Commission Regulation (EC) No 2154/2003 of 10 December 2003 provisionally authorising certain micro-organisms in feedingstuffs (Enterococcus faecium and Lactobacillus acidophilus) (Text with EEA relevance)
Date: 2003-12-10
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, microorganism

11.12.2003

EN

Official Journal of the European Union

L 324/11

COMMISSION REGULATION (EC) No 2154/2003

of 10 December 2003

provisionally authorising certain micro-organisms in feedingstuffs (Enterococcus faecium and Lacto-
bacillus acidophilus)

(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
particular Articles 3 and 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 additive or new
use of an additive already authorised in feedingstuffs,
may be given if the conditions laid down in that Direc-
tive 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.

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

The use of Enterococcus
already been
authorised for a period of four years by the Commission
Regulation (EC) No 666/2003/EC (3) for piglets and pigs
for fattening.

faecium has

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

Data were submitted in support of an application of the
new additive Lactobacillus acidophilus for laying hens.

The use of the Lactobacillus acidophilus for laying hens
and the Enterococcus faecium for sows, 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 delivered
favourable opinions on the safety of the use of these
micro-organisms, under the conditions set out in the
Annex to this Regulation.

The assessment of the applications 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 (4), as amended by
Regulation (EC) No 1882/2003 (5).

(10)

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 additives belonging to the group ‘micro-organisms’ referred
to in the Annex are authorised for use as the additives in
feedingstuffs under the conditions laid down in the Annex.

New data were submitted in support of an application to
extend the authorisation of the use of Enterococcus faecium
to sows.

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

Article 2

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 22, 25.1.2003, p. 28.
(3) OJ L 96, 12.4.2003, p. 11.

(4) OJ L 183, 29.6.1989, p. 1.
(5) OJ L 284, 31.10.2003, p. 1.

L 324/12

EN

Official Journal of the European Union

11.12.2003

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

Done at Brussels, 10 December 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

End of period of
authorisation

ANNEX

.

1
1
1
2
2
0
0
3

.

Micro-organisms

22

Enterococcus faecium

DSM7 134

Preparation
containing a minimum of:

of

Enterococcus

faecium

Sows

—

0,5 × 109

1 × 109

Powder: 1 × 1010 CFU/g of additive

Granules
CFU/g of additive

(micro-encapsulated): 1 × 1010

23

Lactobacillus
philus

D2/CSL

CECT4 529

acido-

Preparation of
containing minimum of:

Lactobacillus

50 × 109 CFU/g additive

acidophilus

Laying hens

—

1 × 109

1 × 109

The directions for use must indicate the
storage
and
pelleting stability both of the additive and
the premixture.

temperature,

shelf-life

Sows 25 days before
during lactation.

farrowing and

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

indicate

the

14.12.2007

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