Pacifiers and sucking/teething aids — HMTc Standard

How every number on this page is set

What this standard coversCovers soothers/pacifiers and sucking/teething aids (the nipple, shield, ring, and any clip in the mouthing zone). Teething toys with play value are certified under Teething toys/teethers; pacifier metal safety is governed via the EN 1400 soother standard.

Pacifiers and sucking/teething aids is a contact product, not a food. Its heavy-metal limits are the element-migration limits required by the EN 1400 soother standard, which applies the EN 71-3 / Toy Safety Directive Category III limits. Pacifiers are excluded from the Toy Safety Directive itself (Annex I item 16), so these migration limits are read across from the toy-migration regime via the EN 1400 route; the limit values are identical — not dietary maximum levels. The standard for each analyte is the strictest limit set by any credible government regulator for this product in its own basis: a lookup of sovereign law, with the measured quantity stated on every row. Where no instrument directly governs the exact product form — a pacifier is excluded from the Toy Safety Directive, a disposable diaper from the REACH textile restriction — the limit is read across from the nearest applicable sovereign limit and labelled as a read-across, never asserted as direct governance. Migration limits (what leaves the article into saliva or food) and total-content limits (how much metal the article contains) are different quantities measured by different methods; they are published as separate ceilings and never combined into one number. A certified product meets every applicable limit at once, each on a like-for-like basis.

Inorganic arsenic and methylmercury are not published for this category: they are ingestion-and-bioaccumulation speciation forms with no migration counterpart in a contact article, and the total-element ceilings (total arsenic, total mercury) bound them. Where a cell is marked not material, no regulator sets a limit and no exposure pathway exists; the determination is recorded, not left blank.

Master Limit Table

Limits in mg/kg, in the basis named on each row. “ND” means not detectable at the regulation’s stated detection limit — the strictest possible ceiling. Sub-rows (↳) are companion ceilings in a different basis that also apply. Tier 1 (Pb, Cd, iAs, Hg) are zero-tolerance toxics; Tier 2 (tAs, Ni, Al, Cr-VI, Sn) carry a transitional allowance under the program’s Status A–E framework. Antimony is regulated in the toy-migration instruments and screened, but is not one of the ten HMTc certification analytes.

Screened, not limited

All ten HMTc certification analytes, plus a total-chromium screen, are accounted for. The analytes below carry no published ceiling for this product because no exposure pathway and no government limit exist; each determination is recorded here rather than left as a silent gap. They are screened during certification, not certified against a number.

Derivation — every government value, side by side

Each row lists every government limit weighed for this analyte in the governing basis, converted to mg/kg; the HMTc limit is the strictest of them. Companion total-content ceilings appear in the Master Limit Table above, not here, because they are a different measured quantity.

Cite this standard