Scope
REACH (Regulation (EC) No 1907/2006) Annex XVII entry 20 restricts organotin compounds in consumer articles. Unlike the total-tin migration limits that govern canned food, the concern here is organotin — tributyltin (TBT), dibutyltin (DBT), and dioctyltin (DOT) — used as PVC heat stabilisers, catalysts, and biocides. Organotin is a distinct chemical species from the inorganic/total tin the HMTc panel measures, and it is the toxicologically active form in polymer and textile articles.
Restrictions
| Organotin class | Limit | Scope |
|---|---|---|
| Tri-substituted (TBT, TPT) | Not to be used above 0.1% by weight of tin (1000 mg/kg as Sn) | Articles generally |
| Dibutyltin (DBT) | Not to be used above 0.1% by weight of tin (1000 mg/kg as Sn) | Mixtures and articles supplied to the general public |
| Dioctyltin (DOT) | Not to be used above 0.1% by weight of tin (1000 mg/kg as Sn) | Textile articles intended to contact skin, childcare articles, gloves, and other listed skin-contact articles |
Why this instrument governs the diaper tin cell
A diaper is a skin-contact childcare article, so the DOT restriction (0.1% Sn) applies. This is the reason the HMTc diaper tin cell is a real limit, not a not-material determination: Smajgl and Obhođaš 2015 detected total tin up to 23.1 mg/kg in diaper topsheets and adhesive tape systems, attributed to organotin PVC stabilisers, with a worst-case infant dermal exposure reaching 20–100% of the organotin tolerable daily intake. The measured levels are below the permissive 1000 mg/kg REACH ceiling but exceed voluntary supplier limits; the finding retires the earlier “no tin source in a diaper” determination. HMTc applies the REACH entry-20 ceiling with a reflex organotin speciation (GC-ICP-MS) on any total-tin detection, and the ratchet tightens toward the TDI-anchored voluntary levels after publication.
Related pages
- Tin
- EU Nickel Directive 94/27/EC
- Diapers and diaper components
- Occurrence of tin in disposable baby diapers
References
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