Section 172.804 - AspartameThe food additive aspartame may be safely used in food in accordance with good manufacturing practice as a sweetening agent and a flavor enhancer in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use under the following conditions:
(a) Aspartame is the chemical 1-methyl N- L-[ALPHA]-aspartyl-L-phenylalanine (C14H18N2O5).(b) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 73-74, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies 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/cfr/ibr-locations.html.(c)(1) When aspartame is used as a sugar substitute tablet for sweetening hot beverages, including coffee and tea, L-leucine may be used as a lubricant in the manufacture of such tablets at a level not to exceed 3.5 percent of the weight of the tablet.(2) When aspartame is used in baked goods and baking mixes, the amount of the additive is not to exceed 0.5 percent by weight of ready-to-bake products or of finished formulations prior to baking. Generally recognized as safe (GRAS) ingredients or food additives approved for use in baked goods shall be used in combination with aspartame to ensure its functionality as a sweetener in the final baked product. The level of aspartame used in these products is determined by an analytical method entitled "Analytical Method for the Determination of Aspartame and Diketopiperazine in Baked Goods and Baking Mixes," October 8, 1992, which was developed by the Nutrasweet Co. 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 are available for inspection 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, 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.(d) To assure safe use of the additive, in addition to the other information required by the Act: (1) The principal display panel of any intermediate mix of the additive for manufacturing purposes shall bear a statement of the concentration of the additive contained therein;(2) The label of any food containing the additive shall bear, either on the principal display panel or on the information panel, the following statement: PHENYLKETONURICS: CONTAINS PHENYLALANINE
The statement shall appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(3) When the additive is used in a sugar substitute for table use, its label shall bear instructions not to use in cooking or baking.(4) Packages of the dry, free-flowing additive shall prominently display the sweetening equivalence in teaspoons of sugar.(e) If the food containing the additive purports to be or is represented for special dietary uses, it shall be labeled in compliance with part 105 of this chapter.39 FR 27319, July 26, 1974 81 FR 5591, 2/3/2016; 88 FR 17720, 3/24/2023 For FEDERAL REGISTER citations affecting § 172.804 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.