(a) Riboflavin-5′-phosphate (sodium) (C17H20N4O9PNa·2H2O, CAS Reg. No 130-40-5) occurs as the dihydrate in yellow to orange-yellow crystals. It is prepared by phosphorylation of riboflavin with chlorophosphoric acid, pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic phosphate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 263, 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 milk products, as defined in §170.3(n)(31) of this chapter, at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formulas 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 51148, Nov. 7, 1983]