Commission Regulation (EC) No 505/2008 of 6 June 2008 concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive (Text with EEA relevance)
Date: 2008-06-06
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval

7.6.2008

EN

Official Journal of the European Union

L 149/33

COMMISSION REGULATION (EC) No 505/2008

of 6 June 2008

concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

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:

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

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
to this Regulation. That application was accompanied
by the particulars
required under
Article 7(3) of Regulation (EC) No 1831/2003.

and documents

the

that

enzyme

New data were submitted in support of the application
for authorisation for sows. The European Food Safety
Authority (‘the Authority’) concluded in its opinion of
2006 (5)
15
June
preparation
Natuphos
(3-phytase) produced by Aspergillus niger
(CBS 101.672) does not have an adverse effect on
consumers, users or the environment and that it is effi-
cacious in improving digestibility of feedingstuffs. In its
opinion of 12 December 2007 (6)
the Authority
concluded that the use of that preparation is safe for
sows. 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.

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

(6)

(7)

HAS ADOPTED THIS REGULATION:

The application concerns authorisation of a new use of
the enzyme preparation 3-phytase (Natuphos 5000,
Natuphos 5000 G, Natuphos 5000 L, Natuphos
10000 G and Natuphos 10000 L) produced by Asper-
gillus niger (CBS 101.672) as a feed additive for sows, to
category ‘zootechnical
be
additive
additives’.

classified in the

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.

The use of that preparation was authorised for weaned
piglets, pigs for fattening and chickens for fattening by
Commission Regulation (EC) No 243/2007 (2), for laying
hens and turkeys for fattening by Commission Regu-
lation (EC) No 1142/2007 (3)
and for ducks by
Commission Regulation (EC) No 165/2008 (4).

(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 73, 13.3.2007, p. 4.
(3) OJ L 256, 2.10.2007, p. 20.
(4) OJ L 50, 23.2.2008, p. 8.

Article 2

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

(5) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed and of
the Scientific Panel on
Genetically Modified Organisms on the safety and efficacy of the
enzyme preparation Natuphos (3-phytase) produced by Aspergillus
niger. The EFSA Journal (2006) 369, 1-19.

(6) Scientific Opinion of

Substances used in Animal Feed on ‘Safety of
preparation of Natuphos (3-phytase)
(2007) 614, 1-5.

the Panel on Additives and Products or
the enzymatic
for sows’. The EFSA Journal

(1)

(2)

(3)

(4)

L 149/34

EN

Official Journal of the European Union

7.6.2008

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

Done at Brussels, 6 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

7.6.2008

EN

Official Journal of the European Union

L 149/35

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