Low-Protein Infant Formula Enriched with Alpha-Lactalbumin during Early Infancy May Reduce Insulin Resistance at 12 Months: A Follow-Up of a Randomized Controlled Trial.

High protein intake during infancy results in accelerated early weight gain and potentially later obesity. The aim of this follow-up study at 12 months was to evaluate if modified low-protein formulas fed during early infancy have long-term effects on growth and metabolism. In a double-blinded RCT, the ALFoNS study, 245 healthy-term infants received low-protein formulas with either alpha-lactalbumin-enriched whey (α-lac-EW; 1.75 g protein/100 kcal), casein glycomacropeptide-reduced whey (CGMP-RW; 1.76 g protein/100 kcal), or standard infant formula (SF; 2.2 g protein/100 kcal) between 2 and 6 months of age. Breastfed (BF) infants served as a reference. At 12 months, anthropometrics and dietary intake were assessed, and serum was analyzed for insulin, C-peptide, and insulin-like growth factor 1 (IGF-1). Weight gain between 6 and 12 months and BMI at 12 months were higher in the SF than in the BF infants (p = 0.019; p < 0.001, respectively), but were not significantly different between the low-protein formula groups and the BF group. S-insulin and C-peptide were higher in the SF than in the BF group (p < 0.001; p = 0.003, respectively), but more alike in the low-protein formula groups and the BF group. Serum IGF-1 at 12 months was similar in all study groups. Conclusion: Feeding modified low-protein formula during early infancy seems to reduce insulin resistance, resulting in more similar growth, serum insulin, and C-peptide concentrations to BF infants at 6-months post intervention. Feeding modified low-protein formula during early infancy results in more similar growth, serum insulin, and C-peptide concentrations to BF infants 6-months post intervention, probably due to reduced insulin resistance in the low-protein groups.

Improving the Nutritional Status of Socially Vulnerable Children in Manaus, Brazilian Amazon, through a Food Supplementation Programme.

Information on the effects of government nutrition programmes provided to socially vulnerable children to improve their nutritional status is scarce. We analysed the effectiveness of a nutritional programme, including food supplementation with infant formula, on the evolution of the weight and height of socially vulnerable children from Manaus in the Brazilian Amazon. This study included 7752 children aged 12-24 months admitted to the programme between 2017 and 2020. Weight and height measurements at admission and every three months thereafter were extracted from the programme database. Weight-for-age, weight-for-height, body mass index-for-age (BMI/A), and height-for-age z-scores were analysed using a multilevel linear regression model, which showed a statistically significant decrease in nutritional deficits toward nutritional recovery at follow-up. The programme's effectiveness was evaluated in 1617 children using a paired analysis comparing data from between 12 and 15 months of age at admission and follow-up after 6-9 months. Children admitted with wasting presented an increase in the BMI/A z-score, whereas children admitted with a risk of being overweight and obese had a statistically significant decrease in the BMI/A z-score. Children admitted with stunted growth also showed increased height-for-age z-scores. The nutrition programme was effective for children experiencing wasting and reducing excess weight.

Diurnal rhythmicity of infant fecal microbiota and metabolites: A randomized controlled interventional trial with infant formula.

Microbiota assembly in the infant gut is influenced by diet. Breastfeeding and human breastmilk oligosaccharides promote the colonization of beneficial bifidobacteria. Infant formulas are supplemented with bifidobacteria or complex oligosaccharides, notably galacto-oligosaccharides (GOS), to mimic breast milk. To compare microbiota development across feeding modes, this randomized controlled intervention study (German Clinical Trial DRKS00012313) longitudinally sampled infant stool during the first year of life, revealing similar fecal bacterial communities between formula- and breast-fed infants (N = 210) but differences across age. Infant formula containing GOS sustained high levels of bifidobacteria compared with formula containing B. longum and B. breve or placebo. Metabolite and bacterial profiling revealed 24-h oscillations and circadian networks. Rhythmicity in bacterial diversity, specific taxa, and functional pathways increased with age and was strongest following breastfeeding and GOS supplementation. Circadian rhythms in dominant taxa were further maintained ex vivo in a chemostat model. Hence, microbiota rhythmicity develops early in life and is impacted by diet.

Evaluation of Prebiotic Glycan Composition in Human Milk and Infant Formula: Profile of Galacto-Oligosaccharides and Absolute Quantification of Major Milk Oligosaccharides by UPLC-Cyclic IM-MS and UPLC-MS/MS.

