HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 283/46
EN
Official Journal of the European Union
25.10.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1040/2013
of 24 October 2013
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma
reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754)
as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus
scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Commission Implementing Regulation (EU) No
1088/2011 ( 3 ) and for laying hens and minor poultry
species for fattening and laying by Commission Imple
Having regard to the Treaty on the Functioning of the European
menting Regulation (EU) No 989/2012 ( 4 ).
Union,
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
in
2003 on additives for use in animal nutrition ( 1 ), and in
its opinions of 12 March 2013 ( 5 ) confirmed its previous
particular Article 9(2) thereof,
conclusions that, under the proposed conditions of use,
the preparation of endo-1,4-beta-xylanase produced by
Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-
glucanase produced by Trichoderma reesei (MUCL 49754)
Whereas:
does not have an adverse effect on animal health, human
health or the environment. The Authority concluded that
the additive has the potential to improve the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
zootechnical performance in pigs for fattening and that
orisation of additives for use in animal nutrition and
this conclusion can be extrapolated to minor porcine
for the grounds and procedures for granting such auth
species for fattening other than Sus scrofa domesticus.
orisation.
The Authority also concluded that the additive has the
potential to improve the final body weight and feed to
gain ratio in turkeys for fattening. The Authority does
not consider that there is a need for specific requirements
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
of post-market monitoring. It also verified the report on
1831/2003, an application was submitted for a new
the method of analysis of the feed additive in feed
use of a preparation of endo-1,4-beta-xylanase
submitted by the Reference Laboratory set up by Regu
produced by Trichoderma reesei (MUCL 49755) and
lation (EC) No 1831/2003.
endo-1,3(4)-beta-glucanase produced by Trichoderma
reesei (MUCL 49754). That application was accompanied
by the particulars and documents required under
Article 7(3) of Regulation (EC) No 1831/2003.
(6) The assessment of the preparation of endo-1,4-beta-
(3) That
application
concerns
the
authorisation
of
a
new
use
xylanase produced by Trichoderma reesei (MUCL 49755)
of a preparation of endo-1,4-beta-xylanase produced by
and endo-1,3(4)-beta-glucanase produced by Trichoderma
Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-
reesei (MUCL 49754) shows that the conditions for auth
glucanase produced by Trichoderma reesei (MUCL 49754)
orisation, as provided for in Article 5 of Regulation (EC)
as a feed additive for pigs for fattening and minor
No 1831/2003, are satisfied. Accordingly, the use of that
porcine species for fattening other than Sus scrofa domes
preparation should be authorised as specified in the
ticus, and turkeys for fattening, to be classified in the
Annex to this Regulation.
additive category ‘zootechnical additives’.
( 3 ) Commission Implementing Regulation (EU) No 1088/2011 of
27 October 2011 concerning the authorisation of an enzyme prep
aration of endo-1,4-beta-xylanase produced by Trichoderma reesei
(4) The
use
of
that
preparation
was
authorised
for
10
years
(MULC 49755) and endo-1,3(4)-beta-glucanase produced by
for chickens for fattening by Commission Regulation
Trichoderma reesei (MULC 49754) as a feed additive for weaned
(EC) No 1091/2009
(
piglets (holder of authorisation Aveve NV) (OJ L 281, 28.10.2011,

2 ), for weaned piglets by
p. 14).
( 4 ) Commission Implementing Regulation (EU) No 989/2012 of
( 1 ) OJ L 268, 18.10.2003, p. 29.
25 October 2012 concerning the authorisation of endo-1,4-beta-
( 2 ) Commission Regulation (EC) No 1091/2009 of 13 November 2009
xylanase produced by Trichoderma reesei (MULC 49755) and endo-
concerning the authorisation of an enzyme preparation of endo-1,4-
1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754)
beta-xylanase produced by Trichoderma reesei (MUCL 49755) and
as a feed additive for laying hens and minor poultry species for
endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL
fattening and laying (holder of authorisation Aveve NV)
49754) as a feed additive for chickens for fattening (holder of auth
(OJ L 297, 26.10.2012, p. 11).
orisation Aveve NV) (OJ L 299, 14.11.2009, p. 6).
( 5 ) EFSA Journal 2013; 11(4):3171 and EFSA Journal 2013; 11(4):3172.

