Commission Regulation (EC) No 654/2000 of 29 March 2000 concerning the authorisation of new additives, new additive uses and new additive preparations in feedingstuffs (Text with EEA relevance)
Date: 2000-03-29
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation

L 79/26

EN

Official Journal of the European Communities

30.3.2000

COMMISSION REGULATION (EC) No 654/2000

of 29 March 2000

concerning the authorisation of new additives, new additive uses and new additive preparations 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 2690/1999 (2)
and in particular Article 3 thereof,

Whereas:

(1)

(2)

(3)

(4)

Directive 70/524/EEC provides that new additives or
new additive uses shall be authorised, taking account of
advances in scientific and technical knowledge.

Council Directive 93/113/EC of 14 December 1993
concerning the use and the marketing of enzymes,
micro-organisms and their preparations in animal nutri-
tion (3), as last amended by Directive 97/40/EC (4), by
derogation from Directive 70/524/EEC,
authorised
Member States to permit provisionally the use and
marketing of enzymes, micro-organisms and their prepa-
rations.

New data were submitted for the replacement of author-
ised preparations of enzymes by new preparations of the
same enzymes.

A provisional authorisation of new additives or new uses
of additives shall be given if, at the level permitted in
it does not adversely affect human or
feedingstuffs,
the environment, nor harm the
animal health or
consumer by altering the characteristics of
livestock
can be
in feedingstuffs
products,
controlled, and it is reasonable to assume, in view of the
available results, that it has a favourable effect on the
characteristics of
those feedingstuffs or on livestock
production when incorporated in such feedingstuffs.

its presence

if

(5)

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 (5) and its

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 326, 18.12.1999, p. 33.
(3) OJ L 334, 31.12.1993, p. 17.
(4) OJ L 180, 9.7.1997, p. 21.
(5) OJ L 183, 29.6.1989, p. 1.

individual directives,

in particular Council
relevant
Directive 90/679/EEC of 26 November 1990 on the
protection of workers from risks related to exposure to
biological agents at work (6), as
last amended by
Commission Directive 75/65/EC (7), are fully applicable
to the use and manipulation by workers of the additives
in feedingstuffs.

(6)

(7)

(8)

The examination of
the dossiers, submitted by the
Member States in accordance with Article 3 of Directive
93/113/EC, indicates that a certain number of prepara-
tions belonging to the groups of enzymes and micro-
organisms can be provisionally authorised.

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the harmless-
ness of these enzyme (8) and micro-organism (9) prepara-
tions.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘Enzymes’ listed in
Annex I to the present Regulation shall be authorised according
to Directive 70/524/EEC as additives in animal nutrition under
the conditions laid down in the said Annex.

Article 2

The particulars concerning the composition of the enzymes
authorised under Nos ‘7’ and ‘8’ are modified, as indicated in
Annex I, under the heading ‘Chemical formula, description’.

Article 3

The preparations belonging to the group ‘Micro-organisms’
listed in Annex II to the present Regulation shall be authorised
according to Directive 70/524/EEC as additives in animal nutri-
tion under the conditions laid down in the said Annex.

(6) OJ L 374, 31.12.1990, p. 1.
(7) OJ L 335, 6.12.1997, p. 17.
(8) Report of the Scientific Committee for Animal Nutrition on the use
of certain enzymes as additives in feedingstuffs, adopted on 4 June
1998, updated on 21 October 1999.

(9) Report of the Scientific Committee for Animal Nutrition on the use
of certain micro-organismes as additives in feedingstuffs, adopted on
26 September 1997, updated on 22 October 1999.

30.3.2000

EN

Official Journal of the European Communities

L 79/27

This Regulation shall enter into force on the third day following publication in the Official Journal of the
European Communities.

Article 4

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

Done at Brussels, 29 March 2000.

