HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 100/28
EN
Official Journal of the European Union
14.4.2011
COMMISSION REGULATION (EU) No 363/2011
of 13 April 2011
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 isoeugenol
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) An
application
for
the
establishment
of
maximum
residue limits (hereinafter ‘MRL’) for isoeugenol in
Atlantic salmon and rainbow trout has been submitted
Having regard to the Treaty on the Functioning of the European
to the European Medicines Agency.
Union,
(4)
The Committee for Medicinal Products for Veterinary Use
Having regard to Regulation (EC) No 470/2009 of the European
recommended establishing MRL for isoeugenol for fin
Parliament and of the Council of 6 May 2009 laying down
fish species, applicable to muscle and skin in natural
Community procedures for the establishment of residue limits
proportions.
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
(5) Table
1
of
the
Annex
to
Regulation
(EU)
No
37/2010
and of the Council and Regulation (EC) No 726/2004 of the
should therefore be amended to include MRL for the
European Parliament and of the Council ( 1 ), and in particular
substance isoeugenol for fin fish species.
Article 14, in conjunction with Article 17, thereof,
(6) It
is
appropriate
to
provide
for
a
reasonable
period
of
Having regard to the opinion of the European Medicines
time for the stakeholders concerned to take measures
Agency formulated by the Committee for Medicinal Products
that may be required to comply with the newly set MRL.
for Veterinary Use,
(7) The
measures
provided
for
in
this
Regulation
are
in
Whereas:
accordance with the opinion of the Standing
Committee on Veterinary Medicinal Products,
(1) The
maximum
residue
limit
for
pharmacologically
active substances intended for use in the Union in
HAS ADOPTED THIS REGULATION:
veterinary medicinal products for food-producing
animals or in biocidal products used in animal
Article 1
husbandry should be established in accordance with
Regulation (EC) No 470/2009.
The Annex to Regulation (EU) No 37/2010 is amended as set
out in the Annex to this Regulation.
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding maximum residue limits in foodstuffs
Article 2
of animal origin are set out in the Annex to Commission
This Regulation shall enter into force on the third day following
Regulation (EU) No 37/2010 of 22 December 2009 on
its publication in the Official Journal of the European Union.
pharmacologically active substances and their classifi
cation regarding maximum residue limits in foodstuffs
of animal origin ( 2 ).
It shall apply from 14 July 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 April 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) OJ L 15, 20.1.2010, p. 1.

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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/29
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following substance is inserted in alphabetical order:
Other Provisions
Pharmacologically
(according to
Therapeutic
active Substance
Marker residue Animal
Species MRL Target
Tissues
Article 14(7) of
Regulation (EC) No
Classification
470/2009)
‘Isoeugenol Isoeugenol Fin
fish 6
000
μg/kg Muscle
and
skin
in
Not applicable Agents
acting
on
the
natural
nervous system/Agents
proportions
acting on the central
nervous system’

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