Heavy Metal Index

Scientific Opinion on the risks to public health related to the presence of nickel in food and drinking water

Source access

Publication
EFSA Journal 2015;13(2):4002, 202 pp.
Year
2015
Authors
EFSA Panel on Contaminants in the Food Chain (CONTAM)
Source type
government report
License
public domain

EFSA CONTAM Panel 2015 — Nickel in food and drinking water: risk assessment

This EFSA CONTAM Panel opinion is the European Union’s primary risk assessment for nickel in food and drinking water. EFSA received the mandate from the Hellenic Food Authority (EFET) in March 2012 (EFSA-Q-2012-00378), originally focused on nickel in vegetables, and extended the scope to water intended for human consumption and natural mineral waters because both pathways contribute to total dietary exposure. The opinion was adopted on 22 January 2015 and runs to 202 pages including eight appendices. The Panel selected reproductive and developmental toxicity (post-implantation fetal loss in rats) as the critical effect for chronic risk characterisation and derived a tolerable daily intake (TDI) of 2.8 µg Ni/kg bw per day from a BMDL10 of 0.28 mg Ni/kg bw per day, applying the default uncertainty factor of 100. For acute risk characterisation in nickel-sensitised individuals (estimated up to 15% of the general population), the Panel selected systemic contact dermatitis (SCD) elicited by oral exposure as the critical effect, derived an acute reference point (BMDL10) of 1.1 µg Ni/kg bw from clinical SCD-elicitation studies, and adopted a margin-of-exposure (MOE) approach with MOE ≥ 10 as indicative of low concern. The Panel concluded that current chronic dietary exposure to Ni is of concern for the general population — mean exposures in toddlers, other children, infants and adolescents are at or above the TDI, and 95th-percentile exposures exceed the TDI for all age classes — and that current acute dietary exposure raises concern for Ni-sensitised individuals because calculated MOEs are considerably below 10 for all age groups. This 2015 opinion remains the operative EU citation for the chronic TDI derivation methodology and is partially superseded for exposure by the 2020 update (see efsa-nickel-contam-2020).

Key numbers

Mandate, scope and dataset (Sections 1–2, 4):

  • Mandate received from EFET March 2012; opinion adopted 22 January 2015.
  • No EU maximum levels for Ni in food. Drinking water parametric value 20 µg Ni/L under Council Directive 98/83/EC; same 20 µg Ni/L maximum limit for natural mineral waters under Commission Directive 2003/40/EC. Both well within the WHO (2005) guideline value of 70 µg Ni/L. WHO (2007) TDI for Ni in drinking water 11 µg Ni/kg bw.
  • IARC (2012): Ni compounds Group 1 (carcinogenic to humans, lung and nasal/paranasal sinus tumours via inhalation). Metallic Ni and Ni alloys IARC Group 2B (1990). No consistent epidemiological signal for non-respiratory tumours; no tumours observed in oral animal carcinogenicity studies; the Panel considered dietary Ni unlikely to cause cancer in humans.
  • 57,928 food/drinking-water samples reported to EFSA after Call for Data; data-cleaning excluded 3,784 with no LOD/LOQ, 4 organoleptic, 605 suspect-sampling, 114 unprocessed-grain-as-crops, 2,902 pre-2003 samples, 32 fermented-milk samples with LOQ 600 µg/kg, eight infant-food samples with LOQ ≥1,000 µg/kg, 47 regular-beer samples with LOQ 5,000 µg/kg, and 13 statistically-outlier beer samples (5,200–14,300 µg/kg) plus one outlier carbonated-water (10,800 µg/kg) and one outlier pork-liver (172,000 µg/kg). Final dataset 44,585 samples (25,700 drinking water + 18,885 food).
  • Geographic distribution skewed: ~80% from one Member State (Germany 79%); Slovakia 11%, Cyprus 5%. Sampling years 2003–2012.
  • Analytical methods reported in <30% of records: ICP-MS 54%, AAS 42%, ICP-AES 3%, electrochemistry (voltammetry/polarography) 1%, spectroscopy 0.2%.
  • Left-censored data 66% of food/water analytical results overall; 35% in food, 89% in drinking water.

