Overview
This is a structural ingredient/profile node for soy-based infant formula routing. Finished formula occurrence values belong on the relevant formula product pages unless a source reports ingredient-only values.
FDA TDS FY2018–FY2020 source observations
FDA measured the prepared foods named below. Each row describes that food and preparation, not every form of this ingredient. Values are µg/kg (ppb) on the FDA sample basis. ND means not detected; it is not a measured zero. Reporting limits can vary between composites. FY2018-FY2020 TDS Elements Analytical Results
| FDA food and preparation | Analyte | Composites | Detected | Detected concentrations (ppb) | Reporting limits (ppb) |
|---|---|---|---|---|---|
| 735: BF, infant formula, soy-based, powdered, prepared with water | tAs | 1 | 0 | ND in all composites | 3 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | Cd | 1 | 0 | ND in all composites | 1 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | Cr | 1 | 0 | ND in all composites | 50 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | Pb | 1 | 0 | ND in all composites | 4 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | tHg | 1 | 0 | ND in all composites | 1 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | Ni | 1 | 0 | ND in all composites | 40 |
| 735: BF, infant formula, soy-based, powdered, prepared with water | U | 1 | 0 | ND in all composites | 1 |
| 768: BF, infant formula, soy-based, powdered | tAs | 2 | 2 | 4.3–7 | 3 |
| 768: BF, infant formula, soy-based, powdered | Cd | 2 | 2 | 6–6.3 | 1 |
| 768: BF, infant formula, soy-based, powdered | Cr | 2 | 2 | 50–90 | 50 |
| 768: BF, infant formula, soy-based, powdered | Pb | 2 | 0 | ND in all composites | 4 |
| 768: BF, infant formula, soy-based, powdered | tHg | 2 | 0 | ND in all composites | 1 |
| 768: BF, infant formula, soy-based, powdered | Ni | 2 | 2 | 180–240 | 40 |
| 768: BF, infant formula, soy-based, powdered | U | 2 | 2 | 7.1–7.7 | 1 |
References
Works cited in this page’s text, in first-appearance order. See Sources for this page’s source inventory. Each title links to its source record, which carries the ingest receipt, the extracted values, and the file hash of the document it was built from.
- FY2018-FY2020 TDS Elements Analytical ResultsDataset
- There is (still) too much aluminium in infant formulasPeer-reviewed
- Assessment of arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyl substances concentrations in human milk and infant formula in the United States: a systematic reviewPeer-reviewed
- Estimated Exposure to Arsenic in Breastfed and Formula-Fed Infants in a United States CohortPeer-reviewed
- Arsenic concentration and speciation in infant formulas and first foodsPeer-reviewed
- Simultaneous Determination of Arsenic, Cadmium, Mercury, and Lead in Raw Ingredients, Nutritional Products, and Infant Formula by Inductively Coupled Plasma Mass Spectrometry: Single-Laboratory ValidationPeer-reviewed
- Final Opinion on tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toysGovernment
Sources
Auto-generated from source-page frontmatter. The "Used on this page for" column is populated by the orchestrator's POPULATE-SOURCE-LEGEND action; pending entries appear as *[awaiting synthesis]*.
