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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR178.3530]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.

Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used in the production of nonfood articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The isoparaffinic petroleum hydrocarbons, produced by synthesis from petroleum gases consist of a mixture of liquid hydrocarbons meeting the following specifications:

Boiling point 63deg. -260 deg. C, as determined by ASTM method D86-82, "Standard Method for Distillation of Petroleum Products," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.

Ultraviolet absorbance:

260-319 millimicrons--1.5 maximum.

320-329 millimicrons--0.08 maximum.

330-350 millimicrons--0.05 maximum.

Nonvolatile residue 0.002 gram per 100 milliliters maximum.

Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under "Specifications" on page 66 of the "Journal of the Association of Official Agricultural Chemists," Vol. 45 (February 1962), which is incorporated by reference, disregarding the last sentence of that procedure. For hydrocarbons boiling below 121 deg. C, the nonvolatile residue shall be determined by ASTM method D1353-78, "Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;" for those boiling above 121 deg. C, ASTM procedure D381-80, "Standard Test Method for Existent Gum in Fuels by Jet Evaporation," which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect.

(c) Isoparaffinic petroleum hydrocarbons are used in the production of nonfood articles. The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect, and the residual remaining in the finished article shall be the minimum amount reasonably attainable.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984]

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