Commission Regulation (EC) No 188/2007 of 23 February 2007 concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed additive (Text with EEA relevance )
Date: 2007-02-23
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, goat, market approval, sheep, zootechnics

24.2.2007

EN

Official Journal of the European Union

L 57/3

COMMISSION REGULATION (EC) No 188/2007

of 23 February 2007
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

therefore not

lation (EC) No 1831/2003 concerns the determination of
the active substance of the feed additive in feed. The
method of analysis referred to in the Annex to this
Regulation is
to be understood as a
Community method of analysis within the meaning of
the
Article 11 of Regulation (EC) No 882/2004 of
European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the veri-
fication of compliance with feed and food law, animal
health and animal welfare rules (2).

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)

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
authorisation 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 dairy goats and
dairy sheep to be classified in the additive category
‘zootechnical additives’.

for piglets

the preparation of Saccharomyces

cerevisiae
The use of
(NCYC Sc 47) was authorised for cattle for fattening by
Commission Regulation (EC) No 316/2003 of 19
February 2003 concerning the permanent authorisation
of an additive in feedingstuffs and the provisional author-
isation of a new use of an additive already authorised in
feedingstuffs (3),
(weaned) by Commission
Regulation (EC) No 2148/2004 of 16 December 2004
concerning the permanent and provisional authorisation
of certain additives in feedingstuffs and the authorisation
of a new use of an additive already authorised in feeding-
stuffs (4), for sows by Commission Regulation (EC) No
1288/2004 of 20 December 2004 concerning the
permanent authorisation of certain additives and the
provisional authorisation of a new use of an additive
already authorised in feedingstuffs (5),
rabbits for
fattening by Commission Regulation (EC) No 600/2005
of 18 April 2005 concerning a new authorisation for 10
years of a coccidiostat as an additive in feedingstuffs, the
provisional
and the
permanent authorisation of certain additives in feeding-
stuffs (6), for dairy cows by Commission Regulation (EC)
No 1811/2005 of 4 November 2005 concerning the
certain
provisional
additives in feedingstuffs and the provisional authori-
sation of a new use of an additive already authorised
in feedingstuffs (7) and for
fattening by
29
of
Commission
September 2006 concerning the authorisation of a new
use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed
additive (8).

for
1447/2006

authorisation of

authorisation of

Regulation No

and permanent

an additive

lambs

for

(2) OJ L 165, 30.4.2004, as corrected by OJ L 191, 28.5.2004, p. 1.
(EC)

by Council Regulation

Regulation
No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

amended

last

as

(4)

The method of analysis included in the application for
authorisation in accordance with Article 7(3)(c) of 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).

(3) OJ L 46, 20.2.2003, p. 15.
(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 amended by Regulation (EC)

No 2028/2006 (OJ L 414, 30.12.2006, p. 26).

(7) OJ L 291, 5.11.2005, p. 12.
(8) OJ L 271, 30.9.2006, p. 28.

L 57/4

EN

Official Journal of the European Union

24.2.2007

(6)

It

the

Food

cerevisiae

environment (1).

New data were submitted in support of the application
for authorisation for dairy goats and dairy sheep. The
(the Authority)
European
Safety Authority
concluded in its opinion of 12 July 2006 that
the
preparation of Saccharomyces
(NCYC Sc 47)
does not have an adverse effect on animal health,
further
human health or
concluded that the preparation of Saccharomyces cerevisiae
(NCYC Sc 47) does not present any other risk for this
additional animal category 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 can improve significantly milk
yield in dairy goats and dairy sheep. The Authority
there is a need for specific
does not consider
requirements of post market monitoring. This opinion
also verifies the report on the method of analysis of
the feed additive in feed submitted by the Community
set up by Regulation (EC)
Reference
No 1831/2003. The assessment of
that preparation
shows that
the conditions for authorisation, provided
for in Article 5 of Regulation (EC) No 1831/2003, are
satisfied. Accordingly, the use of that preparation should
be authorised, as specified in the Annex to this Regu-
lation.

Laboratory

that

(7)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

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’,

Article 2

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

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

Done at Brussels, 23 February 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
product ‘Biosaf Sc 47’, a preparation of Saccharomyces cerevisiae as a
feed additive for dairy small ruminants. Adopted on 12 July 2006,
The EFSA Journal (2006) 379, p. 1.

24.2.2007

EN

Official Journal of the European Union

L 57/5

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