HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 121/26
EN
Official Journal of the European Union
3.5.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 403/2013
of 2 May 2013
concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase
and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for
poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No
1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional
Products)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
a new use for all poultry species for fattening and laying,
requesting that additive to be classified in the additive
category ‘zootechnical additives’. That application was
Having regard to the Treaty on the Functioning of the European
accompanied by the particulars and documents required
Union,
under Article 7(3) of Regulation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
European Parliament and of the Council of 22 September
concluded in its opinion of 17 October 2012 ( 6 ) that,
2003 on additives for use in animal nutrition (
under the proposed conditions of use, the preparation

1 ), and in
particular Article 9(2) thereof,
of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase
and endo-1,4-beta-glucanase produced by Trichoderma
reesei (ATCC 74444) does not have an adverse effect
Whereas:
on animal health, human health or the environment,

and that it has a potential to favourably affect animal
performance in target species. However, based on the
incomplete information provided by the applicant, the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Authority was not in a position to specify the
orisation of additives for use in animal nutrition and
minimum enzyme activities. The Authority does not
for the grounds and procedures for granting such auth
consider that there is a need for specific requirements
orisation. Article 10 of that Regulation provides for the
of post-market monitoring. It also verified the report
re-evaluation of additives authorised pursuant to Council
on the method of analysis of the feed additive in feed
Directive 70/524/EEC ( 2 ).
submitted by the Reference Laboratory set up by Regu
lation (EC) No 1831/2003.
(2) A
preparation
of
endo-1,4-beta-xylanase,
endo-1,3(4)-
beta-glucanase and endo-1,4-beta-glucanase produced
(5) The assessment of the preparation of endo-1,4-beta-
by Trichoderma longibrachiatum (ATCC 74252) was auth
xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-
orised without a time limit in accordance with Directive
glucanase produced by Trichoderma reesei (ATCC 74444)
70/524/EEC as a feed additive for use on chickens for
shows that the conditions for authorisation, as provided
fattening by Commission Regulation (EC) No
for in Article 5 of Regulation (EC) No 1831/2003, are
1259/2004 ( 3 ), on turkeys for fattening by Commission
satisfied. Accordingly, the use of that preparation should
Regulation (EC) No 1206/2005 ( 4 ), and on laying hens
be authorised as specified in the Annex to this Regu
and weaned piglets by Commission Regulation (EC) No
lation.
1876/2006 ( 5 ). That preparation was subsequently
entered in the Register of feed additives as an existing
product, in accordance with Article 10(1) of Regulation
(6)
As a new authorisation is granted in accordance with
(EC) No 1831/2003.
Regulation (EC) No 1831/2003, Regulations (EC) No
1259/2004, (EC) No 1206/2005 and (EC) No
1876/2006 should therefore be amended accordingly.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
(7)
Since safety reasons do not require the immediate appli
of that preparation of endo-1,4-beta-xylanase, endo-
cation of the modifications to the conditions of auth
1,3(4)-beta-glucanase and endo-1,4-beta-glucanase
orisation, it is appropriate to allow a transitional period
produced by Trichoderma reesei (ATCC 74444) (formerly
for interested parties to prepare themselves to meet the
ATCC 74252), as a feed additive for chickens for
new requirements resulting from the authorisation.
fattening, turkeys for fattening, laying hens and piglets
and, in accordance with Article 7 of that Regulation, for
(8) The
measures
provided
for
in
this
Regulation
are
in
( 1 ) OJ L 268, 18.10.2003, p. 29.
accordance with the opinion of the Standing
( 2 ) OJ L 270, 14.12.1970, p. 1.
Committee on the Food Chain and Animal Health,
( 3 ) OJ L 239, 9.7.2004, p. 8.
( 4 ) OJ L 197, 28.7.2005, p. 12.
( 5 ) OJ L 360, 19.12.2006, p. 126.
( 6 ) EFSA Journal 2012; 10(11):2930.

