-
Why Bitrex alone is not allowed as Denaturant for Alcohol
Bitrex is allowed to be used as Denaturant for Alcohol for use in Cosmetics Product along with t-butyl alcohol.We want to know that Bitrex alone is to be used as an Denaturant for Alcohol to be used in Cosmetics Products?Anybody know kindly share supporting documentsWe have been trying to impress indian Govt. authorities that it is the most appropriate denaturant that can used and is so bitter that no one can swallow alcohol containing Bitrex as Denaturant.According to FDA and BIS, they want evidence of USA or EU allowing it being used as Denaturant for Alcohol alone Bitrex.If anybody has USFDA or EU has allowed Bitrex as Denaturant for Alcohol to be used for Cosmetics Product alone kindly share with us. -
5 Replies
-
Anybody have any idea kindly share with me
-
There are three ways that denatured alcohol formulas are accepted by the US government. Only two of them make the formulations public, though.
The first way is the accepted formulas that have been published in the CFR. http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=27:1.0.1.1.17 Using these formulas guarantees automatic acceptance. More info is here: http://www.pharmcoaaper.com/pages/Service/TTB_PDF/misc_info.pdfThe second way is through formulas issued by the TTB division of the ATF, through industry circulars and rulings: http://www.ttb.gov/industrial/sda.shtmlThe third way is for a company to petition the TTB directly. The formulas from these petitions are not made public, so they don’t really help you, but I included this category for completeness. -
in Europe the formula has been standardised since last year, as per directive 162/2013 - denatured alcohol now contains 3% v/v isopropyl alcohol, 3% v/v methyl ethyl ketone and 1 ppm Bitrex as denaturants
the biggest practical problem with only using Bitrex as a denaturant is that it’s easy to remove by distillation; adding isopropyl alcohol and methyl ethyl ketone makes distillation much more difficult, if not impossible
-
In Saudi I didn’t find it too difficult to remove methanol and isopropyl with distillation - obviously the ketone would be the one that stops that.
-
thanks to all of you dear.
Log in to reply.