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6.12.2011 Official
Journal
of
the
European
Union L
322/3
COMMISSION IMPLEMENTING REGULATION (EU) No 1263/2011
of 5 December 2011
concerning the authorisation of Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM
12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus
plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM 12835),
Lactobacillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB
30160), Pediococcus acidilactici (DSM 16243) and Pediococcus pentosaceus (DSM 12834) as feed
additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
European
Food
Safety
Authority
(the
Authority)
concluded in its opinions of 6 September 2011 on
Lactobacillus buchneri (DSM 16774)
( 2 ), Lactobacillus
buchneri (DSM 12856) ( 3 ) and on Lactobacillus brevis
Having regard to the Treaty on the Functioning of the European
(DSM 12835) ( 4 ), that these micro-organisms do not
Union,
have an adverse effect on animal health, human health
or the environment, and that they have the potential to
improve the production of silage from all forages by
increasing acetic production resulting in an extended
Having regard to Regulation (EC) No 1831/2003 of the
aerobic stability of the silage. The Authority does not
European Parliament and of the Council of 22 September
consider that there is a need for specific requirements
2003 on additives for use in animal nutrition ( 1 ), and in
of post-market monitoring. It also verified the report
particular Article 9(2) thereof,
on the method of analysis of the feed additives in feed
submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003.
Whereas:
(5) The
Authority
concluded
in
its
opinions
of
6
September
2011 on Lactobacillus paracasei (DSM 16245) (
(1) Regulation
(EC)
No
1831/2003
provides
for
the
authori

5 ), on Lacto
sation of additives for use in animal nutrition and for the
bacillus paracasei (DSM 16773) ( 6 ), Lactobacillus plantarum
grounds and procedures for granting such authorisation.
(DSM 12836) (


7 ) Lactobacillus plantarum (DSM 12837) ( 8 ),
Lactobacillus rhamnosus (NCIMB 30121) ( 9 ) Lactococcus
lactis (NCIMB 30160) ( 10 ) Pediococcus acidilactici (DSM
16243) ( 11 ) and on Pediococcus pentosaceus (DSM
(2) In
accordance
with
Article
7
of
Regulation
(EC)
12834) ( 12 ), and in its opinion of 8 September 2011
No 1831/2003, applications were submitted for the
on Lactococcus lactis (DSM 11037) ( 13 ) that these micro-
authorisation of Lactobacillus buchneri (DSM 16774),
organisms do not have an adverse effect on animal
Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei
health, human health or the environment, and that
(DSM 16245), Lactobacillus paracasei (DSM 16773), Lacto
they have the potential to improve the production of
bacillus plantarum (DSM 12836), Lactobacillus plantarum
silage from all forages by reducing the pH and increasing
(DSM 12837), Lactobacillus brevis (DSM 12835), Lactoba
the preservation of the dry matter. The Authority does
cillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM
not consider that there is a need for specific requirements
11037), Lactococcus lactis (NCIMB 30160), Pediococcus
of post-market monitoring. It also verified the report on
acidilactici (DSM 16243) and Pediococcus pentosaceus
the method of analysis of the feed additives in feed
(DSM 12834). Those applications were accompanied by
submitted by the Community Reference Laboratory set
the particulars and documents required under Article 7(3)
up by Regulation (EC) No 1831/2003.
of Regulation (EC) No 1831/2003.
(6) The
assessment
of Lactobacillus buchneri (DSM 16774),
(3) The
applications
concern
the
authorisation
of Lactobacillus
Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei
buchneri (DSM 16774), Lactobacillus buchneri (DSM
(DSM 16245), Lactobacillus paracasei (DSM 16773),
12856), Lactobacillus paracasei (DSM 16245), Lactobacillus
paracasei (DSM 16773), Lactobacillus plantarum (DSM
( 2 ) EFSA Journal 2011; 9(9):2359.
12836), Lactobacillus plantarum (DSM 12837), Lactobacillus
( 3 ) EFSA Journal 2011; 9(9):2361.
brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB
( 4 ) EFSA Journal 2011; 9(9):2368.
(
30121), Lactococcus lactis (DSM 11037) Lactococcus lactis

5 ) EFSA Journal 2011; 9(9):2363.
( 6 ) EFSA Journal 2011; 9(9):2370.
(NCIMB 30160), Pediococcus acidilactici (DSM 16243) and
( 7 ) EFSA Journal 2011; 9(9):2367.
Pediococcus pentosaceus (DSM 12834) as feed additives for
( 8 ) EFSA Journal 2011; 9(9):2362.
all animal species, to be classified in the additive category
( 9 ) EFSA Journal 2011; 9(9):2365.
‘technological additives’.
( 10 ) EFSA Journal 2011; 9(9):2366.
( 11 ) EFSA Journal 2011; 9(9):2364.
( 12 ) EFSA Journal 2011; 9(9):2369.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 13 ) EFSA Journal 2011; 9(9):2374.

