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. 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. 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 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