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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 4B4809

Indirect Food Additives: Paper and Paperboard Components

Petitioner: Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Children's Environmental Health Network, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment
Docket number (legacy and/or former docket number(s)): FDA-2015-F-0714
Subject additive and intended use: amending the food additive regulations to no longer provide for the use of three specific perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs.
21 CFR* affected: 176.170; Components of paper and paperboard in contact with aqueous and fatty foods.
Substance(s)*, (CAS Registry® No.):
  • diethanolamine salts of mono- and bis (1 H, 1 H, 2 H, 2 H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4 percent to 54.4 percent as determined on a solids basis; perfluoroalkyl substituted phosphate ester acids, ammonium salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide
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  • pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine, (71608-61-2)
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    Federal Register publication history: Mar 16, 2015; 80 FR 13508; Notice of petition
    Jan 4, 2016; 81 FR 5; Final Rule; Effective date: Jan 4, 2016

     

    *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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