Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as active substances (Text with EEA relevance)
Date: 2003-04-11
Institutions: European Commission
Subjects: herbicide, marketing, marketing standard, pharmaceutical product, plant health product

23.4.2003

EN

Official Journal of the European Union

L 101/3

COMMISSION DIRECTIVE 2003/31/EC

of 11 April 2003

amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione,
linuron, maleic hydrazide and pendimethalin 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/
23/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive 91/
414/EEC concerning the placing of plant protection
products on the market (3), as last amended by Regula-
tion (EC) No 2266/2000 (4), establishes a list of active
substances to be assessed, with a view to their possible
inclusion in Annex I to Directive 91/414/EEC. That list
includes 2,4-DB, beta-cyfluthrin, cyfluthrin,
iprodione,
linuron, maleic hydrazide and pendimethalin.

For these active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulation (EEC) No
3600/92 for a range of uses proposed by the notifiers.
By Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant protec-
tion products and designating the rapporteur Member
State for the implementation of Commission Regulation
(EEC) No 3600/92 (5), as last amended by Regulation
(EC) No 2230/95 (6), the following rapporteur Member
States were designated and submitted the relevant assess-
ment reports and recommendations to the Commission
in accordance with Article 7(1)(c) of Regulation (EEC)
No 3600/92: 2,4-DB: rapporteur Member State Greece,
information was submitted on 30 April
all relevant
1996;
State
Germany, all relevant information was submitted on 4
November 1996; cyfluthrin: rapporteur Member State
Germany, all relevant information was submitted on 4
November 1996;
iprodione: rapporteur Member State
France, all relevant information was submitted on 18
July 1996;
linuron: rapporteur Member State United
Kingdom, all relevant information was submitted on 31
October 1996; maleic hydrazide: rapporteur Member
State Denmark, all relevant information was submitted
rapporteur
on 5 September 1997; pendimethalin:
Member State Spain, all
information was
submitted on 20 May 1998.

rapporteur Member

beta-cyfluthrin:

relevant

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 81, 28.3.2003, p. 39.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(3)

(4)

(5)

(6)

(7)

These assessment reports have been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health.

In accordance with Article 6(4) of Directive 91/414/EEC
and in view of a possible unfavourable decision for 2,4-
DB and for pendimethalin the Commission organised
tripartite meetings with the main data submitter and the
rapporteur Member State on 7 May 1998 and on 4 June
1999. For both substances the main data submitter
the initial
provided further data in order
concerns.

to meet

The reviews of all active substances were finalised on 3
December 2002 in the format of the Commission review
report for 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione,
linuron, maleic hydrazide and pendimethalin.

The reviews of 2,4-DB,
linuron, maleic hydrazide and
pendimethalin did not reveal any open questions or
concerns, which would have required a consultation of
the Scientific Committee on Plants.

The report on beta-cyfluthrin and on cyfluthrin and
further information concerning both substances were
also submitted to the Scientific Committee on Plants for
separate consultations. The Committee was asked to
comment on the appropriate dietary risk assessment to
be used and to confirm that the available ecotoxicolo-
gical data supports uses only in glasshouses and for seed
treatment. In its opinions (7) (8), the Committee suggested
that in addition to a long-term dietary intake risk assess-
ment, as routinely carried out
for plant protection
products, beta-cyfluthrin and cyfluthrin should also
undergo a short-term acute dietary risk assessment to
evaluate their potential neurotoxicity properties. The
Committee confirmed that uses as seed dressing and in
greenhouses (except where beneficial arthropods are
used) can be considered safe for non-target terrestrial
and aquatic organisms, due to the specific circumstances
of these applications and the immobility of beta-cyflu-
thrin and cyfluthrin in soil. The Committee furthermore
supports the conclusions reached during the evaluation
by the Member States that field spray applications of
beta-cyfluthrin and cyfluthrin have not shown to be
sufficiently safe under the criteria required by Annex VI
to Directive 91/414/EEC. Following the opinion of the
Scientific Committee on Plants the short term dietary
risk assessment was subsequently provided and discussed

(7) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of beta-cyfluthrin in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market.
(Opinion expressed by the Scientific Committee on Plants, 28
January 2000).

