Hand Sanitizer Photo © Martinmark Dreamstime

US to Temporarily Relax Hand Sanitizer Purity Rules

June 2, 2020
FDA said they would allow more impurities in alcohol-based hand sanitizer.

In a statement from the Food and Drug Administration, the federal government announced it would relax regulations on impurities in alcohol-based hand sanitizer. The move, announced today by FDA Commissioner Stephen M. Hahn, M.D., is intended to “help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.”

According to the FDA, the agency previously updated its restrictions in April in response to requests from fuel ethanol manufacturers, who had pivoted their supply chains to produce hand sanitizer instead of fuel.

The FDA’s statement said that data produced by those manufacturers showed their fuel ethanol products contained gasoline and benzene, which it said were known carcinogens. The updated guidance allows hand sanitizer to include up to 2 parts per million of benzene.

The coronavirus pandemic has stretched supply chains around the world to the breaking point by playing havoc with the economies and industrial sectors of entire countries. Now, even as the United States has reopened most of its factories, sharp demand for products required to maintain stricter cleanliness standards has put suppliers under strain. The Institute of Supply Managers listed hand sanitizer and a variety of PPE as supplies in notably short supply during May.

The FDA recommends use of hand sanitizer containing at least 60% alcohol as a substitute for washing with ordinary soap and water, and hand sanitizer stations for workers to regularly clean their hands at have become a common feature of reopened factories invested in keeping workers healthy.

While many manufacturers of durable goods have repurposed supply chains to producing face shields, masks, gloves, gowns, and similar products, alcohol-based hand sanitizer has proven a popular COVID-19 relief product for chemical companies and brewers to manufacture at scale. Dow Chemical Co., Ineos, and small distilleries all around the world have turned their stocks of chemical alcohol and chemistry equipment into supply lines for the cleaning agent.

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