Commission Regulation (EC) No 243/2007 of 6 March 2007 concerning the authorisation of 3-phytase (Natuphos) as a feed additive (Text with EEA relevance)
Date: 2007-03-06
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, poultry, swine, veterinary drug, zootechnics

L 73/4

EN

Official Journal of the European Union

13.3.2007

COMMISSION REGULATION (EC) No 243/2007

of 6 March 2007

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

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) 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)

(4)

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 authorisation of
the enzyme
preparation 3-phytase produced by Aspergillus niger (CBS
101.672)
fattening, and
chickens for fattening to be classified in the additive
category ‘zootechnical additives’.

for weaned piglets, pigs for

The European Food Safety Authority (the Authority)
concluded in its opinions of 15 June 2006 and of
17 May 2006 that 3-phytase produced by Aspergillus niger
(CBS 101.672) does not have an adverse effect on animal
health, human health or the environment (2). It further

concluded that the enzyme preparation 3-phytase produced
by Aspergillus niger (CBS 101.672) does not present any
other risk which would, in accordance with Article 5(2) of
Regulation (EC) No 1831/2003, exclude authorisation. The
opinion of the Authority recommends appropriate mea-
sures for user safety. It does not consider that there is a need
for specific requirements of post market monitoring. This
opinion also verifies 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. The assessment of that preparation shows that 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.

(5)

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

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.

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

(1) OL 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) 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. Adopted by FEEDAP Panel on 15 June 2006 and by the GMO
Panel on 17 May 2006. The EFSA Journal (2006) 369, p. 1.

Identi-fication
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.

4a 1600

BASF Aktienge-
sellschaft

3-phytase
EC 3.1.3.8
(Natuphos 5 000 G
Natuphos 5 000 L
Natuphos 10 000 G
Natuphos 10 000 L)

Additive composition
3-phytase produced
by Aspergillus niger (CBS 101.672)
having a minimum activity of:
Solid form: 5 000 FTU/g
Liquid form: 5 000 FTU/ml

ANNEX

Species or
category of
animal

Maximum age

Minimum
content

Maximum
content

Unit of activity/kg of complete
feedingstuff with a moisture
content of 12 %

Piglets
(weaned)

—

500 FTU

Characterisation of the active sub-
stance
3-phytase produced
by Aspergillus niger (CBS 101.672)

Analytical method (1)
Colorimetric method measuring inor-
ganic phosphate released by the enzyme
from phytate substrate.

Pigs for fat-
tening

280 FTU

Chickens for
fattening

—

375 FTU

(1) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

Other provisions

End of period of
authorisation

2.4.2017

1.

2.

In the directions for use of the
additive and premixture, indicate
the storage temperature, storage
life, and stability to pelleting.
For use in weaned piglets up to
35 kg.

3. Recommended dose per kilo-
gram of complete feedingstuff:
500 FTU.
For use in feed containing more
than 0,23 % phytin bound phos-
phorus.

4.

1.

In the direction of use of the
additive and premixtures, indi-
cate the storage life and stability
in pelleting.

2. Recommended dose per kilo-
gram of complete feedingstuff:
400500 FTU.
For use in feed containing more
than 0,23 % phytin bound
phosphorus.

3.

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 kilo-
gram of complete feedingstuff:
500700 FTU.
For use in feed containing more
than 0,23 % phytin bound
phosphorus.

3.

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