Commission Regulation (EC) No 545/2006 of  31 March 2006  amending Regulation (EC) No 1464/2004 as regards the conditions for authorisation of the feed additive  Monteban , belonging to the group of coccidiostats and other medicinal substances   (Text with EEA relevance)
Date: 2006-03-31
Institutions: European Commission
Subjects: food additive, poultry, veterinary drug, veterinary legislation

L 94/26

EN

Official Journal of the European Union

1.4.2006

COMMISSION REGULATION (EC) No 545/2006

of 31 March 2006

amending Regulation (EC) No 1464/2004 as regards the conditions for authorisation of the feed
additive ‘Monteban’, belonging to the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 13(3) thereof,

Whereas:

(1)

substances, was

authorised under

The additive narasin (Monteban, Monteban G 100),
belonging to the group of coccidiostats and other
certain
medicinal
accordance with Council Directive
conditions
in
70/524/EEC (2).
(EC) No
Commission
1464/2004 (3) authorised that additive for 10 years for
use for chickens for fattening, linking the authorisation
to the person responsible for putting that additive into
circulation. That additive was notified as an existing
product on the basis of Article 10 of Regulation (EC)
No 1831/2003. Since all
the information required
under that provision was submitted, that additive was
entered into the Community Register of Feed Additives.

Regulation

50 μg/kg for all wet tissues in chickens for fattening.
Consequently a withdrawal time of one day before the
slaughter was considered sufficient. It may be necessary
to review the maximum residue limit mentioned in the
Annex of this Regulation in light of the results of any
European Medicines Agency
evaluation
concerning the active substance.

the

by

The holder of the authorisation of the additive narasin
(Monteban, Monteban G 100) proposed changing the
terms of the authorisation by submitting an application
to the Commission requesting to introduce MRL as
evaluated by the Authority.

Regulation (EC) No 1464/2004 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(4)

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

(2)

Regulation (EC) No 1831/2003 provides for the possi-
bility to modify the authorisation of an additive further
from the authorisation holder and an
to a request
the European Food Safety Authority (‘the
opinion of
Authority’).

(3)

In its opinion adopted on 27 July 2004, the Authority
proposed to establish a maximum residue limit (MRL) of

The Annex to Regulation (EC) No 1464/2004 is replaced by the
Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day
Journal of the
following that of its publication in the Official
European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 March 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) OJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC)

No 1831/2003.

(3) OJ L 270, 18.8.2004, p. 8.

1.4.2006

EN

Official Journal of the European Union

L 94/27

e
u
d
i
s
e
r

m
u
m
i
x
a
M

e
h
t

n

i

)
s
L
R
M

(

s
t
i

m

i
l

s
f
f
u
t
s
d
o
o
f

t
n
a
v
e
l
e
r

n
i
g
i
r
o

l
a
m
n
a

i

f
o

r
o

s
e
i
c
e
p
s

m
o
r
f

l
a
m
n
a

i

f
o

y
r
o
g
e
t
a
c

d
e
n
r
e
c
n
o
c

g
k
/
n
i
s
a
r
a
N

g

μ
0
5

s
e
u
s
s
i
t

t
e
w

l
l
a

r
o
f

r
o
f

s
n
e
k
c
i
h
c

m
o
r
f

’

