Commission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive (Text with EEA relevance)
Date: 2008-06-17
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, market approval, poultry, swine

L 158/14

EN

Official Journal of the European Union

18.6.2008

COMMISSION REGULATION (EC) No 554/2008

of 17 June 2008

concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive

(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 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 authorisa-
tion.

and on 30 January 2008 (2) that the enzyme preparation
6-phytase (Quantum Phytase) produced by Pichia pastoris
(DSM 15927) does not have an adverse effect on
animals, consumers, or the environment and that it is
efficacious in improving digestibility of
feedingstuffs,
based on the data provided by the applicant. It further
is a mild irritant and a
concluded that
dermal
it may be a potential
respiratory sensitiser. The Authority does not consider
that there is a need for specific requirements of post-
It also verified the report on the
market monitoring.
in feed
feed additive
the
method of
submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003.

the product
and that

analysis of

sensitiser

that

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 a digestibility enhancer, as specified in
the Annex to this Regulation. Measures
should be
provided for the protection of users from the risks
identified in the opinion of the Authority.

are

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

opinion

the

the

of

(5)

(6)

In accordance with Article 7 of Regulation (EC)
No 1831/2003, an application was submitted for the
authorisation of the preparation set out in the Annex
to this Regulation. That application was accompanied
by the particulars
required under
Article 7(3) of Regulation (EC) No 1831/2003.

and documents

HAS ADOPTED THIS REGULATION:

The application concerns authorisation of the enzyme
preparation 6-phytase (Quantum Phytase) produced by
Pichia pastoris
(DSM 15927) as a feed additive for
chickens
for
fattening,
for
fattening, ducks for fattening and piglets (weaned), to
category ‘zootechnical
be
additive
additives’.

classified in the

turkeys

laying

hens,

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.

Article 2

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

(4)

The European Food Safety Authority (the Authority)
concluded in its opinion adopted on 1 February 2007

(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) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) and of the Panel on
Genetically Modified Organisms (GMO) on ‘Safety and efficacy of
the product Quantum Phytase 5000 L and Quantum Phytase 2500
D (6-phytase) as a feed additive for chickens for fattening,
laying
hens, turkeys for fattening, ducks for fattening and piglets (weaned)’.
The EFSA Journal (2008) 627, pp. 1-27.

(1)

(2)

(3)

18.6.2008

EN

Official Journal of the European Union

L 158/15

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

Done at Brussels, 17 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 158/16

EN

Official Journal of the European Union

18.6.2008

f
o

d
n
E

f
o

d
o
i
r
e
p

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

8
1
0
2
7
8

.

.

e
h
t

d
n
a

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
f
i
l

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

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

.

1

f
o

m
a
r
g
o

l
i

k

g
n
i
t
e
l
l
e
p

o
t

y
t
i
l
i

b
a
t
s

r
e
p

e
s
o
d

d
e
d
n
e
m
m
o
c
e
R

.

2

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

i

e
t
e
l
p
m
o
c

:

i

g
n
n
e
t
t
a
f

r
o
f

s
n
e
k
c
i
h
c

U
T
F

0
0
5
2
-
0
0
5

U
T
F

0
0
0
2

:
s
n
e
h

g
n
i
y
a
l

:

i

g
n
n
e
t
t
a
f

r
o
f

s
k
c
u
d

U
T
F

0
0
0
2
-
0
5
2

:

i

g
n
n
e
t
t
a
f

r
o
f

s
y
e
k
r
u
t

U
T
F

0
0
7
2
-
0
0
0
1

:
)
d
e
n
a
e
w

(

s
t
e
l
g
i
p

U
T
F

0
0
5
2
-
0
0
1

—

—

—

—

—

i

g
n
n
i
a
t
n
o
c

d
e
e
f

d
n
u
o
p
m
o
c

n

i

e
s
u

r
o
F

.

