HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 94/14
EN
Official Journal of the European Union
8.4.2011
COMMISSION REGULATION (EU) No 335/2011
of 7 April 2011
amending Regulation (EC) No 1091/2009 as regards the minimum content of the enzyme
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 in feed for
chickens for fattening
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
European
Food
Safety
Authority
(the
Authority)
concluded in its opinion of 10 November 2010 that
Having regard to the Treaty on the Functioning of the European
the data provided from three trials in chickens for
Union,
fattening do not support the reduction of the
minimum recommended dose from 4 000 XU and 900
Having regard to Regulation (EC) No 1831/2003 of the
BGU/kg feed to 2 000 XU and 450 BGU/kg feed because
European Parliament and of the Council of 22 September
analyses of the feeds showed that the intended doses
2003 on additives for use in animal nutrition ( 1 ), and in
were considerably exceeded. However, the data showed
particular Article 13(3) thereof,
that the product is efficacious at a lower dose than the
Whereas:
one currently authorised. According to the Authority the
data indicates, as an approximation, that 3 000 XU and
(1) The
use
of
endo-1,4-beta-xylanase
produced
by
600 BGU/kg feed has the potential to improve growth
Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-
rate and feed to gain ratio in chickens for fattening ( 5 ).
glucanase produced by Trichoderma reesei (MUCL 49754)
was authorised for 10 years for chickens for fattening by
(4) The
conditions
provided
for
in
Article
5
of
Regulation
Commission Regulation (EC) No 1091/2009 of
(EC) No 1831/2003 are satisfied.
13 November 2009 concerning the authorisation of an
(5) Regulation
(EC)
No
1091/2009
should
therefore
be
enzyme preparation of endo-1,4-beta-xylanase produced
amended accordingly.
by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-
beta-glucanase produced by Trichoderma reesei (MUCL
(6) The
measures
provided
for
in
this
Regulation
are
in
49754) as a feed additive for chickens for fattening
accordance with the opinion of the Standing
(holder of authorisation Aveve NV) ( 2 ).
Committee on the Food Chain and Animal Health,
(2) The
holder
of
the
authorisation
submitted
an
application HAS ADOPTED THIS REGULATION:
for changing the terms of the authorisation of this feed
additive when used in chickens for fattening by reducing
Article 1
the minimum recommended dose of endo-1,4-beta-
xylanase produced by Trichoderma reesei (MUCL 49755)
The Annex to Regulation (EC) No 1091/2009 is replaced by the
and endo-1,3(4)-beta-glucanase produced by Trichoderma
text in the Annex to this Regulation.
reesei (MUCL 49754) from 4 000 XU ( 3 )/kg and 900
Article 2
BGU ( 4 )/kg to 2 000 XU/kg and 450 BGU/kg. That appli
cation was accompanied by the relevant data supporting
This Regulation shall enter into force on the 20th day following
the request for the change.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 April 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 299, 14.11.2009, p. 6.
( 3 ) 1 XU is the amount of enzyme which releases 1 μmol of reducing
sugar (xylose equivalent) per minute from xylan of oat spelt at
pH 5,0 and 50 °C.
( 4 ) 1 BGU is the amount of enzyme which releases 1 μmol of reducing
sugar (cellobiose equivalent) per minute from -glucan of barley at
pH 4,8 and 50 °C.
( 5 ) EFSA Journal 2010; 8(12):1919.

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8.4.2011 Off
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description,
category
Maximum
Other provisions
End of period of
the additive
authorisation
analytical method
of animal
age
Units of activity/kg of
authorisation
complete feedingstuff with a
EN
moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a9 Aveve
NV Endo-1,4-beta-xylanase Additive composition
Chickens for
— 3
000
XU
1. In the directions for use of
4 December
EC 3.2.1.8
Preparation of endo-1,4-beta-xylanase
fattening
675 BGU
the additive and premixture
2019
Endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL
indicate the storage
temperature, storage life,
EC 3.2.1.6
49755) and endo-1,3(4)-beta-
glucanase produced by Trichoderma
and stability to pelleting.
reesei (MUCL 49754)
2. For use in feed rich in non-
having a minimum activity of
starch polysaccharides
40 000 XU/g and 9 000 BGU/g
(mainly beta-glucans and
icial
arabinoxylans), e.g.
Characterisation of the active substance
Jour
containing more than 30 %
endo-1,4-beta-xylanase produced by
wheat, barley, rye and/or
nal
Trichoderma reesei (MUCL 49755) and
triticale.
of
endo-1,3(4)-beta-glucanase produced
the
by Trichoderma reesei (MUCL 49754)
3. For safety reasons: breathing
protection, glasses and
European
gloves shall be used during
Analytical method (1 )
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-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 soluble dye released by
action of endo-1,4-beta-xylanase
from dye cross-linked wheat
arabinoxylan substrate,
L
94/15

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L 94/16
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description,
category
Maximum
Other provisions
End of period of
the additive
authorisation
analytical method
of animal
age
Units of activity/kg of
authorisation
complete feedingstuff with a
moisture content of 12 %
— colorimetric method measuring
EN
water soluble dye released by

action of endo-1,3(4)-beta-
glucanase from dye cross-linked
barley beta-glucan substrate.
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
Off
icial
Jour
nal
of
the
European
Union
8.4.2011

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