[Title 21 CFR 184.1408]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE]
[Subpart B - Listing of Specific Substances Affirmed as GRAS]
[Sec. 184.1408 - Licorice and licorice derivatives.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  3
  1996-04-01
  1996-04-01
  false
  Licorice and licorice derivatives.
  184.1408
  Sec. 184.1408
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
    FOOD FOR HUMAN CONSUMPTION
    DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
    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., Secs. 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 also incorporated by reference. 
Copies of all of these methods are available from the Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (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 Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.

[[Page 482]]

    (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) of               0.05  Flavor enhancer,   
 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) of               1.1   Flavor enhancer,   
 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) of              16.0       Do.            
 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) of               3.1       Do.            
 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]