I don't see any explicit guidance on Acetaldehyde. The requirements show 95% ethanol for ethanol-based sanitizer, with a footnote saying actually, "Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly, and the finished hand sanitizer meets the ethanol concentration of 80%."
It goes on to add, "Ethanol produced in facilities normally producing fuel or technical grade may be
considered for use if the ethanol is produced from fermentation and distillation as would
be typically used for consumable goods, and no other additives or other chemicals have
been added to the ethanol. ... Because of the potential for the presence of potentially harmful
impurities due to the processing approach, fuel or technical grade ethanol should only be
used if it meets USP or FCC grade requirements and the ethanol has been screened for
any other potentially harmful impurities not specified in the USP or FCC requirements."
Edit2: Here's the USP guidance on hand sanitizer, which lists Not More Than 10uL/L Acetaldehyde / Ethanol:
https://www.usp.org/sites/default/files/usp/document/health-... Again, it's an ordinary metabolite of ethanol in the body, so this is probably pretty conservative.
Wikipedia notes, "After intravenous injection, the half-life in the blood is approximately 90 seconds." https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits and "According to European Commission's Scientific Committee on Consumer Safety's (SCCS) "Opinion on Acetaldehyde" (2012) the cosmetic products special risk limit is 5 mg/l."
loeg|5 years ago
Edit: Here's the current guidance (may not be the same as from the time of that article): https://www.fda.gov/regulatory-information/search-fda-guidan...
I don't see any explicit guidance on Acetaldehyde. The requirements show 95% ethanol for ethanol-based sanitizer, with a footnote saying actually, "Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly, and the finished hand sanitizer meets the ethanol concentration of 80%."
It goes on to add, "Ethanol produced in facilities normally producing fuel or technical grade may be considered for use if the ethanol is produced from fermentation and distillation as would be typically used for consumable goods, and no other additives or other chemicals have been added to the ethanol. ... Because of the potential for the presence of potentially harmful impurities due to the processing approach, fuel or technical grade ethanol should only be used if it meets USP or FCC grade requirements and the ethanol has been screened for any other potentially harmful impurities not specified in the USP or FCC requirements."
Edit2: Here's the USP guidance on hand sanitizer, which lists Not More Than 10uL/L Acetaldehyde / Ethanol: https://www.usp.org/sites/default/files/usp/document/health-... Again, it's an ordinary metabolite of ethanol in the body, so this is probably pretty conservative.
Wikipedia notes, "After intravenous injection, the half-life in the blood is approximately 90 seconds." https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits and "According to European Commission's Scientific Committee on Consumer Safety's (SCCS) "Opinion on Acetaldehyde" (2012) the cosmetic products special risk limit is 5 mg/l."