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U.S. Department of Health and Human Services

Final Rules and Final Orders: Food Additives and Color Additives

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Petition(s): FDA action

Certain Glycerides; Affirmation of Gras Status

Docket number (legacy and/or former docket number(s)): (78N-0349)
Subject additive and intended use: affirming that the use of mono- and diglycerides, diacetyl tartaric acid esters of mono- and diglycerides, monosodium phosphate derivatives of mono- and diglycerides, glyceryl monostearate, glyceryl monooleate, triacetin (glyceryl triacetate), and tributyrin (glyceryl tributyrate) as direct human food ingredients is generally recognized as safe (GRAS)
21 CFR* affected: 184.1101; Diacetyl tartaric acid esters of mono- and diglycerides
184.1324; Glyceryl monostearate
184.1505; Mono- and diglycerides
184.1323; Glyceryl monooleate
184.1521; Monosodium phosphate derivatives of mono- and diglycerides
184.1901; Triacetin
184.1903; Tributyrin
Substance(s)*, (CAS Registry® No.):
  • diacetyltartaric acid esters of mono- and diglycerides
  • glyceryl monostearate, (31566-31-1)
  • glycerol monopalmitate, (26657-96-5)
  • glyceryl monooleate, (25496-72-4)
  • mono- and diglycerides, (67254-73-3)
  • mono- and diglycerides, monosodium phosphate derivatives
  • triacetin, (102-76-1)
  • tributyrin, (60-01-5)
  • Federal Register publication history: Feb 8, 1983; 48 FR 5751; Proposed rule
    Feb 21, 1989; 54 FR 7401; Final rule; Effective date: Mar 23, 1989
    Mar 31, 1989; 54 FR 13168; Final rule; correction; Effective date: May 1, 1981


     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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