Occurrence and risk assessment of glycidyl and 3-monochloropropanediol esters in infant formulas marketed in Taiwan.

Glycidyl esters (GEs) and 3-monochloropropanediol esters (3-MCPDEs) are process contaminants commonly found in refined edible oils which are often added to infant formulas. The Taiwan Food and Drug Administration (TFDA) launched regulations for GEs in infant formulas that went into effect on 1 July 2021. To investigate levels of GEs and 3-MCPDEs in infant formula powder, 45 products were sampled and analysed during 2020-2021. The contents of GEs and 3-MCPDEs in formulas of different brands significantly varied, but their concentrations in all of the formulas complied with European Union (EU) regulations. Infant formulas containing palm oil had significantly higher 3-MCPDE levels in both extracted oils and milk powder than those without palm oil. Concentrations of GEs and 3-MCPDEs in infant formula powder and extracted oils were significantly lower in products from Europe than those from Australia and New Zealand. Infants aged 0-1 years in Taiwan who consumed only infant formula showed a margin of exposure (MoE) exceeding 25,000. Mean consumer exposures to 3-MCPDEs stayed below the tolerable daily intake (TDI), while high exposures at the 95th percentile (P95) exceeded the TDI by 1.7-fold. Herein, we present the changing trends in the risk assessment results of infant formula across various countries in the decade. Implementation of regulations and mitigation strategy effectively reduced the risk of infants being exposed to GEs and 3-MCPDEs through infant formula.

The occurrence and probabilistic risk assessment of 3-MCPDEs and GEs in infant formulas from Chinese market employing Monte Carlo simulation technique.

3-monochloropropane-1,2-diol esters (3-MCPDEs) and glycidyl esters (GEs) are food contaminants and have arisen continuous attention due to their toxicity, especially towards infants. Current risk assessment of these contaminants was mostly employing deterministic approaches, lacking quantitative characterization of the likelihood, incidence, or severity of the risks involved. Herein, 3-MCPDE and GE levels in 46 representative infant formulas (IFs) from Chinese market were determined by GC-MS/MS. Then, combining the occurrence data and consumption data from China National Food Consumption Survey, the Monte Carlo simulation-based probabilistic model for risk assessment of 3-MCPDEs and GEs in IFs from Chinese market was established. The results showed that all P90 (90th percentiles) hazard quotient values were below 1, demonstrating 3-MCPDEs didn't pose health risks to most populations aged 0-36 months old. However, for 0-12 months old groups, P10 (10th percentiles) margin of exposure values were all below 25000, indicating GEs may pose potential risks to 10% of this group. Uncertainty analysis revealed that the probabilistic model had considered uncertainties of model input and distribution, and realized refined assessment. This study is the first report on probabilistic assessment of 3-MCPDEs and GEs in IFs, which also provided references for the formulation of related regulatory limits in China.

Melamine in Iranian foodstuffs: A systematic review, meta-analysis, and health risk assessment of infant formula.

The presence of melamine in food is one of the most significant threats to consumer health and food safety now confronting the communities. The goal of this systematic review and meta-analysis was to determine the melamine content of different food products available on the Iranian market. The pooled melamine concentration (95% confidence interval) on 484 samples of animal-based foodstuffs was as follows: 0.22 (0.08, 0.36 mg kg-1) for milk, 0.39 (0.25, 0.53 mg kg-1) for coffee mate, 1.45 (1.36, 1.54 mg kg-1) for dairy cream, 0.90 (0.50, 1.29 mg kg-1) for yoghurt, 1.25 (1.20, 1.29 mg kg-1) for cheese, 0.81 (-0.16, 1.78 mg kg-1) for hen eggs, 1.28 (1.25, 1.31 mg kg-1) for poultry meat, 0.58 (0.35, 0.80 mg kg-1) for chocolates, and 0.98 (0.18, 1.78 mg kg-1) for infant formula. Based on the results of health risk assessment study on toddlers under 2 years old who ingested infant formula (as a melamine-sensitive group), all groups of toddlers are at an acceptable level of non-carcinogenic risk (THQ ≤ 1). Toddlers were classified according to their ILCR (carcinogenic risk) levels due to infant formula consumption as follows: under 6 months (0.0000056), 6-12 months (0.0000077), 12-18 months (0.0000102), and 18-24 months (0.0000117). The melamine carcinogenicity in infant formula for children had an ILCR value of 0.000001-0.0001 in the investigation, which was considerable risk. According to the findings, Iranian food products (notably infant formula) should be analyzed for melamine contamination on a regular basis.