For the Commission

David BYRNE

Member of the Commission

No

Additive

Chemical formula, description

Species or category of animal

ANNEX I

Maximum
age

Minimum
content

Maximum
content

Other provisions

4

7

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

EC 3.2.1.6

Preparation of endo-1,3 (4)-
beta-glucanase proudced by
Aspergillus
(CBS
589.94) having a minimum
activity of:

aculeatus

Chickens for fattening

—

Coated form:
50 FBG (1)/g
Liquid form:
120 FBG/ml

Units of activity per kg of complete feedingstuff

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

Endo-1,3(4)-beta-
glucanase:

10 FBG

100 FBG

Endo-1,4-beta-
xylanase

EC 3.2.1.8

Endo-1,4-beta-
glucanase

EC 3.2.1.4

Preparation of endo-1,4-beta-
xylanase
and endo-1,4-beta-
glucanase produced by Asper-
gillus
600.94)
having a minimum activity of:

(CBS

niger

Coated form:
36 000 FXU (2)/g
15 000 BGU (3)/g

Liquid form:
36 000 FXU/g
15 000 BGU/g

Chicken for fattening

—

Endo-1,4-beta-
xylanase:

3 600 FXU

Endo-1,4-beta-
xylanase:

12 000 FXU

Endo-1,4-beta-
glucanase:

Endo-1,4-beta-
glucanase:

1 500 BGU

5 000 BGU

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,3(4)-beta-glucanase:
20 FBG

3. For use in compound feed rich in
non-starch polysaccharides (mainly
beta-glucans), e.g. containing more
than 60 % maize.

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-xylanase:
3 600-6 000 FXU
Endo-1,4-beta-glucanase:
1 500-2 500 BGU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans
and beta-glucans),
e.g. containing more than 35 %
barley and 20 % wheat.

Period of
authorisation

30.11.2000

30.11.2000

L

7
9
/
2
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

.

.

3
0
3
2
0
0
0

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

Piglets

four months Endo-1,4-beta-

xylanase:

6 000 FXU

Endo-1,4-beta-
glucanase:

2 500 BGU

—

—

Turkeys for fattening

—

Endo-1,4-beta-
xylanase:

6 000 FXU

Endo-1,4-beta-
xylanase:

12 000 FXU

Endo-1,4-beta-
glucanase:

Endo-1,4-beta-
glucanase:

2 500 BGU

5 000 BGU

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-xylanase:
6 000 FXU
Endo-1,4-beta-glucanase:
2 500 BGU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans
and beta-glucans),
e.g. containing more than 30 %
wheat and 30 % barley.

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-xylanase:
6 000-12 000 FXU
Endo-1,4-beta-glucanase:
2 500-5 000 BGU

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

Period of
authorisation

30.11.2000

30.11.2000

.

.

3
0
3
2
0
0
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

L

7
9
/
2
9

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

Laying hens

—

Endo-1,4-beta-
xylanase:

12 000 FXU

Endo-1,4-beta-
glucanase:

5 000 BGU

—

—

8

Endo-1,4-beta-
glucanase

EC 3.2.1.4

Endo-1,4-beta-
xylanase

EC 3.2.1.8

Preparation of Endo-1,4-beta-
glucanase and Endo-1,4-beta-
xylanase proudced Aspergillus
niger
(CBS 600.94) having a
minimum activity of:

Coated form:
10 000 BGU (3)/g
4 000 FXU (2)/g

Liquid form:
20 000 BGU/g
8 000 FXU/g

Chickens for fattening

—

Endo-1,4-beta-
glucanase:

3 000 BGU

Endo-1,4-beta-
glucanase:

10 000 BGU

Endo-1,4-beta-
xylanase:

Endo-1,4-beta-
xylanase:

1 200 FXU

4 000 FXU

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-xylanase:
12 000 FXU
Endo-1,4-beta-glucanase:
5 000 BGU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans
and beta-glucans),
e.g. containing more than 20 %
wheat, 10 % barley and 20 %
sunflower.

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-glucanase:
3 000-10 000 BGU
Endo-1,4-beta-xylanase:
1 200-4 000 FXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
beta-glucans
and arabinoxylans),
e.g. containing more than 60 %
barley.

Period of
authorisation

30.11.2000

30.11.2000

L

7
9
/
3
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

.

.

