Höpfner et al. 2025 — Infant Formula Contribution to Dietary Exposure of Nine Elements in Germany

This peer-reviewed German total diet study (TDS) quantifies both the occurrence of nine contaminants and essential elements in powdered infant formula — iAs, Cd, Cr, Pb, Mn, Hg, Ni, Se, and Zn — and the dietary exposure of formula-consuming infants and toddlers aged 0.5 to 3 years, using measured consumption data from the KiESEL survey (n=114 children) combined with occurrence data from the BfR MEAL Study. The study compares exposure against health-based guidance values (HBGVs) and uses a margin of exposure (MoE) approach for Pb and iAs, finding that Cd exposure exceeded the TWI for approximately 30% of infants and toddlers, and that iAs MoEs fell below one for all formula-consuming children. Infant formula contributed up to 64% of reported Zn exposure in infants; reported formula-contribution proportions for iAs, Cr, and Ni were 18%, 19%, and 20%, while Mn was 7%.

Key numbers

Occurrence data (BfR MEAL Study, powdered infant formula, all values upper bound, µg/kg dry weight unless noted):

EU maximum level for Cd in powdered infant formula (cow’s milk): 10 µg/kg; BfR MEAL mean of 4.00 µg/kg is well below this limit.

Dietary exposure from infant formula and total diet (µg/kg body weight/day unless noted, upper bound; medians shown where stated; parenthetical formula-contribution percentages are the source’s Table 5 proportions):

Infants (0.5 to <1 year): iAs from formula median 0.03; reported formula-contribution proportion 18%; total iAs median 0.22 µg/kg bw/day; MoE for total iAs median 0.28 (all 51 infants below MoE of 1, using BMDL05 0.06 µg/kg bw/day for skin cancer).

Toddlers (1 to <3 years): iAs from formula median 0.02; reported formula-contribution proportion 10%; total iAs median 0.21 µg/kg bw/day; MoE median 0.29 (all 63 toddlers below MoE of 1).

Pb: Infants median total 0.26 µg/kg bw/day (P95: 0.33); formula median 0.03; reported formula-contribution proportion 12%; MoE median 1.92 using BMDL01 0.50 µg/kg bw/day for neurotoxicity. No child had MoE below 1.

Cd: Infants median total 0.32 µg/kg bw/day (P95: 0.48); formula median 0.03; reported formula-contribution proportion 10%; 84% of EFSA TWI (2.5 µg/kg bw/week) at mean; 16 of 51 infants (31%) exceeded TWI. Toddlers: median total 0.30 µg/kg bw/day; 18 of 63 (29%) exceeded TWI.

Ni: Infants median total Ni 2.96 µg/kg bw/day; well below EFSA TDI of 13 µg/kg bw/day.

Inorganic Hg (derived from total Hg assuming 100% inorganic for non-fish/seafood): infants median 0.11 µg/kg bw/day; well below EFSA TWI of 4 µg/kg bw/week; reported formula-contribution proportion 18% for infants.

Cr: Total Cr exposure (assuming 100% Cr-III) reached a maximum of 1% of the EFSA TDI (300 µg/kg bw/day) at the 95th percentile (1.93 µg/kg bw/day infants, 2.71 µg/kg bw/day toddlers). Reported formula-contribution proportions were 19% for infants and 8% for toddlers.

Mn: Median total Mn exposure 0.83 mg/day infants (P95 1.51), 1.07 mg/day toddlers (P95 2.35); safe levels of intake 2 mg/day infants and 4 mg/day toddlers. Infants reached 76% of the safe level at the 95th percentile; one infant (2%) exceeded the safe level. No toddler exceeded. Reported formula-contribution proportions were 7% for infants and 4% for toddlers.

Se: Median total Se exposure 15.7 µg/day infants (P95 27.9), 18.9 µg/day toddlers (P95 29.2); UL 55 µg/day infants and 70 µg/day toddlers. Median Se exposure was approximately 30% of UL and the P95 reached 51% (infants). No child exceeded the UL. Reported formula-contribution proportions were 53% for infants and 31% for toddlers.

Zn: Reported formula-contribution proportions were 64% for infants and 43% for toddlers. Median total Zn exposure was 4.09 mg/day in infants and 4.70 mg/day in toddlers. The source states that no UL has been established for infants under one year; toddler Zn exposure was over 60% of the 7 mg/day UL at the median and 93% at the 95th percentile, with 2 toddlers exceeding the UL.

Consumption of infant formula (dry weight): infants mean 8.01 g/kg bw/day (median 6.61; P95 15.8 g/kg bw/day); toddlers mean 4.46 g/kg bw/day (median 3.86; P95 8.38 g/kg bw/day).

Methods (brief)

The BfR MEAL Study (Germany’s first TDS, 2017–2019) provided occurrence data. A single pooled “infant formula” sample combined 15 powdered subsamples: 8 infant formula (pre and stage 1), 4 follow-on formula (stages 2–3), 2 hypoallergenic, and 1 special-medical-needs formula that the source describes as based on cow milk. Elemental determination by ICP-MS (microwave digestion DIN EN 13805:2014); iAs was measured directly by HPLC-ICP-MS/MS for 52 foods where iAs could be expected, while infant formula used the EFSA conversion factor assuming 70% of total As as iAs. Total Hg by direct Hg analyzer (DMA-80). LOD/LOQ for infant formula (dry matrix): iAs LOD 0.001 mg/kg, LOQ 0.003 mg/kg; Cd LOD 0.002 mg/kg, LOQ 0.005 mg/kg; Pb LOD 0.001 mg/kg, LOQ 0.004 mg/kg; Cr LOD 0.02 mg/kg, LOQ 0.05 mg/kg; Ni LOD 0.03 mg/kg, LOQ 0.1 mg/kg; Hg LOD 0.003 mg/kg, LOQ 0.005 mg/kg.