Occurrence and risk assessment of 3-monochloropropanediols esters (3-MCPDE), 2-monochloropropanediol esters (2-MCPDE), and glycidyl esters (GE) in commercial infant formula samples from Malaysia.

The presence of 3-monochloropropanediol esters (3-MCPDE), 2-monochloropropanediol esters (2-MCPDE) and glycidyl esters (GE) in infant formula products has raised serious concerns. They incorporate vegetable oils, particularly palm-based oils, which are well-known to contain large amounts of these process contaminants. An analysis was conducted on infant formula samples (n = 16) obtained from the Malaysian market to determine the levels of 3-MCPDE, 2-MCPDE and GE using gas chromatography-mass spectrometry (GC-MS). The method was validated, with a limit of quantification (LOQ) on instrument of 0.10 µg/g for all analytes. The median concentrations of 3-MCPDE, 2-MCPDE and GE in infant formula in this study were 0.008 µg/g, 0.003 µg/g and 0.002 µg/g respectively. The estimated dietary intakes calculated from consumption of infant formula show higher exposures to infants within the age group of 0 to 5 months, highest for GE (1.61 µg/kg bw/day), followed by 3-MCPDE (0.68 µg/kg bw/day) and 2-MCPDE (0.41 µg/kg bw/day) compared to the age group of 6 to 12 months. Only one sample, relating to GE exposure is a potential risk for both age groups with MOE value below 25,000.

Analysis of Six Human Milk Oligosaccharides (HMO) in Infant Formula and Adult Nutritionals by 2AB Labeling and Quantification with HILIC-FLD: First Action 2022.02.

BACKGROUND: Human milk oligosaccharides (HMO) function as a prebiotic, enhance immune functions, and support brain development for infants when fed mother's milk. These are added to infant formula and adult nutritionals in order provide these same benefits. OBJECTIVE: To develop and validate a method that can meet the AOAC Standard Method Performance Requirements (SMPR®) outlined by the AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) through a single-laboratory validation (SLV). METHODS: This work describes a method that can analyze six different HMOs that include 2'-fucosyllactose, 3-fucosyllactose, 3'-sialyllactose, 6'-sialyllactose, lacto-N-tetraose, and lacto-N-neotetraose. The method utilizes a derivatization procedure that labels the HMO with the fluorescent compound 2-aminobenzamide. The method was optimized to provide a non-toxic derivatization procedure, automate the removal of excess derivatization reagent, and provide a chromatographic separation that can analyze multiple HMOs in a single profile. RESULTS: A summary from the SLV is provided. CONCLUSION: The SLV was reviewed by the AOAC SPIFAN Expert Review Panel, and determined the method met the SMPR requirements for six HMO. HIGHLIGHTS: The method was granted First Action Official MethodsSM status.

[Contamination characteristics and preliminaery exposure risk assessment of chloropropanol esters and glycidyl esters in infant formula sold in Beijing in 2021].

OBJECTIVE: To explore the contamination characteristics of chloropropanol esters and glycidyl esters in infant formulas sold in Beijing in 2021, and to evaluate the exposure risk of chloropropanol esters and glycidyl esters for infants and toldders aged 0-36 months old. METHODS: The contents of chloropropanol esters and glycidyl esters in infant formula samples were determined using gas chromatography-mass spectrometry with deuterated internal standards. Combined with the recommended consumption of infant formulas, the exposure level of chloropropanol esters and glycidyl esters in infants and toddlers aged 0-36 months was calculated. RESULTS: The detection rate of 3-chloropropane-1, 2-diol esters(3-MCPDE), 2-chloropropane-1, 3-diol esters(2-MCPDE) and glycidyl esters in infant formulas were 98.6%, 97.1% and 95.7%, respectively. The average contents of 3-MCPDE, 2-MCPDE and glycidyl esters were 44.54, 15.65 and 12.65 µg/kg. For infant of each age groups, the daily intakes of 3-MCPDE via infant formulas by each infant groups were 0.28-0.90 µg/(kg BW), which were all lower than the tolerable daily intake(TDI, 2 µg/(kg BW));the daily intakes of 2-MCPDE via infant formulas by each infant groups were 0.10-0.29 µg/(kg BW);the exposure levels of glycidyl were 0.08-0.22 µg/(kg BW), and the margin of exposure(MOE) values were all higher than 25 000. CONCLUSION: Chloropropanol esters and glycidyl esters in infant formulas sold in Beijing from 2021 were less polluted and their intake was within the safe range.

