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17.8.2013 Official
Journal
of
the
European
Union L
220/15
COMMISSION IMPLEMENTING REGULATION (EU) No 787/2013
of 16 August 2013
concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed
additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin
Europa N.V.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
weaned piglets and weaned Suidae other than Sus scrofa
domesticus by Commission Implementing Regulation (EU)
No 306/2013 ( 4 ).
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
in
its opinion of 13 March 2013 ( 5 ) confirmed its previous
conclusions that, under the proposed conditions of use,
the preparation of Bacillus subtilis (ATCC PTA-6737) is
Having regard to Regulation (EC) No 1831/2003 of the
presumed safe for animal and human health and the
European Parliament and of the Council of 22 September
environment. The Authority also concluded that the
2003 on additives for use in animal nutrition ( 1 ), and in
additive has the potential to improve the zootechnical
particular Article 9(2) thereof,
performance in turkeys for fattening and that this
conclusion can be extended to turkeys reared for
breeding. The Authority does not consider that there is
a need for specific requirements of post-market moni
Whereas:
toring. It also verified the report on the method of
analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No
1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
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 Bacillus subtilis
orisation.
(ATCC PTA-6737) shows that the conditions for auth
orisation, as 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 Regulation.
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for a new
use of a preparation of Bacillus subtilis (ATCC PTA-
6737). That application was accompanied by the
(7) The
measures
provided
for
in
this
Regulation
are
in
particulars and documents required under Article 7(3)
accordance with the opinion of the Standing
of Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
(3) That
application
concerns
the
authorisation
of
a
new
use
of Bacillus subtilis (ATCC PTA-6737) as a feed additive for
turkeys for fattening and turkeys reared for breeding, to
be classified in the additive category ‘zootechnical
Article 1
additives’.
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘gut flora stabilisers’, is authorised as an additive in
animal nutrition subject to the conditions laid down in that
(4) The
use
of
that
preparation
of Bacillus subtilis (ATCC
Annex.
PTA-6737) was authorised for 10 years for chickens
for fattening by Commission Regulation (EU) No
107/2010 ( 2 ), for chickens reared for laying, ducks for
Article 2
fattening, quails, pheasants, partridges, guinea fowl,
pigeons, geese for fattening and ostriches by Commission
This Regulation shall enter into force on the twentieth day
Implementing Regulation (EU) No 885/2011 ( 3 ) and for
following that of its publication in the Official Journal of the
European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 36, 9.2.2010, p. 1.
( 4 ) OJ L 91, 3.4.2013, p. 5.
( 3 ) OJ L 229, 6.9.2011, p. 3.
( 5 ) EFSA Journal 2013; 11(4):3176.

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L 220/16
EN
Official Journal of the European Union
17.8.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 August 2013.
For the Commission
The President
José Manuel BARROSO

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17.8.2013 Off
ANNEX
Minimum Maximum
content
content
Identification
Species or
number of Name of the holder of
category of Maximum CFU/kg of complete
Other provisions
End of period of
the additive
authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
age
authorisation
feedingstuff with a
EN
moisture content of

12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1823 Kemin
Europa
N.V. Bacillus subtilis Additive composition
Turkeys
— 1
×
108
—
1. In the directions for use of the additive 6 September 2023
(ATCC
for
and premixture, indicate the storage
PTA-6737)
Preparation of Bacillus subtilis (ATCC PTA- fattening
conditions and stability to pelleting.
6737) containing a minimum of 1 × 1010
and
CFU/g additive
turkeys
2. The use is permitted in feed containing
reared for
the authorised coccidiostats: diclazuril,
Solid form
breeding
robenidine hydrochloride, lasalocid A
icial
sodium, maduramicin ammonium, or
Characterisation of the active substance
monensin sodium, on conditions that
Jour
Viable spores of Bacillus subtilis (ATCC
this coccidiostat is authorised for the
nal
PTA-6737)
relevant species.
of
Analytical method (1 )
the
Enumeration: spread plate method using
European
tryptone soya agar with pre heat-
treatment of feed samples.
Identification: pulsed-field gel electro
Union
phoresis (PFGE) method.
(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
L
220/17

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Document Outline

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