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 nickel-risk-assessment reviewed EFSA’s updated public-health evaluation of nickel in food and drinking water, integrating new EU occurrence monitoring data, updated benchmark dose (BMD) methods, and post-2013 toxicology and human evidence to re-derive health-based guidance and characterise both chronic and acute dietary risks relevant to regulatory limit-setting and certification thresholds.
Who was reviewed?
Evidence was reviewed across multiple populations and model systems: EU consumers (infants through very elderly) using EFSA’s consumption database linked to >47,000 nickel analytical results; experimental rodents (notably Sprague–Dawley rats for developmental endpoints and mice for certain reproductive effects); and nickel-sensitised humans evaluated in oral challenge studies for systemic contact dermatitis (SCD). The assessment also considered mechanistic data (absorption differences by fasting/vehicle, oxidative stress, transport via DMT1) to interpret susceptibility and exposure conditions for the nickel-risk-assessment.
Most important findings
For HMTC, the most actionable outputs of this nickel-risk-assessment are the updated chronic guidance value (TDI), the acute reference point used for sensitised individuals (LOAEL with MOE approach), and the identification of young age groups and high-nickel food categories as the most consistent drivers of potential exceedance and certification risk.
| Critical point | Details |
|---|---|
| Updated chronic reference point and TDI | Developmental toxicity in rats—increased post-implantation loss—remained the critical chronic endpoint. A BMDL10 of 1.3 mg Ni/kg bw/day was selected as the reference point, and EFSA derived a TDI of 13 µg/kg bw/day using a default uncertainty factor of 100. |
| Acute risk anchored to sensitised individuals | The critical acute effect was eczematous flare-up (SCD) in nickel-sensitised humans. A BMDL could not be derived; EFSA used a LOAEL of 4.3 µg Ni/kg bw as the acute reference point and applied a margin of exposure (MOE) framework, with MOE ≥ 30 indicating low concern. |
| Chronic exceedance concentrated in infants/children | Mean chronic exposure was generally at/below the TDI, but 95th percentile chronic exposure often exceeded the TDI in toddlers and other children, and in infants in some surveys, signalling potential health concern concentrated in young, high-intake consumers. |
| Key exposure contributors and “hotspot” foods | Highest mean nickel concentrations were seen in legumes, nuts, and oilseeds and products for special nutritional use; for population-wide mean exposure, grains and grain-based products were the largest contributor. At high-end acute exposure, common drivers included beans, coffee, ready-to-eat soups, chocolate, and breakfast cereals. |
| Bioavailability depends on dosing context | Human absorption was low with food (~0.7–2.5%) but much higher in fasted conditions via water (~25–27%), with notable inter-individual variability; this matters for certification because ingestion conditions and matrix can change risk even at similar total nickel. |
Key implications
This nickel-risk-assessment supports tighter, age-protective regulatory approaches by pairing a chronic TDI with an acute MOE framework specifically for sensitised individuals, implying certification should address both average compliance and high-percentile protection. HMTC requirements should prioritise routine testing and tighter action levels for high-contributor categories (grains/cereals, legumes/nuts, chocolate/cocoa, coffee, soups) and for products consumed heavily by toddlers/children. Industry applications include ingredient sourcing controls, process/water-contact verification, and batch release criteria aligned to TDI and acute MOE logic. Key research gaps include human oral bioavailability under realistic meal patterns and larger SCD dose–response datasets; practical recommendations are to adopt matrix-aware limits, require method LOQs fit for low-µg/kg decisions, and flag “sensitised-risk” labelling or guidance where appropriate.
Citation
EFSA Panel on Contaminants in the Food Chain (CONTAM). (2020). Update of the risk assessment of nickel in food and drinking water (Draft scientific opinion). EFSA Journal. doi:10.2903/j.efsa.2020.xxxx
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.
