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FDA Releases Final Rule for Paper and Paperboard Components as Indirect Food Additives

February 11, 2016

UNITED STATES - The U.S. Food and Drug Administration (FDA) released a final rule amending the food additive regulations on paper and paperboard components.
The final rule focuses on 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.
The final rule concludes banning the use of the following perfluoro-alkyl ethyl-containing food-contact substances (FCSs):

  • Diethanolamine salts of mono- and bis (1 H, 1 H, 2 H, 2 H perfluoroalkyl) phosphate
  • Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine
  • 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, poly-phosphoric acid and ammonium hydroxide

FDA justifies the decision to ban the three substances due to its conclusion that data for subsets of long-chain PFCs (demonstrating biopersistence and reproductive and developmental toxicity) are applicable to long-chain PFCs on a general basis and that this data raises significant questions as to the safety of the authorized uses of the three FCSs.