HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
14.11.2012 Official
Journal
of
the
European
Union L
314/15
COMMISSION IMPLEMENTING REGULATION (EU) No 1065/2012
of 13 November 2012
concerning the authorisation of preparations of Lactobacillus plantarum (DSM 23375, CNCM I-3235,
DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT
E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC
55944) 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 opinion of 23 May 2012 ( 2 ) that,
under the proposed conditions of use, the preparations
Having regard to the Treaty on the Functioning of the European
of Lactobacillus plantarum DSM 23375, CNCM I-3235,
Union,
DSM 19457, DSM 16565, DSM 16568, LMG 21295,
CNCM MA 18/5U, NCIMB 30094, VTT E-78076,
ATCC PTSA-6139, DSM 18112, DSM 18113, DSM
18114, ATCC 55943 and ATCC 55944 do not have
Having regard to Regulation (EC) No 1831/2003 of the
an adverse effect on animal health, human health or
European Parliament and of the Council of 22 September
the environment. The preparations of Lactobacillus
2003 on additives for use in animal nutrition ( 1 ), and in
plantarum DSM 23375, CNCM I-3235, DSM 19457,
particular Article 9(2) thereof,
DSM 16565, DSM 16568, LMG 21295, CNCM MA
18/5U and NCIMB 30094 have the potential to
improve the production of silage from all forages by
Whereas:
increasing the preservation of dry matter and reducing
the pH. The preparation of Lactobacillus plantarum VTT
E-78076 has the potential to improve the production
of silage from easy and moderately difficult to ensile
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
material by reducing the pH and ammonia nitrogen.
orisation of additives for use in animal nutrition and
The preparations of Lactobacillus plantarum ATCC PTSA-
for the grounds and procedures for granting such auth
6139, DSM 18112, DSM 18113, DSM 18114, ATCC
orisation. Article 10(7) of Regulation (EC) No
55943 and ATCC 55944 have the potential to
1831/2003 in conjunction with Article 10(1) to (4)
improve the production of silage from easy ensile
thereof sets out specific provisions for the evaluation of
material by reducing the pH and dry matter loss. The
products used in the Union as silage additives at the date
Authority does not consider that there is a need for
that Regulation became applicable.
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
additives in feed submitted by the Community Reference
(2) In
accordance
with
Article
10(1)
of
Regulation
(EC)
No
Laboratory set up by Regulation (EC) No 1831/2003.
1831/2003, the preparations of Lactobacillus plantarum
DSM 23375, CNCM I-3235, DSM 19457, DSM 16565,
DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB
(5) The
assessment
of
the
preparations
of Lactobacillus
30094, VTT E-78076, ATCC PTSA-6139, DSM 18112,
plantarum DSM 23375, CNCM I-3235, DSM 19457,
DSM 18113, DSM 18114, ATCC 55943 and ATCC
DSM 16565, DSM 16568, LMG 21295, CNCM MA
55944 were entered in the Community Register of
18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-
Feed Additives as existing products belonging to the
6139, DSM 18112, DSM 18113, DSM 18114, ATCC
functional group of silage additives, for all animal species.
55943 and ATCC 55944 shows that 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 authorised as specified in
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, appli
the Annex to this Regulation.
cations were submitted for the authorisation of the prep
arations of Lactobacillus plantarum DSM 23375, CNCM
I-3235, DSM 19457, DSM 16565, DSM 16568, LMG
(6)
Since safety reasons do not require the immediate appli
21295, CNCM MA 18/5U, NCIMB 30094, VTT
cation of the modifications to the conditions of auth
E-78076, ATCC PTSA-6139, DSM 18112, DSM
orisation, it is appropriate to allow a transitional period
18113, DSM 18114, ATCC 55943 and ATCC 55944
for interested parties to prepare themselves to meet the
as feed additives for all animal species, requesting those
new requirements resulting from the authorisation.
additives to be classified in the category ‘technological
additives’ and in the functional group ‘silage additives’.
Those applications were accompanied by the particulars
(7) The
measures
provided
for
in
this
Regulation
are
in
and documents required under Article 7(3) of Regulation
accordance with the opinion of the Standing
(EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2012; 10(6):2732.

