Commission Regulation (EC) No 1500/2007 of 18 December 2007 of concerning the authorisation of a new use of 6-phytase EC 3.1.3.26 (Ronozyme) as a feed additive (Text with EEA relevance)
Date: 2007-12-18
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, foodstuffs legislation, poultry, zootechnics

L 333/54

EN

Official Journal of the European Union

19.12.2007

COMMISSION REGULATION (EC) No 1500/2007

of 18 December 2007

of concerning the authorisation of a new use of 6-phytase EC 3.1.3.26 (Ronozyme) as a feed
additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

salmonids
521/2005 (3).

by

Commission

Regulation

(EC) No

Having regard to the Treaty
Community,

establishing the European

(5)

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 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
6-phytase EC 3.1.3.26 (Ronozyme) produced by Asper-
gillus oryzae (DSM 14223), as a feed additive for ducks, to
category ‘zootechnical
be
additive
additives’.

classified in the

The use of the preparation of 6-phytase EC 3.1.3.26
(DSM 14223) was
produced by Aspergillus
authorised without
for
time
fattening, laying hens, turkeys for fattening, piglets, pigs
for fattening and sows by Commission Regulation (EC)
No 255/2005 (2)
authorised for

and provisionally

chickens

oryzae

limit

for

a

(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 45, 16.2.2005, p. 3.

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 6-phytase EC 3.1.3.26
(Ronozyme) produced by Aspergillus oryzae (DSM 14223)
does not have an adverse effect on animal health, human
health or the environment (4). It further concluded that
the 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 additional
animal category. According to that opinion, the use of
that preparation is efficacious in digestibility of feeding-
stuffs. Authority does not 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 assessment of
the
conditions for authorisation, provided for in Article 5
of Regulation (EC) No 1831/2003,
satisfied.
that preparation should be
the use of
Accordingly,
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.

(3) OJ L 84, 2.4.2005, p. 3. Regulation as amended by Regulation (EC)

No 1812/2005 (OJ L 291, 5.11.2005, p. 18).

(4) Opinion of

the Scientific Panel on additives and products or
feed (FEEDAP) on the safety and
substances used in animal
the enzyme preparation Ronozyme P5000 (CT) and
efficacy of
Ronozyme P20000 (L)
feed additive for ducks
(6-phytase) as
according to Regulation (EC) No 1831/2003. Adopted on 10 July
2007, The EFSA Journal (2007) 519, 1-8.

19.12.2007

EN

Official Journal of the European Union

L 333/55

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

L 333/56

EN

Official Journal of the European Union

19.12.2007

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