Commission Regulation (EC) No 2697/2000 of 27 November 2000 concerning the provisional authorisations of additives in feedingstuffs (Text with EEA relevance.)
Date: 2000-11-27
Institutions: European Commission
Subjects: European standard, animal nutrition, food additive, food inspection, marketing standard

16.12.2000

EN

Official Journal of the European Communities

L 319/1

I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 2697/2000

of 27 November 2000

concerning the provisional authorisations of additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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
(EC) No
1887/2000 (2) ((cid:145)the Directive(cid:146)), and in particular Articles 3, 9e
and 9i thereof,

Commission

Regulation

amended

by

Whereas:

(1) Articles 9e(1) and 9i(1) of the Directive provide that a
provisional authorisation of a new additive or a new use
of an additive may be given for a specific period.

(2) Article 4 of Council Directive establishes the procedure

for such authorisation.

of

the

that

duration

(3) Article 9e(2) and (3) and Article 9i(1) of the Directive
provisional
provide
the
five years,
authorisations may not exceed four or
depending on the date of
first provisional
authorisation. When the latter was given before 1 April
1998, the duration of the provisional authorisation may
not exceed five years. In the case of additives whose first
provisional authorisations were given after 1 April
1998, the duration of the provisional authorisation may
not exceed four years.

the

(4)

The first provisional authorisation is given until 30
September of the current year or of the next year then
may be extended each year for one year. During the last
year of the provisional authorisation, the authorisation
fifth
should only be
extended to the
initial
anniversary (as
provisional authorisation.

case may be) of

fourth or

the

the

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

(6)

(7)

(8)

(9)

The current provisional authorisations of many additives
expire on 30 September, and it is appropriate to extend
for one year, or until the fourth or fifth anniversary (as
the case may be) of the initial provisional authorisation,
the period of these authorisations so that the necessary
data for an authorisation for 10 years or without a time
limit
the additive in
question) can be provided.

(depending on the nature of

the period of authorisation of

the
The extension of
provisional authorisations must be considered as a
purely
involving no new
evaluation of the concerned additives.

administrative measure

Provisional authorisations under
this Regulation are
granted for a specified period, but without prejudice to
the possibility that they may be withdrawn at any time
in accordance with Articles 9m and 11 of the Directive.
In particular, authorisations for the use of antibiotics as
additives in feedingstuffs are currently under review in
the light of the fact that the Kingdom of Sweden has
prohibited the use on its territory of all antibiotics as
additives in feedingstuffs on the basis of Article 11 of
the Directive, and the opinion issued by the Scientific
Steering Committee on anti-microbial resistance on 28
May 1999. The Commission is also examining the more
general question of the use of antibiotics as additives in
feedingstuffs.

In the light of
the data submitted in the file and
examined by the Member States, the conditions for the
provisional authorisation under the conditions laid done
in the Annex of
the additives
(cid:145)Tartrazine(cid:146) (E 102), (cid:145)Sunset Yellow FCF(cid:146) (E 110), (cid:145)Patent
Blue V(cid:146) (E 131), and (cid:145)Chlorophyll copper complex(cid:146) (E
141) belonging to the group of (cid:145)Colorants,
including
pigments(cid:146) have been met.

the new uses of

the data submitted in the file and
In the light of
examined by the Member States, the conditions for the
modification of the physical forms under the conditions
laid done in the Annex of the previously provisionally
authorised enzyme preparations No 7 and No 8 have
been met.

L 319/2

EN

Official Journal of the European Communities

16.12.2000

(10)

(11)

(12)

(13)

on

cereus

expiring

provisional

authorisations

(ATCC 14893)

The
30
the micro-organism preparations
September 2000 of
No 1 Bacillus cereus var. toyoi (NCIMB 40112) and No 4
Bacillus
renewed
provisionally until 20 February 2001 in order to allow
sufficient time for the provision of complementary data
and for the safety reassessment of these two strains with
regard to production of
toxins, as requested in the
Opinion of the Scientific Committee for Animal Nutrition on
the safety of use of Bacillus species in animal nutrition
expressed on 17 February 2000.

should be

The Commission has consulted the Scientific Committee
for Animal Nutrition concerning the safety of
the
enzyme preparations included in the Annex to the
present Regulation. The Committee delivered a positive
opinion in the Report of
for
Animal Nutrition on the use of certain enzymes in animal
feedingstuffs adopted on 4 June 1998 and updated on 3
December 1999.

the Scientific Committee

The Commission has consulted the Scientific Committee
for Animal Nutrition concerning the safety of
the
micro-organism preparations included in the Annex to
the present Regulation. The Committee delivered a
positive opinion in the Report on the use of
certain
micro-organisms as additives in feedingstuffs expressed on
26 September 1997 and updated on 27 April 2000.

readability

For
the
provisional authorisations of additives in feedingstuffs
should be consolidated in this Regulation.

coherence

reasons,

and

all

(14)

(15)

The provisional authorisations for most of the additives
expire on 30 September 2000. Therefore, it is necessary
to apply this Regulation from the 1 October 2000.

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

the of

HAS ADOPTED THIS REGULATION:

Article 1

The additives referred to in the Annex to this Regulation are
authorised provisionally in accordance with Council Directive
70/524/EEC under the conditions laid down in this Annex.

Article 2

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

It shall apply from 1 October 2000.

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

Done at Brussels, 27 November 2000.

For the Commission

David BYRNE

Member of the Commission

List of additives linked to a person responsible for putting them into circulation and authorised on a provisional basis for no longer than five years

ANNEX

Registration
No of
additive

Name and registration No of
person responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula,
description

Species or
category of
animal

Maximum age

Minimum
content

Maximum
content

mg of active substance/kg
of complete feedingstuff

Other provisions

Period of
authorisation

Antibiotics

33

Eli Lilly and Company Ltd

A d d i t i v e c o m p o s i t i o n :

Turkeys

(cid:151)

5

10

(cid:151)

30.9.2001 (a)

Avilamycin: 200 g/kg
(Maxus G200, Maxus 200)

Avilamycin 100 g/kg
(Maxus G100, Maxus 100)

Avilamycin: 200 g activity/kg

Soyabean oil or mineral oil:
5 to 30 g/kg

Soyabean hulls qs 1 kg

Avilamycin: 100 g activity /kg

Soyabean oil or mineral oil:
5 to 30 g/kg

Soyabean hulls qs 1 kg

A c t i v e s u b s t a n c e :

Avilamycin,

C57(cid:151)62H82(cid:151)90Cl1(cid:151)2O31(cid:151)32,
CAS No of avilamycin A:
69787-79-7, CAS No of
avilamycin B: 73240-30-9,

Mixture of oligosaccharides of
the orthosomycin group
produced by Streptomyces
viridochromogenes (NRRL 2860),
in granular form.

Factor composition:

Avilamycin A: ¯ 60 %

Avilamycin B: ˜ 18 %

Avilamycin A + B: ¯ 70 %

Other single avilamycins: ˜ 6 %

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Registration
No of
additive

Name and registration No of
person responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula,
description

Species or
category of
animal

Maximum age

Minimum
content

Maximum
content

mg of active substance/kg
of complete feedingstuff

Other provisions

Period of
authorisation

Coccidiostats and other medicinal substances

26

Intervet International bv

A d d i t i v e c o m p o s i t i o n :

Salinomycin sodium
120 g/kg
(Sacox 120)

Salinomycin sodium ¯ 120 g/kg

Silicium dioxide 10 to
100 g/kg

Calcium carbonate 350 to
700 g/kg

A c t i v e s u b s t a n c e :

Salinomycin sodium,

C42H69O11Na,

CAS No: 53003-10-4,

Rabbits for
fattening

(cid:151)

20

25

Use prohibited at least
five days before
slaughter.

20.3.2001 (b)

Indicate in the
instructions for use:

(cid:145)Dangerous for
equines(cid:146).

(cid:145)This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal
substances (e.g.
tiamulin) can be
contra-indicated(cid:146).

Sodium salt of a polyether
monocarboxylic acid produced
by fermentation of Streptomyces
albus (DSM 12217)

Chickens
reared for
laying

Related impurities:

< 42 mg elaiophylin/kg
salinomycin sodium

< 40 g 17-epi-20-desoxy-sali-
nomycin/kg salinomycin
sodium

12 weeks

30

50

Indicate in the
instructions for use:

30.9.2001 (c)

(cid:145)Dangerous for
equines(cid:146).

(cid:145)This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal
substances (e.g.
tiamulin) can be
contra-indicated(cid:146).

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1
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1
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0
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.

Minimum
content

Maximum
content

mg of active substance/kg
of complete feedingstuff

1

1

1

1

Other provisions

Period of
authorisation

Use prohibited at least
five days before
slaughter

20.3.2001 (b)

(cid:151)

30.9.2001 (a)

Registration
No of
additive

Name and registration No of
person responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula,
description

Species or
category of
animal

Maximum age

27

Janssen Animal Health
BVBA

Diclazuril 0,5 g/100 g
(Clinacox 0,5 % Premix)

Diclazuril 0,2 g/100 g
(Clinacox 0,2 % Premix)

A d d i t i v e c o m p o s i t i o n :

Turkeys

12 weeks

Chickens
reared for
laying

16 weeks

Diclazuril: 0,5 g/100 g

Soybean meal: 99,25 g/100 g

Polyvidone K 30: 0,2 g/100 g

Sodium hydroxyde:
0,0538 g/100 g

Diclazuril: 0,2 g/100 g

Soybean meal: 39,7 g/100 g

Polyvidone K 30: 0,08 g/100 g

Sodium hydroxide:
0,0215 g/100 g

Wheat middlings: 60 g/100 g

A c t i v e s u b s t a n c e :

Diclazuril,

C17H9Cl3N4O2,
(–)-4-chlorophenyl[2,6-
dichloro-4-(2,3,4,5-tetrahydro-
3,5-dioxo-1,2,4-triazin-
2-yl)phenyl]acetonitrile

CAS No: 101831-37-2

Related impurities:

Degradation compound
(R064318): ˜ 0,2 %

Other related impurities
(R066891, R066896,
R068610, R070156,
R068584, R070016): ˜ 0,5 %
individually

Total impurities: ˜ 1,5 %

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Registration
No of
additive

Name and registration No of
person responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula,
description

Species or
category of
animal

Maximum age

Minimum
content

Maximum
content

mg of active substance/kg
of complete feedingstuff

Other provisions

Period of
authorisation

28

Alpharma AS

A d d i t i v e c o m p o s i t i o n :

Turkeys

16 weeks

5

5

Maduramicin ammonium
alpha 1 g/100 g
(Cygro 1 %)

Maduramicin ammonium
alpha: 1 g/100 g

Benzyl alcohol: 5 g/100 g

Corn cob grits: qs 100 g

A c t i v e s u b s t a n c e :

Maduramicin ammonium
alpha

C47H83O17N,
CAS No: 84878-61-5,

Ammonium salt of a polyether
monocarboxylic acid produced
by Actinomadura yumaensis
(ATCC 31585) (NRRL 12515).

