Commission Directive 2002/64/EC of 15 July 2002 amending Council Directive 91/414/EEC to include cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen as active substances
Date: 2002-07-15
Institutions: European Commission
Subjects: confidentiality, exchange of information, marketing, plant health product

18.7.2002

EN

Official Journal of the European Communities

L 189/27

COMMISSION DIRECTIVE 2002/64/EC

of 15 July 2002

amending Council Directive 91/414/EEC to include cinidon-ethyl, cyhalofop butyl, famoxadone,
florasulam, metalaxyl-M and picolinafen as active substances

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

concerning picolinafen. Commission Decision 1999/
555/EC (7) confirmed that the dossier was ‘complete’.

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

Whereas:

(1)

(2)

(3)

(4)

(5)

the inclusion of

In accordance with Article 6(2) of Directive 91/414/EEC,
the United Kingdom received on 28 April 1997 an appli-
cation from BASF for
the active
substance cinidon-ethyl in Annex I to Directive 91/414/
EEC. Commission Decision 98/398/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 laid down in Annexes II and III to
Directive 91/414/EEC.

Italy received an application under Article 6(2) of Direc-
tive 91/414/EEC on 30 April 1997 from Dow Agro-
Sciences, concerning cyhalofop butyl. Commission Deci-
sion 98/242/EC (4) confirmed that
the dossier was
‘complete’.

France received an application under Article 6(2) of
Directive 91/414/EEC on 20 October 1996 from DuPont
de Nemours concerning famoxadone. Commission Deci-
sion 97/591/EC (5) confirmed that
the dossier was
‘complete’.

Belgium received an application under Article 6(2) of
Directive 91/414/EEC on 2 February 1998 from Dow
Agro Sciences concerning florasulam. Commission Deci-
sion 98/676/EC (6) confirmed that
the dossier was
‘complete’.

Belgium received an application under Article 6(2) of
Directive 91/414/EEC on 9 February 1996 from Novartis
Crop Protection AG (now Syngenta) concerning meta-
laxyl-m. Decision 97/591/EC confirmed that the dossier
was ‘complete’.

(6)

Germany received an application under Article 6(2) of
Directive 91/414/EEC on 10 May 1999 from BASF-AG

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 148, 6.6.2002, p. 19.
(3) OJ L 176, 20.6.1998, p. 34.
(4) OJ L 96, 28.3.1998, p. 45.
(5) OJ L 239, 30.8.1997, p. 48.
(6) OJ L 317, 26.11.1998, p. 47.

(7)

(8)

(9)

For these active substances, the effects on human health
and the environment have been assessed, in accordance
with 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
2 November 1998 (cinidon-ethyl), 30 November 1998
(cyhalofop butyl), 5 August 1998 (famoxadone), 19
November 1999 (florasulam), 27 July 1999 (metalaxyl-
m) and 21 December 2000 (picolinafen).

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
reviews were finalised on 19 April 2002 in the format of
the Commission review reports for cinidon-ethyl, cyha-
lofop butyl, famoxadone, florasulam, metalaxyl-M and
picolinafen.

The reviews of cinidon-ethyl, metalaxyl-M and picoli-
nafen did not reveal any open questions which would
have required a consultation of the Scientific Committee
on Plants.

In its opinion (8)

(10) As regards cyhalofop butyl, the Scientific Committee on
Plants was asked to comment on potential effects on
aquatic organisms and non-target arthropods and on
operator exposure.
the Committee
noted that aerial application of the active substance may
pose an unacceptable risk to aquatic organisms within
flooded paddy fields and in adjacent drainage canals, if
they are of low depth. Terrestrial applications to flooded
paddies may pose an unacceptable risk to aquatic organ-
isms within the paddy fields. The Committee considered
the use unlikely to be harmful to bees but highlighted
remaining uncertainty with regard to other non-target
arthropods, which should be addressed by an extended
test. This information was subsequently provided and
evaluated. The Committee was further of the opinion
that the operator exposure to cyhalofop-butyl has been
adequately addressed.