Occurrence — Table 7 summary statistics, FoodEx level 1, µg/kg, LB / UB (n samples, % left-censored):

  • Grains and grain-based products: mean 271 LB / 321 UB; P50 136 LB / 180 UB; P95 1,069 LB / 1,078 UB (n=4,291; 26% LC).
  • Vegetables and vegetable products (including fungi): mean 742 LB / 753 UB; P50 52 / 56; P95 9,250 LB / 9,250 UB (n=3,738; 26% LC) — driven by the Cocoa beans and cocoa products (solid) subgroup (mean 9,528 µg/kg, n=238) and Tea and herbs for infusion (solid) subgroup (mean 761–762 µg/kg, n=105) within this FoodEx group.
  • Starchy roots and tubers: mean 123 LB / 150 UB; P95 690 / 690 (n=664) — main-crop potatoes 264–266 µg/kg (n=205).
  • Legumes, nuts and oilseeds: mean 1,862 LB / 1,880 UB; P50 1,154 / 1,154; P95 7,000 LB / 7,000 UB (n=1,218; 3% LC) — Dried beans 3,055–3,077 µg/kg, Soya beans 4,624–4,685 µg/kg, Peanuts 3,537–3,569 µg/kg.
  • Fruit and fruit products: 68 LB / 91 UB; P95 210 / 300 (n=966).
  • Meat and meat products (incl. edible offal): 191 LB / 239 UB (n=2,169; 66% LC).
  • Fish and other seafood: 77 LB / 112 UB (n=718; 61% LC).
  • Milk and dairy products: 71 LB / 93 UB (n=631; 62% LC).
  • Eggs and egg products: 38 LB / 57 UB (n=115; 74% LC).
  • Sugar and confectionery: mean 1,504 LB / 1,586 UB; P50 540 / 705; P95 5,170 / 5,170 (n=1,170) — driven by Chocolate (cocoa) products subgroup mean 3,231–3,236 µg/kg (n=490).
  • Animal and vegetable fats and oils: 315 LB / 378 UB (n=363).
  • Fruit and vegetable juices: 35 LB / 58 UB (n=505).
  • Non-alcoholic beverages (excepting milk-based): 32 LB / 35 UB (n=46) — low concentration but high consumption volume makes this an exposure driver via cocoa beverages (young) and coffee (adults).
  • Alcoholic beverages: 28 LB / 71 UB (n=892; 69% LC).
  • Drinking water: 1 LB / 2 UB; P95 2 / 3 (n=25,700; 89% LC) — lowest mean across FoodEx level 1 groups.
  • Herbs, spices and condiments: mean 1,259 LB / 1,277 UB; P50 560 / 582; P95 4,640 / 4,640 (n=481; 18% LC).
  • Food for infants and small children: 126 LB / 152 UB; P95 500 / 500 (n=309; 45% LC).
  • Products for special nutritional use: mean 1,999 LB / 2,051 UB; P95 9,100 / 9,100 (n=471; 26% LC) — Mineral supplements subgroup 4,707–4,728 µg/kg (n=45).
  • Composite food (including frozen): 181 LB / 184 UB (n=65).
  • Snacks, desserts and other foods: 111 LB / 430 UB (n=73).

Highest-Ni subgroups (Section 4.3.3 and Appendix B1): Cocoa beans and cocoa products (solid) 9,528 µg/kg; Soya beans 4,624–4,685 µg/kg; Mineral supplements 4,707–4,728 µg/kg; Plant formula extracts 3,844–3,860 µg/kg; Peanuts 3,537–3,569 µg/kg; Chocolate (cocoa) products 3,231–3,236 µg/kg; Dried beans 3,055–3,077 µg/kg; Tea and herbs for infusion (solid) 761–762 µg/kg; Main-crop potatoes 264–266 µg/kg. Dilution factors applied during exposure assessment: 100 for tea and herbal teas, 60 for cocoa powder, 18 for coffee beans (7 for espresso, 63 for instant coffee), 8 for follow-on and infant formulae.

