HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 102/10
EN
Official Journal of the European Union
16.4.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 373/2011
of 15 April 2011
concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed
additive for minor avian species except laying birds, weaned piglets and minor porcine species
(weaned) and amending Regulation (EC) No 903/2009 (holder of authorisation Miyarisan
Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
Authority
concluded
in
its
opinion
of
8
December
2010 ( 3 ) that the preparation of Clostridium butyricum
FERM-BP 2789 set out in the Annex, under the
proposed conditions of use, does not have an adverse
Having regard to the Treaty on the Functioning of the European
effect on animal health, human health or the
Union,
environment, and that this additive has the potential to
improve weight gain and the efficiency of feed
conversion in the target species. The Authority also
Having regard to Regulation (EC) No 1831/2003 of the
concluded that the previous strain designation was not
European Parliament and of the Council of 22 September
suitable for an unambiguous identification of the
2003 on additives for use in animal nutrition ( 1 ), and in
production strain and consequently supports the
particular Article 9(2) and Article 13(3) thereof,
applicant’s wish to change it to Clostridium butyricum
FERM-BP 2789. The Authority concluded that the
compatibility has been demonstrated for two additional
coccidiostats. The Authority does not consider that there
Whereas:
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
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
European Union Reference Laboratory for Feed
thorisation of additives for use in animal nutrition, for
Additives set up by Regulation (EC) No 1831/2003.
the grounds and procedures for granting such authori
sation, and for the possibility to modify the authorisation
of a feed additive further to a request from the holder of
the authorisation and an opinion of the European Food
(6)
The proposed change of the terms of the authorisation
Safety Authority (the Authority).
related to the name of the representative of the holder of

the authorisation is purely administrative in nature and
does not entail a fresh assessment of the additives
concerned. The Authority was informed of the appli
(2) The
preparation
of Clostridium butyricum MIYAIRI 588
cation.
(FERM-P 1467) has been authorised as a feed additive
for 10 years for use in chickens for fattening by
Commission Regulation (EC) No 903/2009 ( 2 ).
(7) The
assessment
of
the
preparation
shows
that
the
conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(3) The
applicant
requested
a
modification
of
the
strain
Accordingly, the use of that preparation should be au-
designation from Clostridium butyricum MIYAIRI 588
thorised as specified in the Annex to this Regulation.
(FERM-P 1467) to Clostridium butyricum FERM-BP 2789,
and of the name of the representative of the holder of
the authorisation from Mitsui & Co. Deutschland GmbH
to Miyarisan Pharmaceutical Europe S.L.U. and, in
(8) Regulation
(EC)
No
903/2009
should
therefore
be
accordance with Article 7 of Regulation (EC)
amended accordingly.
No 1831/2003, for a new use of this additive for
minor avian species (except laying hens), weaned piglets
and minor weaned porcine species, requesting that the
additive be classified in the additive category
(9)
Since the modifications on the conditions of the au-
‘zootechnical additives’.
thorisation are not related to safety reasons, it is appro
priate to allow a transitional period for the disposal of
existing stocks of the premixtures and compound feed.
(4) The
application
was
accompanied
by
the
particulars
and
documents required under Article 7(3) of Regulation (EC)
No 1831/2003, and by the relevant data to support its
(10) The
measures
provided
for
in
this
Regulation
are
in
request.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 256, 29.9.2009, p. 26.
( 3 ) EFSA Journal (2011); 9(1):1951.

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EN
16.4.2011 Official
Journal
of
the
European
Union L
102/11
HAS ADOPTED THIS REGULATION:
In point 2 of the ‘Other provisions’ column of the Annex to
Regulation (EC) No 903/2009 the words ‘monensin sodium or
lasalocid’ are added.
Article 1
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
Article 3
group ‘gut flora stabilisers’, is authorised as an additive in
animal nutrition subject to the conditions laid down in that
Feed containing Clostridium butyricum MIYAIRI 588 (FERM-P
Annex.
1467) labelled in accordance with Regulation (EC)
No 903/2009 may continue to be placed on the market and
used until stocks are exhausted.
Article 2
In Regulation (EC) No 903/2009 the words ‘Clostridium
butyricum MIYAIRI 588 (FERM-P 1467)’ and the words
Article 4
‘Mitsui & Co. Deutschland GmbH’ are replaced respectively by
the words ‘Clostridium butyricum FERM-BP 2789’ and by the
This Regulation shall enter into force on the 20th day following
words ‘Miyarisan Pharmaceutical Europe S.L.U’.
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, 15 April 2011.
For the Commission
The President
José Manuel BARROSO

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L 102/12
ANNEX
Minimum
Maximum
Identification
content
content
End of period
number of the Name of the holder of
Other provisions
of
additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
Species or category of animal Maximum age CFU/kg of complete feedingstuff
authorisation
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1830 Miyarisan Phar Clostridium
Additive composition
Minor avian species
— 5
×
108
— 1.
In
the
directions
for
use
6 May 2021
maceutical Co. Ltd butyricum
Preparation of Clostridium (excluding laying birds).
CFU
of the additive and
represented by
FERM BP-2789
butyricum FERM BP-2789
premixture, indicate the
Miyarisan Phar
containing a minimum of
storage temperature,
maceutical Europe
solid form 5 × 108 CFU/g
storage life and stability
S.L.U.
additive.
to pelleting.
Characterisation of the active
2. The use is allowed in feed
Off
substance
containing the authorised
coccidiostats: monensin
icial
Clostridium butyricum FERM
sodium, diclazuril,
BP-2789.
maduramycin
Jour
ammonium, robenidine,
Analytical method (1 )
nal
narasin, narasin/nicar-
Piglets (weaned) and
2,5 × 108
Quantification: pour plate
bazin, semduramicin,
minor porcine species
CFU
of

method based on ISO 15213
decoquinate, salinomycin
(weaned).
the
standard.
sodium or lasalocid
European
Identification: pulsed-field gel
sodium.
electrophoresis (PFGE)
method.
3. For safety: breathing
protection shall be used
Union
during the handling.
(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
16.4.2011

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