3
0
3
2
0
0
0

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

Piglets

Four
months

Endo-1,4-beta-
glucanase:

Endo-1,4-beta-
glucanase:

3 000 BGU

5 000 BGU

Endo-1,4-beta-
xylanase:

Endo-1,4-beta-
xylanase:

1 200 FXU

2 000 FXU

Laying hens

—

Endo-1,4-beta-
glucanase:

5 000 BGU

Endo-1,4-beta-
xylanase:

2 000 FXU

—

—

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-glucanase:
3 000-5 000 BGU
Endo-1,4-beta-xylanase:
1 200-2 000 FXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
beta-glucans
and arabinoxylans),
e.g. containing more than 30 %
barley.

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

2. Recommended dose per kilogram

of complete feedingstuff:

Endo-1,4-beta-glucanase:
5 000 BGU
Endo-1,4-beta-xylanase:
2 000 FXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
beta-glucans
and arabinoxylans),
e.g. containing more than 60 %
barley.

Period of
authorisation

30.11.2000

30.11.2000

.

.

3
0
3
2
0
0
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

L

7
9
/
3
1

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

9

Endo-1,4-beta-
xylanase

EC 3.2.1.8

Preparation of Endo-1,4-beta-
yxlanase produced by Asper-
270.95)
gillus
having a minimum activity of:

(CBS

niger

Solid form:
Endo-1,4-beta-xylanase:
28 000 EXU (4)/g

Liquid form:
Endo-1,4-beta-xylanase:
14 000 EXU/ml

Laying hens

—

Endo-1,4-beta-
xylanase:

2 400 EXU

Turkeys for fattening

—

Endo-1,4-beta-
xylanase:

2 400 EXU

—

—

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

2. Recommended dose per kg of

complete feedingstuff:

Endo-1,4-beta-xylanase:
2 400 - 7 400 EXU

3. For use in compound feed rich in
non-starch
polysaccharides
(mainly arabinoxylans) e.g. conta-
nining more than 30 % wheat
and 30 % rye.

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

2. Recommended dose per kg of

complete feedingstuff:

Endo-1,4-beta-xylanase:
2 400-5 600 EXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans)
containing
more than 30 % wheat and 30 %
rye.

e.g.

Period of
authorisation

30.11.2000

30.11.2000

L

7
9
/
3
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

.

.

3
0
3
2
0
0
0

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

—

Endo-1,3(4)-beta-
glucanase:

600 BGU

Endo-1,4-beta-
xylanase:

800 FXU

13

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

EC 3.2.1.6

Endo-1,4-beta-
xylanase

EC 3.2.1.8

Laying hens

Preparation of
Endo-1,3(4)-
beta-glucanase and Endo-1,4-
by
beta-xylanase
produced
longibrachiatum
Trichoderma
(CBS
a
having
357.94)
minimum activity of:

Powder form:
Endo-1,3(4)-beta-glucanase:
8 000 BGU (5)/g
Endo-1,4-beta-xylanase:
11 000 EXU (4)/g

Granulated form:
Endo-1,3(4)-beta-glucanase:
6 000 BGU/g
Endo-1,4-beta-xylanase:
8 250 EXU/g

Liquid form:
Endo-1,3(4)-beta-glucanase:
2 000 BGU/ml
Endo-1,4-beta-xylanase:
2 750 EXU/ml

Turkeys for fattening

—

Endo-1,3(4)-beta-
glucanase:

600 BGU

Endo-1,4-beta-
xylanase:

800 EXU

—

—

—

—

Period of
authorisation

30.11.2000

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

2. Recommended dose per kg of

complete feedingstuff:

Endo-1,3(4)-beta-glucanase:
600 BGU
Endo-1,4-beta-xlanase
800 EXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans
and beta-glucans),
e.g. containing more than 40 %
wheat and more than 30 % barley.

30.11.2000

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

2. Recommended dose per kg of

complete feedingstuff:

Endo-1,3(4)-beta-glucanase:
600 BGU
Endo-1,4-beta-xylanase:
800 EXU

3. For use in compound feed rich in
non-starch polysaccharides (mainly
arabinoxylans
and beta-glucans),
e.g. containing more than 30 %
wheat or more than 30 % rye.

.

.

