How limits are set
The standard for each analyte is the strictest maximum level set by any credible government regulator, the European Union, the United Kingdom, Codex Alimentarius, Health Canada, China, India, Brazil, the Gulf states (GSO), Australia/New Zealand, and the US FDA, converted into Infant formula (powder)’s own as-sold basis. It is a lookup of sovereign law, carrying at most one disclosed basis conversion where the law is written in another basis, and an explicit read-across where no government regulates the exact product. A certified product sits at or below every applicable sovereign limit at once.
Where no government regulates the exact product for an analyte, the standard does not go blank or invent a number: the limit is read across from the nearest government value for an analogous product, so a certified product still sits at or below a real sovereign limit. The ratchet tightens these after publication as surveillance warrants.
Master Limit Table
All values in ppb (µg/kg), as-sold basis. Every analyte carries a firm ceiling. A brand meeting every value on a like-for-like basis qualifies for the mark.
| Analyte | Tier | HMTc limit | Binding basis |
|---|---|---|---|
| Lead (Pb) | Tier 1 | 20 | strictest government ML (EU) |
| Inorganic arsenic (iAs) | Tier 1 | 20 | strictest government ML (EU) |
| Total arsenic (tAs) | Tier 2 | 50 | strictest government ML (India) |
| Mercury (tHg) | Tier 1 | 15 | strictest government ML (IL) |
| Cadmium (Cd) | Tier 1 | 10 cow / 20 soy | strictest government ML (EU) |
| Total chromium (Cr) | Tier 2 | 2000 | strictest government ML (China) |
| Nickel (Ni) | Tier 2 | 250 cow / 400 soy | strictest government ML (EU) |
| Tin (Sn) | Tier 2 | 5000 | strictest government ML (India) |
| Aluminium (Al) | Tier 2 | 4000 cow / 8000 soy | strictest government ML (AU/NZ) |
Tier 1 (Pb, Cd, iAs, Hg) are zero-tolerance toxics with no established safe threshold. Tier 2 (tAs, Ni, Al, Sn, Cr) are held to the same government limit: tiering sets how the program reacts to an exceedance, not any permission to exceed it. A product is certified only when every analyte is at or below 100% of its published limit; above the limit, on any metal, it is not certified and carries no mark. Arsenic is limited in both forms: total arsenic (tAs) and inorganic arsenic (iAs) are separate ceilings that must both be met, and the species result never replaces the parent total. Total chromium is limited as shown; hexavalent chromium is controlled through it: mandatory Cr-VI speciation on any total-chromium result above 100 ppb, and any quantifiable Cr-VI fails.
Derivation
The full derivation for Infant formula (powder). Each row lists every government maximum level in force worldwide, converted to the as-sold basis; the HMTc limit is the strictest of them, and the last column names which sovereign law binds. A blank cell means that government sets no limit for this analyte in this product.
| Analyte | EU | UK | Codex | Canada | China | India | Brazil | GSO | AU/NZ | HMTc | Binds |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead (Pb) | 20 | 50 | 80¹ | 80¹ | 80 | 200 | 80¹ | 80¹ | 80¹ | 20 | EU |
| Inorganic arsenic (iAs) | 20 | — | — | — | — | — | 160¹ | — | — | 20 | EU |
| Total arsenic (tAs) | — | — | — | — | 500 | 50 | — | — | — | 50 | India |
| Mercury (tHg) | — | — | — | — | — | — | — | — | — | 15 | IL |
| Cadmium (Cd) | 10 | 10 | — | — | — | 100 | 80¹ | 10 | — | 10 | EU |
| Total chromium (Cr) | — | — | — | — | 2000 | — | — | — | — | 2000 | China |
| Nickel (Ni) | 250 | — | — | — | — | — | — | — | — | 250 | EU |
| Tin (Sn) | — | — | — | — | — | 5000 | — | — | — | 5000 | India |
| Aluminium (Al) | — | — | — | — | — | — | — | — | 4000¹ | 4000 | AU/NZ |
All values µg/kg (ppb), as-sold basis. ¹ basis-converted at the 8:1 powder-to-liquid ratio: the only such ratio a government legislates (China GB 2762 footnote c). ² read-across: no government sets this analyte for this exact product; the value is read across from the nearest government value for an analogous product. ³ not material in this matrix: measured but with no standalone number, controlled by the total-metal screen, not an invented value. Variants on this page: cow and soy. Where a cell differs between them the Master Limit Table shows both; the derivation above is for cow.
