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2.2.2013 Official
Journal
of
the
European
Union L
33/19
COMMISSION IMPLEMENTING REGULATION (EU) No 95/2013
of 1 February 2013
concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed
additive for all fish other than salmonids (holder of authorisation Lallemand SAS)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
weaned piglets by Commission Regulation (EU) No
1120/2010 ( 5 ) and for laying hens by Commission Regu
Having regard to the Treaty on the Functioning of the European
lation (EU) No 212/2011 ( 6 ).
Union,
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
Having regard to Regulation (EC) No 1831/2003 of the
concluded in its opinion of 11 September 2012 ( 7 )
European Parliament and of the Council of 22 September
that, under the proposed conditions of use, Pediococcus
2003 on additives for use in animal nutrition (
acidilactici CNCM MA 18/5M has the potential to

1 ), and in
particular Article 9(2) thereof,
produce beneficial effect in development for all fish
increasing the proportion of well conformed fish,
Whereas:
reducing bone deformation.
(6) The
assessment
of Pediococcus acidilactici CNCM MA
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
18/5M shows that the conditions for authorisation, as
orisation of additives for use in animal nutrition and
provided for in Article 5 of Regulation (EC) No
for the grounds and procedures for granting such auth
1831/2003, are satisfied. Accordingly, the use of this
orisation.
preparation should be authorised 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 a new
(7) The
measures
provided
for
in
this
Regulation
are
in
use of a preparation of Pediococcus acidilactici CNCM MA
accordance with the opinion of the Standing
18/5M. That application was accompanied by the
Committee on the Food Chain and Animal Health,
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:
Article 1
(3) The
application
concerns
the
authorisation
of
a
new
use
of Pediococcus acidilactici CNCM MA 18/5M as a feed
The preparation specified in the Annex, belonging to the
additive for all fish, to be classified in the additive
additive category ‘zootechnical additives’ and to the functional
category ‘zootechnical additives’.
group ‘other zootechnical additives’, is authorised as an additive
in animal nutrition subject to the conditions laid down in that
(4) The
use
of Pediococcus acidilactici CNCM MA 18/5M was
Annex.
authorised without a time limit for chickens for fattening
Article 2
by Commission Regulation (EC) No 1200/2005 ( 2 ) and
for pigs for fattening by Commission Regulation (EC) No
This Regulation shall enter into force on the twentieth day
2036/2005 ( 3 ), for 10 years for salmonids and shrimps
following that of its publication in the Official Journal of the
by Commission Regulation (EC) No 911/2009 ( 4 ), for
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 February 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 195, 27.7.2005, p. 6.
( 5 ) OJ L 317, 3.12.2010, p. 12.
( 3 ) OJ L 328, 15.12.2005, p. 13.
( 6 ) OJ L 59, 4.3.2011, p. 1.
( 4 ) OJ L 257, 30.9.2009, p. 10.
( 7 ) EFSA Journal 2012; 10(9):2886.

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L 33/20
ANNEX
Minimum
Maximum
content
content
Identification
Species or
number of the Name of the holder
category of
Maximum
Units of activity/kg of
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
age
authorisation
complete feedingstuff
EN
with a moisture content

of 12 %
Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect growth).
4d1712 Lallemand
SAS Pediococcus Additive composition
All fish — 1
×
109
— 1.
In
the
directions
for
use
of
the
22 February 2023
acidilactici
other than
additive and premixture, indicate
CNCM MA Preparation of Pediococcus acidilactici CNCM salmonids
the storage temperature, storage
18/5M
MA 18/5M containing a minimum of
life and stability to pelleting.
1 × 1010 CFU/g of additive
2. For safety: breathing protection,
Off
Characterisation of active substance
glasses and gloves shall be used
during handling.
icial
Viable cells of Pediococcus acidilactici CNCM MA
18/5 M
Jour
nal
Analytical methods (1 )
of
Enumeration: spread plate method using MRS
the
agar (EN 15786:2009)
European
Identification: Pulsed-Field Gel Electrophoresis
(PFGE)
Union
(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
2.2.2013

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Document Outline

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