HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 335/12
EN
Official Journal of the European Union
14.12.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1334/2013
of 13 December 2013
amending Regulation (EC) No 1290/2008 as regards the name of the holder of the authorisation and
as regards the recommended dose of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and
Lactobacillus farciminis (CNCM-I-3699)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Safety Authority Opinion ( 3 ). The subsequent request to
change the recommended dose is in accordance with this
same Opinion and does not entail a new assessment. The
European Food Safety Authority was informed of the
Having regard to the Treaty on the Functioning of the European
application.
Union,
(5)
In order to adapt to current practice the trade name
Having regard to Regulation (EC) No 1831/2003 of the
should be deleted from Regulation (EC) No 1290/2008.
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,
(6)
To allow Danisco (UK) Ltd to exploit its marketing rights
it is necessary to change the terms of the respective
authorisation.
Whereas:
(7) Regulation
(EC)
No
1290/2008
should
therefore
be
amended accordingly.
(1) Danisco
France
SAS
has
submitted
an
application
in
accordance with Article 13(3) of Regulation (EC) No
1831/2003 proposing to change the name of the
holder of the authorisation as regards Commission Regu
(8)
Since safety reasons do not require the immediate appli
lation (EC) No 1290/2008 ( 2 ).
cation of the amendments made by this Regulation to
Regulation (EC) No 1290/2008, it is appropriate to
provide for a transitional period during which existing
stocks may be used up.
(2) The
applicant
claims
that
it
has
transferred
the
marketing
authorisation for the preparation Lactobacillus rhamnosus
(CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-
3699) to Danisco (UK) Ltd and that the latter now
(9) The
measures
provided
for
in
this
Regulation
are
in
owns the marketing rights for this additive.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) The
aim
of
the
application
is
also
to
enable
the
marketing of the feed additive with a concentration five
HAS ADOPTED THIS REGULATION:
times higher than the minimum concentration. In order
to ensure that the minimum and maximum contents set
out in the Annex to Regulation (EC) No 1290/2008 are
respected, the recommended dose per kilogram of
Article 1
complete feedingstuff has to be modified.
Amendment to Regulation (EC) No 1290/2008
Regulation (EC) No 1290/2008 is amended as follows:
(4) The
proposed
change
of
the
authorisation
holder
is
purely administrative in nature and does not entail a
fresh assessment of the additive concerned. The latter
(1) in the title, the word ‘(Sorbiflore)’ is deleted;
has been authorised on the basis of a European Food
( 3 ) Scientific Opinion of the Panel on Additives and Products or
( 1 ) OJ L 268, 18.10.2003, p. 29.
Substances used in Animal Feed (FEEDAP) on a request from the
( 2 ) Commission Regulation (EC) No 1290/2008 of 18 December 2008
European Commission on the safety and efficacy of the product
concerning the authorisation of a preparation of Lactobacillus
Sorbiflore, a preparation of Lactobacillus rhamnosus and Lactobacillus
rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-
farciminis, as feed additive for piglets. The EFSA Journal (2008) 771,
I-3699) (Sorbiflore) as a feed additive (OJ L 340, 19.12.2008, p. 20).
1-13.

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EN
14.12.2013 Official
Journal
of
the
European
Union L
335/13
(2) the Annex is amended as follows:
(a) in the second column, the words ‘Danisco France SAS’ are replaced by ‘Danisco (UK) Ltd’;
(b) in the third column, the word ‘(Sorbiflore)’ is deleted;
(c) in the ninth column, point 2 is replaced as follows:
‘2. Recommended dose per kilogram of complete feedingstuff: 5 × 10 8 FU’.
Article 2
Transitional measures
Existing stocks which have been produced and labelled before 3 January 2014 in accordance with the rules
applicable before 3 January 2014 may continue to be placed on the market and used until 3 July 2014.
Article 3
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 December 2013.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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