Quantitative analysis and carcinogenic/non-carcinogenic risk assessment of aflatoxin M1 in milk-based baby food and infant formula milk - a case study in Iran.

In this study, solid-phase extraction (SPE) combined with the dispersive liquid-liquid microextraction based on novel hydrophobic deep eutectic solvent (DLLME - DES) has been developed as an ultra-pre-concentration technique for the extraction of aflatoxin M1 (AFM1) in milk-based baby food (MBBF) and infant formula milk (IFM) samples followed by HPLC combined with fluorescence detection (HPLC - FL). In addition, carcinogenic and non-carcinogenic risk assessment was performed by health-related risk factors including liver cancer risk (LCR), margin of exposure (MOE) and target hazard quotient (THQ) were calculated using the mean of AFM1 in different infant food samples. The results of the study showed that the mean of AFM1 was statistically significant different between various brands and types of IFM and MBBF. The results of the study showed that the percentage of positive samples higher than the allowable limit of AFM1 in 36 samples of domestic infant formula milk (DIFM), 24 samples of imported infant formula milk (IIFM), 36 samples of domestic milk-based baby food (DMBBF) and 18 samples of imported milk-based baby food (IMBBF) were 41.6, 12.5, 66.7 and 33.3%, respectively. In addition, estimated values for health risk-related factors including LCR, MOE and THQ indicated that for most infants less than one-year-old were higher than the acceptable levels. Based on the results, it can be concluded that the quality of IFM and MBBF consumed in Iran in terms of AFM1 is poor. Therefore, it is necessary to take appropriate measures to reduce the amount of AFM1 in DIFM and DMBBF, and in addition, the IIFM and IMBBF should be controlled qualitatively before supplying the market.

Assessment of Regulatory Compliance Testing for Vitamin D in Infant Formula-Impact of Delegated Regulation (EU) 2019/828.

BACKGROUND: Since the publication of Standard Method Performance Requirements (SMPR®) for vitamin D in infant formula (SMPR 2011.004) by AOAC INTERNATIONAL, revised vitamin D limits have been recommended by the European Food Safety Authority (EFSA) for infant formula and adopted in Commission Delegated Regulation (EU) 2019/828. The vitamin D range introduced, 2-2.5 µg/100 kcal, is significantly narrower than previous limits specified by Codex Standard 72-1981 and requires lower method reproducibility metrics to adequately assess regulatory compliance. The narrower limits for vitamin D present a significant challenge for current-generation reference analytical methods that comply with SMPR 2011.004. OBJECTIVE: We evaluate the impact of Delegated Regulation (EU) 2019/828 on the demonstrated performance of AOAC Method 2016.05/ISO 20636:2018 to assess the likelihood that vitamin D results produced by the method would be found outside the EU limits when testing infant formula that is compliant as manufactured. METHODS: AOAC Method 2016.05/ISO 20636:2018, specifically data generated during multi-laboratory study, was used as a basis for statistical evaluation of the impact of the narrower EU vitamin D limits. RESULTS: The review of AOAC Method 2016.05/ISO 20636:2018 method performance against the vitamin D regulatory range introduced in (EU) 2019/828 indicates methods capable of performing in alignment with SMPR 2011.004 are likely to produce results that fail to meet EU requirements. CONCLUSIONS: Our assessment illustrates the high probability that a well-manufactured product with vitamin D levels within the EU regulatory range would fail to meet the regulatory requirements due to analytical method variability when tested using fit-for-purpose methods. Further, required method performance cannot be expected with the future development of new methods. To avoid this, consideration should be given to aligning proposed regulatory limits with method performance metrics of current-generation compendial methods. HIGHLIGHTS: Current, state-of-the-art methods cannot consistently verify infant formula product compliance for vitamin D in accordance with (EU) 2019/828.

