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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives

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Petition(s): FAP 5A4810

Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants

Petitioner: Breast Cancer Fund (now the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff
Docket number (legacy and/or former docket number(s)): FDA-2015-F-4317
Subject additive and intended use: partially granting a petition by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.
21 CFR* affected: 172.515; Synthetic flavoring substances and adjuvants.
177.2600; Rubber articles intended for repeated use.
Substance(s)*, (CAS Registry® No.):
  • Benzophenone, (119-61-9)
  • Ethyl acrylate, (140-88-5)
  • Eugenyl methyl ether, (93-15-2)
  • Myrcene, (123-35-3)
  • Pulegone, (89-82-7)
  • Pyridine, (110-86-1)
  • Styrene, (100-42-5)
  • Federal Register publication history: Jan 4, 2016; 81 FR 42; Notice of petition
    Feb 23, 2016; 81 FR 8867; Notification; extension of comment period
    Oct 9, 2018; 83 FR 50490; Final rule; notification of partial denial of petition; Effective date: Oct 9, 2018
    Jan 31, 2022; 85 FR 5555; Final rule; confirmation of effective date.; Effective date: Oct 9, 2018

     

    *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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