Agriculture Reference
In-Depth Information
drugs, and feed additives [35]. This positive list covers 758 substances having at least
provisional MRLs and indicates a safe concentration of 0.01 mg/kg for those
substances without established MRLs. In Australia, the Australian Pesticides and
Veterinary Medicines Authority (APVMA), an Australian government statutory
authority, is responsible for centralizing the registration of all agricultural and
veterinary chemical products into the Australian marketplace. This organization
sets MRLs for agricultural and veterinary chemicals in agricultural produce, particu-
larly those entering the food chain [36].
Internationally, CODEX Alimentarius has also established MRLs for a veterinary
drug or certain veterinary drugs, specifying the species and the target tissue that
should be analyzed [37]. Furthermore, they provide information related to acceptable
daily intake as well as estimated dietary exposure. Many of these CODEX MRLs are
higher than or equal to the MRLs set by the EU, with some exceptions such as
azaperone.
Due to the high interest concerning veterinary medicines, the European Medicines
Agency (EMA) was established in 1995 [38]. The main task of this agency is to
provide scienti
c advice to the Community institutions and the Member States of the
EU in relation to authorization and supervision of medicinal products for human and
veterinary use. It contributed to international activities of the EU through its work
with the European Pharmacopoeia, the World Health Organization (WHO), the
International Conference on Harmonization of Technical Requirements for Registra-
tion of Pharmaceuticals for Human Use (ICH), and the International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). Furthermore, the European Food Safety Authority (EFSA) was
created in 2002 after several food alerts that emerged in the late 1990s [39]. This
institution is an essential tool for coordination and integration of the European food
safety politics.
In the EU, there is no obligation to use standardized analytical methods in
residue control of food-producing animals, whereas application of standardized
methods is mandatory in the U.S. In the EU, analytical methods must meet
minimum performance criteria (e.g., detection limits, selectivity, and speci
city)
as set out in Commission Decision 2002/657/EC [16]. This Decision sets up the
procedures for validation and performance criteria of the analytical methods.
Moreover, the concept of identi
ning
criteria for ion intensities and ion ratios. In this sense, it is important to highlight
that this Decision indicates that chromatographic methods without the use of mass
spectrometric detection are not suitable as con
cation points (IPs) was introduced by de
rmatory methods. Other de
nitions
introduced in the 2002/657 EC guideline are the decision limit CC
α
and the
detection capability CC
β
, which are intended to replace the limits of detection and
quanti
ned as the limit at and above
which a sample is considered to be noncompliant, with an error probability of
cation, respectively. In this context, CC
α
is de
α
(5%), and it is a crucial limit for con
rmatory methods. CC
β
is the smallest amount
of the substance that can be detected and/or quanti
ed in a sample, with an error
probability of
β
(1% for banned substances and 5% for group B substances). A
signi
cant advantage of the EU approach is the high degree of
flexibility, which
