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.html.
(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.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]