Commission Directive 2008/40/EC of 28 March 2008 amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances (Text with EEA relevance)
Date: 2008-03-28
Institutions: European Commission
Subjects: chemical product, market approval, marketing standard, pharmaceutical product, plant health control, plant health product

29.3.2008

EN

Official Journal of the European Union

L 87/5

DIRECTIVES

COMMISSION DIRECTIVE 2008/40/EC

of 28 March 2008

amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron 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,

(4)

Whereas:

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 1490/2002 (3) lay down the detailed rules for the
implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC
and establish 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 amidosulfuron
and nicosulfuron.

(5)

(1)

(2)

For those active substances the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulations (EC) No
451/2000 and (EC) No 1490/2002 for a range of uses
proposed by the notifiers. Moreover, those Regulations
designate the rapporteur Member States which have to
submit the relevant assessment reports and recommen-
dations to the European Food Safety Authority (EFSA) in
accordance with Article 10(1) of Regulation (EC) No
1490/2002. For amidosulfuron and nicosulfuron the
rapporteur Member States were Austria and the United
Kingdom and all relevant information was submitted on
31 May 2005 and 7 December 2005 respectively.

(3)

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 22 January 2007 for amidosulfuron

States

in the format of the EFSA Scientific
and nicosulfuron,
Reports (4). These reports have been reviewed by the
Member
the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 22 January 2008 in the format
of the Commission review reports for amidosulfuron and
nicosulfuron.

and

It has appeared from the various examinations made that
plant protection products containing amidosulfuron and
nicosulfuron may be expected to satisfy, in general, the
requirements laid down in Article 5(1)(a) and (b) of
in particular with regard to the
Directive 91/414/EEC,
examined and detailed in the
uses which were
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 authorisations of
plant protection products
active
substances can be granted in accordance with the
provisions of that Directive.

containing

these

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
the new requirements
which will result from the inclusion.

themselves

to meet

six months after

in Annex I, Member States

(6) Without prejudice to the obligations defined by Directive
91/414/EEC as a consequence of
including an active
substance
should be
allowed a period of
inclusion to
authorisations of plant protection
review existing
products containing amidosulfuron and nicosulfuron to
the requirements laid down by Directive
ensure that
in its Article 13 and the
91/414/EEC,
in particular
in Annex I, are satisfied.
relevant conditions set out
Member States should vary, replace or withdraw, as
appropriate, existing authorisations,
in accordance with
the provisions of Directive 91/414/EEC. By way of dero-
gation from the above deadline, a longer period should
be provided for the submission and assessment of 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.

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

last amended by
Commission Directive 2007/76/EC (OJ L 337, 21.12.2007, p. 100).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regu-

lation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

(4) EFSA Scientific Report (2007) 116, 1-86, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
amidosulfuron (finalised 14 November 2007).
EFSA Scientific Report (2007) 120, 1-91, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
nicosulfuron (finalised 29 November 2007).

L 87/6

EN

Official Journal of the European Union

29.3.2008

(7)

(8)

(9)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 (1) has shown that difficulties can arise in inter-
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further diffi-
culties it therefore appears necessary to clarify the duties
of the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that
Directive. However, this clarification does not impose any
new obligations on Member States or holders of author-
isations compared to the directives which have been
adopted until now amending Annex I.

is

It
therefore
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

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to amidosulfuron and nico-
sulfuron are met, with the exception of those identified in part
B of the entry concerning that active substance, 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 of that Directive.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing amidosulfuron
and nicosulfuron 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 October 2008 at the latest,
Member States shall re-evaluate the product
in accordance
to
with the uniform principles provided for in Annex VI
Directive 91/414/EEC, on the basis of a dossier satisfying the
requirements of Annex III to that Directive and taking into
account part B of
to that Directive
the entry in Annex I
concerning amidosulfuron and nicosulfuron 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.

