Commission Directive 2003/119/EC of 5 December 2003 amending Council Directive 91/414/EEC to include mesosulfuron, propoxycarbazone and zoxamide as active substances (Text with EEA relevance)
Date: 2003-12-05
Institutions: European Commission
Subjects: administrative formalities, confidentiality, exchange of information, marketing standard, plant health product, testing

12.12.2003

EN

Official Journal of the European Union

L 325/41

COMMISSION DIRECTIVE 2003/119/EC

of 5 December 2003

amending Council Directive 91/414/EEC to include mesosulfuron, propoxycarbazone and zoxa-
mide as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 2003/
84/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

for

the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
the authorities of France received on 15 December 2000
an application from Aventis Cropscience France (now
Bayer CropScience)
the active
substance mesosulfuron (in the form of mesosulfuron
methyl) in Annex I to Directive 91/414/EEC. Commis-
sion Decision 2001/287/EC (3)
the
dossier was ‘complete’
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 the sense that

confirmed that

Germany received an application under Article 6(2) of
Directive 91/414/EEC on 25 January 2000, an applica-
tion
from Bayer AG (now Bayer CropScience)
concerning propoxycarbazone (in the form of propoxy-
carbazone sodium;
former name: MKH 65 61). This
application was declared complete by Commission Deci-
sion 2000/463/EC (4).

The United Kingdom received an application under
Article 6(2) of Directive 91/414/EEC on 2 June 1999
from Rohm and Haas France SA (now: Dow Agro-
Sciences) concerning zoxamide (former name: RH-
7281). This application was declared complete by
Commission Decision 2000/540/EC (5).

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 nominated rapporteur Member States submitted
draft assessment reports concerning the substances to
the Commission on 12 December 2001 (mesosulfuron),
26 March 2001 (propoxycarbazone) and 10 August
2001 (zoxamide).

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 247, 30.9.2003, p. 20.
(3) OJ L 99, 10.4.2001, p. 9.
(4) OJ L 183, 22.7.2000, p. 21.
(5) OJ L 230, 12.9.2000, p. 14.

(5)

(6)

(7)

(8)

(9)

(10)

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 October 2003 in the format of
the Commission review report
for mesosulfuron,
propoxycarbazone and zoxamide.

The review of mesosulfuron, propoxycarbazone and
zoxamide did not reveal any open questions or concerns,
which would have required a consultation of the Scien-
tific Committee on Plants.

It has appeared from the various examinations made,
that plant protection products containing the active
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 par-
ticular with regard to the uses which were examined and
detailed in the Commission review report. It is therefore
appropriate to include mesosulfuron, propoxycarbazone
and zoxamide in Annex I, in order to ensure that in all
Member States the authorisations of plant protection
products containing these active substances can be
granted in accordance with the provisions of that Direc-
tive.

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 mesosulfuron, propoxycarbazone and zoxa-
mide and in particular to review existing provisional
authorisations and, by the end of this period at the latest,
to transform those authorisations into full authorisa-
tions, to amend them or to withdraw them in accord-
ance with the provisions of Directive 91/414/EEC.

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

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

L 325/42

EN

Official Journal of the European Union

12.12.2003

Article 2

the latest

1. Member States shall adopt and publish by 30 September
2004 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 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.

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
plant protection product containing mesosulfuron, propoxycar-
bazone or zoxamide to ensure that the conditions relating to
these active substances 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 2004 at the latest.

2.
For each authorised plant protection product containing
mesosulfuron, propoxycarbazone or zoxamide as the only
active substance, 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 thereto. 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 Direc-

tive 91/414/EEC. Where necessary and by 31 August 2005 at
the latest, they shall amend or withdraw the authorisation for
each such plant protection product.

3.
For each plant protection product containing mesosul-
furon, propoxycarbazone or zoxamide together with one or
more active substances which are all listed in Annex I to Direc-
tive 91/414/EEC, Member States shall re-evaluate the product
in accordance with the uniform principles provided for in
Annex VI to that Directive, 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 in Article 4(1)(b), (c), (d) and (e) of Direc-
tive 91/414/EEC. Where necessary, they shall amend or with-
draw the authorisation for each such plant protection product,
by the deadline defined for such an amendment or withdrawal
in the respective Directives which amended Annex I so as to
add the relevant substances to it. Where the respective Direc-
tives set different deadlines, the deadline shall be the latest of
the dates defined.

This Directive shall enter into force on 1 April 2004.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 5 December 2003.

For the Commission

David BYRNE

Member of the Commission

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

ANNEX

No

‘76

Common name,
identification numbers

Mesosulfuron
CAS No 400852-66-6
CIPAC No 441

2-[(4,6-dimethoxypyrimidin-2-
ylcarbamoyl)sulfamoyl]-α-
(methanesulfonamido)-p-toluic
acid

IUPAC name

Purity (1)

Entry into force

Expiration of
inclusion

Specific provisions

930 g/kg

1 April 2004

31 March 2014 Only use as herbicide may be authorised.

77

Propoxycarbazone
CAS No 145026-81-9
CIPAC No 655

2-(4,5-dihydro-4-methyl-5-
oxo-3-propoxy-1H-1,2,4-
triazol-1-yl)carboxamidosulfo-
nylbenzoicacid-methylester

974 g/kg
(expressed
propoxycarba-
zone-sodium)

as

For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on mesosulfuron, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health on 3 October 2003 shall be taken into account. In this overall assess-
ment Member States:
— should pay particular attention to the protection of aquatic plants;
— should pay particular attention to the potential of mesosulfuron and its
metabolites 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.

1 April 2004

31 March 2014 Only use as herbicide may be authorised.

For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on propoxycarbazone, and in particular Appendices I and
II thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 3 October 2003 shall be taken into account. In this overall
assessment Member States:
— should pay particular attention to the potential of propoxycarbazone and
its metabolites for groundwater contamination, when the active substance
is applied in regions with vulnerable soil and/or climate conditions;

— should pay particular attention to the protection of aquatic ecosystems,

especially of aquatic plants.

Risk mitigation measures should be applied where appropriate.
The Member States shall inform the Commission in accordance with Article
13(5) on the specification of the technical material as commercially manufac-
tured.

78

Zoxamide
CAS No 156052-68-5
CIPAC No 640

(RS)-3,5-Dichloro-N-(3-chloro-
1-ethyl-1-methylacetonyl)-p-
toluamide

950 g/kg

1 April 2004

31 March 2014 Only use as fungicide may be authorised.

For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on zoxamide, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health on 3 October 2003 shall be taken into account.

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

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