Investigation of some elements in ready-to-eat infant formulas by inductively coupled plasma-mass spectrometry

Background and Aim: Infant formula products play a vital role in early-life nutrition. Even trace levels of toxic elements such as lead (Pb), mercury (Hg), arsenic (As), and cadmium (Cd) can pose developmental risks in infants. Therefore, elemental analysis of such products is essential for ensuring product safety and public health protection. The U.S. Food and Drug Administration (FDA) has established a validated method (EAM 4.7) for the determination of toxic elements in food using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). In this study, the concentrations of both toxic and essential elements in commercially available ready-to-consume powdered infant formulas were determined using the FDA 4.7 method. The aim of this study is to quantify toxic elements (Hg, Pb, Cd, As) and essential trace elements (Se, Mn, Cu, Zn, Cr, Ni, Mo) in infant formula samples, and to evaluate the results in accordance with FDA and Turkish Food Codex (TGK) regulatory limits. Materials and Methods: A total of 21 different infant formula products were analyzed. Sample preparation was performed using a closed-vessel microwave digestion system. All measurements were conducted on a Thermo ICP-MS instrument. Calibration and sample solutions were prepared using a diluent containing 5% HNO₃, 0.5% HCl, 2% IPA, and a mixed internal standard. Five-level calibration curves were used. Method validation was assessed through recovery, repeatability (RSD), linearity (R²), MBKL, ASDL, ASQL, LOD, and LOQ parameters. Results: Toxic elements in all samples were found to be below both FDA and TGK limits. Recovery values ranged between 85–115%, and RPD values were within acceptable limits (<20%). Most essential elements were also found to be within recommended nutritional reference ranges reported in the literature. Discussion: The results demonstrated the applicability of FDA Method 4.7 for elemental analysis in powdered infant formulas. ICP-MS provided a reliable and sensitive analytical approach for detecting trace levels of toxic metals. The validated method supports the implementation of food safety regulations and contributes to quality control practices in the field of infant nutrition. This study provides both scientific and public health relevance in monitoring heavy metal exposure in early life. Keywords: ICP-MS, FDA 4.7, infant formula, heavy metals, elemental analysis, food safety