HAS ADOPTED THIS DIRECTIVE:

Following that determination Member States shall:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

Article 2

the

laws,

regulations

Member States shall adopt and publish by 30 April 2009 at the
latest
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 May 2009.

(a)

in the case of a product containing amidosulfuron and
nicosulfuron as the only active substance, where necessary,
amend or withdraw the authorisation by 31 October 2012
at the latest; or

(b) in the case of a product containing amidosulfuron and
nicosulfuron as one of several active substances, where
authorisation by
amend or withdraw the
necessary,
31 October 2012 or by the date fixed for
such an
amendment or withdrawal
in the respective Directive or
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 November 2008.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 5

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 28 March 2008.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing amido-
sulfuron and nicosulfuron as active substances by 30 April
2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

29.3.2008

EN

Official Journal of the European Union

L 87/7

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

,

n
o
r
u
f
l
u
s
o
d
m
a

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

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

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

r
o
F

,
I

V

d
n
a

e
h
t

r
a
l
u
c
i
t
r
a
p

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

:

o
t

n
o
i
t
n
e
t
t
a

r
o
f

l
a
i
t
n
e
t
o
p

a

n
o
i
t
a
d
a
r
g
e
d

e
h
t

o
t

f
o

e
u
d

r
e
t
a
w
d
n
u
o
r
g

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

e
m
o
s

y
b

i

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

r
e
t
a
w
d
n
u
o
r
g

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

n

i

d
e
i
l

p
p
a

s
i

t
i

n
e
h
w
s
t
c
u
d
o
r
p

—

.
t
n
u
o
c
c
a

o
t
n

i

n
e
k
a
t

e
b

l
l
a
h
s

8
0
0
2

y
r
a
u
n
a
J

2
2

n
o

h
t
l
a
e
H

.
s
t
n
a
l
p

c
i
t
a
u
q
a

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

—

,
s
n
o
i
t
i
d
n
o
c

c
i
t
a
m

i
l
c

r
o
/
d
n
a

,
s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

,
s
k
s
i
r

d
e
i
f
i
t
n
e
d

i

e
s
e
h
t

o
t

n
o
i
t
a
l
e
r

n
I

.
e
t
a
i
r
p
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
n
o
z

r
e
f
f
u
b

s
a

h
c
u
s

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
f
l
u
s
o
d
m
a

i

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

,
e
r
u
t
s
a
p

d
n
a

s
w
o
d
a
e
m

e
r
u
s
n
e

e
r
o
f
e
b

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

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
s
i
r
o
h
t
u
a

n
a

h
c
u
s

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

e
d
i
c
i
b
r
e
h

s
a

s
e
s
u

y
l
n
O

B

T
R
A
P

A

T
R
A
P

8
1
0
2

r
e
b
m
e
c
e
D

1
3

9
0
0
2

y
r
a
u
n
a
J

1

g
k
/
g
0
7
9
≥

-
1
-
)
l
y
-
2
-
n
d
m

i

i

i
r
y
p
y
x
o
h
t
e
m
d
-
6
4
(
-
3

i

,

-
l
y
n
o
f
l
u
s
l
y
h
t
e
m
N

-

-
l
y
h
t
e
m
N

-

(

a
e
r
u
)
l
y
n
o
f
l
u
s
o
n
m
a

i

r
o

-
3
-
)
l
y
-
2
-
n
d
m

i

i

i
r
y
p
y
x
o
h
t
e
m
d
-
6
4
(
-
1

i

,

a
e
r
u
l
y
o
m
a
f
l
u
s

)
l
y
h
t
e
m

(
l
y
s
e
m

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

,
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

7
-
7
3
-
3
2
9
0
2
1

o
N

S
A
C

5
1
5

o
N

C
A
P
I
C

n
o
r
u
f
l
u
s
o
d
m
A

i

o
N

5
7
1

‘

X
E
N
N
A

:

