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30.4.2013 Official
Journal
of
the
European
Union L
118/17
COMMISSION IMPLEMENTING REGULATION (EU) No 394/2013
of 29 April 2013
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,
(4)
An application for the extension of the existing entry for
monepantel applicable to ovine milk has been submitted
Having regard to the Treaty on the Functioning of the European
to the European Medicines Agency.
Union,
(5) According
to
Article
5
of
Regulation
(EC)
No
470/2009
Having regard to Regulation (EC) No 470/2009 of the European
the European Medicines Agency is to consider using
Parliament and of the Council of 6 May 2009 laying down
MRLs established for a pharmacologically active
Community procedures for the establishment of residue limits
substance in a particular foodstuff for another foodstuff
of pharmacologically active substances in foodstuffs of animal
derived from the same species, or MRLs established for a
origin, repealing Council Regulation (EEC) No 2377/90 and
pharmacologically active substance in one or more
amending Directive 2001/82/EC of the European Parliament
species for other species. The Committee for Medicinal
and of the Council and Regulation (EC) No 726/2004 of the
Products for Veterinary Use recommended the estab
European Parliament and of the Council ( 1 ), and in particular
lishment of a MRL for monepantel for ovine milk, and
Article 14 in conjunction with Article 17 thereof,
the extrapolation of the MRLs for monepantel from
ovine species, applicable to milk to caprine species,
Having regard to the opinion of the European Medicines
applicable to milk.
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
Whereas:
amended to include the MRLs for ovine and caprine
species, applicable to milk.
(1) The
maximum
residue
limit
(MRL)
for
pharmacologically
active substances intended for use in the Union in
(7) It
is
appropriate
to
provide
for
a
reasonable
period
of
veterinary medicinal products for food-producing
time for the stakeholders concerned to take measures
animals or in biocidal products used in animal
that may be required to comply with the newly set MRL.
husbandry should be established in accordance with
(8) The
measures
provided
for
in
this
Regulation
are
in
Regulation (EC) No 470/2009.
accordance with the opinion of the Standing
Committee on Veterinary Medicinal Products,
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding MRLs in foodstuffs of animal origin
HAS ADOPTED THIS REGULATION:
are set out in the Annex to Commission Regulation
Article 1
(EU) No 37/2010 of 22 December 2009 on pharmaco
logically active substances and their classification
The Annex to Regulation (EU) No 37/2010 is amended as set
regarding maximum residue limits in foodstuffs of
out in the Annex to this Regulation.
animal origin ( 2 ).
Article 2
(3)
Monepantel is currently included in Table 1 of the Annex
This Regulation shall enter into force on the twentieth day
to Regulation (EU) No 37/2010 as an allowed substance,
following that of its publication in the Official Journal of the
for ovine and caprine species, applicable to muscle, fat,
European Union.
liver and kidney, excluding animals producing milk for
human consumption.
It shall apply from 29 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.

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L 118/18
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry corresponding to monepantel is replaced by the following:
Pharmacologically active
Other Provisions (according to
Substance
Marker residue Animal
Species MRL Target
Tissues
Article 14(7) of Regulation (EC)
Therapeutic classification
No 470/2009)
EN

‘Monepantel Monepantel-sulfone Ovine,
caprine 700
μg/kg Muscle Antiparasitic
agents/Agents
7 000 μg/kg Fat
acting against endoparasites’
5 000 μg/kg Liver
2 000 μg/kg Kidney
170 μg/kg Milk
Off
icial
Jour
nal
of
the
European
Union
30.4.2013

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Document Outline

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