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1.11.2013 Official
Journal
of
the
European
Union L
292/3
COMMISSION IMPLEMENTING REGULATION (EU) No 1077/2013
of 31 October 2013
concerning the authorisation of a preparation of Enterococcus faecium NBIMCC 8270, Lactobacillus
acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis
NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244, and Streptococcus thermophilus
NBIMCC 8253 as a feed additive for suckling piglets (holder of authorisation Lactina Ltd)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and Streptococcus thermophilus NBIMCC 8253 as a feed
additive for suckling piglets, to be classified in the
additive category ‘zootechnical additives’.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 12 March 2013 ( 2 ) that,
under the proposed conditions of use, the preparation
of Enterococcus faecium NBIMCC 8270, Lactobacillus acido
philus NBIMCC 8242, Lactobacillus helveticus NBIMCC
Having regard to Regulation (EC) No 1831/2003 of the
8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250,
European Parliament and of the Council of 22 September
Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244,
2003 on additives for use in animal nutrition (
and Streptococcus thermophilus NBIMCC 8253 does not

1 ), and in
particular Article 9(2) thereof,
have an adverse effect on animal health, human health
or the environment. The Authority recognised that it has
the potential to increase the body weight in suckling
piglets. 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
Whereas:
analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No
1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(5) The
assessment
of
that
preparation
shows
that
the
conditions for authorisation, as provided for in
orisation.
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that preparation should be auth
orised as specified in the Annex to this Regulation.
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for the auth
orisation of a preparation of Enterococcus faecium NBIMCC
(6) The
measures
provided
for
in
this
Regulation
are
in
8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus
accordance with the opinion of the Standing
helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis
Committee on the Food Chain and Animal Health,
NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus
NBIMCC 8244, and Streptococcus thermophilus NBIMCC
8253. That application was accompanied by the
particulars and documents required under Article 7(3)
HAS ADOPTED THIS REGULATION:
of Regulation (EC) No 1831/2003.
Article 1
(3) That
application
concerns
the
authorisation
of
a
prep
The preparation specified in the Annex, belonging to the
aration of Enterococcus faecium NBIMCC 8270, Lactobacillus
additive category ‘zootechnical additives’ and to the functional
acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC
group ‘gut flora stabilisers’, is authorised as an additive in
8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250,
animal nutrition subject to the conditions laid down in that
Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244,
Annex.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2013; 11(4):3170.

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L 292/4
EN
Official Journal of the European Union
1.11.2013
Article 2
This Regulation shall enter into force on the twentieth day following that of 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, 31 October 2013.
For the Commission
The President
José Manuel BARROSO

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1.11.2013 Off
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
4b1891 Lactina
Ltd Enterococcus
faecium
Additive composition
Suckling
— 5
×
109
— 1.
In
the
directions
for
use
of
the
21 November 2023
NBIMCC 8270
piglets
additive and premixture,
indicate the storage conditions
Preparation of:
and stability to pelleting.
Lactobacillus
acidophilus NBIMCC
8242, Lactobacillus
Enterococcus faecium NBIMCC 8270
2. For suckling piglets up to 35
helveticus NBIMCC
(minimum of 1,4 × 109 CFU/g of additive),
days.
8269,
icial
Lactobacillus acidophilus NBIMCC 8242
3. For safety: it is recommended to
Jour
Lactobacillus
(minimum of 8 × 108 CFU/g of additive),
use breathing protection and
nal
delbrueckii ssp. lactis
Lactobacillus helveticus NBIMCC 8269
gloves during handling.
NBIMCC 8250,
(minimum of 5 × 108 CFU/g of additive),
of
Lactobacillus
Lactobacillus delbrueckii ssp. lactis NBIMCC
the
delbrueckii ssp.
8250 (minimum of 2 × 108 CFU/g of
European
bulgaricus NBIMCC
additive), Lactobacillus delbrueckii ssp.
8244,
bulgaricus NBIMCC 8244 (minimum of
3 × 108 CFU/g of additive), and
and
Union
Streptococcus thermophilus NBIMCC 8253
(minimum of 1,8 × 109 CFU/g of additive)
Streptococcus
containing a minimum of 5 × 109 CFU/g of
thermophilus
additive (total amount)
NBIMCC 8253
Solid form
Characterisation of the active substance
Viable cells of:
Enterococcus faecium NBIMCC 8270
Lactobacillus acidophilus NBIMCC 8242,
Lactobacillus helveticus NBIMCC 8269,
L
Lactobacillus delbrueckii ssp. lactis NBIMCC
292/5
8250, Lactobacillus delbrueckii ssp. bulgaricus
NBIMCC 8244, and

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L 292/6
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
moisture content of 12 %
Streptococcus thermophilus NBIMCC 8253
EN

Analytical method (1 )
Enumeration of:
Enterococcus faecium NBIMCC 8270,
Lactobacillus acidophilus NBIMCC 8242,
Lactobacillus helveticus NBIMCC 8269,
Off
Lactobacillus delbrueckii ssp. lactis NBIMCC
icial
8250, Lactobacillus delbrueckii ssp. bulgaricus
NBIMCC 8244 and Streptococcus thermophilus
Jour
NBIMCC 8253: Spread plate method (EN
15787).
nal
of
the
Identification of Enterococcus faecium NBIMCC
8270, Lactobacillus acidophilus NBIMCC 8242,
European
Lactobacillus helveticus NBIMCC 8269,
Lactobacillus delbrueckii ssp. lactis NBIMCC
8250, Lactobacillus delbrueckii ssp. bulgaricus
NBIMCC 8244, and
Union
Streptococcus thermophilus NBIMCC 8253:
Pulsed Field Gel Electrophoresis (PFGE).
(1 ) 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
1.11.2013

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Document Outline

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