HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 288/60
EN
Official Journal of the European Union
30.10.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1056/2013
of 29 October 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 neomycin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Use. As a result that Committee recommends the modi
fication of the current MRLs for neomycin.
Having regard to the Treaty on the Functioning of the European
Union,
(6) According
to
Article
5
of
Regulation
(EC)
No
470/2009
the European Medicines Agency is to consider using
Having regard to Regulation (EC) No 470/2009 of the European
MRLs established for a pharmacologically active
Parliament and of the Council of 6 May 2009 laying down
substance in a particular foodstuff for another foodstuff
Community procedures for the establishment of residue limits
derived from the same species, or MRLs established for a
of pharmacologically active substances in foodstuffs of animal
pharmacologically active substance in one or more
origin, repealing Council Regulation (EEC) No 2377/90 and
species for other species.
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
(7)
The Committee for Medicinal Products for Veterinary Use
Article 14 in conjunction with Article 17 thereof,
recommended the establishment of a revised MRL for
neomycin for bovine species, applicable to kidney and
liver, and the extrapolation of the revised MRLs for
Having regard to the opinion of the European Medicines
neomycin from cattle to all food-producing species.
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,
(8) Regulation
(EU)
No
37/2010
should
therefore
be
Whereas:
amended accordingly.
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
active substances intended for use in the Union in
(9) 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 are established in accordance with Regulation
(EC) No 470/2009.
(10) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(2) Pharmacologically
active
substances
and
their
classifi
Committee on Veterinary Medicinal Products,
cation regarding MRLs in foodstuffs of animal origin
are set out in the Annex to Commission Regulation
(EU) No 37/2010 ( 2 ).
HAS ADOPTED THIS REGULATION:
(3)
Neomycin is currently included in Table 1 of the Annex
to Regulation (EU) No 37/2010 as an allowed substance,
for all food-producing species, applicable to muscle, fat,
Article 1
liver, kidney, milk and eggs.
The Annex to Regulation (EU) No 37/2010 is amended as set
out in the Annex to this Regulation.
(4)
An application for the modification of the existing entry
for neomycin has been submitted to the European
Medicines Agency.
Article 2
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
(5) Additional
data
on
neomycin
was
provided
and
assessed European Union.
by the Committee for Medicinal Products for Veterinary
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.
It shall apply from 30 December 2013.

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EN
30.10.2013 Official
Journal
of
the
European
Union L
288/61
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 288/62
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance neomycin 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
‘Neomycin (including
Neomycin B All
food
producing
species 500
μg/kg Muscle For
fin
fish
the
muscle
MRL
relates
to
Anti-infectious

framycetin)
“muscle and skin in natural proportions”. agents/Antibiotics’
500 μg/kg Fat
MRLs for fat, liver and kidney do not
5 500 μg/kg Liver
apply to fin fish.
9 000 μg/kg Kidney
For porcine and poultry species the fat
1 500 μg/kg Milk
MRL relates to “skin and fat in natural
proportions”
500 μg/kg Eggs
Off
icial
Jour
nal
of
the
European
Union
30.10.2013

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Document Outline

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