Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (Text with EEA relevance)
Date: 2003-09-25
Institutions: European Commission
Subjects: herbicide, market approval, pesticide, plant health control

L 247/20

EN

Official Journal of the European Union

30.9.2003

COMMISSION DIRECTIVE 2003/84/EC

of 25 September 2003

amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethe-
namid-p, picoxystrobin, fosthiazate and silthiofam 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/
79/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

for

In accordance with Article 6(2) of Directive 91/414/EEC
the authorities of France received on 15 February 1994
an application from Rhône-Poulenc Agro France (now
Bayer CropScience)
the active
substance flurtamone in Annex I to Directive 91/414/
EEC. Commission Decision 1996/341/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 Direc-
tive 91/414/EEC.

the inclusion of

France received an application under Article 6(2) of
Directive 91/414/EEC on 1 February 1996 an applica-
tion
from Bayer AG (now Bayer CropScience)
concerning flufenacet (former name: fluthiamide). This
application was declared complete by Commission Deci-
sion 97/362/EC (4).

Germany received an application under Article 6(2) of
Directive 91/414/EEC on 14 December 1998 from
Schering AgrEvo GmbH (now Bayer
Hoechst
CropScience)
parent
substance of iodosulfuron-methyl-sodium). This applica-
tion was declared complete by Commission Decision
1999/392/EC (5).

iodosulfuron

concerning

(as

Germany received an application under Article 6(2) of
Directive 91/414/EEC on 16 April 1999 from BASF AG
application was
concerning
declared complete by Commission Decision 1999/555/
EC (6).

dimethenamid-p. This

Ireland received an application under Article 6(2) of
Directive 91/414/EEC on 26 May 1999 from Zeneca
Agrochemicals
concerning picoxy-
strobin. This application was declared complete also by
Commission Decision 1999/555/EC.

(now Syngenta)

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 228, 12.9.2003, p. 11.
(3) OJ L 130, 31.5.1996, p. 20.
(4) OJ L 152, 11.6.1997, p. 31.
(5) OJ L 148, 15.6.1999, p. 44.
(6) OJ L 210, 10.8.1999, p. 22.

(6)

(7)

(8)

(9)

(10)

(11)

The United Kingdom received an application under
Article 6(2) of Directive 91/414/EEC on 5 March 1996
from ISK Biosciences Europe SA concerning fosthiazate.
This application was declared complete by Commission
Decision 97/362/EC.

Ireland received an application under Article 6(2) of
Directive 91/414/EEC on 14 December 1998 from
Monsanto Crop Protection concerning silthiofam (former
name:
application was declared
complete by Commission Decision 1999/392/EC.

silthiopham). This

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 a
draft assessment report concerning the substance to the
Commission on 21 May 1997 (flurtamone), 6 January
1998 (flufenacet), 30 May 2000 (iodosulfuron), 26
September 2000 (dimethenamid-p), 11 June 2001
(picoxystrobin), 18 March 1998 (fosthiazate), and 2
October 2000 (silthiofam).

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 4 July 2003 in the format of the
Commission review report
flufenacet,
iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate
and silthiofam.

for flurtamone,

iodosulfuron, dimethenamid-p, picoxy-
The review of
strobin and silthiofam did not reveal any open questions
or concerns, which would have required a consultation
of the Scientific Committee on Plants.

For flurtamone, the documents and information were
also submitted to the Scientific Committee for Plants for
separate consultation. The Scientific Committee for
Plants was consulted twice, mainly to assess the potential
leaching of two metabolites of the active substance, 3-
trifluoromethylbenzoic acid (TFMBA) and trifluoroacetic
acid (TFAA).
the Scientific
Committee recommended with respect to TFMBA the
inclusion of soils with pH values between 7 and 8 in the
sorption studies with this metabolite. As regards the

first opinion (7),

In a

(7) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of flurtamone in Annex I to Directive 91/414/EEC concerning
the placing of plant protection products on the market (SCP/FLURT/
004-Final, adopted on 18 December 1998).

