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?
In this original research article, the focus was on evaluating the levels of heavy metals and metalloids in infant formulas marketed in Brazil and assessing the consequent health risks for children consuming these products. The study specifically quantified concentrations of aluminum (Al), arsenic (As), cadmium (Cd), tin (Sn), mercury (Hg), lead (Pb), and uranium (U) in commercial infant formulas using inductively coupled plasma mass spectrometry (ICP-MS). It further analyzed the potential health risks by calculating the Target Hazard Quotients (THQ) for non-carcinogenic risks and the Target Cancer Risk (TCR) for carcinogenic effects associated with exposure to these elements. The study addressed both “phase 1” formulas (intended for infants 0–6 months) and “phase 2” formulas (for children 6–12 months), emphasizing the vulnerability of infants due to their rapid growth, high food intake relative to body weight, and immature physiological defenses. The research also compared the observed toxic element concentrations to international safety standards and discussed potential contamination sources, such as raw materials, manufacturing processes, and packaging.
Who was studied?
The study analyzed infant formula products widely marketed in Brazil, focusing on those designed for healthy infants aged 0–12 months. A total of 10 brands (five phase 1 and five phase 2 formulas) from three manufacturers were selected, with three batches per brand, resulting in 30 distinct samples. All formulas were cow-milk-based, included unhydrolyzed cow milk proteins, used lactose as a main carbohydrate, and were supplemented with essential fatty acids (DHA and ARA). Specialized formulas (e.g., soy-based, lactose-free, hydrolyzed protein) were excluded. The products were purchased from various retail outlets in Rio de Janeiro’s metropolitan area and analyzed in powdered form. Although actual infants were not enrolled, the health risk assessment modeled exposure scenarios for Brazilian infants consuming these formulas according to manufacturer recommendations, using average body weights for the 0–6 and 7–12 month age groups.
Most important findings
| Finding | Details and Relevance to Certification Programs |
|---|---|
| Elemental concentrations | Al (0.432–1.241 mg/kg), As (0.012–0.034 mg/kg), Sn (0.007–0.095 mg/kg) were highest; Cd and U lowest; Hg not detected; Pb detected in only a few samples. |
| Inter-batch variability | Significant differences for Al, Sn, and U among certain brands/batches, indicating inconsistent manufacturing controls. |
| THQ outcomes | THQ values for Al, Cd, Pb, Sn, Hg, and U were all <1, indicating minimal risk. However, THQ for inorganic As exceeded 1 in most formulas, signaling a potential non-carcinogenic health risk for infants. |
| TCR outcomes | TCR values for Al, As, and Pb were within internationally accepted safe limits (10^-4 to 10^-6), indicating negligible carcinogenic risk under current exposure scenarios. |
| Sources of contamination | Al contamination likely from packaging (Al cans, foil linings); As and other metals/metalloids from environmental, agricultural, and processing sources. |
| Comparison to standards | Most elements measured were within safety guidelines, except for As, where the elevated THQ suggests a need for regulatory scrutiny. |
| Broader context | Similar contamination patterns (especially for Al and As) have been observed in formulas from other countries, indicating a global issue. |
Key implications
For heavy metal certification programs, this study highlights the critical need for routine surveillance of both non-carcinogenic and carcinogenic risks in infant formulas, especially for arsenic. Certification standards should address batch variability, packaging sources, and enforce stricter As limits, ensuring manufacturers’ compliance with international guidelines to protect infant health.
Citation
de Almeida, C.C., Baião, D.d.S., Rodrigues, P.d.A., Saint’Pierre, T.D., Hauser-Davis, R.A., Leandro, K.C., Paschoalin, V.M.F., da Costa, M.P., & Conte-Junior, C.A. (2022). Toxic Metals and Metalloids in Infant Formulas Marketed in Brazil, and Child Health Risks According to the Target Hazard Quotients and Target Cancer Risk. International Journal of Environmental Research and Public Health, 19(18), 11178. https://doi.org/10.3390/ijerph191811178
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.
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 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.
