ATF Ruling 86-3

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
1 . Identification Test (USP XX 1249 XV) Responds to test A and B under polysorbate 60
2. Saponification Value (USP XX 920 SV) 45-55
3. Acid Value (USP XX PG 919) 0-3
4. Hydroxyl Number (USP XX 920 EV) 50-65

Physical Properties
1. Appearance (Visual) Amber Color; Free of Foreign Material
2. Specific Gravity (USP XX PG 978) 1.02-1.12
3. Viscosity (cps. @ 80-F) 500-800

Distilled spirits plant proprietors may produce SDA 38-F using the following formulations:
To every 100 gallons of alcohol add:

(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
for approval.

27 CFR 21.68 and 21.91