Dietary exposure calculated deterministically: mean concentration multiplied by individual reported consumption from KiESEL (n=114 formula-consuming, non-breastfed children aged 0.5–<3 years), divided by individual body weight, summed across 356 MEAL foods. Upper bound approach: values below LOD set to LOD; values below LOQ and above LOD set to LOQ. Breastfed children (n=13) excluded due to absence of breast milk consumption data.

Limitation note: TDS pooled samples preclude characterizing upper-tail distribution of individual products. The 50–100% left-censoring for iAs, Cd, Pb, Hg, and Ni in infant formula means the true exposure from formula is likely lower than the upper bound estimates reported. iAs conversion factor (70%) may overestimate iAs; direct speciation data suggest iAs is actually the predominant As form in infant formula, meaning true iAs could be higher than 70% of total As. Assuming 100% Cr content corresponds to Cr(III) and 100% Hg in infant formula corresponds to inorganic Hg introduces additional uncertainty.

Implications

This TDS-based study contributes infant-formula exposure evidence for Cd, iAs, Pb, Mn, Zn, and inorganic Hg in German infants and toddlers. Its strongest source-page value is the combination of measured formula consumption from KiESEL with BfR MEAL occurrence data, which makes it a population-exposure profile rather than a product-by-product contamination survey.

Cd exceeded the EFSA TWI for approximately 30% of infants and toddlers, and iAs MoEs were below 1 for all formula-consuming children. The low Pb MoEs (approximately 2 at the median) also support retaining Pb in infant-formula evidence summaries, while the Mn and Zn results show why essential elements may still matter in exposure review when formula is a major dietary contributor.

The study does not provide per-product concentration distributions usable as a Path A occurrence dataset. TDS pooling and left-censoring make its values most appropriate for documenting exposure context and identifying analytes that merit continued monitoring, with explicit caveats that the reported formula concentrations are pooled-sample upper-bound means.

Wiki pages this source may touch

• infant-formula-powder
• infant-formula-ingredients
• milk-and-dairy
• lead
• cadmium
• arsenic-inorganic
• nickel
• chromium
• manganese
• zinc
• mercury
• eu-2023-915-cadmium

Verification notes

• Cross-vendor audit (Codex, 2026-05-17) corrected the truncated PDF raw_path, replaced invalid matrix powdered-formula with infant-formula-powder, corrected the Zn/UL statement to reflect that no UL is established for infants under one year and that the 93% UL comparison applies to toddlers, clarified the iAs conversion-factor method for infant formula, replaced the invalid EU regulation link with eu-2023-915-cadmium, and tightened HMTc implication language away from certification-analyte justification.
• Merge-enhance (Claude, 2026-05-18, v2.0 manual-fetch skill): added Mn and Zn to metals: to route this source to the manganese and zinc pages (paper provides exposure-vs-HBGV findings for both that were previously missing from Key numbers); added Cr, Mn, and Se exposure paragraphs to Key numbers covering the EFSA TDI / safe-level-of-intake / UL comparisons reported in Tables 5–6; verified per-table that all numbers match the source. Brand-firewall recheck under the strict 2026-05-17 reading: page body and Methods name no brands attached to contamination values; the only corporate string is the “DMA-80” Hg analyzer model, which is the Exception 2 scientific-method carve-out.
• Audit subagent (Claude general-purpose, 2026-05-18) flagged toddler Mn P95 as 2.68 mg/day when Table 5 reports 2,348 µg/day = 2.35 mg/day; verified against source — corrected to 2.35 (the 2.68 figure was the European-average upper-bound from the paper’s Discussion, not the present study’s own P95). Same audit flagged the “Wiki pages this source may touch” bulleted list as inconsistent with the post-2026-05-18 metals: frontmatter (missing chromium, manganese, zinc, mercury); propagated the four routing bullets to match. iAs attribution-slip and dietary-intake matrix concerns noted but left as-is (cosmetic pattern consistent across other analyte bullets; matrix string benign).
• Manual-fetch recheck (Codex, 2026-05-18) updated the legacy raw_handle, added DOI access URL and SHA-256 provenance, added Se/iHg to the analyte list because the paper reports selenium exposure and converts total Hg to inorganic-Hg exposure, and rewrote the legacy Certification/Courses/App implications into source-evidence context only. No metals/selenium link was added because the current wiki has no selenium metal page.
• Fresh-context audit (Codex subagent Hume, 2026-05-18) returned REVISE. Applied the verified findings: corrected the intro sentence that wrongly grouped Mn with the ~20% formula-contribution analytes (source Table 5: iAs 18%, Cr 19%, Ni 20%, Mn 7%, Zn 64% for infants), clarified that the Key numbers parenthetical contribution percentages are source-reported Table 5 proportions, and softened the Methods description so only the special-medical-needs subsample is described as cow-milk-based per source p. 3. Also changed routing from the non-soy powder row to generic infant-formula-powder because the source does not clearly resolve the soy/non-soy split.

Page history

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