Material Insights · Understanding the Material World

Glycerine: Regulation

Safe in itself, deadly when confused with diethylene glycol

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

ClassificationUN numberKey risks
not classifiednot regulatedLow toxicity. The main risk is adulteration or confusion with diethylene glycol, which has caused fatal poisonings in medicines.

Main rules

WhereRuleEffect
USUSP monograph and FDA guidance requiring testing of glycerine for diethylene glycol and ethylene glycol (indicative)pharma grades need certified supply chains
EUREACH; EP monograph; RED treats crude glycerine as a residue for biofuel accounting (indicative)quality and accounting rules
Indonesiacrude glycerine export levy raised to 10% from 1 Mar 2026 (Argus)favours local refining

India

RuleEffect
Indian Pharmacopoeia monograph and CDSCO testing of excipients for DEG/EG after cough syrup poisonings (indicative)stricter testing of pharma glycerine
FSSAI food additive standards (E422) (indicative)food-grade supply

Trade measures

  • Indonesian 10% crude glycerine export levy (Mar 2026)
  • EU duties on Indonesian biodiesel indirectly affect glycerine supply

Supply risk

Supply is tied to biodiesel policy in Indonesia, Brazil, the EU and the US. Indonesia is the largest exporter of both grades. Pharma-grade supply carries quality and traceability risk.