The US Food and Drug Administration (FDA) published a final rule to amend 21 CFR part 176 of Federal Food Drugs and Cosmetic Act (FFDCA) in the Federal Register on 4 January 2016. It has prohibited the use of three classes of long-chain perfluorinated compounds (PFCs) in food contact materials (FCMs). The rule is effective immediately.

The long-chain perfluorinated compounds (PFCs) are:

1.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;

2.Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); and

3.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 says 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 food-contact substances (FCSs).

The rule amends the food additive Regulation by no longer allowing the substances' use as oil and water repellents in paper and paperboard products.