Commission Regulation (EC) No 101/2009 of 3 February 2009 amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed additive Cycostat 66G (Text with EEA relevance)
Date: 2009-02-03
Institutions: European Commission
Subjects: animal nutrition, food additive, veterinary drug, veterinary legislation

4.2.2009

EN

Official Journal of the European Union

L 34/5

COMMISSION REGULATION (EC) No 101/2009

of 3 February 2009

amending Regulation (EC) No 1800/2004 as regards the terms of the authorisation of the feed
additive Cycostat 66G

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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,

(4)

Whereas:

In its opinion adopted on 16 September 2008 (4), the
Authority concluded that, based on safety considerations,
there is no necessity for setting a withdrawal period for
chickens for fattening and consequently for MRLs.
It
came to the same conclusions concerning turkeys.
suggested
However,
values. It further proposed to maintain the five-day with­
drawal period, to avoid off-flavours in edible tissues from
poultry treated with Cycostat 66G.

in case MRLs are

required,

it

To ensure a high level of safety for the consumers and to
improve the control of the correct use of Cycostat 66G,
it is appropriate to establish MRLs as proposed by the
Authority. To keep acceptable organoleptic properties of
meat, the withdrawal period should be maintained at five
days.

(1)

(2)

substances, was

authorised under

The additive robenidine hydrocloride 66 g/kg (Cycostat
66G), hereinafter referred to as Cycostat 66G, linked to
the holder of authorisation, Alpharma (Belgium) BVBA,
belonging to the group of coccidiostats and other
medicinal
certain
accordance with Council Directive
in
conditions
70/524/EEC (2).
(EC) No
Commission
1800/2004 (3) authorised that additive for 10 years for
use for chickens for fattening, turkeys and rabbits for
fattening. That additive was notified as an existing
product
in accordance with 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

Regulation (EC) No 1831/2003 provides for the possi­
bility of modifying the authorisation of an additive
further to a request from the holder of the authorisation
and an opinion of the European Food Safety Authority
(the Authority). Alpharma (Belgium) BVBA, holder of the
authorisation of Cycostat 66G, has submitted an appli­
cation with which it proposes changing the conditions of
the authorisation for chickens for
fattening and for
turkeys by introducing a maximum residue limit (MRL)
and by modifying the withdrawal period, as evaluated by
the same time it provided data to
the Authority. At
support that request.

(1) OJ L 268, 18.10.2003, p. 29.
(2) OJ L 270, 14.12.1970, p. 1.
(3) OJ L 317, 16.10.2004, p. 37.

(5)

Regulation (EC) No 1800/2004 should therefore be
amended accordingly.

(6)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 1800/2004 is replaced by the
Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

(4) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on a proposal for Maximum Residue Limits
and withdrawal period for Cycostat 66G for chickens for fattening
and turkeys for fattening. The EFSA Journal (2008) 798, 1-15.

L 34/6

EN

Official Journal of the European Union

4.2.2009

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

Done at Brussels, 3 February 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

4.2.2009

EN

Official Journal of the European Union

L 34/7

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
4

.

4
1
0
2
0
1
9
2

.

e
v
i
f

t
s
a
e
l

t
a

d
e
t
i
b
h
o
r
p

i

e
s
U

6
3

0
3

—

s
y
e
k
r
u
T

.

y
e
n
d
k

i

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
2

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
4

.
r
e
v
i
l

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

.
t
a
f
/
n
k
s

i

f
o

g
k
/
e
d
i
r
o
h
c

l

.
r
e
t
h
g
u
a
l
s

e
r
o
f
e
b

s
y
a
d

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
2

—

.
e
l
c
s
u
m

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

.

4
1
0
2
0
1
9
2

.

