Assessing the Risk of Endocrine-disrupting Chemicals in Commercial Baby Formula in Malawi

Assessing the Risk of Endocrine-disrupting Chemicals in Commercial Baby Formula in Malawi | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Assessing the Risk of Endocrine-disrupting Chemicals in Commercial Baby Formula in Malawi Andrew Kachipande, Ben Temba, Silvia Materu, Chikumbusko Kaonga This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3950482/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction Endocrine-disrupting chemicals such as organochlorine pesticides (OCP) and some heavy metals disturb important life functions such as reproduction, metabolism, and growth by interfering with the normal functionality of the human hormonal system. These toxic and persistent chemicals used in agricultural and industrial processes, can enter the baby formula and remain effective for extended periods. These EDCs come from environmental contamination and the manufacturing process of the baby formula. Materials and method In this study, we examined the levels and risk of EDC contamination in a sample of 85 baby formula products available in the Malawian market. Extraction was done using the EU CEN 15662 QuEChERS method and then analyzed using gas-liquid chromatography with fluorescence to quantify OCP contamination. For heavy metals, samples were digested and analyzed using the Analytik Jena microwave digestion system (TOPwave_90_09) and an Atomic Absorption Spectrometer, respectively. The risk of exposure was computed using a hypothetical consumption of infant formula at 12 and 24 months, and weight ranges of 9.25–12.247 kg with corresponding average daily intakes of 0.057–0.2kg. Results EDC contamination ranged from not detected to 0.3 mg/kg. Common EDCs were Aldrin (23%), dieldrin (27%), and lindane (35%). The risk assessment showed a Hazard Index of 1.2. This suggests higher levels of exposure, are more likely to have lasting effects during human development. The detection levels were above the European Food Safety Authority (EFSA) recommended maximum residual limit of 0.01mg/kg. Conclusion Considering the health implications and susceptibility of the babies, it is pertinent to enforce and closely monitor the EDC content of baby formulas in the Malawi market. Food Science & Technology Toxicology Nutrition & Dietetics endocrine disruption chemicals organochlorine pesticides risk assessment Figures Figure 1 1. INTRODUCTION Organochloride pesticides (OCPs) and heavy metals are endocrine-disrupting chemicals (EDCs) that disrupt hormone function, causing adverse effects on organisms, offspring, and populations (Kelemen et al., 2019 ). EDCs can stimulate, block, or change natural hormone synthesis, consequently producing false or abnormal signals (UNEP, 2017). EDCs, found in various industries, are persistent in the environment and can be created by burning materials (Braun, 2017 ; Yesildemir & Akdevelioglu, 2021 ). Even intentionally engineered chemicals like OCP can pose potential harm (Boué et al., 2018 ; de Mendonça Pereira et al., 2020 ). Babies’ consumption of contaminated formula is a global public health concern since EDCs are associated with various health issues such as asthma, learning difficulties, early puberty, infertility, cancer, Parkinson's disease, and obesity ( Muncke, 2011; Birnbaum, 2013 ). EDCs also disrupt thyroid signaling leading to testicular mal-development and disturbance of the central nervous system (Jaacks & Prasad, 2017 ; Kent, 2012 ; Sharma et al., 2021 ). Babies’ increasing vulnerability even to lower doses is attributable to their frequent hand-to-mouth or object-to-mouth behaviour, greater consumption of food and liquids relative to body weight compared with adults, lack of defensive or adaptive mechanisms, and rapid growth (Boué et al., 2018 ; de Mendonça Pereira et al., 2020 ; Eticha et al., 2018 ; Pettoello-Mantovani et al., 2021 ; UNEP, 2017). Several studies show that EDCs are active at low doses with persistent negative health effects (Alexandra & Gugoasa, 2020 ; Fernandino et al., 2022 ; Groh et al., 2021 ; Kahn et al., 2020 ). In Africa, paediatric obesity is increasing coinciding with increased consumption of baby formulas with public health and economic implications (Ferreira et al., 2023 ). OCPs like Dieldrin (1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-endo,exo-1,4:5,8-dimethanonaphthalene), Heptachlor (1aR,2R,2aS,3S,6R,6aR,7S,7aS)-3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-2,7:3,6-dimethanonaphtho[2,3-b]oxirene), Chlordane ( 1,2,4,5,6,7,8,8-Octachloro-3a,4,7,7a-tetrahydro-4,7-methanoindene), DDT (1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane), 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane (1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane), Lindane (1α,2β,3β,4α,5α,6β)-1,2,3,4,5,6-Hexachlorocyclohexane) and Gamma-hexachlorocyclohexane (1α,2β,3β,4α,5α,6β)-γ-Hexachlorocyclohexane are harmful to humans, animals, and aquatic life due to their high bioaccumulation and toxicity. Consumption of contaminated baby formulas by the girl child predisposes her to longer menstrual cycles, missed or irregular periods, and abnormal bleeding upon reaching puberty (Encarnação et al., 2019 ; Predieri & Iughetti, 2022 ; Hatzidaki et al., 2023 ; Street et al., 2023 ). Exposure to bio-toxic heavy metals can occur when they leach from printed surfaces or are introduced through manufacturing processes (Jaishankar et al., 2014 ; McKinlay et al., 2008 ; Yesildemir & Akdevelioglu, 2021 ). Gilbert et al . (2019) highlighted the need for comprehensive risk assessment for EDC safety in Africa through the enactment of laws and enforcement. There is a need for closer quality monitoring of the baby formula as it targets a sensitive group of consumers (Fernandino et al., 2022 ; Kim et al., 2018 ; Rotondo & Chiarelli, 2020 ). The Codex Alimentarius Commission recommends maximum upper limits for OCPs and heavy metals but varies slightly across Europe and the USA (UNEP, 2017). In Malawi, baby formula compliance with the specifications of mandatory Malawi Standard (MS 90:2018) is enforced by the Malawi Bureau of Standards. This standard among others, prescribes maximum residual limits of pesticides with reference to the CAC, microbiological limits, and specifications for iron, zinc, and folic acid. However, enforcement remains challenging due to rampant smuggling and informal distribution channels (Bornman et al., 2017 ; Gálvez-Ontiveros et al., 2020 ). The ubiquitous nature of EDCs makes human exposure almost unavoidable. Nevertheless, it is expedient to reduce exposure to EDCs, through eating organic, eco-labelled products in glass rather than plastic packaging (Gálvez-Ontiveros et al., 2020 ; Street et al., 2018 ). The use of supercritical carbon dioxide extraction as a green separation process helps to reduce the presence of EDCs in infant formula (Torres-Torres et al., 2019 ). In Malawi, there are an estimated 8.9 million children under the age of 2 years (UNICEF, 2023 ). Economic disparities in the country impact the baby formula market, with most families facing significant affordability challenges (Gilbert et al., 2019). The Malawian government promotes exclusive breastfeeding for the first six months of life and public health campaigns emphasize its affordability (Salim & Stones, 2020 ). Nutritional assistance programs like the Malawi Social Cash Transfer Scheme provide financial support to vulnerable households (UNICEF, 2023 ). However, challenges persist, such as limited access to clean water, inadequate healthcare infrastructure, and poverty, which may impact families' ability to afford commercial infant formula (Wiyo & Kadewa, 2020 ). There is a lot of formal and informal trade including pesticide and foodstuffs among these neighbouring countries but also within the region and beyond. Smuggling remains a challenge for the government as it causes losses in customs duty revenue and also increases the risk of sale and distribution and ultimately consumption of non-certified products (Liza et al., 2017 ). Few studies conducted on baby formula in Malawi focused on nutrient and mycotoxin quality (Gilbert et al., 2019). There is generally a lack of information on the EDC quality of baby formulas sold on the Malawi market. This study will provide a baseline as a basis for control initiatives for the safety of baby formulas. Therefore we conducted this research: i) to determine the occurrence of OCP and heavy metals in baby formulas sold in Malawi, and ii) to evaluate the risk to the consumer of dietary exposure through consumption of baby formula at different ages and body weights. 2. MATERIALS AND METHODS 2.1 Description of the study area The study was conducted in all three regions of Malawi, a landlocked Southern African country bordering Mozambique on the east and southern parts, Zambia on the west, and Tanzania on the north. Malawi, located at 13.2543° S and 34.3015° E in the Great Rift Valley, is typically an importing country with few local manufacturing industries (Gilbert et al., 2019). Most business activities take place in the cities of Blantyre, Lilongwe, and Mzuzu, as well as the areas bordering these three countries from which the samples were collected. These areas were selected to ensure wide coverage of the country. 