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 evaluated the total aluminum (Al) concentration and the effect of in vitro digestion on the bioaccessible fraction of Al in 35 different cereal-based baby food samples. The central aim was to quantify not only how much Al is present in these foods, but also how much of it could potentially be absorbed by infants after digestion, addressing a key concern for heavy metal certification programs. The researchers employed inductively coupled plasma optical emission spectrometry (ICP-OES) following oxidative microwave digestion to measure total Al. They further developed and optimized an in vitro digestion protocol tailored to infant gastrointestinal physiology to estimate the proportion of Al that becomes bioaccessible. This dual approach enabled a more accurate risk assessment by not only establishing contamination levels but also contextualizing them in terms of actual exposure risk relative to the Provisional Tolerable Weekly Intake (PTWI) for aluminum set by international guidelines.
Who was studied?
The subjects of this study were 35 samples of commercially available cereal-based baby foods marketed in Campinas, Brazil. The samples represented a variety of formulations and brands, including multicereals, rice flour, corn flour, rice and oat, and cereal blends with fruit (banana, apple, and plum). The study did not involve human or animal subjects; rather, it focused on the chemical analysis of food products intended for infants and young children. For exposure assessment, the risk characterization was modeled based on the typical dietary habits of children aged two to six years, with a presumed average body weight of 15 kg, in accordance with FAO/WHO recommendations.
Most important findings
| Key Finding | Details and Relevance to HTMC Certification |
|---|---|
| Total Al Concentration | Levels varied significantly by product type and brand. Multicereal and fruit-based (plum) cereals had the highest Al concentrations (up to 8.82 mg/kg and 7.49 mg/kg, respectively), while corn and rice flour-based products had the lowest (0.92 mg/kg and 1.09 mg/kg). |
| Bioaccessible Fraction of Al | The fraction of Al released during simulated digestion ranged from 1.5% to 10.4% of total Al content. Single-flour cereals (rice or corn) had higher bioaccessibility than multicereal blends, likely due to compositional differences such as fiber content. |
| Exposure Assessment | Estimated daily consumption of three portions of these cereals by children would contribute up to 10.48% of the PTWI for Al, even at the highest total Al levels detected. When bioaccessibility was considered, actual exposure would be even lower. |
| Method Validation | Analytical protocols demonstrated high precision (CV 2.6%) and accuracy (recoveries 87-101%), with satisfactory detection (53 µg/kg) and quantitation (89 µg/kg) limits, enhancing confidence in the reported data for both regulatory and certification purposes. |
| Risk Contextualization | Despite measurable Al content, the low bioaccessibility and resulting exposure suggest negligible risk from these products when consumed according to manufacturer instructions, supporting their safety from a heavy metal certification perspective. |
Key implications
This study provides a robust framework for heavy metal certification by distinguishing between total and bioaccessible aluminum in infant cereals, emphasizing that risk assessments based solely on total content may overestimate exposure. The validated analytical methods and infant-specific digestion modeling establish reliable benchmarks for regulatory or certification protocols. The findings suggest that, even in products with higher total Al levels, the proportion actually bioaccessible is low and does not pose a health risk under typical consumption patterns. This underscores the importance of including bioaccessibility data in certification criteria to ensure consumer safety and regulatory compliance while avoiding unnecessary market restrictions.
Citation
Lima de Paiva E, Medeiros C, Milani RF, Morgano MA, Pallone JAL, Arisseto-Bragotto AP. Aluminum content and effect of in vitro digestion on bioaccessible fraction in cereal-based baby foods. Food Research International. 2020;131:108965. doi:10.1016/j.foodres.2019.108965
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.
