HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
8.11.2013 Official
Journal
of
the
European
Union L
298/29
COMMISSION IMPLEMENTING REGULATION (EU) No 1113/2013
of 7 November 2013
concerning the authorisation of preparations of Lactobacillus plantarum NCIMB 40027, Lactobacillus
buchneri DSM 22501, Lactobacillus buchneri NCIMB 40788/CNCM I-4323, Lactobacillus buchneri LN
40177/ATCC PTA-6138, and Lactobacillus buchneri LN 4637/ATCC PTA-2494 as feed additives for
all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
accompanied 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)
concluded in its opinions of 12 March 2013 ( 2 ) and
16 April 2013 ( 3 ) that, under the proposed conditions
of use, the preparations concerned do not have an
adverse effect on animal health, human health or the
Having regard to Regulation (EC) No 1831/2003 of the
environment. The Authority also concluded that the
European Parliament and of the Council of 22 September
preparation of Lactobacillus plantarum NCIMB 40027 has
2003 on additives for use in animal nutrition ( 1 ), and in
the potential to improve the production of silage by
particular Article 9(2) thereof,
increasing lactic acid content and the preservation of
dry matter by reducing pH and protein degradation, in
easy and moderately difficult to ensile forage at
1 × 10 8 CFU/kg of fresh material and at 1 × 10 9 CFU/kg
of fresh material in difficult to ensile forage for all
Whereas:
species. It also concluded that the preparation of Lacto
bacillus buchneri DSM 22501 has the potential to improve
the production of silage by reducing pH and ammonia
nitrogen and by the preservation of dry matter, from
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
easy, moderately difficult and difficult to ensile forage;
orisation of additives for use in animal nutrition and
the preparation of Lactobacillus buchneri NCIMB
for the grounds and procedures for granting such auth
40788/CNCM I-4323 has the potential to improve the
orisation. Article 10(7) of Regulation (EC) No
aerobic stability of easy, moderately difficult and difficult
1831/2003 in conjunction with Article 10(1) to (4)
to ensile forage and the preparations of Lactobacillus
thereof sets out specific provisions for the evaluation of
buchneri LN 40177/ATCC PTA-6138, and of Lactobacillus
products used in the Union as silage additives at the date
buchneri LN 4637/ATCC PTA-2494 have the potential to
that Regulation became applicable.
improve the aerobic stability of easy to ensile forage for
all animal species. The 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 additives in feed submitted by the
(2) In
accordance
with
Article
10(1)(b)
of
Regulation
(EC)
No
Reference Laboratory set up by Regulation (EC) No
1831/2003, the preparations of Lactobacillus plantarum
1831/2003.
NCIMB 40027, Lactobacillus buchneri DSM 22501, Lacto
bacillus buchneri NCIMB 40788/CNCM I-4323, Lactoba
cillus buchneri LN 40177/ATCC PTA-6138, and Lactoba
cillus buchneri LN 4637/ATCC PTA-2494 were entered in
the Register of Feed Additives as existing products
(5) The
assessment
of
the
preparations
concerned
shows
that
belonging to the functional group of silage additives,
the conditions for authorisation, as provided for in
for all animal species.
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.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that
(6)
Since safety reasons do not require the immediate appli
Regulation, applications were submitted for the authori
cation of the modifications to the conditions of auth
sation of those preparations as feed additives for all
orisation, it is appropriate to allow a transitional period
animal species, requesting those additives to be classified
for interested parties to prepare themselves to meet the
in the category ‘technological additives’ and in the func
new requirements resulting from the authorisation.
tional group ‘silage additives’. Those applications were
( 2 ) EFSA Journal 2013; 11(4):3168.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 3 ) EFSA Journal 2013; 11(5):3205.

---

L 298/30
EN
Official Journal of the European Union
8.11.2013
(7) The
measures
provided
for
in
this
Regulation
are
in
Article 2
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Transitional measures
The preparations specified in the Annex and feed containing
them, which are produced and labelled before 28 May 2014
HAS ADOPTED THIS REGULATION:
in accordance with the rules applicable before 28 November
2013 may continue to be placed on the market and used
until the existing stocks are exhausted.
Article 1
Article 3
Authorisation
Entry into force
The preparations specified in the Annex belonging to the
additive category ‘technological additives’ and to the functional
This Regulation shall enter into force on the twentieth day
group ‘silage additives’, are authorised as additives in animal
following that of its publication in the Official Journal of the
nutrition, subject to the conditions laid down in that Annex.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 November 2013.
For the Commission
The President
José Manuel BARROSO

