Mark Myers, Altiras R&D Manager, and Todd Pencarinha, Altiras President, published a research paper recommending FDA allow for up to 1000 ppm acetaldehyde content in ethanol products used to manufacture hand sanitizers. This paper involved consolidation of key data from considerable industry R&D studies.
Those studies included research on safe levels of acetaldehyde content in alcoholic beverages, research on the human body’s ability to metabolize acetaldehyde, studies on skin absorption and evaporation rates for acetaldehyde. Below is an excerpt from the executive summary of the published paper.
“Acetaldehyde is a natural fermentation byproduct found in ethanol produced through distillation of fermented grains, corn, and other matter. The urgent need for alcohol-based hand sanitizers due to the COVID-19 pandemic has dramatically increased demand for ethanol, resulting in the diversion of many corn and grain-derived alcohols for this use. At the time of this article, the US FDA has not provided clear guidance on reasonable limits for acetaldehyde content in ethanol used to manufacture hand sanitizers. This report examines data from multiple public and private sources related to oral, dermal, and inhalation exposure to acetaldehyde, and considers those means of exposure against the human body’s ability to metabolize acetaldehyde in order to assess exposure levels of acetaldehyde to consumers using hand sanitizers. We conclude that topical application of hand sanitizers manufactured using ethanol with concentrations of 1000 mg/kg exposes consumers to levels of acetaldehyde well below both common everyday natural sources, and well within acceptable occupational exposure limits. Background Acetaldehyde is a naturally occurring chemical compound found in various food, beverage, and distilled spirits. Acetaldehyde is also approved as a food additive and for use in fragrances (10). It is also an intermediate product of ethanol metabolism in the liver, where ethanol is oxidized to acetaldehyde, which is then further oxidized to acetic acid. Acetaldehyde is also produced in the brain by the oxidation of ethanol (3).”