Commission Regulation (EC) No 1292/2008 of 18 December 2008 concerning the authorisation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) as a feed additive (Text with EEA relevance)
Date: 2008-12-18
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, market approval, poultry

L 340/36

EN

Official Journal of the European Union

19.12.2008

COMMISSION REGULATION (EC) No 1292/2008

of 18 December 2008
concerning the authorisation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) 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:

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 au­
thorisation of
in the Annex.
the preparation set out
That application was accompanied by the particulars
and documents required under Article 7(3) of that Regu­
lation.

(5)

(6)

that Bacillus amyloliquefaciens CECT 5940 (Ecobiol and
Ecobiol plus) does not present any other risk which
would,
in accordance with Article 5(2) of Regulation
(EC) No 1831/2003, exclude authorisation. According
to that opinion, the use of the preparation does not
have an adverse effect on chicken for fattening. The
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

the

application concerns

a
The
preparation of Bacillus
amyloliquefaciens CECT 5940
(Ecobiol and Ecobiol plus), as a feed additive for
chickens for fattening, to be classified in the additive
category ‘zootechnical additives’.

authorisation of

From the Opinion of the European Food Safety Authority
(the Authority) of 16 July 2008 (2) it results that, on the
basis of the data provided by the manufacturer, Bacillus
amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus)
does not have an adverse effect on animal health, human
health or the environment and that it is efficacious in
stabilising the gut flora. The Authority further concluded

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’,

Article 2

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

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

Done at Brussels, 18 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

(1)

(2)

(3)

(4)

(1) OJ L 268, 18.10.2003, p. 29.
(2) Scientific Opinion of

the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on a request from the
European Commission on the safety and efficacy of Ecobiol®
(Bacillus
for
for
fattening. The EFSA Journal (2008) 773, pp. 1-13.

amyloliquefaciens)

feed additives

chickens

as

19.12.2008

EN

Official Journal of the European Union

L 340/37

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