HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 71/40
EN
Official Journal of the European Union
9.3.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 202/2012
of 8 March 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 pegylated bovine granulocyte colony stimulating factor
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
pharmacologically active substances and their classifi
cation regarding maximum residue limits in foodstuffs
Having regard to the Treaty on the Functioning of the European
of animal origin ( 2 ).
Union,
(3) An
application
for
the
establishment
of
maximum
Having regard to Regulation (EC) No 470/2009 of the European
residue limits for pegylated bovine granulocyte colony
Parliament and of the Council of 6 May 2009 laying down
stimulating factor in bovine species has been submitted
Community procedures for the establishment of residue limits
to the European Medicines Agency.
of pharmacologically active substances in foodstuffs of animal
(4)
The Committee for Medicinal Products for Veterinary Use
origin, repealing Council Regulation (EEC) No 2377/90 and
has recommended that there is no need to establish an
amending Directive 2001/82/EC of the European Parliament
MRL for pegylated bovine granulocyte colony stimulating
and of the Council and Regulation (EC) No 726/2004 of the
factor in bovine species.
European Parliament and the Council ( 1 ), and in particular
Article 14 in conjunction with Article 17 thereof,
(5) Table
1
of
the
Annex
to
Regulation
(EU)
No
37/2010
should therefore be amended to include the substance
Having regard to the opinion of the European Medicines
pegylated bovine granulocyte colony stimulating factor
Agency formulated by the Committee for Medicinal Products
in bovine species.
for Veterinary Use,
(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
("MRL") for pharmaco
logically active substances intended for use in the
HAS ADOPTED THIS REGULATION:
Union in veterinary medicinal products for food-
Article 1
producing animals or in biocidal products used in
animal husbandry should be established in accordance
The Annex to Regulation (EU) No 37/2010 is amended as set
with Regulation (EC) No 470/2009.
out in the Annex to this Regulation.
Article 2
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding maximum residue limits in foodstuffs
This Regulation shall enter into force on the third day following
of animal origin are set out in the Annex to Commission
that of its publication in the Official Journal of the European
Regulation (EU) No 37/2010 of 22 December 2009 on
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 March 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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9.3.2012 Off
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following substance is inserted in alphabetical order:
Other Provisions (according to
Pharmacologically active Substance Marker
residue Animal
Species MRL Target
Tissues
Article 14(7) of Regulation (EC)
Therapeutic Classification
No 470/2009)
EN

“Pegylated bovine granulocyte colony Not applicable Bovine No
MRL
required Not
applicable NO
ENTRY Biological/Immunomodulator”
stimulating factor
icial
Jour
nal
of
the
European
Union
L
71/41

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Document Outline

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