2.2 Sample collection and description The originally packaged 85 baby formulas weighing between 500g to 2kg were collected in total; 23 samples from factories (n = 21) in Blantyre, Mulanje, Thyolo, Lilongwe, Mzuzu and 62 samples were collected from supermarkets and mini-supermarkets (n = 40) in Blantyre, Mwanza, Mulanje, Zomba, Machinga, Mangochi, Ntcheu, Dedza, Lilongwe, Salima, Mchinji, Karonga and Mzuzu. There was at least a single sample collected for a qualifying batch from either the factory or supermarket. All baby formulas targeting children up to 24 months were eligible for selection whether fortified or not. The samples were collected between March and June 2023. Samples were vehicle transported in cooler boxes protected from exposure to the sun and excessive heat. They were stored in a cool dry place at room temperature. These 85 samples were either cereal-based (n = 37), milk-based (n = 31), or mixed (combination of cereals, milk, fruit, and vegetables, n = 17). The common ingredients of the baby formula included soya, milk, maize, wheat, rice, and vitamins and minerals constituted in various proportions. Out of the 85 samples, some were powdered (n = 63) while others were semisolid (n = 22). 72.9% of these samples (n = 62) were imported while 27.1% (n = 23) were locally produced. 2.3 Analyzing Organochlorine Pesticides 2.3.1 Extraction Baby formula samples were extracted using the 'Quick, Easy, Cheap, Effective, Rugged and Safe' (QuEChERS) extraction method as described by Perestrelo et al. ( 2019 ). EU CEN 15662 QuEChERS method is a modified dispersive solid phase extraction (dSPE) technique used for the determination of pesticide residues in food samples using gas chromatography coupled with mass spectrometry (GC-MS) analysis. The process involved weighing using Adam Equipment (AAA100L) analytical scale a homogenized 10g sample. Analytic grade acetonitrile (from Glassworld, RSA) was added as an extraction solvent, followed by the addition of a 1-gram QuEChERS extraction salt sachet to each sample-acetonitrile mixture. The contents were vortexed using Thermo Scientific™ (model M37610-33) and centrifuged using the relative centrifugal force (RCF) of 3,904 for the MDR version of ROTOFIX™ 32A to separate the organic phase of the pesticides in the sample. The organic phase was transferred by decanting to a cleanup tube containing dispersive solid-phase extraction (d-SPE) sorbents to selectively retain the OCPs. 2.3.2 Gas Chromatography Analysis The cleaned extract was automatically injected using the split injection method for analysis using gas chromatography-mass spectrometry (Agilent™ GC-MS model 7890A) for selective identification and quantification of OCPs. Quality control includes calibration standards, method validation, and analysis of blank samples and matrix spikes. A standard mix of 17 pesticides ( Atrazine, Atrazine-desethyl, Cyanazine, Sebuthylazin, Simazin, Terbuthylazin, Hexazinone, Chlortoluron, Diuron, Isoproturon, Linuron, Methabenzthiazuron, Metobromuron, Metoxuron, Monolinuron, Metazoachlor, Metolachlor) from Sigma-Aldrich (Organochlorine Pesticides Mix) was used for calibration. The design set LOQ for the equipment is 0.01mg/kg which is also the default maximum residual limit (MRL) for pesticides in food according to the Codex Alimentarius while the LOD is 0.003mg/kg. 2.4 Heavy Metal Analysis The heavy metals targeted for analysis were lead and methylmercury. 2.4.1 Lead Analysis For testing lead, samples were digested in an acid solution using the Analytik Jena™ microwave, from Jos Hansen & Soehne- Germany, digestion system (TOPwave_90_09). The reagents used were trace element grade 55% nitric acid (HNO 3 ) and 70% perchloric acid (HClO 4 ) supplied by Glassworld, RSA. The sample weighing 0.5 g was put into the digestion vessel and reagents were added (2ml HNO 3 and 6ml HClO 4 ). These were vortexed carefully and left for 20 minutes to cool down before heating in the microwave. The sample in the vessel was microwave-heated as in Table 1 below: Table 1 Temperature program for microwave digestion Step 1 2 3 T ( o C) 170 190 210 P (bar) 80 80 80 Power (%) 80 90 100 Ramp (Min) 2 1 1 Time (Min) 10 10 10 The vessels were cooled at room temperature for 20 minutes before transferring the contents into a 50ml volumetric flask. The inner wall of the vessels was rinsed with ultrapure water (from Lab Enterprise, Malawi) which was later poured into the volumetric flask containing the sample. The digest was brought up to volume using ultrapure water. 2.4.2 Methylmercury Analysis A sample weighing 10g was homogenized through manual shaking, added a 5ml stannous chloride (SnCl 2 ) solution supplied by Grassworld, RSA. The contents were centrifuged at the relative centrifugal force (RCF) of 3,904 for the MDR version of ROTOFIX™ 32A for digestion and separation of the supernatant. 2ml of the supernatant were auto-sample injected for analysis using flame-optimized intelligent Atomic Absorption Spectrometer model novAA 350 supplied by Analytik Jena™. Calibration standards were supplied by Merck’s Certipur®; the standards used are traceable to primary standards from PTB (Germany). 2.5 EDC risk assessment The Hazard Index (HI) is a measure of the potential adverse consequences of a substance's exposure, that indicates the likelihood of unfavourable effects. It is based on the Hazard Quotient (HQ), which represents the total hazard quotients for compounds with the same target organ or system. HQ values below 1 indicate minimal adverse consequences. Similar to HQ, cumulative exposures below an HI of 1.0 obtained from target organ-specific HQs are probably not going to have a negative impact on non-cancer health throughout a lifetime of exposure. Below are the formulae used to determine the risk $$EDI=\frac{C x DI}{BW} (\text{E}\text{q}. 2.1)$$ \(THQ=\frac{EDI}{RfD}\) (Eq. 2.2) \(HI={\Sigma }\text{T}\text{H}\text{Q}\) (Eq. 2.3) \(HI=\frac{CXDI}{BWXRfD}\) (Eq. 2.4) Where EDI = Estimated Daily Intake, C = Concentration of the chemical, DI = Daily Intake of the formula, BW = Body Weight, RfD = Reference dosage (MRL) According to the WHO (2016) by 12 months and 24 months body weights average 9.25 and 12.247 kg, respectively; average daily intake of 0.057kg at 12 months and 0.2kg at 24 months. These weights, consumption rates, and MRL values were used to calculate the total hazard index. 3. RESULTS AND DISCUSSION 3.1. Levels of OCP and metals in baby formula Contamination was detected in 65.9% (n = 56) of the samples while 34.1% (n = 29) had no detections. About 22.35% (n = 19) of the samples had the EDCs detected above the recommended MRL of 0.01mg/kg representing 33.9% of all detections. These were Aldrin, Lindane, DDT, Telodrin, Chlordane, Dieldrin, and Lead. DDT was detected in one sample of the baby formula while 2.35% (n = 2) samples contained both telodrin and lead. Detected levels of OCPs and heavy metals in baby formula, as summarized in Table 2 , show that lindane, dieldrin, and Aldrin were the most common OCPs with detection rates at 35.29%, 27.06% and 23.53%, respectively. It further shows there were no detections for toxaphene, heptachlor, and methylmercury. Detected levels ranged from 0 to 0.03mg/kg for OCPs and 0 to 0.3 ppm for lead. Table 2 EDC detection levels in baby formula EDC Min Max Detection rate % Aldrin (mg/kg) ND 0.02 23.53 Toxaphene (mg/kg) ND 0 0 Lindane (mg/kg) ND 0.03 35.29 Heptachlor (mg/kg) ND 0 0 DDT (mg/kg) ND 0.02 1.18 Telodrin (mg/kg) ND 0.02 15.29 Chlorodane (mg/kg) ND 0.02 2.35 Dieldrin (mg/kg) ND 0.02 27.06 Lead (ppm) ND 0.3 2.35 Methyl Mercury (ppm) ND 0 0 The data was categorized to show the distribution of detection levels using Fig. 1 : violin plots below For powdered baby food samples, the majority (61%, n = 52) of the chemical concentrations appear to be at or near zero mg/kg, which complies with the generally accepted safe limit of roughly 0.01 mg/kg. However, chemicals like Aldrin and Dieldrin exhibit a broader distribution of concentrations, indicating variability in the powdered food samples again with median estimates of 0.01 mg/kg, which is the same as the acceptable maximum residual limit. On the other hand, chemical concentrations in semi-solid baby food samples generally suggest compliance with safe limits, as most chemicals appear to have concentrations at or near 0 mg/kg. However, lindane is slightly having an estimated median of 0.01 mg/kg which is the recommended default concentration and might require further investigations. The findings of this study contradict the 2018 Turkish study, where no OCPs or heavy metals were detected, except for arsenic (Kilic et al., 2018 ). A study in Mexico in 2010 (Tolentino et al., 2014 ) detected OCPs in levels below the limits set by the Codex Alimentarius Commission (CAC) suggesting the formulas were safer. The Environmental Defense Fund (EDF) found that 20% of baby food samples contained lead, raising concerns about higher levels of lead exposure in infant formulas (Tolentino et al., 2014 ). However, the findings of this study are consistent with the observations by Kosamu et al. ( 2020 ) that OCPs such as Dieldrin, Heptachlor, Hexachlorobenzene, Toxaphene, DDT are some of the major pesticides used in Malawi. It further underscores rampant unsustainable use resulting in contaminating ingredients such as milk, maize, soy, and vegetables as suspected pathways for OCP in the baby formula as pesticide residues (Kosamu et al., 2020 ; Soko, 2018 ). The current analysis suggests the continued use or presence of outlawed pesticides such as DDT (Soko, 2018 ; Temu et al., 2012 ; Carlucci et a l., 2017). The detection of a greater DDT level (0.03 mg/kg) confirms the findings by Soko ( 2018 ), who linked the availability of DDT in Malawi to a source in adjacent Mozambique. This calls for enhanced strict regulatory action by the relevant authorities (Kosamu et al., 2020 ). Santonicola et al., ( 2018 ) reported that effects such as higher rates of obesity and early menstrual periods, increased risk for breast cancer, as well as high blood pressure, diabetes, and other cardio-metabolic diseases, were common in children whose grandmothers were exposed to DDT before its ban in 1970. 