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4.4.2013 Official
Journal
of
the
European
Union L
94/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 308/2013
of 3 April 2013
concerning the authorisation of a preparation of Lactobacillus plantarum NCIMB 30083 and of a
preparation of Lactobacillus plantarum NCIMB 30084 as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
category ‘technological additives’ and in the functional
group ‘silage additives’. Those applications were accom
panied by the particulars and documents required under
Article 7(3) of Regulation (EC) No 1831/2003.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Having regard to Regulation (EC) No 1831/2003 of the
concluded in its opinion of 13 December 2012 ( 2 ) that,
European Parliament and of the Council of 22 September
under the proposed conditions of use, the preparations
2003 on additives for use in animal nutrition (
concerned are considered safe for target species,

1 ), and in
particular Article 9(2) thereof,
consumers of products from animals fed treated silage
and for the environment. The Authority also concluded
that both preparations have the potential to improve the
production of silage by increasing the preservation of dry
Whereas:
matter and by reducing protein degradation with easy
and moderately difficult to ensile forage species. The
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
verified the report on the methods of analysis of the feed
orisation of additives for use in animal nutrition and
additives in feed submitted by the Reference Laboratory
for the grounds and procedures for granting such auth
set up by Regulation (EC) No 1831/2003.
orisation. Article 10(7) of Regulation (EC) No
1831/2003 in conjunction with Article 10(1) to (4)
thereof sets out specific provisions for the evaluation of
products used in the Union as silage additives at the date
(5) The
assessment
of
the
preparations
concerned
shows
that
that Regulation became applicable.
the conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of those preparations should be
(2) In
accordance
with
Article
10(1)
of
Regulation
(EC)
No
authorised as specified in the Annex to this Regulation.
1831/2003, a preparation of Lactobacillus plantarum
NCIMB 30083 and of a preparation of Lactobacillus
plantarum NCIMB 30084 were entered in the European
Union Register of Feed Additives as existing products
(6)
Since safety reasons do not require the immediate appli
belonging to the functional group of silage additives,
cation of the modifications to the conditions of auth
for all animal species.
orisation, it is appropriate to allow a transitional period
for interested parties to prepare themselves to meet the
new requirements resulting from the authorisation.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, appli
cations were submitted for the authorisation of those
(7) The
measures
provided
for
in
this
Regulation
are
in
preparations as feed additives for all animal species,
accordance with the opinion of the Standing
requesting those additives to be classified in the
Committee on the Food Chain and Animal Health,
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2013; 11(1):3041.

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L 94/2
EN
Official Journal of the European Union
4.4.2013
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The preparations specified in the Annex belonging to the additive category ‘technological additives’ and to
the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the
conditions laid down in that Annex.
Article 2
Transitional measures
The preparations specified in the Annex and feed containing them, which are produced and labelled before
24 October 2013 in accordance with the rules applicable before 24 April 2013 may continue to be placed
on the market and used until the existing stocks are exhausted.
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 shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 April 2013.
For the Commission
The President
José Manuel BARROSO

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4.4.2013 Off
ANNEX
Minimum
Maximum
Identification
Species or
content
content
number of the Name of the holder
category of
Maximum age
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
authorisation
CFU/kg of fresh material
EN
Category of technological additives. Functional group: silage additives

1k20736
— Lactobacillus
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the 24 April
plantarum
species
additive and premixture, indicate
2023
Preparation of Lactobacillus plantarum
the storage temperature and
(NCIMB
(NCIMB 30083) containing a minimum
storage life.
30083)
of 5 × 1010 CFU/g additive
2. Minimum dose of the additive
Characterisation of the active substance
when it is not used in
combination with other micro-
Lactobacillus plantarum (NCIMB 30083)
organisms as silage additive:
1 × 108 CFU/kg of fresh material.
Analytical method (1 )
icial
Enumeration in the feed additive: spread
3. The additive shall be used in easy
Jour
plate method (EN 15787)
and moderately difficult to ensile
material (2 ).
nal
Identification: Pulsed Field Gel Electro
of
phoresis (PFGE).
4. For safety: it is recommended to
the
use breathing protection and
gloves during handling.
European
1k20737 Lactobacillus
Additive composition
All animal
1. In the directions for use of the
24 April
plantarum
species
additive and premixture, indicate
2023
Preparation of Lactobacillus plantarum
the storage temperature and
Union
(NCIMB
(NCIMB 30084) containing a minimum
storage life.
30084)
of 5 × 1010 CFU/g additive
2. Minimum dose of the additive
Characterisation of the active substance
when it is not used in
combination with other micro-
Lactobacillus plantarum (NCIMB 30084)
organisms as silage additive:
1 × 108 CFU/kg of fresh material.
Analytical method (1 )
3. The additive shall be used in easy
Enumeration in the feed additive: spread
and moderately difficult to ensile
plate method (EN 15787)
material (2 ).
Identification: Pulsed Field Gel Electro
4. For safety: it is recommended to
phoresis (PFGE).
use breathing protection and
gloves during handling.
(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
(2 ) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. Moderately difficult to ensile forages: 1,5-3,0 % soluble carbohydrate in fresh material. As defined by Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008,
p. 1).
L
94/3

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