HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 224/6
EN
Official Journal of the European Union
22.8.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 797/2013
of 21 August 2013
concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed
additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr.
Hansen A/S) and repealing Regulation (EC) No 1333/2004
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
on the method of analysis of the feed additive in feed
submitted by the Reference Laboratory set up by Regu
Having regard to the Treaty on the Functioning of the European
lation (EC) No 1831/2003.
Union,
(5) The
assessment
of
the
preparation
of Enterococcus faecium
Having regard to Regulation (EC) No 1831/2003 of the
NCIMB 11181 shows that the conditions for authori
European Parliament and of the Council of 22 September
sation, as provided for in Article 5 of Regulation (EC)
2003 on additives for use in animal nutrition (
No 1831/2003, are satisfied. Accordingly, the use of that

1 ), and in
particular Article 9(2) thereof,
preparation should be authorised as specified in the
Annex to this Regulation.
Whereas:
(6)
As a new authorisation is granted in accordance with
Regulation (EC) No 1831/2003, Regulation (EC) No
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
1333/2004 should be repealed.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation. Article 10 of that Regulation provides for the
(7)
Since safety reasons do not require the immediate appli
re-evaluation of additives authorised pursuant to Council
cation of the modifications to the conditions of auth
Directive 70/524/EEC ( 2 ).
orisation, it is appropriate to allow a transitional period
for the disposal of existing stocks of the additive, pre-
(2) A
preparation
of Enterococcus faecium NCIMB 11181 was
mixtures and compound feed containing it, as authorised
authorised without a time limit in accordance with
by Regulation (EC) No 1333/2004.
Directive 70/524/EEC as a feed additive for use on
calves for rearing and for fattening and weaned piglets
(8) The
measures
provided
for
in
this
Regulation
are
in
by Commission Regulation (EC) No 1333/2004 ( 3 ). That
accordance with the opinion of the Standing
preparation was subsequently entered in the European
Committee on the Food Chain and Animal Health,
Union Register of feed additives as an existing product,
in accordance with Article 10(1)(b) of Regulation (EC) No
1831/2003.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
Article 1
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
The preparation specified in the Annex, belonging to the
of that preparation as a feed additive for calves for
additive category ‘zootechnical additives’ and to the functional
rearing and for fattening and weaned piglets, requesting
group ‘gut flora stabilisers’, is authorised as an additive in
that additive to be classified in the additive category ‘zoo
animal nutrition, subject to the conditions laid down in that
technical additives’. That application was accompanied by
Annex.
the particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
Article 2
Regulation (EC) No 1333/2004 is repealed.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 1 February 2012 ( 4 ) that,
under the proposed conditions of use, the preparation
Article 3
of Enterococcus faecium NCIMB 11181 does not have an
adverse effect on animal health, human health or on the
The preparation specified in the Annex and feed containing that
environment, and that it is efficacious in improving
preparation, which are produced and labelled before 11 March
zootechnical performance of calves for rearing and for
2014 in accordance with the rules applicable before
fattening and weaned piglets. The Authority does not
11 September 2013 may continue to be placed on the
consider that there is a need for specific requirements
market and used until the existing stocks are exhausted.
of post-market monitoring. It also verified the report
Article 4
( 1 ) OJ L 268, 18.10.2003, p. 29.
This Regulation shall enter into force on the twentieth day
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 247, 21.7.2004, p. 11.
following that of its publication in the Official Journal of the
( 4 ) EFSA Journal 2012; 10(2):2574.
European Union.

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EN
22.8.2013 Official
Journal
of
the
European
Union L
224/7
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 August 2013.
For the Commission
The President
José Manuel BARROSO

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L 224/8
ANNEX
Minimum
Maximum
content
content
Identification
number of the Name of the holder
Species or category Maximum
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
of animal
age
CFU/kg of complete
authorisation
feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1708 Chr.
Hansen
A/S Enterococcus
Additive composition
Calves for
6
5 × 108
— 1.
In
the
directions
for
use
of
the
11 September
faecium
rearing and for months
additive and premixture, indicate
2023
Preparation of Enterococcus faecium
fattening
the storage conditions and stability
(NCIMB 11181) (NCIMB 11181) containing a
to pelleting and in water.
minimum of:
Piglets (weaned)
— 5
×
108
—
2. May be used in milk replacers for
Solid form: 5 × 1010 CFU/g of
calves for rearing and for fattening.
additive;
Off
3. For weaned piglets up to 35 kg.
Solid water soluble form: 2 × 1011
icial
CFU/g additive.
4. Recommended minimum doses:
Jour
— calves for rearing and for
fattening: 2 × 1010 CFU/kg
nal
Characterisation of the active substance
complete feed
of
the
Viable cells of Enterococcus faecium
— piglets (weaned): 1 × 1010 –
(NCIMB 11181).
2 × 1010 CFU/kg complete feed
European
5. The water soluble form of the
Analytical method (1 )
preparation may be used for
weaned piglets in water for
Enumeration: spread plate method
Union
drinking with a recommended
using Bile Esculin Azide agar (EN
minimum dose of 1 × 1010 –
15788).
2 × 1010 CFU/L
Identification: Pulsed-Field Gel Elec
6. For user safety: breathing
trophoresis (PFGE)
protection, safety glasses and
gloves should be worn during
handling.
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives.
22.8.2013

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Document Outline

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