Drinking water (Sections 4.1.3, 4.1.4, 4.3.3): EU MS compliance with 20 µg Ni/L parametric value 99%+ in most surveys; <5% of EU population estimated to be exposed to tap water exceeding the limit (De Brouwere et al. 2012). European tap-water Ni 2–13 µg/L typical (IARC 1990; WHO 2000; ATSDR 2005); examples include German median 0.486 µg/L (n=164), Italian 0.6–2.5 µg/L, Norwegian/Swedish/Finnish/Icelandic median 0.369 µg/L, Polish average 3–7 µg/L. European bottled-mineral-water median <1.9 µg/L (n=571 across 23 countries), 90th-percentile 2.2 µg/L (Bertoldi et al. 2011); a 1,785-bottle survey across 884 individual locations showed 95th-percentile 5.8 µg/L (Demetriades 2010b). Carbonated mineral water subgroup mean 7.0 LB / 8.0 UB µg/L (n=2,363) driven by one outlier sample at 10,800 µg/L; without that sample the mean is consistent with other water subgroups. 114 samples in the final dataset exceeded the 20 µg/L EU limit (unspecified bottled n=13, still mineral n=4, carbonated mineral n=54, tap n=12, unspecified drinking n=31). Drinking-water contribution to total dietary Ni exposure 0.0005–1.7% LB-UB across surveys.

Chronic dietary exposure (Section 6.2, Table 9, µg Ni/kg bw per day):

  • Mean exposure across 26 surveys and seven age classes ranged from 2.0 µg/kg bw/day (minimum LB, Elderly) to 13.1 µg/kg bw/day (maximum UB, Toddlers).
    • Infants: min LB 3.3 / median LB n.r. / max UB 6.3 (only two surveys; one covered 16 subjects).
    • Toddlers: min LB 5.3 / median LB 7.4 / max LB 11.0; min UB 7.3 / median UB 10.3 / max UB 13.1.
    • Other children: min LB 4.9 / median LB 6.7 / max LB 8.2; max UB 9.9.
    • Adolescents: min LB 2.7 / median 3.5 / max LB 4.9; max UB 5.9.
    • Adults: min LB 2.2 / median 2.7 / max LB 3.0; max UB 3.6.
    • Elderly: min LB 2.0 / median 2.5 / max LB 2.5; max UB 3.2.
    • Very Elderly: min LB 2.2 / median 2.4 / max LB 2.7; max UB 3.2.
  • 95th-percentile exposure ranged from 3.6 (min LB, Elderly) to 20.1 µg/kg bw/day (max UB, Toddlers). Toddlers: min LB 8.7 / max UB 20.1. Other children: 9.1–18.2. Adolescents: 5.6–12.3. Adults: 3.7–6.9. Elderly: 3.6–5.8. Very Elderly: 4.0–5.7.
  • Mean dietary exposure for toddlers, other children, infants, and adolescents is at or above the TDI; 95th-percentile exposure is above the TDI for all age groups.
  • Main chronic contributors across surveys: grain and grain-based products; non-alcoholic beverages (cocoa beverages in young, coffee in adults); sugar and confectionery (chocolate); legumes, nuts and oilseeds; vegetables and vegetable products (incl. fungi). Milk and dairy products are an important contributor in toddlers. In one young-population survey ‘Non-alcoholic beverages (except milk-based)’ accounted for 41.8% of total Ni exposure due to high cocoa-beverage consumption.
  • Vegetarian sub-population (Table 10, five surveys, 15–237 vegetarians per survey): mean 2.5–3.5 LB / 3.1–4.3 UB µg/kg bw/day (vs. total adult 2.2–2.8 LB / 3.0–3.4 UB); 95th-percentile up to 7.1 µg/kg bw/day UB. Differences modest at most-represented German survey; largest gap in UK. The Panel extended the level of concern to the vegetarian population.

