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25.10.2011 Official
Journal
of
the
European
Union
L
278/5
COMMISSION IMPLEMENTING REGULATION (EU) No 1074/2011
of 24 October 2011
concerning the authorisation of Saccharomyces cerevisiae NCYC R-625 as a feed additive for weaned
piglets (holder of the authorisation Integro Gida SAN. ve TIC. A.S. represented by RM Associates
Ltd)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
animal health, human health or the environment, and
that this additive has the potential to improve the
growth performance in weaned piglets. The Authority
Having regard to the Treaty on the Functioning of the European
does not consider that there is a need for specific
Union,
requirements of post-market monitoring. It also verified
the report on the method of analysis of the feed additive
Having regard to Regulation (EC) No 1831/2003 of the
in feed submitted by the Reference Laboratory set up by
European Parliament and of the Council of 22 September
Regulation (EC) No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of Saccharomyces cerevisiae NCYC R-625
shows that the conditions for authorisation, as
Whereas:
provided for in Article 5 of Regulation (EC) No
1831/2003, are satisfied. Accordingly, the use of this
preparation should be authorised as specified in the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Annex to this Regulation.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation.
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
Committee on the Food Chain and Animal Health,
1831/2003, an application was submitted for the auth
orisation of Saccharomyces cerevisiae NCYC R-625. That
HAS ADOPTED THIS REGULATION:
application was accompanied by the particulars and
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 1
The preparation specified in the Annex, belonging to the
(3) The
application
concerns
the
authorisation
of
the
prep
additive category ‘zootechnical additives’ and to the functional
aration set out in the Annex as a feed additive for
group ‘gut flora stabilisers’, is authorised as an additive in
weaned piglets, to be classified in the additive category
animal nutrition subject to the conditions laid down in that
‘zootechnical additives’.
Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 11 May 2011 ( 2 ) that Sacchar
omyces cerevisiae NCYC R-625, under the proposed
This Regulation shall enter into force on the 20th day following
conditions of use, does not have an adverse effect on
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, 24 October 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2011; 9 (5):2173.

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L 278/6
ANNEX
Minimum
Maximum
Identification
Species or
content
content
End of
number of the
Name of the holder
category of Maximum
Other provisions
period of
additive
of authorisation
Additive
Composition, chemical formula,
description, analytical method
animal
age
CFU/kg of complete feedingstuff
authorisation
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1872 Integro
Gida Saccharomyces Additive composition
Piglets
— 4
x
1010
— 1.
In
the
directions
for
use
of
the
additive
14.11.2021
SAN. ve TIC. A.S. cerevisiae
(weaned)
and premixture, indicate the storage
represented by
NCYC R-625 Preparation of Saccharomyces
temperature, storage life, and stability
RM Associates
cerevisiae NCYC R-625 containing a
to pelleting.
Ltd
minimum of 1 x 1010 CFU/g
additive
2. For use in weaned piglets up to
Characterisation of the active substance
approximately 35 kg.
Off
Saccharomyces cerevisiae NCYC R-625
icial
Method of analysis (1 )
3. For safety: breathing protection shall
Jour
be used during handling.
Enumeration: pour plate method
nal
using yeast extract dextrose chlor
of
amphenicol (CGYE) agar (EN
the
15789)
European
Identification: polymerase chain
reaction (PCR)
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.asp
25.10.2011

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