Commission Regulation (EC) No 2188/2002 of 9 December 2002 concerning the provisional authorisation of new uses of additives in feedingstuffs (Text with EEA relevance)
Date: 2002-12-09
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food inspection, foodstuffs legislation

10.12.2002

EN

Official Journal of the European Communities

L 333/5

COMMISSION REGULATION (EC) No 2188/2002

of 9 December 2002

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 Commission Regulation (EC) No 1756/2002 (2),
and in particular Articles 3 and 9e thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Directive 70/524/EEC provides that a new use in the
case of an already authorised additive
requires a
Community authorisation in accordance with Article 4
of the Directive.

Article 9e(1) of Directive 70/524/EEC provides that
provisional authorisation of a new additive for use in
feedingstuffs or a new use of an additive already
authorised may be given if the conditions of Article
3a(b) to (e) of that Directive are satisfied, and if it is
reasonable to assume, in view of 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 of
up to four years in the case of additives referred to in
Part II of Annex C to Directive 70/524/EEC.

New data were submitted by the producing companies
to extend the authorisation of the two preparations of
enzymes described in Annex I and II to this Regulation,
and which are listed respectively under No 11 and 51 in
the Annexes to Directive 70/524/EEC, to new animal
categories.

The assessment of the dossiers submitted in respect of
the new use of the preparations of enzymes described in
Annex I and II shows that the conditions referred to in
Article 9e(1) are satisfied, and the extensions of use may
therefore be authorised on a provisional basis for a
period of four years.

New data were submitted by the producing company to
extend the authorisation of an enzyme preparation
described in Annex III to this Regulation, and which is
listed under No 51 in the Annexes to Directive 70/524/
EEC, to a new physical
form as regards one animal
category.

(6)

(7)

(8)

(9)

The assessment of the dossier submitted in respect of the
the preparation of enzyme described in
new use of
Annex III shows that the conditions referred to in Article
9e(1) are satisfied, and the extension of use may there-
fore be authorised on a provisional basis for a period of
four years.

The assessment of the dossier also shows that certain
procedures may be required to protect workers from
exposure to the additives listed in the Annexes. Such
protection should however be assured by the application
of Council Directive 89/391/EEC of 12 June 1989 on
the introduction of measures to encourage improve-
ments in the safety and health of workers at work (3).

On 18 April and 19 June 2002 the Scientific Committee
for Animal Nutrition has delivered favourable opinions
with regard to the safety of
the abovementioned
enzymes preparations, under the conditions described 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,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

The preparation belonging to the group ‘Enzymes’
listed in
Annex III to this Regulation is authorised for use as additive in
animal nutrition under the conditions laid down in this Annex.

Article 3

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

(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.

L 333/6

EN

Official Journal of the European Communities

10.12.2002

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

Done at Brussels, 9 December 2002.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

Additive

Chemical formula, description

Species or cate-
gory 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

Laying hens

—

11

Endo-1,4-beta-glucanase
EC 3.2.1.4

Endo-1,3(4)-beta-glucanase
EC 3.2.1.6

Endo-1,4-beta-xylanase
EC 3.2.1.8

of

Preparation
endo-1,4-beta-
glucanase, endo-1,3(4)-beta-gluca-
nase, and endo-1,4-beta-xylanase
produced by Trichoderma longibra-
chiatum (ATCC 74252) having a
minimum activity of:

Granular and liquid form:

Endo-1,4-beta-glucanase:
8 000 U (1)/g or ml

Endo-1,3(4)-beta-glucanase:
18 000 U (2)/g or ml

Endo-1,4-beta-xylanase:
26 000 U (3)/g or ml

—

—

—

Endo-1,4-
beta-gluca-
nase:
400 U

Endo-1,3(4)-
beta-gluca-
nase:
900 U

Endo-1,4-
beta-xyla-
nase:
1 300 U

1. In the directions for use of the
additive and premixture,
indi-
cate the storage temperature,
storage life, and stability to
pelleting.

1.1.2007

2. Recommended

dosages

per
kilogram of complete feeding-
stuff:
endo-1,4-beta-glucanase:
400-1 280 U
endo-1,3(4)-beta-glucanase:
900-2 880 U
endo-1,4-beta-xylanase:
1 300-4 160 U.

3. For use in compound feed rich
in non-starch polysaccharides
(mainly arabinoxylans and beta-
glucans), e.g. containing more
than 40 % wheat,
triticale or
barley.

.

1
0
1
2
2
0
0
2

.

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
C
o
m
m
u
n
i
t
i
e
s

L

3
3
3
/
7

No (or EC
No)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum age

Piglets

—

Minimum
content

Maximum
content

Units of activity/kg of complete
feedingstuff

—

—

—

Endo-1,4-
beta-gluca-
nase:
400 U

Endo-1,3(4)-
beta-gluca-
nase:
900 U

Endo-1,4-
beta-xyla-
nase:
1 300 U

(1) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.
(2) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.
(3) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.

Other provisions

End of period of
authorisation

1. In the directions for use of the
additive and premixture,
indi-
cate the storage temperature,
storage life, and stability to
pelleting.

1.1.2007

2. Recommended

dosages

per
kilogram of complete feeding-
stuff:
endo-1,4-beta-glucanase:
400-1 600 U
endo-1,3(4)-beta-glucanase:
900-3 600 U
endo-1, 4-beta-xylanase:
1 300-5 200 U.

3. For use in compound feed rich
in non-starch polysaccharides
(mainly arabinoxylans and beta-
glucans), e.g. containing more
than 40 % wheat,
triticale or
maize or wheat and 20 % rye.

L

3
3
3
/
8

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
C
o
m
m
u
n
i
t
i
e
s

.

1
0
1
2
2
0
0
2

.

ANNEX II

Additive

Chemical formula, description

Species or cate-
gory 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

51

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-xyla-
nase produced by Bacillus subtilis
(LMG
a
minimum activity of:

S-15136)

having

Endo-1,4-beta-xylanase:

Solid and liquid:
100 IU (1)/g or ml

Turkeys for
fattening

—

10 IU

—

1. In the directions for use of the
additive and premixture,
indi-
cate the storage temperature,
storage life, and stability to
pelleting.

1.1.2007

2. Recommended

per
kilogram of complete feeding-
stuff: 10 IU.

dosages

(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 ºC.

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

.

1
0
1
2
2
0
0
2

.

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
C
o
m
m
u
n
i
t
i
e
s

L

3
3
3
/
9

ANNEX III

Additive

Chemical formula, description

Species or cate-
gory 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

51

Endo-1,4-beta-xylanase:
EC 3.2.1.8

Preparation of endo-1,4-beta-xyla-
nase produced by Bacillus subtilis
(LMG
a
minimum activity of:

S-15136)

having

Endo-1,4-beta-xylanase:

Liquid:
100 IU (1)/ml

Chickens for
fattening

—

10 IU

—

1. In the directions for use of the
additive and premixture,
indi-
cate the storage temperature,
storage life, and stability to
pelleting.

1.1.2007

2. Recommended

per
kilogram of complete feeding-
stuff: 10 IU.

dosages

(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 3 ºC.

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

L

3
3
3
/
1
0

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
C
o
m
m
u
n
i
t
i
e
s

.

1
0
1
2
2
0
0
2

.