3.2 EDC risk assessment The total calculated hazard index was 1.2106 accumulated over 12 months (0.3143) and 24 months (0.8964) period of age. A summary of the calculated hazard quotients at various exposure levels and ages is presented in Table 3 below. A THI of 1.2 presents a higher risk for lifetime EDC-associated problems on the consumer of the formula ( EFSA, 2017). According to the EPA level of concern, a hazard index above 1 shows a higher risk of chronic negative health effects (Hatzidaki et al., 2023 ; Jaishankar et al., 2014 ; Street et al., 2018 ). This entails that babies consuming these formulas may be at risk of EDC-associated neurotoxic effects, reproductive disturbances, altered immune responses, and endocrine disruption. This calls for more determined control efforts since low-dose exposure effects of EDCs can significantly impact infant development, especially in baby formula, due to exposure to other contaminated food and non-food items (Carnevali et al., 2017 ; Sipahi et al., 2015 ). Therefore, to promote safety, risk-based monitoring programs should be reinforced through adequate stakeholder collaboration including quadrilateral efforts involving Malawi and neighbouring countries with whom there is an unregulated illegal trade in pesticides (Soko, 2018 ). Countries should implement pesticide management according to internationally agreed protocols (FAO & WHO, 2023). According to Hatzidaki et al. ( 2023 ), the EU Regulation No. 609/2013 recommends setting pesticide MRL in baby foods at the minimum at the same time encouraging good agricultural practices rather than merely banning the pesticides. Apart from the pesticides and heavy metals, it is recommended to screen the baby formula for other EDCs such as BPA and phthalates which may influence the risk level. On the other hand, encouraging breastfeeding and breastfeeding practices can also help minimize the exposure of babies to EDC-contaminated formulas. On the other hand, quadrilateral efforts involving the four countries will help in reducing the smuggling of potentially unsafe baby formulas. These countries can take advantage of already existing trade cooperation structures to enhance coordinated quality controls perhaps with rapid testing. Policy formulation on control of EDCs would be a helpful step and demonstration of commitment to address this silent pandemic of the new age (Hatzidaki et al., 2023 ). Parents and caregivers need to be equally vigilant in ensuring the safety of the food given to the babies. Table 3 calculated hazard quotients for the EDCs at different exposure levels and ages NAME OF EDC EDC LEVEL (mg/kg) 0.01 0.02 0.03 0.3 RfD EC 12 months 24 months 12 months 24 months 12 months 24 months 12 months 24 months Toxaphene 0.01 0 0 0 0 0 0 0 0 Lindane 0.01 0.0062 0.0163 0.0123 0.0432 0.0185 0.0490 0.0000 0.0000 Heptachlor 0.01 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 DDT 0.01 0.0062 0.0163 0.0123 0.0432 0.0000 0.0000 0.0000 0.0000 Telodrin 0.01 0.0062 0.0163 0.0123 0.0432 0.0000 0.0000 0.0000 0.0000 Chlorodane 0.01 0.0062 0.0163 0.0123 0.0432 0.0000 0.0000 0.0000 0.0000 Dieldrin 0.01 0.0062 0.0163 0.0123 0.0432 0.0000 0.0000 0.0000 0.0000 Lead 0.01 0.0062 0.0163 0.0123 0.0432 0.0000 0.0000 0.1849 0.4899 Mercury 4.3 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 THQ 0.0370 0.0980 0.0739 0.2595 0.0185 0.0490 0.1849 0.4899 HI (12 Months) 0.3143 HI (24 Months) 0.8964 THI 1.2106 4. CONCLUSION This study found that organochlorine pesticides and heavy metal contamination in baby formula exceed the recommended MRL, posing endocrine disruption risks to babies. These formulas may cause neurotoxic effects, reproductive disturbances, altered immune responses, and endocrine disruption. The safety of baby formula is crucial as it deals with a sensitive population, therefore it requires comprehensive pesticide management, good agricultural practices, and enhanced control measures. Encouraging breastfeeding and reducing the smuggling of potentially unsafe formulas can help reduce the risk. There might be a need to study EDC contamination levels in other foods as well. References Alexandra, L., & Gugoasa, D. (2020). Review — Electrochemical Sensors for Determination of the Endocrine Disruptor, Bisphenol Ahttps://doi.org/10.1149/2.0062003JES Aniello, A., Caggiano, R., Macchiato, M., Paolo, C., Ragosta, M., Paino, S., & Cortesi, M. L. (2006). 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THE LANCET Diabetes & Endocrinology , 8 (8), 703–718. https://doi.org/10.1016/S2213-8587(20)30129-7 Kelemen, H., Hancu, G., & Papp, L. A. (2019). Analytical methodologies for the determination of ticagrelor. Biomedical Chromatography , 33 (7). https://doi.org/10.1002/bmc.4528 Kent, G. (2012). Infant feeding practices in Bhaktapur, Nepal: a cross-sectional, health facility based survey. https://doi.org/10.1186/s13006-014-0020-7 Kilic, S., Tongur, T., Kilic, M., & Erkaymaz, T. (2018). Determination of Some Endocrine-Disrupting Metals and Organochlorinated Pesticide Residues in Baby Food and Infant Formula in Turkish Markets. Food Analytical Methods 2018 11:12 , 11 (12), 3352–3361. https://doi.org/10.1007/S12161-018-1299-6 Kim, D. H., Choi, S. M., Lim, D. S., Roh, T., Jun, S., Yoon, S., Kim, M. K., Yoon, K. S., Kim, H. S., Kim, W., & Lee, B. (2018). Risk assessment of endocrine disrupting phthalates and hormonal alterations in children and adolescents. Journal of Toxicology and Environmental Health, Part A , 00 (00), 1–15. https://doi.org/10.1080/15287394.2018.1543231 Kosamu, I., Kaonga, C., & Utembe, W. (2020). A critical review of the status of pesticide exposure management in Malawi. International Journal of Environmental Research and Public Health , 17 (18), 1–13. https://doi.org/10.3390/ijerph17186727 Liza, L., Mupanduki, N., & Ndonga, D. (2017). Impact and Implications of the WTO Trade Facilitation Agreement in East and Southern Africa 2 nd WCO ESA Regional Research Conference East and Southern Africa Region World Customs Organization. www.wcoesarocb.org McKinlay, R., Plant, J. A., Bell, J. N. B., & Voulvoulis, N. (2008). Endocrine disrupting pesticides: implications for risk assessment. Environ Int , 34 (2), 168–183. https://doi.org/10.1016/j.envint.2007.07.013 Nutr, A., & Lönnerdal, B. (2012). Preclinical Assessment of Infant Formula. Metab , 60 , 196–199. https://doi.org/10.1159/000338209 Organization, W. H. (2016). Infant and young child feeding. https://doi.org/10.1787/health_glance_ap-2016-20-en Ortega-García, J. A., Olano-Soler, H. A., Martínez-Álvarez, A., Campillo-López, F., Gomariz-Peñalver, V., Mendiola-Olivares, J., Iglesias-Gómez, C., & Escribano-Muñoz, A. (2016). Breastfeeding duration and anogenital distance in 2-year-old infants. Breastfeeding Medicine , 11 (7), 350–355. https://doi.org/10.1089/bfm.2016.0034 Perestrelo, R., Silva, P., Porto-Figueira, P., Pereira, J. A. M., Silva, C., Medina, S., & Câmara, J. S. (2019). QuEChERS - Fundamentals, relevant improvements, applications, and future trends. Analytica Chimica Acta , 1070 , 1–28. https://doi.org/10.1016/j.aca.2019.02.036 Pettoello-Mantovani, M., Mestrovic, J., Namazova-Baranova, L., Giardino, I., Somekh, E., & Vural, M. (2021). Ensuring Safe Food for Infants: The Importance of an Integrated Approach to Monitor and Reduce the Risks of Biological, Chemical, and Physical Hazards. The Journal of Pediatrics , 229 , 315-316.e2. https://doi.org/10.1016/j.jpeds.2020.10.074 Predieri, B., & Iughetti, L. (2022). New insights on the effects of endocrine-disrupting chemicals on children. 98 . https://doi.org/10.1016/j.jped.2021.11.003 Rotondo, E., & Chiarelli, F. (2020). Endocrine-Disrupting Chemicals and Insulin Resistance in Children. https://doi.org/10.3390/biomedicines8060137 Salim, Y. M., & Stones, W. (2020). Determinants of exclusive breastfeeding in infants of six months and below in Malawi: A cross-sectional study. BMC Pregnancy and Childbirth , 20 (1), 4–11. https://doi.org/10.1186/s12884-020-03160-y Santonicola, S., Ferrante, M. C., Leo, G., Murru, N., Anastasio, A., & Mercogliano, R. (2018). Study on endocrine disruptors levels in raw milk from cow’s farms : Risk assessment. https://doi.org/10.4081/ijfs.2018.7668 Sharma, B. M., Bharat, G. K., Chakraborty, P., Martiník, J., Audy, O., Kukučka, P., Přibylová, P., Kukreti, P. K., Sharma, A., Kalina, J., Steindal, E. H., & Nizzetto, L. (2021). A comprehensive assessment of endocrine-disrupting chemicals in an Indian food basket: Levels, dietary intakes, and comparison with European data. Environmental Pollution , 288 , 117750. https://doi.org/10.1016/J.ENVPOL.2021.117750 Sipahi, H., Eken, A., Aydın, A., Şahin, G., & Baydar, T. (2015). Safety assessment of essential and toxic metals in infant formulas. Turkish Journal of Pediatrics , 56 (4), 385–391. Soko, J. J. (2018). Agricultural pesticide use in Malawi. Journal of Health and Pollution , 8 (20). https://doi.org/10.5696/2156-9614-8.20.181201 Street, M. E., Angelini, S., Bernasconi, S., Burgio, E., Cassio, A., Catellani, C., Cirillo, F., Deodati, A., Fabbrizi, E., Fanos, V., Gargano, G., Grossi, E., Iughetti, L., Lazzeroni, P., Mantovani, A., Migliore, L., Palanza, P., Panzica, G., Papini, A. M., … Amarri, S. (2018). Current knowledge on endocrine disrupting chemicals (EDCs) from animal biology to humans, from pregnancy to adulthood: Highlights from a national Italian meeting. International Journal of Molecular Sciences , 19 (6). https://doi.org/10.3390/ijms19061647 Street, M. E., Shulhai, A. M., Rotondo, R., Giannì, G., & Caffarelli, C. (2023). Current knowledge on the effects of environmental contaminants in early life nutrition. Frontiers in Nutrition , 10 (June), 1–9. https://doi.org/10.3389/fnut.2023.1120293 Temu, E. A., Coleman, M., Abilio, A. P., & Kleinschmidt, I. (2012). High Prevalence of Malaria in Zambezia, Mozambique : The Protective Effect of IRS versus Increased Risks Due to Pig-Keeping and House Construction. 