Commission Regulation (EC) No 418/2001 of 1 March 2001 concerning the authorisations of new additives and uses of additives in feedingstuffs (Text with EEA relevance)
Date: 2001-03-01
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food inspection, marketing standard

2.3.2001

EN

Official Journal of the European Communities

L 62/3

COMMISSION REGULATION (EC) No 418/2001

of 1 March 2001

concerning the authorisations of new additives and uses of additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Commission Regulation (EC) No 2697/2000 (2),
and in particular Article 4 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 70/524/EEC provides that new additives or
uses of additives may be authorised following the review
of an application made in accordance with article 4 of
the Directive.

Article 9e(1) of the Directive provides that provisional
authorisation of new additives or uses of additives may
be given if the conditions of Articles 3a(b) to (e) of
Directive 70/524/EEC are satifisfied and if its reasonable
to assume, in view of the available results, that when
used in animal nutrition it has one of the effects referred
to in Article 2(a). Such provisional authorisation may be
given for a period up to four years in the case of
additives referred to in Part
II of Annex C to the
Directive.

The assessment of dossiers submitted shows that the
new micro-organism and enzyme preparations and the
new uses of the micro-organism and enzyme prepara-
tions described in Annex I and II satisfy the abovemen-
tioned conditions and may therefore be authorised on a
provisional basis for a four-year period.

Article 2(aaa) of Directive 70/524/EEC requires author-
isations for coccidiostats to be linked to the person
responsible for putting them into circulation.

Article 9b of Directive 70/524/EEC provides that the
authorisations of such substances shall be given for a
period of 10 years from the date on which final author-
isation takes effect, if all conditions laid down in Article
3a of Directive 70/524/EEC are met.

The assessment of the dossier submitted shows that the
coccidiostat described in Annex III satisfies all
the
requirements of Article 3a, when used in the anidmal
category and under the conditions described in the said
Annex.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 319, 16.12.2000, p. 1.

The assessment of
the dossiers shows that certain
procedures may be required to protect workers from
exposure to the additives. Such protection should
however be assured by the application of Council
Directive 89/391/EEC of 12 June 1989 on the introduc-
tion of measures to encourage improvements in the
safety and health of workers at work (3) and the Direct-
ives made under it.

(8)

(9)

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the harmless-
ness of the enzyme and micro-organism preparations
and of the coccidiostat, and with regard to the favour-
able effect on animal production of the latter, under the
conditions described in the said Annexes.

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group ‘Micro-organisms’
listed in Annex I to the present Regulation are authorised for
use as additives in animal nutrition under the conditions laid
down in that Annex.

Article 2

The preparations belonging to the group ‘Enzymes’ listed in
Annex II to the present Regulation are authorised for use as
additives in animal nutrition under the conditions laid down in
that Annex.

Article 3

The additive belonging to the group ‘Coccidiostats and other
medicinal substances’ listed in Annex III to the present Regula-
tion is authorised for use as additive in animal nutrition under
the conditions laid down in that Annex.

Article 4

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

It shall apply from 1 March 2001.

(3) OJ L 183, 29.6.1989, p. 1.

L 62/4

EN

Official Journal of the European Communities

2.3.2001

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

Done at Brussels, 1 March 2001.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

No (or EC No)

Additive

Chemical formula, description

20

21

Bacillus licheniformis
DSM 5749

Bacillus subtilis
DSM 5750

(In a 1/1 ratio)

Enterococcus faecium
DSM 3530

Mixture of Bacillus
licheniformis
and Bacillus subtilis containing a
minimum of

3,2 × 109 CFU/g of the additive
(1,6 × 109 UFC/g of each bacte-
rium)

Preparation of Enterococcus faecium
containing a minimum of

2,5 × 109 CFU/g

Species or
category of
animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

Other provisions

Calves

6 month

1,28 × 109

1,6 × 109

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

Period of
authorisation

28.2.2005

Calves

6 months

1 × 109

1 × 109

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

28.2.2005

.