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EN
25.10.2013 Official
Journal
of
the
European
Union L
283/47
(7) The
measures
provided
for
in
this
Regulation
are
in group ‘digestibility enhancers’, is authorised as an additive in
accordance with the opinion of the Standing
animal nutrition subject to the conditions laid down in that
Committee on the Food Chain and Animal Health,
Annex.
HAS ADOPTED THIS REGULATION:
Article 2
Article 1
This Regulation shall enter into force on the twentieth day
The preparation specified in the Annex, belonging to the
following that of its publication in the Official Journal of the
additive category ‘zootechnical additives’ and to the functional
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 283/48
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
number of the
holder of
Additive
Composition, chemical formula, description,
Species or category of
Maximum
Units of activity/kg of
Other provisions
End of period of
additive
authorisation
analytical method.
animal
age
authorisation
complete feedingstuff with
EN
a moisture content of

12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a9 Aveve
NV Endo-1,4-beta-
Additive composition
Pigs for fattening
— 4
000
XU — 1.
In
the
directions
for
use
14 November 2023
xylanase
of the additive and
EC 3.2.1.8
Preparation of endo-1,4-beta-xylanase Minor porcine species
900 BGU
premixture, indicate the
produced by Trichoderma reesei (MUCL for fattening other
storage conditions, and
Endo-1,3(4)-
49755) and endo-1,3(4)-beta-glucanase than Sus scrofa
stability to pelleting.
beta-glucanase
produced by Trichoderma reesei (MUCL domesticus
Off
EC 3.2.1.6
49754) having a minimum activity of:
2. For use in feed rich in
icial
40 000 XU (1 ) and 9
000
BGU
(2 )/g Turkeys for fattening
non-starch polysac
Solid and liquid forms
charides (mainly beta-
Jour
glucans and arabin
nal
Characterisation of the active substance
oxylans)
of
the
endo-1,4-beta-xylanase produced by
3. For safety: breathing
Trichoderma reesei (MUCL 49755) and
protection, glasses and
European
endo-1,3(4)-beta-glucanase produced by
gloves shall be used
Trichoderma reesei (MUCL 49754)
during handling.
Union
Analytical method (3 )
Characterisation of the active substance
in the additive:
— colorimetric method based on
reaction of dinitrosalicylic acid on
reducing sugar produced by action
of endo-1,4-beta-xylanase on a
xylan containing substrate;
— colorimetric method based on
reaction of dinitrosalicylic acid on
reducing sugar produced by action
of endo-1,3(4)-beta-glucanase on a
beta-glucan containing substrate.
25.10.2013
Characterisation of the active substances
in the feedingstuffs:

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25.10.2013 Off
Minimum
Maximum
content
content
Identification
Name of the
number of the
holder of
Additive
Composition, chemical formula, description,
Species or category of
Maximum
Units of activity/kg of
Other provisions
End of period of
additive
authorisation
analytical method.
animal
age
authorisation
complete feedingstuff with
a moisture content of
12 %
— colorimetric method measuring
EN
water soluble dye released by

action of endo-1,4-beta-xylanase
from dye cross-linked wheat arabin
oxylan substrate;
— colorimetric method measuring
water soluble dye released by
action of endo-1,3(4)-beta-glucanase
from dye cross-linked barley
betaglucan substrate.
icial
(1 ) XU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) per minute from xylan of oat spelt at pH 4,8 and 50 °C.
(2 ) BGU is the amount of enzyme which liberates 1 micromole of reducing sugars (cellobiose equivalents) per minute from -glucan of barley at pH 5,0 and 50 °C.
Jour
(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
nal
of
the
European
Union
L
283/49

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Document Outline

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