Related impurities:

Maduramicin ammonium beta:
< 10 %

30.9.2001 (c)

Use prohibited at least
five days before
slaughter.

Indicate in the
instructions for use:

(cid:145)Dangerous for
equines(cid:146).

(cid:145)This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal
substances (e.g.
tiamulin) can be
contra-indicated(cid:146).

List of other additives authorised on a provisional basis for no longer than four years or five years in the case of additives which have been the subject of provisional authorisation before
1 April 1998

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Colourants, including pigments

1. Carotenoids and xanthophylls:

E 160a

Beta-carotene

E 161g

Canthaxanthin

C40H56

C40H52O2

Canaries

Pet and
ornamental
birds

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

30.9.2001 (d)

30.9.2001 (d)

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No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

12

Astaxanthin-rich Phaffia
rhodozyma (ATCC 74219)

Concentrated biomass of the yeast
Phaffia rhodozyma (ATCC 74219),
killed, containing at least 4,0 g
astaxanthin per kilogram of
additive and having a maximum
ethoxyquin content of
2 000 mg/kg.

Salmon

(cid:151)

(cid:151)

100

The maximum content
astaxanthin.

is expressed as

30.9.2001 (d)

Use permitted only from the age of six
months onwards.

of

the

additive with
The mixture
canthaxanthin is allowed provided that the
total
concentration of astaxanthin and
canthaxanthin does not exceed 100 mg/kg
in the complete feedingstuff.

Ethoxyquin content to be declared.

Trout

(cid:151)

(cid:151)

100

The maximum content
astaxanthin.

is expressed as

30.9.2001 (d)

Use permitted only from the age of six
months onwards.

of

the

The mixture
additive with
canthaxanthin is allowed provided that the
total
concentration of astaxanthin and
canthaxanthin does not exceed 100 mg/kg
in the complete feedingstuff.

2. Other colourants:

E 102

Tartrazine

C16H9N4O9S2Na3

E 110

Sunset yellow FCF

C16H10N2O7S2Na2

Ethoxyquin content to be declared.

Grain-eating
ornamental
birds

Small rodents

Grain-eating
ornamental
birds

(cid:151)

(cid:151)

(cid:151)

(cid:151)

150

(cid:151)

(cid:151)

150

150

Small rodents

(cid:151)

(cid:151)

150

(cid:151)

(cid:151)

(cid:151)

(cid:151)

30.9.2001

30.9.2001

30.9.2001

30.9.2001

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No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

E 131

Patent blue V

Calcium salt of the disulphonic
acid of m-hydroxytetraethyl-
diamino triphenylcarbinol
anhydride

E 141

Chlorophyll copper
complex

(cid:151)

Grain-eating
ornamental
birds

Small rodents

Grain-eating
ornamental
birds

Small rodents

(cid:151)

(cid:151)

(cid:151)

(cid:151)

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

(cid:151)

(cid:151)

(cid:151)

(cid:151)

150

150

150

150

(cid:151)

(cid:151)

(cid:151)

(cid:151)

Other provisions

Period of
authorisation

No
(or EC No)

Element

Additive

Chemical formula

Maximum content of the element in mg/kg of complete feedingstuff

Other provisions

E 4

Copper-Cu

Copper-lysine sulphate

Cu(C6H13N2O2)2.SO4

Pigs for fattening:

Trace elements

(cid:151) in Member States where the mean density of the porcine
population is equal to or higher than 175 pigs per 100 ha
of utilisable agricultural land:
(cid:151) up to 16 weeks: 175 (total)

(cid:151) in Member States where the mean density of the porcine
population is lower than 175 pigs per 100 ha of utilisable
agricultural land:
(cid:151) up to 16 weeks: 175 (total)

Pigs for fattening:

(cid:151) in Member States where the mean density of the porcine
population is equal to or higher than 175 pigs per 100 ha
of utilisable agricultural land:
(cid:151) from 17th week up to slaughter: 35 (total)

(cid:151) in Member States where the mean density of the porcine
population is lower than 175 pigs per 100 ha of utilisable
agricultural land:
(cid:151) from 17th week up to six months: 100 (total)
(cid:151) over six months up to slaughter: 35 (total)

Breeding pigs: 35 (total)

Other species or categories of animals, with the exception of
calves prior to the start of rumination and sheep: 35 (total)

30.9.2001

30.9.2001

30.9.2001

30.9.2001

Period of
authorisation

30.9.2001 (e)

Not more than 50 mg/kg
of copper in the
complete feedingstuff
may come from
copper-lysine sulphate.

30.9.2001 (e)

Not more than 25 mg/kg
of copper in the
complete feedingstuffs
may come from
copper-lysine sulphate.

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No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Binders, anti-caking agents and coagulants

3

4

Clinoptilolite of volcanic
origin

Calcium hydrated aluminosilicate
of volcanic origin containing a
minimum of 85 % of clinoptilolite
and a maximum of 15 % of
feldspar, micas and clays free of
fibres and quartz.

Maximum lead content: 80 mg/kg

Pigs

Rabbits

Poultry

Clinoptilolite of
sedimentary origin

Hydrated calcium aluminosilicate
of sedimentary origin containing at
least 80 % clinoptilolite and a
maximum 20 % of clay minerals,
free of fibres and quartz.

Maximum content in dioxins (1)

Pigs for
fattening

Chickens for
fattening

Turkeys for
fattening

Bovines

Salmon

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

20 000

All feedingstuffs

30.9.2001 (f)

20 000

All feedingstuffs

30.9.2001 (f)

20 000

All feedingstuffs

30.9.2001 (f)

20 000

All feedingstuffs

30.9.2001 (o)

20 000

All feedingstuffs

30.9.2001 (o)

20 000

All feedingstuffs

30.9.2001 (o)

20 000

All feedingstuffs

30.9.2001 (o)

20 000

All feedingstuffs

30.9.2001 (o)

1

3-phytase
EC 3.1.3.8

Preparation of 3-phytase produced
by Aspergillus niger (CBS 114.94)
having a minimum phytase activity
of 5 000 FTU (2)/g for solid and
liquid preparations

Enzymes

Turkeys

(cid:151)

125 FTU

(cid:151)

1.

Indicate in the directions for use for
the additive and the premixture the
storage temperature, storage duration
and stability on pelleting.

30.9.2001 (d)

2. Recommended dose per kilogram of
complete feedingstuff: 200 to 800
FTU.

3.

For use in compound feedingstuffs
with a minimum content of 0,3 %
phytate, e.g. 20 % wheat.

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No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

2

3-phytase
EC 3.1.3.8

Preparation of 3-phytase produced
by Aspergillus oryzae (DSM 10 289)
having a minimum activity of:

Coated form: 2 500 FYT (3)/g

Liquid form: 5 000 FYT/g

Piglets

4 months

250 FYT

1 000 FYT

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff: 500 FYT.

3.

For use in compound feed rich in
phytates, e.g. containing more than
(maize, barley, oats,
40 % cereals
wheat,
and
pulses.

triticale), oilseeds

rye,

Pigs for
fattening

(cid:151)

400 FYT

1 000 FYT

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff: 500 FYT.

3.

For use in compound feed rich in
phytates, e.g. containing more than
(maize, barley, oats,
40 % cereals
wheat,
and
pulses.

triticale), oilseeds

rye,

Chickens for
fattening

(cid:151)

200 FYT

1 000 FYT

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff: 500 FYT.

L

3
1
9
/
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

3.

For use in compound feed rich in
phytates, e.g. containing more than
(maize, barley, oats,
40 % cereals
and
wheat,
pulses.

triticale), oilseeds

rye,

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Laying hens

(cid:151)

500 FYT

1 000 FYT

1.

for use of

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

30.9.2001 (h)

2. Recommended

dose

per

kg

of

complete feedingstuff: 750 FYT.

3.

For use in compound feed rich in
phytates, e.g. containing more than
(maize, barley, oats,
40 % cereals
wheat,
and
pulses.

triticale), oilseeds

rye,

3

4

Alpha-galactosidase
EC 3.2.1.22

Preparation of alpha-galactosidase
produced by Aspergillus oryzae
(DSM 10 286) having a minimum
activity of:

Liquid form: 1 000 GALU (4)/g

Chickens for
fattening

(cid:151)

300 GALU 1 000 GALU 1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 450 GALU.

3.

For use in compound feed rich in
oligosaccharides, e.g. containing more
than 25 % soy meal, cotton seed cakes,
peas.

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

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

Coated form: 50 FBG (5)/g

Liquid form: 120 FBG/g

Piglets

4 months

25 FBG

40 FBG

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff: 25 FBG.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans),
containing more
than 50 % maize or barley.

polysaccharides

e.g.

.

1
6
1
2
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

3
1
9
/
1
1

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Chickens for
fattening

(cid:151)

10 FBG

100 FBG

1.

for use of

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

30.9.2001 (m)

2. Recommended dose per kilogram of

complete feedingstuff: 20 FBG.

3.

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

polysaccharides

e.g.

5

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Aspergillus
oryzae (DSM 10287) having a
minimum activity of:

Coated form: 1 000 FXU (6)/g

Liquid form: 650 FXU/ml

Chickens for
fattening

(cid:151)

80 FXU

200 FXU

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 150 FXU.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 50 % wheat.

polysaccharides

Turkeys for
fattening

(cid:151)

225 FXU

600 FXU

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 225 to 600 FXU.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 50 % wheat.

polysaccharides

L

3
1
9
/
1
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Piglets

4 months

200 FXU

(cid:151)

1.

for use of

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

2. Recommended dose per kilogram of
complete feedingstuff: 200 FXU.

3.

For use in compound feed rich in
non-starch
(mainly
e.g.containing more
arabinoxylans),
than 50 % wheat.

polysaccharides

Period of
authorisation

30.9.2001 (g)

6

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 Humicola
insolens (DSM 10442) having a
minimum activity of:
Coated form:
800 FXU (7)/g
75 FBG (8)/g
Microgranulated form:
800 FXU/g
75 FBG/g

Liquid form:
550 FXU/ml
50 FBG/ml

Chickens for
fattening

(cid:151)

200 FXU

1 000 FXU

1.

