HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 281/14
EN
Official Journal of the European Union
28.10.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 1088/2011
of 27 October 2011
concerning the authorisation of an enzyme preparation 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 weaned piglets (holder of authorisation Aveve NV)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
1,4-beta-xylanase produced by Trichoderma reesei (MULC
49755) and endo-1,3(4)-beta-glucanase produced by
Trichoderma reesei (MULC 49754) for weaned piglets.
The European Food Safety Authority (‘the Authority’)
Having regard to the Treaty on the Functioning of the European
concluded in its opinion of 16 June 2011 ( 3 ) that,
Union,
under the proposed conditions of use, the enzyme prep
aration 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)
Having regard to Regulation (EC) No 1831/2003 of the
does not have an adverse effect on animal health, human
European Parliament and of the Council of 22 September
health or the environment, and that the use of that
2003 on additives for use in animal nutrition ( 1 ), and in
preparation can significantly increase the body weight
particular Article 9(2) thereof,
gain and can improve feed to gain ratio in weaned
piglets. The Authority does not consider that there is a
need for specific requirements of post-market moni
toring. It also verified the report on the method
Whereas:
of analysis of the feed additive in feed submitted by
the Reference Laboratory set up by Regulation (EC)
No 1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(6) The
assessment
of
the
enzyme
preparation
of
endo-1,4-
orisation.
beta-xylanase produced by Trichoderma reesei (MULC
49755) and endo-1,3(4)-beta-glucanase produced by
Trichoderma reesei (MULC 49754) shows that the
conditions for authorisation, as provided for in
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
1831/2003, an application was submitted for the auth
Accordingly, the use of this preparation should be auth
orisation of the enzyme preparation of endo-1,4-beta-
orised as specified in the Annex to this Regulation.
xylanase produced by Trichoderma reesei (MULC 49755)
and endo-1,3(4)-beta-glucanase produced by Trichoderma
reesei (MULC 49754). The application was accompanied
by the particulars and documents required pursuant to
(7) The
measures
provided
for
in
this
Regulation
are
in
Article 7(3) of Regulation (EC) No 1831/2003.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
the
authorisation
of
the
enzyme preparation of endo-1,4-beta-xylanase produced
HAS ADOPTED THIS REGULATION:
by Trichoderma reesei (MULC 49755) and endo-1,3(4)-
beta-glucanase produced by Trichoderma reesei (MULC
49754) as a feed additive for weaned piglets, to be clas
sified in the additive category ‘zootechnical additives’.
Article 1
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’, is authorised as an additive in
(4) The
use
of
that
preparation
was
authorised
for
10
years animal nutrition, subject to the conditions laid down in that
for chickens for fattening by Commission Regulation
Annex.
(EC) No 1091/2009 ( 2 ).
Article 2
(5) New
data
were
submitted
in
support
of
the
application
for the authorisation of the enzyme preparation of endo-
This Regulation shall enter into force on the 20th day following
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 ) EFSA Journal 2011;9(6):2278.

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EN
28.10.2011 Official
Journal
of
the
European
Union L
281/15
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 October 2011.
For the Commission
The President
José Manuel BARROSO

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L 281/16
ANNEX
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
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers.
4a9 Aveve
NV Endo-1,4-beta- Additive composition
Piglets
— 4
000
XU — 1.
In
the
directions
for
use
17.11.2021
xylanase
(weaned)
900 BGU
of the additive and
Preparation of endo-1,4-beta-xylanase
premixture, indicate the
EC 3.2.1.8
produced by Trichoderma reesei (MULC
storage temperature,
49755) and endo-1,3(4)-beta-glucanase
storage life, and stability
Endo-1,3(4)-
produced by Trichoderma reesei (MULC
to pelleting.
beta-glucanase
49754) having a minimum activity of:
Off
40 000 XU (1 ) and 9 000 BGU (2 )/g
2. For use in weaned piglets
icial
EC 3.2.1.6
up to approximately
Characterisation of the active substance
35 kg.
Jour
endo-1,4-beta-xylanase produced by
3. For safety: breathing
nal
Trichoderma reesei (MULC 49755) and
protection, glasses and
of
endo-1,3(4)-beta-glucanase produced by
gloves shall be used
the
Trichoderma reesei (MULC 49754)
during handling.
European
Analytical method (3 )
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-β-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)-β-glucanase on a β-glucan
containing substrate.
Characterisation of the active substances in
the feedingstuffs:
— colorimetric method measuring water-
28.10.2011
soluble dye released by action of
endo-1,4-beta-xylanase from dye
cross-linked wheat arabinoxylan
substrate,

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28.10.2011 Off
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 %
— colorimetric method measuring water-
soluble dye released by action of
EN
endo-1,3(4)-beta-glucanase from dye

cross-linked barley betaglucan sub
strate.
(1 ) 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
icial
Jour
nal
of
the
European
Union
L
281/17

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