Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (Text with EEA relevance)
Date: 2003-03-25
Institutions: European Commission
Subjects: herbicide, market approval, plant health control

28.3.2003

EN

Official Journal of the European Union

L 81/39

COMMISSION DIRECTIVE 2003/23/EC

of 25 March 2003

amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron,
foramsulfuron, oxadiargyl and cyazofamid as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2002/
81/EC (2), and in particular Article 6(1) thereof,

Whereas:

For these 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 nominated rapporteur Member States, submitted a
draft assessment report concerning the substance to the
Commission on 9 September 1999 (imazamox), 10 May
2000 (oxasulfuron), 20 May 1998 (ethoxysulfuron), 1
June 2001 (foramsulfuron), 20 July 1999 (oxadiargyl)
and 27 August 2001 (cyazofamid).

(1)

(2)

(3)

(4)

(5)

(6)

In accordance with Article 6(2) of Directive 91/414/EEC
France received on 2 December 1997 an application
from Cyanamid NV/SA (now BASF AG) for the inclusion
of the active substance imazamox in Annex I to Direc-
tive 91/414/EEC. Commission Decision 1998/676/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.

(8)

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 3 December 2002 in the format
of
imazamox,
oxadiargyl, oxasulfuron, ethoxysulfuron, foramsulfuron
and cyazofamid.

the Commission review reports

for

Italy received a similar application on 29 May 1998
from Novartis Protezione Piante SpA (now Syngenta)
concerning oxasulfuron. This application was declared
complete by Commission Decision 1999/237/EC (4).

Italy received a similar application on 3 July 1996 from
Hoechst Schering AgrEvo GmbH (now Bayer Crop
Science concerning ethoxysulfuron. This application was
declared complete by Commission Decision 97/591/
EC (5).

Germany received a similar application on 30 March
2000 from Aventis Crop Science (now Bayer Crop
Science) concerning foramsulfuron. This application was
declared complete by Commission Decision 2000/540/
EC (6).

Italy received a similar application on 16 June 1997
from Rhone-Poulenc Agro SA (now Bayer Crop Science)
concerning oxadiargyl. This application was declared
complete by Commission Decision 98/398/EC (7).

France received a similar application on 16 December
1999 from Ishira Sangyo Kaisha Ltd concerning cyazo-
famid. This application was declared complete by
Commission Decision 2000/412/EC (8).

(9)

The reviews of imazamox, oxasulfuron foramsulfuron,
oxadiargyl and cyazofamid did not reveal any open ques-
tions or concern, which would have required a consulta-
tion of the Scientific Committee on Plants.

(10)

The documents and information on ethoxysulfuron were
also submitted to the Scientific Committee for Plants for
separate consultation. In a first consultation the Scien-
tific Committee was invited to comment on the occur-
rence of uterine tumours in rats. In its opinion (9) the
Committee considered the increase in uterine tumour
incidence in rats of no relevance to human risk as it
occurred only at a high dose causing marked general
toxicity. No additional mechanistic studies were deemed
necessary. An additional consultation was made on the
potential
second
opinion (10) the Committee concluded that assessment of
the risk of ethoxysulfuron to aquatic organisms was
lacking in several respects, in particular with respect to
sediment-dwelling organisms. Also assessment of the risk
to aquatic plants and algae from the metabolite Hoe
136086 of ethoxysulfuron was considered incomplete.

risk to aquatic organisms.

In its

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 12.10.2002, p. 28.
(3) OJ L 317, 26.11.1998, p. 47.
(4) OJ L 87, 31.3.1999, p. 15.
(5) OJ L 239, 30.8.1997, p. 48.
(6) OJ L 230, 12.9.2000, p. 14.
(7) OJ L 176, 20.6.1998, p. 34.
(8) OJ L 155, 28.6.2000, p. 62.

(9) Opinion of the Scientific Committee on Plants regarding the evalua-
tion of ethoxysulfuron in the context of Council Directive 91/414/
EEC concerning the placing of plant protection products on the
market SCP/ETHOXY/002-Final — adopted 22 September 2000.
(10) Opinion on the evaluation of ethoxysulfuron (AE F095404) in the
context of Council Directive 91/414/EEC concerning the placing of
plant protection products on the market — SCP/ETHOXY-Bis/002
adopted 7 June 2001.

L 81/40

EN

Official Journal of the European Union

28.3.2003

(11)

(12)

Additional studies and information were subsequently
provided by the applicant and the risk assessment for
the active substance and its degradation products was
revised by the rapporteur Member State.

