27 C.F.R. Subpart F—Formulas and Statements of Process
Title 27 - Alcohol, Tobacco Products and Firearms
(a) Each article made with specially denatured spirits shall be made in accordance with (1) an approved formula, Form 5150.19, or (2) an approved general-use formula prescribed in this subpart, approved by the appropriate TTB officer as an alternate method, or published as a TTB ruling in the TTB Bulletin. The manufacturer shall file Form 5150.19, along with the sample(s) required by §20.92, and obtain an approved formula before manufacturing the article. (b) An article made in accordance with a formula on Form 1479–A approved under previous regulations in part 211 of this chapter will be considered to comply with the requirements of this subpart. (c) Any person who has approved formulas or statements of process, Form 1479–A or Form 5150.19, which have been discontinued or have become obsolete, may submit these formulas or statements of process to the appropriate TTB officer for cancellation. (a) For each formula submitted in accordance with §20.91 covering a toilet preparation made with S.D.A. Formula No. 39–C and containing an essential oil, the manufacturer shall submit a 0.5-ounce sample of the essential oil used in the article. The appropriate TTB officer may also require the manufacturer to submit a sample of any ingredient which is not adequately described in the formula. (b) For each formula submitted in accordance with §20.91, the appropriate TTB officer may require the manufacturer to submit a 4-ounce sample of the finished article. (c) The appropriate TTB officer may, at any time, require submission of samples of: (1) Any ingredient used in the manufacture of an article, or; (2) Any article. [T.D. ATF– 199, 50 FR 1962, Mar. 6, 1985, as amended by T.D. ATF–435, 66 FR 5474, Jan. 19, 2001] (a) General. Except as provided in paragraph (b) of this section, any change of ingredients or quantities of ingredients listed in an appoved formula shall constitute a different article for which a different approved formula is required by §20.91. (b) Exceptions. A different approved formula is not required for the following— (1) A change from an ingredient identified in the formula by a brand name to the same quantity of a chemically identical ingredient acquired under a different brand name, or (2) A change of an ingredient which is a coloring material. (a) Manufacturers shall submit a statement of process on Form 5150.19, in accordance with paragraph (b) of this section, covering the following activities: (1) If specially denatured spirits are used for laboratory or mechanical purposes, other than use of S.D.A. Formula No. 3–A, 3–C, or 30 for laboratory or mechanical purposes not in the development of a product; (2) If specially denatured spirits are used in a manufacturing process in which none of the specially denatured spirits remains in the finished product; (3) If specially denatured spirits, completely denatured alcohol, or articles are used in a manufacturing process and are to be recovered; or (4) If recovered denatured spirits are to be redenatured. (b) The manufacturer shall submit a separate Form 5150.19 for each activity described in paragraph (a) of this section describing the process completely. (1) If specially denatured spirits are used for laboratory or mechanical purposes, other than use of S.D.A. Formula No. 3–A, 3–C, or 30 for laboratory or mechanical purposes not in the development of a product, the Form 5150.19 shall identify the formula number of specially denatured spirits, a description of the laboratory or mechanical use, and the approximate annual quantity to be used. (2) If the Form 5150.19 is submitted covering activities described in paragraphs (a)(2), (a)(3), or (a)(4) of this section, the Form 5150.19 shall also contain the following information: (i) Flow diagrams shall be submitted with the Form 5150.19 clearly depicting the equipment in its relative operating sequence, with essential connecting pipelines and valves. All major equipment shall be identified as to its use. The direction of flow through the pipelines shall be indicated in the flow diagram. The flow diagram, shall be accompanied by a written description of the flow of materials through the system. (ii) The statement of process shall describe the chemical composition of the recovered spirits. The statement of process shall be accompanied by a statement of the intended use of the recovered spirits. (a) A user may use limited quantities of specially denatured spirits in the manufacture of samples of articles for submission in accordance with §20.92. (b) A user may prepare developmental samples of articles, of limited sizes and quantities, for one-time shipment to prospective customers. The