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 reviewed
This scoping review synthesized heavy metals in baby foods and infant formulas by mapping where and how often toxic elements are detected, summarizing reported concentrations, and comparing them against international maximum levels (MLs) where available. The authors focused on lead (Pb),cadmium (Cd), arsenic (As), and mercury (Hg) in commercially processed baby foods and infant formulas intended for children under 36 months, drawing on global evidence published between 2014 and 2024. To make highly heterogeneous studies comparable, they standardized concentration units to mg/kg and grouped products into practical regulatory categories: seven baby-food groups by primary ingredient (including cereals, rice mixes, fish mixes, roots/tubers, and mixed foods) and infant formulas by stage (stage 1, 2, 3), specialty needs, and whether products lacked stage labeling. The review also summarized the subset of included sources that performed health risk assessments, emphasizing hazard quotient and hazard index approaches, and highlighted gaps where monitoring frameworks (notably national Total Diet Studies) have not consistently captured infant-targeted products.
Who was reviewed
The evidence base comprised 75 included sources (mostly peer-reviewed studies plus a small number of national reports and a nonprofit report) covering 580 baby-food items and 251 infant-formula items tested worldwide. The “who” here is not human participants directly, but rather the populations implicitly represented by regulated product categories: infants and toddlers consuming age-staged formulas and common complementary foods, especially cereals and rice based products introduced after ~6 months. Geographically, the literature was concentrated in Europe and Asia, with additional contributions from the Americas (including the United States), Africa, and Oceania; at the country level, Poland, the United States, and Spain contributed the most studies. Across the included testing, baby foods contributed 1,766 heavy-metal determinations and infant formulas contributed 653 determinations, giving a broad but uneven picture of supply-chain performance and surveillance coverage. This matters for HMTC-style programs because it shows that the certification target is global and highly variable, while documentation practices (for example, incomplete formula staging or protein source labeling) can limit exposure attribution and comparability even when laboratory measurements exist.
Most important findings
Across the global evidence on heavy metals in baby foods and infant formulas, detectable Pb, Cd, and As appeared in well over half of tested items, and exceedances of international MLs clustered in specific, high-risk categories especially rice and fish based baby foods and early stage formulas creating clear priorities for HMTC testing panels, category-specific limits, and documentation requirements.
| Critical point | Details |
|---|---|
| High detection prevalence in baby foods | Heavy metals were detected in 65% of evaluated baby-food determinations overall; Pb, Cd, and As were each detected in roughly seven out of ten assessed baby-food items, while Hg was detected in about one third, indicating that “non-detect” cannot be assumed for most processed infant foods. |
| Category hotspots for arsenic and mercury | Fish and fish mixes showed universal detection of As and Hg in the reviewed determinations, and rice/rice mixes had near-universal As detection with frequent Hg detection, aligning with known environmental pathways (aquatic contamination for Hg and soil/irrigation contributions for As in cereals). |
| Exceedances concentrate in rice, fish, cereals, and mixed foods | Median concentrations and ML exceedances were most prominent for As in fish mixes and rice mixes, for Cd in cereals and mixed-food categories, and for Pb in rice mixes and fish mixes—supporting category-specific certification thresholds and intensified lot testing for these product types. |
| Infant formula: early stages show the highest Pb exceedance | Pb was detected in most formula items, with stage 1 and stage 2 formulas showing the highest median Pb concentrations and very high proportions of Pb results exceeding the referenced MLs—critical because these products are often sole-source nutrition for infants. |
| “Without stage” labeling is a risk-management problem | Formulas lacking stage information had the highest median As concentration and very high As exceedance proportions, suggesting that incomplete labeling can correlate with weaker traceability and makes risk-based certification harder without added documentation rules. |
| Health risk signals cluster by age and product type | Among studies performing risk assessment, reported non-cancer risk concerns were most consistently identified for rice products in infants ≥6 months and for stage 1–2 formulas in infants ≤12 months, reinforcing HMTC’s need to tie certification decisions to realistic consumption patterns and age bands. |
| Analytical-method standardization is part of compliance | The review noted heavy reliance on modern multi-element techniques (notably ICP-based methods) and emphasized the value of low detection limits, reproducibility, and participation in quality-control programs—directly relevant to HMTC lab qualification and audit criteria. |
Key implications
For HMTC, the primary regulatory impact is that category- and age-specific controls are justified because exceedances cluster in rice, cereals, fish mixes, and early-stage formulas, while global monitoring remains inconsistent. Certification requirements should mandate validated multi-element methods with low detection limits, routine proficiency testing, and stronger product metadata (stage, protein source, ingredient primacy) to enable exposure attribution. Industry applications include risk-based supplier approval for rice and seafood inputs, tighter specifications for water/processing aids, and lot-level release testing for high-risk SKUs. Research gaps include weak comparability of health-risk assessments and limited identification of contamination points across the chain. Practical recommendations are to harmonize reporting templates, require speciation where relevant (especially for arsenic), and link limits to consumption-weighted risk for infants.
Citation
Collado-López S, Rodríguez Hernández MF, Mariscal-Moreno RM, Téllez-Rojo MM, Betanzos-Robledo L, Reyes Luna M, Cantoral-Preciado A. Concentrations of Heavy Metals in Processed Baby Foods and Infant Formulas Worldwide: A Scoping Review. Nutr Rev. 2025;84(2):448-461.
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.
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.
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.
Arsenic is a naturally occurring metalloid that ranks first on the ATSDR toxic substances list. Inorganic arsenic contaminates water, rice and consumer products, and exposure is linked to cardiovascular disease, cognitive deficits, low birth weight and cancer. HMTC’s stringent certification applies ALARA principles to protect vulnerable populations.
Mercury (Hg) is a neurotoxic heavy metal found in various consumer products and environmental sources, making it a major public health concern. Its regulation is critical to protect vulnerable populations from long-term health effects, such as neurological impairment and cardiovascular disease. The HMTC program ensures that products meet the highest standards for mercury safety.
