HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
26.10.2012 Official
Journal
of
the
European
Union L
297/11
COMMISSION IMPLEMENTING REGULATION (EU) No 989/2012
of 25 October 2012
concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC
49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed
additive for laying hens and minor poultry species for fattening and laying (holder of
authorisation Aveve NV)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
by Trichoderma reesei (MULC 49755) and endo-1,3(4)-
beta-glucanase produced by Trichoderma reesei (MULC
49754) for laying hens and minor poultry species for
Having regard to the Treaty on the Functioning of the European
fattening and laying. The European Food Safety
Union,
Authority (‘the Authority’) concluded in its opinion of
23 May 2012 ( 4 ) that the use of endo-1,4-beta-xylanase
produced by Trichoderma reesei (MULC 49755) and endo-
Having regard to Regulation (EC) No 1831/2003 of the
1,3(4)-beta-glucanase produced by Trichoderma reesei
European Parliament and of the Council of 22 September
(MULC 49754) does not have an adverse effect on
2003 on additives for use in animal nutrition (
animal health, human health or the environment, and

1 ), and in
particular Article 9(2) thereof,
that the use of that preparation can significantly
increase egg mass and can improve feed to eggs mass
ratio in laying hens and minor poultry species for laying
and can improve the zootechnical parameters in minor
Whereas:
poultry species for fattening. The Authority does not
consider that there is a need for specific requirements
of post-market monitoring. It also verified the report
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
on the method of analysis of the feed additive in feed
orisation of additives for use in animal nutrition and
submitted by the Reference Laboratory set up by Regu
for the grounds and procedures for granting such auth
lation (EC) No 1831/2003.
orisation.
(6) The
assessment
of
that
preparation
shows
that
the
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
conditions for authorisation, as provided for in
1831/2003, an application was submitted for the auth
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
orisation of endo-1,4-beta-xylanase produced by
Accordingly, the use of this preparation should be auth
Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-
orised as specified in the Annex to this Regulation.
glucanase produced by Trichoderma reesei (MULC

49754). The application was accompanied by the
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
the
authorisation
of
endo-1,4-
beta-xylanase produced by Trichoderma reesei (MULC
49755) and endo-1,3(4)-beta-glucanase produced by
Trichoderma reesei (MULC 49754) as a feed additive for
HAS ADOPTED THIS REGULATION:
laying hens and minor poultry species for fattening and
laying, to be classified in the additive category ‘zoo
technical additives’.
Article 1
Endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as
(4) The
use
of
those
enzymes
was
authorised
for
10
years specified in the Annex, belonging to the additive category ‘zoo
for chickens for fattening by Commission Regulation
technical additives’ and to the functional group ‘digestibility
(EC) No 1091/2009 (
enhancers’, are authorised as an additive in animal nutrition,

2 ) and for 10 years for weaned
piglets by Commission Implementing Regulation (EU)
subject to the conditions laid down in that Annex.
No 1088/2011 ( 3 ).
Article 2
(5) New
data
were
submitted
in
support
of
the
application
for the authorisation of endo-1,4-beta-xylanase produced
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 299, 14.11.2009, p. 6.
( 3 ) OJ L 281, 28.10.2011, p. 14.
( 4 ) EFSA Journal 2012;10(6):2728.

---

L 297/12
EN
Official Journal of the European Union
26.10.2012
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 October 2012.
For the Commission
The President
José Manuel BARROSO

---

26.10.2012 Off
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum age
Other provisions
End of period of
additive
authorisation
analytical method.
animal
Units of activity/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a9 Aveve
NV Endo-1,4-beta- Additive composition
Laying hens
— 4
000
XU — 1.
In
the
directions
for
use
15 November 2022
xylanase
and minor
900 BGU
of the additive and
Preparation of endo-1,4-beta-xylanase
poultry
premixture, indicate the
EC 3.2.1.8
produced by Trichoderma reesei (MULC species for
storage temperature,
49755) and endo-1,3(4)-beta-glucanase
laying
storage life, and stability
Endo-1,3(4)-
produced by Trichoderma reesei (MULC
to pelleting.
beta-glucanase
49754) having a minimum activity of:
40 000 XU (1 ) and 9 000 BGU (2 )/g
2. For use in feed rich in
EC 3.2.1.6
icial
starch and non-starch
Characterisation of the active substance
polysaccharides (mainly
Jour
Minor
3 000 XU
beta-glucans and arabin
endo-1,4-beta-xylanase produced by
poultry
675 BGU
oxylans).
nal
Trichoderma reesei (MULC 49755) and species for
of
endo-1,3(4)-beta-glucanase produced fattening
3. For safety: breathing
the
by Trichoderma reesei (MULC 49754)
protection, glasses and
gloves shall be used
European
Analytical method (3 )
during handling.
Characterisation of the active substance
in the additive:
Union
— 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
β-glucan containing substrate.
Characterisation of the active
substances in the feed
— colorimetric method measuring
water soluble dye released by
L
action of endo-1,4-beta-xylanase
297/13
from dye cross-linked wheat arabin
oxylan substrate;

---

L 297/14
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum age
Other provisions
End of period of
additive
authorisation
analytical method.
animal
Units of activity/kg of complete
authorisation
feedingstuff with a moisture
content of 12 %
— colorimetric method measuring
water soluble dye released by
EN
action of endo-1,3(4)-beta-

glucanase from dye cross-linked
barley betaglucan substrate.
(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 ) 1 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.
(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
Off
icial
Jour
nal
of
the
European
Union
26.10.2012

---

Document Outline

• �

---