Heavy Metal Content in Infant Formula: Safety Evaluation in China Original paper

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical 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.

    Read More

October 4, 2025

Researched by:

  • Dr. Umar Aitsaam ID
    Dr. Umar Aitsaam

    User avatarClinical 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.

    Read More

Last Updated: 2025-10-04

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Dr. Umar Aitsaam

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?

This original research article investigated the levels and dietary risk of four toxic elements, chromium (Cr), arsenic (As), cadmium (Cd), and lead (Pb), in cow milk-based infant formulas available on the Chinese market. Using inductively coupled plasma mass spectrometry (ICP-MS), the researchers analyzed 93 samples (27 domestic and 66 imported) collected from Beijing supermarkets between 2019 and 2020. The study aimed to quantify the concentrations of these elements, compare domestic and imported products, assess compliance with national and international regulatory limits, and evaluate the potential health risks to infants aged 0.5 to 5 years. The risk assessment incorporated estimated daily intake (EDI), target hazard quotient (THQ), and hazard index (HI) calculations, considering the unique physiological susceptibilities of infants and using established oral reference doses (RfD) as benchmarks.

Who was studied?

The analysis focused on infant formula products rather than individual consumers, but the health risk assessments were modeled for the primary consumers: Chinese infants, both boys and girls, aged 0.5 to 5 years. The formulas represented major domestic brands (Feihe, Junlebao, Yili) and international brands (including Illuma, Arla, Abbott, Nestle, HiPP, Biostime, Nutricia, Friesland, Meadjohnson, Wyeth, Anmum, Karihome, and a2), collectively covering the breadth of the Beijing infant formula market. The study stratified formulas by stage (1 through 4), reflecting different infant growth phases, ensuring that the exposure scenarios modeled real-world feeding practices across early childhood. The risk calculations accounted for age- and sex-specific body weights and formula intake volumes to reflect the vulnerability and exposure levels of the target population.

Most important findings

ParameterResult/Details
Heavy Metal ContentCr: 2.51–83.80 μg/kg; As: 0.89–7.87 μg/kg; Cd: 0.13–3.58 μg/kg; Pb: 0.36–5.75 μg/kg. Domestic vs imported showed no significant differences, except slightly lower Cd in domestic samples. All values were below China, EU, and Codex Alimentarius maximum limits.
Risk AssessmentEstimated daily intakes (EDI) for all four metals were below their respective oral reference doses. Target hazard quotient (THQ) for each metal and hazard index (HI) for combined exposure were consistently below 1 across all age groups and both sexes, indicating no significant non-carcinogenic health risk. Highest HI observed was 0.209 in girls (age 0.5 years), with risk decreasing as age increased.
Comparison to Other CountriesThe observed heavy metal content was similar or lower than levels reported internationally, including studies from Tanzania, Saudi Arabia, Poland, Canada, and others. The risk metrics were generally lower than those reported in Nigeria, Turkey, Ethiopia, and Iran.
Regulatory RelevanceAll Pb and Cd levels were below Chinese and international (EU, Codex) maximum limits for infant formula. No international standards exist for Cr or As in formula, but observed levels were well below oral toxicity reference points.

Key implications

The findings demonstrate that heavy metal content in infant formula on the Chinese market, both domestic and imported, is consistently below regulatory safety thresholds, with no significant health risk for infants aged 0.5 to 5 years. This supports the reliability of current safety standards and monitoring for heavy metal certification programs. However, the study underscores the importance of continued surveillance and further reduction of toxic element residues due to infants’ heightened vulnerability and the lack of regulatory limits for certain elements such as Cr and As.

Citation

Su C, Zheng N, Gao Y, Huang S, Yang X, Wang Z, Yang H, Wang J. Content and dietary exposure assessment of toxic elements in infant formulas from the Chinese market. Foods. 2020;9(12):1839. doi:10.3390/foods9121839

Cadmium (Cd)

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.

Lead (Pb)

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.

Heavy Metals

Heavy metals are high-density elements that accumulate in the body and environment, disrupting biological processes. Lead, cadmium, arsenic, mercury, nickel, tin, aluminum, and chromium are of greatest concern due to persistence, bioaccumulation, and health risks, making them central to the HMTC program’s safety standards.