Commission Directive 2006/41/EC of  7 July 2006  amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances   (Text with EEA relevance)
Date: 2006-07-07
Institutions: European Commission
Subjects: marketing, marketing standard, plant health product

L 187/24

EN

Official Journal of the European Union

8.7.2006

COMMISSION DIRECTIVE 2006/41/EC

of 7 July 2006

amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active
substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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)

(3)

for

the inclusion of

Pursuant to Article 6(2) of Directive 91/414/EEC Belgium
received, on 26 September 2001, an application from
Sumitomo Chemical Takeda Agro Company
Ltd,
London,
the active substance
clothianidin in Annex I
to Directive 91/414/EEC.
Commission Decision 2002/305/EC (2) confirmed that
the dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annexes II and III to Directive
91/414/EEC.

Germany received an application pursuant to Article 6(2)
of Directive 91/414/EEC on 16 October 2000 from
Stähler Agrochemie GmbH & Co., KG (now Stähler Inter-
national GmbH & Co., KG) (on behalf of the Taskforce
Stähler Agrochemie GmbH & Co. KG, Tokuyama Europe
GmbH and Tomen France SA) for the inclusion of the
active substance pethoxamid in Annex I
to Directive
91/414/EEC. Commission Decision 2001/626/EC (3)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

For those active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants. The
designated rapporteur Member States submitted draft
reports concerning the substances to the
assessment
Commission on 4 June 2003 (clothianidin)
and
27 August 2002 (pethoxamid), respectively.

(5)

(6)

The draft assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 27 January 2006 in the format of
the Commission review reports for clothianidin and
pethoxamid.

The review of clothianidin and pethoxamid did not reveal
any open questions or concerns, which would have
required a consultation of the Scientific Committee on
Plants or of the European Food Safety Authority which
has taken over the role of that Committee.

the

products

protection

containing

It has appeared from the various examinations made that
active
plant
substances concerned may be expected to satisfy,
in
general, the requirements laid down in Article 5(1) (a)
and (b) and Article 5(3) of Directive 91/414/EEC,
in
particular with regard to the uses which were examined
is
and detailed in the Commission review reports.
clothianidin and
therefore
pethoxamid in Annex I to that Directive,
in order to
ensure that in all Member States the authorisations of
plant protection products
active
substances may be granted in accordance with the
provisions of that Directive.

to include

appropriate

containing

these

It

products

containing

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
review existing provisional
protection
or
clothianidin
pethoxamid to ensure that the requirements laid down
by Directive 91/414/EEC, in particular in its Article 13
in Annex I, are
and the relevant conditions set out
satisfied. Member States should transform existing pro-
visional authorisations into full authorisations, amend
them or withdraw them in accordance with the
provisions of Directive 91/414/EEC. By derogation
from the above deadline, a longer period should be
provided for
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.

the submission and assessment of

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

last amended by

Commission Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).

(2) OJ L 104, 20.4.2002, p. 42.
(3) OJ L 217, 11.8.2001, p. 14.

(8)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

8.7.2006

EN

Official Journal of the European Union

L 187/25

(9)

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 latest

1. Member States shall adopt and publish by 31 January
2007 at
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 2007.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

for

shall

plant

States

products

protection

in accordance with Directive
1. Member
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
clothianidin or pethoxamid as active substances by 31 January
2007. By that date,
the
conditions in Annex I to that Directive relating to clothianidin
or pethoxamid, respectively, are met, with the exception of
those identified in part B of the entry concerning those active
substances, 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.

in particular verify that

they shall

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing clothianidin or
pethoxamid 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 2006 at the latest, Member
in accordance with the
States shall re-evaluate the product
to Directive
uniform principles provided for
91/414/EEC, on the basis of
the
requirements of Annex III to that Directive and taking into
to that Directive
the entry in Annex I
account part B of
concerning clothianidin or pethoxamid. On the basis of 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.

in Annex VI
a dossier

satisfying

(c),

Following that determination Member States shall:

(a) in the

case of a product

containing clothianidin or
pethoxamid as the only active substance, where necessary,
amend or withdraw the authorisation by 31 January 2008
at the latest; or

(b) in

a

of

the

case

several

product

containing
active

clothianidin
or pethoxamid as one of
substances,
where necessary, amend or withdraw the authorisation by
31 January 2008 or by the date fixed for
such an
in the respective Directive or
amendment or withdrawal
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 2006.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 7 July 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 187/26

EN

Official Journal of the European Union

8.7.2006

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