CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR173.160]

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

Subpart B - Enzyme Preparations and Microorganisms

Sec. 173.160 Candida guilliermondii.

The food additive Candida guilliermondii may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions:

(a) The food additive is the enzyme system of the viable organism Candida guilliermondii and its concomitant metabolites produced during the fermentation process.

(b)(1) The nonpathogenic and nontoxicogenic organism descending from strain, American Type Culture Collection (ATCC) No. 20474, ¹ is classified as follows:

Class: Deuteromycetes.

Order: Moniliales.

Family: Cryptococcaceae.

Genus: Candida.

Species: guilliermondii.

Variety: guilliermondii.

(2) The toxonomic characteristics of the reference culture strain ATCC No. 20474 agree in the essentials with the standard description for Candida guilliermondii variety guilliermondii 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.

(c)(1) The additive is used or intended for use as a pure culture in the fermentation process for the production of citric acid using an acceptable aqueous carbohydrate substrate.

(2) The organism Candida quilliermondii is made nonviable and is completely removed from the citric acid during the recovery and purification process.

(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.

¹ Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023]