Exposure assessment on aflatoxin M1 from milk and dairy products-relation to public health.

BACKGROUND-AIM: Aflatoxin M1 (AFM1) contaminates milk and dairy products that are widely consumed foods. Therefore, there is increased concern for human exposure to the toxic action and the negative health effects that AFM1 presents. The aim of this study was to assess the contamination levels with AFM1, of dairy products available in the Greek market (Thessaly), and also to estimate the relevant nutritional exposure. METHODS: A total of 52 infant milk, 25 Feta cheese and 32 pasteurized milk samples were randomly selected from the market. The determination of AFM1 was based on indirect immunoenzymatic ELISA method with two analytical packages; namely Tecna (Italy) and Prognosis Biotech (Greece), for comparison purposes, strictly following the manufacturer's instructions. The estimated daily intake (EDI) of AFM1 through dairy consumption and the relevant hazard index (HI) were calculated. RESULTS: The levels of AFM1, in all samples tested, were below the tolerable maximum level of 50 ng/L for milk and 25 ng/L for infant formulas (EC Regulation 1881/2006), while concentrations were very low (0.23-9.38 ng/L for infant formula, 0.54-4.09 ng/L for cheese and 0.20-17.84 ng/L for pasteurized milk). The exposure assessment revealed that infants, toddlers and children were the most exposed groups in AFM1 via milk and formula consumption (0.65, 0.35 and 0.35 respectively). The HI was also noticed higher in those ages, with the maximum value to reach 1.90. Though, for feta cheese the exposure was calculated as very low (EDI: 0.01 and HI: 0.05). Comparing the two analytical packages used, no statistically significant difference was found (p-value >0.05). CONCLUSIONS: Milk and dairy products tested were found safe for consumption, regarding the AFM1 levels. From a public health perspective, the results are satisfactory, given that the population exposure to AFM1, based on the nutrient profile, was rather limited.

Assessing the safety of bioactive ingredients in infant formula that affect the immune system: recommendations from an expert panel.

Bioactive ingredients for infant formula have been sought to reduce disparities in health outcomes between breastfed and formula-fed infants. Traditional food safety methodologies have limited ability to assess some bioactive ingredients. It is difficult to assess the effects of nutrition on the infant immune system because of coincident developmental adaptations to birth, establishment of the microbiome and introduction to solid foods, and perinatal environmental factors. An expert panel was convened to review information on immune system development published since the 2004 Institute of Medicine report on evaluating the safety of new infant formula ingredients and to recommend measurements that demonstrate the safety of bioactive ingredients intended for that use. Panel members participated in a 2-d virtual symposium in November 2020 and in follow-up discussions throughout early 2021. Key topics included identification of immune system endpoints from nutritional intervention studies, effects of human milk feeding and human milk substances on infant health outcomes, ontologic development of the infant immune system, and microbial influences on tolerance. The panel explored how "nonnormal" conditions such as preterm birth, allergy, and genetic disorders could help define developmental immune markers for healthy term infants. With consideration of breastfed infants as a reference, ensuring proper control groups, and attention to numerous potential confounders, the panel recommended a set of standard clinical endpoints including growth, response to vaccination, infection and other adverse effects related to inflammation, and allergy and atopic diseases. It compiled a set of candidate markers to characterize stereotypical patterns of immune system development during infancy, but absence of reference ranges, variability in methods and populations, and unreliability of individual markers to predict disease prevented the panel from including many markers as safety endpoints. The panel's findings and recommendations are applicable for industry, regulatory, and academic settings, and will inform safety assessments for immunomodulatory ingredients in foods besides infant formula.

Occurrence of 3- and 2-monochloropropanediol esters in infant formulas in China and exposure assessment.