(8) Opinion of the scientific Committee on Plants regarding the inclu-
sion of cyfluthrin in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market.
(Opinion expressed by the Scientific Committee on Plants, 28
January 2000).

L 101/4

EN

Official Journal of the European Union

23.4.2003

(8)

(9)

with the Member States. It was concluded that the short-
term intake of residues is not likely to exceed acceptable
limits.

The report on iprodione and further information were
also submitted to the Scientific Committee on Plants for
separate consultation. The Scientific Committee was
asked to comment on the predicted environmental
concentrations in soil and groundwater, and on the
acceptable operator exposure level proposed by the
rapporteur. In its opinion (1), the Committee agreed that
sufficient information was available to reliably estimate
the leaching behaviour of the substance for soils with
pH above 6. However, the assessment of leaching in soils
with pH below 6 deserves further attention, since, for
soils with pH below 6, leaching at concentration levels
exceeding 0,1 µg/l may occur in some realistic vulner-
able situations. The Committee saw no need to use an
additional safety factor for the derivation of the accep-
table operator exposure level. The observations of the
Scientific Committee were taken into account in this
Directive and the review report.

It has appeared from the various examinations made that
plant protection products containing 2,4-DB, beta-cyflu-
thrin, cyfluthrin, iprodione, linuron, maleic hydrazide or
pendimethalin 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 report.
It is therefore appro-
priate to include these active substances in Annex I, in
order to ensure that in all Member States the authorisa-
tion of plant protection products containing this active
substance can be granted in accordance with the provi-
sions of that Directive.

(10)

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

iprodione,

(12) After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant protec-
tion products containing 2,4-DB, beta-cyfluthrin, cyflu-
thrin,
linuron, maleic hydrazide or pendi-
methalin, and in particular, to review existing authorisa-
tions to ensure that the conditions regarding those active
substances set out in Annex I to Directive 91/414/EEC
are satisfied. A longer period should be provided for the
submission and assessment of the complete dossier of
each plant protection product in accordance with the
uniform principles laid down in Directive 91/414/EEC.

(13)

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

(14)

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.

They shall apply those provisions from 1 July 2004.

When Member States adopt this provision, 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.

(11) A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements which
will result from the inclusion.

(1) Opinion of the Scientific Committee on Plants on specific questions
from the Commission concerning the evaluation of iprodione in the
context of Council Directive 91/414/EEC. SCP/IPRODIO/002-final
adopted 31 January 2002.

Article 3

iprodione,

1. Member States shall review the authorisation for each
plant protection product containing 2,4-DB, beta-cyfluthrin,
cyfluthrin,
linuron, maleic hydrazide or pendi-
methalin 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 and by 30 June 2004 at the
latest, they shall amend or withdraw the authorisation.

23.4.2003

EN

Official Journal of the European Union

L 101/5

2. Member States shall, for each authorised plant protection
product containing 2,4-DB, beta-cyfluthrin, cyfluthrin,
ipro-
dione, linuron, maleic hydrazide or pendimethalin 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 2003 at the latest, re-evaluate the product in accor-
dance 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 to that Directive. 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 December 2007
at the latest, they shall amend or withdraw the authorisation.

This Directive shall enter into force on 1 January 2004.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 11 April 2003.

For the Commission

David BYRNE

Member of the Commission

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EC

ANNEX

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

No

Common name,
identification
numbers

‘47

2,4-DB

CAS No
94-82-6

CIPAC No
83

4-(2,4-dichlorophenoxy) butyric
acid

48

Beta-cyfluthrin

CAS No
68359-37-5
(unstated
stereochemistry)

CIPAC No
482

(1RS,3RS;1RS,3SR)-3- (2,2-dichlor-
ovinyl)-2,2-dimethylcyclopropane-
carboxylic acid (SR)-α-cyano- (4-
fluoro-3-phenoxy-phenyl)methyl
ester

940 g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on 2,4-DB, and in particular Appen-
dices 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 protection of groundwater when
the active substance is applied in regions with vulnerable soil and/or
climatic conditions. Risk mitigation measures should be applied,
where appropriate.