Acute dietary exposure (Section 6.3, Table 11, µg Ni/kg bw per day; UB):

  • Mean acute exposure ranged 3.4 µg/kg bw (95% CI 3.1–3.7, Adolescents one survey) to 14.3 µg/kg bw (95% CI 13.2–15.5, Toddlers one survey) in the young population.
  • Mean acute exposure ranged 2.5 µg/kg bw (95% CI 2.2–2.9, Elderly) to 4.9 µg/kg bw (95% CI 4.6–5.5, Adults) in the adult population.
  • 95th-percentile acute exposure ranged 8.6 µg/kg bw (95% CI 8.0–9.1, Adolescents) to 35.0 µg/kg bw (95% CI 26.8–47.2, Toddlers) in the young population.
  • 95th-percentile acute exposure ranged 5.5 µg/kg bw (95% CI 5.1–6.0, Elderly) to 11.8 µg/kg bw (95% CI 10.6–13.8, Adults) in adults.
  • Infants: mean 5.6–6.4 µg/kg bw; 95th-percentile 15.1 (95% CI 14.3–15.9) min, max not robust.
  • Acute and chronic exposures are similar in magnitude because Ni occurs widely in regularly-consumed foods.

Hazard characterisation (Section 7):

  • Toxicokinetics: oral bioavailability of soluble Ni 1–40% depending on fasting state, vehicle, and Ni species; ~27 ± 17% in fasted drinking-water administration vs. ~0.7 ± 0.4% in food (Sunderman et al. 1989). Mean elimination half-life ~28 ± 9 hours in human volunteers. Ni is actively transferred across the blood–placental barrier; fetal organ concentrations exceed maternal (Hou et al. 2011 rat ⁶³Ni study).
  • Critical chronic effect: reproductive and developmental toxicity (post-implantation loss). BMD analysis of pooled F0/F1 post-implantation-loss data from the SLI (2000a) dose-range-finding study (0, 2.2, 4.4, 6.6, 11, 17 mg Ni/kg bw/day, 7–8 animals/group) and SLI (2000b) full 2-generation study (0, 0.2, 0.6, 1.1, 2.2 mg Ni/kg bw/day, 25–28 animals/group) using a multistage model: combined data BMD10 0.76 / BMDL10 0.28 mg Ni/kg bw/day (Cochran-Armitage trend p = 0.00013). DRF alone: BMD10 0.48 / BMDL10 0.20 mg Ni/kg bw/day. 2-GEN alone: BMD10 0.72 / BMDL10 0.22 mg Ni/kg bw/day. Sensitivity check using ≥3 post-implantation losses per litter cutoff: BMDL10 0.19–0.28 mg Ni/kg bw/day.
  • Chronic TDI = BMDL10 / UF = 0.28 mg Ni/kg bw/day ÷ 100 = 2.8 µg Ni/kg bw/day. Lower than NOAEL-derived values from other bodies (NOAEL 1.1 or 2.2 mg Ni/kg bw/day); EFSA notes BMD is the more advanced method and that this is the first BMD analysis of the complete SLI datasets.
  • Critical acute effect (Ni-sensitised individuals): systemic contact dermatitis (SCD) eczematous flare-up after oral Ni challenge. BMD analysis of three clinical SCD-elicitation studies (Table 20):
    • Gawkrodger et al. (1986): BMD10 5.8 / BMDL10 2.6 µg Ni/kg bw.
    • Hindsén et al. (2001): BMD10 2.6 / BMDL10 1.6 µg Ni/kg bw.
    • Jensen et al. (2003) (selected, most sensitive): BMD10 2.6 / BMDL10 1.1 µg Ni/kg bw — incidence 1/10, 4/10, 4/10, 7/10 at doses 0, 0.3, 1, 4 mg Ni per person, assuming 70 kg adult bw.
  • Acute reference point = BMDL10 1.1 µg Ni/kg bw; MOE approach with MOE ≥ 10 indicative of low concern. Mean-exposure MOEs across age groups range ~0.08–0.44 (RP 1.1 ÷ exposures 2.5–14.3 µg/kg bw); 95th-percentile MOEs ~0.03–0.20 — all considerably below 10.

