HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 8/20
EN
Official Journal of the European Union
11.1.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 20/2014
of 10 January 2014
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 butafosfan
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
The Committee for Medicinal Products for Veterinary Use
recommended that there is no need to establish an MRL
for butafosfan for porcine species.
Having regard to the Treaty on the Functioning of the European
Union,
(6) According
to
Article
5
of
Regulation
(EC)
No
470/2009
the European Medicines Agency is to consider using
Having regard to Regulation (EC) No 470/2009 of the European
MRLs established for a pharmacologically active
Parliament and of the Council of 6 May 2009 laying down
substance in a particular foodstuff for another foodstuff
Community procedures for the establishment of residue limits
derived from the same species, or MRLs established for a
of pharmacologically active substances in foodstuffs of animal
pharmacologically active substance in one or more
origin, repealing Council Regulation (EEC) No 2377/90 and
species for another species.
amending Directive 2001/82/EC of the European Parliament

and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council ( 1 ), and in particular
Article 14 in conjunction with Article 17 thereof,
(7) The
CVMP
recommended
the
extrapolation
of
the
evaluation results of butafosfan from bovine and
Having regard to the opinion of the European Medicines
porcine species to all mammalian food-producing
Agency formulated by the Committee for Medicinal Products
species.
for Veterinary Use,
Whereas:
(8) The
entry
for
butafosfan
in
Table
1
of
the
Annex
to
Regulation (EU) No 37/2010 should therefore be
amended to include the substance butafosfan for all
mammalian food-producing species, while establishing
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
the absence of the need to establish an MRL.
active substances intended for use in the Union in
veterinary medicinal products for food-producing
animals or in biocidal products used in animal
husbandry are established in accordance with Regulation
(EC) No 470/2009.
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on Veterinary Medicinal Products,
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding MRLs in foodstuffs of animal origin
are set out in the Annex to Commission Regulation
(EU) No 37/2010 (
HAS ADOPTED THIS REGULATION:

2 ).
(3)
Butafosfan is currently included in Table 1 of the Annex
to Regulation (EU) No 37/2010 as an allowed substance
Article 1
for bovine species, while establishing the absence of the
The Annex to Regulation (EU) No 37/2010 is amended as set
need to establish an MRL.
out in the Annex to this Regulation.
(4)
An application for the extension of the existing entry for
butafosfan applicable to porcine species has been
Article 2
submitted to the European Medicines Agency.
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
11.1.2014 Official
Journal
of
the
European
Union
L
8/21
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 January 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance butafosfan is replaced by the
following:
Other provisions
Pharmacologically
(according to
Therapeutic
active substance Marker residue Animal
species MRL Target
tissues
Article 14(7) of
Regulation (EC)
classification
No 470/2009)
‘Butafosfan NOT
All mammalian No MRL
NOT
NO ENTRY Alimentary
tract
APPLICABLE food producing required
APPLICABLE
and metabolism/
species
mineral supple
ments’

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Document Outline

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