Prebiotic oligosaccharides have attracted immense interest in the infant formula (IF) industry due to their unique health benefits for infants. There is a need for the reasonable supplementation of prebiotics in premium IF products. Herein, we characterized the profile of galacto-oligosaccharides (GOS) in human milk (HM) and IF using ultrahigh-performance liquid chromatography-cyclic ion mobility-mass spectrometry (UPLC-cIM-MS) technique. Additionally, we further performed a targeted quantitative analysis of five essential HM oligosaccharides (HMOs) in HM (n = 196), IF (n = 50), and raw milk of IF (n = 10) by the high-sensitivity UPLC-MS/MS method. HM exhibited a more abundant and variable HMO composition (1183.19 to 2892.91 mg/L) than IF (32.91 to 56.31 mg/L), whereas IF contained extra GOS species and non-negligible endogenous 3'-sialyllactose. This also facilitated the discovery of secretor features within the Chinese population. Our study illustrated the real disparity in the prebiotic glycome between HM and IF and provided crucial reference for formula improvement.

Whey protein hydrolysates and infant formulas: Effects on physicochemical and biological properties.

Whey protein hydrolysates are recognized for their substantial functional and biological properties. Their high digestibility and amino acid composition make them a valuable ingredient to hydrolyzed whey infant formulas, enhancing both product functionality and nutritional values for infant growth. It is important to understand the functional and biological properties of whey protein hydrolysates for their applications in infant formula systems. This review explored preparation methods of whey protein hydrolysates for infant formula-based applications. The effects of whey protein hydrolysate on the physicochemical and biological properties of hydrolyzed whey infant formulas were summarized. The influences of whey protein hydrolysates on the functional and nutritional properties of formulas from manufacturing to infant consumption were discussed. Whey protein hydrolysates are crucial components in the preparation of infant formula, tailored to meet the functional and nutritional demands of the product. The selection of enzyme types and hydrolysis parameters is decisive for obtaining "optimal" whey protein hydrolysates that match the intended characteristics. "Optimal" whey protein hydrolysates offer diverse functionalities, including solubility, emulsification and production stability to hydrolyzed whey infant formulas during manufacturing processes and formulations. They simultaneously promote protein digestibility, infant growth and other potential health benefits, including reduced allergenic potential, as supported by in vitro, in vivo and clinical trials. Overall, the precise selection of enzymes and hydrolysis parameters in the production of whey protein hydrolysates is crucial in achieving the desired characteristics and functional benefits for hydrolyzed whey infant formulas, making them critical in the development of infant nutrition products.

Complementary Feeding: Tradition, Innovation and Pitfalls.

According to WHO, "complementary feeding (CF) is the process starting when breast milk alone or infant formula alone is no longer sufficient to meet the nutritional requirements of infants, and therefore, other foods and liquids are needed, along with breast human milk or a breastmilk substitute". CF is one of the most important "critical and sensitive periods" in human life: indeed, timing and approaches to solid foods introduction in an infant's nutrition are of utmost importance as potential epigenetic factors from infancy to adulthood. CF is also deeply influenced by each country and single-family traditions, culture, and beliefs. The aim of our narrative review is to analyze traditional CF practices, including innovative and alternative ones that emerged in the last decades, such as baby-led weaning or plant-based weaning, and to evaluate their effects on the risk of developing non-communicable diseases. Moreover, we will discuss pitfalls and misunderstandings that pediatricians frequently have to face when dealing with complementary feeding. Health care professionals must not have prejudices against parents' wishes or traditions about CF; rather, they should support and educate them in case of any alternative CF choice, always pursuing the infant's adequate growth, neuro- and taste development, and the achievement of correct eating behavior as the primary goal.

Cross-Sectional Analysis of Infant Diet, Outcomes, Consumer Behavior and Parental Perspectives to Optimize Infant Feeding in Response to the 2022 U.S. Infant Formula Shortage.

