Commission Regulation (EC) No 2437/2000 of 3 November 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives in feedingstuffs (Text with EEA relevance)
Date: 2000-11-03
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation

L 280/28

EN

Official Journal of the European Communities

4.11.2000

COMMISSION REGULATION (EC) No 2437/2000

of 3 November 2000

concerning the permanent authorisation of an additive and the provisional authorisation of new
additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

(7)

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 1887/2000 (2),
and in particular Article 3 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

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

Article 9d of the Directive provides that an additive of a
type listed in Part II of Annex C to the Directive shall be
authorised, where,
the
dossier, all the conditions laid down in Article 3a of the
Directive are met.

following an evaluation of

Article 9e of the Directive provides that an additive of
the same type may be provisionally authorised for a
period of up to four years where, following an evalu-
ation of the dossier referred to above, the conditions of
Article 3a(b) to (e) of the Directive are satisfied and if it
is reasonable to assume, in view of the available results,
that the conditions laid down in Article 3a(a) are also
met.

The assessment of the dossier submitted shows that the
micro-organism preparation described in Annexes I and
II to this Regulation satisfies the conditions of Article
3a(b) to (e) of the Directive. Further,
it satisfies the
conditions of Article 3a(a) when used in relation to
piglets.

It is also reasonable to assume, in view of the available
results, that the conditions laid down in Article 3a(a) are
met in relation to the use of the same micro-organism
preparation for the categories of animals listed in Annex
II to the Regulation.

The assessment of the dossiers submitted shows that the
enzyme preparations described in Annex III
to this
Regulation satisfy the conditions for preliminary author-
isation specified in Article 9e of the Directive, when
used in relation to the categories of animal, and in

accordance with the other provisions, specified in Annex
III to this Regulation.

individual directives,

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) and its
relevant
in particular Council
Directive 90/679/EEC (4), as last amended by Commis-
sion Directive 97/65/EC (5), on the protection of workers
from risks related to exposure to biological agents at
work, are fully applicable to the use and manipulation
by workers of the additives in feedingstuffs.

(8)

(9)

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the harmless-
ness of the enzyme and micro-organism preparations
and with regard to the favourable effect on piglets of the
micro-organism preparation.

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘micro-organisms’
listed in Annexes I and II to the present Regulation shall be
authorised according to Directive 70/524/EEC as additive in
animal nutrition under the conditions laid down in the said
Annexes.

Article 2

listed in
The preparations belonging to the group ‘enzymes’
Annex III
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.

Article 3

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

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 227, 7.9.2000, p. 13.

(3) OJ L 183, 29.6.1989, p. 1.
(4) OJ L 374, 31.12.1990, p. 1.
(5) OJ L 335, 6.12.1997, p. 17.

4.11.2000

EN

Official Journal of the European Communities

L 280/29

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

Done at Brussels, 3 November 2000.

For the Commission

David BYRNE

Member of the Commission

EC No

Additive

Chemical formula, description

E 1700

Bacillus licheniformis (DSM 5749)

Bacillus subtilis (DSM 5750)

(In a 1/1 ratio)

Mixture of Bacillus
licheniformis
and Bacillus subtilis containing a
minimum of 3,2 × 109 CFU/g of
the additive (1,6 × 109 CFU/g of
each bacterium)

ANNEX I

Species or cate-
gory of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

Piglets

2 months

1,28 × 109

3,2 × 109

Other provisions

Period of
authorisation

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

Without a
time limit

L

2
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N

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.

.

4
1
1
2
0
0
0

No (or EC No)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum age

ANNEX II

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

0,96 × 109

1,92 × 109

20

Bacillus licheniformis (DSM 5749)

Bacillus subtilis (DSM 5750)

(In a 1/1 ratio)

Mixture of Bacillus
licheniformis
and Bacillus subtilis containing a
minimum of 3,2 × 109 CFU/g of
the additive (1,6 × 109 CFU/g of
each bacterium)

Sows

Pigs for
fattening

15 days pre
partum and
during lacta-
tion period

—

0,48 × 109

1,28 × 109

Chickens for
fattening

—

3,2 × 109

3,2 × 109

Turkeys for
fattening

—

1,28 × 109

3,2 × 109

.

.