i

g
n
n
e
t
t
a
f

m
u
m
i
x
a
M

t
n
e
t
n
o
c

m
u
m
n
M

i

i

t
n
e
t
n
o
c

X
E
N
N
A

f
o

d
o
i
r
e
p

f
o

d
n
E

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

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

e
v
i
t
c
a

f
o

g
m

f
o

g
k
/
e
c
n
a
t
s
b
u
s

f
f
u
t
s
g
n
d
e
e
f

i

e
t
e
l
p
m
o
c

m
u
m
i
x
a
M

e
g
a

s
e
i
c
e
p
S

r
o

y
r
o
g
e
t
a
c

l
a
m
n
a

i

f
o

l
a
c
i
m
e
h
c

,

n
o
i
t
i
s
o
p
m
o
C

n
o
i
t
p
i
r
c
s
e
d

,

a
l
u
m
r
o
f

e
v
i
t
i
d
d
A

)
e
m
a
n

e
d
a
r
T

(

d
n
a

e
m
a
N

n
o
i
t
a
r
t
s
i
g
e
r

f
o

r
e
b
m
u
n

n
o
s
r
e
p

e
l
b
i
s
n
o
p
s
e
r

g
n
i
t
t
u
p

r
o
f

o
t
n

i

e
v
i
t
i
d
d
a

n
o
i
t
a
l
u
c
r
i
c

-
s
i
g
e
R

n
o
i
t
a
r
t

f
o

r
e
b
m
u
n

e
v
i
t
i
d
d
a

”

n
a

s
n
i
a
t
n
o
c

f
f
u
t
s
g
n
d
e
e
f

i

s
i
h
T
“

h
t
i

w

e
s
u

s
u
o
e
n
a
t
l
u
m

i
s

:
e
r
o
h
p
o
n
o

i

.

g
.
e
(

s
e
c
n
a
t
s
b
u
s

l
a
n
i
c
i
d
e
m

n
i
a
t
r
e
c

d
e
t
a
c
i
d
n
i
a
r
t
n
o
c

e
b

n
a
c

)

n

i
l

u
m
a
i
t

,
s
e
i
c
e
p
s

i

e
n
u
q
e

”

s
t
i
b
b
a
r

d
n
a

s
y
e
k
r
u
t

r
o
f

s
u
o
r
e
g
n
a
D

“

4
1
0
2
8
1
2

.

.

:
e
s
u

r
o
f

s
n
o
i
t
c
u
r
t
s
n

i

e
h
t

n

i

e
t
a
c
i
d
n
I

.
r
e
t
h
g
u
a
l
s

e
r
o
f
e
b

y
a
d

e
n
o

t
s
a
e
l

t
a

d
e
t
i
b
h
o
r
p

i

e
s
U

0
7

0
6

—

r
a
l
u
n
a
r
g

n

i

,
)

2
9
0
8

L
R
R
N

(

%
0
9
≥

:

y
t
i
v
i
t
c
a

A

n
i
s
a
r
a
N

m
r
o
f

s
n
e
i
c
a
f
o
e
r
u
a

y
b

d
e
c
u
d
o
r
p

d
i
c
a

s
e
c
y
m
o
t
p
e
r
t
S

c
i
l
y
x
o
b
r
a
c
o
n
o
m

r
e
h
t
e
y
l
o
p

9
-
3
1
-
4
3
1
5
5

:
r
e
b
m
u
n

S
A
C

1
1
O
2
7
H
3
4
C

,

n
i
s
a
r
a
N

e
c
i
r

r
o

n
u
r

l
l
i

m

n
a
e
b
y
o
S

g
k
/
g
0
2
-
0

:
e
t
i
l

u
c
i
m
r
e
V

g
k
/
g
0
3
-
0
1

:
e
c
n
a
t
s
b
u
s

e
v
i
t
c
A

g
k
1

s
q

s
l
l

u
h

s
n
e
k
c
i
h
C

:

n
o
i
t
i
s
o
p
m
o
c

e
v
i
t
i
d
d
A

g
k
/
g
0
0
1

n
i
s
a
r
a
N

d
n
a

y
l
l
i
L

i
l

E

i

g
n
n
e
t
t
a
f

:
l
i

o

l
a
r
e
n
m

i

r
o

l
i

o

n
a
e
b
y
o
S

)

0
0
1
G

n
a
b
e
t
n
o
M

r
o
f

g
k
/
y
t
i
v
i
t
c
a

g
0
0
1

:

n
i
s
a
r
a
N

,

n
a
b
e
t
n
o
M

(

y
n
a
p
m
o
C

d
e
t
i

m
i
L

5
6
7

E

‘

s
e
c
n
a
t
s
b
u
s

l
a
n
i
c
i
d
e
m

r
e
h
t
o

d
n
a

s
t
a
t
s
o
i
d
i
c
c
o
C