Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. 
Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. What was reviewed?
This review summarizes the EFSA nickel risk assessment update 2020, hereafter referred to as the EFSA nickel risk assessment update 2020, as captured in the UK Committee on Toxicity (COT) background paper responding to EFSA’s public consultation on nickel in food and drinking water. The document outlines EFSA’s revised chronic tolerable daily intake, the acute effect endpoint for nickel-sensitized individuals, the benchmark modeling methods applied, and UK-specific exposure estimates. It also collates prior regulatory values from Denmark and the WHO and frames questions for expert deliberation, thereby providing a compact translational bridge between EFSA’s technical analyses and policy and certification stakeholders. Notably, it documents EFSA’s decision to base chronic risk on reproductive toxicity in rats and acute risk on systemic contact dermatitis elicited by oral nickel challenge in sensitized humans.
Who was reviewed?
The EFSA nickel risk assessment update 2020 synthesizes evidence from experimental rat studies and controlled human oral challenge studies while also compiling UK dietary exposure distributions across life stages. Chronic dose–response modeling relied on one- and two-generation reproductive studies with nickel sulfate hexahydrate in rats, while acute thresholds were derived from human provocation studies in nickel-sensitized volunteers. Population exposure characterization includes UK infants, toddlers, children, adolescents, adults, the elderly, and the very elderly, with summary statistics presented for mean and 95th percentile chronic intakes and for high-percentile acute intakes under upper-bound assumptions. The COT paper reproduces these distributions to contextualize UK risk relative to EFSA’s revised guidance values and margin-of-exposure criteria.
Most important findings
| Critical point | Details |
|---|---|
| Revised chronic TDI established | EFSA set a tolerable daily intake of 13 µg/kg bw/day for oral nickel, derived from a BMDL10 of 1.3 mg/kg bw/day for post-implantation loss in rats and an uncertainty factor of 100 to address inter- and intra-species variability. This shifts the prior 2015 TDI upward (from 2.8 µg/kg bw/day) after reanalysis using individual-animal data and model averaging per updated BMD guidance. |
| Acute effect anchored to human SCD | For acute risk, EFSA selected systemic contact dermatitis (eczema flare-ups) in nickel-sensitized individuals following oral exposure, identifying a LOAEL of 4.3 µg/kg bw from a 0.3 mg/person oral challenge dose. Because a definitive acute reference dose was not set, EFSA applied an MOE approach. |
| Acute MOE criterion for low concern | An MOE ≥30 indicates low acute concern. This composite includes factors for LOAEL-to-NOAEL extrapolation, high response incidence at the LOAEL, small study size, uncertainty around a low threshold, and the quality-of-life impact of reactions in sensitized persons. |
| UK chronic exposure vs TDI | For the UK, mean chronic exposures across all age groups are below the revised TDI. However, 95th percentile exposures for infants, toddlers, and other children exceed the TDI by up to 190%, signaling potential concern for high-end consumers in younger cohorts. The tabulated UK data are reproduced in the annex. |
| UK acute exposure and MOEs | The COT paper presents acute MOEs by age, calculated against 4.3 µg/kg bw. MOEs range from 0.12 to 1.2, with the lowest values in young age groups, far below the EFSA low-concern benchmark of 30 and implying acute risk for sensitized individuals. A summary table of MOEs appears on page 6 of the document. |
| Continuity with prior evaluations | EFSA retained reproductive/developmental toxicity in rats as the critical chronic endpoint and human SCD as the acute endpoint, noting no adequate new studies to alter the acute dose–response basis. |
| Regulatory comparators | The paper notes Denmark’s TDI of 5.5 µg/kg bw and WHO’s 70 µg/L drinking-water guideline, situating EFSA’s values among existing benchmarks. |
Key implications
For primary regulatory impacts, the EFSA nickel risk assessment update 2020 justifies a 13 µg/kg bw/day TDI and an MOE-based acute framework focused on sensitized individuals. Certification requirements should verify chronic compliance against the TDI and ensure acute MOE ≥30 for products or lots. Industry applications include product formulation, sourcing, and consumer advisories for nickel-sensitized groups. Research gaps include better thresholds for oral SCD and refined infant exposure data. Practical recommendations emphasize validated nickel analytics, conservative batch controls, and transparent labeling.
Citation
Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT). Discussion paper for the EFSA Public Consultation on the draft “Update of the risk assessment of nickel in food and drinking water.” July 2020.
Nickel is a widely used transition metal found in alloys, batteries, and consumer products that also contaminates food and water. High exposure is linked to allergic contact dermatitis, organ toxicity, and developmental effects, with children often exceeding EFSA’s tolerable daily intake of 3 μg/kg bw. Emerging evidence shows nickel crosses the placenta, elevating risks of preterm birth and congenital heart defects, underscoring HMTC’s stricter limits to safeguard vulnerable populations.
Nickel is a widely used transition metal found in alloys, batteries, and consumer products that also contaminates food and water. High exposure is linked to allergic contact dermatitis, organ toxicity, and developmental effects, with children often exceeding EFSA’s tolerable daily intake of 3 μg/kg bw. Emerging evidence shows nickel crosses the placenta, elevating risks of preterm birth and congenital heart defects, underscoring HMTC’s stricter limits to safeguard vulnerable populations.
