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8.4.2011 Official
Journal
of
the
European
Union L
94/17
COMMISSION REGULATION (EU) No 336/2011
of 7 April 2011
amending Regulation (EC) No 1292/2008 as regards the use of the feed additive Bacillus
amyloliquefaciens CECT 5940 in feed containing diclazuril, monensin sodium and nicarbazin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
monensin sodium, diclazuril, nicarbazin, robenidine
hydrochloride, salinomycin sodium, lasalocid sodium,
narasin/nicarbazin, maduramycin ammonium, deco
Having regard to the Treaty on the Functioning of the European
quinate or semduramicin sodium for chickens for
Union,
fattening. The holder of the authorisation submitted the
relevant data to support its request.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition (
(5) The
Authority
concluded
in
its
opinion
of
9
November

1 ), and in
2010 that the additive Bacillus amyloliquefaciens CECT
particular Article 13(3) thereof,
5940 is compatible with diclazuril, monensin sodium
and nicarbazin ( 3 ).
Whereas:
(6) The
conditions
provided
for
in
Article
5
of
Regulation
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
(EC) No 1831/2003 are satisfied.
thorisation of additives for use in animal nutrition and
for the grounds and procedures for granting such au-
thorisation.
(7) Regulation
(EC)
No
1292/2008
should
therefore
be
amended accordingly.
(2) Regulation
(EC)
No
1831/2003
provides
for
the
possi
bility to modify the authorisation of a feed additive
(8) The
measures
provided
for
in
this
Regulation
are
in
further to a request from the holder of the authorisation
accordance with the opinion of the Standing
and an opinion of the European Food Safety Authority
Committee on the Food Chain and Animal Health,
(the Authority).
HAS ADOPTED THIS REGULATION:
(3) The
use
of
the
micro-organism
preparation
of Bacillus
amyloliquefaciens CECT 5940 was authorised for 10
years for chickens for fattening by Commission Regu
lation (EC) No 1292/2008 of 18 December 2008
Article 1
concerning the authorisation of Bacillus amyloliquefaciens
The Annex to Regulation (EC) No 1292/2008 is replaced by the
CECT 5940 (Ecobiol and Ecobiol Plus) as a feed
text in the Annex to this Regulation.
additive ( 2 ).
Article 2
(4) The
holder
of
the
authorisation
submitted
an
application
for a modification of the authorisation of this additive to
This Regulation shall enter into force on the 20th day following
allow its use in feed containing the coccidiostats
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, 7 April 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 340, 19.12.2008, p. 36.
( 3 ) EFSA Journal 2010; 8(12):1918.

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L 94/18
ANNEX
The Annex to Regulation (EC) No 1292/2008 is replaced by the following:
‘ANNEX
EN
Minimum
Maximum

Identification Name of the
Species or
content
content
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum age
Other provisions
End of period of
the additive
authorisation
method
animal
authorisation
CFU/kg of complete feedingstuff
with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1822 Norel
SA Bacillus
amylo Additive composition
Chickens for
— 1
×
109
— 1.
In
the
directions
for
use 8.1.2019
liquefaciens
fattening
of the additive and
CECT 5940
Preparation of Bacillus amyloliquefaciens CECT 5940
premixture, indicate the
Off
containing a minimum of 1 × 109 CFU/g additive
storage temperature,
icial
storage life and stability
Characterisation of active substance
to pelleting.
Jour
Spores of Bacillus amyloliquefaciens CECT 5940
2. May be used in feed
nal
containing the permitted
of
Analytical methods (1 )
coccidiostats: diclazuril,
the
monensin sodium, or
European
Enumeration: spread plate method using tryptone
nicarbazin.
soya agar following a heat treatment.
3. For
safety
reasons:
Identification: pulsed-field gel electrophoresis
breathing protection;
Union
(PFGE) method.
glasses and gloves shall
be used during handling
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: www.irmm.jrc.be/crl-feed-additives’
8.4.2011

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