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CFR Regulation

FORMULAS FOR DENATURED ALCOHOL AND RUM

Citation
27 CFR Part 21
Current through
Sections
102
§ 21.1Scope of regulations.

The regulations in this part relate to the formulation of completely denatured alcohol, specially denatured alcohol, and specially denatured rum; to the specifications for denaturants; and to the uses of denatured spirits.

§ 21.2Forms prescribed.

(a) General. The appropriate TTB officer is authorized to prescribe all forms required by this part. All of the information called for in each form shall be furnished as indicated by the headings on the form and the instructions on or pertaining to the form. In addition, information called for in each form shall be furnished as required by this part. The form will be filed in accordance with the instructions for the form.

(b) Forms prescribed by this part are available for printing through the TTB Web site ( https://www.ttb.gov ) or by mailing a request to the Alcohol and Tobacco Tax and Trade Bureau, National Revenue Center, 550 Main Street, Room 8970, Cincinnati, OH 45202.

§ 21.3Stocks of discontinued formulas.

Denaturers, or specially denatured spirits dealers or users, having on hand stocks of denaturants or formulas of specially denatured spirits no longer authorized by this part may—

(a) Continue to supply or use those stocks in accordance with existing permits until the stocks are exhausted;

(b) Use up those stocks in any manufacturing process approved by the appropriate TTB officer, pursuant to an application filed with such officer on TTB Form 5150.19, Formula for Articles made with Specially Denatured Alcohol and Rum;

(c) On approval of an application, filed with the appropriate TTB officer and approved by such officer, destroy those stocks under whatever supervision the appropriate TTB officer requires; or

(d) Otherwise dispose of those stocks in a manner satisfactory to the appropriate TTB officer, pursuant to approval of an application.

§ 21.4Related regulations.

The procedural and substantive requirements relative to the production of denatured alcohol and specially denatured rum are prescribed in part 19 of this chapter, and those relative to the distribution and use of denatured alcohol and specially denatured rum are prescribed in part 20 of this chapter.

§ 21.5Denatured spirits for export.

Spirits may be denatured in accordance with formulas prescribed by the government of a foreign country to which the denatured spirits will be exported. However, the denaturer must first apply for and obtain written permission from the appropriate TTB officer. The application shall be submitted to the appropriate TTB officer and shall contain the following information:

(a) A complete list of ingredients for the spirits to be denatured.

(b) The exact amount of each ingredient to be used in denaturing the spirits.

(c) A copy (accompanied by an English translation as necessary) of the law or regulations of the foreign country to which the denatured spirits will be exported, specifying the denatured spirits formulation prescribed by that country.

§ 21.6Incorporations by reference.

(a) “The United States Pharmacopoeia (Twentieth Revision, Official from July, 1980) and the National Formulary (Fifteenth Edition, Official from July 1, 1980)” published together as “The USP and NF Compendia,” are incorporated by reference in this part. This incorporation by reference was approved by the Director of the Federal Register. The publication is available from the United States Pharmacopoeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852, or may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

(b) Material from Parts 23, 25, and 29 of the 1980 Annual Book of ASTM Standards is incorporated by reference in this part. This incorporation by reference was approved by the Director of the Federal Register. These publications are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pennsylvania 19103, or may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) Material from the “Official Methods of Analysis of the Association of Official Analytical Chemists (13th Edition 1980)” (AOAC) is incorporated by reference in this part. This incorporation by reference was approved by the Director of the Federal Register. This publication is available from the Association of Official Analytical Chemists, 11 North 19th Street, Suite 210, Arlington, Virginia 22209, or may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

§ 21.7Delegations of the Administrator.

The regulatory authorities of the Administrator contained in this part are delegated to appropriate TTB officers. These TTB officers are specified in the current version of TTB Order 1135.21, Delegation of the Administrator's Authorities in 27 CFR Part 21, Formulas for Denatured Alcohol and Rum. You may obtain a copy of this order by accessing the TTB Web site ( https://www.ttb.gov ) or by mailing a request to the Alcohol and Tobacco Tax and Trade Bureau, National Revenue Center, 550 Main Street, Room 8970, Cincinnati, OH 45202.

§ 21.11Meaning of terms.

When used in this part and in forms prescribed under this part, unless the context otherwise requires, terms have the meanings given in this section. Words in the plural form include the singular, and vice versa, and words indicating the masculine gender include the feminine. The terms “includes” and “including” do not exclude things not mentioned which are in the same general class.

Administrator. The Administrator, Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury, Washington, DC.

Alcohol. The spirits known as ethyl alcohol, ethanol, or spirits of wine, from whatever source or by whatever process produced. The term does not include such spirits as whisky, brandy, rum, gin, or vodka.

Appropriate TTB officer. An officer or employee of the Alcohol and Tobacco Tax and Trade Bureau (TTB) authorized to perform any functions relating to the administration or enforcement of this part by the current version of TTB Order 1135.21, Delegation of the Administrator's Authorities in 27 CFR Part 21, Formulas For Denatured Alcohol and Rum.

