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9.2.2012 Official
Journal
of
the
European
Union L
36/25
COMMISSION IMPLEMENTING REGULATION (EU) No 107/2012
of 8 February 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 octenidine dihydrochloride
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
pharmacologically active substances and their classifi
cation regarding maximum residue limits in foodstuffs
of animal origin (
Having regard to the Treaty on the Functioning of the European

2 ).
Union,
(3) An
application
for
the
establishment
of
maximum
residue limits (hereinafter 'MRL') for octenidine dihydro
Having regard to Regulation (EC) No 470/2009 of the European
chloride for cutaneous use in all mammalian food-
Parliament and of the Council of 6 May 2009 laying down
producing species has been submitted to the European
Community procedures for the establishment of residue limits
Medicines Agency.
of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and
(4)
The Committee for Medicinal Products for Veterinary Use
amending Directive 2001/82/EC of the European Parliament
has recommended that there is no need to establish an
and of the Council and Regulation (EC) No 726/2004 of the
MRL for octenidine dihydrochloride in all mammalian
European Parliament and of the Council ( 1 ), and in particular
food-producing species, for cutaneous use only.
Article 14 in conjunction with Article 17 thereof,
(5) Table
1
of
the
Annex
to
Regulation
(EU)
No
37/2010
Having regard to the opinion of the European Medicines
should therefore be amended to include the substance
Agency formulated by the Committee for Medicinal Products
octenidine dihydrochloride for cutaneous use in all
for Veterinary Use,
mammalian food-producing species.
(6) 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 veterinary
HAS ADOPTED THIS REGULATION:
medicinal products for food-producing animals or in
biocidal products used in animal husbandry should be
Article 1
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
Article 2
cation regarding maximum residue limits in foodstuffs
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 February 2012.
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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L 36/26
EN
Official Journal of the European Union
9.2.2012
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
active Substance
Marker residue Animal
Species MRL Target
Tissues
Article 14(7) of
Therapeutic Classification
Regulation (EC)
No 470/2009)
'Octenidine
Not applicable All
mammalian
No MRL required Not
applicable For
cutaneous
use
Anti-infectious agents/
dihydrochloride
food-producing
only.
Antiseptics'
species

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Document Outline

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