Risk characterisation (Section 8, Conclusions):

  • Chronic: mean dietary Ni at or above the TDI in toddlers, other children, infants and adolescents; 95th-percentile above TDI in all age classes. Current chronic dietary exposure to Ni is of concern for the general population, and the concern extends to the vegetarian sub-population (highest estimated 95th-percentile 7.1 µg Ni/kg bw/day UB).
  • Acute: MOEs considerably below 10 across all age groups at both mean and 95th-percentile exposures. At current dietary Ni exposure, Ni-sensitised individuals may develop eczematous flare-up skin reactions. The Panel could not predict what proportion of sensitised individuals would actually develop reactions.
  • Allergic contact dermatitis estimated prevalence up to 15% in the general population (often undiagnosed). The 2.8 µg Ni/kg bw/day chronic TDI may therefore not be sufficiently protective of Ni-sensitised individuals.
  • Non-dietary contributions: occupational Ni exposure (Ni-soluble species 0.004–0.07 mg/m³ producing systemic doses 0.2–3.9 µg/kg bw/day in 70-kg workers); cigarette-smoke Ni exposure 7–160 ng/kg bw/day for a 30-cigarette-per-day smoker (negligible vs. dietary).

Methods (brief)

Occurrence data collection (Section 3, 4.3): Call for Data via EFSA’s Evidence Management Unit; submissions followed EFSA Guidance on Standard Sample Description (EFSA 2010a). Data cleaning excluded duplicates, samples without LOD/LOQ, organoleptic-method samples, suspect-sampling records, unprocessed-grain-as-crops codifications, samples pre-2003, and statistical outliers identified by Tukey’s method (1977) and not confirmed by data providers. Drinking-water analyses with LOQ ≥4 µg/L excluded as unfit-for-purpose (4 µg/L = LOD reference per Council Directive 98/83/EC and Commission Directive 2003/40/EC). All analytical results expressed as whole weight except 490 records with no information.

Analytical methods: Where reported, ICP-MS 54% and AAS 42% (FAAS, GFAAS) dominated; ICP-AES 3%, electrochemistry 1%, spectroscopy 0.2%. Lowest LOQ in food: 0.002 µg/kg (ICP-MS, alcoholic beverages); 1 µg/kg (AAS, fish/seafood and sugar/confectionery). In drinking water: 0.001 µg/L (ICP-MS and FAAS, FAAS after chelation-extraction). European standardised method ISO 8294:1994 (GFAAS, LOD <250 µg/kg) for total Ni in animal and vegetable fats and oils. Four European standardised methods for water (ISO 8288:1986 FAAS post-chelation-extraction, EN ISO 15586:2004 GFAAS, EN ISO 11885:2009 ICP-OES, EN ISO 17294-1:2004 and 17294-2:2003 ICP-MS). Performance criteria EN 13804:2013. Council Directive 98/83/EC requires water-method LOD ≤2 µg/L (≤10% of parametric value). Reference materials and proficiency testing schemes (FAPAS, Bipea) catalogued in Appendix A. Left-censored data treated by substitution: LB replaces <LOQ and <LOD with zero; UB replaces <LOD with LOD value and <LOQ with LOQ value (WHO/IPCS 2009 method; EFSA 2010b).