CFR. The Code of Federal Regulations.

C.D.A. Completely denatured alcohol.

Completely denatured alcohol. The spirits known as alcohol, as defined in this section, denatured pursuant to completely denatured alcohol formulas prescribed in subpart C of this part.

Denaturant. A material authorized by this part to be added to spirits in order to make those spirits unfit for beverage or internal human medicinal use.

Denatured spirits. Alcohol or rum to which denaturants have been added as provided in this part.

Essential oil. Any of the volatile odoriferous natural oils found in plants, which impart to such plants odor, and often other characteristic properties; also, imitations of such natural oils, as well as aromatic substances, and synthetic oils, which possess the denaturing characteristics of such natural oils.

Gallon. The liquid measure equivalent to the volume of 231 cubic inches.

Manufacturer or user. A person who holds a permit, issued under part 20 of this chapter, to withdraw and use specially denatured alcohol or specially denatured rum, or to recover completely or specially denatured alcohol, or specially denatured rum, or articles manufactured with denatured spirits, or a distilled spirits plant proprietor qualified under part 19 of this chapter as a processor.

N.F. The National Formulary. The lastest edition is intended unless otherwise specified. The designations “U.S.P.” and “N.F.” are considered interchangeable when preparations are transferred from one publication to the other. (For incorporation by reference, see § 21.6(a).)

Proof. The ethyl alcohol content of a liquid at 60 degrees Fahrenheit, stated as twice the percent of ethyl alcohol by volume.

Rum. Any spirits produced from sugar cane products and distilled at less than 190 proof in such manner that the spirits possess the taste, aroma, and characteristics generally attributed to rum.

S.D.A. Specially denatured alcohol.

Specially denatured alcohol. Those spirits known as alcohol, as defined in this section, denatured pursuant to the specially denatured alcohol formulas authorized under subpart D of this part.

Specially denatured rum. Those spirits known as rum, as defined in this section, denatured pursuant to the specially denatured rum formula authorized under subpart D of this part.

Spirits or distilled spirits. Alcohol or rum as defined in this part.

U.S.C. The United States Code.

U.S.P. The United States Pharmacopoeia. The latest edition is intended unless otherwise specified. The designations “U.S.P.” and “N.F.” are considered interchangeable when preparations are transferred from one publication to the other. (For incorporation by reference, see § 21.6(a).)

§ 21.21General.

(a) Alcohol shall be completely denatured only in accordance with formulas prescribed in this subpart (or in accordance with § 21.5).

(b) Denaturers may be authorized to add a small quantity of an odorant, rust inhibitor, or dye to completely denatured alcohol. Any such addition shall be made only on approval by the appropriate TTB officer. Request for such approval shall be submitted to the appropriate TTB officer.

(c) Odorants or perfume materials may be added to denaturants authorized for completely denatured alcohol in amounts not greater than 1 part to 250, by weight. However, such addition shall not decrease the denaturing value nor change the chemical or physical constants beyond the limits of the specifications for these denaturants as prescribed in subpart E, except as to odor. Proprietors of distilled spirits plants using denaturants to which such odorants or perfume materials have been added shall inform the appropriate TTB officer, in writing, of the names and properties of the odorants or perfume materials so used.

(d) TTB will apply an analytical tolerance of ±5 percent and use standard rounding rules in determining whether completely denatured alcohol complies with the formula prescribed in this subpart (or in accordance with § 21.5).

§ 21.22Formula No. 18.

To every 100 gallons of ethyl alcohol of not less than 160 proof add:

2.50 gallons of either methyl isobutyl ketone, mixed isomers of nitropropane, or methyl n- butyl ketone;

0.125 gallon of pyronate or a similar compound;

0.50 gallon acetaldol (beta-hydroxybutyraldehyde); and

1.00 gallon of either kerosene, deodorized kerosene, gasoline, unleaded gasoline, rubber hydrocarbon solvent, or heptane.

§ 21.23Formula No. 19.

To every 100 gallons of ethyl alcohol of not less than 160 proof add:

4.0 gallons of either methyl isobutyl ketone, mixed isomers of nitropropane, or methyl n- butyl ketone; and

1.0 gallon of either kerosene, deodorized kerosene, gasoline, unleaded gasoline, rubber hydrocarbon solvent, or heptane.

§ 21.24Formula No. 20.

(a) Formula. To every 100 gallons of ethyl alcohol of not less than 195 proof add:

A total of 2.0 gallons of either unleaded gasoline, rubber hydrocarbon solvent, kerosene, deodorized kerosene, alkylate, ethyl tertiary butyl ether, high octane denaturant blend, methyl tertiary butyl ether, naphtha, natural gasoline, raffinate, or any combination of these; or

A total of 5.0 gallons of toluene.

(b) Authorized use. Restricted to fuel use, comparable to specially denatured alcohol “Use Code No.” 611, 612, 613, 620, and 630.

