Commission Regulation (EC) No 2013/2001 of 12 October 2001 concerning the provisional authorisation of a new additive use and the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2001-10-12
Institutions: European Commission
Subjects: animal nutrition, application of EU law, food additive

L 272/24

EN

Official Journal of the European Communities

13.10.2001

COMMISSION REGULATION (EC) No 2013/2001

of 12 October 2001

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

(Text with EEA relevance)

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 2001/46/EC of the European Parliament
and of the Council (2), and in particular Article 3 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 70/524/EEC provides that new uses of addi-
tives may be authorised following the review of an
application made in accordance with Article 4 of the
Directive.

Article 9e(1) of Directive 70/524/EEC provides that
provisional authorisation of a new use of an additive
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 authorisations may be given for a period up
to four years in the case of additives referred to in Part II
of Annex C to Directive 70/524/EEC.

The assessment of the dossier submitted in respect of the
new use of the enzyme preparation described in Annex I
shows that it satisfies those conditions and may there-
fore be authorised on a provisional basis for a four-year
period.

The assessment of this dossier also shown that certain
precautions should be taken in order to avoid exposure
of workers to these additives. Such protection should be
assured by the application of Community legislation on
the safety and health of workers at work.

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the safety of
this enzyme preparation.

The Chernobyl accident caused radioactive caesium
fallout, which contaminated forage in certain regions of
northern Europe. Due to the long physical half-life of
radiocaesium, this fallout still affects animal production.

This emergency situation still continues in particular in
Norway. The substance listed in Annex II to this Regula-
tion may be used to decontaminate affected forage. The
competent authorities of Norway therefore supported a
dossier, seeking an extension of the period of author-
isation of this substance.

(7)

(8)

This additive is intended to be used only in contami-
nated areas for a limited period of time. Under normal
conditions there is no need for the use of this additive,
however, it should be kept available in case of similar
future accidents in the Community.

As no adverse effects were detected during its national
use at Member State level nor since the provisional
authorisation which was given at Community level in
1996, all conditions in Article 3a of Directive 70/
524/EEC are met. Therefore a permanent authorisation
of this additive belonging to the group of radionuclide
binders listed in Annex II should be given.

(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘Enzymes’
listed in
Annex I is authorised for use as additive in animal nutrition
under the conditions laid down in Annex I.

Article 2

The additive belonging to the group ‘Radionuclide binders’,
listed in Annex II is authorised for use as additive in animal
nutrition under the conditions laid down in Annex II.

Article 3

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

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 234, 1.9.2001, p. 55.

It shall apply from 14 October 2001.

13.10.2001

EN

Official Journal of the European Communities

L 272/25

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

Done at Brussels, 12 October 2001.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

No
(or EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Turkeys for
fattening

—

54

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

Endo-1,4-beta-xylanase:
EC 3.2.1.8

produced

Preparation of endo-1,3(4)-beta-
glucanase produced by Aspergillus
aculeatus (CBS 589.94), endo-1,4-
beta-glucanase
by
Trichoderma longibrachiatum (CBS
592.94), alpha-amylase produced
by Bacillus amyloliquefaciens (DSM
9553) and endo-1,4-beta-xylanase
produced by Trichoderma viride
(NIBH FERM BP 4842) having a
minimum activity of:

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

Endo-1,4-beta-glucanase:
120 000 U (2)/g

Alpha-amylase:
400 U (3)/g

Endo-1,4-beta-xylanase:
210 000 U (4)/g

Minimum
content

Maximum
content

Units of activity/kg
of complete feedingstuff

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

Endo-1,4-beta-
glucanase:
6 000 U

Alpha-
amylase:
20 U

Endo-1,4-beta-
xylanase:
10 500 U

—

—

—

—

Other provisions

End of period
of authorisation

13.10.2005

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

2. Recommended dose per kilo-
gram of complete feedingstuff:
endo-1,3(4)-beta-glucanase:
500 to 1 500 U
endo-1,4-beta-glucanase:
6 000 to 18 000 U
alpha-amylase: 20 to 60 U
endo-1,4-beta-xylanase:
10 500 to 31 500 U

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

beta-glucans

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

L

2
7
2
/
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
3
1
0
2
0
0
1

.

ANNEX II

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

End of period
of authorisa-
tion

.

1
3
1
0
2
0
0
1

.

Radionuclide binders

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

1.1

(III)
Ferric
hexacyanoferrate (II)

ammonium

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

Ruminants
(domestic
and wild)

Calves
prior to the
start
of
rumination

Lambs
prior to the
start
of
rumination

Kids prior
to the start
rumina-
of
tion

—

50

500

Indicate in the instructions for use:
‘Only for limited geographical areas in case of
contamination with radionuclides’

Without
time limit

‘The quantity of ferric (III) ammonium hexa-
cyanoferrate (II)
in the daily ration must be
between 10 mg and 150 mg for 10 kg of
body weight’

—

50

500

Indicate in the instructions for use:
‘Only for limited geographical areas in case of
contamination with radionuclides’

Without
time limit

‘The quantity of ferric (III) ammonium hexa-
cyanoferrate (II)
in the daily ration must be
between 10 mg and 150 mg for 10 kg of
body weight’

—

50

500

Indicate in the instructions for use:
‘Only for limited geographical areas in case of
contamination with radionuclides’

Without
time limit

‘The quantity of ferric (III) ammonium hexa-
cyanoferrate (II)
in the daily ration must be
between 10 mg and 150 mg for 10 kg of
body weight’

—

50

500

Indicate in the instructions for use:
‘Only for limited geographical areas in case of
contamination with radionuclides’

Without
time limit

‘The quantity of ferric (III) ammonium hexa-
cyanoferrate (II)
in the daily ration must be
between 10 mg and 150 mg for 10 kg of
body weight’

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

2
7
2
/
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

Pigs
(domestic
and wild)

—

50

500

End of period
of authorisa-
tion

Without
time limit

Other provisions

Indicate in the instructions for use:
‘Only for limited geographical areas in case of
contamination with radionuclides’

‘The quantity of ferric (III) ammonium hexa-
cyanoferrate (II)
in the daily ration must be
between 10 mg and 150 mg for 10 kg of
body weight’

L

2
7
2
/
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
3
1
0
2
0
0
1

.