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19.9.2012 Official
Journal
of
the
European
Union L
252/17
COMMISSION IMPLEMENTING REGULATION (EU) No 841/2012
of 18 September 2012
concerning the authorisation of Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum
(NCIMB 30148) as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
micro-organisms Lactobacillus plantarum (NCIMB 41028)
and Lactobacillus plantarum (NCIMB 30148) do not have
an adverse effect on animal health, human health or the
Having regard to the Treaty on the Functioning of the European
environment, and that these micro-organisms have the
Union,
potential to improve the production of silage from all
forages by increasing the preservation of dry matter and
Having regard to Regulation (EC) No 1831/2003 of the
reducing the loss of protein. The Authority also verified
European Parliament and of the Council of 22 September
the report on the method of analysis of the feed additives
2003 on additives for use in animal nutrition ( 1 ), and in
in feed submitted by the Reference Laboratory set up by
particular Article 9(2) thereof,
Regulation (EC) No 1831/2003.
Whereas:
(6) The
assessment
of
the
micro-organisms Lactobacillus
plantarum (NCIMB 41028) and Lactobacillus plantarum
(NCIMB 30148) shows that the conditions for authori
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
sation, as provided for in Article 5 of Regulation (EC) No
orisation of additives for use in animal nutrition and
1831/2003, are satisfied. Accordingly, the use of those
for the grounds and procedures for granting such auth
micro-organisms should be authorised as specified in the
orisation. Article 10(7) of Regulation (EC) No
Annexes to this Regulation.
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
(7) Since
modifications
to
the
conditions
of
authorisation
of
that Regulation became applicable.
the micro-organisms Lactobacillus plantarum (NCIMB
41028) and Lactobacillus plantarum (NCIMB 30148) are
(2)
In accordance with Article 10(1)(b) and Article 7 of
introduced and as there are no direct immediate effects
Regulation (EC) No 1831/2003, the micro-organisms
on safety, a reasonable period should be allowed to
Lactobacillus plantarum (NCIMB 41028) and Lactobacillus
elapse before authorisation in order to allow the
plantarum (NCIMB 30148) were entered in the
interested parties to prepare themselves to meet the
Community Register of Feed Additives as existing
new requirements resulting from the authorisation. In
products belonging to the functional group of silage
addition, it is appropriate to allow a transitional period
additives, for all animal species.
for the disposal of existing stocks of those micro-
organisms and of feed containing them.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, appli
(8) It
is
disproportionately
complex
for
operators
to
adapt
cations were submitted for the authorisation of the
repeatedly and from one day to the other labels of feed
micro-organisms Lactobacillus plantarum (NCIMB 41028)
containing different additives which have been
and Lactobacillus plantarum (NCIMB 30148) as feed
successively authorised according to the procedure laid
additives for all animal species, requesting those
down in Article 10(2) of Regulation (EC) No 1831/2003
additives to be classified in the category ‘technological
and for which new labelling rules are to be complied
additives’ and in the functional group ‘silage additives’.
with. It is therefore appropriate to reduce the adminis
Those applications were accompanied by the particulars
trative burden on the operators by providing a period of
and documents required under Article 7(3) of Regulation
time allowing a smooth conversion of labelling.
(EC) No 1831/2003.
(9) The
measures
provided
for
in
this
Regulation
are
in
(4)
The applications concern the authorisation of the micro-
accordance with the opinion of the Standing
organisms Lactobacillus plantarum (NCIMB 41028) and
Committee on the Food Chain and Animal Health,
Lactobacillus plantarum (NCIMB 30148) as feed additives
for all animal species, to be classified in the additive
category ‘technological additives’.
HAS ADOPTED THIS REGULATION:
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 1
concluded in its opinion of 13 December 2011 ( 2 ) that,
under the proposed conditions of use, the
The micro-organism specified in Annex I, belonging to the
additive category ‘technological additives’ and to the functional
( 1 ) OJ L 268, 18.10.2003, p. 29.
group ‘silage additives’, is authorised as an additive in animal
( 2 ) EFSA Journal 2012; 10(1):2529.
nutrition subject to the conditions laid down in that Annex.

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L 252/18
EN
Official Journal of the European Union
19.9.2012
Article 2
with the previous conditions of authorisation before 19 May
2013 may continue to be placed on the market until stocks are
The micro-organism specified in Annex II, belonging to the
exhausted.
additive category ‘technological additives’ and to the functional
group ‘silage additives’, is authorised as an additive in animal
nutrition subject to the conditions laid down in that Annex.
Article 4
Transitional measures
Article 3
Existing stocks of the micro-organisms referred to in Article 1
Labelling requirements
and in Article 2 and of feed containing them at the date of
entry into force of this Regulation may continue to be placed
Feed containing the micro-organisms referred to in Article 1
on the market and used under the previous conditions of auth
and in Article 2 shall be labelled in accordance with this Regu
orisation until they are exhausted.
lation at the latest by 19 May 2013.
Article 5
However, feed containing the micro-organisms referred to in
Article 1 and in Article 2 which has been labelled in accordance
This Regulation shall enter into force on 19 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO

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19.9.2012 Off
ANNEX I
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 authori
the additive authorisation
analytical method
animal
age
sation
CFU/kg of fresh
material
EN

Category of technological additives. Functional group: silage additives
1k20713
— Lactobacillus Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
additive 19 November 2022
plantarum
species
and premixture, indicate the storage
(NCIMB 41028) Preparation of Lactobacillus plantarum
temperature and storage life.
NCIMB 41028 containing a minimum of
7 × 1010 CFU/g additive
2. Minimum dose of the additive when used
not in combination with other micro-
Characterisation of the active substance
organisms as silage additive: 1 × 109
CFU/kg fresh material.
Lactobacillus plantarum NCIMB 41028
3. For safety: it is recommended to use
icial
Analytical method (1 )
breathing protection and gloves during
Jour
handling.
Enumeration in the feed additive: spread
plate method (EN 15787)
nal
of
Identification: pulsed field gel electro
the
phoresis (PFGE)
European
(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
Union
L
252/19

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L 252/20
ANNEX II
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
1k20714
— Lactobacillus Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
of
the
additive 19 November 2022
plantarum
Preparation of Lactobacillus plantarum
species
and premixture, indicate the storage
(NCIMB 30148) NCIMB 30148 containing a minimum of
temperature and storage life.
7 × 1010 CFU/g additive
2. Minimum dose of the additive when used
not in combination with other micro-
Characterisation of the active substance
organisms as silage additive: 1 × 109
Lactobacillus plantarum NCIMB 30148
CFU/kg fresh material.
Off
3. For safety: it is recommended to use
icial
Analytical method (1 )
breathing protection and gloves during
Jour
Enumeration in the feed additive: spread
handling.
plate method (EN 15787)
nal
Identification: pulsed field gel electro
of
phoresis (PFGE)
the
(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
European
Union
19.9.2012

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Document Outline

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