21 C.F.R. § 172.833

Current through September 30, 2024
Section 172.833 - Sucrose acetate isobutyrate (SAIB)

Sucrose acetate isobutyrate may be safely used in foods in accordance with the following prescribed conditions:

(a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB, is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).
(b) SAIB, a pale, straw-colored liquid, meets the following specifications:
(1) Assay: Not less than 98.8 percent and not more than 101.9 percent, based on the following formula:

Assay = ((SV 0.10586) ÷ 56.1) * 100

Where SV = Saponification value

(2) Saponification value: 524-540 determined using 1 gram of sample by the "Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials," in the "Compendium of Food Additive Specifications, Addendum 4, Food and Agriculture Organization of the United Nations (FAO), Food and Nutrition Paper 5, Revision 2" (1991), pp. 203 and 204, which is incorporated by reference, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or 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.
(3) Acid value: Not to exceed 0.20 determined using 50 grams of sample by the "Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials," in the "Compendium of Food Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2," p. 189 (1991), which is incorporated by reference; see paragraph (b)(2) of this section for availability of the incorporation by reference.
(4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the "Atomic Absorption Spectrophotometric Graphite Furnace Method, Method I," in the "Food Chemicals Codex," 4th ed. (1996), pp. 763 and 764, with an attached modification to the sample digestion section in Appendix III.B (July 1996), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or 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.
(5) Triacetin: Not to exceed 0.10 percent determined by gas chromatography as described in the "Guide to Specifications for General Notices, General Analytical Techniques, Identification Tests, Test Solutions, and Other Reference Materials," in the "Compendium of Food Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2," (1991), pp. 13-26, which is incorporated by reference; see paragraph (b)(2) of this section for availability of the incorporation by reference.
(c) The food additive is used as a stabilizer (as defined in § 170.3(o)(28) of this chapter) of emulsions of flavoring oils in nonalcoholic beverages.
(d) The total SAIB content of a beverage containing the additive does not exceed 300 milligrams/kilogram of the finished beverage.

21 C.F.R. §172.833

64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999, as amended at 78 FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17721, Mar. 24, 2023
81 FR 5591, 2/3/2016; 88 FR 17721, 3/24/2023