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EN
Official Journal of the European Union
13.8.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 775/2013
of 12 August 2013
concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive
for chickens reared for laying and minor poultry species other than those used for laying (holder of
authorisation Lactosan GmbH & Co KG)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
of Enterococcus faecium DSM 7134 does not have an
adverse effect on animal health, human health or the
Having regard to the Treaty on the Functioning of the European
environment, and that since the potential to improve
Union,
zootechnical parameters was already demonstrated in
Having regard to Regulation (EC) No 1831/2003 of the
chickens for fattening, this conclusion can be extended
European Parliament and of the Council of 22 September
to chickens reared for laying and extrapolated to minor
2003 on additives for use in animal nutrition ( 1 ), and in
poultry species other than those used for laying. The
particular Article 9(2) thereof,
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
Whereas:
verified the report on the method of analysis of the feed
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
additive in feed submitted by the Reference Laboratory
orisation of additives for use in animal nutrition and
set up by Regulation (EC) No 1831/2003.
for the grounds and procedures for granting such auth
(6) The
assessment
of
the
preparation
of Enterococcus faecium
orisation.
DSM 7134 shows that the conditions for authorisation,
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
as provided for in Article 5 of Regulation (EC) No
1831/2003, an application was submitted for a new
1831/2003, are satisfied. Accordingly, the use of this
use of a preparation of Enterococcus faecium DSM 7134.
preparation should be authorised as specified in the
That application was accompanied by the particulars and
Annex to this Regulation.
documents required under Article 7(3) of Regulation (EC)
No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in

accordance with the opinion of the Standing
(3) The
application
concerns
a
request
of
a
new
use
of
a
Committee on the Food Chain and Animal Health,
preparation of Enterococcus faecium DSM 7134 as a feed
additive for chickens reared for laying and minor poultry
HAS ADOPTED THIS REGULATION:
species other than those used for laying, to be classified
Article 1
in the additive category ‘zootechnical additives’.
The preparation specified in the Annex, belonging to the
(4) The
use
of
that
preparation
of Enterococcus faecium DSM
additive category ‘zootechnical additives’ and to the functional
7134 was authorised for 10 years, for piglets and pigs
group ‘gut flora stabilisers’, is authorised as an additive in
for fattening by Commission Regulation (EC) No
animal nutrition subject to the conditions laid down in that
538/2007 ( 2 ), for sows by Commission Regulation (EC)
Annex.
No 1521/2007 ( 3 ), and for chickens for fattening by
Commission Regulation (EU) No 998/2010 ( 4 ).
Article 2
(5) The
European
Food
Safety
Authority
(‘the
Authority’) This Regulation shall enter into force on the twentieth day
concluded in its opinion of 12 March 2013 ( 5 ) that,
following that of its publication in the Official Journal of the
under the proposed conditions of use, the preparation
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 128, 16.5.2007, p. 16.
( 3 ) OJ L 335, 20.12.2007, p. 24.
( 4 ) OJ L 290, 6.11.2010, p. 22.
( 5 ) EFSA Journal 2013; 11(4):3167.

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13.8.2013 Off
ANNEX
Minimum
Maximum
Identification Name of the
Species or
content
content
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
authorisation
CFU/kg of complete feedingstuff
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1841 Lactosan Enterococcus
Additive composition
Chickens
— 5
×
108
— 1.
In
the
directions
for
use
of
the
2 September
GmbH & Co faecium DSM
reared for
additive and premixture,
2023
KG
7134
Preparation of Enterococcus faecium DSM
laying
indicate the storage conditions
7134 containing a minimum of:
and stability to pelleting.
Minor
Powder: 1 × 1010 CFU/g of additive
poultry
2. The use is permitted in feed
species
containing the authorised
Granulated (microencapsulated): 1 × 1010
(other than
coccidiostats: diclazuril, halo
CFU/g of additive
those used
fuginone hydrobromide,
icial
Characterisation of the active substance
for laying)
robenidine hydrochloride, deco
quinate, lasalocid A sodium,
Jour
Viable cells of Enterococcus faecium DSM
maduramicin ammonium or
nal
7134
monensin sodium, on
conditions that this coccidiostat
of
Analytical method (1 )
is authorised for the relevant
the
species.
Enumeration: spread plate method using bile
European
esculin azide agar (EN 15788)
3. For safety: it is recommended to
Identification: Pulsed Field Gel Electro
use breathing protection and
phoresis (PFGE).
gloves during handling.
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
L
217/33

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Document Outline

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