Commission Regulation (EC) No 490/2004 of 16 March 2004 concerning the provisional authorization of a new use of an additive already authorized in feedingstuffs (Saccharomyces cerevisiae) (Text with EEA relevance)
Date: 2004-03-16
Institutions: European Commission
Subjects: animal nutrition, equidae, food additive, food safety, market approval, microorganism

17.3.2004

EN

Official Journal of the European Union

L 79/23

COMMISSION REGULATION (EC) No 490/2004

of 16 March 2004

concerning the provisional authorization of a new use of an additive already authorized in feeding-
stuffs (Saccharomyces cerevisiae)

(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 Regulation (EC) No 1756/2002 (2), and in particu-
lar Articles 3 and 9e(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Directive 70/524/EEC provides 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, which includes micro-organisms,
provisional authorisation 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 reason-
able 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 provi-
sional 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.

cerevisiae

The use of the micro-organism preparation of Saccharo-
(CBS 493.94) has been provisionally
myces
authorised, for the first time, for calves by Commission
Regulation (EC) No 1436/1998 (3),
for
fattening by Commission Regulation (EC) No 866/
1999 (4) and for dairy cows by Commission Regulation
(EC) No 937/2001 (5). These authorisations have been
last modified by Commission Regulation (EC) No 2200/
2001 (6).

cattle

for

New data were submitted in support of an application to
extend the authorisation of this additive to horses.

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

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.
(3) OJ L 191, 7.7.1998, p. 15.
(4) OJ L 108, 27.4.1999, p. 21.
(5) OJ L 130, 12.5.2001, p. 25.
(6) OJ L 299, 15.11.2001, p. 1.

(6)

(7)

(8)

The European Food Safety Authority (Scientific Panel on
Additives and Products or Substances Used in Animal
Feed) delivered a favourable opinion on 13 November
2003 on the safety of the additive when used in the
animal category horses, under the conditions of use set
out in the annex to this Regulation.

The use of this additive for horses should therefore be
provisionally authorised for a period of four years.

The assessment of the application shows that certain
procedures should be required to protect workers from
exposure to the additive set out in the Annex. 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 (7), as amended
the European
by Regulation (EC) No 1882/2003 of
Parliament and of the Council (8).

(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

Article 1

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

(7) OJ L 183, 29.6.1989, p. 1.
(8) OJ L 284, 31.10.2003, p. 1.

L 79/24

EN

Official Journal of the European Union

17.3.2004

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

Done at Brussels, 16 March 2004.

For the Commission

David BYRNE

Member of the Commission

No (or
EC No)

Additive

Chemical formula, description

‘Micro-organisms

ANNEX

Species or
category of
animal

Maximum
age

Minimu
content

Maximu
content

CFU/kg of complete
feedingstuff

5

Saccharomyces cerevisiae

CBS 493.94

of

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

Horses

—

4 × 109

2,5 × 1010

Other provisions

End of period of authori-
sation

.

.

1
7
3
2
0
0
4

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

indicate the

the additive and
storage temperature,

The quantity of Saccharomyces cerevisiae in the
daily ration must not exceed 4.17 × 1010 CFU for
100 kg of body weight.

Use permitted from two months post weaning
onwards.

17.3.2008

20.3.2008’

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