In May of 2022, millions of U.S. parents encountered uncertainty in safely feeding their infants due to the infant formula shortage. METHODS: An anonymous, electronic, cross-sectional, retrospective survey was used. RESULTS: U.S. parents (n = 178) whose infants were ~10 weeks old during the shortage completed the survey. Of parents, 81% switched formulas during the shortage, 87% switched because they could not find the formula they typically used, 34% switched 3-5 times, 29% of parents visited ≥4 stores/24 h and 26% of parents traveled >20 miles/24 h to purchase formula. Use of infant formula increased (p < 0.01); in infants requiring specialty formula, use of intact cow's milk formula increased (p < 0.05) and use of premature infant formulas decreased (p < 0.05). Infants relying on specialty formulas experienced at least one undesirable outcome compared with non-specialty users. Parents used social media, relatives/friends and healthcare providers for support during the shortage, but their helpfulness scores were suboptimal. Parents reported the need for greater infant formula availability, free prenatal lactation education and postpartum lactation support. CONCLUSIONS: Government, regulatory and healthcare policy oversight are needed to protect the infant feeding system, including more commercially available products, access to banked donor milk and lactation support.

Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Pre-, and Postbiotics: A Multi-Country Multi-Center Prospective Randomized Controlled Study in Infants with Regurgitation.

This multi-center prospective randomized controlled trial was a tolerance and safety study investigating the thickener locust bean gum (LBG) in infants with regurgitation, to support the re-evaluation of the safety of LBG in infant formula. The primary objective was to demonstrate that after an 8-week intervention, stool consistency was not inferior (i.e., was not looser or more watery) in infants fed an anti-regurgitation (AR) formula containing LBG vs. the stool consistency of infants fed with an unthickened control formula. A total of 103 full-term infants with regurgitation were randomized to the test or control formula. The test formula contained LBG (0.4 g/100 mL), short-chain galacto-oligosaccharides, and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1; 0.4 g/100 mL) and postbiotics and the control formula contained scGOS/lcFOS (0.8 g/100 mL), the same amount of postbiotics, and did not contain LBG. The average stool consistency score at the 8th intervention week was the primary outcome parameter. Secondary outcome parameters were stool consistency at other timepoints, stool frequency, Infant Gastrointestinal Symptom Questionnaire (IGSQ) score, growth, (serious) adverse events ([S]AEs), regurgitation severity, and infant well-being. Overall, the infants were 36.9 ± 12.9 [mean ± SD] days old, 62.7% girls in the test, and 50.0% girls in the control group. The primary analysis showed that the test group did not have looser or more watery stools than the control group. IGSQ sum scores decreased comparably in both groups. The frequency of regurgitation was significantly lower in the test group compared to the control group (mixed model repeated measurement, p ≤ 0.028) and parent-reported well-being scores were favorable. Adequate growth was observed in both groups. Both products were well-tolerated and safe and the AR formula with LBG was efficacious in reducing regurgitation frequency. This study provides further evidence for the dietary management of regurgitation by LBG-containing formulae in infants who are not exclusively breastfed, and the reassurance it can bring to parents.

Fat globule diameter in infant formulas.

OBJECTIVES: The lipid fraction, fatty acid profile, and diameter of fat globules of infant formulas show great differences from human milk. These characteristics influence fat digestion and, consequently, the development and health of infants. The aim of this study was to evaluate the diameter of fat globules in infant formulas and compare them with those in human milk. METHODS: The diameter of fat globules of 10 infant formulas and human milk samples was determined using scanning electron microscopy. RESULTS: The starter infant formula was the only one that showed a mean diameter value (3.52 ± 2.17 µm) similar to that obtained for human milk (3.44 ± 1.68 µm). The starter infant formula showed the highest values of volume-surface D3,2 (6.13 µm) and volume-weighted D4,3, (7.05 µm) mean diameters among the infant formulas analyzed, and close to those obtained for the human milk sample (5.16 and 5.98 µm, respectively). The infant formulas whey protein partially hydrolyzed, soy protein isolate-based, whey protein extensively hydrolyzed, and thickened with pregelatinized starch had the lowest mean diameters of fat globules 0.64 ± 0.22, 0.70 ± 0.19, 1.06 ± 0.34, and 1.22 ± 0.48 µm, respectively. CONCLUSION: The analysis of principal components showed that none of the analyzed infant formulas had similarity with the diameter of fat globules and the fatty acid profile of human milk.

Tolerance development in cow's milk-allergic children receiving amino acid-based formula with synbiotics: 36-Months follow-up of a randomized controlled trial (PRESTO Study).

