Commission Directive 2004/30/EC of 10 March 2004 amending Council Directive 91/414/EEC to include benzoic acid, flazasulfuron and pyraclostrobin as active substances (Text with EEA relevance)
Date: 2004-03-10
Institutions: European Commission
Subjects: exchange of information, market approval, marketing standard, plant health product

L 77/50

EN

Official Journal of the European Union

13.3.2004

COMMISSION DIRECTIVE 2004/30/EC

of 10 March 2004

amending Council Directive 91/414/EEC to include benzoic acid, flazasulfuron and pyraclostrobin
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), and in particular Article 6(1) thereof,

Whereas:

In accordance with Article 6(2) of Directive 91/414/EEC
Germany received on 25 May 1998 an application from
Menno Chemie Vertriebs-Ges. for the inclusion of the
active substance benzoic acid in Annex I to Directive
98/676/EC (2)
91/414/EEC.
Commission Decision
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.

Spain received an application under Article 6(2) of
Directive 91/414/EEC on 16 December 1996 from ISK
Biosciences Europe SA concerning flazasulfuron. This
application was declared complete by Commission Deci-
sion 97/865/EC (3).

Germany received an application under Article 6(2) of
Directive 91/414/EEC on 28 February 2000 from BASF
AG concerning pyraclostrobin (former name: BAS
500F). This application was declared complete by
Commission Decision 2000/540/EC (4).

(9)

(10)

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 assessment reports concerning the substances to
the Commission on 22 November 2000 (benzoic acid),
1 August 1999 (flazasulfuron) and 23 November 2001
(pyraclostrobin).

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 benzoic acid, flazasul-
furon and pyraclostrobin.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-

sion Directive 2003/119/EC (OJ L 325, 12.12.2003, p. 41).

(2) OJ L 317, 26.11.1998, p. 47.
(3) OJ L 351, 23.12.1997, p. 67.
(4) OJ L 230, 12.9.2000, p. 14.

(6)

(7)

(8)

The review of benzoic acid, flazasulfuron and pyraclos-
trobin 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 benzoic acid, flazasulfuron and
pyraclostrobin in Annex I, in order to ensure that in all
Member States the authorisations of plant protection
products containing these active substances may 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 benzoic acid, flazasulfuron or pyraclostrobin
and in particular to review existing provisional authori-
sations 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.

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.

Article 2

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

(1)

(2)

(3)

(4)

(5)

13.3.2004

EN

Official Journal of the European Union

L 77/51

They shall apply those provisions from 1 December 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 benzoic acid, flazasulfuron
or pyraclostrobin 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 with-
draw authorisations in accordance with Directive 91/414/EEC
by 30 November 2004 at the latest.

2.
For each authorised plant protection product containing
benzoic acid, flazasulfuron or pyraclostrobin 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 30 November 2005
at the latest, they shall amend or withdraw the authorisation
for each such plant protection product.

For each plant protection product containing benzoic
3.
acid, flazasulfuron or pyraclostrobin together with one or more
active substances which are all listed in Annex I to Directive
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 evalua-
tion, 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. Where necessary, they shall amend or withdraw
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 Directives
set different deadlines, the deadline shall be the latest of the
dates defined.

This Directive shall enter into force on 1 June 2004.

Article 4

This Directive is addressed to the Member States.

Article 7

Done at Brussels, 10 March 2004.

For the Commission

David BYRNE

Member of the Commission

No

‘80

Common name, identification
numbers

Benzoic acid
CAS No 65-85-0
CIPAC No 622

In Annex I to Directive 91/414/EEC the following rows are added at the end of the table

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

benzoic acid

990 g/kg

1 June 2004

31 May 2014

Only uses as disinfectant may be
authorised.
For the implementation of the uniform
principles of Annex VI, the conclusions
of the review report on benzoic acid,
and in particular Appendices I and II
thereof, as finalised in the Standing
Committee on the Food Chain and
Animal Health on 28 November 2003
shall be taken into account.

81

Flazasulfuron
CAS No 104040-78-0
CIPAC No 595

1-(4,6-dimethoxypyrimidin-2-yl)-
3-(3-trifluoromethyl-2-pyridyl-
sulphonyl)urea

940 g/kg

1 June 2004

31 May 2014

be

as herbicide may

Only uses
authorised.
For the implementation of the uniform
principles of Annex VI, the conclusions
of the review report on flazasulfuron,
and in particular Appendices I and II
thereto, as finalised in the Standing
Committee on the Food Chain and
Animal Health on 28 November 2003
shall be taken into account.
In this
overall assessment Member States
— should pay particular attention to
groundwater
the
contamination, when the
active
substance is applied in regions with
vulnerable
climate
conditions,

potential

and/or

soil

for

— should pay particular attention to
the protection of aquatic plants.
Risk mitigation measures should be
applied where appropriate.
inform the
The Member States shall
Commission
accordance with
Article 13(5) on the specification of
the technical material as commercially
manufactured.

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No

82

Common name, identification
numbers

Pyraclostrobin
CAS No 175013-18-0
CIPAC No 657

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

N-(2-{[1-(4-chloro-

methyl
phenyl)-1H-pyrazol-3-yl]oxy-
methyl}phenyl)
carbamate

N-methoxy

975 g/kg
The manufacturing impurity dime-
thylsulfate (DMS) is condidered to be
toxicological concern and must
of
not
of
0,0001 % in the technical product

concentration

exceed

a

1 June 2004

31 May 2014

as

be

fungicide may

Only uses
authorised.
For the implementation of the uniform
principles of Annex VI, the conclusions
of the review report on pyraclostrobin,
and in particular Appendices I and II
thereto, as finalised in the Standing
Committee on the Food Chain and
Animal Health on 28 November 2003
shall be taken into account.
In this
overall assessment Member States
— should pay particular attention to
the protection of aquatic organ-
isms, especially fish,

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

— should pay particular attention to
the protection of terrestrial arthro-
pods and earthworms.

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

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