HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 330/14
EN
Official Journal of the European Union
30.11.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1119/2012
of 29 November 2012
concerning the authorisation of preparations of Pediococcus acidilactici CNCM MA 18/5M DSM
11673, Pediococcus pentosaceus DSM 23376, NCIMB 12455 and NCIMB 30168, Lactobacillus
plantarum DSM 3676 and DSM 3677 and Lactobacillus buchneri DSM 13573 as feed additives for
all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
the production of silage from all forages by reducing the
pH and increasing the preservation of dry matter and/or
Having regard to the Treaty on the Functioning of the European
protein. It also concluded that the preparations of Lacto
Union,
bacillus plantarum DSM 3676 and Lactobacillus plantarum
DSM 3677 concerned have the potential to improve the
Having regard to Regulation (EC) No 1831/2003 of the
production of silage from easy and moderately difficult
European Parliament and of the Council of 22 September
to ensile material by increasing the lactic acid content
2003 on additives for use in animal nutrition ( 1 ), and in
and the preservation of dry matter, by reducing the pH
particular Article 9(2) thereof,
and moderately the loss of protein. It also concluded that
the preparation of Lactobacillus buchneri DSM 13573
Whereas:
concerned has the potential to increase acetic acid
concentration for a wide range of forages. The
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Authority does not consider that there is a need for
orisation of additives for use in animal nutrition and
specific requirements of post-market monitoring. It also
for the grounds and procedures for granting such auth
verified the report on the method of analysis of the feed
orisation. Article 10(7) of Regulation (EC) No
additives in feed submitted by the Community Reference
1831/2003 in conjunction with Article 10(1) to (4)
Laboratory set up by Regulation (EC) No 1831/2003.
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.
(2) In
accordance
with
Article
10(1)
of
Regulation
(EC)
No
Accordingly, the use of those preparations should be
1831/2003, preparations of Pediococcus acidilactici CNCM
authorised as specified in the Annex to this Regulation.
MA 18/5M DSM 11673, Pediococcus pentosaceus DSM
23376, Pediococcus pentosaceus NCIMB 12455, Pediococcus
pentosaceus NCIMB 30168, Lactobacillus plantarum DSM
(6) Since
safety
considerations
do
not
require
the
immediate
3676, Lactobacillus plantarum DSM 3677 and Lactobacillus
application of the modifications to the conditions of
buchneri DSM 13573 were entered in the Community
authorisation, it is appropriate to allow a transitional
Register of Feed Additives as existing products
period for interested parties to prepare themselves to
belonging to the functional group of silage additives,
meet the new requirements resulting from the authori
for all animal species.
sation.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No (7) The
measures
provided
for
in
this
Regulation
are
in
1831/2003 in conjunction with Article 7 thereof, appli
accordance with the opinion of the Standing
cations were submitted for the authorisation of those
Committee on the Food Chain and Animal Health,
preparations as feed additives for all animal species,
requesting those additives to be classified in the
category ‘technological additives’ and in the functional
HAS ADOPTED THIS REGULATION:
group ‘silage additives’. Those applications were accom
panied by the particulars and documents required under
Article 1
Article 7(3) of Regulation (EC) No 1831/2003.
Authorisation
(4) The
European
Food
Safety
Authority
(‘the
Authority’) The preparations specified in the Annex belonging to the
concluded in its opinions of 23 May 2012 ( 2 ) and
additive category ‘technological additives’ and to the functional
14 June 2012 ( 3 ) that, under the proposed conditions
group ‘silage additives’, are authorised as additives in animal
of use, the preparations concerned do not have an
nutrition, subject to the conditions laid down in that Annex.
adverse effect on animal health, human health or the
environment. The Authority also concluded that the
preparations of Pediococcus acidilactici CNCM MA 18/5M
Article 2
DSM 11673, Pediococcus pentosaceus DSM 23376, Pedi
Transitional measures
ococcus pentosaceus NCIMB 12455, Pediococcus pentosaceus
NCIMB 30168 concerned have the potential to improve
The preparations specified in the Annex and feed containing
them, which are produced and labelled before 20 June 2013
in accordance with the rules applicable before 20 December
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2012; 10(6):2733.
2012 may continue to be placed on the market and used
( 3 ) EFSA Journal 2012; 10(7):2780.
until the existing stocks are exhausted.

