Commission Regulation (EC) No 261/2003 of 12 February 2003 concerning the provisional authorisation of new uses of additives in feedingstuffs (Text with EEA relevance)
Date: 2003-02-12
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food inspection, foodstuffs legislation

L 37/12

EN

Official Journal of the European Union

13.2.2003

COMMISSION REGULATION (EC) No 261/2003

of 12 February 2003

concerning the provisional authorisation of new uses of additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Regulation (EC) No 1756/2002 (2), and in parti-
cular Articles 3 and 9e thereof,

Whereas:

(1)

(2)

(3)

(4)

Directive 70/524/EEC provides that a new use of an
additive
a Community
authorisation in accordance with Article 4 of the Direc-
tive.

already authorised requires

is reasonable to assume,

Directive 70/524/EEC provides that provisional authori-
sation of a new additive for use in feedingstuffs or a new
use of an additive already authorised may be given if the
conditions laid down in that Directive are satisfied and if
it
the available
results, that when used in animal nutrition it has one of
the effects referred to in Article 2(a) of that Directive.
Such provisional authorisation may be given for a period
not exceeding four years in the case of additives referred
to in Part II of Annex C to that Directive.

in view of

New data were submitted by the producing companies
in support of application to extend the authorisation of
the two preparations of the enzymes set out in Annex I
and II to this Regulation, and which are listed under
Numbers 50 and 51 in the Annexes to Directive 70/
524/EEC, to new animal categories.

The assessments of the applications for authorisation
submitted in respect of the new use of the preparations
of the enzymes set out in Annex I and II, show that the

conditions referred to in Article 9e(1) of Directive 70/
524/EEC are satisfied, and the extensions of use should
therefore be authorised on a provisional basis for a
period of four years.

The assessments of
the applications also show that
certain procedures may be required to protect workers
from exposure to the additives set out in Annexes I and
II. Such protections should however be assured by the
application of Council Directive 89/391/EEC of 12 June
1989 on the introduction of measures to encourage
improvements in the safety and health of workers at
work (3).

The Scientific Committee for Animal Nutrition has deliv-
ered favourable opinions with regard to the safety of
those preparations, under the conditions set out in the
Annexes to this Regulation.

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

(5)

(6)

(7)

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘Enzymes’
listed in
Annex I and II are authorised for use as additives in animal
nutrition under the conditions laid down in these Annexes.

Article 2

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

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

Done at Brussels, 12 February 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.

(3) OJ L 183, 29.6.1989, p. 1.

ANNEX I

Additive

Chemical formula, description

Species
or category
of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg
of complete feedingstuff

Other provisions

End of period
of authorisation

No
(or EC No)

Enzymes

50

6-phytase
EC 3.1.3.26

Preparation of 6-phytase produced by
Aspergillus oryzae (DSM 11857) having
a minimum activity of:

Sows

—

750 FYT

—

Coated form:
2 500 FYT/g (1)

Liquid form:
5 000 FYT/g

—

—

(1) 1 FYT is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C.

1. In the directions for use of the addi-
indicate the
storage life,

tive and premixture,
storage temperature,
and stability to pelleting

1.2.2007

2. Recommended dose per kg of
750-

feedingstuff:

complete
1 000 FYT

3. For

in

use

feed
containing more than 0,25 % phytin
bound phosphorus

compound

.

.

1
3
2
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

L

3
7
/
1
3

Additive

Chemical formula, description

No
(or EC No)

Enzymes

ANNEX II

Species
or category
of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg of complete
feedingstuff

51

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase
EC 3.2.1.8 produced by Bacillus subtilis
(LMG S-15136) having a minimum
activity of:

Pigs for
fattening

10 IU

Endo-1,4-beta-xylanase:

100 IU/g (1)

(1) 1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.

Other provisions

End of period of
authorisation

1.1.2007

1. In the directions for use of the addi-
indicate the
storage life,

tive and premixture,
storage temperature,
and stability to pelleting

2. Recommended dose per kilogram of

complete feedingstuff:

Endo-1,4-beta-xylanase: 10 IU/kg

3. For use in compound feed rich in
arabinoxylans e.g. minimum 40 %
wheat or barley

L

3
7
/
1
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
3
2
2
0
0
3