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Title 27Chapter ISubchapter APart 20 → Subpart F


Title 27: Alcohol, Tobacco Products and Firearms
PART 20—DISTRIBUTION AND USE OF DENATURED ALCOHOL AND RUM


Subpart F—Formulas and Statements of Process


Contents
§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   [Reserved]
§20.104   Residual alcohol in spirit vinegar.

General-Use Formulas

§20.111   General.
§20.112   Special industrial solvents general-use formula.
§20.113   Proprietary solvents general-use formula.
§20.114   Tobacco flavor general-use formula.
§20.115   Ink general-use formula.
§20.116   Low alcohol general-use formula.
§20.117   Reagent alcohol general-use formula.
§20.118   Rubbing alcohol general-use formula.
§20.119   Toilet preparations containing not less than 10% essential oils general-use formula.
§20.120   Multi-purpose general-use formula.
§20.121   Vinegar general-use formula.
§20.122   S.D.A. 39-C general-use formula.
§20.123   Pressurized container general-use formula.
§20.124   Duplicating fluid and ink solvent general-use formula.

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§20.91   Formula.

(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 on the TTB Web site at https://www.ttb.gov.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.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59456, Aug. 30, 2016]

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§20.92   Samples.

(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 9162, Mar. 6, 1985, as amended by T.D. ATF-435, 66 FR 5474, Jan. 19, 2001]

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§20.93   Changes to formulas.

(a) General. Except as provided in paragraph (b) of this section, any change of ingredients or quantities of ingredients listed in an approved 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.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59456, Aug. 30, 2016]

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§20.94   Statement of process.

(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.

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§20.95   Developmental samples of articles.

(a) Samples for submission to TTB. Prior to receiving formula approval on TTB Form 5150.19, a user may use S.D.S. in the manufacture of samples of articles for submission in accordance with §20.92. However, the user may only use the limited quantity of S.D.S. that is necessary to produce the samples.

(b) Samples for shipment to prospective customers. Prior to submitting a formula and statement of process on TTB Form 5150.19, a user may use S.D.S. to prepare developmental samples of articles for shipment to prospective customers. Only one sample of each formulation of the article under development may be sent to each customer. Each sample shall be no larger than necessary for the customer to determine whether the product meets its requirements. The user shall maintain records showing:

(1) The types of product samples prepared;

(2) The size of the samples sent, on a one-time basis, to each prospective customer; and

(3) The names and addresses of the prospective customers.

(c) Formula requirement. Before the user begins to make a quantity greater than specified in this section, formula approval on TTB Form 5150.19 is required.

(Approved by the Office of Management and Budget under control number 1513-0062)

[TD TTB-140, 81 FR 59456, Aug. 30,2016]

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Approval Policies

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§20.100   General.

(a) In addition 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 9162, Mar. 6, 1985, as amended by T.D. ATF-435, 66 FR 5474, Jan. 19, 2001; TD TTB-140 81 FR 59457, Aug. 30, 2016]

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§20.101   Drafting formulas.

(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%.

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§20.102   Bay rum, alcoholado, or alcoholado-type toilet waters.

Unless manufactured exclusively for export under a formula approved by TTB and endorsed “For Export Only,” bay rum, alcoholado, or alcoholado-type toilet waters made with S.D.S. shall contain in each gallon of finished product:

(a) 71 milligrams of denatonium benzoate (also known as benzyldiethyl (2:6-xylylcarbamoyl methyl) ammonium benzoate) in addition to any of this material used as a denaturant in the specially denatured alcohol;

(b) 2 grams of tartar emetic; or

(c) 0.5 avoirdupois ounce of sucrose octaacetate.

[TD TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.103   [Reserved]

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§20.104   Residual alcohol in spirit vinegar.

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.

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General-Use Formulas

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§20.111   General.

(a) Formula approval obtained on TTB Form 5150.19 is not required for an article made in accordance with any approved general-use formula that is specified in §§20.112 through 20.124, that is approved by the appropriate TTB officer as an alternate method, or that is published as a TTB Ruling on the TTB Web site at https://www.ttb.gov. However, a statement of process on TTB Form 5150.19 is still required in any of the circumstances described in §20.94.

(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.

(c) The manufacturer shall ensure that each finished article made pursuant to a general-use formula is unfit for beverage use and is incapable of being reclaimed or diverted to beverage use or internal human use.

(Approved by the Office of Management and Budget under control number 1513-0061)

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§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 S.D.A.:

(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), propylene glycol monomethyl ether, 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 §21.107 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.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.113   Proprietary solvents general-use formula.

A proprietary solvent made pursuant to this formula shall be made with alcohol denatured in accordance with S.D.A. Formula No. 1, 3-A, or 3-C and shall contain, for every 100 parts (by volume) of S.D.A.:

(a) No less than 1 part (by volume) of one or any combination of the following: Gasoline, unleaded gasoline, heptane, or rubber hydrocarbon solvent, and

(b) No less than 3 parts (by volume) of one or any combination of the following: Ethyl acetate (equivalent to 85 percent ester content, as defined in §21.107 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.

[TD TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.114   Tobacco flavor general-use formula.