19 FBG

94 FBG

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff:

400 FXU
38 FBG.

3.

polysaccharides

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

Piglets

4 months

240 FXU

1 000 FXU

1.

22 FBG

94 FBG

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff:

400 FXU
38 FBG.

3.

polysaccharides

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

.

1
6
1
2
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

3
1
9
/
1
3

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Pigs for
fattening

(cid:151)

200 FXU

800 FXU

1.

19 FBG

75 FBG

conditions of use of

the
In the
additive and premixture,
indicate the
storage temperature, storage life, and
the stability to pelleting.

30.9.2001 (i)

2. Recommended
feedingstuff:

dose

per

kg

of

400 FXU
38 FBG.

3.

polysaccharides

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

7

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 Aspergillus
niger (CBS 600.94) having a
minimum activity of:

Chickens for
fattening

(cid:151)

3 600 FXU

12 000FXU

1.

1 500 BGU

5 000 BGU

for use of

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

30.9.2001 (g*)

Coated form:
36 000 FXU (9)/g
15 000 BGU (10)/g

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

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

2. Recommended dose per kilogram of

complete feedingstuff:

3 600 to 6 000 FXU
1 500 to 2 500 BGU.

3.

polysaccharides

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

L

3
1
9
/
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

C
o
m
m
u
n
i
t
i
e
s

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

Piglets

4 months

6 000 FXU

2 500 BGU

(cid:151)

(cid:151)

1.

for use of

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

30.9.2001 (m)

E
N

2. Recommended dose per kilogram of

complete feedingstuff:

6 000 FXU
2 500 BGU.

3.

polysaccharides

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

Turkeys for
fattening

(cid:151)

6 000 FXU

12 000 FXU

1.

2 500 BGU

5 000 BGU

for use of

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

30.9.2001 (m)

2. Recommended dose per kilogram of

complete feedingstuff:

6 000 to 12 000 FXU
2 500 to 5 000 BGU.

3.

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

polysaccharides

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
1
9
/
1
5

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Laying hens

(cid:151)

12 000FXU

5 000 BGU

(cid:151)

(cid:151)

1.

for use of

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

30.9.2001 (m)

2. Recommended dose per kilogram of

complete feedingstuff:

12 000 FXU
5 000 BGU.

3.

polysaccharides

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

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 produced by Aspergillus
niger (CBS 600.94) having a
minimum activity of:

Chickens for
fattening

(cid:151)

3 000 BGU

10 000 BGU

1.

1 200 FXU

4 000 FXU

for use of

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

30.9.2001 (g*)

Coated form:
10 000 BGU (10)/g
4 000 FXU (9)/g

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

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

2. Recommended dose per kilogram of

complete feedingstuff:

3 000 to 10 000 BGU
1 200 to 4 000 FXU.

3.

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

polysaccharides

L

3
1
9
/
1
6

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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Piglets

4 months

3 000 BGU

5 000 BGU

1.

1 200 FXU

2 000 FXU

for use of

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

30.9.2001 (h*)

Laying hens

(cid:151)

5 000 BGU

2 000 FXU

(cid:151)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

3 000 to 5 000 BGU
1 200 to 2 000 FXU.

3.

1.

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

polysaccharides

for use of

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

30.9.2001 (m)

2. Recommended dose per kilogram of

complete feedingstuff:

5 000 BGU
2 000 FXU.

3.

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

polysaccharides

.

1
6
1
2
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

3
1
9
/
1
7

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

9

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Aspergillus
niger (CBS 270.95) having a
minimum activity of:

Solid form: 28 000 EXU (11)/g

Liquid form: 14 000 EXU/ml

Chickens for
fattening

(cid:151)

1 400 EXU

(cid:151)

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 1 400 EXU.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 50 % wheat.

polysaccharides

Laying hens

(cid:151)

2 400 EXU

(cid:151)

1.

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:
2 400 to 7 400 EXU.

per

kg

of

3.

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

polysaccharides

Turkeys for
fattening

(cid:151)

2 400 EXU

(cid:151)

1.

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:
2 400 to 5 600 EXU.

per

kg

of

3.

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

polysaccharides

L

3
1
9
/
1
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

10

Alpha-amylase
EC 3.2.1.1

Preparation of alpha-amylase
produced by Bacillus
amyloliquefaciens (CBS 360.94)
having a minimum activity of:

Solid form: 45 000 RAU (12)/g

Liquid form: 20 000 RAU/ml

Piglets

4 months

1 800 RAU

(cid:151)

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 1 800 RAU.

3.

For use, exclusively, in compound feed
liquid feeding systems,
destined for
and
feed
starch-rich
materials (e.g. containing more than
35 % wheat).

containing

Pigs for
fattening

(cid:151)

1 800 RAU

(cid:151)

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 1 800 RAU.

3.

For use, exclusively, in compound feed
liquid feeding systems,
destined for
and
feed
starch-rich
materials (e.g. containing more than
35 % wheat).

containing

Sows

(cid:151)

1 800 RAU

(cid:151)

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of
complete feedingstuff: 1 800 RAU.

3.

For use, exclusively, in compound feed
liquid feeding systems,
destined for
and
feed
starch-rich
materials (e.g. containing more than
35 % wheat).

containing

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
1
9
/
1
9

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Chickens for
fattening

(cid:151)

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

Preparation of endo-1,4-beta-
glucanase, endo-1,3(4)-beta-
glucanase and endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (ATCC 74 252)
having a minimum activity of:

Endo-1,4-beta-glucanase:
8 000 U (13)/ml

Endo-1,3(4)-beta-glucanase:
18 000 U (14)/ml

Endo-1,4-beta-xylanase:
26 000 U (15)/ml

12

Endo-1,4-beta-glucanase
EC 3.2.1.4

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

Preparation of endo-1,4-beta-
glucanase, endo-1,3(4)-beta-
glucanase and endo-1,4-beta-
xylanase produced by Trichoderma
viride (FERM BP-4447) having a
minimum activity of:

Endo-1,4-beta-xylanase
EC 3.2.1.8

Endo-1,4-beta-glucanase:
8 000 U (13)/g

Chickens for
fattening

(cid:151)

Endo-1,3(4)-beta-glucanase:
18 000 U (14)/g

Endo-1,4-beta-xylanase:
26 000 U (15)/g

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

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

Endo-
1,4-beta-
xylanase:
1 300 U

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

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

Endo-
1,4-beta-
xylanase:
650 U

(cid:151)

1.

for use of

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

30.9.2001 (g)

(cid:151)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

endo-1,4-beta-glucanase:
400 to 1 600 U

endo-1,3(4)-beta-glucanase:
900 to 3 600 U

endo-1,4-beta-xylanase:
1 300 to 5 200 U.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
arabinoxylans and beta-glucans), e.g.
containing more than 30 % wheat or
barley and 10 % rye.

(cid:151)

1.

for use of

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

30.9.2001 (g)

(cid:151)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

endo-1,4-beta-glucanase:
800 to 1 200 U
endo-1,3(4)-beta-glucanase:
1 800 to 2 700 U
endo-1,4-beta-xylanase:
2 600 to 3 900 U.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
arabinoxylans and beta-glucans), e.g.
containing more than 20 % wheat and
20 % barley, and/or 25 % rye.

L

3
1
9
/
2
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

Laying hens

(cid:151)

Turkeys for
fattening

(cid:151)

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

Endo-
1,3(4)-beta-
glucanase:
1 440 U

Endo-
1,4-beta-
xylanase:
2 080 U

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

Endo-
1,3(4)-beta-
glucanase:
1 800 U

Endo-
1,4-beta-
xylanase:
2 600 U

(cid:151)

1.

for use of

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

30.9.2001 (g)

E
N

(cid:151)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

endo-1,4-beta-glucanase:
640 to 1 280 U

endo-1,3(4)-beta-glucanase:
1 440 to 2 880 U

endo-1,4-beta-xylanase:
2 080 to 4 160 U.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
arabinoxylans and beta-glucans), e.g.
containing more than 20 % wheat and
20 % barley and/or 25 % rye.

(cid:151)

1.

for use of

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

30.9.2001 (g**)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-glucanase:
800 to 1 200 U

endo-1,3(4)-beta-glucanase:
1 800 to 2 700 U

endo-1,4-beta-xylanase:
2 600 to 3 900 U.

3.

polysaccharides

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

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
1
9
/
2
1

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

13

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

Powder form:
8 000 BGU (16)/g
11 000 EXU (17)/g

Granulated form:
6 000 BGU/g
8 250 EXU/g

Liquid form:
2 000 BGU/ml
2 750 EXU/ml

Chickens for
fattening

(cid:151)

100 BGU

130 EXU

(cid:151)

(cid:151)

1.

for use of

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

30.9.2001 (g)

2. Recommended dose per kilogram of

complete feedingstuff:

100 BGU
130 EXU.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
beta-glucans and arabinoxylans), e.g.
containing more than 30 % wheat and
30 % barley, or 20 % rye.

Laying hens

(cid:151)

600 BGU

800 EXU

(cid:151)

(cid:151)

1.

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:

per

kg

of

600 BGU
800 EXU.

3.

polysaccharides

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

L

3
1
9
/
2
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Turkeys for
fattening

(cid:151)

600 BGU

800 EXU

(cid:151)

(cid:151)

1.

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:
600 BGU
800 EXU.

per

kg

of

3.

polysaccharides

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

14

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Aspergillus
niger (CBS 520.94) having a
minimum activity of:

Chickens for
fattening

(cid:151)

Endo-
1,4-beta-
xylanase:
300 U

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
Endo-1,4-beta-xylanase:
600 U (18)/g

Liquid form:
Endo-1,4-beta-xylanase:
300 U/ml

2. Recommended

dose per

kilogram

complete feedingstuff:
endo-1,4-beta-xylanase:
300 to 600 U.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 50 % wheat.

polysaccharides

15

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
viride (CBS 517.94) having a
minimum activity of:

Chickens for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
Endo-1,3(4)-beta-glucanase:
650 U (19)/g

Liquid form:
Endo-1,3(4)-beta-glucanase:
325 U/ml

2. Recommended dose per kilogram of

complete feedingstuff:
endo-1,3(4)-beta-glucanase:
325 to 650 U.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans), e.g. containing more
than 50 % barley.

polysaccharides

.