3
0
3
2
0
0
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

L

7
9
/
3
3

No

Additive

Chemical formula, description

Species or category of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity per kg of complete feedingstuff

Other provisions

48

Alpha-amylase

EC 3.2.1.1

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

EC 3.2.1.6

Preparation of Alpha-amylase
Endo-1,3(4)-beta-gluca-
and
by Bacillus
produced
nase
amyloliquefaciens
(DSM 9553)
having a minimum activity of:

Coated form:
Alpha-amylase:
200 KNU (6)/g
Endo-1,3(4)-beta-glucanase:
350 FBG (1)/g

Liquid form:
Alpha-amylase:
130 KNU/ml
Endo-1,3(4)-beta-glucanase:
225 FBG/ml

Chickens for fattening

—

Alpha-amylase:

Alph-amylase:

10 KNU

40 KNU

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

Endo-1,3(4)-beta-
glucanase:

Endo-1,3(4)-beta-
glucanase:

2. Recommended dose per kg of

complete feedingstuff:

17 FBG

70 FBG

Turkeys for fattening

—

Alpha-amylase:

Alpha-amylase:

40 KNU

80 KNU

Endo-1,3(4)-beta-
glucanase:

Endo-1,3(4)-beta-
glucanase:

70 FBG

140 FBG

Alpha-amylase:
20 KNU
Endo-1,3(4)-beta-glucanase:
35 FBG

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

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

2. Recommended dose per kg of

complete feedingstuff:

Alpha-amylase: 40 KNU
Endo-1,3(4)-beta-glucanase:
70 FBG

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

(1) One FBG is the amount of enzyme which liberates one micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C.
(2) One FXU is the amount of enzyme which liberates 0,15 micromole of xylose from azurine-cross-linked xylan per minute at pH 5,0 and 40 °C.
(3) One BGU is the amount of enzyme which liberates 0,15 micromoles of glucose from azurine-cross-linked beta-glucan per minute at pH 5,0 and 40 °C.
(4) One EXU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.
(5) One BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °C.
(6) One KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37 °C.

Period of
authorisation

30.11.2000

30.11.2000

L

7
9
/
3
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
C
o
m
m
u
n
i
t
i
e
s

.

.

3
0
3
2
0
0
0

ANNEX II

CFU/kg of complete feedingstuff

No

Additive

Chemical formula,
description

Species or category of animal

Maximum
age

Minimum
content

11

Enterococcus
faecium
DSM 5464

Preparation of Enterococcus
a
faecium
minimum of: 5 × 1010 CFU/g
additive

containing

Chickens for fattening

—

0,5 × 109

Maximum
content

1 × 109

Calves

four months

0,5 × 1010

1 × 109

17

Lactobacillus casei
NCIMB 30096

Mixture of Lactobacillus casei
and
faecium
Enterococcus
containing a minimum of:

Calves

Enterococcus
faecium
NCIMB 30098

Lactobacillus casei
20 × 109 CFU/g

and:

six months

Lactobacillus casei
0,5 × 109

Lactobacillus casei
1 × 109

Enterococcus faecium
1,5 × 109

Enterococcus faecium
3 × 109

18

Enterococcus
faecium
CECT 4515

Enterococcus faecium
6 × 109 CFU/g additive

Preparation of Enterococcus
faecium containing a mini-
mum of
1 × 1010 CFU/g additive

Piglets

four months

1 × 109

1 × 109

Calves

six months

1 × 109

1 × 109

.

.

3
0
3
2
0
0
0

Other provisions

Period of
authorisation

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

the
indicate
storage

2. May be used in compound feed
containing the permitted coccidio-
stats: amprolium, diclazuril, halofu-
ginone, monensin-sodium, metil-
clorpindol,
methylbenzoquate,
nicarbazin.

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting.

indicate

and premixture

In the directions for use of the addi-
tive
the
storage temperature storage life and
stability to pelleting.

indicate

and premixture

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting.

indicate

and premixture

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting.

indicate

30.11.2000

E
N

30.11.2000

30.11.2000

30.11.2000

30.11.2000

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

7
9
/
3
5