Risk to human health related to the presence of perfluoroalkyl substances in food

EFSA Panel on Contaminants in the Food Chain (CONTAM); Dieter Schrenk; Margherita Bignami; 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 E. Ntzani; Annette  Petersen; Salomon Sand; Christiane  Vleminckx; Heather Wallace; Lars Barregård; Sandra Ceccatelli; Jean-Pierre Cravedi; Thorhallur Ingi Halldorsson; Line Småstuen Haug; Niklas Johansson; Helle Katrine  Knutsen; Martin  Rose; Alain-Claude  Roudot; Henk van Loveren; Günter  Vollmer; Karen Mackay; Francesca Riolo; Tanja  Schwerdtle

doi:10.2903/sp.efsa.2020.EN-1931

Risk to human health related to the presence of perfluoroalkyl substances in food

EFSA Panel on Contaminants in the Food Chain (CONTAM), Dieter Schrenk, Margherita Bignami, 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 E. Ntzani, Annette Petersen, Salomon Sand, Christiane Vleminckx, Heather Wallace, Lars Barregård, Sandra Ceccatelli, Jean-Pierre CravediThorhallur Ingi Halldorsson, Line Småstuen Haug, Niklas Johansson, Helle Katrine Knutsen, Martin Rose, Alain-Claude Roudot, Henk van Loveren, Günter Vollmer, Karen Mackay, Francesca Riolo, Tanja Schwerdtle

Applied Medicine

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Abstract

The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’ contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.

Original language	English
Article number	e06223
Number of pages	391
Journal	EFSA Journal
Volume	18
Issue number	9
DOIs	https://doi.org/10.2903/sp.efsa.2020.EN-1931
Publication status	Published - 17 Sept 2020

Bibliographical note

Acknowledgements: The Panel wishes to thank the following for their support provided to this scientific output as Hearing experts: Klaus Abraham, Esben Budtz-Jørgensen, Tony Fletcher, Philippe Grandjean, Hans Mielke and Hans Rumke and EFSA staff members: Davide Arcella, Marco Binaglia, Petra Gergelova, Elena Rovesti and Marijke Schutte. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. The Panel would also like to thank the following authors and co-authors for providing additional information in relation to their respective studies: Berit Granum, Margie M Peden-Adams, Thomas Webster.

Keywords

PFAS
food
exposure
mixtures
immune system
PBPK
risk assessment

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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EFSA Panel on Contaminants in the Food Chain (CONTAM), Schrenk, D., Bignami, M., Bodin, L., Chipman, J. K., del Mazo, J., Grasl-Kraupp, B., Hogstrand, C., Hoogenboom, L., Leblanc, J. C., Nebbia, C. S., Nielsen, E., Ntzani, E. E., Petersen, A., Sand, S., Vleminckx, C., Wallace, H., Barregård, L., Ceccatelli, S., ... Schwerdtle, T. (2020). Risk to human health related to the presence of perfluoroalkyl substances in food. EFSA Journal, 18(9), Article e06223. https://doi.org/10.2903/sp.efsa.2020.EN-1931

EFSA Panel on Contaminants in the Food Chain (CONTAM), Schrenk, D, Bignami, M, Bodin, L, Chipman, JK, del Mazo, J, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, L, Leblanc, JC, Nebbia, CS, Nielsen, E, Ntzani, EE, Petersen, A, Sand, S, Vleminckx, C, Wallace, H, Barregård, L, Ceccatelli, S, Cravedi, J-P, Halldorsson, TI, Haug, LS, Johansson, N, Knutsen, HK, Rose, M, Roudot, A-C, van Loveren, H, Vollmer, G, Mackay, K, Riolo, F & Schwerdtle, T 2020, 'Risk to human health related to the presence of perfluoroalkyl substances in food', EFSA Journal, vol. 18, no. 9, e06223. https://doi.org/10.2903/sp.efsa.2020.EN-1931

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abstract = "The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and {\textquoteleft}other children{\textquoteright} showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. {\textquoteleft}Fish meat{\textquoteright}, {\textquoteleft}Fruit and fruit products{\textquoteright} and {\textquoteleft}Eggs and egg products{\textquoteright} contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.",

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note = "Acknowledgements: The Panel wishes to thank the following for their support provided to this scientific output as Hearing experts: Klaus Abraham, Esben Budtz-J{\o}rgensen, Tony Fletcher, Philippe Grandjean, Hans Mielke and Hans Rumke and EFSA staff members: Davide Arcella, Marco Binaglia, Petra Gergelova, Elena Rovesti and Marijke Schutte. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. The Panel would also like to thank the following authors and co-authors for providing additional information in relation to their respective studies: Berit Granum, Margie M Peden-Adams, Thomas Webster.",

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T1 - Risk to human health related to the presence of perfluoroalkyl substances in food

AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)

AU - Schrenk, Dieter

AU - Bignami, Margherita

AU - Bodin, Laurent

AU - Chipman, James Kevin

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 E.

AU - Petersen, Annette

AU - Sand, Salomon

AU - Vleminckx, Christiane

AU - Wallace, Heather

AU - Barregård, Lars

AU - Ceccatelli, Sandra

AU - Cravedi, Jean-Pierre

AU - Halldorsson, Thorhallur Ingi

AU - Haug, Line Småstuen

AU - Johansson, Niklas

AU - Knutsen, Helle Katrine

AU - Rose, Martin

AU - Roudot, Alain-Claude

AU - van Loveren, Henk

AU - Vollmer, Günter

AU - Mackay, Karen

AU - Riolo, Francesca

AU - Schwerdtle, Tanja

N1 - Acknowledgements: The Panel wishes to thank the following for their support provided to this scientific output as Hearing experts: Klaus Abraham, Esben Budtz-Jørgensen, Tony Fletcher, Philippe Grandjean, Hans Mielke and Hans Rumke and EFSA staff members: Davide Arcella, Marco Binaglia, Petra Gergelova, Elena Rovesti and Marijke Schutte. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. The Panel would also like to thank the following authors and co-authors for providing additional information in relation to their respective studies: Berit Granum, Margie M Peden-Adams, Thomas Webster.

PY - 2020/9/17

Y1 - 2020/9/17

N2 - The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’ contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.

AB - The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’ contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.

KW - PFAS

KW - food

KW - exposure

KW - mixtures

KW - immune system

KW - PBPK

KW - risk assessment

U2 - 10.2903/sp.efsa.2020.EN-1931

DO - 10.2903/sp.efsa.2020.EN-1931

M3 - Article

SN - 1831-4732

VL - 18

JO - EFSA Journal

JF - EFSA Journal

IS - 9

M1 - e06223

ER -

Risk to human health related to the presence of perfluoroalkyl substances in food

Abstract

Bibliographical note

Keywords

UN SDGs

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