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Heavy Metal Index

EU REACH Annex XVII entry 20 — organotin compounds in skin-contact and childcare articles

Scope REACH (Regulation (EC) No 1907/2006) Annex XVII entry 20 restricts organotin compounds in consumer articles.

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 classLimitScope
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.

References

Works cited in this page’s text, in first-appearance order. Each title links to its source record, which carries the ingest receipt, the extracted values, and the file hash of the document it was built from.

  1. Occurrence of tin in disposable baby diapersŠmajgl D and Obhođaš J · X-Ray Spectrometry · 2015 · doi.org/10.1002/xrs.2609Peer-reviewed

Update history

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