Agriculture Reference
In-Depth Information
VDs were approved to be used as growth promoters in food-producing animals in
the 1950s. Since then, the European countries have been concerned about their use.
Studies demonstrating the negative effect on human health of VD residues led the EU
to establish strict regulated controls of the use of these substances in living animals.
The
ca-
tions were developed for the establishment of a common framework regulating the
production and distribution of VDs as well as the establishment of protocols for
the analysis, production control, marketing, and free circulation of VDs among the
Member States of the European Community (EC) [20
first documents were published in 1981 [18,19] and their subsequent modi
23]. All these directives were
merged in a single document, Directive 2001/82/CE [24], which has been subse-
quently modi
-
27].
Regarding the food safety issue,
ed [25
-
ned a series of legislative
documents in order to ensure a high standard of protection for consumers. Council
Regulation 2377/90/EC [28] was the
the EU has de
first document related to the control of VD
residues. This document regulated the use of VDs, describing the procedure for
establishing maximum residue limits (MRLs) and
fixing the MRLs for veterinary
medicinal products in foodstuffs of animal origin. This regulation classi
ed pharma-
cologically active substances in four annexes: (I) substances for which a MRL has
been
fixed; (II) substances not subject to MRL; (III) substances for which a
provisional MRL was established; and (IV) substances for which no MRL can be
established because residues of those substances, at any concentration, constitute a
hazard to human health or data were incomplete and could not permit a MRL to be
set [28].
This Directive has been modi
ed several times and it has been replaced by
Commission Regulation (EU) 37/2010 [7]. This has simpli
ca-
tion system established in Regulation 2377/90/EC, thus applying the established
Regulation (EC) No. 470/2009. In this way, all pharmacologically active substances
(formerly separated in four groups) are now organized in two separate tables: allowed
and prohibited substances. Moreover, the prohibition on the use of growth-promoting
agents (GPAs) (e.g., hormones and
ed the initial classi
β
-agonists) was laid down in Council Directive
96/22/EC [29].
Additionally, Council Directive 96/23/EC was established to describe guidelines
for residue control and it divided all pharmacologically active substances into two
groups:
Group A, which comprises prohibited substances (listed in the prohibited
substances in Regulation 37/2010/EC or in Annex IV of Regulation 2377/
90/EC).
Group B, which comprises substances with
final and provisional MRLs (listed in
the allowed substances in Regulation 37/2010/EC or in Annexes I and III of
Regulation 2377/90/EC).
At this point, it is important to mention two concepts that have been developed
after the establishment of the MRL: minimum required performance limit (MRPL)
and zero tolerance. MRPL is de
ned as the lowest concentration that of
cial control