7 (2). https://doi.org/10.1371/journal.pone.0031409 European Union (2017). European Union report on pesticide residues in food. EFSA Journal , 15 (4). https://doi.org/10.2903/j.efsa.2017.4791 Tolentino, R. G., León, S. V., Bermúdez, B. S., Flores, G. P., Lourdes, M. De, Vega, R., & Vázquez, C. R. (2014). Organochlorine Pesticides in Infant Milk Formulas Marketed in the South of Mexico City . July , 1290–1298. Torres-Torres, E. Y., Montiel, C., Araiza-Olivera, D., Gutierrez-Aguilar, M., Gimeno, M., & García-Arrazola, R. (2019). Extracting endocrine disrupting compounds from infant formula using supercritical carbon dioxide. Journal of Supercritical Fluids , 152 , 1–7. https://doi.org/10.1016/j.supflu.2019.104554 UNICEF. (2023). Country Office Annual Report 2022 . 1–7. United Nations Environment Programme. (2017). Overview Report I: Worldwide initiatives to identify endocrine disrupting chemicals (EDCs) and potential EDCs The International Panel on Chemical Pollution (IPCP) . July , 1–40. https://wedocs.unep.org/bitstream/handle/20.500.11822/25633/EDC_report1.pdf?sequence=1&isAllowed=y Vanderford, B. J., Pearson, R. A., Rexing, D. J., & Snyder, S. A. (2003). Analysis of Endocrine Disruptors, Pharmaceuticals, and Personal Care Products in Water Using Liquid Chromatography/Tandem Mass Spectrometry. Analytical Chemistry , 75 (22), 6265–6274. https://doi.org/10.1021/ac034210g Wiyo, K. A., & Kadewa, W. (2020). Will Malawi meet the MDGs targets for water and sanitation at the district level ? evidence from the 2008 national census. January . https://doi.org/10.15406/apar.2019.09.00403 Yesildemir, O., & Akdevelioglu, Y. (2021). Endocrine Disruptors in Baby Formulas: A Literature Review. Selcuk Journal of Agriculture and Food Sciences , 35 (3), 272–279. https://doi.org/10.15316/SJAFS.2021.257 Ying, G. G. (2012). Endocrine Disrupting Chemicals. What? Where? In Analysis of Endocrine Disrupting Compounds in Food . https://doi.org/10.1002/9781118346747.ch1 Additional Declarations The authors declare no competing interests. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3950482","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":272384164,"identity":"5037346e-ccf8-4247-8a74-e3d3c1a3dc2b","order_by":0,"name":"Andrew Kachipande","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6klEQVRIiWNgGAWjYDACHgYGZgYDECuB8QGIz0eKFmYQxcNGnBYwSGCTAFEEtfD3HH74uaDgjrw5e/Kxyq85djJsDMwPH93Ao0XibJux9AyDZ4Y7e56l3Zbdlgx0GJuxcQ4+a84zmDHzGBxm3HAjx+y25DZmoBYeNml8WuTPs38DabHfcCP/W7HktnrCWgzO9oBtSQTawsb4cdthwloMz5wpluYxeJa84cwzY2nGbcd52JgJ+EXuTPrGzzx/7thuOJ788OPPbdX2/OzNDx/j9T4EHACTzDxgkrByhBbGH8SpHgWjYBSMghEGAK3LSDkv1yaEAAAAAElFTkSuQmCC","orcid":"","institution":"Malawi Bureau of Standards. Sokoine University of Agriculture","correspondingAuthor":true,"prefix":"","firstName":"Andrew","middleName":"","lastName":"Kachipande","suffix":""},{"id":272384165,"identity":"f47362b5-3766-483c-ad98-e2fc4c64ad29","order_by":1,"name":"Ben Temba","email":"","orcid":"","institution":"Sokoine University of Agriculture","correspondingAuthor":false,"prefix":"","firstName":"Ben","middleName":"","lastName":"Temba","suffix":""},{"id":272384166,"identity":"4d348673-8bf4-4625-922b-2743e8076a65","order_by":2,"name":"Silvia Materu","email":"","orcid":"","institution":"Sokoine University of Agriculture","correspondingAuthor":false,"prefix":"","firstName":"Silvia","middleName":"","lastName":"Materu","suffix":""},{"id":272384167,"identity":"04cc86d0-d566-442b-ac10-87238d1fcf19","order_by":3,"name":"Chikumbusko Kaonga","email":"","orcid":"","institution":"Malawi University of Business and Applied Sciences","correspondingAuthor":false,"prefix":"","firstName":"Chikumbusko","middleName":"","lastName":"Kaonga","suffix":""}],"badges":[],"createdAt":"2024-02-12 07:46:44","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-3950482/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3950482/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":51077885,"identity":"4532e819-496f-4685-8f89-54c306dd299e","added_by":"auto","created_at":"2024-02-13 18:51:55","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":49846,"visible":true,"origin":"","legend":"\u003cp\u003eViolin plots showing EDC concentration against the distribution of detected contamination levels\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3950482/v1/020c4f68ff048208c9488219.png"},{"id":51079312,"identity":"d8735400-66d3-4e3f-a1ad-8a01c72de08d","added_by":"auto","created_at":"2024-02-13 18:59:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":421492,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3950482/v1/df3a80ce-39fa-4786-b704-38ba9f293dda.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eAssessing the Risk of Endocrine-disrupting Chemicals in Commercial Baby Formula in Malawi\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"1. INTRODUCTION","content":"\u003cp\u003eOrganochloride pesticides (OCPs) and heavy metals are endocrine-disrupting chemicals (EDCs) that disrupt hormone function, causing adverse effects on organisms, offspring, and populations (Kelemen et al., \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). EDCs can stimulate, block, or change natural hormone synthesis, consequently producing false or abnormal signals (UNEP, 2017). EDCs, found in various industries, are persistent in the environment and can be created by burning materials (Braun, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Yesildemir \u0026amp; Akdevelioglu, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). Even intentionally engineered chemicals like OCP can pose potential harm (Bou\u0026eacute; et al., \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; de Mendon\u0026ccedil;a Pereira et al., \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e2020\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eBabies\u0026rsquo; consumption of contaminated formula is a global public health concern since EDCs are associated with various health issues such as asthma, learning difficulties, early puberty, infertility, cancer, Parkinson's disease, and obesity ( Muncke, 2011; Birnbaum, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). EDCs also disrupt thyroid signaling leading to testicular mal-development and disturbance of the central nervous system (Jaacks \u0026amp; Prasad, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Kent, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e2012\u003c/span\u003e; Sharma et al., \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). Babies\u0026rsquo; increasing vulnerability even to lower doses is attributable to their frequent hand-to-mouth or object-to-mouth behaviour, greater consumption of food and liquids relative to body weight compared with adults, lack of defensive or adaptive mechanisms, and rapid growth (Bou\u0026eacute; et al., \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; de Mendon\u0026ccedil;a Pereira et al., \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Eticha et al., \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Pettoello-Mantovani et al., \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; UNEP, 2017). Several studies show that EDCs are active at low doses with persistent negative health effects (Alexandra \u0026amp; Gugoasa, \u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Fernandino et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Groh et al., \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; Kahn et al., \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). In Africa, paediatric obesity is increasing coinciding with increased consumption of baby formulas with public health and economic implications (Ferreira et al., \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOCPs like \u003cb\u003eDieldrin\u003c/b\u003e (1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-endo,exo-1,4:5,8-dimethanonaphthalene), \u003cb\u003eHeptachlor\u003c/b\u003e (1aR,2R,2aS,3S,6R,6aR,7S,7aS)-3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-2,7:3,6-dimethanonaphtho[2,3-b]oxirene), \u003cb\u003eChlordane\u003c/b\u003e \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003e(\u003c/span\u003e 1,2,4,5,6,7,8,8-Octachloro-3a,4,7,7a-tetrahydro-4,7-methanoindene), \u003cb\u003eDDT\u003c/b\u003e (1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane), \u003cb\u003e1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane\u003c/b\u003e (1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane), \u003cb\u003eLindane\u003c/b\u003e (1α,2β,3β,4α,5α,6β)-1,2,3,4,5,6-Hexachlorocyclohexane) and \u003cb\u003eGamma-hexachlorocyclohexane\u003c/b\u003e (1α,2β,3β,4α,5α,6β)-γ-Hexachlorocyclohexane are harmful to humans, animals, and aquatic life due to their high bioaccumulation and toxicity. Consumption of contaminated baby formulas by the girl child predisposes her to longer menstrual cycles, missed or irregular periods, and abnormal bleeding upon reaching puberty (Encarna\u0026ccedil;\u0026atilde;o et al., \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Predieri \u0026amp; Iughetti, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Hatzidaki et al., \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Street et al., \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e2023\u003c/span\u003e). Exposure to bio-toxic heavy metals can occur when they leach from printed surfaces or are introduced through manufacturing processes (Jaishankar et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2014\u003c/span\u003e; McKinlay et al., \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2008\u003c/span\u003e; Yesildemir \u0026amp; Akdevelioglu, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eGilbert \u003cem\u003eet al\u003c/em\u003e. (2019) highlighted the need for comprehensive risk assessment for EDC safety in Africa through the enactment of laws and enforcement. There is a need for closer quality monitoring of the baby formula as it targets a sensitive group of consumers (Fernandino et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Kim et al., \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Rotondo \u0026amp; Chiarelli, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). The Codex Alimentarius Commission recommends maximum upper limits for OCPs and heavy metals but varies slightly across Europe and the USA (UNEP, 2017). In Malawi, baby formula compliance with the specifications of mandatory Malawi Standard (MS 90:2018) is enforced by the Malawi Bureau of Standards. This standard among others, prescribes maximum residual limits of pesticides with reference to the CAC, microbiological limits, and specifications for iron, zinc, and folic acid. However, enforcement remains challenging due to rampant smuggling and informal distribution channels (Bornman et al., \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; G\u0026aacute;lvez-Ontiveros et al., \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e2020\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe ubiquitous nature of EDCs makes human exposure almost unavoidable. Nevertheless, it is expedient to reduce exposure to EDCs, through eating organic, eco-labelled products in glass rather than plastic packaging (G\u0026aacute;lvez-Ontiveros et al., \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Street et al., \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). The use of supercritical carbon dioxide extraction as a green separation process helps to reduce the presence of EDCs in infant formula (Torres-Torres et al., \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e2019\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn Malawi, there are an estimated 8.9\u0026nbsp;million children under the age of 2 years (UNICEF, \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e2023\u003c/span\u003e). Economic disparities in the country impact the baby formula market, with most families facing significant affordability challenges (Gilbert et al., 2019). The Malawian government promotes exclusive breastfeeding for the first six months of life and public health campaigns emphasize its affordability (Salim \u0026amp; Stones, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). Nutritional assistance programs like the Malawi Social Cash Transfer Scheme provide financial support to vulnerable households (UNICEF, \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e2023\u003c/span\u003e). However, challenges persist, such as limited access to clean water, inadequate healthcare infrastructure, and poverty, which may impact families' ability to afford commercial infant formula (Wiyo \u0026amp; Kadewa, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). There is a lot of formal and informal trade including pesticide and foodstuffs among these neighbouring countries but also within the region and beyond. Smuggling remains a challenge for the government as it causes losses in customs duty revenue and also increases the risk of sale and distribution and ultimately consumption of non-certified products (Liza et al., \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2017\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eFew studies conducted on baby formula in Malawi focused on nutrient and mycotoxin quality (Gilbert et al., 2019). There is generally a lack of information on the EDC quality of baby formulas sold on the Malawi market. This study will provide a baseline as a basis for control initiatives for the safety of baby formulas. Therefore we conducted this research: i) to determine the occurrence of OCP and heavy metals in baby formulas sold in Malawi, and ii) to evaluate the risk to the consumer of dietary exposure through consumption of baby formula at different ages and body weights.\u003c/p\u003e"},{"header":"2. MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Description of the study area\u003c/h2\u003e \u003cp\u003eThe study was conducted in all three regions of Malawi, a landlocked Southern African country bordering Mozambique on the east and southern parts, Zambia on the west, and Tanzania on the north. Malawi, located at 13.2543\u0026deg; S and 34.3015\u0026deg; E in the Great Rift Valley, is typically an importing country with few local manufacturing industries (Gilbert et al., 2019). Most business activities take place in the cities of Blantyre, Lilongwe, and Mzuzu, as well as the areas bordering these three countries from which the samples were collected. These areas were selected to ensure wide coverage of the country.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Sample collection and description\u003c/h2\u003e \u003cp\u003eThe originally packaged 85 baby formulas weighing between 500g to 2kg were collected in total; 23 samples from factories (n\u0026thinsp;=\u0026thinsp;21) in Blantyre, Mulanje, Thyolo, Lilongwe, Mzuzu and 62 samples were collected from supermarkets and mini-supermarkets (n\u0026thinsp;=\u0026thinsp;40) in Blantyre, Mwanza, Mulanje, Zomba, Machinga, Mangochi, Ntcheu, Dedza, Lilongwe, Salima, Mchinji, Karonga and Mzuzu. There was at least a single sample collected for a qualifying batch from either the factory or supermarket. All baby formulas targeting children up to 24 months were eligible for selection whether fortified or not. The samples were collected between March and June 2023. Samples were vehicle transported in cooler boxes protected from exposure to the sun and excessive heat. They were stored in a cool dry place at room temperature. These 85 samples were either cereal-based (n\u0026thinsp;=\u0026thinsp;37), milk-based (n\u0026thinsp;=\u0026thinsp;31), or mixed (combination of cereals, milk, fruit, and vegetables, n\u0026thinsp;=\u0026thinsp;17). The common ingredients of the baby formula included soya, milk, maize, wheat, rice, and vitamins and minerals constituted in various proportions. Out of the 85 samples, some were powdered (n\u0026thinsp;=\u0026thinsp;63) while others were semisolid (n\u0026thinsp;=\u0026thinsp;22). 72.9% of these samples (n\u0026thinsp;=\u0026thinsp;62) were imported while 27.1% (n\u0026thinsp;=\u0026thinsp;23) were locally produced.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Analyzing Organochlorine Pesticides\u003c/h2\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003e2.3.1 Extraction\u003c/h2\u003e \u003cp\u003eBaby formula samples were extracted using the 'Quick, Easy, Cheap, Effective, Rugged and Safe' (QuEChERS) extraction method as described by Perestrelo et al. (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). EU CEN 15662 QuEChERS method is a modified dispersive solid phase extraction (dSPE) technique used for the determination of pesticide residues in food samples using gas chromatography coupled with mass spectrometry (GC-MS) analysis. The process involved weighing using Adam Equipment (AAA100L) analytical scale a homogenized 10g sample. Analytic grade acetonitrile (from Glassworld, RSA) was added as an extraction solvent, followed by the addition of a 1-gram QuEChERS extraction salt sachet to each sample-acetonitrile mixture. The contents were vortexed using Thermo Scientific\u0026trade; (model M37610-33) and centrifuged using the relative centrifugal force (RCF) of 3,904 for the MDR version of ROTOFIX\u0026trade; 32A to separate the organic phase of the pesticides in the sample. The organic phase was transferred by decanting to a cleanup tube containing dispersive solid-phase extraction (d-SPE) sorbents to selectively retain the OCPs.