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7.11.2013 Official
Journal
of
the
European
Union L
296/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 1101/2013
of 6 November 2013
concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 and Lactobacillus
rhamnosus DSM 7133 as a feed additive for calves for rearing and amending Regulation (EC) No
1288/2004 (holder of authorisation Lactosan GmbH & CoKG)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of a prep
aration of Enterococcus faecium DSM 7134 and Lactobacillus
Having regard to the Treaty on the Functioning of the European
rhamnosus DSM 7133, as a feed additive for calves for
Union,
rearing, requesting that additive to be classified in the
additive category ‘zootechnical additives’ That application
was accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No
Having regard to Regulation (EC) No 1831/2003 of the
1831/2003.
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 13 March 2013 ( 4 ) that,
under the proposed conditions of use in feed, the prep
Whereas:
aration of Enterococcus faecium DSM 7134 and Lactobacillus
rhamnosus DSM 7133 does not have an adverse effect on
animal and consumer health, and for the environment
and it has the potential to improve the zootechnical
performance in target animals. It also verified the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
report on the method of analysis of the feed additive
for the grounds and procedures for granting such auth
in feed submitted by the Reference Laboratory set up
orisation. Article 10 of that Regulation provides for the
by Regulation (EC) No 1831/2003.
re-evaluation of additives authorised pursuant to Council
Directive 70/524/EEC ( 2 ).
(5) The
assessment
of
the
preparation
of Enterococcus faecium
DSM 7134 and Lactobacillus rhamnosus DSM 7133 shows
(2) A
preparation
of Enterococcus faecium DSM 7134 and
that the conditions for authorisation, as provided for in
Lactobacillus rhamnosus DSM 7133 was authorised
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
without a time limit in accordance with Directive
Accordingly, the use of that preparation should be auth
70/524/EEC as a feed additive for use on calves by
orised as specified in the Annex to this Regulation.
Commission Regulation (EC) No 1288/2004 ( 3 ). That
preparation was subsequently entered in the Register of
feed additives as an existing product, in accordance with
Article 10(1)(b) of Regulation (EC) No 1831/2003.
(6)
As a consequence of the granting of a new authorisation
under Regulation (EC) No 1831/2003, the provisions on
( 1 ) OJ L 268, 18.10.2003, p. 29.
Enterococcus faecium DSM 7134 and Lactobacillus rhamnosus
( 2 ) Council Directive 70/524/EEC of 23 November 1970 concerning
DSM 7133 contained in Regulation (EC) No 1288/2004
additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).
should be deleted. Regulation (EC) No 1288/2004 should
( 3 ) Commission Regulation (EC) No 1288/2004 of 14 July 2004
be therefore amended accordingly.
concerning the permanent authorisation of certain additives and
the provisional authorisation of a new use of an additive already
authorised in feedingstuffs (OJ L 243, 15.7.2004, p. 10).
( 4 ) EFSA Journal 2013; 11(4):3175.

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L 296/2
EN
Official Journal of the European Union
7.11.2013
(7)
Since safety reasons do not require the immediate appli
Article 2
cation of the modifications to the conditions of auth
orisation, it is appropriate to allow a transitional period
In Annex I to Regulation (EC) No 1288/2004 the provisions on
for interested parties to prepare themselves to meet the
E 1706, Enterococcus faecium DSM 7134 and Lactobacillus
new requirements resulting from the authorisation.
rhamnosus DSM 7133 are deleted.
(8) The
measures
provided
for
in
this
Regulation
are
in
Article 3
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 27 May
HAS ADOPTED THIS REGULATION:
2014 in accordance with the rules applicable before
27 November 2013 may continue to be placed on the
Article 1
market and used until the existing stocks are exhausted.
The preparation specified in the Annex, belonging to the
Article 4
additive category ‘zootechnical additives’ and to the functional
group ‘gut flora stabilisers’, is authorised as an additive in
This Regulation shall enter into force on the twentieth day
animal nutrition subject to the conditions laid down in that
following that of its publication in the Official Journal of the
Annex.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 November 2013.
For the Commission
The President
José Manuel BARROSO

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7.11.2013 Off
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum age
CFU/kg of complete
Other provisions
End of period of
additive
authorisation
method
animal
authorisation
feedingstuff with a
EN
moisture content of 12 %

or of milk replacer
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1706 Lactosan Enterococcus
Additive composition
Calves for
4 months 1
×
109
— 1.
In
the
directions
for
use
of
27 November 2023
GmbH & Co faecium DSM
rearing
the additive and
KG
7134
Preparation of:
premixture, indicate the
Lactobacillus
Enterococcus faecium DSM 7134 containing a
storage conditions and
rhamnosus
minimum of 7 × 109 CFU/g of additive, and
stability to pelleting.
DSM 7133
Lactobacillus rhamnosus DSM 7133:
2. For safety: it is recom
mended to use breathing
icial
3 × 109 CFU/g of additive
protection and gloves
during handling.
Jour
(ratio 7:3) Solid form
nal
of
Characterisation of the active substance
the
Viable cells of:
European
Enterococcus faecium DSM 7134, and Lactobacillus
rhamnosus DSM 7133
Union
Analytical method (1 )
Enumeration of:
Enterococcus faecium DSM 7134: spread plate
method using bile esculin azide agar (EN
15788)
Lactobacillus rhamnosus DSM 7133: spread plate
method using MRS agar (EN 15787)
Identification of Enterococcus faecium DSM 7134,
and Lactobacillus rhamnosus DSM 7133: Pulsed
Field Gel Electrophoresis (PFGE).
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
L
296/3

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Document Outline

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