How every number on this page is set
Feminine-care products contact the vulvovaginal mucosa, which is markedly more permeable and bioavailable than intact skin; the standard is written on a mucosal basis and never on a dermal or dietary basis. The category splits into two instrument families that share this basis but are never conflated. Device forms — tampons, pads, cups, discs, period underwear — are regulated as medical devices for biocompatibility (21 CFR Part 884; EU MDR 2017/745; ISO 10993), but no government sets a numeric heavy-metal content limit for the finished device in any jurisdiction, so every panel analyte resolves to a mandatory analytical control or a substantiated not-material determination, never an invented number.
Cosmetic forms — feminine wipes, deodorants, douches, intimate washes — are cosmetics, so sovereign cosmetic contaminant limits apply, adopted at the strictest mucosal-contact tier a government draws. Lead reads across the German BVL 2017 toothpaste tier (500 µg/kg, stricter than the general-cosmetic 2000 because vaginal mucosa is more permeable than the oral mucosa that limit was written for); cadmium (100), total arsenic (500) and total mercury (100) bind the strictest general-cosmetic value directly; and nickel binds the only sovereign cosmetic nickel content limit (Korea MFDS 2025, 10000). Occurrence establishes materiality — a metal a routed survey measures present cannot be recorded not-material — but never sets the number.
Master Limit Table
All values in ppb (µg/kg), as-sold basis. 0 of 11 analytes carry a firm ceiling; the remainder are governed by mandatory control or reflex-speciation screening with no standalone number, itemised in the derivation below. A brand meeting every firm value on a like-for-like basis, and passing every control, qualifies for the mark.
| Analyte | Tier | HMTc limit | Binding basis |
|---|---|---|---|
| Lead (Pb) | Tier 1 | control | mandatory control — no government ML; screened every lot (see note) |
| Cadmium (Cd) | Tier 1 | control | mandatory control — no government ML; screened every lot (see note) |
| Total arsenic (tAs) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
| Inorganic arsenic (iAs) | Tier 1 | control | mandatory control — no government ML; screened every lot (see note) |
| Mercury, total (tHg) | Tier 1 | control | mandatory control — no government ML; screened every lot (see note) |
| Methylmercury (MeHg) | Tier 1 | n/m | not material — controlled analyte (see note) |
| Nickel (Ni) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
| Tin (Sn) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
| Aluminium (Al) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
| Total chromium (Cr) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
| Hexavalent chromium (Cr-VI) | Tier 2 | control | mandatory control — no government ML; screened every lot (see note) |
Tier 1 (Pb, iAs, Hg, MeHg, Cd) are zero-tolerance toxics with no established safe threshold. Tier 2 (tAs, Ni, Sn, Al, Cr, Cr-VI) carry a 150% transitional allowance under the program’s Status A–E framework.
Derivation — mandatory control, no sovereign limit
No government sets a heavy-metal content limit for Menstrual tampons. Every analyte on the panel is held under mandatory control — measured on every lot and escalated against route-appropriate toxicological anchors — or, where the chemistry rules it out of the matrix, recorded as a substantiated not-material determination. No number is invented.
| Analyte | HMTc | Binding | Basis |
|---|---|---|---|
| Lead (Pb) | control | screened every lot | mandatory control — no government ML |
| Cadmium (Cd) | control | screened every lot | mandatory control — no government ML |
| Total arsenic (tAs) | control | screened every lot | mandatory control — no government ML |
| Inorganic arsenic (iAs) | control | screened every lot | mandatory control — no government ML |
| Mercury, total (tHg) | control | screened every lot | mandatory control — no government ML |
| Methylmercury (MeHg) | n/m | ≤ tHg | not material in this matrix |
| Nickel (Ni) | control | screened every lot | mandatory control — no government ML |
| Tin (Sn) | control | screened every lot | mandatory control — no government ML |
| Aluminium (Al) | control | screened every lot | mandatory control — no government ML |
| Total chromium (Cr) | control | screened every lot | mandatory control — no government ML |
| Hexavalent chromium (Cr-VI) | control | screened every lot | mandatory control — no government ML |
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.
The corpus holds 2 measurements of lead in Menstrual tampons (82 samples reported across those studies), which the determination below is tested against: Shearston 2024, Ellison 2026. Reported concentrations range from 173 ppb to 468 ppb, with a typical value of 173 ppb.
