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172.829 Neotame.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.829 Neotame.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.829]

[Page 86]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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--
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-[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 
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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 829


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