Commission Regulation (EC) No 538/2007 of 15 May 2007 concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive (Text with EEA relevance)
Date: 2007-05-15
Institutions: European Commission
Subjects: animal feedingstuffs, fattening, food additive, foodstuffs legislation, swine, zootechnics

L 128/16

EN

Official Journal of the European Union

16.5.2007

COMMISSION REGULATION (EC) No 538/2007

of 15 May 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,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
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)

(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 a new use of
the preparation of Enterococcus
faecium DSM 7134
(Bonvital), as a feed additive for piglets (weaned) and
to be classified in the additive
fattening,
pigs
category ‘zootechnical additives’.

for

by

Commission

The use of the preparation of Enterococcus faecium DSM
7134 (Bonvital) was authorised for piglets and pigs for
fattening
(EC) No
666/2003 (2) concerning the provisional authorisation
of the use of certain micro-organisms in feedingstuffs,
for
(EC) No
by Commission Regulation
2154/2003 (3) concerning the provisional authorisation
of certain micro-organisms in feedingstuffs (Enterococcus
faecium and Lactobacillus acidophilus),
for chickens for

Regulation

sows

(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.

by

Regulation

Commission

(EC) No
fattening
521/2005 (4) concerning the permanent authorisation
of an additive and the provisional authorisation of a
new use of certain additives already authorised in
feedingstuffs.

(weaned) and pigs

New data were submitted in support of the application
for authorisation for piglets
for
fattening. The European Food Safety Authority (the
Authority) concluded in its opinion of 23 January
2007 that the preparation of Enterococcus faecium DSM
7134 (Bonvital) does not have an adverse effect on
animal health, human health or the environment (5).
According to that opinion, the use of that preparation
is
in improving performance parameters
according to doses recommended by the Authority in
piglets and pigs for fattening. The Authority does not
consider that there is a need for specific requirements
of post market monitoring. That opinion 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.

efficacious

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)

(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 ‘gut
is authorised as an additive in
animal nutrition subject to the conditions laid down in that
Annex.

flora stabilisers’,

(4) OJ L 84, 2.4.2005, p. 3.
(5) 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 piglets and pigs for fattening. Adopted on 23 January
2007. The EFSA Journal (2007) 440, p. 1 to 9.

16.5.2007

EN

Official Journal of the European Union

L 128/17

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, 15 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 128/18

EN

Official Journal of the European Union

16.5.2007

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