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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 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)
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  • butyl benzyl phthalate, (85-68-7)
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  • butyl decyl phthalate (n-butyl n-decyl phthalate), (89-19-0)
    		•
  • butyl octyl phthalate (n-butyl n-octyl phthalate), (84-78-6)
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  • butyl phthalyl butyl glycolate (butyl carbobutoxymethyl phthalate), (85-70-1)
    		•
  • castor oil phthalate with adipic acid and fumaric acid-diethylene glycol, (68650-73-7)
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  • 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)
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  • didecyl phthalate (di-n-decyl phthalate), (84-77-5)
    		•
  • diethyl phthalate, (84-66-2)
    		•
  • dihexyl phthalate (di-n-hexyl phthalate), (84-75-3)
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  • dihydroabietyl phthalate, (26760-71-4)
    		•
  • diisobutyl phthalate, (84-69-5)
    		•
  • diisooctyl phthalate, (27554-26-3)
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  • dimethyl phthalate (dimethyl orthophthalate), (131-11-3)
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  • 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)
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  • 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; Effective date: 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)
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