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6.9.2011 Official
Journal
of
the
European
Union L
229/7
COMMISSION IMPLEMENTING REGULATION (EU) No 887/2011
of 5 September 2011
concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive
for chickens for fattening (holder of the authorisation Norel SA)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
animal health, consumer health or the environment, and
that this additive has the potential to improve the body
Having regard to the Treaty on the Functioning of the European
weight gain and feed to gain ratio in chickens for
Union,
fattening. The Authority does not consider that there is
a need for specific requirements of post-market moni
toring. It also verified the report on the method of
Having regard to Regulation (EC) No 1831/2003 of the
analysis of the feed additive in feed submitted by the
European Parliament and of the Council of 22 September
Community Reference Laboratory set up by Regulation
2003 on additives for use in animal nutrition ( 1 ), and in
(EC) No 1831/2003.
particular Article 9(2) thereof,
(5) The
assessment
of
the
preparation
of Enterococcus faecium
Whereas:
CECT 4515 shows that the conditions for authorisation,
as provided for in Article 5 of Regulation (EC) No
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
1831/2003, are satisfied. Accordingly, the use of this
orisation of additives for use in animal nutrition and
preparation should be authorised as specified in the
for the grounds and procedures for granting such auth
Annex to this Regulation.
orisation.
(6) The
measures
provided
for
in
this
Regulation
are
in
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
accordance with the opinion of the Standing
1831/2003, an application was submitted for the auth
Committee on the Food Chain and Animal Health,
orisation of the preparation of Enterococcus faecium CECT
4515. That application was accompanied by the
HAS ADOPTED THIS REGULATION:
particulars and documents required pursuant to
Article 7(3) of Regulation (EC) No 1831/2003.
Article 1
The preparation specified in the Annex, belonging to the
(3) The
application
concerns
the
authorisation
of
the
prep
aration set out in the Annex as a feed additive for
additive category ‘zootechnical additives’ and to the functional
chickens for fattening, to be classified in the additive
group ‘gut flora stabilisers’, is authorised as an additive in
category ‘zootechnical additives’.
animal nutrition subject to the conditions laid down in that

Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 16 March 2011 ( 2 ) that Enter
ococcus faecium CECT 4515, under the proposed
This Regulation shall enter into force on the 20th day following
conditions of use, does not have an adverse effect on
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, 5 September 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2011; 9 (3):2118.

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L 229/8
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the additive authorisation
analytical method
animal
age
CFU/kg of complete
authorisation
feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1713 Norel
SA Enterococcus Additive composition:
Chickens
— 1
×
109
—
1. In the directions for use of the additive 26 September 2021
faecium CECT
for
and premixture, indicate the storage
4515
Preparation of Enterococcus faecium CECT fattening
temperature, storage life, and stability to
4515 containing a minimum of 1 × 109
pelleting.
CFU/g additive
2. The use is permitted in feed containing
Characterisation of the active substance:
one of the authorised coccidiostats:
Off
monensin sodium, diclazuril, nicarbazin,
icial
Enterococcus faecium CECT 4515
decoquinate, robenidine hydrochloride,
semduramycin sodium, narasin, sali
Jour
Method of Analysis (1 ):
nomicin sodium, lasalocid sodium
narasin/nicarbazin or maduramycin
nal
Enumeration: spread plate method using bile
ammonium.
of
esculin azide agar (EN 15788)
the
3. For safety: breathing protection shall be
European
Identification: Pulsed-Field Gel Electro
used during the handling.
phoresis (PFGE)
Union
(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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