HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 49/8
EN
Official Journal of the European Union
24.2.2011
COMMISSION REGULATION (EU) No 170/2011
of 23 February 2011
concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets
(weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 6 October 2010 ( 7 ) that,
under the proposed conditions of use, Saccharomyces
Having regard to the Treaty on the Functioning of the European
cerevisiae MUCL 39885 does not have an adverse effect
Union,
on animal health, human health or on the environment,
and that it has the potential to improve the zootechnical
performance of the target species. The Authority does
Having regard to Regulation (EC) No 1831/2003 of the
not consider that there is a need for specific requirements
European Parliament and of the Council of 22 September
of post-market monitoring. It also verified the report on
2003 on additives for use in animal nutrition ( 1 ), and in
the method of analysis of the feed additive in feed
particular Article 9(2) thereof,
submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003.
Whereas:
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(6) The
assessment
of Saccharomyces cerevisiae MUCL 39885
orisation of additives for use in animal nutrition and
shows that the conditions for authorisation, as provided
for the grounds and procedures for granting such auth
for in Article 5 of Regulation (EC) No 1831/2003, are
orisation. Article 10 of that Regulation provides for the
satisfied. Accordingly, the use of this preparation should
re-evaluation of additives authorised pursuant to Council
be authorised as specified in the Annex to this Regu
Directive 70/524/EEC ( 2 ).
lation.
(2) The
preparation
of Saccharomyces cerevisiae MUCL 39885
was authorised in accordance with Directive 70/524/EEC
(7)
As a consequence of a new authorisation being granted
as a feed additive without a time limit for use on piglets
by this Regulation, the entry for Saccharomyces cerevisiae
(weaned) by Commission Regulation (EC)
MUCL 39885 in Regulation (EC) No 1200/2005 should
No 1200/2005
( 3 ), for cattle for fattening by
be deleted.
Commission Regulation (EC) No 492/2006 ( 4 ). The
additive was subsequently entered in the Community
Register of feed additives as an existing product, in
accordance with Article 10(1)(b) of Regulation (EC) No
(8)
Since the modifications to the conditions of the auth
1831/2003.
orisation are not related to safety reasons, it is appro
priate to allow a transitional period for the disposal of
existing stocks of pre-mixtures and compound feed
(3) The
preparation
of Saccharomyces cerevisiae MUCL 39885
containing this preparation.
was also authorised in accordance with Regulation (EC)
No 1831/2003 as a feed additive for 10 years for use in
sows by Commission Regulation (EC) No 896/2009 ( 5 )
and for dairy cows and horses by Commission Regu
(9) The
measures
provided
for
in
this
Regulation
are
in
lation (EU) No 1119/2010 ( 6 ).
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(4) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No 1831/2003 in conjunction with Article 7 of that
Regulation, an application was submitted for the re-
evaluation of Saccharomyces cerevisiae MUCL 39885 as a
HAS ADOPTED THIS REGULATION:
feed additive for piglets (weaned) requesting that additive
to be classified in the additive category ‘zootechnical
additives’. That application was accompanied by the
particulars and documents required under Article 7(3)
Article 1
of Regulation (EC) No 1831/2003.
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
( 1 ) OJ L 268, 18.10.2003, p. 29.
group ‘gut flora stabilisers’, is authorised as an additive in
( 2 ) OJ L 270, 14.12.1970, p. 1.
animal nutrition subject to the conditions laid down in that
( 3 ) OJ L 195, 27.7.2005, p. 6.
Annex.
( 4 ) OJ L 89, 28.3.2006, p. 6.
( 5 ) OJ L 256, 29.9.2009, p. 6.
( 6 ) OJ L 317, 3.12.2010, p. 9.
( 7 ) EFSA Journal 2010; 8(10):1864.

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EN
24.2.2011 Official
Journal
of
the
European
Union
L
49/9
Article 2
70/524/EEC may continue to be placed on the market and
used until the existing stocks are exhausted.
In Annex II to Regulation (EC) No 1200/2005, the entry E
1710, additive: Saccharomyces cerevisiae MUCL 39885, is deleted.
Article 3
Article 4
Pre-mixtures and compound feed containing Saccharomyces
This Regulation shall enter into force on the 20th day following
cerevisiae MUCL 39885 labelled in accordance with Directive
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, 23 February 2011.
For the Commission
The President
José Manuel BARROSO

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L 49/10
ANNEX
Minimum
Maximum
Identification
Species or
content
content
number of the Name of the holder of
category of
Maximum age
Other provisions
End of period of
additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
animal
authorisation
CFU/kg of complete feedingstuff
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1710 Prosol
SpA Saccharomyces
Additive composition
Piglets
3 × 109
— 1.
In
the
directions
for
use
16 March 2021
cerevisiae
Preparation of Saccharomyces (weaned)
of the additive and
MUCL 39885
cerevisiae MUCL 39885 containing
premixture, indicate the
a minimum of 1 × 109 CFU/g
storage temperature,
storage life and stability
to pelleting.
Characterisation of active substance
2. For safety: glasses and
Viable cells of Saccharomyces
Off
gloves shall be used
cerevisiae MUCL 39885
during handling.
icial
Analytical methods (1 )
3. For piglets (weaned) up
Jour
to 35 kg.
Enumeration: pour plate method
nal
using chloramphenicol glucose
of
yeast extract agar
the
Identification: polymerase chain
reaction (PCR) method
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
24.2.2011

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