Open AccessRisk assessment of ochratoxin A in food
Author(s) -
Schrenk Dieter,
Bodin Laurent,
Chipman James Kevin,
del Mazo Jesús,
GraslKraupp Bettina,
Hogstrand Christer,
Hoogenboom Laurentius Ron,
Leblanc JeanCharles,
Nebbia Carlo Stefano,
Nielsen Elsa,
Ntzani Evangelia,
Petersen Annette,
Sand Salomon,
Schwerdtle Tanja,
Vleminckx Christiane,
Wallace Heather,
Alexander Jan,
Dall'Asta Chiara,
Mally Angela,
Metzler Manfred,
Binaglia Marco,
Horváth Zsuzsanna,
Steinkellner Hans,
Bignami Margherita
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6113
Subject(s) - ochratoxin a , genotoxicity , reference dose , carcinogen , mycotoxin , ochratoxin , food contaminant , food safety , european commission , toxicology , medicine , european union , biology , physiology , zoology , food science , risk assessment , toxicity , computer security , computer science , genetics , business , economic policy
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 BMDL 10 of 4.73 μg/kg body weight (bw) per day was calculated from kidney lesions observed in pigs. For characterisation of neoplastic effects, a BMDL 10 of 14.5 μg/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 BMDL 10 based on the non‐neoplastic endpoint resulted in MOE s of more than 200 in most consumer groups, indicating a low health concern with the exception of MOE s for high consumers in the younger age groups, indicating a possible health concern. When compared with the BMDL 10 based on the neoplastic endpoint, MOE s 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.