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EN
Official Journal of the European Union
18.2.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 140/2012
of 17 February 2012
concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying
(holder of authorisation Huvepharma NV Belgium)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 15 November 2011 ( 3 )
Having regard to the Treaty on the Functioning of the European
that, under the proposed conditions of use, monensin
Union,
sodium does not have an adverse effect on human
health, animal health or the environment, and that its
Having regard to Regulation (EC) No 1831/2003 of the
use is efficacious in controlling eimeria infections. It
European Parliament and of the Council of 22 September
also verified the report on the method of analysis of
2003 on additives for use in animal nutrition ( 1 ), and in
the feed additive in feed submitted by the Reference
particular Article 9(2) thereof,
Laboratory set up by Regulation (EC) No 1831/2003.
Whereas:
(6) The
assessment
of
monensin
sodium
shows
that
the
conditions for authorisation, as provided for in
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
orisation of additives for use in animal nutrition and
Accordingly, the use of this preparation should be auth
for the grounds and procedures for granting such auth
orised as specified in the Annex to this Regulation.
orisation.
(7) The
measures
provided
for
in
this
Regulation
are
in
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
accordance with the opinion of the Standing
1831/2003, an application was submitted for the auth
Committee on the Food Chain and Animal Health,
orisation of monensin sodium. That application was
accompanied by the particulars and documents required
HAS ADOPTED THIS REGULATION:
under Article 7(3) of Regulation (EC) No 1831/2003.
Article 1
(3) The
application
concerns
the
authorisation
of
monensin The preparation specified in the Annex, belonging to the
sodium as a feed additive for chickens reared for laying,
additive category ‘coccidiostats and histomonostats’, is auth
to be classified in the additive category ‘coccidiostats and
orised as an additive in animal nutrition, subject to the
histomonostats’.
conditions laid down in that Annex.
(4) The
use
of
monensin
sodium
was
authorised
for
10
years
Article 2
as a feed additive for use in chickens for fattening and
turkeys up to 16 weeks by Commission Regulation (EC)
This Regulation shall enter into force on the 20th day following
No 109/2007 ( 2 ).
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, 17 February 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 31, 6.2.2007, p. 6.
( 3 ) EFSA Journal 2011; 9(12):2442.

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18.2.2012 Off
ANNEX
Minimum Maximum
content
content
Provisional maximum
Identification Name of the
Species or
End of
residue limits (MRLs)
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
mg of active
Other provisions
period of
in the relevant
the additive
authorisation
(Trade name)
analytical method
animal
age
substance/kg of
authori
EN
complete feedingstuff
sation
foodstuffs of animal
origin

with a moisture content
of 12 %
Coccidiostats and histomonostats
51701 Huvepharma
Monensin
Additive composition
Chickens
16
100 125 1.
Use
prohibited
at
least
1
day
9 March 25 μg monensin
NV Belgium
sodium
reared for
weeks
before slaughter.
2022
sodium/kg of wet
(Coxidin)
Monensin sodium technical substance laying
skin + fat
equivalent to monensin activity: 25 %
2. The additive shall be incorporated
Perlite: 15 %–20 %
in compound feedingstuffs in the
8 μg monensin
Calcium carbonate q.s.100 %
form of a premixture.
sodium/kg of wet
liver, wet kidney
icial
3. Monensin sodium shall not be
Active substance
and wet muscle
mixed with other coccidiostats.

Jour
C 36H 61O 11Na
4. Indicate in the instructions for
nal
Sodium salt of polyether monocarboxylic
use:
acid produced by Streptomyces cinnamonensis
of
28682, LMG S-19095 in powder form.
‘Dangerous for equines. This feed
the
ingstuff contains an ionophore:
Factor composition
European
avoid simultaneous adminis
Monensin A: not less than 90 %
tration with tiamulin and
Monensin A + B: not less than 95 %
monitor for possible adverse
Monensin C: 0,2-0,3 %
reactions when used concurrently
Union
with other medicinal substances’.
Analytical method (1 )
5. Wear suitable protective clothing,
Method for determination of the active
gloves and eye/face protection. In
substance: high performance liquid chroma
case of insufficient ventilation in
tography (HPLC) with post-column derivati
the premises, wear suitable
sation and UV-VIS (EN ISO standard method
respiratory equipment.
14183:2008)
6. A
post-market
monitoring
programme on the resistance to
Eimeria spp. shall be planned
and executed by the holder of
authorisation.
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
L
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