HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 8/18
EN
Official Journal of the European Union
11.1.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 19/2014
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 chloroform
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) An
application
for
the
establishment
of
maximum
residue limits for chloroform in all ruminants and
porcine species has been submitted to the European
Medicines Agency.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
The Committee for Medicinal Products for Veterinary Use
Having regard to Regulation (EC) No 470/2009 of the European
(‘CVMP’) recommended that there is no need to establish
Parliament and of the Council of 6 May 2009 laying down
an MRL for chloroform for all ruminants and porcine
Community procedures for the establishment of residue limits
species.
of pharmacologically active substances in foodstuffs of animal
origin, repealing Council Regulation (EEC) No 2377/90 and
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
(6) For
the
protection
of
human
health
it
has
to
be
ensured
Article 14 in conjunction with Article 17 thereof,
that consumer exposure to residues will remain below
the acceptable daily intake, as specified in Article 6 of
Regulation (EC) No 470/2009. Therefore, it is necessary
to restrict the use of chloroform to excipients in vaccines
Having regard to the opinion of the European Medicines
and to limit the amount of the substance that can be
Agency formulated by the Committee for Medicinal Products
administered.
for Veterinary Use,
Whereas:
(7) According
to
Article
5
of
Regulation
(EC)
No
470/2009
the European Medicines Agency is to consider using
MRLs established for a pharmacologically active
substance in a particular foodstuff for another foodstuff
(1) The
maximum
residue
limit
(‘MRL’)
for
pharmacologically
derived from the same species, or MRLs established for a
active substances intended for use in the Union in
pharmacologically active substance in one or more
veterinary medicinal products for food-producing
species for another species. The CVMP recommended
animals or in biocidal products used in animal
the extrapolation of the absence of the need to
husbandry are established in accordance with Regulation
establish a MRL for chloroform from all ruminants and
(EC) No 470/2009.
porcine species to all mammalian food producing
species.
(2) Pharmacologically
active
substances
and
their
classifi
cation regarding MRLs in foodstuffs of animal origin
are set out in the Annex to Commission Regulation
(8) Table
1
of
the
Annex
to
Regulation
(EU)
No
37/2010
(EU) No 37/2010 ( 2 ).
should be amended to include the substance chloroform
for all mammalian food producing species, while estab
lishing the absence of the need to establish a MRL, and
the entry for chloroform in Table 2 of that Annex should
(3) Chloroform
is
currently
included
in
Table
2
of
the
Annex
be deleted.
to Regulation (EU) No 37/2010 as a prohibited
substance.
( 1 ) OJ L 152, 16.6.2009, p. 11.
( 2 ) Commission Regulation (EU) No 37/2010 of 22 December 2009 on
(9) The
measures
provided
for
in
this
Regulation
are
in
pharmacologically active substances and their classification regarding
maximum residue limits in foodstuffs of animal origin (OJ L 15,
accordance with the opinion of the Standing
20.1.2010, p. 1).
Committee on Veterinary Medicinal Products,

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EN
11.1.2014 Official
Journal
of
the
European
Union
L
8/19
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of 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, 10 January 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX
The Annex to Regulation (EU) No 37/2010 is amended as follows:
(1) in Table 1 the substance chloroform is inserted as follows:
Other Provisions (according
Pharmacologically
to Article 14(7) of
Therapeutic
active Substance Marker residue Animal
Species MRL Target
Tissues
Regulation (EC)
Classification
No 470/2009)
‘Chloroform NOT
All mammalian No MRL NOT
Only to be used as an NO
APPLICABLE food producing required APPLICABLE excipient in vaccines
ENTRY’
species
and only at
concentrations not
exceeding 1 % w/v
and total doses not
exceeding 20 mg per
animal.
(2) in Table 2 the substance chloroform is deleted.

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