# Industrial enzymes: Regulation

Why enzyme dust is a breathing hazard for workers

Source page: https://www.materialinsights.org/chemicals/enzymes/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 |
|---|---|---|
| Respiratory sensitiser category 1 for many enzymes | none | Occupational asthma from enzyme dust, which drove the shift to encapsulated granules in detergents. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **EU** | Food enzymes Regulation 1332/2008 (Union list); feed additive Regulation 1831/2003; REACH for technical enzymes | Pre-approval for food and feed uses. |
| **US** | FDA GRAS notices; EPA TSCA for GMO production strains | Market entry route for food enzymes. |
| **Global** | JECFA specifications | Purity standards for food enzymes. |

#### India

| Rule | Effect |
|---|---|
| **FSSAI approval of food enzymes (Food Additives Regulations; enzyme list) (indicative)** | Lists permitted enzymes and sources |
| **GEAC and DBT rules for GMO production strains (indicative)** | Can slow approval of new strains |

#### Trade measures

- No anti-dumping duty on enzymes found in sources reached

#### Supply risk

Concentrated in a few companies with proprietary strains, but each runs several plants. Not on critical lists.

## Other sections

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