Commission Regulation (EC) No 537/2007 of 15 May 2007 concerning the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm) as a feed additive (Text with EEA relevance)
Date: 2007-05-15
Institutions: European Commission
Subjects: animal feedingstuffs, dairy cow, food additive, foodstuffs legislation, zootechnics

16.5.2007

EN

Official Journal of the European Union

L 128/13

COMMISSION REGULATION (EC) No 537/2007

of 15 May 2007

concerning the authorisation of

the fermentation product of Aspergillus oryzae (NRRL 458)
(Amaferm) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 provides for the author-
isation 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 author-
isation 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 the fermen-
458
tation
(Amaferm), as a feed additive for dairy cows, to be clas-
sified in the additive category ‘zootechnical additives’.

of Aspergillus

oryzae NRRL

product

The European Food Safety Authority (the Authority)
concluded in its opinion of 8 March 2006 that
the
fermentation product of Aspergillus oryzae NRRL 458
(Amaferm) does not have an adverse effect on animal

(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).

that

health, human health or the environment (2). It further
concluded that
fermentation product does not
present any other risk which would, in accordance with
Article 5(2) of Regulation (EC) No 1831/2003, exclude
authorisation. Amaferm has shown to produce positive
effects on milk yield of dairy cows. The opinion of the
Authority recommends appropriate measures for user
safety.
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.

It does not consider 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

(5)

(6)

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.

(2) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
product ‘Amaferm’ authorised as a feed additive for dairy cows and
cattle
fattening in accordance with Regulation (EC) No
1831/2003 Adopted on 18 March 2006. The EFSA Journal (2006)
337, pp. 1 to 17.

for

L 128/14

EN

Official Journal of the European Union

16.5.2007

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

Done at Brussels, 15 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

16.5.2007

EN

Official Journal of the European Union

L 128/15

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