[Title 21 CFR 172.878]
[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 172 - FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION]
[Subpart I - Multipurpose Additives]
[Sec. 172.878 - White mineral oil.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  3
  1996-04-01
  1996-04-01
  false
  
  172.878
  Sec. 172.878
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
    FOOD FOR HUMAN CONSUMPTION
    FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
    Multipurpose Additives
  


Sec. 172.878   White mineral oil.

    White mineral oil may be safely used in food in accordance with the 
following conditions:
    (a) White mineral oil is a mixture of liquid hydrocarbons, 
essentially paraffinic and naphthenic in nature obtained from petroleum. 
It is refined to meet the following specifications:
    (1) It meets the test requirements of the United States Pharmacopeia 
XX (1980) for readily carbonizable substances (page 532).
    (2) It meets the test requirements of U.S.P. XVII for sulfur 
compounds (page 400).

[[Page 99]]

    (3) It meets the specifications prescribed in the ``Journal of the 
Association of Official Analytical Chemists,'' Volume 45, page 66 
(1962), which is incorporated by reference, after correction of the 
ultraviolet absorbance for any absorbance due to added antioxidants. 
Copies of the material incorporated by reference are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (b) White mineral oil may contain any antioxidant permitted in food 
by regulations issued in accordance with section 409 of the Act, in an 
amount not greater than that required to produce its intended effect.
    (c) White mineral oil is used or intended for use as follows:

------------------------------------------------------------------------
                                               Limitation (inclusive of 
                                              all petroleum hydrocarbons
                     Use                          that may be used in   
                                                combination with white  
                                                     mineral oil)       
------------------------------------------------------------------------
1. As a release agent, binder, and lubricant  Not to exceed 0.6% of the 
 in or on capsules and tablets containing      capsule or tablet.       
 concentrates of flavoring, spices,                                     
 condiments, and nutrients intended for                                 
 addition to food, excluding confectionery.                             
2. As a release agent, binder, and lubricant  Not to exceed 0.6% of the 
 in or on capsules and tablets containing      capsule or tablet.       
 food for special dietary use.                                          
3. As a float on fermentation fluids in the   In an amount not to exceed
 manufacture of vinegar and wine to prevent    good manufacturing       
 or retard access of air, evaporation, and     practice.                
 wild yeast contamination during                                        
 fermentation.                                                          
4. As a defoamer in food....................  In accordance with Sec.   
                                               173.340 of this chapter. 
5. In bakery products, as a release agent     Not to exceed 0.15% of    
 and lubricant.                                bakery products.         
6. In dehydrated fruits and vegetables, as a  Not to exceed 0.02% of    
 release agent.                                dehydrated fruits and    
                                               vegetables.              
7. In egg white solids, as a release agent..  Not to exceed 0.1% of egg 
                                               white solids.            
8. On raw fruits and vegetables, as a         In an amount not to exceed
 protective coating.                           good manufacturing       
                                               practice.                
9. In frozen meat, as a component of hot-     Not to exceed 0.095% of   
 melt coating.                                 meat.                    
10. As a protective float on brine used in    In an amount not to exceed
 the curing of pickles.                        good manufacturing       
                                               practice.                
11. In molding starch used in the             Not to exceed 0.3 percent 
 manufacture of confectionery.                 in the molding starch.   
12. As a release agent, binder, and           Not to exceed 0.15 percent
 lubricant in the manufacture of yeast.        of yeast.                
13. As an antidusting agent in sorbic acid    Not to exceed 0.25 percent
 for food use.                                 in the sorbic acid.      
14. As release agent and as sealing and       Not to exceed 0.2 percent 
 polishing agent in the manufacture of         of confectionery.        
 confectionery.                                                         
15. As a dust control agent for wheat, corn,  Applied at a level of no  
 soybean, barley, rice, rye, oats, and         more than 0.02 percent by
 sorghum.                                      weight of grain.         
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 
FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 
19, 1984; 54 FR 24897, June 12, 1989]