30.9.2003

EN

Official Journal of the European Union

L 247/21

the Committee found the available
metabolite TFAA,
data insufficient to assess the risk of contamination of
groundwater. Subsequently, further studies were under-
taken by the applicant for both metabolites. In its second
opinion (1)
the Scientific Committee concluded that
concentrations of TFMBA leaching to groundwater from
soils with pH above 5 may exceed 0,1 g/l in a small
percentage of cases/situations. The Committee further
concluded that the metabolite TFAA does not represent
an unacceptable risk to aquatic organisms via ground-
water but the toxicological information made available
to the Committee was still insufficient. The recommen-
dations of
the Scientific Committee were taken into
account during the further review and in this Directive
and in the Review Report. After the missing information
was subsequently delivered by the applicant and evalu-
ated by the rapporteur Member State. The evaluation
within the Standing Committee concluded that
there
would be no unacceptable influence of the metabolites
TFMBA and TFAA on the environment if appropriate
risk mitigation measures are applied.

(12) As regards flufenacet, the Scientific Committee for Plants
was asked to comment on two degradation products
the active substance, which were
(M2 and M4) of
detected in lysimeters leachates, and on the exposure of
operators. In its opinion (2) the Committee found for the
M2 and M4 metabolites that
the risk to non-target
terrestrial organisms were not yet adequately assessed
and also identified other degradation products for which
the risk to non-target organisms needed further evalua-
tion. The Committee was of the opinion that operator
risk assessment of
flufenacet has been adequately
addressed but noted that the sensitising potential of the
formulation deserves proper attention. The recommen-
dations of
the Scientific Committee were taken into
account during the further review and in this Directive
and in the Review Report. After the missing information
was subsequently delivered by the applicant and evalu-
ated by the rapporteur Member State. The evaluation
within the Standing Committee concluded that the risk
by all
identified degradation products for non-target
organisms would be acceptable and that the sensitising
risk would also be acceptable if appropriate risk mitiga-
tion measures are applied.

(14)

the potential

In its opinion (3)

poisoning incidents.
the Committee
found that based on the available information no safe
use scenario could be identified which poses no unac-
ceptable risk to groundwater. The Committee noted that
it is possible that lysimeter studies demonstrate lack of
leaching for one or more use scenarios but none were
reported. Also the risk of the different metabolites to soil
organisms had not been sufficiently addressed. The
Committee further considered that
for
exposure of birds and wild mammals by all the routes
mentioned above required further consideration. Finally,
the Committee was of the opinion that NTE (neuropathy
target esterase) inhibition by fosthiazate and its isomers
had not been adequately assessed. The recommendations
of the Scientific Committee were taken into account
during the further review and in this Directive and in
the Review Report. After the missing information was
subsequently delivered by the applicant and evaluated by
the rapporteur Member State and taking into account
appropriate measures of risk mitigation measures, the
evaluation within the Standing Committee concluded
that no harmful effects are to be expected from NTE
inhibition by fosthiazate and its isomers. The evaluation
within the Standing Committee further concluded that
the risk by the parent substances and the identified
degradation products for the groundwater, soil organ-
isms, birds and wild mammals would be acceptable if
appropriate risk mitigation measures are applied.

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)
in
and (b) and Article 5(3) of Directive 91/414/EEC,
particular with regard to the uses which were examined
and detailed in the Commission review report.
is
therefore appropriate to include flurtamone, flufenacet,
iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate
and silthiofam 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.

It

(13) As regards fosthiazate,

the Scientific Committee was
asked to comment on the potential
for leaching to
groundwater, on the risk to soil dwelling non-target
organisms, on the risk to birds and wild mammals, and
on the possible risk of organophosphate-induced delayed
in humans following severe
polyneuropathy (OPIDP)

(1) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of flurtamone in Annex I to Directive 91/414/EEC concerning
the placing of plant protection products on the market (SCP/FLURT/
018-Final, adopted on 26 January 2001).