.
r
e
t
h
g
u
a
l
s

e
r
o
f
e
b

s
y
a
d

e
v
i
f

t
s
a
e
l

t
a

d
e
t
i
b
h
o
r
p

i

e
s
U

6
6

0
5

—

s
t
i
b
b
a
R

r
o
f

i

g
n
n
e
t
t
a
f

l

,
e
d
i
r
o
h
c
o
r
d
y
h

i

i

e
n
d
n
e
b
o
R

,
l

C
H

.

5
N
2
l
C
3
1
H
5
1
C

)
e
n
e
d

l

i
l
y
z
n
e
b
o
r
o
h
c
-
p
(
[
s
i
b
-
3
1

,

,

7
-
0
5
-
5
7
8
5
2

:
r
e
b
m
u
n

S
A
C

:
s
e
i
t
i
r
u
p
m

i

d
e
t
a
l
e
R

,
e
d
i
r
o
h
c

l

­
o
r
d
y
h

i

i

e
n
d
n
a
u
g
-
]
o
n
m
a

i

­
e
d

i
l
y
z
n
e
b
-
l
C
-
p
(
[
s
i
r
T
-

″

N

,

′

N
N

,

%
5
0
≤

,

i

i

:
e
n
d
n
a
u
g
]
o
n
m
a
)
e
n

i

­
a
r
d
y
h
]
e
n
e
d

i
l
y
z
n
e
b
-
l
C
-
4
[
-
s
i
B

%
5
0
≤

,

:
e
n
i
z

)
s
L
R
M

(

s
t
i

m
i
L

e
u
d
i
s
e
R

m
u
m
i
x
a
M

f
o

s
f
f
u
t
s
d
o
o
f

t
n
a
v
e
l
e
r

e
h
t

n

i

n
i
g
i
r
o

l
a
m
n
a

i

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

r
o

s
e
i
c
e
p
S

f
o

y
r
o
g
e
t
a
c

l
a
m
n
a

i

,

a
l
u
m
r
o
f

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

e
v
i
t
i
d
d
A

)
e
m
a
n

e
d
a
r
T

(

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

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

r
o
f

e
l
b
i
s
n
o
p
s
e
r

e
v
i
t
i
d
d
a

g
n
i
t
t
u
p

n
o
i
t
a
l
u
c
r
i
c

o
t
n

i

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

f
o

r
e
b
m
u
n

e
v
i
t
i
d
d
a

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
3
1

.
t
a
f
/
n
k
s

i

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
2

.
e
l
c
s
u
m

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

.

y
e
n
d
k

i

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
5
3

.
r
e
v
i
l

t
e
w

f
o

g
k
/
e
d
i
r
o
h
c

l

.
r
e
t
h
g
u
a
l
s

e
r
o
f
e
b

s
y
a
d

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
r

g

μ

0
0
8

.

4
1
0
2
0
1
9
2

.

e
v
i
f

t
s
a
e
l

t
a

d
e
t
i
b
h
o
r
p

i

e
s
U

6
3

0
3

—

s
n
e
k
c
i
h
C

r
o
f

i

g
n
n
e
t
t
a
f

l

:
e
d
i
r
o
h
c
o
r
d
y
h

i

i

e
n
d
n
e
b
o
R

g
k
/
g
6
6

e
d
i
r
o
h
c

l

:
e
t
a
r
d
y
h
d

i

e
t
a
f
l
u
s

m
u
i
c
l
a
C

g
k
/
g
4
9
8

g
k
/
g
0
4

:
e
t
a
n
o
f
l
u
s
o
n
g
i
L

:
e
c
n
a
t
s
b
u
s

e
v
i
t
c
A

g
k
/
g
6
6

)

G
6
6

t
a
t
s
o
c
y
C

(

:

n
o
i
t
i
s
o
p
m
o
c

e
v
i
t
i
d
d
A

­
o
r
d
y
h

i

i

e
n
d
n
e
b
o
R

a
m
r
a
h
p
A

l

)

m
u
i
g
l
e
B

(

A
B
V
B

8
5
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