HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 28/30
EN
Official Journal of the European Union
31.1.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 84/2014
of 30 January 2014
concerning the authorisation of preparations of Pediococcus pentosaceus DSM 14021, Pediococcus
pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 as feed additives for all animal
species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
fed with the treated silage and for the environment. The
Authority also concluded that all three preparations have
the potential to improve the production of silage by
Having regard to the Treaty on the Functioning of the European
reducing the pH and increasing the lactic acid concen
Union,
tration, resulting in an increased preservation of dry
matter in easy and moderately difficult to ensile forage.
The Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
Having regard to Regulation (EC) No 1831/2003 of the
verified the report on the methods of analysis of the feed
European Parliament and of the Council of 22 September
additives in feed submitted by the Reference Laboratory
2003 on additives for use in animal nutrition ( 1 ), and in
set up by Regulation (EC) No 1831/2003.
particular Article 9(2) thereof,
Whereas:
(5) The
assessment
of
the
preparations
concerned
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
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
authorised as specified in the Annex to this Regulation.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation. Article 10(7) of Regulation (EC) No
1831/2003 in conjunction with Article 10(1) to (4)
(6)
Since safety reasons do not require the immediate appli
thereof sets out specific provisions for the evaluation of
cation of the modifications to the conditions of auth
products used in the Union as silage additives at the date
orisation, it is appropriate to allow a transitional period
that Regulation became applicable.
for interested parties to prepare themselves to meet the
new requirements resulting from the authorisation.
(2) In
accordance
with
Article
10(1)(b)
of
Regulation
(EC)
No
1831/2003, the preparations of Pediococcus pentosaceus
(7) The
measures
provided
for
in
this
Regulation
are
in
DSM 14021, Pediococcus pentosaceus DSM 23688, Pedi
accordance with the opinion of the Standing
ococcus pentosaceus DSM 23689 were entered in the
Committee on the Food Chain and Animal Health,
Register of Feed Additives as existing products
belonging to the functional group of silage additives,
for all animal species.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, appli
Article 1
cations were submitted for the authorisation of those
preparations as feed additives for all animal species,
Authorisation
requesting those additives to be classified in the
category ‘technological additives’ and in the functional
The preparations specified in the Annex belonging to the
group ‘silage additives’. Those applications were accom
additive category ‘technological additives’ and to the functional
panied by the particulars and documents required under
group ‘silage additives’, are authorised as additives in animal
Article 7(3) of Regulation (EC) No 1831/2003.
nutrition, subject to the conditions laid down in that Annex.

(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 18 June 2013 ( 2 ) that,
Transitional measures
under the proposed conditions of use, the use of the
strains in the production of silage is presumed safe for
The preparations specified in the Annex and feed containing
livestock species, consumers of products from animals
them, which are produced and labelled before 20 August
2014 in accordance with the rules applicable before 20 February
( 1 ) OJ L 268, 18.10.2003, p. 29.
2014 may continue to be placed on the market and used until
( 2 ) EFSA Journal 2013; 11(7):3284.
the existing stocks are exhausted.

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EN
31.1.2014 Official
Journal
of
the
European
Union L
28/31
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, 30 January 2014.
For the Commission
The President
José Manuel BARROSO

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L 28/32
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

1k1009
— Pediococcus
Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
the
20 February 2024
pentosaceus DSM
animal
additive and premixture,
14021
Preparation of Pediococcus pentosaceus DSM
species
indicate the storage conditions.
14021 containing a minimum of
1 × 1011 CFU/g additive
2. Minimum content of the
additive when used without
Characterisation of the active substance
combination with other micro-
Off
organisms as silage additives:
icial
Viable cells of Pediococcus pentosaceus DSM
1 × 108 CFU/Kg fresh material
14021
in easy and moderately difficult
Jour
to ensile material (2 ).
Analytical method (1 )
nal
3. For safety: it is recommended
of
Enumeration in the feed additive: spread plate
to use breathing protection,
the
method using MRS agar (EN 15786)
eye protection and gloves
during handling.
European
Identification: Pulsed Field Gel Electrophoresis
(PFGE).
Union
1k1010 Pediococcus
Additive composition
All
1. In the directions for use of the
pentosaceus DSM
animal
additive and premixture,
23688
Preparation of Pediococcus pentosaceus DSM
species
indicate the storage conditions.
23688 containing a minimum of
1 × 1011 CFU/g additive
2. Minimum content of the
additive when used without
Characterisation of the active substance
combination with other micro-
organisms as silage additives:
Viable cells of Pediococcus pentosaceus DSM
1 × 108 CFU/Kg fresh material
23688
in easy and moderately difficult
to ensile material (2 ).
Analytical method (1 )
3. For safety: it is recommended
Enumeration in the feed additive: spread plate
to use breathing protection,
method using MRS agar (EN 15786)
eye protection and gloves
during handling.
31.1.2014
Identification: Pulsed Field Gel Electrophoresis
(PFGE).

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31.1.2014 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
1k1011
— Pediococcus
Additive composition
All
—
—
— 1.
In
the
directions
for
use
of
the
20 February 2024
pentosaceus DSM
animal
additive and premixture,
23689
Preparation of Pediococcus pentosaceus DSM
species
indicate the storage conditions.
EN
23689 containing a minimum of

1 × 1011 CFU/g additive
2. Minimum content of the
additive when used without
Characterisation of the active substance
combination with other micro-
organisms as silage additives:
Viable cells of Pediococcus pentosaceus DSM
1 × 108 CFU/Kg fresh material
23689
in easy and moderately difficult
to ensile material (2 ).
Analytical method (1 )
3. For Safety: it is recommended
Enumeration in the feed additive: spread plate
to use breathing protection, eye
method using MRS agar (EN 15786)
protection and gloves during
icial
handling.
Jour
Identification: Pulsed Field Gel Electrophoresis
(PFGE).
nal
of
(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
the
(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. Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).
European
Union
L
28/33

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Document Outline

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