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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2014]
[CITE: 21CFR172.878]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I--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).

(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:

UseLimitation (inclusive of all petroleum hydrocarbons that may be used in combination with white mineral oil)
1. As a release agent, binder, and lubricant in or on capsules and tablets containing concentrates of flavoring, spices, condiments, and nutrients intended for addition to food, excluding confectioneryNot to exceed 0.6% of the capsule or tablet.
2. As a release agent, binder, and lubricant in or on capsules and tablets containing food for special dietary useNot to exceed 0.6% of the capsule or tablet.
3. As a float on fermentation fluids in the manufacture of vinegar and wine to prevent or retard access of air, evaporation, and wild yeast contamination during fermentationIn an amount not to exceed good manufacturing practice.
4. As a defoamer in foodIn accordance with 173.340 of this chapter.
5. In bakery products, as a release agent and lubricantNot to exceed 0.15% of bakery products.
6. In dehydrated fruits and vegetables, as a release agentNot to exceed 0.02% of dehydrated fruits and vegetables.
7. In egg white solids, as a release agentNot to exceed 0.1% of egg white solids.
8. On raw fruits and vegetables, as a protective coatingIn an amount not to exceed good manufacturing practice.
9. In frozen meat, as a component of hot-melt coatingNot to exceed 0.095% of meat.
10. As a protective float on brine used in the curing of picklesIn an amount not to exceed good manufacturing practice.
11. In molding starch used in the manufacture of confectioneryNot to exceed 0.3 percent in the molding starch.
12. As a release agent, binder, and lubricant in the manufacture of yeastNot to exceed 0.15 percent of yeast.
13. As an antidusting agent in sorbic acid for food useNot to exceed 0.25 percent in the sorbic acid.
14. As release agent and as sealing and polishing agent in the manufacture of confectioneryNot to exceed 0.2 percent of confectionery.
15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and sorghumApplied at a level of no more than 0.02 percent by weight of grain.
16. As a dust control agent for riceISO 100 oil viscosity (100 centistokes (cSt) at 100 deg. 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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