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20.4.2011 Official
Journal
of
the
European
Union L
104/7
COMMISSION IMPLEMENTING REGULATION (EU) No 389/2011
of 19 April 2011
concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and
alpha-amylase as feed additive for laying hens (holder of authorisation Danisco Animal Nutrition)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
European
Food
Safety
Authority
(the
Authority)
concluded in its opinion of 7 December 2010 ( 3 ) that
the enzyme preparation of endo-1,4-beta-xylanase,
subtilisin and alpha-amylase, under the proposed
conditions of use, does not have an adverse effect on
Having regard to the Treaty on the Functioning of the European
animal health, human health or the environment, and
Union,
that that additive has the potential to improve egg
parameter production in laying hens. The Authority
does not consider that there is a need for specific
requirements of post-market monitoring. It also verified
Having regard to Regulation (EC) No 1831/2003 of the
the report on the method of analysis of the feed additive
European Parliament and of the Council of 22 September
in feed submitted by the European Union Reference
2003 on additives for use in animal nutrition ( 1 ), and in
Laboratory for Feed Additives set up by Regulation (EC)
particular Article 9(2) thereof,
No 1831/2003.
Whereas:
(6) The
assessment
of
the
enzyme
preparation
of
endo-1,4-
beta-xylanase, subtilisin and alpha-amylase shows that
the conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
Accordingly, the use of this preparation should be au-
thorisation of additives for use in animal nutrition and
thorised as specified in the Annex to this Regulation.
for the grounds and procedures for granting such au-
thorisation.
(7) The
measures
provided
for
in
this
Regulation
are
in
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
accordance with the opinion of the Standing
1831/2003, an application was submitted for the au-
Committee on the Food Chain and Animal Health,
thorisation of an enzyme preparation of endo-1,4-beta-
xylanase produced by Trichoderma reesei ATCC PTA 5588,
subtilisin produced by Bacillus subtilis ATCC 2107 and
alpha-amylase produced by Bacillus amyloliquefaciens
ATCC 3978. That application was accompanied by the
HAS ADOPTED THIS REGULATION:
particulars and documents required under Article 7(3) of
Regulation (EC) No 1831/2003.
Article 1
(3) The
application
concerns
the
authorisation
of
an
enzyme
preparation of endo-1,4-beta-xylanase subtilisin and
The preparation specified in the Annex, belonging to the
alpha-amylase as a feed additive for laying hens, to be
additive category ‘zootechnical additives’ and to the functional
classified in the additive category ‘zootechnical additives’.
group ‘digestibility enhancers’, is authorised as an additive in

animal nutrition subject to the conditions laid down in that
Annex.
(4) The
use
of
the
preparation
of
endo-1,4-beta-xylanase,
subtilisin and alpha-amylase has been authorised for
10 years for chickens for fattening, for ducks, and for
Article 2
turkeys for fattening by Commission Regulation (EC) No
1087/2009 ( 2 ).
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 297, 13.11.2009, p. 4.
( 3 ) EFSA Journal (2011); 9(1):1949.

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L 104/8
EN
Official Journal of the European Union
20.4.2011
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 April 2011.
For the Commission
The President
José Manuel BARROSO

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20.4.2011 Off
ANNEX
Minimum content Maximum
content
Identification Name of the
Species or
number of
holder of
Additive Composition,
chemical
formula,
description,
analytical
method
category of Maximum
Other provisions
End of period of
the additive authorisation
animal
age
Units of activity/kg of
authorisation
complete feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a10 Danisco Endo-1,4-beta- Additive composition
Laying
— endo-1,4-beta- — 1.
In
the
directions
for
10 May 2021
Animal
xylanase
hens
xylanase
use of the additive,
Nutrition
EC 3.2.1.8
Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei
indicate the storage
(ATCC PTA 5588), alpha-amylase produced by Bacillus amylolique
300 U
temperature, storage
Subtilisin
faciens (ATCC 3978) and subtilisin produced by Bacillus subtilis
life, and stability to
EC 3.4.21.62
(ATCC 2107), solid form having a minimum activity of:
subtilisin
pelleting.
Alpha-amylase — endo-1,4-beta-xylanase 1 500 U (1 )/g,
4 000 U
2. For
use
in
EC 3.2.1.1
icial
— subtilisin 20 000 U (2 )/g,
alpha-amylase
compound feed rich
in starch and non-
Jour
— alpha-amylase 2 000 U (3 )/g.
400 U
starch polysac
nal
Characterisation of the active substance
charides (mainly
arabinoxylans and
of
Endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA
beta-glucans), e.g.
the
5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC
containing more
3978) and subtilisin produced by Bacillus subtilis (ATCC 2107).
than 40 % maize.
European
Analytical methods (4 )
3. For safety reasons:
Determination of the active substance in the additive, premixtures
breathing protection,
and feedingstuffs.
glasses and gloves
Union
shall be used during
Endo-1,4-beta-xylanase: colorimetric method based on the quantifi
handling.
cation of water soluble dyed fragments produced by the action of
endo-1,4-beta-xylanase on commercially available azurine cross-
linked wheat arabinoxylan substances.
Alpha-amylase: colorimetric method based on the quantification of
water soluble dyed fragments produced by the action of alpha-
amylase on commercially available azurine cross-linked starch
polymer substances.
Subtilisin: colorimetric method based on the quantification of water
soluble dyed fragments (azurine) produced by the action of subtilisin
on commercially available cross-linked casein substances.
(1 ) 1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt xylan substrate per minute at pH 5,3 and 50 °C.
(2 ) 1 U is the amount of enzyme which liberates 1 μmol of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.
(3 ) 1 U is the amount of enzyme which liberates 1 μmol of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.
L
(4 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives
104/9

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