.

2
3
2
0
0
1

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

6
2
/
5

ANNEX II

No (or
EC No)

Additive

Chemical formula, decription

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg complete
feedingstuff

Other provisions

23

Endo-1,4-beta-
xylanase
EC 3.2.1.8

of

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

Turkeys for
fattening

—

700 IFP

—

Solid form: 70 000 IFP (1)/g

Liquid form: 7 000 IFP/ml

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

2. Recommended

dose

per

complete feedingstuff: 1 400 IFP

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

Laying hens

—

840 IFP

—

Piglets

2 months

7 500 BXU

7 500 BU

—

—

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

2. Recommended

dose

per

complete feedingstuff: 840 IFP

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

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

2. Recommended

per

dose
complete feedingstuff:
7 500 to 15 000 BXU
7 500 to 15 000 BU

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

27

Endo-1,4-beta-
xylanase
EC 3.2.1.8

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

of

by

Trichoderma

Preparation
produced
529.94)
produced
526.94) having a minimum activity of:

endo-1,4-beta-xylanase
(CBS
and endo-1,3(4)-beta-glucanase
(CBS

Trichoderma

reesei

reesei

by

Solid form:
200 000 BXU (2)/g
200 000 BU (3)/g

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

L

6
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

Period of
authorisation

28.2.2005

28.2.2005

28.2.2005

.

.

2
3
2
0
0
1

No (or
EC No)

Additive

Chemical formula, decription

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg complete
feedingstuff

Other provisions

28

3-Phytase
EC 3.1.3.8

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

Chickens
for fattening

—

500 PPU

—

Solid form: 5 000 PPU (4)/g

Liquid form: 1 000 PPU/g

30

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

Endo-1,-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:

Powder form:
Endo-1,3(4)-beta-glucanase: 2 000 U (5)/g
Endo-1,4-beta-xylanase: 1 400 U/g (6)/g

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

Turkeys for
fattening

—

Laying hens

—

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

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

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

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

—

—

—

—

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

dose
complete feedingstuff: 500 to 750 PPU
3. For use in compound feed containing more
than 0,22 % phytin bound phosphorus

2. Recommended

per

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

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 100 U
endo-1,4-beta-xylanase: 70 U

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

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

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 100 U
endo-1,4-beta-xylanase: 70 U

3. For use in compound feed rich in non-
beta-
starch
glucans and arabinoxylans), e.g. continaing
more than 60 % barley or 30 % wheat

polysaccharides

(mainly

Period of
authorisation

28.2.2005

28.2.2005

28.2.2005

.

.

2
3
2
0
0
1

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

6
2
/
7

Species or
category of
animal

Maximum
age

Pigs
fattening

for

—

Chickens
for fattening

—

No (or
EC No)

Additive

Chemical formula, decription

59

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

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

Subtilisin
EC 3.4.21.62

Alpha-amylase
EC 3.2.1.1

Polygalacturonase
EC 3.2.1.15

of

endo-1,4-beta-xylanase
Preparation
produced by Trichoderma longibrachiatum
(ATCC 2105), endo-1,3(4)-beta-glucanase
and alpha-amylase produced by Bacillus
amyloliquefaciens
subtilisin
produced by Bacillus subtilis (ATCC 2107),
polygalacturonase produced by Aspergillus
aculeatus (CBS 589.94) having a minimum
activity of:

(DSM 9553),

Endo-1,4-beta-xylanase: 300 U (7)/g
Endo-1,3(4)-beta-glucanase: 150 U (8)/g
Subtilisin: 4 000 U (9)/g
Alpha-amylase: 400 U (10)/g
Polygalacturonase: 25 U (11)/g