1
6
1
2
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

3
1
9
/
2
3

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

16

Endo-1,4-beta-glucanase
EC 3.2.1.4

Preparation of endo-1,4-beta-
glucanase produced by Trichoderma
longibrachiatum (IMI SD 142)
having a minimum activity of:

Chickens for
fattening

(cid:151)

250 CU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

Solid form:
2 000 CU (20)/g

Liquid form:
2 000 CU/ml

2. Recommended
complete
1 000 CU.

dose
feedingstuff:

per

kg
500

of
to

3.

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

polysaccharides

Laying hens

(cid:151)

250 CU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
1 000 CU.

dose
feedingstuff:

per

kg
500

of
to

3.

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

polysaccharides

Piglets

4 months

250 CU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
1 000 CU.

dose
feedingstuff:

per

kg
500

of
to

3.

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

polysaccharides

L

3
1
9
/
2
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Pigs for
fattening

(cid:151)

250 CU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
1 000 CU.

dose
feedingstuff:

per

kg
500

of
to

3.

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

polysaccharides

17

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (IMI SD 135)
having a minimum activity of:

Chickens for
fattening

(cid:151)

750 EPU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

Solid form:
6 000 EPU (21)/g

Liquid form:
6 000 EPU/ml

2. Recommended
complete
3 000 EPU.

dose

feedingstuff:

per

kg
1 500

of
to

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 40 % wheat or maize.

polysaccharides

Laying hens

(cid:151)

750 EPU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
3 000 EPU.

dose

feedingstuff:

per

kg
1 500

of
to

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 40 % wheat or maize.

polysaccharides

.

1
6
1
2
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

3
1
9
/
2
5

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Piglets

4 months

750 EPU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
3 000 EPU.

dose

feedingstuff:

per

kg
1 500

of
to

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 40 % wheat or maize.

polysaccharides

Pigs for
fattening

(cid:151)

750 EPU

(cid:151)

1.

for use of

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

30.9.2001 (g**)

2. Recommended
complete
3 000 EPU.

dose

feedingstuff:

per

kg
1 500

of
to

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 40 % wheat or maize.

polysaccharides

Turkeys for
fattening

(cid:151)

750 EPU

(cid:151)

1.

for use of

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

30.9.2001 (n)

2. Recommended
complete
3 000 EPU.

dose

feedingstuff:

per

kg
1 500

of
to

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 35 % wheat or maize.

polysaccharides

L

3
1
9
/
2
6

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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

18

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus
niger (MUCL 39199) having a
minimum activity of:

Chickens for
fattening

(cid:151)

100 AGL

(cid:151)

1.

for use of

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

30.9.2001 (g)

E
N

Solid form:
2 000 AGL (22)/g

Liquid form:
500 AGL/ml

2. Recommended dose per kilogram of
complete feedingstuff: 100 AGL.

3.

For use in compound feed rich in
(mainly
non-starch
beta-glucans), e.g. containing more
than 40 % barley and 20 % wheat.

polysaccharides

19

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus
niger (MUCL 39199) having a
minimum activity of:

Chickens for
fattening

(cid:151)

25 AGL

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
1 500 AGL (22)/g

Liquid form:
200 AGL/g

2. Recommended dose per kilogram of
complete feedingstuff: 25 to 100 AGL.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans), e.g. containing more
than 50 % barley.

polysaccharides

20

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (MUCL 39203)
having a minimum activity of:

Chickens for
fattening

(cid:151)

100 AXC

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
2 000 AXC (23)/g

Liquid form:
500 AXC/ml

2. Recommended dose per kilogram of
complete feedingstuff: 100 AXC.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 40 % wheat or rye.

polysaccharides

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
1
9
/
2
7

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

21

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (MUCL 39203)
having a minimum activity of:

Chickens for
fattening

(cid:151)

25 AXC

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
1 500 AXC (23)/g

Liquid form:
200 AXC/g

2. Recommended dose per kilogram of
complete feedingstuff: 25 to 100 AXC.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 50 % wheat.

polysaccharides

22

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (CNCM MA 6-10 W)
having a minimum activity of:

Chickens for
fattening

(cid:151)

1 050 BGN

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
70 000 BGN (24)/g

Liquid form:
14 000 BGN/ml

2. Recommended dose per kilogram of
complete feedingstuff: 2 800 BGN.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans), e.g. containing more
than 50 % barley.

polysaccharides

23

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (CNCM MA 6-10 W)
having a minimum activity of:

Chickens for
fattening

(cid:151)

1 050 IFP

(cid:151)

1.

for use of

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

30.9.2001 (g)

Solid form:
70 000 IFP (25)/g

Liquid form:
7 000 IFP/ml

2. Recommended dose per kilogram of
complete feedingstuff: 1 400 IFP.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 56 % wheat.

polysaccharides

L

3
1
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

24

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

Preparation of endo-1,4-beta-
xylanase and endo-1,3(4)-beta-
glucanase produced by Aspergillus
niger (CNCM I-1517) having a
minimum activity of:

28 000 QXU (26)/g

140 000 QGU (27)/g

Chickens for
fattening

(cid:151)

420 QXU

1 120 QXU

1.

2 100 QGU

5 600 QGU

for use of

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

30.9.2001 (g)

25

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,3(4)-beta-
glucanase and endo-1,4-beta-
xylanase produced by Aspergillus
niger (NRRL 25541) having a
minimum activity of:

Endo-1,3(4)-beta-glucanase:
1 100 U (28)/g

Endo-1,4-beta-xylanase:
1 600 U (29)/g

Chickens for
fattening

(cid:151)

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

Endo-
1,4-beta-
xylanase:
200 U

2. Recommended dose per kilogram of

complete feedingstuff:

560 QXU
2 800 QGU.

3.

polysaccharides

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

(cid:151)

1.

for use of

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

30.9.2001 (g)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

endo-1,3(4)-beta-glucanase:
138 U
endo-1,4-beta-xylanase:
200 U.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
beta-glucans and arabinoxylans), e.g.
containing more than 50 % barley or
30 % wheat and 30 % maize.

.

1
6
1
2
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

3
1
9
/
2
9

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

26

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
reesei (CBS 526.94) having a
minimum activity of:

Solid form: 350 000 BU (30)/g

Liquid form: 50 000 BU/g

Laying hens

(cid:151)

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

Endo-
1,4-beta-
xylanase:
200 U

(cid:151)

1.

for use of

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

30.9.2001 (g)

(cid:151)

2. Recommended dose per kilogram of

complete feedingstuff:

endo-1,3(4)-beta-glucanase:
138 U
endo-1,4-beta-xylanase:
200 U.

3.

polysaccharides

For use in compound feed rich in
non-starch
(mainly
arabinoxylans and beta-glucans), e.g.
containing more than 50 % barley or
30 % wheat and 30 % maize.

Chickens for
fattening

(cid:151)

23 000 BU

(cid:151)

1.

for use of

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

30.9.2001 (j)

2. Recommended dose per kilogram of
to
feedingstuff:

23 000

complete
50 000 BU.

3.

For use in compound feed rich in
(mainly
non-starch
glucans), e.g. containing more than
20 % barley or 30 % rye.

polysaccharides

Piglets

4 months

26 000 BU

(cid:151)

1.

for use of

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

30.9.2001 (j)

2. Recommended dose per kilogram of
to
feedingstuff:

26 000

complete
35 000 BU.

3.

For use in compound feed rich in
(mainly
non-starch
glucans), e.g. containing more than
60 % barley or wheat.

polysaccharides

L

3
1
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

27

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
reesei (CBS 529.94) and endo-
1,3(4)-beta-glucanase produced by
Trichoderma reesei (CBS 526.94)
having minimum activities of:

Solid form:
200 000 BXU (31)/g
200 000 BU (30)/g

Liquid form:
30 000 BXU/g
30 000 BU/g

28

3-Phytase
EC 3.1.3.8

Preparation of 3-phytase produced
by Trichoderma reesei (CBS 528.94)
having a minimum activity of:

Solid form: 5 000 PPU (32)/g

Liquid form: 1 000 PPU/g

Chickens for
fattening

(cid:151)

2 500 BXU

(cid:151)

1.

2 500 BU

for use of

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

30.9.2001 (j)

2. Recommended dose per kilogram of

complete feedingstuff:

10 000 BXU
10 000 BU.

3.

polysaccharides

For use in compound feed rich in
(mainly
non-starch
arabinoxylans
e.g.
and
containing more than 40 % wheat or
30 % rye.

glucans),

Piglets

4 months

250 PPU

(cid:151)

1.

for use of

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

30.9.2001 (j)

2. Recommended dose per kilogram of
to

feedingstuff:

500

complete
750 PPU.

3.

For use in compound feed rich in
phytates, e.g. containing more than
50 % cereals
(corn, barley, wheat),
tapioca, oilseeds and pulses.

Pigs for
fattening

(cid:151)

500 PPU

(cid:151)

1.

for use of

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

30.9.2001 (j)

2. Recommended dose per kilogram of
to

feedingstuff:

500

complete
750 PPU.

3.

For use in compound feed rich in
phytates, e.g. containing more than
50 % cereals
(corn, barley, wheat),
tapioca, oilseeds and pulses.

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
1
9
/
3
1

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

29

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Geosmithia
emersonii (IMI SD 133) having a
minimum activity of:

Endo-1,3(4)-beta-glucanase:
5 500 U (33)/g

Chickens for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (h)

30

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,3(4)-beta-
glucanase and endo-1,4-beta-
xylanase produced by Penicillium
funiculosum (IMI SD 101) having a
minimum activity of:

Chickens for
fattening

(cid:151)

Powder form:
Endo-1,3(4)-beta-glucanase:
2 000 U (34)/g
Endo-1,4-beta-xylanase:
1 400 U (35)/g

Liquid form:
Endo-1,3(4)-beta-glucanase:
500 U/ml
Endo-1,4-beta-xylanase:
350 U/ml

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 250 U.

3.

For use in compound feed rich in
non-starch polysaccharides,
(mainly
beta-glucans), e.g. containing more
than 50 % barley.

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

Endo-
1,4-beta-
xylanase:
70 U

(cid:151)

1.

for use of

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

30.9.2001 (h)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase:
100 U

endo-1,4-beta-xylanase:
70 U.

3.

For use in compound feed rich in
(mainly
non-starch polysaccharides,
beta-glucans and arabinoxylans), e.g.
containing more than 50 % barley or
60 % wheat.

