FDA is banning 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 revocation came as a response to a petition filed by the Natural Resources Defense Council (NRDC), 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, the Children’s Environmental Working Group, and Improving Kids’ Environment.
According to FDA, the decision reflects new data linking these substances to structurally similar toxic compounds. Because of this, FDA says there is no longer a “reasonable certainty” these substances would cause no harm from their use as FCSs.
“The FDA's ban is an important first step—but just a first step—toward improving the safety of our food supply,” says Erik Olson, director of the NRDC’s health program. “Now it should act on our petition to ban the seven other chemicals we believe—and government agencies such as the toxicology program at the National Institutes of Health have found—cause cancer.”
The three FCSs include:
1. Diethanolamine salts of mono- and bis (1H,1H,2H,2H 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-omegaperfluoro-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.
Although FDA says it appears manufacturers generally have stopped using these products, this action means that any continued use of the PFCs covered by the regulation is no longer permitted. Any use of these substances would need to be authorized through the Food Contact Notification Process, which would need to address FDA’s safety concerns.
FDA authorized the use of several long-chain PFCs as grease proofing agents before these recent safety concerns came to light. These authorizations include the food additive regulation for long-chain PFCs authorized prior to 2000 (which is being revoked by this action), and Food Contact Notifications (FCNs) that became effective after 2000.
In 2010, FDA identified safety concerns through a comprehensive review of the available literature. FDA then worked with industry to stop distribution of the long-chain PFCs most commonly used in food packaging at that time: those subject to FCNs. By October 1, 2011 these manufacturers had voluntarily stopped distributing these long-chain PFCs.
Upon publication of the final rule, the food additive petition process includes a 30 day period to file objections by any person adversely affected. The submission period for objections began Jan. 4. To submit objections by mail, send to FDA at: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.