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 | HMTc limit | Binding basis |
|---|---|---|
| Lead (Pb) | 20 | strictest government ML (EU) |
| Inorganic arsenic (iAs) | 20 | strictest government ML (EU) |
| Total arsenic (tAs) | 50 | strictest government ML (India) |
| Mercury (tHg) | 15 | strictest government ML (IL) |
| Cadmium (Cd) | 10 cow / 20 soy | strictest government ML (EU) |
| Total chromium (Cr) | 2000 | strictest government ML (China) |
| Nickel (Ni) | 250 cow / 400 soy | strictest government ML (EU) |
| Tin (Sn) | 5000 | strictest government ML (India) |
| Aluminium (Al) | 4000 cow / 8000 soy | strictest government ML (AU/NZ) |
Every claim analyte is equal at the gate. A product is certified only when every analyte is at or below 100% of its published government floor or disclosed read-across; 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.
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.