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6.9.2011 Official
Journal
of
the
European
Union L
229/3
COMMISSION IMPLEMENTING REGULATION (EU) No 885/2011
of 5 September 2011
concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens
reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for
fattening and ostriches (holder of authorisation Kemin Europa N.V.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Authority (the Authority) concluded in its opinion of
15 March 2011 (
Having regard to the Treaty on the Functioning of the European

3 ) that, under the proposed conditions
of use, Bacillus subtilis (ATCC PTA-6737) does not have
Union,
an adverse effect on animal health, consumer health or
Having regard to Regulation (EC) No 1831/2003 of the
the environment, and that the use of this preparation can
European Parliament and of the Council of 22 September
improve the zootechnical performance of the animal
2003 on additives for use in animal nutrition ( 1 ), and in
species. The Authority does not consider that there is a
particular Article 9(2) thereof,
need for specific requirements of post-market moni
toring. It also verified the report on the method of
Whereas:
analysis of the feed additive in feed submitted by the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
authori
Community Reference Laboratory set up by Regulation
sation of additives for use in animal nutrition and for the
(EC) No 1831/2003.
grounds and procedures for granting such authorisation.
(6) The
assessment
of Bacillus subtilis (ATCC PTA-6737)
(2) In
accordance
with
Article
7
of
Regulation
(EC)
shows that the conditions for authorisation, as
No 1831/2003, an application was submitted for the
provided for in Article 5 of Regulation (EC)
authorisation of the preparation of Bacillus subtilis
No 1831/2003, are satisfied. Accordingly, the use of
(ATCC PTA-6737). The application was accompanied
this preparation should be authorised as specified in
by the particulars and documents required under
the Annex to this Regulation.
Article 7(3) of Regulation (EC) No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in
(3) The
application
concerns
the
authorisation
of
the
prep
accordance with the opinion of the Standing
aration of Bacillus subtilis (ATCC PTA-6737) as a feed
Committee on the Food Chain and Animal Health,
additive for chickens reared for laying, ducks for
fattening, quails, pheasants, partridges, guinea fowl,
HAS ADOPTED THIS REGULATION:
pigeons, geese for fattening and ostriches, to be classified
in the additive category ‘zootechnical additives’.
Article 1
(4) The
use
of
the
preparation
of Bacillus subtilis (ATCC
The preparation specified in the Annex, belonging to the
PTA-6737) was authorised for 10 years for chickens
additive category ‘zootechnical additives’ and to the functional
for fattening by Commission Regulation (EU)
group ‘gut flora stabilisers’, is authorised as an additive in
No 107/2010 ( 2 ).
animal nutrition, subject to the conditions laid down in that
Annex.
(5) New
data
were
submitted
in
support
of
the
application
for the authorisation of Bacillus subtilis (ATCC PTA-6737)
Article 2
for chickens reared for laying, ducks for fattening, quails,
pheasants, partridges, guinea fowl, pigeons, geese for
This Regulation enters into force on the 20th day following its
fattening and ostriches. The European Food Safety
publication in the Official Journal of the European Union.
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 September 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 36, 9.2.2010, p. 1.
( 3 ) EFSA Journal 2011; 9(3):2114.

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L 229/4
ANNEX
Minimum
Maximum
Identification
Species or
content
content
End of period
number of the Name of the holder of
category of
Maximum age
Other provisions
of
additive
authorisation
Additive
Composition, chemical formula,
description, analytical method.
animal
CFU /kg of complete feedingstuff
authorisation
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1823 Kemin
Europa
N.V. Bacillus
subtilis (ATCC Additive composition:
Chickens
— 1
×
107
— 1.
In
the
directions
for
use
26 September
PTA-6737)
Preparation of Bacillus subtilis
reared for
of the additive and
2021
(ATCC PTA-6737) containing a
laying
premixture, indicate the
minimum of 1 × 1010 CFU/g
storage temperature,
additive
Ducks for
storage life and stability
fattening,
to pelleting
Characterisation of the active
quails,
Off
substance:
pheasants,
2. The use is allowed in feed
partridges,
containing one of the
icial
Spores of Bacillus subtilis (ATCC
guinea fowl,
authorised coccidiostats:
PTA-6737)
pigeons,
diclazuril, decoquinate,
Jour
geese for
salinomycin sodium,
Analytical method (1 ):
nal
fattening
narasin/nicarbazin,
Enumeration: spread plate method
lasalocid A sodium,
of
using tryptone soya agar with pre-
Ostriches
maduramycin
the
heat treatment of feed samples
ammonium, monensin
European
Identification: pulsed-field gel
sodium, narasin or
electrophoresis (PFGE) method
robenidine hydrochloride
on condition that this
coccidiostat is authorised
Union
for the relevant species
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
6.9.2011

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