(a) Magnesium sulfate (MgSO4.7H2O, CAS Reg. No. 10034-99-8) occurs naturally as the mineral epsomite. It is prepared by neutralization of magnesium oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solution to crystallization.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, 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 Sec. 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 flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; and a processing aid as defined in Sec. 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13560, Apr. 5, 1985] Sec. 184.1443a Malt.
(a) Malt is an enzyme preparation obtained from barley which has been softened by a series of steeping operations and germinated under controlled conditions. It is a brown, sweet, and viscous liquid or a white to tan powder. Its characterizing enzyme activities are [alpha]-amylase (EC 3.2.1.1.) and [beta]-amylase (EC 3.2.1.2).
(b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and 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 Sec. 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 GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze starch or starch-derived polysaccharides.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]