TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

subpart c - SOLVENTS, LUBRICANTS, RELEASE AGENTS AND RELATED SUBSTANCES

173.280 - Solvent extraction process for citric acid.

A solvent extraction process for recovery of citric acid from conventional Aspergillus niger fermentation liquor may be safely used to produce food-grade citric acid in accordance with the following conditions: (a) The solvent used in the process consists of a mixture of n-octyl alcohol meeting the requirements of 172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of 172.882 of this chapter, and tridodecyl amine.

  (b) The component substances are used solely as a solvent mixture and in a manner that does not result in formation of products not present in conventionally produced citric acid.

  (c) The citric acid so produced meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 8687, which is incorporated by reference (Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.), and the polynuclear aromatic hydrocarbon specifications of 173.165.

  (d) Residues of n-octyl alcohol and synthetic isoparaffinic petroleum hydrocarbons are removed in accordance with good manufacturing practice.

Current good manufacturing practice results in residues not exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm synthetic isoparaffinic petroleum hydrocarbons in citric acid.

  (e) Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per billion.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984]