Commission Regulation (EC) No 1801/2003 of 14 October 2003 provisionally authorising the new use of a certain micro-organism in feedingstuffs (Text with EEA relevance)
Date: 2003-10-14
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, microorganism

L 264/16

EN

Official Journal of the European Union

15.10.2003

COMMISSION REGULATION (EC) No 1801/2003

of 14 October 2003

provisionally authorising the new use of a certain micro-organism 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 Article 3 and Article 9e(1) thereof,

Whereas:

Directive 70/524/EEC requires that no additive may be
put into circulation unless a Community authorisation
has been granted.

In the case of additives referred to in Part II of Annex C
to Directive 70/524/EEC, which include micro-organ-
isms, provisional authorisation of a new use of an addi-
tive in feedingstuffs may be given if the conditions laid
down 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.

(6)

(7)

(8)

the Enterococcus

The use of
faecium, specified in the
Annex, should therefore be authorised on a provisional
basis for a period of
four years and be included in
Chapter IV of the list of authorised additives.

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion on the safety of the use of that
Enterococcus faecium, which is to be used in feedingstuffs
for turkeys, under the conditions set out in the Annex to
this Regulation.

The assessment of the application shows that certain
procedures are required to protect workers from expo-
sure to the additives set out in the Annex. However,
such protection is 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 (5).

(9)

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:

This additive has already been authorised by Commis-
sion Regulation No 1411/1999/EC (3) for piglets, and by
Commission Regulation (EC) No 1636/1999 (4)
for
calves and chickens for fattening.

Article 1

New data were submitted in support of an application to
extend the authorisation of
the use to turkeys for
fattening.

The assessment of
the application for authorisation
submitted in respect of the micro-organism specified in
the Annex to this Regulation, shows that the conditions
referred to in Article 9e(1) of Directive 70/524/EEC are
satisfied.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 22, 25.1.2003, p. 28.
(3) OJ L 164, 30.6.1999, p. 56.
(4) OJ L 194, 27.7.1999, p. 17.

The additive belonging to the group ‘Micro-organisms’ referred
to in the Annex is authorised for use as an additive in feeding-
stuffs under the conditions laid down in the Annex.

Article 2

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

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

(1)

(2)

(3)

(4)

(5)

15.10.2003

EN

Official Journal of the European Union

L 264/17

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

Done at Brussels, 14 October 2003.

For the Commission

David BYRNE

Member of the Commission

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

Period of
authorisation

ANNEX

‘Micro-organisms

13

Enterococcus faecium
DSM 10.663/NCIMB
10 415

granulated

Preparation of Enterococcus
containing
faecium
minimum of:
Powder
and
forms:
3,5 × 1010 CFU/g additive
Coated form:
2,0 × 1010 CFU/g additive
Liquid form:
1 × 1010 CFU/ml additive

Turkeys
fattening

for

—

1 × 107

1 × 109

From 18.10.2003
to 18.10.2007’

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

2. May be used in compound feed
containing the permitted cocci-
diostats:
lasalocid
diclazuril,
sodium, maduramicin ammo-
nium monensin sodium, halo-
fuginone, robenidine.

L

2
6
4
/
1
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
U
n
o
n

i

.

1
5
1
0
2
0
0
3

.