[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.829 Neotame.
(a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[alpha]-
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), Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD
20740. Copies may be examined at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., 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--
(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-[alpha]-
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 [deg]C
[[alpha]]D: -40.0[deg] to 43.4[deg] calculated on a dry
(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]
Additives that reference this regulation: