Commission Regulation (EC) No 316/2003 of 19 February 2003 concerning the permanent authorisation of an additive in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (Text with EEA relevance)
Date: 2003-02-19
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, microorganism

20.2.2003

EN

Official Journal of the European Union

L 46/15

COMMISSION REGULATION (EC) No 316/2003

of 19 February 2003

concerning the permanent authorisation of an additive in feedingstuffs and the provisional authori-
sation of a new use of an additive already authorised 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 Commission Directive 2003/7/EC (2), and in parti-
cular Articles 3, 9d, and 9e thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Article 9d(1) of Directive 70/524/EEC provides that
additives referred to in Part II of Annex C to that Direc-
tive may be authorised without a time limit if the condi-
tions laid down in Article 3(a) are satisfied.

New data were submitted by the producing company in
support of an application for authorisation without a
time limit of the micro-organism preparation set out in
this Regulation.

The assessment of
the application for authorisation
submitted in respect of that micro-organism preparation,
shows that all the conditions required for an authorisa-
tion, as provided for in Directive 70/524/EEC are satis-
fied.

That micro-organism preparation may therefore be
authorised for an unlimited period.

Directive 70/524/EEC provides that a new use of an
additive
a Community
authorisation.

already authorised requires

Directive 70/524/EEC provides that provisional authori-
sation of a new additive for use in feedingstuffs or of a
new use of an additive already authorised may be given
if the conditions laid down in that Directive 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) of that Directive.
Such provisional authorisation may be given for a period
not exceeding four years in the case of additives referred
to in Part II of Annex C to that Directive.

(7)

(8)

New data were submitted by the producing company in
support of an application to extend the authorisation of
an enzyme preparation set out in this Regulation.

the application for authorisation
The assessment of
submitted in respect of the new use of the preparation
of this enzyme, shows that the conditions provided for
in Directive 70/524/EEC for provisional authorisation
are satisfied.

(9)

This enzyme preparation should therefore be provision-
ally authorised for a period of four years.

(10)

The assessment of the application shows that certain
procedures should be required to protect workers from
exposure to the additives set out in the Annexes. Such
protection should be assured by the application of
Council Directive 89/391/EEC of 12 June 1989 on the
introduction of measures to encourage improvements in
the safety and health of workers at work (3).

(11)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group ‘Micro-organisms’ as
set out in Annex I is authorised for use as additive in animal
nutrition under the conditions laid down in that Annex.

Article 2

The preparation belonging to the group ‘Enzymes’ as set out in
Annex II
is provisionally authorised for use as additive in
animal nutrition under the conditions laid down in that Annex.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 22, 25.1.2003, p. 28.

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

L 46/16

EN

Official Journal of the European Union

20.2.2003

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

It shall apply from 1 March 2003.

Article 3

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

Done at Brussels, 19 February 2003.

For the Commission

David BYRNE

Member of the Commission

Additive

Chemical formula, description

Species
or category
of animal

Maximum
age

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

Other provisions

End of period
of authorisation

No (or EC
No)

‘Micro-organisms

ANNEX I

E 1702

Saccharomyces cerevisiae

NCYC Sc 47

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

minimum

a

Cattle for
fattening

—

4 × 109

8 × 109

Without time limit’

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

Indicate in the instructions for use:
“the quantity of Saccharomyces cere-
visae in the daily ration must not
exceed 2,5 × 109 CFU for 100 kg of
bodyweight and 0,5 × 1010 CFU for
each additional 100 kg of body-
weight.”

.

.

2
0
2
2
0
0
3

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N

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Additive

Chemical formula, description

No (or EC
No)

‘Enzymes

ANNEX II

Species
or category
of animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg of complete
feedingstuff

24

Endo-1,4-beta-xylanase
EC 3.2.1.8

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

Turkeys for
fattening

—

280 QXU

840 QXU

1 400 QGU

4 200 QGU

28 000 QXU (1)/g
140 000 QGU (2)/g

Other provisions

End of period of
authorisation

28.2.2007

1. In the directions for use of the addi-
indicate the
storage life,

tive and premixture,
storage temperature,
and stability to pelleting.

2. Recommended dose per kilogram of

complete feedingstuff:

560 QXU
2 800 QGU.

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

(1) 1 QXU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 5,1 and 50 °C.
(2) 1 QGU is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °C.’

L

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