US FDA to temporarily allow benzene, acetaldehyde in hand sanitizer

HOUSTON (ICIS)– The US Food and Drug Administration recently announced new rule changes to secure the supply of hand sanitizer across the country.

This change will allow small amounts of impurities, such as benzene, to be in sanitizer products that are produced often through ethanol production.

The new FDA guidance allows up to 2 parts per million (ppm) of benzene and 50 ppm of acetaldehyde, according to the statement.

The ethanol industry has put large investments towards the ramp up of the output of corn-based alcohol sanitizer at a time when fuel demand has hit new lows due to lockdowns across the US.

Some fuel producers have even made the switch from fuel production to industrial, and industrial contracts settled at record highs on increased demand.

This comes as the FDA had previously tightened restrictions on sanitizer production in April.

“We previously updated these temporary guidances in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents). These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers,” The FDA said in a statement.

Ethanol is used as a gasoline blendstock, in pharmaceuticals, and in food and beverage applications, such as hand sanitizers and vodka.