Commission Regulation (EC) No 866/1999 of 26 April 1999 concerning the authorisation of new additives and new additive uses in feedingstuffs
Date: 1999-04-26
Institutions: European Commission
Subjects: animal nutrition, food additive, food inspection, marketing standard

27. 4. 1999

EN

Official Journal of the European Communities

L 108/21

COMMISSION REGULATION (EC) No 866/1999

of 26 April 1999

concerning the authorisation of new additives and new additive uses in feeding-
stuffs

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1),
as last amended by Directive 1999/20/EC (2), and in
particular Articles 3 and 9j thereof,

(1) Whereas Directive 70/524/EEC provides that new
additives or new additive uses may be authorised,
taking account of advances in scientific and tech-
nical knowledge;

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

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

(4) Whereas

the Scientific Committee for Animal
Nutrition has delivered a favourable opinion with
regard to the harmlessness of these preparations;

(5) Whereas the measures provided for in this Regula-
tion are in accordance with the opinion of the
Standing Committee on Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘enzymes' and
listed in Annex I to this Regulation may be authorised
according to Directive 70/524/EEC as additives in animal
nutrition under the conditions laid down in that Annex.

Article 2

The preparations belonging to the group ‘micro-orga-
nisms' and listed in Annex II to this Regulation may be
authorised according to Directive 70/524/EEC as addi-
tives in animal nutrition under the conditions laid down
in that Annex.

Article 3

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

It shall apply from 1 July 1999.

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

Done at Brussels, 26 April 1999.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 80, 25.3.1999, p. 20.
(3) OJ L 334, 31.12.1993, p. 17.
(4) OJ L 180, 9.7.1997, p. 21.

No

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

Units of activity per kg
of complete feedingstuff

Other provisions

ANNEX I

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 (1)/g

Liquid form: 5 000 FYT/g

Laying hens

(cid:190)

500 FYT

1 000 FYT

Piglets

Four months

3 000 BGU
1 200 FXU

5 000 BGU
2 000 FXU

8

Endo-1,4-betaglucan-
ase
EC 3.2.1.4

Endo-1,4-betaxylana-
se
EC 3.2.1.8

and

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

Solid and liquid forms:

Endo-1,4-beta-glucanase:
10 000 BGU (2)/g

Endo-1,4-beta-xylanase:
4 000 FXU (3)/g

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

2. Recommended dose per kg of
complete feedingstuff: 750 FYT.

e.g.

3. For use in compound feed rich in
containing more
phytates,
than 40 % cereals (corn, barley,
oats, wheat, rye, triticale), oilseeds
and pulses.

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

2. Recommended dose per kg of

complete feedingstuff:

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

non-starch

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

Period of
authorisation

30. 9. 1999

30. 9. 1999

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4

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1
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9
9

No

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

Units of activity per kg
of complete feedingstuff

Other provisions

29

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

of

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

Chickens
fattening

5 500 U (4)/g

for

(cid:190)

250 U

(cid:190)

Chickens
fattening

for

(cid:190)

(cid:190)

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

Endo-1,4-
beta-xyla-
nase: 70 U

30

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

Endo-1,4-beta-xyla-
nase
EC 3.2.1.8

of

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

Powder form

Endo-1,3(4)-beta-glucanase:
2 000 U (5)/g

Endo-1,4-beta-xylanase:
1 400 U (6)/g

Liquid form

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

Endo-1,4-beta-xylanase: 350 U/ml

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

2. Recommended dose per kg of
complete feedingstuff: 250 U.

non-starch

3. For use in compound feed rich
in
polysaccharides.
(mainly beta-glucans), e.g. con-
taining more than 50 % barley.

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

2. Recommended dose per kg of

complete feedingstuff:

Endo-1,3(4)-beta-glucanase: 100 U
Endo-1,4-beta-xylanase: 70 U.

non-starch

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

Period of
authorisation

30. 9. 1999

30. 9. 1999

2
7

.

4

.

