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22.10.2011 Official
Journal
of
the
European
Union L
277/11
COMMISSION IMPLEMENTING REGULATION (EU) No 1068/2011
of 21 October 2011
concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by
Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM
18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys
reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds
(holder of authorisation BASF SE)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
1,4-beta-xylanase produced by Aspergillus niger (CBS
109.713) and endo-1,4-beta-glucanase produced by
Aspergillus niger (DSM 18404) for chickens reared for
Having regard to the Treaty on the Functioning of the European
laying, turkeys for breeding purposes, turkeys reared for
Union,
breeding, other minor avian species (other than ducks for
fattening) and ornamental birds. The European Food
Safety Authority (‘the Authority’) concluded in its
Having regard to Regulation (EC) No 1831/2003 of the
opinion of 11 May 2011 ( 3 ) that, under the proposed
European Parliament and of the Council of 22 September
conditions of use, the enzyme preparation of endo-1,4-
2003 on additives for use in animal nutrition ( 1 ), and in
beta-xylanase produced by Aspergillus niger (CBS
particular Article 9(2) thereof,
109.713) and endo-1,4-beta-glucanase produced by
Aspergillus niger (DSM 18404) for chickens reared for
laying, turkeys for breeding purposes, turkeys reared for
Whereas:
breeding, other minor avian species (other than ducks for
fattening) and ornamental birds does not have an adverse
effect on animal health, human health or the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
environment, and that the use of that preparation can
orisation of additives for use in animal nutrition and
improve the zootechnical performances of the target
for the grounds and procedures for granting such auth
species. The Authority does not consider that there is a
orisation.
need for specific requirements of post-market moni
toring. 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
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for the auth
1831/2003.
orisation of the enzyme preparation of endo-1,4-beta-
xylanase produced by Aspergillus niger (CBS 109.713)
and endo-1,4-beta-glucanase produced by Aspergillus
(6) The
assessment
of
the
enzyme
preparation
of
endo-1,4-
niger (DSM 18404). The application was accompanied
beta-xylanase produced by Aspergillus niger (CBS
by the particulars and documents required under
109.713) and endo-1,4-beta-glucanase produced by
Article 7(3) of Regulation (EC) No 1831/2003.
Aspergillus niger (DSM 18404) shows that the conditions
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
(3) The
application
concerns
the
authorisation
of
the
use of this preparation should be authorised as specified
enzyme preparation of endo-1,4-beta-xylanase produced
in the Annex to this Regulation.
by Aspergillus niger (CBS 109.713) and endo-1,4-beta-
glucanase produced by Aspergillus niger (DSM 18404) as
a feed additive for chickens reared for laying, turkeys for
(7) The
measures
provided
for
in
this
Regulation
are
in
breeding purposes, turkeys reared for breeding, other
accordance with the opinion of the Standing
minor avian species (other than ducks for fattening)
Committee on the Food Chain and Animal Health,
and ornamental birds, to be classified in the additive
category ‘zootechnical additives’.
HAS ADOPTED THIS REGULATION:
(4) The
use
of
that
preparation
was
authorised
for
10
years
for chickens for fattening, turkeys for fattening, laying
hens, ducks for fattening and weaned piglets by
Article 1
Commission Regulation (EC) No 271/2009 ( 2 ).
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
(5) New
data
were
submitted
in
support
of
the
application group ‘digestibility enhancers’, is authorised as an additive in
for the authorisation of the enzyme preparation of endo-
animal nutrition, subject to the conditions laid down in that
Annex.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 91, 3.4.2009, p. 5.
( 3 ) EFSA Journal 2011;9(5):2172.

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L 277/12
EN
Official Journal of the European Union
22.10.2011
Article 2
This Regulation shall enter into force on the 20th day following 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, 21 October 2011.
For the Commission
The President
José Manuel BARROSO

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22.10.2011 Off
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
Units of activity/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers.
4a7 BASF
SE Endo-1,4- Additive composition
Minor
— 280
TXU — 1.
In
the
directions
for
use
of
the
11.11.2021
beta-xylanase
Preparation of endo-1,4-beta-xylanase produced
poultry
additive and premixture, indicate
species for
125 TGU
the storage temperature, storage
EC 3.2.1.8
by Aspergillus niger (CBS 109.713) and endo-1,4-
beta-glucanase produced by Aspergillus niger
fattening
life, and stability to pelleting.
Endo-1,4-
(DSM 18404) having a minimum activity of:
(other than
2. Recommended
doses
per
beta-glucanase
ducks for
Solid form
fattening)
kilogram of complete feed
EC 3.2.1.4
5 600 TXU (1 ) and 2 500 TGU (2 )/g
and
ingstuffs:
icial
ornamental
Liquid form
— minor poultry species for
birds
fattening (other than ducks)
Jour
5 600 TXU and 2 500 TGU/g
and ornamental birds: 280-
nal
Characterisation of the active substance
840 TXU/125-375 TGU,
Chickens
560 TXU
of
endo-1,4-beta-xylanase produced by Aspergillus
reared for
— chickens reared for laying,
250 TGU
the
niger (CBS 109.713)
laying,
turkeys for breeding
turkeys for
purposes, turkeys reared for
European
and endo-1,4-beta-glucanase produced by Asper
breeding
breeding and all minor avian
gillus niger (DSM 18404)
purposes,
species for laying: 560-840
turkeys
Analytical method (3 )
TXU/250-375 TGU.
reared for
Union
For quantification of endo-1,4-beta-xylanase
breeding and
3. For safety: breathing protection,
activity:
all minor
glasses and gloves shall be used
avian species
during handling.
viscosimetric method based on decrease of
viscosity produced by action of endo-1,4-beta-
for laying
xylanase on the xylan containing substrate
(wheat arabinoxylan) at pH 3,5 and 55 °C.
For quantification of endo-1,4-beta-glucanase
activity:
viscosimetric method based on decrease of
viscosity produced by action of endo-1,4-beta-
glucanase on the glucan containing substrate
(barley betaglucan) at pH 3,5 and 40 °C.
(1 ) 1 TXU is the amount of enzyme which liberates 5 micromoles of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.
(2 ) 1 TGU is the amount of enzyme which liberates 1 micromoles of reducing sugars (glucose equivalents) from barley -glucan per minute at pH 3,5 and 40 °C.
(3 ) 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
L
277/13

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