CAS 75-21-8 · REACH · European Union

Ethylene oxide (oxirane) under REACH

C2H4O · 环氧乙烷

Status: Registered. Ethylene oxide is fully registered under REACH at the highest tonnage band (>1,000,000 tonnes/year). **Distinguishing pattern: most-restricted production substance + Carc 1A + Muta 1B + Press. Gas + Flam. Gas + IARC Group 1 carcinogen since 1994 + EPA TSCA Section 6 active risk-management rule (40 CFR Part 751 Subpart D) finalised + EO is structurally NOT internationally traded as bulk (intra-complex captive consumption) + ethylene glycol (MEG batch 8) downstream chain (~75% of demand) (NEW combined).** Reg (EC) 1272/2008 harmonised classification: Carc 1A + Muta 1B + Acute Tox. 3 inhalation + STOT SE 3 + Eye Irrit. 2 + Press. Gas + Flam. Gas 1A. NOT SVHC. NOT Annex XIV. NOT a drug precursor. NO active EU AD case on Chinese-origin EO currently (largely irrelevant due to bulk-trade constraint).

Ethylene oxide carries **heaviest hazard profile alongside benzene batch 22 + formaldehyde batch 18 + butadiene batch 27**: Carc 1A + Muta 1B + Press. Gas + Flam. Gas 1A + IARC Group 1 carcinogen since 1994. **EO is structurally NOT internationally traded as bulk** (intra-complex captive consumption dominates due to safety + handling complexity); standalone EO export is rare. The dominant practitioner-facing concern is **medical device + cosmetic / personal-care sterilant applications** + **EO residue compliance for imported food + feed products**. NOT SVHC despite Carc 1A + Muta 1B (kept off because of essential industrial use; ~75% of demand is ethylene glycol / MEG batch 8 chain). Major Chinese producers: Sinopec (Yangzi + Shanghai + Maoming), Wanhua Chemical Yantai, Hengli Petrochemical Dalian, Zhejiang Petrochemical / ZRCC. China dominates global capacity (~50%, ~15-20 Mt/yr EO-equivalent). Production: ethylene + oxygen direct oxidation with silver catalyst (~99% globally). End-use: MEG (batch 8 chain) ~75%, surfactants + ethoxylates ~10%, polyether polyols ~5%, ethanolamines ~5%.

Listing and threshold

Substance Ethylene oxide (oxirane) (CAS 75-21-8), C2H4O
Regime EU Regulation (EC) No 1907/2006: Registration, Evaluation, Authorisation and Restriction of Chemicals
Jurisdiction European Union (EU-27 plus EEA: Iceland, Liechtenstein, Norway)
Status Registered
Tonnage threshold Registration required for any importer or manufacturer placing >1 t/year on the EU market

Classifications under this regime

  • Harmonised CLP classification: Flam. Gas 1A (H220), Press. Gas, Carc. 1A (H350, "may cause cancer"), 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 (flame), GHS04 (gas cylinder), GHS06 (skull and crossbones), GHS08 (health hazard, carcinogen / mutagen / target organ)
  • **IARC: Group 1 (carcinogenic to humans) since 1994 IARC Monograph 60; reaffirmed 2012 Monograph 100F** (verify Volumes 60 plus 100F against https://monographs.iarc.who.int/list-of-classifications)
  • NOT subject to Drug Precursors or Explosives Precursors scheduling
  • ADR / RID transport classification: Class 2.3 (toxic gas), UN 1040 (refrigerated liquefied), Packing Group not applicable

Restrictions and conditions of use

  • NOT on REACH Annex XIV (Authorisation list)
  • NOT classified as SVHC (despite Carc 1A + Muta 1B classification, kept off SVHC because of essential industrial use including ethylene glycol / MEG batch 8 chain)
  • NO active EU AD case on Chinese-origin EO currently (bulk-trade structurally limited)
  • Carbon Border Adjustment Mechanism (CBAM): NOT in CBAM Phase 1 scope; potential Phase 2 candidate post-2026 review
  • EU Reg 10/2011 food-contact: EO specific migration limit (SML "ND" non-detectable)
  • EU Industrial Emissions Directive (IED) requires permitting
  • EU Directive 2004/37/EC Carcinogens and Mutagens at Work: occupational exposure limit 1.8 mg/m^3 8-hr TWA (verify current OEL value against https://eur-lex.europa.eu/eli/dir/2004/37/oj before relying)
  • EU Reg 396/2005 Pesticide Residues: EO residue MRL set very low for food + feed
  • EU Reg 540/2011 Plant Protection Products: EO use as fumigant prohibited since 1991

Importer obligations

A non-EU producer cannot register directly under REACH. The EU importer of record must hold a registration or rely on an Only Representative (OR). **EO is structurally NOT internationally traded as bulk** (intra-complex captive consumption dominates due to safety + handling complexity); the dominant practitioner-facing layer for EO importers is **medical device + cosmetic / personal-care sterilant applications** + **EO residue compliance for imported food + feed products** (EU MRL set very low). Major Chinese producers (Sinopec Yangzi + Sinopec Shanghai + Sinopec Maoming, Wanhua Chemical Yantai, Hengli Petrochemical Dalian, Zhejiang Petrochemical Zhoushan / ZRCC) are integrated upstream of MEG (batch 8) and other ethylene-oxide-derivative chains; standalone EO export is rare.

Required documents

  • REACH registration number on the EU side (registrant or OR-appointed)
  • Safety Data Sheet (SDS) compliant with REACH Annex II in destination Member State language(s) reflecting H220 / H315 / H319 / H331 / H335 / H340 / H350 / H373 classification
  • CLP-compliant labelling with GHS02 + GHS04 + GHS06 + GHS08 pictograms and DANGER signal word
  • Customs entry with HS code 291010 (ethylene oxide)
  • ADR consignment note for transport (Class 2.3 toxic gas, UN 1040, refrigerated liquefied)
  • Reg 396/2005 EO residue compliance documentation for imported food + feed products

Common compliance traps

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

  • **EO is structurally NOT internationally traded as bulk** (intra-complex captive consumption dominates due to safety + handling complexity); standalone EO export is rare
  • The dominant practitioner-facing concern for EO is **medical device + cosmetic / personal-care sterilant applications** + **EO residue compliance for imported food + feed products** (EU MRL set very low)
  • **Carc 1A + Muta 1B + Press. Gas + Flam. Gas 1A + IARC Group 1 hazard profile** drives the heaviest workplace exposure-control overhead in the dataset alongside benzene batch 22 + formaldehyde batch 18 + butadiene batch 27
  • NOT SVHC despite Carc 1A + Muta 1B (kept off because of essential industrial use; ~75% of demand is ethylene glycol / MEG batch 8 chain)
  • NOT in CBAM Phase 1 scope
  • EU Directive 2004/37/EC OEL 1.8 mg/m³ 8-hr TWA
  • Major Chinese producers: Sinopec (Yangzi + Shanghai + Maoming), Wanhua Chemical Yantai, Hengli Petrochemical Dalian, Zhejiang Petrochemical Zhoushan / ZRCC. China dominates global capacity (~50%, ~15-20 Mt/yr EO-equivalent)
  • Production route: ethylene + oxygen direct oxidation with silver catalyst (~99% globally)
  • End-use mix: ethylene glycol (MEG batch 8 chain, ~75%), surfactants + ethoxylates (~10%), polyether polyols (~5%), ethanolamines (~5%), other (~5%)

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 REACH, see the REACH glossary entry.

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Cross-jurisdiction profile and sourcing references

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