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8.9.2011 Official
Journal
of
the
European
Union L
231/15
COMMISSION IMPLEMENTING REGULATION (EU) No 900/2011
of 7 September 2011
concerning the authorisation of lasalocid A sodium as a feed additive for pheasants, guinea fowl,
quails and partridges other than laying birds (holder of authorisation Alpharma (Belgium) BVBA)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
partridges other than laying birds. The European Food
Safety Authority (‘the Authority’) concluded in its
Having regard to the Treaty on the Functioning of the European
opinion of 16 March 2011 (
Union,

4 ) that, under the proposed
conditions of use, lasalocid A sodium, CAS number
Having regard to Regulation (EC) No 1831/2003 of the
25999-20-6, does not have an adverse effect on animal
European Parliament and of the Council of 22 September
health, human health or the environment and that it is
2003 on additives for use in animal nutrition ( 1 ), and in
efficacious to control coccidiosis in the target species. It
particular Article 9(2) thereof,
considers that there is a need for specific requirements of
a post-market monitoring program on the resistance to
Whereas:
bacteria and Eimeria spp. It also verified the report on the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
method of analysis of the feed additive in feed submitted
orisation of additives for use in animal nutrition and
by the Community Reference Laboratory set up by Regu
for the grounds and procedures for granting such auth
lation (EC) No 1831/2003.
orisation.
(6) The
assessment
of
lasalocid
A
sodium,
CAS
number
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
25999-20-6, shows that the conditions for authorisation,
1831/2003, an application was submitted for the auth
as provided for in Article 5 of Regulation (EC) No
orisation of lasalocid A sodium, CAS number 25999-20-
1831/2003, are satisfied. Accordingly, the use of this
6. The application was accompanied by the particulars
preparation should be authorised as specified in the
and documents required pursuant to Article 7(3) of
Annex to this Regulation.
Regulation (EC) No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in
(3) The
application
concerns
the
authorisation
of
lasalocid
A
accordance with the opinion of the Standing
sodium, CAS number 25999-20-6, as a feed additive for
Committee on the Food Chain and Animal Health,
pheasants, guinea fowl, quails and partridges other than
laying birds, to be classified in the additive category
HAS ADOPTED THIS REGULATION:
‘coccidiostats and histomonostats’.
Article 1
(4) The
use
of
that
preparation
was
authorised
for
10
years The preparation specified in the Annex, belonging to the
for chickens for fattening and for chickens reared for
additive category ‘coccdiostats and histomonostats’ is authorised
laying up to 16 weeks by Commission Regulation (EC)
as an additive in animal nutrition, subject to the conditions laid
No 1455/2004 ( 2 ), and for turkeys up to 16 weeks by
down in that Annex.
Commission Regulation (EU) No 874/2010 ( 3 ).
Article 2
(5) New
data
were
submitted
in
support
of
the
application
for authorisation of lasalocid A sodium, CAS number
This Regulation shall enter into force on the 20th day following
25999-20-6, for pheasants, guinea fowl, quails and
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, 7 September 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 269, 17.8.2004, p. 14.
( 3 ) OJ L 263, 6.10.2010, p. 1.
( 4 ) The EFSA Journal 2011; 9(4):2116.

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L 231/16
ANNEX
Minimum
Maximum
Maximum
Identification Name of the
Species or
content
content
Residue Limits
number of
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of (MRLs) in the
the additive authorisation
analytical method
animal
age
authorisation
relevant
mg/kg of complete feedingstuff
foodstuffs of
with a moisture content of 12 %
EN
animal origin

Category of coccidiostats and histomonostats
5 1 763 Alpharma Lasalocid A Additive composition:
Pheasants,
— 75 125 1.
Use
prohibited
at
least
5
days
28 September Commission
(Belgium)
sodium
guinea fowl,
before slaughter.
2021
Regulation (EU)
BVBA
15 g/100 g Lasalocid A sodium: 15 g/100 g
quails and
2. Indicate in the instructions for
No 37/2010 (3 )
(Avatec
Calcium sulphate dihydrate:
partridges
use:
150 G)
80,9 g/100 g
except laying
‘Dangerous for equine species’
Calcium lignosulphonate: 4 g/100 g
birds
Ferric oxide: 0,1 g/100 g
thereof.
‘This feedingstuff contains an
Off
ionophore: simultaneous use
icial
Active substance:
with certain medicinal
substances can be contra-
Jour
Lasalocid A sodium,
indicated’.
C
nal
34H 53NaO 8,
3. A post-market monitoring
CAS number: 25999-20-6,
program on the resistance to
of
sodium salt of 6-[(3R, 4S, 5S, 7R)-7-
bacteria and Eimeria spp. shall
the
[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-
be planned and executed by
5-ethyl—5-hydroxy-6-methyltet
the holder of authorisation.
European
rahydro-2H-pyran2-yl]-tetrahydro-3-
4. The additive shall be incor
methyl-2-furyl]-4-hydroxy-3,5-
porated in compound feed in
dimethyl-6-oxononyl]-2 hydroxy-3-
the form of a premixture.
methyl benzoate, produced by Strep
Union
5. Lasalocid A sodium shall not
tomyces lasaliensis subsp. Lasaliensis
be mixed with other cocci
(ATCC 31180)
diostats.
Related impurities:
Lasalocid sodium B-E: ≤ 10 %
Analytical methods (1 ):
Reversed-phase high performance
liquid chromatography (HPLC) with
spectrofluorometric detector
(Commission Regulation (EC) No
152/2009) (2 )
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(2 ) OJ L 54, 26.2.2009, p. 1.
(3 ) OJ L 15, 20.1.2010, p. 1.
8.9.2011

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