1
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9
9

E
N

O

f
f
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J
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No

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

Units of activity per kg
of complete feedingstuff

Other provisions

31

Endo-1,4-betaxyla-
nase
EC 3.2.1.8

Preparation of endo-1,4-beta-xyla-
nase produced by Trichoderma
longibrachiatum (CBS
614-94)
having a minimum activity of:

Chickens
fattening

for

(cid:190)

600 EU

(cid:190)

Solid form: 300 EU (7)/g

Liquid form: 1 000 EU/g

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

2. Recommended dose per kg of
complete feedingstuff: 600 EU.

non-starch

3. For use in compound feed rich
polysaccharides
e.g.
60 %

in
(mainly
containing more
wheat.

arabinoxylans),
than

Laying hens

(cid:190)

300 EU

(cid:190)

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

2. Recommended dose per kg of
complete feedingstuff: 600 EU.

non-starch

3. For use in compound feed rich
polysaccharides
in
(mainly arabinoxylans), e.g. con-
taining more than 60 % wheat.

(1) One FYT is the amount of enzyme which liberates one micromole of inorganic phosphate per minute using Na-phytate as substrate at pH 5,5 and 37 (cid:176)C.
(2) One BGU is the amount of enzyme which liberates 0,15 micromoles of glucose per mintue from azurine-crosslinked beta-glucan at pH 5,0 and 40 (cid:176)C
(3) One FXU is the amount of enzyme which liberates 0,15 micromoles of xylose per minute from azurine-crosslinked xyland at pH 5,0 y and at 40 (cid:176)C
(4) One U is the amount of enzyme which liberates 2,78 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 (cid:176)C
(5) One U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 (cid:176)C
(6) One U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 (cid:176)C
(7) One EU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,5 and 40 (cid:176)C

Period of
authorisation

30. 9. 1999

30. 9. 1999

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ANNEX II

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 author-
isation

5

9

Saccharomyces
visiae
CBS 493. 94

cere-

Preparation of Saccharomyces
ce-
revisiae containing a minimum of
1 ·10 8 CFU/g additive

Cattle for
fattening

(cid:190)

1,7 · 108

1,7 · 108

Pediococcus acidilac-
tici
CNCM MA 18/5M

Preparation of Pediococcus acidilac-
containing a minimum of
tici
1 · 1010 CFU/g of additive

Chickens for
fattening

(cid:190)

1 · 109

1 · 1010

Piglets

Four months

1 · 109

1 · 109

Pigs

(cid:190)

1 · 109

1 · 109

30.9.1999

30.9.1999

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

The quantity of Saccharomyces cere-
visiae in the daily ration must not
exceed
100
kg body weight. Add 1 · 108 CFU
for each extra 100 kg body weight.

7,5 · 108 CFU for

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

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

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

30.9.1999

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

30.9.1999

2
7

.

4

.

1
9
9
9

E
N

O

f
f
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J
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2
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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 author-
isation

10

Enterococcus
faecium
NCIMB 10415

Preparation of Enterococcus faecium
containing a minimum of:

Chickens for
fattening

(cid:190)

0,3 · 109

2,8 · 109

Microencapsulated form:

1,0 · 1010 CFU/g additive
1,75 · 1010 CFU/g additive

Pigs

(cid:190)

0,35 · 109

1,5 · 109

30.9.1999

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

May be used in compound feed
containing the permitted coccidio-
stats: amprolium, amprolium/ethopa-
bate, diclazuril, halofuginone, madur-
amicin ammonium, meticlorpindol,
meticlorpindol/methylbenzoquate,
monensin sodium, robenidine, sal-
inomycin sodium

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

30.9.1999

Sows

(cid:190)

0,2 · 109

1,25 · 109

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

30.9.1999

Cattle for
fattening

(cid:190)

0,25 · 109

0,6 · 109

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

30.9.1999

of

quantity

The
Enterococcus
faecium in the daily ration must not
exceed
100
kg body weight. Add 1 · 109 CFU
for each additional 100 kg body
weight.

1 · 109 CFU for

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9
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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 author-
isation

Preparation of Enterococcus faecium
containing a minimum of:

Piglets

Four months

0,3 · 109

1,4 · 109

Microencapsulated form:

1,0 · 1010 CFU/g additive
1,75 · 1010 CFU/g additive

and

Granulated form:

3,5 · 1010 CFU/g additive

Calves

Six months

0,35 · 109

6,6 · 109

11

Enterococcus
um
DSM 5464

faeci-

Preparation of Enterococcus faecium
containing a minimum of:

5 · 1010 CFU/g additive

Piglets

Four months

0,5 · 109

1 · 109

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

Granulated form to be used exclu-
sively in milk replacers.

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

Granulated form to be used exclu-
sively in milk replacers.

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

30.9.1999

30.9.1999

30.9.1999

2
7

.

4

.

1
9
9
9

E
N

O

f
f
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J
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