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EN
30.11.2012 Official
Journal
of
the
European
Union L
330/15
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, 29 November 2012.
For the Commission
The President
José Manuel BARROSO

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L 330/16
ANNEX
Minimum
Maximum
Identification
Name of the
Species or
content
content
End of period
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
Other provisions
of
additive
authorisation
method
animal
age
authorisation
CFU/kg of fresh material
EN
Category of technological additives. Functional group: silage additives

1k2104
— Pediococcus
acidilactici
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
CNCM MA 18/5M
species
additive and premixture, indicate
2022
DSM 11673
Preparation of Pediococcus acidilactici CNCM MA
the storage temperature and
18/5M DSM 11673 containing a minimum of
storage life.
3 × 109 CFU/g additive
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Pediococcus acidilactici CNCM MA 18/5M DSM
silage additives: 3 × 107 CFU/Kg
Off
11673
fresh material.
icial
Analytical method (1 )
3. For safety: it is recommended to
Jour
use breathing protection and
Enumeration in the feed additive: spread plate
nal
gloves during handling.
method (EN 15786)
of
the
Identification: pulsed field gel electrophoresis
(PFGE)
European
1k2105
— Pediococcus
pentosaceus
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
DSM 23376
species
additive and premixture, indicate
2022
Union
Preparation of Pediococcus pentosaceus DSM
the storage temperature and
23376 containing a minimum of 1 × 1011
storage life.
CFU/g additive
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Pediococcus pentosaceus DSM 23376
silage additives: 1 × 108 CFU/Kg
fresh material.
Analytical method (1 )
3. For safety: it is recommended to
Enumeration in the feed additive: spread plate
use breathing protection and
method (EN 15786)
gloves during handling.
Identification: pulsed field gel electrophoresis
(PFGE)
1k2106
— Pediococcus
pentosaceus
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
30.11.2012
NCIMB 12455
species
additive and premixture, indicate
2022
Preparation of Pediococcus pentosaceus NCIMB
the storage temperature and
12455 containing a minimum of 3 × 109
storage life.
CFU/g additive

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30.11.2012 Off
Minimum
Maximum
Identification
Name of the
Species or
content
content
End of period
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
Other provisions
of
additive
authorisation
method
animal
age
authorisation
CFU/kg of fresh material
Characterisation of the active substance
2. Minimum dose of the additive
when used without combination
Pediococcus pentosaceus NCIMB 12455
with other micro-organisms as
EN
silage additives: 3 × 107 CFU/Kg

Analytical method (1 )
fresh material.
Enumeration in the feed additive: spread plate
3. For safety: it is recommended to
method (EN 15786)
use breathing protection and
gloves during handling.
Identification: pulsed field gel electrophoresis
(PFGE)
1k2107
— Pediococcus
pentosaceus Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
NCIMB 30168
species
additive and premixture, indicate
2022
Preparation of Pediococcus pentosaceus NCIMB
the storage temperature and
30168 containing a minimum of 5 × 1010
icial
storage life.
CFU/g additive
Jour
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
nal
with other micro-organisms as
Pediococcus pentosaceus NCIMB 30168
of
silage additives: 1 × 108 CFU/Kg
the
fresh material.
Analytical method (1 )
European
3. For safety: it is recommended to
Enumeration in the feed additive: spread plate
use breathing protection and
method (EN 15786)
gloves during handling.
Union
Identification: pulsed field gel electrophoresis
(PFGE)
1k20731
— Lactobacillus
plantarum
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
DSM 3676
species
additive and premixture, indicate
2022
Preparation of Lactobacillus plantarum DSM 3676
the storage temperature and
containing a minimum of 6 × 1011 CFU/g
storage life.
additive
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Lactobacillus plantarum DSM 3676
silage additives: 1 × 108 CFU/Kg
fresh material.
Analytical method (1 )
3. The additive shall be used in easy
Enumeration in the feed additive: spread plate
and moderately difficult to ensile
method (EN 15787)
material (2 ).
L
Identification: pulsed field gel electrophoresis
4. For safety: it is recommended to
330/17
(PFGE)
use breathing protection and
gloves during handling.

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L 330/18
Minimum
Maximum
Identification
Name of the
Species or
content
content
End of period
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
Other provisions
of
additive
authorisation
method
animal
age
authorisation
CFU/kg of fresh material
1k20732
— Lactobacillus
plantarum
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
DSM 3677
species
additive and premixture, indicate
2022
Preparation of Lactobacillus plantarum DSM 3677
the storage temperature and
EN
containing a minimum of 4 × 1011 CFU/g
storage life.

additive
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Lactobacillus plantarum DSM 3677
silage additives: 1 × 108 CFU/Kg
fresh material.
Analytical method (1 )
3. The additive shall be used in easy
Enumeration in the feed additive: spread plate
and moderately difficult to ensile
method (EN 15787)
material (2 ).
Off
Identification: pulsed field gel electrophoresis
4. For safety: it is recommended to
icial
(PFGE)
use breathing protection and
gloves during handling.
Jour
nal
1k20733
— Lactobacillus
buchneri
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
20 December
of
DSM 13573
species
additive and premixture, indicate
2022
the
Preparation of Lactobacillus buchneri DSM 13573
the storage temperature and
containing a minimum of 2 × 1011 CFU/g
storage life.
European
additive
2. Minimum dose of the additive
Characterisation of the active substance
when used without combination
with other micro-organisms as
Union
Lactobacillus buchneri DSM 13573
silage additives: 1 × 108 CFU/Kg
fresh material.
Analytical method (1 )
3. For safety: it is recommended to
Enumeration in the feed additive: spread plate
use breathing protection and
method (EN 15787)
gloves during handling.
Identification: pulsed field gel electrophoresis
(PFGE)
(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. Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
30.11.2012

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Document Outline

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