Commission Regulation (EC) No 937/2001 of 11 May 2001 concerning the authorisation of new additive uses, new additive preparation, the prolongation of provisional authorisations and the 10 year authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2001-05-11
Institutions: European Commission
Subjects: animal nutrition, enzyme, food additive, food inspection, market approval, microorganism, veterinary drug

12.5.2001

EN

Official Journal of the European Communities

L 130/25

COMMISSION REGULATION (EC) No 937/2001

of 11 May 2001

concerning the authorisation of new additive uses, new additive preparation, the prolongation of
provisional authorisations and the 10 year authorisation of an additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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)

Directive 70/524/EEC provides that new additives and
new 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 a new additive or new use of an addi-
tive may be given if the conditions of Article 3a(b) to (e)
are satisfied and if it is 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 the dossiers submitted in respect of
the new uses of the enzyme and micro-organism prepa-
rations described in Annexes I and II shows that they
satisfy the abovementioned conditions and may there-
fore be authorised on a provisional basis for a four-year
period.

New data were submitted to extend the authorisation of
an enzyme preparation provisionally listed under No 11
to a new physical form. The assessment of the dossier
submitted shows that the new physical form may be
provisionally authorised.

cereus var.

On 1 October 2000, the authorisation of the micro-
toyoi
organism preparation No 1 Bacillus
(NCIMB 40 112) was provisionally renewed for a limited
period, in order to provide sufficient time for the safety
reassessment of the strain with regard to production of
toxins, as requested in the opinion of
the Scientific
Committee for Animal Nutrition (SCAN) on the safety of
use of bacillus species in animal nutrition adopted on 17
February 2000.

According to the SCAN opinion on Bacillus cereus var.
toyoi (NCIMB 40 112) adopted on 21 March 2001, the
assessment of the dossiers submitted shows that the
product may be considered safe as regard toxin produc-
tion. The provisional authorisation of the product may
therefore be resumed.

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
the
coccidiostat described in Annex IV satisfies all
requirements of Article 3a, when used in the animal
category and under the conditions described in the said
Annex.

The assessment of the dossier shows that certain proced-
ures 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 introduction of meas-
ures to encourage improvements in the safety and health
of workers at work (3).

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

(7)

(8)

(9)

(10)

(11)

(12)

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 ‘Enzymes’ listed in
Annex I to the present Regulation are authorised for use as
additives in animal nutrition under the conditions laid down in
the Annex.

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

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

L 130/26

EN

Official Journal of the European Communities

12.5.2001

Article 2

Article 4

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

The additive belonging to the ‘Coccidiostats and other medi-
cinal substances’ listed in Annex IV to the present Regulation is
authorised for use as additive in animal nutrition under the
conditions laid down in that Annex.

Article 3

The provisional authorisations of the preparation belonging to
the group ‘Micro-organisms’
listed in Annex III are resumed
under the conditions laid down in the Annex.

Article 5

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 June 2001.

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

Done at Brussels, 11 May 2001.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

No
(or EC No)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum age

Chickens for
fattening

—

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

of

endo-1,4-beta-
Preparation
glucanase, endo-1,3(4)-beta-gluca-
nase and endo-1,4-beta-xylanase
produced by Trichoderma longibra-
chiatum (ATCC 74 252) having a
minimum activity of:
Granular and Liquid form:

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

Endo-1,3(4)-beta-glucanase:
18 000 U (2)/g or ml

Endo-1,4-beta-xylanase:
26 000 U (3)/g or ml

Minimum
content

Maximum
content

Units of activity/kg of complete
feedingstuff

—

—

—

Endo-1,4-
beta-gluca-
nase:
400 U

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

Endo-1,4-
beta-xyla-
nase:
1 300 U

Other provisions

Period of autho-
risation

30.6.2004

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

2. Recommended dosages per
kilogram of complete feeding-
stuff:
Endo-1,4-beta-glucanase: 400-
1 600 U
Endo-1,3(4)-beta-glucanase:
900-3 600 U
Endo-1,4-beta-xylanase:
1 300-5 200 U.

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

.

.

1
2
5
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
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p
e
a
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C
o
m
m
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i
t
i
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s

L

1
3
0
/
2
7

No
(or EC No)

Additive

Chemical formula, description

Species or cate-
gory of animal

Maximum age

Turkeys for
fattening

—

Minimum
content

Maximum
content

Units of activity/kg of complete
feedingstuff

—

—

—

Endo-1,4-
beta-gluca-
nase:
400 U

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

Endo-1,4-
beta-xyla-
nase:
1 300 U

51

Endo-1,4-beta-xylanase
EC 3.2.1.8

of

endo-1,4-beta-
Preparation
xylanase produced by Bacillus
subtilis (LMG S-15136) having a
minimum activity of 100 IU (4)/g

Piglets

2 months

10 IU

—

(1) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.
(2) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.
(3) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.
(4) 1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.

