HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 141/4
EN
Official Journal of the European Union
28.5.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 489/2013
of 27 May 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 double stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of
the coat protein and part of the intergenic region of the Israel Acute Paralysis Virus
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
substance a standard pharmacological and toxicological
approach, including the setting of a level of acceptable
daily intake, is not appropriate and that there is no need
Having regard to the Treaty on the Functioning of the European
to establish an MRL, applicable to honey, for double
Union,
stranded ribonucleic acid homologous to viral ribonucleic
acid coding for part of the coat protein and part of the
intergenic region of the Israel Acute Paralysis Virus for
Having regard to Regulation (EC) No 470/2009 of the European
bees.
Parliament and of the Council of 6 May 2009 laying down
Community procedures for the establishment of residue limits
of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and
(5) According
to
Article
5
of
Regulation
(EC)
No
470/2009
amending Directive 2001/82/EC of the European Parliament
the European Medicines Agency is to always consider the
and of the Council and Regulation (EC) No 726/2004 of the
use of MRLs established for a pharmacologically active
European Parliament and of the Council ( 1 ), and in particular
substance in a particular foodstuff for another foodstuff
Article 14 in conjunction with Article 17 thereof,
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 the opinion of the European Medicines
Products for Veterinary Use has concluded that the extra
Agency formulated by the Committee for Medicinal Products
polation to other food producing species cannot be
for Veterinary Use,
supported for this substance.
Whereas:
(6) Table
1
of
the
Annex
to
Regulation
(EU)
No
37/2010
should therefore be amended to include the substance
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
double stranded ribonucleic acid homologous to viral
active substances intended for use in the Union in
ribonucleic acid coding for part of the coat protein and
veterinary medicinal products for food-producing
part of the intergenic region of the Israel Acute Paralysis
animals or in biocidal products used in animal
Virus for bees while establishing the absence of the need
husbandry should be established in accordance with
to establish a MRL, applicable to honey.
Regulation (EC) No 470/2009.
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding MRLs in foodstuffs of animal origin
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
are set out in the Annex to Commission Regulation
Committee on Veterinary Medicinal Products,
(EU) No 37/2010 of 22 December 2009 on pharmaco

logically active substances and their classification
regarding maximum residue limits in foodstuffs of
animal origin ( 2 ).
HAS ADOPTED THIS REGULATION:
(3) An
application
for
the
establishment
of
MRLs
for
double
stranded ribonucleic acid homologous to viral ribonucleic
acid coding for part of the coat protein and part of the
Article 1
intergenic region of the Israel Acute Paralysis Virus for
The Annex to Regulation (EU) No 37/2010 is amended as set
bees has been submitted to the European Medicines
out in the Annex to this Regulation.
Agency.
(4)
The Committee for Medicinal Products for Veterinary Use
Article 2
has recommended that for this pharmacologically active
This Regulation shall enter into force on the twentieth day
( 1 ) OJ L 152, 16.6.2009, p. 11.
following that of its publication in the Official Journal of the
( 2 ) OJ L 15, 20.1.2010, p. 1.
European Union.

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EN
28.5.2013 Official
Journal
of
the
European
Union L
141/5
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 May 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following substance is inserted in alphabetical order:
Other Provisions
Pharmacologically active
(according to
Therapeutic
Substance
Marker residue
Animal
Species
MRL
Target
Tissues
Article 14(7) of
Regulation (EC)
Classification
No 470/2009)
‘Double stranded ribo NOT
Bees No
MRL
Honey NO
ENTRY NO
ENTRY’
nucleic acid homologous APPLICABLE
required
to viral ribonucleic acid
coding for part of the
coat protein and part of
the intergenic region of
the Israel Acute Paralysis
Virus

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Document Outline

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