Petition(s): FAP 8B4820

Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers

• Petitioner: Flexible Vinyl Alliance (FVA)
• Docket number (legacy and/or former docket number(s)): FDA-2018-F-3757
• Subject additive and intended use: amending the food additive regulations to no longer provide for the use of 25 plasticizers (23 ortho-phthalates and 2 related compounds) in various food contact applications because these uses have been abandoned.
• 21 CFR* affected: 175.105 Adhesives. ; 175.300 Resinous and polymeric coatings ; 175.320 Resinous and polymeric coatings for polyolefin films ; 175.380 Xyleneformaldehyde resins condensed with 4,4’-isopropylidenediphenol-epichlorohydrin epoxy resins ; 175.390 Zinc-silicon dioxide matrix coatings ; 176.170 Components of paper and paperboard in contact with aqueous and fatty foods ; 176.180 Components of paper and paperboard in contact with dry food ; 176.300 Slimicides ; 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid ; 177.1200 Cellophane ; 177.1210 Closures with sealing gaskets for food containers ; 177.1400 Hydroxyethyl cellulose film, water-insoluble ; 177.1460 Melamine-formaldehyde resins in molded articles ; 177.1590 Polyester elastomers ; 177.2420 Polyester resins, cross-linked ; 177.2600 Rubber articles intended for repeated use ; 178.3740 Plasticizers in polymeric substances ; 178.3910 Surface lubricants used in the manufacture of metallic articles
• Substance(s)*, (CAS Registry® No.): amyl decyl phthalate (n-amyl n-decyl phthalate), (7493-81-4) ; 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 (octyldecyl phthalate/n-octyl n-decyl phthalate), (119-07-3) ; di(2-ethylhexyl) hexahydrophthalate, (84-71-9) ; di(butoxyethyl) phthalate (bis(2-n-butoxyethyl) phthalate), (117-83-9) ; dibutyl phthalate (di-n-butyl phthalate), (84-74-2) ; didecyl phthalate (di-n-decyl phthalate), (84-77-5) ; diethyl phthalate, (84-66-2) ; dihexyl phthalate (di-n-hexyl phthalate), (84-75-3) ; dihydroabietyl phthalate, (26760-71-4) ; diisobutyl phthalate, (84-69-5) ; diisooctyl phthalate, (27554-26-3) ; dimethyl phthalate (dimethyl orthophthalate), (131-11-3) ; dimethylcyclohexyl phthalate, (1322-94-7) ; dioctyl phthalate (di-n-octyl phthalate), (117-84-0) ; diphenyl phthalate, (84-62-8) ; diphenylguanidine phthalate, (17573-13-6) ; 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: Nov 14, 2018 83 FR 56750 Notification of petition ; May 20, 2022 87 FR 31080 Final Rule May 20, 2022

 

*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)