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L 322/4
EN
Official Journal of the European Union
6.12.2011
Lactobacillus plantarum (DSM 12836), Lactobacillus
HAS ADOPTED THIS REGULATION:
plantarum (DSM 12837), Lactobacillus brevis (DSM
12835), Lactobacillus rhamnosus (NCIMB 30121), Lacto
coccus lactis (DSM 11037), Lactococcus lactis (NCIMB
Article 1
30160), Pediococcus acidilactici (DSM 16243) and Pedi
ococcus pentosaceus (DSM 12834) shows that the
The micro-organisms specified in the Annex belonging to the
conditions for authorisation, as provided for in
additive category ‘technological additives’ and to the functional
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
group ‘silage additives’, are authorised as additives in animal
Accordingly, the use of those micro-organisms should be
nutrition subject to the conditions laid down in that Annex.
authorised as specified in the Annex to this Regulation.
Article 2
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
This Regulation shall enter into force on the 20th day following
Committee on the Food Chain and Animal Health,
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, 5 December 2011.
For the Commission
The President
José Manuel BARROSO

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6.12.2011 Off
ANNEX
Minimum
Maximum
Identification Name of the
content
content
number of
holder of
Additive
Composition, chemical formula, description,
Species or category Maximum
Other provisions
End of period of
the additive
authori
analytical method.
of animal
age
authorisation
sation
CFU/kg of fresh material
EN
Category of technological additives. Functional group: silage additives.

1k2074
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
buchneri
Preparation of Lactobacillus buchneri (DSM
species
additive and premixture, indicate
(DSM 16774)
16774) containing a minimum of
the storage temperature and storage
5 × 1011 CFU/g additive
life.
Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
Lactobacillus buchneri (DSM 16774)
other micro-organisms as silage
Analytical method (1 )
additives: 1 × 108 CFU/kg fresh
Enumeration: spread plate method using
material.
icial
MSR agar (EN 15787)
3. For safety: it is recommended to use
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
Jour
phoresis (PFGE).
during handling.
nal
of
1k2075
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
the
buchneri
Preparation of Lactobacillus buchneri (DSM
species
additive and premixture, indicate
European
(DSM 12856)
12856) containing a minimum of
the storage temperature and storage
5 × 1011 CFU/g additive
life.
Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
Lactobacillus buchneri (DSM 12856)
Union
other micro-organisms as silage
Analytical method (1 )
additives: 1 × 108 CFU/kg fresh
Enumeration: spread plate method using
material.
MSR agar (EN 15787)
3. For safety: it is recommended to use
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
phoresis (PFGE).
during handling.
1k2076
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
paracasei
Preparation of Lactobacillus paracasei (DSM
species
additive and premixture, indicate
(DSM 16245)
16245) containing a minimum of
the storage temperature and storage
5 × 1011 CFU/g additive
life.
Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
Lactobacillus paracasei (DSM 16245)
other micro-organisms as silage
Analytical method (1 )
additives: 1 × 108 CFU/kg fresh
Enumeration: spread plate method using
material.
MSR agar (EN 15787)
3. For safety: it is recommended to use
L
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
322/5
phoresis (PFGE).
during handling.

---

L 322/6
Minimum
Maximum
Identification Name of the
content
content
number of
holder of
Additive
Composition, chemical formula, description,
Species or category Maximum
Other provisions
End of period of
the additive
authori
analytical method.
of animal
age
authorisation
sation
CFU/kg of fresh material
1k2077
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
paracasei
species
additive and premixture, indicate
Preparation of Lactobacillus paracasei (DSM
the storage temperature and storage
(DSM 16773)
16773) containing a minimum of
EN
life.
4 × 1011 CFU/g additive

2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
Lactobacillus paracasei (DSM 16773)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Enumeration: spread plate method using
3. For safety: it is recommended to use
MSR agar (EN 15787)
breathing protection and gloves
during handling.
Identification: Pulsed-Field Gel Electro
Off
phoresis (PFGE).
icial
1k2078
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
Jour
plantarum
species
additive and premixture, indicate
Preparation of Lactobacillus plantarum (DSM
the storage temperature and storage
nal
(DSM 12836)
12836) containing a minimum of
life.
of
5 × 1011 CFU/g additive
the
2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
European
Lactobacillus plantarum (DSM 12836)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Union
Enumeration: spread plate method using
3. For safety: it is recommended to use
MSR agar (EN 15787)
breathing protection and gloves
during handling.
Identification: Pulsed-Field Gel Electro
phoresis (PFGE).
1k2079
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
plantarum
species
additive and premixture, indicate
Preparation of Lactobacillus plantarum (DSM
the storage temperature and storage
(DSM 12837)
12837) containing a minimum of
life.
5 × 1011 CFU/g additive
2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
Lactobacillus plantarum (DSM 12837)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Enumeration: spread plate method using
3. For safety: it is recommended to use
6.12.2011
MSR agar (EN 15787)
breathing protection and gloves
during handling.
Identification: Pulsed-Field Gel Electro
phoresis (PFGE).