L

3
1
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

31

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (CBS 614.94)
having a minimum activity of:

Solid form: 300 EU (36)/g

Liquid form: 1 000 EU/g

Chickens for
fattening

(cid:151)

600 EU

(cid:151)

1.

for use of

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

30.9.2001 (h)

2. Recommended

dose

per

kg

of

complete feedingstuff: 600 EU.

3.

For use in compound feed rich in
(mainly
non-starch
arabinoxylans), e.g. containing more
than 60 % wheat.

polysaccharides

32

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

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106)
having a minimum activity of:

Endo-1,3(4)-beta-glucanase:
200 U (19)/ml

Laying hens

(cid:151)

300 EU

(cid:151)

1.

for use of

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

30.9.2001 (h)

2. Recommended

dose

per

kg

of

complete feedingstuff: 600 EU.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 60 % wheat.

polysaccharides

Chickens for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 100 U.

3.

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

polysaccharides

.

1
6
1
2
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

3
1
9
/
3
3

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Endo-1,3(4)-beta-glucanase:
1 200 U/ml

Piglets

4 months

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 400 U.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans), e.g. containing more
than 55 % barley.

polysaccharides

Pigs for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

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

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans), e.g. containing more
than 70 % barley.

polysaccharides

L

3
1
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

33

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (ATCC 2105)
having a minimum activity of:

Chickens for
fattening

(cid:151)

Endo-
1,4-beta-
xylanase:
500 U

(cid:151)

1.

for use of

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

30.9.2001 (i)

Powder form:
Endo-1,4-beta-xylanase:
2 000 U (37)/g

Liquid form:
Endo-1,4-beta-xylanase:
5 000 U/ml

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase:
500 to 2 500 U.

3.

For use in compound feed rich in
(mainly
non-starch
arabinoxylans), e.g. containing more
than 55 % wheat or 60 % rye.

polysaccharides

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

Laying hens

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase:
2 000 U.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 35 % wheat.

polysaccharides

Powder form:
Endo-1,4-beta-xylanase:
4 000 U/g

Liquid form:
Endo-1,4-beta-xylanase:
10 000 U/ml

Powder form:
Endo-1,4-beta-xylanase:
4 000 U/g

Liquid form:
Endo-1,4-beta-xylanase:
8 000 U/ml

Piglets

4 months

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase:
5 000 U.

3.

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

polysaccharides

Pigs for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (i)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase:
4 000 U.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 35 % wheat.

polysaccharides

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
1
9
/
3
5

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

34

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Alpha-amylase
EC 3.2.1.1

35

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,3(4)-beta-
glucanase and endo 1,4-beta-
xylanase produced by Aspergillus
niger (NRRL 25541) and of
alpha-amylase produced by
Aspergillus oryzae (ATCC 66222)
having a minimum activity of:

Endo-1,3(4)-beta-glucanase:
275 U (28)/g

Endo-1,4-beta-xylanase:
400 U (38)/g

Alpha-amylase:
3 100 U (39)/g

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum
(ATCC 2105) having a minimum
activity of:

Endo-1,3(4)-beta-glucanase:
80 U (19)/g

Endo-1,4-beta-xylanase:
180 U (37)/g

Piglets

4 months

Laying hens

(cid:151)

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

Endo-
1,4-beta-
xylanase:
240 U

Alpha-
amylase:
1 860 U

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

Endo-
1,4-beta-
xylanase:
180 U

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 165 U
endo-1,4-beta-xylanase: 240 U
alpha-amylase: 1 860 U.

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
and
containing
more than 45 % barley and 10 %
wheat or 10 % maize.

beta-glucans),

e.g.

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 80 U
endo-1,4-beta-xylanase: 180 U.

3.

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

L

3
1
9
/
3
6

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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

36

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta- xylanase produced
by Trichoderma longibrachiatum IMI
SD 135) having a minimum
activity of:

endo-1,3(4)-beta-glucanase:
300 U (19)/g

endo-1,4-beta-xylanase: 300 U (37)/g

Chickens for
fattening

(cid:151)

Laying hens

(cid:151)

37

Endo-1,4-beta-xylanase
EC 3.2.1.8

Subtilisin
EC 3.4.21.62

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (ATCC 2105) and
subtilisin produced by Bacillus
subtilis (ATCC 2107), with a
minimum activity of:

Endo-1,4-beta-xylanase:
2 500 U (37)/g

Subtilisin: 800 U (40)/g

Chickens for
fattening

(cid:151)

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

Endo-
1,4-beta-
xylanase:
300 U

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

Endo-
1,4-beta-
xylanase:
300 U

Endo-
1,4-beta-
xylanase:
500 U

Subtilisin:
160 U

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 300 U
endo-1,4-beta-xylanase: 300 U.

3.

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

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 300 U
endo-1,4-beta-xylanase: 300 U.

3.

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

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

per

dose
complete feedingstuff:
endo-1,4-beta-xylanase: 500-2 500 U
subtilisin: 160-800 U.

kg

of

3.

For use
containing more than 65 % wheat.

in compound feed e.g.

.

1
6
1
2
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

3
1
9
/
3
7

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Turkeys

(cid:151)

Piglets

4 months

Pigs for
fattening

(cid:151)

38

Endo-1,4-beta-xylanase
EC 3.2.1.8

Subtilisin
EC 3.4.21.62

39

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (ATCC 2105) and
subtilisin produced by Bacillus
subtilis (ATCC 2107) having a
minimum activity of:

Endo-1,4-beta-xylanase:
5 000 U (37)/g

Subtilisin: 500 U (40)/g

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum
(ATCC 2105) having a minimum
activity of:

Endo-1,3(4)-beta-glucanase:
400 U (19)/g

Endo-1,4-beta-xylanase:
400 U (37)/g

Endo-
1,4-beta-
xylanase:
825 U

Subtilisin:
265 U

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

Subtilisin:
500 U

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

Endo-
1,4-beta-
xylanase:
400 U

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

per

kg

of

2. Recommended

dose
complete feedingstuff:
endo-1,4-beta-xylanase:
825 to 2 500 U
subtilisin: 265 to 800 U.

3.

For use
containing more than 45 % wheat.

in compound feed e.g.

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

per

dose
complete feedingstuff:
endo-1,4-beta-xylanase: 5 000 U
subtilisin: 500 U.

kg

of

3.

For use
containing more than 40 % wheat.

in compound feed e.g.

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 400 U
endo-1,4-beta-xylanase: 400 U.

3.

For use in compound feed rich in
non-starch
(mainly
beta-glucans and arabinoxylans) e.g.
containing more than 65 % barley.

polysaccharides

L

3
1
9
/
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

40

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Subtilisin
EC 3.4.21.62

41

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Subtilisin
EC 3.4.21.62

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106),
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum
(ATCC 2105) and subtilisin
produced by Bacillus subtilis (ATCC
2107) having a minimum activity
of:

Endo-1,3(4)-beta-glucanase:
100 U (19)/g

Endo-1,4-beta-xylanase:
300 U (37)/g

Subtilisin: 800 U (40)/g

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106),
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum
(ATCC 2105) and subtilisin
produced by Bacillus subtilis (ATCC
2107) having a minimum activity
of:

Endo-1,3(4)-beta-glucanase:
100 U (19)/g

Endo-1,4-beta-xylanase:
2 500 U (37)/g

Subtilisin: 800 U (40)/g

Chickens for
fattening

(cid:151)

Chickens for
fattening

(cid:151)

Laying hens

(cid:151)

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

Endo-
1,4-beta-
xylanase:
90 U

Subtilisin:
240 U

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

Endo-
1,4-beta-
xylanase:
625 U

Subtilisin:
200 U

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

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

Subtilisin:
800 U

Period of
authorisation

30.9.2001 (k)

(cid:151)

1.

for use of

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

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase:
30 to 100 U
endo-1,4-beta-xylanase: 90 to 300 U
subtilisin: 240 to 800 U.

3.

For use
containing more than 60 % barley.

in compound feed e.g.

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase:
25 to 100 U
endo-1,4-beta-xylanase:
625 to 2 500 U
subtilisin: 200 to 800 U.

3.

For use
in compound feed e.g.
containing more than 30 % wheat and
10 % barley.

(cid:151)

1.

for use of

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

30.9.2001 (k)

(cid:151)

(cid:151)

2. Recommended

kg

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 100 U
endo-1,4-beta-xylanase: 2 500 U
subtilisin: 800 U.

of

3.

For use
in compound feed e.g.
containing more than 50 % wheat and
25 % barley.

.

1
6
1
2
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

3
1
9
/
3
9

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

42

Endo-1,4-beta-xylanase
EC 3.2.1.8

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (IMI SD 135)
having a minimum activity of:

Solid form:
Endo-1,4-beta-xylanase:
4 000 U (37)/g

Characteristics of the authorised
preparation:
Endo-1,4-beta-xylanase: 1,99 %

Wheat: 97,7 %

Calcium propionate: 0,3 %
Lecithin: 0,01 %

Piglets

4 months

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

(cid:151)

1.

for use of

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

30.9.2001 (k)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase: 4 000 U.

3.

For use in compound feed rich in
non-starch polysaccharides,
(mainly
arabinoxylans), e.g. containing more
than 60 % wheat.

Pigs for
fattening

(cid:151)

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

(cid:151)

1.

for use of

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

30.9.2001 (n)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase: 4 000 U.

3.

For use in compound feed rich in
non-starch
(mainly
arabinoxylans), e.g. containing more
than 60 % wheat.

polysaccharides

Piglets

4 months

43

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

Alpha-amylase
EC 3.2.1.1

Preparation of endo-1,4-beta-
xylanase produced by Trichoderma
longibrachiatum (IMI SD 135),
endo-1,3(4)-beta-glucanase
produced by Trichoderma
longibrachiatum (ATCC 2106) and
alpha-amylase produced by Bacillus
amyloliquefaciens (DSM 9553)
having a minimum activity of:

Endo-1,4-beta-xylanase:
3 975 U (37)/g
Endo-1,3(4)-beta-glucanase:
125 U (19)/g
Alpha-amylase: 1 000 U (41)/g

Endo-
1,4-beta-
xylanase:
3 975 U

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

Alpha-
amylase:
1 000 U

(cid:151)

1.

for use of

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

30.9.2001 (l)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,4-beta-xylanase: 3 975 U
endo-1,3(4)-beta-glucanase: 125 U
alpha-amylase: 1 000 U.

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
containing
and
e.g.
beta-glucans),
more
than 30 % wheat and 20 %
barley and 20 % rye.

