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 Oct 9, 2018 ; Jan 31, 2022 85 FR 5555 Final rule; confirmation of 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)