Commission Regulation (EC) No 242/2007 of 6 March 2007 concerning the authorisation of endo-1,4-beta xylanase EC 3.2.1.8 (Belfeed B1100MP and Belfeed B1100ML) as a feed additive (Text with EEA relevance)
Date: 2007-03-06
Institutions: European Commission
Subjects: animal nutrition, food additive, poultry, veterinary legislation, zootechnics

13.3.2007

EN

Official Journal of the European Union

L 73/1

I

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)

REGULATIONS

COMMISSION REGULATION (EC) No 242/2007

of 6 March 2007

concerning the authorisation of endo-1,4-beta xylanase EC 3.2.1.8 (Belfeed B1100MP and Belfeed
B1100ML) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Commu-
nity,

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisa-
tion of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.

(2)

(3)

In accordance with Article 7 of Regulation (EC) No 1831/
2003, an application was submitted for the authorisation of
the preparation set out in the Annex. That application was
accompanied by the particulars and documents required
under Article 7(3) of that Regulation.

The application concerns a new use of the preparation of
endo-1,4-beta xylanase EC 3.2.1.8 produced by Bacillus
subtilis (LMG S-15136), as a feed additive for ducks, to be
classified in the additive category ‘zootechnical additives’.

(4)

The method of analysis included in the application for
authorisation in accordance with Article 7(3)(c) of

(1) OJ L 268, 18.10.2003, p. 29. Regulation as amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

therefore not

Regulation (EC) No 1831/2003 concerns the determination
of the active substance of the feed additive in feed. The
method of analysis referred to in the Annex to this
Regulation is
to be understood as a
Community method of analysis within the meaning of
Article 11 of Regulation (EC) No 882/2004 of
the
European Parliament and of
the Council of 29 April
2004 on official controls performed to ensure the
verification of compliance with feed and food law, animal
health and animal welfare rules (2).

(5)

The use of endo-1,4-beta xylanase EC 3.2.1.8 produced by
Bacillus subtilis (LMG S-15136) was authorised without a
time limit for piglets (weaned) by Commission Regulation
(EC) No 1206/2005 (3) and for chickens for fattening by
Commission Regulation (EC) No 1259/2004 (4). New data
were submitted in support of an application for authorisa-
tion for ducks. The European Food Safety Authority (the
Authority) concluded in its opinion of 15 June 2006 (5)
that the safety of this additive for the consumer, the user
and the environment have already been established and will
not be changed by the proposed new use.
further
concluded, that the use of the preparation does not have an
adverse effect on this additional animal category and that
the use of that preparation can improve the zootechnical
parameters in ducks. The 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
the feed additive in feed submitted by the
analysis of

It

(2) OJ L 165, 30.4.2004, p. 1; corrected by OJ L 191, 28.5.2004, p. 1.
Regulation as last amended by Council Regulation (EC) No 1791/
2006 (OL L 363, 20.12.2006, p. 1).

(3) OJ L 197, 28.7.2005, p. 12.
(4) OJ L 239, 9.7.2004, p. 8.
(5) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
enzyme preparation Belfeed B1100MP and belfeed B1100ML (endo-
1-4-beta xylanase) authorised as a feed additive in accordance with
Council Directive 70/524/EEC. Adopted on 15 June 2006. The EFSA
Journal (2006) 368, 1.

L 73/2

EN

Official Journal of the European Union

13.3.2007

Community Reference Laboratory set up by Regulation (EC)
No 1831/2003.

HAS ADOPTED THIS REGULATION:

(6)

that preparation shows

The assessment of
the
conditions for authorisation, provided for in Article 5 of
Regulation (EC) No 1831/2003, are satisfied. Accordingly,
the use of
that preparation should be authorised, as
specified in the Annex to this Regulation.

that

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 animal
nutrition subject to the conditions laid down in that Annex.

(7)

The measures provided for
in this Regulation are in
accordance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

Article 2

This Regulation shall enter into force on the 20th day following
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, 6 March 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

ANNEX

Species or
category of
animal

Maximum
age

Minimum
content

Maximum
content

Units of activity/kg of com-
plete feedingstuff with a
moisture content of 12 %

Ducks

—

10 IU

—

Identification
number of the
additive

Name of the holder of
authorisation

Additive (trade name)

Composition, chemical formula, description,
analytical method

Category of zootechnical additives. Functional group: digestibility enhancers.

4a1606

Beldem SA

endo-1,4-beta-
xylanase
EC 3.2.1.8
(Belfeed B1100MP
Belfeed B1100ML)

Additive composition
Preparation of endo-1,4-beta- xylanase
EC 3.2.1.8 having a minimum of activity
solid and liquid form 100 IU (1) /g or ml

Characterisation of the active sub-
stance
endo-1,4-beta-xylanase EC 3.2.1.8 pro-
duced by Bacillus subtilis (LMG S-15136)

Analytical method (2)
Colorimetric method measuring water
soluble dye released by the enzyme from
azurine crosslinked wheat arabinoxylan
substrate

(1) One IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 oC.
(2) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

.

.

1
3
3
2
0
0
7

Other provisions

End of period of
authorisation

1.

In the directions for use of the
additive and premixture, indicate
the storage temperature, storage
life and stability to pelleting.
2. Recommended dose per kg of
endo-

complete
feedingstuffs:
1,4-beta-xylanase: 10 IU
For use in compound feed rich
in non-starch polysaccharides
(mainly arabinoxylans), e.g. con-
taining more than 40 % wheat.
If
is handled or
mixed in a confined atmosphere,
it is recommended to use safety
glasses and masks for mixing if
the mixers are not equipped with
exhaust systems.

the product

3.

4.

2.4.2017

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