§ 21.25Formula No. 35.

Formula. To every 100 gallons of alcohol of not less than 185 proof add:

29.75 gallons of ethyl acetate having an ester content of 100 percent by weight or the equivalent thereof not to exceed 35 gallons of ethyl acetate with an ester content of not less than 85 percent by weight.

§ 21.26Formula No. 12-A.

Formula. To every 100 gallons of alcohol of not less than 185 proof add:

Five gallons of toluene or 5 gallons of heptane.

§ 21.31General.

(a) Formulas for specially denatured spirits. Alcohol and rum shall be specially denatured only in accordance with formulas prescribed in this subpart (or in accordance with § 21.5).

(b) Proof of spirits for denaturation. Alcohol of not less than 185 proof shall be used in the manufacture of all formulas of specially denatured alcohol, unless otherwise specifically stated or unless otherwise authorized by the appropriate TTB officer. Rum for denaturation shall be of not less than 150 proof and may be denatured only in accordance with Formula No. 4.

(c) Use of Denatured Spirits. Users and manufacturers holding approved Forms 5150.19 (formerly 1479-A) covering use in processes or manufacture of products no longer authorized for a particular formula may continue that use. Pursuant to written application and subject to the provisions of 26 U.S.C. Chapter 51, part 20 of this chapter, and this part, the appropriate TTB officer, may authorize the use of any formula of specially denatured alcohol or specially denatured rum for uses not specifically authorized in this part. The code number before each item under “authorized uses” shall be used in reporting the use of specially denatured alcohol or specially denatured rum.

(d) Analytical tolerance. TTB will apply an analytical tolerance of ±5% and use standard rounding rules in determining whether specially denatured spirits complies with the formula prescribed in this subpart (or in accordance with § 21.5).

§ 21.32Formula No. 1.

(a) Formula. To every 100 gallons of alcohol add:

Four gallons of methyl alcohol and either

1/8 avoirdupois ounce of denatonium benzoate, N.F.; 1 gallon of methyl isobutyl ketone; 1 gallon of mixed isomers of nitropropane; or 1 gallon of methyl n- butyl ketone.

(b) Authorized uses. (1) As a solvent:

011. Cellulose coatings.

012. Synthetic resin coatings.

013. Shellac coatings.

014. Other natural resin coatings.

016. Other coatings.

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

032. Transparent sheeting.

033. Explosives.

034. Cellulose intermediates and industrial collodions.

035. Soldering flux.

036. Adhesives and binders.

041. Proprietary solvents.

042. Solvents and thinners (other than proprietary solvents or special industrial solvents).

043. Solvents, special (restricted sale).

051. Polishes.

052. Inks (not including meat branding inks).

053. Stains (wood, etc.).

141. Shampoos.

142. Soap and bath preparations.

311. Cellulose compounds (dehydration).

312. Sodium hydrosulfite (dehydration).

315. Other dehydration products.

320. Petroleum products.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

351. Processing dyes and intermediates.

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

354. Processing rosin.

355. Processing rubber (latex).

358. Processing other chemicals.

359. Processing miscellaneous products.

410. Disinfectants, insecticides, fungicides, and other biocides.

420. Embalming fluids and related products.

430. Sterilizing and preserving solutions.

440. Industrial detergents and soaps.

450. Cleaning solutions (including household detergents).

481. Photoengraving and rotogravure dyes and solutions.

482. Other dye solutions.

485. Miscellaneous solutions (including duplicating fluids).

(2) As a raw material:

521. Ethyl acetate.

522. Ethyl chloride.

523. Other ethyl esters.

530. Ethylamines.

540. Dyes and intermediates.

551. Acetaldehyde.

552. Other aldehydes.

561. Ethyl ether.

562. Other ethers.

571. Ethylene dibromide.

572. Ethylene gas.

573. Xanthates.

574. Fulminate of mercury and other detonators.

575. Drugs and medicinal chemicals.

579. Other chemicals.

(3) As a fuel:

611. Automobile and supplementary fuels.

612. Airplane and supplementary fuels.

613. Rocket and jet fuels.

620. Proprietary heating fuels.

630. Other fuel uses.

(4) As a fluid:

710. Scientific instruments.

720. Brake fluids.

730. Cutting oil.

740. Refrigerating uses.

750. Other fluid uses.

760. Proprietary anti-freeze.

(5) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

900. Specialized uses (unclassified).

§ 21.33Formula No. 2-B.

(a) Formula. To every 100 gallons of alcohol add:

One-half gallon of rubber hydrocarbon solvent,

1/2 gallon of toluene,

1/2 gallon of heptane,

1/2 gallon of hexane (mixed isomers), or

1/2 gallon of n -hexane.

