The Bureau of Alcohol, Tobacco and Firearms (ATF) has been asked whether Poloxamer 407, N.F. and PEG-40 Sorbitan Diisostearate, may be used as substitute denaturants in lieu of Polysorbate 80, N.F. in Specially Denatured Alcohol Formula No. 38-F (SDA 38-F). Under the authority of 27 CFR 21.91, the Director, ATF, may authorize the use of substitute denaturants where the substitution will not jeopardize the revenue. ATF has examined samples of Poloxamer 407, N.F. and PEG-40 Sorbitan Dilsostearate, and determined that both materials are comparable to Polysorbate 80, N.F. when used as a denaturant. Held, Poloxamer 407, N.F. and PEG-40 Sorbitan Diisostearate, provided PEG-40 Sorbitan Diisostearate, meets specifications described below, are suitable substitute denaturants for Polysorbate 80, N.F. in SDA 38-F on an equal quantity ( 1: 1 ) basis. The chemical and physical specifications for PEG-40 Sorbitan Diisostearate are as follows: Chemical Properties
Physical Properties
Distilled spirits
plant proprietors may produce SDA 38-F using the following formulations:
(1) Six pounds of either boric acid, N.F. or Polysorbate 80, N.F. or Poloxamer 407, N.F. or PEG40 Sorbitan Diisostearate; 11/3 pounds of thymol, N.F.; 11/3 pounds of chlorothymol, N.F. XII; and 11/3 pounds of menthol, U.S.P.; or (2) A total of at least 3 pounds of any two or more denaturing materials listed under SDA Formula No. 38-B (SDA 38-B), plus sufficient boric acid, N.F. or Polysorbate 80, N.F. or Poloxamer 407, N.F. or PEG40 Sorbitan Diisostearate, to total 10 pounds of denaturant; or (3) Seven pounds of zinc chloride, U.S.P., 2.6 fluid ounces of hydrochloric acid, N.F., and a total of 3 pounds of any two or more of the denaturing materials listed under SDA 38-B. All formulas on ATF
Form 5150,19, Formula and/or Process for Articles Made with Specially
Denatured Spirits, calling for the use of SDA 38-F are required to be
approved by the Director, ATF. All references to SDA 38-F on approved
formulas are required to be specific with respect to the type of SDA 38-F
being used. Manufacturers currently using SDA 38-F who will now use Poloxamer
407, N.F. or PEG40 Sorbitan Diisostearate, in SDA 38-F are required to
revise their formulas to reflect that fact and submit them to ATF 27 CFR 21.68 and
21.91 |