3

d
n
u
o
b
-
n
i
t
y
h
p

%
5
2
0

,

n
a
h
t

e
r
o
m

s
u
r
o
h
p
s
o
h
p

l
i
t
n
u

s
t
e
l
g
i
p

d
e
n
a
e
w

n

i

e
s
u

r
o
F

.

4

g
k
5
3

y
l
e
t
a
m
i
x
o
r
p
p
a

d
e
s
u

e
b

l
l
a
h
s

s
e
v
o
l
g

d
n
a

g
n

i
l

d
n
a
h

s
e
s
s
a
l
g

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
o
F

.

5

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

s
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

e
g
a

m
u
m
i
x
a
M

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

(

r
e
d
o
h

l

e
h
t

f
o

e
m
a
N

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

f
o

-
i
f
i
t
n
e
d
I

n
o
i
t
a
c

f
o

r
e
b
m
u
n

e
h
t

e
v
i
t
i
d
d
a

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

—

—

—

—

—

U
T
F

0
0
5

U
T
F

0
0
0
2

U
T
F

0
5
2

U
T
F

0
0
0
1

U
T
F

0
0
1

—

—

—

—

—

s
n
e
k
c
i
h
C

r
o
f

i

g
n
n
e
t
t
a
f

g
n
i
y
a
L

s
n
e
h

r
o
f

s
k
c
u
D

i

g
n
n
e
t
t
a
f

r
o
f

s
y
e
k
r
u
T

i

g
n
n
e
t
t
a
f

s
t
e
l
g
i
P

)
d
e
n
a
e
w

(

s
i
r
o
t
s
a
p

a
i

h
c
i
P

m
u
m
n
m

i

i

y
b

d
e
c
u
d
o
r
p

e
s
a
t
y
h
p
-
6

a

g
n
i
v
a
h

)

7
2
9
5
1

M
S
D

(

:
f
o

y
t
i
v
i
t
c
a

s
i
r
o
t
s
a
p

a
i

h
c
i
P

y
b

d
e
c
u
d
o
r
p

e
s
a
t
y
h
p
-
6

e
c
n
a
t
s
b
u
s

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

)
2
(

d
o
h
t
e

m

l
a
c
i
t
y
l
a
n
A

)

7
2
9
5
1

M
S
D

(

n
o
i
t
c
a
e
r

n
o

d
e
s
a
b

d
o
h
t
e
m

c
i
r
t
e
m

l

i
r
o
o
C

a

n
o

n
o
i
t
c
a
e
r

c
i
n
a
g
r
o

n
o

y
b

e
t
a
d
b
y
l
o
m
o
d
a
n
a
v

f
o

d
e
c
u
d
o
r
p

e
t
a
h
p
s
o
h
p

i

m
u
d
o
s
(

e
t
a
r
t
s
b
u
s

i

g
n
n
a
t
n
o
c
-
e
t
a
t
y
h
p

.

C

°
7
3

d
n
a

,

5
5
H
p

t
a

)
e
t
a
h
p
s
o
h
p

)
1
(

g
/
U
T
F

0
0
5
2

:

m
r
o
f

d

i
l

o
S

l

/

m
U
T
F

0
0
0
5

:

m
r
o
f

i

d
u
q
i
L

e
s
a
t
y
h
P

m
u
t
n
a
u
Q

(

D

0
0
5
2

e
s
a
t
y
h
P

m
u
t
n
a
u
Q

)
L

0
0
0
5

.

6
2
3
1
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
t
y
h
p
-
6

e
m
y
z
n
E

B
A

H
b
m
G

5
a
4

s
e
v
i
t
i
d
d
a
-
d
e
e
f
-
l
r
c
/
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

.

C

°
7
3

d
n
a

,

5
5
H
p

t
a

e
t
a
t
y
h
p

i

m
u
d
o
s

m
o
r
f

e
t
u
n
m

i

r
e
p

e
t
a
h
p
s
o
h
p

c
i
n
a
g
r
o
n

i

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

U
T
F

1

)
1
(

)
2
(