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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 2019.

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, 2019]
[CITE: 21CFR184.1257]



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. 184.1257 Clove and its derivatives.

(a) Cloves are the dried unopened flower buds and calyx tubes, harvested before the flowers have opened, of the clove tree Eugenia caryophyllata Thunberg, native to tropical Asia. Their derivatives include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves, CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol , CAS Reg. No. 97-53-0), oleoresins, and natural extractives obtained from clove buds, leaves, and stems.

(b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet the specifications of the "Food Chemicals Codex," 4th ed. (1996), pp. 104-105, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html. As determined by analytical methods in the "Food Chemicals Codex," clove oleoresin or other natural extractives (other than clove oils) meet the "Food Chemicals Codex" specifications for clove (clove bud) oil and the following modifications:

(1) The assay for phenols, as eugenol , by the "Food Chemicals Codex" test, 4th ed. (pp. 104-105), or the volatile oils content by the "Food Chemicals Codex" test, 4th ed. (pp. 104-105) should conform to the representation of the vendor;

(2) Optical rotation of the volatile oil between -2deg. and 0deg. ;

(3) Refractive index of the volatile oil between 1.527 and 1.538 at 20 deg. C;

(4) Specific gravity of the volatile oil between 1.036 and 1.060; and

(5) Residual solvent free, except those solvents that are GRAS or within tolerance levels as specified in part 173, subpart C, of this chapter.

(c) Clove and its derivatives are used as flavoring agents and adjuvants as defined in 170.3(0)(12) of this chapter.

(d) The ingredients are used in food at levels not to exceed good manufacturing practice in accordance with 184.1(b)(1).

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

[44 FR 3964, Jan. 19, 1979, as amended at 47 FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999; 81 FR 5595, Feb. 3, 2016]

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