L

3
1
9
/
4
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

44

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Alpha-amylase
EC 3.2.1.1

45

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Alpha-amylase
EC 3.2.1.1

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum
(ATCC 2105) and alpha-amylase
produced by Bacillus
amyloliquefaciens (DSM 9553)
having a minimum activity of:

Endo-1,3(4)-beta-glucanase:
250 U (19)/g
Endo-1,4-beta-xylanase:
400 U (37)/g
Alpha-amylase: 1 000 U (41)/g

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum (IMI
SD 135) and alpha-amylase
produced by Bacillus
amyloliquefaciens (DSM 9553)
having a minimum activity of:

Endo-1,3(4)-beta-glucanase:
250 U (19)/g
Endo-1,4-beta-xylanase:
400 U (37)/g
Alpha-amylase: 1 000 U (41)/g

Piglets

4 months

Piglets

4 months

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

Endo-
1,4-beta-
xylanase:
400 U

Alpha-
amylase:
1 000 U

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

Endo-
1,4-beta-
xylanase:
400 U

Alpha-
amylase:
1 000 U

(cid:151)

1.

for use of

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

30.9.2001 (l)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 250 U
endo-1,4-beta-xylanase: 400 U
alpha-amylase: 1 000 U.

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
and
containing
more than 50 % barley.

beta-glucans),

e.g.

(cid:151)

1.

for use of

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

30.9.2001 (l)

(cid:151)

(cid:151)

2. Recommended

dose
complete feedingstuff:

per

kg

of

endo-1,3(4)-beta-glucanase: 250 U
endo-1,4-beta-xylanase: 400 U
alpha-amylase: 1 000 U.

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
and
containing
more than 35 % barley.

beta-glucans),

e.g.

.

1
6
1
2
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

3
1
9
/
4
1

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

Pigs for
fattening

(cid:151)

Piglets

4 months

46

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Polygalacturonase
EC 3.2.1.15

47

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Alpha-amylase
EC 3.2.1.1

Polygalacturonase
EC 3.2.1.15

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106) and
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum (IMI
SD 135) and polygalacturonase
produced by Aspergillus aculeatus
(CBS 589.94) having a minimum
activity of:

Endo-1,3(4)-beta-glucanase:
400 U (19)/g
Endo-1,4-beta-xylanase:
400 U (37)/g
Polygalacturonase: 50 U (41)/g

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106),
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum (IMI
SD 135), alpha-amylase produced
by Bacillus amyloliquefaciens (DSM
9553), polygalacturonase produced
by Aspergillus aculeatus (CBS
589.94) having a minimum
activity of:

Endo-1,3(4)-beta-glucanase:
150 U (19)/g
Endo-1,4-beta-xylanase:
4 000 U (37)/g
Alpha-amylase: 1 000 U (41)/g
Polygalacturonase: 25 U (42)/g

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

Endo-
1,4-beta-
xylanase:
400 U

Polygalac-
turonase:
50 U

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

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

Alpha-
amylase:
1 000 U

Polygalac-
turonase:
25 U

(cid:151)

1.

for use of

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

30.9.2001 (l)

(cid:151)

(cid:151)

2. Recommended

kg

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 400 U
endo-1,4-beta-xylanase: 400 U
polygalacturonase: 50 U.

of

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
and
containing
more than 40 % barley.

beta-glucans),

e.g.

(cid:151)

1.

for use of

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

30.9.2001 (l)

(cid:151)

(cid:151)

(cid:151)

of

2. Recommended

kg

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 150 U
endo-1,4-beta-xylanase: 4 000 U
alpha-amylase: 1 000 U
polygalacturonase: 25 U.

3.

For use in compound feed containing
cereals rich in starch and non-starch
polysaccharides (mainly arabinoxylans
containing
and
more than 20 % barley and 35 %
wheat.

beta-glucans),

e.g.

L

3
1
9
/
4
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

48

Alpha-amylase
EC 3.2.1.1

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

Preparation of alpha-amylase and
endo-1,3(4)-beta-glucanase
produced by Bacillus
amyloliquefaciens (DSM 9553)
having a minimum activity of:

Coated form:
Alpha-amylase: 200 KNU (43)/g
Endo-1,3(4)-beta-glucanase:
350 FBG (44)/g

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

Chickens for
fattening

(cid:151)

10 KNU

40 KNU

1.

17 FBG

70 FBG

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:

per

kg

of

20 KNU
35 FBG.

3.

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

polysaccharides

Turkeys for
fattening

(cid:151)

40 KNU

80 KNU

1.

70 FBG

140 FBG

for use of

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

30.9.2001 (m)

2. Recommended

dose
complete feedingstuff:
40 KNU
70 FBG.

per

kg

of

3.

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

polysaccharides

.

1
6
1
2
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

3
1
9
/
4
3

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Period of
authorisation

49

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

Endo-1,4-beta-xylanase
EC 3.2.1.8

Alpha-amylase:
EC 3.2.1.1

Bacillolysin EC
EC 3.4.24.28

Polygalacturonase
EC 3.2.1.15

Preparation of endo-1,3(4)-beta-
glucanase produced by Trichoderma
longibrachiatum (ATCC 2106),
endo-1,4-beta-xylanase produced
by Trichoderma longibrachiatum (IMI
SD 135), alpha-amylase produced
by Bacillus amyloliquefaciens (DSM
9553), bacillolysin produced by
Bacillus amyloliquefaciens (DSM
9554) and polygalacturonase
produced by Aspergillus aculeatus
(CBS 589.94) having a minimum
activity of:

Endo-1,3(4)-beta-glucanase:
150 U (19)/g

Endo-1,4-beta-xylanase:
1 500 U (37)/g

Alpha-amylase: 500 U (41)/g

Bacillolysin: 800 U (40)/g

Polygalacturonase: 50 U (42)/g

Chickens for
fattening

(cid:151)

Laying hens

(cid:151)

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

Endo-
1,4-beta-
xylanase:
1 500 U

Alpha-
amylase:
500 U

Bacillolysin:
800 U

Polygalac-
turonase:
50 U

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

Endo-
1,4-beta-
xylanase:
1 500 U

Alpha-
amylase:
500 U

Bacillolysin:
800 U

Polygalac-
turonase:
50 U

(cid:151)

1.

for use of

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

30.9.2001 (n)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

of

2. Recommended

kg

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 150 U
endo-1,4-beta-xylanase: 1 500 U
alpha-amylase: 500 U
bacillolysin: 800 U
polygalacturonase: 50 U.

3.

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

polysaccharides

(cid:151)

1.

for use of

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

30.9.2001 (n)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

of

2. Recommended

kg

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 150 U
endo-1,4-beta-xylanase: 1 500 U
alpha-amylase: 500 U
bacillolysin: 800 U
polygalacturonase: 50 U.

3.

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

polysaccharides

L

3
1
9
/
4
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

50

6-phytase
EC 3.1.3.26

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

Chickens for
fattening

(cid:151)

250 FYT

(cid:151)

1.

for use of

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

Period of
authorisation

30.9.2001 (n)

Coated form:
2 500 FYT (3)/g

Liquid form:
5 000 FYT/g

2. Recommended
complete
1 000 FYT.

dose
feedingstuff:

per

kg
500

of
to

3.

For use in compound feed containing
more
than 0,25 % phytin bound
phosphorus.

Laying hens

(cid:151)

250 FYT

(cid:151)

1.

for use of

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

30.9.2001 (n)

2. Recommended
complete
1 000 FYT.

dose
feedingstuff:

per

kg
500

of
to

3.

For use in compound feed containing
than 0,25 % phytin bound
more
phosphorus.

Turkeys for
fattening

(cid:151)

250 FYT

(cid:151)

1.

for use of

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

30.9.2001 (n)

2. Recommended
complete
1 000 FYT.

dose
feedingstuff:

per

kg
500

of
to

3.

For use in compound feed containing
more
than 0,25 % phytin bound
phosphorus.

Piglets

2 months

500 FYT

(cid:151)

1.

for use of

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

30.9.2001 (n)

2. Recommended
complete
1 000 FYT.

dose
feedingstuff:

per

kg
500

of
to

3.

For use in compound feed containing
than 0,25 % phytin bound
more
phosphorus.

.

1
6
1
2
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

3
1
9
/
4
5

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete feedingstuff

Other provisions

Pigs for
fattening

(cid:151)

500 FYT

(cid:151)

1.

for use of

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

2. Recommended
complete
1 000 FYT.

dose
feedingstuff:

per

kg
500

of
to

3.

For use in compound feed containing
more
than 0,25 % phytin bound
phosphorus.

Period of
authorisation

30.9.2001 (n)

51

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

100 IU (45)/g

Chickens for
fattening

(cid:151)

10 IU

(cid:151)

1.

for use of

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

30.9.2001 (n)

52

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

Endo-1,4-beta-glucanase
EC 3.2.1.4

Alpha-amylase:
EC 3.2.1.1

Chickens for
fattening

(cid:151)

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

Endo-
1,4-beta-
glucanase:
12 000 U

Alpha-
amylase:
40 U

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) and alpha-amylase
produced by Bacillus
amyloliquefaciens (DSM 9553)
having a minimum activity of:

Liquid form:

Endo-1,3(4)-beta-glucanase:
10 000 U (46)/ml

Endo-1,4-beta-glucanase:
120 000 U (47)/ml

Alpha-amylase:
400 U (48)/ml

2. Recommended

per
complete feedingstuff: 10 IU.

dose

kg

of

3.

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

polysaccharides

(cid:151)

1.

for use of

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

30.9.2001 (n)

(cid:151)

(cid:151)

2. Recommended

per

kg

of

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase:
1 000 to 2 000 U
endo-1,4-beta-glucanase:
12 000 to 24 000 U
alpha-amylase:
40 to 80 U.

3.

For use in compound feed rich in
non starch polysaccharides
(mainly
arabinoxylans and beta-glucans) e.g.
containing more than 20 % wheat and
15 % sorghum and 5 % maize.

L

3
1
9
/
4
6

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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

1

Bacillus cereus var. toyoi
NCIMB 40112/
CNCM I-1012

Preparation of Bacillus cereus var.
toyoi containing a minimum of
1 (cid:215) 1010 CFU/g additive

Chickens for
fattening

(cid:151)

0,2 (cid:215) 109

1 (cid:215) 109

Micro-organisms

Laying hens

(cid:151)

0,2 (cid:215) 109

1 (cid:215) 109

Calves

6 months

0,5 (cid:215) 109

1 (cid:215) 109

Cattle for
fattening

(cid:151)

0,2 (cid:215) 109

0,2 (cid:215) 109

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

indicate

the

permitted

May be used in compound feed containing
coccidiostats: monensin
the
sodium,
salinomycin
sodium, amprolium-ethopabate, meticlor-
pindol-methyl
decoquinate,
benzoquate,
robenidine, narasin, halofuginone.

lasolacid sodium,

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

indicate

the

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

indicate

the

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

indicate

the

The quantity of Bacillus cereus var. toyoi in
the daily ration must not exceed 1,0 (cid:215) 109
CFU for 100 kg body weight. Add
0,2 (cid:215) 109 CFU for each additional 100 kg
body weight.

