21 C.F.R. § 184.1278

Diacetyl

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(a) Diacetyl (C4H6O2, CAS Reg. No. 431-03-8) is a clear yellow to yellowish green liquid with a strong pungent odor. It is also known as 2,3-butanedione and is chemically synthesized from methyl ethyl ketone. It is miscible in water, glycerin, alcohol, and ether, and in very dilute water solution, it has a typical buttery odor and flavor.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 368, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[48 FR 51907, Nov. 15, 1983]

Notes of Decisions

Cited in 1 case, 2013–2013 · leading case: Daughetee v. Chr. Hansen, Inc., 960 F. Supp. 2d 849 (N.D. Iowa 2013).

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Daughetee v. Chr. Hansen, Inc., 960 F. Supp. 2d 849 (N.D. Iowa 2013). “See 21 C.F.R. § 184.1278 . Accordingly, no statutory exception applies and the Daughetees’ claims are subject to Iowa’s fifteen year statute of repose.”

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