Exposure assessment (Sections 5, 6): Chronic exposure for 26 dietary surveys in 17 EU countries combined Ni mean occurrence with individual-level consumption from the EFSA Comprehensive European Food Consumption Database. Acute exposure for 32 surveys in 22 countries calculated per reporting day by multiplying total food consumption by a randomly drawn occurrence value (UB scenario), divided by individual body weight; 100 iterations per reporting day; 95% confidence intervals as 2.5th–97.5th percentiles. Mean and 95th-percentile exposure characterised per age class (Infants <12 months, Toddlers ≥12 to <36 months, Other children ≥36 months to <10 years, Adolescents 10 to <18 years, Adults 18 to <65 years, Elderly 65 to <75 years, Very elderly ≥75 years). Vegetarian sub-population characterised for surveys with ≥15 adult vegetarians (five surveys). Foods linked at the lowest possible FoodEx level. Dilution factors applied for dry-to-as-consumed conversions (tea 100, herbal tea 100, cocoa powder 60, coffee beans 18 with 7 for espresso and 63 for instant, follow-on and infant formula 8). >98% of eating occasions in the database covered by occurrence data. 95th-percentile estimates with <60 observations not reported as statistically unrobust per EFSA (2011b).

Toxicology and dose-response (Section 7): Repeat-dose, developmental, reproductive, genotoxicity, and carcinogenicity literature reviewed. Critical chronic effect identified via consistent post-implantation-loss/perinatal-lethality finding in rats exposed orally to Ni chloride or Ni sulphate. PROAST software (version 26) applied for BMD analysis. Quantal/dichotomous data: default BMR 10% extra risk; combined SLI (2000a, b) F0/F1 post-implantation-loss data fit with multistage model (goodness-of-fit p=0.54, BMD10 0.76 / BMDL10 0.28 mg Ni/kg bw/day). Continuous-data BMR 5% applied to Panday & Srivastava (2000) sperm-motility data (BMDL05 0.42/0.46 mg Ni/kg bw/day) and sperm-count data (BMDL05 0.38/0.43 mg Ni/kg bw/day) as supporting information. Default uncertainty factor 100 (10× interspecies, 10× intra-species). Acute hypersensitivity endpoint dose-response: quantal multistage analysis of three published clinical SCD-elicitation studies in Ni-sensitised volunteers (Gawkrodger 1986 n=10, Hindsén 2001 n=10, Jensen 2003 n=10 per dose group at 0/0.3/1/4 mg Ni per person); 70 kg default adult bw applied for unit conversion. Jensen 2003 selected as most sensitive (BMDL10 0.08 mg Ni/person → 1.1 µg Ni/kg bw). MOE ≥10 set as low-concern threshold based on inter-individual variability in immune response not necessarily captured by the limited study cohorts. Uncertainty analysis (Section 9) qualitatively summarised in Table 21; the Panel concluded the impact of uncertainties on the risk assessment is large and the assessment is more likely to overestimate than underestimate the risk.

Implications

Certification: Establishes the operative EU chronic TDI for Ni (2.8 µg Ni/kg bw/day) and the operative acute reference point (1.1 µg Ni/kg bw for Ni-sensitised individuals). This is the first BMD-derived TDI for Ni and supersedes the prior NOAEL-derived values from other institutions (WHO 2007 TDI 11 µg Ni/kg bw/day; NOAEL 1.1 or 2.2 mg Ni/kg bw/day in older risk assessments). The opinion catalogues by far the largest European Ni occurrence dataset to date (44,585 samples) and shows that mean exposure in toddlers, other children, infants, and adolescents already meets or exceeds the chronic TDI before any consideration of non-dietary contributions. Cocoa beans/products (9.5 mg/kg), soya beans (4.6 mg/kg), peanuts (3.5 mg/kg), dried beans (3.1 mg/kg), chocolate (3.2 mg/kg), and dry tea/herbs-for-infusion (0.76 mg/kg) are the highest-Ni food categories; herbs, spices and condiments at 1.26 mg/kg LB (P95 4.64 mg/kg) are an additional high-concentration category relevant to the 05_PB_Vanilla_Spices folder. The drinking-water EU parametric value (20 µg Ni/L) holds across most of the EU but contributes only 0.0005–1.7% of total dietary Ni exposure; the 70 µg Ni/L WHO guideline is the looser international comparator. No EU MLs for Ni in any food category as of this opinion’s adoption; the Panel did not propose food MLs. EFSA’s 2020 update (cited efsa-nickel-contam-2020) revised the chronic TDI upward to 13 µg/kg bw/day on reconsideration of the dose-response endpoint; the 2015 opinion remains the citation for the originally-derived TDI methodology and for the comprehensive occurrence/exposure characterisation.