20.2.2001 (i)

20.2.2001 (i)

20.2.2001 (i)

20.2.2001 (i)

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
1
9
/
4
7

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

Breeding does

(cid:151)

0,1 (cid:215) 109

5 (cid:215) 109

Rabbits for
fattening

(cid:151)

0,1 (cid:215) 109

5 (cid:215) 109

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: robenidine.

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

indicate

the

20.2.2001 (i)

20.2.2001 (i)

3

Saccharomyces cerevisiae
NCYC Sc 47

Preparation of Saccharomyces
cerevisiae containing a minimum of
5 (cid:215) 109 CFU/g additive

Cattle for
fattening

May be used in compound feed containing
the permitted coccidiostats: meticlorpindol,
robenidine, salinomycin sodium.

(cid:151)

4 (cid:215) 109

8 (cid:215) 109

Indicate in the instructions for use:

20.2.2001 (b)

daily

(cid:145)The quantity of Saccharomyces cerevisiae in
the
exceed
ration must
2,5 (cid:215) 1010 CFU for 100 kg of bodyweight.
Add 0,5 (cid:215) 1010 CFU for each additional
100 kg bodyweight.(cid:146)

not

Rabbits for
fattening

(cid:151)

2,5 (cid:215) 109

5 (cid:215) 109

Sows

(cid:151)

5 (cid:215) 109

2,5 (cid:215) 1010

Piglets

4 months

5 (cid:215) 109

1 (cid:215) 1010

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

indicate

the

May be used in compound feed containing
the permitted coccidiostat: meticlorpindol.

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

indicate

the

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

indicate

the

30.9.2001 (g)

30.9.2001 (g)

30.9.2001 (g)

L

3
1
9
/
4
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

4

Bacillus cereus
ATCC 14893

Preparation of Bacillus cereus
containing a minimum 1010 CFU/g
additive

Rabbits for
fattening

(cid:151)

0,5 (cid:215) 109

2 (cid:215) 109

(cid:151)

20.2.2001 (b)

Breeding rabbits

(cid:151)

0,5 (cid:215) 109

2 (cid:215) 109

(cid:151)

Piglets

4 months

5 (cid:215) 108

1 (cid:215) 1010

Pigs for
fattening

Sows

(cid:151)

2 (cid:215) 108

1 (cid:215) 109

8,5 (cid:215) 108

1,2 (cid:215) 109

15 days
before
farrowing
and during
lactation

Calves

16 weeks

1 (cid:215) 109

1,2 (cid:215) 109

Chickens for
fattening

(cid:151)

2 (cid:215) 108

1 (cid:215) 109

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

indicate

the

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

indicate

the

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

indicate

the

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

indicate

the

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: amprolium,
lasalocid sodium, madura-
halofuginone,
micin
sodium,
narasin,
salinomycin sodium, meticlor-
pindol, diclazuril.

ammonium, monensin

20.2.2001 (b)

20.2.2001 (g)

20.2.2001 (g)

20.2.2001 (g)

20.2.2001 (g)

20.2.2001 (g)

.

1
6
1
2
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

3
1
9
/
4
9

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

Turkeys for
fattening

26 weeks

2 (cid:215) 108

1 (cid:215) 109

5

Saccharomyces cerevisiae
CBS 493.94

Preparation of Saccharomyces
cerevisiae containing a minimum of:
1 (cid:215) 108 CFU/g additive

Calves

6 months

2 (cid:215) 108

2 (cid:215) 109

Cattle for
fattening

(cid:151)

1,7 (cid:215) 108

1,7 (cid:215) 108

6

Saccharomyces cerevisiae
CNCM I-1079

Preparation of Saccharomyces
cerevisiae containing a minimum of:
2 (cid:215) 1010 CFU/g additive

Sows

(cid:151)

2 (cid:215) 109

1 (cid:215) 1010

Piglets

4 months

6 (cid:215) 109

3 (cid:215) 1010

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

indicate

the

in

used
feed
May
be
containing
the permitted coccidiostats:
amprolium, halofuginone, meticlorpindol/
methylbenzoquate, diclazuril, nifursol.

compound

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

indicate

the

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

indicate

the

The quantity of Saccharomyces cerevisiae in
the daily ration must not exceed 7,5 (cid:215) 108
CFU for 100 kg body weight. Add 1 (cid:215) 108
CFU for each additional 100 kg body
weight.

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

indicate

the

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

indicate

the

20.2.2001 (g)

30.9.2001 (g)

30.9.2001 (h)

30.9.2001 (g)

30.9.2001 (g)

L

3
1
9
/
5
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
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

7

Saccharomyces cerevisiae
CNCM I-1077

Preparation of Saccharomyces
cerevisiae containing a minimum of:
2 (cid:215) 1010 CFU/g additive

Dairy cows

(cid:151)

5,5 (cid:215) 108

2,1 (cid:215) 109

Cattle for
fattening

(cid:151)

1 (cid:215) 109

1,5 (cid:215) 109

8

Enterococcus faecium
ATCC 53519

Enterococcus faecium
ATCC 55593

[In a 1/1 ratio]

Mixture of: encapsulated
Enterococcus faecium ATCC 53519
and encapsulated Enterococcus
faecium ATCC 55593 containing a
minimum of 2 (cid:215) 108 CFU/g of the
additive (i.e. a minimum of 1 (cid:215) 108
CFU/g of each bacterium)

Chickens for
fattening

(cid:151)

1 (cid:215) 108

1 (cid:215) 108

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

indicate

the

The quantity of Saccharomyces cerevisiae in
the daily ration must not exceed 8,4 (cid:215) 109
CFU for 100 kg body weight. Add
1,8 (cid:215) 109 CFU for each additional 100 kg
body weight.

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

indicate

the

The quantity of Saccharomyces cerevisiae in
the daily ration must not exceed 4,6 (cid:215) 109
CFU for 100 kg bodyweight. Add 2 (cid:215) 109
CFU for
kg
bodyweight.

additional

each

100

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: amprolium,
decoquinate, halofuginone,
lasalocid so-
dium, maduramicin ammonium, monensin
sodium, narasin, nicarbazin, narasin/nicar-
bazin, salinomycin sodium.

30.9.2001 (g)

E
N

30.9.2001 (g)

30.9.2001 (g)

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
1
9
/
5
1

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

L

3
1
9
/
5
2

9

Pediococcus acidilactici
CNCM MA 18/5M

Preparation of Pediococcus acidilactici
containing a minimum of 1 (cid:215) 1010
CFU/g of additive

Chickens for
fattening

(cid:151)

1 (cid:215) 109

1 (cid:215) 1010

Piglets

4 months

1 (cid:215) 109

1 (cid:215) 109

Pigs for
fattening

(cid:151)

1 (cid:215) 109

1 (cid:215) 109

10

Enterococcus faecium
NCIMB 10415

Preparation of Enterococcus faecium
containing a minimum of:

Chickens for
fattening

(cid:151)

0,3 (cid:215) 109

2,8 (cid:215) 109

Microencapsulated form:

1,0 (cid:215) 1010 CFU/g additive

1,75 (cid:215) 1010 CFU/g additive

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: amprolium,
meticlorpindol, decoquinate, halofuginone,
narasin, salinomycin sodium, nicarbazin,
maduramicin ammonium, diclazuril.

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

indicate

the

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

indicate

the

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: amprolium,
amprolium/ethopabate, diclazuril, halofu-
ginone, maduramicin ammonium, meti-
clorpindol, meticlorpindol/methylbenzo-
quate, monensin
robenidine,
salinomycin sodium.

sodium,

30.9.2001 (h)

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

30.9.2001 (h)

30.9.2001 (h)

30.9.2001 (h)

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

Pigs for
fattening

(cid:151)

0,35 (cid:215) 109

1,5 (cid:215) 109

Sows

(cid:151)

0,2 (cid:215) 109

1,25 (cid:215) 109

Cattle for
fattening

(cid:151)

0,25 (cid:215) 109

0,6 (cid:215) 109

Preparation of Enterococcus faecium
containing a minimum of:

Piglets

4 months

0,3 (cid:215) 109

1,4 (cid:215) 109

microencapsulated form:

1,0 (cid:215) 1010 CFU/g additive
1,75 (cid:215) 1010 CFU/g additive

and

granulated form:

3,5 (cid:215) 1010 CFU/g additive

Calves

6 months

0,35 (cid:215) 109

6,6 (cid:215) 109

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

indicate

the

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

indicate

the

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

indicate

the

The quantity of Enterococcus faecium in the
daily ration must not exceed 1 (cid:215) 109 CFU
for 100 kg body weight. Add 1 (cid:215) 109 CFU
for each additional 100 kg body weight.

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

indicate

the

Granulated form to be used exclusively in
milk replacers.

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

indicate

the

Granulated form to be used exclusively in
milk replacers.

30.9.2001 (h)

E
N

30.9.2001 (h)

30.9.2001 (h)

30.9.2001 (h)

30.9.2001 (h)

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
1
9
/
5
3

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

11

Enterococcus faecium
DSM 5464

Preparation of Enterococcus faecium
containing a minimum of:
5 (cid:215) 1010 CFU/g additive

Piglets

4 months

0,5 (cid:215) 109

1 (cid:215) 109

Chickens for
fattening

(cid:151)

0,5 (cid:215) 109

1 (cid:215) 109

Calves

4 months

0,5 (cid:215) 109

1 (cid:215) 109

12

Lactobacillus farciminis
CNCM MA 67/4R

Preparation of Lactobacillus
farciminis containing a minimum
of: 1 (cid:215) 109 CFU/g additive

Piglets

4 months

1 (cid:215) 109

1 (cid:215) 1010

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

indicate

the

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

indicate

the

May be used in compound feed containing
the permitted coccidiostats: amprolium,
diclazuril,
monensin-
halofuginone,
sodium, metilclorpindol, methylbenzoquate,
nicarbazin.

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

indicate

the

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

indicate

the

30.9.2001 (h)

30.9.2001 (m)

30.9.2001 (m)

30.9.2001 (i)

L

3
1
9
/
5
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

.