| # | Citation | Year | Type | Used on this page for |
|---|---|---|---|---|
| 1 | Largueza et al. 2026. Essential and Potentially Toxic Elements in Commercial Milk Formulas: Health Risk Assessment Through a Systematic Review and Meta-analysis, Biological Trace Element Research | 2026 | Peer-reviewed | BR/EU/US Al, iAs, tAs, Cd, Co, Cr, Cu, Fe, MeHg, Mn, Ni, Pb, U, Zn occurrence in Systematic review with meta-analysis of 30 observational studies (PRISMA, OSF.IO/2YNKB registered), 18 with pooled meta-analysis data, covering three… (n=30) |
| 2 | Dobrzyńska et al. 2025. Analysis of the Elemental Composition of Milk Formulae: Impact on the Nutritional Status of Infants From Birth to 1 Year of Age, Biological Trace Element Research | 2025 | Peer-reviewed | PL/EU tAs, Cd, tHg, Ni, Sn, Cr, Co, Cu, Mn occurrence in All powdered milk formulae available on the Polish market 2019-2023 for infants up to 12 months of age:… (n=149) |
| 3 | Thoerig et al. 2025. Assessment of arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyl substances concentrations in human milk and infant formula in the United States: a systematic review, American Journal of Clinical Nutrition, Vol. 122, pp. 1006-1026 | 2025 | Peer-reviewed | Systematic review of U.S. As, Cd, Pb, Hg, and PFAS evidence in human milk and infant formula including soy-based products; summary distributions by matrix and analyte |
| 4 | FDA 2022. FY2018-FY2020 TDS Elements Analytical Results, FDA Total Diet Study | 2022 | Government dataset | US-FDA Pb, Cd, tAs, iAs, tHg, Ni, Cr, U, Sb occurrence in 3276 prepared food, beverage and water composites across 307 TDS foods, FY2018-FY2020 US collections (n=3276) |
| 5 | Frisbie et al. 2019. Manganese levels in infant formula and young child nutritional beverages in the United States and France: Comparison to breast milk and regulations, PLOS ONE | 2019 | Peer-reviewed | US/FR/EU Mn occurrence in 44 infant formulas and young-child nutritional beverage products purchased in the United States (n=25) and France (n=19), selected… (n=44) |
| 6 | BfR 2018. EU maximum levels for cadmium in food for infants and young children sufficient - Exposure to lead should fundamentally be reduced to the achievable minimum, BfR Opinion No. 026/2018 | 2018 | Government report | DE/EU Cd, Pb occurrence in BfR assessment of German Federal Control Plan 2015 and Monitoring 2015 occurrence data for foods for infants and… (n=522) |
| 7 | SCHEER 2017. Final Opinion on tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys, Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), European Commission | 2017 | Government report | EU Al occurrence in Review of regulatory opinions and dietary exposure data for children and adults |
| 8 | Pacquette et al. 2016. Simultaneous Determination of Arsenic, Cadmium, Mercury, and Lead in Raw Ingredients, Nutritional Products, and Infant Formula by Inductively Coupled Plasma Mass Spectrometry: Single-Laboratory Validation, Journal of AOAC International, Vol. 99, No. 3, pp. 766-779 | 2016 | Peer-reviewed | ICP-MS method validation for simultaneous As, Cd, Hg, Pb determination in infant formula matrices including soy-based powders; documents the analytical platform used in downstream occurrence surveys |
| 9 | Carignan et al. 2015. Estimated Exposure to Arsenic in Breastfed and Formula-Fed Infants in a United States Cohort, Environmental Health Perspectives, Vol. 123, No. 5, pp. 500-506 | 2015 | Peer-reviewed | U.S. infant cohort study comparing iAs/tAs biomarker exposure in breastfed vs formula-fed infants, including soy-formula feeding mode |
| 10 | Mania et al. 2015. Toxic Elements in Commercial Infant Food, Estimated Dietary Intake, and Risk Assessment in Poland, Polish Journal of Environmental Studies | 2015 | Peer-reviewed | PL/EU Pb, Cd, tAs, tHg occurrence in Approximately 1,000 commercial infant-food samples collected from retail markets in all Polish provinces during the 2009-2013 sanitary-epidemiological monitoring… (n=1000) |
| 11 | FSA 2014. Survey of metals and other elements in commercial infant foods, infant formula and non-infant specific foods, Food Standards Agency report | 2014 | Government report | GB Al, Sb, tAs, iAs, Cd, Cr, Cu, Pb, Mn, tHg, Ni, Se, Sn, Zn occurrence in Forty-seven infant formula samples, 200 commercial infant foods, and 50 composite ‘other foods’ samples purchased from UK retail… (n=297) |
| 12 | UK Committee on Toxicity 2013. Statement on the potential risks from aluminium in the infant diet, Committee on Toxicity (COT), Statement 2013/01, June 2013 | 2013 | Government report | UK Al occurrence in Synthesis of UK Drinking Water Inspectorate 2011 tap-water survey (n=42,400 England/Wales, n=1,730 Northern Ireland, n=5,020 Scotland); FSA 2006… |