---

8.11.2013 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

1k20743
— Lactobacillus Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
28 November 2023
plantarum NCIMB
animal
the additive and premixture,
40027
Preparation of Lactobacillus plantarum NCIMB
species
indicate the storage
40027 containing a minimum of
conditions.
1 × 1011 CFU/g additive.
2. Minimum content of the
Characterisation of the active substance
additive when used without
combination with other
icial
Viable cells of Lactobacillus plantarum NCIMB
micro-organisms as silage
40027.
additives:
Jour
Analytical method (1 )
— 1 × 108 CFU/kg fresh
nal
material in easy and
of
Enumeration in the feed additive: spread plate
moderately difficult to
the
method (EN 15787).
ensile material (2 ).
European
Identification: Pulsed Field Gel Electrophoresis
— 1 × 109 CFU/kg fresh
(PFGE).
material in difficult to
ensile material (3 ).
Union
3. For safety: it is recommended
to use breathing protection
and gloves during handling.
1k20738 Lactobacillus
Additive composition
All
1. In the directions for use of
buchneri DSM
animal
the additive and premixture,
22501
Preparation of Lactobacillus buchneri DSM 22501
species
indicate the storage
containing a minimum of 5 × 1010 CFU/g
temperature and storage life.
additive.
2. Minimum content of the
additive when it is not used in
combination with other
micro-organisms as silage
additive: 1 × 108 CFU/kg of
fresh material.
3. For safety: it is recommended
L
to use breathing protection
298/31
and gloves during handling.

---

L 298/32
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
Characterisation of the active substance
Viable cells of Lactobacillus buchneri DSM 22501.
EN
Analytical method (1 )

Enumeration in the feed additive: spread plate
method (EN 15787).
Identification: Pulsed Field Gel Electrophoresis
(PFGE).
1k20739
— Lactobacillus Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
28 November 2023
Off
buchneri
animal
the additive and premixture,
Preparation of Lactobacillus buchneri NCIMB
species
indicate the storage
icial
NCIMB
40788/CNCM I-4323 containing a minimum of
temperature and storage life.
40788/CNCM
3 × 109 CFU/g additive.
Jour
I-4323
2. Minimum content of the
Characterisation of the active substance
nal
additive when used without
of
Viable cells of Lactobacillus buchneri NCIMB
combination with other
40788/CNCM I-4323.
micro-organisms as silage
the
additives: 1 × 108 CFU/kg
European
Analytical method (1 )
fresh material.
Enumeration in the feed additive: spread plate
3. For safety: it is recommended
method (EN 15787).
to use breathing protection
and gloves during handling.
Union
Identification: Pulsed Field Gel Electrophoresis
(PFGE).
1k20740
— Lactobacillus Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
28 November 2023
buchneri
animal
the additive and premixture,
Preparation of Lactobacillus buchneri LN
species
indicate the storage
LN 40177/ATCC
40177/ATCC PTA-6138 containing a
temperature and storage life.
PTA-6138
minimum of 1 × 1010 CFU/g additive.
2. Minimum content of the
additive when used without
combination with other
micro-organisms as silage
additives: 1 × 108 CFU/kg
fresh material.
8.11.2013
3. The additive shall be used in
easy to ensile material (4 ).

---

8.11.2013 Off
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
Characterisation of the active substance
4. For safety: it is recommended
to use breathing protection
Viable cells of Lactobacillus buchneri LN
and gloves during handling.
EN
40177/ATCC PTA-6138.

Analytical method (1 )
Enumeration in the feed additive: spread plate
method (EN 15787).
Identification: Pulsed Field Gel Electrophoresis
(PFGE).
1k20741
— Lactobacillus Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
28 November 2023
buchneri
animal
the additive and premixture,
Preparation of Lactobacillus buchneri
species
indicate the storage
icial
LN 4637/ATCC
LN 4637/ATCC PTA-2494 containing a
temperature and storage life.
PTA-2494
minimum of 1 × 1010 CFU/g additive.
Jour
Characterisation of the active substance
2. Minimum content of the
nal
additive when used without
Viable cells of Lactobacillus buchneri
combination with other
of
LN 4637/ATCC PTA-2494.
micro-organisms as silage
the
additives: 1 × 108 CFU/kg
European
Analytical method (1 )
fresh material.
Enumeration in the feed additive: spread plate
3. The additive shall be used in
method (EN 15787).
easy to ensile material (4 )
Union
Identification: Pulsed Field Gel Electrophoresis
4. For safety: it is recommended
(PFGE).
to 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 forage: 1,5-3,0 % soluble carbohydrates in the fresh material. Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
(3 ) Difficult to ensile forage: < 1,5 % soluble carbohydrates in the fresh material. Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
(4 ) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
L
298/33

---

Document Outline

• �

---