4
1
1
2
0
0
0

Period of
authorisation

30.9.2001

30.9.2001

30.9.2001

30.9.2001

Other provisions

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

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

In the directions for use of the
additive and premixture, indicate
the storage temperature, storage
life and stability to pelleting.
May be used in compound feed
containing the permitted cocci-
diostats: amprolium ethopabate,
diclazuril, halofuginone, methyl-
benzoquate/meticlorpindol,
monensin sodium, nifursol and
robenidine.

In the directions for use of the
additive and premixture, indicate
the storage temperature, storage
life and stability to pelleting.
May be used in compound feed
containing the permitted cocci-
diostats: amprolium ethopabate,
diclazuril, halofuginone, methyl-
benzoquate/meticlorpindol,
monensin sodium, nifursol and
robenidine.

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
f

t
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e

E
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a
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u
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i
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s

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1

No (or
EC-No)

53

ANNEX III

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum
age

Minimum

Maximum

Units of activity/kg
complete feedingstuff

Other provisions

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.2.1.1

Bacillolysine
EC 3.4.24.28

Endo-1,4-beta-xylanase
EC 3.2.1.8

aculeatus

produced

alpha-amylase,

longibrachiatum

Preparation of endo-1,3(4)-beta-glucanase
produced by Aspergillus
(CBS
589.94), endo-1,4-beta-glucanase produced
(CBS
by Trichoderma
592.94),
by
Bacillus amyloliquefaciens (DSM 9553), bacil-
lolysin produced by Bacillus amyloliquefaciens
(DSM 9554) and endo-1,4-beta-xylanase
produced by Trichoderma viride (NIBH FERM
BP 4842) having a minimum activity of:
Endo-1,3(4)-beta-glucanase: 2 350 U/g (1)
Endo-1,4-beta-glucanase: 4 000 U/g (2)
Alpha-amylase: 400 U/g (3)
Bacillolysin: 450 U/g (4)
Endo-1,4-beta-xylanase: 20 000 U/g (5)

Piglets

2 months

Chickens
for
fattening

—

Endo-1,3(4)-
beta-glucanase:
2 350 U

Endo-1,4-beta-
glucanase:
4 000 U

Alpha-amylase:
400 U

Bacillolysin:
450 U

Endo-1,4-
beta-xylanase:
20 000 U

Endo-1,3(4)-
beta-glucanase:
1 175 U

Endo-1,4-beta-
glucanase:
2 000 U

Alpha-amylase:
200 U

Bacillolysin:
225 U

Endo-1,4-
beta-xylanase:
10 000 U

—

—

—

—

—

—

—

—

—

—

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life and stability to pelleting
kilogram of

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 2 350 U
endo-1,4-beta-glucanase: 4 000 U
alpha-amylase: 400 U
bacillolysin: 450 U
endo-1,4-beta-xylanase: 20 000 U

3. For use in compound feed rich in non-
starch polysaccharides (mainly beta-glucans
and arabinoxylans), e.g. containing more
than 25 % barley and 20 % maize.

per

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 1 175 - 2 350 U
endo-1,4-beta-glucanase: 2 000 - 4 000 U
alpha-amylase: 200 - 400 U
bacillolysin: 225 - 450 U
endo-1,4-beta-xylanase:
20 000 U

10 000

-

3. For use in compound feed rich in non-
starch polysaccharides (mainly beta-glucans
and arabinoxylans), e.g. containing more
than 45 % wheat

Period of
authorisation

30.9.2001

30.9.2001

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O

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0
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No (or
EC-No)

54

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum
age

Minimum

Maximum

Units of activity/kg
complete feedingstuff

Other provisions

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.4.1.1

Endo-1,4-beta-xylanase
EC 3.2.1.8

aculeatus

produced

alpha-amylase

longibrachiatum

Preparation of endo-1,3(4)-beta-glucanase,
produced by Aspergillus
(CBS
589.94), endo-1,4-beta-glucanase produced
(CBS
by Trichoderma
by
592.94),
Bacillus amyloliquefaciens (DSM 9553) and
endo-
by
Trichoderma viride (NIBH FERM BP 4842)
having a minimum activity of:
Endo-1,3(4)-beta-glucanase: 10 000 U/g (1)
Endo-1,4-beta-glucanase: 120 000 U/g (2)
Alpha-amylase: 400 U/g (3)
Endo-1,4-beta-xylanase: 210 000 U/g (5)

