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184.1257 Clove and its derivatives.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1257 Clove and its derivatives.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1257]

[Page 509-510]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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 
caryophyllata

[[Page 510]]

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 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 
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[deg] and 0[deg];
    (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 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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1257


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