| 13 | Jackson et al. 2012. Arsenic concentration and speciation in infant formulas and first foods, Pure and Applied Chemistry, Vol. 84, No. 2, pp. 215-223 | 2012 | Peer-reviewed | HPLC-ICP-MS arsenic speciation data (iAs, MMA, DMA) in U.S. infant formulas including soy-based powders; primary source for soy formula iAs occurrence |
| 14 | Burrell et al. 2010. There is (still) too much aluminium in infant formulas, BMC Pediatrics | 2010 | Peer-reviewed | UK Al occurrence in Fifteen commercial infant formula products on the UK market; ready-made liquid and powdered formats; cow-milk-based and soya-based; first-infant,… (n=15) |
| 15 | ATSDR 2008. Toxicological Profile for Aluminum, U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry | 2008 | Government report | US Al occurrence in Synthesis of peer-reviewed human and animal toxicology, exposure, and environmental-fate data; no original sampling |
| 16 | JECFA 2007. Evaluation of certain food additives and contaminants — Sixty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series 940 (Sixty-seventh meeting of JECFA, Rome, 20-29 June 2006) | 2007 | Government report | international Al, MeHg, tHg occurrence in Aluminium: total dietary exposure derived from market-basket and duplicate-diet surveys in adults (France, Germany, UK, USA, China), Total… |
| 17 | Committee on Toxicity of 2003. COT statement on a survey of metals in infant food, Committee on Toxicity statement | 2003 | Government report | GB Al, Sb, tAs, Cd, Cr, Cu, Pb, tHg, Ni, Se, Sn, Zn occurrence in Commercial UK baby foods and formulae, including infant formulae, manufactured baby foods, desserts, rusks, and infant drinks, surveyed… (n=189) |
Why this commodity accumulates heavy metals
Soy-based infant formula uses soy protein isolate as the protein base rather than cow-milk protein. The soy protein isolate carries the source-soybean Al, Ni, and Cd profile at concentrated per-mass levels because protein extraction concentrates these metals; see Soy for the soybean-stage rationale. Soy-based formula consequently carries elevated Al, Ni, and Cd relative to cow-milk-based formula even when the rest of the formulation (carbohydrate source, fat blend, vitamin-mineral premix) is identical. Multiple infant-formula surveys document this consistently: Burrell 2010 UK soy powder formula at 4.3 µg/g aluminum, which translates to roughly 629 µg/L prepared-for-feeding under standard 1:7 reconstitution.
Soy-based formula is medically indicated for infants with cow-milk-protein allergy or galactosemia, and is otherwise consumed by infants of vegan families or by parents of preference. The HMTc Cat 1 Step 0 lock splits soy-based formula from non-soy into separate product rows (Infant Formula, Powder (Soy-Based) and Infant Formula, RTF Liquid (Soy-Based)) because the Al/Ni/Cd-elevated profile warrants separate certification analysis. The HMTc panel concerns for soy-based infant formula are dominantly Al, Ni, and Cd (the soy-protein-isolate inheritance pathway), plus the standard Pb concerns common to all infant formulas. Arsenic occurrence in soy-based formula sits at 7-12 ppb tAs/iAs medium-confidence based on the U.S. systematic review by Thoerig 2025, the U.S. cohort biomarker work by Carignan 2015, and the speciation survey by Jackson 2012.
Heavy metal contamination profile
The body-level analyte snapshot for soy-based formula follows the per-format pages: see Infant Formula, Powder (Soy-Based) and Infant Formula, RTF Liquid (Soy-Based) for the format-specific concentration tables. The dominant analytes of concern (Al, Ni, Cd) reflect the soy-protein-isolate inheritance described above; the contributing sources documented in the Source legend collectively establish the multi-fold Al elevation versus cow-milk formula.
| Analyte | Coverage | Typical (ppb) | Confidence | Key sources |
|---|---|---|---|---|
| Pb | data gap | — | — | — |
| Cd | data gap | — | — | — |
| iAs | n=3 | 7–12 | medium | 5, 4, 1 |
| tAs | n=4 | 7–12 | medium | 5, 4, 3 |
| tHg | data gap | — | — | — |
| Ni | data gap | — | — | — |
| Al | data gap | — | — | — |
| Cr | data gap | — | — | — |
| Sn | data gap | — | — | — |
| U | data gap | — | — | — |
Ranges by source, region, and variety
Variance within soy-based infant formula tracks four dimensions: source-soybean origin (US Midwest vs Brazilian vs Argentine vs Chinese vs European soy production), the protein-isolation process used by the soy-isolate supplier, the manufacturer’s formulation choices (vitamin-mineral premix supplier, water source), and historical generation (post-2020 vs pre-2010 manufacturer responses to the Al-in-soy-formula debate documented in Burrell 2010 and earlier work).
