Commission Regulation (EC) No 1521/2007 of 19 December 2007 concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive (Text with EEA relevance )
Date: 2007-12-19
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, swine, zootechnics

L 335/24

EN

Official Journal of the European Union

20.12.2007

COMMISSION REGULATION (EC) No 1521/2007

of 19 December 2007
concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed
additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

No 521/2005 (4) and for ten years (Bonvital) for piglets
(weaned) and pigs for fattening by Commission Regu-
lation (EC) No 538/2007 (5).

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:

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. This application was accompanied by the
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.

(6)

(7)

further concluded that

New data were submitted in support of the application
for authorisation for sows. The European Food Safety
Authority (the Authority) concluded in its opinion of
10 July 2007 that the preparation Enterococcus faecium
DSM 7134 (Bonvital) does not have an adverse effect
on animal health, human health or the environment (6).
It
this preparation does not
present any other risk which would, in accordance with
Article 5(2) of Regulation (EC) No 1831/2003, exclude
category.
authorisation for
According to this opinion, the use of this preparation
is efficacious in improving the performance parameters
of sows. The Authority does not consider that there is a
need for the specific requirements of post market moni-
toring. This opinion also verified the report on the
method of analysis of feed additive in feed submitted
by the Community Reference Laboratory set up by Regu-
lation (EC) No 1831/2003.

additional

animal

this

this preparation shows

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

the preparation Enterococcus

The application concerns the authorisation of a new use
faecium DSM 7134
of
(Bonvital), as a feed additive for sows, to be classified
in the additive category ‘zootechnical additives’.

HAS ADOPTED THIS REGULATION:

faecium DSM
the preparation Enterococcus
The use of
7134 was authorised provisionally for piglets and pigs
for
fattening by Commission Regulation (EC) No
666/2003 (2), provisionally for sows by Commission
Regulation (EC) No 2154/2003 (3), provisionally for
chickens for fattening by Commission Regulation (EC)

(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 96, 12.4.2003, p. 11.
(3) OJ L 324, 11.12.2003, p. 11.

Article 1

The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘gut
is authorised as an additive in
animal nutrition subject to the conditions laid down in this
Annex.

flora stabilisers’,

(4) 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).

(5) OJ L 128, 16.5.2007, p. 16.
(6) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
product ‘Bonvital’, a preparation of Enterococcus faecium as a feed
additive for sows. Adopted on 10 July 2007. The EFSA Journal
(2007) 521, p. 1-8.

(1)

(2)

(3)

(4)

20.12.2007

EN

Official Journal of the European Union

L 335/25

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, 19 December 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 335/26

EN

Official Journal of the European Union

20.12.2007

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