965 g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are
currently not adequately supported and have not shown to be accep-
table under the criteria required by Annex VI. To support authorisa-
tions for such uses, data and information to prove their acceptability
to human consumers and the environment will have to be generated
and submitted to the Member States. This will be the case in parti-
cular for data to assess in all detail the risks of outdoor foliar uses
and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on beta-cyfluthrin, 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 protection of
non-target arthropods. Conditions of authorisation should include
adequate risk mitigation measures.

L

1
0
1
/
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
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p
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a
n
U
n
o
n

i

.

.

2
3
4
2
0
0
3

No

Common name,
identification
numbers

49

Cyfluthrin

CAS No
68359-37-5
(unstated
stereochemistry)

CIPAC No
385

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

(RS),-α-cyano-4-fluoro-3-phenoxy-
benzyl-(1RS,3RS;1RS,3SR)-3-(2,2-
dichlorovinyl)-2,2-dimethycyclo-
propanecarboxylate

920 g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are
currently not adequately supported and have not shown to be accep-
table under the criteria required by Annex VI. To support authorisa-
tions for such uses, data and information to prove their acceptability
to human consumers and the environment will have to be generated
and submitted to the Member States. This will be the case in parti-
cular for data to assess in all detail the risks of outdoor foliar uses
and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on cyfluthrin, 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 protection of
non-target arthropods. Conditions of authorisation should include
adequate risk mitigation measures.

50

Iprodione

CAS No
36734-19-7

CIPAC No
278

3-(3,5-dichlorophenyl)-N-
isopropyl-2,4-dioxo-imidazolidine-
1-carboximide

960 g/kg

1 January 2004

31 December 2013

Only use as fungicide may be authorised

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on iprodione, 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 ground water
contamination when the active substance is applied at high use
rates (in particular use in turf) on acidic soils (pH below 6) under
vulnerable climatic conditions,

— must carefully consider the risk to aquatic invertebrates if the
active substance is applied directly adjacent to surface waters. Risk
mitigation measures should be applied, where appropriate.

.

.

2
3
4
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
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t
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e

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a
n
U
n
o
n

i

L

1
0
1
/
7

No

Common name,
identification
numbers

51

Linuron

CAS No
330-55-2

CIPAC No
76

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

3-(3,4-dichlorophenyl)-1-methoxy-
1-methylurea

900 g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on linuron, and in particular Appen-
dices 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 protection of wild mammals,
non-target arthropods and aquatic organisms. Conditions of
authorisation should include risk mitigation measures, where
appropriate,

— must pay particular attention to the protection of operators.

hydra-

6-hydroxy-2H-pyridazin-3-one

940 g/kg

1 January 2004

31 December 2013

Only use as growth regulator may be authorised

The active
substance shall
comply with
Council Directive
79/117/EEC (2), as
amended by
Council Directive
90/533/EEC (3).

For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on maleic hydrazide, and in parti-
cular 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 protection of non-target
arthropods and must ensure that the conditions of authorisation
include risk mitigation measures, where appropriate,

— must pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions. Risk mitigation
measures should be applied, where appropriate.

52

Maleic
zide

CAS No
123-33-1

CIPAC No
310

L

1
0
1
/
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

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a
n
U
n
o
n

i

.

.

2
3
4
2
0
0
3

No

Common name,
identification
numbers

53

Pendimethalin

CAS No
40487-42-1

CIPAC No
357

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

N-(1-ethylpropyl)-2,6-dinitro-3,4-
xylidene

900 g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

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

— must pay particular attention to the protection of aquatic organ-
isms and non-target terrestrial plants. Conditions of authorisation
must include risk mitigation measures, where appropriate,

— must pay particular attention to the possibility of short-range

transport of the active substance in air.

(1) Further details on identity and specification of active substance are provided in the review report.
(2) OJ L 33, 8.2.1979, p. 36.
(3) OJ L 296, 27.10.1990 p. 63.’

.

.

2
3
4
2
0
0
3

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9