Exposure to lead and cadmium released from ceramics and glassware intended to come into contact with food

Overview

This peer-reviewed paper from the Department of Food Safety at Poland’s National Institute of Public Health–National Institute of Hygiene (NIPH-NIH, Warsaw) reports a three-year national monitoring study of lead and cadmium migration from ceramic and glass food-contact articles sold on the Polish market. Sanitary-Epidemiological Stations across all Polish provinces sampled 1,273 items during 2010–2012; migration was measured into 4% acetic acid food simulant (24 h, 22±2 °C, in the dark) by Flame Atomic Absorption Spectrometry (FAAS) in PN-EN ISO/IEC 17025-accredited provincial laboratories using the EU-harmonised PN-EN 1388-1:2000 and PN-EN 1388-2:2000 test methods. Lead and cadmium release were usually below analytical detection limits; permissible-limit exceedances were rare and concentrated in imported decorated articles (mainly from Asia) and in the decorated rims of beverage glassware — a surface for which no EU limit currently exists. The maximum migration observed was 163.8 mg lead (Pb)/product and 8.96 mg cadmium (Cd)/product from the rim of a single imported glass mug. The authors carry the per-article migration limits permitted under EU Directive 84/500/EEC (as amended by 2005/31/EC) and the Polish PN-B-13210:1997 standard for rims through to dietary-exposure modelling and conclude that the existing EU migration limits, even when complied with, can drive intakes close to or above the EFSA BMDL01 for lead and TWI for cadmium — especially in 20 kg children, where modelled exceedances reach 30–34× BMDL01 (Pb, neurotoxic) and 3–4.2× TWI (Cd).

Key numbers

Sampling structure (Materials and Methods, p. 303)

2010 (n=423): 281 decorated ceramic samples (114 mug/beverage vessels, 99 deep dishes, 68 flat dishes) + 142 glassware samples (108 decorated-rim + 34 crystal).
2011 (n=392): 225 decorated ceramic samples (105 mug/beverage vessels, 65 deep dishes, 55 flat dishes) + 167 glassware samples (131 decorated-rim + 36 crystal).
2012 (n=458): 245 decorated ceramic samples (112 drinking vessels, 69 deep dishes, 64 flat dishes) + 213 glassware samples (154 decorated-rim + 59 crystal).
Total: 1,273 ceramic and glassware items.

Permissible migration limits used as reference (Table 1, p. 304, transcribed from EU Directive 84/500/EEC as amended)

Category	Description	Pb	Cd	Unit
Category 1	Articles which cannot be filled, and articles which can be filled with an internal depth ≤ 25 mm from the lowest point to the upper rim	0.8	0.07	mg/dm²
Category 2	All other articles which can be filled	4.0	0.3	mg/L
Category 3	Packaging and storage vessels > 3 L capacity	1.5	0.1	mg/L

Polish Standard PN-B-13210:1997 sets a migration limit for the rims of vessels for beverages at 2.0 mg Pb / product and 0.2 mg Cd / product. No EU limit exists for migration from rims that come into direct contact with the mouth or from the inside surface or rims of glassware.

Flat ceramic dishes (n=197 over 2010–2012; Results, p. 304; Tables 2 and 3)

Pb: 2 imported decorated samples exceeded the Category 1 limit of 0.8 mg/dm²: 0.9 and 11.9 mg/dm² (both 2012, both imported decorated plates per Table 3).
Cd: never exceeded the 0.07 mg/dm² limit across the three years.
Proportion of samples with detectable Pb above LOD: ~17 %. Proportion with detectable Cd: ~7 %.

Deep ceramic dishes (n=233 over 2010–2012, excluding vessels for beverages; Results p. 304; Tables 2 and 3)

Of the 233 samples, ~66 % were < LOD for Pb and ~87 % < LOD for Cd.
Measurable but permissible-limit-compliant Pb in 75 samples (92 % imported); measurable Cd in 31 samples (97 % imported).
5 imported samples exceeded the Category 2 Pb limit of 4.0 mg/L: 4.7, 4.9, 5.6, 6.1, 8.6 mg/L (2010: 2 samples; 2011: 2 samples; 2012: 1 sample per Table 3).
0 samples exceeded the Category 2 Cd limit of 0.3 mg/L.

Ceramic mugs / vessels for beverages (n=331 inner-surface + 303 rim, 2010–2012; Results p. 304; Tables 2 and 3)

Inner surface (n=331): Pb detectable in only 8 samples; Cd detectable in only 6 samples; no exceedance of permissible limits (Category 2 thresholds: Pb 4.0 mg/L, Cd 0.3 mg/L).
Rims of ceramic vessels (n=303 across 2010–2012, per Table 2 column totals): measurable Pb migration in 46 samples, of which 4 imports exceeded the 2.0 mg/product PN-B-13210:1997 rim limit: 2.1, 3.7, 4.2, and 14.4 mg Pb / product.
Rims of ceramic vessels for Cd: only 18 of 303 samples had detectable Cd migration; 0 samples exceeded the 0.2 mg/product PN-B-13210:1997 rim limit.

