Code of Federal Regulations Title 21. Food and Drugs § 21.184.1676 Pyridoxine hydrochloride

(a)Pyridoxine hydrochloride (C₈H₁₁NO₃HC1, 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:

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