Commission Directive 2006/10/EC of  27 January 2006  amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active substances   (Text with EEA relevance)
Date: 2006-01-27
Institutions: European Commission
Subjects: environmental protection, market approval, marketing standard, pesticide, plant health legislation, plant health product, public health

L 25/24

EN

Official Journal of the European Union

28.1.2006

COMMISSION DIRECTIVE 2006/10/EC

of 27 January 2006

amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active
substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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:

(1)

(2)

for

the

In accordance with Article 6(2) of Directive 91/414/EEC
Spain received on 7 December 1998 an application from
SKW Trostberg AG (on behalf of the Taskforce SKW
Trosberg AG (Degussa AG) and Kyowa Hakko Kogyo
Co.Ltd.)
substance
forchlorfenuron in Annex I
to Directive 91/414/EEC.
Commission Decision 2000/181/EC (2) confirmed that
the dossier was ‘complete’ in the sense that it could be
considered as satisfying, in principle, the data and infor-
mation requirements of Annexes II and III to Directive
91/414/EEC.

inclusion of

the active

indoxacarb

The Netherlands received an application under Article
6(2) of Directive 91/414/EEC on 6 October 1997 from
the active
DuPont de Nemours for the inclusion of
substance
to Directive
91/414/EEC. Commission Decision 1998/398/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 Directive 91/414/EEC.

in Annex

I

(3)

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

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2006/6/EC (OJ L 12, 18.1.2006, p. 21).

(2) OJ L 57, 2.3.2000, p. 35.
(3) OJ L 176, 20.6.1998, p. 34.

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 2 March 2001 (forchlorfenuron) and
7 February 2000 (indoxacarb).

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 23 September 2005 in the
format of the Commission review reports for forchlor-
fenuron and indoxacarb.

The review of forchlorfenuron did not reveal any open
questions or concerns, which would have required a
consultation of the Scientific Committee on Plants or
of the European Food Safety Authority which has taken
over the role of that Committee.

For indoxacarb,
two questions were submitted to the
Scientific Committee on Plants (SCP). The SCP was
asked to comment on the NOEL (No observed effect
level) for effects on red blood cells in rats and on the
adequate basis for the derivation of an Acute Reference
Dose (ARfD) for indoxacarb.

(4)

(5)

(6)

the SCP stated that

In its opinion (4)
the changes
observed in some Red Blood Cells parameters were
generally slight and not accompanied by significant reti-
culocytosis,
a mild
haemolytic effect. While a clear NOEL could not be
established, the SCP concluded on a dose up to which
the effects observed are not adverse.

giving the overall picture of

The SCP furthermore replied that the general and non-
specific signs of toxicity observed in the acute neuro-
toxicity study in rats can be used as a basis for the
derivation of the ARfD.

(4) Opinion of the Scientific Committee on Plants on specific questions
indoxacarb
Scientific

from the Commission concerning the evaluation of
(SCP/Indoxa/002-Final);
the
Committee on Plants on 18 July 2002).

adopted

opinion

by

(7)

(8)

28.1.2006

EN

Official Journal of the European Union

L 25/25

the SCP were taken into
The recommendations of
review by the Member
account during the further
Standing
States
and the Commission within the
Committee on the Food Chain and Animal Health,
in
this Directive and in the Review Report. This evaluation
established the relevant endpoints (ARfD and Acceptable
daily intake = ADI) on the basis of the exposure levels
identified by the SCP.

(11)

(12)

is

therefore
It
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

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)
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.
is
therefore appropriate to include forchlorfenuron and
indoxacarb in Annex I to that Directive,
in order to
ensure that in all Member States the authorisations of
active
plant protection products
substances may be granted in accordance with the
provisions of that Directive.

containing

these

It

six months after

in Annex I, Member States

(9) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant
review existing provisional
protection products
forchlorfenuron or
containing
indoxacarb to ensure that the requirements laid down
by Directive 91/414/EEC, in particular in its Article 13
and the relevant conditions set out
in Annex I, are
satisfied. Member States should transform existing provi-
sional authorisations
into full authorisations, amend
them or withdraw them in accordance with the
provisions of Directive 91/414/EEC. By derogation
from the above deadline, a longer period should be
provided for
the
complete Annex III dossier of each plant protection
product for each intended use in accordance with the
uniform principles laid down in Directive 91/414/EEC.

the submission and assessment of

(10)

The inclusion of forchlorfenuron in Annex I to Directive
91/414/EEC is based on a dossier covering the use of this
active substance on kiwi fruits. Other uses are currently
not adequately supported by data from the notifier and
not all of the risks from such uses have shown to be
the criteria required by
adequately addressed under
If Member States are to
to that Directive.
Annex VI
grant
should
therefore require the data and information necessary to
prove that the uses are compatible with the criteria in
Directive 91/414/EEC, in particular concerning the effect
on human consumers and the environment.

for other uses,

authorisations

they

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

the latest

1. Member States shall adopt and publish by 30 September
2006 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 2006.

