[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: 21CFR184.1408]
[Page 532-533]
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. 184.1408 Licorice and licorice derivatives.
(a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome
and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza.
Licorice extract is that portion of the licorice root that is, after
maceration, extracted by boiling water. The extract can be further
purified by filtration and by treatment with acids and ethyl alcohol.
Licorice extract is sold as a liquid, paste (``block''), or spray-dried
powder.
(2) Ammoniated glycyrrhizin is prepared from the water extract of
licorice root by acid precipitation followed by neutralization with
dilute ammonia. Monoammonium glycyrrhizinate
(C42H61O16NH45H2O,
CAS Reg. No. 1407-03-0) is prepared from ammoniated glycyrrhizin by
solvent extraction and separation techniques.
(b) The ingredients shall meet the following specifications when
analyzed:
(1) Assay. The glycyrrhizin content of each flavoring ingredient
shall be determined by the method in the Official Methods of Analysis of
the Association of Official Analytical Chemists, 13th Ed., Sec. Sec.
19.136-19.140, which is incorporated by reference, or by methods 19.CO1
through 19.CO4 in the Journal of the Association of Official Analytical
Chemists, 65:471-472 (1982), which are
[[Page 533]]
also incorporated by reference. Copies of all of these methods are
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite
500, Gaithersburg, MD 20877, 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.
(2) Ash. Not more than 9.5 percent for licorice, 2.5 percent for
ammoniated glycyrrhizin, and 0.5 percent for monoammonium
glycyrrhizinate on an anhydrous basis as determined by the method in the
Food Chemicals Codex, 3d Ed. (1981), p. 466, 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.
(3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an
anhydrous basis as determined by the method in the Food Chemicals Codex,
3d Ed. (1981), p. 466, which is incorporated by reference.
(4) Heavy metals (as Pb). Not more than 40 parts per million as
determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p.
512, which is incorporated by reference.
(5) Arsenic (As). Not more than 3 parts per million as determined by
the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which is
incorporated by reference.
(c) In accordance with Sec. 184.1(b)(2), these ingredients are used
in food only within the following specific limitations:
------------------------------------------------------------------------
Maximum level in
food (percent
Category of food glycyrrhizin Functional use
content of food)
(as served)
------------------------------------------------------------------------
Baked foods, Sec. 170.3(n)(1) 0.05 Flavor enhancer,
of this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(o)(12)
of this chapter.
Alcoholic beverages, Sec. 0.1 Flavor enhancer,
170.3(n)(2) of this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(o)(12)
of this chapter;
surface-active
agent, Sec.
170.3(o)(29) of
this chapter.
Nonalcoholic beverages, Sec. 0.15 Do.
170.3(n)(3) of this chapter.
Chewing gum, Sec. 170.3(n)(6) 1.1 Flavor enhancer,
of this chapter. Sec. 170.3(o)(11)
of this chapter;
flavoring agent,
Sec. 170.3(n)(12)
of this chapter.
Hard candy, Sec. 170.3(n)(25) 16.0 Do.
of this chapter.
Herbs and seasonings, Sec. 0.15 Do.
170.3(n)(26) of this chapter.
Plant protein products, Sec. 0.15 Do.
170.3(n)(33) of this chapter.
Soft candy, Sec. 170.3(n)(38) 3.1 Do.
of this chapter.
Vitamin or mineral dietary 0.5 Do.
supplements.
All other foods except sugar 0.1 Do.
substitutes, Sec. 170.3(n)(42)
of this chapter. The ingredient
is not permitted to be used as
a nonnutritive sweetener in
sugar substitutes.
------------------------------------------------------------------------
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989]
Additives that reference this regulation: |
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