(b) Authorized uses. (1) As a solvent:

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

032. Transparent sheeting.

033. Explosives.

311. Cellulose compounds (dehydration).

312. Sodium hydrosulfite (dehydration).

315. Other dehydration products.

320. Petroleum products.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

349. Miscellaneous drug processing (including manufacture of pills).

351. Processing dyes and intermediates.

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

358. Processing other chemicals.

359. Processing miscellaneous products.

(2) As a raw material:

521. Ethyl acetate.

522. Ethyl chloride.

523. Other ethyl esters.

524. Sodium ethylate, anhydrous.

530. Ethylamines.

540. Dyes and intermediates.

551. Acetaldehyde.

552. Other aldehydes.

561. Ethyl ether.

562. Other ethers.

571. Ethylene dibromide.

572. Ethylene gas.

573. Xanthates.

575. Drugs and medicinal chemicals.

576. Organo-silicone products.

579. Other chemicals.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

(c) Conditions governing use. This formula shall be used in a closed and continuous system unless otherwise authorized by the appropriate TTB officer.

§ 21.35Formula No. 3-A.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of cyclohexane or methyl alcohol.

(b) Authorized uses. (1) As a solvent:

011. Cellulose coatings.

012. Synthetic resin coatings.

016. Other coatings.

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

032. Transparent sheeting.

033. Explosives.

034. Cellulose intermediates and industrial collodions.

035. Soldering flux.

036. Adhesives and binders.

041. Proprietary solvents.

043. Solvents, special (restricted sale).

051. Polishes.

052. Inks (including meat branding inks).

053. Stains (wood, etc.).

141. Shampoos.

142. Soap and bath preparations.

311. Cellulose compounds (dehydration).

312. Sodium hydrosulfite (dehydration).

315. Other dehydration products.

320. Petroleum products.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

351. Processing dyes and intermediates.

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

354. Processing rosin.

355. Processing rubber (latex).

358. Processing other chemicals.

359. Processing miscellaneous products.

410. Disinfectants, insecticides, fungicides, and other biocides.

420. Embalming fluids and related products.

430. Sterilizing and preserving solutions.

440. Industrial detergents and soaps.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

481. Photoengraving and rotogravure dyes and solutions.

482. Other dye solutions.

485. Miscellaneous solutions (including duplicating fluids).

(2) As a raw material:

530. Ethylamines.

540. Dyes and intermediates.

575. Drugs and medicinal chemicals.

576. Organo-silicone products.

579. Other chemicals.

590. Synthetic resins.

(3) As a fuel:

611. Automobile and supplementary fuels.

612. Airplane and supplementary fuels.

613. Rocket and jet fuels.

620. Proprietary heating fuels.

630. Other fuel uses.

(4) As a fluid:

710. Scientific instruments.

720. Brake fluids.

730. Cutting oils.

740. Refrigerating uses.

750. Other fluid uses.

(5) Miscellaneous uses:

810. General laboratory and experimental use (own use only).

811. Laboratory reagents for sale.

812. Product development and pilot plant uses (own use only).

900. Specialized uses (unclassified).

§ 21.37Formula No. 3-C.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of isopropyl alcohol.

(b) Authorized uses. (1) As a solvent:

011. Cellulose coatings.

012. Synthetic resin coatings.

016. Other coatings.

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

032. Transparent sheeting.

033. Explosives.

034. Cellulose intermediates and industrial collodions.

035. Soldering flux.

036. Adhesives and binders.

043. Solvents, special (restricted sale).

051. Polishes.

052. Inks (including meat branding inks).

053. Stains (wood, etc.).

141. Shampoos.

142. Soaps and bath preparations.

311. Cellulose compounds (dehydration).

312. Sodium hydrosulfite (dehydration).

315. Other dehydration products.

320. Petroleum products.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

351. Processing dyes and intermediates.

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

354. Processing rosin.

355. Processing rubber (latex).

358. Processing other chemicals.

359. Processing miscellaneous products.

410. Disinfectants, insecticides, fungicides, and other biocides.

420. Embalming fluids and related products.

430. Sterilizing and preserving solutions.

440. Industrial detergents and soaps.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

481. Photoengraving and rotogravure dyes and solutions.

482. Other dye solutions.

485. Miscellaneous solutions (including duplicating fluids).

(2) As a raw material:

530. Ethylamines.

540. Dyes and intermediates.

575. Drugs and medicinal chemicals.

576. Organo-silicone products.

579. Other chemicals.

590. Synthetic resins.

(3) As a fuel:

611. Automobile and supplementary fuels.

612. Airplane and supplementary fuels.

613. Rocket and jet fuels.

620. Proprietary heating fuels.

630. Other fuel uses.

(4) As a fluid:

710. Scientific instruments.

720. Brake fluids.

730. Cutting oils.

740. Refrigerating uses.

750. Other fluid uses.

(5) Miscellaneous uses:

810. General laboratory and experimental use (own use only).

811. Laboratory reagents for sale.

812. Product development and pilot plant uses (own use only).

900. Specialized uses (unclassified).

(c) Conditions governing use. This formula shall not be used in manufacturing Reagent alcohol general-use formula under § 20.117 of this chapter.

