HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 100/26
EN
Official Journal of the European Union
14.4.2011
COMMISSION REGULATION (EU) No 362/2011
of 13 April 2011
amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and
their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the
substance monepantel
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
for ovine and caprine species, applicable to muscle, fat,
liver and kidney, excluding animals producing milk for
human consumption. The provisional maximum residue
limits (hereinafter ‘MRLs’) for that substance set out for
Having regard to the Treaty on the Functioning of the European
caprine species will expire on 1 January 2011.
Union,
(4) An
application
for
the
extension
of
the
expiry
date
for
Having regard to Regulation (EC) No 470/2009 of the European
provisional MRLs of the existing entry for monepantel
Parliament and of the Council of 6 May 2009 laying down
applicable to caprine species has been submitted to the
Community procedures for the establishment of residue limits
European Medicines Agency.
of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and
amending Directive 2001/82/EC of the European Parliament
and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council ( 1 ), and in particular
(5)
The Committee for Medicinal Products for Veterinary Use
Article 14, in conjunction with Article 17, thereof,
has recommended the extension of the time period for
which the provisional MRLs for monepantel for caprine
species apply.
Having regard to the opinion of the European Medicines
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,
(6) The
entry
for
monepantel
in
Table
1
of
the
Annex
to
Regulation (EU) No 37/2010 should therefore be
amended to extend the provisional MRLs for caprine
species. The provisional MRLs set out in that Table for
Whereas:
monepantel for caprine species should expire on
1 January 2012.
(1) The
maximum
residue
limit
for
pharmacologically
active
substances intended for use in the Union in veterinary
medicinal products for food-producing animals or in
(7) The
measures
provided
for
in
this
Regulation
are
in
biocidal products used in animal husbandry should be
accordance with the opinion of the Standing
established in accordance with Regulation (EC)
Committee on Veterinary Medicinal Products,
No 470/2009.
HAS ADOPTED THIS REGULATION:
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding maximum residue limits in foodstuffs
of animal origin are set out in the Annex to Commission
Regulation (EU) No 37/2010 of 22 December 2009 on
pharmacologically active substances and their classifi
Article 1
cation regarding maximum residue limits in foodstuffs
of animal origin ( 2 ).
The Annex to Regulation (EU) No 37/2010 is amended as set
out in the Annex to this Regulation.
(3)
Monepantel is currently included in Table 1 of the Annex
to Regulation (EU) No 37/2010 as an allowed substance,
Article 2
( 1 ) OJ L 152, 16.6.2009, p. 11.
This Regulation shall enter into force on the third day following
( 2 ) OJ L 15, 20.1.2010, p. 1.
its publication in the Official Journal of the European Union.

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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/27
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 April 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX
The entry Monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 shall be replaced by the following:
Pharmacologically
Other Provisions (according to
active Substance
Marker residue Animal
Species MRL Target
Tissues
Article 14(7) of Regulation (EC)
Therapeutic Classification
No 470/2009)
‘Monepantel Monepantel-sulfone Ovine 700
μg/kg
Muscle
Not for use in animals Antiparasitic agents/Agents
producing milk for human acting against endoparasites
7 000 μg/kg Fat
consumption.
5 000 μg/kg Liver
2 000 μg/kg Kidney
Caprine 700
μg/kg
Muscle
Provisional MRLs shall Antiparasitic agents/Agents
expire on 1 January 2012. acting against endoparasites’
7 000 μg/kg Fat
Not for use in animals
5 000 μg/kg Liver
producing milk for human
2 000 μg/kg Kidney
consumption.

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