1,4-beta-xylanase

produced

55

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.2.1.1

Bacillolysin
EC 3.4.24.28

produced

alpha-amylase

Preparation of endo-1,3(4)-beta-glucanase,
producerd by Aspergillus aculeatus
(CBS
589.94), endo-1,4-beta-glucanase produ-
ceerd by Trichoderma longibrachiatum (CBS
592.94),
by
Bacillus amyloliquefaciens (DSM 9553) and
bacillolysine, produced by Bacillus amyloli-
quefaciens (DSM 9554) having a minimum
activity of:
Endo-1,3(4)-beta-glucanase: 3 000 U/g (1)
Endo-1,4-beta-glucanase: 5 000 U/g (2)
Alpha-amylase: 540 U/g (3)
Bacillolysin: 450 U/g (4)

Chickens
for
fattening

—

Piglets

2 months

Endo-1,3(4)-
beta-gluca-
nase:
1 000 U

Endo-1,4-
beta-gluca-
nase:
12 000 U

Alpha-amylase:
40 U

Endo-1,4-
beta-xylanase:
21 000 U

Endo-1,3(4)-
beta-glucanase:
1 500 U

Endo-1,4-beta-
glucanase:
2 500 U

Alpha-amylase:
270 U

Bacillolysin:
225 U

—

—

—

—

—

—

—

—

per

1 000

2. Recommended

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
2 000 U
endo-1,4-beta-glucanase:
24 000 U
alpha-amylase: 40 - 80 U
endo-1,4-beta-xylanase: 21 000 - 42 000 U
3. For use in compound feed rich in non-starch
polysaccharides
(mainly beta-glucans and
arabinoxylans), e.g. containing more than
45 % wheat

12 000

-

-

per

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
3 000 U
endo-1,4-beta-glucanase: 2 500 - 5 000 U
alpha-amylase: 270 - 540 U
bacillolysin: 225 - 450 U

1 500

-

3. For use in compound feed rich in starch and
non-starch polysaccharides, e.g. containing
more than 35 % wheat and 15 % barley

Period of
authorisation

30.9.2001

30.9.2001

.

.

4
1
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2
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0
0

E
N

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No (or
EC-No)

55
(cont'd)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum
age

Pigs for
fattening

—

Chickens
for
fattening

—

Minimum

Maximum

Units of activity/kg
complete feedingstuff

Other provisions

Endo-1,3(4)-
beta-glucanase:
1 500 U

Endo-1,4-beta-
glucanase:
2 500 U

Alpha-amylase:
270 U

Bacillolysin:
225 U

Endo-1,3(4)-
beta-glucanase:
1 500 U

Endo-1,4-beta-
glucanase:
2 500 U

Alpha-amylase:
270 U

Bacillolysin:
225 U

—

—

—

—

—

—

—

—

per

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
3 000 U
endo-1,4-beta-glucanase: 2 500 - 5 000 U
alpha-amylase: 270 - 540 U
bacillolysin: 225 - 450 U

1 500

-

3. For use in compound feed rich in starch and
non-starch polysaccharides, e.g. containing
more than 50 % barley

per

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
3 000 U
endo-1,4-beta-glucanase: 2 500 - 5 000 U
alpha-amylase: 270 - 540 U
bacillolysin: 225 - 450 U

1 500

-

3. For use in compound feed rich in starch and
non-starch polysaccharides, e.g. containing
more than 50 % maize or 50 % wheat

Period of
authorisation

30.9.2001

30.9.2001

L

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3
4

E
N

O

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.

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2
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0
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No (or
EC-No)

55
(cont'd)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum
age

Laying
hens

—

Chickens
for
fattening

—

56

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.2.1.1

Bacillolysin:
EC 3.4.24.28

aculeatus

produced

alpha-amylase

longibrachiatum

Preparation of endo-1,3(4)-beta-glucanase
produced by Aspergillus
(CBS
589.94), endo-1,4-beta-glucanase produced
(CBS
by Trichoderma
592.94),
by
Bacillus amyloliquefaciens (DSM 9553) and
bacillolysin produced by Bacillus amylolique-
(DSM 9554) having a minimum
faciens
activity of:
Endo-1,3(4)-beta-glucanase: 6 000 U/g (1)
Endo-1,4-beta-glucanase: 3 500 U/g (2)
Alpha-amylase 1 400 U/g (3)
Bacillolysin: 450 U/g (4)