---

6.12.2011 Off
Minimum
Maximum
Identification Name of the
content
content
number of
holder of
Additive
Composition, chemical formula, description,
Species or category Maximum
Other provisions
End of period of
the additive
authori
analytical method.
of animal
age
authorisation
sation
CFU/kg of fresh material
1k20710
— Lactobacillus
brevis
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
species
additive and premixture, indicate
(DSM 12835)
Preparation of Lactobacillus brevis (DSM
the storage temperature and storage
12835) containing a minimum of
EN
life.
5 × 1011 CFU/g additive

2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
Lactobacillus brevis (DSM 12835)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Enumeration: spread plate method using
3. For safety: it is recommended to use
MSR agar (EN 15787)
breathing protection and gloves
during handling.
Identification: Pulsed-Field Gel Electro
phoresis (PFGE).
icial
1k20711
— Lactobacillus
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
Jour
rhamnosus
species
additive and premixture, indicate
Preparation of Lactobacillus rhamnosus
the storage temperature and storage
nal
(NCIMB 30121)
(NCIMB 30121) containing a minimum of
life.
of
4 × 1011 CFU/g additive
the
2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
European
Lactobacillus rhamnosus (NCIMB 30121)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Union
Enumeration: spread plate method using
3. For safety: it is recommended to use
MSR agar (EN 15787)
breathing protection and gloves
during handling.
Identification: Pulsed-Field Gel Electro
phoresis (PFGE).
1k2081
— Lactococcus
lactis
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
species
additive and premixture, indicate
(DSM 11037)
Preparation of Lactococcus lactis (DSM 11037)
the storage temperature and storage
containing a minimum of
life.
5 × 1010 CFU/g additive
2. Minimum dose of the additive when
Characterisation of the active substance:
used without combination with
Lactococcus lactis (DSM 11037)
other micro-organisms as silage
additives: 1 × 108 CFU/kg fresh
Analytical method (1 )
material.
Enumeration: pour plate method using MSR
3. For safety: it is recommended to use
agar (ISO 15214)
breathing protection and gloves
L
during handling.
322/7
Identification: Pulsed-Field Gel Electro
phoresis (PFGE).

---

L 322/8
Minimum
Maximum
Identification Name of the
content
content
number of
holder of
Additive
Composition, chemical formula, description,
Species or category Maximum
Other provisions
End of period of
the additive
authori
analytical method.
of animal
age
authorisation
sation
CFU/kg of fresh material
1k2082
— Lactococcus
lactis
Additive composition:
All animal
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
(NCIMB 30160)
Preparation of Lactococcus lactis (NCIMB
species
additive and premixture, indicate
30160) containing a minimum of
the storage temperature and storage
EN
4 × 1011 CFU/g additive
life.

Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
Lactococcus lactis (NCIMB 30160)
other micro-organisms as silage
Analytical method (1 )
additives: 1 × 108 CFU/Kg fresh
Enumeration: pour plate method using MSR
material.
agar (ISO 15214)
3. For safety: it is recommended to use
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
phoresis (PFGE).
during handling.
Off
1k2102
— Pediococcus
Additive composition:
All animal
—
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
icial
acidilactici
Preparation of Pediococcus acidilactici (DSM
species
additive and premixture, indicate
(DSM 16243)
16243) containing a minimum of
the storage temperature and storage
Jour
5 × 1011 CFU/g additive
life.
nal
Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
of
Pediococcus acidilactici (DSM 16243)
other micro-organisms as silage
the
Analytical method (1 )
additives: 1 × 108 CFU/kg fresh
European
Enumeration: spread plate method using
material.
MSR agar (EN 15786)
3. For safety: it is recommended to use
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
Union
phoresis (PFGE).
during handling.
1k2103
— Pediococcus
Additive composition:
All animal
—
—
— 1.
In
the
directions
for
use
of
the
26.12.2021
pentosaceus
Preparation of Pediococcus pentosaceus (DSM
species
additive and premixture, indicate
(DSM 12834)
12834) containing a minimum of
the storage temperature and storage
4 × 1011 CFU/g additive
life.
Characterisation of the active substance:
2. Minimum dose of the additive when
used without combination with
Pediococcus pentosaceus (DSM 12834)
other micro-organisms as silage
Analytical method (1 )
additives: 1 × 108 CFU/kg fresh
Enumeration: spread plate method using
material.
MSR agar (EN 15786)
3. For safety: it is recommended to use
Identification: Pulsed-Field Gel Electro
breathing protection and gloves
phoresis (PFGE).
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
6.12.2011

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