FDA Updates Guidance on Ethanol for Use in Hand Sanitizers

In light of the ongoing COVID-19 pandemic, on August 7th, 2020 the FDA once again updated its guidance for its “nonbinding recommendations” for the manufacture of hand sanitizers. The guidance document is titled “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” and can be viewed in .pdf format by clicking on the title above. This specific guidance did not change the overall recommended composition of contaminants in ethanol, but added some additional limits for products that fail to meet the 300 ppm limit on “all other impurities”. According to the new guidance, if ethanol meets the other criteria of Table 1 within the document (and shown below for convenience) then users and manufacturers can consider additional limits on other impurities that are now shown in Table 2 (also added below for convenience).

Table 1

ImpurityInterim Limit under this policy
MethanolNMT 630 ppm
BenzeneNMT 2 ppm
AcetaldehydeNMT 50 ppm*
Acetal (1,1-diethoxyethane)NMT 50 ppm
Sum of all other impuritiesNMT 300 ppm

Table 2

ImpurityInterim Limit under this policy
AcetoneNMT 4400 ppm
n-propanol (1-propanol)NMT 1000 ppm
Ethyl acetateNMT 2200 ppm
Sec-butanol (2-butanol)NMT 6200 ppm
Iso-butanol (2-methyl-1-propanol)NMT 21700 ppm
n-butanol (1-butanol)NMT 1000 ppm
iso-amyl alcohol (3-methyl-1-butanol)NMT 4100 ppm
Amyl alcoholNMT 4100 ppm

Altiras offers hand sanitizers and also offers hand sanitizer recycling for products that no longer meet FDA requirements. Please email us for more information.