HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 347/12
EN
Official Journal of the European Union
15.12.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1206/2012
of 14 December 2012
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus
oryzae (DSM 10287) as a feed additive for poultry for fattening, weaned piglets and pigs for
fattening and amending Regulations (EC) No 1332/2004 and (EC) No 2036/2005 (holder of the
authorisation DSM Nutritional Products)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 12 June 2012 ( 5 ) that,
under the proposed conditions of use, the preparation
Having regard to the Treaty on the Functioning of the European
of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by
Union,
Aspergillus oryzae (DSM 10287), does not have an
adverse effect on animal health, human health or the
environment, and that it has a potential to favourably
Having regard to Regulation (EC) No 1831/2003 of the
affect animal performance in chickens for fattening,
European Parliament and of the Council of 22 September
turkeys for fattening and ducks for fattening. This
2003 on additives for use in animal nutrition ( 1 ), and in
conclusion can be extrapolated to all minor poultry
particular Article 9(2) thereof,
species for fattening. It is also concluded that the
additive has the potential to favourably affect animal
performance in piglets and pigs for fattening. The
Whereas:
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
additive in feed submitted by the Reference Laboratory
orisation of additives for use in animal nutrition and
set up by Regulation (EC) No 1831/2003.
for the grounds and procedures for granting such auth
orisation. Article 10 of that Regulation provides for the
(5) The assessment of the preparation of endo-1,4-beta-
re-evaluation of additives authorised pursuant to Council
xylanase (EC 3.2.1.8) produced by Aspergillus oryzae
Directive 70/524/EEC ( 2 ).
(DSM 10287) shows that the conditions for authori
sation, as provided for in Article 5 of Regulation (EC)
No 1831/2003, are satisfied. Accordingly, the use of that
(2) A
preparation
of
endo-1,4-beta-xylanase
(EC
3.2.1.8)
preparation should be authorised as specified in the
produced by Aspergillus oryzae (DSM 10287) was auth
Annex to this Regulation.
orised without a time limit in accordance with Directive
70/524/EEC as a feed additive for use on chickens for
(6)
As a consequence of the granting of a new authorisation
fattening, turkeys for fattening and piglets by
under Regulation (EC) No 1831/2003, Regulations (EC)
Commission Regulation (EC) No 1332/2004 ( 3 ) and
No 1332/2004 and (EC) No 2036/2005 should therefore
authorised for four years for pigs for fattening and
be amended accordingly.
ducks by Commission Regulation (EC) No 2036/2005 ( 4 ).
That preparation was subsequently entered in the
Register of feed additives as an existing product,
(7)
Since safety reasons do not require the immediate appli
in accordance with Article 10(1) of Regulation (EC)
cation of the modifications to the conditions of auth
No 1831/2003.
orisation, it is appropriate to allow a transitional period
for interested parties to prepare themselves to meet the
new requirements resulting from the authorisation.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that Regu
(8) The
measures
provided
for
in
this
Regulation
are
in
lation, an application was submitted for the re-evaluation
accordance with the opinion of the Standing
of that preparation of endo-1,4-beta-xylanase (EC
Committee on the Food Chain and Animal Health,
3.2.1.8) produced by Aspergillus oryzae (DSM 10287), as
a feed additive for chickens and turkeys for fattening,
HAS ADOPTED THIS REGULATION:
weaned piglets, pigs for fattening and ducks and, in
accordance with Article 7 of that Regulation, for a new
Article 1
use for all poultry species for fattening, requesting that
additive to be classified in the additive category ‘zoo
Authorisation
technical additives’. That application was accompanied
by the particulars and documents required under
The preparation specified in the Annex, belonging to the
Article 7(3) of Regulation (EC) No 1831/2003.
additive category ‘zootechnical additives’ and to the functional

group ‘digestibility enhancers’, is authorised as an additive in
animal nutrition, subject to the conditions laid down in that
( 1 ) OJ L 268, 18.10.2003, p. 29.
Annex.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 247, 21.7.2004, p. 8.
( 4 ) OJ L 328, 15.12.2005, p. 13.
( 5 ) EFSA Journal 2012; 10(7):2790.

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EN
15.12.2012 Official
Journal
of
the
European
Union L
347/13
Article 2
Article 3
Amendments to Regulation (EC) No 1332/2004
Amendment to Regulation (EC) No 2036/2005
Regulation (EC) No 1332/2004 is amended as follows:
In Annex III to Regulation (EC) No 2036/2005, the entry for
No 5, Endo-1,4-beta-xylanase EC 3.2.1.8, is deleted.
Article 4
(1) Article 1 is replaced by the following:
Transitional measures
The preparation specified in the Annex and feed containing that
‘Article 1
preparation, which are produced and labelled before 4 July
2013 in accordance with the rules applicable before 4 January
The preparation belonging to the group ‘Enzymes’, as set
2013 may continue to be placed on the market and used until
out in Annex II, is authorised for use without a time limit as
the existing stocks are exhausted.
additive in animal nutrition under the conditions laid down
in that Annex.’;
Article 5
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
(2) Annex I is deleted.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 December 2012.
For the Commission
The President
José Manuel BARROSO

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L 347/14
ANNEX
Minimum
Maximum
content
content
Identification
Species or
number of the Name of the holder
category of
Maximum
Units of activity/kg of
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description, analytical
method
animal
age
authorisation
complete feedingstuff
EN
with a moisture content

of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a1607 DSM
Nutritional
Endo-1,4-
Additive composition
Poultry for
— 100
FXU
— 1.
In
the
directions
for
use
of
the
4 January 2023
Products
beta-xylanase
fattening
additive and premixture, indicate
Preparation of endo-1,4-beta-xylanase
the storage temperature, storage life
EC 3.2.1.8
produced by Aspergillus oryzae (DSM 10287)
and stability to pelleting.
having a minimum activity of:
Piglets
200 FXU
(weaned)
2. Recommended maximum dose per
Off
Solid form: 1 000 FXU (1 )/g
kilogram of complete feedingstuff
Pigs for
icial
for:
Liquid form: 650 FXU/ml
fattening
Jour
— poultry for fattening: 200 FXU
nal
Characterisation of the active substance
— piglets (weaned): 400 FXU
of
endo-1,4-beta-xylanase produced by
— pigs for fattening: 200 FXU.
the
Aspergillus oryzae (DSM 10287)
3. For use in feed rich in non-starch
European
polysaccharides (mainly arabin
Analytical method (2 )
oxylans)
For quantification of endo-1,4-beta-xylanase
4. For use in weaned piglets up to
Union
produced by Aspergillus oryzae (DSM 10827)
approximately 35 kg.
in a feed additive:
5. For safety: breathing protection and
Colorimetric method measuring water soluble
gloves shall be used during handling.
dyed fragments released by endo-1,4-beta-
xylanase from azo-wheat-arabinoxylan
substrate dyed with remazol-brilliant blue.
For quantification of endo-1,4-beta-xylanase
produced by Aspergillus oryzae (DSM
10827) in premixtures and feedingstuffs:
Colorimetric method measuring water soluble
dyed fragments released by endo-1,4-beta-
xylanase from azurin-cross linked wheat
arabinoxylan substrate.
(
15.12.2012
1 ) 1 FXU is the amount of enzyme which liberates 7,8 micromole of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.
(2 ) 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

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