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14.12.2012 Official
Journal
of
the
European
Union L
342/25
COMMISSION IMPLEMENTING REGULATION (EU) No 1196/2012
of 13 December 2012
amending Regulation (EU) No 9/2010 as regards the minimum content of a preparation of endo-1,4-
beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive in feed for laying
hens (holder of authorisation Danisco Animal Nutrition)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
Authority
concluded
in
its
opinion
of
22
May
2012 ( 5 ) that, under the new proposed conditions of
Having regard to the Treaty on the Functioning of the European
use, the preparation concerned is efficacious at the
Union,
requested minimum dose of 625 U/kg. The Authority
does not consider that there is a need for specific
Having regard to Regulation (EC) No 1831/2003 of the
requirements of post-market monitoring. It also verified
European Parliament and of the Council of 22 September
the report on the method of analysis of the feed additive
2003 on additives for use in animal nutrition (
in feed submitted by the Reference Laboratory set up by

1 ), and in
particular Article 13(3) thereof,
Regulation (EC) No 1831/2003.
Whereas:
(4) The
conditions
provided
for
in
Article
5
of
Regulation
(EC) No 1831/2003 are satisfied.
(1)
The use of a preparation of endo-1,4-beta-xylanase (EC
3.2.1.8) produced by Trichoderma reesei (ATCC PTA
(5) Regulation
(EU)
No
9/2010
should
therefore
be
amended
5588), belonging to the additive category of ‘zoo
accordingly.
technical additives’, was authorised for 10 years as a
feed additive for use on chickens for fattening, laying
hens, ducks and turkeys for fattening by Commission
(6) The
measures
provided
for
in
this
Regulation
are
in
Regulation (EU) No 9/2010 (
accordance with the opinion of the Standing

2 ), for weaned piglets and
pigs for fattening by Commission Implementing Regu
Committee on the Food Chain and Animal Health,
lation (EU) No 528/2011 ( 3 ) and for minor poultry
species other than ducks by Commission Implementing
HAS ADOPTED THIS REGULATION:
Regulation (EU) No 1021/2012 ( 4 ).
Article 1
(2) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No
1831/2003, the holder of the authorisation has proposed
The Annex to Regulation (EU) No 9/2010 is amended in
changing the terms of the authorisation of the prep
accordance with the Annex to this Regulation.
aration concerned by reducing its minimum content
from 2 500 U/kg to 625 U/kg as regards the use on
Article 2
laying hens. The application was accompanied by the
relevant supporting data. The Commission forwarded
This Regulation shall enter into force on the twentieth day
that application to the European Food Safety Authority
following that of its publication in the Official Journal of the
(hereinafter ‘the Authority’).
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 December 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 3, 7.1.2010, p. 10.
( 3 ) OJ L 143, 31.5.2011, p. 10.
( 4 ) OJ L 307, 7.11.2012, p. 68.
( 5 ) EFSA Journal 2012; 10(6):2739.

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L 342/26
ANNEX
The Annex to Regulation (EU) No 9/2010 is replaced by the following:
‘ANNEX
Minimum
Maximum
EN
content
content

Identification
Species or
number of Name of the holder
category of Maximum
Units of activity/kg of
Other provisions
End of period of
the additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
age
authorisation
complete feedingstuff with
a moisture content of
12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a11 Danisco
Animal
Endo-1,4-beta-
Additive composition
Chickens
625 U
1. In the directions for use of the additive 13 January 2020
Nutrition
xylanase
for
and premixture, indicate the storage
Off
Preparation of endo-1,4-beta-xylanase fattening
temperature, storage life and stability to
icial
(legal entity:
EC 3.2.1.8
(EC 3.2.1.8) produced by Trichoderma
pelleting.
Danisco (UK)
reesei
Jour
Limited)
Laying
625 U
2. For use in feed rich in non-starch poly
(ATCC PTA 5588) with a minimum
hens
saccharides (mainly beta- arabinoxylans).
nal
activity of 40 000 U (1 )/g
of
Ducks 625
U
the
Characterisation of the active substance
European
Turkeys
1 250 U
endo-1,4-beta-xylanase (EC 3.2.1.8)
for
produced by Trichoderma reesei (ATCC fattening
PTA 5588)
Union
Analytical method (2 )
For quantification of endo-1,4-beta-
xylanase activity:
colorimetric method based on the
quantification of water soluble dyed
fragments produced by the action of
endo-1,4-beta-xylanase on azurine
cross-linked wheat arabinoxylan at pH
4,25 and 50 °C.
(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 arabinoxylan substrate at pH 5,3 and 50 °C in one minute.
(2 ) 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’
14.12.2012

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Document Outline

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