21 C.F.R. § 172.878   White mineral oil.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart I—Multipurpose Additives

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§ 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).

(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, 5100 Paint Branch Pkwy., College Park, MD 20740, 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.php.

(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 §                                               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.16. As a dust control agent for rice........  ISO 100 oil viscosity (100                                               centistokes (cSt) at                                               100°F) applied at a                                               level of no more than                                               0.08 percent by weight of                                               the rice 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; 63 FR 66014, Dec. 1, 1998]

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