This tobacco flavor general-use formula authorizes the production of any finished article made with alcohol denatured in accordance with S.D.A. Formula No. 4 or S.D.R. Formula No. 4 which—

(a) Contains flavors sufficient to ensure that the article is unfit for beverage or internal human use,

(b) May contain other ingredients, and

(c) Is packaged, labeled, and sold or used as a tobacco flavor only.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.115   Ink general-use formula.

This ink general-use formula authorizes the production of any finished article made with alcohol denatured in accordance with S.D.A. Formula No. 1, 3-A, 3-C, 13-A, 23-A, 30, 32, 35-A, or 40-B, which—

(a) Contains pigments, dyes, or dyestuffs, which, alone or in combination with solvents or other ingredients, are sufficient to ensure that the article is unfit for beverage use,

(b) May contain other ingredients, and

(c) Is packaged, labeled and sold or used as an ink.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.116   Low alcohol general-use formula.

This low alcohol general-use formula authorizes the production of any finished article containing not more than 5 percent alcohol by weight or volume. Articles containing no alcohol, or whose manufacture involves the recovery of S.D.S., shall be covered by a statement of process on TTB Form 5150.19 submitted under §20.94.

[T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§20.117   Reagent alcohol general-use formula.

(a) General. Reagent alcohol must be made in accordance with paragraph (b) of this section and labeled in accordance with paragraph (c) of this section. Reagent alcohol is—

(1) Treated as an article if distributed and used in accordance with paragraph (d) of this section; or

(2) Treated as S.D.A. if distributed and used in accordance with paragraph (e) of this section.

(b) Formula. Reagent alcohol shall be made with 95 parts (by volume) of S.D.A. 3-A, and 5 parts (by volume) of isopropyl alcohol. Water may be added at the time of manufacture. Reagent alcohol shall not contain any ingredient other than those specified in this paragraph.

(c) Labeling. Each container of reagent alcohol, regardless of size, shall have affixed to it a label containing the following words that are as conspicuous as any other words on the container labels: “Reagent Alcohol: Specially Denatured Alcohol Formula 3-A, 95 parts by vol.; and Isopropyl Alcohol, 5 parts by vol.” If water is added at the time of manufacture, the label shall specify the composition of the product as diluted.

(d) Distribution and use of reagent alcohol as an article. Reagent alcohol is treated as an article if distributed exclusively for the purpose of scientific use. Only the following distributions of reagent alcohol are permitted under this paragraph:

(1) For scientific use. (i) In smaller containers. The manufacturer or repackager of the reagent alcohol, or an S.D.S. dealer, may distribute reagent alcohol in containers not exceeding four liters to laboratories or other persons who require reagent alcohol for scientific use.

(ii) In bulk containers. The manufacturer of the reagent alcohol, or an S.D.S. dealer, may distribute reagent alcohol in containers larger than four liters to a laboratory or other person requiring reagent alcohol for scientific use if that laboratory or person is qualified to receive bulk shipments of reagent alcohol on October 31, 2016 or has received, from the appropriate TTB officer, approval of a letterhead application containing the following information:

(A) The applicant's name, address, and permit number, if any;

(B) An explanation of the applicant's need for bulk quantities of reagent alcohol;

(C) A description of the security measures that will be taken to segregate reagent alcohol from denatured spirits or other alcohol that may be on the same premises; and

(D) A statement that the applicant will allow any appropriate TTB officer to inspect the applicant's premises.

(2) For repackaging. The manufacturer of the reagent alcohol, or an S.D.S. dealer, may distribute reagent alcohol in containers larger than 4 liters to the persons specified in this paragraph. Those persons must repackage the reagent alcohol in containers not exceeding 4 liters, label the smaller packages in accordance with paragraph (c) of this section, and redistribute them in accordance with paragraph (d)(1)(i) of this section. The persons to whom reagent alcohol may be distributed in bulk for repackaging under this paragraph are:

(i) A proprietor of a bona fide laboratory supply house; and

(ii) Any other person who was qualified to receive bulk shipments of reagent alcohol on October 31, 2016, or who has received, from the appropriate TTB officer, approval of a letterhead application containing all of the information required by paragraph (d)(1)(ii)(A) through (D), in addition to the following:

(A) A statement that the applicant will comply with the labeling, packaging, and distribution requirements of paragraphs (c) and (d)(1) of this section; and

(B) A statement that the applicant will comply with the requirements of §20.133.

(3) For redistribution. The manufacturer of the reagent alcohol, or an S.D.S. dealer, may distribute reagent alcohol in containers of any size to an S.D.S. dealer for redistribution in accordance with this section. An S.D.S. dealer distributing or redistributing reagent alcohol may repackage it in containers of any size permitted under this section that is necessary for the conduct of business.

(e) Distribution and use of reagent alcohol in manufacturing. Reagent alcohol is treated as S.D.A. if distributed for the purpose of manufacturing. The following requirements apply to reagent alcohol treated as S.D.A.:

(1) The manufacturer of the reagent alcohol, or an S.D.S. dealer, may distribute reagent alcohol in containers of any size to the persons specified in this paragraph for use in manufacturing.

