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26.2.2011 Official
Journal
of
the
European
Union L
53/33
COMMISSION REGULATION (EU) No 184/2011
of 25 February 2011
concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens
reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of
authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
reared for laying, turkeys and minor avian species. The
European Food Safety Authority (the Authority)
concluded in its opinion of 5 October 2010 ( 4 ) that
Bacillus subtilis C-3102 (DSM 15544), under the
Having regard to the Treaty on the Functioning of the European
proposed conditions of use, does not have an adverse
Union,
effect on animal health, human health or the
environment, and that its use can improve the weight
gain of the target species. The Authority does not
consider that there is a need for specific requirements
Having regard to Regulation (EC) No 1831/2003 of the
of post-market monitoring. It also verified the report
European Parliament and of the Council of 22 September
on the method of analysis of the feed additive in feed
2003 on additives for use in animal nutrition ( 1 ), and in
submitted by the Community Reference Laboratory set
particular Article 9(2) thereof,
up by Regulation (EC) No 1831/2003.
Whereas:
(6) The
assessment
of Bacillus subtilis C-3102 (DSM 15544)
shows that the conditions for authorisation, as provided
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au
for in Article 5 of Regulation (EC) No 1831/2003, are
thorisation of additives for use in animal nutrition and
satisfied. Accordingly, the use of this preparation should
for the grounds and procedures for granting such
be authorised as specified in the Annex to this
authorisation.
Regulation.
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No 1831/2003, an application was submitted for the
(7) The
measures
provided
for
in
this
Regulation
are
in
authorisation of the preparation set out in the Annex
accordance with the opinion of the Standing
to this Regulation. That application was accompanied
Committee on the Food Chain and Animal Health,
by the particulars and documents required under
Article 7(3) of Regulation (EC) No 1831/2003.
(3) The
application
concerns
the
authorisation
of
a
new
use HAS ADOPTED THIS REGULATION:
of Bacillus subtilis C-3102 (DSM 15544) as a feed additive
for chickens reared for laying, turkeys and minor avian
species, to be classified in the additive category
‘zootechnical additives’.
Article 1
The preparation specified in the Annex, belonging to the
(4) The
use
of Bacillus subtilis C-3102 (DSM 15544) has been
additive category ‘zootechnical additives’ and to the functional
authorised for 10 years for chickens for fattening by
group ‘gut flora stabilisers’, is authorised as an additive in
Commission Regulation (EC) No 1444/2006 (
animal nutrition subject to the conditions laid down in that

2 ) and for
weaned piglets by Commission Regulation (EU)
Annex.
No 333/2010 ( 3 ).
(5) New
data
were
submitted
in
support
of
the
application
Article 2
for the authorisation of the preparation for chickens
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 271, 30.9.2006, p. 19.
( 3 ) OJ L 102, 23.4.2010, p. 19.
( 4 ) EFSA Journal 2010; 8(10):1867.

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L 53/34
EN
Official Journal of the European Union
26.2.2011
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 February 2011.
For the Commission
The President
José Manuel BARROSO

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26.2.2011 Off
ANNEX
Minimum
Maximum
content
content
Identification
number of
Name of the holder of
Species or category of Maximum
Other provisions
End of period of
the additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
animal
age
CFU/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1820 Calpis
Co.
Ltd
Japan,
Bacillus subtilis Additive composition
Chickens reared for
— 5
×
108
— 1.
In
the
directions
for
use
of
the
18 March 2021
represented by Calpis C-3102 (DSM Preparation of Bacillus subtilis
laying
additive and premixture,
Co. Ltd Europe Repre 15544)
C-3102 DSM 15544 containing
indicate the storage
sentative Office, France
a minimum of 1 × 1010 CFU/g
Turkeys, minor
3 × 108
temperature, storage life and
avian species and
stability to pelleting.
Characterisation of active substance
other ornamental
and game birds
2. For safety: breathing protection,
Viable spores of Bacillus subtilis
glasses and gloves shall be used
C-3102 (DSM 15544)
during handling.
icial
Analytical methods (1 )
3. May be used in feed containing
Jour
the following coccidiostats
Enumeration: spread plate
where authorised: decoquinate,
nal
method using tryptone soya
monensin sodium, robenidine
agar with preheat treatment of
of
hydrochloride, diclazuril,
feed samples
the
lasalocid sodium, halofuginone,
Identification: Pulsed Field Gel
narasin, salinomycin sodium,
European
Electrophoresis (PFGE)
maduramycin ammonium,
narasin-nicarbazin, semdu
ramycin sodium or nicarbazin.
Union
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
L
53/35

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