[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
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
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,
(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 Center
for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., 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
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
(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[deg] and 0[deg];
(3) Refractive index of the volatile oil between 1.527 and 1.538 at
(4) Specific gravity of the volatile oil between 1.036 and 1.060;
(5) Residual solvent free, except those solvents that are GRAS or
within tolerance levels as specified in part 173, subpart C, of this
(c) Clove and its derivatives are used as flavoring agents and
adjuvants as defined in Sec. 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 Sec. 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]
Additives that reference this regulation: