Commission Regulation (EC) No 1446/2006 of 29 September 2006 concerning the authorisation of Enterococcus faecium (Biomin IMB52) as a feed additive   (Text with EEA relevance)
Date: 2006-09-29
Institutions: European Commission
Subjects: fattening, food additive, foodstuffs legislation, market approval, poultry, zootechnics

30.9.2006

EN

Official Journal of the European Union

L 271/25

COMMISSION REGULATION (EC) No 1446/2006

of 29 September 2006
concerning the authorisation of Enterococcus faecium (Biomin IMB52) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

2004 on official controls performed to ensure the veri-
fication of compliance with feed and food law, animal
health and animal welfare rules (2).

Having regard to the Treaty
Community,

establishing the European

(5)

Having regard to Regulation (EC) No 1831/2003 of
the
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition (1), and in
particular Article 9(2) thereof,

Whereas:

Regulation (EC) No 1831/2003 provides for the author-
isation of additives for use in animal nutrition and for
the grounds and procedures for granting such authori-
sation.

In accordance with Article 7 of Regulation (EC) No
1831/2003, an application was submitted for the author-
isation of the preparation set out in the Annex. That
application was accompanied by the particulars and
documents required under Article 7(3) of that Regulation.

The application concerns authorisation of the preparation
Enterococcus faecium (Biomin IMB52) a feed additive for
chickens for fattening, to be classified in the additive
category ‘zootechnical additives’.

(6)

(1)

(2)

(3)

(4)

for

fattening.

faecium DSM
the preparation Enterococcus
The use of
3530 was already authorised for calves up to six
months of age by Commission Regulation (EC) No
418/2001 of 1 March 2001 concerning the authorisation
of new additives and uses of additives in feedingstuffs (3).
New data were submitted in support of an application
for authorisation for chickens
In its
assessment,
the European Food Safety Authority (the
Authority) concludes that the safety of this additive for
the consumer, the user and the environment have already
been established and will not be changed by the
proposed new use. It further concludes that the use of
the preparation does not have an adverse effect on this
additional animal category and that
that
preparation can improve the zootechnical parameters in
chickens for fattening. It does not consider that there is a
need for specific requirements of post-market moni-
toring. The opinion of the Authority recommends appro-
priate measures for user safety. This opinion also verifies
the report on the method of analysis of the feed additive
in feed
the Community Reference
Laboratory set up by Regulation (EC) No 1831/2003.
The assessment of
the
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
Accordingly,
that preparation should be
the use of
authorised, as specified in the Annex to this Regulation.

that preparation shows

submitted by

the use of

that

are

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:

The method of analysis included in the application for
authorisation in accordance with Article 7(3)(c) of Regu-
lation (EC) No 1831/2003 concerns the determination of
the active substance of the feed additive in feed. The
method of analysis referred to in the Annex to this
Regulation is
to be understood as a
Community method of analysis within the meaning of
the
Article 11 of Regulation (EC) No 882/2004 of
European Parliament and of the Council of 29 April

therefore not

Article 1

The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘gut
is authorised as an additive in
animal nutrition subject to the conditions laid down in that
Annex.

flora stabilisers’,

(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 165, 30.4.2004, as corrected by OJ L 191, 28.5.2004, p. 1.
amended by Commission Regulation (EC) No

Regulation as
776/2006 (OJ L 136, 24.5.2006, p. 3).

(3) OJ L 62, 2.3.2001, p. 3.

L 271/26

EN

Official Journal of the European Union

30.9.2006

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 2

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

Done at Brussels, 29 September 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

30.9.2006

EN

Official Journal of the European Union

L 271/27

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

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

f
f
u
t
s
g
n
d
e
e
f

i

e
t
e
l
p
m
o
c

f
o

g
k
/
U
F
C

%
2
1

f
o

t
n
e
t
n
o
c

e
r
u
t
s
i
o
m
a

h
t
i

w

X
E
N
N
A

e
g
a

m
u
m
i
x
a
M

l
a
m
n
a

i

f
o

y
r
o
g
e
t
a
c

d
o
h
t
e
m

l
a
c
i
t
y
l
a
n
a

,

n
o
i
t
p
i
r
c
s
e
d

r
o

s
e
i
c
e
p
S

,

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

e
v
i
t
i
d
d
A

)
e
m
a
n

e
d
a
r
T

(

e
h
t

f
o

e
m
a
N

f
o

r
e
d
o
h

l

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

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

f
o

r
e
b
m
u
n

e
v
i
t
i
d
d
a

e
h
t

.
s
r
e
s
i
l
i
b
a
t
s

a
r
o
l
f

t
u
g

:

p
u
o
r
g

l
a
n
o
i
t
c
n
u
F

.
s
e
v
i
t
i
d
d
a

l
a
c
i
n
h
c
e
t
o
o
z

f
o

y
r
o
g
e
t
a
C

-
i
c
c
o
c

d
e
t
t
i

m
r
e
p

e
h
t

i

g
n
n
i
a
t
n
o
c

r
o

i

m
u
d
o
s

n
i
s
n
e
n
o
m

:
s
t
a
t
s
o
d

i

d
e
e
f

n

i

d
e
t
t
i

m
r
e
p

s
i

e
s
u

e
h
T

.

