How every number on this page is set
What this standard coversCovers bottle nipples, teats, and spouts (silicone, latex). Pacifier nipples are certified under Pacifiers and sucking/teething aids.
Bottle nipples and spouts is a contact product, not a food. Its heavy-metal limits are specific migration limits into the milk or food it holds (EU Regulation 10/2011; US FDA food-contact provisions). Regulation 10/2011 is written for plastics; for glass and stainless-steel components the same limits are applied as a conservative read-across, since no stricter metal-food-contact sovereign limit exists — 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.
| Analyte | Tier | HMTc limit | Basis | Strictest government | Rationale |
|---|---|---|---|---|---|
| Lead (Pb) | Tier 1 | ND (<0.01) | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| ↳ Total-lead content ceiling (children's-product / mouthable-article law) | 90 | total lead content (mg/kg of product) | Washington State | companion ceiling | |
| Arsenic, total (tAs) | Tier 2 | ND (<0.01) | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| Cadmium (Cd) | Tier 1 | ND (<0.002) | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| ↳ Total-cadmium content ceiling (children's-product law) | 40 | total cadmium content (mg/kg of product) | Washington State | companion ceiling | |
| Mercury, total (tHg) | Tier 1 | ND (<0.01) | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| Nickel (Ni) | Tier 2 | 0.02 | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| Aluminium (Al) | Tier 2 | 1 | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| Chromium, total (Cr) | Tier 2 | ND (<0.01) | specific migration into food (mg/kg food) | European Union | regulatory-alignment |
| Chromium VI (Cr-VI) | Tier 2 | ND (<0.01) | specific migration into food, not detectable at LOD; source unit mg/kg food | European Union (read-across) | regulatory-alignment |
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.
| Analyte | Why it carries no ceiling for this product |
|---|---|
| Inorganic arsenic (iAs) | No inorganic-arsenic migration limit; bounded by the tAs specific-migration ceiling. |
| Methylmercury (MeHg) | No methylmercury pathway in a nipple/teat. Bounded by the tHg ceiling. |
| Tin (Sn) | Inorganic tin has no migration pathway from a platinum-cured silicone or latex nipple; food-grade nipples are platinum-cured, not condensation-cured (which would use organotin catalysts). Certification requires platinum-cure documentation or an organotin screen; the separate EU toy organic-tin migration limit (Cat III 12 mg/kg) covers organotin, which the inorganic-Sn cell does not bound. |
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.
| Analyte | Government limits considered (mg/kg) | HMTc | Binds |
|---|---|---|---|
| Lead (Pb) | European Union 0.01 | ND (<0.01) | European Union |
| Arsenic, total (tAs) | European Union 0.01 | ND (<0.01) | European Union |
| Cadmium (Cd) | European Union 0.002 | ND (<0.002) | European Union |
| Mercury, total (tHg) | European Union 0.01 | ND (<0.01) | European Union |
| Nickel (Ni) | European Union 0.02 | 0.02 | European Union |
| Aluminium (Al) | European Union 1 | 1 | European Union |
| Chromium, total (Cr) | European Union 0.01 | ND (<0.01) | European Union |
| Chromium VI (Cr-VI) | European Union 0.01 (read-across) | ND (<0.01) | European Union (read-across) |
Cite this standard
Pendergrass, K. “Bottle nipples and spouts.” In Heavy Metal Tested & Certified (HMTc) Infant and Child Contact Products standard, version 1.0 (2026-08-10). Institute of Contaminant Standards (ICS), 2026.
The evidence each limit is applied to lives on the independent Heavy Metal Index; HMTc cites it one way and never the reverse. HMTc standards are living, versioned documents; this page reflects 1.0 (2026-08-10).
Source regulations
Every government regulation weighed to set this standard, evaluated against each other in the correct basis. The strictest applicable limit binds each analyte; basis is never conflated across families.
| # | Regulation | Instrument | Basis | Role in this standard |
|---|---|---|---|---|
| 1 | EU Regulation 10/2011 (plastic food-contact, Annex II) | Migration limit | specific migration into food | Binds one or more migration/extraction limits |
| 2 | Washington Children’s Safe Product Act | Content limit | total content | Companion total-content ceiling |