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EN
3.5.2013 Official
Journal
of
the
European
Union L
121/27
HAS ADOPTED THIS REGULATION:
Article 3
Amendment to Regulation (EC) No 1206/2005
Article 1
In the Annex to Regulation (EC) No 1206/2005 all the data
Authorisation
contained in the entry E1602 are deleted.
The preparation specified in the Annex, belonging to the
Article 4
additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’, is authorised as an additive in
Amendments to Regulation (EC) No 1876/2006
animal nutrition, subject to the conditions laid down in that
Annex.
Regulation (EC) No 1876/2006 is amended as follows:
1. Article 3 is deleted;
Article 2
2. Annex III is deleted.
Amendments to Regulation (EC) No 1259/2004
Article 5
Regulation (EC) No 1259/2004 is amended as follows:
Transitional measures
1. Article 2 is replaced by the following:
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before
‘Article 2
23 November 2013 in accordance with the rules applicable
before 23 May 2013, may continue to be placed on the
The preparations belonging to the group “Enzymes”, as set
market and used until the existing stocks are exhausted.
out in Annexes III, IV, V and VI are authorised for use
without a time limit as additives in animal nutrition under
Article 6
the conditions laid down in those Annexes.’;
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
2. Annex II is deleted.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 May 2013.
For the Commission
The President
José Manuel BARROSO

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L 121/28
ANNEX
Minimum content
Maximum
content
Identification
Species or
number of the Name of the holder
category of
Maximum
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
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
4a1602i DSM
Nutritional Endo-1,4-beta- Additive composition
Poultry for
— endo-1,4-beta- — 1.
In
the
directions
for
use
of
the
23 May 2023
Products
xylanase
fattening
xylanase:
additive and premixture,
Preparation of endo-1,4-beta-xylanase,
other than
135 U
indicate the storage
EC 3.2.1.8
endo-1,3(4)-beta-glucanase and endo-1,4- turkeys for
temperature, storage life and
Endo-1,3(4)-
beta-glucanase, produced by Trichoderma
fattening
endo-1,3(4)-
stability to pelleting.
beta-glucanase reesei (ATCC 74444) having a minimum
beta-glucanase:
activity of:
35 U
2. For use in feed rich in non-
Off
EC 3.2.1.6
starch polysaccharides (mainly
icial
Endo-1,4-beta- endo-1,4-beta-xylanase 2 700 U (1 )/ml or g
endo-1,4-beta-
beta-glucans and arabinoxylans).
glucanase
additive
glucanase:
3. For use in weaned piglets up to
Jour
40 U
EC 3.2.1.4
endo-1,3(4)-beta-glucanase 700 U (2 )/ml or
35 kg.
nal
g additive
Poultry for
endo-1,4-beta-
4. For safety: breathing protection
of
endo-1,4-beta-glucanase 800 U (3 )/ml or g laying
xylanase:
and gloves shall be used during
the
additive
216 U
handling.
European
(Liquid and solid form)
endo-1,3(4)-
beta-glucanase:
56 U
Union
endo-1,4-beta-
glucanase:
Characterisation of the active substance
64 U
endo-1,4-betaxylanase, endo-1,4-betag
Turkeys for
endo-1,4-beta-
lucanase and endo-1,3(4)-betaglucanase,
fattening
xylanase:
produced by Trichoderma reesei (ATCC
270 U
74444)
Piglets
(weaned)
endo-1,3(4)-
beta-glucanase:
70 U
endo-1,4-beta-
Analytical method (4 )
glucanase:
Characterisation of the active substances in
80 U
the feedingstuff:
— Colorimetric method measuring water
3.5.2013
soluble dye released by the action of
endo-1,4-beta-xylanase from cross-
linked birchwood azoxylan substrate

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3.5.2013 Off
Minimum content
Maximum
content
Identification
Species or
number of the Name of the holder
category of
Maximum
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
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 the action of
EN
endo-1,3(4)-beta-glucanase from cross-

linked azobarley glucan substrate
— Colorimetric method measuring water
soluble dye released by the action of
endo-1,4-beta-glucanase from cross-
linked azocarboxymethylcellulose
substrate.
(1 ) 1 U is the amount of enzyme which liberates 1 micromoles of glucose from wheat arabinoxylan per minute at pH 5,0 and 40 °C.
(2 ) 1 U is the amount of enzyme which liberates 1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.
(3 ) 1 U is the amount of enzyme which liberates 1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.
icial
(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
Jour
nal
of
the
European
Union
L
121/29

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Document Outline

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