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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 3]
[Revised as of April 1, 2016]
[CITE: 21CFR184.1976]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED ASAFE
S
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1976 Candelilla wax.

(a) Candelilla wax (CAS Reg. No. 8006-44-8) is obtained from the candelilla plant. It is a hard,
yellowish-brown, opaque-to-translucent wax. Candelilla wax is prepared by immersing the plants in
boiling water containing sulfuric acid and skimming off the w
ax that rises to the surface. It is composed of
about 50 percent hydrocarbons with smaller amounts of esters and free acids.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 67, which is
incorporated by reference. Copies are available from the National Academy Press, 2101 Co nstitution Ave.
NW., Washington, DC 20418, or available for inspection 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.
(c) In accordance with 184.1(b)(1), the ingredient is used in food with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the o f llowing current good manufacturing practice
conditions of use:
(1) The ingredient is used as a lubricant as defined in 170.3(o)(18) of this chapt
er and as a surface-
finishing agent as defined in 170.3(o)(30) of this chapter.
(2) The ingredient is used in the o
f llowing foods at levels not to exceed current good manufacturing
practice: in chewing gum as defined in 170.3(n)(6) of this chapter and in hard candy as defined in 170.3(n)
(25) of this chapter.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or
have been waived.

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