Period of
authorisation

30.9.2001

30.9.2001

Minimum

Maximum

Units of activity/kg
complete feedingstuff

Other provisions

Endo-1,3(4)-
beta-glucanase:
1 500 U

Endo-1,4-beta-
glucanase:
2 500 U

Alpha-amylase:
270 U

Bacillolysin:
225 U

Endo-1,3(4)-
beta-glucanase:
6 000 U

Endo-1,4-beta-
glucanase:
3 500 U

Alpha-
amylase:
1 400 U

Bacillolysin:
450 U

—

—

—

—

—

—

—

—

per

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
3 000 U
endo-1,4-beta-glucanase: 2 500 - 5 000 U
alpha-amylase: 270 - 540 U
bacillolysin: 225 - 450 U

1 500

-

3. For use in compound feed rich in starch and
non-starch polysaccharides, e.g. containing
more than 40 % maize and 10 % rye

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 6 000 U
endo-1,4-beta-glucanase: 3 500 U
alpha-amylase: 1 400 U
bacillolysin: 450 U

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

.

.

4
1
1
2
0
0
0

E
N

O

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f
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a
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5

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum
age

Minimum

Maximum

Units of activity/kg
complete feedingstuff

Other provisions

No (or
EC-No)

57

Chickens
for
fattening

—

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.2.1.1

Bacillolysine:
EC 3.4.24.28

Preparation of endo-1,3(4)-beta-glucanase
produced by Aspergillus aculeatus
(CBS
589.94),
endo-1,4-beta-glucanase
produced by Trichoderma longibrachiatum
(CBS 592.94), alpha-amylase produced by
Bacillus amyloliquefaciens (DSM 9553) and
bacillolysin produced by Bacillus amyloli-
quefaciens (DSM 9554) having a minimum
activity of:
Endo-1,3(4)-beta-glucanase: 3 000 U/g (1)
Endo-1,4-beta-glucanase: 9 000 U/g (2)
Alpha-amalyse 540 U/g (3)
Bacillolysin: 450 U/g (4)

Piglets

2 months

58

Endo-1,3(4)-beta-glu-
canase
EC 3.2.1.6

Endo-1,4-beta-glu-
canase
EC 3.2.1.4

Alpha-amylase
EC 3.2.1.1

Bacillolysin
EC 3.4.24.28

aculeatus

produced

alpha-amylase

Preparation of endo-1,3(4)-beta-glucanase
produced by Aspergillus
(CBS
589.94), endo-1,4-beta-glucanase produced
longibrachiatum 7 (CBS
by Trichoderma
592.94),
by
Bacillus amyloliquefaciens (DSM 9553) and
bacillolysin produced by Bacillus amylolique-
(DSM 9554) having a minimum
faciens
activity of:
Endo-1,3(4)-beta-glucanase: 2 350 U/g (1)
Endo-1,4-beta-glucanase: 5 000 U/g (2)
Alpha-amylase 400 U/g (3)
Bacillolysin: 5 000 U/g (4)

Endo-1,3(4)-
beta-glucanase:
3 000 U

Endo-1,4-beta-
glucanase:
9 000 U

Alpha-amylase:
540 U

Bacillolysin:
450 U

Endo-1,3(4)-
beta-glucanase:
2 350 U

Endo-1,4-beta-
glucanase:
5 000 U

Alpha-amylase:
400 U

Bacillolysin:
5 000 U

—

—

—

—

—

—

—

—

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 3 000 U
endo-1,4-beta-glucanase: 9 000 U
alpha-amylase: 540 U
bacillolysin: 450 U

3. For use in compound feed rich in starch
and non-starch polysaccharides
(mainly
cellulose and hemicellulose), e.g. containing
more than 20 % sunflower meal and 10 %
soya meal

1. In the directions for use of the additive and
premixture,
indicate the storage tempera-
ture, storage life, and stability to pelleting
kilogram of

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 2 350 U
endo-1,4-beta-glucanase: 5 000 U
alpha-amylase: 400 U
bacillolysin: 5 000 U

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

polysaccharides

(mainly

(1) 1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30 °C.
(2) 1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50 °C.
(3) 1 U is the amount of enzyme which hydrolises 1 micromole of glucosidic linkages from water insoluble cross-linked starch polymer per minute at pH 7,5 and 37 °C.
(4) 1 U is the amount of enzyme which makes 1 microgram of azo-casein soluble in trichloracetic acid per minute at pH 7,5 and 37 °C .
(5) 1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50 °C.

Period of
authorisation

30.9.2001

30.9.2001

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