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

e
l
b
a
t

e
h
t

f
o

d
n
e

e
h
t

t
a

d
e
d
d
a

e
b

l
l
a
h
s

y
r
t
n
e

i

g
n
w
o

l
l

o
f

e
h
T

L 87/8

EN

Official Journal of the European Union

29.3.2008

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

,

n
o
r
u
f
l
u
s
o
c
i
n

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

8
0
0
2

y
r
a
u
n
a
J

2
2

n
o

r
a
l
u
c
i
t
r
a
p

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

:

o
t

n
o
i
t
n
e
t
t
a

.

d
e
s
i
r
o
h
t
u
a

e
b

y
a
m

e
d
i
c
i
b
r
e
h

s
a

s
e
s
u

y
l
n
O

B

T
R
A
P

A

T
R
A
P

8
1
0
2

r
e
b
m
e
c
e
D

1
3

9
0
0
2

y
r
a
u
n
a
J

1

g
k
/
g
0
3
9
≥

-
2
-
n
d
m

i

i

i
r
y
p
y
x
o
h
t
e
m
d
-
6
4
(
[
-
2

i

,

-

,

N
N

-
]
l
y
o
m
a
f
l
u
s
)
l
y
o
m
a
b
r
a
c
l
y

i

e
d
m
a
n
i
t
o
c
i
n
l
y
h
t
e
m
d

i

r
o

-
3
-
)
l
y
-
2
-
n
d
m

i

i

i
r
y
p
y
x
o
h
t
e
m
d
-
6
4
(
-
1

i

,

-
2
-
l
y
o
m
a
b
r
a
c
l
y
h
t
e
m
d
-
3

i

(

a
e
r
u
)
l
y
n
o
f
l
u
s
l
y
d
i
r
y
p

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

,
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

4
-
9
0
-
1
9
9
1
1
1

o
N

S
A
C

9
0
7

o
N

C
A
P
I
C

n
o
r
u
f
l
u
s
o
c
i
N

6
7
1

o
t

n

i

t
n
e
m
n
o
r
i
v
n
e

c
i
t
a
u
q
a

e
h
t

f
o

e
r
u
s
o
p
x
e

l
a
i
t
n
e
t
o
p

e
h
t

d
e
i
l

p
p
a

s
i

n
o
r
u
f
l
u
s
o
c
i
n

n
e
h
w

N
D
U
D

e
t
i
l

o
b
a
t
e
m

,
s
n
o
i
t
i
d
n
o
c

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
h
t

t
a
h
t

e
r
u
s
n
e

t
s
u
m
d
n
a

s
t
n
a
l
p

c
i
t
a
u
q
a

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

,
e
t
a
i
r
p
o
r
p
p
a

e
r
e
h
w

,
e
d
u
l
c
n

i

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

f
o

s
n
o
i
t
i
d
n
o
c

,
s
e
n
o
z

r
e
f
f
u
b

s
a

h
c
u
s

s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

t
a
h
t

e
r
u
s
n
e

t
s
u
m

d
n
a

s
t
n
a
l
p

t
e
g
r
a
t
-
n
o
n

f
o

n
o
i
t
c
e
t
o
r
p

-
o
r
p
p
a

e
r
e
h
w

,
e
d
u
l
c
n

i

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

f
o

s
n
o
i
t
i
d
n
o
c

e
h
t

e
h
t

-
o
n

d
l
e
i
f
-
n

i

n
a

s
a

h
c
u
s

s
e
r
u
s
a
e
m

n
o
i
t
a
g
i
t
i

m

k
s
i
r

,
e
t
a
i
r
p

,
e
n
o
z

r
e
f
f
u
b

y
a
r
p
s

r
e
d
n
u

r
e
t
a
w

e
c
a
f
r
u
s

d
n
a

r
e
t
a
w
d
n
u
o
r
g

f
o

n
o
i
t
c
e
t
o
r
p

e
h
t

—

—

—

—

’

.
s
n
o
i
t
i
d
n
o
c

c
i
t
a
m

i
l
c

d
n
a

l
i

o
s

e
l
b
a
r
e
n
u
v

l

.
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

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
(