(2) Opinion of the Scientific Committee on Plants on specific questions
from the Commission concerning the evaluation of flufenacet [FOE
5043] in the context of Directive 91/414/EEC, (SCP/FLUFEN/002-
Final, adopted 17 October 2001).

(15) 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 flurtamone, flufenacet, iodosulfuron, dimethe-
namid-p, picoxystrobin, fosthiazate and silthiofam 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 provi-
sions of Directive 91/414/EEC.

(3) Opinion on specific questions from the Commission concerning the
evaluation of fosthiazate [IKKI-1145/TO-1145] in the context of
adopted 20
Directive 91/414/EEC,
December 2001).

(SCP/FOSTHIAZ/002-Final,

L 247/22

EN

Official Journal of the European Union

30.9.2003

(16)

(17)

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,

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

Member States shall adopt and publish by 30 June 2004 at the
latest the laws, regulations and administrative provisions neces-
sary to comply with this Directive. They shall forthwith inform
the Commission thereof.

complied with. Where necessary, they shall amend or withdraw
authorisations in accordance with Directive 91/414/EEC by 30
June 2004 at the latest.

2.
For each authorised plant protection product containing
flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxy-
strobin,
fosthiazate or silthiofam 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
December 2004 at the latest, Member States shall re-evaluate
the product in accordance with the uniform principles provided
for in Annex VI, on the basis of a dossier satisfying the require-
ments of Annex III thereto. On the basis of that evaluation,
they shall determine whether the product satisfies the condi-
tions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/
414/EEC. Where necessary and by 30 June 2005 at the latest,
they shall amend or withdraw the authorisation for each such
plant protection product.

Article 4

They shall apply those provisions from 1 July 2004.

This Directive shall enter into force on 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.

This Directive is addressed to the Member States.

Article 5

Article 3

1. Member States shall review the authorisation for each
flufenacet,
plant protection product containing flurtamone,
iodosulfuron, dimethenamid-p, picoxystrobin,
fosthiazate or
silthiofam to ensure that the conditions relating to these active
substances set out in Annex I to Directive 91/414/EEC are

Done at Brussels, 25 September 2003.

For the Commission

David BYRNE

Member of the Commission

No

Common Name, Identifica-
tion Numbers

‘64

Flurtamone

CAS No 96525-23-4

ANNEX

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

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

(RS)-5-methylamino-2-
phenyl-4-(a,a,a-
trifluoro-m-tolyl) furan-
3 (2H)-one

960 g/kg

1 January 2004

31 December 2013

Only uses as herbicide may be authorised.

the uniform principles of Annex VI,

the
For the implementation of
conclusions of the review report on flurtamone, and in particular Appen-
dices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 4 July 2003 shall be taken into account. In
this overall assessment Member States:
— should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil
and/or climate conditions,

— should pay particular attention to the protection of algae and other

aquatic plants.

Risk mitigation measures should be applied where appropriate.

65

Flufenacet

CAS No 142459-58-3

CIPAC No 588

4'-fluoro-N-isopropyl-
2-[5-(trifluoromethyl)-
1,3,4-thiadiazol-2-ylox-
y]acetanilide

4-iodo-2-[3-(4-
methoxy-6-methyl-
1,3,5-triazin-2-yl)-urei-
dosulfonyl]benzoate

66

Iodosulfuron

CAS No 185119-76-0
(parent)

144550-36-7 (iodosul-
furon-methyl-sodium)

CIPAC No 634 (parent)

634.501 (iodosulfuron-
methyl-sodium)

950 g/kg

1 January 2004

31 December 2013

Only uses as herbicide may be authorised.

the uniform principles of Annex VI,

For the implementation of
the
conclusions of the review report on flufenacet, and in particular Appen-
dices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 4 July 2003 shall be taken into account. In
this overall assessment Member States:
— should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil
and/or climate conditions,

— should pay particular attention to the protection of algae and aquatic

plants,

— should pay particular attention to the protection of operators.

Risk mitigation measures should be applied where appropriate.