user shall maintain records showing— (1) The types of product samples prepared, (2) The size and number of samples sent, on a one-time basis, to each prospective customer, and (3) The names and addresses of the prospective customers. [T.D. ATF– 199, 50 FR 1962, Mar. 6, 1985, as amended by T.D. ATF–435, 66 FR 5474, Jan. 19, 2001] (a) In addiition to the limitations in this part, and if necessary to protect the revenue or public safety, the appropriate TTB officer, when approving Form 5150.19 may: (1) Specify on the Form 5150.19 the size of containers in which any article may be sold; (2) Specify the maximum quantity that may be sold to any person at one time; or (3) Restrict the sale of an article to a specific class of vendee and for a specific use. (b) Approval by the appropriate TTB officer of formulas, samples, or statements of process means only that they meet the standards of the Alcohol and Tobacco Tax and Trade Bureau. The approval does not require the issuance of a permit under subpart D of this part to withdraw and use specially denatured spirits in those formulas, articles, or statements of process. [T.D. ATF– 199, 50 FR 1962, Mar. 6, 1985, as amended by T.D. ATF–435, 66 FR 5474, Jan. 19, 2001] (a) In preparing Form 5150.19, the manufacturer shall, for each ingredient containing ethyl alcohol, identify— (1) The percent alcohol by volume of the ingredient, if known, and (2) The supplier's name and serial number or approval date of the supplier's approved formula covering the manufacture of the ingredient. (b) In preparing Form 5150.19, manufacturers may— (1) Identify ingredients by generic names rather than brand names, and (2) Identify quantities of ingredients used in ranges rather than in finite quantities. (c) If ranges of ingredients are used, as authorized by paragraph (b)(2) of this section— (1) The lower range shall not be zero for any ingredient, and (2) The range for usage of specially denatured spirits shall not exceed ±5%. All bay rum, alcoholado, or alcoholado-type toilet waters made with specially denatured alcohol shall contain: (a) 1.10 grains of benzyldiethyl (2:6-xylylcarbamoyl methyl) ammonium benzoate (Bitrex (THS–839)) in each gallon of finished product in addition to any of this material used as a denaturant in the specially denatured alcohol, or (b) 32 grains of tartar emetic in each gallon of finished product, or (c) 0.5 avoirdupois ounce of sucrose octaacetate in each gallon of finished product. Each article made with S.D.A. Formula No. 39–C shall contain in each gallon of finished product not less than 2 fluid ounces of perfume material (essential oils, isolates, aromatic chemicals, etc.) satisfactory to the appropriate TTB officer. Commercial strength (40 grain) vinegar made from specially denatured alcohol may contain trace amounts of residual alcohol, not to exceed 0.5 percent of alcohol by volume, in the finished product.
Title 27: Alcohol, Tobacco and Firearms
PART 20—DISTRIBUTION AND USE OF DENATURED ALCOHOL AND RUM
Subpart F—Formulas and Statements of Process
§ 20.91 Formula.
§ 20.92 Samples.
§ 20.93 Changes to formulas.
§ 20.94 Statement of process.
§ 20.95 Developmental samples of articles.
Approval Policies
§ 20.100 General.
§ 20.101 Drafting formulas.
§ 20.102 Bay rum, alcoholado, or alcoholado-type toilet waters.
§ 20.103 Articles made with S.D.A. Formula No. 39–C.
§ 20.104 Residual alcohol in spirit vinegar.
General-Use Formulas
§ 20.111 General.
(a) An approved formula on Form 5150.19 is not required for an article made in accordance with any approved general-use formula prescribed by §§20.112 through 20.119, approved by the appropriate TTB officer as an alternate method, or published as a TTB ruling in the TTB Bulletin.
(b) Any interested party may petition TTB for approval of a new general-use formula by submitting a letter describing the proposed general-use formula to the appropriate TTB officer.
(Approved by the Office of Management and Budget under control number 1512–0336)§ 20.112 Special industrial solvents general-use formula.
(a) A special industrial solvent is any article made with any other ingredients combined with the ingredients in the minimum ratios prescribed in this section. A special industrial solvent shall be made with S.D.A. Formula No. 1, 3A, or 3C containing, for every 100 parts (by volume) of alcohol:
(1) No less than 1 part (by volume) of one or any combination of the following: methyl isobutyl ketone, methyl n-butyl ketone, nitropropane (mixed isomers), or ethylene glycol monoethyl ether, and
(2) No less than 5 parts (by volume) of one or any combination of the following: ethyl acetate (equivalent to 85% ester content, as defined in §21.106 of this chapter), isopropyl alcohol, or methyl alcohol.