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L 314/16
EN
Official Journal of the European Union
14.11.2012
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
4 June 2013 in accordance with the rules applicable before 4 December 2012 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, 13 November 2012.
For the Commission
The President
José Manuel BARROSO

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14.11.2012 Off
ANNEX
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
EN

Category of technological additives. Functional group: silage additives
1k20716
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
(DSM
Preparation of Lactobacillus plantarum (DSM 23375)
and storage life.
23375)
containing a minimum of 2 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
Lactobacillus plantarum (DSM 23375)
organisms as silage additives: 1 × 108
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
icial
Enumeration in the feed additive: spread plate
breathing protection and gloves during
method using MRS agar (EN 15787)
handling.
Jour
Identification in the feed additive: pulsed-field gel
nal
electrophoresis (PFGE).
of
the
1k20717
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
European
Preparation of Lactobacillus plantarum (CNCM I-3235)
species
premixture, indicate the storage temperature
2022
(CNCM
containing a minimum of 5 × 1010 CFU/g additive
and storage life.
I-3235)
Characterisation of the active substance
2. Minimum dose of the additive when used
without combination with other micro-
Lactobacillus plantarum (CNCM I-3235)
Union
organisms as silage additives: 2 × 107
Analytical method (1 )
CFU/kg fresh material.
Enumeration in the feed additive: spread plate
3. For safety: it is recommended to use
method using MRS agar (EN 15787)
breathing protection and gloves during
handling.
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).
1k20718
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
Preparation of Lactobacillus plantarum (DSM 19457)
species
premixture, indicate the storage temperature
2022
(DSM
containing a minimum of 1 × 1010 CFU/g additive
and storage life.
19457)
Characterisation of the active substance
2. Minimum dose of the additive when used
without combination with other micro-
Lactobacillus plantarum (DSM 19457)
organisms as silage additives: 5 × 107
Analytical method (1 )
CFU/kg fresh material.
Enumeration in the feed additive: spread plate
3. For safety: it is recommended to use
L
method using MRS agar (EN 15787)
breathing protection and gloves during
handling.
314/17
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).

---

L 314/18
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
1k20719
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
EN
(DSM
Preparation of Lactobacillus plantarum (DSM 16565)
and storage life.

16565)
containing a minimum of 5 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
Lactobacillus plantarum (DSM 16565)
organisms as silage additives: 1 × 108
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
Enumeration in the feed additive: spread plate
breathing protection and gloves during
method using MRS agar (EN 15787)
handling.
Identification in the feed additive: pulsed-field gel
Off
electrophoresis (PFGE).
icial
Jour
1k20720
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
nal
plantarum
species
premixture, indicate the storage temperature
2022
(DSM
Preparation of Lactobacillus plantarum (DSM 16568)
and storage life.
of
16568)
containing a minimum of 5 × 1010 CFU/g additive
the
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
European
Lactobacillus plantarum (DSM 16568)
organisms as silage additives: 1 × 108
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
Union
Enumeration in the feed additive: spread plate
breathing protection and gloves during
method using MRS agar (EN 15787)
handling.
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).
1k20721
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
(LMG
Preparation of Lactobacillus plantarum (LMG 21295)
and storage life.
21295)
containing a minimum of 5 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
Lactobacillus plantarum (LMG 21295)
organisms as silage additives: 1 × 108
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
Enumeration in the feed additive: spread plate
breathing protection and gloves during
14.11.2012
method using MRS agar (EN 15787)
handling.
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).

---

14.11.2012 Off
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
1k20722
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
EN
(CNCM MA Preparation of Lactobacillus plantarum (CNCM MA
and storage life.

18/5U)
18/5U) containing a minimum of 2 × 1010 CFU/g
additive
2. Minimum dose of the additive when used
without combination with other micro-
Characterisation of the active substance
organisms as silage additives: 1 × 108
Lactobacillus plantarum (CNCM MA 18/5U)
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
breathing protection and gloves during
Enumeration in the feed additive: spread plate
handling.
method using MRS agar (EN 15787)
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).
icial
Jour
1k20723
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
nal
plantarum
species
premixture, indicate the storage temperature
2022
of
(NCIMB
Preparation of Lactobacillus plantarum (NCIMB 30094)
and storage life.
30094)
containing a minimum of 5 × 1010 CFU/g additive
the
2. Minimum dose of the additive when used
Characterisation of the active substance
European
without combination with other micro-
Lactobacillus plantarum (NCIMB 30094)
organisms as silage additives: 1 × 109
CFU/kg fresh material.
Analytical method (1 )
3. For safety: it is recommended to use
Union
Enumeration in the feed additive: spread plate
breathing protection and gloves during
method using MRS agar (EN 15787)
handling.
Identification in the feed additive: pulsed-field gel
electrophoresis (PFGE).
1k20724
— Lactobacillus Additive composition
All animal
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
(VTT
Preparation of Lactobacillus plantarum (VTT E-78076)
and storage life.
E-78076)
containing a minimum of 1 × 1011 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
Lactobacillus plantarum (VTT E-78076)
organisms as silage additives: 1 × 109
CFU/Kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy and
Enumeration in the feed additive: spread plate
moderately difficult to ensile material (2 ).
method using MRS agar (EN 15787)
L
4. For safety: it is recommended to use
Identification in the feed additive: pulsed-field gel
314/19
breathing protection and gloves during
electrophoresis (PFGE).
handling.