US-market soy-based formula, EU-market soy-based formula, and emerging-market soy-based formula carry different baseline profiles reflecting these per-region soy-supplier and per-manufacturer differences. The Al elevation in soy formula relative to cow-milk formula is consistent across markets at multiple-fold; absolute levels vary by manufacturer. Arsenic occurrence in U.S.-market soy-based formula sits in the 7-12 ppb range across the Jackson 2012 and Carignan 2015 cohort work, with the systematic review by Thoerig 2025 confirming the range across the broader U.S. literature.
Processing effects
Soy-based infant formula manufacturing follows the same processing chain as cow-milk-based formula (see Infant Formula Powder and Infant Formula Rtf Liquid) with soy protein isolate substituted for the milk-protein-and-lactose ingredients. The protein-isolation step at the upstream soy-supplier stage is the dominant metal-concentration-from-raw-soybean event; once the isolate is incorporated into formula, downstream processing follows the standard infant-formula pathway without changing the Al/Ni/Cd-elevated profile. ICP-MS analytical methods for soy-formula matrices are validated in Pacquette 2016.
Ingredient-derivative risk
Soy-based formula derivatives are the same format set as other infant formulas: powder, ready-to-feed (RTF) liquid, and concentrated liquid. The Cat 1 Step 0 lock variants (Infant Formula, Powder (Soy-Based), Infant Formula, RTF Liquid (Soy-Based)) carry the same soy-protein-isolate inheritance; format affects per-volume concentration via reconstitution ratio but not per-gram-protein concentration. Older soy-formula generations carry higher Al than current production because manufacturer responses to Burrell 2010 and subsequent regulatory attention have driven reductions; historical stock and emerging-market supply may still carry higher Al concentrations.
Mitigation options
Sourcing levers (Supply-chain screening) for soy-based formula are limited because the soy-isolate ingredient itself carries the elevated Al/Ni profile by species characteristic. The dominant brand-side decisions are: soy-supplier specification (testing of incoming soy protein isolate for Al, Ni, Cd against the per-mass-in-finished-formula compliance target); soy-origin selection within low-Al soybean production regions (limited efficacy because species-level Al accumulation dominates); and hydrolysate or amino-acid formula substitution for infants with cow-milk-protein allergy as an alternative to soy-based formula where medically appropriate.
Agronomic levers (Agronomic mitigation) operate at the soybean-production stage; see Soy for soil-Cd remediation and Al-uptake-management interventions.
Processing levers (Processing mitigation) are limited at the formula-manufacturing stage; the Al/Ni profile is in the soy protein isolate already. Upstream soy-isolate processing improvements (acid-base extraction modifications, ion-exchange polishing) carry potential but are not standard in commodity-grade isolate production.
Formulation levers (Formulation mitigation) include the alternative-base-protein substitution (hydrolyzed cow-milk protein, amino-acid-based formula) for medical-indication infants where soy is not the only option.
Testing and QC levers (Testing and quality-control mitigation) are mature: lot-level Al, Ni, Cd, Pb testing on finished soy-based formula against the EU 10 ppb Pb prepared-for-feeding ML and applicable Al/Ni reference levels (EFSA TWI for Al). The ICP-MS method validated by Pacquette 2016 is the operative analytical platform.
Packaging and storage levers (Packaging and storage mitigation) include can-lining specification (BPA-NI epoxy or food-grade alternative) and aluminum-foil-lined packaging considerations to avoid Al migration from packaging into prepared formula.
Regulatory limits that apply
- eu-2023-915 — EU Reg. 2023/915 sets binding maximum levels for infant formula: Pb 10 ppb prepared-for-feeding (≈70 ppb powder basis), Cd 5 ppb, iAs 20 ppb, Hg 20 ppb. These apply to soy-based formula identically to cow-milk-based.
- fda2020-inorganic-arsenic-infant-rice-cereal — FDA Closer to Zero iAs framework covers rice-containing formula.
- Codex Alimentarius CXS 72-1981 (infant formula) and CXS 156-1987 (follow-up formula) establish composition standards.
- JECFA Al PTWI of 2 mg/kg b.w./week and EFSA TWI of 1 mg/kg b.w./week are the relevant dose-response references per SCHEER 2017; soy-based formula at the upper end of the Al-concentration range documented by Burrell 2010 and subsequent literature can deliver Al intakes that approach or exceed these reference levels for exclusive-soy-formula-fed infants.
- California Prop 65 (california-prop65) Pb MADL applied to infant formula yields stringent serving-based screen.
Update history
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