(2) A person may receive reagent alcohol for use in manufacturing if the person:

(i) Holds a permit as an S.D.A. user;

(ii) Has received formula approval on TTB Form 5150.19 to use reagent alcohol in manufacturing; and

(iii) Treats the reagent alcohol as S.D.A., not an article.

(Approved by the Office of Management and Budget under control number 1513-0061)

[T.D. TTB-140, 81 FR 59457, Aug. 30, 2016]

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§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 A
S.D.A. formula no. 23-H103.3 fl. oz.
Sucrose octa-acetate0.5 av.oz.
Waterq.s. 1 gallon.
(If desired, odorous, medicinal and/or colorative ingredients may be added.)
Formula B
S.D.A. formula no. 23-H103.3 fl. oz.
Benzyldiethyl (2: 6-xylylcarbamoyl methyl) ammonium benzoate (denatonium benzoate) 0.88 grains.
Waterq.s. 1 gallon.
(If desired, odorous, medicinal and/or colorative ingredients may be added.)

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985, as amended by T.D. TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.119   Toilet preparations containing not less than 10% essential oils general-use formula.

This general-use formula describes an article containing not less than 10% essential oils by volume made with a formulation of S.D.A. authorized for that article on the following list:

ArticleProduct code No.Formula authorized
Bath preparations1421, 3-A, 3-B, 3-C, 23-A, 30, 36, 38-B, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Colognes12238-B, 39, 39-A, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Deodorants (body)11423-A, 38-B, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Hair and scalp preparations1113-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 hand)11323-A, 23-H, 31-A, 37, 38-B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Perfume materials (processing)12138-B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Perfumes and perfume tinctures12138-B, 39, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Shampoos1411, 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, toilet1421, 3-A, 3-C, 23-A, 30, 36, 38-B, 39-B, 39-C, 40, 40-A, 40-B, 40-C.
Toilet waters12238-B, 39, 39-A, 39-B, 39-C, 40, 40-A, 40-B, 40-C.

[T.D. ATF-199, 50 FR 9162, Mar. 6, 1985; 50 FR 20099, May 14, 1985; T.D. TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.120   Multi-purpose general-use formula.

TTB authorizes this general-use formula for the manufacture of any article that:

(a) Is made with alcohol denatured in accordance with S.D.A. Formula No. 1, 3-A, 13-A, 19, 23-A, 23-H, 30, 32, 35-A, 36, 37, 38-D, 40, 40-A, and/or 40-B, but no other specially denatured spirits formula;

(b) Conforms to one of the Use Codes specified in part 21 of this chapter authorized for the S.D.A. formulation(s) being used to make the article, other than Use Code 900, as described in part 21 of this chapter; and

(c) Contains sufficient additional ingredients, other than the denaturants prescribed for the applicable S.D.A. formula(s) —

(1) To definitely change the composition and character of the S.D.A. used to make the article, and

(2) To ensure that the finished article is unfit for beverage or other internal human use, and, unless approved under §20.193(b), is incapable of being reclaimed or diverted to beverage use or internal human use; and

(d) Does not conform to any other general-use formula provided in subpart F of this part.

[TD TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.121   Vinegar general-use formula.

The vinegar general-use formula is a formula for making vinegar with alcohol denatured in accordance with S.D.A. Formula No. 18 in a process whereby all of the ethyl alcohol, except residual alcohol within the limit specified in §20.104, loses its identity by being converted to vinegar.

[TD TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.122   S.D.A. 39-C general-use formula.

S.D.A. 39-C general-use formula is a formula for articles made with alcohol denatured in accordance with S.D.A. Formula No. 39-C. Articles made pursuant to this general-use formula shall contain, in each gallon of finished product, not less than 2 fl. oz. of perfume material (essential oils as defined in §21.11, isolates, aromatic chemicals, etc.). Unless approved with the endorsement “for export only,” all articles made with alcohol denatured in accordance with S.D.A. Formula No. 39-C must be made in accordance with this formula.

[TD TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.123   Pressurized container general-use formula.

This general-use formula describes an article, made with alcohol denatured in accordance with S.D.A. Formula No. 40-C, that 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.

[TD TTB-140, 81 FR 59458, Aug. 30, 2016]

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§20.124   Duplicating fluid and ink solvent general-use formula.

(a) Duplicating fluids and ink solvents under this general-use formula shall be made with alcohol denatured in accordance with S.D.A. Formula No. 1, 3-A, 3-C, 13-A, 23-A, 30, 32, 35-A, or 40-B, and

(1) Shall contain, for every 100 parts (by volume) of denatured alcohol:

(i) No less than 1 part (by volume) of n-propyl acetate, and no less than 10 parts (by volume) of one or any combination of isopropyl alcohol or methyl alcohol; or

(ii) No less than 5 parts (by volume) of n-propyl acetate; and

(2) May contain additional ingredients.

(b) Duplicating fluids and ink solvents are intended for use in the printing industry, shall not be sold for general solvent use, and shall not be distributed through retail channels for sale as consumer commodities for personal or household use.

[TD TTB-140, 81 FR 59458, Aug. 30, 2016]

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