Courses: Worked example of the BMD approach (PROAST, dichotomous multistage, BMR 10%, combined-dataset analysis) replacing NOAEL/LOAEL methodology for a developmental endpoint with sparse individual-level data; the case study shows how datasets too small or noisy for individual-litter analysis can still be analysed at the aggregate (incidence-per-treatment-group) level if goodness-of-fit and BMD/BMDL ratio criteria are met. Illustrates the two-track risk-characterisation pattern for substances with distinct chronic systemic and acute hypersensitivity endpoints: a TDI for the general population plus a separate MOE-based acute reference point for sensitised individuals. The 15% prevalence of Ni allergic contact dermatitis in the general population (often undiagnosed) is a recurring teaching point for why a single TDI cannot be assumed to protect the most-sensitive sub-population. The opinion is also a worked example of the limits of risk-characterisation when oral-absorption rates depend strongly on fasting state and food matrix (1–40% range); the Panel’s choice to use external dose for both the RP and the exposure estimate, while noting this likely overestimates risk, is documented as a conservative defensible choice.

App: Confirms that cocoa beans and cocoa products, soya beans, peanuts, dried beans, chocolate-containing confectionery, and dry tea/herbs are the highest-Ni food categories per the EU occurrence dataset. For ingredient-list inference, cocoa-based powdered beverages, chocolate-containing snacks/desserts, soy-protein-isolate-containing formulas, peanut-butter products, dry tea/herbal-infusion products, and herb/spice/condiment-heavy preparations should weight Ni-contamination probability upward. Drinking-water contribution to Ni intake is negligible across age classes (0.0005–1.7%); ingredients-list inference does not need to model water-source variation for Ni. Powdered infant formula receives an 8× dilution factor in EFSA’s exposure modelling — relevant for translating powder concentrations to as-consumed estimates.