The presence of 3-monochloropropane-1,2-diol (3-MCPD) esters and 2-MCPD esters in infant formulas have raised a number of food safety concerns. Here, a dietary exposure assessment was conducted for 3-and 2-MCPD esters in infant formulas available for consumption in Chinese infant and toddlers aged 0-3 years old. This work presents the occurrence data for 3-and 2-MCPD ester in 874 infant formulas purchased in China between 2015 and 2017. The concentrations of 3-MCPD esters ranged from ND to 1.469 mg/kg, with concentrations of 2-MCPD esters ranging from ND to 0.218 mg/kg. The LODs of 3-and 2-MCPD esters were 0.027-0.074 mg/kg. The mean exposures of infants and toddlers to 3-MCPD esters from formulas were lower than the tolerable daily intake (TDI, 2 µg/kg bw/day, established by EFSA), while high exposures (95th percentile) to 3-MCPD esters ranged from 0.907 to 2.520 µg/kg bw/day. On the whole, the health risk of Chinese infant and toddlers exposed to 3-MCPD esters was low, but the health risk of some infants aged 0-6 months with high formula consumption (95th percentile) raises some concern.

Potential for Manganese-Induced Neurologic Harm to Formula-Fed Infants: A Risk Assessment of Total Oral Exposure.

BACKGROUND: High oral exposure and biological vulnerabilities may put formula-fed infants at risk for manganese-induced neurotoxicity. OBJECTIVES: We sought to characterize manganese concentrations in public drinking water and prepared infant formulas commonly purchased in the United States, integrate information from these sources into a health risk assessment specific to formula-fed infants, and examine whether households that receive water with elevated manganese concentrations avoid or treat the water, which has implications for formula preparation. METHODS: Manganese was measured in 27 infant formulas and nearly all Minnesota community public water systems (CPWS). The risk assessment produced central tendency and upper-end exposure estimates that were compared to a neonatal animal-based health reference dose (RfD) and considered possible differences in bioavailability. A survey study assessed esthetic concerns, treatment, and use of water in a Twin Cities community with various levels of manganese in drinking water. RESULTS: Ten percent of CPWSs were estimated to exceed the EPA health advisory level of 300 µg/L. Manganese concentrations in formula ranged from 69.8 to 741 µg/L, with amino acid>soy>cow's milk formula concentrations. Central tendency estimates of soy and amino acid formula reconstituted with water at the CPWS 95th percentile manganese concentration exceeded the neonatal-based RfD. Upper-end estimates of manganese intake from formula alone, independent of any water contribution, equaled or exceeded the neonatal-based RfD. In the survey study, we observed increased awareness of esthetic issues and water avoidance at higher manganese concentrations, but these concentrations were not a reliable consumption deterrent, as the majority of households with inside tap drinking water results above 300 µg/L reported drinking the water. DISCUSSION: Excessive exposure to manganese early in life can have long-lasting neurological impacts. This assessment underscores the potential for manganese overexposure in formula-fed infants. U.S. agencies that regulate formula and drinking water must work collaboratively to assess and mitigate potential risks. https://doi.org/10.1289/EHP7901.

Occurrence, exposure evaluation and risk assessment in child population for aflatoxin M1 in dairy products in Brazil.

This study aimed to evaluate the risk concerning child population's health because of the occurrence of AFM1 in UHT milk, powdered milk (PM) and infant formulae (IF). Determination of AFM1 was performed in 60 samples and evaluation of the mycotoxin exposure was carried out through the determination of the estimated daily intake (EDI), whereas risk characterization was evaluated with the calculation of the risk of Hepatocellular Carcinoma (HCC) and the Margin of Exposure (MOE). AFM1 ranged from 150 to 1020 ng/kg, and all the positive samples exceeded the limits stablished by European Community. The EDI for AFM1 ranged according to the age group of the population studied (0-5 years old) from 0.828 to 2.523, 0-2.113 and 0.029-0.833 ng/kg b. w./day in UHT, PM and IF, respectively. The number of HCC cases associated with AFM1 exposure (0.0015 a 0.0045) was higher than the limit of 0.001 case/100,000. MOE values for AFM1 were 728 to 239, considerably below the security margin of 10,000. These results point to a potential risk to the health of Brazilian child population exposed to AFM1 in dairy products.

Lead and cadmium in infant milk and cereal based formulae marketed in Nigeria: a probabilistic non-carcinogenic human health risk assessment.

