HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 143/6
EN
Official Journal of the European Union
31.5.2011
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 527/2011
of 30 May 2011
concerning the authorisation of a preparation of endo-1,4-β-xylanase produced by Trichoderma
reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and
polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) as feed additive for weaned
piglets (holder of the authorisation Aveve NV)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
2 February 2011 ( 3 ) that the preparation set out in the
Annex, under the proposed conditions of use, does not
have an adverse effect on animal health, consumer health
or the environment, and that this additive has the
Having regard to the Treaty on the Functioning of the European
potential to increase the body weight and feed to gain
Union,
ratio in the target species. The Authority does not
consider that there is a need for specific requirements
of post-market monitoring. It also verified the report
Having regard to Regulation (EC) No 1831/2003 of the
on the method of analysis of the feed additive in feed
European Parliament and of the Council of 22 September
submitted by the Reference Laboratory for Feed Additives
2003 on additives for use in animal nutrition (
set up by Regulation (EC) No 1831/2003.

1 ), and in
particular Article 9(2) thereof,
(5)
The assessment of the preparation set out in the Annex
Whereas:
shows that the conditions for authorisation, as provided
for in Article 5 of Regulation (EC) No 1831/2003, are
satisfied. Accordingly, the use of this preparation should
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au
be authorised as specified in the Annex to this Regu
thorisation of additives for use in animal nutrition and
lation.
for the grounds and procedures for granting such au
thorisation.
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for the au
Committee on the Food Chain and Animal Health,
thorisation of the preparation of endo-1,4-β-xylanase
(EC 3.2.1.8) produced by Trichoderma reesei (MUCL
49755), endo-1,3(4)-β-glucanase (EC 3.2.1.6) produced
by Trichoderma reesei (MUCL 49754) and polygalactu
HAS ADOPTED THIS REGULATION:
ronase (EC 3.2.1.15) produced by Aspergillus aculeatus
(CBS 589.94), as set out in the Annex. That application
was accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No
1831/2003.
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
(3) The
application
concerns
the
authorisation
of
the
prep
animal nutrition subject to the conditions laid down in that
aration set out in the Annex as a feed additive for
Annex.
weaned piglets, to be classified in the additive category
‘zootechnical additives’.
Article 2
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinions of 8 July 2009 ( 2 ) and
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 ) The EFSA Journal (2009) 1186, 1-17.
( 3 ) EFSA Journal (2011); 9(2):2010.

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EN
31.5.2011 Official
Journal
of
the
European
Union L
143/7
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 May 2011.
For the Commission
The President
José Manuel BARROSO

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L 143/8
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
Units of activity/kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a 14 Aveve
NV Endo-1,4-β-xylanase
Additive composition
Piglets
Endo-1,4-β-
— 1.
In
the
directions
for
use
20 June 2021
EC 3.2.1.8
(weaned)
xylanase:
of the additive and
Preparation of endo-1,4-β-xylanase (EC
2 140 XU
premixture, indicate the
Endo-1,3(4)-β-
3.2.1.8) produced by Trichoderma reesei
storage temperature,
glucanase
(MUCL 49755), endo-1,3(4)-β-glucanase
Endo-1,3(4)-
storage life, and stability
Off
EC 3.2.1.6
(EC 3.2.1.6) produced by Trichoderma
β-glucanase:
to pelleting.
icial
Polygalacturonase
reesei (MUCL 49754) and polygalactu
1 230 BGU
EC 3.2.1.15
ronase (EC 3.2.1.15) produced by Asper
2. For piglets (weaned) up to
Jour
gillus aculeatus (CBS 589.94) having a
Polygalactu
35 kg.
minimum activity of:
ronase: 46
nal
PGLU
3. For use in compound feed
solid form:
rich in non-starch polysac
of
charides.
the
Endo-1,4-β-xylanase: 21 400 XU (1 )/g
European
Endo-1,3(4)-β-glucanase: 12 300 BGU (2 )/g
Polygalacturonase: 460 PGLU (3 )/g.
Union
liquid form:
Endo-1,4-β-xylanase: 10 700 XU/g
Endo-1,3(4)-β-glucanase: 6 150 BGU/g
Polygalacturonase: 230 PGLU/g.
Characterisation of the active substance
Endo-1,4-β-xylanase (EC 3.2.1.8)
produced by Trichoderma reesei, endo-
1,3(4)-β-glucanase (EC 3.2.1.6) produced
by Trichoderma reesei and polygalacturonase
(EC 3.2.1.15) produced by Aspergillus
aculeatus
Method of Analysis (4 )
31.5.2011
Characterisation of the active substances in
the additive and feedingstuffs:

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31.5.2011 Off
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
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-1,4-β-xylanase from dye cross-

linked wheat arabinoxylan substrate,
— colorimetric method measuring water
soluble dye released by action of
endo-1,3(4)-β-glucanase from dye
cross-linked barley betaglucan
substrate,
— viscosimetric method based on a
decrease of viscosity produced by
action of polygalacturonase on the
icial
pectin-containing substrate, poly
methylgalacturonic acid.
Jour
(1 ) 1 XU is the amount of enzyme which releases 1 μmol of reducing sugar (xylose equivalent) per minute from xylan of oat spelt at 50 °C and pH 4,8.
nal
(2 ) 1 BGU is the amount of enzyme which releases 1 μmol of reducing sugar (cellobiose equivalent) per minute from β-glucan of barley at 50 °C and pH 5,0.
of
(3 ) 1 PGLU is the amount of enzyme which releases 1 μmol of reducing sugar (glucose equivalent) per minute from polymethylgalacturonic acid (pectin containing substrate) at 35 °C and pH 4,8.
(4 ) 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
the
European
Union
L
143/9

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