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:
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.
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.
The citric acid so produced meets the polynuclear aromatic hydrocarbon specifications of § 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/cfr/ibr-locations.html.
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.
Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per billion.
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