The objective of the present study is to assess the rates of acquired tolerance to cow's milk (CM) after 36 months in subjects who consumed amino acid-based formula with synbiotics (AAF-S) or amino acid-based formula without synbiotics (AAF) during a 1-year intervention period in early life as part of the PRESTO study (Netherlands Trial Register number NTR3725). Differences in CM tolerance development between groups were analysed using a logistic regression model. Results show that the proportion of subjects (mean [±SD] age, 3.8 ± 0.27 years) who developed CM tolerance after 36 months was similar in the group receiving AAF-S (47/60 [78%]) and in the group receiving AAF (49/66 [74%]) (p = 0.253), that is, figures comparable to natural outgrowth of CM allergy. Our data suggest that the consumption of AAF and absence of exposure to CM peptides do not slow down CM tolerance acquisition.

Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial.

Importance: Maternal milk feeding of extremely preterm infants during the birth hospitalization has been associated with better neurodevelopmental outcomes compared with preterm formula. For infants receiving no or minimal maternal milk, it is unknown whether donor human milk conveys similar neurodevelopmental advantages vs preterm formula. Objective: To determine if nutrient-fortified, pasteurized donor human milk improves neurodevelopmental outcomes at 22 to 26 months' corrected age compared with preterm infant formula among extremely preterm infants who received minimal maternal milk. Design, Setting, and Participants: Double-blind, randomized clinical trial conducted at 15 US academic medical centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants younger than 29 weeks 0 days' gestation or with a birth weight of less than 1000 g were enrolled between September 2012 and March 2019. Intervention: Preterm formula or donor human milk feeding from randomization to 120 days of age, death, or hospital discharge. Main Outcomes and Measures: The primary outcome was the Bayley Scales of Infant and Toddler Development (BSID) cognitive score measured at 22 to 26 months' corrected age; a score of 54 (score range, 54-155; a score of ≥85 indicates no neurodevelopmental delay) was assigned to infants who died between randomization and 22 to 26 months' corrected age. The 24 secondary outcomes included BSID language and motor scores, in-hospital growth, necrotizing enterocolitis, and death. Results: Of 1965 eligible infants, 483 were randomized (239 in the donor milk group and 244 in the preterm formula group); the median gestational age was 26 weeks (IQR, 25-27 weeks), the median birth weight was 840 g (IQR, 676-986 g), and 52% were female. The birthing parent's race was self-reported as Black for 52% (247/478), White for 43% (206/478), and other for 5% (25/478). There were 54 infants who died prior to follow-up; 88% (376/429) of survivors were assessed at 22 to 26 months' corrected age. The adjusted mean BSID cognitive score was 80.7 (SD, 17.4) for the donor milk group vs 81.1 (SD, 16.7) for the preterm formula group (adjusted mean difference, -0.77 [95% CI, -3.93 to 2.39], which was not significant); the adjusted mean BSID language and motor scores also did not differ. Mortality (death prior to follow-up) was 13% (29/231) in the donor milk group vs 11% (25/233) in the preterm formula group (adjusted risk difference, -1% [95% CI, -4% to 2%]). Necrotizing enterocolitis occurred in 4.2% of infants (10/239) in the donor milk group vs 9.0% of infants (22/244) in the preterm formula group (adjusted risk difference, -5% [95% CI, -9% to -2%]). Weight gain was slower in the donor milk group (22.3 g/kg/d [95% CI, 21.3 to 23.3 g/kg/d]) compared with the preterm formula group (24.6 g/kg/d [95% CI, 23.6 to 25.6 g/kg/d]). Conclusions and Relevance: Among extremely preterm neonates fed minimal maternal milk, neurodevelopmental outcomes at 22 to 26 months' corrected age did not differ between infants fed donor milk or preterm formula. Trial Registration: ClinicalTrials.gov Identifier: NCT01534481.

Global and regional prevalence of Cronobacter sakazakii in powdered milk and flour.

