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4.3.2011 Official
Journal
of
the
European
Union L
59/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 212/2011
of 3 March 2011
concerning the authorisation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for
laying hens (holder of authorisation Lallemand SAS)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Regulation (EC) No 911/2009 ( 4 ) and for weaned piglets
by Commission Regulation (EU) No 1120/2010 ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(5)
New data were submitted in support of the application
for the authorisation of Pediococcus acidilactici CNCM MA
18/5M for laying hens. The European Food Safety
Having regard to Regulation (EC) No 1831/2003 of the
Authority (‘the Authority’) concluded in its opinion of
European Parliament and of the Council of 22 September
5 October 2010 ( 6 ) that Pediococcus acidilactici CNCM
2003 on additives for use in animal nutrition ( 1 ), and in
MA 18/5M, under the proposed conditions of use, does
particular Article 9(2) thereof,
not have an adverse effect on animal health, human
health or the environment, and that its use significantly
increased the laying intensity of the target species. The
Whereas:
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
additive in feed submitted by the Community Reference
thorisation of additives for use in animal nutrition and
Laboratory set up by Regulation (EC) No 1831/2003.
for the grounds and procedures for granting such au-
thorisation.
(6) The
assessment
of Pediococcus acidilactici CNCM MA
18/5M shows that the conditions for authorisation, as
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
provided for in Article 5 of Regulation (EC) No
1831/2003, an application was submitted for the au-
1831/2003, are satisfied. Accordingly, the use of this
thorisation of Pediococcus acidilactici CNCM MA 18/5M.
preparation should be authorised as specified in the
That application was accompanied by the particulars
Annex to this Regulation.
and documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
the
authorisation
of
a
new
use
of Pediococcus acidilactici CNCM MA 18/5M as a feed
additive for laying hens, to be classified in the additive
category ‘zootechnical additives’.
HAS ADOPTED THIS REGULATION:

Article 1
(4) The
use
of Pediococcus acidilactici CNCM MA 18/5M was
authorised without a time limit for chickens for fattening
The preparation specified in the Annex, belonging to the
by Commission Regulation (EC) No 1200/2005 ( 2 ),
additive category ‘zootechnical additives’ and to the functional
without a time limit for pigs for fattening by
group ‘gut flora stabilisers’, is authorised as an additive in
Commission Regulation (EC) No 2036/2005 ( 3 ) and for
animal nutrition subject to the conditions laid down in that
10 years for salmonids and shrimps by Commission
Annex.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 4 ) OJ L 257, 30.9.2009, p. 10.
( 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 ) EFSA Journal 2010; 8(10):1865.

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L 59/2
EN
Official Journal of the European Union
4.3.2011
Article 2
This Regulation shall enter into force on the 20th day following 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, 3 March 2011.
For the Commission
The President
José Manuel BARROSO

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4.3.2011 Off
ANNEX
Minimum
Maximum
Identification Name of the holder
Species or
content
content
number of
of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the additive
authorisation
analytical method
animal
age
authorisation
CFU/kg of complete feedingstuff
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4d1712 Lallemand
SAS Pediococcus Additive composition
Laying
— 1
×
109
— 1.
In
the
directions
for
use
of
the
24 March 2021
acidilactici
hens
additive and premixture, indicate
CNCM MA Preparation of Pediococcus acidilactici
the storage temperature, storage
18/5M
CNCM MA 18/5M containing a
life and stability to pelleting.
minimum of 1 × 1010 CFU/g
2. For safety: breathing protection,
Characterisation of active substance
glasses and gloves shall be used
Viable cells of Pediococcus acidilactici CNCM
during handling.
MA 18/5 M
icial
Analytical methods (1 )
Jour
Enumeration: spread plate method using
MSR agar (EN 15786:2009)
nal
Identification: Pulsed Field Gel Electro
of
phoresis (PFGE)
the
European
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
Union
L
59/3

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