HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
30.10.2013 Official
Journal
of
the
European
Union L
288/63
COMMISSION IMPLEMENTING REGULATION (EU) No 1057/2013
of 29 October 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 manganese carbonate
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4)
An application for the extension of the existing entry for
manganese carbonate to include parenteral use in bovine
species has been submitted to the European Medicines
Agency.
Having regard to the Treaty on the Functioning of the European
Union,
(5) 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 other 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,
(6)
The Committee for Medicinal Products for Veterinary Use
recommended the extension of MRL for manganese
carbonate in bovine species to include parenteral use,
and has recommended the extrapolation of the MRLs
Having regard to the opinion of the European Medicines
for manganese carbonate in bovine species to all food-
Agency formulated by the Committee for Medicinal Products
producing species.
for Veterinary Use,
(7) Regulation
(EU)
No
37/2010
should
therefore
be
Whereas:
amended to include the substance manganese carbonate
for parenteral use in all food-producing species.
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
active substances intended for use in the Union in
(8) The
measures
provided
for
in
this
Regulation
are
in
veterinary medicinal products for food-producing
accordance with the opinion of the Standing
animals or in biocidal products used in animal
Committee on Veterinary Medicinal Products,
husbandry are established in accordance with Regulation
(EC) No 470/2009.
HAS ADOPTED THIS REGULATION:
(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 (
Article 1

2 ).
The Annex to Regulation (EU) No 37/2010 is amended as set
out in the Annex to this Regulation.
(3) Manganese
carbonate
is
currently
included
in
Table
1
of
the Annex to Regulation (EU) No 37/2010 as an allowed
substance, for all food-producing species, for oral use
Article 2
only.
This Regulation shall enter into force on the third day following
( 1 ) OJ L 152, 16.6.2009, p. 11.
that of its publication in the Official Journal of the European
( 2 ) OJ L 15, 20.1.2010, p. 1.
Union.

---

L 288/64
EN
Official Journal of the European Union
30.10.2013
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2013.
For the Commission
The President
José Manuel BARROSO

---

30.10.2013 Off
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance manganese carbonate is replaced by the following:
Pharmacologically active
Other Provisions (according to
substance
Marker residue Animal
Species MRL Target
Tissues
Article 14(7) of Regulation (EC)
Therapeutic Classification
No 470/2009)
EN

‘Manganese carbonate NOT
APPLICABLE All
food
producing
species NO
MRL
REQUIRED NOT
APPLICABLE NO
ENTRY Alimentary
tract
and
metabolism/mineral
supplements’
icial
Jour
nal
of
the
European
Union
L
288/65

---

Document Outline

• �

---