§ 21.38Formula No. 4.

(a) Formula. To every 100 gallons of alcohol, or to every 100 gallons of rum of not less than 150 proof, add:

One gallon of the following solution: Five gallons of an aqueous solution containing 40 percent nicotine; 3.6 avoirdupois ounces of methylene blue, U.S.P.; and water sufficient to make 100 gallons.

(b) Authorized uses. (1) As a solvent:

460. Tobacco sprays and flavors.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.41Formula No. 13-A.

(a) Formula. To every 100 gallons of alcohol add:

Ten gallons of ethyl ether.

(b) Authorized uses. (1) As a solvent:

015. Candy glazes.

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

032. Transparent sheeting.

034. Cellulose intermediates and industrial collodions.

052. Inks (not including meat branding inks).

241. Collodion, U.S.P.

331. Processing pectin.

332. Processing other food products.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

358. Processing other chemicals.

359. Processing miscellaneous products.

430. Sterilizing and preserving solutions.

481. Photoengraving and rotogravure solutions and dyes.

485. Miscellaneous solutions.

(2) As a raw material:

523. Miscellaneous ethyl esters.

561. Ethyl ether.

562. Other ethers.

575. Drugs and medicinal chemicals.

579. Other chemicals.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.43Formula No. 18.

(a) Formula. To every 100 gallons of alcohol of not less than 160 proof add:

One hundred gallons of vinegar of not less than 90-grain strength or 150 gallons of vinegar of not less than 60-grain strength.

(b) Authorized uses. (1) As a raw material:

511. Vinegar.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.44Formula No. 19.

(a) Formula. To every 100 gallons of alcohol add:

One hundred gallons of ethyl ether.

(b) Authorized uses. (1) As a solvent:

031. Photographic film and emulsions.

034. Cellulose intermediates and industrial collodions.

241. Collodion, U.S.P.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.47Formula No. 23-A.

(a) Formula. To every 100 gallons of alcohol add:

Eight gallons of acetone, U.S.P.

(b) Authorized uses. (1) As a solvent:

011. Cellulose coatings.

012. Synthetic resin coatings.

013. Shellac coatings.

014. Other natural resin coatings.

015. Candy glazes.

016. Other coatings.

032. Transparent sheeting.

034. Cellulose intermediates and industrial collodions.

035. Soldering flux.

036. Adhesives and binders.

042. Solvents and thinners (other than proprietary solvents or special industrial solvents).

052. Inks (including meat branding inks).

053. Stains (wood, etc.).

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Body deodorants and deodorant creams.

141. Shampoos.

142. Soaps and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

244. Antiseptic solutions, U.S.P. or N.F.

249. Miscellaneous external pharmaceuticals, U.S.P. or N.F.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

358. Processing other chemicals.

359. Processing miscellaneous products.

410. Disinfectants, insecticides, fungicides, and other biocides.

420. Embalming fluids and related products.

430. Sterilizing and preserving solutions.

440. Industrial detergents and soaps.

450. Cleaning solutions (including household detergents).

482. Miscellaneous dye solutions.

485. Miscellaneous solutions.

(2) As a fluid:

740. Refrigerating uses.

750. Miscellaneous fluid uses.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.49Formula No. 23-H.

(a) Formula. To every 100 gallons of alcohol add:

Eight gallons of acetone, U.S.P., and 1.5 gallons of methyl isobutyl ketone.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

113. Lotions and creams (hand, face, and body).

210. External pharmaceuticals, not U.S.P. or N.F.

220. Rubbing alcohols.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.50Formula No. 25.

(a) Formula. To every 100 gallons of alcohol add:

Twenty pounds of iodine, U.S.P., and 15 pounds of either potassium iodide, U.S.P., or sodium iodide, U.S.P.

(b) Authorized uses. (1) As a solvent:

230. Tinctures of iodine.

249. Miscellaneous external pharmaceuticals, U.S.P. or N.F.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.51Formula No. 25-A.

(a) Formula. To every 100 gallons of alcohol add:

A solution composed of 20 pounds of iodine, U.S.P.; 15 pounds of either potassium iodide, U.S.P., or sodium iodide, U.S.P.; and 15 pounds of water.

(b) Authorized uses. (1) As a solvent:

230. Tinctures of iodine.

249. Miscellaneous external pharmaceuticals, U.S.P. or N.F.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.55Formula No. 28-A.

(a) Formula. To every 100 gallons of alcohol add:

One gallon or any combination totaling 1 gallon of either gasoline, unleaded gasoline, heptane, or rubber hydrocarbon solvent.