(7) OJ L 210, 10.8.1999, p. 22.
(8) Opinion of the scientific Committee on Plants on the evaluation of
cyhalofop-butyl (DE-537) in the context of Council Directive 91/
414/EEC concerning the placing of plant-protection products on the
market (SCP/CYHALO/002 final, adopted 7 March 2001).

L 189/28

EN

Official Journal of the European Communities

18.7.2002

(11) As regards famoxadone, the Committee was asked to
comment on the effects to Daphnia and earthworms, in
particular in relation to degradation products of
the
active substance and on the relevance to humans of the
eye effect observed in the 12-month dog study and
possible implications for risk assessment for operators.
In its opinion (1) the Committee commented that the risk
to Daphnia of famoxadone and its metabolites has been
sufficiently addressed. The Committee further noted that
the metabolites IN-KZ007 and IN-JS940 are unlikely to
present an acute risk to earthworms but was unable to
evaluate the likely chronic risks of the parent substance
or metabolites to earthworms when more than six appli-
cations per season are assumed. The Committee, finally,
was of the opinion that the eye effect of famoxadone in
dogs is to be considered relevant for humans pending a
more complete understanding of
the mechanism of
action. The observations of
the Scientific Committee
were taken into consideration in formulating this Direc-
tive and the relevant review report.

(12) As regards florasulam,

a

threshold of

the Committee was asked to
comment on the relevance of two degradation products
of the active substance (ASTCA and DFP-ASTCA), and
on the approach proposed to establish an acute reference
dose. In its opinion (2) the Committee concluded that
modelling results do not indicate potential groundwater
toxicological
contamination above
concern for the parent substance or its breakdown
products. Neither the active substance nor the main
metabolite appears to pose an unacceptable risk to non-
target aquatic organisms. Data reportedly showing no
toxicity to soil and aquatic organisms of the degradation
products ASTCA and DFP-ASTCA were not available to
the Committee, and would need to be assessed. This
information was subsequently submitted by the notifier
and evaluated by the rapporteur Member State. The
Committee was further of the opinion that the allocation
of an acute reference dose is not warranted.

(13)

the

products

containing

It has appeared from the various examinations made that
active
plant-protection
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
the
products
containing the active substances concerned can be
granted in accordance with the provisions of that Direc-
tive.

plant-protection

authorisations

of

(14)

The Commission review report is required for the proper
several
implementation by the Member States, of

(1) Opinion of the Scientific Committee on Plants on specific questions
from the Commission concerning the evaluation of famoxadone in
the context of Directive 91/414/EEC concerning the placing of
plant-protection products on the market (SCP/FAMOX/002 final,
adopted 5 September 2001).

(2) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of florasulam in Annex I to Directive 91/414/EEC concerning
(SCP/
the placing of plant-protection products on the market
FLORAS/002 final, adopted 29 October 2001).

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, should be kept available or made available by
the Member States for consultation by any interested
parties.

(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 cinidon-ethyl, cyhalofop butyl, famoxadone,
florasulam, metalaxyl-M or picolinafen and in particular
to review existing provisional authorisations and, by the
end of
to transform those
authorisations into full authorisations, to amend them or
to withdraw them in accordance with the provisions of
Directive 91/414/EEC.

this period at

the latest,

(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 keep available the review reports for
cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, meta-
laxyl-M and picolinafen, except
information
within the meaning of Article 14 of Directive 91/414/EEC, for
consultation by any interested parties or shall make it available
to them on specific request.

for confidential

Article 3

Member States shall adopt and publish by 31 March 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 April 2003.

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.

18.7.2002

EN

Official Journal of the European Communities

L 189/29

Article 4

1. Member States shall review the authorisation for each
plant-protection product containing cinidon-ethyl, cyhalofop
butyl, famoxadone, florasulam, metalaxyl-M or picolinafen 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 the authorisa-
tion in accordance with Directive 91/414/EEC before 31 March
2003.

2. Member States shall, for each authorised plant-protection
product containing cinidon-ethyl, cyhalofop butyl, famoxadone,
florasulam, metalaxyl-M or picolinafen 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 1 October
2002, 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 Directive 91/414/EEC. Where neces-
sary and by 31 March 2004 at the latest, they shall amend or
withdraw the authorisation for each such plant-protection
product.

This Directive shall enter into force on 1 October 2002.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 15 July 2002.

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

Common name, identification
numbers

‘33

Cinidon-ethyl

CAS No 142891-20-1

CIPAC No 598

IUPAC name

Purity (1)

Entry into force

(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-
1-ene-1,2-dicarboximido)phenyl]acrylate

940 g/kg

1 October 2002

Expiration of
inclusion

30 September
2012

34

Cyhalofop butyl

CAS No 122008-85-9

CIPAC No 596

Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy)
phenoxy]propionate

950 g/kg

1 October 2002

30 September
2012

L

1
8
9
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
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r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

Specific provisions

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on cinidon-ethyl,
and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal
Health on 19 April 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 (e.g. soils with
neutral or high pH values) and/or climatic conditions,

— should pay particular attention to the protection of

aquatic organisms.

Conditions of authorisation must
measures, where appropriate.

include risk-mitigation

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on cyhalofop butyl,
and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal
Health on 19 April 2002 shall be taken into account. In this
overall assessment:

— Member States must carefully consider the potential
impact of aerial applications to non-target organisms and
in particular to aquatic species. Conditions of author-
isation must include restrictions or risk mitigation meas-
ures, where appropriate,

— Member States must carefully consider the potential
impact of terrestrial applications on aquatic organisms
within paddy fields. Conditions of authorisation must
include risk-mitigation measures, where appropriate.

.

.

1
8
7
2
0
0
2

No

Common name, identification
numbers

35

Famoxadone

CAS No 131807-57-3

CIPAC No 594

IUPAC name

Purity (1)

Entry into force

3-anilino-5-methyl-5-(4-phenoxyphe-
nyl)-1,3-oxazolidine-2,4-dione

960 g/kg

1 October 2002

Expiration of
inclusion

30 September
2012

36

Florasulam

CAS No 145701-23-1

CIPAC No 616

2(cid:1), 6(cid:1), 8-Trifluoro-5-methoxy-[1,2,4]-tria-
zolo [1,5-c] pyrimidine-2-sulphonanilide

970 g/kg

1 October 2002

30 September
2012

Specific provisions

Only uses as fungicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on famoxadone, and
in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 19 April 2002 shall be taken into account. In this overall
assessment:

— Member States must pay particular attention to potential
chronic risks of the parent substance or metabolites to
earthworms,

— Member States must pay particular attention to the
protection of aquatic organisms and must ensure that the
conditions of authorisation include, where appropriate,
risk-mitigation measures,

— Member States should pay particular attention to the

protection of operators.

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on florasulam, and
in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 19 April 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 climatic
conditions. Conditions of authorisation must
include
risk-mitigation measures, where appropriate.

.

.

1
8
7
2
0
0
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

L

1
8
9
/
3
1

No

Common name, identification
numbers

37

Metalaxyl-M

CAS No 70630-17-0

CIPAC No 580

IUPAC name

Purity (1)

Entry into force

Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-
acetyl] amino} propionate

910 g/kg

1 October 2002

Expiration of
inclusion

30 September
2012

38

Picolinafen

CAS No 137641-05-5

CIPAC No 639

4(cid:1)-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]
picolinanilide

970 g/kg

1 October 2002

30 September
2012

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

Specific provisions

Only uses as fungicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on Metalaxyl-M, and
in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 19 April 2002 shall be taken into account. In this overall
assessment:

— particular attention should be given to the potential for
groundwater contamination by the active substance or its
degradation products CGA 62826, and CGA 108906
when the active substance is applied in regions with
vulnerable soil and/or climatic conditions. Risk-mitiga-
tion measures should be applied, where appropriate.

Only uses as herbicide may be authorised.

For the implementation of the uniform principles of Annex
VI, the conclusions of the review report on picolinafen, and
in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health
on 19 April 2002 shall be taken into account. In this overall
assessment Member States:

— must pay particular attention to the protection of aquatic
organisms. Conditions of authorisation should include
risk-mitigation measures, where appropriate.

L

1
8
9
/
3
2

E
N

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a
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C
o
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i
t
i
e
s

.

.

1
8
7
2
0
0
2