Perfluoroalkyl Ethyl Toxicity Concerns in Food Packaging
In January 2016, the U.S. Food & Drug Administration (FDA) published a final rule that prohibited the use of three specific perfluoroalkyl ethyl containing chemicals because of toxicity concerns. These chemicals had been in use to make paper and paperboard packaging resistant to oil and water for use in direct contact with aqueous and fatty foods.
In November 2016, the FDA published a final rule banning the use of two other perfluorinated containing substances. Again, these had been used as oil and water repellants for paper and paperboard for use in direct contact with aqueous and fatty foods.
Both rulings affected 21 CFR Part 176 with §176.170 amended. With regard to the Jan 4, 2016 ruling.
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 affected 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 are advantageous.
At the time of the ban in Jan 2016, §176.170 compliant aqueous coatings that did not use the banned materials were available. They were being used successfully to provide effective oil and water-resistant paper and paperboard for use in contact with aqueous and fatty foods.
The January 2016 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.
The 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 stated that “there is no longer a reasonable certainty” of no harm from the food contact use of these substances.
The January ban came about as the result of a petition filed by a large number of health advocacy groups. The petition associated the chemicals with birth defects, reproductive health, and cancer. The petition, now added 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.
What is a PFOA or a PFOS?
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 in food packaging topcoats, 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, wildlife, 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.
The November ban resulted from a petition on behalf of the 3M Corp. asking the FDA to amend the food additive regulations to no longer permit the use of two substances whose use had been intentionally and permanently abandoned. 3M had decades ago petitioned the FDA who authorized certain uses of both perfluorinated compounds (PFOS) under 21 CFR 176.170.
With regard to the Nov 17, 2016 ruling.
2. Amend §176.170 in table (a)(5) by removing the entries for “ammonium bis (N-ethyl-2-perfluoroakylsulfonamido ethyl) phosphates” and “perfluoroalkyl acrylate copolymer”.
The two November 2016 banned chemicals are: 1) Ammonium bis (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15% ammonium mono (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95% C8 and the salts have a fluorine content of 50.2% to 52.8% as determined on a solids basis; and 2) perfluoroalkyl acrylate copolymer (CAS 92265-81-1), containing 35 to 40 weight- percent fluorine produced by the copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2-methyl-oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid, 2[[(heptadecafluoro-octyl)sulfony]methyl amino]ethyl ester.
Cork Coatings for Direct and Indirect Food Contact are Free of FDA Banned Chemicals
Cork, from its inception, has developed and offered a wide range of aqueous coatings. Among these is 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 foods.
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 carryout 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 Cork aqueous coatings can be applied off-line or in-line, giving control to create a substrate designed to satisfy a customer’s requirements. Contact Cork today to explore your options.