Update of the risk assessment of mineral oil hydrocarbons in food

Dieter Schrenk; Margherita Bignami; Laurent Bodin; 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; Christophe Goldbeck; Konrad Grob; Jose Ángel Gómez Ruiz; Olaf Mosbach-Schulz; Marco Binaglia; James Kevin Chipman

doi:10.2903/j.efsa.2023.8215

Update of the risk assessment of mineral oil hydrocarbons in food

Dieter Schrenk, Margherita Bignami, Laurent Bodin, 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, Christophe Goldbeck, Konrad Grob, Jose Ángel Gómez RuizOlaf Mosbach-Schulz, Marco Binaglia, James Kevin Chipman

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Abstract

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.

Original language	English
Pages (from-to)	e08215
Journal	EFSA Journal
Volume	21
Issue number	9
DOIs	https://doi.org/10.2903/j.efsa.2023.8215
Publication status	Published - 2023

Keywords

Mineral oil hydrocarbons (MOH)
MOSH
MOAH
alkanes
aromatic hydrocarbons
human dietary exposure
toxicity

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10.2903/j.efsa.2023.8215

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Schrenk, D., Bignami, M., Bodin, L., del Mazo, J., Grasl-Kraupp, B., Hogstrand, C., Hoogenboom, L., Leblanc, J.-C., Nebbia, C. S., Nielsen, E., Ntzani, E., Petersen, A., Sand, S., Schwerdtle, T., Vleminckx, C., Wallace, H., Alexander, J., Goldbeck, C., Grob, K., ... Chipman, J. K. (2023). Update of the risk assessment of mineral oil hydrocarbons in food. EFSA Journal, 21(9), e08215. https://doi.org/10.2903/j.efsa.2023.8215

@article{261b3f403f43428c9ba56a486ece620c,

title = "Update of the risk assessment of mineral oil hydrocarbons in food",

abstract = "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.",

keywords = "Mineral oil hydrocarbons (MOH), MOSH, MOAH, alkanes, aromatic hydrocarbons, human dietary exposure, toxicity",

author = "Dieter Schrenk and Margherita Bignami and Laurent Bodin and {del Mazo}, Jes{\'u}s and Bettina Grasl-Kraupp and Christer Hogstrand and Hoogenboom, {Laurentius (Ron)} and Jean-Charles Leblanc and Nebbia, {Carlo Stefano} and Elsa Nielsen and Evangelia Ntzani and Annette Petersen and Salomon Sand and Tanja Schwerdtle and Christiane Vleminckx and Heather Wallace and Jan Alexander and Christophe Goldbeck and Konrad Grob and {G{\'o}mez Ruiz}, {Jose {\'A}ngel} and Olaf Mosbach-Schulz and Marco Binaglia and Chipman, {James Kevin}",

year = "2023",

doi = "10.2903/j.efsa.2023.8215",

language = "English",

volume = "21",

pages = "e08215",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "9",

}

Schrenk, D, Bignami, M, Bodin, L, del Mazo, J, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, L, Leblanc, J-C, Nebbia, CS, Nielsen, E, Ntzani, E, Petersen, A, Sand, S, Schwerdtle, T, Vleminckx, C, Wallace, H, Alexander, J, Goldbeck, C, Grob, K, Gómez Ruiz, JÁ, Mosbach-Schulz, O, Binaglia, M & Chipman, JK 2023, 'Update of the risk assessment of mineral oil hydrocarbons in food', EFSA Journal, vol. 21, no. 9, pp. e08215. https://doi.org/10.2903/j.efsa.2023.8215

TY - JOUR

T1 - Update of the risk assessment of mineral oil hydrocarbons in food

AU - Schrenk, Dieter

AU - Bignami, Margherita

AU - Bodin, Laurent

AU - del Mazo, Jesús

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Hoogenboom, Laurentius (Ron)

AU - Leblanc, Jean-Charles

AU - Nebbia, Carlo Stefano

AU - Nielsen, Elsa

AU - Ntzani, Evangelia

AU - Petersen, Annette

AU - Sand, Salomon

AU - Schwerdtle, Tanja

AU - Vleminckx, Christiane

AU - Wallace, Heather

AU - Alexander, Jan

AU - Goldbeck, Christophe

AU - Grob, Konrad

AU - Gómez Ruiz, Jose Ángel

AU - Mosbach-Schulz, Olaf

AU - Binaglia, Marco

AU - Chipman, James Kevin

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Mineral oil hydrocarbons (MOH)

KW - MOSH

KW - MOAH

KW - alkanes

KW - aromatic hydrocarbons

KW - human dietary exposure

KW - toxicity

U2 - 10.2903/j.efsa.2023.8215

DO - 10.2903/j.efsa.2023.8215

M3 - Article

SN - 1831-4732

VL - 21

SP - e08215

JO - EFSA Journal

JF - EFSA Journal

IS - 9

ER -

Update of the risk assessment of mineral oil hydrocarbons in food

Abstract

Keywords

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