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

shall

States

products

protection

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
containing
plant
for
authorisations
indoxacarb as active substances by 30
forchlorfenuron or
September 2006. By that date, they shall
in particular verify
that the conditions in Annex I to that Directive relating to
forchlorfenuron and indoxacarb, respectively, are met, with
the exception of
the entry
concerning those active substances, and that the holder of the
authorisation has, or has access to, a dossier satisfying the
requirements of Annex II to that Directive in accordance with
the conditions of Article 13.

those identified in part B of

L 25/26

EN

Official Journal of the European Union

28.1.2006

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing forchlorfenuron
or indoxacarb 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 March 2006 at the latest, Member
in accordance with the
States shall re-evaluate the product
to Directive
uniform principles provided for
91/414/EEC, on the basis of
the
requirements of Annex III to that Directive and taking into
to that Directive
the entry in Annex I
account part B of
concerning forchlorfenuron and indoxacarb, respectively. 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.

in Annex VI
a dossier

satisfying

Following that determination Member States shall:

(b) in the case of a product containing forchlorfenuron or
indoxacarb as one of
several active substances, where
necessary, amend or withdraw the authorisation by 30
September 2007 or by the date fixed for
such an
in the respective Directive or
amendment or withdrawal
Directives which added the relevant substance or substances
to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 April 2006.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 27 January 2006.

(a)

in the case of a product containing forchlorfenuron or
indoxacarb as the only active substance, where necessary,
amend or withdraw the authorisation by 30 September
2007 at the latest; or

For the Commission

Markos KYPRIANOU
Member of the Commission

28.1.2006

EN

Official Journal of the European Union

L 25/27

s
n
o
i
s
i
v
o
r
p

c
i
f
i
c
e
p
S

n
o
i
s
u
l
c
n

i

f
o

n
o
i
t
a
r
i
p
x
E

e
c
r
o
f

o
t
n

i

y
r
t
n
E

)
1
(

y
t
i
r
u
P

e
m
a
N

C
A
P
U

I

X
E
N
N
A

e
l
b
a
t

e
h
t

f
o

d
n
e

e
h
t

t
a

d
e
d
d
a

e
r
a

s

w
o
r

i

g
n
w
o

l
l

o
f

e
h
t

C
E
E
/
4
1
4
/
1
9

e
v
i
t
c
e
r
i
D

o
t

I

x
e
n
n
A

n
I

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

r
o
t
a
l
u
g
e
r

h
t
w
o
r
g

t
n
a
l
p

s
a

s
e
s
u

y
l
n
O

B

T
R
A
P

n
o
i
t
c
e
t
o
r
p

t
n
a
l
p

e
s
i
r
o
h
t
u
a

o
t

s
n
o
i
t
a
c
i
l

p
p
a

g
n
i
s
s
e
s
s
a

n
I

n
a
h
t

r
e
h
t
o

s
e
s
u

r
o
f

n
o
r
u
n
e
f
r
o
h
c
r
o
f

l

i

g
n
n
i
a
t
n
o
c

s
t
c
u
d
o
r
p

r
a
l
u
c
i
t
r
a
p

y
a
p

l
l
a
h
s

s
e
t
a
t
S

r
e
b
m
e
M

,
s
t
n
a
l
p

i

w
k

i

n

i

e
r
u
s
n
e

l
l
a
h
s

d
n
a

,
)
b
(
)

1
4

(

e
l
c
i
t
r
A

n

i

a
i
r
e
t
i
r
c

e
h
t

o
t

n
o
i
t
n
e
t
t
a

e
r
o
f
e
b

d
e
d
i
v
o
r
p

s
i

n
o
i
t
a
m
r
o
f
n

i

d
n
a

a
t
a
d

y
r
a
s
s
e
c
e
n

y
n
a

t
a
h
t

.

