The US Food and Drug Administration (FDA) has prohibited the use of three classes of long-chain perfluorinated compounds (PFCs) in food contact materials (FCMs).
The compounds 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%t to 54.4% as determined on a solids basis;
- pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS 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.
The ban comes in response to a 2014 petition from a coalition of NGOs.
The FDA says it acted on newly available data showing the toxicity of substances with similar structures to the compounds. This demonstrated there is “no longer a reasonable certainty of no harm from the food-contact use.”
The rule, which takes effect immediately, 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.
The NGO petition noted that the US companies using these compounds voluntarily ceased their use in 2011, at the FDA’s urging.
However the Environmental Working Group (EWG) – one of the petitioning organisations – says the rule is “too little, too late”.
“The FDA’s belated action comes more than a decade after EWG and other advocates sounded alarms, and five years after US chemical companies stopped making the chemicals,” it says.
“It does nothing to prevent food processors and packagers from using almost 100 related chemicals that may also be hazardous.”
The EWG advocates that food contact materials be proven safe before being allowed on the market.
The organisations who petitioned the FDA in October 2014 were
- 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;
- the Environmental Working Group; and
- Improving Kids’ Environment.