(b) Authorized uses. (1) As a fuel:

611. Automobile and supplementary fuels.

612. Airplane and supplementary fuels.

613. Rocket and jet fuels.

620. Proprietary heating fuels.

630. Other fuel uses.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.56Formula No. 29.

(a) Formula. To every 100 gallons of alcohol add:

One gallon of 100 percent acetaldehyde or 5 gallons of an alcohol solution of acetaldehyde containing not less than 20 percent acetaldehyde, or 1 gallon of ethyl acetate having an ester content of 100 percent, or, where approved by the appropriate TTB officer, as to material and quantity, not less than 6.8 pounds if solid, or 1 gallon if liquid, of any chemical. When material other than acetaldehyde or ethyl acetate is proposed to be used, the user shall submit an application for such use to the appropriate TTB officer. The application shall include specifications, assay methods, and an 8-ounce sample of the substitute material for analysis.

(b) Authorized uses. (1) As a raw material:

511. Vinegar.

512. Acetic acid.

521. Ethyl acetate.

522. Ethyl chloride.

523. Other ethyl esters.

530. Ethylamines.

540. Dyes and intermediates.

551. Acetaldehyde.

552. Other aldehydes.

561. Ethyl ether.

562. Other ethers.

571. Ethylene dibromide.

572. Ethylene gas.

573. Xanthates.

575. Drugs and medicinal chemicals.

579. Other chemicals.

580. Synthetic rubber.

590. Synthetic resins.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

(c) Conditions governing use. This formula is restricted to processes in which the alcohol loses its identity by being converted into other chemicals.

§ 21.57Formula No. 30.

(a) Formula. To every 100 gallons of alcohol add:

Ten gallons of methyl alcohol.

(b) Authorized uses. (1) As a solvent:

011. Cellulose coatings.

012. Synthetic resin coatings.

021. Cellulose plastics.

022. Non-cellulose plastics, including resins.

031. Photographic film and emulsions.

035. Soldering flux.

036. Adhesives and binders.

042. Solvents and thinners (other than proprietary solvents or special industrial solvents).

051. Polishes.

052. Inks (not including meat branding inks).

053. Stains.

142. Soap and bath preparations.

331. Processing pectin.

332. Processing other food products.

341. Processing crude drugs.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

345. Processing blood and blood products.

349. Miscellaneous drug processing (including manufacture of pills).

352. Processing perfume materials and fixatives.

353. Processing photographic chemicals.

358. Processing other chemicals.

359. Processing miscellaneous products.

410. Disinfectants, insecticides, fungicides, and other biocides.

430. Sterilizing and preserving solutions.

440. Industrial detergents and soaps.

450. Cleaning solutions (including household detergents).

481. Photoengraving and rotogravure solutions and dyes.

482. Other dye solutions.

485. Miscellaneous solutions (including duplicating fluids).

(2) As a raw material:

575. Drugs and medicinal chemicals.

576. Organo-silicone products.

579. Other chemicals.

590. Synthetic resins.

(3) As a fluid in:

740. Refrigerating uses.

750. Other fluid uses:

(4) Miscellaneous uses:

810. General laboratory and experimental use (own use only).

811. Laboratory reagents for sale.

812. Product development and pilot plant uses (own use only).

§ 21.58Formula No. 31-A.

(a) Formula. To every 100 gallons of alcohol add:

One hundred pounds of glycerin (glycerol), U.S.P., and 20 pounds of hard soap, N.F. XI.

(b) Authorized uses. (1) As a solvent:

113. Lotions and creams (hands, face, and body).

131. Tooth paste and tooth powder.

141. Shampoos.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.59Formula No. 32.

(a) Formula. To every 100 gallons of alcohol add:

Five gallons of ethyl ether.

(b) Authorized uses. (1) As a solvent:

031. Photographic film and emulsions.

034. Cellulose intermediates and industrial collodions.

052. Inks (not including meat branding inks).

241. Collodion, U.S.P.

311. Ethyl cellulose compounds (dehydration).

332. Processing miscellaneous food products.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

430. Sterilizing and preserving solutions.

481. Photoengraving and rotogravure solutions and dyes.

485. Miscellaneous solutions.

(2) As a raw material:

522. Ethyl chloride.

523. Other ethyl esters.

561. Ethyl ether.

562. Other ethers.

571. Ethylene dibromide.

572. Ethylene gas.

575. Drugs and medicinal chemicals.

579. Other chemicals.

580. Synthetic rubber.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.62Formula No. 35-A.

(a) Formula. To every 100 gallons of alcohol add:

4.25 gallons of ethyl acetate having an ester content of 100 percent by weight or the equivalent thereof not to exceed 5 gallons of ethyl acetate with an ester content of not less than 85 percent by weight.

(b) Authorized uses. (1) As a solvent:

015. Candy glazes.

052. Inks.

331. Processing pectin.

332. Processing other food products.

342. Processing glandular products, vitamins, hormones, and yeasts.

343. Processing antibiotics and vaccines.

344. Processing medicinal chemicals (including alkaloids).

349. Miscellaneous drug processing (including manufacture of pills).

358. Processing miscellaneous chemicals.

359. Processing miscellaneous products.

485. Miscellaneous solutions.

(2) As a raw material:

511. Vinegar.

512. Acetic acid.

521. Ethyl acetate.

523. Other ethyl esters.

590. Synthetic resins.

910. Animal feed supplements.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.63Formula No. 36.

(a) Formula. To every 100 gallons of alcohol add:

Three gallons of ammonia, aqueous, 27 to 30 percent by weight; 3 gallons of strong ammonia solution, N.F.: 17.5 pounds of caustic soda, liquid grade, containing 50 percent sodium hydroxide by weight; 8.75 pounds of potassium hydroxide, on an anhydrous basis or 12.0 pounds of caustic soda, liquid grade, containing 73 percent sodium hydroxide by weight.

