HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 282/36
EN
Official Journal of the European Union
24.10.2013
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 1016/2013
of 23 October 2013
concerning the authorisation of a preparation of a micro-organism strain DSM 11798 of the
Coriobacteriaceae family as a feed additive for pigs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
micro-organism strain DSM 11798 of the Coriobacte
riaceae family is safe for the target species, for the
human health and for the environment. It recognised
that it has the capacity to biotransform trichothecenes
Having regard to the Treaty on the Functioning of the European
from contaminated feed for pigs. The Authority does
Union,
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 Reference Laboratory set up by Regu
lation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
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,
(5)
The assessment of the preparation of a micro-organism
strain DSM 11798 of the Coriobacteriaceae family shows
that the conditions for authorisation, as provided for in
Whereas:
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that preparation should be auth
orised as specified in the Annex to this Regulation.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation.
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for the auth
orisation of a preparation of a micro-organism strain
DSM 11798 of the Coriobacteriaceae family. That appli
HAS ADOPTED THIS REGULATION:
cation was accompanied by the particulars and
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 1
The preparation specified in the Annex, belonging to the
(3) That
application
concerns
the
authorisation
of
a
prep
aration of a micro-organism strain DSM 11798 of the
additive category ‘technological additives’ and to the functional
Coriobacteriaceae family as a feed additive for pigs, to be
group ‘substances for the reduction of the contamination of
classified in the additive category ‘technological additives’.
feed by mycotoxins’, is authorised as an additive in animal

nutrition subject to the conditions laid down in that Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
in
its opinion of 16 April 2013 ( 2 ) concluded that, under
Article 2
the proposed conditions of use, the preparation of a
This Regulation shall enter into force on the twentieth day
( 1 ) OJ L 268, 18.10.2003, p. 29.
following that of its publication in the Official Journal of the
( 2 ) EFSA Journal 2013; 11(5):3203.
European Union.

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EN
24.10.2013 Official
Journal
of
the
European
Union L
282/37
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 282/38
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
CFU/kg of complete
the additive authorisation
method.
animal
age
authorisation
feedingstuff with a moisture
content of 12 %
EN

Category of technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: Deoxynivalenol (DON)
1m01
— Micro-organism
Additive composition
Pigs
— 1,7
×
108
— 1.
In
the
directions
for
use
of
the
13 November 2023
strain DSM
additive and premixture, indicate
11798 of the Preparation of a micro-organism strain DSM
the storage temperature, storage
Coriobacteriaceae
11798 of the Coriobacteriaceae family containing a
life and stability to pelleting.
family
minimum of 5 × 109 CFU/g of additive.
2. The use of the additive is
Solid form
allowed in feedingstuffs
complying with the European
Off
Characterisation of the active substance
Union legislation on undesirable
icial
substances in animal feed.
Viable cells of: micro-organism strain DSM 11798
Jour
of the Coriobacteriaceae family
3. For safety: it is recommended to
use breathing protection and
nal
Analytical method (1 )
gloves during handling.
of
Enumeration of micro-organism strain DSM
the
11798 of the Coriobacteriaceae family: pour plate
European
method using VM agar supplemented with
Oxyrase.
Identification of micro-organism strain DSM
Union
11798 of the Coriobacteriaceae family: Pulsed Field
Gel Electrophoresis (PFGE).
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://www.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
24.10.2013

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Document Outline

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