60

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

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

of

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

Endo-1,4-beta-xylanase: 5 000 U (7)/g
Endo-1,3(4)-beta-glucanase: 50 U (8)/g

Chickens
for fattening

—

Minimum
content

Maximum
content

Units of activity/kg complete
feedingstuff

Other provisions

—

—

—

—

—

—

—

—

—

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

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

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

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

Subtilisin:
4 000 U

Alpha-
amylase:
400 U

Polygalac-
turonase:
25 U

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

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

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

2. Recommended

per

dose
complete feedingstuff:
endo-1,3(4)-beta-glucanase: 100 U
endo-1,4-beta-xylanase: 70 U

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

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

2. Recommended

per

dose
complete feedingstuff:
endo-1,4-beta-xylanase: 300 U
endo-1,3(4)-beta-glucanase: 150 U
subtilisin: 4 000 U
alpha-amylase: 400 U
polygalacturonase: 25 U

3. For use in compound feed rich in starch
(mainly
e.g.

and non-starch polysaccharides
arabinoxylans
and
containing more than 40 % maize

beta-glucans),

per

2. Recommended

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

dose
complete feedingstuff:
endo-1,4-beta-xylanase: 500 to 2 500 U
endo-1,3(4)-beta-glucanase: 5 to 25 U
3. For use in compound feed rich in non-
starch polysaccharides (mainly beta-glucans
and arabinoxylans), e.g. containing more
than 20 % barley and 40 % wheat

L

6
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

Period of
authorisation

28.2.2005

28.2.2005

28.2.2005

.

.

2
3
2
0
0
1

No (or
EC No)

Additive

Chemical formula, decription

61

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

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

of

Preparation
produced
526.94) having a minimum activity of:

endo-1,4-beta-xylanase
(CBS

Trichoderma

reesei

by

Powder form:
Endo-1,(4)-beta-xylanase:
17 000 BXU (2)/g
Endo-1,3(4)-beta-xylanase:
11 000 BU/ (3)/g

Liquid form:
Endo-1,4-beta-xylanase: 22 000 U/ml
Endo-1,3(4)-beta-glucanase: 15 000 U/ml

Species or
category of
animal

Maximum
age

Chickens
for fattening

—

Minimum
content

Maximum
content

Units of activity/kg complete
feedingstuff

—

—

Endo-1,4-
beta-xylanase:
17 000 BXU

Endo-1,3(4)-
beta-gluca-
nase:
11 000 BU

Period of
authorisation

28.2.2005

Other provisions

per

2. Recommended

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

dose
complete feedingstuff:
endo-1,4-beta-xylanase: 17 000 BXU
endo-1,3(4)-beta-glucanase: 11 000 BU
3. For use in compound feed rich in non-
starch polysaccharides (mainly beta-glucans
and arabinoxylans), e.g. containing more
than 40 % barley or 55 % wheat

(1) 1 IFP is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,8 and 50°C.
(2) 1 BXU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (xylose equivalents) from birch xylan per minute at pH 5,3 and 50 °C.
(3) 1 BU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (glucose equivalents) from barley-glucan per minute at pH 4,8 and 50 °C.
(4) 1 PPU is the amount of enzyme which liberates 1 micromole of inorganic phosphate from sodium phytate per minute at pH 5,0 and 37 °C.
(5) 1 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 °C.
(6) 1 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 °C.
(7) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.
(8) 1 U 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 °C.
(9) 1 U is the amount of enzyme which liberates 1 micromole of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.
(10) 1 U is the amount of enzyme which liberates 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.
(11) 1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 °C.

.

.

2
3
2
0
0
1

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

6
2
/
9

Registration
number of
additive

Name and registration
number of person respon-
sible for putting additive
into circulation

E771

Janssen Animal
Health B.V.B.A

ANNEX III

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

Turkeys for
fattening

12 weeks

1

1

Use
at
prohibited
least five days before
slaughter

28.2.2011

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

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

Additive composition

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

Active substance:

,

17

Cl
9

O
2
4

Diclazuril,
C
N
H
3
(±)-4-chlorophenyl[2,6-dichloro-4-
(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-
triazin-2-yl)phenyl]acetonitrile,
CAS number: 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 %

L

6
2
/
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

.

.

2
3
2
0
0
1