Cronobacter sakazakii (Cz) infections linked with powdered milk/flour (PMF) are on the increase in recent times. The current study aimed at assessing worldwide and regional prevalence of Cz in PMF. Cz-PMF-directed data were conscientiously mined in four mega-databases via topic-field driven PRISMA protocol without any restriction. Bivariate analysis of datasets was conducted and then fitted to random-intercept logistic mixed-effects regressions with leave-one-study-out-cross-validation (LOSOCV). Small-study effects were assayed via Egger's regression tests. Contributing factors to Cz contamination/detection in PMF were determined using 1000-permutation-bootstrapped meta-regressions. A total of 3761 records were found out of which 68 studies were included. Sample-size showed considerable correlation with Cz positivity (r = 0.75, p = 2.5e-17), Milkprod2020 (r = 0.33, p = 1.820e-03), and SuDI (r = - 0.30, p = 4.11e-03). The global prevalence of Cz in PMF was 8.39% (95%CI 6.06-11.51, PI: 0.46-64.35) with LOSOCV value of 7.66% (6.39-9.15; PI: 3.10-17.70). Cz prevalence in PMF varies significantly (p < 0.05) with detection methods, DNA extraction method, across continents, WHO regions, and world bank regions. Nation, detection method, world bank region, WHO region, and sample size explained 53.88%, 19.62%, 19.03%, 15.63%, and 9.22% of the true differences in the Cz prevalence in PMF, respectively. In conclusion, the results indicated that national will power in the monitoring and surveillance of Cz in PMF matched with adequate sample size and appropriate detection methods will go a long way in preventing Cz contamination and infections.

Optimizing ARA and DHA in infant formula: A systematic review of global trends, regional disparities, and considerations for precision nutrition.

In the context of precision nutrition, the addition of ARA and DHA in infant formula needs to consider more factors. This study conducted a comprehensive literature review, including 112 relevant Chinese and English articles, to summarize and analyze the global levels of ARA, DHA, and the ARA/DHA ratio in breast milk. The data were correlated with local aquatic products intake and children's IQ. The results indicated that the average level of DHA in breast milk across regions is lower than that of ARA. Variations in DHA content were identified as a primary factor influencing ARA/DHA ratio fluctuations. Breast milk ARA and DHA levels decrease with prolonged lactation periods but increase over the past 22 years. Correlation analysis revealed a significant positive relationship between aquatic products intake and breast milk DHA levels (r = 0.64, p < 0.05). Breast milk DHA levels also showed a significant positive correlation with children's IQ (r = 0.67, p < 0.01). Stable breast milk ARA content did not exhibit significant correlations with aquatic products intake or children's IQ (r = 0, p > 0.05). Among 22 infant formula products available in China, only 5 had ARA levels within the range of breast milk. Most formula products had higher ARA levels than DHA, resulting in ARA/DHA ratios generally exceeding 1. The temporal and spatial variability in breast milk ARA and DHA levels may lead to diverse health outcomes in infants. Therefore, the addition of ARA and DHA in infant formula should consider this variability, including the molecular forms and positional isomerism of the added ARA and DHA. Additionally, considering the impact of different cognitive development tests and infant's gene expression on formula assessment results, there is a need to establish a more comprehensive infant health assessment system to guide the addition of ARA and DHA in formula.

Bovine milk ß-casein: Structure, properties, isolation, and targeted application of isolated products.

ß-Casein, an important protein found in bovine milk, has significant potential for application in the food, pharmaceutical, and other related industries. This review first introduces the composition, structure, and functional properties of ß-casein. It then reviews the techniques for isolating ß-casein. Chemical and enzymatic isolation methods result in inactivity of ß-casein and other components in the milk, and it is difficult to control the production conditions, limiting the utilization range of products. Physical technology not only achieves high product purity and activity but also effectively preserves the biological activity of the components. The isolated ß-casein needs to be utilized effectively and efficiently for various purity products in order to achieve optimal targeted application. Bovine ß-casein, which has a purity higher than or close to that of breast ß-casein, can be used in infant formulas. This is achieved by modifying its structure through dephosphorylation, resulting in a formula that closely mimics the composition of breast milk. Bovine ß-casein, which is lower in purity than breast ß-casein, can be maximized for the preparation of functional peptides and for use as natural carriers. The remaining byproducts can be utilized as food ingredients, emulsifiers, and carriers for encapsulating and delivering active substances. Thus, realizing the intensive processing and utilization of bovine ß-casein isolation. This review can promote the industrial production process of ß-casein, which is beneficial for the sustainable development of ß-casein as a food and material. It also provides valuable insights for the development of other active substances in milk.

Unlocking the mysteries of milk oligosaccharides: Structure, metabolism, and function.

