HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 38/14
EN
Official Journal of the European Union
9.2.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 116/2013
of 8 February 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 eprinomectin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substance in a particular foodstuff for another foodstuff
derived from the same species, or MRLs established for a
pharmacologically active substance in one or more
Having regard to the Treaty on the Functioning of the European
species for other species. The Committee for Medicinal
Union,
Products for Veterinary Use recommended the estab
lishment of a provisional MRL for eprinomectin for
Having regard to Regulation (EC) No 470/2009 of the European
ovine species, applicable to muscle, fat, liver, kidney
Parliament and of the Council of 6 May 2009 laying down
and milk, and the extrapolation of the MRLs for eprino
Community procedures for the establishment of residue limits
mectin from ovine and bovine species, applicable to
of pharmacologically active substances in foodstuffs of animal
muscle, fat, liver, kidney and milk to caprine species,
origin, repealing Council Regulation (EEC) No 2377/90 and
establishing a provisional MRL, applicable to muscle,
amending Directive 2001/82/EC of the European Parliament
fat, liver, kidney and milk.
and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council ( 1 ), and in particular
Article 14 in conjunction with Article 17 thereof,
(6) The
CVMP
recommended
the
establishment
of
a
provisional MRL for ovine and caprine species as the
scientific data is incomplete for the proposed analytical
Having regard to the opinion of the European Medicines
method for monitoring residues in ovine and caprine
Agency formulated by the Committee for Medicinal Products
species.
for Veterinary Use,
Whereas:
(7) The
entry
for
eprinomectin
in
Table
1
of
the
Annex
to
Regulation (EU) No 37/2010 should therefore be
amended to include the provisional MRLs for ovine
(1) The
maximum
residue
limit
(hereinafter
‘MRL’)
for
phar
and caprine species, applicable to muscle, fat, liver,
macologically active substances intended for use in the
kidney and milk. The provisional MRLs set out in that
Union in veterinary medicinal products for food-
Table for ovine and caprine species should expire on
producing animals or in biocidal products used in
1 July 2014.
animal husbandry should be established in accordance
with Regulation (EC) No 470/2009.
(8) It
is
appropriate
to
provide
for
a
reasonable
period
of
time for the stakeholders concerned to take measures
(2) Pharmacologically
active
substances
and
their
classifi
that may be required to comply with the newly set MRL.
cation regarding MRLs in foodstuffs of animal origin
are set out in the Annex to Commission Regulation
(EU) No 37/2010 of 22 December 2009 on pharmaco
logically active substances and their classification
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
regarding maximum residue limits in foodstuffs of
Committee on Veterinary Medicinal Products,
animal origin (


2 ).
(3) Eprinomectin
is
currently
included
in
Table
1
of
the HAS ADOPTED THIS REGULATION:
Annex to Regulation (EU) No 37/2010 as an allowed
substance, for bovine species, applicable to muscle, fat,
liver kidney and milk.
Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set
(4)
An application for the extension of the existing entry for
out in the Annex to this Regulation.
eprinomectin applicable to ovine species has been
submitted to the European Medicines Agency.
Article 2
(5) According
to
Article
5
of
Regulation
(EC)
No
470/2009 This Regulation shall enter into force on the twentieth day
the European Medicines Agency is to consider using
following that of its publication in the Official Journal of the
MRLs established for a pharmacologically active
European Union.
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.
It shall apply from 10 April 2013.

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EN
9.2.2013 Official
Journal
of
the
European
Union L
38/15
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 February 2013.
For the Commission
The President
José Manuel BARROSO

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L 38/16
ANNEX
The entry corresponding to eprinomectin in Table 1 of the Annex to Regulation (EU) No 37/2010 is replaced by the following:
Pharmacologically active
Substance
Marker residue Animal
Species MRL Target
Tissues
Other Provisions (according to Article 14(7) of
Regulation (EC) No 470/2009)
Therapeutic Classification
EN
‘Eprinomectin Eprinomectin
B1a Bovine 50
μg/kg Muscle NO
ENTRY Antiparasitic
agents/Agents
acting
against

250 μg/kg Fat
endo- and ectoparasites’
1 500 μg/kg Liver
300 μg/kg Kidney
20 μg/kg Milk
Ovine, caprine 50
μg/kg Muscle The
MRLs
laid
down
for
these
animal
species
250 μg/kg Fat
are provisional MRLs. They shall expire on
1 500 μg/kg Liver
1 July 2014.
300 μg/kg Kidney
20 μg/kg Milk
Off
icial
Jour
nal
of
the
European
Union
9.2.2013

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Document Outline

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