Commission Regulation (EC) No 164/2008 of 22 February 2008 amending Regulation (EC) No 1444/2006 as regards the minimum content of the feed additive Bacillus subtilis C-3102 (Calsporin) (Text with EEA relevance)
Date: 2008-02-22
Institutions: European Commission
Subjects: animal feedingstuffs, fattening, food additive, foodstuffs legislation, market approval, poultry, zootechnics

L 50/6

EN

Official Journal of the European Union

23.2.2008

COMMISSION REGULATION (EC) No 164/2008

of 22 February 2008

amending Regulation (EC) No 1444/2006 as regards the minimum content of the feed additive
Bacillus subtilis C-3102 (Calsporin)

(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 13(3) thereof,

Whereas:

(1)

(2)

(3)

The additive Bacillus
subtilis C-3102 (Calsporin) was
authorised under certain conditions in accordance with
Regulation (EC) No 1831/2003. Commission Regulation
(EC) No 1444/2006 (2) authorised that additive for ten
years for use for chickens for fattening,
linking the
authorisation to the holder of authorisation for putting
that additive into circulation.

Regulation (EC) No 1831/2003 provides for the possi-
bility of modifying the authorisation of an additive
further to a request from the holder of the authorisation
and an opinion of the European Food Safety Authority
(‘the Authority’).

The holder of
Bacillus

the authorisation of

the feed additive
subtilis C-3102 (Calsporin) has submitted an

application which proposes changing the terms of the
authorisation by reducing the minimum content of that
additive.

the
In its opinion adopted on 18 September 2007,
the minimum
Authority has proposed to reduce
content of active substance from 1 × 109 CFU to
5 × 108 CFU because there is evidence of efficacy at
the lowest dose proposed (3).

Regulation (EC) No 1444/2006 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(4)

(5)

(6)

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 1444/2006 is replaced by the
Annex to this Regulation.

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, 22 February 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

(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 271, 30.9.2006, p. 19.

(3) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on Safety and efficacy of
Calsporin, a preparation of Bacillus subtilis, as a feed additive for
chickens for
fattening in accordance with Regulation (EC) No
1831/2003. The EFSA Journal (2007) 543, 1-8.

23.2.2008

EN

Official Journal of the European Union

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