C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE › Subpart B—Listing of Specific Substances Affirmed as GRAS

21 C.F.R. § 184.1866

High fructose corn syrup

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(a) High fructose corn syrup, a sweet, nutritive saccharide mixture containing either approximately 42 or 55 percent fructose, is prepared as a clear aqueous solution from high dextrose-equivalent corn starch hydrolysate by partial enzymatic conversion of glucose (dextrose) to fructose using an insoluble glucose isomerase enzyme preparation described in § 184.1372. The product containing more than 50 percent fructose (dry weight) is prepared through concentration of the fructose portion of the mixture containing less than 50 percent fructose.

(b) The ingredient shall conform to the identity and specifications listed in the monograph entitled “High-Fructose Corn Syrup” in the Food Chemicals Codex, 4th ed. (1996), pp. 191-192, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 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 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/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.

[61 FR 43450, Aug. 23, 1996, as amended at 78 FR 14667, Mar. 7, 2013; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023]
Notes of Decisions
Cited in 3 cases, 2009–2017 · leading case: Holk v. Snapple Beverage Corp., 575 F.3d 329 (3rd Cir. 2009).
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Holk v. Snapple Beverage Corp., 575 F.3d 329 (3rd Cir. 2009). “, 21 C.F.R. § 184.1866 ; .Committee on Food Chemicals Codex, Institute of Medicine, Food Chemical Codex 191-92 (4th ed.”
Am. Beverage Ass'n v. City & Cnty. of San Francisco, 871 F.3d 884 (9th Cir. 2017). “This is contrary to statements by the FDA that added sugars are “generally recognized as safe,” 21 C.F.R. § 184.1866 , and “can be a part of a healthy dietary pattern when not consumed in excess amounts,” 81 Fed.”
Am. Beverage Assn. v. City & Cnty. of San Francisco (9th Cir. 2017). “This is contrary to statements by the FDA that added sugars are “generally recognized as safe,” 21 C.F.R. § 184.1866 , and “can be a part of a healthy dietary pattern when not consumed in excess amounts,” 81 Fed.”
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