 150, Conclusion regarding the peer review
of the pesticide risk assessment of the active substance sulcotrione (finalised
31 July 2008).
EFSA Scientific Report (2008) 176, Conclusion regarding the peer review
of
tebuconazole
(finalised 25 September 2008).
EFSA Scientific Report (2008) 177, Conclusion regarding the peer review
of
triadimenol
the pesticide
(25 September 2008).

risk assessment of

risk assessment of

the pesticide

the active

the active

substance

substance

20.12.2008

EN

Official Journal of the European Union

L 344/79

the Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
the Commission
28 October 2008 in the format of
review reports
calcium
for
cymoxanil,
phosphide,
dodemorph, 2,5-dichlorobenzoic acid methylester, meta­
mitron, sulcotrione, tebuconazole and triadimenol.

aluminium phosphide,

magnesium

phosphide,

(4)

products

protection

containing

sulcotrione,

tebuconazole or
in general,

It has appeared from the various examinations made that
plant
aluminium
phosphide, calcium phosphide, magnesium phosphide,
cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methyl-
tria­
ester, metamitron,
dimenol may be expected to satisfy,
the
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC,
in particular with regard to the
examined and detailed in the
uses which were
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
active
substances can be granted in accordance with the
provisions of that Directive.

containing

these

of

by

the

the

impact

of water

soil metabolite M3

(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 for metamitron to
further information as
require the notifier to submit
regards
on
groundwater, on residues in rotational crops, on the
long term risk to insectivorous birds and on the
that may be
specific risk to birds and mammals
contaminated
field.
in
intake
Furthermore, for sulcotrione it is appropriate to require
the notifier to submit further information as regards the
the cyclohexadione
degradation in soil and water of
moiety and the long term risk to insectivorous birds.
In addition, it is appropriate to require that tebuconazole
should be subjected to further testing for the confir­
mation of the risk assessment for birds and mammals
and such information should be presented by the notifier.
Moreover, it is appropriate to require that tebuconazole
and triadimenol be subjected to further testing of their
potential endocrine disrupting properties, as soon as
OECD test guidelines on endocrine disruption, or, alter­
natively, Community agreed test guidelines exist. Finally,
it is appropriate to require that triadimenol should be
subjected to further
the
chemical specification and the long risk to birds and
be
and
mammals
presented by the notifier.

testing for confirmation of

such information should

that

(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

containing

magnesium

six months after

in Annex I, Member States

aluminium phosphide,
phosphide,

(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
calcium
products
phosphide,
cymoxanil,
dodemorph, 2,5-dichlorobenzoic acid methylester, meta­
mitron, sulcotrione,
to
the requirements laid down by Directive
ensure that
in its Article 13 and the
91/414/EEC,
in particular
relevant conditions set out
in Annex I, are satisfied.
Member States should vary, replace or withdraw, as
appropriate, existing authorisations,
in accordance with
the provisions of Directive 91/414/EEC. By way of dero­
gation 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.

tebuconazole and triadimenol

(8)

(9)

(10)

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

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 28 February 2010 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 March 2010.

L 344/80

EN

Official Journal of the European Union

20.12.2008

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.

that evaluation,

the
basis of
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

they shall determine whether

Article 3

Following that determination Member States shall:

for

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
containing
products
authorisations
aluminium phosphide,
calcium phosphide, magnesium
phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid
methylester, metamitron, sulcotrione,
tebuconazole and tria­
dimenol as active substances by 28 February 2010.

protection

plant

(a)

in the case of a product containing aluminium phosphide,
calcium phosphide, magnesium phosphide,
cymoxanil,
dodemorph, 2,5-dichlorobenzoic acid methylester, meta­
tebuconazole or triadimenol as the
mitron, sulcotrione,
only
or
necessary,
active
withdraw the authorisation by 28 February 2014 at the
latest; or

substance, where

amend

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to aluminium phosphide,
calcium phosphide, magnesium phosphide,
cymoxanil,
dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron,
sulcotrione, tebuconazole and triadimenol 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.

(b) in the case of a product containing aluminium phosphide,
calcium phosphide, magnesium phosphide,
cymoxanil,
dodemorph, 2,5-dichlorobenzoic acid methylester, meta­
mitron, sulcotrione, tebuconazole or triadimenol as one of
several
amend or
withdraw the authorisation by 28 February 2014 or by
the date fixed for such an amendment or withdrawal
in
the respective Directive or Directives which added the
relevant substance or substances to Annex I to Directive
91/414/EEC, whichever is the latest.

substances, where necessary,

active

sulcotrione,

tebuconazole

and triadimenol

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing aluminium
phosphide,
calcium phosphide, magnesium phosphide,
cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester,
metamitron,
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 August 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 aluminium phosphide,
calcium phosphide, magnesium phosphide,
cymoxanil,
dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron,
sulcotrione, tebuconazole and triadimenol respectively. On the

This Directive shall enter into force on 1 September 2009.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 19 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

20.12.2008

EN

Official Journal of the European Union

L 344/81

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20.12.2008

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EN

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EN

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20.12.2008

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EN

Official Journal of the European Union

20.12.2008

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