Risk assessment of ochratoxin A in food

EFSA Panel on Contaminants in the Food Chain (CONTAM), Dieter Schrenk, Laurent Bodin, James Kevin Chipman, Jesús del Mazo, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo Stefano Nebbia, Elsa Nielsen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Tanja Schwerdtle, Christiane Vleminckx, Heather Wallace, Jan Alexander, Chiara Dall'Asta, Angela MallyManfred Metzler, Marco Binaglia, Zsuzsanna Horváth, Hans Steinkellner, Margherita Bignami

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Abstract

The European Commission asked EFSA to update their 2006 opinion on ochratoxin A (OTA) in food. OTA is produced by fungi of the genus Aspergillus and Penicillium and found as a contaminant in various foods. OTA causes kidney toxicity in different animal species and kidney tumours in rodents. OTA is genotoxic both in vitro and in vivo; however, the mechanisms of genotoxicity are unclear. Direct and indirect genotoxic and non-genotoxic modes of action might each contribute to tumour formation. Since recent studies have raised uncertainty regarding the mode of action for kidney carcinogenicity, it is inappropriate to establish a health-based guidance value (HBGV) and a margin of exposure (MOE) approach was applied. For the characterisation of non-neoplastic effects, a BMDL10 of 4.73 ?g/kg body weight (bw) per day was calculated from kidney lesions observed in pigs. For characterisation of neoplastic effects, a BMDL10 of 14.5 ?g/kg bw per day was calculated from kidney tumours seen in rats. The estimation of chronic dietary exposure resulted in mean and 95th percentile levels ranging from 0.6 to 17.8 and from 2.4 to 51.7 ng/kg bw per day, respectively. Median OTA exposures in breastfed infants ranged from 1.7 to 2.6 ng/kg bw per day, 95th percentile exposures from 5.6 to 8.5 ng/kg bw per day in average/high breast milk consuming infants, respectively. Comparison of exposures with the BMDL10 based on the non-neoplastic endpoint resulted in MOEs of more than 200 in most consumer groups, indicating a low health concern with the exception of MOEs for high consumers in the younger age groups, indicating a possible health concern. When compared with the BMDL10 based on the neoplastic endpoint, MOEs were lower than 10,000 for almost all exposure scenarios, including breastfed infants. This would indicate a possible health concern if genotoxicity is direct. Uncertainty in this assessment is high and risk may be overestimated.
Original languageEnglish
Article numbere06113
Number of pages112
JournalEFSA Journal
Volume18
Issue number5
Early online date13 May 2020
DOIs
Publication statusPublished - May 2020

Keywords

  • Ochratoxin
  • hazard characterisation
  • dietary exposure assessment
  • margin of exposure approach
  • risk characterisation
  • IMMUNOAFFINITY COLUMN CLEANUP
  • OXIDATIVE DNA-DAMAGE
  • DOUBLE-STRAND BREAKS
  • TANDEM MASS-SPECTROMETRY
  • BLOOD MONONUCLEAR-CELLS
  • MAPK SIGNALING PATHWAYS
  • PERFORMANCE LIQUID-CHROMATOGRAPHY
  • A-INDUCED CYTOTOXICITY
  • EXPERIMENTAL PORCINE NEPHROPATHY
  • CHRONIC INTERSTITIAL NEPHROPATHY

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    EFSA Panel on Contaminants in the Food Chain (CONTAM), Schrenk, D., Bodin, L., Chipman, J. K., del Mazo, J., Grasl-Kraupp, B., Hogstrand, C., Hoogenboom, L. R., Leblanc, J-C., Nebbia, C. S., Nielsen, E., Ntzani, E., Petersen, A., Sand, S., Schwerdtle, T., Vleminckx, C., Wallace, H., Alexander, J., Dall'Asta, C., ... Bignami, M. (2020). Risk assessment of ochratoxin A in food. EFSA Journal, 18(5), [e06113]. https://doi.org/10.2903/j.efsa.2020.6113