Update of the risk assessment of nickel in food and drinking water

D. Schrenk; M. Bignami; L. Bodin; J.K. Chipman; J. del Mazo; B. Grasl-Kraupp; C. Hogstrand; L. Hoogenboom; J.-C. Leblanc; C.S. Nebbia; E. Ntzani; A. Petersen; S. Sand; T. Schwerdtle; C. Vleminckx; H. Wallace; T. Guérin; P. Massanyi; H. Van Loveren; K. Baert; P. Gergelova; E. Nielsen; EFSA Panelon Contaminants in the Food Chain (contam)

doi:10.2903/j.efsa.2020.6268

Update of the risk assessment of nickel in food and drinking water

D. Schrenk, M. Bignami, L. Bodin, J.K. Chipman, J. del Mazo, B. Grasl-Kraupp, C. Hogstrand, L. Hoogenboom, J.-C. Leblanc, C.S. Nebbia, E. Ntzani, A. Petersen, S. Sand, T. Schwerdtle, C. Vleminckx, H. Wallace, T. Guérin, P. Massanyi, H. Van Loveren, K. BaertP. Gergelova, E. Nielsen, EFSA Panelon Contaminants in the Food Chain (contam)

Nutritional Sciences

Research output: Contribution to journal › Article › peer-review

152 Citations (Scopus)

Abstract

The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post-implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 μg/kg bw. Eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest-observed-adverse-effect-level of 4.3 μg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel-sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern. © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Original language	English
Journal	EFSA J.
Volume	18
Issue number	11
DOIs	https://doi.org/10.2903/j.efsa.2020.6268
Publication status	Published - 5 Nov 2020

Keywords

dietary exposure
food
margin of exposure (MOE)
Nickel
sensitisation
tolerable daily intake (TDI)
toxicity

UN SDGs

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

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10.2903/j.efsa.2020.6268

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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., Ntzani, E., Petersen, A., Sand, S., Schwerdtle, T., Vleminckx, C., Wallace, H., Guérin, T., Massanyi, P., Van Loveren, H., ... (contam), EFSA. P. C. I. T. F. C. (2020). Update of the risk assessment of nickel in food and drinking water. EFSA J., 18(11). https://doi.org/10.2903/j.efsa.2020.6268

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abstract = "The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post-implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 μg/kg bw. Eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest-observed-adverse-effect-level of 4.3 μg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel-sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern. {\textcopyright} 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.",

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author = "D. Schrenk and M. Bignami and L. Bodin and J.K. Chipman and {del Mazo}, J. and B. Grasl-Kraupp and C. Hogstrand and L. Hoogenboom and J.-C. Leblanc and C.S. Nebbia and E. Ntzani and A. Petersen and S. Sand and T. Schwerdtle and C. Vleminckx and H. Wallace and T. Gu{\'e}rin and P. Massanyi and {Van Loveren}, H. and K. Baert and P. Gergelova and E. Nielsen and (contam), {EFSA Panelon Contaminants in the Food Chain}",

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Schrenk, D, Bignami, M, Bodin, L, Chipman, JK, del Mazo, J, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, L, Leblanc, J-C, Nebbia, CS, Ntzani, E, Petersen, A, Sand, S, Schwerdtle, T, Vleminckx, C, Wallace, H, Guérin, T, Massanyi, P, Van Loveren, H, Baert, K, Gergelova, P, Nielsen, E & (contam), EFSAPCITFC 2020, 'Update of the risk assessment of nickel in food and drinking water', EFSA J., vol. 18, no. 11. https://doi.org/10.2903/j.efsa.2020.6268

TY - JOUR

T1 - Update of the risk assessment of nickel in food and drinking water

AU - Schrenk, D.

AU - Bignami, M.

AU - Bodin, L.

AU - Chipman, J.K.

AU - del Mazo, J.

AU - Grasl-Kraupp, B.

AU - Hogstrand, C.

AU - Hoogenboom, L.

AU - Leblanc, J.-C.

AU - Nebbia, C.S.

AU - Ntzani, E.

AU - Petersen, A.

AU - Sand, S.

AU - Schwerdtle, T.

AU - Vleminckx, C.

AU - Wallace, H.

AU - Guérin, T.

AU - Massanyi, P.

AU - Van Loveren, H.

AU - Baert, K.

AU - Gergelova, P.

AU - Nielsen, E.

AU - (contam), EFSA Panelon Contaminants in the Food Chain

PY - 2020/11/5

Y1 - 2020/11/5

N2 - The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post-implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 μg/kg bw. Eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest-observed-adverse-effect-level of 4.3 μg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel-sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern. © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

AB - The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post-implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 μg/kg bw. Eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest-observed-adverse-effect-level of 4.3 μg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel-sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern. © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

KW - dietary exposure

KW - food

KW - margin of exposure (MOE)

KW - Nickel

KW - sensitisation

KW - tolerable daily intake (TDI)

KW - toxicity

U2 - 10.2903/j.efsa.2020.6268

DO - 10.2903/j.efsa.2020.6268

M3 - Article

SN - 1831-4732

VL - 18

JO - EFSA J.

JF - EFSA J.

IS - 11

ER -

Update of the risk assessment of nickel in food and drinking water

Abstract

Keywords

UN SDGs

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