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 Zn exposure and 20% of iAs, Cr, and Mn exposure in infants at the median.
Key numbers
Occurrence data (BfR MEAL Study, powdered infant formula, all values upper bound, µg/kg dry weight unless noted):
| Analyte | BfR MEAL mean | German food monitoring mean (range) | Measurements <LOQ BfR MEAL (%) |
|---|---|---|---|
| iAs | 4.55 | 20.0 (all at LOQ) | 50 |
| Cd | 4.00 | 5.94 (1.00–17.0) | 50 |
| Cr | 32.8 | 78.5 (3.50–200) | 0 |
| Pb | 4.00 | 9.99 (1.00–20.0) | 75 |
| Mn | 840 | 1,182 (50.0–3,533) | 0 |
| Hg | 3.00 (all <LOQ) | 1.57 (1.00–3.14) | 100 |
| Ni | 78.8 | 156 (8.00–600) | 50 |
| Se | 130 | 211 (11.8–420) | 0 |
| Zn | 40.0 mg/kg | 35.4 mg/kg (0.30–55.7) | 0 |
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, median):
Infants (0.5 to <1 year): iAs from formula 0.03 (18% of total); 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 0.02 (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 contribution 0.03 (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 contribution 0.03 (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; formula contributed 18% for infants.
Zn: Infants formula contribution 64% (median); median total Zn 4,087 µg/day in infants (approaching 95% of infant UL of approximately 4,310 µg/day at the 95th percentile).
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 subsamples: 8 infant formula (pre and stage 1), 4 follow-on formula (stages 2–3), 2 hypoallergenic, and 1 special medical needs formula, all cow-milk-based, analyzed in powder form. Elemental determination by ICP-MS (microwave digestion DIN EN 13805:2014); iAs measured directly by HPLC-ICP-MS/MS for 52 foods with known high iAs; conversion factor of 70% total As as iAs was applied to infant formula because direct measurement was below LOQ. 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
Certification: This TDS-based study confirms that Cd and iAs are the priority analytes for regulatory concern in German infant formula. Cd exceeded the EFSA TWI for approximately 30% of infants and toddlers even at upper-bound estimates. iAs MoEs were below 1 for all formula-consuming children, indicating a non-trivial concern. These data support HMT&C’s use of Cd and iAs as primary certification analytes for infant formula. The low Pb MoEs (approximately 2 at median) also indicate Pb warrants ongoing monitoring. The study does not provide per-product concentration distributions usable as a Path A dataset; its value is as a TDS-based population exposure profile.
Courses: Illustrates how TDS pooling differs from individual product monitoring: BfR MEAL values are generally lower than national food monitoring ranges because TDS uses lower LOQs and pooled samples reduce variance. Demonstrates the MoE approach for analytes without established HBGVs (Pb, iAs).
App: TDS mean occurrence values for powdered infant formula (iAs 4.55, Cd 4.00, Pb 4.00, Cr 32.8, Ni 78.8 µg/kg dry weight) can inform default concentration assumptions for the infant formula ingredient node when product-specific data are absent, with the caveat that these are pooled-sample upper bound means, not product-distribution midpoints.