Open AccessUpdate of the risk assessment of nickel in food and drinking water
Author(s) -
Schrenk Dieter,
Bignami Margherita,
Bodin Laurent,
Chipman James Kevin,
del Mazo Jesús,
GraslKraupp Bettina,
Hogstrand Christer,
Hoogenboom Laurentius Ron,
Leblanc JeanCharles,
Nebbia Carlo Stefano,
Ntzani Evangelia,
Petersen Annette,
Sand Salomon,
Schwerdtle Tanja,
Vleminckx Christiane,
Wallace Heather,
Guérin Thierry,
Massanyi Peter,
Van Loveren Henk,
Baert Katleen,
Gergelova Petra,
Nielsen Elsa
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.2020.6268
Subject(s) - risk assessment , environmental health , food science , nickel , environmental science , medicine , chemistry , computer science , organic chemistry , computer security
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 BMDL 10 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.