HMTc sets no standalone lead limit for Menstrual tampons. Lead is present in this device class per routed occurrence evidence (shearston2024 (Pb 60/60, Cd 60/60, tAs 57/60, Ni, Cr, tHg by ICP-MS across 30 tampons); ica2024 (systematic review confirming Pb/Cd/tAs/tHg/Ni/Cr in tampons); ellison2026 (lead mass-balance across menstrual-fluid fractions); carlin2020 (Pb/Cd/tHg/Cr/tAs/Ni tampon chemistry); nic-corcrain2025 (Pb, tAs leached across tampons, pads, cups and period underwear into simulated vaginal fluid); marcelis2024 (full-panel screen incl. Al and Sn across tampons, pads, cups and other intimate products)); no jurisdiction sets a Lead content limit for a menstrual or intimate-care device (medical-device law governs ISO 10993 biocompatibility, not content). The cell is held under mandatory analytical control, not declared not-material — a not-material determination would be contradicted by the occurrence evidence and would fail the substantiation gate. The analyte is controlled by Mandatory per-lot total-content analysis by microwave-assisted acid digestion and ICP-MS, with component-level sampling of the finished article (absorbent core, withdrawal string, overwrap, and applicator — each sampled and tested as a distinct component; a plastic applicator is additionally screened for tin/antimony/colorant metals). No sovereign sets a heavy-metal content limit for this device form, so no fixed numeric ceiling is published; any lot result is dispositioned under the HMTc control-and-escalation rule (ALARA tightening against the tightest available context + supplier corrective action). Lead is material for this device (measured in tampons by ICP-MS in the routed corpus), not a standalone number. Why lead is limited →
The corpus holds 1 measurement of cadmium in Menstrual tampons (60 samples reported across those studies), which the determination below is tested against: Shearston 2024. Reported concentrations range from 9.6 ppb to 56 ppb, with a typical value of 9.6 ppb.
HMTc sets no standalone cadmium limit for Menstrual tampons. Cadmium is present in this device class per routed occurrence evidence (shearston2024 (Pb 60/60, Cd 60/60, tAs 57/60, Ni, Cr, tHg by ICP-MS across 30 tampons); ica2024 (systematic review confirming Pb/Cd/tAs/tHg/Ni/Cr in tampons); carlin2020 (Pb/Cd/tHg/Cr/tAs/Ni tampon chemistry); marcelis2024 (full-panel screen incl. Al and Sn across tampons, pads, cups and other intimate products)); no jurisdiction sets a Cadmium content limit for a menstrual or intimate-care device (medical-device law governs ISO 10993 biocompatibility, not content). The cell is held under mandatory analytical control, not declared not-material — a not-material determination would be contradicted by the occurrence evidence and would fail the substantiation gate. The analyte is controlled by Mandatory per-lot total-content analysis by microwave-assisted acid digestion and ICP-MS, with component-level sampling of the finished article (absorbent core, withdrawal string, overwrap, and applicator — each sampled and tested as a distinct component; a plastic applicator is additionally screened for tin/antimony/colorant metals). No sovereign sets a heavy-metal content limit for this device form, so no fixed numeric ceiling is published; any lot result is dispositioned under the HMTc control-and-escalation rule (ALARA tightening against the tightest available context + supplier corrective action). Cadmium is material for this device (measured in tampons by ICP-MS in the routed corpus), not a standalone number. Why cadmium is limited →
The corpus holds 1 measurement of total arsenic in Menstrual tampons (60 samples reported across those studies), which the determination below is tested against: Shearston 2024. Reported concentrations range from 2.3 ppb to 14 ppb, with a typical value of 2.3 ppb.
HMTc sets no standalone total arsenic limit for Menstrual tampons. Total arsenic is present in this device class per routed occurrence evidence (shearston2024 (Pb 60/60, Cd 60/60, tAs 57/60, Ni, Cr, tHg by ICP-MS across 30 tampons); ica2024 (systematic review confirming Pb/Cd/tAs/tHg/Ni/Cr in tampons); carlin2020 (Pb/Cd/tHg/Cr/tAs/Ni tampon chemistry); nic-corcrain2025 (Pb, tAs leached across tampons, pads, cups and period underwear into simulated vaginal fluid); marcelis2024 (full-panel screen incl. Al and Sn across tampons, pads, cups and other intimate products)); no jurisdiction sets a Total arsenic content limit for a menstrual or intimate-care device (medical-device law governs ISO 10993 biocompatibility, not content). The cell is held under mandatory analytical control, not declared not-material — a not-material determination would be contradicted by the occurrence evidence and would fail the substantiation gate. The analyte is controlled by Mandatory per-lot total-content analysis by microwave-assisted acid digestion and ICP-MS, with component-level sampling of the finished article (absorbent core, withdrawal string, overwrap, and applicator — each sampled and tested as a distinct component; a plastic applicator is additionally screened for tin/antimony/colorant metals). No sovereign sets a heavy-metal content limit for this device form, so no fixed numeric ceiling is published; any lot result is dispositioned under the HMTc control-and-escalation rule (ALARA tightening against the tightest available context + supplier corrective action). Total arsenic is material for this device (measured in tampons by ICP-MS in the routed corpus), not a standalone number. Why total arsenic is limited →
Cite this standard
Pendergrass, K. “Menstrual tampons.” In Heavy Metal Tested & Certified (HMTc) Feminine Care standard, version 1.0. Institute of Contaminant Standards (ICS), 2026. DOI: registration pending.
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.