Scientific Opinion on Lead in Food

Overview

The EFSA Panel on Contaminants in the Food Chain Scientific Opinion on Lead in Food, adopted 18 March 2010 (re-published 2013 with editorial corrections), pooled 94,126 quantified analytical results submitted by 14 Member States and Norway over 2003–2009 and concluded that the prior JECFA provisional tolerable weekly intake of 25 µg/kg body weight per week was no longer appropriate because the available human data show no threshold for the critical lead-induced effects. The Panel derived three Benchmark Dose Lower Confidence Limits from blood lead concentrations and identified developmental neurotoxicity in young children, increased systolic blood pressure in adults, and chronic kidney disease in adults as the critical endpoints. Estimated dietary exposures in European 1–7 year-old children and in some high-consumer adults sit at or above the BMDL intake values, so the possibility of effects in those subgroups cannot be excluded. This opinion is the literature backbone behind EU contaminant limits for lead and supplies the BMDL₀₁ of 12 µg/L B-Pb (≈ 0.50 µg/kg b.w. per day dietary equivalent) used as the children’s neurodevelopmental reference point throughout European regulatory practice.

Key numbers

Critical endpoints and Benchmark Dose Lower Confidence Limits (Section 8.6, Tables 32 and 34, and Section 9):

Lower-bound (LB) and upper-bound (UB) dietary lead exposures by population subgroup (Table 29, Sections 7.2–7.4):

Margins of exposure relative to the BMDLs (Table 38):

EU-pooled occurrence statistics for the largest food categories (adjusted means and 95th percentiles in mg/kg; LB and UB by GEMS/Food convention; outliers >10× next-highest excluded). Selected from Tables 5–19 and the adjusted-mean summary in Table 20:

Breast-milk and infant-formula occurrence (Section 5.7):

Toxicokinetic anchors (Section 8.1):

Non-dietary exposure summary (Table 29):

Headline regulatory conclusion (Sections 8.6.2 and 9.4): “The CONTAM Panel concluded that the present PTWI of 25 µg/kg b.w. is no longer appropriate and noted that there was no evidence for a threshold for a number of critical endpoints including developmental neurotoxicity and renal effects in adults. Therefore, a margin of exposure approach was applied to risk characterisation.” For dietary intake the conversions used were B-Pb 36 µg/L ≈ 90.0 µg/60 kg = 1.50 µg/kg b.w./day (SBP) and B-Pb 15 µg/L ≈ 37.5 µg/60 kg = 0.63 µg/kg b.w./day (kidney), per the Carlisle and Wade (1992) equation in adults, and IEUBK-derived 0.50 µg/kg b.w./day for the 12 µg/L children’s BMDL₀₁ (Table 37, p. 101).

Methods (brief)

This is a Scientific Opinion of the EFSA CONTAM Panel, not a primary occurrence study; the underlying analytical data were generated by Member-State control laboratories and submitted under the DATEX-2008-0002 call (closed July 2008). Of 139,423 submitted results, 139,113 remained after first-pass cleaning, and 94,126 were retained for the calculation of food-category lead concentrations after exclusion of pre-2003 samples and submissions with LOD > 0.1 mg/kg or LOQ > 0.3 mg/kg. Reported analytical methods were graphite-furnace atomic absorption spectrometry (GFAAS, 24.3 % of samples), ICP-MS (9.8 %), unspecified AAS, flame AAS, and ICP-AES; method was not reported for 52.5 % of samples. Median LODs varied by method (ICP-MS 0.003 mg/kg, AAS 0.006 mg/kg, GFAAS 0.010 mg/kg) and by matrix (tap and bottled water medians 0.0003–0.0007 mg/kg; solid foods 0.005–0.05 mg/kg). All results were converted to mg/kg with 1 kg ≈ 1 L for liquids. Lower- and upper-bound means were calculated per GEMS/Food convention (non-detects set to zero and to the LOD/LOQ respectively). Sampling adjustment factors (SAFs) derived from the German DONALD survey corrected the unbalanced sampling frequency to the consumption structure of the EFSA Concise European Food Consumption Database (15 broad food groups, 28 sub-groups), and adjusted means in Table 20 were combined with individual-level consumption data from 19 EU countries plus Norway to compute deterministic mean and 95th-percentile dietary exposures by country, sex, and age (probabilistic Monte Carlo simulation with the Creme system gave comparable means and was used as a cross-check). Long-term child exposure was modelled with the beta-binomial-normal (BBN) model in MCRA software (de Boer and Van der Voet, 2007) across 4–13 national surveys per age year (1–14 y, 10 countries). Dose-response modelling used the EFSA Benchmark Dose framework: for IQ, a logarithmic and a piecewise-linear (knot at 100 µg/L) regression on the Lanphear et al. (2005) individual-data pooled analysis of seven cohorts (n=1,333; Budtz-Jørgensen, 2010 commissioned by EFSA), with the piecewise-linear estimate (BMDL₀₁ = 12.0 µg/L for concurrent B-Pb) chosen because the logarithmic model has infinite slope at zero; for SBP, the arithmetic mean of BMDL₀₁ across four B-Pb studies (Vupputuri 2003; Nash 2003; Glenn 2003, 2006), giving 36 µg/L; for CKD, log-probit and multistage quantal models on NHANES (1999–2006) data (Navas-Acien et al., 2009; n=14,778), giving BMDL₁₀ = 15 µg/L. Conversion of blood-lead BMDLs to dietary equivalents used the Carlisle and Wade (1992) regression for adults (negligible air and soil/dust contribution assumed) and IEUBKwin version 1.1 for infants and children (food, soil/dust, air, drinking water). Reference materials, individual lab certifications, recovery corrections, and HORRAT compliance requirements followed Commission Regulation (EC) No 333/2007 (criteria approach).

Implications

Certification: This opinion is the European literature anchor for B-Pb-based BMDLs and supplies the children’s 12 µg/L B-Pb / 0.50 µg/kg b.w./day dietary-equivalent reference point used implicitly in subsequent EU maximum-level setting for lead. It contributes occurrence data for cereals, vegetables (leafy and root in particular), potatoes, fruits, meat (especially game and offal), bivalve molluscs, infant formula, milk and dairy, tea, cocoa, herbs, and bottled and tap water across an aggregated EU-wide sampling frame. Margins of exposure below 1 for children 1–7 years and high-consumer adults relative to the kidney BMDL₁₀ are direct inputs to category-level threshold work for infant and follow-on food, ready-to-consume infant formula, leafy and root vegetables, cereal grains, and game-derived foods. Use of the IEUBK model and the BMDL₀₁ of 12 µg/L B-Pb in this opinion is consistent with the framework EFSA carried into the 2013 update opinion and into the 2023 EU maximum-level revision for lead in infant and young child foods.

Courses: Useful for the EU regulatory-history modules and for the dose-response section of any neurodevelopmental-lead unit. The opinion explains why a threshold-based PTWI was abandoned and how the margin-of-exposure framework is applied to a non-threshold genotoxic-carcinogen-adjacent contaminant; the piecewise-linear vs logarithmic IQ-model choice is a textbook example for benchmark-dose pedagogy.

App: Provides population-anchored mean and high-consumer dietary lead exposure estimates by age band that the app can use as European baselines for adult, child, and infant scenarios. Per-category mean and P95 occurrence values supply default contamination values where no narrower source has populated the ingredient page. Breast-milk lead (Pb) of 0.0016 mg/L and ready-to-consume infant formula 0.0020–0.0047 mg/kg are usable defaults for infant-exposure modelling when no brand- or product-specific value is available.

Microbiome: Not directly addressed by this opinion.

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