910 g/kg

1 January 2004

31 December 2013

Only uses as herbicide may be authorised.

the uniform principles of Annex VI,

the
For the implementation of
conclusions of
the review report on iodosulfuron, and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 4 July 2003 shall be taken into
account. In this overall assessment Member States:
— should pay particular attention to the potential of iodosulfuron and its
metabolites
active
substance is applied in regions with vulnerable soil and/or climate
conditions,

contamination, when the

groundwater

for

— should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

.

.

3
0
9
2
0
0
3

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N

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No

Common Name, Identifica-
tion Numbers

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

67

Dimethenamid-p

CAS No 163515-14-8

CIPAC No 638

S-2-chloro-N-(2,4-
dimethyl-3-thienyl)-N-
(2-methoxy-1-methy-
lethyl)-acetamide

890 g/kg
(preli-
minary value based
on a pilot plant)

68

Picoxystrobin

CAS No 117428-22-5

CIPAC No 628

(E)-3-methoxy-

Methyl
2-{2-[6-(trifluoro-
methyl) -2- pyridyloxy-
methyl]phenyl} acrylate

(preli-
950 g/kg
minary value based
on a pilot plant)

1 January 2004

31 December 2013

Only uses as herbicide may be authorised.

the uniform principles of Annex VI,

For the implementation of
the
conclusions of the review report on dimethenamid-p, and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 4 July 2003 shall be taken into
account. In this overall assessment Member States:
— should pay particular attention to the potential of the metabolites of
dimethenamid-p 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 ecosys-

tems, 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 commer-
cially manufactured.

1 January 2004

31 December 2013

Only uses as fungicide may be authorised.

the uniform principles of Annex VI,

For the implementation of
the
conclusions of the review report on picoxystrobin, and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 4 July 2003 shall be taken into
account. In this overall assessment Member States:
— should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil
and/or climate conditions,

— should pay particular attention to the protection of soil organisms,
— should pay particular attention to the protection of aquatic ecosys-

tems.

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 commer-
cially manufactured.

L

2
4
7
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2
4

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69

Fosthiazate

CAS No 98886-44-3

CIPAC No 585

(RS)-S-sec-butyl O-ethyl
2-oxo-1,3-thiazolidin-
3-ylphosphonothioate

930 g/kg

1 January 2004

31 December 2013

Only uses as nematicide may be authorised.

the uniform principles of Annex VI,

For the implementation of
the
conclusions of the review report on fosthiazate, and in particular Appen-
dices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 4 July 2003 shall be taken into account. In
this overall assessment Member States:

.

.

3
0
9
2
0
0
3

No

Common Name, Identifica-
tion Numbers

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

— should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil
and/or climate conditions,

.

.

3
0
9
2
0
0
3

— should pay particular attention to the protection of birds and wild
mammals in particular if the substance is applied during the breeding
season,

E
N

— should pay particular attention to the protection of non-target soil

organisms.

70

Silthiofam

CAS No 175217-20-6

CIPAC No 635

N-allyl-4,5-dimethyl-2-
(trimethylsilyl)thio-
phene-3-carboxamide

Risk mitigation measures should be applied where appropriate. In order
to mitigate the potential risk to small birds, product authorisations must
require that a very high level of incorporation of granules into soil is
achieved.

The Member States shall
inform the Commission in accordance with
Article 13(5) on the specification of the technical material as commer-
cially manufactured.

950 g/kg

1 January 2004

31 December 2013

Only uses as fungicide may be authorised.

Uses other than seed treatments are currently not adequately supported
by data. To support authorisations for such uses, data and information to
prove their acceptability for consumers, operators and the environment
will have to be generated and submitted to the Member States.

the uniform principles of Annex VI,

For the implementation of
the
conclusions of the review report on silthiofam, and in particular Appen-
dices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 4 July 2003 shall be taken into account. In
this overall assessment Member States must pay particular attention to the
protection of operators. Risk mitigation measures must be applied, where
appropriate.

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

O

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