Commission Regulation (EC) No 879/2004 of 29 April 2004 concerning the provisional authorization of a new use of an additive already authorized in feedingstuffs (Saccharomyces cerevisiae) (Text with EEA relevance)
Date: 2004-04-29
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, microorganism, plant health control

30.4.2004

EN

Official Journal of the European Union

L 162/65

COMMISSION REGULATION (EC) No 879/2004

of 29 April 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 Com-
munity,

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.

The use of the micro-organism preparation of Saccharo-
myces cerevisiae (MUCL 39885) has been provisionally
authorised, for the first time, for piglets and cattle for
fattening by Commission Regulation (EC) No 1411/
1999 (3).

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

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 164, 30.6.1999, p. 56.

(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 27 January
2004 on the safety of the additive when used in the
animal category dairy cows, under the conditions of use
set out in the annex to this Regulation.

The use of this additive for dairy cows 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 (4).

(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.

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

L 162/66

EN

Official Journal of the European Union

30.4.2004

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

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE

Member of the Commission

ANNEX

Additive

Chemical formula, description

Species or cate-
gory 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

14

Saccharomyces
siae

MUCL 39885

cerevi-

of

Saccharomyces
Preparation
cerevisiae containing a minimum
of:

Powder, spheric and oval granu-
lated forms:
1 × 109 CFU/g additive

Dairy cows

—

1,23 × 109

2,33 × 109

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

3.5.2007

The quantity of Saccharomyces cerevisiae in
the daily ration must not exceed 8,4 × 109
till 600 kg.
CFU per 100 kg body weight
Over 600 kg add 0,9 × 109 CFU for each
additional 100 kg body weight.

.

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