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24.4.2013 Official
Journal
of
the
European
Union L
112/13
COMMISSION IMPLEMENTING REGULATION (EU) No 374/2013
of 23 April 2013
concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed
additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd
represented by Miyarisan Pharmaceutical Europe S.L.U.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 11 December 2012 ( 4 ) that,
Having regard to the Treaty on the Functioning of the European
under the proposed conditions of use, the preparation of
Union,
Clostridium butyricum (FERM BP-2789) does not have an
adverse effect on animal health, human health and the
Having regard to Regulation (EC) No 1831/2003 of the
environment. It also concluded that the additive shows
European Parliament and of the Council of 22 September
some potential to improve performance in chickens
2003 on additives for use in animal nutrition ( 1 ), and in
reared for laying. The Authority does not consider that
particular Article 9(2) thereof,
there is a need for specific requirements of post-market
monitoring. It also verified the report on the method of
Whereas:
analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
1831/2003.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(6) The
assessment
of
the
preparation
of Clostridium butyricum
orisation.
(FERM BP-2789) shows that the conditions for authori
sation, as provided for in Article 5 of Regulation (EC) No
(2) The
use
of
a
preparation
of Clostridium butyricum (FERM
1831/2003, are satisfied. Accordingly, the use of that
BP-2789), belonging to the additive category of ‘zoo
preparation should be authorised as specified in the
technical additives’, was authorised for 10 years as a
Annex to this Regulation.
feed additive for use on chickens for fattening by
Commission Regulation (EC) No 903/2009 (
(7) The
measures
provided
for
in
this
Regulation
are
in

2 ) and for
accordance with the opinion of the Standing
minor avian species (excluding laying birds) and for
Committee on the Food Chain and Animal Health,
weaned piglets and minor porcine species (weaned) by

Commission Implementing Regulation (EU) No
HAS ADOPTED THIS REGULATION:
373/2011 ( 3 ).
Article 1
(3) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for a new
The preparation specified in the Annex, belonging to the
use of the preparation of Clostridium butyricum (FERM
additive category ‘zootechnical additives’ and to the functional
BP-2789) for chickens reared for laying, requesting that
group ‘gut flora stabilisers’, is authorised as an additive in
the additive be classified in the additive category ‘zoo
animal nutrition subject to the conditions laid down in that
technical additives’.
Annex.
Article 2
(4) The
application
was
accompanied
by
the
particulars
and
documents required under Article 7(3) of Regulation (EC)
This Regulation shall enter into force on the twentieth day
No 1831/2003, and by the relevant data to support its
following that of its publication in the Official Journal of the
requests.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 256, 29.9.2009, p. 26.
( 3 ) OJ L 102, 16.4.2011, p. 10.
( 4 ) EFSA Journal 2013; 11(1):3040.

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L 112/14
ANNEX
Minimum
Maximum
content
content
Identification
number of Name of the holder of
Species or category Maximum
Other provisions
End of period of
the additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
of animal
age
CFU/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1830 Miyarisan
Phar
Clostridium
Additive composition
Chickens reared
— 2,5
×
108
— 1.
In
the
directions
for
use
of
the
14 May 2023
maceutical Co. Ltd butyricum
for laying
additive and premixture,
represented by
(FERM BP-2789)
Preparation of Clostridium butyricum
indicate the storage
Miyarisan Phar
(FERM BP-2789) containing in
temperature, storage life and
maceutical Europe
solid form a minimum of 5 × 108
stability to pelleting.
S.L.U.
CFU/g additive.
2. The use is allowed in feed
Characterisation of the active substance
containing the authorised
Off
Viable spores of Clostridium butyricum
coccidiostats: monensin sodium,
icial
FERM BP-2789.
diclazuril, salinomycin sodium
or lasalocid sodium.
Analytical method (1 )
Jour
3. For safety: breathing protection
Quantification: pour plate method
nal
and safety glasses shall be used
based on ISO 15213 standard.
during the handling.
of
Identification: pulsed-field gel elec
the
trophoresis (PFGE) method.
European
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additives
Union
24.4.2013

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Document Outline

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