HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 338/20
EN
Official Journal of the European Union
12.12.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1186/2012
of 11 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 phoxim
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) According
to
Article
5
of
Regulation
(EC)
No
470/2009
the European Medicines Agency is to consider using
MRLs established for a pharmacologically active
Having regard to the Treaty on the Functioning of the European
substance in a particular foodstuff for another foodstuff
Union,
derived from the same species, or MRLs established for a
pharmacologically active substance in one or more
species for other species. The Committee for Medicinal
Having regard to Regulation (EC) No 470/2009 of the European
Products for Veterinary Use recommended establishing a
Parliament and of the Council of 6 May 2009 laying down
MRL for phoxim for bovine species applicable to muscle,
Community procedures for the establishment of residue limits
fat, liver and kidney, excluding animals producing milk
of pharmacologically active substances in foodstuffs of animal
for human consumption, and the extrapolation of the
origin, repealing Council Regulation (EEC) No 2377/90 and
MRLs for phoxim from ovine, bovine and porcine
amending Directive 2001/82/EC of the European Parliament
species, and chicken to all food-producing species
and of the Council and Regulation (EC) No 726/2004 of the
except fin fish, applicable to muscle, fat, liver, kidney
European Parliament and of the Council ( 1 ), and in particular
and eggs, excluding animals producing milk for human
Article 14 in conjunction with Article 17 thereof,
consumption.
Having regard to the opinion of the European Medicines
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,
(6) The
entry
for
phoxim
in
Table
1
of
the
Annex
to
Regu
lation (EU) No 37/2010 should therefore be amended to
include all food-producing species except fin fish.
Whereas:
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically (7) It
is
appropriate
to
provide
for
a
reasonable
period
of
active substances intended for use in the Union in
time for the stakeholders concerned to take measures
veterinary medicinal products for food-producing
that may be required to comply with the newly set MRL.
animals or in biocidal products used in animal
husbandry should be established in accordance with
Regulation (EC) No 470/2009.
(8) 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 of 22 December 2009 on pharmaco
logically active substances and their classification
HAS ADOPTED THIS REGULATION:
regarding maximum residue limits in foodstuffs of
animal origin ( 2 ).
Article 1
(3) Phoxim
is
currently
included
in
Table
1
of
the
Annex
to
Regulation (EU) No 37/2010 as an allowed substance, for
The Annex to Regulation (EU) No 37/2010 is amended as set
ovine species, applicable to muscle, fat and kidney, for
out in the Annex to this Regulation.
porcine species, applicable to muscle, skin and fat, liver
and kidney and for chicken, applicable to muscle, skin
and fat, liver, kidney and eggs, excluding animals
producing milk for human consumption.
Article 2
This Regulation shall enter into force on the third day following
(4)
An application for the extension of the existing entry for
that of its publication in the Official Journal of the European
phoxim to include bovine species has been submitted to
Union.
the European Medicines Agency.
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.
It shall apply from 13 February 2013.

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EN
12.12.2012 Official
Journal
of
the
European
Union L
338/21
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 December 2012.
For the Commission
The President
José Manuel BARROSO

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L 338/22
ANNEX
The entry corresponding to phoxim 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
No 470/2009)
EN

‘Phoxim Phoxim All
food-producing
species
25 μg/kg Muscle For
porcine
and
poultry
Antiparasitic agents/Agents
except fin fish.
550 μg/kg Fat
species the fat MRL relates against ectoparasites.’
50 μg/kg Liver
to “skin and fat in natural
30 μg/kg Kidney
proportions”.
60 μg/kg Eggs
Not for use in animals from
which milk is produced for
human consumption.
Off
icial
Jour
nal
of
the
European
Union
12.12.2012

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Document Outline

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