(a) Sodium sesquicarbonate (Na2CO3·NaHCO3·2H2O, CAS Reg. No. 533-96-0) is prepared by: (1) Partial carbonation of soda ash solution followed by crystallization, centrifugation, and drying; (2) double refining of trona ore, a naturally occurring impure sodium sesquicarbonate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 299, 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 pH control agent as defined in § 170.3(o)(23) of this chapter.

(2) The ingredient is used in cream at levels not to exceed current good manufacturing practice. Current good manufacturing practice utilizes a level of the ingredient sufficient to control lactic acid prior to pasteurization and churning of cream into butter.

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

[48 FR 52443, Nov. 18, 1983]