The U.S. Food and Drug Administration (FDA) published a final rule amending the food additive regulations to no longer permit the use of three 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. All three of the FCSs are classified as long-chain perfluorinated compounds (at least 8 carbons in length). The three FCSs are:
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;
Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); and
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.
FDA took this action in response to a petition filed on March 16, 2015, by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children’s Environmental Health Network, Environmental Working Group, and Improving Kids’ Environment. The petition cited a 2010 FDA memorandum on the available literature for long-chain PFCs, which concluded that data demonstrating reproductive and developmental toxicity for long-chain perfluorocarboxylic acids and fluorotelomer alcohols was applicable to long-chain PFCs on a general basis.
In removing the clearance for the three FCSs, FDA determined that even through there are no available toxicological studies conducted with the three FCSs that address the endpoints of reproductive or developmental toxicity, new data is available demonstrating the toxicity of substances which are structurally similar to these compounds. The Agency also cited a lack of both adequate migration data to determine dietary exposure to the FCSs from the food-contact use and sufficient data to account for a consumer's systemic exposure resulting from chronic dietary exposure to these FCSs. As a result, FDA concluded that there was no longer a reasonable certainty of no harm for the food contact use of these FCSs.
FDA received comments from industry on the petition noting that the use of the three FCSs as listed in § 176.170 had been abandoned. The rule was published on January 4, 2016, and amends Title 21 Code of Federal Regulation (C.F.R.) § 176.170.