Mouthwash/oral rinse — HMTc Standard

How every number on this page is set

Two boundary decisions in this category are disclosed rather than assumed. FIRST, breath fresheners split by presentation: the row certifies cosmetic-presentation forms (sprays, strips, films, non-food oral tablets) on the cosmetic instrument family, and food-presented mints, gums and confectionery lozenges are routed out to Category 33 rather than certified against a cosmetic ceiling — the relevant food instrument (the FDA lead action level for candy likely to be frequently consumed by small children, 100 ug/kg) is five times stricter than this category's lead value, so the routing is in the protective direction. SECOND, articles are not stretched onto cosmetic limits: a toothbrush, a floss, an irrigator tip and a tongue scraper each take a real article-scoped sovereign lead ceiling and a full-panel component-level control, and never a toothpaste value. Total chromium is a control rather than a published screen value in every row because no sovereign publishes a chromium content limit for any product form in this category; hexavalent chromium is deliberately NOT registered as a method artifact here, because oral-care matrices routinely contain peroxide and persulfate oxidising systems in which the reduction of Cr(VI) to Cr(III) cannot be assumed. Tin and aluminium are controls with declaration reconciliation rather than impurity ceilings, because stannous fluoride is an authorised active and hydrated alumina is a conventional abrasive, so both elements are present by design in compliant products.

Master Limit Table

All values in ppb (µg/kg), as-sold basis. 5 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.

Tier 1 (Pb, iAs, Hg, MeHg, Cd) are zero-tolerance toxics with no established safe threshold. Tier 2 (tAs, Cr-VI, Ni, Sn, Al, Cr) carry a 150% transitional allowance under the program’s Status A–E framework.

Derivation — every government’s number, side by side

The full derivation for Mouthwash/oral rinse. 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.

All values µg/kg (ppb), as-sold basis. ² no government regulates this analyte for this exact product form: the value is a disclosed read-across from the nearest applicable government maximum, and the derivation names the instrument it comes from. It is never taken from occurrence data. After publication the standards ratchet may tighten it, using certified-lot results only. ³ not material in this matrix: controlled by reflex speciation or packaging control, not a standalone number. &sup4; no sovereign maximum exists for this analyte in this product, but a credible exposure pathway does — it is screened on every lot under ALARA against the tightest analogous reference, not assigned an invented number.

Cite this standard

Pendergrass, K. “Mouthwash/oral rinse.” In Heavy Metal Tested & Certified (HMTc) Oral 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.