HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 336/14
EN
Official Journal of the European Union
8.12.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1161/2012
of 7 December 2012
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 fenbendazole
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substance, for all ruminants, applicable to muscle, fat,
liver, kidney and milk, and for porcine and equidae
species applicable to muscle, fat, liver and kidney.
Having regard to the Treaty on the Functioning of the European
Union,
(4)
An application for the extension of the existing entry for
fenbendazole to include chicken has been submitted to
the European Medicines Agency.
Having regard to Regulation (EC) No 470/2009 of the European
Parliament and of the Council of 6 May 2009 laying down
(5) According
to
Article
5
of
Regulation
(EC)
No
470/2009
Community procedures for the establishment of residue limits
the European Medicines Agency is to consider using
of pharmacologically active substances in foodstuffs of animal
MRLs established for a pharmacologically active
origin, repealing Council Regulation (EEC) No 2377/90 and
substance in a particular foodstuff for another foodstuff
amending Directive 2001/82/EC of the European Parliament
derived from the same species, or MRLs established for a
and of the Council and Regulation (EC) No 726/2004 of the
pharmacologically active substance in one or more
European Parliament and of the Council (
species for other species. The Committee for Medicinal

1 ), and in particular
Article 14 in conjunction with Article 17 thereof,
Products for Veterinary Use CVMP recommended the
extrapolation of the MRLs for fenbendazole from all
ruminants, porcine and equidae species to all food-
producing species except fin fish, applicable to muscle,
fat, liver, kidney, milk and eggs.
Having regard to the opinion of the European Medicines
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,
(6) The
entry
for
fenbendazole
in
Table
1
of
the
Annex
to
Regulation (EU) No 37/2010 should therefore be
amended to include all food-producing species except
fin fish, and the target tissue eggs.
Whereas:
(7) It
is
appropriate
to
provide
for
a
reasonable
period
of
time for the stakeholders concerned to take measures
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
that may be required to comply with the newly set MRL.
active substances intended for use in the Union in
veterinary medicinal products for food-producing
animals or in biocidal products used in animal
(8) The
measures
provided
for
in
this
Regulation
are
in
husbandry should be established in accordance with
accordance with the opinion of the Standing
Regulation (EC) No 470/2009.
Committee on Veterinary Medicinal Products,
HAS ADOPTED THIS REGULATION:
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding MRLs in foodstuffs of animal origin
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
This Regulation shall enter into force on the third day following
(3) Fenbendazole
is
currently
included
in
Table
1
of
the that of its publication in the Official Journal of the European
Annex to Regulation (EU) No 37/2010 as an allowed
Union.
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.
It shall apply from 6 February 2013.

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EN
8.12.2012 Official
Journal
of
the
European
Union L
336/15
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 December 2012.
For the Commission
The President
José Manuel BARROSO

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L 336/16
ANNEX
The entry corresponding to fenbendazole in Table 1 of the Annex to Regulation (EU) No 37/2010 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
EN
No 470/2009)

‘Fenbendazole Sum
of
extractable
residues
which
All food-producing species
50 μg/kg Muscle For
porcine
and
poultry
species
Antiparasitic agents/Agents against
may be oxidised to oxfendazole except fin fish
50 μg/kg Fat
the fat MRL relates to “skin and endoparasites’
sulfone
500 μg/kg Liver
fat in natural proportions”
50 μg/kg Kidney
10 μg/kg Milk
1 300 μg/kg Eggs
Off
icial
Jour
nal
of
the
European
Union
8.12.2012

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Document Outline

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