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 reports.
It is
therefore appropriate to include these active substances
in Annex I, in order to ensure that in all Member States
products
the
containing this active substance can be granted in accor-
dance with the provisions of that Directive.

authorisations

protection

plant

of

The Commission review reports are required for the
proper implementation by the Member States, of several
sections of the uniform principles laid down in Directive
91/414/EEC. It is, therefore, appropriate to provide that
the finalised review reports, except for confidential infor-
mation within the meaning of Article 14 of Directive
91/414/EEC, should be kept available or made available
by the Member States for consultation by any interested
parties.

imazamox,

(13) After inclusion, Member States should be allowed a
reasonable period to implement the provisions of Direc-
tive 91/414/EEC as regards plant protection products
containing
ethoxysulfuron,
foramsulfuron, oxadiargyl or cyazofamid and in parti-
cular 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.

oxasulfuron,

Article 2

Member States shall adopt and publish by 31 December 2003
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 January 2004.

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.

Article 3

1. Member States shall review the authorisation for each
plant protection product containing imazamox, oxasulfuron,
ethoxysulfuron, foramsulfuron, oxadiargyl, or cyazofamid 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 the authorisa-
tion in accordance with Directive 91/414/EEC before 31
December 2003.

2. Member States shall, for each authorised plant protection
product containing imazamox, oxasulfuron, ethoxysulfuron,
foramsulfuron, oxadiargyl, or cyazofamid 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
June 2003, 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 thereto. On the basis of that evaluation, they shall
determine whether the product satisfies the conditions set out
(d) and (e) of Directive 91/414/EEC.
in Article 4(1)(b),
Where necessary and by 31 December 2004 at the latest, they
shall amend or withdraw the authorisation for each such plant
protection product.

(c),

(14)

(15)

It is therefore appropriate to amend Directive 91/414/
EEC accordingly.

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

Article 4

This Directive shall enter into force on 1 July 2003.

This Directive is addressed to the Member States.

Article 5

HAS ADOPTED THIS DIRECTIVE:

Done at Brussels, 25 March 2003.

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

For the Commission

David BYRNE

Member of the Commission

ANNEX

In Annex I the following rows are added at the end of the table:

No

Common name, identification
numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘41

Imazamox
CAS No 114311-32-9
CIPAC No 619

(±)-2-(4-isopropyl-4-methyl-5-oxo-
2-imidazolin-2-yl)-5-(methoxy-
methyl) nicotinic acid

42

Oxasulfuron
CAS No 144651-06-9
CIPAC No 626

Oxetan-3-yl
midin-2-yl)
benzoate

2[(4,6-dimethylpyri-
carbamoyl-sulfamoyl]

950 g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on imazamox, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular
attention to the potential
for groundwater contamination,
when the active substance is applied in regions with vulnerable
soil and/or climate conditions. Risk mitigation measures
should be applied where appropriate.

960 g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on oxasulfuron, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account.
— Member States must pay particular attention to the protec-
tion of groundwater, when the active substance is applied
in regions with vulnerable soil and/or climate conditions.

Risk mitigation measures should be applied, where appro-
priate.

43

Ethoxysulfuron
CAS No 126801-58-9
CIPAC No 591

3-(4,6-dimethoxypyrimidin-2-yl)-
1-(2-ethoxyphenoxy-sulfonyl)urea

950 g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on ethoxysulfuron, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account.

Member States should pay particular attention to the protec-
tion of non-target aquatic plants and algae in drainage canals.
Risk mitigation measures should be applied where appro-
priate.

.

.

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No

Common name, identification
numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

44

Foramsulfuron
CAS No 173159-57-4
CIPAC No 659

1-(4,6-dimethoxypyrimidin-2-yl)-
3-(2-dimethylcarbamoyl-5-forma-
midophenylsulfonyl)urea

45

Oxadiargyl
CAS No 39807-15-3
CIPAC No 604

5-tert-butyl-3-(2,4-dichloro-5-
propargyloxyphenyl)-1,3,4
oxadiazol-2-(3H)-one

46

Cyazofamid
CAS No 120116-88-3
CIPAC No 653

4-chloro-2cyano-N,N-dimethyl-5-
P-tolylimidazole -1-sulfonamide

940 g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on foramsulfuron, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular
attention to the protection of aquatic plants. Risk mitigation
measures should be applied, where appropriate.

980 g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on oxadiargyl, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular
attention to the protection of algae and aquatic plants. Risk
mitigation measures should be applied where appropriate.

935 g/kg

1 July 2003

30 June 2013

Only uses as fungicide may be authorised.

For the implementation of the uniform principles of Annex VI,
the conclusions of the review report on cyazofamid, and in
particular Appendices I and II
thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
3 December 2002 shall be taken into account. In this overall
assessment
— Member States must pay particular attention to the protec-

tion of aquatic organisms;

— Member States must pay particular attention to the degra-
dation kinetics of the metabolite CTCA in soil, especially
for Northern European regions.

Risk mitigation measures or use restrictions should be applied
where appropriate.

(1) Further details on identity and specification of active substances are provided in the review report.’

L

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