(b) Special industrial solvents are intended for use as ingredients or solvents in manufacturing processes and shall not be distributed through retail channels for sale as consumer commodities for personal or household use. When a special industrial solvent is used in the manufacture of an article for sale, sufficient ingredients shall be added to definitely change the composition and character of the special industrial solvent. A special industrial solvent shall not be reprocessed into another solvent intended for sale if the other solvent would contain more than 50% alcohol by volume.
(c) If this article contains more than 4% by weight of methyl alcohol, the label shall have a skull and crossed bones symbol and the following words: “danger,” “poison,” “vapor harmful,” “May be fatal or cause blindness if swallowed,” and “Cannot be made nonpoisonous.”
§ 20.113 Proprietary solvents general-use formula.
(a) A proprietary solvent is any article made with any other ingredients combined with the ingredients in the minimum ratios prescribed in this section. A proprietary solvent shall be made with S.D.A. Formula No. 1 or 3–A containing, for every 100 parts (by volume) of alcohol:
(1) No less than 1 part (by volume) of one or any combination of the following: gasoline, unleaded gasoline, heptane, or rubber hydrocarbon solvent, and
(2) No less than 3 parts (by volume) of one or any combination of the following: ethyl acetate (equivalent to 85% ester content, as defined in §21.106 of this chapter), methyl isobutyl ketone, methyl n-butyl ketone, tert-butyl alcohol, sec-butyl alcohol, nitropropane (mixed isomers), ethylene glycol monoethyl ether, or toluene.
(b) If this article contains more than 4% by weight of methyl alcohol, the label shall have a skull and crossed bones symbol and the following words: “danger,” “poison,” “vapor harmful,” “May be fatal or cause blindness if swallowed,” and “Cannot be made nonpoisonous.”
§ 20.114 Tobacco flavor general-use formula.
Tobacco flavor general-use formula is any finished article made with S.D.A. Formula No. 4 or S.D.R. Formula No. 4 which—
(a) Contains sufficient flavors,
(b) May contain other ingredients, and
(c) Is packaged, labeled, and sold or used as a tobacco flavor only.
§ 20.115 Ink general-use formula.
Ink general-use formula is any finished article made with S.D.A. Formula No. 1, 3–A, 3–C, 13–A, 23–A, 30, 32, or 33 which—
(a) Contains sufficient pigments, dyes, or dyestuffs,
(b) May contain other ingredients, and
(c) Is packaged, labeled and sold or used as an ink.
§ 20.116 Low alcohol general-use formula.
Low alcohol general-use formula is a finished article containing not more than 5% alcohol by volume.
§ 20.117 Reagent alcohol general-use formula.
(a) Reagent alcohol is an article (1) made in accordance with paragraph (b) of this section, (2) packaged and labeled in accordance with paragraph (c) of this section, and (3) distributed in accordance with paragraph (d) of this section.
(b) Reagent alcohol shall be made with 95 parts (by volume) of S.D.A. Formula No. 3–A, and 5 part (by volume) of isopropyl alcohol. Water may be added at the time of manufacture. Reagent alcohol shall not contain any ingredient other than those named in this paragraph.
(c)(1) Except as provided in paragraph (d) of this section, reagent alcohol shall be packaged by the manufacturer in containers not exceeding four liters. Each container shall have affixed to it a label with the following words, as conspicuously as any other words on the labels: “Reagent Alcohol, Specially Denatured Alcohol Formula 3–A–95 parts by vol., and Isopropyl Alcohol—5 parts by vol.”
(2) Because this article contains more than 4% by weight of methyl alcohol, the label shall have a skull and crossbones symbol and the following words: “danger,” “poison,” “vapor harmful,” “May be fatal or cause blindness if swallowed,” and “Cannot be made nonpoisonous
(3) If water is added at the time of manufacture, the label shall reflect the composition of the diluted product. If the addition of water reduces the methyl alcohol concentration to less than 4% by weight, the requirements of paragraph (c)(2) of this section shall not apply.
