In response to concerns over potential reproductive and developmental toxicity caused by water repellants in paperboard that come into contact with food, the FDA is amending its food additive regulations to prohibit the use of three, specific food-contact substances (FCSs) that contain perfluoroalkyl ethyl. The FDA’s Final rule, which amends 21 C.F.R. Sec. 176.170 and is effective January 4, 2016, comes in response to the agency’s finding that it can no longer be reasonably certain that using the FCSs in paperboard that comes into contact with food will pose no harm (Final rule, 81 FR 5, January 4, 2016).
Petition. In March 2015, 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, Environmental Working Group, and Improving Kids’ Environment filed a food additive petition with the FDA seeking to ban the use of three FCSs that contain perfluoroalkyl ethyl and are used as water repellants for paper and paperboard that came into contact with food.
The petition claimed that the available data demonstrates that the there is no longer a reasonable certainty of no harm from food contact use of the three FCSs, which are long-chain perfluorinated compounds (PFCs).
Food additives. The three FCSs are regulated as additives under Section 409 of the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 348). Section 402(a)(2)(c)(1) of the FDC Act provides that any food that contains any additive that is unsafe shall be deemed to be adulterated (21 U.S.C. § 342(a)(2)(c)(1)). In order for the FDA to grant a petition seeking to ban a food additive based on concerns relating to toxicity, the data must demonstrate to the agency that there is no longer “a reasonable certainty of no harm for the intended use of the substance.”
Data. The petitions argued that a 2010 FDA memorandum demonstrated that the FCSs pose toxicity concerns. The memorandum set forth the agency’s findings that long-chain perfluorocarboxylic acids and fluorotelomer alcohols, which are subsets of long-chain PFCs, demonstrate reproductive and developmental toxicity in animal models. The FDA further determined that, based on the structural similarity and in the absence of contradictory data to prove otherwise, the data demonstrating reproductive and developmental toxicity was generally applicable to long-chain PFCs.
Safety. In response to the petition, the FDA conducted an updated review of the data and confirmed its 2010 findings that the data was applicable to long-chain PFCs on a general basis and that the data raises “significant questions” as to the safety of the FCSs. Additionally, the FDA found that there is a lack of data specific to the three FCSs relating to reproductive and developmental toxicity and for determining dietary exposure from food-contact use. There was also insufficient data to account for consumer exposure resulting from chronic dietary exposure to the FCSs. Therefore, the agency concluded that there is no longer a reasonable certainty of no harm when the FCSs are used in products that come in contact with food.
Companies: Natural Resources Defense Council; Center for Food Safety; Breast Cancer Fund; Center for Environmental Health; Clean Water Action; Center for Science in the Public Interest; Children’s Environmental Health Network; Environmental Working Group; Improving Kids’ Environment
MainStory: TopStory FinalRules FDCActNews AdulterationNews FoodNews FoodSafetyNews FoodStandardsNews
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