Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter BPart 172Subpart I → §172.829


Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart I—Multipurpose Additives


§172.829   Neotame.

(a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).

(b) Neotame meets the following specifications when it is tested according to the methods described or referenced in the document entitled “Specifications and Analytical Methods for Neotame” dated April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount Prospect, IL 60056. The Director of the Office of the Federal Register has approved the incorporation by reference of this material 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), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., rm. 1C-100, College Park, MD 20740, 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.

(1) Assay for neotame, not less than 97.0 percent and not more than 102.0 percent on a dry basis.

(2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine), not more than 1.5 percent.

(3) Other related substances, not more than 2.0 percent.

(4) Lead, not more than 2.0 milligrams per kilogram.

(5) Water, not more than 5.0 percent.

(6) Residue on ignition, not more than 0.2 percent

(7) Specific rotation, determined at 20 °C [α]D: −40.0° to 43.4° calculated on a dry basis.

(c) The food additive neotame may be safely used as a sweetening agent and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice, in an amount not to exceed that reasonably required to accomplish the intended technical effect, in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

(d) When neotame is used as a sugar substitute tablet, L-leucine may be used as a lubricant in the manufacture of tablets at a level not to exceed 3.5 percent of the weight of the tablet.

(e) If the food containing the additive purports to be or is represented to be for special dietary use, it shall be labeled in compliance with part 105 of this chapter.

[67 FR 45310, July 9, 2002, as amended at 81 FR 5591, Feb. 3, 2016]

Need assistance?