Commission Regulation (EC) No 209/2008 of 6 March 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf Sc 47) as a feed additive (Text with EEA relevance)
Date: 2008-03-06
Institutions: European Commission
Subjects: animal feedingstuffs, fattening, food additive, food safety, market approval, swine, zootechnics

7.3.2008

EN

Official Journal of the European Union

L 63/3

COMMISSION REGULATION (EC) No 209/2008

of 6 March 2008
concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf Sc 47) as a feed
additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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,

(5)

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the author-
isation 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 author-
isation of the preparation set out in the Annex. That
application was accompanied by the particulars and
documents required under Article 7(3) of that Regulation.

The application concerns authorisation of a new use of
the preparation Saccharomyces
cerevisiae NCYC Sc 47
(Biosaf Sc 47) as a feed additive for pigs for fattening,
to be classified in the additive category ‘zootechnical
additives’.

the preparation of Saccharomyces

cerevisiae
The use of
authorised for dairy cows by
NCYC Sc 47 was
Commission Regulation (EC) No 1811/2005 (2),
for
cattle for fattening by Commission Regulation (EC) No
316/2003 (3), for piglets (weaned) by Commission Regu-

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) OJ L 291, 5.11.2005, p. 12.
(3) OJ L 46, 20.2.2003, p. 15.

Commission

for
Regulation

lation (EC) No 2148/2004 (4), for sows by Commission
Regulation (EC) No 1288/2004 (5),
for
fattening
(EC) No
by
600/2005 (6),
for horses by Commission Regulation
(EC) No 186/2007 (7) and for dairy goats and dairy
No
sheep
Regulation
Commission
188/2007 (8),
for lambs for fattening by Commission
Regulation (EC) No 1447/2006 (9).

rabbits

(EC)

by

New data were submitted in support of an application
for authorisation for pigs for fattening. The European
Food Safety Authority (the Authority) concludes in its
opinion of 22 November 2007 that the safety of Sacchar-
omyces cerevisiae (Biosaf Sc 47) for the consumer, the user
and the environment has already been established by its
previous opinions (10). It further concludes that the use of
the preparation does not present a risk for this additional
animal category and that the use of that preparation can
improve performance parameters in pigs for fattening.
The Authority does not consider that there is a need
for specific requirements of post market monitoring. 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.

that preparation shows

The assessment of
the
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
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(6)

(7)

(4) OJ L 370, 17.12.2004, p. 24. Regulation as amended by Regulation

(EC) No 1980/2005 (OJ L 318, 6.12.2005, p. 3).

(5) OJ L 243, 15.7.2004, p. 10. Regulation as amended by Regulation

(EC) No 1812/2005 (OJ L 291, 5.11.2005, p. 18).

(6) OJ L 99, 19.4.2005, p. 5. Regulation as last amended by Regulation

(EC) No 496/2007 (OJ L 117, 5.5.2007, p. 9).

(7) OJ L 63, 1.3.2007, p. 6.
(8) OJ L 57, 24.2.2007, p. 3.
(9) OJ L 271, 30.9.2006, p. 28.
(10) 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 Biosaf Sc 47
(Saccharomyces cerevisiae) as feed additive for pigs for fattening. The
EFSA Journal (2007) 585, 1-9.

L 63/4

EN

Official Journal of the European Union

7.3.2008

HAS ADOPTED THIS REGULATION:

animal nutrition subject to the conditions laid down in that
Annex.

Article 1

Article 2

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

flora stabilisers’,

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

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

Done at Brussels, 6 March 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

7.3.2008

EN

Official Journal of the European Union

L 63/5

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