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003e2.3.2 Gas Chromatography Analysis\u003c/h2\u003e \u003cp\u003eThe cleaned extract was automatically injected using the split injection method for analysis using gas chromatography-mass spectrometry (Agilent\u0026trade; GC-MS model 7890A) for selective identification and quantification of OCPs. Quality control includes calibration standards, method validation, and analysis of blank samples and matrix spikes. A standard mix of 17 pesticides ( Atrazine, Atrazine-desethyl, Cyanazine, Sebuthylazin, Simazin, Terbuthylazin, Hexazinone, Chlortoluron, Diuron, Isoproturon, Linuron, Methabenzthiazuron, Metobromuron, Metoxuron, Monolinuron, Metazoachlor, Metolachlor) from Sigma-Aldrich (Organochlorine Pesticides Mix) was used for calibration. The design set LOQ for the equipment is 0.01mg/kg which is also the default maximum residual limit (MRL) for pesticides in food according to the Codex Alimentarius while the LOD is 0.003mg/kg.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Heavy Metal Analysis\u003c/h2\u003e \u003cp\u003eThe heavy metals targeted for analysis were lead and methylmercury.\u003c/p\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003e2.4.1 Lead Analysis\u003c/h2\u003e \u003cp\u003eFor testing lead, samples were digested in an acid solution using the Analytik Jena\u0026trade; microwave, from Jos Hansen \u0026amp; Soehne- Germany, digestion system (TOPwave_90_09). The reagents used were trace element grade 55% nitric acid (HNO\u003csub\u003e3\u003c/sub\u003e) and 70% perchloric acid (HClO\u003csub\u003e4\u003c/sub\u003e) supplied by Glassworld, RSA. The sample weighing 0.5 g was put into the digestion vessel and reagents were added (2ml HNO\u003csub\u003e3\u003c/sub\u003e and 6ml HClO\u003csub\u003e4\u003c/sub\u003e). These were vortexed carefully and left for 20 minutes to cool down before heating in the microwave. The sample in the vessel was microwave-heated as in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e below:\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTemperature program for microwave digestion\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT (\u003csup\u003eo\u003c/sup\u003eC)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e170\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e190\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e210\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eP (bar)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePower (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRamp (Min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTime (Min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe vessels were cooled at room temperature for 20 minutes before transferring the contents into a 50ml volumetric flask. The inner wall of the vessels was rinsed with ultrapure water (from Lab Enterprise, Malawi) which was later poured into the volumetric flask containing the sample. The digest was brought up to volume using ultrapure water.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e2.4.2 Methylmercury Analysis\u003c/h2\u003e \u003cp\u003eA sample weighing 10g was homogenized through manual shaking, added a 5ml stannous chloride (SnCl\u003csub\u003e2\u003c/sub\u003e) solution supplied by Grassworld, RSA. The contents were centrifuged at the relative centrifugal force (RCF) of 3,904 for the MDR version of ROTOFIX\u0026trade; 32A for digestion and separation of the supernatant. 2ml of the supernatant were auto-sample injected for analysis using flame-optimized intelligent Atomic Absorption Spectrometer model novAA 350 supplied by Analytik Jena\u0026trade;. Calibration standards were supplied by Merck\u0026rsquo;s Certipur\u0026reg;; the standards used are traceable to primary standards from PTB (Germany).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e2.5 EDC risk assessment\u003c/h2\u003e \u003cp\u003eThe Hazard Index (HI) is a measure of the potential adverse consequences of a substance's exposure, that indicates the likelihood of unfavourable effects. It is based on the Hazard Quotient (HQ), which represents the total hazard quotients for compounds with the same target organ or system. HQ values below 1 indicate minimal adverse consequences. Similar to HQ, cumulative exposures below an HI of 1.0 obtained from target organ-specific HQs are probably not going to have a negative impact on non-cancer health throughout a lifetime of exposure.\u003c/p\u003e \u003cp\u003eBelow are the formulae used to determine the risk\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\u003cdiv format=\"TEX\" class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e\n$$EDI=\\frac{C x DI}{BW} (\\text{E}\\text{q}. 2.1)$$\u003c/div\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003e \u003cspan class=\"InlineEquation\"\u003e \u003cspan class=\"mathinline\"\u003e\\(THQ=\\frac{EDI}{RfD}\\)\u003c/span\u003e \u003c/span\u003e(Eq.\u0026nbsp;2.2)\u003c/p\u003e \u003cp\u003e \u003cspan class=\"InlineEquation\"\u003e \u003cspan class=\"mathinline\"\u003e\\(HI={\\Sigma }\\text{T}\\text{H}\\text{Q}\\)\u003c/span\u003e \u003c/span\u003e (Eq.\u0026nbsp;2.3)\u003c/p\u003e \u003cp\u003e \u003cspan class=\"InlineEquation\"\u003e \u003cspan class=\"mathinline\"\u003e\\(HI=\\frac{CXDI}{BWXRfD}\\)\u003c/span\u003e \u003c/span\u003e (Eq.\u0026nbsp;2.4)\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003eWhere\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eEDI\u0026thinsp;=\u0026thinsp;Estimated Daily Intake,\u003c/p\u003e\u003cp\u003eC\u0026thinsp;=\u0026thinsp;Concentration of the chemical,\u003c/p\u003e\u003cp\u003eDI\u0026thinsp;=\u0026thinsp;Daily Intake of the formula,\u003c/p\u003e\u003cp\u003eBW\u0026thinsp;=\u0026thinsp;Body Weight,\u003c/p\u003e\u003cp\u003eRfD\u0026thinsp;=\u0026thinsp;Reference dosage (MRL)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAccording to the WHO (2016) by 12 months and 24 months body weights average 9.25 and 12.247 kg, respectively; average daily intake of 0.057kg at 12 months and 0.2kg at 24 months. These weights, consumption rates, and MRL values were used to calculate the total hazard index.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. RESULTS AND DISCUSSION","content":"\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Levels of OCP and metals in baby formula\u003c/h2\u003e \u003cp\u003eContamination was detected in 65.9% (n\u0026thinsp;=\u0026thinsp;56) of the samples while 34.1% (n\u0026thinsp;=\u0026thinsp;29) had no detections. About 22.35% (n\u0026thinsp;=\u0026thinsp;19) of the samples had the EDCs detected above the recommended MRL of 0.01mg/kg representing 33.9% of all detections. These were Aldrin, Lindane, DDT, Telodrin, Chlordane, Dieldrin, and Lead. DDT was detected in one sample of the baby formula while 2.35% (n\u0026thinsp;=\u0026thinsp;2) samples contained both telodrin and lead. Detected levels of OCPs and heavy metals in baby formula, as summarized in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, show that lindane, dieldrin, and Aldrin were the most common OCPs with detection rates at 35.29%, 27.06% and 23.53%, respectively. It further shows there were no detections for toxaphene, heptachlor, and methylmercury. Detected levels ranged from 0 to 0.03mg/kg for OCPs and 0 to 0.3 ppm for lead.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEDC detection levels in baby formula\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEDC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMax\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDetection rate %\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAldrin (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23.53\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eToxaphene (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLindane (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeptachlor (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDDT (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTelodrin (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChlorodane (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDieldrin (mg/kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e27.06\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLead (ppm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMethyl Mercury (ppm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eND\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe data was categorized to show the distribution of detection levels using Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e: violin plots below\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFor powdered baby food samples, the majority (61%, n\u0026thinsp;=\u0026thinsp;52) of the chemical concentrations appear to be at or near zero mg/kg, which complies with the generally accepted safe limit of roughly 0.01 mg/kg. However, chemicals like Aldrin and Dieldrin exhibit a broader distribution of concentrations, indicating variability in the powdered food samples again with median estimates of 0.01 mg/kg, which is the same as the acceptable maximum residual limit. On the other hand, chemical concentrations in semi-solid baby food samples generally suggest compliance with safe limits, as most chemicals appear to have concentrations at or near 0 mg/kg. However, lindane is slightly having an estimated median of 0.01 mg/kg which is the recommended default concentration and might require further investigations.