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Title 21

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Displaying title 21, up to date as of 6/04/2026. Title 21 was last amended 6/03/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter B —Food for Human Consumption
  4. Part 184 —Direct Food Substances Affirmed as Generally Recognized as Safe
  5. Subpart B —Listing of Specific Substances Affirmed as GRAS
  6. § 184.1890
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eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

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Editorial Note on Part 184

Editorial Note:

Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.

§ 184.1890 α-Tocopherols.

(a) The α-tocopherols that are the subject of this GRAS affirmation regulation are limited to the following:

(1) d -α-Tocopherol (CAS Reg. No. 59-02-9) is the chemical [2R,4′R,8′R]-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl-tridecyl)-6-chromanol. It occurs commercially as a concentrate and is a red, nearly odorless, viscous oil. It is obtained by vacuum steam distillation of edible vegetable oil products.

(2) dl -α-Tocopherol (CAS Reg. No. 10191-41-0) is a mixture of stereoisomers of 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl-tridecyl)-6-chromanol. It is chemically synthesized by condensing racemic isophytol with trimethyl hydroquinone. It is a pale yellow viscous oil at room temperature.

(b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(3), the affirmation of the ingredients as generally recognized as safe is limited to the following conditions of use while the agency concludes the general evaluation of all food uses of tocopherols:

(1) The ingredients are used as inhibitors of nitrosamine formation.

(2) The ingredients are used in pump-cured bacon at levels not to exceed current good manufacturing practice.

[49 FR 13348, Apr. 4, 1984]

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