# Ethylene oxide: Regulation

A known carcinogen and the new steriliser rules

Source page: https://www.materialinsights.org/chemicals/ethylene_oxide/regulation/

What this tab covers How it is regulated and what could disrupt supply: hazard classification, rules in the EU, US and India, anti-dumping duties and other trade measures, and supply-risk notes.

#### Hazards

| Classification | UN number | Key risks |
|---|---|---|
| Flammable gas cat 1; chemically unstable gas; acute toxicity cat 3 (inhalation); carcinogenic cat 1B; mutagenic cat 1B; reproductive toxicity cat 1B | UN1040 | Carcinogen (IARC Group 1); can decompose explosively without oxygen; runaway polymerisation if contaminated. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **US** | EPA NESHAP for commercial EO sterilisers (2024) and HON rule for chemical plants (2024) | Cuts EO emissions by about 90% at sterilisers; raises compliance costs (indicative). |
| **EU** | REACH (CMR); EO banned as a biocide for food use; Seveso III | EO residues in foods (e.g. sesame) triggered EU recalls in 2020-2021. |
| **China** | Hazardous chemicals catalogue; key supervised hazardous process | Strict permits. |

#### India

| Rule | Effect |
|---|---|
| **MSIHC Rules 1989** | EO listed as hazardous; safety reports and emergency plans. |
| **FSSAI and APEDA controls on EO residues in spices** | After 2020-2024 EU and Hong Kong rejections of Indian spices for EO residue, India tightened testing (indicative). |

#### Trade measures

- No significant duties on EO itself
- EU and others reject food imports with EO residues

#### Supply risk

Local supply depends on one or two nearby producers; an outage strands ethoxylate and sterilisation users. Not on critical lists.

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/ethylene_oxide/index.md)
- [Overview](https://www.materialinsights.org/chemicals/ethylene_oxide/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/ethylene_oxide/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/ethylene_oxide/routes/index.md)
- [Production](https://www.materialinsights.org/chemicals/ethylene_oxide/production/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/ethylene_oxide/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/ethylene_oxide/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/ethylene_oxide/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/ethylene_oxide/movement/index.md)
- [Characteristics](https://www.materialinsights.org/chemicals/ethylene_oxide/characteristics/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/ethylene_oxide/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/ethylene_oxide/links/index.md)