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7.5.2013 Official
Journal
of
the
European
Union L
125/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 413/2013
of 6 May 2013
concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed
additive for use in water for drinking for weaned piglets, pigs for fattening, laying hens and
chickens for fattening (holder of authorisation Lallemand SAS)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Commission Regulation (EU) No 1120/2010 ( 5 ), for
laying hens by Commission Regulation (EU) No
Having regard to the Treaty on the Functioning of the European
212/2011 ( 6 ) and for all fish other than salmonids by
Union,
Commission Implementing Regulation (EU) No
95/2013 ( 7 ).
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
2003 on additives for use in animal nutrition (
concluded in its opinion of 12 June 2012 ( 8 ) that,

1 ), and in
particular Article 9(2) thereof,
under the proposed conditions of use, the preparation
of Pediococcus acidilactici CNCM MA 18/5M, does not
have an adverse effect on animal health, human health
Whereas:
or the environment, and that it has the potential to
improve the performance in target species.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
(6) The
assessment
of
the
preparation
of Pediococcus acidil
for the grounds and procedures for granting such auth
actici CNCM MA 18/5M shows that the conditions for
orisation.
authorisation, as provided for in Article 5 of Regulation
(EC) No 1831/2003, are satisfied. Accordingly, the use of
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
this preparation should be authorised as specified in the
1831/2003, an application was submitted for a new
Annex to this Regulation.
use of a preparation of Pediococcus acidilactici CNCM MA
18/5M. That application was accompanied by the
(7) The
measures
provided
for
in
this
Regulation
are
in
particulars and documents required under Article 7(3)
accordance with the opinion of the Standing
of Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
a
request
of
a
new
use
of
a HAS ADOPTED THIS REGULATION:
preparation of Pediococcus acidilactici CNCM MA 18/5M as
a feed additive for use in water for drinking on weaned
Article 1
piglets, pigs for fattening, laying hens and chickens for
fattening, to be classified in the additive category ‘zoo
The preparation specified in the Annex, belonging to the
technical additives’.
additive category ‘zootechnical additives’ and to the functional

group ‘gut flora stabilisers’, is authorised as an additive in
animal nutrition subject to the conditions laid down in that
(4) The
use
of
that
preparation
of Pediococcus acidilactici
Annex.
CNCM MA 18/5M was authorised without a time limit
for chickens for fattening by Commission Regulation
Article 2
(EC) No 1200/2005 ( 2 ) and for pigs for fattening by
Commission Regulation (EC) No 2036/2005 ( 3 ), for
This Regulation shall enter into force on the twentieth day
10 years for salmonids and shrimps by Commission
following that of its publication in the Official Journal of the
Regulation (EC) No 911/2009 ( 4 ), for weaned piglets by
European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 5 ) OJ L 317, 3.12.2010, p. 12.
( 2 ) OJ L 195, 27.7.2005, p. 6.
( 6 ) OJ L 59, 4.3.2011, p. 1.
( 3 ) OJ L 328, 15.12.2005, p. 13.
( 7 ) OJ L 33, 2.2.2013, p. 19.
( 4 ) OJ L 257, 30.9.2009, p. 10.
( 8 ) EFSA Journal 2012; 10(7):2776.

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L 125/2
EN
Official Journal of the European Union
7.5.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 May 2013.
For the Commission
The President
José Manuel BARROSO

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7.5.2013 Off
ANNEX
Minimum
Maximum
Identification Name of the
Species or
content
content
number of
holder of
Additive
Composition, chemical formula, description, analytical category of Maximum
Other provisions
End of period of
the additive
authorisation
method
animal
age
authorisation
CFU/l of water for
drinking
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4d1712 Lallemand Pediococcus
Additive composition
Piglets
— 5
×
108
—
1. In the directions for use of the additive 27 May 2023
SAS
acidilactici
(weaned)
indicate the storage temperature, storage life.
CNCM MA
Preparation of Pediococcus acidilactici CNCM MA
18/5M
18/5M containing a minimum of 1 × 1010
Pigs for
2. For piglets (weaned) up to 35 kg.
CFU/g additive
fattening
3. For safety: breathing protection, glasses and
Characterisation of active substance
Laying
gloves shall be used during handling.
hens
Viable cells of Pediococcus acidilactici CNCM MA
4. The water for drinking containing the
18/5 M
Chickens
additive may be used simultaneously with
for
feed for chickens for fattening containing
icial
Analytical methods (1 )
fattening
the following coccidiostats: decoquinate,
Jour
Enumeration: spread plate method
halofuginone, narasin, salinomycin sodium,
using MRS agar (EN 15786:2009)
maduramicin ammonium, diclazuril.
nal
Identification: Pulsed Field Gel Electrophoresis
5. The additive shall be mixed with other feed
of
(PFGE)
additives or feed materials in order to allow
the
its complete homogeneous dispersion in
European
water for drinking
(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
Union
L
125/3

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Document Outline

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