Prescription food for special medical purposes (FSMPs) and modified milk products (MMPs) for babies in the infancy period available in pharmacies are increasingly frequently used for newborns and infants-especially in cases where allergies and food-borne diseases are diagnosed. However, there is a lack of scientific study around the safety assessment of the elemental impurities in these products. Importantly, the allergen Ni and the problematic metal Cr are little considered. Hence, the aim of this article was the toxicological analysis of Ni and Cr impurities in prescription FSMPs (n = 6) and MMPs (n = 6) for newborns and infants available in Polish pharmacies. For the best safety assessment, we include three approaches including (1) the levels of Ni and Cr in powdered products, (2) assessment of the daily dose depending on age and body weight of newborns and infants, and (3) the weekly intake of Ni and Cr in samples in comparison to provisional tolerable weekly intake (PTWI). Our results show that, on the basis of our data, the products from pharmacies in Poland investigated in this study do not represent a real health hazard to newborns and infants, although there may be a requirement for the monitoring of levels of Ni. Our results are pioneer and provide valuable data for other scientists and manufacturers.
Keywords: Chromium; Elemental impurities; Infants; Modified milk products for babies; Nickel; Prescription food for special medical purposes; Safety assessment.