Commission Directive 2005/3/EC of 19 January 2005 amending Council Directive 91/414/EEC to include imazosulfuron, laminarin, methoxyfenozide and s-metolachlor as active substancesText with EEA relevance
Date: 2005-01-19
Institutions: European Commission
Subjects: herbicide, insecticide, marketing standard, pharmaceutical product, plant health product, public health, testing

22.1.2005

EN

Official Journal of the European Union

L 20/19

COMMISSION DIRECTIVE 2005/3/EC

of 19 January 2005

amending Council Directive 91/414/EEC to include imazosulfuron, laminarin, methoxyfenozide and
s-metolachlor 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)

(3)

In accordance with Article 6(2) of Directive 91/414/EEC
Germany received on 27 June 1996 an application from
Spiess-Urania Chemicals GmbH for the inclusion of the
active substance imazosulfuron in Annex I to Directive
97/865/EC (2)
Commission
91/414/EEC.
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.

Decision

Belgium received an application under Article 6(2) of
Directive 91/414/EEC on 29 March 2001 from
Goëmar SA for the inclusion of the active substance
laminarin in Annex
to Directive 91/414/EEC.
Commission Decision 2001/861/EC (3) 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.

I

The United Kingdom received an application under
Article 6(2) of Directive 91/414/EEC on 21 February
2000 from Rohm and Haas France SA (now Dow AgroS-
ciences) for the inclusion of the active substance meth-
oxyfenozide
to Directive 91/414/EEC.
Commission Decision 2001/385/EC (4) 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.

in Annex I

(4)

Belgium received an application under Article 6(2) of
Directive 91/414/EEC on 1 August 1997 from Novartis

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

last amended by

Commission Directive 2004/99/EC (OJ L 309, 6.10.2004, p. 6).

(2) OJ L 351, 23.12.1997, p. 67.
(3) OJ L 321, 6.12.2001, p. 34.
(4) OJ L 137, 19.5.2001, p. 30.

for
s-metolachlor

the inclusion of
in Annex

the active
NV (now Syngenta)
to Directive
substance
98/512/EC (5)
91/414/EEC.
Commission
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.

Decision

I

(5)

(6)

(7)

(8)

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 17 June 1998 (imazosulfuron), on 2
June 2003 (laminarin), on 2 August 2002 (methoxyfe-
nozide) and 3 May 1999 (s-metolachlor).

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 8 October 2004 in the format of
the Commission review reports
imazosulfuron,
laminarin, methoxyfenozide and s-metolachlor.

for

review were

For imazosulfuron, the dossier and the information from
also submitted to the Scientific
the
Committee on Plants. The report of
this Committee
was formally adopted on 25 April 2001 (6).

acute

invertebrates,

fish and the

The Committee was asked to comment on the relevance
of the metabolite IPSN due to its presence in soil and
water. In its opinion the Committee concluded that there
is no significant health risk arising from IPSN in the
groundwater, and that the risk to soil micro-organisms,
aquatic
risk to
earthworms are sufficiently addressed. The Committee
also concluded that on the basis of worst-case exposure
estimates further information is required to assess some
other risks from IPSN. The Committee finally concluded
that the risk to the environment and the toxicological
risk to human health from the parent substance and/or
metabolites other than IPSN, in some studies formed at
levels comparable to IPSN, have not been fully assessed
and therefore should be addressed during the further
evaluation.

(5) OJ L 228, 15.8.1998, p. 35.
(6) Opinion of
regarding the
inclusion of
to Council Directive
91/414/EEC concerning the placing of plant protection products
on the market — SCP/IMAZO/002-Final, published 21 May 2001.

the Scientific Committee on Plants
imazosulfuron in Annex I

L 20/20

EN

Official Journal of the European Union

22.1.2005

(9)

The recommendations of the Scientific Committee were
taken into account during the further review,
in this
Directive and in the Review Report.

(10) With respect to IPSN, additional data on the risk based
on worst-case exposure estimates and identified by the
Scientific Committee have been delivered by the notifier
evaluation within the Standing
and assessed. The
Committee concluded that in the light of the additional
data submitted by the notifier, and under the proposed
conditions of use, there would be no harmful effect on
humans from IPSN.

(16)

(17)

regards plant protection
Directive 91/414/EEC as
products containing those substances and in particular
to review existing provisional authorisations and, by
the end of this period at the latest, to transform those
authorisations into full authorisations, to amend them or
to withdraw them in accordance with the provisions of
Directive 91/414/EEC.

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

(11) With respect

to imazosulfuron and other metabolites
than IPSN, no other metabolites than IPSN occur in
levels that are considered as ‘relevant’
in the sense of
the provisions of Directive 91/414/EEC. Therefore the
evaluation within the Standing Committee concluded
that the risk can be assessed with the data available.

HAS ADOPTED THIS DIRECTIVE:

(12)

(13)

(14)

Following this assessment,
the evaluation within the
Standing Committee furthermore concluded that under
the proposed conditions of use,
the
maximum dose rate of 0,05 kg active substance/ha,
and when appropriate risk mitigation measures are
applied, there would be no harmful effect on humans
from
and no unacceptable risk to the environment
imazosulfuron and its metabolites.

in particular

The review of laminarin, methoxyfenozide and s-meto-
lachlor did not reveal any open questions or concerns,
which would have
the
Scientific Committee on Plants or of
the European
Food Safety Authority.

required a consultation of

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
and detailed in the Commission review report.
is
imazosulfuron,
therefore
to
include
laminarin, methoxyfenozide
in
and
Annex I,
in order to ensure that in all Member States
products
the
containing these active substances may be granted in
accordance with the provisions of that Directive.

authorisations

s-metolachlor

appropriate

protection

plant

of

It

(15) After inclusion of imazosulfuron, laminarin, methoxyfe-
to Directive
allowed a
the provisions of

nozide and s-metolachlor
91/414/EEC, Member States
reasonable period to implement

in Annex I

should be

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 30 September
2005 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 October 2005.

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

1. Member States shall review the authorisation for each
laminarin,
plant protection product containing imazosulfuron,
methoxyfenozide or s-metolachlor to ensure that the conditions
relating to this active substance set out in Annex I to Directive
91/414/EEC are complied with. Where necessary, they shall
amend or withdraw authorisations
in accordance with
Directive 91/414/EEC by 30 September 2005 at the latest.

22.1.2005

EN

Official Journal of the European Union

L 20/21

For each authorised plant protection product containing
2.
imazosulfuron, laminarin, methoxyfenozide or s-metolachlor 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 March 2005 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. On the basis of that evaluation, they shall
determine whether the product satisfies the conditions set out in
Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

(a)

case of

a product

in the
containing imazosulfuron,
laminarin, methoxyfenozide or s-metolachlor as the only
active substance, where necessary, amend or withdraw the
authorisation by 30 September 2006 at the latest; or

(b) in the

case of

containing imazosulfuron,
laminarin, methoxyfenozide or s-metolachlor as one of
amend or
several

substances, where necessary,

a product

active

withdraw the authorisation by 30 September 2006 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

Article 4

This Directive shall enter into force on 1 April 2005.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 19 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 20/22

EN

Official Journal of the European Union

22.1.2005

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EN

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L 20/23

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