Commission Regulation (EC) No 165/2008 of 22 February 2008 concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive (Text with EEA relevance)
Date: 2008-02-22
Institutions: European Commission
Subjects: food additive, market approval, poultry, veterinary inspection, zootechnics

L 50/8

EN

Official Journal of the European Union

23.2.2008

COMMISSION REGULATION (EC) No 165/2008

of 22 February 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

Having regard to Regulation (EC) No 1831/2003 of
the
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:

(1)

(2)

(3)

(4)

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 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 Aspergillus niger
(CBS 101.672) as a feed additive for ducks, to be clas-
sified in the additive category ‘zootechnical additives’.

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) and for
laying hens and turkeys for fattening by Commission
Regulation (EC) No 1142/2007 (3).

New data were submitted in support of the application
for authorisation for ducks. The European Food Safety
Authority (the Authority) concluded in its opinions of
18 September 2007 that
the enzyme preparation 3-
phytase (Natuphos 5000, Natuphos 5000 G, Natuphos
5000 L, Natuphos 10000 G and Natuphos 10000 L)
produced by Aspergillus niger (CBS 101.672) does not
have an adverse effect on consumers, users or the envi-
ronment (4). According to that opinion, the use of that
preparation does not have an adverse effect on this addi-
tional animal category and it is efficacious in improving
feedingstuffs. The Authority does not
digestibility of
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 additive in feed
submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003.

that preparation shows

the
The assessment of
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
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:

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.

Article 2

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

(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) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on the safety and
efficacy of the enzyme preparation of Natuphos (3-phytase) as a
feed additive for ducks. The EFSA Journal (2007) 544, 1-10.

23.2.2008

EN

Official Journal of the European Union

L 50/9

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

Done at Brussels, 22 February 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 50/10

EN

Official Journal of the European Union

23.2.2008

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