Application of the Margin of Exposure (MoE) Approach to Substances in Food that are Genotoxic and Carcinogenic Preface

Food Standards Agency, UK.
Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association (Impact Factor: 2.9). 01/2010; 48 Suppl 1:S34-41. DOI: 10.1016/j.fct.2009.10.037
Source: PubMed


Aflatoxin B1 (AFB1) has been consistently shown to be a potent mutagen and is a liver carcinogen in humans and a wide range of animal species. The Fisher rat appears to be the most sensitive animal model. Dose-response modelling results in a BMDL(10) of 250 ng/kg-bw/d. Estimates of mean dietary exposure estimates were 0.4 ng/kg-bw/d and 2.6 ng/kg-bw/d, representing regions with low and high exposure, respectively. The MOEs for mean exposure therefore range from 100 to 600.

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    • "0.340 μg/kg BW·day, BMDL10 (human) = 0.87 μg/ kg BW·day, BMDL1 (rat and human) = 0.078 μg/kg BW·day, T25 = 0.39 μg/kg (Benford et al., 2010; JECFA, 2007 "
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    ABSTRACT: In this study the impact of setting European criteria on exposure to aflatoxin B1 via nuts and figs and ochratoxin A via dried fruits is evaluated for the Belgian population, as an example of the European population. Two different scenarios were evaluated. In scenario 1 all collected literature data are considered, assuming that there is no border control nor legal limits in Europe. In the second scenario, contamination levels above the maximum limits are excluded. The results from scenario 1 demonstrated that if no regulation is in place, AFB1 and OTA concentrations reported in the analysed food can have potential health risk to the population. The estimated exposure of OTA for scenario 2 is below the TDI of 5 ng/kg BW⋅day, indicating that OTA concentrations accepted by EU legislation pose a low risk to the Belgian population. For AFB1, the MOE values of scenario 2 are above 10,000 and can be considered to be of low health concern, based on BDML10 for humans, except for figs (MOE = 5782). This means that for all matrices, with exception of figs, the maximum values of AFB1 in the European legislation are sufficient to be of a low health concern for consumers. Copyright © 2014. Published by Elsevier Ltd.
    Food and Chemical Toxicology 11/2014; 75C:112-117. DOI:10.1016/j.fct.2014.10.021 · 2.90 Impact Factor
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    ABSTRACT: Het RIVM en de Wageningen Universiteit hebben in 2007 de IPRA-methode (Integrated Probabilistic Risk Assessment) ontwikkeld om te kunnen inschatten welk deel van de bevolking effect ondervindt van niet-kankerverwekkende stoffen in voeding. Uit onderzoek van het RIVM, in opdracht van de nieuwe Voedsel en Waren Autoriteit (nVWA) blijkt dat de IPRA-methode ook voor kankerverwekkende stoffen kan worden gebruikt. Met de IPRA-methode kan de mate van onzekerheid in de beschikbare gegevens vertaald worden in onzekerheidsmarges in de uitkomst. Hiermee wordt een realistischer beeld gegeven van het potentiële effect op de gezondheid. In het rapport staat beschreven hoe de gegevens waarmee de IPRA-methode rekent moeten worden geïnterpreteerd, evenals de daaruit afgeleide uitkomsten.

  • Journal für Verbraucherschutz und Lebensmittelsicherheit 09/2010; 5(3):297-304. DOI:10.1007/s00003-010-0619-6 · 0.72 Impact Factor
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