HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
26.10.2012 Official
Journal
of
the
European
Union L
297/15
COMMISSION IMPLEMENTING REGULATION (EU) No 990/2012
of 25 October 2012
concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA
26/4U) as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
consider that there is a need for specific requirements of
post-market monitoring. It also verified the report on the
method of analysis of the feed additive in feed submitted
Having regard to the Treaty on the Functioning of the European
by the Community Reference Laboratory set up by Regu
Union,
lation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
(5) The
assessment
of
the
preparation
shows
that
the
European Parliament and of the Council of 22 September
conditions for authorisation, as provided for in
2003 on additives for use in animal nutrition (
Article 5 of Regulation (EC) No 1831/2003, are satisfied.

1 ), and in
particular Article 9(2) thereof,
Accordingly, the use of the preparation should be auth
orised as specified in the Annex to this Regulation.
Whereas:
(6)
Since safety reasons do not require the immediate appli
cation of the modifications to the conditions of auth
orisation, it is appropriate to allow a transitional period
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
for interested parties to prepare themselves to meet the
orisation of additives for use in animal nutrition and
new requirements resulting from the authorisation.
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)
thereof sets out specific provisions for the evaluation of
(7) The
measures
provided
for
in
this
Regulation
are
in
products used in the Union as silage additives at the date
accordance with the opinion of the Standing
that Regulation became applicable.
Committee on the Food Chain and Animal Health,
(2) In
accordance
with
Article
10(1)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1831/2003, a preparation of Propionibacterium acidipro
pionici (CNCM MA 26/4U), hereinafter ‘the preparation’,
was entered in the Community Register of Feed Additives
Article 1
as an existing product belonging to the functional group
of silage additives, for all animal species.
Authorisation
The preparation specified in the Annex belonging to the
additive category ‘technological additives’ and to the functional
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No group ‘silage additives’, is authorised as an additive in animal
1831/2003 in conjunction with Article 7 thereof, an
nutrition, subject to the conditions laid down in that Annex.
application was submitted for the authorisation of the
preparation as a feed additive for all animal species,
requesting that additive to be classified in the category
‘technological additives’ and in the functional group
Article 2
‘silage additives’. That application was accompanied by
Transitional measures
the particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 15 May
2013 in accordance with the rules applicable before
15 November 2012 may continue to be placed on the
(4) The
European
Food
Safety
Authority
(the
Authority) market and used until the existing stocks are exhausted.
concluded in its opinion of 25 April 2012 ( 2 ) that,
under the proposed conditions of use, the preparation
does not have an adverse effect on animal health,
human health or the environment, and that the use of
Article 3
the preparation has the potential to improve the aerobic
Entry into force
stability of the treated silage. The Authority does not
This Regulation shall enter into force on the twentieth day
( 1 ) OJ L 268, 18.10.2003, p. 29.
following that of its publication in the Official Journal of the
( 2 ) EFSA Journal 2012; 10(5):2673.
European Union.

---

L 297/16
EN
Official Journal of the European Union
26.10.2012
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 October 2012.
For the Commission
The President
José Manuel BARROSO

---

26.10.2012 Off
ANNEX
Minimum
Maximum
Identification
Species or
content
content
number of the Name of the holder
category of
Maximum age
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
authorisation
CFU/kg of fresh material
EN
Category of technological additives. Functional group: silage additives

1k2111
— Propionibacterium
Additive composition
All animal
—
—
— 1.
In
the
directions
for
use
15 November
acidipropionici
species
of the additive and
2022
(CNCM MA
Preparation of Propionibacterium acidipro
premixture, indicate the
26/4U)
pionici (CNCM MA 26/4U) containing a
storage temperature and
minimum of 1 x 108 CFU/g additive
storage life.
Characterisation of the active substance
2. Minimum dose of the
additive when it is not
Propionibacterium acidipropionici (CNCM MA
used in combination
26/4U)
with other micro-
icial
Analytical method (1 )
organisms as silage
additive: 1 x 108 CFU/kg
Jour
Enumeration in the feed additive: spread
of fresh material.
plate method (EN 15787)
nal
3. For safety: it is recom
of
Identification: Pulsed Field Gel Electro
mended to use breathing
the
phoresis (PFGE).
protection and gloves
during handling.
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
297/17

---

Document Outline

• �

---