L

1
3
0
/
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

Other provisions

Period of autho-
risation

31.5.2005

31.5.2005

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

2. Recommended dosages per
kilogram of complete feeding-
stuff: endo-1,4-beta-glucanase:
400-800 U
endo-1,3(4)-beta-glucanase:
900-1 800 U
endo-1,4-beta-xylanase:
1 300-2 600 U.

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

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

2. Recommended dose per kilo-
gram of complete feedingstuff:
10 IU.

3. For use in compound feed
e. g.
rich in arabinoxylan,
containing more than 40 %
wheat.

.

.

1
2
5
2
0
0
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

ANNEX II

3

5

Saccharomyces cerevisiae
NCYC Sc 47

Saccharomyces cerevisiae
CBS 493.94

Preparation of Saccharomyces cerevisiae
of
containing
5 × 109 CFU/g of additive

minimum

a

Preparation of Saccharomyces cerevisiae
containing
of
1 × 108 CFU/g additive

minimum

a

Dairy cows

—

4 × 108

2 × 109

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

The quantity of Saccharomyces cerevisiae
in the daily ration must not exceed
5,6 × 109 CFU per 100 kg of body
weight. Add 8,75 × 109 per
each
additional 100 kg body weight.

Dairy cows

—

5 × 107

3,5 × 108

and premixture,

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

indicate

The quantity of Saccharomyces cerevisiae
in the daily ration must not exceed
1,2 × 109 CFU for 100 kg
body
weight. Add 1,7 × 108 CFU per each
additional 100 kg body weight.

.

.

1
2
5
2
0
0
1

Period
of authorisation

31.5.2005

31.5.2005

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
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p
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a
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C
o
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m
u
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i
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i
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s

L

1
3
0
/
2
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

ANNEX III

1

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

Preparation of Bacillus
toyoi
containing a minimum of 1 × 1010 CFU/g
additive

cereus var.

Chickens
for fattening

—

0,2 × 109

1 × 109

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

May be used in compound feed containing the
permitted coccidiostats: monensin sodium,
lasolacid sodium, salinomycin sodium, deco-
quinate, robenidine, narasin, halofuginone.

Period of
authorisation

1.3.2002

Laying hens

—

0,2 × 109

1 × 109

Calves

6 months

0,5 × 109

1 × 109

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

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

1.3.2002

1.3.2002

Cattle for
fattening

—

0,2 × 109

0,2 × 109

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

1.3.2002

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

L

1
3
0
/
3
0

E
N

O

f
f
i
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i
a
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J
o
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a
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o
f

t
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E
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C
o
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u
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i
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i
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s

.

.

1
2
5
2
0
0
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

Breeding
does

—

0,1 × 109

5 × 109

Other provisions

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

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

Period of
authorisation

1.3.2002

Rabbits
fattening

for

—

0,1 × 109

5 × 109

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

1.3.2002

May be used in compound feed containing the
permitted coccidiostats:
salino-
mycin sodium.

robenidine,

.

.

1
2
5
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
f

t
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E
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1

ANNEX IV

Registration
number of
additive

Name and registration
number of person
responsible for putting
additive into
circulation

Coccidiostats and other medicinal substances

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

E 766

Intervet International
bv

Salinomycin
120 g/kg
(Sacox 120)

sodium

Additive composition:
Salinomycin sodium ≥ 120 g/kg
Silicon dioxide 10-100 g/kg
Calcium carbonate 350-700 g/kg

Rabbits for
fattening

—

20

25

Active substance:
Salinomycin sodium,
C42H69O11Na,
CAS number: 53003-10-4
sodium salt of a polyether monocar-
boxylic acid produced by fermenta-
tion of Streptomyces albus (DSM
12217)

Related impurities:
< 42 mg elaiophylin/kg salinomycin
sodium,
< 40 g de 17-epi-20-desoxy-salino-
mycin/kg salinomycin sodium.

31.5.2011

in

Use
at
prohibited
least 5 days before
slaughter.
Indicate
the
instructions for use:
‘Dangerous for equi-
nes’.
feedingstuff
‘This
iono-
an
contains
simultaneous
phore:
use
certain
medicinal substances
(e.g. tiamulin) can be
contra-indicated’

with

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.

.

1
2
5
2
0
0
1