Milk oligosaccharides (MOs), complex carbohydrates prevalent in human breast milk, play a vital role in infant nutrition. Serving as prebiotics, they inhibit pathogen adherence, modulate the immune system, and support newborn brain development. Notably, MOs demonstrate significant variations in concentration and composition, both across different species and within the same species. These characteristics of MOs lead to several compelling questions: (i) What distinct beneficial functions do MOs offer and how do the functions vary along with their structural differences? (ii) In what ways do MOs in human milk differ from those in other mammals, and what factors drive these unique profiles? (iii) What are the emerging applications of MOs, particularly in the context of their incorporation into infant formula? This review delves into the structural characteristics, quantification methods, and species-specific concentration differences of MOs. It highlights the critical role of human MOs in infant growth and their potential applications, providing substantial evidence to enhance infant health and development.

Quantitative Analysis of Nervonic and Erucic Acids in Human Milk: Comparison with Infant Formula with Different Fat Sources and Nutritional Stages.

This study aims to quantitatively analyze nervonic (C24:1 n-9) and erucic (C22:1 n-9) acids in human milk (HM) collected from Korean mothers, along with the infant formulas (IFs) with different fat sources and nutritional stages. The content of nervonic and erucic acids in HM from Korean mothers were 2.13 and 2.81 mg/100 g, accounting for 0.06 and 0.08% of the total fatty acids (FAs), respectively. These acids in IFs based on fat from plant-oil formula were higher than those in IFs based on cow milk formula. The composition of erucic acid in IFs based on cow milk formula and plant-oil formula increased with the nutritional stages, while nervonic acid only increased in IFs based on the plant-oil formula.

A 21-day safety evaluation of biotechnologically produced 3-fucosyllactose (3-FL) in neonatal farm piglets to support use in infant formulas.

3-Fucosyllactose (3-FL) is one of the most abundant fucosylated oligosaccharides in human breast milk and is an approved infant formula ingredient world-wide. 3-FL functions as a prebiotic to promote early microbial colonization of the gut, increase pathogen resistance and modulate immune responses. To investigate safety and potential gut microbiota effects, 3-FL was fed for 21-days to farm piglets beginning on Postnatal Day (PND) 2. Fructooligosaccharide (FOS), an approved infant formula ingredient, was used as a reference control. Standard toxicological endpoints were evaluated, and the gut microbiota were assessed. Neither 3-FL (245.77 and 489.72 mg/kg/day for males and 246.57 and 494.18 mg/kg/day for females) nor FOS (489.44 and 496.33 mg/kg/day males and females, respectively) produced any adverse differences in growth, food intake or efficiency, clinical observations, or clinical or anatomic pathology changes. Differences in the gut microbiota after 3-FL consumption (versus control and FOS groups) included the absence of Bifidobacterium species from the piglets, enrichment of Prevotellamassilia timonensis, Blautia species, Mediterranea massiliensis, Lachnospiraceae incertae sedis, and Eubacterium coprostanoligens and lower relative abundance of Allisonella histaminiformans and Roseburia inulinivorans. This study further supports the safe use of 3-FL produced using biotechnology as a nutritional ingredient in foods.

Trace elements in commercially available infant formulas in Iran: Determination and estimation of health risks.

Infants are significantly more vulnerable to trace elements from their foods. The objective of the present study was to ascertain the concentrations of some trace elements namely; arsenic, cadmium, chromium, copper, nickel and lead in infant formulas sold in Iran and to estimate the potential health risks to the infants through consumption of these products. The mean concentrations of As, Cd, Cr, Cu, Ni and Pb in infant formula samples were 0.006, 0.040, 0.3980, 2.014, 0.166 and 0.285 mg/kg, respectively. The mean levels of the trace elements were in the following order: Cu > Cr > Pb > Ni > Cd > As. For arsenic, cadmium and copper, calculated EWIs (estimated weekly intakes) were within the PTWIs (provisional tolerated weekly intakes) recommended by FAO/WHO. For chromium, nickel and lead, the calculated EWIs were higher than the PTWIs in 88.8 %, 75 %, and 61.1 % of the formulas. HQs of Pb, Cu, Cd and As were above the safe limits, indicating health concerns from the consumption of some infant formulas. Based on the CR classification, CR values of some elements including Cd, Cr and Ni were above 1 × 10-4 in some brands, indicating that exposure to these elements from infant formulas may cause health risks. Therefore, regular monitoring of all the raw materials, stages of production and storage of infant formulas is essential to limit the exposure of this vulnerable age group to toxic trace elements.