d
e
t
n
a
r
g

s
i

n
o
i
t
a
z
i
r
o
h
t
u
a

n
a

h
c
u
s

x
e
n
n
A

f
o

s
e
l
p
i
c
n
i
r
p
m
r
o
f
i
n
u

e
h
t

f
o

n
o
i
t
a
t
n
e
m
e
l
p
m

i

e
h
t

r
o
F

,

n
o
r
u
n
e
f
r
o
h
c
r
o
f

l

n
o

t
r
o
p
e
r

w
e
i
v
e
r

e
h
t

f
o

s
n
o
i
s
u
l
c
n
o
c

e
h
t

,
I

V

n

i

d
e
s
i
l
a
n
i
f

s
a

,
f
o
e
r
e
h
t

I
I

d
n
a

I

s
e
c
i
d
n
e
p
p
A

r
a
l
u
c
i
t
r
a
p

n

i

d
n
a

l
a
m
n
A

i

d
n
a

n
i
a
h
C

d
o
o
F

e
h
t

n
o

e
e
t
t
i

m
m
o
C

i

g
n
d
n
a
t
S

e
h
t

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

e
b

l
l
a
h
s

5
0
0
2

r
e
b
m
e
t
p
e
S

3
2

n
o

h
t
l
a
e
H

y
a
p

t
s
u
m

s
e
t
a
t
S

r
e
b
m
e
M

t
n
e
m

s
s
e
s
s
a

l
l
a
r
e
v
o

s
i
h
t

n
I

r
e
t
a
w
d
n
u
o
r
g

r
o
f

l
a
i
t
n
e
t
o
p

e
h
t

o
t

n
o
i
t
n
e
t
t
a

r
a
l
u
c
i
t
r
a
p

A

T
R
A
P

6
1
0
2

h
c
r
a
M

1
3

6
0
0
2

l
i
r
p
A

1

g
k
/
g

8
7
9
≥

n

i

d
e
i
l

p
p
a

s
i

e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

e
h
t

n
e
h
w

,

i

n
o
i
t
a
n
m
a
t
n
o
c

-
o
r
p
p
a

e
r
e
h
w

d
e
i
l

p
p
a

e
b

l

d
u
o
h
s

s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
R

.
s
n
o
i
t
i
d
n
o
c

c
i
t
a
m

i
l
c

r
o
/
d
n
a

l
i

o
s

e
l
b
a
r
e
n
u
v

l

h
t
i

w

s
n
o
i
g
e
r

.
e
t
a
i
r
p

A

T
R
A
P

6
1
0
2

h
c
r
a
M

1
3

6
0
0
2

l
i
r
p
A

1

:
)
l
a
i
r
e
t
a
M

x
e
n
n
A

f
o

s
e
l
p
i
c
n
i
r
p
m
r
o
f
i
n
u

e
h
t

f
o

n
o
i
t
a
t
n
e
m
e
l
p
m

i

e
h
t

r
o
F

d
n
a

,

b
r
a
c
a
x
o
d
n

i

n
o

t
r
o
p
e
r

w
e
i
v
e
r

e
h
t

f
o

s
n
o
i
s
u
l
c
n
o
c

e
h
t

,
I

V

e
h
t

n

i

d
e
s
i
l
a
n
i
f

s
a

,
f
o
e
r
e
h
t

I
I

d
n
a

I

s
e
c
i
d
n
e
p
p
A

r
a
l
u
c
i
t
r
a
p

n

i

h
t
l
a
e
H

l
a
m
n
A

i

d
n
a

n
i
a
h
C

d
o
o
F

e
h
t

n
o

e
e
t
t
i

m
m
o
C

i

g
n
d
n
a
t
S

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

e
b

l
l
a
h
s

5
0
0
2

r
e
b
m
e
t
p
e
S

3
2

n
o

y
a
p

t
s
u
m

s
e
t
a
t
S

r
e
b
m
e
M

t
n
e
m

s
s
e
s
s
a

l
l
a
r
e
v
o

s
i
h
t

n
I

.
s

m

s
i
n
a
g
r
o

c
i
t
a
u
q
a

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

o
t

n
o
i
t
n
e
t
t
a

r
a
l
u
c
i
t
r
a
p

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

e
d
i
c
i
t
c
e
s
n

i

s
a

s
e
s
u

y
l
n
O

B

T
R
A
P

b
r
a
c
a
x
o
d
n

i

g
k
/
g

l
a
c
i
n
h
c
e
T

(

C
T

8
2
6
≥

i

-
3
-
)
l
y
n
d
i
r
y
p
-
4
-
o
r
o
h
c
-
2
(
-
1

l

a
e
r
u
l
y
n
e
h
p

8
-
0
6
-
7
5
1
8
6

o
N

S
A
C

3
3
6

o
N

C
A
P
I
C

,

,

,

-
5
a
4
3
2
-
o
r
o
h
c
-
7
[
-

l

N

-
)

S

(

l
y
h
t
e
m

b
r
a
c
a
x
o
d
n
I

0
2
1

)
l
y
n
o
b
r
a
c
y
x
o
h
t
e
m

(
-
a
4
-
o
r
d
y
h
a
r
t
e
t

)
y
x
o
h
t
e
m
o
r
o
u
l
f
i
r
t
(
-

-
2
-
n
i
z
a
i
d
a
x
o
]
4
3
1
[
]

,

,

e

′
4
-
]
l
y
n
o
b
r
a
c
l
y

,

-
2
1
[
o
n
e
d
n

i

e
t
a
l
i

n
a
b
r
a
c

6
-
4
4
-
4
8
5
3
7
1

o
N

S
A
C

2
1
6

o
N

C
A
P
I
C

,
e
m
a
N

n
o
m
m
o
C

s
r
e
b
m
u
N

n
o
i
t
a
c
i
f
i
t
n
e
d
I

o
N

n
o
r
u
n
e
f
r
o
h
c
r
o
F

l

9
1
1

‘

,
s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

e
d
u
l
c
n

i

l

d
u
o
h
s

’

e
s
u

f
o

s
n
o
i
t
i
d
n
o
C

.
e
t
a
i
r
p
o
r
p
p
a

e
r
e
h
w

.
t
r
o
p
e
r

w
e
i
v
e
r

e
h
t

n

i

d
e
d
i
v
o
r
p

e
r
a

s
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

f
o

n
o
i
t
a
c
i
f
i
c
e
p
s

d
n
a

y
t
i
t
n
e
d

i

n
o

s
l
i
a
t
e
d

r
e
h
t
r
u
F

)
1
(