Commission Regulation (EC) No 1141/2007 of 1 October 2007 concerning the authorisation of 3-phytase (ROVABIO PHY AP and ROVABIO PHY LC) as a feed additive (Text with EEA relevance)
Date: 2007-10-01
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, poultry, swine, zootechnics

2.10.2007

EN

Official Journal of the European Union

L 256/17

COMMISSION REGULATION (EC) No 1141/2007

of 1 October 2007

concerning the authorisation of 3-phytase (ROVABIO PHY AP and ROVABIO PHY LC) 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

authorisation of

application concerns

The
the
preparation of 3-phytase produced by Penicillium funi-
culosum (CBS 111 433)
and
ROVABIO PHY LC), as a feed additive for chickens for
laying hens, piglets (weaned) and pigs for
fattening,
fattening to be
category
‘zootechnical additives’.

(ROVABIO PHY AP

classified in the

additive

The European Food Safety Authority (the Authority)
concluded in its opinion of 17 April 2007 and 22
the preparation 3-phytase produced
March 2007 that
by Penicillium funiculosum (CBS 111 433)
(ROVABIO

(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).

It

further

PHY AP and ROVABIO PHY LC) does not have an
adverse effect on animal health, human health or the
environment (2).
that
that
concluded
preparation 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 measures 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
the
analysis of
Community Reference Laboratory set up by Regulation
(EC) No 1831/2003.

submitted

additive

feed

the

by

(5)

(6)

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

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 and the Scientific Panel on
Genetically Modified Organisms on the safety and efficacy of the
enzyme preparation of 3-phytase produced by Penicillium funiculosum
(CBS 111 433) (ROVABIO PHY AP and ROVABIO PHY LC), as a
feed additive for chickens for fattening, laying hens, piglets (weaned)
and pigs for fattening in accordance with Regulation (EC) No
1831/2003. Adopted on 17 April 2007 and 22 March 2007. The
EFSA Journal (2007) 471, 1 to 29.

L 256/18

EN

Official Journal of the European Union

2.10.2007

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

Done at Brussels, 1 October 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

2.10.2007

EN

Official Journal of the European Union

L 256/19

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