1
6
1
2
2
0
0
0

.

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

.

1
6
1
2
2
0
0
0

.

13

Enterococcus faecium
DSM 10663/
NCIMB 10415

Preparation of Enteroccocus faecium
containing a minimum of:

powder and granulated forms:
3,5 (cid:215) 1010 CFU/g additive

coated form:
2,0 (cid:215) 1010 CFU/g additive

liquid form:
1 (cid:215) 1010 CFU/ml additive

Piglets

4 months

1 (cid:215) 109

1 (cid:215) 1010

Calves

6 months

1 (cid:215) 109

1 (cid:215) 1010

Chickens for
fattening

(cid:151)

1 (cid:215) 109

1 (cid:215) 1010

14

Saccharomyces cerevisiae
MUCL 39885

Preparation of Saccharomyces
cerevisiae containing a minimum of:

Piglets

4 months

3 (cid:215) 109

3 (cid:215) 109

Powder, spheric and oval
granulated forms:
1 (cid:215) 109 CFU/g additive

Cattle for
fattening

(cid:151)

9 (cid:215) 109

9 (cid:215) 109

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

indicate

the

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

indicate

the

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

indicate

the

halofuginone,

May be used in compound feed containing
the permitted coccidiostats: amprolium,
amprolium-ethopabat, decoquinate, dicla-
zuril,
sodium,
maduramicin ammonium, meticlorpindol/
sodium,
methylbenzoquate, monensin
narasin, nicarbazin,
salino-
mycin sodium.

robenidine,

lasalocid

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

indicate

the

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

indicate

the

daily

The quantity of Saccharomyces cerevisiae in
the
exceed
ration must
1,6 (cid:215) 1010 CFU per 100 kg body weight.
Add 3,2 (cid:215) 109 CFU for each additional
100 kg body weight.

not

30.9.2001 (i)

30.9.2001 (k)

30.9.2001 (k)

30.9.2001 (i)

30.9.2001 (i)

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
1
9
/
5
5

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Other provisions

Period of
authorisation

15

Enteroccocus faecium
NCIMB 11181

Preparation of Enteroccocus faecium
containing a minimum of:

Calves

6 months

5 (cid:215) 108

2 (cid:215) 109

Powder form:
4 (cid:215) 1011 CFU/g additive

Coated form:
5 (cid:215) 1010 CFU/g additive

Piglets

4 months

5 (cid:215) 108

2 (cid:215) 109

16

17

Enteroccocus faecium
DSM 7134

Lactobacillus rhamnosus
DSM 7133

Mixture of:

Calves

6 months

1 (cid:215) 109

6 (cid:215) 109

Enterococcus faecium containing a
minimum of: 7 (cid:215) 109 CFU/g

and of

Lactobacillus rhamnosus containing a
minimum of: 3 (cid:215) 109 CFU/g

Piglets

4 months

1 (cid:215) 109

5 (cid:215) 109

Lactobacillus casei
NCIMB 30096

Enterococcus faecium
NCIMB 30098

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

Lactobacillus casei
2 (cid:215) 109 CFU/g

and

Enterococcus faecium 6 (cid:215) 109 CFU/g

Calves

6 months

Lactobacillus
casei
0,5 (cid:215) 109

Lactobacillus
casei
1 (cid:215) 109

Enterococcus
faecium
1,5 (cid:215) 109

Enterococcus
faecium
3 (cid:215) 109

18

Enteroccocus faecium
CECT 4515

Preparation of Enterococcus faecium
containing a minimum of 1 (cid:215) 1010
CFU/g additive

Piglets

4 months

1 (cid:215) 109

1 (cid:215) 109

Calves

6 months

1 (cid:215) 109

1 (cid:215) 109

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

indicate

the

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

indicate

the

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

indicate

the

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

indicate

the

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

indicate

the

premixture

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

indicate

the

premixture

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

indicate

the

30.9.2001 (l)

30.9.2001 (l)

30.9.2001 (l)

30.9.2001 (l)

30.9.2001 (m)

30.9.2001 (m)

30.9.2001 (m)

L

3
1
9
/
5
6

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
6
1
2
2
0
0
0

.

No
(or EC No)

19

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Streptococcus-infantarius
CNCM I-841

Lactobacillus plantarum
CNCM I-840

Mixture of:

Calves

6 months

Streptococcus infantarius and
Lactobacillus plantarum containing a
minimum of:

Streptococcus infantarius
0,5 (cid:215) 109 CFU/g

and

Lactobacillus plantarum
2 (cid:215) 109 CFU/g

Minimum
content

Maximum
content

CFU/kg of complete
feedingstuff

Streptococcus
infantarius
1 (cid:215) 109

Streptococcus
infantarius
1 (cid:215) 109

Lactobacillus
plantarum
0,5 (cid:215) 109

Lactobacillus
plantarum
0,5 (cid:215) 109

Other provisions

Period of
authorisation

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

indicate

the

30.9.2001 (n)

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete
feedingstuff

Other provisions

Duration of
authorisation

Radionuclide binders

1. Radioactive caesium binders (137Cs and 134Cs)

Ferric (III) ammonium
hexacyanoferrate (II)

NH4Fe(III)[Fe(II)(CN)6)]

Ruminants
(domestic and
wild)

Calves prior to
the start of
rumination

(cid:151)

50

500

Indicate in the instructions for use:

13.10.2001 (c)

ferric (III) ammonium
(cid:145)The quantity of
hexacyanoferrate (II)
in the daily ration
must be between 10 mg and 150 mg for
10 kg of body weight(cid:146)

(cid:151)

50

500

Indicate in the instructions for use:

13.10.2001 (c)

ferric (III) ammonium
(cid:145)The quantity of
hexacyanoferrate (II)
in the daily ration
must be between 10 mg and 150 mg for
10 kg of body weight(cid:146)

.

1
6
1
2
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

3
1
9
/
5
7

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

mg/kg of complete
feedingstuff

Other provisions

Duration of
authorisation

Lambs prior to
the start of
rumination

Kids prior to
the start of
rumination

Pigs (domestic
and wild)

(cid:151)

50

500

Indicate in the instructions for use:

13.10.2001 (c)

(cid:145)The quantity of
ferric (III) ammonium
in the daily ration
hexacyanoferrate (II)
must be between 10 mg and 150 mg for
10 kg of body weight(cid:146)

(cid:151)

50

500

Indicate in the instructions for use:

13.10.2001 (c)

ferric (III) ammonium
(cid:145)The quantity of
hexacyanoferrate (II)
in the daily ration
must be between 10 mg and 150 mg for
10 kg of body weight(cid:146)

(cid:151)

50

500

Indicate in the instructions for use:

13.10.2001 (c)

ferric (III) ammonium
(cid:145)The quantity of
hexacyanoferrate (II)
in the daily ration
must be between 10 mg and 150 mg for
10 kg of body weight(cid:146)

First authorisation: Commission Directive 97/72/EC (OJ L 351, 23.12.1997, p. 55).

First authorisation: Commission Directive 96/66/EC (OJ L 272, 25.10.1996, p. 32).

First authorisation: Commission Regulation (EC) No 639/1999 (OJ L 82, 26.3.1999, p. 6).
First authorisation: Commission Regulation (EC) No 1245/1999 (OJ L 150, 17.6.1999, p. 15).

(a)
(b) First authorisation: Commission Directive 96/7/EC (OJ L 51, 1.3.1996, p. 45).
(c)
(d) First authorisation: Commission Regulation (EC) No 2316/98 (OJ L 289, 28.10.1998, p. 4).
(e)
(f)
(g) First authorisation: Commission Regulation (EC) No 1436/98 (OJ L 191, 7.7.1998, p. 15).
(g*) First authorisation: Commission Regulation (EC) No 1436/98 (OJ L 191, 7.7.1998, p. 15) with modification of form/concentration in Commission Regulation (EC) No 654/2000 (OJ L 79, 30.3.2000, p. 26).
(g**) First authorisation: Commission Regulation (EC) No 1436/98 (OJ L 191, 7.7.1998, p. 15) and modification of the conditions of use in Commission Regulation (EC) No 1353/2000 (OJ L 155, 28.6.2000, p. 15).
(h) First authorisation: Commission Regulation (EC) No 866/1999 (OJ L 108, 27.4.1999, p. 21).
(h*) First authorisation: Commission Regulation (EC) No 866/1999 (OJ L 108, 27.4.1999, p. 21) with modification of concentration in Commission Regulation (EC) No 654/2000 (OJ L 79, 30.3.2000, p. 26).
(i)
First authorisation: Commission Regulation (EC) No 1411/1999 (OJ L 164, 30.6.1999, p. 56).
(j)
First authorisation: Commission Regulation (EC) No 2374/98 (OJ L 295, 4.11.1998, p. 3).
(k) First authorisation: Commission Regulation (EC) No 1636/1999 (OJ L 194, 27.7.1999, p. 17).
(l)
(m) First authorisation: Commission Regulation (EC) No 654/2000 (OJ L 79, 30.3.2000, p. 26).
(n) First authorisation: Commission Regulation (EC) No 1353/2000 (OJ L 155, 28.6.2000, p. 15).
(o) First authorisation: Commission Regulation (EC) No 1887/2000 (OJ L 227, 7.9.2000, p. 13).
(1)
(2) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 (cid:176)C.
(3) 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 (cid:176)C.
(4) 1 GALU is the amount of enzyme which hydrolyses 1 micromole of p-nitrophenyl-alpha-galactopyranoside per minute at pH 5,0 and 30 (cid:176)C.
(5) 1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 (cid:176)C.
(6) 1 FXU is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 (cid:176)C.
(7) 1 FXU is the amount of enzyme which liberates 3,1 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 (cid:176)C.
(8) 1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 6,0 and 50 (cid:176)C.
(9) 1 FXU is the amount of enzyme which liberates 0,15 micromoles of xylose from azurine-cross-linked xylan per minute at pH 5,0 and 40 (cid:176)C.

First authorisation: Commission Regulation (EC) No 2690/1999 (OJ L 326, 18.12.1999, p. 33).

In the absence of the establishment, if required, of a specific maximum limit based on sufficient data on the presence of dioxins, the maximum limit of 500 pg WHO-PCCD/F-TEQ/kg will apply from 15 October 2000.

L

3
1
9
/
5
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
6
1
2
2
0
0
0

.

16.12.2000

EN

Official Journal of the European Communities

L 319/59

.

C

(cid:176)
0
3

d
n
a

,

6
6
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p

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