Commission Regulation (EC) No 1293/2008 of 18 December 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (Text with EEA relevance)
Date: 2008-12-18
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, sheep, zootechnics

L 340/38

EN

Official Journal of the European Union

19.12.2008

COMMISSION REGULATION (EC) No 1293/2008

of 18 December 2008
concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20
and Levucell SC10 ME) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 9(2) thereof,

Whereas:

New data were submitted in support of an application
for authorisation for lambs. The European Food Safety
Authority (the Authority) concluded in its opinion of
cerevisiae CNCM
that Saccharomyces
16 July 2008 (4)
I-1077 (Levucell SC20/Levucell SC10 ME) does not
have an adverse effect on animal health, human health
It further concluded that Saccha­
or the environment.
romyces cerevisiae CNCM I-1077 (Levucell SC20/Levucell
SC10 ME) does not present any other
risk which
would,
in accordance with Article 5(2) of Regulation
(EC) No 1831/2003, exclude authorisation. According
to that opinion, the use of that preparation is safe for
lambs. That opinion also states that that preparation can
produce a beneficial effect on final weight and average
daily gain. The Authority does not consider that there is
a need for specific requirements of post market moni­
toring.
It also verified the report on the method of
analysis of the feed additive in feed submitted by the
Community Reference Laboratory set up by Regulation
(EC) No 1831/2003.

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the autho­
risation of additives for use in animal nutrition and for
the grounds and procedures for granting such authori­
sation.

In accordance with Article 7 of Regulation (EC) No
1831/2003, an application was submitted for the au­
thorisation of
in the Annex.
the preparation set out
That application was accompanied by the particulars
and documents required under Article 7(3) of that Regu­
lation.

(6)

(7)

that preparation shows

the
The assessment of
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
Accordingly,
that preparation should be
the use of
authorised, as specified in the Annex to this Regulation.

that

are

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

opinion

the

the

of

the preparation of Saccharomyces

The application concerns the authorisation of a new use
cerevisiae CNCM
of
I-1077 (Levucell SC20, Levucell SC10 ME), as a feed
to be classified in the additive
lambs,
additive for
category ‘zootechnical additives’.

HAS ADOPTED THIS REGULATION:

The use of Saccharomyces cerevisiae CNCM I-1077 was
authorised without a time limit
for dairy cows and
cattle for fattening by Commission Regulation (EC) No
1200/2005 (2) and, until 22 March 2017, for dairy goats
and dairy sheep by Commission Regulation (EC) No
226/2007 (3).

(1) OJ L 268, 18.10.2003, p. 29.
(2) OJ L 195, 27.7.2005, p. 6.
(3) OJ L 64, 2.3.2007, p. 26.

Article 1

The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘gut
is authorised as an additive in
animal nutrition subject to the conditions laid down in that
Annex.

flora stabilisers’,

(4) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on the safety and efficacy of Levucell
SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as
feed additive for lambs for fattening. The EFSA Journal (2008) 772,
1-11.

19.12.2008

EN

Official Journal of the European Union

L 340/39

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 2

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

Done at Brussels, 18 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 340/40

EN

Official Journal of the European Union

19.12.2008

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