Occurrence and derivation rationale
For each analyte on the panel: what the peer-reviewed and survey literature measured in this category, cited one way to the Heavy Metal Index, and the Method v2.0 reasoning behind the certification limit, including, where no government sets a number, why the program sets one anyway. Occurrence figures are literature findings; the derivation is the certifier's.
2 studies in the certified-market pool measured lead in Infant Formula Powder across 48 certified-market samples. The pooled distribution centres on a median of 0.1 ppb and reaches 16 ppb at the 95th percentile. Mgbemena 2026, Dokhtkkhatibi 2024.
HMTc sets 20 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. The certified-market pool's P97 is 17 ppb, against a government ceiling of 20 ppb. Why lead is limited →
7 studies in the corpus measured inorganic arsenic in Infant Formula Powder (105503 samples reported across those studies): Barber 2025, Hopfner 2025, Houlihan 2019, Signes-Pastor 2018, EFSA 2014, FSA 2014, FSANZ 2011.
HMTc sets 20 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. Why inorganic arsenic is limited →
17 studies in the corpus measured total arsenic in Infant Formula Powder (110202 samples reported across those studies): Barber 2025, Dobrzynska 2025, Alyasiri 2024, EFSA 2024, Garuba 2024, Alharbi 2023, Demir 2023, Gredilla 2022 and 9 more.
HMTc sets 50 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. Why total arsenic is limited →
2 studies in the certified-market pool measured total mercury in Infant Formula Powder across 11 certified-market samples. The pooled distribution centres on a median of 84 ppb and reaches 967 ppb at the 95th percentile. Tatsuta 2024, FSANZ 2011.
HMTc sets 15 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. The certified-market pool's P97 is 1 mg/kg, at or above the government ceiling of 15 ppb, so the government maximum binds. Why total mercury is limited →
2 studies in the certified-market pool measured cadmium in Infant Formula Powder across 58 certified-market samples. The pooled distribution centres on a median of 0.1 ppb and reaches 0.2 ppb at the 95th percentile. Mgbemena 2026, Dokhtkkhatibi 2024.
HMTc sets 10 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. The certified-market pool's P97 is 0.2 ppb (provisional), against a government ceiling of 10 ppb. Why cadmium is limited →
1 study in the certified-market pool measured nickel in Infant Formula Powder across 20 certified-market samples. The pooled distribution centres on a median of 0.2 ppb and reaches 0.2 ppb at the 95th percentile. Mgbemena 2026.
HMTc sets 250 ppb (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. The certified-market pool's P97 is 0.2 ppb, against a government ceiling of 250 ppb. Why nickel is limited →
6 studies in the corpus measured tin in Infant Formula Powder (741 samples reported across those studies): Dobrzynska 2025, Demir 2023, Gredilla 2022, Astolfi 2021, FSA 2014, Cot 2003.
HMTc sets 5 mg/kg (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. Why tin is limited →
10 studies in the corpus measured aluminium in Infant Formula Powder (1306 samples reported across those studies): Rahati 2026, Garuba 2024, Demir 2023, Gredilla 2022, Astolfi 2021, Unuvar 2017, Odhiambo 2015, FSA 2014 and 2 more.
