HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 307/60
EN
Official Journal of the European Union
7.11.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1019/2012
of 6 November 2012
amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-
beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive in feed for chickens
for fattening and for ducks (holder of authorisation BASF SE)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
European
Food
Safety
Authority
(hereinafter
‘the
Authority’) concluded in its opinion of 2 February
Having regard to the Treaty on the Functioning of the European
2012 ( 4 ) that, under the new proposed conditions of
Union,
use, the enzyme concerned is efficacious at the
requested minimum dose of 280 TXU/kg. The
Authority does not consider that there is a need for
Having regard to Regulation (EC) No 1831/2003 of the
specific requirements of post-market monitoring.
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
(4) The
conditions
provided
for
in
Article
5
of
Regulation
particular Article 13(3) thereof,
(EC) No 1831/2003 are satisfied.
Whereas:
(5) Commission
Regulation
(EC)
No
1096/2009
should
therefore be amended accordingly.
(1) The
enzyme
endo-1,4-beta-xylanase
produced
by Asper
(6) The
measures
provided
for
in
this
Regulation
are
in
gillus niger (CBS 109.713), belonging to the additive
accordance with the opinion of the Standing
category of ‘zootechnical additives’ was authorised for
Committee on the Food Chain and Animal Health,
10 years as a feed additive for use on chickens for
fattening and for ducks by Commission Regulation (EC)
HAS ADOPTED THIS REGULATION:
No 1096/2009 ( 2 ) and for use on turkeys for fattening
by Commission Regulation (EC) No 1380/2007 ( 3 ).
Article 1
Regulation (EC) No 1096/2009 is amended in accordance with
(2) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No the Annex to this Regulation.
1831/2003, the holder of the authorisation has proposed
changing the terms of the authorisation of the enzyme
Article 2
concerned by reducing its minimum content from 560
TXU/kg to 280 TXU/kg as regards use on chickens for
This Regulation shall enter into force on the twentieth day
fattening and ducks. The application was accompanied by
following that of its publication in the Official Journal of the
the relevant supporting data.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 November 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 301, 17.11.2009, p. 3.
( 3 ) OJ L 309, 27.11.2007, p. 21.
( 4 ) EFSA Journal 2012; 10(2):2575.

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7.11.2012 Off
ANNEX
The Annex to Regulation (EC) No 1096/2009 is replaced by the following:
‘ANNEX
EN
Minimum
Maximum

content
content
Identification
Species or
number of the Name of the holder
category of
Maximum age
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
Units of activity/kg of complete
authorisation
feedingstuff with a moisture
content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers.
4a62 BASF
SE Endo-1,4-beta-
Additive composition
Chickens for
— 280
TXU
— 1.
In
the
directions
for
use
7.12.2019
xylanase
fattening
of the additive and
Preparation of endo-1,4-beta-xylanase
premixture, indicate the
EC 3.2.1.8
produced by Aspergillus niger (CBS
storage temperature,
icial
109.713) having a minimum activity of:
storage life and stability
Jour
solid form: 5 600 TXU (1 )/g
to pelleting.
liquid form: 5 600 TXU/ml
nal
2. Recommended maximum
dose per kilogram of
of
Characterisation of the active substance
complete feedingstuff for
the
Endo-1,4-beta-xylanase produced by Asper
chickens for fattening
European
gillus niger (CBS 109.713)
and ducks: 800 TXU.
Ducks 280
TXU
Analytical method (2 )
3. For use in feed rich in
starch and non-starch
Union
Viscosimetric method based on decrease of
polysaccharides (mainly
viscosity produced by action of endo-1,4-
beta-glucans and arabin
beta-xylanase on the xylan-containing
oxylans).
substrate (wheat arabinoxylan) at pH 3,5
and 55 °C
(1 ) 1 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.
(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’
L
307/61

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Document Outline

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