FDA Banned Three Perfluoroalkyl Ethyl Containing Chemicals
The U. S. Food & Drug Administration (FDA) has banned three specific perfluoroalkyl ethyl containing chemicals because of toxicity concerns. The chemicals have been used to make paper and paperboard packaging resistant to oil and water for use in contact with aqueous and fatty foods. Affected is 21 CFR Part 176 with §176.170 amended, effective January 4, 2016.
§176.170 [Amended] 2. Amend §176.170 in the table in paragraph (a)(5) by removing the entries for “Diethanolamine salts of mono and bis,” “Pentanoic acid,” and Perfluoroalkyl substituted phosphate ester acids.”
The ban affects certain common food packaging items such as, pizza delivery boxes, microwave popcorn bags, pastry bags, and other fast food containers, as well as other products where water and grease resistance is advantageous.
However, it must be noted here that alternate §176.170 compliant aqueous packaging coatings not using these banned materials are available, and are being used to provide effective oil and water resistant paper and paperboard for use in contact with aqueous and fatty foods.
The three banned chemicals each contain perfluoroalkyl ethyl, placing them in a class of chemicals called aspoly-and perfluoroalkyl substances, or PFOA, PFOS, & “PFOS-related” products capable of degrading into PFOA.
These banned chemicals contain extended perfluorinated alkyd chains ≥ eight carbons (C8) in length with all of the hydrogens replaced by fluorine, making them perfluorinated. These show biopersistence or accumulation of the chemicals that the human body isn’t able to remove completely.
The FDA states “there is no longer a reasonable certainty” of no harm from the food contact use of these substances.
The ban has come about as the result of a petition filed by a large number of health-advocacy groups including the Natural Resources Defense Council, the Center for Food Safety, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, the Breast Cancer Fund, Children’s Environmental Health Network, Environmental Working Group, and Improving Kids’ Environment.
The petition associated the chemicals with birth defects, reproductive health, and cancer. The petition, now acted upon, proposed the amending of §176.170 (21 CFR 176.170) to eliminate the use of three perfluoroalkyl ethyl chemicals used to produce oil and water resistant paper and paperboard for use in contact with aqueous and fatty foods.
Perfluorooctanoic acid (PFOA) is a man-made chemical, also known as C8. It is used in processes to make polytetrafluoroethylene (PTFE) for which Teflon® is a brand, and similar chemicals (fluorotelomers), however it is burned off during the process and is not present in significant amounts in final products. It is also a breakdown product of chemicals that have been used to coat food packaging, stain-resistant clothing, carpeting, and furniture. PFOA is broadly toxic and can remain in the environment and the human body for a long time, and also be present in some foods, dust and drinking water making it a health concern.
PFOS, the perfluorooctane sulphonate anion, or PFOS (C8) related substances capable of degrading into PFOA are a health concern accumulating in humans, wild life, and animals. EPA has summarized, “it thus appears to combine Persistence, Bioaccumulation, and Toxicity properties to an extraordinary degree”. Perfluorooctanesulfonic acid, or perfluorooctane sulfonate, a fluorosurfactant, is recognized as a man-made global pollutant. Because of this their production has been systematically phased out, except for a few specialized uses.
Cork, from its inception, has developed and offered a wide range of aqueous coatings.
A grouping of FDA §176.170 compliant oil & water resistant coatings suitable for coating paper and paperboard substrates for use in contact with aqueous and fatty food conveyance are among these.
These Cork aqueous coatings are free of the FDA banned chemicals, PFOA, PFOS, or PFOS related products capable of degrading into PFOA. Cork oil and water resistant aqueous coatings are commonly in use for fast food carry out packaging, (i.e., French fries, onion rings, burgers, various sandwiches, fried chicken, and Chinese food, etc) Other food products such as bakery, pastries, frozen foods, microwavable and ovenable foods, and roasted chicken, are also being routinely packaged.
Lastly, from the printer/converters perspective, these aqueous coatings can be applied off-line or in-line, giving control to the printer/converter to create a substrate designed to satisfy an individual customers’ requirements.
Any Questions about Food Contact Coatings? Speak with the Coatings Experts at Cork Industries: (800) 394-9550 or Contact Us.