US FDA bans three perfluorinated FCMs

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 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. These include microwave popcorn bags and pizza boxes.