Petition(s): FAP 6B4815

Natural Resources Defense Council, et al.; Denial of Food Additive Petition; Denial Without Prejudice of Food Additive Petition

• Petitioner: Breast Cancer Fund (now Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council
• Docket number (legacy and/or former docket number(s)): FDA-2016-F-1253
• Subject additive and intended use: denying a food additive petition (FAP 6B4815) submitted by Natural Resources Defense Council, et al., requesting that we amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates.
• 21 CFR* affected: No regulations are affected.
• Substance(s)*, (CAS Registry® No.): amyl decyl phthalate (n-amyl n-decyl phthalate), (7493-81-4) ; bis(2-ethylhexyl) phthalate, (117-81-7) ; butyl benzyl phthalate, (85-68-7) ; butyl decyl phthalate (n-butyl n-decyl phthalate), (89-19-0) ; butyl octyl phthalate (n-butyl n-octyl phthalate), (84-78-6) ; butyl phthalyl butyl glycolate (butyl carbobutoxymethyl phthalate), (85-70-1) ; castor oil phthalate with adipic acid and fumaric acid-diethylene glycol, (68650-73-7) ; castor oil, phthalate, hydrogenated ; decyl octyl phthalate (octyl decyl phthalate), (119-07-3) ; di(butoxyethyl) phthalate (bis(2-n-butoxyethyl) phthalate), (117-83-9) ; diallyl phthalate, (131-17-9) ; dibutyl phthalate, (84-74-2) ; dicyclohexyl phthalate, (84-61-7) ; didecyl phthalate, (84-77-5) ; diethyl phthalate, (84-66-2) ; dihexyl phthalate, (84-75-3) ; dihydroabietyl phthalate, (26760-71-4) ; diisobutyl phthalate, (84-69-5) ; diisodecyl phthalate, (26761-40-0) ; diisononyl phthalate, (28553-12-0) ; diisooctyl phthalate, (27554-26-3) ; dimethyl phthalate (dimethyl orthophthalate), (131-11-3) ; dimethylcyclohexyl phthalate, (1322-94-7) ; dioctyl phthalate, (117-84-0) ; diphenyl phthalate, (84-62-8) ; dodecyl phthalate, (21577-80-0) ; ethyl phthalyl ethyl glycolate (ethyl carbethoxymethyl phthalate), (84-72-0) ; methyl phthalyl ethyl glycolate (1,2-benzenedicarboxylic acid, 1-(2- ethoxy-2-oxoethyl) 2-methyl ester), (85-71-2)
• Federal Register publication history: May 16, 2016 81 FR 31877 Notification of petition ; May 20, 2022 87 FR 31066 Notification; denial of petition.

 

*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)