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Verification notes

  • 2026-05-28 (v2.0 manual-fetch merge-enhance of the 2026-05-14 batch-ingest page).
  • Legacy raw_handle: manual-fetch-kimi replaced with per-PDF MFK_ form (MFK_efsa-scientific-opinion-on-the-risks-to-public-hea) per current convention.
  • Truncated raw_path (...presence of nickel in food and drinking .pdf) restored to full filename (...presence of nickel in food and drinking water.pdf).
  • Added raw_sha256 (a9709fa1…), access_url (DOI), tier_rationale, and absolute page count (202 pp.) in publication.
  • ingredients expanded from {cocoa, legumes, cereals, water, vegetables} to also include herbs-and-spices, tea, coffee, chocolate, and peanuts. The opinion explicitly catalogues each of these as a major Ni occurrence category and/or a major chronic-exposure contributor (cocoa beverages and chocolate via ‘Non-alcoholic beverages’ and ‘Sugar and confectionery’; coffee as the main adult contributor to ‘Non-alcoholic beverages’; herbs/spices/condiments as a discrete FoodEx group with mean LB 1,259 µg/kg; tea-infusions with 100× dilution factor flagging dry tea as a high-concentration source).
  • products field promoted from [] to a 15-slug list covering the food-category exposure drivers and the drinking-water categories the opinion materially characterises (chocolate, coffee, tea, tea-infusions, condiments-general, spices, bottled-drinking-water, mineral-water, legumes-pulses-other, peanuts, peanut-butter, infant-food-general, infant-formula-powder, breakfast-cereals, bread-and-baked-goods). The earlier products: [] was the Phase-1 frontmatter discipline defect flagged by audit-routing-discipline.mjs (a food paper with product-shaped matrices but no products declared); promotion to populated routes the source to the relevant product-category pages.
  • matrices expanded from {dietary-intake, drinking-water, food} to also include food-contact-materials (the opinion discusses stainless-steel cookware leaching though excludes the contribution from the dataset) and infant-formula (formula receives the 8× dilution factor in the exposure model and is part of the ‘Food for infants and small children’ high-volume contributor).
  • Key numbers expanded substantially to capture: (i) the full Table 7 occurrence summary across all FoodEx level-1 groups, (ii) the high-Ni subgroup values (cocoa beans 9,528 µg/kg, soya beans 4,624–4,685, peanuts 3,537–3,569, dried beans 3,055–3,077, chocolate cocoa products 3,231–3,236, tea/herbs-for-infusion solid 761–762, herbs/spices/condiments mean LB 1,259), (iii) drinking-water compliance and bottled-water occurrence detail, (iv) full chronic-exposure means and 95th-percentiles by age class (Table 9), (v) full acute-exposure ranges by age class (Table 11), (vi) vegetarian sub-population values (Table 10), (vii) the complete BMD/BMDL derivation for both chronic and acute endpoints (Tables 19 and 20), (viii) the analytical-method composition (ICP-MS 54%, AAS 42%, ICP-AES 3%, electrochemistry 1%, spectroscopy 0.2%), and (ix) the data-cleaning exclusions (3,784 + 4 + 605 + 114 + 2,902 + 32 + 8 + 47 + 13 statistical outliers + 1 carbonated water + 1 pork liver).
  • Methods section expanded to record: Call-for-Data procedure and EFSA Guidance on Standard Sample Description; substitution method for left-censored data with Method explicitly attributed to WHO/IPCS 2009 + EFSA 2010b; dilution factors and their values; PROAST version 26; BMR 10% default for chronic, BMR 5% supporting analysis on sperm parameters, three-study BMD analysis of SCD with Jensen 2003 selected as most sensitive; MOE ≥ 10 rationale.
  • Lead paragraph rewritten to consolidate the two-endpoint structure (chronic TDI plus acute MOE) and to surface the 15% allergic-contact-dermatitis prevalence as the structural reason for the acute reference point.
  • The legacy heading ## Wiki pages updated on ingest replaced with the current ## Wiki pages this source may touch per the documented heading convention (CLAUDE.md Part 5b; audit-prompt.md Check 2).
  • Wikilink [[regulations/efsa-nickel-tdi-2015]] corrected to [[regulations/efsa-nickel-tdi]] to match the actual regulation-page slug (no year suffix); the wiki/regulations/ directory contains efsa-nickel-tdi.md and eu-nickel-directive-94-27-ec.md as the two relevant Ni regulation pages.
  • No primary brand-attributed contamination data in the opinion (the underlying occurrence dataset is anonymous food samples submitted to EFSA by Member-State authorities); no Part 12 brand-firewall edits required. The 13 outlier beer samples (5.2–14.3 mg Ni/L) the Panel excluded are identified by sampling country only, not by brand.
  • No synthesis claims; no HMTc threshold proposals (Part 2 firewall intact). The Implications/Certification block records the TDI and acute RP as EFSA’s derivations and notes the subsequent revision of the chronic TDI in the 2020 update without proposing or comparing HMTc thresholds.
  • Part 12 method-vendor exception preserved: the methods narrative records standardised method codes (ISO 8288:1986, EN ISO 15586:2004, EN ISO 11885:2009, EN ISO 17294-1:2004, EN ISO 17294-2:2003, ISO 8294:1994), the PROAST software identity, the proficiency-test scheme names (FAPAS, Bipea), and Tukey’s outlier method — all method/instrument identifiers, not contamination-value attributions, and therefore exempt from Part 12 stripping.

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