HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
15.6.2013 Official
Journal
of
the
European
Union L
163/13
COMMISSION IMPLEMENTING REGULATION (EU) No 544/2013
of 14 June 2013
concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284,
Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed
additive for chickens for fattening (holder of authorisation Biomin GmbH)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and Enterococcus faecium DSM 21913 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 it has the potential to improve
Union,
the performance of chickens for fattening. The
Authority does not consider that there is a need for
Having regard to Regulation (EC) No 1831/2003 of the
specific requirements of post-market monitoring. It also
European Parliament and of the Council of 22 September
verified the report on the method of analysis of the feed
2003 on additives for use in animal nutrition ( 1 ), and in
additive in feed submitted by the Reference Laboratory
particular Article 9(2) thereof,
set up by Regulation (EC) No 1831/2003.
Whereas:
(5) The
assessment
of
the
preparation
of Bifidobacterium
animalis ssp. animalis DSM 16284, Lactobacillus salivarius
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
ssp. salivarius DSM 16351 and Enterococcus faecium DSM
orisation of additives for use in animal nutrition and
21913 shows that the conditions for authorisation, as
for the grounds and procedures for granting such auth
provided for in Article 5 of Regulation (EC) No
orisation.
1831/2003, are satisfied. Accordingly, the use of this
preparation should be authorised as specified in the
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
Annex to this Regulation.
1831/2003, an application was submitted for the auth
orisation of a preparation of Bifidobacterium animalis ssp.
(6) The
measures
provided
for
in
this
Regulation
are
in
animalis DSM 16284, Lactobacillus salivarius ssp. salivarius
accordance with the opinion of the Standing
DSM 16351 and Enterococcus faecium DSM 21913. That
Committee on the Food Chain and Animal Health,
application was accompanied by the particulars and
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:

(3) The
application
concerns
the
authorisation
of
a
prep
Article 1
aration of Bifidobacterium animalis ssp. animalis DSM
The preparation specified in the Annex, belonging to the
16284, Lactobacillus salivarius ssp. salivarius DSM 16351
additive category ‘zootechnical additives’ and to the functional
and Enterococcus faecium DSM 21913 as a feed additive
group ‘gut flora stabilisers’, is authorised as an additive in
for chickens for fattening, to be classified in the additive
animal nutrition subject to the conditions laid down in that
category ‘zootechnical additives’.
Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 14 November 2012 ( 2 )
that, under the proposed conditions of use, the prep
This Regulation shall enter into force on the twentieth day
aration of Bifidobacterium animalis ssp. animalis DSM
following that of its publication in the Official Journal of the
16284, Lactobacillus salivarius ssp. salivarius DSM 16351
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 June 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2012; 10(12):2965.

---

L 163/14
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
of authorisation
analytical method
animal
age
CFU (1 )/kg of complete
authorisation
feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1890 Biomin
GmbH Bifidobac
Additive composition
Chickens for
— 1
×
108
1 × 109
1. In the directions for use of the 5 July 2023
terium
fattening
additive and premixture, indicate the
animalis ssp. Preparation in form of a mixture of:
storage temperature, storage life and
animalis
Bifidobacterium animalis ssp. animalis DSM
stability to pelleting.
DSM 16284, 16284 containing a minimum of 3 × 109
Lactobacillus
2. The additive may be used with feed
CFU/g additive
salivarius ssp.
containing the following coccidiostats:
Off
salivarius
Lactobacillus salivarius ssp. salivarius DSM
maduramicin ammonium, diclazuril or
icial
DSM 16351 16351 containing a minimum of 1 × 109
robenidine hydrochloride.
and Enter CFU/g additive
3. For safety: breathing protection,
Jour
ococcus
Enterococcus faecium DSM 21913 containing a
glasses and gloves shall be used
nal
faecium DSM minimum of 6 × 109 CFU/g additive
during handling.
21913
of
Solid preparation (ratio 3:1:6)
the
Characterisation of active substance
European
Viable cells of Bifidobacterium animalis ssp.
animalis DSM 16284, Lactobacillus salivarius
ssp. salivarius DSM 16351, and Enterococcus
Union
faecium DSM 21913
Analytical methods (2 )
For the enumeration of:
Bifidobacterium animalis ssp. animalis DSM
16284: spread plate method EN 15785
Lactobacillus salivarius ssp. salivarius DSM
16351: spread plate method EN 15787
Enterococcus faecium DSM 21913 spread plate
method EN 15788
For the identification:
Pulsed Field Gel Electrophoresis (PFGE)
(1 ) As total content of the mixture.
(2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
15.6.2013

---

Document Outline

• �

---