Glasses for beverages — inner surface and decorated rims (n=393 inner + 275 rim-decorated beverage glasses + 95 vodka/wine glasses with decorated rims; Results p. 304)

Inner-surface detectable Pb: ~5 % of samples; inner-surface detectable Cd: ~2 % of samples; all results for Cd migrating from vodka/wine glass inner surfaces were < LOD.
Rim of 275 decorated beverage glasses: 57 (20 %) exceeded the 2.0 mg Pb / product PN-B-13210:1997 rim limit.
Rim of 95 decorated vodka/wine glasses: 10 (11 %) exceeded the 2.0 mg Pb / product PN-B-13210:1997 rim limit.
Rim of 275 decorated beverage glasses: 52 (19 %) exceeded the 0.2 mg Cd / product PN-B-13210:1997 rim limit.
Rim of 95 decorated vodka/wine glasses: 7 (7 %) exceeded the 0.2 mg Cd / product PN-B-13210:1997 rim limit.
Detectable-but-compliant Pb migration from rims: 27 samples (7.3 % of decorated-rim glassware). Detectable-but-compliant Cd: 41 samples (11 %).
Most non-compliant items came from Asian countries. Highest single result: rim of an imported glass mug at 163.8 mg Pb / product and 8.96 mg Cd / product (Abstract; reaffirmed Results p. 304).

Crystal glassware vessels (n=129; Results p. 307)

96 % of crystal samples were manufactured in Poland or other EU countries.
1 sample exceeded the Category 2 Cd limit (0.3 mg/L) at 0.447 mg/L Cd.
0 samples exceeded the Category 2 Pb limit (4.0 mg/L).
In 45 % of crystal samples, detectable Pb migration fell within the 0.5–2.0 mg/L band.
18.6 % of crystal samples were < LOD for Pb.

RASFF context (Results p. 307)

2010–2012: 80 RASFF notifications concerning health threats from high Pb and Cd migration from ceramics and glassware in food contact. A significant share originated from Poland and concerned decorated-rim glassware. Most notified products were manufactured in China; some came from EU Member States. RASFF-reported maxima during the period: 163.8 mg Pb / product and 8.96 mg Cd / product (the same article surfaced in this study’s worst-case finding, per Abstract).

Reference toxicological values used by the authors (Introduction, p. 302)

JECFA 2010: withdrew the 0.025 mg/kg b.w. PTWI for Pb, concluding it could no longer be considered health-protective.
EFSA 2010 (CONTAM Panel Scientific Opinion on Lead): Pb BMDL01 in children 0.5 µg/kg b.w./day (neurotoxic / developmental neurotoxicity endpoint); Pb BMDL10 in adults 0.63 µg/kg b.w./day (nephrotoxic endpoint); Pb BMDL01 1.5 µg/kg b.w./day (cardiovascular endpoint).
EFSA 2009 + 2011 (Cd Scientific Opinion + Statement on TWI): Cd TWI reduced 2.8-fold from PTWI 0.007 mg/kg b.w. to TWI 0.0025 mg/kg b.w.
JECFA 2010: replaced Cd PTWI with Provisional Tolerable Monthly Intake (PTMI) of 0.025 mg/kg b.w.

Risk-assessment exposure estimates from the worst-case migration scenarios (Results and Discussion, pp. 307)

The authors model dietary exposure if articles release Pb and Cd at the maximum permissible levels.

Pb migration at EU Directive 84/500/EEC limits:

Deep plate (Category 2; 0.5 L volume, 4.0 mg/L → 2.0 mg Pb released): adult 70 kg b.w. → 2.5-fold exceedance of BMDL01 (cardiovascular); child 20 kg b.w. → 30-fold exceedance of BMDL01 (neurotoxic).
Flat plate (Category 1; 20 cm diameter, 2.4 mg Pb released at limit): adult 70 kg b.w. → >3-fold exceedance of BMDL01 (cardiovascular); child 20 kg b.w. → 34-fold exceedance of BMDL01 (neurotoxic).

Cd migration at EU Directive 84/500/EEC limits:

Deep plate (0.5 L volume; 0.15 mg Cd released at limit): adult 70 kg b.w. → 86 % of TWI; child 20 kg b.w. → 3-fold exceedance of TWI.
Flat plate (20 cm diameter; 0.21 mg Cd released at limit): adult 70 kg b.w. → 120 % of TWI; child 20 kg b.w. → 4.2-fold exceedance of TWI.

