Menstrual discs — HMTc Standard

How limits are 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 per-metal numeric content limit for a menstrual product.

Rather than leave those cells blank, the standard reads a limit across by analogy: for each analyte it adopts the strictest health-based limit a government has set for an article in comparable prolonged mucosal contact, and holds the device to that number. The read-across is disclosed and deliberately conservative, so every device cell is a read-across to a named government limit and never a number HMTc originated, with inorganic arsenic and methylmercury bounded by their parent totals and measured every lot.

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.

This is Method v2. Why Method v1 was retired is on the method page.

Master Limit Table

All values in ppb (µg/kg), as-sold basis. 9 of 11 analytes carry a firm ceiling; the remaining 2 are toxic species bounded by their parent totals (species ≤ total, measured on every lot), so every analyte carries an enforceable ceiling. A brand meeting every value on a like-for-like basis qualifies for the mark.

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.

Derivation

For Menstrual discs, each HMTc limit is a disclosed read-across to the strictest health-based limit a government sets for a comparable mucosal-contact article, named in the Binding column. Cosmetic forms bind a cosmetic limit that applies to the product directly; device forms, for which no government sets a per-metal numeric content limit, carry the same value by read-across by analogy. Inorganic arsenic and methylmercury are bounded by their parent totals, and no number is originated by HMTc.

Risk Flag

On the published occurrence literature to date, Menstrual discs 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.