Commission Regulation (EC) No 497/2007 of 4 May 2007 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (Text with EEA relevance )
Date: 2007-05-04
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, swine, zootechnics

5.5.2007

EN

Official Journal of the European Union

L 117/11

COMMISSION REGULATION (EC) No 497/2007

of 4 May 2007

concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 to this
Regulation. That application was accompanied by the
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.

(6)

(7)

by

fattening
(EC) No
943/2005 (3) and without a time limit for laying hens
by Commission Regulation (EC) No 1810/2005 (4).

Commission

Regulation

EC

the

3.2.1.8

produced

environment (5).

New data were submitted in support of an application
for authorisation for piglets (weaned). The European
Food Safety Authority (the Authority) concluded in its
opinion of 17 October 2006 that the preparation of
by
endo-1,4-beta-xylanase
Trichoderma longibrachiatum (CNCM MA 6-10)
(Safizym
X) does not have an adverse effect on animal health,
further
human health or
concluded that that preparation does not present any
other risk which would, in accordance with Article 5(2)
of Regulation (EC) No 1831/2003, exclude authorisation.
According to that opinion, the use of that preparation
does not have an adverse effect on these additional
animal categories. The Authority does not consider that
there is a need for specific requirements of post market
monitoring. It also verified the report on the method of
analysis of the feed additive in feed submitted by the
Community Reference Laboratory set up by Regulation
(EC) No 1831/2003.

It

that preparation shows

The assessment of
the
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
that preparation should be
the use of
Accordingly,
authorised, as specified in the Annex to this Regulation.

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

The application concerns a new use of the preparation of
by
endo-1,4-beta-xylanase
Trichoderma longibrachiatum (CNCM MA 6-10)
(Safizym
X), as a feed additive for piglets (weaned), to be classified
in the additive category ‘Zootechnical additives’.

produced

3.2.1.8

EC

The use of endo-1,4-beta-xylanase EC 3.2.1.8 produced
by Trichoderma longibrachiatum (CNCM MA 6-10) was
a
authorised without
for
time
(EC) No
fattening
Commission
1453/2004 (2), without a time limit
turkeys for

limit
Regulation
for

chickens

for

by

(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 269, 17.8.2004, p. 3.

HAS ADOPTED THIS REGULATION:

Article 1

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

(3) OJ L 159, 22.6.2005, p. 6.
(4) OJ L 291, 5.11.2005, p. 5. Regulation as amended by Regulation

(EC) No 184/2007 (OJ L 63, 1.3.2007, p. 1).

(5) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
enzyme preparation Safizym X (endo-1,4-beta-xylanase) as feed
additive
in accordance with Regulation (EC) No
1831/2003. Adopted on 17 October 2006, The EFSA Journal
(2006) 405, 1-10.

for piglets

(1)

(2)

(3)

(4)

L 117/12

EN

Official Journal of the European Union

5.5.2007

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, 4 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

5.5.2007

EN

Official Journal of the European Union

L 117/13

d
o
i
r
e
p

f
o

d
n
E

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

f
o

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
o

g
k
/
y
t
i
v
i
t
c
a

f
o

t
i
n
U

a

h
t
i

w

f
f
u
t
s
g
n
d
e
e
f

i

e
t
e
l
p
m
o
c

%
2
1

f
o

t
n
e
t
n
o
c

e
r
u
t
s
i
o
m

X
E
N
N
A

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

,

n
o
i
t
p
i
r
c
s
e
d

,

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

d
o
h
t
e
m

l
a
c
i
t
y
l
a
n
a

e
v
i
t
i
d
d
A

)
e
m
a
n

e
d
a
r
T

(

f
o

e
m
a
N

f
o

r
e
d
o
h

l

e
h
t

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
c
n
a
h
n
e

y
t
i
l
i
b
i
t
s
e
g
i
d

:

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

7
1
0
2
5
5
2

.

.

,
e
r
u
t
x
i
m
e
r
p

d
n
a

e
v
i
t
i
d
d
a

e
h
t

-
r
e
p
m
e
t

y
t
i
l
i

b
a
t
s

d
n
a

,
e
f
i
l

e
g
a
r
o
t
s

,
e
r
u
t
a

e
g
a
r
o
t
s

e
h
t

e
t
a
c
i
d
n

i

f
o

e
s
u

r
o
f

s
n
o
i
t
c
e
r
i
d

e
h
t

n
I

.

