CAS 75-21-8 · AICIS · Australia

Ethylene oxide (oxirane) under AICIS

C2H4O · 环氧乙烷

Status: Listed. EO is on the AICIS Inventory of Industrial Chemicals as a Listed Industrial Chemical. Australia adopted the GHS classification matching REACH (Carc 1A + Muta 1B + Press. Gas + Flam. Gas 1A + Acute Tox. 3 inhalation + STOT SE 3 + STOT RE 2). **SUSMP Schedule 7 (Dangerous Poison) applies for industrial-grade EO above concentration cutoffs** (similar to formaldehyde batch 18 + benzene batch 22 + aniline batch 26 + butadiene batch 27). NOT on Australian Drug Control Act precursor list. NO active Australian AD/CVD case. Australia has minimal domestic EO production capacity (Qenos Botany Sydney and Qenos Altona Melbourne are integrated to ethylene chain but EO is small-scale captive); imports of bulk EO are extremely rare due to safety + handling complexity. Sterilant-grade EO for medical-device sterilisation is the dominant Australian EO use.

AICIS treats EO as a routine listed industrial chemical with **SUSMP Schedule 7 (Dangerous Poison) scheduling for industrial-grade above concentration cutoffs**. **EO is structurally NOT internationally traded as bulk**; standalone EO import is rare. The dominant practitioner-facing concern is **medical-device sterilisation (TGA + ARTG + GMP compliance)** + **EO residue compliance for imported food + cosmetic products**. NO active Australian AD/CVD case. ChAFTA preferential zero-duty available but bulk-trade structurally limited. Major Australian downstream consumers: medical-device sterilisation contractors (Steritech / Sterigenics).

Listing and threshold

Substance Ethylene oxide (oxirane) (CAS 75-21-8), C2H4O
Regime Australian Industrial Chemicals Introduction Scheme (AICIS), administered by the Department of Health
Jurisdiction Australia
Status Listed
Tonnage threshold AICIS introducer registration required for any business introducing >100 kg/year of any industrial chemical

Classifications under this regime

  • Listed Industrial Chemical on AICIS Inventory
  • Australian GHS classification: Flam. Gas 1A (H220), Press. Gas, Carc. 1A (H350), Muta. 1B (H340), Acute Tox. 3 inhalation (H331), STOT SE 3 (H335), Eye Irrit. 2 (H319), Skin Irrit. 2 (H315), STOT RE 2 (H373)
  • Signal word: DANGER. GHS pictograms: GHS02 + GHS04 + GHS06 + GHS08
  • **SUSMP Schedule 7 (Dangerous Poison)** applies for industrial-grade EO above concentration cutoffs
  • NOT on Australian Drug Control Act precursor list
  • Australian Dangerous Goods Code (ADG 7.7): Class 2.3 (toxic gas), UN 1040 (refrigerated liquefied)
  • Safe Work Australia workplace exposure standard: 1 ppm 8-hr TWA
  • **IARC: Group 1 (carcinogenic to humans)**

Restrictions and conditions of use

  • No AICIS-specific use restrictions for industrial-grade EO above concentration cutoffs
  • SUSMP Schedule 7 retail packaging rules apply for industrial-grade above cutoffs
  • NO active Australian AD/CVD case on Chinese-origin EO currently
  • WHS Regulation 2011 hazardous-chemicals handling requirements apply
  • **TGA + Therapeutic Goods (Excluded Goods) Determination**: medical-device sterilisation with EO must comply with TGA + ARTG + GMP requirements
  • ChAFTA preferential zero-duty applies to Chinese-origin EO (HS 291010)

Importer obligations

The Australian importer of record must be registered with AICIS. **EO is structurally NOT internationally traded as bulk**; standalone EO import is rare. The dominant practitioner-facing concern for EO importers is **medical-device sterilisation (TGA + ARTG + GMP compliance)** + **EO residue compliance for imported food + cosmetic products**. Major Australian downstream consumers: medical-device sterilisation contractors (Steritech / Sterigenics, Steritech Medical Sciences), pharmaceutical sector (Mayne Pharma, CSL Behring sterilisation contracts).

Required documents

  • AICIS introducer registration certificate (annual)
  • WHS-compliant Safety Data Sheet (Safe Work Australia model code format) reflecting H220 / H315 / H319 / H331 / H335 / H340 / H350 / H373 classification
  • Customs entry (ICS / ABF) with HS code 291010
  • **SUSMP Schedule 7 (Dangerous Poison) labelling compliance** for industrial-grade above cutoffs
  • ChAFTA Form CO certificate of origin for preferential treatment
  • Industrial-grade specification certificate (minimum 99.9% purity)
  • ADG 7.7 Class 2.3 dangerous-goods transport documentation (refrigerated liquefied gas)
  • TGA + ARTG + GMP documentation for medical-device sterilisation applications

Common compliance traps

The pitfalls that have bitten importers on this lane in the past. None of these is theoretical.

  • AICIS registration must be CURRENT at customs clearance
  • WHS hazardous-chemicals register entry required at handling facilities; refrigerated liquefied gas storage + ATEX-zoned warehousing required
  • **SUSMP Schedule 7 (Dangerous Poison) compliance is the dominant practitioner overhead** for industrial-grade above cutoffs
  • Carc 1A + Muta 1B + Press. Gas + IARC Group 1 hazard profile drives heaviest WHS workplace exposure-control overhead
  • **EO is structurally NOT internationally traded as bulk**; standalone EO import is rare
  • NO active Australian AD/CVD case
  • ChAFTA preferential zero-duty makes Chinese-origin EO competitive but bulk-trade structurally limited
  • Major Australian downstream consumers: medical-device sterilisation contractors (Steritech / Sterigenics)

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for ethylene oxide (oxirane), see the CAS 75-21-8 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the ethylene oxide (oxirane) cornerstone hub covers the full sourcing chain.

For the structure and history of AICIS, see the AICIS glossary entry.

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Cross-jurisdiction profile and sourcing references

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