HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 289/30
EN
Official Journal of the European Union
31.10.2013
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 1059/2013
of 29 October 2013
concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed
additive for cattle for fattening and amending Regulation (EC) No 492/2006 (holder of the
authorisation Prosol SpA)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
cows and horses by Commission Regulation (EU) No
1119/2010 ( 5 ), and for weaned piglets by Commission
Regulation (EU) No 170/2011 ( 6 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that Regu
Having regard to Regulation (EC) No 1831/2003 of the
lation, an application was submitted for the re-evaluation
European Parliament and of the Council of 22 September
of that preparation as a feed additive for cattle for
2003 on additives for use in animal nutrition (
fattening, requesting that additive to be classified in the

1 ), and in
particular Article 9(2) thereof,
additive category ‘zootechnical additives’. That application
was accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No
1831/2003.
Whereas:
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
concluded in its opinion of 13 March 2013 (
orisation of additives for use in animal nutrition and

7 ) that,
under the proposed conditions of use, the preparation
for the grounds and procedures for granting such auth
of Saccharomyces cerevisiae MUCL 39885 does not have
orisation. Article 10 of that Regulation provides for the
an adverse effect on animal health, human health or
re-evaluation of additives authorised pursuant to Council
the environment and it has the potential to improve
Directive 70/524/EEC ( 2 ).
the final body weight, the feed to gain ratio and the
average daily gain. The Authority does not consider
that there is a need for specific requirements of post-
(2) A
preparation
of Saccharomyces cerevisiae MUCL 39885
market monitoring. It also verified the report on the
was authorised without a time limit in accordance with
method of analysis of the feed additive in feed
Directive 70/524/EEC as a feed additive for use on cattle
submitted by the Reference Laboratory set up by Regu
for fattening by Commission Regulation (EC) No
lation (EC) No 1831/2003.
492/2006 ( 3 ). That preparation was subsequently
entered in the Register of feed additives as an existing
product, in accordance with Article 10(1)(b) of Regu
lation (EC) No 1831/2003.
(6) The
assessment
of
the
preparation
of Saccharomyces
cerevisiae MUCL 39885 shows that the conditions for
authorisation, as provided for in Article 5 of Regulation
(EC) No 1831/2003, are satisfied. Accordingly, the use of
(3) The
preparation
of Saccharomyces cerevisiae MUCL 39885
that preparation should be authorised as specified in the
was also authorised for 10 years for sows by
Annex to this Regulation.
Commission Regulation (EC) No 896/2009 ( 4 ), for dairy
( 5 ) Commission Regulation (EU) No 1119/2010 of 2 December 2010
( 1 ) OJ L 268, 18.10.2003, p. 29.
concerning the authorisation of Saccharomyces cerevisiae MUCL 39885
( 2 ) Council Directive 70/524/EEC of 23 November 1970 concerning
as a feed additive for dairy cows and horses and amending Regu
additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).
lation (EC) No 1520/2007 (holder of the authorisation Prosol SpA)
( 3 ) Commission Regulation (EC) No 492/2006 of 27 March 2006
(OJ L 317, 3.12.2010, p. 9).
concerning the provisional and permanent authorisation of certain
( 6 ) Commission Regulation (EU) No 170/2011 of 23 February 2011
additives in feedingstuffs (OJ L 89, 28.3.2006, p. 6).
concerning the authorisation of Saccharomyces cerevisiae MUCL 39885
( 4 ) Commission Regulation (EC) No 896/2009 of 25 September 2009
as a feed additive for piglets (weaned) and amending Regulation (EC)
concerning the authorisation of a new use of Saccharomyces cerevisiae
No 1200/2005 (holder of authorisation Prosol SpA) (OJ L 49,
MUCL 39885 as a feed additive for sows (holder of the authori
24.2.2011, p. 8).
sation Prosol SpA) (OJ L 256, 29.9.2009, p. 6).
( 7 ) EFSA Journal 2013; 11(4):3174.

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EN
31.10.2013 Official
Journal
of
the
European
Union L
289/31
(7)
As a consequence of the granting of a new authorisation
group ‘gut flora stabilisers’, is authorised as an additive in
under Regulation (EC) No 1831/2003, the provisions on
animal nutrition subject to the conditions laid down in that
Saccharomyces cerevisiae MUCL 39885 contained in Regu
Annex.
lation (EC) No 492/2006 should be deleted. Regulation
(EC) No 492/2006 should therefore be amended accord
ingly.
Article 2
In Annex II to Regulation (EC) No 492/2006 the entry on E
(8)
Since safety reasons do not require the immediate appli
1710, Saccharomyces cerevisiae MUCL 39 885 is deleted.
cation of the modifications to the conditions of auth
orisation, it is appropriate to allow a transitional period
for interested parties to prepare themselves to meet the
Article 3
new requirements resulting from the authorisation.
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 19 May
(9) The
measures
provided
for
in
this
Regulation
are
in 2014 in accordance with the rules applicable before
accordance with the opinion of the Standing
19 November 2013 may continue to be placed on the
Committee on the Food Chain and Animal Health,
market and used until the existing stocks are exhausted.
HAS ADOPTED THIS REGULATION:
Article 4
Article 1
This Regulation shall enter into force on the twentieth day
The preparation specified in the Annex, belonging to the
following that of its publication in the Official Journal of the
additive category ‘zootechnical additives’ and to the functional
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 289/32
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive authorisation
method
animal
age
CFU/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1710 Prosol
Saccharomyces
Additive composition
Cattle for
— 4
×
109
— 1.
In
the
directions
for
use
of
the
19 November 2023
SpA
cerevisiae MUCL
fattening
additive and premixture, indicate
39885
Preparation of Saccharomyces cerevisiae MUCL
the storage conditions and
39885
stability to pelleting.
containing a minimum of:
2. Minimum recommended
content of additive for head per
Powder: 1 × 109 CFU/g of additive
Off
day: 3,6 × 1010 CFU.
icial
Solid form
3. For safety: glasses and gloves
shall be used during handling.
Jour
Characterisation of the active substance
nal
Viable cells of Saccharomyces cerevisiae MUCL 39885
of
the
Analytical method (1 )
European
Enumeration: pour plate method using
chloramphenicol glucose yeast extract agar
(EN15789:2009)
Union
Identification: polymerase chain reaction (PCR)
method
(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
31.10.2013

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Document Outline

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