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Heavy Metal Index

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

Regulation

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

Page snapshot
Referenced by6 pages
JurisdictionEU
Effective2012-01-01

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. This is not the full corpus for this page; it is only what the prose above draws on. The complete set of sources is listed under Sources below. 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.2609Review

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.

CommitDateChangeDescription
4aa8d04072026-08-11major1 source added; 2 sections added; narrative text revised
5fcb75d182026-08-10correction1 source added; contamination-profile values revised; 4 sections added