HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 29/36
EN
Official Journal of the European Union
1.2.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 81/2012
of 31 January 2012
concerning the denial of authorisation of Lactobacillus pentosus (DSM 14025) as a feed additive
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
information
available
does
not
permit
the
risk
to
be
excluded that Lactobacillus pentosus (DSM 14025) may
spread resistance to those antibiotics to micro-organisms.
Consequently, it has not been established that Lactoba
Having regard to the Treaty on the Functioning of the European
cillus pentosus (DSM 14025) does not have an adverse
Union,
effect on animal health, human health and the
environment, when used under the proposed conditions.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(6) The
conditions
for
authorisation,
as
provided
for
in
2003 on additives for use in animal nutrition ( 1 ), and in
Article 5 of Regulation (EC) No 1831/2003, are
particular Article 9(2) thereof,
therefore not satisfied. Accordingly, the authorisation of
Lactobacillus pentosus (DSM 14025) as a feed additive
should be denied.
Whereas:
(7) Since
further
use
of Lactobacillus pentosus (DSM 14025) as
a feed additive may cause a risk to human and animal
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
health, respective products should be withdrawn from
orisation of additives for use in animal nutrition and
the market as soon as possible.
for the grounds and procedures for granting or denying
such authorisation. Article 10(7) of Regulation (EC) No
1831/2003 provides for the evaluation of substances,
micro-organisms and preparations used in the Union as
silage additives at the date that Regulation became appli
(8) The
measures
provided
for
in
this
Regulation
are
in
cable. Silage additives were not subject to evaluation or
accordance with the opinion of the Standing
authorisation under previous Union legislation.
Committee on the Food Chain and Animal Health,
(2)
In accordance with Article 10(1)(b) and Article 10(7) of
HAS ADOPTED THIS REGULATION:
Regulation (EC) No 1831/2003, the preparation Lactoba
cillus pentosus (DSM 14025) was entered in the Register
of feed additives as a silage additive for all animal species.
Article 1
Authorisation of Lactobacillus pentosus (DSM 14025) as an
(3) In
accordance
with
Article
10(2)
in
conjunction
with additive in animal nutrition is denied.
Article 7 of Regulation (EC) No 1831/2003, an appli
cation was submitted for the authorisation of Lactobacillus
pentosus (DSM 14025) as a feed additive for all animal
species, with the request to classify it in the category
‘technological additives’ and in the functional group
Article 2
‘silage additives’. That application was accompanied by
Existing stocks of Lactobacillus pentosus (DSM 14025) and
the particulars and documents required under
premixtures containing it shall be withdrawn from the market
Article 7(3) of Regulation (EC) No 1831/2003.
as soon as possible and at the latest by 22 April 2012. Silage
produced with Lactobacillus pentosus (DSM 14025) before the
date of entry into force of this Regulation may be used up
until stocks are exhausted.
(4) The
European
Food
Safety
Authority
(the
Authority)
concluded in its opinion of 16 November 2011 ( 2 ) that
Lactobacillus pentosus (DSM 14025) is resistant to three
antibiotics used in human and veterinary medicine.
Article 3
( 1 ) OJ L 268, 18.10.2003, p. 29.
This Regulation shall enter into force on the 20th day following
( 2 ) EFSA Journal 2011; 9(11):2449.
its publication in the Official Journal of the European Union.

---

EN
1.2.2012 Official
Journal
of
the
European
Union L
29/37
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 January 2012.
For the Commission
The President
José Manuel BARROSO

---