Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. 
Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. What was studied?
The study assessed the contribution of infant formula to the dietary exposure of nine selected elements, most notably several heavy metals and essential trace elements, in German infants and toddlers aged 0.5 to 3 years. The research focused on inorganic arsenic (iAs), cadmium (Cd), chromium (Cr), manganese (Mn), mercury (Hg), nickel (Ni), lead (Pb), selenium (Se), and zinc (Zn), evaluating both total dietary exposure and the specific contribution of infant formula. Exposure assessments were based on occurrence data from Germany’s first Total Diet Study (BfR MEAL Study) and consumption data from the representative KiESEL nutrition survey. The study compared the calculated exposures to established health-based guidance values (HBGVs) or, where these were unavailable, used the margin of exposure (MoE) approach. The focus keyphrase “infant formula heavy metal exposure” is central to this analysis, as the findings directly inform the heavy metal certification landscape for infant nutrition products.
Who was studied?
The primary population studied consisted of German children aged 0.5 to <1 year (infants, n=51) and 1 to <3 years (toddlers, 63) who consumed infant formula (breastfed children were excluded due lack of intake data). their food consumption patterns captured over multi-day dietary records, ensuring a representative cross-section. this cohort allowed for realistic estimation daily long-term exposure the target elements, as opposed estimates based solely on manufacturer instructions or average population data. by targeting sensitive age group, infants toddlers with high relative limited variety study addresses those most vulnerable contaminants thus relevant heavy metal regulation.< p>
Most important findings
| Critical Point | Details |
|---|---|
| Cadmium (Cd) exposure | Median exposures approached/exceeded 80% of the TWI; about 30% of infants and toddlers exceeded the health-based guidance value. Infant formula contributed up to 10% of total Cd exposure for mean consumers. |
| Inorganic arsenic (iAs) exposure | Median exposures were 0.22 µg/kg bw/day (infants) and 0.21 µg/kg bw/day (toddlers); MoE below 1 for all children, indicating potential risk. Infant formula contributed 18% (infants) and 10% (toddlers) to total iAs exposure. |
| Lead (Pb) exposure | Median exposures were 0.26 µg/kg bw/day (infants) and 0.22 µg/kg bw/day (toddlers). MoEs were close to 1 in high consumers, suggesting margins of safety are narrow. |
| Manganese (Mn) and Zinc (Zn) | 95th percentile exposures for Mn and Zn approached or exceeded their health-based guidance values; infant formula accounted for up to 64% (Zn) and 20% (Mn) of total exposure in infants. Two toddlers exceeded the Zn upper intake level. |
| Mercury (Hg), Chromium (Cr), Nickel (Ni), Selenium (Se) exposures | All were well below their respective HBGVs; no exceedances observed. Infant formula contributed minor proportions to total exposure for these elements. |
| Variability and limitations | High proportion of measurements below LOQ for several metals introduces uncertainty; results likely overestimate actual exposure due to upper bound approach. Exclusion of breastfed children limits generalizability. |
| Regulatory comparisons | Most element concentrations in infant formula were below EU and Codex maximum levels, but iAs and Cd exposures highlight need for continued monitoring and possible stricter regulation under infant formula heavy metal exposure guidelines. |
Key implications
This study underscores that, while most heavy metals in infant formula remain below regulatory thresholds, exposures to cadmium and inorganic arsenic are concerning, with a notable proportion of children exceeding health-based guidance values. These findings call for targeted mitigation strategies, stricter monitoring, and refined certification criteria within the “infant formula heavy metal exposure” regulatory framework.
Citation
Höpfner T, Wollenberg M, Jäger A, Stadion M, Jung C, Klook AL, Lindtner O. The contribution of infant formula to the food survey-based dietary exposure of nine selected elements. J Environ Expo Assess. 2025;4:9. doi:10.20517/jeea.2024.45
Cadmium is a persistent heavy metal that accumulates in kidneys and bones. Dietary sources include cereals, cocoa, shellfish and vegetables, while smokers and industrial workers receive higher exposures. Studies link cadmium to kidney dysfunction, bone fractures and cancer.
Nickel is a widely used transition metal found in alloys, batteries, and consumer products that also contaminates food and water. High exposure is linked to allergic contact dermatitis, organ toxicity, and developmental effects, with children often exceeding EFSA’s tolerable daily intake of 3 μg/kg bw. Emerging evidence shows nickel crosses the placenta, elevating risks of preterm birth and congenital heart defects, underscoring HMTC’s stricter limits to safeguard vulnerable populations.
Lead is a neurotoxic heavy metal with no safe exposure level. It contaminates food, consumer goods and drinking water, causing cognitive deficits, birth defects and cardiovascular disease. HMTC’s rigorous lead testing applies ALARA principles to protect infants and consumers and to prepare brands for tightening regulations.