HMTc sets 4 mg/kg (regulatory-alignment): the strictest applicable government maximum level for this product form, adopted under Method v2.0 as the default certification standard. Why aluminium is limited →
Risk Flag
On the published occurrence literature to date, Infant formula (powder) shows no systematic gap between typical market levels and the limit: the limit being the strictest government maximum for the product (Method v2.0). Certification is decided on a product’s own tested result, not on a distribution; an individual lot or supplier can still exceed a limit.
See the cross-category summary of the ingredients that most often struggle.
Source regulations
Every published government regulation weighed to set this standard, evaluated against each other. The strictest applicable maximum level binds each analyte; the rest are comparators, and where no government regulates the exact product the value is read across from the nearest government limit. Follow a reference for the source document and its per-analyte limits: the Derivation table above shows every value side by side.
| # | Regulation | Year | Instrument | Role in this standard |
|---|---|---|---|---|
| 1 | Commission Regulation (EU) 2023/915 | 2023 | Maximum levels | Binds lead, inorganic arsenic, cadmium, nickel |
| 2 | GB 2762: National Food Safety Standard | 2022 | Maximum levels | Binds total chromium; Comparator for lead |
| 3 | FSSAI (Contaminants, Toxins and Residues) Regulations | 2011 | Maximum levels | Binds tin; Comparator for lead, cadmium |
| 4 | FSANZ Food Standards Code: Schedule 19 | 2015 | Maximum levels | Binds aluminium; Comparator for lead |
| 5 | Israel Food Contaminants Standard (FCS) | 2016 | Maximum levels | Binds total mercury; Comparator for lead, inorganic arsenic, cadmium |
| 6 | Contaminants in Food (retained Reg. 1881/2006) | 2006 | Maximum levels | Comparator for lead, cadmium |
| 7 | Codex General Standard CXS 193-1995 | 1995 | Codex standard | Comparator for lead |
| 8 | Health Canada, List of Contaminants and Adulterating Substances | 2016 | Maximum/action levels | Comparator for lead |
| 9 | ANVISA RDC, Inorganic Contaminant Limits | 2022 | Maximum levels | Comparator for lead, inorganic arsenic, cadmium |
| 10 | GSO 193: Gulf Technical Regulation | 2021 | Maximum levels | Comparator for lead, cadmium |
| 11 | Fiji Food Safety Regulations | 2009 | Maximum levels | Comparator for lead |
| 12 | Singapore Food Regulations | 2023 | Maximum levels | Comparator for lead |
| 13 | Thailand MOPH Notification No. 414 | 2020 | Maximum levels | Comparator for lead |
Cite this standard
Pendergrass, K. (2026). Infant formula (powder): HMTc standard (Standard No. 10.83138/hmtc.std.1.infant-formula-powder). Institute of Contaminant Standards. https://doi.org/10.83138/hmtc.std.1.infant-formula-powder
© 2026 Institute of Contaminant Standards / Heavy Metal Certified. All rights reserved.
The literature baseline for every analyte is maintained independently at the Heavy Metal Index. This certification standard applies those findings; the two are kept editorially separate by design.
Version history
The dated editions of this standard. Each is kept at a stable permalink, so a regulator or brand can reconstruct exactly what the standard required on any date: the edition record, not an editorial commit trail. Version-pinned DOIs link here once each edition is deposited.
| Version | Date | Status | What changed |
|---|---|---|---|
| v3.1 | 2026-08-06 | current | Register-completeness correction. Mercury tightened 20→15 and soy cadmium 20→10 (Israel FCS-2016, now the strictest applicable formula MLs). Compiler hardened (multilingual canned-gating, powder-scoped reconstitution, read-across as comparator) against a 7× expanded government register. |
| v3.0 | 2026-08-05 | superseded | Initial government-limit standard (Method v2.0): the strictest sovereign maximum by lookup, converted to the as-sold powder basis; read-across for the cells no government regulates the exact product. Mercury 20 (China GB 2762 read-across), Cr-VI controlled via total-Cr + reflex speciation. |