(a) Pyridoxine hydrochloride (C8H11NO3·HCl, CAS Reg. No. 58-56-0) is the chemical 3-hydroxy-4,5-dihydroxymethy-2-methylpyridine hydrochloride that is prepared by chemical synthesis.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 260, 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 as a nutrient supplement as defined in §170.3(o)(20) of this chapter.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in §170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases as defined in §170.3(n)(3) of this chapter; breakfast cereals as defined in §170.3(n)(4) of this chapter; dairy product analogs as defined in §170.3(n)(10) of this chapter; meat products as defined in §170.3(n)(29) of this chapter; milk products as defined in §170.3(n)(31) of this chapter; plant protein products as defined in §170.3(n)(33) of this chapter; and snack foods as defined in §170.3(n)(37) of this chapter. Pyridoxine hydrochloride 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 51615, Nov. 10, 1983]