Commission Regulation (EC) No 1290/2008 of 18 December 2008 concerning the authorisation of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-3699) (Sorbiflore) as a feed additive (Text with EEA relevance)
Date: 2008-12-18
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, food safety, market approval, swine

L 340/20

EN

Official Journal of the European Union

19.12.2008

COMMISSION REGULATION (EC) No 1290/2008

of 18 December 2008
concerning the authorisation of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and
Lactobacillus farciminis (CNCM-I-3699) (Sorbiflore) 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:

(1)

(2)

(3)

(4)

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

The application concerns a new authorisation of a
preparation of Lactobacillus
(CNCM-I-3698)
and Lactobacillus
farciminis
(Sorbiflore),
as a feed additive for piglets,
to be classified in the
additive category ‘zootechnical additives’.

(CNCM-I-3699)

rhamnosus

From the Opinion of the European Food Safety Authority
(the Authority) of 15 July 2008 (2) it results that, based
on the data provided by the manufacturer, a preparation
of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus
farciminis (CNCM-I-3699) (Sorbiflore) does not have an

adverse effect on animal health, human health or the
environment and it
in improving the
is efficacious
weight gain. The Authority further concluded that that
preparation may be a potential respiratory sensitiser. 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
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)

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘other zootechnical additives’, is authorised as an additive
in animal nutrition subject to the conditions laid down in that
Annex.

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) 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 the product
Sorbiflore, a preparation of Lactobacillus rhamnosus and Lactobacillus
farciminis, as feed additive for piglets. The EFSA Journal (2008) 771,
pp. 1-13.

19.12.2008

EN

Official Journal of the European Union

L 340/21

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