HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 143/2
EN
Official Journal of the European Union
2.6.2012
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 466/2012
of 1 June 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 clorsulon
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Ireland
has
submitted
to
the
European
Medicines
Agency
a request for an opinion for the extrapolation of the
existing entry for clorsulon applicable to bovine milk.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
The Committee for Medicinal Products for Veterinary Use
(CVMP) has recommended the establishment of a
provisional MRL for clorsulon for bovine milk and the
Having regard to Regulation (EC) No 470/2009 of the European
removal of the provision banning the use of that
Parliament and of the Council of 6 May 2009 laying down
substance in animals from which milk is produced for
Community procedures for the establishment of residue limits
human consumption.
of pharmacologically active substances in foodstuffs of animal

origin, repealing Council Regulation (EEC) No 2377/90 and
amending Directive 2001/82/EC of the European Parliament
(6) The
entry
for
clorsulon
in
Table
1
of
the
Annex
to
and of the Council and Regulation (EC) No 726/2004 of the
Regulation (EU) No 37/2010 should therefore be
European Parliament and the Council ( 1 ), and in particular
amended to include the recommended provisional MRL
Article 14 in conjunction with Article 17 thereof,
for bovine milk and to remove the existing ban.
Having regard to the opinion of the European Medicines
(7)
The provisional MRL for clorsulon set out in that Table
Agency formulated by the Committee for Medicinal Products
should expire on 1 January 2014. The CVMP recom
for Veterinary Use,
mended a two-year period to allow for the completion
of scientific studies required to respond to the list of
questions addressed by the CVMP to Ireland.
Whereas:
(8) 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
active substances intended for use in the Union in
that may be required to comply with the newly set MRL.
veterinary medicinal products for food-producing
animals or in biocidal products used in animal
husbandry should be established in accordance with
(9) 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
HAS ADOPTED THIS REGULATION:
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
Article 1
logically active substances and their classification
regarding MRLs in foodstuffs of animal origin ( 2 ).
The Annex to Regulation (EU) No 37/2010 is amended as set
out in the Annex to this Regulation.
(3)
Clorsulon is currently included in Table 1 of the Annex
to Regulation (EU) No 37/2010 as an allowed substance,
Article 2
for bovine species, applicable to muscle, liver and
This Regulation shall enter into force on the third day following
kidney, excluding animals producing milk for human
that of its publication in the Official Journal of the European
consumption.
Union.
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.
It shall apply from 1 August 2012.

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EN
2.6.2012 Official
Journal
of
the
European
Union L
143/3
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 June 2012.
For the Commission
The President
José Manuel BARROSO

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L 143/4
ANNEX
The entry corresponding to clorsulon in Table 1 of the Annex to Regulation (EU) No 37/2010 is replaced by the following:
Other provisions
Pharmacologically active substance Marker
residue Animal
species MRL Target
tissues
(according to Article 14(7) of
Therapeutic classification
Regulation (EC) No 470/2009)
EN

‘Clorsulon Clorsulon Bovine 35
μg/kg Muscle Antiparasitic
agents/Agents
against
100 μg/kg Liver
endoparasites’
200 μg/kg Kidney
16 μg/kg Milk Provisional
MRL
shall
expire
on 1 January 2014
Off
icial
Jour
nal
of
the
European
Union
2.6.2012

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Document Outline

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