Commission Regulation (EC) No 1501/2007 of 18 December 2007 concerning the authorisation of a new use of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (Text with EEA relevance)
Date: 2007-12-18
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, foodstuffs legislation, poultry, zootechnics

19.12.2007

EN

Official Journal of the European Union

L 333/57

COMMISSION REGULATION (EC) No 1501/2007

of 18 December 2007

concerning the authorisation of a new use of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a
feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

ten years for piglets (weaned) by Commission Regulation
(EC) No 497/2007 (5).

Having regard to the Treaty
Community,

establishing the European

(5)

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

Whereas:

Regulation (EC) No 1831/2003 provides for the autho-
risation of additives for use in animal nutrition and for
the grounds and procedures for granting such authori-
sation.

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

The application concerns a new use of the preparation of
by
endo-1,4-beta-xylanase
Trichoderma longibrachiatum (CNCM MA 6-10)
(Safizym
X), as a feed additive for ducks, to be classified in the
additive category ‘zootechnical additives’.

produced

3.2.1.8

EC

(6)

(7)

(1)

(2)

(3)

(4)

It

further

environment (6).

New data were submitted in support of an application
for authorisation for ducks. The European Food Safety
Authority (the Authority) concluded in its opinion of
10 July 2007 that
the preparation of endo-1,4-beta-
xylanase EC 3.2.1.8 produced by Trichoderma longibra-
(Safizym X) does not have
chiatum (CNCM MA 6-10)
an adverse effect on animal health, human health or
the
that
preparation does not present any other
risk which
would,
in accordance with Article 5(2) of Regulation
(EC) No 1831/2003, exclude authorisation for this addi-
tional animal category. According to that opinion, the
use of that preparation is efficacious in digestibility of
feedingstuffs. The Authority does not consider that there
is a need for specific requirements of post market moni-
toring.
It also verified the report on the method of
analysis of the feed additive in feed submitted by the
Community Reference Laboratory set up by Regulation
(EC) No 1831/2003.

concluded that

that preparation shows

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

that

are

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

opinion

the

the

of

The use of the preparation of endo-1,4-beta-xylanase EC
3.2.1.8 produced by Trichoderma longibrachiatum (CNCM
MA 6-10) was authorised without a time limit
for
chickens for fattening by Commission Regulation (EC)
No 1453/2004 (2), without a time limit for turkeys for
(EC) No
fattening
943/2005 (3), without a time limit for laying hens by
Commission Regulation (EC) No 1810/2005 (4) and for

Commission

Regulation

by

HAS ADOPTED THIS REGULATION:

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.

(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).

(2) OJ L 269, 17.8.2004, p. 3.
(3) OJ L 159, 22.6.2005, p. 6.
(4) OJ L 291, 5.11.2005, p. 5. Regulation as amended by Regulation

(EC) No 184/2007 (OJ L 63, 1.3.2007, p. 1).

(5) OJ L 117, 5.5.2007, p. 11.
(6) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
enzyme preparation Safizym X (endo-1,4-beta-xylanase) as feed
in accordance with Regulation (EC) No
additive
1831/2003. Adopted on 10 July 2007 The EFSA Journal
(2007)
520, 1-8.

for ducks

L 333/58

EN

Official Journal of the European Union

19.12.2007

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 2

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 December 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

19.12.2007

EN

Official Journal of the European Union

L 333/59

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