Commission Directive 2008/116/EC of 15 December 2008 amending Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor as active substances (Text with EEA relevance)
Date: 2008-12-15
Institutions: European Commission
Subjects: EU Member State, chemical product, environmental impact, marketing standard, microorganism, plant health control, plant health product

L 337/86

EN

Official Journal of the European Union

16.12.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/116/EC

of 15 December 2008

amending Council Directive 91/414/EEC to include aclonifen,

imidacloprid and metazachlor as

active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

rapporteur Member State was United Kingdom and all
relevant information was submitted on 30 September
2005.

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:

(3)

(4)

(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 aclonifen, imida­
cloprid and metazachlor.

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.
the
rapporteur Member State was Germany and all relevant
information was submitted on 11 September 2006 and
the
on 13 June 2006 respectively. For metazachlor

imidacloprid

aclonifen

and

For

(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.

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 31 July 2008 for
aclonifen, on
29 May 2008 for imidacloprid and on 14 April 2008
for metazachlor in the format of the EFSA Scientific
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 26 September 2008 in the
format of the Commission review reports for aclonifen,
imidacloprid and metazachlor.

States

and

It has appeared from the various examinations made that
plant protection products containing aclonifen,
imida­
cloprid and metazachlor 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
active
substances can be granted in accordance with the
provisions of that Directive.

containing

these

(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
it is appropriate to require that
conditions. Therefore,
testing for
aclonifen should be subjected to further
evaluation of residues in rotational crops and for the

the pesticide risk assessment of

(4) EFSA Scientific Report (2008) 149, Conclusion regarding the peer
the active substance

review of
aclonifen (finalised 31 July 2008).
EFSA Scientific Report (2008) 148, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance imida­
cloprid (finalised 29 May 2008).
EFSA Scientific Report (2008) 145, Conclusion regarding the peer
review of the pesticide risk assessment of the active substance meta­
zachlor (finalised 14 April 2008).

16.12.2008

EN

Official Journal of the European Union

L 337/87

this stage is considered to be sufficient

confirmation of the risk assessment for birds, mammals,
aquatic organisms and non-target plants and that imida­
cloprid should be subjected to further testing for confir­
mation of the risk assessment for operators and workers
and the risk to birds and mammals and such studies
should be presented by the notifier. Furthermore for
metazachlor it is appropriate to obtain additional infor­
mation on certain specific points. Article 5(5) of
Directive 91/414/EEC provides that an inclusion may
be reviewed at any time if there are indications that
the criteria referred to in paragraphs 1 and 2 are no
longer satisfied. The notifier has submitted information
which at
to
address the relevance of certain metabolites. However, a
decision on the classification of metazachlor under
Council Directive 67/548/EEC of 27 June 1967 on the
approximation of
laws, regulations and administrative
provisions relating to the classification, packaging and
labelling of dangerous substances (1) is not yet finalised.
Such decision might lead to the need for further infor­
mation on these metabolites. The information submitted
by the notifier to address the relevance of the metabolites
479M04, 479M08, 479M09, 479M11 and 479M12
with respect to cancer is, at this stage, considered as
sufficient. However,
if a decision is adopted under
Directive 67/548/EEC by which metazachlor is classified
as ‘limited evidence of a cancerogenic effect’,
further
information will be needed on the relevance of those
to cancer. Article 6(1) of
metabolites with respect
Directive 91/414/EEC provides that the inclusion of a
substance in Annex I to that Directive may be subject
to conditions. The inclusion of metazachlor
should
to a condition concerning the
therefore be subject
that
case
submission
substance is classified under Directive 67/548/EEC.

information

further

of

in

(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

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 aclonifen,
imidacloprid and meta­
zachlor to ensure that the requirements laid down by
in particular in its Article 13
Directive 91/414/EEC,
in Annex I, are
and the relevant conditions set out
replace or
satisfied. Member
withdraw, as appropriate, existing authorisations,
in
accordance
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
for each
dossier of each plant protection product

provisions

should

States

vary,

with

the

of

intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

inclusions

in
The experience gained from previous
Annex I to Directive 91/414/EEC of active substances
assessed in the framework of Commission Regulation
(EEC) No 3600/92 (2) 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

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

(8)

(9)

(10)

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 January 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 February 2010.

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
aclonifen,
imidacloprid and metazachlor as active substances
by 31 January 2010.

protection

products

plant

for

(1) OJ 196, 16.8.1967, p. 1.

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

L 337/88

EN

Official Journal of the European Union

16.12.2008

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to aclonifen, imidacloprid and
metazachlor 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.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing aclonifen, imida­
cloprid and metazachlor 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 July 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
the
requirements of Annex III to that Directive and taking into
account part B of
to that Directive
the entry in Annex I
imidacloprid and metazachlor respect­
concerning aclonifen,
they shall determine
ively. On the basis of that evaluation,
whether
in
satisfies
Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

the product

conditions

a dossier

satisfying

set out

the

necessary,
31 January 2014 at the latest; or

amend or withdraw the

authorisation by

amend or withdraw the

(b) in the case of a product containing aclonifen, imidacloprid
and metazachlor as one of several active substances, where
authorisation by
necessary,
31 January 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.

Article 4

This Directive shall enter into force on 1 August 2009.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 15 December 2008.

Following that determination Member States shall:

(a)

in the case of a product containing aclonifen, imidacloprid
the only active substance, where
and metazachlor as

For the Commission

Androulla VASSILIOU
Member of the Commission

16.12.2008

EN

Official Journal of the European Union

L 337/89

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EN

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