November 21, 2016
In response to a petition filed on behalf of the 3M Corporation, the U.S. Food and Drug Administration is amending a food additive regulation to no longer authorize the use of two long-chain perfluorinated compounds (PFCs) used in “grease-proof” food packaging. 3M’s petition provided evidence that the use of these compounds, for which 3M stated it was the sole domestic and international manufacturer, has been completely and permanently abandoned by industry in the U.S. market. FDA’s action in amending this regulation is not based on a safety evaluation; rather, it is based on the abandonment of these uses. Although manufacturers have voluntarily stopped using these products, FDA’s action means that any food additive use of the PFCs covered by the regulations is no longer authorized.
The FDA had authorized the use of long-chain PFCs for specific food-contact uses such as coatings on fast-food wrappers, to-go boxes, and pizza boxes before new scientific information brought safety concerns to light. In 2010, the FDA identified safety concerns through a comprehensive review of the available literature. These safety concerns included systemic and developmental toxicity in combination with biopersistence. The FDA then worked with industry to stop distribution of the long-chain PFCs most commonly used in food packaging at that time, which are authorized under food contact notifications. By October 1, 2011 these manufacturers had assured the FDA that they had voluntarily stopped distributing these long-chain PFCs.
In January 2016, the FDA amended a food additive regulation to no longer allow the use of three long-chained PFCs, and is now amending this regulation to no longer authorize the remaining two long-chain PFCs. The FDA’s action means that any food additive use of these substances is no longer allowed. If a company wanted to use these products in the future as food additives, it would have to submit a new application to the agency and demonstrate that its use in food is safe.
The publication of the final rule revoking the food additive regulation includes a 30 day period to file objections by any person adversely affected by this action. Objections can be submitted electronically to http://www.regulations.gov under FDA docket #FDA-2016-F-1153 starting on November 22, 2016.
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
All objections must include the agency name and docket number.
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