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14.12.2012 Official
Journal
of
the
European
Union L
342/23
COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2012
of 13 December 2012
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma
koningii (MUCL 39203) for turkeys for fattening and turkeys reared for breeding (holder of
authorisation Lyven)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
on animal health, human health or the environment, and
that it has the potential to improve feed to gain ratio in
Having regard to the Treaty on the Functioning of the European
turkeys for fattening. It also concluded that this
Union,
conclusion can be extended to turkeys reared for
breeding. The Authority does not consider that there is
Having regard to Regulation (EC) No 1831/2003 of the
a need for specific requirements of post-market moni
European Parliament and of the Council of 22 September
toring. It also verified the report on the method of
2003 on additives for use in animal nutrition ( 1 ), and in
analysis of the feed additive in feed submitted by the
particular Article 9(2) thereof,
Reference Laboratory set up by Regulation (EC) No
Whereas:
1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(5) The assessment of the preparation of endo-1,4-beta-
orisation of additives for use in animal nutrition and
xylanase (EC 3.2.1.8) produced by Trichoderma koningii
for the grounds and procedures for granting such auth
(MUCL 39203) shows that the conditions for authori
orisation.
sation, as provided for in Article 5 of Regulation (EC)
No 1831/2003, are satisfied. Accordingly, the use of that
(2) The use of a preparation of endo-1,4-beta-xylanase
preparation should be authorised as specified in the
(EC 3.2.1.8) produced by Trichoderma koningii (MUCL
Annex to this Regulation.
39203) was authorised without time limit for chickens
for fattening by Commission Regulation (EC) No
(6) The
measures
provided
for
in
this
Regulation
are
in
828/2007 ( 2 ).
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for a new
use of the preparation of endo-1,4-beta-xylanase
HAS ADOPTED THIS REGULATION:
(EC 3.2.1.8) produced by Trichoderma koningii (MUCL
39203) for turkeys for fattening and turkeys reared for
Article 1
breeding requesting that the additive be classified in the
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’. That application
additive category ‘zootechnical additives’ and to the functional
was accompanied by the particulars and documents
group ‘digestibility enhancers’, is authorised as an additive in
required under Article 7(3) of Regulation (EC) No
animal nutrition subject to the conditions laid down in that
1831/2003.
Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 4 July 2012 ( 3 ) that, under
the proposed conditions of use, the preparation of endo-
This Regulation shall enter into force on the twentieth day
1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma
following that of its publication in the Official Journal of the
koningii (MUCL 39203) does not have an adverse effect
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 184, 14.7.2007, p. 12.
( 3 ) EFSA Journal 2012; 10(7):2843

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L 342/24
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
Units of activity/kg of
Other provisions
End of period of
additive
authorisation
method
animal
age
authorisation
complete feedingstuff with
EN
a moisture content of

12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a1642 Lyven Endo-1,4-
Additive composition
Turkeys for
— 75
AXC
— 1.
In
the
directions
for
use
of
the
3 January 2023
beta-xylanase
fattening
additive and premixture, indicate
Preparation of endo-1,4-beta-xylanase produced
the storage temperature, storage life
EC 3.2.1.8
by Trichoderma koningii (MUCL 39203) having a Turkeys
and stability to pelleting.
minimum activity of:
reared for
breeding
2. Recommended maximum dose per
Off
Solid form: 1 500 AXC (1 )/g
kilogram of complete feedingstuff
icial
for turkeys for fattening and turkeys
Liquid form: 200 AXC/ml
reared for breeding: 100 AXC.
Jour
nal
Characterisation of the active substance
3. For use in feed rich in non-starch
polysaccharides (mainly arabin
of
endo-1,4-beta-xylanase produced by Trichoderma
oxylans)
the
koningii (MUCL 39203)
4. For safety: breathing protection,
European
glasses and gloves shall be used
Analytical method (2 )
during handling.
For quantification of endo-1,4-beta-xylanase
Union
produced by Trichoderma koningii (MUCL
39203) in feed:
Colorimetric method based on the quantifi
cation of dyed oligomers produced by the
action of endo-1,4-beta-xylanase on Remazol-
Brilliant-Blue-R xylan at pH 4,7 and 30 °C
(1 ) 1 AXC is the amount of enzyme which liberates 17,2 micromoles of reducing sugars (maltose equivalents) from oat xylan per minute at pH 4,7 and 30 °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
14.12.2012

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Document Outline

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