Update of the risk assessment of mineral oil hydrocarbons in food

Abstract Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species‐specific diff...

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Main Authors: EFSA Panel on Contaminants in the Food Chain (CONTAM), Dieter Schrenk, Margherita Bignami, Laurent Bodin, Jesús delMazo, 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, Christophe Goldbeck, Konrad Grob, Jose Ángel Gómez Ruiz, Olaf Mosbach‐Schulz, Marco Binaglia, James Kevin Chipman
Format: Article
Language:English
Published: Wiley 2023-09-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2023.8215
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author EFSA Panel on Contaminants in the Food Chain (CONTAM)
Dieter Schrenk
Margherita Bignami
Laurent Bodin
Jesús delMazo
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
Christophe Goldbeck
Konrad Grob
Jose Ángel Gómez Ruiz
Olaf Mosbach‐Schulz
Marco Binaglia
James Kevin Chipman
author_facet EFSA Panel on Contaminants in the Food Chain (CONTAM)
Dieter Schrenk
Margherita Bignami
Laurent Bodin
Jesús delMazo
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
Christophe Goldbeck
Konrad Grob
Jose Ángel Gómez Ruiz
Olaf Mosbach‐Schulz
Marco Binaglia
James Kevin Chipman
author_sort EFSA Panel on Contaminants in the Food Chain (CONTAM)
collection DOAJ
description Abstract Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species‐specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague–Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound–upper bound (LB–UB) means and 95th percentiles of 0.085–0.126 and 0.157–0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB–UB mean and 95th percentile estimations of 0.003–0.031 and 0.011–0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.
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spelling doaj.art-da9fe94501bd4b9da4fb3ffa0d865a392023-09-29T11:30:29ZengWileyEFSA Journal1831-47322023-09-01219n/an/a10.2903/j.efsa.2023.8215Update of the risk assessment of mineral oil hydrocarbons in foodEFSA Panel on Contaminants in the Food Chain (CONTAM)Dieter SchrenkMargherita BignamiLaurent BodinJesús delMazoBettina Grasl‐KrauppChrister HogstrandLaurentius (Ron) HoogenboomJean‐Charles LeblancCarlo Stefano NebbiaElsa NielsenEvangelia NtzaniAnnette PetersenSalomon SandTanja SchwerdtleChristiane VleminckxHeather WallaceJan AlexanderChristophe GoldbeckKonrad GrobJose Ángel Gómez RuizOlaf Mosbach‐SchulzMarco BinagliaJames Kevin ChipmanAbstract Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species‐specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague–Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound–upper bound (LB–UB) means and 95th percentiles of 0.085–0.126 and 0.157–0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB–UB mean and 95th percentile estimations of 0.003–0.031 and 0.011–0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.https://doi.org/10.2903/j.efsa.2023.8215Mineral oil hydrocarbons (MOH)MOSHMOAHalkanesaromatic hydrocarbonshuman dietary exposure
spellingShingle EFSA Panel on Contaminants in the Food Chain (CONTAM)
Dieter Schrenk
Margherita Bignami
Laurent Bodin
Jesús delMazo
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
Christophe Goldbeck
Konrad Grob
Jose Ángel Gómez Ruiz
Olaf Mosbach‐Schulz
Marco Binaglia
James Kevin Chipman
Update of the risk assessment of mineral oil hydrocarbons in food
EFSA Journal
Mineral oil hydrocarbons (MOH)
MOSH
MOAH
alkanes
aromatic hydrocarbons
human dietary exposure
title Update of the risk assessment of mineral oil hydrocarbons in food
title_full Update of the risk assessment of mineral oil hydrocarbons in food
title_fullStr Update of the risk assessment of mineral oil hydrocarbons in food
title_full_unstemmed Update of the risk assessment of mineral oil hydrocarbons in food
title_short Update of the risk assessment of mineral oil hydrocarbons in food
title_sort update of the risk assessment of mineral oil hydrocarbons in food
topic Mineral oil hydrocarbons (MOH)
MOSH
MOAH
alkanes
aromatic hydrocarbons
human dietary exposure
url https://doi.org/10.2903/j.efsa.2023.8215
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