BACKGROUND: There has been concern on the likelihood of contamination of infant formulae and consequent health risk in children. OBJECTIVE: This study has assessed and compared the lead and cadmium levels in infant formulae commonly consumed in Nigeria with international regulatory limits. It has also compared the estimated daily intake with Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Proposition 65 Provisional Tolerable Daily Intake. MATERIAL AND METHODS: Lead and cadmium levels in 26 different brands of infant formulae purchased from stores in Port-Harcourt, Rivers state, Nigeria in January 2018 were assayed by Atomic Absorption Spectrophotometry. RESULTS: The lead and cadmium levels in milk based infant formulae ranged from 0.61-3.50 mg/kg and 0.01-0.55 mg/kg respectively whereas the range of the lead and cadmium levels in the cereal and cereal mix based were 0.29-1.95 mg/kg and 0.02-0.37 mg/kg, and 0.47-2.34 mg/kg and 0.001-0.46 mg/kg respectively. The mean lead level in the milk-based formulae (1.49 0.89 mg/kg) was slightly higher than other groups of formulae but the difference was not significant (p<0.05). The mean level of cadmium (0.17 mg/kg) in milk-based infant formulae was higher than levels in cereal and cereal mix but there was no significant statistical difference (p<0.05) between the samples. The lead and cadmium level in milk, cereal and cereal mixed based infant formulae were above the food safe limits. CONCLUSIONS: The consumption of infant formulae may add to the body burden of cadmium and lead of children with attendant public health implication. Regular monitoring and safety assessment of metals contamination of these infant formulae is advised.

Health risk assessment of aflatoxin M1 in infant formula milk in IR Iran.

In this study, two accurate, precise, selective and sensitive methods were developed for determining aflatoxin M1 (AFM1) in infant formula milk using immunoaffinity column clean-up followed by high performance liquid chromatography (HPLC) with fluorescence detection. The validated methods were used for determination of AFM1 in 29 samples of 6 different infant formula milk brands and the risk of AFM1 in infants aged zero to 6 months old was assessed using cancer risk, Margin of Exposure (MOE) and Hazard Index (HI). Only one sample (3.4%) was contaminated with AFM1. Although the results showed that MOE values for the mean and median exposure to AFM1 was <10,000 in infants, the additional cancer risk due to mean and median exposure to AFM1 in infant <6 months were 0.00010 and 0.00012 additional cases per year per 105 individuals, respectively, which indicates no health concern. In addition, HI values for the mean and median exposure to AFM1 for infants were quite below one which indicates no health concern. To the best of our knowledge, this is the first report on risk assessment of AFM1 in infant formula milk consumed by Iranian infants <6 months old, presenting a low risk for the evaluated groups.

Public Health and Paediatric Risk Assessment of Aluminium, Arsenic and Mercury in Infant Formulas Marketed in Nigeria.

OBJECTIVES: Infant formulas are useful alternatives to breast milk in many circumstances but may pose health risks to infants and children due to contamination by potentially toxic metals. This study aimed to determine the aluminium, arsenic and mercury concentrations and carry out an exposure health risk assessment in commonly consumed infant formulas in Nigeria. METHODS: Different brands of both locally manufactured and imported infant formulas were purchased in March 2017 from stores in Port Harcourt, Nigeria. Analysis of metals in the samples was performed by atomic absorption spectrophotometry. The health risk was assessed by comparing estimated daily intake of aluminium, arsenic and mercury with the provisional tolerable daily intake acceptable by the Joint Food and Agricultural Organization/World Health Organization Expert Committee on Food Additives (JECFA). RESULTS: A total of 26 infant formulas were analysed. The levels of arsenic were higher in cereal-based formulas compared to milk-based formulas, but the difference was not significant (P >0.05). The intake levels of aluminium, arsenic and mercury in infant formulas were found to be 8.02-14.2%, 437.1-771% and 23.7-41.8% of the provisional tolerable daily intake JECFA threshold values, respectively. CONCLUSION: Commonly consumed infant formulas in Nigeria may add to the body burden of arsenic in children.

Polycyclic aromatic hydrocarbons in infant formulae, follow-on formulae, and baby foods in Iran: An assessment of risk.

