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2.2.2013 Official
Journal
of
the
European
Union L
33/21
COMMISSION IMPLEMENTING REGULATION (EU) No 96/2013
of 1 February 2013
concerning the authorisation of a preparation of Lactobacillus buchneri NCIMB 30139 and of a
preparation of Lactobacillus casei ATTC PTA 6135 as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and the preparation of Lactobacillus casei ATTC PTA 6135
has the potential to improve the production of silage
from easy to ensile material by reducing the pH and
Having regard to the Treaty on the Functioning of the European
increasing the preservation of dry matter. The
Union,
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
verified the report on the methods of analysis of the feed
Having regard to Regulation (EC) No 1831/2003 of the
additives in feed submitted by the Reference Laboratory
European Parliament and of the Council of 22 September
set up by Regulation (EC) No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
the
preparations
concerned
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 those preparations should be
authorised 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
(6)
Since safety reasons do not require the immediate appli
orisation. Article 10(7) of Regulation (EC) No
cation of the modifications to the conditions of auth
1831/2003 in conjunction with Article 10(1) to (4)
orisation, it is appropriate to allow a transitional period
thereof sets out specific provisions for the evaluation of
for interested parties to prepare themselves to meet the
products used in the Union as silage additives at the date
new requirements resulting from the authorisation.
that Regulation became applicable.
(7) The
measures
provided
for
in
this
Regulation
are
in
(2) In
accordance
with
Article
10(1)
of
Regulation
(EC)
No
accordance with the opinion of the Standing
1831/2003, a preparation of Lactobacillus buchneri NCIMB
Committee on the Food Chain and Animal Health,
30139 and a preparation of Lactobacillus casei ATTC PTA
6135 were entered in the Community Register of Feed
Additives as existing products belonging to the functional
HAS ADOPTED THIS REGULATION:
group of silage additives, for all animal species.
Article 1
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
Authorisation
1831/2003 in conjunction with Article 7 thereof, appli
cations were submitted for the authorisation of those
The preparations specified in the Annex belonging to the
preparations as feed additives for all animal species,
additive category ‘technological additives’ and to the functional
requesting those additives to be classified in the
group ‘silage additives’, are authorised as additives in animal
category ‘technological additives’ and in the functional
nutrition, subject to the conditions laid down in that Annex.
group ‘silage additives’. Those applications were accom
panied by the particulars and documents required under
Article 7(3) of Regulation (EC) No 1831/2003.
Article 2
Transitional measures
(4) The
European
Food
Safety
Authority
(‘the
Authority’) The preparations specified in the Annex and feed containing
concluded in its opinions of 11 September 2012 ( 2 )
them, which are produced and labelled before 22 August
and 12 September 2012 ( 3 ) that, under the proposed
2013 in accordance with the rules applicable before 22 February
conditions of use, the preparations concerned do not
2013, may continue to be placed on the market and used until
have an adverse effect on animal health, human health
the existing stocks are exhausted.
or the environment. The Authority also concluded that
the preparation of Lactobacillus buchneri NCIMB 30139
has the potential to improve the preservation of easy
Article 3
to ensile material by increasing acetic acid production
Entry into force
This Regulation shall enter into force on the twentieth day
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2012; 10(9):2883.
following that of its publication in the Official Journal of the
( 3 ) EFSA Journal 2012; 10(9):2884.
European Union.

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L 33/22
EN
Official Journal of the European Union
2.2.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 February 2013.
For the Commission
The President
José Manuel BARROSO

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2.2.2013 Off
ANNEX
Minimum
Maximum
Identification Name of the
Species or
content
content
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the additive authorisation
analytical method
animal
age
authorisation
CFU/kg of fresh material
EN
Category of technological additives. Functional group: silage additives

1k20734
— Lactoba
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
22 February 2023
cillus
Preparation of Lactobacillus buchneri NCIMB 30139
species
additive and premixture, indicate
buchneri
containing a minimum of 5 × 1010 CFU/g additive
the storage temperature and
NCIMB
storage life.
30139
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
Lactobacillus buchneri NCIMB 30139
with other micro-organisms as
silage additives: 1 × 108 CFU/kg
fresh material.
icial
Analytical method (1 )
3. The additive shall be used in easy
Jour
Enumeration in the feed additive: spread plate
to ensile material (2 ).
method (EN 15787)
nal
Identification: Pulsed Field Gel Electrophoresis
4. For safety: it is recommended to
of
(PFGE)
use breathing protection and
the
gloves during handling.
European
1k20735
— Lactoba
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
22 February 2023
cillus casei
species
additive and premixture, indicate
Preparation of Lactobacillus casei ATTC PTA 6135
the storage temperature and
Union
ATTC PTA containing a minimum of 1 × 1010 CFU/g additive
storage life.
6135
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Lactobacillus casei ATTC PTA 6135
silage additives: 1,3 × 106 CFU/kg
fresh material.
3. The additive shall be used in easy
Analytical method (1 )
to ensile material (2 ).
Enumeration in the feed additive: spread plate
4. For safety: it is recommended to
method (EN 15787)
use breathing protection and
gloves during handling.
Identification: Pulsed Field Gel Electrophoresis
(PFGE)
L
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(
33/23
2 ) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. As defined in Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).

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Document Outline

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