(4) A back label shall be attached showing the word “ANTIDOTE”, followed by suitable directions for an antidote.
(d)(1) Reagent alcohol may be distributed in containers not exceeding 4 liters exclusively to laboratories or persons who require reagent alcohol for scientific use.
(2) Reagent alcohol may be distributed in bulk containers to proprietors of bona fide laboratory supply houses for packaging and resale, and to any other person who was qualified to receive bulk shipments of reagent alcohol on the effective date of this part. Reagent alcohol may also be distributed in bulk containers to any person who has received approval of a letterhead application containing the following:
(i) The applicant's name, address, and permit number, if any;
(ii) A description of the security measures which will be taken to segregate reagent alcohol from denatured spirits or other alcohol which may be on the same premises;
(iii) A statement that labels required by paragraph (c) of this section will be affixed to containers of reagent alcohol filled by the applicant;
(iv) A statement that the applicant will allow appropriate TTB officers to inspect the applicant's premises; and
(v) A statement that the applicant will comply with the requirements of §20.133.
(Approved by the Office of Management and Budget under control number 1512–0336)[T.D. ATF– 199, 50 FR 1962, Mar. 6, 1985, as amended by T.D. ATF–435, 66 FR 5474, Jan. 19, 2001]
§ 20.118 Rubbing alcohol general-use formula.
(a) Rubbing alcohol is an article made with S.D.A. Formula No. 23–H (1) containing 70% ethyl alcohol by volume (2) made in accordance with one of the two formulas prescribed in paragraph (b) of this section, and (3) labeled in accordance with §20.134(e) of this part.
(b) Either of the following two formulas is approved for manufacturing rubbing alcohol:
Formula AS.D.A. formula 103.3 fl. oz. no. 23-HSucrose octa- 0.5 av.oz. acetate Water q.s. 1 gallon. (If desired, ordorous, medicinal and/or colorative ingredients may be added.) Formula BS.D.A. formula 103.3 fl. oz. no. 23-HBenzyldiethyl (2: 0.88 grains. 6-xylylcarbamoyl methyl) ammonium benzoate (Bitrex (THS-839)) Water q.s. 1 gallon. (If desired, odorous, medicinal and/or colorative ingredients may be added.)
§ 20.119 Toilet preparations containing not less than 10% essential oils general-use formula.This general-use formula shall consist of an article containing not less than 10% essential oils by volume made with a formula of S.D.A. authorized for that article on the following list: |
------------------------------------------------------------------------ Product Article code Formula authorized No.------------------------------------------------------------------------Bath preparations.................... 142 1, 3-A, 3-B, 3-C, 23-A, 30, 36, 38-B, 39-B, 39- C, 40, 40-A, 40-B, 40- C.Colognes............................. 122 38-B, 39, 39-A, 39-B, 39- C, 40, 40-A, 40-B, 40- C.Deodorants (body).................... 114 23-A, 38-B, 39-B, 39-C, 40, 40-A, 40-B, 40-C.Hair and scalp preparations.......... 111 3-B, 23-A, 23-F, 23-H, 37, 38-B, 39, 39-A, 39- B, 39-C, 39-D, 40, 40- A, 40-B, 40-C.Lotions and creams (body, face, and 113 23-A, 23-H, 31-A, 37, 38- hand). B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.Perfume materials (processing)....... 121 38-B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.Perfumes and perfume tinctures....... 121 38-B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.Shampoos............................. 141 1, 3-A, 3-B, 3-C, 23-A, 27-B, 31-A, 36, 38-B, 39-A, 39-B, 40, 40-A, 40-B, 40-C.Soaps, toilet........................ 142 1, 3-A, 3-C, 23-A, 30, 36, 38-B, 39-B, 39-C, 40, 40-A, 40-B, 40-C.Toilet waters........................ 122 38-B, 39, 39-A, 39-B, 39- C, 40, 40-A, 40-B, 40- C.------------------------------------------------------------------------
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[T.D. ATF–199, 50 FR 9162, Mar. 6, 1985; 50 FR 20099, May 14, 1985] Browse Previous | Browse Next
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