(b) Authorized uses. (1) As a solvent:

141. Shampoos.

142. Soap and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

450. Cleaning solutions (including household detergents).

(2) As a raw material:

530. Ethylamines.

540. Dyes and intermediates.

579. Other chemicals.

(3) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.64Formula No. 37.

(a) Formula. To every 100 gallons of alcohol add:

Forty-five fluid ounces of eucalyptol, N.F. XII, 30 avoirdupois ounces of thymol, N.F., and 20 avoirdupois ounces of menthol, U.S.P.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

131. Dentifrices.

132. Mouth washes.

210. External pharmaceuticals, not U.S.P. or N.F.

244. Antispetic solutions, U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

430. Sterilizing and preserving solutions.

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.65Formula No. 38-B.

(a) Formula. To every 100 gallons of alcohol add:

Ten pounds of any one, or a total of 10 pounds of two or more, of the oils and substances listed below:

Alpha terpineol

Anethole, N.F.

Anise oil, N.F.

Bay oil (myrcia oil), N.F. XI.

Benzaldehyde, N.F.

Bergamot oil, N.F. XI.

Bitter almond oil, N.F. X.

Camphor, U.S.P.

Cedar leaf oil, U.S.P. XIII.

Chlorothymol, N.F. XII.

Cinnamic aldehyde, N.F. IX.

Cinnamon oil, N.F.

Citronella oil, natural.

Clove oil, N.F.

Coal tar, U.S.P.

Cornmint oil.

Distilled lime oil.

Eucalyptol, N.F. XII.

Eucalyptus oil, N.F.

Eugenol, U.S.P.

Guaiacol, N.F. X.

L(-)-Carvone.

Lavender oil, N.F.

Lemon oil.

Menthol, U.S.P.

Methyl salicylate, N.F.

Mustard oil, volatile (allyl isothiocyanate), U.S.P. XII.

Peppermint oil, N.F.

Peppermint oil, terpeneless.

Phenol, U.S.P.

Phenyl salicylate (salol), N.F. XI.

Pine oil, N.F. XII.

Pine needle oil, dwarf, N.F.

Rosemary oil, N.F. XII.

Safrole.

Sassafras oil, N.F. XI.

Spearmint oil, N.F.

Spearmint oil, terpeneless.

Spike lavender oil, natural.

Storax, U.S.P.

Thyme oil, N.F. XII.

Thymol, N.F.

Tolu balsam, U.S.P.

Turpentine oil, N.F. XI.

If it is shown that none of the above single denaturants or combinations can be used in the manufacture of a particular product, the user may submit an application to the appropriate TTB officer, requesting permission to use another essential oil or substance having denaturing properties satisfactory to the appropriate TTB officer. In such a case the user shall furnish the appropriate TTB officer, with specifications, assay methods, the name and address of the manufacturer, and an 8-ounce sample of the denaturant for analysis.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

131. Dentifrices.

132. Mouth washes.

141. Shampoos.

142. Soap and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

243. Liniments, U.S.P. or N.F.

244. Antiseptic solutions, U.S.P. or N.F.

249. Miscellaneous external pharmaceuticals, U.S.P. or N.F.

349. Miscellaneous drug processing (including manufacture of pills).

410. Disinfectants, insecticides, fungicides, and other biocides.

430. Sterilizing and preserving solutions.

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.67Formula No. 38-D.

(a) Formula. To every 100 gallons of alcohol add:

Two and one-half pounds of menthol, U.S.P., and 2.5 gallons of formaldehyde solution, U.S.P.

(b) Authorized uses. (1) As a solvent:

131. Dentifrices.

132. Mouth washes.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.68Formula No. 38-F.

(a) Formula. To every 100 gallons of alcohol add:

(1) Six pounds of either boric acid, N.F., Polysorbate 80, N.F., or Poloxamer 407, N.F.; 1

1 / 3 pounds of thymol, N.F.; 1

1 / 3 pounds of chlorothymol, N.F. XII; and 1

1 / 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 Formula No. 38-B, plus sufficient boric acid, N.F., Polysorbate 80, N.F., or Poloxamer 407, N.F. 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 Formula No. 38-B.