1

.

g
n
i
t
e
l
l
e
p

o
t

:
f
f
u
t
s
g
n
d
e
e
f

i

e
t
e
l
p
m
o
c

f
o

m
a
r
g

-
o

l
i

k

r
e
p

e
s
o
d

d
e
d
n
e
m
m
o
c
e
R

.

2

.

P
F
I

0
8
6
1

o
t

p
u

)
d
e
n
a
e
w

(

s
t
e
l
g
i
p

.
t
h
g
i
e
w

y
d
o
b

f
o

g
k

r
o
F

5
3

.

3

s
e
d
i
r
a
h
c
c
a
s
y
l
o
p

h
c
r
a
t
s
-
n
o
n

n

i

.

g
.
e

%
0
2

,
)
s
n
a
l
y
x
o
n
b
a
r
a

i

y
l
n
i
a
m

(

n
a
h
t

e
r
o
m

i

g
n
n
i
a
t
n
o
c

h
c
i
r

d
e
e
f

d
n
u
o
p
m
o
c

n

i

e
s
u

r
o
F

.

4

.
t
a
e
h
w

P
F
I

0
4
8

—

)
d
e
n
a
e
w

(

s
t
e
l
g
i
P

e
s
a
n
a
l
y
x
-
a
t
e
b
-
4
1
-
o
d
n
e

,

f
o

n
o
i
t
a
r
a
p
e
r
P

m
u
t
a
i
h
c
a
r
b
i
g
n
o
l

a
m

r
e
d
o
h
c
i
r
T

y
b

d
e
c
u
d
o
r
p

a

g
n
i
v
a
h

)

W
0
1
-
6

A
M

M
C
N
C

(

:
f
o

y
t
i
v
i
t
c
a

m
u
m
n
m

i

i

y
b

d
e
c
u
d
o
r
p

e
s
a
n
a
l
y
x
-
a
t
e
b
-
4
1
-
o
d
n
e

,

A
M

M
C
N
C

(

m
u
t
a
i
h
c
a
r
b
i
g
n
o
l

a
m

r
e
d
o
h
c
i
r
T

)
2
(

d
o
h
t
e
m

l
a
c
i
t
y
l
a
n
A

)

W
0
1
-
6

,

-
a
t
e
b
-
4
1
-
o
d
n
e

r
o
f

y
a
s
s
a

r
a
g
u
s

g
n
i
c
u
d
e
R

f
o

n
o

n
o
i
t
c
a
e
r

c
i
r
t
e
m

i
r
o
o
c

l

y
b

e
s
a
n
a
l
y
x

t
n
e
g
a
e
r

d
i
c
a

c
i
l
y
c
i
l
a
s
o
r
t
i
n
d

i

.

d
l
e
i
y

r
a
g
u
s

g
n
i
c
u
d
e
r

g
/
)
1
(

P
F
I

0
0
0
0
7

:

m
r
o
f

r
e
d
w
o
P

l

m
/
P
F
I

0
0
0
7

:

m
r
o
f

i

d
u
q
i
L

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

:

e
c
n
a
t
s
b
u
s

)

X

m
y
z
i
f
a
S
(

.

8
1
2
3

.

.

C
E

:

n
o
i
t
i
s
o
p
m
o
c

e
v
i
t
i
d
d
A

e
s
a
n
a
l
y
x
-
a
t
e
b
-
4
1
-
o
d
n
E

,

e
l
l
e
i
r
t
s
u
d
n
I

e
r
f
f
a
s
e
L

é
t
é
i
c
o
S

3
1
6
1
a
4

.

C

°
0
5

d
n
a

8
4

,

H
p

t
a

e
t
u
n
m

i

r
e
p

n
a
l
y
x

t
a
o

m
o
r
f

)
s
t
n
e
l
a
v
i
u
q
e

e
s
o
l
y
x
(

s
r
a
g
u
s

g
n
i
c
u
d
e
r

f
o

e
l
o
m
o
r
c
i
m

1

s
e
t
a
r
e
b

i
l

h
c
i
h
w

e
m
y
z
n
e

f
o

t
n
u
o
m
a

e
h
t

s
i

P
F
I

1

/
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
(

)
2
(