StacksVerified U.S. regulatory reference

21 CFR §173.165

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The food additive Candida lipolytica may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions:
  1. (a)The food additive is the enzyme system of the organism Candida lipolytica and its concimitant metabolites produced during the fermentation process.
  2. (b)
    1. (1)The nonpathogenic organism is classified as follows:
    2. (2)The taxonomic characteristics of the culture agree in essential with the standard description for Candida lipolytica variety lipolytica listed in “The Yeasts—A Toxonomic Study,” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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.
  3. (c)The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid from purified normal alkanes.
  4. (d)The additive is so used that the citric acid produced conforms to 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. The additive meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in this paragraph: