FDA Bans Three Packaging Additives

In the final rule Indirect Food Additives: Paper and Paperboard Components issued December 31, FDA amended the food additive regulations to no longer provide for 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 because 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 action is in response to a petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the CenteThe U.S. Food and Drug Administration is revoking its food additive regulation for use of three long-chain perfluorinated compounds (PFCs) in response to a Food Additive Petition filed 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, the Children’s Environmental Working Group, and Improving Kids’ Environment.

Although it appears that manufacturers generally have stopped using these products, FDA’s 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 had authorized the use of several long-chain PFCs as grease-proofing agents before 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, the FDA identified safety concerns through a comprehensive review of the available literature.  The 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.