Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive   (Text with EEA relevance)
Date: 2006-09-29
Institutions: European Commission
Subjects: animal health, animal nutrition, fattening, food additive, market approval, poultry, zootechnics

30.9.2006

EN

Official Journal of the European Union

L 271/19

COMMISSION REGULATION (EC) No 1444/2006

of 29 September 2006
concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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 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. That
application was accompanied by the particulars and
documents required under Article 7(3) of that Regulation.

(6)

The European Food Safety Authority (the Authority)
concluded in its opinion of 8 March 2006 that Bacillus
subtilis C-3102 (Calsporin) does not have an adverse
effect on animal health, human health or the envir-
onment (3). It further concluded that Bacillus subtilis C-
3102 (Calsporin) 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 that preparation can improve the
zootechnical parameters in chickens for
It
does not consider
there is a need for specific
requirements of post market monitoring. The opinion
of the Authority recommends appropriate measures for
user safety. 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 Regu-
that
lation (EC) No 1831/2003. The assessment of
preparation shows that the conditions for authorisation,
provided for
in Article 5 of Regulation (EC) No
1831/2003, are satisfied. Accordingly, the use of that
preparation should be authorised, as specified in the
Annex to this Regulation.

fattening.

that

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 authorisation of the preparation
Bacillus subtilis C-3102 (Calsporin) a feed additive for
chickens for fattening, to be classified in the additive
category ‘zootechnical additives’.

The method of analysis included in the application for
authorisation in accordance with Article 7(3)(c) of Regu-
lation (EC) No 1831/2003 concerns the determination of
the active substance of the feed additive in feed. The
method of analysis referred to in the Annex to this
Regulation is
to be understood as a
Community method of analysis within the meaning of
Article 11 of Regulation (EC) No 882/2004 of
the
European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the veri-
fication of compliance with feed and food law, animal
health and animal welfare rules (2).

therefore not

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.

(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 165, 30.4.2004, as corrected by OJ L 191, 28.5.2004, p. 1.
amended by Commission Regulation (EC) No

Regulation as
776/2006 (OJ L 136, 24.5.2006, p. 3).

(3) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
product Calsporin a preparation of Bacillus subtilis C-3102, as a feed
additive for chickens for fattening in accordance with Regulation
(EC) No 1831/2003. Adopted on 8 March 2006. The EFSA Journal
(2006) 336, p. 1 to 15.

(1)

(2)

(3)

(4)

L 271/20

EN

Official Journal of the European Union

30.9.2006

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

Done at Brussels, 29 September 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

30.9.2006

EN

Official Journal of the European Union

L 271/21

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