(b) Authorized uses. (1) As a solvent:

132. Mouth washes.

210. External pharmaceuticals, not U.S.P. or N.F.

244. Antiseptic solutions, U.S.P. or N.F.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.71Formula No. 39-B.

(a) Formula. To every 100 gallons of alcohol add:

Two and one-half gallons of diethyl phthalate and

1/8 gallon of tert- butyl alcohol.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

141. Shampoos.

142. Soap and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.72Formula No. 39-C.

(a) Formula. To every 100 gallons of alcohol add:

One gallon of diethyl phthalate.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

142. Soaps and bath preparations.

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.73Formula No. 39-D.

(a) Formula. To every 100 gallons of alcohol add:

One gallon of bay oil (myrcia oil), N.F. XI, and either 50 avoirdupois ounces of quinine sulfate, U.S.P., 50 avoirdupois ounces of sodium salicylate, U.S.P.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.74Formula No. 40.

(a) Formula. To every 100 gallons of alcohol add

1/8 gallon of tert -butyl alcohol, and:

One and one-half avoirdupois ounces of either (1) brucine alkaloid, (2) brucine sulfate, N.F. IX, (3) quassin, or (4) any combination of two or of three of those denaturants.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

141. Shampoos.

142. Soaps and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.75Formula No. 40-A.

(a) Formula. To every 100 gallons of alcohol add:

One pound of sucrose octaacetate and

1/8 gallon of tert -butyl alcohol.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

141. Shampoos.

142. Soaps and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.76Formula No. 40-B.

(a) Formula. To every 100 gallons of alcohol add:

One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and

1/8 gallon of tert -butyl alcohol.

(b) Authorized uses. (1) As a solvent:

052. Inks.

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

141. Shampoos.

142. Soaps and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

485. Miscellaneous solutions.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.77Formula No. 40-C.

(a) Formula. To every 100 gallons of alcohol add:

Three gallons of tert -butyl alcohol.

(b) Authorized uses. (1) As a solvent:

111. Hair and scalp preparations.

112. Bay rum.

113. Lotions and creams (hand, face, and body).

114. Deodorants (body).

121. Perfumes and perfume tinctures.

122. Toilet waters and colognes.

141. Shampoos.

142. Soaps and bath preparations.

210. External pharmaceuticals, not U.S.P. or N.F.

410. Disinfectants, insecticides, fungicides, and other biocides.

450. Cleaning solutions (including household detergents).

470. Theater sprays, incense, and room deodorants.

485. Miscellaneous solutions.

(2) Miscellaneous uses.

812. Product development and pilot plant uses (own use only).

(c) Conditions governing use. This formula shall be used only in the manufacture of products which will be packaged in pressurized containers in which the liquid contents are in intimate contact with the propellant and from which the contents are not easily removable in liquid form.

§ 21.79Formula No. 44.

(a) Formula. To every 100 gallons of alcohol add:

Ten gallons of n -butyl alcohol

(b) Authorized uses. (1) As a solvent:

430. Sterilizing and preserving solutions.

(2) Miscellaneous uses:

812. Product development and pilot plant uses (own use only).

§ 21.80Formula No. 45.

(a) Formula. To every 100 gallons of alcohol add:

Three hundred pounds of refined white or orange shellac.

(b) Authorized uses. (1) As a solvent:

015. Candy glazes.

(2) Miscellaneous uses:

812 Product development and pilot plant uses (own use only).

§ 21.91General.

Denaturants prescribed in this part shall comply with the specifications set forth in this subpart. However, in order to meet requirements of national defense or for other valid reasons, the appropriate TTB officer may, pursuant to written application filed by the denaturer, authorize variations from such specifications or authorize the use of substitute denaturants if such variation or substitution will not jeopardize the revenue. Each such application shall identify the applicant by name, address, and permit number; state the number of each formula of specially denatured alcohol involved; explain why the use of the substitute denaturant, or the variation from specifications, as the case may be, is necessary; and include, as applicable, either the identity of the approved denaturant for which substitution is desired and the identity of the substitute denaturant (including the name of the manufacturer) or the identity of the prescribed specifications and the proposed variation from those specifications. The application shall be accompanied by an 8-ounce sample of the proposed denaturing material for analysis. The authorization of a substitute denaturant may be published in a TTB Ruling.

§ 21.92Denaturants listed as U.S.P. or N.F.

Denaturing materials and products listed in this part as “U.S.P.” or “N.F.” shall meet the specifications set forth in the current United States Pharmacopoeia or National Formulary, or the latest volume of these publications in which the denaturants appeared as official preparations.

§ 21.93Acetaldehyde.

(a) Aldehyde content (as acetaldehyde). Not less than 95.0 percent by weight.

(b) Color. Colorless.

(c) Odor. Characteristic pungent, fruity odor.

(d) Specific gravity at 15.56 °/15.56 °C. Not less than 0.7800.

102 sections

Cite this law

FORMULAS FOR DENATURED ALCOHOL AND RUM (U.S.C.). Retrieved via LawPlayer, https://lawplayer.com/us/act/cfr-title-27-part-21

United States government works (U.S. Code, Code of Federal Regulations) are in the public domain under 17 U.S.C. § 105.

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