Commission Regulation (EC) No 1137/2007 of 1 October 2007 concerning the authorisation of Bacillus subtilis (O35) as a feed additive (Text with EEA relevance)
Date: 2007-10-01
Institutions: European Commission
Subjects: animal health, animal nutrition, food additive, poultry, zootechnics

2.10.2007

EN

Official Journal of the European Union

L 256/5

COMMISSION REGULATION (EC) No 1137/2007

of 1 October 2007
concerning the authorisation of Bacillus subtilis (O35) 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:

Regulation (EC) No 1831/2003 provides for the authori-
sation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.

an application was

In accordance with Article 7 of Regulation (EC) No
1831/2003,
the
authorisation of the preparation set out in the Annex
to this Regulation. That application was accompanied
by the particulars
required under
Article 7(3) of Regulation (EC) No 1831/2003.

and documents

submitted for

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

application concerns

The
the
preparation of Bacillus subtilis DSM 17299 (O35) as a
feed additive for chickens for fattening to be classified
in the additive category ‘zootechnical additives’.

authorisation of

the

HAS ADOPTED THIS REGULATION:

The European Food Safety Authority (the Authority)
concluded in its opinion of 17 October 2006 that the
preparation of Bacillus subtilis DSM 17299 (O35) does
not have an adverse effect on animal health, human
health or the environment (2). It further concluded that
that preparation does not present any other risk which

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’,

(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) 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
microbiological product ‘O35’, a preparation of Bacillus subtilis, as
a feed additive for chickens for fattening in accordance with Regu-
lation (EC) No 1831/2003. Adopted on 17 October 2006. The EFSA
Journal (2006) 406, p. 1-11.

Article 2

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

(1)

(2)

(3)

(4)

L 256/6

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 256/7

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