Industrial enzymes: Regulation

Why enzyme dust is a breathing hazard for workers

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.