---

L 314/20
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
1k20725
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
EN
(ATCC
Preparation of Lactobacillus plantarum (ATCC PTSA-
and storage life.

PTSA-6139)
6139) containing a minimum of 1 × 1010 CFU/g
additive
2. Minimum dose of the additive when used
without combination with other micro-
Characterisation of the active substance
organisms as silage additives: 2 × 107
Lactobacillus plantarum (ATCC PTSA-6139)
CFU/kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy to ensile
material (3 ).
Enumeration in the feed additive: spread plate
method using MRS agar (EN 15787)
4. For safety: it is recommended to use
breathing protection and gloves during
Identification in the feed additive: pulsed-field gel
Off
handling.
electrophoresis (PFGE).
icial
Jour
1k20726
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
nal
plantarum
species
premixture, indicate the storage temperature
2022
(DSM
Preparation of Lactobacillus plantarum (DSM 18112)
and storage life.
of
18112)
containing a minimum of 1 × 1010 CFU/g additive
the
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
European
Lactobacillus plantarum (DSM 18112)
organisms as silage additives: 5 × 106
CFU/kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy to ensile
Union
Enumeration in the feed additive: spread plate
material (3 ).
method using MRS agar (EN 15787)
4. For safety: it is recommended to use
Identification in the feed additive: pulsed-field gel
breathing protection and gloves during
electrophoresis (PFGE).
handling.
1k20727
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
(DSM
Preparation of Lactobacillus plantarum (DSM 18113)
and storage life.
18113)
containing a minimum of 1 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
Lactobacillus plantarum (DSM 18113)
organisms as silage additives: 2 × 107
CFU/kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy to ensile
Enumeration in the feed additive: spread plate
material (3 ).
method using MRS agar (EN 15787)
14.11.2012
4. For safety: it is recommended to use
Identification in the feed additive: pulsed-field gel
breathing protection and gloves during
electrophoresis (PFGE).
handling.

---

14.11.2012 Off
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
1k20728
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
EN
(DSM
Preparation of Lactobacillus plantarum (DSM 18114)
and storage life.

18114)
containing a minimum of 1 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
organisms as silage additives: 2 × 107
Lactobacillus plantarum (DSM 18114)
CFU/kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy to ensile
Enumeration in the feed additive: spread plate
material (3 ).
method using MRS agar (EN 15787)
4. For safety: it is recommended to use
Identification in the feed additive: pulsed-field gel
breathing protection and gloves during
icial
electrophoresis (PFGE).
handling.
Jour
1k20729
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
nal
plantarum
species
premixture, indicate the storage temperature
2022
of
(ATCC
Preparation of Lactobacillus plantarum (ATCC 55943)
and storage life.
the
55943)
containing a minimum of 1 × 1010 CFU/g additive
2. Minimum dose of the additive when used
European
Characterisation of the active substance
without combination with other micro-
organisms as silage additives: 2 × 107
Lactobacillus plantarum (ATCC 55943)
CFU/kg fresh material.
Union
Analytical method (1 )
3. The additive shall be used in easy to ensile
Enumeration in the feed additive: spread plate
material (3 ).
method using MRS agar (EN 15787)
4. For safety: it is recommended to use
Identification in the feed additive: pulsed-field gel
breathing protection and gloves during
electrophoresis (PFGE).
handling.
1k20730
— Lactobacillus Additive composition
All animal
—
—
—
1. In the directions for use of the additive and
4 December
plantarum
species
premixture, indicate the storage temperature
2022
(ATCC
Preparation of Lactobacillus plantarum (ATCC 55944)
and storage life.
55944)
containing a minimum of 1 × 1010 CFU/g additive
2. Minimum dose of the additive when used
Characterisation of the active substance
without combination with other micro-
organisms as silage additives: 5 × 106
Lactobacillus plantarum (ATCC 55944)
CFU/kg fresh material.
Analytical method (1 )
3. The additive shall be used in easy to ensile
L
314/21
Enumeration in the feed additive: spread plate
material (3 ).
method using MRS agar (EN 15787)

---

L 314/22
Minimum Maximum
Identification Name of
Species or
content
content
number of the holder
Additive
Composition, chemical formula, description, analytical
category of Maximum
Other provisions
End of period of
the additive of authori
method
age
authorisation
sation
animal
CFU/kg of fresh
material
Identification in the feed additive: pulsed-field gel
4. For safety: it is recommended to use
electrophoresis (PFGE).
breathing protection and gloves during
EN
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 (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Moderately difficult to ensile forages: 1,5-3,0 % soluble carbohydrate in fresh material (e.g. meadow
grass, fescue or wilted alfalfa). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
(3 ) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Regulation (EC) No 429/2008.
Off
icial
Jour
nal
of
the
European
Union
14.11.2012

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Document Outline

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