Pb and Cd migration at PN-B-13210:1997 rim limits (2.0 mg Pb / product and 0.2 mg Cd / product):

Pb (rim): adult → >2.5-fold BMDL01; 20 kg child → ~30-fold BMDL01.
Cd (rim): adult → ~equal to TWI; 20 kg child → 4-fold exceedance of TWI.
The authors note these intakes assume once-weekly use of the article; daily use would multiply intakes seven-fold.

Background dietary intake (other sources — food, water, air) the authors carry into the risk picture (Results p. 307):

Adults: Cd background ≈ 70 % of TWI; Pb background ≈ 35 % of BMDL01 (cardiovascular) and ≈ 80 % of BMDL01 (nephrotoxic).
Children: Cd background ≈ 150 % of TWI; Pb background ≈ 200 % of BMDL01.

Methods (brief)

National monitoring sampling 2010–2012 by representatives of the Polish Sanitary-Epidemiological Stations across all provinces, following plans and guidelines from the Department of Food Safety at NIPH-NIH that took regional inhabitant counts and import/domestic ratios into account. The laboratory sample for each migration test comprised 4 individual identical products from the same manufacturer, material, decoration, shape, dimensions, and batch. Migration testing followed PN-EN 1388-1:2000 (lead and cadmium from ceramic ware) and PN-EN 1388-2:2000 (lead and cadmium from silicate surfaces other than ceramic ware), which are the Polish national implementations of the EU-harmonised migration test method: 24 h incubation in 4 % acetic acid food simulant at 22 ± 2 °C in the dark. Analytical determination was by Flame Atomic Absorption Spectrometry (FAAS) in the laboratories of the Provincial Sanitary-Epidemiological Stations, each holding PN-EN ISO/IEC 17025:2005 accreditation. Methods met the validation and performance criteria set out in Commission Directive 2005/31/EC (which amends Council Directive 84/500/EEC). Migration is reported in the article-category-specific basis (mg/dm² for shallow articles, mg/L for fillable articles, mg/product for rims).

Speciation flags. Pb and Cd are reported as total Pb and total Cd; no speciation discipline is required for these elements in the food-contact-material migration framework. The paper does not discuss species-specific measurements (Pb compounds, Cd compounds) — total-metal migration into the acid simulant is the regulatory endpoint.

Acid-simulant basis. Migration values are leachate concentrations from 4 % acetic acid contact with the article surface, normalised to the article’s regulatory category (per dm² of surface for shallow articles, per L of fill volume for deep articles, per article for rims). They are not food-borne concentrations: the simulant is a worst-case acidic-food proxy. The authors flag this explicitly in Results and Discussion (p. 307): real-use intakes will likely be lower because real food contact times are shorter than 24 h, releases decline with repeated use of an article, and not all foods are as acidic as the simulant.

Methodological limitations explicitly named by the authors (Discussion, p. 307):

Migration kinetics from ceramics are reported in the prior literature (refs. 24 and 32 of the paper) as non-linear over consecutive extractions; the 24 h single-extraction test does not capture the full release profile.
Real food–contact times are shorter than the 24 h simulant exposure used in the test method.
Lead and cadmium release decreases on repeated use, so real intakes by users may be lower than the simulant-based worst-case figures the risk assessment uses.
The dietary-exposure scenarios assume the modelled article is used at the permitted migration limit; values for non-compliant imported articles can be far higher (single article released 163.8 mg Pb / product).

Implications

The study reports migration of lead and cadmium from ceramic and glass tableware into a 4% acetic-acid simulant under EU-harmonised migration test methods, not contamination of food as consumed. Sampling is stratified by article origin (imported, EU, Polish domestic), and exceedances concentrate in imports from outside the EU. For rims of beverage vessels, the paper documents that no EU limit exists for migration from rims; PN-B-13210:1997 (2.0 mg Pb and 0.2 mg Cd per product) is the only quantitative reference in scope. The authors’ own risk-assessment math, carried at face value, shows that even compliance with the EU Directive 84/500/EEC Category 1 and 2 limits drives modelled child exposures 30–34× above the EFSA Pb BMDL01 (neurotoxic) and 3–4.2× above the EFSA Cd TWI.
Courses. A defensible national-monitoring case study for brand-QA and regulatory-affairs audiences on (a) how the EU-harmonised migration test method works in practice, (b) how the article-category basis (mg/dm² vs mg/L vs mg/product) shapes what a “permissible limit” actually means in terms of consumer exposure, and (c) how the import-origin sampling stratification surfaces a contamination geography (Asia / China-origin imports dominate the exceedance distribution). Useful as a supply-chain-import-control teaching example.
App. Not directly applicable to ingredient contamination_profile data because the matrices measured are food-contact-material leachates, not food ingredients. Relevant to a future food-contact-material / cookware module of the app.
Microbiome. Not addressed in this source.

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