Twenty-seven samples of infant formulae and follow-on formulae and fifteen samples of baby food from Iranian markets were analyzed for concentrations of four polycyclic aromatic hydrocarbons (PAH4) determined by use of gas chromatography coupled to mass spectrophotometry. An assessment of risks posed to infants and toddlers was conducted by calculating the margin of exposure and incremental lifetime cancer risk (ILCR) by use of the Monte Carlo Simulation Method. Benzo (a) anthracene, was not detected in any of the samples, while approximately 64.3% samples contained detectable amounts of benzo (a) pyrene, while chrysene was observed in three samples and benzo (b) fluoranthene was detected in one sample. One of the samples contained 1.43 µg PAH4/kg, which was greater than the maximum tolerable limit (MTL; 1 µg/kg) stated in Commission Regulation (EU) 2015/1125. Accordingly, the 95% ILCRs in the infants/toddlers due to ingestion of milk powder and baby foods were determined to be 1.3 × 10-6 and 7.3 × 10-7, respectively. Also, the 95th centiles of the MOEs, due to ingesting milk powder or baby foods by infants/toddlers were estimated to be 3.6 × 104 and 7.2 × 104, respectively. In Iran, infants and toddlers are not at serious health risk (MOE ≥ 1 × 104 and ILCR < 1 × 10-4).

Amount, Preparation and Type of Formula Consumed and Its Association with Weight Gain in Infants Participating in the WIC Program in Hawaii and Puerto Rico.

The aim of this study was to assess the association between amount (below or above recommendations), preparation (liquid vs. powder), and type (regular vs. hydrolysate) of infant formula consumed and weight in infants participating in the Women, Infant and Children (WIC) Program in Hawaii (HI) and Puerto Rico (PR). This was a secondary analysis of 162 caregivers with healthy term 0⁻2-month-old infants. Socio-demographics, infant food frequency questionnaires, and weight and length were assessed at baseline and after four months. Infant feeding practices were associated with weight-for-length z-scores using multivariable logistic regression. In total, 37.7% were exclusively breastfed and 27.2% were exclusively formula-fed. Among formula users, regular (63.6%) and powder (87.0%) formula were the most common; 43.2% consumed formula above recommendations. Most infants had rapid weight gain (61.1%). Infants fed regular formula had higher odds of overweight after four months (adjusted OR = 8.77, 95% CI: 1.81⁻42.6) and higher odds of rapid weight gain (adjusted OR = 3.10, 95% CI: 1.12, 8.61). Those exclusively formula fed had higher odds of slow weight gain (adjusted OR = 4.07, 95% CI: 1.17⁻14.2). Formula preparation and amount of formula were not associated with weight. These results could inform the WIC program's nutrition education messages on infant feeding. Studies with longer follow-up are needed to confirm these results.

Environmental Chemicals in Breast Milk and Formula: Exposure and Risk Assessment Implications.

BACKGROUND: Human health risk assessment methods have advanced in recent years to more accurately estimate risks associated with exposure during childhood. However, predicting risks related to infant exposures to environmental chemicals in breast milk and formula remains challenging. OBJECTIVES: Our goal was to compile available information on infant exposures to environmental chemicals in breast milk and formula, describe methods to characterize infant exposure and potential for health risk in the context of a risk assessment, and identify research needed to improve risk analyses based on this type of exposure and health risk information. METHODS: We reviewed recent literature on levels of environmental chemicals in breast milk and formula, with a focus on data from the United States. We then selected three example publications that quantified infant exposure using breast milk or formula chemical concentrations and estimated breast milk or formula intake. The potential for health risk from these dietary exposures was then characterized by comparison with available health risk benchmarks. We identified areas of this approach in need of improvement to better characterize the potential for infant health risk from this critical exposure pathway. DISCUSSION: Measurements of chemicals in breast milk and formula are integral to the evaluation of risk from early life dietary exposures to environmental chemicals. Risk assessments may also be informed by research investigating the impact of chemical exposure on developmental processes known to be active, and subject to disruption, during infancy, and by analysis of exposure-response data specific to the infant life stage. Critical data gaps exist in all of these areas. CONCLUSIONS: Better-designed studies are needed to characterize infant exposures to environmental chemicals in breast milk and infant formula as well as to improve risk assessments of chemicals found in both foods. https://doi.org/10.1289/EHP1953.