\u003c/p\u003e \u003cp\u003eThe findings of this study contradict the 2018 Turkish study, where no OCPs or heavy metals were detected, except for arsenic (Kilic et al., \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). A study in Mexico in 2010 (Tolentino et al., \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2014\u003c/span\u003e) detected OCPs in levels below the limits set by the Codex Alimentarius Commission (CAC) suggesting the formulas were safer. The Environmental Defense Fund (EDF) found that 20% of baby food samples contained lead, raising concerns about higher levels of lead exposure in infant formulas (Tolentino et al., \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2014\u003c/span\u003e). However, the findings of this study are consistent with the observations by Kosamu et al. (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2020\u003c/span\u003e) that OCPs such as Dieldrin, Heptachlor, Hexachlorobenzene, Toxaphene, DDT are some of the major pesticides used in Malawi. It further underscores rampant unsustainable use resulting in contaminating ingredients such as milk, maize, soy, and vegetables as suspected pathways for OCP in the baby formula as pesticide residues (Kosamu et al., \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Soko, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e2018\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe current analysis suggests the continued use or presence of outlawed pesticides such as DDT (Soko, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Temu et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2012\u003c/span\u003e; Carlucci \u003cem\u003eet a\u003c/em\u003el., 2017). The detection of a greater DDT level (0.03 mg/kg) confirms the findings by Soko (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e2018\u003c/span\u003e), who linked the availability of DDT in Malawi to a source in adjacent Mozambique. This calls for enhanced strict regulatory action by the relevant authorities (Kosamu et al., \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). Santonicola et al., (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2018\u003c/span\u003e) reported that effects such as higher rates of obesity and early menstrual periods, increased risk for breast cancer, as well as high blood pressure, diabetes, and other cardio-metabolic diseases, were common in children whose grandmothers were exposed to DDT before its ban in 1970.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e3.2 EDC risk assessment\u003c/h2\u003e \u003cp\u003eThe total calculated hazard index was 1.2106 accumulated over 12 months (0.3143) and 24 months (0.8964) period of age. A summary of the calculated hazard quotients at various exposure levels and ages is presented in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e below.\u003c/p\u003e \u003cp\u003eA THI of 1.2 presents a higher risk for lifetime EDC-associated problems on the consumer of the formula ( EFSA, 2017). According to the EPA level of concern, a hazard index above 1 shows a higher risk of chronic negative health effects (Hatzidaki et al., \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Jaishankar et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2014\u003c/span\u003e; Street et al., \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). This entails that babies consuming these formulas may be at risk of EDC-associated neurotoxic effects, reproductive disturbances, altered immune responses, and endocrine disruption. This calls for more determined control efforts since low-dose exposure effects of EDCs can significantly impact infant development, especially in baby formula, due to exposure to other contaminated food and non-food items (Carnevali et al., \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Sipahi et al., \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e2015\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTherefore, to promote safety, risk-based monitoring programs should be reinforced through adequate stakeholder collaboration including quadrilateral efforts involving Malawi and neighbouring countries with whom there is an unregulated illegal trade in pesticides (Soko, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Countries should implement pesticide management according to internationally agreed protocols (FAO \u0026amp; WHO, 2023). According to Hatzidaki et al. (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2023\u003c/span\u003e), the EU Regulation No. 609/2013 recommends setting pesticide MRL in baby foods at the minimum at the same time encouraging good agricultural practices rather than merely banning the pesticides. Apart from the pesticides and heavy metals, it is recommended to screen the baby formula for other EDCs such as BPA and phthalates which may influence the risk level.\u003c/p\u003e \u003cp\u003eOn the other hand, encouraging breastfeeding and breastfeeding practices can also help minimize the exposure of babies to EDC-contaminated formulas. On the other hand, quadrilateral efforts involving the four countries will help in reducing the smuggling of potentially unsafe baby formulas. These countries can take advantage of already existing trade cooperation structures to enhance coordinated quality controls perhaps with rapid testing. Policy formulation on control of EDCs would be a helpful step and demonstration of commitment to address this silent pandemic of the new age (Hatzidaki et al., \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2023\u003c/span\u003e). Parents and caregivers need to be equally vigilant in ensuring the safety of the food given to the babies.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ecalculated hazard quotients for the EDCs at different exposure levels and ages\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"10\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eNAME OF EDC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEDC LEVEL (mg/kg)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c10\" namest=\"c9\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRfD EC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e24 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e24 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003e12 months\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003e24 months\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eToxaphene\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLindane\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0185\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0490\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeptachlor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDDT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTelodrin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChlorodane\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDieldrin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLead\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0062\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0123\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0432\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.1849\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.4899\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMercury\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eTHQ\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.0370\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.0980\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.0739\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.2595\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.0185\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.0490\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e\u003cb\u003e0.1849\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e\u003cb\u003e0.4899\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHI (12 Months)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.3143\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHI (24 Months)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.8964\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eTHI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e1.2106\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"4. CONCLUSION","content":"\u003cp\u003eThis study found that organochlorine pesticides and heavy metal contamination in baby formula exceed the recommended MRL, posing endocrine disruption risks to babies. These formulas may cause neurotoxic effects, reproductive disturbances, altered immune responses, and endocrine disruption. The safety of baby formula is crucial as it deals with a sensitive population, therefore it requires comprehensive pesticide management, good agricultural practices, and enhanced control measures. Encouraging breastfeeding and reducing the smuggling of potentially unsafe formulas can help reduce the risk. There might be a need to study EDC contamination levels in other foods as well.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eAlexandra, L., \u0026amp; Gugoasa, D. (2020). 