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19.12.2013 Official
Journal
of
the
European
Union L
343/31
COMMISSION IMPLEMENTING REGULATION (EU) No 1365/2013
of 18 December 2013
concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces
cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a
feed additive for minor poultry species for fattening and for chickens reared for laying (holder of
authorisation Kerry Ingredients and Flavours)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
use
of
that
preparation
was
authorised
for
10
years
for chickens for fattening by Commission Implementing
Regulation (EU) No 237/2012 ( 2 ).
Having regard to the Treaty on the Functioning of the European
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
Union,
concludes in its opinion of 18 June 2013 ( 3 ) that,
under the proposed conditions of use, the preparation
of alpha-galactosidase produced by Saccharomyces cerevisiae
(CBS 615.94) and endo-1,4-beta-glucanase produced by
Aspergillus niger (CBS 120604) does not have an adverse
effect on animal health, human health or the
Having regard to Regulation (EC) No 1831/2003 of the
environment and it has the potential to be efficacious
European Parliament and of the Council of 22 September
on chickens reared for laying and that can be extra
2003 on additives for use in animal nutrition ( 1 ), and in
polated to minor poultry species for fattening. The
particular Article 9(2) thereof,
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
additive in feed submitted by the Reference Laboratory
set up by Regulation (EC) No 1831/2003.
Whereas:
(6)
The assessment of the preparation of alpha-galactosidase
produced by Saccharomyces cerevisiae (CBS 615.94) and
endo-1,4-beta-glucanase produced by Aspergillus niger
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(CBS 120604) shows that the conditions for authori
orisation of additives for use in animal nutrition and
sation, as provided for in Article 5 of Regulation (EC)
for the grounds and procedures for granting such auth
No 1831/2003, are satisfied. Accordingly, the use of that
orisation.
preparation should be authorised as specified in the
Annex to this Regulation.
(7) 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 a new

use of a preparation of alpha-galactosidase produced by
Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-
glucanase produced by Aspergillus niger (CBS 120604).
HAS ADOPTED THIS REGULATION:
That 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
additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’, is authorised as an additive in
animal nutrition subject to the conditions laid down in that
(3) That
application
concerns
the
authorisation
of
a
new
use Annex.
of a preparation of alpha-galactosidase produced by
Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-
( 2 ) Commission Implementing Regulation (EU) No 237/2012 of
glucanase produced by Aspergillus niger (CBS 120604) as
19 March 2012 concerning the authorisation of alpha-galactosidase
a feed additive for minor poultry species for fattening
(EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and
and for chickens reared for laying, to be classified in
endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger
the additive category ‘zootechnical additives’.
(CBS 120604) as a feed additive for chickens for fattening (holder
of authorisation Kerry Ingredients and Flavours) (OJ L 80,
20.3.2012, p. 1).
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 3 ) EFSA Journal 2013; 11(7):3286.

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L 343/32
EN
Official Journal of the European Union
19.12.2013
Article 2
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, 18 December 2013.
For the Commission
The President
José Manuel BARROSO

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19.12.2013 Off
ANNEX
Minimum content
Maximum
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula,
category of
Maximum
Other provisions
End of period of
the additive authorisation
description, analytical method
animal
age
Units of activity/kg of complete
authorisation
feedingstuff with a moisture content
EN
of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a17 Kerry
Alpha-
Additive composition
Minor poultry
— alpha-
—
1. In the directions for use of the additive 8 January 2024
Ingredients galactosidase Preparation of alpha-galactosidase species for
galactosidase
and premixture, indicate the storage
and
EC 3.2.1.22 produced by Saccharomyces cerevisiae
fattening.
50 U
conditions and stability to pelleting.
Flavours
Endo-1,4-
(CBS 615.94) and endo-1,4-beta-
Chickens
endo-1,4-beta-
2. Maximum recommended dose:
beta-
glucanase produced by Aspergillus
reared for
glucanase 285 U
— 100 U alpha-galactosidase/kg of
glucanase
niger (CBS 120604) having a
laying.
complete feed,
EC 3.2.1.4
minimum activity of:
— 570 U endo-1,4-beta-glucanase/kg
— 1 000 U (1 ) alpha-galactosidase/g,
icial
of complete feed.
— 5 700 U (2 ) endo-1,4-beta-gluc
3. For safety: breathing protection, glasses
Jour
anase/g.
and gloves shall be used during hand
nal
Solid form
ling.
of
Characterisation of the active substance
the
alpha-galactosidase (EC 3.2.1.22)
produced by Saccharomyces cerevisiae
European
(CBS 615.94) and endo-1,4-beta-
glucanase (EC 3.2.1.4) produced by
Aspergillus niger (CBS 120604).
Union
Analytical method (3 )
For the determination of:
— alpha-galactosidase: colorimetric
method measuring p-nitrophenol
released by action of alpha-
galactosidase from p-nitro
phenyl-alpha-galactopyranoside
substrate,
— endo-1,4-beta-glucanase: colori
metric method measuring water
soluble dye released by action
of endo-1,4-beta-glucanase from
azurine-crosslinked barley glucan
substrate.
(1 ) 1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.
(2 ) 1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.
L
(3 ) Details of the analytical methods are available at the following address of the Reference Laboratory:
343/33
http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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Document Outline

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