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A plain oatmeal pacifier and a separate burgundy teething ring illustrating eu reach 2009 annex xvii entry 20 organotin research context.

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

An EU restriction addressing organotin compounds in consumer articles, including textiles, skin contact articles and childcare products.

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 a source record with bibliographic details, reported findings, and document provenance.

  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

No substantive edit history is available in this build. The full commit record is available in git.