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QuEChERS - Fundamentals, relevant improvements, applications, and future trends. \u003cem\u003eAnalytica Chimica Acta\u003c/em\u003e, \u003cem\u003e1070\u003c/em\u003e, 1\u0026ndash;28. https://doi.org/10.1016/j.aca.2019.02.036\u003c/li\u003e\n \u003cli\u003ePettoello-Mantovani, M., Mestrovic, J., Namazova-Baranova, L., Giardino, I., Somekh, E., \u0026amp; Vural, M. (2021). Ensuring Safe Food for Infants: The Importance of an Integrated Approach to Monitor and Reduce the Risks of Biological, Chemical, and Physical Hazards. \u003cem\u003eThe Journal of Pediatrics\u003c/em\u003e, \u003cem\u003e229\u003c/em\u003e, 315-316.e2. https://doi.org/10.1016/j.jpeds.2020.10.074\u003c/li\u003e\n \u003cli\u003ePredieri, B., \u0026amp; Iughetti, L. (2022). New insights on the effects of endocrine-disrupting chemicals on children. \u003cem\u003e98\u003c/em\u003e. https://doi.org/10.1016/j.jped.2021.11.003\u003c/li\u003e\n \u003cli\u003eRotondo, E., \u0026amp; Chiarelli, F. (2020). Endocrine-Disrupting Chemicals and Insulin Resistance in Children. https://doi.org/10.3390/biomedicines8060137\u003c/li\u003e\n \u003cli\u003eSalim, Y. M., \u0026amp; Stones, W. (2020). Determinants of exclusive breastfeeding in infants of six months and below in Malawi: A cross-sectional study. \u003cem\u003eBMC Pregnancy and Childbirth\u003c/em\u003e, \u003cem\u003e20\u003c/em\u003e(1), 4\u0026ndash;11. https://doi.org/10.1186/s12884-020-03160-y\u003c/li\u003e\n \u003cli\u003eSantonicola, S., Ferrante, M. C., Leo, G., Murru, N., Anastasio, A., \u0026amp; Mercogliano, R. (2018). Study on endocrine disruptors levels in raw milk from cow\u0026rsquo;s farms : Risk assessment. \u0026nbsp; https://doi.org/10.4081/ijfs.2018.7668\u003c/li\u003e\n \u003cli\u003eSharma, B. M., Bharat, G. K., Chakraborty, P., Martin\u0026iacute;k, J., Audy, O., Kukučka, P., Přibylov\u0026aacute;, P., Kukreti, P. K., Sharma, A., Kalina, J., Steindal, E. H., \u0026amp; Nizzetto, L. (2021). A comprehensive assessment of endocrine-disrupting chemicals in an Indian food basket: Levels, dietary intakes, and comparison with European data. \u003cem\u003eEnvironmental Pollution\u003c/em\u003e, \u003cem\u003e288\u003c/em\u003e, 117750. https://doi.org/10.1016/J.ENVPOL.2021.117750\u003c/li\u003e\n \u003cli\u003eSipahi, H., Eken, A., Aydın, A., Şahin, G., \u0026amp; Baydar, T. (2015). Safety assessment of essential and toxic metals in infant formulas. \u003cem\u003eTurkish Journal of Pediatrics\u003c/em\u003e, \u003cem\u003e56\u003c/em\u003e(4), 385\u0026ndash;391.\u003c/li\u003e\n \u003cli\u003eSoko, J. J. (2018). Agricultural pesticide use in Malawi. \u003cem\u003eJournal of Health and Pollution\u003c/em\u003e, \u003cem\u003e8\u003c/em\u003e(20). https://doi.org/10.5696/2156-9614-8.20.181201\u003c/li\u003e\n \u003cli\u003eStreet, M. E., Angelini, S., Bernasconi, S., Burgio, E., Cassio, A., Catellani, C., Cirillo, F., Deodati, A., Fabbrizi, E., Fanos, V., Gargano, G., Grossi, E., Iughetti, L., Lazzeroni, P., Mantovani, A., Migliore, L., Palanza, P., Panzica, G., Papini, A. M., \u0026hellip; Amarri, S. (2018). Current knowledge on endocrine disrupting chemicals (EDCs) from animal biology to humans, from pregnancy to adulthood: Highlights from a national Italian meeting. \u003cem\u003eInternational Journal of Molecular Sciences\u003c/em\u003e, \u003cem\u003e19\u003c/em\u003e(6). https://doi.org/10.3390/ijms19061647\u003c/li\u003e\n \u003cli\u003eStreet, M. E., Shulhai, A. M., Rotondo, R., Giann\u0026igrave;, G., \u0026amp; Caffarelli, C. (2023). Current knowledge on the effects of environmental contaminants in early life nutrition. \u003cem\u003eFrontiers in Nutrition\u003c/em\u003e, \u003cem\u003e10\u003c/em\u003e(June), 1\u0026ndash;9. https://doi.org/10.3389/fnut.2023.1120293\u003c/li\u003e\n \u003cli\u003eTemu, E. A., Coleman, M., Abilio, A. P., \u0026amp; Kleinschmidt, I. (2012). High Prevalence of Malaria in Zambezia, Mozambique : The Protective Effect of IRS versus Increased Risks Due to Pig-Keeping and House Construction. \u003cem\u003e7\u003c/em\u003e(2). https://doi.org/10.1371/journal.pone.0031409\u003c/li\u003e\n \u003cli\u003eEuropean Union (2017). European Union report on pesticide residues in food. \u003cem\u003eEFSA Journal\u003c/em\u003e, \u003cem\u003e15\u003c/em\u003e(4). https://doi.org/10.2903/j.efsa.2017.4791\u003c/li\u003e\n \u003cli\u003eTolentino, R. G., Le\u0026oacute;n, S. V., Berm\u0026uacute;dez, B. S., Flores, G. P., Lourdes, M. De, Vega, R., \u0026amp; V\u0026aacute;zquez, C. R. (2014). \u003cem\u003eOrganochlorine Pesticides in Infant Milk Formulas Marketed in the South of Mexico City\u003c/em\u003e. \u003cem\u003eJuly\u003c/em\u003e, 1290\u0026ndash;1298.\u003c/li\u003e\n \u003cli\u003eTorres-Torres, E. Y., Montiel, C., Araiza-Olivera, D., Gutierrez-Aguilar, M., Gimeno, M., \u0026amp; Garc\u0026iacute;a-Arrazola, R. (2019). Extracting endocrine disrupting compounds from infant formula using supercritical carbon dioxide. \u003cem\u003eJournal of Supercritical Fluids\u003c/em\u003e, \u003cem\u003e152\u003c/em\u003e, 1\u0026ndash;7. https://doi.org/10.1016/j.supflu.2019.104554\u003c/li\u003e\n \u003cli\u003eUNICEF. (2023). \u003cem\u003eCountry Office Annual Report 2022\u003c/em\u003e. 1\u0026ndash;7.\u003c/li\u003e\n \u003cli\u003eUnited Nations Environment Programme. (2017). \u003cem\u003eOverview Report I: Worldwide initiatives to identify endocrine disrupting chemicals (EDCs) and potential EDCs The International Panel on Chemical Pollution (IPCP)\u003c/em\u003e. \u003cem\u003eJuly\u003c/em\u003e, 1\u0026ndash;40. https://wedocs.unep.org/bitstream/handle/20.500.11822/25633/EDC_report1.pdf?sequence=1\u0026amp;isAllowed=y\u003c/li\u003e\n \u003cli\u003eVanderford, B. J., Pearson, R. A., Rexing, D. J., \u0026amp; Snyder, S. A. (2003). Analysis of Endocrine Disruptors, Pharmaceuticals, and Personal Care Products in Water Using Liquid Chromatography/Tandem Mass Spectrometry. \u003cem\u003eAnalytical Chemistry\u003c/em\u003e, \u003cem\u003e75\u003c/em\u003e(22), 6265\u0026ndash;6274. https://doi.org/10.1021/ac034210g\u003c/li\u003e\n \u003cli\u003eWiyo, K. A., \u0026amp; Kadewa, W. (2020). Will Malawi meet the MDGs targets for water and sanitation at the district level ? evidence from the 2008 national census. \u003cem\u003eJanuary\u003c/em\u003e. https://doi.org/10.15406/apar.2019.09.00403\u003c/li\u003e\n \u003cli\u003eYesildemir, O., \u0026amp; Akdevelioglu, Y. (2021). Endocrine Disruptors in Baby Formulas: A Literature Review. \u003cem\u003eSelcuk Journal of Agriculture and Food Sciences\u003c/em\u003e, \u003cem\u003e35\u003c/em\u003e(3), 272\u0026ndash;279. https://doi.org/10.15316/SJAFS.2021.257\u003c/li\u003e\n \u003cli\u003eYing, G. G. (2012). Endocrine Disrupting Chemicals. What? Where? In \u003cem\u003eAnalysis of Endocrine Disrupting Compounds in Food\u003c/em\u003e. https://doi.org/10.1002/9781118346747.ch1\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"endocrine disruption chemicals, organochlorine pesticides, risk assessment","lastPublishedDoi":"10.21203/rs.3.rs-3950482/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3950482/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEndocrine-disrupting chemicals such as organochlorine pesticides (OCP) and some heavy metals disturb important life functions such as reproduction, metabolism, and growth by interfering with the normal functionality of the human hormonal system. These toxic and persistent chemicals used in agricultural and industrial processes, can enter the baby formula and remain effective for extended periods. These EDCs come from environmental contamination and the manufacturing process of the baby formula.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and method\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, we examined the levels and risk of EDC contamination in a sample of 85 baby formula products available in the Malawian market. Extraction was done using the \u0026nbsp;EU CEN 15662 QuEChERS method and then analyzed using gas-liquid chromatography with fluorescence to quantify OCP contamination. For heavy metals, samples were digested and analyzed using the Analytik Jena microwave digestion system (TOPwave_90_09) and an Atomic Absorption Spectrometer, respectively. \u0026nbsp;The risk of exposure was computed using a hypothetical consumption of infant formula at 12 and 24 months, and weight ranges of 9.25–12.247 kg with corresponding average daily intakes of 0.057–0.2kg.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEDC contamination ranged from not detected to 0.3 mg/kg. Common EDCs were Aldrin (23%), dieldrin (27%), and lindane (35%). The risk assessment showed a Hazard Index of 1.2. This suggests higher levels of exposure, are more likely to have lasting effects during human development. The detection levels were above the European Food Safety Authority (EFSA) recommended maximum residual limit of 0.01mg/kg.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsidering the health implications and susceptibility of the babies, it is pertinent to enforce and closely monitor the EDC content of baby formulas in the Malawi market.\u003c/p\u003e","manuscriptTitle":"Assessing the Risk of Endocrine-disrupting Chemicals in Commercial Baby Formula in Malawi","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-13 18:51:50","doi":"10.21203/rs.3.rs-3950482/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fd31a858-81f0-4131-a0d4-2617bb4a34a4","owner":[],"postedDate":"February 13th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":28727083,"name":"Food Science \u0026 Technology"},{"id":28727084,"name":"Toxicology"},{"id":28727085,"name":"Nutrition \u0026 Dietetics"}],"tags":[],"updatedAt":"2024-02-13T18:51:50+00:00","versionOfRecord":[],"versionCreatedAt":"2024-02-13 18:51:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3950482","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3950482","identity":"rs-3950482","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}