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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR184.1978]



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 AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 184.1978 Carnauba wax.

(a) Carnauba wax (CAS Reg. No. 008-015-869) is obtained from the leaves and buds of the Brazilian wax palm Copernicia cerifera Martius. The wax is hard, brittle, sparingly soluble in cold organic solvents and insoluble in water. It is marketed in five grades designated No. 1 through No. 5. Grades No. 4 and No. 5 represent the bulk of the commercial trade volume. These commercial grades consist chiefly of C24 to C32 normal saturated monofunctional fatty acids and normal saturated monofunctional primary alcohols.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution 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 following current good manufacturing practice conditions of use:

(1) The ingredient is used as an anticaking agent as defined 170.3(o)(1) of this chapter; as a formulation aid as defined in 170.3(o)(14) of this chapter; as a lubricant and release agent as defined in 170.3(o)(18) of this chapter; and as a surface-finishing agent as defined in 170.3(o)(30) of this chapter.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in 170.3(n)(1) of this chapter; chewing gun as defined in 170.3(n)(6) of this chapter; confections and frostings as defined in 170.3(n)(9) of this chapter; fresh fruits and fruit juices as defined in 170.3(n)(16) of this chapter; gravies and sauces as defined in 170.3(n)(24) of this chapter; processed fruits and fruit juices as defined in 170.3(n)(35) of this chapter; and soft candy as defined in 170.3(n)(38) of this chapter.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[48 FR 51147, Nov. 7, 1983]

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