21 CFR § 184.1930 - Vitamin A.

§ 184.1930 Vitamin A.


(1)Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol 9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5-yl)-7,9,11,13-nonatetraen-15-ol. It may be nearly odorless or have a mild fishy odor. Vitamin A is extracted from fish liver oils or produced by total synthesis from β-ionone and a propargyl halide.

(2)Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is the acetate ester of retinol. It is prepared by esterifying retinol with acetic acid.

(3)Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is the palmitate ester of retinol. It is prepared by esterifying retinol with palmitic acid.

(b) The ingredient meets the specifications for vitamin A in the Food Chemicals Codex, 3d Ed. (1981), p. 342, 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)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. Vitamin A may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act.

(d)Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[48 FR 51610, Nov. 10, 1983]