21 CFR § 184.1257 - Clove and its derivatives.

§ 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/federal_register/code_of_federal_regulations/ibr_locations.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 −2° and 0°;

(3) Refractive index of the volatile oil between 1.527 and 1.538 at 20 °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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