HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 108/6
EN
Official Journal of the European Union
20.4.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 334/2012
of 19 April 2012
concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed
additive for rabbits for fattening and non food-producing rabbits and amending Regulation (EC) No
600/2005 (holder of the authorisation Société Industrielle Lesaffre)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
is a need for specific requirements of post-market moni
toring. It also verified the report on the method of
analysis of the feed additive in feed submitted by the
Having regard to the Treaty on the Functioning of the European
Reference Laboratory set up by Regulation (EC)
Union,
No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
(5) The
assessment
of Saccharomyces cerevisiae CNCM I-4407
European Parliament and of the Council of 22 September
shows that the conditions for authorisation, as provided
2003 on additives for use in animal nutrition ( 1 ), and in
for in Article 5 of Regulation (EC) No 1831/2003, are
particular Article 9(2) thereof,
satisfied. Accordingly, the use of this preparation should
be authorised as specified in the Annex to this
Whereas:
Regulation.


(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(6)
As a consequence of the granting of a new authorisation
orisation of additives for use in animal nutrition and
under Regulation (EC) No 1831/2003, the provisions on
for the grounds and procedures for granting such auth
Saccharomyces cerevisiae NCYC Sc47 contained in Regu
orisation. Article 10 of that Regulation provides for the
lation (EC) No 600/2005 should be deleted.
re-evaluation of additives authorised pursuant to Council
Directive 70/524/EEC ( 2 ).
(7)
Since the modifications on the conditions of the auth
orisation of the feed additive are not related to safety
(2) The
preparation
of Saccharomyces cerevisiae NCYC Sc47
reasons, it is appropriate to allow a transitional period
was authorised without a time limit in accordance with
for the disposal of existing stocks of the premixtures and
Directive 70/524/EEC as a feed additive for use on
compound feed, as authorised by Regulation (EC)
rabbits for fattening by Commission Regulation (EC)
No 600/2005.
No 600/2005 ( 3 ). That preparation was subsequently
entered in the Community Register of feed additives as
(8) The
measures
provided
for
in
this
Regulation
are
in
an existing product, in accordance with Article 10(1) of
accordance with the opinion of the Standing
Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
of Saccharomyces cerevisiae CNCM I-4407, formerly NCYC
Article 1
Sc47, as a feed additive for rabbits for fattening and, in
accordance with Article 7 of that Regulation, for a new
The preparation specified in the Annex, belonging to the
use for non food-producing rabbits, requesting that
additive category ‘zootechnical additives’ and to the functional
additive to be classified in the additive category ‘zoo
group ‘gut flora stabilisers’, is authorised as an additive in
technical additives’. That application was accompanied
animal nutrition, subject to the conditions laid down in that
by the particulars and documents required under
Annex.
Article 7(3) of Regulation (EC) No 1831/2003.
Article 2
(4) The
European
Food
Safety
Authority
(‘the
Authority’) The entry for E 1702 in Annex III to Regulation (EC)
concluded in its opinion of 13 December 2011 ( 4 ) that,
No 600/2005 is deleted.
under the proposed conditions of use, Saccharomyces
cerevisiae CNCM I-4407 does not have an adverse effect
on animal health, consumer health or the environment,
Article 3
and that it has a potential to reduce mortality in rabbits
for fattening. The Authority does not consider that there
The preparation of Saccharomyces cerevisiae NCYC Sc47, as auth
orised by Regulation (EC) No 600/2005, and premixtures and
compound feed containing it, labelled in accordance with
( 1 ) OJ L 268, 18.10.2003, p. 29.
Directive 70/524/EEC before the entry into force of this Regu
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 99, 19.4.2005, p. 5.
lation may continue to be placed on the market and used until
( 4 ) EFSA Journal 2012; 10(1):2531.
the existing stocks are exhausted.

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EN
20.4.2012 Official
Journal
of
the
European
Union L
108/7
Article 4
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, 19 April 2012.
For the Commission
The President
José Manuel BARROSO

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L 108/8
ANNEX
Minimum
Maximum
content
content
Identification Name of the
number of the
holder of
Additive
Composition, chemical formula, description,
Species or category of
Other provisions
End of period of
additive
authorisation
analytical method
animal
Maximum age
CFU/kg of complete
authorisation
feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1702 Société
Sacchar
Additive composition
Rabbits for fattening
— 5
×
109
— In
the
directions
for
use
of
the
11 May 2022
Industrielle omyces
Preparation of dried cells of Sacchar
and non food-
additive and premixture, indicate
Lesaffre
cerevisiae
omyces cerevisiae CNCM I-4407
producing rabbits
the storage temperature, storage life
CNCM
containing a minimum of 5 × 109
and stability to pelleting.
I-4407
CFU/g
Characterisation of active substance
Off
icial
Saccharomyces cerevisiae CNCM I-4407
Jour
Analytical methods (1 )
nal
Enumeration: Pour plate method using
a yeast extract dextrose chlor
of
amphenicol (CGYE) agar — EN 15789.
the
Identification: polymerase chain
European
reaction (PCR) method).
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
20.4.2012

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Document Outline

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