n
i
z
a
b
r
a
c
i
n
-
n
i
s
a
r
a
n

d
n
a

g
n

i
l

d
n
a
h

g
n
i
r
u
d

n
o
i
t
c
e
t
o
r
p

i

g
n
h
t
a
e
r
b

:

y
t
e
f
a
s

r
e
s
u

r
o
F

.
s
e
s
s
a
l
g

y
t
e
f
a
s

e
h
t

m
o
r
f

s
r
a
e
y

0
1

o
t
n

i

y
r
t
n
e

f
o

e
t
a
d

-
u
g
e
R

s
i
h
t

f
o

e
c
r
o
f

n
o
i
t
a
l

e
t
a
c
i
d
n

i

,
e
r
u
t
x
i
m
e
r
p

d
n
a

e
v
i
t
i
d
d
a

e
h
t

f
o

e
s
u

r
o
f

s
n
o
i
t
c
e
r
i
d

e
h
t

n
I

e
g
a
r
o
t
s

,
e
r
u
t
a
r
e
p
m
e
t

e
g
a
r
o
t
s

.

g
n
i
t
e
l
l
e
p

o
t

y
t
i
l
i

b
a
t
s

d
n
a

e
h
t

e
f
i
l

9
0
1
×
5
2

,

8
0
1
×
5

—

r
o
f

s
n
e
k
c
i
h
C

i

g
n
n
e
t
t
a
f

)
e
d
a
r
g

d
o
o
f
(

s
t
a
f

d
e
t
a
n
e
g
o
r
d
y
H

%
5
–

/
+

0
5

e
v
i
t
c
a

e
h
t

f
o

n
o
i
t
a
s
i
r
e
t
c
a
r
a
h
C

-
r
o
o
r
c
i
m

e
l
b
a
i
v

f
o

e
r
u
t
l
u
c

e
r
u
P

:

e
c
n
a
t
s
b
u
s

)

0
3
5
3

M
S
D

a
i
r
e
t
c
a
b

d
i
c
a

c
i
t
c
a
l
(

s

m

s
i
n
a
g

m
u
i
c
e
a
f

s
u
c
c
o
c
o
r
e
t
n
E

f
o

n
o
i
t
a
r
a
p
e
r
p

g
/
U
F
C

d
o
o
f
(

r
e
d
w
o
p

k

l
i

%
5
–

/
+

%
5
–

/
+

m

d
e
m
m
k
S

i

e
v
i
t
i
d
d
a

5
1

e
s
o
c
u
G

l

0
1

)
e
d
a
r
g

1
1
0
1
×
0
1

,

0
3
5
3

M
S
D

:

n
o
i
t
i
s
o
p
m
o
c

m
u
i
c
e
a
f

s
u
c
c
o
c
o
r
e
t
n
E

e
v
i
t
i
d
d
A

f
o

t
n
e
t
n
o
c

m
u
m
n
m

i

i

h
t
i

w

)

2
5
B
M

I

i

n
m
o
B

i

(

0
3
5
3

M
S
D

m
u
i
c
e
a
f

s
u
c
c
o
c
o
r
e
t
n
E

H
b
m
G

i

n
m
o
B

i

0
5
8
1
b
4

e
d
i
z
a

n

i
l

u
c
s
e

e
l
i

b

g
n
i
s
u

d
o
h
t
e
m

e
t
a
l
p

d
a
e
r
p
s

n
o
i
t
a
r
e
m
u
n
E

)
1
(

d
o
h
t
e
m

l
a
c
i
t
y
l
a
n
A

.
r
a
g
a

/
a
a
f
l
r
c
/
l

m
t
h
/
e
b
.
c
r
j
.

m
m

r
i
.

w
w
w

:

y
r
o
t
a
r
o
b
a
L

e
c
n
e
r
e
f
e
R

y
t
i
n
u
m
m
o
C

e
h
t

f
o

s
s
e
r
d
d
a

i

g
n
w
o

l
l

o
f

e
h
t

t
a

e
l
b
a
l
i
a
v
a

e
r
a

s
d
o
h
t
e
m

l
a
c
i
t
y
l
a
n
a

e
h
t

f
o

s
l
i
a
t
e
D

)
1
(