(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.